Država: Australija
Jezik: engleski
Izvor: Department of Health (Therapeutic Goods Administration)
follitropin delta, Quantity: 72 microgram
Ferring Pharmaceuticals Pty Ltd
follitropin delta
Injection, solution
Excipient Ingredients: phenol; methionine; sodium sulfate decahydrate; dibasic sodium phosphate dodecahydrate; polysorbate 20; phosphoric acid; sodium hydroxide; water for injections
Subcutaneous
Pack of 1 pre-filled multidose pen and 15 needles
(S4) Prescription Only Medicine
Controlled ovarian stimulation for the development of multiple follicles in women undergoing assisted reproductive technologies (ART) such as an in vitro fertilisation (IVF) or intracytoplasmic sperm injection (ICSI) cycle.
Visual Identification: REKOVELLE solution for injection is a sterile aqueous solution supplied in colourless cartridges. It is intended to be used for subcutaneous administration with the REKOVELLE pre-filled pen.; Container Type: Cartridge; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Licence status A
2017-09-21
REKOVELLE ® _SOLUTION FOR INJECTION IN A PRE-FILLED PEN_ _follitropin delta (rhu)_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about REKOVELLE. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you using REKOVELLE against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT REKOVELLE IS USED FOR REKOVELLE contains follitropin delta, which is a recombinant human follicle-stimulating hormone (FSH) produced in a human cell line (PER.C6 ® ) by recombinant DNA technology. REKOVELLE belongs to a class of hormones called gonadotropins. FSH is necessary for the growth and development of egg sacs (follicles) in women. This medicine is used for controlled ovarian stimulation for the development of multiple follicles in women undergoing assisted reproductive technologies (ART) such as an in vitro fertilisation (IVF) or intracytoplasmic sperm injection (ICSI) cycle. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. This medicine is not addictive. It is available only with a doctor's prescription. This medicine is not expected to affect your ability to drive a car or operate machinery. BEFORE YOU USE REKOVELLE _WHEN YOU MUST NOT USE IT_ DO NOT USE REKOVELLE IF YOU HAVE AN ALLERGY TO: • any medicine containing the active substance • any of the ingredients listed at the end of this leaflet. Some of the symptoms of an allergic reaction may include: • shortness of breath • wheezing or difficulty breathing • swelling of the face, lips, tongue or other parts of the body • rash, itching or hives on the skin. DO NOT USE REKOVELLE IF ANY OF THE FOLLOWING APPLY TO YOU: • tumours Pročitajte cijeli dokument
#45403-v3G AUSTRALIAN PI - REKOVELLE ® (FOLLITROPIN DELTA*) SOLUTION FOR INJECTION PRE-FILLED MULTIDOSE PEN 1 NAME OF THE MEDICINE Follitropin delta* 2 QUALITATIVE AND QUANTITATIVE COMPOSITION *Follitropin delta (rhu) is a recombinant human follicle-stimulating hormone (FSH) produced in a human cell line (PER.C6 ® ) by recombinant DNA technology REKOVELLE 12 micrograms: contains 12 micrograms follitropin delta (rhu) in 0.36 mL. One pre-filled multidose pen contains 12 micrograms follitropin delta (rhu)* in 0.36 mL solution REKOVELLE 36 micrograms: contains 36 micrograms follitropin delta (rhu) in 1.08 mL. One pre-filled multidose pen contains 36 micrograms follitropin delta (rhu)* in 1.08 mL solution REKOVELLE 72 micrograms: contains 72 micrograms follitropin delta (rhu) in 2.16 mL. One pre-filled multidose pen contains 72 micrograms follitropin delta (rhu)* in 2.16 mL solution Each mL of the solution contains 33.3 micrograms of follitropin delta (rhu). This medicinal product contains less than 1 mmol (23 mg) sodium per dose. REKOVELLE (follitropin delta) solution for injection includes the following excipients: phenol, polysorbate 20, methionine, sodium sulfate, dibasic sodium phosphate dodecahydrate, phosphoric acid (for pH adjustment), sodium hydroxide (for pH adjustment) and water for injections. 3 PHARMACEUTICAL FORM Follitropin delta is a recombinant human follicle-stimulating hormone (FSH) produced in a human cell line (PER.C6 ® ) by recombinant DNA technology. The average molecular weights of the glycosylated α and β subunits are approximately 15,200 and 18,500 Daltons (Da), respectively. Thus, approximately 40% of the total molecular weight of the molecule is due to glycosylation. No animal- derived materials are used in the REKOVELLE manufacturing processes. Solution for injection in a pre-filled multidose pen with injection needles. Clear and colourless solution. The pH of the solution is 6.0–7.0. #45403-v3G 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Controlled ovarian stimulation for th Pročitajte cijeli dokument