Medicinal Products

PARACETAMOL B BRAUN 10 mg / mL

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

Injection solution for IV infusion
Box of 10 bottles of 100 ml
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 IV infusion Pack of 10 bottles of 100 ml

The 100 ml bottle is reserved for adults, adolescents and children weighing more than 33 kg.

The 50 ml bottle is reserved for full-term infants, infants, very young children and children weighing less than 33 kg.

Dosage:

The dose to be administered and the size of the vial to be used depends solely on the weight of the patient. The volume administered should not exceed the established dose. If appropriate, the desired volume should be diluted in an appropriate infusion solution prior to administration (see section Instructions for use, handling and disposal ) or use a syringe pump.

Bottle of 50 ml

Patient weight

Dose to be administered up to 4 times a day

Minimum interval between doses

Maximum daily dose **

£ 10 kg *

7.5 mg / kg

(ie 0.75 ml of solution / kg)

4 hours

30 mg / kg (ie 3 ml / kg)

> 10 kg and 33 kg

15 mg / kg (ie 1.5 ml of solution / kg)

4 hours

60 mg / kg (ie 6 ml / kg) without exceeding 2000 mg (ie 4 flasks)

Bottle of 100 ml

Patient weight

Dose (by administration)

Minimum interval between doses

Maximum daily dose **

> 33 kg and 50 kg

15 mg / kg (ie 1.5 ml of solution / kg)

4 hours

60 mg / kg (ie 6 ml / kg) without exceeding 3000 mg (ie 3 vials)

> 50 kg

1000 mg (1 bottle)

4 hours

4000 mg (4 bottles)

* Premature neonates:

There are no safety and efficacy data available for preterm neonates (see also section 5.2 Pharmacokinetic properties ).

** Patients receiving other medicines containing paracetamol:

The maximum daily dose indicated in the table above is for patients not receiving any other product containing paracetamol and should be adjusted for this type of medication. See also Warnings and Precautions for Use .

Severe renal insufficiency:

When paracetamol is administered to patients with severe renal impairment (creatinine clearance ≤ 30 ml / min), it is recommended to reduce the dose and increase the minimum interval between each administration to 6 hours ( see section Pharmacokinetic properties ).

Adults with hepatocellular insufficiency, chronic alcoholism, chronic malnutrition (low hepatic glutathione reserves), dehydration:

The maximum daily dose should not exceed 3000 mg (see Warnings and Precautions ).

Administration mode

Intravenous way.

The paracetamol solution is administered by intravenous infusion of 15 minutes.

For instructions on drug dilution before administration, see Instructions for Use, Handling and Disposal .

Single use only. Any unused solution should be removed.

Before administration, the product should be examined visually for particulate matter and discoloration. Use only if the solution is clear, colorless or slightly yellowish, and the vial is intact.

As with all infusion solutions in air-filled containers, it is recalled that close monitoring is required, especially 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 to prevent air embolism.

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).

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