PARACETAMOL FRESENIUS 10 MGML

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

PARACETAMOL

Available from:

NEOPHARM (ISRAEL) 1996 LTD

ATC code:

N02BE01

Pharmaceutical form:

SOLUTION FOR INFUSION

Composition:

PARACETAMOL 10 MG/ML

Administration route:

I.V

Prescription type:

Required

Manufactured by:

FRESENIUS KABI AUSTRIA GmbH

Therapeutic area:

PARACETAMOL

Therapeutic indications:

Paracetamol – Fresenius is indicated for:- the short-term treatment of moderate pain, especially following surgery- the short-term treatment of fever.when administration by intravenous route is clinically justified by an urgent need to treat pain or hyperthermia and/or when other routes of administration are not possible.

Authorization date:

2020-05-31

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
PARACETAMOL FRESENIUS 10 mg/ml
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml solution for infusion contains 10 mg paracetamol.
Each 50 ml vial contains 500 mg paracetamol.
Each 100 ml vial contains 1000 mg paracetamol.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for infusion.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Paracetamol Fresenius 10 mg/ml is indicated for:
●
short-term treatment of moderate pain, especially following surgery,
●
short-term treatment of fever,
when administration by intravenous route is clinically justified by an
urgent need to treat pain or
hyperthermia and/or when other routes of administration are not
possible.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
The 100 ml vial is restricted to adults, adolescents and children
weighing more than 33 kg.
The 50 ml vial is restricted to toddlers and children weighing
more than 10 kg and up to
33 kg.
_POSOLOGY: _
_ _
THE DOSE TO BE ADMINISTERED AND THE BOTTLE SIZE TO BE USED DEPEND
EXCLUSIVELY ON THE PATIENT`S
WEIGHT. THE VOLUME TO BE ADMINISTERED MUST NOT EXCEED THE DETERMINED
DOSE. IF APPLICABLE, THE
DESIRED VOLUME MUST BE DILUTED IN A SUITABLE SOLUTION FOR INFUSION
PRIOR TO ADMINISTRATION (SEE
SECTION 6.6) OR A SYRINGE DRIVER MUST BE USED.
Dosing based on patient weight (please see the dosing table here
below)
50 ML
VIAL
PATIENT WEIGHT
DOSE
PER ADMINISTRATION
VOLUME PER
ADMINISTRATION
MAXIMUM VOLUME OF
PARACETAMOL 10 MG/ML
PER ADMINISTRATION
BASED ON UPPER WEIGHT
LIMITS OF GROUP (ML)**
MAXIMUM DAILY
DOSE*
> 10 kg to

33 kg
15 mg/kg
1.5 ml/kg
49.5 ml
60 mg/kg
not exceeding 2 g
Take care when prescribing and administering Paracetamol 10 mg/ml to
avoid dosing errors due to
confusion between milligram (mg) and millilitre (ml), which could
result in accidental over- dose and
death. Take care to ensure the proper dose is communicated and
dispensed. When writing
prescriptions, include both the total dose in mg and the total dos