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CALPOL INFANT Oral suspension (2021)

Αναφορές

Βιβλιογραφική αναφορά

Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
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Περιεχόμενα

1. Name of the medicinal product

CALPOL Infant Suspension.

2. Qualitative and quantitative composition

CALPOL Infant Suspension contains 120mg Paracetamol in each 5ml. <u>Excipients:</u> sucrose (contains 2.2 g of sucrose per 5 ml), sorbitol liquid ((E420) contains 0.45 g sorbitol liquid per 5ml), sodium ...

3. Pharmaceutical form

Oral Suspension. A pink strawberry flavoured suspension.

4.1. Therapeutic indications

CALPOL Infant Suspension is indicated for the treatment of mild to moderate pain and as an antipyretic. It can be used in many conditions including headache, toothache, earache, teething, sore throat, ...

4.2. Posology and method of administration

For the relief of fever after vaccinations at 2, 3 and 4 months 2.5ml. This dose may be given up to 4 times a day starting at the time of vaccination. Do not give more than 4 doses in any 24 hour period. ...

4.3. Contraindications

Hypersensitivity to paracetamol or to any of the excipients listed in section 6.1.

4.4. Special warnings and precautions for use

Do not exceed the recommended dose. Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help straight away. Quick medical attention is critical for ...

4.5. Interaction with other medicinal products and other forms of interaction

Drugs which induce hepatic microsomal enzymes Metabolism of paracetamol possibly accelerated by carbamazepine, fosphenytoin, phenytoin, phenobarbital, primidone (also isolated reports of hepatotoxicity). ...

4.6. Fertility, pregnancy and lactation

Pregnancy A large amount of data on pregnant women indicate neither malformative, nor feto/neonatal toxicity. Epidemiological studies on neurodevelopment in children exposed to paracetamol in utero show ...

4.7. Effects on ability to drive and use machines

None known.

4.8. Undesirable effects

Adverse drug reactions (ADRs) identified during clinical trials and post-marketing experience with paracetamol are listed below by System Organ Class (SOC). The frequencies are defined according to the ...

4.9. Overdose

Liver damage is possible in adults and adolescents (≥12 years of age) who have taken 7.5g or more of paracetamol. It is considered that excess quantities of a toxic metabolite (usually adequately detoxified ...

5.1. Pharmacodynamic properties

<b>Pharmacotherapeutic group:</b> Other Analgesics and Antipyretics (Anilides) <b>ATC Code:</b> N02BE01 Paracetamol has analgesic and antipyretic effects that do not differ significantly from those of ...

5.2. Pharmacokinetic properties

Absorption Paracetamol is rapidly and almost completely absorbed from the gastrointestinal tract with peak plasma concentrations occurring 0.5-2 hours after dosing. The plasma half-life is approximately ...

5.3. Preclinical safety data

Preclinical data reveal no special hazard for humans based on conventional studies of single and repeated dose toxicity, genotoxicity, and carcinogenicity. Conventional studies using the currently accepted ...

6.1. List of excipients

Sucrose Sorbitol Liquid (Non Crystallising) (E420) Glycerol Xanthan Gum Microcrystalline cellulose and carmellose sodium Polysorbate 80 Acesulfame Potassium Propyl Parahydroxybenzoate (E216) Ethyl Parahydroxybenzoate ...

6.2. Incompatibilities

None known.

6.3. Shelf life

3 years.

6.4. Special precautions for storage

Do not store above 25°C. Keep bottle in the outer carton.

6.5. Nature and contents of container

Amber glass bottle with a two-piece white plastic child-resistant external cap, fitted with an inner plastic cap, including a tamper evident ring fitted with a polyethylene or polyvinylidene chloride (PVDC) ...

6.6. Special precautions for disposal and other handling

No special requirements for disposal.

7. Marketing authorization holder

McNeil Products Limited, 50-100 Holmers Farm Way, High Wycombe, Buckinghamshire, HP12 4EG, UK

8. Marketing authorization number(s)

PL 15513/0004

9. Date of first authorization / renewal of the authorization

28 April 1997 / 31<sup>st</sup> March 2003

10. Date of revision of the text

04 January 2021

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