Medicinal Products

PARACETAMOL ACTAVIS 10 mg / mL

Generic drug of the therapeutic class: Analgesics
active ingredients: Paracetamol
laboratory: Actavis Group Ptc Ehf

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

Indication

PARACETAMOL actavis 10 mg / ml 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 of administration is clinically justified. by the urgency of treating pain or hyperthermia and / or when other routes of administration are not possible.

Dosage PARACETAMOL ACTAVIS 10 mg / mL Solution for IV infusion Pack of 10 vials of 100 ml

Intravenous way.

Dosage

Adults and adolescents weighing more than 50 kg

1 gram of paracetamol per administration, ie a 100 ml vial, 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 grams.

Children weighing more than 33 kg (approximately 11 years), adolescents and adults weighing less than 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 without exceeding 3 grams.

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 without exceeding 2 grams.

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.

There are no efficacy and safety data available in preterm infants (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 ).

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

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

Paracetamol ACTAVIS 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 after preparation (including infusion time).

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 ACTAVIS 10 mg / ml is contraindicated:

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

· In case of severe hepatocellular insufficiency.

Paracetamol Side Effects Actavis

Adverse events were classified according to their incidence using the following classification:

Very common (1/10), common (1/100, 1/10), infrequent (1/1000, 1/100), rare (1/10 000, 1/1000) ), very rare (<1 / 10, 000), not known (can not be estimated from the available data)

System

Rare

Very rare

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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