MEDOFED Oral solution (2020)
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Περιεχόμενα
1. Name of the medicinal product
Medofed 30mg/1.25mg per 5ml oral solution.
2. Qualitative and quantitative composition
Each 5ml of solution contains 30mg pseudoephedrine hydrochloride and 1.25 mg triprolidine hydrochloride. <u>Excipients with known effect:</u> sucrose, methyl para-hydroxybenzoate, tartrazine yellow lake. ...
3. Pharmaceutical form
Oral solution. Clear, yellow, flavoured solution for oral administration.
4.1. Therapeutic indications
Medofed syrup contains a decongestant and antihistamine and is indicated for the management of upper respiratory tract conditions such as the common cold, hay fever, allergic and vasomotor rhinitis and ...
4.2. Posology and method of administration
Posology Adults and children 12 years and over 10 ml every 4-6 hours up to four times a day. Paediatric population Children 6-12 years 5 ml every 4-6 hours, up to three times a day. Maximum daily dose: ...
4.3. Contraindications
Medofed Syrup is contraindicated in individuals with known hypersensitivity to the active substances or to any of the excipients listed in section 6.1. Medofed Syrup is contra-indicated in patients with ...
4.4. Special warnings and precautions for use
Medofed Syrup may cause drowsiness. This product should not be used to sedate a child. If any of the following occur, this product should be stopped: Hallucinations Restlessness Sleep disturbances Ischaemic ...
4.5. Interaction with other medicinal products and other forms of interaction
<u>MAOIs and/or RIMAs:</u> Pseudoephedrine exerts its vasoconstricting properties by stimulating α-adrenergic receptors and displacing noradrenaline from neuronal storage sites. Since MAOIs impede the ...
4.6. Fertility, pregnancy and lactation
There are no adequate and well-controlled studies for pseudoephedrine, triprolidine in pregnant or breast-feeding women. Pregnancy This product should not be used during pregnancy unless the potential ...
4.7. Effects on ability to drive and use machines
Medofed Syrup may have a moderate influence on the ability to drive and use machines. This combination may cause dizziness or drowsiness and impair performance in tests of auditory vigilance. Patients ...
4.8. Undesirable effects
Placebo-controlled studies with sufficient adverse event data were not available for the combination of pseudoephedrine and triprolidine. Adverse drug reactions identified during clinical trials and post-marketing ...
4.9. Overdose
Symptoms The effects of acute toxicity from this combination may include drowsiness, incoordination, weakness, irritability, palpitations, hypertension, convulsions and difficulty with micturition. <u> ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Sympathomimetics, pseudoephedrine, combinations <b>ATC code:</b> R01BA52 Triprolidine provides symptomatic relief in conditions believed to depend wholly, or partly, upon ...
5.2. Pharmacokinetic properties
After the administration of 10 ml pseudoephedrine hydrochloride/triprolidine hydrochloride syrup in healthy adult volunteers, the peak plasma concentration (C<sub>max</sub>) of triprolidine is approximately ...
5.3. Preclinical safety data
Mutagenicity There is insufficient information available to determine whether triprolidine or pseudoephedrine have mutagenic potential. Carcinogenicity There is insufficient information available to determine ...
6.1. List of excipients
Sucrose Glycerol Methyl para-Hydroxybenzoate (Ε218) Sodium Benzoate (E211) Tartrazine Yellow Lake (E102) Strawberry flavour Purified Water
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
36 months unopened.
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 pilar proof lined with atoxic polyvinyl chloride liner. Bottles containing either 100 ml or 150 ml or 200 ml of Medofed ...
6.6. Special precautions for disposal and other handling
Not applicable.
7. Marketing authorization holder
MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus
8. Marketing authorization number(s)
19978
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 20/12/2005 Date of renewal authorisation: 30/07/2013
10. Date of revision of the text
09/2020
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