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From part of the guide:. Bro, can i ask? Atlantica Indonesia now hv caps If someone is Lvthey should get a higher quality box, but that is all dependent on if the developers of AO Indonesia actually made that change.

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Induction of ovulation and pregnancy in the anovulatory, infertile woman in whom the cause of anovulation is secondary and not due to primary ovarian failure and who has been appropriately pretreated with human menotropins. See prescribing information for menotropins for dosage and administration for that drug product. A dosage of 10, USP units is recommended in the labeling for menotropins.

Two-vial package: Withdraw sterile air from lyophilized vial and inject into diluent vial. Remove 1—10 mL from diluent and add to lyophilized vial; agitate gently until powder is completely dissolved in solution. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Two-vial package containing:. When reconstituted, each 10 mL vial contains:.

Reconstituted solution is stable for 60 days when refrigerated. All rights reserved. DailyMed will deliver notification of updates and additions to Drug Label information currently shown on this site through its RSS feed. DailyMed will deliver this notification to your desktop, Web browser, or e-mail depending on the RSS Reader you select to use.

Due to inconsistencies between the drug labels on DailyMed and the pill images provided by RxImage , we no longer display the RxImage pill images associated with drug labels. We anticipate reposting the images once we are able identify and filter out images that do not match the information provided in the drug labels.

View Package Photos. Drug Label Info. NDC National Drug Code - Each drug product is assigned this unique number which can be found on the drug's outer packaging. In general, HCG is thought to induce testicular descent in situations when descent would have occurred at puberty. HCG thus may help predict whether or not orchiopexy will be needed in the future. Although, in some cases, descent following HCG administration is permanent, in most cases, the response is temporary.

Selected cases of hypogonadotropic hypogonadism hypogonadism secondary to a pituitary deficiency in males. Induction of ovulation and pregnancy in the anovulatory, infertile woman in whom the cause of anovulation is secondary and not due to primary ovarian failure, and who has been appropriately pretreated with human menotropins.

Anaphylaxis has been reported with urinary-derived HCG products. General Since androgens may cause fluid retention, HCG should be used with caution in patients with cardiac or renal disease, epilepsy, migraine, or asthma. Pediatric Use Induction of androgen secretion by HCG may induce precocious puberty in pediatric patients treated for cryptorchidism.

Hypersensitivity reactions, both localized and systemic in nature, have been reported. The following regimens have been advocated by various authorities: Prepubertal cryptorchidism not due to anatomical obstruction. If this course of treatment is not successful, another series is begun 1 month later, giving USP units per injection. Directions for Reconstitution Two-vial package: Withdraw sterile air from lyophilized vial and inject into diluent vial. Two-vial package containing: mL lyophilized multiple dose vial containing: 10, USP units chorionic gonadotropin per vial, NDC When reconstituted, each 10 mL vial contains: Chorionic gonadotropin 10, USP units Monobasic sodium phosphate 5 mg Dibasic sodium phosphate 4.

Version Files Jun 5, 14 current download Dec 11, 12 download Nov 30, 11 download Jan 26, 10 download Dec 20, 9 download Apr 22, 8 download Aug 22, 7 download Apr 28, 6 download Sep 14, 4 download Aug 26, 3 download Jan 11, 1 download. Merck is not associated with any individuals or organizations that may charge patients a fee to assist them in completing enrollment forms for our programs.

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ORGANON SCHERING PLOUGH SWORDS

Due to rapid redistribution [see Clinical Pharmacology The rate of administration should be adjusted according to the patient's twitch response as monitored with the use of a peripheral nerve stimulator. Inhalation anesthetics, particularly enflurane and isoflurane, may enhance the neuromuscular blocking action of nondepolarizing muscle relaxants.

Spontaneous recovery and reversal of neuromuscular blockade following discontinuation of ZEMURON infusion may be expected to proceed at rates comparable to that following comparable total doses administered by repetitive bolus injections [see Clinical Pharmacology These infusion solutions should be used within 24 hours of mixing. Unused portions of infusion solutions should be discarded.

When halothane is used, a 0. The time to maximum block for an intubating dose was shortest in infants 28 days up to 3 months and longest in neonates birth to less than 28 days. The duration of clinical relaxation following an intubating dose is shortest in children greater than 2 years up to 11 years and longest in infants.

When halothane is used for general anesthesia, patients ranging from 3 months old through adolescence can be administered ZEMURON maintenance doses of 0. Additional information for administration to pediatric patients of all age groups is presented elsewhere in the label [see Clinical Pharmacology Spontaneous recovery and reversal of neuromuscular blockade following discontinuation of ZEMURON infusion may be expected to proceed at rates comparable to that following similar total exposure to single bolus doses [see Clinical Pharmacology No differences in duration of neuromuscular blockade following maintenance doses of ZEMURON were observed between these subjects and younger subjects, but greater sensitivity of some older individuals cannot be ruled out [see Clinical Pharmacology Patients with Renal or Hepatic Impairment: No differences from patients with normal hepatic and kidney function were observed for onset time at a dose of 0.

When compared to patients with normal renal and hepatic function, the mean clinical duration is similar in patients with end-stage renal disease undergoing renal transplant, and is about 1. Patients with renal failure may have a greater variation in duration of effect [see Use in Specific Populations 8. An analysis across all US controlled clinical studies indicates that the pharmacodynamics of ZEMURON are not different between obese and nonobese patients when dosed based upon their actual body weight.

Patients with Reduced Plasma Cholinesterase Activity: Rocuronium metabolism does not depend on plasma cholinesterase so dosing adjustments are not needed in patients with reduced plasma cholinesterase activity. Patients with Prolonged Circulation Time: Because higher doses of ZEMURON produce a longer duration of action, the initial dosage should usually not be increased in these patients to reduce onset time; instead, in these situations, when feasible, more time should be allowed for the drug to achieve onset of effect [see Warnings and Precautions 5.

Potentiation is minimal when administration of the recommended dose of ZEMURON occurs prior to the administration of these potent inhalation agents. The median clinical duration of a dose of 0. Infusion solutions should be used within 24 hours of mixing. Visual Inspection: Parenteral drug products should be inspected visually for particulate matter and clarity prior to administration whenever solution and container permit.

Do not use solution if particulate matter is present. NOTE: Seven different "day label strips" are provided to accommodate the selected start regimen. The patient should place the self-adhesive "day label strip" that corresponds to her starting day on the blister card above the first row of tablets. Using a Sunday start, tablets are taken daily without interruption as follows: The first light yellow tablet should be taken on the first Sunday after menstruation begins if menstruation begins on Sunday, the first light yellow tablet is taken on that day.

Tablets are then taken sequentially following the arrows marked on the blister card. One light yellow tablet is taken daily for 7 days, followed by 1 orange tablet daily for 7 days, 1 red tablet daily for 7 days, and then 1 green inactive tablet daily for 7 days.

For all subsequent cycles, the patient then begins a new tablet regimen on the next day Sunday after taking the last green inactive tablet. If a patient misses 1 active tablet in Weeks 1, 2, or 3, she should take the missed tablet as soon as she remembers.

If the patient misses 2 consecutive active tablets in Week 1 or Week 2, the patient should take 2 tablets the day she remembers and 2 tablets the next day; thereafter, the patient should resume taking 1 tablet daily until she finishes the cycle pack. The patient should be instructed to use a back-up method of birth control such as condoms or spermicide if she has intercourse in the 7 days after she restarts her pills.

If the patient misses 2 consecutive red active tablets in the third week or misses 3 or more active tablets in a row at any time during the cycle, the patient should keep taking 1 active tablet daily until the next Sunday. On Sunday the patient should throw out the rest of that cycle pack and start a new cycle pack that same day.

The patient should be instructed to use a back-up method of birth control if she has intercourse in the 7 days after restarting her pills. Complete instructions to facilitate patient counseling on proper pill usage can be found in Detailed or Brief Patient Labeling "How to Take the Pill" section. Counting the first day of menstruation as "Day 1", the first light yellow tablet should be taken on the first day of menstrual bleeding.

Tablets are then taken sequentially without interruption as follows: One light yellow tablet daily for 7 days, then 1 orange tablet daily for 7 days, followed by 1 red tablet daily for 7 days and then 1 green inactive tablet daily for 7 days. For all subsequent cycles, the patient then begins a new tablet regimen on the next day after taking the last green inactive tablet.

If the patient misses 2 consecutive red tablets in the third week or misses 3 or more active tablets in a row at any time during the cycle, the patient should throw out the rest of that cycle pack and start a new cycle pack that same day. Breakthrough bleeding, spotting, and amenorrhea are frequent reasons for patients discontinuing oral contraceptives. In breakthrough bleeding, as in all cases of irregular bleeding from the vagina, non-functional causes should be considered.

In undiagnosed persistent or recurrent abnormal bleeding from the vagina, adequate diagnostic measures are indicated to rule out pregnancy or malignancy. If both pregnancy and pathology have been excluded, time or a change to another preparation may solve the problem. Changing to an oral contraceptive with a higher estrogen content, while potentially useful in minimizing menstrual irregularity, should be done only if necessary since this may increase the risk of thromboembolic disease.

Using a Sunday start, tablets are taken daily without interruption as follows: The first white tablet should be taken on the first Sunday after menstruation begins if menstruation begins on Sunday, the first white tablet is taken on that day. One white tablet is taken daily for 21 days, followed by 1 green inactive tablet daily for 7 days. If a patient misses 1 white active tablet in Weeks 1, 2, or 3, she should take the missed tablet as soon as she remembers.

If the patient misses 2 consecutive white tablets in Week 1 or Week 2, the patient should take 2 tablets the day she remembers and 2 tablets the next day; thereafter, the patient should resume taking 1 tablet daily until she finishes the cycle pack. If the patient misses 2 consecutive white tablets in the third week or misses 3 or more white tablets in a row at any time during the cycle, the patient should keep taking 1 white tablet daily until the next Sunday.

Counting the first day of menstruation as "Day 1", the first white tablet should be taken on the first day of menstrual bleeding. Tablets are then taken sequentially without interruption as follows: One white tablet daily for 21 days, then one green inactive tablet daily for 7 days. If a patient misses 1 white tablet, she should take the missed tablet as soon as she remembers.

If the patient misses 2 consecutive white tablets in the third week or misses 3 or more white tablets in a row at any time during the cycle, the patient should throw out the rest of that cycle pack and start a new cycle pack that same day. Do not mix Follistim AQ with any other medicines in the same vial or in the same syringe. It is recommended that Follistim AQ administration be stopped if the ovarian monitoring suggests an increased risk of OHSS or abdominal pain occurs. Most OHSS occurs after treatment has been discontinued and reaches its maximum at about seven to ten days post-ovulation.

The concomitant therapy should be continued for at least 3 to 4 months before any improvement in spermatogenesis can be expected. If a man has not responded after this period, the combination therapy may be continued. Treatment response has been noted at up to 12 months. The pharmacist or individual responsible for mixing the agent should wear gloves, and take precautions to avoid contact of BCG with broken skin. Persons administering vaccines should take necessary precautions to minimize risk for spreading disease.

Hands should be washed before each new patient is seen. Syringes and needles used for applications must be sterile and preferably disposable to minimize the risk of contamination. A separate needle and syringe should be used for each application. Disposable needles and the multiple puncture device should be discarded as biohazardous waste in labeled, puncture-proof containers to prevent inadvertent needlestick injury or reuse.

Reconstituted vaccine should be kept refrigerated, protected from exposure to direct sunlight, and used within 2 hours. Freezing of the reconstituted product is not recommended. Reconstitution should result in a uniform suspension of the bacilli. BCG vaccination is reserved for persons who have a reaction of less than 5mm induration after skin testing with 5 TU of PPD tuberculin. The preferred method of skin testing is the Mantoux tuberculin skin-test using 0.

The vaccine is to be administered after fully explaining the risks and benefits to the vaccinee, parent, or guardian. BCG vaccination should not be given to individuals previously infected with M. The vaccine is administered percutaneously utilizing a sterile multiple puncture device. After the vaccine is prepared, the skin site is cleansed with an alcohol or acetone sponge and allowed to dry thoroughly.

Tuberculin reactivity resulting from BCG vaccination should be documented. A vaccinated person should be tuberculin skin tested 2—3 months after BCG administration, and the test results, in millimeters of induration, should be recorded in the person's medical record. Administer the vaccine in the deltoid region. If a vaccinated infant remains tuberculin negative to 5 TU on skin testing, and if indications for vaccination persist, the infant should receive a full dose after 1 year of age.

Toggle navigation. Already have an account? Get email alerts and dashboard notifications when your medications are recalled by the FDA. Enter Password Confirm Password. Create Account. Organon Usa Inc. Manufacturer Details There are currently no manufacturer details available. Drugs Pregnyl. The following regimens have been advocated by various authorities: Prepubertal cryptorchidism not due to anatomical obstruction. If this course of treatment is not successful, another series is begun 1 month later, giving USP units per injection.

Selected cases of hypogonadotropic hypogonadism in males. Directions for Reconstitution Two-vial package: Withdraw sterile air from lyophilized vial and inject into diluent vial. More Info. Changing From a CHC: The woman may switch from her previous CHC on any day, but at the latest on the day following the usual hormone-free interval, if she has been using her hormonal method consistently and correctly, or if it is reasonably certain that she is not pregnant.

Use after Abortion or Miscarriage The woman may start using NuvaRing within the first five days following a complete first trimester abortion or miscarriage, and she does not need to use an additional method of contraception. Inadvertent Removal or Expulsion NuvaRing can be accidentally expelled, for example, while removing a tampon, during intercourse, or with straining during a bowel movement.

If NuvaRing is out of the vagina for more than three continuous hours: During Weeks 1 and 2: Contraceptive efficacy may be reduced. One of the following two options should be chosen: Insert a new ring immediately. Inserting a new ring will start the next three-week use period. The woman may not experience a withdrawal bleed from her previous cycle.

However, breakthrough spotting or bleeding may occur. Insert a new ring no later than seven days from the time the previous ring was removed or expelled, during which time she may have a withdrawal bleed. Prolonged Ring-Free Interval If the ring-free interval has been extended beyond one week, consider the possibility of pregnancy, and an additional method of contraception, such as male condoms with spermicide, MUST be used until NuvaRing has been used continuously for seven days.

Ring Breakage There have been reported cases of NuvaRing disconnecting at the weld joint. If the woman has adhered to the prescribed regimen and misses two consecutive periods, rule out pregnancy. If the woman has retained one NuvaRing for longer than four weeks, rule out pregnancy. Do not inject subcutaneously or intravenously. A starting daily dose of 50 international units of Follistim AQ Cartridge is administered [see Dosage and Administration 2. Subsequent dosage adjustments are made at weekly intervals based upon ovarian response.

The following should be considered when planning the woman's individualized dose: Appropriate Follistim AQ Cartridge dose adjustment s should be used to prevent multiple follicular growth and cycle cancellation. The maximum, individualized, daily dose of Follistim AQ Cartridge is international units. When pre-ovulatory conditions are reached, 5, to 10, international units of hCG are used to induce final oocyte maturation and ovulation. The woman and her partner should be encouraged to have intercourse daily, beginning on the day prior to the administration of hCG and until ovulation becomes apparent [see Warnings and Precautions 5.

During treatment with Follistim AQ Cartridge and during a two-week post-treatment period, the woman should be assessed at least every other day for signs of excessive ovarian stimulation. It is recommended that Follistim AQ Cartridge administration be stopped if the ovarian monitoring suggests an increased risk of OHSS or abdominal pain occurs.

A starting dose of international units actual cartridge doses of Follistim AQ Cartridge is administered [see Dosage and Administration 2. Subsequent to the first 7 days of treatment, the dose can be adjusted down or up based upon the woman's ovarian response as determined by ultrasound evaluation of follicular growth and serum estradiol levels.

Dosage reduction in high responders can be considered from the 6th day of treatment onward according to individual response. The following should be considered when planning the woman's individualized dose: For most normal responding women, the daily starting dose can be continued until pre-ovulatory conditions are achieved seven to twelve days.

For low or poor responding women, the daily dose should be increased according to the ovarian response. When a sufficient number of follicles of adequate size are present, dosing of Follistim AQ Cartridge is stopped and final maturation of the oocytes is induced by administering hCG at a dose of 5, to 10, international units.

Oocyte egg retrieval should be performed 34 to 36 hours following the administration of hCG. An initial dosage of 1, international units of hCG should be administered at twice weekly intervals to normalize serum testosterone levels.

If serum testosterone levels have not normalized after 8 weeks of hCG treatment, the hCG dose can be increased to 3, international units twice weekly [see Clinical Studies After normal serum testosterone levels have been reached, Follistim AQ Cartridge should be administered by subcutaneous injection concomitantly with hCG treatment. Follistim is given at a dosage of international units per week, as either international units twice weekly or international units three times per week, in combination with the same hCG dose used to normalize testosterone levels.

Based on delivery of a higher dose of follitropin beta with the Follistim AQ Cartridge and pen injector [see Dosage and Administration 2. Ganirelix Acetate. Wash hands thoroughly with soap and water. The injection site should be swabbed with a disinfectant to remove any surface bacteria. Clean about two inches around the point where the needle will be inserted and let the disinfectant dry for at least one minute before proceeding.

With syringe held upward, remove needle cover. Pinch up a large area of skin between the finger and thumb. Vary the injection site a little with each injection. When the needle is correctly positioned, it will be difficult to draw back on the plunger. If any blood is drawn into the syringe, the needle tip has penetrated a vein or artery. If this happens, withdraw the needle slightly and reposition the needle without removing it from the skin. Alternatively, remove the needle and use a new, sterile, prefilled syringe.

Cover the injection site with a swab containing disinfectant and apply pressure; the site should stop bleeding within one or two minutes. Once the needle is correctly placed, depress the plunger slowly and steadily, so the solution is correctly injected and the skin is not damaged. Pull the syringe out quickly and apply pressure to the site with a swab containing disinfectant. Use the sterile, prefilled syringe only once and dispose of it properly. Progestin-only contraceptives: There are several types of progestin-only methods.

The woman should be advised to use a barrier method until 7 days after insertion. The woman has had a medical history and physical examination, including a gynecologic examination, performed. The woman has received a copy of the Patient Labeling included in packaging. The woman has reviewed and completed a consent form to be maintained with the woman's chart. The woman does not have allergies to the antiseptic and anesthetic to be used during insertion. The following equipment is needed for the implant insertion: An examination table for the woman to lie on Sterile surgical drapes, sterile gloves, antiseptic solution, sterile marker optional Local anesthetic, needles, and syringe Sterile gauze, adhesive bandage, pressure bandage Insertion Procedure Step 1.

Figure 1 Step 2. Figure 2 Step 4. Clean the insertion site with an antiseptic solution. Figure 3 Step 8. Figure 4 Step 9. Figure 5 Step Figure 6 Step Figure 7 Step Figure 8 Step If the rod is not palpable: If you cannot feel the implant or are in doubt of its presence, the implant may not have been inserted or it may have been inserted deeply: Check the applicator.

The needle should be fully retracted and only the purple tip of the obturator should be visible. Use other methods to confirm the presence of the implant. Given the radiopaque nature of the implant, suitable methods for localization are two-dimensional X-ray and X-ray computerized tomography CT scan.

If these methods fail, call for information on the procedure for measuring etonogestrel blood levels. Remove the implant under aseptic conditions. The following equipment is needed for removal of the implant: An examination table for the woman to lie on Sterile surgical drapes, sterile gloves, antiseptic solution, sterile marker optional Local anesthetic, needles, and syringe Sterile scalpel, forceps straight and curved mosquito Skin closure, sterile gauze, adhesive bandage and pressure bandages Removal Procedure Step 1.

Figure 9 Step 2. Figure 10 Step 3. Figure 11 Step 4. Figure 12 Step 5. Figure 13 Figure 14 Step 6. Figure 15 Figure 16 Step 7. Figure 17 Step 8. Localization and Removal of a Non-Palpable Implant There have been occasional reports of migration of the implant; usually this involves minor movement relative to the original position, but may lead to the implant not being palpable at the location in which it was placed.

Timing of insertion depends on the woman's recent contraceptive history, as follows: No preceding hormonal contraceptive use in the past month IMPLANON should be inserted between Day 1 first day of menstrual bleeding and Day 5 of the menstrual cycle, even if the woman is still bleeding. At the latest, IMPLANON should be inserted on the day following the usual tablet-free, ring-free, patch-free or placebo tablet interval of the previous combined hormonal contraceptive.

The following equipment is needed for the implant insertion: An examination table for the woman to lie on Sterile surgical drapes, sterile gloves, antiseptic solution, sterile marker optional Local anesthetic, needles, and syringe Sterile gauze, adhesive bandage, pressure bandage An applicator and its parts are shown below Figures 1a and 1b.

Insertion Procedure Step 1. Have the woman lie on her back on the examination table with her non-dominant arm flexed at the elbow and externally rotated so that her wrist is parallel to her ear or her hand is positioned next to her head Figure 2. Figure 2 Step 2. Make two marks with a sterile marker: first, mark the spot where the etonogestrel implant will be inserted, and second, mark a spot a few centimeters proximal to the first mark Figure 3.

Figure 3 Step 4. Then remove the needle shield, while holding the applicator upright. Therefore, after you remove the needle shield, keep the applicator in the upright position until the moment of insertion Step Figure 4 Step Lift the skin up with the tip of the needle, but keep the needle in the subdermal connective tissue Figure 6.

While "tenting" lifting the skin, gently insert the needle to its full length. Keep the needle parallel to the surface of the skin during insertion Figure 7. Break the seal of the applicator by pressing the obturator support Figure 8. Figure 9 Step While holding the obturator fixed in place on the arm, fully retract the cannula Figure Note: This procedure is opposite from an injection.

By holding the obturator fixed in place on the arm and fully retracting the cannula, the implant will be left in its correct subdermal position. Do not simultaneously retract the obturator and cannula from the patient's arm. Figure 10 In this figure, the right hand is holding the obturator in place while the left hand is retracting the cannula. Confirm that the implant has been inserted by checking the tip of the needle for the absence of the implant.

After insertion of the implant, the grooved tip of the obturator will be visible inside the needle Figure Figure 11 Step Figure 12 Step If the rod is not palpable: If you cannot feel the implant or are in doubt of its presence, the implant may not have been inserted or it may have been inserted deeply: Check the tip of the needle for the absence of the implant.

After insertion of the implant, the grooved tip of the obturator will be visible inside the needle. Suitable methods to locate are: ultrasound US with a high-frequency linear array transducer 10 MHz or greater or magnetic resonance imaging MRI. Before removal of the implant, the healthcare provider should confirm that: The woman does not have allergies to the antiseptic or anesthetic to be used.

Locate the implant by palpation and mark the distal end end closest to the elbow , for example, with a sterile marker Figure Figure 13 Step 2. Figure 14 Step 3. Push down the proximal end of the implant Figure 15 to stabilize it; a bulge may appear indicating the distal end of the implant. Figure 15 Step 4. Figure 16 Step 5. If the implant is encapsulated, make an incision into the tissue sheath and then remove the implant with the forceps Figures 17 and Figure 17 Figure 18 Step 6. Figure 19 Figure 20 Step 7.

Figure 21 Step 8. Localization and Removal of a Non-Palpable Implant There have been occasional reports of migration of the implant; usually this involves minor movement relative to the original position [see Warnings and Precautions 5. Elderly and Patients with Renal or Hepatic Impairment The clearance of mirtazapine is reduced in elderly patients and in patients with moderate to severe renal or hepatic impairment.

Information for Patients Patients should be advised that taking REMERON can cause mild pupillary dilation, which in susceptible individuals, can lead to an episode of angle-closure glaucoma. Drug Admixture Incompatibility: ZEMURON is physically incompatible when mixed with the following drugs: amphotericin hydrocortisone sodium succinate amoxicillin insulin azathioprine Intralipid cefazolin ketorolac cloxacillin lorazepam dexamethasone methohexital diazepam methylprednisolone erythromycin thiopental famotidine trimethoprim furosemide vancomycin If ZEMURON is administered via the same infusion line that is also used for other drugs, it is important that this infusion line is adequately flushed between administration of ZEMURON and drugs for which incompatibility with ZEMURON has been demonstrated or for which compatibility with ZEMURON has not been established.

If the patient has adhered to the prescribed regimen and misses two consecutive periods, pregnancy should be ruled out. A starting daily dose of 75 international units of Follistim AQ is administered for at least the first 7 days. The following should be considered when planning the woman's individualized dose: Appropriate Follistim AQ dose adjustment s should be used to prevent multiple follicular growth and cycle cancellation.

The maximum, individualized, daily dose of Follistim AQ is international units. When pre-ovulatory conditions are reached, to 10, international units of hCG are used to induce final oocyte maturation and ovulation. During treatment with Follistim AQ and during a two-week post-treatment period, the woman should be assessed at least every other day for signs of excessive ovarian stimulation.

A starting dose of to international units of Follistim AQ is administered subcutaneously or intramuscularly daily for at least the first 4 days of treatment. Subsequent dosing beyond the first 4 days of treatment is adjusted based upon the woman's ovarian response as determined by ultrasound evaluation of follicular growth and serum estradiol levels. The following should be considered when planning the woman's individualized dose: For most normal responding women, the daily starting dose can be continued until pre-ovulatory conditions are achieved six to twelve days.

When a sufficient number of follicles of adequate size are present, dosing of Follistim AQ is stopped and final maturation of the oocytes is induced by administering hCG at a dose of to 10, international units. An initial dosage of international units of hCG should be administered at twice weekly intervals to normalize serum testosterone levels. If serum testosterone levels have not normalized after 8 weeks of hCG treatment, the hCG dose can be increased to international units twice weekly [see Clinical Studies After normal serum testosterone levels have been reached, Follistim AQ should be administered by subcutaneous injection concomitantly with hCG treatment.

Follistim AQ should be given at a dosage of international units per week, as either international units twice weekly or international units three times per week, in combination with the same hCG dose used to normalize testosterone levels. Administer the vaccine in the deltoid region Figure 1.

Position the arm to maintain a horizontal surface where the vaccine is to be placed. Figure 1 2. Drop the immunizing dose of 0. At Merck, we believe that no one should go without the medicines or vaccines they need. That is why the company provides certain medicines and adult vaccines for free to people who do not have prescription drug or health insurance coverage and who, without our assistance, cannot afford their Merck medicine and vaccines.

This is consistent with Merck's long-held values and traditions of putting patients first. If you or someone you know needs help paying for medicines or adult vaccines, the Merck Patient Assistance Program, Inc. Merck is a proud participant in the Medicine Assistance Tool.

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The dosage regimen employed in any particular case will depend upon the indication for the use, the age and weight of the patient, and the physician's preference. The following regimens have been advocated by various authorities:. Prepubertal cryptorchidism not due to anatomical obstruction. Therapy is usually instituted in children between the ages of 4 and 9. Selected cases of hypogonadotropic hypogonadism in males.

Induction of ovulation and pregnancy in the anovulatory, infertile woman in whom the cause of anovulation is secondary and not due to primary ovarian failure and who has been appropriately pretreated with human menotropins. See prescribing information for menotropins for dosage and administration for that drug product. A dosage of 10, USP units is recommended in the labeling for menotropins. Two-vial package: Withdraw sterile air from lyophilized vial and inject into diluent vial.

Remove 1—10 mL from diluent and add to lyophilized vial; agitate gently until powder is completely dissolved in solution. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Two-vial package containing:. When reconstituted, each 10 mL vial contains:.

Reconstituted solution is stable for 60 days when refrigerated. All rights reserved. DailyMed will deliver notification of updates and additions to Drug Label information currently shown on this site through its RSS feed. DailyMed will deliver this notification to your desktop, Web browser, or e-mail depending on the RSS Reader you select to use.

Due to inconsistencies between the drug labels on DailyMed and the pill images provided by RxImage , we no longer display the RxImage pill images associated with drug labels. We anticipate reposting the images once we are able identify and filter out images that do not match the information provided in the drug labels. View Package Photos. Drug Label Info.

NDC National Drug Code - Each drug product is assigned this unique number which can be found on the drug's outer packaging. In general, HCG is thought to induce testicular descent in situations when descent would have occurred at puberty. HCG thus may help predict whether or not orchiopexy will be needed in the future.

Although, in some cases, descent following HCG administration is permanent, in most cases, the response is temporary. Selected cases of hypogonadotropic hypogonadism hypogonadism secondary to a pituitary deficiency in males. Induction of ovulation and pregnancy in the anovulatory, infertile woman in whom the cause of anovulation is secondary and not due to primary ovarian failure, and who has been appropriately pretreated with human menotropins.

Anaphylaxis has been reported with urinary-derived HCG products. General Since androgens may cause fluid retention, HCG should be used with caution in patients with cardiac or renal disease, epilepsy, migraine, or asthma.

Pediatric Use Induction of androgen secretion by HCG may induce precocious puberty in pediatric patients treated for cryptorchidism. Hypersensitivity reactions, both localized and systemic in nature, have been reported. The following regimens have been advocated by various authorities: Prepubertal cryptorchidism not due to anatomical obstruction. Other countries may have different regulatory requirements and review practices that may require referencing different information.

If you are a resident of a country other than the United States, please see our worldwide locations to find information about our offices around the globe. Trademarks appearing on this website are owned, licensed to, promoted or distributed by Merck, its subsidiaries or affiliates, except as noted.

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The increase in risk was observed after the first year and persisted. During an average follow-up of 4. Large doses of estrogen 5 mg conjugated estrogens per day , comparable to those used to treat cancer of the prostate and breast, have been shown in a large prospective clinical trial in men to increase the risks of nonfatal myocardial infarction, pulmonary embolism, and thrombophlebitis.

The increase in VTE risk was observed during the first year and persisted. If feasible, estrogens should be discontinued at least 4 to 6 weeks before surgery of the type associated with an increased risk of thromboembolism, or during periods of prolonged immobilization. The use of unopposed estrogens in women with intact uteri has been associated with an increased risk of endometrial cancer. The reported endometrial cancer risk among unopposed estrogen users is about 2-to fold greater than in non-users, and appears dependent on duration of treatment and on estrogen dose.

Most studies show no significant increased risk associated with use of estrogens for less than one year. The greatest risk appears associated with prolonged use, with increased risks of to fold for five to ten years or more and this risk has been shown to persist for at least 8 to 15 years after estrogen therapy is discontinued. There is no evidence that the use of natural estrogens results in a different endometrial risk profile than synthetic estrogens of equivalent estrogen dose.

Adding a progestin to estrogen therapy has been shown to reduce the risk of endometrial hyperplasia, which may be a precursor to endometrial cancer. The use of estrogens and progestins by postmenopausal women has been reported to increase the risk of breast cancer. The results from observational studies are generally consistent with those of the WHI clinical trial and report no significant variation in the risk of breast cancer among different estrogens or progestins, doses, or routes of administration.

In the WHI trial and from observational studies, the excess risk increased with duration of use. From observational studies, the risk appeared to return to baseline in about five years after stopping treatment. After a mean follow-up of 5. Among women who reported prior use of hormone therapy, the relative risk of invasive breast cancer was 1. Among women who reported no prior use of hormone therapy, the relative risk of invasive breast cancer was 1.

Metastatic disease was rare with no apparent difference between the two groups. Other prognostic factors such as histologic subtype, grade and hormone receptor status did not differ between the groups. The use of estrogen plus progestin has been reported to result in an increase in abnormal mammograms requiring further evaluation. All women should receive yearly breast examinations by a healthcare provider and perform monthly breast self-examinations.

In addition, mammography examinations should be scheduled based on patient age, risk factors, and prior mammogram results. After an average follow-up of 5. A meta-analysis of 17 prospective and 35 retrospective epidemiology studies found that women who used hormonal therapy for menopausal symptoms had an increased risk for ovarian cancer.

The primary analysis, using case-control comparisons, included 12, cancer cases from the 17 prospective studies. The relative risks associated with current use of hormonal therapy was 1. The relative risk associated with combined current and recent use discontinued use within 5 years before cancer diagnosis was 1. The exact duration of hormone therapy use associated with an increased risk of ovarian cancer, however, is unknown. A 2-to 4-fold increase in the risk of gallbladder disease requiring surgery in postmenopausal women receiving estrogens has been reported.

Estrogen administration may lead to severe hypercalcemia in patients with breast cancer and bone metastases. If hypercalcemia occurs, use of the drug should be stopped and appropriate measures taken to reduce the serum calcium level. Retinal vascular thrombosis has been reported in patients receiving estrogens. Discontinue medication pending examination if there is sudden partial or complete loss of vision, or a sudden onset of proptosis, diplopia, or migraine.

If examination reveals papilledema or retinal vascular lesions, estrogens should be permanently discontinued. Addition of a progestin when a woman has not had a hysterectomy. Studies of the addition of a progestin for 10 or more days of a cycle of estrogen administration, or daily with estrogen in a continuous regimen, have reported a lowered incidence of endometrial hyperplasia than would be induced by estrogen treatment alone.

Endometrial hyperplasia may be a precursor to endometrial cancer. There are, however, possible risks that may be associated with the use of progestins with estrogens compared to estrogen-alone regimens. These include a possible increased risk of breast cancer. In a small number of case reports, substantial increases in blood pressure have been attributed to idiosyncratic reactions to estrogens. In a large, randomized, placebo-controlled clinical trial, a generalized effect of estrogen therapy on blood pressure was not seen.

Blood pressure should be monitored at regular intervals with estrogen use. In patients with pre-existing hypertriglyceridemia, estrogen therapy may be associated with elevations of plasma triglycerides leading to pancreatitis and other complications.

Estrogens may be poorly metabolized in patients with impaired liver function. For patients with a history of cholestatic jaundice associated with past estrogen use or with pregnancy, caution should be exercised and in the case of recurrence, medication should be discontinued. Estrogen administration leads to increased thyroid-binding globulin TBG levels. Patients with normal thyroid function can compensate for the increased TBG by making more thyroid hormone, thus maintaining free T 4 and T 3 serum concentrations in the normal range.

Patients dependent on thyroid hormone replacement therapy who are also receiving estrogens may require increased doses of their thyroid replacement therapy. These patients should have their thyroid function monitored in order to maintain their free thyroid hormone levels in an acceptable range.

Because estrogens may cause some degree of fluid retention, patients with conditions that might be influenced by this factor, such as a cardiac or renal dysfunction, warrant careful observation when estrogens are prescribed. Endometriosis may be exacerbated with administration of estrogens.

A few cases of malignant transformation of residual endometrial implants have been reported in women treated post-hysterectomy with estrogen alone therapy. For patients known to have residual endometriosis post-hysterectomy, the addition of progestin should be considered.

Estrogens may cause an exacerbation of asthma, diabetes mellitus, epilepsy, migraine or porphyria, systemic lupus erythematosus, and hepatic hemangiomas and should be used with caution in women with these conditions. Some studies have shown that women taking estrogen replacement therapy have hypercoagulability, primarily related to decreased antithrombin activity.

This effect appears dose-and duration-dependent and is less pronounced than that associated with oral contraceptive use. Also, postmenopausal women tend to have increased coagulation parameters at baseline compared to premenopausal women. There is some suggestion that low dose postmenopausal mestranol may increase the risk of thromboembolism, although the majority of studies of primarily conjugated estrogens users report no such increase.

Certain patients may develop undesirable manifestations of estrogenic stimulation, such as abnormal uterine bleeding and mastodynia. Estrogen administration should be initiated at the lowest dose approved for the indication and then guided by clinical response rather than by serum hormone levels e. Increased thyroid-binding globulin TBG levels leading to increased circulating total thyroid hormone levels as measured by protein-bound iodine PBI , T 4 levels by column or by radioimmunoassay or T 3 levels by radioimmunoassay.

T 3 resin uptake is decreased, reflecting the elevated TBG. Free T 4 and free T 3 concentrations are unaltered. Patients on thyroid replacement therapy may require higher doses of thyroid hormone. Other binding proteins may be elevated in serum i. Free hormone concentrations may be decreased. Long-term continuous administration of estrogen, with and without progestin, in women with and without a uterus, has shown an increased risk of endometrial cancer, breast cancer, and ovarian cancer.

Long-term continuous administration of natural and synthetic estrogens in certain animal species increases the frequency of carcinomas of the breast, uterus, cervix, vagina, testis, and liver. Estradiol Valerate Injection should not be used during pregnancy. Estrogen administration to nursing mothers has been shown to decrease the quantity and quality of the milk.

Detectable amounts of estrogens have been identified in the milk of mothers receiving this drug. Caution should be exercised when Estradiol Valerate Injection is administered to a nursing woman. Safety and effectiveness in pediatric patients have not been established. Large and repeated doses of estrogen over an extended period of time may accelerate epiphyseal closure.

Therefore, periodic monitoring of bone maturation and effects on epiphyseal centers is recommended in patients in whom bone growth is not complete. Clinical studies of estradiol valerate did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Women treated with conjugated estrogens plus medroxyprogesterone acetate were reported to have a two-fold increase in the risk of developing probable dementia.

Alzheimer's disease was the most common classification of probable dementia in both the conjugated estrogens plus medroxyprogesterone acetate group and the placebo group. Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates. Changes in vaginal bleeding pattern and abnormal withdrawal bleeding or flow; breakthrough bleeding; spotting; dysmenorrhea, increase in size of uterine leiomyomata; vaginitis, including vaginal candidiasis; change in amount of cervical secretion; changes in cervical ectropion; ovarian cancer; endometrial hyperplasia; endometrial cancer.

Tenderness, enlargement, pain, nipple discharge, galactorrhea; fibrocystic breast changes; breast cancer. Deep and superficial venous thrombosis; pulmonary embolism; thrombophlebitis; myocardial infarction; stroke; increase in blood pressure. Nausea, vomiting; abdominal cramps, bloating; cholestatic jaundice; increased incidence of gallbladder disease; pancreatitis, enlargement of hepatic hemangiomas. Chloasma or melasma, which may persist when drug is discontinued; erythema multiforme; erythema nodosum; hemorrhagic eruption; loss of scalp hair; hirsutism; pruritus, rash.

Headache; migraine; dizziness; mental depression; chorea; nervousness; mood disturbances; irritability; exacerbation of epilepsy, dementia. For medical advice about adverse reactions contact your medical professional. Serious ill effects have not been reported following acute ingestion of large doses of estrogen-containing drug products by young children.

Overdosage of estrogen may cause nausea and vomiting, and withdrawal bleeding may occur in females. When estrogen is prescribed for a postmenopausal woman with a uterus, progestin should also be initiated to reduce the risk of endometrial cancer. A woman without a uterus does not need progestin. Use of estrogen, alone or in combination with a progestin, should be with the lowest effective dose and for the shortest duration consistent with treatment goals and risks for the individual woman.

Patients should be reevaluated periodically as clinically appropriate e. For women who have a uterus, adequate diagnostic measures, such as endometrial sampling, when indicated, should be undertaken to rule out malignancy in cases of undiagnosed persistent or recurring abnormal vaginal bleeding.

Care should be taken to inject deeply into the upper, outer quadrant of the gluteal muscle following the usual precautions for intramuscular administration. By virtue of the low viscosity of the vehicles, the various preparations of Estradiol Valerate Injection, may be administered with a small gauge needle i. Since the 40 mg potency provides a high concentration in a small volume, particular care should be observed to administer the full dose.

Estradiol Valerate Injection should be visually inspected for particulate matter and color prior to administration; the solution is clear, colorless to pale yellow. Storage at low temperatures may result in the separation of some crystalline material which redissolves readily on warming. Note: A dry needle and syringe should be used. Use of a wet needle or syringe may cause the solution to become cloudy; however, this does not affect the potency of the material.

Patients should be started at the lowest dose for the indication. The lowest effective dose of Estradiol Valerate Injection has not been determined for any indication. Treated patients with an intact uterus should be monitored closely for signs of endometrial cancer, and appropriate diagnostic measures should be taken to rule out malignancy in the event of persistent or recurring abnormal vaginal bleeding.

For treatment of moderate to severe vasomotor symptoms, vulvar and vaginal atrophy associated with the menopause, the lowest dose and regimen that will control symptoms should be chosen and medication should be discontinued as promptly as possible.

For treatment of female hypoestrogenism due to hypogonadism, castration, or primary ovarian failure. For treatment of advanced androgen-dependent carcinoma of the prostate, for palliation only. There may be new information. The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.

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