CALPOL INFANT Oral suspension (2021)
Βιβλιογραφική αναφορά
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Περιεχόμενα
1. Name of the medicinal product
CALPOL Infant Suspension.
2. Qualitative and quantitative composition
CALPOL Infant Suspension contains 120mg Paracetamol in each 5ml.
Excipients:
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 thro...
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 p...
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...
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 hepatotoxi...
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...
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...
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 d...
5.1. Pharmacodynamic properties
Pharmacotherapeutic group:
Other Analgesics and Antipyretics (Anilides)
ATC Code:
N02BE01
Paracetamol has analgesic and antipyretic effects that do not differ significantly from those of aspirin...
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 approxim...
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 ...
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)...
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 chlori...
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
st
March 2003
10. Date of revision of the text
04 January 2021
Πηγαίο έγγραφο
Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση:
