Tryptorelyn | Triptorelin-long lyophilisate for pri.r-ra for in / mouse. enter prolong. released 3.75 mg vial 1 pc.

Special Price $124.95 Regular Price $157.00
In stock
SKU
BID825573
Latin name

Triptorelin-long
Latin name

Triptorelin-long

Pharmacological action of

Antitumor agent - gonadotropin releasing hormone analogue

Indications

In women

1. Preoperative treatment of uterine fibroids:

- in patients with anemia (hemoglobin < 80 g / l)

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

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

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

In men

1. Prostate cancer:

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

- treatment of metastatic prostate cancer.

Contraindications

- Hypersensitivity to triptorelin, other GnRH analogs, drug and solvent components

- a condition after previous surgical testicular

ectomy - pregnancy,

breastfeeding period - children under 18 years of age.

Caution:

- In patients with prostate cancer at high risk for ureteral obstruction or spinal cord compression

- in patients with an established diagnosis of osteoporosis or a high risk of developing it

- in patients diagnosed with depression

- in patients taking anticoagulants since the development of a hematoma at the injection site

is possible - during long-term androgen deprivation in patients with congenital prolonged QT interval syndrome, with electrolyte disturbances and or congestive heart failure, or in patients taking antiarrhythmic drugs of class IA or class III

- when performing androgen deprivation in men with a high risk of developing metabolic disorders and cardiovascular diseases

- when performing an ART program in patients with polycystic ovaries, especially in cases where the number of follicles determined by Ultrasound, more than 10.

Use during pregnancy and lactation

The use of triptorelin in pregnancy is contraindicated.

Before starting therapy, women with preserved reproductive potential should be carefully examined to exclude pregnancy. The non-hormonal method of contraception should be used throughout the treatment, up to the restoration of menstruation.

The use of triptorelin during breastfeeding is contraindicated.

Composition

Composition per 1 vial (lyophilisate):

Active ingredient:

Tryptorelin acetate

3, 92 mg (4.12 mg *)

in terms of tryptorelin

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, a 5% excess of the active substance is incorporated in the preparation to ensure the introduction of an effective dose.

Solvent for suspension: mannitol, 0.8% solution.

Composition per 1 ml: D - mannitol - 8.0 mg, water for injection - up to 1.0 ml.

Side effects of

Adverse reactions in men

Adverse reactions with triptorelin are associated with its expected pharmacological effects: an initial increase in testosterone concentration and then almost complete suppression of testosterone synthesis.

The frequency of adverse reactions that may occur during therapy is given as the following gradation: very often (> 1/10), often (> 1/100, <1/10), infrequently (> 1/1000, <1 / 100), rarely (> 1/10000, <1/1000), very rarely (<1/10000) and the frequency is unknown (the frequency cannot be determined based on available data).

Infectious and parasitic diseases: very rarely - rhinopharyngitis.

Immune system disorders: very rarely - anaphylactic reactions, hypersensitivity.

Metabolic and nutritional disorders: rare - anorexia, decreased appetite, increased appetite very rarely - diabetes mellitus frequency is unknown - gout.

Mental disorders: often - mood changes, depression, sleep disturbances, decreased libido rarely - irritability, insomnia very rarely - confusion, decreased activity, feelings of euphoria, frequency is unknown - feelings of anxiety, loss of libido.

Violations of the nervous system: very often - lower limb paresthesia often - headache rarely - paresthesia, taste disturbance, drowsiness, astasia (impaired standing ability, associated with impaired coordination), lethargy very rarely - memory impairment frequency unknown - dizziness.

Disorders of the organ of vision: very rarely - discomfort in the eyes, blurred vision, frequency unknown - impaired vision.

Hearing disorders and labyrinth disorders: rarely - tinnitus frequency unknown - vertigo.

Vascular disorders: very often - flushing infrequently - increased blood pressure, thromboembolism, frequency is unknown - decreased blood pressure.

Disorders of the respiratory system, chest and mediastinal organs: infrequently - bronchial asthma rarely - shortness of breath very rarely - nosebleeds, shortness of breath that occurs while lying down.

Disorders of the gastrointestinal tract: often - nausea rarely - abdominal pain, constipation, diarrhea, vomiting, bloating, flatulence, dry mouth frequency is unknown - gastralgia.

Disorders of the skin and subcutaneous tissue: very often - hyperhidrosis infrequently - hypotrichosis rarely - alopecia, acne, itching, rash very rarely - blisters frequency unknown - Quincke's edema, urticaria, purpura.

Violations of the musculoskeletal and connective tissue: very often - back pain often - pain in the extremities rarely - muscle spasm, muscle weakness, myalgia, arthralgia very rarely - swelling of the joints, stiffness of muscles and joints, osteoarthritis frequency is unknown - bone muscle pain, stiffness of joints, bone pain.

Disorders of the kidneys and urinary tract: very often - dysuria.

Disorders from the genitals and mammary gland: often - erectile dysfunction rarely - gynecomastia, testicular atrophy, testicular pain, breast engorgement, frequency is unknown - chest pain, lack of ejaculation.

General disorders and disorders at the injection site: very often - asthenia often - fatigue, reaction at the injection site, pain at the injection site, redness at the injection site, inflammation at the injection site, swelling, irritability rarely - pain is very rare - fever, flu-like frequency syndrome is unknown - discomfort, chest pain, malaise.

Laboratory and instrumental data: infrequently - increased activity of lactate dehydrogenase, gamma-glutamyl transferase, weight loss rarely - increased activity of alanine aminotransferase, aspartate aminotransferase, increased body weight, increased concentration of creatinine, plasma urea in blood plasma, very rarely - increased activity of alkaline phosphatase, alkaline phosphatase activity hyperthermia frequency unknown - increased blood pressure.

Tryptorelin causes a short-term increase in the concentration of circulating testosterone during the first week after the first injection of the drug. In this regard, there may be a temporary deterioration in symptoms of prostate cancer, which is usually manifested by disorders of the urinary tract, increased pain due to metastatic lesions. These symptoms are transient and usually disappear after 1-2 weeks.

In isolated cases, obstruction of the urinary tract or metastatic compression of the spinal cord is noted. As a result, patients with metastatic lesions of the spinal cord and / or obstruction of the upper or lower urinary tract should be monitored more carefully during the first few weeks after starting therapy. The use of GnRH agonists for the treatment of prostate cancer may be associated with an increased risk of bone loss, the development of osteoporosis and an increased risk of bone fractures.

Patients receiving long-term therapy with GnRH analogues in combination with radiation therapy may experience more adverse reactions, especially from the gastrointestinal tract, which are associated with the course of radiation therapy.

Adverse reactions in women

As a result of a decrease in estrogen concentration, the most common adverse reactions may be: headache, decreased libido, sleep disturbance, mood changes, dyspareunia, dysmenorrhea, vaginal bleeding, ovarian hyperstimulation syndrome, ovarian enlargement, pelvic pain , abdominal pain, dryness of the mucous membrane of the vagina and vulva, increased sweating, flushing and asthenia.

The frequency of adverse reactions that may occur during therapy is given as the following gradation: very often (> 1/10), often (> 1/100, <1/10), infrequently (> 1/1000, <1 / 100), rarely (> 1/10000, <1/1000), very rarely (<1/10000) and the frequency is unknown (the frequency cannot be determined based on available data).

Disorders of the immune system: infrequently - anaphylactic reactions frequency unknown - hypersensitivity.

Mental disorders: very often - decreased libido, mood changes, sleep disorders often - depression, depressed mood, frequency is unknown - feelings of anxiety, confusion.

Disorders of the nervous system: very often - headache frequency unknown - dizziness, paresthesia.

Disorders of the organ of vision: frequency unknown - blurred vision, visual impairment.

Hearing disorders and labyrinth disorders: frequency unknown - vertigo.

Vascular disorders: very often - hot flashes.

Disorders of the respiratory system, chest and mediastinal organs: frequency unknown - shortness of breath.

Disorders of the gastrointestinal tract: very often - abdominal pain often - nausea, abdominal discomfort, frequency unknown - diarrhea, vomiting. Disorders from the skin and subcutaneous tissues: very often - hyperhidrosis frequency is unknown - angioedema, itching, rash, urticaria.

Violations of the musculoskeletal and connective tissue: very often - bone pain often - arthralgia, muscle spasm infrequently - back pain frequency unknown - myalgia, muscle weakness, bone resorption.

Disorders from the genitals and mammary gland: very often - vaginal bleeding, dryness of the vaginal mucosa, dyspareunia, dysmenorrhea, ovarian hyperstimulation syndrome, ovarian enlargement, pain in the pelvic area, menorrhagia, metrorrhagia often - pain in the mammary glands frequency is unknown - amenorrhea.

General disorders and disorders at the injection site: very often - asthenia often - fatigue, irritability, reactions at the injection site, pain at the injection site, erythema and inflammation at the injection site, frequency is unknown - fever, malaise.

Laboratory and instrumental data: often - increased body weight infrequently - increased activity of lactate dehydrogenase, gamma-glutamyl transferase, alanine aminotransferase, aspartate aminotransferase, increased cholesterol concentration, frequency is unknown - increased blood pressure, decreased body weight.

At the beginning of treatment, during a period of short-term increase in the concentration of estradiol in the blood plasma, symptoms of endometriosis, including pelvic pain and dysmenorrhea, may be aggravated. These symptoms are transient and usually disappear after 1-2 weeks. Uterine bleeding, including menorrhagia, metrorrhagia can occur within one month after the first injection. An increase in ovarian size, pain in the pelvic area and / or pain in the abdomen may be observed.

Overdose

Cases of an overdose of triptorelin are not described.

In case of overdose, symptomatic therapy is indicated.

Storage conditions

Store in a dark place at a temperature not exceeding 25 РC.

Keep out of the reach of children.

Expiration

Lyophilisate - 2 years

Solvent - 3 years.

Do not use after the expiry date stated on the package.

Deystvuyuschee substances

Tryptorelyn

dosage form

solution for injection

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