Country: Armenja
Lingwa: Ingliż
Sors: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
paracetamol
Farmaclair
N02BE01
paracetamol
125mg
suppositories rectal
(10/2x5/)
OTC
Registered
2018-09-17
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Panadol Baby 125 mg Suppositories 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each suppository contains Paracetamol Ph. Eur. 125 mg. 3. PHARMACEUTICAL FORM Suppository 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Symptomatic treatment of pain from mild to moderate intensity and / or fever. Panadol Baby suppositories 125 mg are for children aged 6 to 18 months (with body weight of 7 to 10 kg). 4.2. POSOLOGY AND METHOD OF ADMINISTRATION For rectal administration only. Clean hands and free up the suppository from plastic coat. Carefully get in the suppository rectally (mostly after purgative enema or physical defecation). Convenient administration is achieved by lateral position of baby with moving up the leg to abdomen. Average single dose depends on child weight and equal to 10 – 15 mg/ kg, have to be taken 3-4 times 6 hours throughout the 24-hour period. Maximum daily doses should not exceed 60 mg / kg. Children weight from 7 till 10 kg (aged 6-18 months): 1suppositories (125 mg) as required every six hours. Not more than four doses in any 24 hour period. Maximum duration of continued use without medical advice: 3 days. Do not exceed the stated dose. Stop taking this medicine and consult your doctor in case of the therapeutic effect is absent. Due to potential toxicity of such medicine rectal administration of paracetamol should be as short as possible. Use the lowest recommended doses to achieve effect. 4.3. CONTRAINDICATIONS Hypersensitivity to paracetamol or any of the other constituents; Hepatocellular insufficiency; Recent inflammation or bleeding in rectum; 4.4. SPECIAL WARNINGS AND PRECAUTIONS FOR USE Contains paracetamol. Do not use with any other paracetamol-containing products. The concomitant use with other products containing paracetamol may lead to an overdose. Paracetamol overdose may cause liver failure which can lead to liver transplant or death. Underlying liver disease increases the risk of paracetamolrelat Aqra d-dokument sħiħ