Medicinal Products

PARACETAMOL PANPHARMA 10 mg / mL

Generic drug of the therapeutic class: Analgesics
active ingredients: Paracetamol
laboratory: Panmedica

Injection solution for IV infusion
Box of 50 Pockets (PVC) of 100 ml
All forms

Indication

PARACETAMOL PANPHARMA 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 PANPHARMA 10 mg / mL Solution for IV infusion Box of 50 Pouches (PVC) 100 ml

Intravenous way.

10 ml glass bottle: for term infants and infants under 10 kg.

Pocket or 50 ml glass bottle: reserved for infants and children over 10 kg and under 33 kg.

Pocket or glass bottle of 100 ml: reserved for adults, adolescents and children over 33 kg (about 11 years).

Dosage:

Adults and adolescents weighing more than 50 kg :

1 g of paracetamol per administration, ie a 100 ml bag, up to 4 times a day.

Respect an interval of at least 4 hours between two administrations.

The maximum daily dose should not exceed 4 g.

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 ).

Children over 33 kg (approximately 11 years), adolescents and adults under 50 kg :

15 mg / kg of paracetamol per administration, ie 1.5 ml of solution per kg, up to 4 times per day.

Respect an interval of at least 4 hours between two administrations.

The maximum daily dose should not exceed 60 mg / kg (not to exceed 3 g).

Children over 10 kg (approximately 1 year) and under 33 kg :

15 mg / kg of paracetamol per administration, ie 1.5 ml of solution per kg, up to 4 times per day.

Respect an interval of at least 4 hours between two administrations.

The maximum daily dose should not exceed 60 mg / kg (not to exceed 2 g).

Term infants, infants and children under 10 kg (approximately 1 year) :

7.5 mg / kg of paracetamol per administration, ie 0.75 ml of solution per kg, up to 4 times per day.

Respect an interval of at least 4 hours between two administrations.

The maximum daily dose should not exceed 30 mg / kg.

In preterm infants, efficacy and safety data are not available (see section 5.2 ).

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 ).

Administration mode :

The paracetamol solution is administered as an intravenous infusion of 15 minutes (see section 4.8 ).

To collect the solution from the vials, use a 0.8 mm needle (21 gauge needle) and pierce the stopper in the vertical position where indicated.

Before administration, inspect the product visually for particulate matter. For single use only.

The paracetamol solution may optionally be diluted in 0.9% sodium chloride solution or 5% glucose solution to a factor of 10. In this case, the diluted solution must be used within one hour. follows its preparation (including infusion time).

Against indications

PARACETAMOL PANPHARMA 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.

Side effects Paracetamol Panpharma

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 liver transaminases

Platelets / blood

thrombocytopenia

leukopenia

neutropenia

Cases of pain and burning at the injection site have been reported that may be related to an initial infusion rate that is too fast, not necessarily disappearing after the decrease in flow rate.

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

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

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