Medicinal Products

PARACETAMOL B BRAUN 10 mg / ml solution for infusion box of 20 ampoules of 10 ml

Generic drug of the therapeutic class: Analgesics
active ingredients: Paracetamol
laboratory: B-Braun Melsungen

Injection solution for IV infusion
All forms

Indication

PARACETAMOL B. BRAUN 10 mg / ml is indicated in:

· The short-term treatment of pain of moderate intensity, especially in the postoperative period.

· 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 B BRAUN 10 mg / ml solution for infusion box of 20 ampoules of 10 ml

PARACETAMOL B. BRAUN 10 mg / ml is indicated in:

· The short-term treatment of pain of moderate intensity, especially in the postoperative period.

· 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.

Against indications

· Hypersensitivity to paracetamol, propacetamol hydrochloride (paracetamol precursor) or to any of the excipients listed under Composition .

· Cases of severe hepatocellular insufficiency.

Side effects Paracetamol B Braun

As with all drugs containing paracetamol, the adverse effects of the drug are rare (≥ 1/10 000 to <1/1000) or very rare (<1/10 000). They are described below:

Class of organ system

Rare (≥ 1/10 000 to <1/1000)

Very rare (<1 / 10, 000)

Not known (can not be estimated from the available data)

Blood and lymphatic system disorders

-

Thrombocytopenia, leukopenia, neutropenia

-

Immune system disorders

-

Hypersensitivity reaction (1)

-

Heart conditions

-

-

Tachycardia (2)

Vascular disorders

hypotension

-

Congestive puff (2)

Hepatobiliary disorders

Elevation of liver transaminase levels

-

-

Skin and subcutaneous tissue disorders

-

-

Pruritus (2)

Erythema (2)

General disorders and administration site conditions

Discomfort

-

-

(1) Very rare cases of hypersensitivity reactions, ranging from simple rash or hives to anaphylactic shock, have been reported and require discontinuation of treatment.

(2) Isolated cases

Adverse events at the injection site were frequently reported during clinical trials (pain and burning sensation).

Reporting of suspected adverse reactions

The reporting of suspected adverse reactions after authorization of the drug is important. It allows continuous monitoring of the benefit / risk ratio of the drug. Healthcare professionals declare any suspected adverse reaction via the national reporting system: National Agency for the Safety of Medicines and Health Products (Ansm) and the network of Regional Pharmacovigilance Centers - Website: www.ansm.sante.fr

Popular Posts

Category Medicinal Products, Next Article