MEDORPHAN Oral solution (2019)
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Περιεχόμενα
1. Name of the medicinal product
Medorphan 7.5mg/5ml oral solution.
2. Qualitative and quantitative composition
Medorphan contains 7.5 mg dextromethorphan hydrobromide Ph Eur in each 5 ml of oral solution. <u>Excipients with known effect:</u> sucrose, sorbitol, liquid glucose and ethanol. For the full list of excipients, ...
3. Pharmaceutical form
Oral solution. The solution is a slightly yellowish, transparent, clear, flavoured liquid.
4.1. Therapeutic indications
Medorphan is indicated as an antitussive, for the relief of persistent, dry, irritating cough.
4.2. Posology and method of administration
Posology Adults and children aged 12 years and over Oral. 10 ml syrup (15 mg dextromethorphan) 4 times a day. <u>Maximum daily dose:</u> 40 ml syrup (60 mg dextromethorphan). Paediatric population Children ...
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Medorphan is contraindicated in individuals who are taking, or have taken, monoamine oxidase inhibitors within ...
4.4. Special warnings and precautions for use
Medorphan should not be administered to patients with chronic or persistent cough, such as occurs with asthma, or where cough is accompanied by excessive secretions, unless directed by a physician. There ...
4.5. Interaction with other medicinal products and other forms of interaction
The concomitant use of a dextromethorphan-containing product and monoamine oxidase inhibitors can occasionally result in symptoms such as hyperpyrexia, hallucinations, gross excitation or coma. CYP2D6 ...
4.6. Pregnancy and lactation
Although dextromethorphan has been in widespread use for many years without apparent ill consequence, there is insufficient information on the effects of administration during human pregnancy. In addition, ...
4.7. Effects on ability to drive and use machines
Unlikely to produce an effect.
4.8. Undesirable effects
Side effects attributed to dextromethorphan are uncommon; occasionally dizziness, nausea, vomiting, or gastro-intestinal disturbance may occur. Reporting of suspected adverse reactions Reporting suspected ...
4.9. Overdose
Signs and symptoms Dextromethorphan overdose may be associated with nausea, vomiting, dystonia, agitation, confusion, somnolence, stupor, nystagmus, cardiotoxicity (tachycardia, abnormal ECG including ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Opium alkaloids and derivatives <b>ATC code:</b> R05DA09 Dextromethorphan is an antitussive drug. It exerts its antitussive activity by acting on the cough centre in the ...
5.2. Pharmacokinetic properties
Absorption Dextromethorphan is well absorbed from the gut following oral administration. Due to individual differences in the metabolism of dextromethorphan, pharmacokinetic values are highly variable. ...
5.3. Preclinical safety data
Mutagenicity There is insufficient information to determine whether dextromethorphan has mutagenic potential. Carcinogenicity There is insufficient information to determine whether dextromethorphan has ...
6.1. List of excipients
Saccharin Sodium, Sodium Benzoate, Sugar (Sucrose), Liquid Glucose, Sorbitol solution 70%, Glycerol, Absolute Ethanol, Levomenthol, Citric acid anhydrous, Caramel flavour (liquid), Peach flavour (liquid), ...
6.2. Incompatibilities
None known.
6.3. Shelf life
24 months.
6.4. Special precautions for storage
Store below 25°C in the original package.
6.5. Nature and contents of container
150 ml and 200 ml Type III (Ph.Eur) brown glass bottles closed with caps (aluminium sheet; liner EPE sealing disk: hot-foamed polyethylene). Not all pack sizes may be marketed.
6.6. Special precautions for disposal and other handling
None applicable. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
7. Marketing authorization holder
MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus
8. Marketing authorization number(s)
21899
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 14/10/2013 Date of latest renewal: 26/09/2019
10. Date of revision of the text
12/2019
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