In general, do not exceed 35 days of treatment, unless an estradiol rise indicates imminent follicular development. As in the initial cycle, do not administer doses larger than International Units of FSH per day. To report SUSPECTED ADVERSE REACTIONS, contact EMD Serono atExt or FDA at FDA or www. Gonal-f is a drug used in infertility treatments Insemination, IVF, directed relations. The pharmacokinetic parameters of follitropin alfa following subcutaneous administration of GONAL-F are presented in Table 4. Read the "Instructions for Use" that comes with GONAL-F for information about the right way to use GONAL-F. Expert Opin Drug Deliv ;13 9 — The dosing scheme is stepwise and is individualized for each woman [see Clinical Studies Drug Class. Do not use doses greater than International Units per day. If you no longer wish to have this DailyMed RSS service, simply delete the copied URL from your RSS Reader. Hugues J and Durnerin I. Discourage intercourse when the risk for OHSS is increased [see Warnings and Precautions 5. Insert the needle through the center circle of the rubber stopper on the vial of the Gonal-F powder while keeping it in a straight, upright position. In most instances, treatment of women with Gonal-F will result only in follicular recruitment and development. Avoid pelvic examination or intercourse, as these may cause rupture of an ovarian cyst, which may result in hemoperitoneum. Schats R, et al. Desde ya, muchas gracias. Hola a todos. Call your healthcare provider right away if you have symptoms of an ectopic pregnancy including: stomach or pelvic pain especially on one side neck pain nausea and vomiting shoulder pain rectal pain miscarriage. Gonal-F Multi-Dose is supplied in a sterile, lyophilized white powder in multiple dose vials filled with International Units or International Units in order to deliver International Units and International Units FSH, respectively, after reconstitution with diluent Bacteriostatic Water for Injection, USP, containing 0. By sharing this post, you are helping us to keep ourselves motivated to work even harder. Inform women that the risk of spontaneous abortion miscarriage is increased with gonadotropin products including Gonal-F. Generic Name: follitropin alfa Dosage Form: injection.
Patient Prefer Adherence ;— The increased risk may be a factor of the underlying infertility [see Warnings and Precautions 5. Last updated on Jan 1, The increased risk may be a factor of the underlying infertility. Clinical evaluation may reveal hypovolemia, hemoconcentration, electrolyte imbalances, ascites, hemoperitoneum, pleural effusions, hydrothorax, acute pulmonary distress, and thromboembolic reactions [see Warnings and Precautions 5.
Approval: GONAL-F may increase your chance of having a pregnancy that is abnormally outside of your womb. In a randomized, open-labeled, active-comparator trial conducted in the U. Necessary Necessary. Slowly inject the Bacteriostatic Water into the vial of GONAL-F powder by pressing down on the syringe plunger.
Gonal-F is a sterile, lyophilized powder intended for subcutaneous injection after reconstitution. This may be estimated by ultrasound alone or in combination with measurement of serum estradiol levels. However, causality has not been established. Approval: 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. You can ask your pharmacist or healthcare provider for information about Gonal-F that is written for health professionals. Encourage the woman and her partner to have intercourse daily, beginning on the day prior to the administration of hCG and until ovulation becomes apparent. Quantity of Parts. Accessed: December Otros idiomas English Deutsch Italiano. Do you need a fertility treatment? Gonal-F is a gonadotropins product capable of causing in women, Ovarian Hyperstimulation Syndrome OHSS with or without pulmonary or vascular complications [see Warnings and Precautions 5. A baby born after an ART cycle may have an increased chance of having birth defects. Gonal-F is used in: infertile women to: help healthy ovaries develop mature and release an egg to help you get pregnant cause your ovaries to make multiple more than 1 eggs as part of an Assisted Reproductive Technology ART program infertile men to: help develop and produce mature sperm. GONAL-F contains no luteinizing hormone LH activity. Events Events Calendar Congresses Webinars COVID Webinars. Abdominal pain, abdominal distension, gastrointestinal symptoms including nausea, vomiting and diarrhea, severe ovarian enlargement [see Warnings and Precautions 5. Related Resources Medline Plus Clinical Trials PubMed All Citations Adverse Effects Therapeutic Use Pharmacology Clinical Trials Biochemical Data Summary. Stop using GONAL-F and call your healthcare provider right away if you have symptoms of OHSS, including:. The following are the dosages available and their prices:. Treatment, consisting of limited intravenous fluids, electrolytes, human serum albumin, is intended to normalize electrolytes while maintaining an acceptable but somewhat reduced intravascular volume. Caution: Do not use a microwave or other heating element to warm up the reconstituted liquid.
Comodo SSL Certificate. You can ask your pharmacist or healthcare provider for information about Gonal-F that is written for health professionals. OHSS occurs after gonadotropin treatment has been discontinued and it can develop rapidly, reaching its maximum about seven to ten days following treatment. Contact your doctor immediately if you are concerned that you have given yourself too much Gonal-f or in case of misuse. To report SUSPECTED ADVERSE REACTIONS, contact EMD Serono atExt or FDA at FDA or www. I am a Healthcare Professional YOUR COUNTRY Please select a country International English Austria Algeria Argentina Brazil Central America and Caribbean Colombia Chile China Ecuador France French Speaking Africa Germany India Indonesia Iran Iraq Japan Japan Technology Jordan Korea Lebanon Mexico Palestine Peru Russia Spain Syria Sweden Turkey UAE United Kingdom.
If you miss or forget to take a dose, do not double your next dose. Gonal-F may cause serious lung problems including fluid in your lungs atelectasistrouble breathing acute respiratory distress syndromeand worsening of asthma. For more information, go to www. Industrial Alce Blanco, C. Gonadotropin therapy requires the availability of appropriate monitoring facilities [see Warnings and Precautions 5. Signatory of the Diversity Charter. No, the sensation of this type of injection is generally a quick pinching, tingling or stinging type of sensation, but they are not painful. Pharmacodynamic effect lagged behind FSH serum concentration. Do not use Gonal-F if you are a woman or man who: is allergic to recombinant human FSH or any of the ingredients in Gonal-F. Does Gonal-f have to be refrigerated? In animal studies, the continuous administration of recombinant human FSH during pregnancy resulted in a decrease in the number of viable fetuses and difficult and prolonged delivery. Blood clots can cause: blood vessel problems thrombophlebitis stroke loss of your arm or leg blood clot in your lung pulmonary embolus heart attack GONAL-F may cause serious side effects in women, including: ovarian hyperstimulation syndrome OHSS. Also, tell your doctor or pharmacist about your medical history, especially if you have experienced or are experiencing other fertility or health problems. Multi-fetal gestation and births have been reported with all gonadotropin therapy, including therapy with GONAL-F. If you use this medicine to get pregnant, you may also need occasional ultrasound exams. Depending on the concentration of this hormone, Gonal-f is sold in different types and each one has a specific composition. You may need to mix this medicine with a liquid diluent before using it. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Women were randomized to Gonal-Fadministered subcutaneously, or a comparator urofollitropin product, administered intramuscularly. Tell your healthcare provider if you have any side effect that bothers you or that does not go away. Firouz F and Boivin J. The ultimate goal of using this medicine is not the same in IVF and IUI cycles, as one shall see below:. Inform women that the risk of spontaneous abortion miscarriage is increased with gonadotropin products including GONAL-F.
Advise women and men to discontinue Gonal-F and seek immediate medical attention if any signs or symptoms of a hypersensitivity reaction occur [see Warnings and Precautions 5. Do not use Gonal-F for a condition for which it was not prescribed. Gonal-F is a prescription medicine containing follicle-stimulating hormone FSH. It is not known if Gonal-F is safe or works in children. Drug Class.
Immediately throw away dispose of the needle and syringe into your FDA-cleared sharps container See Step 4 : How to throw away used needles and syringes. Ask your healthcare provider for instructions. FSH serum levels following fixed during the first five days and then adjusted doses of Gonal-F were found to be poor predictors of follicular growth rate. The risk of spontaneous abortion miscarriage is increased with gonadotropin products, including GONAL-F. As in the initial cycle, do not administer doses larger than International Units of FSH per day.