NORISTERAT Solution for injection (2019)
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Περιεχόμενα
1. Name of the medicinal product
Noristerat 200mg, solution for intramuscular injection.
2. Qualitative and quantitative composition
1ml Noristerat contains 200mg norethisterone enantate in oily solution. <u>Excipient with known effect:</u> 333.8 mg benzyl benzoate in 1 ml ampoule. For the full list of excipients, see Section 6.1. ...
3. Pharmaceutical form
Solution for injection.
4.1. Therapeutic indications
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 ...
4.2. Posology and method of administration
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 ...
4.3. Contraindications
Known or suspected pregnancy. Current or severe hepatic disease as long as liver function values have not returned to normal. Previous or existing liver tumours. Severe diabetes with vascular changes. ...
4.4. Special warnings and precautions for use
Medical Examination Assessment of women prior to starting Noristerat (and at regular intervals thereafter) should include a personal and family medical history of each woman. Physical examination should ...
4.5. Interaction with other medicinal products and other forms of interaction
Note: The prescribing information of concomitant medications should be consulted to identify potential interactions. There are no data on progestogen-only injectables drug interactions. Effects of other ...
4.6. Pregnancy and lactation
Pregnancy Noristerat is contraindicated in pregnancy. Like all nortestosterone derivatives used for contraception, Noristerat has slight androgenic activity, and a virilising effect on the external genitalia ...
4.7. Effects on ability to drive and use machines
None known.
4.8. Undesirable effects
<b>Undesirable effects that have been reported in users of Noristerat (based on post-marketing data) are:</b> System Organ Class Very common<br /> ≥1/10 Common<br /> ≥1/100 and <1/10 Uncommon<br /> ≥1/1.000 ...
4.9. Overdose
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 ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Progestogens <b>ATC code:</b> None assigned Mechanism of action Noristerat is a depot contraceptive. The mode of action, following injection, is initially inhibition of ...
5.2. Pharmacokinetic properties
Absorption Norethisterone enantate was completely absorbed after intramuscular injection. The ester was quickly and eventually completely hydrolyzed to its pharmacologically active compound norethisterone ...
5.3. Preclinical safety data
Non-clinical data reveal no special risk for humans based on studies of repeated dose toxicity, genotoxicity, carcinogenicity and toxicity to reproduction which is not already included in other relevant ...
6.1. List of excipients
Castor oil for injection Benzyl benzoate
6.2. Incompatibilities
In the absence of compatibility studies, this medicinal product should not be mixed with other medicinal products.
6.3. Shelf life
5 years.
6.4. Special precautions for storage
Store below 25°C. Protect from light.
6.5. Nature and contents of container
Carton containing one 1ml glass ampoule.
6.6. Special precautions for disposal and other handling
Keep out of the reach of children.
7. Marketing authorization holder
Bayer plc, 400 South Oak Way, Reading, RG2 6AD
8. Marketing authorization number(s)
PL 00010/0548
9. Date of first authorization / renewal of the authorization
23 February 2009
10. Date of revision of the text
17 October 2019
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