ATALINE Syrup (2017)
Βιβλιογραφική αναφορά
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Περιεχόμενα
1. Name of the medicinal product
Ataline 1.5 mg/5 ml syrup.
2. Qualitative and quantitative composition
Each teaspoon (5 ml) of syrup contains 1.5 mg terbutaline sulfate. <u>Excipients with known effect:</u> methyl-parahydroxybenzoate, propyl-parahydroxybenzoate, sorbitol, sucrose. For the full list of excipients ...
3. Pharmaceutical form
Syrup. Transparent, clear, flavoured liquid.
4.1. Therapeutic indications
Ataline syrup is indicated for bronchodilation. Terbutaline is a selective β<sub>2</sub>-adrenergic agonist recommended for the relief and prevention of bronchospasm in bronchial asthma and other bronchopulmonary ...
4.2. Posology and method of administration
Posology When used as maintenance therapy the patient should also receive optimal anti-inflammatory therapy, e.g. inhaled corticosteroids, leukotriene receptor antagonists. Terbutaline has a duration of ...
4.3. Contraindications
Hypersensitivity to the active substance, to sympathomimetic amines or to any of the excipients listed in section 6.1.
4.4. Special warnings and precautions for use
As for all beta<sub>2</sub>-agonists caution should be observed in patients with thyrotoxicosis. Cardiovascular effects may be seen with sympathomimetic drugs, including terbutaline. There is some evidence ...
4.5. Interaction with other medicinal products and other forms of interaction
Beta-blocking agents (including eye-drops), especially the non-selectiveones such as propranolol, may partially or totally inhibit the effect of β-stimulants. Therefore, terbutaline preparations and non-selective ...
4.6. Pregnancy and lactation
Pregnancy Although no teratogenic effects have been observed in animals or in patients, terbutaline should only be administered with caution during the first trimester of pregnancy. Maintenance treatment ...
4.7. Effects on ability to drive and use machines
Ataline has no or negligible influence on the ability to drive and use machines.
4.8. Undesirable effects
Summary of the safety profile The intensity of the adverse reactions depends on dosage and route of administration. Most of the adverse reactions are characteristic of sympathomimetic amines. The majority ...
4.9. Overdose
<u>Symptoms:</u> Headache, anxiety, tremor, nausea, tonic muscle cramps, palpitations, tachycardia, arrhythmia. A fall in blood pressure sometimes occurs. <u>Laboratory Findings:</u> Hyperglycaemia, hypokalaemia ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> selective β<sub>2</sub>-agonist, terbutaline <b>ATC code:</b> R03CC03 Terbutaline is a selective β<sub>2</sub>-adrenergic stimulant having the following pharmacological ...
5.2. Pharmacokinetic properties
<u>Tablet/Syrup:</u> The bronchodilating effect has in clinical trials been shown to have duration for up to 8 hours. Absorption and distribution There is a considerable first–pass metabolism in the intestinal ...
5.3. Preclinical safety data
The major toxic effect of terbutaline, observed in toxicological studies in rats and dogs at exposures in excess of maximum human exposure, is focal myocardial necrosis. This type of cardiotoxicity is ...
6.1. List of excipients
Methyl-parahydroxybenzoate Propyl-parahydroxybenzoate Sorbitol 70% (non-crystallising) Orange dry flavour Sucrose Highly purified water
6.2. Incompatibilities
None known.
6.3. Shelf life
60 months.
6.4. Special precautions for storage
Store below 25ºC.
6.5. Nature and contents of container
Brown glass bottles containing 100ml of syrup.
6.6. Special precautions for disposal and other handling
None.
7. Marketing authorization holder
MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus
8. Marketing authorization number(s)
21398
9. Date of first authorization / renewal of the authorization
30/05/2012 – 19/04/2017
10. Date of revision of the text
19/04/2017
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