Description

Buy Diphereline Triptorelin 3,75 mg/ml powder with solvent

Description of Diphereline 3,75mg/ml solution for injection:

Powder and solvent for sustained release injection suspension.

Lyophilisate for the preparation of a suspension for intramuscular administration of a prolonged action of white or white with a creamy tint, dispersible in the attached solvent to form a suspension of white or white with a creamy tint.

Ingredients:

active ingredient: triptorelin;

1 bottle contains triptorelin acetate, corresponding to 3.75 mg of triptorelin;

other components: D, L lactide coglycolide polymer, mannitol (E 421), carmellose sodium, polysorbate 80;

Solvent composition: 1 ampoule contains mannitol (E 421), water for injection.

Pharmacological Properties of Diphereline 3,75mg/ml solution for injection:

Pharmachologic effect:
Synthetic decapeptide, analogue of natural GnRH. Diferelin®, after a short initial period of stimulation of the gonadotropic function of the pituitary gland, has an inhibitory effect on the secretion of gonadotropin, followed by suppression of testicular and ovarian function.

Chronic use of Diphereline® inhibits ovarian estrogen secretion until menopause and also reduces testosterone secretion, which can reach levels seen after surgical castration.

Pharmacokinetics:
Suction and distribution

After the intramuscular administration of the suspension, an initial phase of rapid release of the active substance begins, followed by a constant release phase. At the same time, Cmax of triptorelin in blood plasma is 0.32±0.12 ng/ml, and the average amount of constantly released triptorelin is 46.6±7.1 µg/day.

The bioavailability of the drug when administered once a month is 53%.

Indications for use Diphereline 3,75mg/ml solution for injection:

• prostate cancer;
• premature puberty;
• genital and extragenital endometriosis;
• uterine fibromyoma (before surgery);
• female infertility (in the program of in vitro fertilization).

Contraindications for use Diphereline 3,75mg/ml solution for injection:

• pregnancy;
• lactation period (breastfeeding);
• hypersensitivity to triptorelin, other components of the drug and other GnRH analogues.

With caution, the drug should be prescribed for osteoporosis.

Precautions & Warning for use Diphereline 3,75mg/ml solution for injection:

At the beginning of treatment, an increase in clinical symptoms is possible, and therefore Diferelin® should be used with caution in patients with prostate cancer at risk of developing ureteral obstruction or spinal cord compression. Careful medical supervision of these patients during the first month of therapy is necessary.

Before starting therapy with Diferelin, it is necessary to confirm the absence of pregnancy.

The drug is used with caution in patients with polycystic ovary syndrome when conducting ovulation stimulation schemes. This is due to the fact that in a small number of patients, the number of induced follicles may increase.

It is necessary to carefully monitor the level of stimulation of the cycle during in vitro fertilization in order to identify patients at risk of developing ovarian hyperstimulation syndrome, since the severity and frequency of manifestations of the syndrome may depend on the dosing regimen of gonadotropin. If necessary, the introduction of human chorionic gonadotropin should be discontinued.

Side  Effects:

Allergic reactions: urticaria, rash, itching; very rarely – Quincke’s edema.

From the musculoskeletal system: with prolonged use – demineralization of bones, which is a risk of developing osteoporosis. At the beginning of treatment for prostate cancer, patients may experience a temporary increase in pain in the bones affected by metastases (treatment is symptomatic). There have been isolated cases of obstruction of the ureters and the appearance of symptoms associated with compression by spinal cord metastases (they disappear after 1-2 weeks). Also during this period, there may be a temporary increase in the activity of acid phosphatase in the blood plasma.

From the reproductive system: in men – a decrease in potency; in women – headache, depression, sweating and changes in libido, dryness of the vaginal mucosa, dyspareunia and changes in the size of the mammary glands. When used in combination with gonadotropins, cases of ovarian hyperstimulation syndrome have been reported. When treating precocious puberty, girls may experience spotting from the vagina. Prolonged use of the drug can cause hypogonadotropic amenorrhea.

From the digestive system: in isolated cases – nausea, vomiting.

From the side of the cardiovascular system: in isolated cases – arterial hypertension, a feeling of hot flashes.

From the side of the central nervous system: in isolated cases – increased emotional lability, visual impairment.

Others: in isolated cases – an increase in body weight, an increase in body temperature.

Local reactions: in isolated cases – pain at the injection site.

Interaction:

The drug interaction of the drug Difhereline® is not described.

Overdose:

To date, cases of overdose of Diferelin® have not been reported.

Storage:

The drug should be stored out of the reach of children at a temperature not exceeding 25°C.

Shelf life:

2 year.