Product Technical Specification
- Finished Dosage Form: Solution for infusion 150mg/ml filled in 1g/ 6.7ml type I glass ampoules (primary packaging)
- Packaging: BTx3 in a PVC/ALU blister placed in a carton box
- Administration: Ampoule concentrate is diluted in the content of 100ml 0.9% NaCl solution, mixed & infused slowly over a period of 15min
Efficacy Profile
- First line therapy for pain relief and fever management in post-operative patients
- Rapid pain relief and fever management3
- First pain relief 5-10 min post administration
- Maximum analgesic effect within 1 hour
- Decreases fever within 30 min post administration
- Analgesic & antipyretic effect lasts up to 6 hrs
- First line therapy in the treatment of childhood fever5,6
- Decreases the required dose of centrally acting agents (morphine, pethidine) in severe pain 1 when administered concomitantly
- 33% Reduction in morphine administration requirements, over a 24hr period in post-operative, orthopaedic patients3
Safety Profile
- 25 years of clinical experience
- Excellent Pharmacovigilance record: No Adverse Events reported
- No inhibitory effect on platelet aggregation3.
- Can be administered to patients with neutropenia and thrombocytopenia
- Not an NSAID: Free of all related SAEs of the category3
- Can be administered to patients with active, or history of GI ulcer
- Very rare incidence of hypersensitivity reactions
- Does not precipitate bronco-spasm
- Low impact on renal function
Dosage
Adult | 1g every 4-6 hours | maximum daily dose 4g |
Adult &children
33kg<weight<50kg |
15mg/kg/dose
4-6 hours |
maximum daily dose
60mg/kg(Not more than 3g |
Children
10kg<weight<33kg |
15mg/kg/dose
4-6 hours |
maximum daily dose
60mg/kg(Not more than 2g) |
Neonates
weight<10kg |
7.5mg/kg/dose
4-6 hours |
maximum daily dose
30mg/kg |