Nandrolone Phenylpropionate

1. Name of the product

Nandrolone Phenylpropionate — 100 mg/mL

Sterile oily solution for intramuscular injection.

2. Qualitative and quantitative composition

3. Pharmaceutical form

Sterile oily solution for intramuscular injection. Intramuscular use only. Not for intravenous administration.

4. Clinical particulars

4.1 Indications

Supplied for professional and research applications only. Any therapeutic application is determined exclusively by a qualified physician on the basis of individual clinical assessment. This product is not intended for self-medication.

4.2 Posology and method of administration

As directed by the physician. Dose, injection interval and treatment duration are established by the treating clinician. The solution must be administered by deep intramuscular injection using aseptic technique. Do not exceed the regimen prescribed.

4.3 Contraindications

• Known hypersensitivity to the active substance or to any of the excipients, including benzyl alcohol.
• Carcinoma of the prostate or of the male mammary gland.
• Hypercalcaemia or hypercalciuria associated with malignancy.
• Pregnancy and breast-feeding.
• Severe hepatic, renal or cardiac insufficiency.

4.4 Special warnings and precautions for use

• Androgen administration requires periodic monitoring of haematocrit, hepatic function, lipid profile and, in males, prostate-specific antigen.
• Pre-existing hypertension, epilepsy, migraine, diabetes mellitus or skeletal metastases require heightened supervision, as fluid retention may aggravate these conditions.
• Oil-based formulations carry a risk of pulmonary oil microembolism if inadvertently injected intravascularly; aspirate before injection.
• Benzyl alcohol may cause toxic and anaphylactoid reactions in infants and children up to three years of age.
• Androgens may accelerate the growth of an existing, undiagnosed prostatic carcinoma.

4.5 Interaction with other medicinal products

Androgens may potentiate the anticoagulant effect of coumarin-type agents, requiring more frequent monitoring of prothrombin time. Concurrent use with corticosteroids or corticotropin may increase the risk of oedema. Androgens may reduce blood glucose and therefore insulin or oral antidiabetic requirements. Enzyme-inducing agents may alter plasma concentrations.

4.6 Fertility, pregnancy and lactation

Contraindicated in pregnancy owing to the risk of virilisation of a female foetus, and during breast-feeding. Androgens may impair fertility by suppressing the hypothalamic-pituitary-gonadal axis and spermatogenesis.

4.7 Effects on ability to drive and use machines

No direct effect on the ability to drive or operate machinery is expected.

4.8 Undesirable effects

• Injection site reactions: pain, erythema, induration, transient discomfort.
• Endocrine: suppression of endogenous testosterone production, gynaecomastia, menstrual irregularity, virilisation in females.
• Cardiovascular: fluid retention, elevated blood pressure, adverse shifts in HDL/LDL cholesterol.
• Hepatobiliary: elevation of hepatic transaminases.
• Haematological: increased haematocrit and erythrocyte count.
• Dermatological: acne, seborrhoea, alopecia in predisposed individuals.
• Psychiatric: mood alteration, irritability, disturbed sleep.

If any adverse effect becomes serious, or if an effect not listed in this leaflet is observed, medical advice must be sought without delay.

4.9 Overdose

Acute overdose after intramuscular administration is unlikely. In the event of excessive exposure, discontinue administration and institute symptomatic and supportive care under medical supervision.

5. Pharmacological properties

5.1 Pharmacodynamic properties

Nandrolone binds the cytoplasmic androgen receptor with high affinity and the activated complex regulates transcription at androgen response elements, promoting structural protein synthesis and nitrogen retention in skeletal muscle. Reduction by 5-alpha reductase yields dihydronandrolone, a metabolite of reduced androgenic activity, and aromatisation proceeds at a substantially lower rate than for testosterone.

Pharmacotherapeutic group: Androgens / anabolic steroid, parenteral.

5.2 Pharmacokinetic properties

5.3 Preclinical safety data

Each production lot is released against the full pharmaceutical testing protocol: identity and purity by HPLC (specification ≥ 98 %), verification of concentration against label claim (± 5 %), sterility in accordance with USP <71>, bacterial endotoxin quantification by LAL assay (< 0.25 EU/mL) and inspection of particulate matter in accordance with USP <788>.

6. Pharmaceutical particulars

6.1 List of excipients

Refined carrier oil (vehicle), benzyl alcohol (preservative), benzyl benzoate (co-solvent).

6.2 Incompatibilities

In the absence of compatibility studies this medicinal product must not be mixed with other products in the same syringe.

6.3 Shelf life

36 months from the date of manufacture. Do not use after the expiry date printed on the carton and vial label. Once broached, use within the period advised by the physician.

6.4 Special precautions for storage

Store below 30 °C. Do not refrigerate or freeze. Protect from light. Keep the vial in the outer carton. Keep out of the reach and sight of children.

6.5 Nature and contents of container

Type I amber glass multiple dose vial with bromobutyl rubber closure and aluminium flip-off seal, supplied in a printed outer carton.

6.6 Special precautions for disposal

Any unused product or waste material must be disposed of in accordance with local requirements. Do not dispose of via wastewater or household waste.

7. Authentication

Every unit carries a unique authentication code on the outer packaging. The code confirms that the product originates from Biomedica and has not been substituted. Verify it before use.

8. Manufacturer

Biomedica
Pharmaceutical manufacturing — GMP compliant
biomedicapharmacies@protonmail.com
biomedica.it.com