Each ml of the oily Solution Contains:
Nandrotone Decanoate USP…..100 mg (USP Specs)
Deka-Duralin “100” is a high dosage form of nandrolone decanoate designed especially for adjuvant therapy in the treatment of certain blood disorders,Nandrolone, the pharmacologically active substance of the preparation, is chemically related to the male hormone. Compared to testosterone, it has an enhanced anabolic and a reduced andorgenic activity. This has been demonstrated in animal bioassays and explained by receptor binding studies. The low androgenicity of nandrolone is confirmed in clinical use.
In animals, nandrolone decanoate possesses an erythropoiesis stimulating effect probably by directly stimulating the haematopoie.tic stem cells in the bone marrow and by increasing the release of erythopoietin. It also affords protection against the bone marrow depression caused by cytotoxic agent. In the human, Deka-Duralin “100” stimulates erythropoiesis ad.domonstrated by rises in the red blood cell mass, and in the haemoglobin and haematrocrit values. This effect is utilized therapeutically in the treatment of anaemia due to a decreased production of erythropoietin, bone marrow depression induced by chemotherapy, or hypoplasia of the stem cells in the bone marrow, In the latter condition (e.g. aplastic anaemia) the erythropoietic response is frequently accomanied by a positive effect on leucopoiesis and thrombopoiesis. Androgenic effects (e.g. virilisation ) are relatively uncommon at the recommended dosages. Nandrolone lacks the C17 alpha-alkyi group which is associated with the occurrence of liver dysfunction and cholestasis. .
Nandrolone decanoate is slowly released from the injection site into the blood with a half-life of 6 days. In the blood, the ester is rapidly hydrolysed to nandrolone 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 3-4 hours. Nandrolone is metabolised by the liver, 19-norandrosterone, 19-norepiandrosterone and 19-noretiocholanolone have been identified as metabolites in the urine. It is not know whether these metabolites display a pharmacological action.
Anaemia of chronic renal failure Males : 200 mg every week •Females : 100 mg every week
Aplastic Anaemia . 50-150 mg every week
Anaemia due to cytotoxic therapy 200mg every week, starting 2 week prior to the course of cytotoxic therapy. This treatment should be continued throughout cytotoxic therapy and thereafter during the recovery period until the blood count has returned to normal. or as prescribed by the physician.
N.B:- Treatment with Deka-Duralin “100” does not substitute for other therapeutic measures.
– The onset of a therapeutic effect may vary widely among patients. If no satisfactory response occurs after 3-6 months of treatment, administration should be discontinued.
– After a satisfactory improvement or a normalisation of the red blood picture has been obtained, treatment should be withdrawn gradually on the basis of regular monitoring of the haematologlcal parameters. Should a relapse occur at any time ‘whilst the dose is being reduced or after stopping the treatment, re-institution of therapy should be considered.
– A dosage scheme for children cannot be given because of insufficient clinical experience.
Deka-Duralin “100” should be administered by .deep intramuscular injection.
– Know or suspected carcinoma of the prostate or breast in the male.
Use During Pregnancy and Breast-Feeding
This medicine is contraindicated during pregnancy because of possible mas£ulinization of the foetus. There are insufficient data on the use of the medicine during breast, feeding to assess potential harm to the infant or a possible influence on milk production.
Warnings and Precautions
– The recommended dosages should not be exceeded.
– If signs of virilisation develop, discontinuation of the treatment should be considered preferably in consultation with the patient.
– It is recommended to monitor patients with any of the following conditions:
– Latentorovertcardiac-failure; renaldysfunction, hypertensionormigraine(ora-history • of these conditions,) since-anabolic steroids may occasionally induce fluid retention:
– incomplete statural growth , since anabolic steroids in high dosages may accelerate epiphyseal closure:
– Skeletal metastasis of breast carcinoma. In these patients hypercalcaemia may develop both spontaneously and as a result of anabolic steroid therapy. The later can be indicative of a positive tumour response to the hormonal treatment. Nevertheless, the hypercalcaemia should first be treated appropriately and after restoration of normal calcium levels hormone therapy can be resumed.
® Liver Dysfunction.
– The use of anabolic steroids to enhance athletic ability may carry severe risks to the user’s health and should be discouraged.
Anabolic steroids may improve glucose tolerance and decrease the need for insulin or other antidiabetic medicines in diabetes.
Although only one possible case of interaction with an oral anticoagulant has been observed, .it is advisable to check the prothrombin time regularly when Deka-Duralin “100” is used in patients on anticoagulant therapy.
The High dosages, which are required to obtain a therapeutic effect in the indications mentioned may cause:
– Virilistion which appears in sensitive women as hoarseness, acne, hirsutism and increase of libido; in prepubertal boys as an increased frequency of erections-and phallic enlargement, and in girls as an increase of public hair and clitoral hypertrophy, Hoarseness may be the first symptom of vocal change which may end in a long lasting, sometimes irreversible deepening of the voice.
– Inhibition of spermatogenesis,
– Premature epiphyseal closure.
– Fluid retention.
– Occasionally, abnormal values in some liver function tests. These changes appear to “be reversible after completion of the treatment course.
The acute toxicity of nandrolone decanoate in animals is very-low. There are no reports of acute overdosage with Deka-Duralin “100” in the human;
To be sold on the prescription of a registered medical practitioner only.
Store at 8-30°C. Protect from light.
Keep out of the reach of children.