RESTANDOL TESTOCAPS Capsule (2019)
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Περιεχόμενα
Name of the medicinal product
Restandol Testocaps 40 mg capsule.
Qualitative and quantitative composition
Each capsule contains 40.0mg Testosterone Undecanoate which is equivalent to 25.3 mg testosterone. For the full list of excipients, see section 6.1.
Pharmaceutical form
Capsule. Soft oval, glossy capsules, transparent, orange in colour, with a yellow oily fill.
Therapeutic indications
Clinical Indications Testosterone replacement therapy for male hypogonadism, when testosterone deficiency has been confirmed by clinical features and biochemical tests. Examples of hypogonadal disorder ...
Posology and method of administration
Posology In general, the dose should be adjusted according to the response of the individual patient. Adults The initial dosage required will usually be 120-160 mg daily for 2-3 weeks. Subsequent dosage ...
Contraindications
Known or suspected carcinoma of the prostate or breast (see section 4.4). History of liver tumours. Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 (see section ...
Special warnings and precautions for use
Medical examination Testosterone level should be monitored at baseline and at regular intervals during treatment. Clinicians should adjust the dosage individually to ensure maintenance of eugonadal testosterone ...
Interaction with other medicinal products and other forms of interaction
Concurrent administration of liver enzyme inducing drugs such as rifampicin, barbiturates, carbamazepine, dichloralphenazone, phenylbutazone, phenytoin or primidone may decrease the effect of Restandol ...
Fertility, pregnancy and lactation
Pregnancy and lactation Restandol Testocaps are not indicated for treatment in women and therefore must not be used by pregnant or breast-feeding women. If used during pregnancy Restandol Testocaps pose ...
Effects on ability to drive and use machines
Restandol Testocaps has no influence on the ability to drive or use machines.
Undesirable effects
The following adverse reactions have been associated with androgen therapy in general. The most appropriate MedDRA term to describe a certain adverse event is listed. All adverse reactions listed by system ...
Overdose
The acute toxicity of testosterone is low. High doses of Restandol Testocaps may cause gastrointestinal complaints due to the castor oil present in the capsule. Treatment consists of supportive measures. ...
Pharmacodynamic properties
Pharmacotherapeutic group: Androgens ATC code: G03BA03 Restandol Testocaps, after oral administration, delivers physiological amount of testosterone in the circulation. Treatment of hypogonadal men also ...
Pharmacokinetic properties
Absorption Restandol Testocaps must be taken with a normal meal or breakfast to ensure absorption. Food enhances the absorption of Restandol Testocaps: In healthy volunteers the AUC of testosterone was ...
Preclinical safety data
Preclinical data with androgens in general reveal no special hazards for humans. Experimental data in rodents have shown testosterone can promote the development of certain tumours in hormone responsive ...
List of excipients
Capsule contents <u>Each capsule contains:</u> Castor oil Propylene glycol laurate (E477) <em>Capsule shell:</em> Glycerin Sunset Yellow (E110) Gelatin <em>Printing ink:</em> Opacode WB white <em>Auxiliary ...
Incompatibilities
Not applicable.
Shelf life
3 years.
Special precautions for storage
Store below 30°C; do not refrigerate or freeze; store in the original package and keep the blister in the outer carton.
Nature and contents of container
A box of Restandol Testocaps contains either 3 or 6 sachets, each containing a blister with 10 capsules.
Special precautions for disposal and other handling
Any unused product or waste material should be disposed of in accordance with local requirements. See also Special precautions for storage (section 6.4) and Posology and method of administration (section ...
Marketing authorization holder
Merck Sharp & Dohme Limited, Hertford Road, Hoddesdon, Hertfordshire, EN11 9BU, UK
Marketing authorization number(s)
PL 00025/0595
Date of first authorization / renewal of the authorization
14/1/81 / 8/11/2004
Date of revision of the text
31/01/2019
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