Buy Diferelin lyophilisate 3.75 mg + dissolve + syringe + 2 needles

Triptorelin

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Available since: 2019-09-19

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Clinical Pharmacology

Antitumor agent - gonadotropin-releasing hormone analogue

Indications

Among women

1. Preoperative treatment of uterine fibroids:

- in patients with anemia (hemoglobin <80 g="" l="" p="">

- to reduce the size of fibromyomyoma in order to facilitate surgical intervention (to reduce the volume of blood loss and the duration of the operation) or to change the surgical tactics (laparoscopic or transvaginal access).

2. Genital and extragenital endometriosis (I-IV stage).

3. Treatment of female infertility: induction of ovulation in combination with gonadotropins (FSH, CMH (human menopausal gonadotropin), hCG (human chorionic gonadotropin)) in assisted reproductive technology programs (ART).

In men

1. Prostate cancer:

- treatment of locally advanced prostate cancer as a monotherapy, as part of a combination therapy or adjuvant with radiotherapy;

- treatment of metastatic prostate cancer.

Composition

The composition of 1 bottle (lyophilisate):

Active substance:
Triptorelin Acetate	3.92 mg (4.12 mg *)
in terms of triptorelin	3.75 mg (3.94 mg *)
Excipients:
DL - lactic and glycolic acid copolymer (1: 1)	200 mg
D - Mannitol	85 mg
Carmellose sodium	30 mg
Polysorbate-80	2 mg

* Taking into account the peculiarities of the dosage form, the preparation contains 5% excess of the active substance to ensure the administration of an effective dose.

The solvent for the preparation of suspensions: mannitol, a solution of 0.8%.

The composition of 1 ml: D - mannitol - 8.0 mg, water for injection to 1.0 ml.

Triptorelin is marketed under different brands and generic names, and comes in different dosage forms:

Brand name	Manufacturer	Country	Dosage form
			lyophilisate
Diferelin	Ipsen pharma	France	lyophilisate
Diferelin	Ipsen pharma	France	vials
Decapeptyl			solution

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Dosage and Administration

The drug is administered only in / m.

For prostate cancer Diferelin® is administered in a dose of 3.75 mg (1 injection) every 4 weeks, for a long time.

With premature puberty the drug is prescribed to patients with a body weight of more than 20 kg, 3.75 mg every 28 days, to patients with a body weight less than 20 kg, 1.875 mg every 28 days.

With endometriosis the drug is administered at a dose of 3.75 mg 1 time in 4 weeks. The injection is carried out in the first 5 days of the menstrual cycle. The duration of treatment is not more than 6 months.

With female infertility the drug is prescribed in a dose of 3.75 mg (1 injection) on the 2nd day of the cycle. Communication with gonadotropins should be monitored after desensitization of the pituitary gland (plasma estrogen concentration less than 50 pg / ml is usually determined 15 days after the injection of the drug Diferelin®).

With uterine fibroids the drug should be administered in the first 5 days of the menstrual cycle. The drug is prescribed 3.75 mg every 4 weeks. The duration of treatment is 3 months for patients preparing for surgery.

Rules for the preparation and administration of suspensions

A suspension for i / m administration is prepared by dissolving the lyophilisate in the attached solvent immediately prior to administration. Stir the contents of the bottle with caution until a homogeneous suspension.

Cases of incomplete injection, leading to the loss of a greater amount of suspension than usually remains in the syringe for injection, must be reported to your doctor.

Introduction should be carried out in strict accordance with the instructions.

The patient should be lying down. Disinfect the skin of the buttocks.

Break the neck of the ampoule (point on the front side above).
Draw the solvent into a syringe with a needle.
Remove the protective plastic cap from the top of the bottle.
Transfer the solvent to the lyophilized vial.
Pull the needle so that it remains in the vial, but does not touch the suspension.
Without turning the bottle, gently shake the contents until a homogeneous suspension.
Check the absence of agglomerates before you put the suspension in the syringe (if there are no agglomerates, shake to complete homogeneity).
Without overturning the bottle, draw the entire suspension into a syringe.
Remove the needle used to prepare the suspension, and attach another needle tightly to the tip of the syringe. Hold only the colored tip.
Remove air from syringe.
Immediately inject into the gluteus maximus muscle.
Dispose of needles in sharps containers.

Adverse reactions

Allergic reactions: urticaria, rash, itching; very rarely - angioedema.

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

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 change in the size of the mammary glands. When used in combination with gonadotropins, cases of ovarian hyperstimulation syndrome have been reported. When treating premature puberty, girls may experience bloody discharge from the vagina. Prolonged use of the drug can cause hypogonadotropic amenorrhea.

From the digestive system: in rare cases - nausea, vomiting.

Since the cardiovascular system: in rare cases - arterial hypertension, sensation of hot flashes.

From the side of the central nervous system: in isolated cases - increased emotional lability, impaired vision.

Other: in isolated cases - an increase in body weight, an increase in body temperature.

Local reactions: in rare cases - pain at the injection site.

Carefully: should be prescribed for osteoporosis.

Drug interactions

Drug interaction of the drug Diferelin® is not described.

Pregnancy and Lactation

Diferelin® is contraindicated for use during pregnancy and lactation (breastfeeding).

Special instructions

At the beginning of treatment, there may be an increase in clinical symptoms, and therefore, Diferelin® should be carefully prescribed to patients with prostate cancer, who are at risk of developing obstruction of the ureters or compression of the spinal cord. Careful medical observation of these patients is necessary during the first month of therapy.

Before initiating Diphereline therapy, it is necessary to confirm the absence of pregnancy.

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

It is necessary to carefully monitor the level of cycle stimulation 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 dosage regimen of gonadotropin. If necessary, the introduction of human chorionic gonadotropin should be discontinued.

Impact on the ability to drive vehicles and other mechanisms that require high concentration of attention

No information available.

Overdosage

To date, no cases of overdose of Diferelin® have been reported.

Brand name: Triptorelin Long
Active ingredient: Triptorelin
Dosage form: Lyophilisate: lyophilized powder (brittle lyophilisate) or a porous mass compacted into a tablet, of a white or white color with a yellowish tinge.
Manufacturer: Samson-Med OAO