Medicinal Products

PERFALGAN 10 mg / mL

Generic drug of the therapeutic class: Analgesics
active ingredients: Paracetamol
laboratory: Bristol Myers Squibb

Injection solution for IV infusion
Case of 12 bottles of 50 ml
All forms

Indication

PERFALGAN is indicated for the short-term treatment of moderate-intensity pain, particularly in the post-operative 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 other routes of administration are not possible.

Dosage PERFALGAN 10 mg / mL Solution for IV infusion Pack of 12 bottles of 50 ml

Intravenous way.

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

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

Dosage

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

Patient weight

Dose by administration

Volume by administration

Maximum volume per administration based on upper limits of group weight (mL) **

Daily dose

maximum ***

≤ 10 kg *

7.5 mg / kg

0.75 mL / kg

7.5 mL

30 mg / kg

> 10 kg to ≤ 33kg

15 mg / kg

1.5 mL / kg

49.5 mL

60 mg / kg without exceeding 2g

> 33 kg to ≤ 50kg

15 mg / kg

1.5 mL / kg

75 mL

60 mg / kg without exceeding 3g

Patient weight

Dose by administration

Volume by administration

Maximum volume per administration **

Daily dose

maximum ***

> 50 kg with risk factors for hepatoxicity

1g

100 mL

100 mL

3 g

> 50 kg without hepatoxicity risk factors

1 g

100 mL

100 mL

4 g

* Premature neonates: There are no efficacy and safety data available in premature neonates (see section 5.2 ).

** Patients with a lower weight should receive smaller volumes.

The interval between two administrations is 4 hours minimum. Do not administer more than 4 doses per 24 hours.

The interval between two administrations in patients with severe renal impairment is at least 6 hours.

*** Maximum daily dose: The maximum daily dose as presented in the table above is intended for patients not receiving other products containing paracetamol and should be adjusted accordingly, taking into account these products.

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

Take special care when prescribing and administering PERFALGAN to avoid dose-related errors due to confusion between milligrams (mg) and milliliters (mL), which can lead to an accidental overdose that can be fatal. Make sure the right dose is communicated and administered. When prescribing, it is recommended to indicate the dose in mg and the corresponding volume.

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

Patients with a weight ≤ 10 kg:

· The PERFALGAN glass pouch or bottle should not be used directly as an infusion given the small volume of the drug to be administered in this population

· The volume to be administered should be withdrawn from the vial or pouch and can be administered as is or diluted (in a volume of 1 to 9) in 0.9% sodium chloride solution or a solution of glucose at 5% and administered in 15 minutes.

· A 5 or 10 mL syringe should be used to measure the appropriate dose based on the child's weight and volume to be taken. However, this volume should never exceed 7.5 mL per dose.

· The user should refer to the dosing recommendations of the summary of product characteristics.

Text concerning the 50 ml and 100 ml bottles:

To collect the solution, use a 0.8 mm (21-gauge) diameter needle and punch the stopper vertically at the designated point.

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.

Text concerning the 50 ml bottle:

PERFALGAN in a 50 ml vial may be diluted in 0.9% sodium chloride solution or glucose solution (in a volume from 1 to 9). In this case, the diluted solution must be used within one hour of its preparation (including the infusion time).

Against indications

PERFALGAN is contraindicated:

In case of hypersensitivity to paracetamol or propacetamol hydrochloride (paracetamol prodrug) or to any of the excipients.

· In case of severe hepatocellular insufficiency.

Perfalgan 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

Very rare

> 1/10 000, <1/1000

<1/10 000

General

Discomfort.

Hypersensitivity reaction.

Cardiovascular

Hypotension.

Hepatic

Elevation of hepatic transaminases.

Platelets / blood

Thrombocytopenia.

Leukopenia.

Neutropenia.

Frequent injection site reactions have been reported in clinical trials (pain and burning sensation).

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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