TESTOGEL Gel (2018)
Βιβλιογραφική αναφορά
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Περιεχόμενα
Name of the medicinal product
TESTOGEL 50 mg, gel in sachet.
Qualitative and quantitative composition
One sachet of 5 g contains 50 mg of testosterone. For the full list of excipients, see section 6.1.
Pharmaceutical form
Gel in sachet. Transparent or slightly opalescent, colourless gel in sachet.
Therapeutic indications
Testosterone replacement therapy for male hypogonadism when testosterone deficiency has been confirmed by clinical features and biochemical tests (see 4.4 Special warnings and precautions for use).
Posology and method of administration
Cutaneous use. Adult and Elderly men The recommended dose is 5 g of gel (i.e. 50 mg of testosterone) applied once daily at about the same time, preferably in the morning. The daily dose should be adjusted ...
Contraindications
Testogel is contraindicated: in cases of known or suspected prostatic cancer or breast carcinoma, in cases of known hypersensitivity to the active substance or any of the excipients listed in section 6.1. ...
Special warnings and precautions for use
Testogel should be used only if hypogonadism (hyper- and hypogonadotrophic) has been demonstrated and if other etiology, responsible for the symptoms, has been excluded before treatment is started. Testosterone ...
Interaction with other medicinal products and other forms of interaction
Oral anticoagulants: Changes in anticoagulant activity (the increased effect of the oral anticoagulant by modification of coagulation factor hepatic synthesis and competitive inhibition of plasma protein ...
Pregnancy and lactation
Testogel is intended for use by men only. Testogel is not indicated in pregnant or breast feeding women. No clinical trials have been conducted with this treatment in women. Pregnant women must avoid any ...
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
The most frequently observed adverse drug reactions at the recommended dosage of 5 g of gel per day were skin reactions (10%): reaction at the application site, erythema, acne, dry skin. Adverse drug reactions ...
Overdose
Only one case of acute testosterone overdose following an injection has been reported in the literature. This was a case of a cerebrovascular accident in a patient with a high plasma testosterone concentration ...
Pharmacodynamic properties
Pharmacotherapeutic group: Androgens ATC code: G03BA03 Endogenous androgens, principally testosterone, secreted by the testes and its major metabolite DHT, are responsible for the development of the external ...
Pharmacokinetic properties
The percutaneous absorption of testosterone ranges from approximately 9% to 14% of the applied dose. Following percutaneous absorption, testosterone diffuses into the systemic circulation at relatively ...
Preclinical safety data
Testosterone has been found to be non-mutagenic in vitro using the reverse mutation model (Ames test) or hamster ovary cells. A relationship between androgen treatment and certain cancers has been found ...
List of excipients
Carbomer 980 Isopropyl myristate Ethanol 96% Sodium hydroxide Purified water
Incompatibilities
Not applicable.
Shelf life
Shelf life: 3 years.
Special precautions for storage
This medicinal product does not require any special storage conditions.
Nature and contents of container
5 g in sachet (PET/Aluminium/LDPE). Boxes of 1, 2, 7, 10, 14, 28, 30, 50, 60, 90 or 100 sachets. Not all pack sizes may be marketed.
Special precautions for disposal and other handling
No special requirements.
Marketing authorization holder
Besins Healthcare (UK) Limited, 1st Floor, 28 Poland Street, London, W1F 8QN, United Kingdom
Marketing authorization number(s)
PL 42714/0002
Date of first authorization / renewal of the authorization
04/11/2006
Date of revision of the text
10 August 2018
Πηγαίο έγγραφο
Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση:
