Ginipral solution for infection. 10mkg/2ml amp. 2 ml No. 5

Solution is applied to injections of Ginipral at the following indications:

• short-term treatment of an uncomplicated course of premature births: oppression of sokratitelny uterine activity at patients with duration of gestation from 22nd to 37 weeks in the absence of medical or gynecologic contraindications to performing tokolitichesky therapy;
• before version from cross situation;
• as an emergency measure at premature births before transportation of the pregnant woman in hospital.

Structure

Active ingredient - hexoprenaline (one ampoule on 2 ml contains 0.01 mg of a hexoprenalin of sulfate).

Excipients: sodium metabisulphite (E 223); dinatrium edetat; sodium chloride; sulphuric, divorced acid (for adjustment rn); water for injections.

Contraindication

• hypersensitivity to a hexaprenalin or to any component of drug;
• presence of any disease up to 22 weeks of pregnancy;
• medicament use as tokolitichesky means to patients with coronary heart disease in the anamnesis or to patients with essential risk factors of developing coronary heart disease;
• threat of an abortion at the I and II trimesters of pregnancy;
• any disease of mother or a fruit at which preservation of pregnancy is dangerous, for example, heavy degree of a toxaemia, a pre-natal infection, vaginal bleeding owing to placental presentation, an eclampsia or a heavy preeclampsia, placental detachment or compression of an umbilical cord;
• pre-natal death of a fruit, lethal congenital anomalies in the anamnesis or lethal chromosomal anomalies;
• bronchial asthma with hypersensitivity to sulfates;
• a disease of a cardiovascular system, in particular tachyarrhythmia, myocarditis, defect of the mitral valve;
• hyperthyroidism;
• serious illness of a liver and kidneys;
• glaucoma;
to
• use of the medicament "Ginipral" is contraindicated to the patients having diseases against the background of which use of beta-adrenergic agonists can have undesirable action, for example, pulmonary hypertensia, diseases of a cardiovascular system (a hypertrophic subaortic stenosis or an obstacle to a blood flow from a left ventricle, for example, an aortal stenosis).

Route of administration

For intravenous jet administration or infusion.

Specified dosage can be applied only as approximate as the tocolysis demands individual approach to the patient.

. Treatment is carried out only in correctly equipped institutions for implementation of constant control behind the state of health of mother and a fruit.

should use the Drug "Ginipral" after diagnosing of premature births and an exception of any contraindications to use of a hexoprenalin as soon as possible.

during therapy by medicament needs to carry out appropriate assessment of a condition of a cardiovascular system by means of continuous monitoring of the ECG.

Dosage

Before version from cross situation and at use as the emergency action at premature births before transportation of the pregnant woman in hospital. The recommended dose - 10 mkg (one ampoule on 2 ml) the medicament "Ginipral" divorced in 10 ml of 0.9% of solution of sodium of chloride or 5% glucose solution to enter within 5-10 minutes intravenously. In case of need to continue the Ginipral medicament treatment, a concentrate for preparation of solution for infusions.

Short-term treatment of premature births in the presence of shortening and/or disclosures of a neck of the uterus. In an initiation of treatment begin with jet introduction of a dose 10 mkg (one ampoule on 2 ml) with the subsequent infusion of the medicament "Ginipral" with a speed of 0.3 mkg/minute. As alternative treatment the use only of infusions of the medicament "Ginipral" with a speed of 0.3 mkg/minute without preliminary jet administration of medicament is possible. To enter intravenously by drop infusion (when calculating rate of administering with use of usual infusional systems to consider that 20 drops = 1 ml). The necessary number of ampoules of a concentrate for infusions to dissolve in 500 ml 0.9% of solution of sodium of chloride or 5% glucose solution.

Short-term treatment of premature births without shortening or disclosure of a neck of the uterus. The recommended dose: continuous infusion of 0.075 mkg/minute. To enter intravenously by drop infusion (when calculating rate of administering with use of usual infusional systems to consider that 20 drops = 1 ml). The necessary number of ampoules of a concentrate for infusions to dissolve 0.9% of solution of sodium of chloride or 5% of solution of glucose in 500 ml.

treatment Duration

Duration of tokolitichesky treatment depends on the existing degree of risk of termination of pregnancy (a tendency to reduction of an interval between pains, conditions of a neck of the uterus) and on severity of side effects (for example increase in heart rate). Side effects should be minimized as far as it is possible.

48 hours as data of researches demonstrate that by means of tokolitichesky therapy it is possible to delay childbirth from 48 o'clock. During randomized controlled studies the significant influence of treatment of the medicament "Ginipral" on perinatal lethality or incidence was not observed. The delay of childbirth by means of the medicament "Ginipral" can be used for use of other measures which considerably improve perinatal health.

Drug is not intended to

Feature of use

for use for children.

Drivers

Drug has no

or has insignificant influence on speed of response at control of motor transport or other mechanisms.

Overdose

Symptoms of overdose can be

: substantial increase of heart rate of mother, tremor, heartbeat, headache, perspiration.

Usually for elimination of these symptoms the reduction of a dosage of medicament suffices

. For elimination of heavy symptoms of overdose the use of non-selective beta blockers which competitively inhibit effect of the medicament "Ginipral" is recommended.

Side effects

Most widespread side effects of the medicament "Ginipral" are connected by

with pharmacological properties of beta-adrenergic agonists. For the purpose of elimination or reduction of emergence of undesirable effects carry out careful control of hemodynamic parameters, such as arterial blood pressure, heart rate and the corresponding correction of a dose of drug. These effects usually disappear after medicament phase-out.

Metabolic disturbances: often (≥ 1:100, <1:10) - a hypopotassemia.

from nervous system: very often (≥ 1:10) - a tremor.

from a cardiovascular system: very often (≥ 1:10) - tachycardia; often (≥ 1:100, <1:10) - heartbeat, decrease in diastolic pressure, arterial hypotension.

from skin and hypodermic cellulose: often (≥ 1:100, <1:10) - perspiration.

Storage conditions

to Store

in original packing at a temperature not above 25 °C, out of children's reach.

Expiration date - 3 years.

Restored solution: chemical and physical stability of the restored solution after dilution (0.9% solution of sodium of chloride or 5% glucose solution) was shown within 24 hours at a temperature of 15-25 °C. From the microbiological point of view medicament should be used immediately. In case of non-use at once terms and storage conditions of the restored solution to its use is responsibility of the user.