APOTEL 1000mg i.v. Paracetamol

Apotel 1000mg/6,7ml i.v. paracetamol

Solution for infusion 150mg/ml filled in 1g/ 6.7ml type I glass ampoules (primary packaging)

Description

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