SUPRECUR Solution for injection (2020)
Βιβλιογραφική αναφορά
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Περιεχόμενα
1. Name of the medicinal product
Suprecur Injection.
2. Qualitative and quantitative composition
Suprecur Injection contains 1.00mg buserelin as buserelin acetate in 1ml aqueous solution. 1.00mg buserelin is equivalent to 1.05mg buserelin acetate. Suprecur Injection also contains 10mg benzyl alcohol ...
3. Pharmaceutical form
Solution for Injection.
4.1. Therapeutic indications
Pituitary desensitisation in preparation for ovulation induction regimens using gonadotrophins.
4.2. Posology and method of administration
The total daily dose is usually in the range 200-500 microgram (μg) given as a single injection by the subcutaneous route. Treatment should start in the early follicular phase (day 1) or, provided the ...
4.3. Contraindications
Buserelin should not be used if the tumour is found to be insensitive to hormone manipulation or in cases of undiagnosed vaginal bleeding. It is contraindicated in cases of known hypersensitivity to LHRH, ...
4.4. Special warnings and precautions for use
Suprecur injection is for subcutaneous administration ONLY. There is an increased risk of incident depression (which may be severe) in patients undergoing treatment with GnRH agonists, such as Buserelin. ...
4.5. Interaction with other medicinal products and other forms of interaction
During treatment with Suprecur, the effect of antidiabetic agents may be attenuated. In concomitant treatment with sexual hormones (add back), the dosage is to be selected so as to ensure that the overall ...
4.6. Pregnancy and lactation
Pregnancy must be excluded before starting buserelin and the medication should be stopped on the day of administration of hCG. Buserelin passes into breast milk in small amounts. Although negative effects ...
4.7. Effects on ability to drive and use machines
Certain adverse effects (e.g. dizziness) may impair the ability to concentrate and react, and therefore constitute a risk in situations where these abilities are of special importance (e.g. operating a ...
4.8. Undesirable effects
The following CIOMS frequency rating is used: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1000 to <1/100); rare (≥1/10 000 to <1/1000); very rare (<1/10 000), not known (cannot be estimated ...
4.9. Overdose
Overdose may lead to signs and symptoms such as asthenia, headache, nervousness, hot flushes, dizziness, nausea, abdominal pain, oedemas of the lower extremities, and mastodynia as well as to local reactions ...
5.1. Pharmacodynamic properties
Buserelin is a synthetic peptide. It is a superactive analogue of natural gonadotrophin releasing hormone (gonadorelin, LHRH or GNRH). After an initial stimulation of gonadotrophin release, it down-regulates ...
5.2. Pharmacokinetic properties
The bioavailability of buserelin after subcutaneous injection is 100%. C<sub>max</sub> occurs at about 1 hour post-injection. The half-life after injection is about 80 minutes. Buserelin accumulates preferentially ...
5.3. Preclinical safety data
No signs of toxicity or histopathological changes were detected in long-term pharmacology and toxicology studies with buserelin in rats, dogs, and monkeys; the endocrine effects observed were restricted ...
6.1. List of excipients
Sodium chloride Ph.Eur. Sodium dihydrogen phosphate BP. Sodium hydroxide BP. Benzyl alcohol BP. Water for Injections Ph. Eur.
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
Unopened: 2 years (see section 6.6). Once opened use within 15 days.
6.4. Special precautions for storage
Do not store above 25°C. Do not freeze. Keep the vials in the outer carton in order to protect from light.
6.5. Nature and contents of container
Box of 2 5.5 ml multidose vials each containing 1.05 mg buserelin acetate per 1 ml, corresponding to 1.00 mg buserelin per 1 ml.
6.6. Special precautions for disposal and other handling
Each vial contains enough material for 10 doses. After finishing the course of treatment the vial should be disposed of and a new vial started for the next treatment. Do not use if the contents of the ...
7. Marketing authorization holder
Neon Healthcare Limited, Mill Studio Business Centre, Crane Mead, Ware, Hertfordshire, SG12 9PY, United Kingdom
8. Marketing authorization number(s)
PL 45043/0051
9. Date of first authorization / renewal of the authorization
23 April 2002
10. Date of revision of the text
01/12/2020
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