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Testosterone Enantate Ampoules

Last Updated on eMC 02-Dec-2016 View document  | Alliance Pharmaceuticals Contact details

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC.  For each version, we show the dates it was published on the eMC and the reasons for change.

Updated on 02-Dec-2016 and displayed until Current

Reasons for adding or updating:

  • Change to section 4.4 - Special warnings and precautions for use

Date of revision of text on the SPC: 21-Oct-2016

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



 

4.4    Special warnings and precautions for use

    
Clotting disorders

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.

Updated on 15-Jan-2016 and displayed until 02-Dec-2016

Reasons for adding or updating:

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Fertility, pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 6.2 - Incompatibilities

Date of revision of text on the SPC: 05-Jan-2016

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Changes are highlighted in red text below:

4.5    Interaction with other medicinal products and other forms of interaction

 

Barbiturates and other enzyme inducers

Interactions can occur with drugs that induce microsomal enzymes which can result in increased clearance of testosterone Phenobarbital increases the break-down of steroid hormones in the liver (possible impairment of efficacy).

 

Oxyphenbutazone

Increased oxyphenbutazone serum levels have been reported.

 

Oral anticoagulants

The clotting status should be monitored particularly closely when Testosterone Enantate is administered together with coumarin derivatives.

 

Hypoglycaemics

The hypoglycaemic effect of antidiabetics may be enhanced, possibly requiring a reduction in dosage of the hypoglycaemic agent.

 

 

4.6    Fertility, pregnancy and lactation

Pregnancy

Testosterone Enantate is intended for use by men only. Testosterone Enantate is not indicated in pregnant or breast feeding women (see 5.3 Preclinical safety data).

 

Lactation

Testosterone Enantate is intended for use by men only.  Testosterone Enantate is not indicated in breast feeding women (see 5.3 Preclinical safety data).

 

Fertility

Testosterone Enantate replacement therapy may reversibly reduce spermatogenesis (see 4.8 Undesirable effects and 5.3 Preclinical safety data).

 

4.8    Undesirable effects

Undesirable effects are listed by MedDRA System Organ Classes.

Assessment of undesirable effects is based on the following frequency groupings:

Very common: ≥1/10

Common: ≥1/100 to <1/10

Uncommon: ≥1/1,000 to <1/100

Rare: ≥1/10,000 to <1/1,000

Very rare: <1/10,000

Not known: cannot be estimated from the available data

 

 

Tabulated list of adverse reactions

The table below includes adverse drug reactions from spontaneous reporting and from the scientific literature for which a frequency cannot be estimated from the available data.

 

System Organ Class

Undesirable effectFrequency Common

Frequency Unknown

Neoplasms benign, malignant and unspecified (including cysts and polyps)

Benign tumour of liver

 

Malignant liver tumour

Not knownBenign tumour of liver

 

Malignant liver tumour

Blood and lymphatic

system disorders

 

 

 

 

 

 

Polycythaemia

 

Not known

Haematocrit increased,

 

Red blood cell count increased,

 

Haemoglobin increased

 

CommonPolycythaemia

 

Immune system disorders

Hypersensitivity

 

Not knownHypersensitivity

Metabolism and nutrition disorders

Hypercalcaemia

 

Water retention

 

Not knownHypercalcaemia

Water retention

Psychiatric disorders

Depression

 

Anxiety

 

Not knownDepression

Anxiety

Nervous system disorders

Headache

 

Paraesthesia

 

Not knownHeadache

Paraesthesia

Cardiac disorders

Disorder circulatory system

 

Not knownDisorder circulatory system

Gastrointestinal disorders

Abdominal disorder

 

Intra-abdominal haemorrhage

 

Nausea

 

Not knownAbdominal disorder

Intra-abdominal haemorrhage

Nausea

Hepatobiliary disorders

Liver function test abnormal

 

Jaundice

 

Liver enlargement

 

Not knownLiver function test abnormal

Jaundice

Liver enlargement

Skin and subcutaneous

tissue disorders

Acne

 

Alopecia

 

Rash

 

Urticaria

 

Pruritus

 

Male pattern baldness

 

Hair growth increased

 

Not knownAcne

Alopecia

Rash

Urticaria

Pruritus

Male pattern baldness

Musculoskeletal and connective tissue disorders

Premature epiphyseal closure*

 

Bone formation increased

 

Not knownPremature epiphyseal closure*

Bone formation increased

General disorders and

administration site

conditions

Injection site reaction**

 

Asthenia

 

Oedema

 

Not knownInjection site reaction**

Asthenia

Oedema

Investigations

Prostatic specific antigen increased

 

Not knownProstatic specific antigen increased

Reproductive system and

breast disorders

Libido increased

 

Libido decreased

 

Gynaecomastia

 

Prostatic disorder

 

Erection increased

 

Spermatogenesis abnormal

 

Precocious puberty*

 

Not knownLibido increased

Libido decreased

Gynaecomastia

Prostatic disorder

Erection increased

Spermatogenesis abnormal

Precocious puberty*

 

 






























































































6.2
   Incompatibilities

 

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.None so far known.

Updated on 06-Mar-2015 and displayed until 15-Jan-2016

Reasons for adding or updating:

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.8 - Undesirable effects - how to report a side effect

Date of revision of text on the SPC: 24-Feb-2015

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Changes are highlighted in red text below:

4.1
     
Therapeutic indications


Androgen deficiency in the male
.
Testosterone replacement therapy for male hypogonadism, when testosterone deficiency has been confirmed by clinical features and biochemical tests.

 

4.4    Special warnings and precautions for use


There is limited experience on the safety and efficacy of the use of
Testosterone Enantate in patients over 65 years of age.  Currently, there is no consensus about age specific testosterone reference values. However, it should be taken into account that physiologically testosterone serum levels are lower with increasing age.

Haemoglobin and haematocrit should be checked periodically in patients on long-term androgen therapy to detect cases of polycythaemia (see section 4.8 Undesirable effects

In patients receiving long-term androgen therapy, the following laboratory parameters should also be monitored regularly: haemoglobin and haematocrit (to detect cases of polycythaemia), liver function tests and lipid profile.

Testosterone Enantate should be used with caution in patients with cardiac impairment (including ischaemic heart disease), hypertension, epilepsy, migraine, diabetes mellitus or skeletal metastases.  

In patients suffering from severe cardiac, hepatic or renal insufficiency or ischaemic heart disease, treatment with testosterone may cause severe complications characterised by oedema with or without congestive cardiac failure. In such case, treatment must be stopped immediately.

Testosterone may cause a rise in blood pressure and Testosterone Enantate should be used with caution in men with hypertension.

Testosterone Enantate should be used with caution in patients with epilepsy, migraine, diabetes mellitus or skeletal metastases.

Testosterone level should be monitored at baseline and at regular intervals during treatment. Clinicians should adjust the dosage individually to ensure maintenance of eugonadal testosterone levels.

 

4.8     Undesirable effects

 

System Organ Class

Frequency Common

Frequency Unknown

Blood and lymphatic

system disorders

Haematocrit increased, Red blood cell count increased, Haemoglobin increased

Polycythaemia

 

 
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

Updated on 04-Mar-2014 and displayed until 06-Mar-2015

Reasons for adding or updating:

  • Change to section 1 - Name of the medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Fertility, pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.6 - Special precautions for disposal and other handling

Date of revision of text on the SPC: 20-Feb-2014

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



 

1.         NAME OF THE MEDICINAL PRODUCT

 

Testosterone Enantate 250 mg/ ml Solution for Injection. Ampoules

 

2.         QUALITATIVE AND QUANTITATIVE COMPOSITION

 

Each 1ml ampoule contains 250mg Testosterone Enantate (the equivalent of about 180 mg testosterone)Ph.Eur in oily solution.

For the full list of excipients, see section 6.1.

 

3.         PHARMACEUTICAL FORM

 

Clear, yellowish oily solution.

 

4.         CLINICAL PARTICULARS

 

4.1      Therapeutic indications

 

Mammary carcinoma in the female.

Androgen deficiency in the male.

 

4.2      Posology and method of administration

 

Solution 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.

Females - mammary carcinoma: 250mg every two weeks by intramuscular injection.

Males - Hypogonadism: To stimulate development of underdeveloped androgen-dependent organs and for initial treatment of deficiency symptoms, 250mg Testosterone Enantate intramuscularly every two to three weeks.

 

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.

Special populations

Children and adolescents

Testosterone 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 patients

Limited 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 impairment

No 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 impairment

No formal studies have been performed in patients with renal impairment.

4.3      Contraindications

·             

·         Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

·         Androgen-dependent carcinoma of the prostate or of the male mammary gland Prostatic carcinoma, mammary carcinoma in males,

·         Hhypercalcaemia,

·         Past or present liver tumours

·         Nnephrosis,

·            pregnancy and breast feeding. Previous or existing liver tumours (in advanced mammary carcinoma in the female only) if these are not due to metastases.

 

4.4      Special warnings and precautions for use

 

Older patients treated with androgens may be at increased risk for the development of prostatic hyperplasia.  Although there are no clear indications that androgens actually generate prostatic carcinoma, these can enhance the growth of any existing prostatic carcinoma. Therefore carcinoma of the prostate has to be excluded before starting therapy with testosterone preparations.

As a precaution, regular examinations of the prostate are recommended in men.

Haemoglobin and haematocrit should be checked periodically in patients on long-term androgen therapy to detect cases of polycythaemia (see section 4.8 Undesirable effects)

Testosterone Enantate should be used with caution in the elderly and in patients with renal, hepatic or cardiac impairment (including ischaemic heart disease), hypertension, epilepsy, migraine, diabetes mellitus or skeletal metastases.     

Cases of benign and malignant liver tumours, which may lead to life-threatening intra-abdominal haemorrhage, have been observed after the use of Testosterone Enantate. If severe upper abdominal complaints, liver enlargement or signs of intra-abdominal haemorrhage occur, a liver tumour should be included in the differential-diagnosis and, if necessary, the preparation should be withdrawn.

Caution should be exercised in patients predisposed to oedema, as treatment with androgens may result in increased sodium retention (see 4.8 Undesirable effects).     

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.

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.

High dose or long term administration of testosterone occasionally increases the tendency to water retention and oedema. Caution should therefore be exercised in patients predisposed to oedema.

 

In rare cases benign and in even rarer cases malignant liver tumours leading in isolated cases to life-threatening intra-abdominal haemorrhage have been observed after the use of hormonal substances such as Testosterone Enantate. If severe upper abdominal complaints, liver enlargement or signs of intra-abdominal haemorrhage occur, a liver tumour should be included in the differential diagnosis and, if necessary, the preparation should be withdrawn. Regular examination of the prostate is advisable for men receiving androgen therapy.

In women: If hypercalcaemia develops, therapy must be discontinued.

 

4.6   Fertility, pregnancy and lactation

 

Contra-indicated in pregnancy.

Testosterone Enantate is intended for use by men only. Testosterone Enantate is not indicated in pregnant or breast feeding women (see 5.3 Preclinical safety data).

Testosterone Enantate replacement therapy may reversibly reduce spermatogenesis (see 4.8 Undesirable effects and 5.3 Preclinical safety data).

 

4.8   Undesirable effects

Tabulated list of adverse reactions

The table below includes adverse drug reactions from spontaneous reporting and from the scientific literature for which a frequency cannot be estimated from the available data.

 

System Organ Class

Frequency Unknown

Neoplasms benign, malignant and unspecified (including cysts and polyps)

Benign tumour of liver

 

Malignant liver tumour

 

 

Blood and lymphatic

system disorders

Polycythaemia

Immune system disorders

Hypersensitivity

Metabolism and nutrition disorders

Hypercalcaemia

Water retention

Psychiatric disorders

Depression

Anxiety

Nervous system disorders

Headache

Paraesthesia

Cardiac disorders

Disorder circulatory system

Gastrointestinal disorders

Abdominal disorder

Intra-abdominal haemorrhage

Nausea

Hepatobiliary disorders

Liver function test abnormal

Jaundice

Liver enlargement

 

Skin and subcutaneous

tissue disorders

Acne

Alopecia

Rash

Urticaria

Pruritus

Male pattern baldness

Musculoskeletal and connective tissue disorders

Premature epiphyseal closure*

Bone formation increased

General disorders and

administration site

conditions

Injection site reaction**

Asthenia

Oedema

 

Investigations

Prostatic specific antigen increased

Reproductive system and

breast disorders

Libido increased

Libido decreased

Gynaecomastia

Prostatic disorder

Erection increased

Spermatogenesis abnormal

Precocious puberty*

 

 

 

*In pre-pubertal males

 

**Injection site pain, Injection site erythema, Injection site induration, Injection site swelling, Injection site inflammation

Description of selected adverse reactions

Injections 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.

Water retention and oedema (associated with high doses or long term administration), severe upper abdominal complaints, liver tumours or enlargement, intra-abdominal haemorrhage, prostate abnormalities, hypercalcaemia and frequent or persistent erections may occur. See section 4.4 Special Warnings and Special Precautions for Use for further information on these undesirable effects.

Women treated with Testosterone Enantate may develop signs of virilization, (e.g. acne, hirsutism, voice changes). Particular care is therefore necessary in women whose occupations involve singing or speaking.

Spermatogenesis is inhibited by long-term and high-dose treatment with Testosterone Enantate.

In rare cases, coughing, dyspnoea and circulatory irregularities may occur during or immediately after the injection. Experience has shown that these reactions can be avoided by injecting very slowly.

Other undesirable effects that have been reported are headache, depression, nausea, cholestatic jaundice, gynaecomastia, polycythaemia, anxiety, asthenia, generalised paraesthesia, increased bone growth, male pattern baldness, precocious sexual development and premature closure in pre-pubertal males.

 

4.9   4.9   Overdose

 

No special therapeutic measure apart from termination of therapy with the drug or dose reduction is necessary after overdosage.

 

5.         PHARMACOLOGICAL PROPERTIES

 

5.1      Pharmacodynamic properties

 

Pharmacotherapeutic group:

Androgens, 3-oxoandrosten (4) derivatives

 

ATC Code: G03BA03

 

5.3   5.3  Preclinical safety data

 

Administration of Testosterone Enantate should not be administered is contraindicated during pregnancy due to the possibility of virilisation of the female foetus.

 

6.6   Special precautions for disposal of a used medicinal product or waste materials         derived from such medicinal product and other handling of the product (use           “Instructions for use, handling and disposal" on eMC/IPHA

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Updated on 02-Feb-2011 and displayed until 04-Mar-2014

Reasons for adding or updating:

  • Change to section 7 - Marketing Authorisation Holder

Date of revision of text on the SPC: 10-Jan-2011

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Change of Marketing Authorisation Holder from Cambridge Laboratories to Alliance Pharmaceuticals Ltd

Updated on 30-Sep-2003 and displayed until 02-Feb-2011

Reasons for adding or updating:

  • Correction of spelling/typing errors
  • Change to section 5.2 - Pharmacokinetic Properties

Updated on 26-Nov-2001 and displayed until 30-Sep-2003

Reasons for adding or updating:

  • Correction of spelling/typing errors

Updated on 06-Jul-2001 and displayed until 26-Nov-2001

Reasons for adding or updating:

  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC

Updated on 06-Sep-1999 and displayed until 06-Jul-2001

Reasons for adding or updating:

  • No reasons supplied

Company contact details

Alliance Pharmaceuticals

Company image
Address

Avonbridge House, Bath Road, Chippenham, Wiltshire, SN15 2BB

Fax

+44 (0)1249 466 977

Telephone

+44 (0)1249 466 966

Medical Information e-mail

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Active ingredients

testosterone enantate

Legal categories

POM - Prescription Only Medicine

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