ACTIFED Syrup (2021)
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Περιεχόμενα
1. Name of the medicinal product
ACTIFED 30mg/1.25mg per 5ml Syrup.
2. Qualitative and quantitative composition
ACTIFED Syrup contains 1.25 mg Triprolidine hydrochloride and 30 mg Pseudoephedrine hydrochloride in each 5 ml. <u>Excipients:</u> Also includes the following substances in each 5 ml: Sucrose 3.5 g Methyl ...
3. Pharmaceutical form
Syrup. A clear, golden yellow syrup.
4.1. Therapeutic indications
ACTIFED 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. Children 6-12 years 5 ml every 4-6 hours, up to three times a day. Maximum daily dose: 15ml syrup. A pharmacist ...
4.3. Contraindications
ACTIFED Syrup is contra-indicated in individuals with known hypersensitivity to pseudoephedrine, triprolidine or to any of the excipients listed in section 6.1. ACTIFED Syrup is contra-indicated in patients ...
4.4. Special warnings and precautions for use
ACTIFED 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 Severe ...
4.5. Interaction with other medicinal products and other forms of interaction
MAOIs and/or RIMAs: Pseudoephedrine exerts its vasoconstricting properties by stimulating α-adrenergic receptors and displacing noradrenaline from neuronal storage sites. Since MAOIs impede the metabolism ...
4.6. Fertility, pregnancy and lactation
There are no adequate and well-controlled studies for pseudoephedrine, triprolidine in pregnant or breast-feeding women. Fertility There is no information on the effects of ACTIFED syrup on human fertility. ...
4.7. Effects on ability to drive and use machines
ACTIFED Syrup may have a moderate influence on the ability to drive and use machines. ACTIFED Syrup may cause dizziness or drowsiness and impair performance in tests of auditory vigilance. Patients should ...
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 ACTIFED Syrup may include drowsiness, incoordination, weakness, irritability, palpitations, hypertension, convulsions and difficulty with micturition. Pseudoephedrine ...
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 ACTIFED Syrup in healthy adult volunteers, the peak plasma concentration (C<sub>max</sub>) of triprolidine is approximately 5.5-6.0 ng/ml, occurring at about 1.5 hours ...
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 hydroxybenzoate (E218) Sodium benzoate (E211) Quinoline yellow (E104) Sunset yellow (E110) Water
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
3 years.
6.4. Special precautions for storage
Do not store above 25°C. Store in the original container. Keep the bottle tightly closed.
6.5. Nature and contents of container
100 ml amber glass bottles with metal roll on closures or HDPE screw caps. Each cap type containing PVDC-lined wads or polyethylene/expanded polyethylene laminated wad. 100 ml amber glass bottles with ...
6.6. Special precautions for disposal and other handling
No special requirements. Any unused product or waste material should be disposed of in accordance with local requirements.
7. Marketing authorization holder
Johnson & Johnson (Ireland) Limited, Airton Road, Tallaght, Dublin 24, Ireland
8. Marketing authorization number(s)
PA0330/049/001
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 01 April 1978 Date of last renewal: 01 April 2008
10. Date of revision of the text
May 2021
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