- 1. Name of the medicinal product
- 2. Qualitative and quantitative composition
- 3. Pharmaceutical form
- 4. Clinical particulars
- 4.1 Therapeutic indications
- 4.2 Posology and method of administration
- 4.3 Contraindications
- 4.4 Special warnings and precautions for use
- 4.5 Interaction with other medicinal products and other forms of interaction
- 4.6 Fertility, pregnancy and lactation
- 4.7 Effects on ability to drive and use machines
- 4.8 Undesirable effects
- 4.9 Overdose
- 5. Pharmacological properties
- 5.1 Pharmacodynamic properties
- 5.2 Pharmacokinetic properties
- 5.3 Preclinical safety data
- 6. Pharmaceutical particulars
- 6.1 List of excipients
- 6.2 Incompatibilities
- 6.3 Shelf life
- 6.4 Special precautions for storage
- 6.5 Nature and contents of container
- 6.6 Special precautions for disposal and other handling
- 7. Marketing authorisation holder
- 8. Marketing authorisation number(s)
- 9. Date of first authorisation/renewal of the authorisation
- 10. Date of revision of the text
Method of AdministrationSolution for intramuscular injection.The injection must be administered extremely slowly (see 4.4 Special warnings and precautions for use and 4.8 Undesirable effects). The oily solution is injected immediately after its drawing up into the syringe.
PosologyTo stimulate development of underdeveloped androgen-dependent organs and for initial treatment of deficiency symptoms, 250mg Testosterone Enantate intramuscularly every two to three weeks.For maintenance treatment: 250mg Testosterone Enantate intramuscularly every three to six weeks, according to individual requirement.Serum testosterone levels should be measured before start of treatment and occasionally during the treatment at the end of an injection interval. Serum levels below normal range would indicate the need for a shorter injection interval. In case of high serum levels an extension of the injection interval may be considered.
Paediatric populationTestosterone Enantate is not indicated for use in children and adolescents (see 4.4 Special warnings and precautions for use).Safety and efficacy have not been adequately determined in children and adolescents.
Elderly patientsLimited data do not suggest the need for a dosage adjustment in elderly patients (see 4.4 Special warnings and precautions for use).
Patients with hepatic impairmentNo formal studies have been performed in patients with hepatic impairment. The use of Testosterone Enantate is contraindicated in men with past or present liver tumours (see 4.3 Contraindications).
Patients with renal impairmentNo formal studies have been performed in patients with renal impairment.
Testosterone should be used with caution in patients with thrombophilia, as there have been post-marketing studies and reports of thrombotic events in these patients during testosterone therapy.In children testosterone, besides masculinisation, can cause accelerated growth and bone maturation and premature epiphyseal closure, thereby reducing final height.Testosterone Enantate should not be used in women since, depending on the individual sensitivity to androgenic impulses, women may develop signs of virilisation, e.g. acne, hirsutism, voice changes.Pre-existing sleep apnoea may be potentiated.Androgens should not be used for enhancing muscular development in healthy individuals or for increasing physical ability.As with all oily solutions, Testosterone Enantate must be injected strictly intramuscularly and very slowly. Pulmonary microembolism of oily solutions can lead to signs and symptoms such as cough, dyspnoea and chest pain. There may be other signs and symptoms including vasovagal reactions such as malaise, hyperhydrosis, dizziness, paraesthesia, or syncope. These reactions may occur during or immediately after the injection and are reversible. Treatment is usually supportive, e.g. by administration of oxygen.If, in individual cases, frequent or persistent erections occur, the dose should be reduced or the treatment discontinued in order to avoid injury to the penis.
Barbiturates and other enzyme inducersInteractions can occur with drugs that induce microsomal enzymes which can result in increased clearance of testosterone
OxyphenbutazoneIncreased oxyphenbutazone serum levels have been reported.
Oral anticoagulantsThe clotting status should be monitored particularly closely when Testosterone Enantate is administered together with coumarin derivatives.
HypoglycaemicsThe hypoglycaemic effect of antidiabetics may be enhanced, possibly requiring a reduction in dosage of the hypoglycaemic agent.
PregnancyTestosterone Enantate is intended for use by men only. Testosterone Enantate is not indicated in pregnant women (see 5.3 Preclinical safety data).
LactationTestosterone Enantate is intended for use by men only. Testosterone Enantate is not indicated in breast feeding women (see 5.3 Preclinical safety data).
FertilityTestosterone Enantate replacement therapy may reversibly reduce spermatogenesis (see 4.8 Undesirable effects and 5.3 Preclinical safety data).
|System Organ Class||Undesirable effect||Frequency|
|Neoplasms benign, malignant and unspecified (including cysts and polyps)||Benign tumour of liver Malignant liver tumour||Not known|
|Blood and lymphatic system disorders||Polycythaemia||Not known|
|Haematocrit increased Red blood cell count increased Haemoglobin increased||Common|
|Immune system disorders||Hypersensitivity||Not known|
|Metabolism and nutrition disorders||Hypercalcaemia Water retention||Not known|
|Psychiatric disorders||Depression Anxiety||Not known|
|Nervous system disorders||Headache Paraesthesia||Not known|
|Cardiac disorders||Disorder circulatory system||Not known|
|Gastrointestinal disorders||Abdominal disorder Intra-abdominal haemorrhage Nausea||Not known|
|Hepatobiliary disorders||Liver function test abnormal Jaundice Liver enlargement||Not known|
|Skin and subcutaneous tissue disorders||Acne Alopecia Rash Urticaria Pruritus Male pattern baldness||Not known|
|Musculoskeletal and connective tissue disorders||Premature epiphyseal closure* Bone formation increased||Not known|
|General disorders and administration site conditions||Injection site reaction** Asthenia Oedema||Not known|
|Investigations||Prostatic specific antigen increased||Not known|
|Reproductive system and breast disorders||Libido increased Libido decreased Gynaecomastia Prostatic disorder Erection increased Spermatogenesis abnormal Precocious puberty*||Not known|
Description of selected adverse reactionsInjections of oily solutions such as Testosterone Enantate have been associated with systemic reactions: cough, dyspnoea, chest pain. There may be other signs and symptoms including vasovagal reactions such as malaise, hyperhydrosis, dizziness, paraesthesia, or syncope.High-dosed or long-term administration of testosterone increases the tendency to water retention and oedema.Spermatogenesis is inhibited by long-term and high-dosed treatment with Testosterone Enantate.If, in individual cases, frequent or persistent erections occur, the dose should be reduced or the treatment discontinued in order to avoid injury to the penis.
Reporting of suspected adverse reactionsReporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
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