Χώρα: Αυστραλία
Γλώσσα: Αγγλικά
Πηγή: Department of Health (Therapeutic Goods Administration)
Follitropin alfa, Quantity: 900 IU
Theramex Australia Pty Ltd
Injection, solution
Excipient Ingredients: polysorbate 20; benzalkonium chloride; sodium hydroxide; water for injections; benzyl alcohol; mannitol; methionine; monobasic sodium phosphate dihydrate
Subcutaneous
1
(S4) Prescription Only Medicine
1. The treatment of anovulatory infertility in women who have been unresponsive to clomiphene citrate or where clomiphene citrate is contraindicated.,2. For controlled ovarian hyperstimulation in women undergoing assisted reproductive technologies.,3. OVALEAP is indicated with concomitant human chorionic gonadotrophin (hCG) therapy for the stimulation of spermatogenesis in gonadotrophin-deficient men in whom hCG alone is ineffective.
Visual Identification: Clear and colourless liquid in a cartridge consisting of a glass carpule with a grey rubber stopper and a cartridge seal; Container Type: Cartridge; Container Material: Glass Type I Clear; Container Life Time: 36 Months; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Registered
2021-03-10
OVALEAP ® O V A L E A P ® CONSUMER MEDICINE INFORMATION (CMI) SUMMARY The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist. 1. WHY AM I USING OVALEAP? OVALEAP contains the active ingredient follitropin alfa. OVALEAP is used to stimulate development of follicles in women who do not ovulate and women undergoing assisted reproductive technologies (ART) such as in vitro fertilisation (IVF) and in men in combination with hCG to stimulate the production of sperm. For more information, see Section 1. Why am I using OVALEAP? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE OVALEAP? Do not use if you have ever had an allergic reaction to OVALEAP or any of the ingredients listed at the end of the CMI. TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME PREGNANT OR ARE BREASTFEEDING. For more information, see Section 2. What should I know before I use OVALEAP? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with OVALEAP and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI. 4. HOW DO I USE OVALEAP? • Your doctor will decide the correct dose of OVALEAP for you. Your dose of OVALEAP may be adjusted depending on your individual response to treatment. Please consult your doctor if you are in any doubt. • OVALEAP is given as a course of daily injections. You should have your injection at the same time each day. More instructions can be found in Section 4. How do I use OVALEAP? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING OVALEAP? THINGS YOU SHOULD DO • Remind any doctor, dentist, or pharmacist you visit that you are using OVALEAP. • See your doctor regularly. Your doctor will monitor you closely throughout your treatment. THINGS YOU SHOULD NOT DO • Do not stop using this medicine suddenly. • Do not use OVALEAP if you are pregnant or breastfeeding • Do not us Διαβάστε το πλήρες έγγραφο
OVALEAP PRODUCT INFORMATION PI V5-0321 1 AUSTRALIAN PRODUCT INFORMATION – OVALEAP ® (FOLLITROPIN ALFA (RCH)) SOLUTION FOR INJECTION 1. NAME OF THE MEDICINE Follitropin alfa (rch) OVALEAP is a biosimilar medicine to GONAL-f ® solution for injection. The evidence for comparability supports the use of OVALEAP for the listed indications. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION OVALEAP is produced by a Chinese Hamster Ovary cell line transfected with the human FSH subunit genes (i.e. by recombinant DNA technology). Each cartridge contains the active ingredient follitropin alfa (rch) (recombinant human follicle stimulating hormone) 300 IU/0.5 mL, 450 IU/0.75 mL or 900 IU/1.5 mL. For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS. 3. PHARMACEUTICAL FORM Solution for injection available in packs containing 1 glass cartridge and 10 or 20 injection needles. The Ovaleap cartridge is designed for use in conjunction with the Ovaleap Pen only, which is separately available. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS 1. The treatment of anovulatory infertility in women who have been unresponsive to clomiphene citrate or where clomiphene citrate is contraindicated. 2. For controlled ovarian hyperstimulation in women undergoing assisted reproductive technologies. 3. OVALEAP is indicated with concomitant human chorionic gonadotrophin (hCG) therapy for the stimulation of spermatogenesis in gonadotrophin-deficient men in whom hCG alone is ineffective. 4.2 DOSE AND METHOD OF ADMINISTRATION Treatment with OVALEAP should be initiated under the supervision of a physician experienced in the treatment of fertility disorders. OVALEAP should be administered subcutaneously. The injection site should be alternated daily to prevent lipoatrophy. Self-administration of OVALEAP should only be performed by patients who are well motivated, adequately trained and who have access to expert advice. Ovaleap cartridge should only be administered using the OVALEAP Pen. The instructions for use of the pen will be provided Διαβάστε το πλήρες έγγραφο