Translation of the instruction Mose

INGAMIST solution for injections of 100 mg/ml

Instruction

For medical use of medicine

Ingamist

(ingamist)

Ingredients:

Active ingredient: Acetylcysteinum;

1 ml 100 mg

contain Acetylcysteinum

Excipients: sodium edetat, sodium hydroxide, water for injections.

Dosage form.

Solution for injections

Main physical and chemical properties: transparent colourless liquid with a slight smell of sulfur.

After opening of an ampoule at long contact with air can appear weak one-time — a violet shade.

Pharmacotherapeutic group.

Mucolytic means. code atkh r05c v01.

Pharmacological properties.

Pharmacodynamics.

Acetylcysteinum dilutes a phlegm. In structure of Acetylcysteinum the sulfhydryl groups promote a rupture of disulfide bridges of acid mucopolysaccharides of a phlegm that leads to depolarization of mukoproteid and reduction of viscosity of slime. Drug keeps activity in the presence of a purulent phlegm.

Acetylcysteinum has the antioxidant effect caused by presence of nucleophilic thiol SH group, easily gives hydrogen, neutralizing oxidizing radicals.

Protective mechanism of Acetylcysteinum is based by

on ability of its reactive sulfhydryl groups to connect free radicals.

Acetylcysteinum easily gets in a cell, is deacetylated to L — cysteine from which intracellular glutathione is synthesized.

Glutathione — high-reactive tripeptide, powerful antioxidant, the cytoprotector taking endogenous and exogenous free radicals, toxins. Acetylcysteinum prevents exhaustion and promotes increase in synthesis of the intracellular glutathione participating in oxidation-reduction processes of cages, promoting thus a detoxication of hazardous substances.

Pharmacokinetics.

At intravenous administration of 600 mg of Acetylcysteinum the maximum concentration in blood plasma makes 300 mmol/l, elimination half-life of blood — 2 hours. The general clearance — 0.21 l/h/kg, and distribution volume at the plateau — 0.34 l/kg. Acetylcysteinum gets into intercellular space, is mainly distributed in a liver, kidneys, lungs, a bronchial secret. Acetylcysteinum and its metabolites are removed generally by kidneys.

Clinical characteristics.

Indication.

Acute and chronic diseases of respiratory organs which are followed by the increased formation of a phlegm.

Contraindication.

Hypersensitivity to Acetylcysteinum or to other components of medicine, a peptic ulcer of a stomach and duodenum in an aggravation stage, a pneumorrhagia, pulmonary bleeding.

Interaction with other medicines and other types of interactions.

Simultaneous use of Acetylcysteinum with antibechics can increase stagnation of a phlegm because of suppression of a tussive reflex.

Concomitant use of Acetylcysteinum and nitroglycerine can lead

to strengthening of vasodilating action of the last. Patsiyentov it is necessary to warn about a possibility of a lowering of arterial pressure and developing of a headache.

to

does not recommend application of antibiotics and Acetylcysteinum in one syringe: decrease of the activity of antibiotics is possible.

Due to the property to form chelate structures, atsetiltsstein the bioavailability of salts of such metals as gold, calcium, iron can lower

. Therefore it is recommended to use these medicines at different times.

Laboratory indicators

Use of Acetylcysteinum can change

results of quantitative definition of salicylates a colorimetric method and also results of definition of ketones in urine.

Feature of application.

to Patients with bronchial asthma, during therapy by an ingamist it is necessary to be under control of the doctor. in case of development of a bronchospasm the intake of Acetylcysteinum should be stopped immediately.

Ingamist should be applied with care the patient with a peptic ulcer in the anamnesis, especially in case of the accompanying intake of other medicines which irritate a mucous membrane of a stomach.

Intake of Acetylcysteinum, generally at the beginning of therapy, does secretion of bronchial glands to less viscous and can increase its volume. If the patient cannot effectively cough up a phlegm, it is necessary to make a postural drainage and aspiration of contents of bronchial tubes.

Intravenously needs to administer the medicament under strict observation of the doctor. Side effects at intravenous administration of Acetylcysteinum can arise more often if to enter medicine too quickly or in high doses. Therefore it is recommended to follow accurately the instructions provided in the sections "Route of Administration and Doses".

Medicine contains 43 mg (1.9 mmol) of sodium in one ampoule. It should be considered to patients who are on a controlled sodium diet.

Ingamista Solution should not contact to rubber and metal surfaces.

Slight sulfuric smell of solution is a characteristic smell of active agent.

an ampoule to open

At intravenous administration just before use of medicine. At topical administration perhaps partial use of contents of an ampoule: the remained solution can be used (at observance of storage conditions) within 24 hours only for topical administration; introduction of the remained solution for injections is forbidden.

Use during pregnancy or feeding by a breast

during pregnancy and feeding by a breast use of Acetylcysteinum is only possible

if the expected advantage for mother exceeds potential risk for a fruit or the child, under direct observation of the doctor.

Ability to influence speed of response at control of motor transport or other mechanisms.

do not have

data confirming influence on speed of response.

Route of administration and doses.

Topical administration

Inhalation introduction: the adult on 1 ampoule 1–2 times a day on doctor's orders. within 5–10 days, to children of 6 years — up to 1 ampoule 1–2 times a day on doctor's orders within 5–10 days.

Endobronchial introduction: to adults and children of 6 years — up to 1 ampoule 1–2 times a day.

System application

Intramuscular introduction

Adult — on 1 ampoule of 300 mg 1–2 times a day to enter

deeply intramusculary.

Intravenous administration

Medicine to enter

slowly by drop infusion into 0.9% solution of sodium of chloride or 5% glucose solution.

Adult on 1 ampoule of 300 mg 1–2 times a day.

Children.

For intramuscular and intravenous administration to children medicament is not used (mainly oral dosage forms).

For topical administration medicine to children to appoint more senior than 6 years.

Overdose.

Symptoms

Symptoms of overdose are similar

At intravenous administration

to symptoms of the side reactions having heavy degree.

Treatment

Treatment demands the immediate termination of administration of medicine and performing symptomatic therapy. Specific antidote is absent. Carrying out dialysis is effective.

At topical administration

Symptoms

High doses can cause discharge of a large amount of bronchopulmonary secretion that can lead to obstruction of airways.

Treatment

Mechanical removal of slime from a tracheobronchial tree.

Side reactions.

At topical administration such reactions are possible

:

from the immune system: reactions of hypersensitivity;

from respiratory organs: bronchospasm, rhinorrhea;

from digestive organs: stomatitis, nausea, vomiting;

from integuments: urticaria, rash, itch.

At parenteral application such reactions are possible

:

from the immune system: acute anaphylaxis, anaphylactic reactions, anaphylactoid reactions, hypersensitivity;

from a cardiovascular system: tachycardia, lowering of arterial pressure;

from respiratory organs: a bronchospasm, dispnoe

from digestive organs: nausea, vomiting, abdominal pain, diarrhea, dyspepsia, heartburn;

from integuments: a Quincke's disease, a small tortoiseshell, hyperaemia,

burning in the injection site, rash, an itch, in isolated cases is possible

development of a syndrome

Stephens's

— Johnson and a Lyell's disease;

Other: a face edema, a headache, a ring in ears, a hemorrhage, a hyperthermia, anemia, increase in a prothrombin time.

Expiration date.

2 years.

Storage conditions.

to Store

at a temperature not above 30 °C in original packing.

to Store

out of children's reach.

Incompatibility.

Solution of the ingamist should not contact to rubber and metal surfaces.

Packing.

On 3 ml in ampoules from dark glass; on 5 ampoules in blister strip packaging; on 2 planimetric packs in a pack.

Category of a holiday.

According to the prescription.

Producer.

Ltd company "a yuriya — pharmaceutical".

Location of the producer and its address of the place of implementation of activity.

Ukraine, 18030, m Cherkasy, st. verbovetsky, 108. ph. (044) 281-01-01.