Paracetamol 10 mg/ml solution for infusion

Paracetamol
Paracetamol 10 mg/ml solution for infusion

Description

Paracetamol 10 mg/ml Solution for Infusion is contained in a flexible polyolefin bag.
The bag is packaged inside a heat-sealed aluminium outer packaging with an oxygen absorber. The solution is clear.

Paracetamol is available in two presentations tailored to patients' needs:

  • a 100 ml single-access bag for use only in adults, adolescents and children over 33 kg.
  • a 50 ml dual-access bag for newborns, infants and children under 33 kg.
These presentations must be adapted according to the individual specific patient weight.

Qualitative and quantitative composition

One 100 ml bag contains 1000 mg paracetamol.
One 50 ml bag contains 500 mg paracetamol.
Excipients: sodium acetate trihydrate, glacial acetic acid, 1 N sodium hydroxide, water for injections. Warning: This product contains sodium.

Therapeutic indications

Paracetamol Solution for Infusion is indicated in the short-term treatment of moderate pain, particularly post-surgery pain, and in the short-term treatment of fever, when the intravenous route is clinically justified by the urgent need to treat pain or hyperthermia and/or when other routes of administration cannot be used.

Method of sterilization

Steam sterilization at 121C in the outer packaging for 15 minutes.

Storage conditions and shelf life

  • Before opening the outer packaging: shelf life of 24 months.
  • After opening the outer packaging: immediate use is recommended.
  • After dilution: use within 2 hours (including the infusion time).

Compliance

This product is manufactured in accordance with Good Manufacturing Practices and conforms to the Marketing Authorization dossier. It satisfies the requirements of the current European Pharmacopoeia. The oxygen absorber is food grade.

Use

  • Check the expiry date.
  • Remove the bag from the outer packaging using the "easy opening" notches and check to make sure it is intact. On contact with air, the oxygen absorber sachet becomes warm.
  • Check that the solution is clear, colourless and free of particles.
  • Check the opening of the hanging loop and that there is no leakage from the bag. Discard any bag that is damaged or part-used or where the hanging loop is not open.
  • Remove the protector from the infusion site.
  • Connect the infusion unit to the bag as far as it will go by making a twisting movement.
  • Take care to exclude air and do not connect in series.
  • Dispose of the outer packaging and the oxygen absorber in the non-contaminated waste.
  • Refer to the Summary of Product Characteristics for full details.

Packaging

DescriptionUnits per boxCartons per palletUnits per pallet
50 ml bag, dual-access50562800
100 ml bag, single-access50562800