Ország: Írország
Nyelv: angol
Forrás: HPRA (Health Products Regulatory Authority)
PARACETAMOL
Docpharma BVBA
PARACETAMOL
10 Mg/Ml
Solution for Infusion
Product subject to prescription which may not be renewed (A)
Withdrawn
2012-02-07
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Paracetamol Docpharma 10 mg/ml solution for infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One ml contains 10 mg paracetamol One 100 ml vial contains 1000 mg paracetamol. Excipients: sodium 0.04 mg/ml. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for infusion. The solution is clear and slightly yellowish. pH= 5.0-6.0 ; osmolarity = 280-320 mOsmol/l. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Paracetamol Docpharma is indicated for the short-term treatment of moderate pain, especially following surgery, and for the short-term treatment of fever, when administration by intravenous route is clinically justified by an urgent need to treat pain or hyperthermia and/or when other routes of administration are not possible. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Intravenous use. Paracetamol Docpharma is restricted to adults, adolescents and children weighing more than 33 kg (approximately 11 years old). Posology: • Adolescents and adults weighing more than 50 kg: Per administration 1000 mg paracetamol, i.e. one 100 ml vial, up to four times a day. The minimum interval between each administration must be 4 hours. The maximum daily dose must not exceed 4 g. In adults with hepatocellular insufficiency, chronic alcoholism, chronic malnutrition (low reserves of hepatic glutathione), dehydration: The maximum daily dose must not exceed 3 g (see section 4.4). • Children weighing more than 33 kg (approximately 11 years old), adolescents and adults weighing less than 50 kg: Per administration 15 mg/kg paracetamol, i.e. 1.5 ml solution per kg up to four times a day. The minimum interval between each administration must be 4 hours. The maximum daily dose must not exceed 60 mg/kg Olvassa el a teljes dokumentumot