Gynipral, solution for injections 10mcg/2ml, 2ml x 5 ampoules — Made in Austria — Free Delivery

Brand: TAKEDA PHARMA
Product Code: Gynipral
Availability: In Stock

$25.87

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Description

Product description

Solution for injection "Gynipral" is used for the following indications:

short-term treatment of uncomplicated course of preterm labor: inhibition of uterine contractile activity in patients with a gestational age of 22 to 37 weeks in the absence of medical or gynecological contraindications to tocolytic therapy;
before turning the fetus from the transverse position;
as an emergency measure for preterm labor before transporting the pregnant woman to the hospital.

Compound

The active substance is hexoprenaline (one 2 ml ampoule contains 0.01 mg of hexoprenaline sulfate).

Excipients: sodium metabisulphite (E 223); disodium edetate; sodium chloride; sulfuric acid, diluted (for pH adjustment); water for injections.

Contraindications

hypersensitivity to hexaprenaline or to any component of the preparation;
the presence of any disease before the 22nd week of pregnancy;
the use of the preparation as a tocolytic agent in patients with a history of coronary heart disease or in patients with significant risk factors for coronary heart disease;
the threat of miscarriage during the I and II trimesters of pregnancy;
any disease of the mother or fetus in which the continuation of pregnancy is dangerous, for example, a severe degree of toxemia, intrauterine infection, vaginal bleeding due to placenta previa, eclampsia or severe preeclampsia, placental abruption or umbilical cord compression;
intrauterine fetal death, history of lethal congenital anomalies or lethal chromosomal abnormalities;
bronchial asthma with hypersensitivity to sulfates;
diseases of the cardiovascular system, in particular tachyarrhythmia, myocarditis, mitral valve disease;
hyperthyroidism;
severe liver and kidney disease;
glaucoma;
the use of the preparation "Gynipral" is contraindicated in patients with diseases against which the use of beta-agonists may have an undesirable effect, for example, pulmonary hypertension, diseases of the cardiovascular system (hypertrophic obstructive cardiomyopathy or obstruction of blood flow from the left ventricle, for example, aortic stenosis) .

Mode of application

For intravenous bolus injection or infusion.

The indicated dosage can only be used as an indication, since tocolysis requires an individual approach to the patient.

The initiation of therapy with Gynipral should only be carried out by obstetricians / physicians with experience in the use of tocolytic agents. Treatment is carried out only in properly equipped institutions to constantly monitor the health of the mother and fetus.

The preparation "Gynipral" should be used as early as possible after the diagnosis of preterm labor and the exclusion of any contraindications to the use of hexoprenaline.

During preparation therapy, it is necessary to carry out a proper assessment of the state of the cardiovascular system using continuous ECG monitoring.

Dosages

Before turning the fetus from a transverse position and when used as an emergency measure for preterm labor before transporting the pregnant woman to the hospital. The recommended dose is 10 µg (one 2 ml ampoule) of Gynipral, diluted in 10 ml of 0.9% sodium chloride solution or 5% glucose solution, administered intravenously over 5-10 minutes. If necessary, continue treatment with Gynipral, a concentrate for solution for infusion.

Short-term treatment of preterm labor in the presence of shortening and / or dilatation of the cervix. At the beginning of treatment, they begin with a jet injection of a dose of 10 μg (one 2 ml ampoule) followed by an infusion of the Gynipral preparation at a rate of 0.3 μg / minute. As an alternative treatment, it is possible to use only infusions of the preparation "Gynipral" at a rate of 0.3 μg / minute without prior jet administration of the preparation. Administer intravenously by drip (when calculating the rate of administration using conventional infusion systems, take into account that 20 drops = 1 ml). Dissolve the required number of ampoules of concentrate for infusion in 500 ml of 0.9% sodium chloride solution or 5% glucose solution.

Short-term treatment of preterm labor without shortening or opening of the cervix. Recommended dose: continuous infusion of 0.075 mcg/minute. Administer intravenously by drip (when calculating the rate of administration using conventional infusion systems, take into account that 20 drops = 1 ml). Dissolve the required number of ampoules of concentrate for infusion in 500 ml of 0.9% sodium chloride solution or 5% glucose solution.

Duration of treatment

The duration of tocolytic treatment depends on the existing degree of risk of termination of pregnancy (tendency to decrease the interval between contractions, the condition of the cervix) and the severity of side effects (for example, an increase in heart rate). Side effects should be minimized as much as possible.

The duration of treatment should not exceed 48 hours, as research data indicate that with the help of tocolytic therapy it is possible to delay labor for up to 48 hours. In the course of randomized controlled trials, there was no statistically significant effect of Gynipral treatment on perinatal mortality or morbidity. Postponement of labor with Gynipral can be used to apply other measures that significantly improve perinatal health.

Application features

Children

The preparation is not intended for use in children.

Drivers

The preparation has no or little effect on the reaction rate when driving vehicles or using other mechanisms.

Overdose

Overdose symptoms can be: a significant increase in the mother's heart rate, tremors, palpitations, headache, sweating.

Usually, to eliminate these symptoms, it is enough to reduce the dosage of the preparation. To eliminate severe symptoms of overdose, the use of non-selective beta-blockers is recommended, which competitively inhibit the action of the preparation "Gynipral".

Side effects

The most common side effects of the preparation "Gynipral" are associated with the pharmacological properties of beta-agonists. In order to eliminate or reduce the occurrence of undesirable effects, hemodynamic parameters such as blood pressure, heart rate and appropriate dose adjustment are carefully monitored. These effects usually disappear after discontinuation of the preparation.

Metabolic disorders: often (≥ 1:100, < 1:10) - hypokalemia.

From the nervous system: very often (≥ 1:10) - tremor.

From the side of the cardiovascular system: very often (≥ 1:10) - tachycardia; often (≥ 1:100, <1:10) - palpitations, decreased diastolic pressure, arterial hypotension.

From the side of the skin and subcutaneous tissue: often (≥ 1:100, < 1:10) - sweating.

Storage conditions

Store in the original packaging at a temperature not exceeding 25°C, out of the reach of children.

Shelf life - 3 years.

Reconstituted solution: The chemical and physical stability of the reconstituted solution after dilution (0.9% sodium chloride solution or 5% glucose solution) was demonstrated for 24 hours at 15-25°C. From a microbiological point of view, the preparation should be used immediately. In case of non-use immediately, the terms and conditions of storage of the reconstituted solution for its use are the responsibility of the user.

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