SUPREFACT Nasal spray (2019)
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Περιεχόμενα
Name of the medicinal product
Suprefact Nasal Spray.
Qualitative and quantitative composition
Suprefact nasal spray contains 100 micrograms buserelin as buserelin acetate in 1 spray dose of aqueous solution containing benzalkonium chloride as preservative. 100 micrograms buserelin is equivalent ...
Pharmaceutical form
Nasal spray.
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, p 1889-95, 1980) in which suppression of testosterone ...
Posology and method of administration
Initiation of therapy: is most conveniently carried out in hospital; 0.5 ml Suprefact injection should be injected subcutaneously at 8 hourly intervals for 7 days. Maintenance therapy: on the 8<sup>th ...
Contraindications
Buserelin should not be used if the tumour is found to be insensitive to hormone manipulation, after surgical removal of the testes. It is contraindicated in cases of known hypersensitivity to benzalkonium ...
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. Treatment should be symptomatic. ...
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
The intra-nasal absorption rate of buserelin is about 3%. Metabolic inactivation by peptidases occurs in the liver and kidney. The drug is also inactivated by pituitary membrane enzymes. After intra-nasal ...
Preclinical safety data
None stated.
List of excipients
Sodium chloride Citric acid monohydrate Sodium citrate dihydrate Benzalkonium chloride Water for injections
Incompatibilities
Not applicable.
Shelf life
Shelf life: 2½ years.
Special precautions for storage
Store below 25°C. The spray solution should last for 1 week of treatment. Any residual material after this time should be discarded.
Nature and contents of container
Box of 4 bottles each containing 10g solution and 4 spray pumps.
Special precautions for disposal and other handling
How to use the spray bottle. Remove spray cap from bottle. Remove metered dose nebulizer from transparent plastic container and take off both protective caps. Screw nebuliser on to bottle. Before first ...
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 04425/0279
Date of first authorization / renewal of the authorization
16 June 2006
Date of revision of the text
13 August 2019
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