BUTAMIRATE Syrup
Βιβλιογραφική αναφορά
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Περιεχόμενα
1. Name of the medicinal product
1.5 mg/ml, syrup.
2. Qualitative and quantitative composition
Each ml of syrup contains butamirate citrate 1.5 mg. Excipient with known effect: sorbitol. For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Syrup. Colourless or pale yellow liquid.
4.1. Therapeutic indications
Symptomatic treatment of dry, irritant cough of any aetiology.
4.2. Posology and method of administration
Posology Children 3-6 years: 5 ml 3 times daily. Children 6-12 years: 10 ml 3 times daily. Adolescents over 12 years: 15 ml 3 times daily. Adults: 15 ml 4 times daily. The maximum duration of treatment ...
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Children under 3 years of age.
4.4. Special warnings and precautions for use
Butamirate suppresses the cough reflex and therefore the concomitant use with expectorants should be avoided since it may lead to mucus retention in the airways, which increases the risk of bronchospasm ...
4.5. Interaction with other medicinal products and other forms of interaction
Concomitant use with expectorants should be avoided (see section 4.4).
4.6. Pregnancy and lactation
Pregnancy No specific studies have been conducted to assess safety of butamirate in pregnant women or during breast-feeding. Therefore butamirate should not be used in the first trimester of pregnancy. ...
4.7. Effects on ability to drive and use machines
The medicinal product should be used with caution in drivers and individuals using machines, since the active substance may cause drowsiness in rare cases.
4.8. Undesirable effects
The adverse drug reactions are divided into groups according to MedDRA terminology together with their frequency: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1 000 to <1/100); rare (≥1/10 ...
4.9. Overdose
Symptoms Butamirate overdose may lead to the following symptoms: drowsiness, dizziness, nausea, vomiting, diarrhoea, hypotension. Management Gastric lavage and administration of activated charcoal in order ...
5.1. Pharmacodynamic properties
Pharmacotherapeutic group: Other cough suppressants АТС code: R05DB13 Mechanism of action and pharmacodynamic effects Butamirate citrate exerts antitussive action and is not chemically or pharmacologically ...
5.2. Pharmacokinetic properties
Absorption It can be estimated from available data, that butamirate ester is absorbed well and rapidly. It is completely hydrolysed to 2-phenylbutyric acid and diethylaminoetoxyethanol. Effect of food ...
5.3. Preclinical safety data
Animal studies and in vitro experiments based on acute, repeated dose toxicity, toxicity to reproduction and mutagenicity of butamirate reveal no hazard for humans within the therapeutic use of the product. ...
6.1. List of excipients
Sorbitol (E420) Glycerol (E422) Sucralose (E955) Sodium benzoate (E211) Citric acid monohydrate Caramel flavour (also contains propylene glycol (E1520)) Bitter Chocolate Flavour F 2428 (also contains propylene ...
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
Shelf life: 2 years. After first opening: 6 months.
6.4. Special precautions for storage
Do not store above 25°C. Do not refrigerate or freeze.
6.5. Nature and contents of container
Amber glass bottle or polyethylene terephthalate bottle with child-proof HDPE screw cap with outer PP cap, PP measuring cup, carton box. Pack size: 100 ml or 200ml. Not all pack sizes may be marketed. ...
6.6. Special precautions for disposal and other handling
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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