DECAPEPTYL depot amp. 3.75 mg.

INGREDIENTS:
One pre-filled syringe with 172 mg powder contains:
- Drug 4.12 mg triptorelin acetate / 1:1 /, 3.75 mg triptorelin
Excipients - poly / glycolic acid , lactic acid / / 1-1 / , propylene glycol octanoate decanoate .

A pre-filled syringe with a 1 ml suspension of solvent contains : Dextran 70 , polysorbate 80, sodium chloride , sodium dihydrogen phosphate dihydrate, sodium hydroxide, water for injections.

Mechanism of action:
Decapeptyl Depot is a synthetic decapeptide analogue of the natural hormone gonadorelin .
In children with signs of early puberty further formation of sexual characteristics suppress or delay the development of the typical age.
In women Decapeptyl Depot inhibits release of estrogen by the ovaries , which is desirable in the case of estrogen - dependent diseases or in the case of prevention of an unwanted increased hormone secretion .
In men Decapeptyl Depot inhibits release of testosterone and inhibits the growth of hormone-dependent prostate cancer .

INDICATION
children:
Treatment of proven central precocious puberty
women:
In the case of complaints from benign growth of muscle tissue in the uterus for the reduction of fibroids before planned surgery and reduction of symptoms such as pain and bleeding .
Symptomatic endometriosis confirmed by laparoscopy , as shown in suppressing the formation of hormones in the ovaries to the extent that the operative treatment is not primarily indicated.

In assisted treatment initiation of pregnancy to prevent undesired high hormone secretion .

men:
Treatment of advanced hormone-dependent tumors of the prostate.

CONTRAINDICATIONS :
When should you not use Decapeptyl Depot?
Total:
In the case of known hypersensitivity to triptorelin , poly / glycolic acid, lactic acid / / 1:1 / dextran 70 or any of the excipients should not be treated with Decapeptyl Depot.

children:
Progressive brain tumors.

women:
Prior therapy should be available off pregnancy. Lactation should be discontinued before treatment. If symptomatic osteoporosis should be used Decapeptyl Depot
In-vitro fertilization : particularly in patients with polycystic ovaries Decapeptyl Depot should be used very carefully.

men:
- In case of confirmed hormone independent tumor
- As a single agent for patients with prostate cancer, and pressure on the spinal cord or spinal cord metastases impaired feeling pain or paralysis of the legs , the bladder or intestine
- After surgical removal of the gonads treatment Decapeptyl Depot is not indicated.

DOSAGE AND ADMINISTRATION :
Decapeptyl Depot injected once every 28 days, by subcutaneous or intramuscular deep . The injection site should be changed every time.
In order to achieve success in treatment is important to observe the 4- week regimen.

children:
Treatment begins with the injection of a syringe , each equivalent to 3.75 mg of triptorelin in prime , fourteenth and twenty- eighth day .
It is therefore an injection every 4 weeks. If there is no sufficient effect can be given as one injection every 3 weeks. Dosing should be based on body weight. Children weighing less than 20 mg a dose of 1.875 mg / half dose / children weighing between 20 and 30 mg given 2.5 mg, and children weighing more than 30 mg - 3.75 mg triptorelin / full dose / .

women:
- Treatment of uterine myomas and endometriosis :
Once every 4 weeks injected one syringe , equivalent to 3.75 mg of triptorelin . Treatment should be initiated during the first 5 days of the menstrual cycle.
Assisted reproductive techniques:
Decapeptyl Depot is administered once a day, 2/3 or at day 22 of the cycle.

men:
Once every 4 weeks injected one syringe , equivalent to 3.75 mg of triptorelin . In view of continuous suppression of testosterone levels is important to observe the four -week cycle of use.

Notes for specific groups of patients:
- No need to adjust the dose in elderly patients
- According to the latest data does not need dose reduction or extension of the dosing interval in patients with impaired renal function.

Change in the pattern of treatment as determined by your doctor.

Duration of treatment :
- Central precocious puberty
Treatment should be discontinued if bone reaches maturity in girls over 12 and boys over 13 years.

Decapeptyl Depot treatment is usually long and should not be stopped without the approval of the physician .

- Uterine myomas and endometriosis
The duration of treatment depends on the initial severity of anti endometriosis and the evolution of its clinical manifestations and the evolution of the volume of uterine fibroids determined by ultrasound at the time of treatment. Normally, the maximum effect is achieved after 3 to 4 injections.
In terms of the possible effect on bone density treatment duration should not exceed 6 months.

- Prostate Cancer
Treatment with Decapeptyl Depot is usually long .


SIDE EFFECTS :
Total:
as a consequence of reduced levels of testosterone or estrogen is expected most patients to have hot flushes . When men are often seen impotence and decreased libido, while women are expected bleeding / papchivost , sweating, vaginal dryness and / or dyspareunia , decreased libido and mood swings.
In men they occur deterioration of the symptoms and complaints e. urinary tract obstruction , pain in skeletal metastases due to , compression of the spinal cord , muscle fatigue and lymphatic edema of the legs in the first week of treatment.
In some cases observed urinary obstruction with decreased renal function and neurological manifestations of compression with asthenia and paraesthesia of the legs.

children:
In children may sometimes be observed bleeding , vomiting , nausea, anaphylaxis.

After a treatment period of several months can be seen the loss of trabecular bone . This is usually reversible after discontinuation.

women:
When women are sometimes observed a slight increase in serum cholesterol , vision , back pain and paresthesias .

men:
When men were infrequent headache, sweating and gynecomastia. Sometimes it can be observed thromboembolic disorders , testicular atrophy , decreased beard growth , loss of hair on the chest , arms, legs . There may be observed hypertension , loss of appetite , abdominal pain , dry mouth , weight changes and exacerbation of asthma.

Men and women :
The following adverse reactions were observed frequently in men and women : depressed mood , agitation , nausea, pain and weakness in the joints , muscles, and sleep disorders. Furthermore, the observed temporary pain at the injection site and hypersensitivity reactions such as itching, skin rashes and fever . Sometimes seen increased enzymatic activity , anaphylaxis and foreign body reactions .