SUPREFACT Injection (2018)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Suprefact Injection.
Qualitative and quantitative composition
Suprefact Injection contains 1.00mg buserelin as buserelin acetate in 1ml aqueous solution. 1.00mg buserelin is equivalent to 1.05mg buserelin acetate. Suprefact Injection also contains 10mg benzyl alcohol ...
Pharmaceutical form
Injection.
Therapeutic indications
For the treatment of advanced hormone dependent prostatic carcinoma (stage C or stage D according to the classification of Murphy et al, in Cancer 45, p1889-95, 1980) in which suppression of testosterone ...
Posology and method of administration
Initiation of therapy: is most conveniently carried out in hospital; 0.5ml Suprefact injection should be injected subcutaneously at 8 hourly intervals for 7 days. Maintenance therapy: on the 8th day of ...
Contraindications
Buserelin should not be used if the tumour is found to be insensitive to hormone manipulation or after surgical removal of the testes. It is contraindicated in cases of known hypersensitivity to LHRH, ...
Special warnings and precautions for use
There is an increased risk of incident depression (which may be severe) in patients undergoing treatment with GnRH agonists, such as Buserelin. Patients should be informed accordingly and treated as appropriate ...
Interaction with other medicinal products and other forms of interaction
During treatment with Suprefact, the effect of antidiabetic agents may be attenuated (see section 4.8). Since androgen deprivation treatment may prolong the QT interval, the concomitant use of Suprefact ...
Pregnancy and lactation
Suprafact is contraindicated in pregnancy. It is intended for the treatment of advanced prostatic carcinoma, it should not be used in pregnant or lactating women (see 4.3 Contraindications). Buserelin ...
Effects on ability to drive and use machines
Certain adverse effects (eg. dizziness) may impair the ability to concentrate and react, and therefore constitute a risk in situations where these abilities are of special importance (eg. Operating a vehicle ...
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 ...
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 ...
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 ...
Pharmacokinetic properties
Metabolic inactivation by peptidases occurs in the liver and kidney. The drug is also inactivated by pituitary membrane enzymes.
Preclinical safety data
None stated.
List of excipients
Sodium chloride Sodium dihydrogen phosphate Sodium hydroxide Benzyl alcohol Water for injections
Incompatibilities
Not applicable.
Shelf life
Shelf life Unopened: 2 years. Once opened use within 15 days.
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.
Nature and contents of container
Box of 1 5.5 ml multidose vial containing 1.05 mg buserelin acetate per 1ml, corresponding to 1.00mg buserelin per 1 ml. Pack size: 2 individual cardboard boxes are wrapped together in a clear plastic ...
Special precautions for disposal and other handling
No special instructions.
Marketing authorization holder
Aventis Pharma Limited, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK Trading as: Sanofi, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK
Marketing authorization number(s)
PL 04425/0268
Date of first authorization / renewal of the authorization
16 June 2006
Date of revision of the text
13 August 2019
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