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SPC, UK: Suprefact Injection (2012)

Αναφορές

Βιβλιογραφική αναφορά

Στοιχεία εκδότη

Εκδότης :
SANOFI
Διεύθυνση :
1 Onslow Street, Guildford, Surrey, GU1 4YS, UK
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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).

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

In isolated cases severe hypersensitivity reactions with shock can occur. These may become manifest as reddening of the skin, itching, skin rashes (including urticaria) and allergic asthma with dyspnoea ...

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

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

Sanofi-aventis or Sanofi One Onslow Street Guildford Surrey GU1 4YS 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

22 August 2012