SUSTANON Solution for injection (2020)
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Περιεχόμενα
1. Name of the medicinal product
Sustanon 250, 250mg/ml solution for injection.
2. Qualitative and quantitative composition
Sustanon 250 is a solution in oil. Each ampoule contains 1 ml arachis oil containing the following active substances: 30 mg Testosterone propionate 60 mg Testosterone phenylpropionate 60 mg Testosterone ...
3. Pharmaceutical form
Solution for injection. A clear, pale yellow solution.
4.1. Therapeutic indications
Testosterone replacement therapy for male hypogonadism, when testosterone deficiency has been confirmed by clinical features and biochemical tests. Testosterone administration may also be used as supportive ...
4.2. Posology and method of administration
Posology In general, the dose should be adjusted to the response of the individual patient. Adults (incl. elderly) Usually, one injection of 1ml per 3 weeks is adequate. Paediatric population Safety and ...
4.3. Contraindications
Pregnancy (see section 4.6). Known or suspected carcinoma of the prostate or breast (see section 4.4.). Breast-feeding. Hypersensitivity to the active substance or to any of the excipients listed in section ...
4.4. 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 ...
4.5. Interaction with other medicinal products and other forms of interaction
Enzyme-inducing agents may decrease and enzyme-inhibiting drugs may increase testosterone levels. Therefore, adjustment of the dose of Sustanon 250 may be required. Insulin and other anti-diabetic medicines ...
4.6. Fertility, pregnancy and lactation
Sustanon 250 is contra-indicated in women who are pregnant (see section 4.3). Pregnancy There are no adequate data for the use of Sustanon 250 in pregnant women. In view of the risk of virilisation of ...
4.7. Effects on ability to drive and use machines
Sustanon 250 has no influence on the ability to drive and use machines.
4.8. Undesirable effects
Due to the nature of Sustanon 250 side effects cannot be quickly reversed by discontinuing medication. Injectables in general, may cause a local reaction at the injection site. The following adverse reactions ...
4.9. Overdose
The acute toxicity of testosterone is low. If symptoms of chronic overdose occur (e.g. polycythaemia, priapism) treatment should be discontinued and after disappearance of the symptoms, be resumed at lower ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Androgens <b>ATC code:</b> G03BA03 Treatment of hypogonadal men with Sustanon 250 results in a clinically significant rise of plasma concentrations of testosterone, dihydrotestosterone, ...
5.2. Pharmacokinetic properties
Sustanon 250 contains four esters of testosterone with different durations of action. The esters are hydrolysed into the natural hormone testosterone as soon as they enter the general circulation. Absorption ...
5.3. Preclinical safety data
Preclinical data with androgens in general reveal no hazard for humans. The use of androgens in different species has been demonstrated to result in virilisation of the external genitals of female foetuses. ...
6.1. List of excipients
Arachis oil Benzyl alcohol
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
3 years.
6.4. Special precautions for storage
Store below 30°C Do not refrigerate or freeze. Store in the original package in order to protect from light.
6.5. Nature and contents of container
Each colourless glass ampoule is filled with 1 ml of Sustanon 250. A box of Sustanon 250 contains 1 ampoule. Not all pack sizes may be marketed. In correspondence please quote batch number.
6.6. Special precautions for disposal and other handling
Any unused product or waste material should be disposed of in accordance with local requirements.
7. Marketing authorization holder
ASPEN PHARMA TRADING LIMITED, 3016 LAKE DRIVE, CITYWEST BUSINESS CAMPUS, DUBLIN 24, IRELAND
8. Marketing authorization number(s)
PL 39699/0059
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 28/02/1973 Date of latest renewal: 29/11/2002
10. Date of revision of the text
24/06/2020
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