Triptorelin-long - instructions for use, doses, side effects, contraindications

Active substance:
Triptorelin acetate	3.92 mg (4.12 mg)
in terms of tritorelin	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% surplus of the active substance is incorporated in the preparation to ensure the introduction of an effective dose.

Solvent for suspension: mannitol, a solution of 0.8%.

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

Description:

Lyophilizate: lyophilized powder (brittle lyophilizate) or compressed into a tablet porous mass of white or white with a yellowish hue.

Solvent: clear, colorless liquid.

Reduced suspension: Homogeneous suspension of white or white with a yellowish hue.When standing, the suspension precipitates, but it is easily resuspended by shaking. The suspension should be allowed to pass into the syringe through needle No. 0840.

Pharmacotherapeutic group:antitumor agent - gonadotropin-releasing hormone analogue

ATX: & nbsp

L.02.A.E.04 Triptorelin

Pharmacodynamics:

Triptorelin is a synthetic decapeptide, an analog of natural gonadotropin-releasing hormone (GnRH).

The replacement of the 6th amino acid residue in the molecule resulted in a more pronounced affinity for GnRH receptors and greater metabolic stability and biological activity of triptorelin compared with endogenous GnRH.

In the initial period after the introduction tryptorelin, competitively binding to the receptors of the anterior pituitary cells, stimulates the pituitary gland secretion of follicle-stimulating hormone (FSH) and luteinizing hormone (LH) and, as a result, causes a short-term increase in the concentration of sex hormones in the blood plasma (testosterone in men and estradiol in women). After prolonged stimulation (a constant concentration of triptorelin in the blood plasma), the pituitary gland becomes insensitive to the action of GnRH, which leads to a decrease in the concentration of sex hormones in the blood plasma to the post-cystic or menopausal level.

These effects are reversible after the abolition of therapy.

Therapeutically this leads to a reduction in the growth of testosterone-sensitive prostate tumors in men and a reduction in endometriosis and estrogen-dependent uterine myoma in women. For uterine myoma, the maximum benefit from therapy is observed in women with anemia (hemoglobin <8 g / dL).

Suppression of intermediate endogenous peaks of luteinizing hormone allows to increase the quality of folliculogenesis, increasing the number of ripening follicles, and as a consequence, to increase the probability of pregnancy per cycle.

Pharmacokinetics:

Suction

After intramuscular injection, the rapid release of tryptorelin begins, followed by a continuous release phase (28 days). The maximum concentration is 0.32 ± 0.12 ng / ml. The average amount of constantly released tryptorelin is 46.6 ± 7.1 μg / day. Bioavailability with intramuscular injection is about 53% for 1 month.

Distribution

Triptorelin does not bind to blood plasma proteins. Cumulation in the tissues does not occur.

Metabolism

Metabolism of triptorelin is unknown. Metabolites are not revealed.

Excretion

It is excreted by the liver and kidneys 3 times slower than natural GnRH, the process consists of two phases - fast and slow elimination. Less than 4% Triptorelin in unchanged form is excreted by the kidneys.

Pharmacokinetics in selected patient groups

In patients with impaired renal function the half-life of triptorelin is 1.4-2.7 times longer than in healthy people.

For patients with impaired renal function, adaption and individualization of therapy with tryptorelin is not required due to the secondary role of the kidney in the excretion of tryptorelin and its wide range of therapeutic effects as an active substance.

Indications:

Have women

1. Preoperative treatment of uterine fibroids:

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

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

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

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

In men

1. Prostate cancer:

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

- treatment of metastatic prostate cancer.

Contraindications:

- Hypersensitivity to tryptorelin, other GnRH analogues, the components of the preparation and the solvent;

- condition after previous surgical testicularectomy;

- pregnancy, the period of breastfeeding;

- children's age till 18 years.

Carefully:

- In patients with prostate cancer with a high risk of obstruction of the ureters or compression of the spinal cord;

- in patients with an established diagnosis of osteoporosis or a high risk of its development;

- in patients with diagnosed depression;

- in patients taking anticoagulants, since it is possible to develop a hematoma at the injection site;

- when carrying out long-term androgen deprivation in patients with congenital elongated interval syndrome QT, with electrolyte disorders or chronic heart failure, or in patients taking antiarrhythmic drugs of class IA or Class III;

- when androgen deprivation is carried out in men with a high risk of developing metabolic disorders and cardiovascular diseases;

- when the ART program is performed in patients with polycystic ovaries, especially in cases where the number of follicles detected by ultrasound is greater than 10.

Pregnancy and lactation:

Contraindicated in the use of triptorelin during pregnancy.

Before starting therapy, women with preserved reproductive potential should be carefully examined for pregnancy exclusion. Non-hormonal method of contraception should be used throughout the treatment, until the recovery of menstruation.

The use of tryptorelin during breastfeeding is contraindicated.

Dosing and Administration:

A drug Tryptorelin-long injected intramuscularly (IM). Place the drug should be changed.

A drug Tryptorelin-long It should be used only under the supervision of a physician with experience in this indications.

Fibromyoma of the uterus and endometriosis

A drug Tryptorelin-long injected at a dose of 3.75 mg (1 injection) IM once every 28 days. Treatment should be started in the first 5 days of the menstrual cycle.

The duration of treatment depends on the severity of endometriosis and the observed clinical picture (functional and anatomical changes) and changes in the size of uterine fibroids, determined by ultrasound, on the background of therapy. The duration of the drug in endometriosis is 4-6 months because of the possible effect on bone density.

The duration of therapy for preoperative treatment of uterine fibroids is no more than 3 months.

It is not recommended to repeat a course of treatment with tryptorelin or other GnRH agonists.

ART

A drug Tryptorelin-Lopg injected once in a dose of 3.75 mg (1 injection) in / m on the 2nd day of the menstrual cycle.

Prostate Cancer

A drug Tryptorelin-long injected at a dose of 3.75 mg (1 injection) IM once every 28 days, prolonged.

In patients with locally advanced prostate cancer, in combination with radiotherapy, prolonged antiandrogen therapy (3 years) is preferable to short-term antiandrogen therapy (6 months).

Use in selected patient groups

Dose adjustment in elderly patients and patients with impaired renal function not required.

Rules for the preparation of suspension and drug administration

The drug is administered only intramuscularly.

- A suspension for the IM injection is prepared immediately before administration with the aid of the supplied solvent.

- The drug should be prepared and administered only by specially trained medical personnel.

- Vial with preparation Tryptorelin-long keep strictly vertically. Tapping lightly on the vial, make sure that the entire preparation is on the bottom of the vial.

- Open the syringe, attach the supplied 0.8 mm x 40 mm needle to the solvent intake.

- Open the ampoule with the solvent and fill the syringe with all the contents of the ampoule, set the syringe to the level of 2 ml.

- Remove the plastic cap from the vial containing the drug. Disinfect the rubber stopper of the vial with a tampon moistened with alcohol. Insert the needle into the vial with the drug through the center of the rubber plug and carefully insert the solvent into the inner wall of the vial without touching the needle with the contents of the vial.

- Remove the syringe from the needle from the vial.

- The bottle must remain stationary until the solvent is completely soaked in the preparation and the suspension is formed.Do not turn the vial over, check for a dry residue near the walls and bottom of the vial. If you find a dry residue of the drug, leave the vial until it is completely soaked (about 3-5 minutes).

- After you are convinced of the absence of residues of a dry preparation, the contents of the vial gently stir in circular motions for 30-60 seconds until a uniform suspension is formed.

- Do not overturn or shake the bottle.

- Replace the needle on the syringe with a needle measuring 1.2 mm x 50 mm (for a set of slurry). Insert the needle through the rubber stopper into the vial. Then cut the needle cut down and, tilting the vial at an angle of 45 degrees, slowly put the suspension in the syringe completely. Do not flip the bottle when typing. A small amount of the drug can remain on the walls and bottom of the vial. The consumption of the residue on the walls and the bottom of the vial is taken into account.

- Immediately after dialing the suspension into the syringe, remove the needle. Replace the needle with a size of 1.1 mm x 40 mm, gently turn the syringe and remove air from the syringe.

- Suspension of the drug should be administered immediately after preparation.

- Using an alcohol sponge, disinfect the injection site.Insert the needle deep into the gluteus muscle, then gently pull the plunger of the syringe backward to make sure that there is no damage to the vessel. Insert the suspension slowly with constant pressure on the syringe plunger. When clogging the needle, replace it with another needle of the same diameter.

- Dispose of the needles in containers designed for sharp objects.

- With repeated injections, the left and right gluteal muscles should be alternated.

- About incomplete injection, leading to the loss of a large amount of suspension, it is necessary to inform the attending physician.

Side effects:

Undesirable reactions in men

Undesired reactions with triptorelin are associated with its expected pharmacological effects: 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 in 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 can not be determined based on the available data).

Infectious and parasitic diseases: very rarely - rhinopharyngitis.

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

Disorders from the metabolism and nutrition: rarely - anorexia, decreased appetite, increased appetite; rarely - diabetes; frequency unknown - gout.

Disorders of the psyche: often - mood changes, depression, sleep disturbances, decreased libido; rarely - irritability, insomnia; very rarely - confusion, decreased activity, a sense of euphoria; frequency unknown - a sense of anxiety, loss of libido.

Disturbances from the nervous system: very often - paresthesia of the lower extremities; often - headache; rarely - paresthesia, taste disorder, drowsiness, astasia (impaired ability to stand, associated with impaired coordination), lethargy; very rarely - memory impairment; frequency unknown - dizziness.

Disturbances on the part of the organ of sight: rarely - discomfort in the eyes, blurred vision; frequency unknown - impaired vision.

Hearing disorders and labyrinthine disorders: rarely - tinnitus; frequency unknown - Vertigo.

Vascular disorders: very often - "tides"; infrequently - increased blood pressure, thromboembolism; frequency unknown - lowering blood pressure.

Disturbances from the respiratory system, chest and mediastinal organs: infrequently - bronchial asthma; rarely - dyspnea; rarely - nosebleeds, dyspnoea, which occurs when lying down.

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

Disturbances from the skin and subcutaneous tissues: very often - hyperhidrosis; infrequently - hypotrichosis; rarely - alopecia, acne, itching, rash; very rarely blisters; frequency unknown - Quincke's edema, hives, purpura.

Disturbances from musculoskeletal and connective tissue: very often - back pain; often - pain in the limbs; rarely - muscle spasm, muscle weakness, myalgia, arthralgia; very rarely - swelling of joints, stiffness of muscles and joints, osteoarthritis; frequency unknown - musculoskeletal pain, joint stiffness, bone pain.

Disorders from the kidneys and urinary tract: Often - dysuria.

Violations of the genitals and mammary gland: often - erectile dysfunction; rarely - gynecomastia,Atrophy of testicles, pain in the testicles, engorgement of the mammary glands; frequency unknown - pain in the breast, absence of ejaculation.

General disorders and disorders at the site of administration: 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; very rarely - fever, flu-like syndrome; the frequency is unknown - a feeling of discomfort, chest pain, malaise.

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

Triptorelin 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 worsening of symptoms of prostate cancer, which is usually manifested by disorders of the urinary tract, increased pain associated with metastatic damage. 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 consequence, patients with metastatic spinal cord lesions and / or obstruction of the upper or lower urinary tract should be monitored more closely within the first few weeks after initiation of 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 radiotherapy may experience more unwanted reactions, especially from the gastrointestinal tract, which are associated with the course of radiation therapy.

Undesirable reactions in women

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

Immune system disorders: infrequently, anaphylactic reactions; frequency unknown - hypersensitivity.

Disorders of the psyche: very often - decreased libido, mood changes, sleep disturbances; often - depression, depressed mood; frequency is unknown - a sense of anxiety, confusion.

Disturbances from the nervous system: Often - headache; frequency unknown - dizziness, paresthesia.

Disturbances on the part of the organ of sight: frequency unknown - blurred vision, visual impairment.

Hearing disorders and labyrinthine disorders: frequency unknown - Vertigo.

Vascular disorders: Often - "tides".

Disturbances from the respiratory system, chest and mediastinal organs: frequency unknown - dyspnea.

Disorders from the gastrointestinal tract: Often - abdominal pain; often - nausea, a feeling of discomfort in the abdomen; frequency unknown - diarrhea, vomiting. Disturbances from the skin and subcutaneous tissues: very often - hyperhidrosis; frequency unknown - angioedema, itching, rash, urticaria.

Disturbances from musculoskeletal and connective tissue: Often - pain in the bones; often - arthralgia, muscle spasm; infrequently - backache; frequency unknown - myalgia, muscle weakness, bone resorption.

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

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

Laboratory and instrumental data: often - weight gain; infrequently - increased activity of lactate dehydrogenase, gamma-glutamyltransferase, alanine aminotransferase, aspartate aminotransferase, increased cholesterol concentration; frequency unknown - increase in blood pressure, weight loss.

At the beginning of treatment during a period of short-term increase in the concentration of estradiol in the blood plasma, the symptoms of endometriosis, including pain in the pelvic region and dysmenorrhea, can be exacerbated. These symptoms are transient and, as a rule, disappear after 1-2 weeks. Uterine bleeding, including menorrhagia, metrorrhagia may occur within one month after the first injection. There may be an increase in the size of the ovaries, pain in the pelvic region and / or pain in the abdominal region.

Overdose:

Cases of an overdose with tryptorelin are not described.

In case of an overdose, symptomatic therapy is indicated.

Interaction:

There have been no controlled clinical studies of the interaction of tryptorelin with other drugs. However, the possibility of interaction of triptorelin with other drugs, including drugs that promote the release of histamine, is not excluded.

It is not recommended to appoint tryptorelin simultaneously with drugs that increase the concentration of prolactin in the blood plasma, as these drugs reduce the number of GnRH receptors in the pituitary gland.

It is also necessary to take special precautions and control the concentration of sex hormones in the blood plasma when using triptorelin in combination with drugs that affect the secretion of the pituitary gonadotropins.

Long-term androgen deprivation can lengthen the interval QT. It is necessary to assess the risk / benefit ratio prior to the appointment of triptorelin to patients with congenital elongated interval syndrome QT, with electrolyte disorders or chronic heart failure; or patients taking medications that can lengthen the interval QT, or drugs that can cause the development of bidirectional spindle-shaped ventricular tachycardia, such as antiarrhythmic drugs of classes IA (eg, quinidine, procainamide) or III (e.g., amiodarone, sotalol).

Special instructions:

Caution should be observed in patients taking anticoagulants, since it is possible to develop a hematoma at the injection site.

Fibromyoma of the uterus and endometriosis

Before starting treatment, pregnancy should be excluded.

A drug Tryptorelin-long it is necessary to appoint only after in-depth diagnosis of uterine myoma and endometriosis (laparoscopy and / or hysteroscopy).

Throughout the treatment period, including within 3 months of the last injection, non-hormonal contraceptives should be used. Because of the possible effect of the drug Tryptorelin-long on bone mineral density, treatment should not be recommended for more than 6 months. It is not recommended to repeat a course of therapy with tryptorelin or other analogues of GnRH.

Treatment of uterine fibroids should be carried out under the supervision of ultrasound,as a rapid decrease in the size of the uterus in some cases can lead to the development of uterine bleeding of varying duration and intensity.

With uterine myoma, the most appropriate combination of drug therapy Tryptorelin-long with the subsequent surgical treatment. The appointment of triptorelin leads to a significant decrease in the size of the myomatous uterus, which facilitates the technique of the operation. It is especially advisable to conduct a course of therapy with tryptenelin in young patients in order to maintain the reproductive function, when an organosaving operation can be performed with the help of laparoscopic technique.

During the first month, bleeding / spotting from the vagina of varying intensity and duration is possible. With continued bloody discharge / bleeding after the first month, it is necessary to determine the concentrations of estradiol in the blood plasma. When the concentration of estradiol is lower than 50 pg / ml, other organic lesions are possible.

After discontinuing therapy with tryptorelin, the function of the ovaries is restored after 7-12 weeks. Given that menstruation should stop during therapy tryptoline, the patient should be properly instructed about what she should tell her doctor if regular menstruation persists. Prostate Cancer

At an early stage, the drug Tryptorelin-long causes a temporary increase in the concentration of testosterone in the blood plasma. As a result, during the first weeks of therapy, the appearance and intensification of clinical symptoms (in particular, bone pains, dysuric disorders) that are transitory in nature and in which symptomatic therapy should be given may occur. As with the use of other GnRH agonists, individual cases of compression of the spinal cord or obstruction of the urinary tract can be identified. With compression of the spinal cord or obstruction of the urinary tract, standard treatment of these complications should be prescribed and in urgent cases, an orchiectomy (surgical castration) is to be performed.

It is necessary to carefully monitor patients during the first few weeks of therapy (testosterone concentration in the blood plasma should not exceed 1 ng / ml), especially in patients with metastatic spinal cord injuries, patients with risk of spinal cord compression or obstruction of the urinary tract.For the same reason, special attention should be given at the beginning of treatment to patients with signs of compression of the spinal cord, identified in the preliminary examination. During the initial phase of therapy, an additional use of antiandrogenic drugs should be considered to prevent an initial increase in plasma testosterone concentration and worsening of clinical symptoms.

Epidemiological data showed that patients during androgen deprivation therapy may develop metabolic disorders (eg, impaired glucose tolerance); increase the risk of cardiovascular disease. However, prospective data did not confirm the relationship between the treatment of GnRH agonists and the increase in mortality from cardiovascular diseases. Patients with a high risk of metabolic and cardiovascular disease should be carefully screened prior to treatment and carefully observed during androgen deprivation therapy.

At the beginning of therapy, a temporary increase in the activity of acid phosphatase in the blood plasma can be observed.

Function of the sex glands and pituitary gland

The use of tryptorelin in therapeutic doses leads to suppression of the "sex glands-pituitary" system. Normal functioning of the sex glands and pituitary gland usually restored after discontinuation of therapy. The results of a diagnostic test of the gonadotropic function of the pituitary gland, performed during and after discontinuation of therapy, may therefore be incorrect.

Osteoporosis

The use of GnRH agonists can cause a decrease in bone mineral density (BMD).

In men, prolonged androgen deprivation with bilateral orchiectomy or with the use of GnRH analogs can be associated with an increased risk of bone loss and can lead to osteoporosis and an increased risk of fracture of the bones.

Preliminary data suggest that the use of bisphosphonates in combination with GnRH can reduce the loss of BMD. Particular attention should be given to patients with risk factors for osteoporosis (for example: chronic alcohol dependence, smoking, long-term therapy with drugs that reduce BMD, such as anticonvulsant drugs or glucocorticosteroids, history of hereditary osteoporosis, insufficiency or eating disorders).

In women, the use of GnRH agonists is probably the cause of a decrease in BMD by an average of 1% per month for six months of treatment. Every 10% reduction in BMD leads to an increase in the risk of fracture of the bones by approximately 2-3 times.

In most women, BMD is restored after cessation of therapy.

There is no available data on the use of tryptorelin in patients with established osteoporosis or with risk factors for osteoporosis (eg chronic alcohol dependence, smoking, long-term therapy with drugs that reduce BMD, such as anticonvulsant drugs or glucocorticosteroids, history of hereditary osteoporosis, insufficiency or eating disorders, such as anorexia nervosa). Given that the reduction of BMD is more possible in such patients, treatment with tryptorelin should be administered on an individual basis and can only be initiated if the benefit obtained from the treatment exceeds the risk. An additional examination should be considered to avoid loss of BMD.

Pituitary Tumor

Rarely, the use of GnRH agonists may reveal the presence of previously unidentified gonadotropic pituitary adenoma.Hemorrhage in the pituitary gland is characterized by sudden headache, visual disturbances and ophthalmoplegia.

Depression

Patients receiving triptorelin therapy have an increased risk of developing depression (which can be severe). Patients should be informed about the possible development of depression, and in the case of development of depression should receive appropriate therapy. Patients with already known depression should be carefully monitored during therapy.

Interval lengthening QT

Induction of ovulation in the ART

In the treatment of infertility by the IVF method, the drug Tryptorelin-long It should only be used under the supervision of a specialist with experience in this field.

When carrying out IVF, the drug Tryptorelin-long It is used to stabilize the concentration of endogenous sex hormones followed by the introduction of gonadotropins to stimulate the growth of follicles. The use of tryptorelin avoids the premature spontaneous ovulation of stimulated follicles, which increases the effectiveness of the IVF program as a whole.

It is recommended to use the drug with caution Tryptorelin-long with IVF in patients with polycystic ovary syndrome; it is possible to stimulate a large number of follicles.

Due to the fact that the use of the drug Tryptorelin-long can lead to the development of the syndrome of ovarian hyperstimulation, regular clinical monitoring is required, including ultrasound of the ovaries.

It is required to determine the concentration of estradiol in the blood plasma in order to control the response of the ovaries during induction of ovulation within the ART (interruption of the ovulation stimulation cycle with excessive ovarian response and discontinuation of injectionsgonadotropin) and clinical manifestations of ovarian hyperstimulation syndrome.

Correction of dose

It is necessary to correct the dose of antihypertensive drugs when combined with the drug Triptorelin-long.

Effect on the ability to drive transp. cf. and fur:

Currently, data on the possible effects of the drug Tryptorelin-long there is no ability to manage vehicles and mechanisms. Nevertheless, the use of the drug may lead to the development of such unwanted reactions as headache, decreased vision, drowsiness, which can adversely affect the ability to drive vehicles and perform potentially dangerous activities that require increased concentration and speed of psychomotor reactions. In the event of the above symptoms, you should refrain from managing the vehicles and mechanisms.

Form release / dosage:

Lyophilizate for suspension for intramuscular injection with sustained release, 3.75 mg.

Packaging:

Lyophilizate, containing 3.75 mg of triptorelin, in bottles of dark glass with a capacity of 10 ml,hermetically sealed with rubber stoppers and aluminum-plastic caps.

2 ml of solvent (mannitol, 0.8% solution) in neutral glass ampoules.

In a contour mesh box made of polymer film or cardboard, 1 bottle with drug, 1 ampoule with a solvent, 1 single-use syringe with a capacity of 5 ml, packed in an individual contoured cell package, 1 solvent needle 0.8 mm x 40 mm, packed in a cellular package complete with a syringe, 1 needle for a suspension of 1.2 mm x 50 mm in size, packed in an individual contour mesh package, 1 a needle for injection with a size of 1.1 mm x 40 mm, packed in an individual contour mesh package, a knife for opening ampoules or scarifier, 2 alcohol wipes.

A contoured cellular package from a polymer film is sealed with a combined coating material and a self-adhesive label is applied.

When you pack the solvent to prepare the suspension in the import ampoules that have a ring of tension for opening or the point of fracture, the knife or scarifier is not injected into the ampoule. The kit is designed for one injection.

1 circuit cell pack together with the instruction for use is placed in a cardboard box.

Storage conditions:

Store in a dark place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

Lyophilizate - 2 years;

Solvent - 3 years.

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

Terms of leave from pharmacies:On prescription

Registration number:LP-003647

Date of registration:20.05.2016

Expiration Date:20.05.2021

The owner of the registration certificate:NATIVA, LLC NATIVA, LLC Russia

Manufacturer: & nbsp

NATIVA, LLC Russia

Information update date: & nbsp13.07.2016

Illustrated instructions

Instructions

Tryptorelin-long (Triptorelin-long)