Nandrolone decanote Injection USP 50mg/1ml in Prefilled Syringe Taj Pharma

  1. Name of the medicinal product

Nandrolone decanote Injection USP 50mg/1ml in Prefilled Syringe Taj Pharma

  1. Qualitative and quantitative composition
    a) Nandrolone decanote Injection USP 50mg/1ml in Prefilled Syringe

Each ml Contains:

Nandrolone Deconoate                       50mg

Benzyl Alcohol                                1.5%v/v

Arachis Oil                                               q.s

For the full list of excipients, see section 6.1.

  1. Pharmaceutical form

Prefilled syringe.

  1. Clinical particulars

4.1 Therapeutic indications

For use in osteoporosis in post-menopausal women.

Established osteoporosis should have been diagnosed by the following parameters:

  1. i) crush or wedge fractures of the vertebrae
  2. ii) other osteoporotic fractures

iii) established reduction in bone mineral content as measured by accepted BMC measurements.

4.2 Posology and method of administration

Posology:

Post-menopausal women

50mg every three weeks

The 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:

Nandrolone decanote should be administered by deep intramuscular injection

4.3 Contraindications

Pregnancy (see section 4.6).

Breast-feeding

Porphyria

Hypersensitivity to the active substance or to any of the excipients, including arachis oil. Nandrolone decanote is therefore contraindicated in patients allergic to peanuts or soya (see section 4.4).

4.4 Special warnings and precautions for use

Medical examination:

Physicians should consider monitoring patients receiving Nandrolone decanote before the start of treatment, at quarterly intervals for the first 12 months and yearly thereafter for the following parameters:

  • Hematocrit and hemoglobin to exclude polycythemia.

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 – Nandrolone decanote can improve glucose tolerance in diabetic patients (see section 4.5).
  • Anti-coagulant therapy – Nandrolone decanote 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 Nandrolone decanote 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 Nandrolone decanote 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.

Drug abuse and dependence:

Anabolic androgenic steroids have been subject to abuse, typically at doses higher than recommended for the approved indication(s) and in combination with testosterone. Abuse of anabolic androgenic steroids including testosterone can lead to serious adverse reactions including: cardiovascular (with fatal outcomes in some cases), hepatic and/or psychiatric events. Anabolic androgenic steroid abuse may result in dependence and withdrawal symptoms upon significant dose reduction or abrupt discontinuation of use. The abuse of anabolic androgenic steroids including testosterone carries serious health risks and is to be discouraged.

Excipients:

Nandrolone decanote 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 Nandrolone decanote (see section 4.3).

Nandrolone decanote 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 Nandrolone decanote in high dosages may accelerate epiphyseal closure and sexual maturation.

4.5 Interaction with other medicinal products and other forms of interaction

Enzyme-inducing agents may decrease and enzyme-inhibiting drugs may increase nandrolone levels. Therefore, adjustment of the dose of Nandrolone decanote may be required.

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 Nandrolone decanote treatment.

Anti-coagulant therapy:

High doses of Nandrolone decanote 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 Nandrolone decanote with rhEPO (recombinant human erythropoietin), especially in females, may enable a reduction of the erythropoietin dose to reduce anemia.

4.6 Pregnancy, lactation and fertility

Nandrolone decanote is contra-indicated in women who are pregnant (see section 4.3).

Pregnancy

There are no adequate data for the use of Nandrolone decanote in pregnant women. In view of the risk of virilisation of the foetus, Nandrolone decanote should not be used during pregnancy. Treatment with Nandrolone decanote should be discontinued when pregnancy occurs.

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, Nandrolone decanote should not be used during lactation.

Fertility:

In men treatment with Nandrolone decanote 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).

4.7 Effects on ability to drive and use machines

Nandrolone decanote has no influence on the ability to drive and use machines.

4.8 Undesirable effects

Due to the nature of Nandrolone decanote , side effects cannot be quickly reversed by discontinuing medication. Injectables in general, may cause local reaction at the injection site.

Nandrolone decanote at the recommended dosages is unlikely to produce virilising effects. High dosages, prolonged treatment and/or too frequent administration may cause:

System Organ ClassMedDRA term
Endocrine disordersVirilism
Metabolism and nutrition disordersLipids abnormal1
Psychiatric disordersLibido increased
Vascular disordersHypertension
Respiratory, thoracic and mediastinal disordersDysphonia
Gastrointestinal disordersNausea
Hepatobiliary disordersHepatic function abnormal

Peliosis hepatis

Liver tumours

Skin and subcutaneous tissue disordersAcne

Pruritus

Hirsutism

Renal and urinary disordersUrine flow decreased
Reproductive system and breast disordersEnlarged clitoris
General disorders and administration site conditionsOedema

Injection site reaction

Sodium retention

InvestigationsHaemoglobin increased
  1. Decrease in serum LDL-C, HDL-C and triglycerides.

Virilisation which appears in sensitive women as hoarseness, acne, hirsutism and increase of libido. Hoarseness may be the first symptom of vocal change which may end in long-lasting, sometimes irreversible deepening of the voice.

The terms used to describe the undesirable effects above are also meant to include synonyms and related terms.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important.

4.9 Overdose

The acute toxicity of nandrolone decanoate in animals is very low. There are no reports of acute overdosage with Nandrolone decanote in the human.

  1. Pharmacological properties

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Anabolic steroids.

Nandrolone is chemically related to testosterone and shows enhanced anabolic and a reduced androgenic activity.

In humans Nandrolone decanote has been shown to positively influence calcium metabolism and to increase bone mass in osteoporosis.

Androgenic effects (e.g. virilisation) are relatively uncommon at the recommended dosages. Nandrolone lacks the C17 alpha-alkyl group which is associated with the occurrence of liver dysfunction and cholestasis.

5.2 Pharmacokinetic properties

Absorption

Nandrolone decanoate is slowly released from the injection site into the blood with a half-life of 6 days.

Distribution

The 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 excretion

Nandrolone 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.

5.3 Preclinical safety data

Toxicity studies in animals after repeated dosing did not indicate a safety risk for humans. No formal studies to assess reproduction toxicity, genotoxicity and carcinogenicity have been conducted by the company. As a class, anabolic steroids are considered to be probably carcinogenic to humans (IARC Group 2a).

The use of androgens in different species has resulted in virilisation of the external genitals of female foetuses. Investigations into the genotoxic potential of nandrolone showed it to be positive in an in vitro micronucleus assay and an in vivo micronucleus assay in mouse but not rat, and in the comet assay of mouse and rat. The clinical relevance of these findings is unknown, therefore the risk to patients cannot be ruled out.

  1. Pharmaceutical particulars

6.1 List of excipients

Benzyl alcohol Arachis oil

6.2 Incompatibilities

None known

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

Nandrolone 50 mg/ml solution for injection: 1 ml Prefilled syringes.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal and other handling

No special requirements for disposal.

7.Manufactured in India by:

TAJ PHARMACEUTICALS LTD.

Mumbai, India

Unit No. 214.Old Bake House,

Maharashtra chambers of Commerce Lane,

Fort, Mumbai – 400001

at:Gujarat, INDIA.

Customer Service and Product Inquiries:

1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)

Monday through Saturday 9:00 a.m. to 7:00 p.m. EST

E-mail: tajgroup@tajpharma.com

Nandrolone decanoate Injection USP 50mg/1ml in Prefilled Syringe Taj Pharma

Package leaflet: Information for the patient

 (Nandrolone decanoate)

Read all of this leaflet carefully before this medicine is administered because it contains important information for you.

  • Keep this leaflet. You may need to read it
  • If you have any further questions ask your doctor, pharmacist or
  • This medicine has been prescribed for you Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
  • If you get any side effects talk to your doctor, pharmacist or This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
  1. What Nandrolone decanoate is and what it is used for
  2. What you need to know before Nandrolone decanoate is given to you
  3. How Nandrolone decanoate is given to you
  4. Possible side effects
  5. How to store Nandrolone decanoate
  6. Contents of the pack and other information
1.What Nandrolone decanoate is and what it is used for

Nandrolone decanoate is a clear yellow oily solution for injection containing 50 mg/ml of the active ingredient nandrolone decanoate.

The active substance, nandrolone decanoate belongs to the group of medicines known as anabolic steroids that help to prevent bone loss.

Nandrolone decanoate is used in osteoporosis, when bones thin and become brittle, after the menopause.

2.What you need to know before Nandrolone decanoate is given to you
Do not receive Nandrolone decanoate:
  • If you are pregnant or think you may be pregnant (see section 2 “pregnancy, breast-feeding and fertility”).
  • If you are allergic to nandrolone decanoate or any of the ingredients of this medicine (listed in section 6).
  • In children under the age of 3
  • If you have porphyria (an inherited blood disorder).If you are allergic to peanuts or soya (see section 2 “Nandrolone decanoate contains Arachis oil (peanut oil) and Benzyl alcohol”).
Warnings and precautions

If you notice any signs of masculinization (for instance lowering of the voice or increase in body or facial hair), consult your doctor immediately.

Extra supervision by your doctor may be necessary in some cases; particularly the elderly. At regular intervals, blood tests will be done to check the oxygen-carrying substance in your red blood cells (haemoglobin). In very rare cases the number of red blood cells will increase too much leading to complications.

Medical checks may also be necessary in some other conditions.

Talk to your doctor, pharmacist or nurse before Nandrolone decanoate is given to you if you have ever had, still have or are suspected to have:

  • breast cancer which has spread to the bones;
  • Kidney or lung cancer
  • heart disease
  • kidney disease
  • liver disease
  • high blood pressure
  • diabetes mellitus
  • epilepsy
  • migraine
Other medicines and Nandrolone decanoate

Tell your doctor, pharmacist or nurse if you are taking, have recently taken, or might take any other medicines-even those not prescribed.

Other medicines may affect how Nandrolone decanoate works or Nandrolone decanoate may affect how they work. Therefore; you must tell your doctor, pharmacist or nurse if you are using, or about to use:

  • Insulin and/or other medicines to control your blood sugar
  • Erythropoietin (medicine to reduce anemia);
  • Medicines to reduce the clotting of your blood (anti-coagulants)

 

The use of anabolic steroids like Nandrolone decanoate may lead to a reduction of the doses of these medicines.

Also, tell your doctor, pharmacist or nurse if you are using or about to use the hormone ACTH or corticosteroids (used to treat various conditions such as rheumatism, arthritis, allergic conditions and asthma). The use of anabolic steroids like Nandrolone decanoatemay increase the risk of water retention especially if your heart and liver are not working properly.

Laboratory tests:

Anabolic steroids may also affect the results of some laboratory tests (e.g. thyroid gland). Therefore, you must tell your doctor or the laboratory staff performing the tests that you are using this medicine.

Nandrolone decanoate with food and drink

This medicine can be injected without taking consideration of meals and drinks.

Pregnancy, breast-feeding and fertility

This medicine must not be taken by women who are pregnant or think that they are pregnant, or by women who are breast-feeding.

In women, treatment with Nandrolone decanoate can lead to an irregular or absent menstrual cycle.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor, pharmacist or nurse for advice before taking any medicine.

Driving and using machines

As far as is known, Nandrolone decanoate has no influence on driving and using machines.

Nandrolone decanoate contains Arachis oil (peanut oil) and Benzyl alcohol

This medicine also contains:

  • Arachis oil (peanut oil) – If you are allergic to peanut or soya, you should not be given this medicine (see “Do not receive Nandrolone decanoate”).
  • Benzyl alcohol (100 mg per ml solution) – Products containing benzyl alcohol must not be given to premature babies or Benzyl alcohol may cause toxic reactions and allergic reactions in infants and children up to 3 years old.
    Improper use

Nandrolone is classified as a prohibited substance under the Olympic Movement Anti-doping Code (OMAC 1999). The misuse of this medicine to enhance ability in sports carries serious health risks and is to be discouraged.

Drug abuse and dependence

This medicine should only be given by a doctor or nurse and used exactly as your doctor has told you. Abuse of anabolic androgenic steroids, especially if you use too much of this medicine alone or with testosterone, can cause serious health problems to your heart and blood vessels (that can lead to death), mental health and/or the liver. Individuals who have abused anabolic androgenic steroids may become dependent and experience withdrawal symptoms when the dosage changes significantly or is stopped immediately. You should not abuse this medicine alone or with testosterone because it carries serious health risks.

3.How Nandrolone decanoate is given to you

This medicine should only be given by a doctor or a nurse. The injections are given deeply into a muscle (for instance in the buttock, upper leg or upper arm.)

The dose depends on your illness and how bad it is. Your doctor will decide the dose.

If you receive more Nandrolone decanoate than you should

Your doctor or nurse will inject this medicine into you. If you have the impression that the effect of this medicine is too strong then please talk to your doctor or nurse immediately.

If you forgot to get your injection of Nandrolone decanoate

Your doctor or nurse will inject this medicine into you. Should you miss a scheduled injection then please talk to your doctor or nurse as soon as possible. No double dose should be injected to make up for forgotten individual doses.

If you stop treatment with Nandrolone decanoate

The effects of this medicine do not stop immediately after discontinuation, but gradually subside. When treatment with this medicine is stopped, complaints such as those experienced before treatment may re- occur within a few weeks.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

4.Possible side effects

Like all medicines this medicine can cause side effects, although not everybody gets them. Dependent on

the dose, frequency and total period of administration of Nandrolone decanoate the following undesirable effects may occur:

  • Fluid retention in the tissues, usually marked by swelling of the ankles or feet or increased blood pressure
  • An increase in male characteristics in women; your voice may get deeper and you may notice some hair growth or acne
  • Acne
  • Increased sexual desire
  • Nausea
  • Itching
  • Increased haemoglobin
  • Changes in blood lipids
  • Abnormal liver function
  • Liver anatomy changes
  • Hoarseness
  • Change of the voice
  • Increased body or facial hair
  • Enlargement of the clitoris
  • Masculinization
  • Abnormal blood tests

Nandrolone decanoate may affect some liver tests or may cause liver tumours, although very rarely. Due to the nature of Nandrolone decanoate, side effects cannot be quickly reversed by discontinuing medication.

Injectables, in general, may cause local reaction at the injection site.

Reporting of side effects

If you get any side effects talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.

5.How to store Nandrolone decanoate

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the carton or label after the term “exp.” (expiry date). The expiry date refers to the last day of that month.

Store below 30ºC. Do not refrigerate or freeze.

Store in the original package in order to protect from light. Do not throw away medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6.Contents of the pack and other information What Nandrolone decanoate contains
  • The active substance is Nandrolone decanoate, 50 mg per ml
  • The other ingredients are 100mg/ml benzyl alcohol and Arachis
What Nandrolone decanoate looks like and contents of the pack

Nandrolone decanoate50 mg solution for injection is a slightly yellow, oily solution filled in a 1ml clear glass ampoule and sold in packs of 1, 3 or 6 ampoules

7.Manufactured in India by:

TAJ PHARMACEUTICALS LTD.

Mumbai, India

Unit No. 214.Old Bake House,

Maharashtra chambers of  Commerce Lane,

Fort, Mumbai – 400001

at:Gujarat, INDIA.

Customer Service and Product Inquiries:

1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)

Monday through Saturday 9:00 a.m. to 7:00 p.m. EST

E-mail: tajgroup@tajpharma.com