Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: Bayer plc, 400 South Oak Way, Reading, RG2 6AD
Noristerat is a depot contraceptive. It is intended for short-term use when a high level of efficacy independent of possible errors by the patient is required. It has been licensed for short-term use by women whose partners undergo vasectomy, until the vasectomy is effective, and women immunised against rubella, to prevent pregnancy during the period of activity of the virus.
Use after delivery or abortion: Noristerat can generally be used immediately after delivery or abortion (but see Section 4.6 ‘Use during lactation’).
200 mg Noristerat intramuscularly provides contraception for eight weeks. The first injection should be given within the first five days of a menstrual cycle (the first day of menstruation counting as day 1), unless it is given so soon after delivery or abortion that no possibility of pregnancy exists. Provided the injection is carried out according to these instructions, no additional contraceptive cover is required. The injection may be repeated once, after eight weeks. Noristerat must always be injected deep into the gluteal muscles, care being taken that no liquid runs back from the injection site, which could result in loss of efficacy. The viscosity of the liquid at low temperatures is high, necessitating considerable pressure of injection. Therefore it is suggested that the ampoule be immersed in warm water before injection. A needle of at least medium bore should be used, and care taken to ensure that the needle is securely attached to the syringe. The injection must be administered extremely slowly (see Section 4.4 Special Warnings and Precautions for use).
Presentation of a single use injectable and administration by a physician minimize the risk of overdose. There have been no reports of serious deleterious effects from overdose. There are no antidotes and further treatment should be symptomatic.
5 years.
Store below 25°C.
Protect from light.
Carton containing one 1ml glass ampoule.
Keep out of the reach of children.
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