• DECANDROL Balkan Pharmaceuticals

Nandrolone decanoate

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

• Keep this leaflet. You may need to read it again.

• If you have any further questions, ask your doctor or pharmacist or nurse.

• This medicine has been prescribed for you only. You do not have to give it to others. It can harm them, even if they have the same signs of illness as yours.

• If you have any side effects, talk to your doctor or pharmacist or nurse. These include any possible side effects not mentioned in this leaflet. See section 4.

What you find in this leaflet:

1. What Decandrol is and what it is used for

2. What you need to know before you use Decandrol

3. How to use Decandrol

4. Possible side effects

5. How to store Decandrol

6. Packaging content and other information


1. What Decandrol is and what it is used for

Decandrol injection can be used during recovery therapy after a disease (rebound period) and for the treatment of anemia resulting from chronic renal failure.

2. What you need to know before you use Decandrol

Do not use Decandrol injection if you are allergic (hypersensitive) to the active substance or any of the other ingredients of Decandrol.

You should not take Decandrol if you are pregnant or breast-feeding. Additional contraindications are prostate carcinoma or breast carcinoma in men.

Decandrol injection is not recommended for children and adolescents below the age of 18 due to a lack of data on safety and efficacy.

Take special care with Decandrol injections

Treatment with Decandrol requires caution in the case (or antecedents) of heart and circulatory disorders, liver and kidney dysfunction, as well as epilepsy, migraine and glaucoma.

During treatment with Decandrol it is recommended to check the intraocular pressure (eg eye pressure) regularly that there is a chance of retention of sodium and water. Hepatic impairment may occur, hepatic function testing should therefore be performed after 4 weeks of treatment.

Before initiating the treatment and later on, prostate rectal control is recommended during the treatment. In diabetes, it is advisable to adjust the doses of anti-hyperglycaemic agents.

In patients with malignant tumors the duration of treatment will be determined individually and according to liver parameters.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Other medicines (blood glucose lowering medicines called antidiabetic medicines and so-called coumarin derivatives used to prevent blood clotting) may affect the effect of Decandrol.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine.

Decandrol should not be used during pregnancy and lactation.

Driving and using machines

Treatment with Decandrol has no influence on the ability to drive and use machines.

Important information about some ingredients of Decandrol

Decandrol contains benzyl alcohol, so Decandrol will not be used in patients with allergy to benzyl alcohol.

3. How to use Decandrol

Decandrol should always be used in the dose, in the manner and for the time period prescribed by your doctor.

The usual dose is the following:

Anemia resulting from chronic renal failure:

Men: 200 mg/week administered as a muscle injection.

Women: 100 mg/week, injected into the muscle.

Period of convalescence:

Adults: 50 mg every 3-4 weeks, deeply intramuscularly.

If you get more Decandrol than you should

Cases of overdose have not been reported. In the case of abuse of preparations containing nandrolone (high doses as anabolic remedy) severe endocrine, metabolic and psychiatric adverse reactions are reported.

4. Possible side effects

Like all medicines, Decandrol can cause side effects, although not everybody gets them.

Decandrol injection in therapeutic doses is unlikely can cause side effects. During the prolonged treatment, the following side effects (frequency data not available) were observed:

Hypersensitivity reactions, inhibition of sex hormone secretion;

In women – virilization signs (for example, acne, hirsutism, male alopecia, irreversible thickening of the voice, dysmenorrhea, clitoral hypertrophy). Craving can be the first sign of tonality change, which can be long lasting and sometimes irreversible;

In men can cause gynecomastia and inhibit spermatogenesis.

In adolescent boys, frequent erections and penis enlargement can be observed.

In girls – increased pubic hair and clitoral hypertrophy.

Other side effects: libido change, nausea, vomiting, decreased appetite, stopping or suppressing bile flow, choking, jaundice, , increased blood urea concentration, positive nitrate balance, hypercalcemia (especially in bed care patients, and metastatic breast cancer patients). Change (increase) in liver function indices. Long-term oral administration of C17-alpha-active anabolic steroids has reported rare cases of hepatic tumors. The link between the appearance of hepatic tumors and the injectable administration of C17-alkyl steroids, such as nandrolone ethers, is unlikely, but should not be completely ruled out.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Reporting adverse reactions

If you experience any side effects, talk to your doctor or pharmacist.

These include any possible side effects not mentioned in this leaflet. By reporting side effects, you can help provide additional information on the safety of this medicine.

5. How to store Decandrol

Keep out of the reach and sight of children.

Keep protected from light and temperatures below 25 °C.

Do not use Decandrol after the expiry date which is stated on the pack after “EXP”. The expiration date refers to the last day of that month.

No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer need. These measures will help to protect the environment.

6. Packaging content and other information

What Decandrol 50 mg/ml solution for injection contains

The active substance is nandrolone decanoate.

One milliliter of solution for injection contains 50 mg of nandrolone decanoate.

The other ingredients are: benzylbenzoate, benzyl alcohol, oil of peaches.


What Decandrol 50 mg/ml solution for injection looks like and contents of the pack

Decandrol 50 mg/ml solution for injection is a clear, colorless to light yellow solution.

It is available in 1 ml ampoules in a box of two (2) PVC vials of five (5) ampoules.


What Decandrol 200 mg/ml solution for injection contains

The active substance is nandrolone decanoate.

One milliliter of solution for injection contains 200 mg of nandrolone decanoate.

The other ingredients are: benzylbenzoate, benzyl alcohol, peach oil.


What Decandrol 200 mg/ml solution for injection looks like and contents

Decandrol 200 mg/ml solution for injection is a clear, colorless to light yellow solution.

It is available in 1 ml ampoules in a box of two (2) PVC vials of five (5) ampoules and ten (10) ml vials of one (1) vial in the carton.


CERTIFICATE OF REGISTRATION

SC Balkan Pharmaceuticals SRL N. Grădescu str., 4, MD-2002, or. Chisinau, Republic of Moldova.

The manufacturer

SC Balkan Pharmaceuticals SRL Industrial Street, 7 / A, MD-2091, or. Singera, Republic of Moldova.

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DECANDROL Balkan Pharmaceuticals

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