· Male hypogonadism, documented deficiency in testosterone, whatever its etiology

The oily solution should be administered very slowly (see Warnings and Precautions for Use) and immediately after opening the ampule. It is advisable to use, for the injection, a syringe of glass.

Dosage

250 mg IM every 2 to 4 weeks

Serum testosterone levels should be measured before the start of treatment and occasionally during treatment at the end of the interval between two injections. Serum levels below normal may indicate that it is necessary to shorten the intervals between injections. In the case of high serum levels, an increase in the time interval between injections may be considered.
Child and adolescent

ANDROTARDYL is not indicated for use in children and adolescents (see Warnings and Precautions for Use).


Limited data do not suggest the need to adjust doses, in elderly patients (see section Caveats and Precautions for Use). >
Hepatic impairment

No formal studies have been conducted in patients with hepatic impairment. The use of ANDROTARDYL is contraindicated in patients with hepatic tumors, a history of liver tumor or severe hepatic impairment (see section 4.3). >

Renal insufficiency

No formal studies have been conducted in patients with renal insufficiency. The use of ANDROTARDYL is contraindicated in patients with renal impairment, severe (see section Contraindications)

ANDROGENE (H. Sex hormones)

ATC code: G03B A03.

In the hypogonadic subjects, testosterone produces: bone growth arrest, by welding conjugation cartilages, usually preceded by a growth spurt, development of the external and internal genital organs, a thrust of the hair, A development of the skeletal musculature, a reduction of urinary excretion of nitrogen, sodium, potassium, chlorine, phosphorus and phosphorus. Water.

Testosterone does not induce testicular development: it decreases the pituitary secretion of gonadotropins.

Not applicable

· Androgen-dependent and prostate-dependent breast cancer

· Prostate adenoma

· Hypercalcemia associated with a tumor, malignant

· Hepatic tumor or tumor antecedent, hepatic

· Heart failure, renal or hepatic, severe

· Known hypersensitivity to testosterone or to any of the excipients

Population, pediatric

In children, testosterone, in addition to virilization, can lead to accelerated growth and maturation, bone and early welding of the conjugation cartilages, leading to a reduction in size; Definitive. Therefore, use of ANDROTARDYL is not recommended in children and adolescents.


Treatment with ANDROTARDYL should be initiated only if hypogonadism (hypo or hypergonadotrophic) has been confirmed and other causes of symptomatology have been excluded. Testosterone deficiency should be clearly demonstrated by clinical signs (regression, secondary sexual characteristics, change in body composition, asthenia, decreased libido, erectile dysfunction ...) and confirmed by 2 separate dosages of testosterone .

Population over 65 years of age

The experience of using ANDROTARDYL in patients over 65 years of age is limited. At present, there is no consensus as to the normal values ​​of testosterone in relation to age. However, it should be taken into account that the physiological values ​​of testosteroneemia decrease with age.

Medical examination

Before initiating treatment with testosterone, patients must undergo a thorough examination in order to rule out any risk of pre-existing prostate cancer. Careful and regular monitoring of the prostate and breasts should be carried out according to the usual recommended methods (rectal examination and PSA test - prostate-specific antigen), at least once a year in any patient undergoing treatment , By testosterone and twice a year in elderly and at risk patients (factors, clinical or familial).


On the other hand, because of the variability of test results between different laboratories, all testosterone assays must be performed by the same laboratory for a given subject.

Tumors

Androgens can accelerate the progression of locally advanced or metastatic prostate cancer.

To date, there is no evidence that they increase the risk of prostate cancer or benign prostatic hyperplasia. Similarly, there is no evidence that they can convert cancer of the subclinical prostate into clinically detectable prostate cancer, although this can not be totally excluded to date. >

Therefore, it is imperative to eliminate prostate cancer before starting treatment with testosterone-based preparations.


In case of abdominal pain, severe, hepatomegaly, or signs, intra-abdominal hemorrhage, a hepatic tumor, should be considered in the diagnosis. >
Other

ANDROTARDYL, which may lead to hydro-sodium retention, should be used with caution in patients with cardiac, hepatic or renal disease, or risk factors for edema. Br>

In general, restrictions on the use of intramuscular injections in patients with acquired or hereditary abnormalities of blood coagulation should be observed. Code>
ANDROTARDYL should not be used in women because, depending on individual susceptibility to androgens, it may develop signs of virilization such as acne, hirsutism, change in voice (see). >

ANDROTARDYL should be used with caution in patients with cancer at risk, hypercalcemia and hypercalciuria associated with bone metastases. Regular monitoring of serum calcium in these patients is recommended.

If, in individual cases, frequent or persistent erections occur, the dose should be reduced or treatment discontinued, to avoid penile lesions (see section 4.4). >

Pre-existing sleep apnea may worsen under treatment.

Androgens should not be used to develop the muscular mass of healthy subjects nor to increase physical capacities

The attention of sportsmen and sportswomen will be drawn to the fact that this specialty contains an active ingredient which can induce a positive reaction of the tests performed during the antidoping tests. Code>
Administration

As with all oily solutions, ANDROTARDYL should only be injected intramuscularly and very slowly. Pulmonary micro-embolism due to oily solutions may, in rare cases, lead to signs and symptoms such as cough, dyspnea, chest pain. Other signs and symptoms including vaso-vagal reactions may occur such as, malaise, hyperhidrosis, dizziness, paresthesias or syncope. These reactions may occur during or immediately after injection, and are reversible. Treatment is usually symptomatic, for example, by oxygen therapy.
This drug contains oil, castor and can induce allergic, severe reactions.


+ Antivitamins K: increased haemorrhagic risk by direct effect on coagulation and / or systems fibrinolytics

More frequent control of INR. Adaptation of the dosage of antivitamin K during androgen treatment and are discontinued.

In the absence of compatibility studies, this medicinal product should not be mixed with other medicines.


Pregnancy and lactation

ANDROTARDYL is not indicated for use in women and should not be used in pregnant or lactating women (see section Preclinical safety data).



Fertility

Testosterone replacement therapy may reversibly reduce spermatogenesis (see section 4.4).



The most commonly observed adverse reactions associated with treatment with ANDROTARDYL are injection site reactions and general administration-related disorders.
System organ class *

Unknown frequency

Benign and malignant tumors

Neoplasms of the liver, benign and malignant (Warnings and Precautions),

Blood and lymphatic system disorders

Polyglobulia (see section Caveats and precautions for use)

Hemoglobin, increased

Hematocrit, increased

Immune system disorders

Hypersensitivity

Hepatobiliary disorders

Tests of liver function abnormal

Jaundice

Skin and subcutaneous tissue disorders

Acne

Alopecia
Rash

Urticaria

Pruritus

General disorders and site abnormalities

Various types of injection site reactions *

Reproductive system and breast disorders

Increase in antigens, specific prostate (PSA)

Increased libido

Decreased libido

Gynecomastia

* MedDRA most appropriate to describe a certain adverse reaction and its associated synonyms or diseases is based on the MedDRA version 13.1

* Pain, erythema, inflammation at the injection site.

Description of some special undesirable effects

Injections of oily solutions such as ORGOTARDYL have been associated with micro systemic reactions, pulmonary embolism, which can lead to signs and symptoms such as cough, dyspnea, chest pain. Other signs and symptoms including vaso-vagal reactions may occur such as malaise, hyperhidrosis, dizziness, paresthesia or syncope (see section 4.4).

High-dose or long-term treatment with testosterone (especially ANDROTARDYL) increases the tendency to retention, hydrosodicity and edema (see sections 4.4 and 4.4). >

Spermatogenesis is reversibly inhibited by long-term and high-dose therapy with ANDROTARDYL (see Warnings and Precautions for Use).
Frequent or persistent erections have been reported (see Warnings and Precautions for Use).
· Male hypogonadism, documented deficiency in testosterone, whatever its etiology