Ambrobene 15 mg / 2 ml 5's solution for injection in ampoules

The instruction for medical use


of Ambrobene® medicine

the Trade name
of Ambrobene®

the International unlicensed



name Ambroxol Dosage Form Solution for injections, 15 mg / 2.0 ml

Structure
One ampoule contains
active agent: Ambroxol hydrochloride of 0.0150 g,
excipients: citric acid, sodium chloride, sodium phosphate heptahydrate, acid of chlorohydrogen 25%, water for injections.

The description
Transparent from colourless till light yellow color solution.

Pharmacotherapeutic group
Expectorant drugs. Mucolytics. Ambroxol
the ATX R 05CB 06 Code

Pharmacological action
the Pharmacokinetics
Linking with proteins makes about 85%. The half-life period is about 22 hours. Discharge occurs through kidneys for 90% in the form of metabolites and for 10% in the form of not changed Ambroxol.
The pharmacodynamics
of Ambrobene® normalizes the changed bronchopulmonary secretion, improves rheological indicators of a phlegm, reducing its viscosity, facilitates removal of a phlegm from bronchial tubes. Амбробене® activation of a system of surface-active substances is promoted through direct impact on pnevmotsita of type 2 in alveoluses also by Klara cell, stimulates education and removal of surface-active material (surfactant) in alveolar and bronchial area of germinal and adult lungs. In addition, antioxidant effects of Ambroxol are established. After use of Ambrobene® the concentration of antibiotics in a phlegm and a bronchial secret increases.

Indications
of Ambrobene® it is applied for the purpose of sekretolitichesky therapy in acute and chronic bronkhopulmonalny diseases in which discharge and expectoration of a phlegm is broken:
- acute and chronic bronchitis, pneumonia
- bronchial asthma with difficulty of an otkhozhdeniye of a phlegm
- a bronchoectatic disease.

The route of administration and doses
of Ambrobene® enter solution for injections intramusculary, subcutaneously or intravenously (slowly struyno or by drop infusion). As solvent apply 0.9% solution of sodium of chloride, 5% glucose solution, Ringer-Locke's solution or other basic solution with pH not higher than 6.3.
The adult usually appoint 2 ml 2-3 times a day, in hard cases the dose can be doubled.
To children drug is appointed in a daily dose at the rate of 0.0012-0.0016 g to 1 kg of body weight.
Usually to children up to 2 years appoint 1 ml (1/2 ampoules) 2 times a day,
from 2nd to 5 years - on 1 ml (1/2 ampoules) 3 times,
is more senior than 5 years - on 2 ml (1 ampoule) 2-3 times.
At respiratory a distress syndrome at newborn and premature children: the daily dose of Ambrobene® of an ampoule increases to 0.01 g/kg (in hard cases - up to 0.03 g/kg, distributing on 3-4 introductions).
Injections stop after disappearance of acute manifestations of a disease and pass to intake or rectal administration of other dosage forms of the drug Ambrobene®.
Duration of treatment depends on features of a course of the disease. It is not recommended to apply Ambrobene® without medical appointment more than 4-5 days.

Side effects
Seldom
- a headache, fatigue, weakness, weight in legs
- gastralgias, nausea, vomiting
- reactions of hypersensitivity (skin rash, a face edema, dispnoe, an itching)
- heat
Very seldom
- allergic reactions, including an acute anaphylaxis.

Contraindications
- hypersensitivity to Ambroxol and/or other components of drug
- the I trimester of pregnancy

Medicinal interactions
At simultaneous use of Ambrobene® and:
- antibechic drugs – difficulty of removal of a phlegm from bronchial tubes against the background of reduction of a tussive reflex is possible.

Special instructions
Should be meant that 1 ampoule contains 1 mmol of sodium (23 mg).
At fast intravenous administration it is possible to provoke headaches, feeling of fatigue and weight in legs.
At restriction of functional capacity of kidneys and/or in a serious illness of a liver of Ambrobene® it is necessary to apply with extra care, reducing the applied dose and increasing time between administrations of drug.
Pregnancy and the period of a lactation
In spite of the fact that there are no reliable data of negative influence of Ambrobene® on a fruit and babies, use of drug in II and III trimesters of pregnancy and in the period of a lactation perhaps after the careful analysis of a ratio advantage/risk the attending physician so far.
Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms


the Overdose
Symptoms does not influence: excitement, diarrhea, the raised sialosis, vomiting and hypotension
Treatment: symptomatic therapy.

A form of release and packing
On 15 mg / 2 drug ml in ampoules of orange glass. On 5 ampoules together with the instruction for medical use in the state and Russian languages place in a pack from cardboard.


To Store storage conditions at a temperature not above 25C.
To store out of children's reach!



Not to apply a period of storage of 5 years after expiry date!

Prescription status
According to the prescription



Merkle GmbH Producer, Germany

the Owner of the registration certificate
'ratiopharm GmbH', Germany

the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods)
of ratiopharm Kazakhstan LLP, Almaty, Al-Farabi Ave., 19,
BC Nurly-Tau, 1B, office 603, Phone number: (727) 3110915, Fax: (727) 3110734,
e-mail: teva@teva.kz