Medicinal Products

PARACETAMOL KABI 10 mg / mL

Generic drug of the therapeutic class: Analgesics
active ingredients: Paracetamol
laboratory: Fresenius Kabi France

Injection solution for IV infusion
Box of 10 bottles of 100 ml
All forms

Indication

PARACETAMOL KABI is indicated for the short-term treatment of moderate pain, particularly in the postoperative period and in the short-term treatment of fever, when the intravenous route is clinically justified by the urgency of treating pain. or hyperthermia and / or when other routes of administration are not possible.

Dosage PARACETAMOL KABI 10 mg / mL Solution for IV infusion Pack of 10 bottles of 100 ml

Intravenous way.

Bottle and 100 ml bag: reserved for adults, teenagers and children over 33 kg.

50 ml bottle: reserved for newborns, infants and children under 33 kg.

Dosage:

The dosage is based on the weight of the patient (see dosage table below):

Patient weight

Dose per dose

Volume per take

Maximum volume of Paracetamol Kabi 10 mg / ml per dose based on the higher weight limits (mL) ***

Maximum daily dose **

≤ 10 kg *

7.5 mg / kg

0.75 ml / kg

7.5 ml

30 mg / kg

> 10 kg and ≤ 33 kg

15 mg / kg

1.5 ml / kg

49.5 ml

60 mg / kg without exceeding 2 g

> 33 kg and ≤ 50 kg

15 mg / kg

1.5 ml / kg

75 ml

60 mg / kg without exceeding 2 g

> 50 kg with additional risk factors for hepatotoxicity

1 g

100 ml

100 ml

3 g

> 50 kg without additional risk factors for hepatotoxicity

1 g

100 ml

100 ml

4 g

* Premature neonate: no safety and efficacy data are available in preterm neonates (see section Pharmacokinetic properties )

** Maximum daily dose: The maximum daily dose presented in the table above is valid for patients not receiving other medicines containing paracetamol and should be adjusted if necessary taking into account the intake of such drugs

*** Lighter patients will require lower volumes

The interval between two administrations must be at least 4 hours.

In severe renal impairment, the interval between two administrations should be at least 6 hours.

A maximum of 4 doses for 24 hours should be administered.

Severe renal insufficiency

It is recommended to increase the interval between 2 administrations to at least 6 hours when paracetamol is administered in patients with severe renal impairment (creatinine clearance ≤ 30 ml / min) (see section 5.2 ).

In adult patients, in case of hepatocellular insufficiency, chronic alcoholism, chronic malnutrition (low liver glutathione reserves) or dehydration, the maximum daily dose should not exceed 3 g (see Warnings and Precautions section). employment ).

Administration mode

RISK OF MEDICINAL ERRORS

Take special care when prescribing or administering Paracetamol Kabi 10 mg / ml to avoid dose-related errors due to confusion between milligrams (mg) and milliliters (ml) that could lead to accidental overdose and death. Make sure the appropriate dose is communicated and dispensed. On the prescription, it is necessary to indicate both the total dose in mg and the total volume in ml. Make sure the dose is measured and administered properly.

The paracetamol solution is administered as an intravenous infusion of 15 minutes.

Patients of weight ≤ 10 kg:

The Paracetamol Kabi 10 mg / ml vial should not be suspended as an infusion because of the small volume of medication to be administered to these patients.

The volume to be administered must be withdrawn from the vial and may be administered as is or diluted (in a volume of 1 to 9) in 0.9% sodium chloride or 5% glucose and administered as 15 minutes

A 5 or 10 ml syringe can be used to measure the appropriate dose for the child's weight and the desired volume. However, the volume should never exceed 7.5 ml per dose.

The user should refer to the product information for dosing recommendations.

For 50 ml bottles:

The Paracetamol Kabi 10 mg / ml vial may optionally be diluted (in a volume ranging from 1 to 9) in a solution of 0.9% sodium chloride or 5% glucose. In this case, the diluted solution must be used within one hour of preparation (including infusion time).

For bottles of 50 ml and 100 ml:

To collect the solution, a 0.8 mm needle (Gauge 21 needle) should be used and the stopper should be punctured vertically at the designated spot.

As with all infusion solutions packaged in glass vials, it is recalled that close monitoring is especially recommended at the end of the infusion regardless of the route of administration. This monitoring at the end of the infusion is particularly applicable to intravenous infusions in order to avoid gaseous embolism.

Against indications

PARACETAMOL KABI is contraindicated:

· If hypersensitivity to paracetamol or propacetamol hydrochloride (paracetamol prodrug) or to any of the excipients,

· In case of severe hepatocellular insufficiency.

Paracetamol Kabi side effects

As with all drugs containing paracetamol, side reactions are rare (> 1/10 000, <1/1000) or very rare (<1/10 000), they are described below:

System

Rare
> 1/10 000, <1/1000

Very rare
<1/10 000

General

Discomfort

Hypersensitivity reaction

Cardiovascular

hypotension

Hepatic

Elevation of liver transaminases

Platelets / blood

thrombocytopenia
leukopenia
neutropenia

Very rare cases of hypersensitivity reactions ranging from simple skin rash or urticaria to anaphylactic shock have been reported and require discontinuation of treatment.

Cases of erythema, flushing, pruritus and tachycardia have been reported.

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