PARACETAMOL BAXTER Solution for infusion Ref.[50860] Active ingredients: Paracetamol

Source: Health Products Regulatory Authority (IE)  Revision Year: 2023  Publisher: Baxter Holding B.V., Kobaltweg 49, 3542CE Utrecht, Netherlands

Product name and form

Paracetamol 10 mg/ml solution for infusion.

Pharmaceutical Form

Solution for infusion.

The solution is clear, colourless to slightly yellowish and free from visible particles.

Osmolality 270 to 310 mOsm/kg.

pH: 4.5–6.5

Qualitative and quantitative composition

1 ml contains 10 mg paracetamol.

Each vial of 50 ml contains 500 mg paracetamol.

Each vial of 100 ml contains 1000 mg paracetamol.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Paracetamol

Paracetamol is a medication used to treat pain and fever. It does appear to selectively inhibit COX activities in the brain, which may contribute to its ability to treat fever and pain.

List of Excipients

Cysteine hydrochloride monohydrate (E920)
Disodium phosphate (E339)
Hydrochloric acid, concentrated (for pH adjustment) (E507)
Mannitol (E421)
Sodium hydroxide (for pH adjustment) (E524)
Water for injections

Pack sizes and marketing

50 ml fill volume in 100 ml Type II clear glass vial with chlorobutyl rubber stopper and red color aluminium flip-off cap.

100 ml fill volume in 100 ml Type II clear glass vial with chlorobutyl rubber stopper and blue color aluminium flip-off cap.

Pack size: pack of 25 vials.

Marketing authorization holder

Baxter Holding B.V., Kobaltweg 49, 3542CE Utrecht, Netherlands

Marketing authorization dates and numbers

PA2299/049/001

Date of first authorisation: 3rd December 2021

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