The instruction for medical use
of Ambro® medicine
the Trade name
the International unlicensed
name Ambroxol Dosage Form Solution for injections of 15 mg / 2 ml, 2 ml
of 2 ml of solution contain
active agent – Ambroxol a hydrochloride
(in terms of 100% substance) 15.0 mg,
excipients: citric acid monohydrate, sodium chloride, sodium hydrophosphate heptahydrate, 1M chlorohydrogen acid, water for injections.
the Transparent colourless or slightly painted liquid
Drugs for elimination of symptoms of cold and cough.
Expectorant drugs. Mucolytics. Ambroxol.
The ATX R05CB06 code
Pharmacokinetics Absorption properties of Ambroxol fast and rather full, with linear dependence in the therapeutic range. The maximum concentration of active ingredient in blood plasma is reached in 30 minutes – 3 hours. In blood plasma about 90% of drug contacts proteins. Distribution of Ambroxol between blood and fabrics happens quickly, high concentration of active agents in lungs is observed. Plasma elimination half-life makes 7-12 hours, accumulation in fabrics is not revealed. Ambroxol is metabolized generally in a liver by conjugation. It is removed by kidneys: 90% in the form of water-soluble metabolites, in not changed look – 5%. T1/2 increases at heavy HPN, does not change in an abnormal liver function.
of Ambro® – mucolytic drug. Possesses sekretomotorny, sekretolitichesky and expectorant action, stimulates serous cells of glands of a mucous membrane of bronchial tubes, increases the content of mucous secretion and discharge of surfactant in alveoluses and bronchial tubes, normalizes the broken ratio of serous and mucous components of a phlegm. Activating the hydrolyzing enzymes and strengthening release of lysosomes from cells Klara, reduces viscosity of a phlegm. Increases physical activity of a ciliary epithelium, increases mukotsiliarny transport.
of Ambro® 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
enter Solution for injections intramusculary, subcutaneously or intravenously (slowly struyno or by drop infusion). For in/in drop the introductions of 50 ml part in 500 ml of infusion solution (as solvent apply 0.9% NaCl solution, 5% dextrose solution. Enter during 2 h with a speed of 84 of cap/min.
The adult appoint 15 mg (1 ampoule) 2-3 times a day, in hard cases – on 30 mg (2 ampoules) 2-3 times a day.
To children under 2 years enter 7.5 mg (1/2 ampoules) 2 times.
Children are from 2 to 5 years old – on 7.5 mg (1/2 ampoules) 3 times a day, 5 years are more senior – on 15 mg (1 ampoule) 2-3 times a day.
At respiratory the distress syndrome at premature children and newborns a daily dose of Ambro® is increased to 10 mg/kg (in hard cases – up to 30 mg/kg), distributing on 3-4 introductions. Parenteral administration stops after disappearance of acute manifestations of a disease (pass to intake or rectal administration).
It is not recommended to apply without medical appointment more than within 4-5 days.
At fast in in introduction – feeling of catalepsy, an adynamia, intensive headaches, decrease in the ABP, an asthma, a hyperthermia, a fever
– a headache, fatigue, weakness, weight in legs
– allergic reactions (skin rash, a small tortoiseshell, a Quincke’s disease breath disturbance, temperature reaction with a fever)
– diarrhea, dryness of a mucous membrane of an oral cavity and airways, a dieback, a rhinorrhea, constipations, a dysuria. At prolonged use in high doses – the gastralgia, nausea, vomiting
In some cases
– are possible heavy reactions of anaphylactic type
of the Contraindication
– hypersensitivity to Ambroxol and/or other components of drug
– a peptic ulcer of a stomach and duodenum
– the I trimester of pregnancy and the period of a lactation
– phenylketonuria (for the dosage forms containing aspartame)
is not recommended simultaneous use of drug with the medicines having antibechic activity (for example, containing codeine) because of difficulty of removal of a phlegm from bronchial tubes against the background of reduction of cough. Simultaneous use of Ambroxol with antibiotics (amoxicillin, tsefuroksy, erythromycin, doxycycline and others) improves receipt of antibiotics in pulmonary ways that can reduce treatment terms.
Ambro® solution for injections is incompatible in one syringe or a dropper with other medicines, value rn whom it exceeds 6.3 as has acid properties.
With care are appointed in an abnormal liver function or kidneys, motor dysfunction of bronchial tubes or at discharge of a large amount of secretion (because of threat of an accumulation of slime). In heavy abnormal liver functions and kidneys it is necessary to reduce a dosage or to increase intervals between receptions.
Pregnancy and the period of a lactation
are not present reliable data of negative influence of Ambro® 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 Now.
Features of influence of medicine on ability to run motor transport and potentially dangerous mechanisms
Considering side effects of medicine it is necessary to be careful at control of motor transport or potentially dangerous mechanisms
Symptoms – excitement, diarrhea, the raised sialosis, vomiting and hypotension
Treatment – symptomatic
the Form of release and packing
On 2 ml spill in ampoules of spray filling of light-protective glass with a point or a ring of a break.
On each ampoule paste the label from paper label or writing.
On 5 ampoules pack into blister strip packaging from a film of polyvinylchloride and aluminum foil.
Blister strip packagings together with the approved iinstruktion on medical use in the state and Russian languages place in boxes of cardboard for a retail container or corrugated.
To Store storage conditions in the dry, protected from light place at a temperature not higher than 30 wasps.
To store out of children’s reach!
not to apply a period of storage after an expiration date.
According to the prescription
JSC Khimpharm Producer,
Republic of Kazakhstan, Shymkent, Rashidov St., 81
the Owner of the registration certificate
of JSC Khimpharm, the Republic of Kazakhstan
the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods) of JSC Khimpharm, Shymkent, Republic of Kazakhstan, Rashidov St., 81 Phone number 7252 (561342) Fax number 7252 (561342) the E-mail address of firstname.lastname@example.org
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