- 1. Name of the medicinal product
- 2. Qualitative and quantitative composition
- 3. Pharmaceutical form
- 4. Clinical particulars
- 4.1 Therapeutic indications
- 4.2 Posology and method of administration
- 4.3 Contraindications
- 4.4 Special warnings and precautions for use
- 4.5 Interaction with other medicinal products and other forms of interaction
- 4.6 Pregnancy, lactation and fertility
- 4.7 Effects on ability to drive and use machines
- 4.8 Undesirable effects
- 4.9 Overdose
- 5. Pharmacological properties
- 5.1 Pharmacodynamic properties
- 5.2 Pharmacokinetic properties
- 5.3 Preclinical safety data
- 6. Pharmaceutical particulars
- 6.1 List of excipients
- 6.2 Incompatibilities
- 6.3 Shelf life
- 6.4 Special precautions for storage
- 6.5 Nature and contents of container
- 6.6 Special precautions for disposal and other handling
- 7. Marketing authorisation holder
- 8. Marketing authorisation number(s)
- 9. Date of first authorisation/renewal of the authorisation
- 10. Date of revision of the text
Post-menopausal women50mg every three weeksThe duration of treatment depends on the clinical response and the possible occurrence of side-effects.We would recommend that the effectiveness of therapy be monitored with the appropriate methods for osteoporosis on a 6-12 monthly basis.
Method of administration:Deca-Durabolin should be administered by deep intramuscular injection
Conditions that need supervision:Patients, especially the elderly, with the following conditions should be monitored for: • Tumours - Mammary carcinoma, hypernephroma, bronchial carcinoma and skeletal metastases. In these patients hypercalcaemia or hypercalciuria may develop spontaneously, and also during androgen therapy. Nevertheless, the hypercalcaemia or hypercalciuria should first be treated appropriately and after restoration of normal calcium levels, if judged necessary and taking into account the risks and benefits on a case by case basis, hormone therapy can be resumed, with caution. • Pre-existing conditions-In patients with pre-existing cardiac, renal or hepatic insufficiency/disease or epilepsy or migraine anabolic steroid treatment may cause complications characterized by oedema with or without congestive heart failure. In such cases treatment must be stopped immediately. Patients who experienced myocardial infarction, cardiac-, hepatic- or renal insufficiency, hypertension, epilepsy, or migraine should be monitored due to the risk of deterioration of or reoccurrence of disease. In such cases treatment must be stopped immediately. • Diabetes mellitus - Deca-Durabolin can improve glucose tolerance in diabetic patients (see section 4.5). • Anti-coagulant therapy - Deca-Durabolin can enhance the anti-coagulant action of coumarin-type agents (see also section 4.5). • Liver dysfunction - caution should be used in patients with severe hepatic impairment and Deca-Durabolin 50mg/ml should only be used if the benefits outweigh the risks.
Adverse events:If anabolic steroid-associated adverse reactions occur (see section 4.8), treatment with Deca-Durabolin should be discontinued and, upon resolution of complaints, treatment can be resumed.
Virilisation:Patients should be informed about the potential occurrence of signs of virilisation. In particular, singers and women with speech professions should be informed about the risk of deepening of the voice.If signs of virilisation develop, the risk/benefit ratio has to be newly assessed with the individual patient.
(Mis) use in sports:Nandrolone is classified as a prohibited substance under the Olympic Movement Anti- doping Code (OMAC 1999). The misuse of Nandrolone and other anabolic steroids to enhance ability in sports carries serious health risks and is to be discouraged. Excipients: Deca-Durabolin contains arachis oil (peanut oil) and should not be taken/applied by patients known to be allergic to peanut. As there is a possible relationship between allergy to peanut and allergy to soya, patients with soya allergy should also avoid Deca-Durabolin (see section 4.3).Deca-Durabolin 50mg/ml contains 100 mg benzyl alcohol per ml solution and must not be given to premature babies or neonates. Benzyl alcohol may cause anaphylactoid reactions in infants and children up to 3 years old.
Paediatric Population:Safety and efficacy have not been adequately determined in children and adolescents. In pre-pubertal children statural growth and sexual development should be monitored since anabolic steroids in general and Deca-Durabolin in high dosages may accelerate epiphyseal closure and sexual maturation.
Insulin and other anti-diabetic medicines:Anabolic steroids may improve glucose tolerance and decrease the need for insulin or other anti-diabetic drugs in diabetic patients (see section 4.4). Patients with diabetes mellitus should therefore be monitored especially at the beginning or end of treatment and at periodic intervals during Deca-Durabolin treatment.
Anti-coagulant therapy:High doses of Deca-Durabolin may enhance the anti-coagulant action of coumarin- type agents (see section 4.4). Therefore close monitoring of prothrombin time and if necessary a dose reduction of the anti-coagulant is required during therapy.
ACTH or corticosteroids:The concurrent administration of anabolic steroids with ACTH or corticosteroids may enhance edema formations; thus these active substances should be administered cautiously, particularly in patients with cardiac or hepatic disease or in patient predisposed to edema (see section 4.4).
Laboratory test interactions:Anabolic steroids may decrease levels of thyroxine-binding globulin resulting in decreased total T4 serum levels and increases resin uptake of T3 and T4. Free thyroid hormone levels remain unchanged, however, and there is no clinical evidence of thyroid dysfunction.
Recombinant Human Erythropoietin:Combination of Deca-Durabolin with rhEPO (recombinant human erythropoietin), especially in females, may enable a reduction of the erythropoietin dose to reduce anemia.
Lactation:There are no adequate data for the use of this medicine during lactation to assess potential harm to the infant or a possible influence on milk production. Therefore, Deca-Durabolin should not be used during lactation.
Fertility:In men treatment with Deca-Durabolin can lead to fertility disorders by repressing sperm-formation. In women treatment with androgens can lead to an infrequent or repressed menstrual cycle (see section 4.8).
|System Organ Class||MedDRA term*|
|Metabolism and nutrition disorders||Lipids abnormal1|
|Psychiatric disorders||Libido increased|
|Respiratory, thoracic and mediastinal disorders||Dysphonia|
|Hepatobiliary disorders||Hepatic function abnormal Peliosis hepatis Liver tumours|
|Skin and subcutaneous tissue disorders||Acne Pruritus Hirsutism|
|Renal and urinary disorders||Urine flow decreased|
|Reproductive system and breast disorders||Enlarged clitoris|
|General disorders and administration site conditions||Oedema Injection site reaction Sodium retention|
AbsorptionNandrolone decanoate is slowly released from the injection site into the blood with a half-life of 6 days.
DistributionThe ester is rapidly hydrolysed to nandrolone in the blood with a half-life of one hour or less. The half-life for the combined process of hydrolysis of nandrolone decanoate and of distribution and elimination of nandrolone is 4.3 hours.
Biotransformation and excretionNandrolone is metabolised by the liver. 19-norandrosterone, 19-noretiocholanolone and 19-norepiandrosterone have been identified as metabolites in the urine. It is not known whether these metabolites display a pharmacological action.
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