Land: Irland
Sprache: Englisch
Quelle: HPRA (Health Products Regulatory Authority)
Testosterone
Kyowa Kirin Holdings B.V.
G03BA; G03BA03
Testosterone
2 percent weight/weight
Gel
Product subject to prescription which may not be renewed (A)
3-oxoandrosten (4) derivatives; testosterone
Marketed
2006-08-04
PACKAGE LEAFLET: INFORMATION FOR THE USER TOSTRAN 2% GEL Testosterone READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Tostran is and what it is used for 2. What you need to know before you use Tostran 3. How to use Tostran 4. Possible side effects 5. How to store Tostran 6. Contents of the pack and other information 1. WHAT TOSTRAN IS AND WHAT IT IS USED FOR The active substance, testosterone, is a male hormone, which is a type of androgen. Tostran is used in adult men for testosterone replacement to treat various health problems caused by a lack of testosterone (male hypogonadism). This should be confirmed by two separate blood testosterone measurements and also include clinical symptoms such as: − impotence − infertility − low sex drive − tiredness − depressive moods − bone loss caused by low hormone levels 2. WHAT YOU NEED TO KNOW BEFORE YOU USE TOSTRAN Tostran must only be used if hypogonadism has been confirmed by your doctor, based on your symptoms and laboratory tests. Other reasons for your symptoms must have been excluded by your doctor prior to the start of treatment. Only men can use Tostran. Tostran has not been tested in males less than 18 years of age, and there is limited experience of treating men older than 65 years of age. DO NOT USE TOSTRAN: If you: - are allergic to testosterone or to any of the other ingredients of this medicine (listed in section 6.) - have or are suspected of having cancer of the breast or prostate If any of these applies to you, tell your doct Lesen Sie das vollständige Dokument
Health Products Regulatory Authority 22 February 2024 CRN00DSD4 Page 1 of 8 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Tostran 2% Gel 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One gram of gel contains 20 mg testosterone. One press of the canister piston delivers 0.5 g of gel containing 10 mg testosterone. Excipient(s) with known effect: One gram of gel contains 1 mg butylhydroxytoluene. One gram of gel contains 350 mg propylene glycol. For the full list of excipients, see Section 6.1. 3 PHARMACEUTICAL FORM Gel. Clear, colourless to slightly yellow gel. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Testosterone replacement therapy for male hypogonadism when testosterone deficiency has been confirmed by clinical features and biochemical tests (see Section 4.4). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults and Elderly Men_ The recommended starting dose of Tostran is 3 g gel (60 mg of testosterone) applied once daily at approximately the same time each morning. Dose titration should be based on both serum testosterone levels and the existence of clinical signs and symptoms related to androgen deficiency. It should be taken into account that physiological testosterone levels decline with increasing age. The daily dose should not exceed 4 g of gel (80 mg testosterone). _Paediatric Population_ Tostran is not indicated for use in children and has not been clinically evaluated in males under 18 years of age. _Method of administration_ For cutaneous use. The dose can be applied to the abdomen (entire dose over an area of at least 10 by 30 cm), or to BOTH inner thighs (one half of the dose over an area of at least 10 by 15 cm for each inner thigh). Daily rotation between the abdomen and inner thighs is recommended to minimise application site reactions. The gel should be applied to clean, dry, intact skin. It should be rubbed in gently with one finger until dry, then the application site should be covered, preferably with loose clothing. Hands should then be washed with soap and w Lesen Sie das vollständige Dokument