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Novo - Panadol Baby sirup
« on: 05-06-2010, 11:36:20 »



1. NAME OF THE MEDICINAL PRODUCT

   

Panadol Baby 120mg/5ml Oral Suspension


2. QUALITATIVE AND QUANTITATIVE COMPOSITION

   

Each 5 ml spoonful of suspension contains paracetamol 120mg.

Excipients: Each 5ml contains: Sorbitol 0.67g, Maltitol 3.5g, Hexacol Carmoisine Supra (E122) 0.05mg and Parahydroxybenzoates 7.5mg.

For a full list of excipients, see section 6.1.

   
3. PHARMACEUTICAL FORM

   

Oral suspension.

Opaque, pink oral suspension with an odour of strawberry.


4. CLINICAL PARTICULARS
      
4.1 Therapeutic indications
   

Panadol Baby suspension is recommended for the relief of pains of teething, toothache and sore throats and for reducing fever often associated with colds and 'flu' and childhood infections such as chicken pox, whooping cough, measles and mumps.


4.2 Posology and method of administration
   

This product is intended for oral use in children ages:

2 -3 months:   half a 5ml spoonful (60mg) to be taken 4-6 hourly up to a maximum of 4 doses per 24 hours.
3 months- 1 year:   half to one 5ml spoonful (60-120mg) to be taken 4-6 hourly up to a maximum of 4 doses per 24 hours.
1 -6 years:   one to two 5ml spoonfuls (120-240mg) to be taken 4-6 hourly up to a maximum of 4 doses per 24 hours.
6 -12 years:   two to four 5ml spoonfuls (240-480mg) to be taken 4-6 hourly up to a maximum of 4 doses per 24 hours.

Not more than four doses should be given in any 24 hour period.

If your baby was born prematurely and is less than 3 months old consult your doctor prior to use.


Method of Administration

Panadol Baby suspension is for oral administration only.


4.3 Contraindications
   
Hypersensitivity to paracetamol or any of the other constituents.

4.4 Special warnings and precautions for use
   
Care is advised in the administration of paracetamol to patients with severe renal or hepatic impairment. The hazard of overdose is greater in those with non-cirrhotic alcoholic liver disease.

Do not exceed the recommended dose.

Maximum duration of continued use without medical advice: 3 days.

Patients should be advised not to take other paracetamol-containing products concurrently.

If symptoms persist, consult your doctor.

Prolonged use except under medical supervision may be harmful.

If your baby was born prematurely and is less than 3 months old consult your doctor prior to use.

If your child has a known intolerance to some sugars, contact your doctor before use as this product contains maltitol syrup and sorbitol.

Keep out of the reach and sight of children.

Immediate medical advice should be sought in the event of an overdose, even if the patient feels well because of the risk of irreversible liver damage.

Contains Hexacol Carmoisine Supra (E122) and parahydroxybenzoates (E219, E215 and E217) which may cause allergic reactions, possibly delayed.

Maltitol & Sorbitol liquid:

Patients with rare hereditary problems of fructose intolerance should not take this medicine. Each 120mg/5 ml suspension contains sorbitol (E 420) at 666.5 mg per 5 ml suspension.

nastavak -> http://www.medicines.ie/medicine/5686/SPC/Panadol+Baby+120mg+5ml+Oral+Suspension/

download -> http://www.medicines.ie/medicine/8691/PIL/Panadol+Baby+Suspension/


 

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