PARACETAMOL B. BRAUN 10 MGML

Land: Israel

Sprog: engelsk

Kilde: Ministry of Health

Aktiv bestanddel:

PARACETAMOL

Tilgængelig fra:

LAPIDOT MEDICAL IMPORT AND MARKETING LTD

ATC-kode:

N02BE01

Lægemiddelform:

SOLUTION FOR INFUSION

Sammensætning:

PARACETAMOL 10 MG/ML

Indgivelsesvej:

I.V

Recept type:

Required

Fremstillet af:

B.BRAUN MELSUNGEN AG, GERMANY

Terapeutisk område:

PARACETAMOL

Terapeutiske indikationer:

Paracetamol is indicated for the short-term treatment of moderate pain, especially following surgery and for 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.

Autorisation dato:

2020-02-29

Produktets egenskaber

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Paracetamol B. Braun 10 mg/ml
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml solution for infusion contains 10 mg paracetamol.
Each 10 ml ampoule contains 100 mg paracetamol
Each 50 ml bottle contains 500 mg paracetamol.
Each 100 ml bottle contains 1000 mg paracetamol.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for infusion.
The solution is clear and colourless to slightly pinkish-orangish.
Perception may vary.
Theoretical Osmolarity 305 mOsm/l
pH
4.5
–
5.5
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Paracetamol B. Braun 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 hy-
perthermia and/or when other routes of administration are not
possible.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
The 100 ml bottle is restricted to adults, adolescents and children
weighing more than 33 kg.
The 50 ml bottle is restricted to toddlers and children weighing
more than 10 kg and up to
33 kg.
The 10 ml ampoule is restricted to term newborn infants, infants and
toddlers weighing up to 10 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)
10 ML AMPOULE
PATIENT
WEIGHT
DOSE
PER ADMINISTRATION
VOLUME PER AD-
MINISTRATION
MAXIMUM VOLUME OF PARACETA-
MOL B. BRAUN 10 MG/ML PER
ADMINISTRATION BASED ON UPPER
WEIGHT LIMITS OF GROUP (ML)***
MAXIMUM
DAILY DOSE**

10 kg*
7.5 mg/kg
0.75 ml/kg
7.5 ml
30 mg/kg
50 ML BOTTLE
100 ML BOTTLE
PATIENT WEIGHT
DOSE
(PER ADMIN-
ISTRATION)