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SPC, UK: TESTIM Transdermal Gel (2018)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

TESTIM 50 mg Transdermal Gel.

Qualitative and quantitative composition

One single dose container of 5g contains 50 mg testosterone. Excipient with known effect: 5 g contains 0.25 g propylene glycol. For the full list of excipients, see section 6.1.

Pharmaceutical form

Transdermal Gel. A clear to translucent gel.

Therapeutic indications

Testosterone replacement therapy for male hypogonadism when testosterone deficiency has been confirmed by clinical features and biochemical tests (see section 4.4).

Posology and method of administration

Posology Adults and the Elderly The recommended starting dose of TESTIM is testosterone 50mg (1 tube)/per day. Dose titration should be based on serum testosterone levels or the persistence of clinical ...

Contraindications

Androgens are contraindicated in men with carcinoma of the breast or known or suspected carcinoma of the prostate. Hypersensitivity to the active substance, which is chemically synthesized from soy, or ...

Special warnings and precautions for use

Prior to testosterone initiation, all patients must undergo a detailed examination in order to exclude the risk of pre-existing prostate cancer. Careful and regular monitoring of the breast and prostate ...

Interaction with other medicinal products and other forms of interaction

When androgens are used simultaneously with anti-coagulants, the anti-coagulant effects may be increased. Patients receiving oral anticoagulants require close monitoring, especially when androgen therapy ...

Pregnancy and lactation

TESTIM is not indicated for women and must not be used in pregnant or breastfeeding women. Testosterone may induce virilising effects on the female foetus. Pregnant women should avoid skin contact with ...

Effects on ability to drive and use machines

No studies on the effects on the ability to drive and use machines have been performed.

Undesirable effects

Summary of the safety profile In double-blind clinical trials comparing TESTIM to placebo, the most frequently observed adverse drug reactions in TESTIM treated patients were application site erythema ...

Overdose

Reports describing overdose have included doses up to TESTIM 150 mg. No dose limiting toxicity has been reported from these spontaneous cases.

Pharmacodynamic properties

Pharmacotherapeutic group: Androgens ATC code: G03BA03 Testosterone and dihydrotestosterone (DHT), endogenous androgens, are responsible for the normal growth and development of the male sex organs and ...

Pharmacokinetic properties

TESTIM dries very quickly when applied to the skin surface. The skin acts as a reservoir for the sustained release of testosterone into the systemic circulation. With once daily application of TESTIM 50mg ...

Preclinical safety data

Toxicological studies have not revealed effects other than those which can be explained based on the hormonal profile of TESTIM.

List of excipients

Purified water Pentadecalactone Carbomer 980 Carbomer copolymer Propylene glycol Glycerol Macrogol 1000 Ethanol Trometamol

Incompatibilities

Not applicable.

Shelf life

Shelf life: 24 months.

Special precautions for storage

Do not store above 25°C. This medicinal product is flammable and should be protected from direct sunlight.

Nature and contents of container

TESTIM is supplied in unit dose aluminium tubes with epoxy phenolic liners and screw caps, each containing 5g gel. The tubes are packed in cartons containing 7, 14, 30 and 90 tubes. Not all pack sizes ...

Special precautions for disposal and other handling

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Marketing authorization holder

Endo Ventures Limited, First Floor, Minerva House, Simmonscourt Road, Ballsbridge, Dublin 4, IRELAND

Marketing authorization number(s)

PL 43808/0018

Date of first authorization / renewal of the authorization

20/02/2009

Date of revision of the text

09/10/2018

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