Regulatory Information
DCH AURIGA SINGAPORE
DCH AURIGA SINGAPORE
Therapeutic
Prescription Only
Formulation Information
INJECTION
**4.2 Posology and method of administration** Deca-Durabolin should be administered by deep intramuscular injection. For treatment of osteoporosis: 50 mg once every 3 weeks For the palliative treatment of selected cases of disseminated mammary carcinoma in women: 50mg every 2 – 3 weeks As an adjunct to specific therapies and dietary measures in pathologic conditions characterized by a negative nitrogen balance: 25–50 mg every 3 weeks. N.B. For an optimal therapeutic effect it is necessary to administer adequate amounts of vitamins, minerals and protein in a calorie-rich diet. Safety and efficacy have not been adequately determined in children and adolescents (see section 4.4 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).
INTRAMUSCULAR
Medical Information
**4.1 Therapeutic indications** - Treatment of osteoporosis - For the palliative treatment of selected cases of disseminated mammary carcinoma in women. - As an adjunct to specific therapies and dietary measures in pathologic conditions characterized by a negative nitrogen balance
**4.3 Contraindications** - Pregnancy (see Section 4.6 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_) - Known or suspected carcinoma of the prostate or breast in the male (see section 4.4 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_) - Hypersensitivity to the active substance or to any of the excipients, including arachis oil. Deca-Durabolin is therefore contraindicated in patients allergic to peanuts or soya (see section 4.4 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_)
A14AB01
nandrolone
Manufacturer Information
DCH AURIGA SINGAPORE
Ever Pharma Jena GmbH (bulk and primary packager)
Active Ingredients
Documents
Package Inserts
Deca-Durabolin PI (May 2017) clean copy.pdf
Approved: May 24, 2017