TESTIM Transdermal Gel (2018)
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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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