NEBIDO Solution for injection (2018)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Nebido 1000 mg/4 ml, solution for injection.
Qualitative and quantitative composition
Each ml solution for injection contains 250 mg testosterone undecanoate corresponding to 157.9 mg testosterone. Each ampoule/vial with 4 ml solution for injection contains 1000 mg testosterone undecanoate ...
Pharmaceutical form
Solution for injection. Clear, yellowish oily solution.
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 One ampoule/vial of Nebido (corresponding to 1000 mg testosterone undecanoate) is injected every 10 to 14 weeks. Injections with this frequency are capable of maintaining sufficient testosterone ...
Contraindications
The use of Nebido is contraindicated in men with: androgen-dependent carcinoma of the prostate or of the male mammary gland, past or present liver tumours, hypersensitivity to the active substance or to ...
Special warnings and precautions for use
Nebido is not recommended for use in children and adolescents. Nebido should be used only if hypogonadism (hyper- and hypogonadotrophic) has been demonstrated and if other aetiology, responsible for the ...
Interaction with other medicinal products and other forms of interaction
Oral anti-coagulants Testosterone and derivatives have been reported to increase the activity of coumarin derived oral anti-coagulants. Patients receiving oral anti-coagulants require close monitoring, ...
Pregnancy and lactation
Fertility Testosterone replacement therapy may reversibly reduce spermatogenesis (see sections 4.8 and 5.3). Pregnancy and breastfeeding Nebido is not indicated for use in women and must not be used in ...
Effects on ability to drive and use machines
Nebido has no influence on the ability to drive and use machines.
Undesirable effects
Summary of the safety profile Regarding undesirable effects associated with the use of androgens, please also refer to section 4.4. The most frequently reported undesirable effects during treatment with ...
Overdose
No special therapeutic measure apart from termination of therapy with the medicinal product or dose reduction is necessary after overdose.
Pharmacodynamic properties
Pharmacotherapeutic group: Androgens, 3-oxoandrosten (4) derivatives ATC code: G03BA03 Testosterone undecanoate is an ester of the naturally occurring androgen, testosterone. The active form, testosterone, ...
Pharmacokinetic properties
Absorption Nebido is an intramuscularly administered depot preparation of testosterone undecanoate and thus circumvents the first-pass effect. Following intramuscular injection of testosterone undecanoate ...
Preclinical safety data
Toxicological studies have not revealed other effects than those which can be explained based on the hormone profile of Nebido. Testosterone has been found to be non-mutagenic in vitro using the reverse ...
List of excipients
Benzyl benzoate Castor oil, refined
Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Shelf life
Shelf life: 5 years. The medicinal product must be used immediately after first opening.
Special precautions for storage
This medicinal product does not require any special storage conditions.
Nature and contents of container
Ampoule: 5-ml brown glass (type I) ampoules, containing a fill volume of 4 ml. Pack size: 1 4 ml. Vial: 6ml brown glass (type I) vial with grey bromobutyl (foil-clad ETFE) injection stopper and bordered ...
Special precautions for disposal and other handling
At cold storage temperatures the properties of this oil-based solution might temporarily change (e.g. higher viscosity, cloudiness). If stored at cold temperature, the product should be brought to room ...
Marketing authorization holder
Bayer plc, 400 South Oak Way, Reading, RG2 6AD
Marketing authorization number(s)
PL 00010/0549
Date of first authorization / renewal of the authorization
Date of first authorisation: 20<sup>th</sup> October 2004 Date of lastest renewal: 25<sup>th</sup> November 2008
Date of revision of the text
5<sup>th</sup> October 2018
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