PARACETAMOL TARO I.V. 10 MGML

Valsts: Izraēla

Valoda: angļu

Klimata pārmaiņas: Ministry of Health

Aktīvā sastāvdaļa:

PARACETAMOL

Pieejams no:

TARO INTERNATIONAL LTD, ISRAEL

ATĶ kods:

N02BE01

Zāļu forma:

SOLUTION FOR INFUSION

Kompozīcija:

PARACETAMOL 10 MG/ML

Ievadīšanas:

I.V

Receptes veids:

Required

Ražojis:

NEOGEN N.V., BELGIUM

Ārstniecības joma:

PARACETAMOL

Ārstēšanas norādes:

Short term treatment of moderate pain, especially following surgery and for 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.

Autorizācija datums:

2020-01-31

Produkta apraksts

PARACETAMOL TARO I.V. 10 MG/ML
_Solution for Infusion_
Prescribing Information
1.
NAME OF THE MEDICINAL PRODUCT
PARACETAMOL TARO I.V. 10 MG/ML
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml contains 10 mg paracetamol.
One 50 ml vial contains 500 mg paracetamol.
One 100 ml vial contains 1000 mg paracetamol.
Excipients: Sodium 0.076 mg/ml
For a full list of excipients, see section 6.1_ List of excipients_.
3.
PHARMACEUTICAL FORM
Solution for infusion.
The solution is clear and colourless to slightly yellowish.
4.
CLINICAL DATA
_4.1 _
_THERAPEUTICAL INDICATIONS_
PARACETAMOL TARO I.V. 10 MG/ML 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.
_4.2 _
_POSOLOGY AND METHOD OF ADMINISTRATION_
Intravenous route. As ready-to-use solution or after dilution.
Before administration, the product should be visually inspected for
any particulate matter and discolouration. The content of one vial
is for single use only.
The 100 ml vial is restricted to adults, adolescents and children
weighing more than 33 kg.
The 50 ml vial is restricted to term newborn infants, infants,
toddlers
and children weighing less than 33 kg.
POSOLOGY:
Dosing based on patient weight (please see the dosing table here
below)
PATIENT WEIGHT
DOSE PER
ADMINISTRATION
VOLUME PER
ADMINISTRATION
MAXIMUM
VOLUME OF
_PARACETAMOL _
_TARO I.V. 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
> 10 KG TO
≤ 33 KG
15 mg/kg
1.5 ml/kg
49.5 ml
60 mg/kg
not
exceeding
2 g
> 33 KG TO
≤ 50 KG
15 mg/kg
1.5 ml/kg
75 ml
60 mg/kg
not
exceeding
3 g
> 50 KG WITH
ADDITIONAL RISK
FACTORS FOR
HEPATOTOXICITY
1 g
100 ml
100 ml
3 g
> 50 KG AND NO
ADDITIONAL RISK
FACTORS FOR
HEPATOTOXICITY
1 g
100 ml
100 ml
4 g
*
PRE-TERM
NEWBORN
INFANT