MEDOFED COMPOUND Oral solution (2020)
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Περιεχόμενα
1. Name of the medicinal product
Medofed Compound Oral Solution.
2. Qualitative and quantitative composition
Each 5 ml of Medofed Compound oral solution contains 100 mg Guaifenesin, 15 mg Dextromethorphan hydrobromide, 20 mg Pseudoephedrine hydrochloride and 1.25 mg Triprolidine hydrochloride. <u>Excipients with ...
3. Pharmaceutical form
Oral Solution. Red, clear, flavored solution.
4.1. Therapeutic indications
Medofed Compound is indicated for the symptomatic relief of upper respiratory tract disorders accompanied by productive or dry cough, which benefit from the administration of a nasal decongestant, a histamine ...
4.2. Posology and method of administration
Posology Adults 10 ml every 4-6 hours up to 4 times a day. Paediatric population <u>Children over 12 years:</u> as for adults. <u>Children 6-12 years:</u> 5 ml every 4-6 hours up to 4 times a day. <u> ...
4.3. Contraindications
Hypersensitivity to the active substances or to any of the excipients listed in section 6.1. Individuals who are taking or have taken monoamine oxidase inhibitors within the preceding two weeks. The concomitant ...
4.4. Special warnings and precautions for use
Ischaemic colitis Some cases of ischaemic colitis have been reported with pseudoephedrine. Pseudoephedrine should be discontinued and medical advice sought if sudden abdominal pain, rectal bleeding or ...
4.5. Interaction with other medicinal products and other forms of interaction
Concomitant use of Medofed Compound with sympathomimetic agents (such as decongestants, appetite suppressants and amphetamine-like psychostimulants) or with monoamine oxidase inhibitors, which interfere ...
4.6. Fertility, pregnancy and lactation
Pregnancy Although pseudoephedrine and triprolidine have been in widespread use for many years without apparent ill consequence, there are no specific data on their use during pregnancy. Caution should ...
4.7. Effects on ability to drive and use machines
Medofed Compound may cause drowsiness and impair performance in tests of auditory vigilance. Patients should not drive a vehicle or operate machinery until they have determined their own response.
4.8. Undesirable effects
Adverse reactions are listed below, by system organ class and by frequency. Frequencies are defined as: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to ...
4.9. Overdose
Symptoms The effects of acute toxicity from Medofed Compound may include drowsiness, lethargy, dizziness, ataxia, weakness, hypotonicity, respiratory depression, dryness of the skin and mucous membranes, ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Opium derivatives and expectorants <b>ATC code:</b> R05FA02 Pseudoephedrine Pseudoephedrine has a direct and indirect sympathomimetic activity and is an orally effective ...
5.2. Pharmacokinetic properties
Pseudoephedrine Pseudoephedrine is rapidly and completely absorbed after oral administration. After an oral dose of 180 mg to man, peak plasma concentrations of 500-900 ng/ml were obtained about 2 hours ...
5.3. Preclinical safety data
The active ingredients are well-known constituents of medicinal products and their safety profiles are well documented. The results of pre-clinical studies do not add anything of relevance for therapeutic ...
6.1. List of excipients
Propylene glycol Glycerol Sorbitol 70% Sodium benzoate Sucrose Sodium saccharin Citric acid Ponceau red E124 Acacia gum Ethanol absolute Peppermint oil Cherry Morella Purified water
6.2. Incompatibilities
None known.
6.3. Shelf life
36 months.
6.4. Special precautions for storage
Store below 25°C in the original package in order to protect from light.
6.5. Nature and contents of container
Amber glass bottles having metal roll-on closures or plastic screw caps. Each cap type is pilfar proof lined with atoxic polyvinyl chloride liner. Bottles containing either 100 ml, 150 ml or 200 ml of ...
6.6. Special precautions for disposal and other handling
No special requirements for disposal.
7. Marketing authorization holder
MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus
8. Marketing authorization number(s)
19889
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 28/12/2005 Date of Renewal Authorisation: 29/01/2015
10. Date of revision of the text
05/2020
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