Paracetamol Kabi 10mgml Solution for Infusion

البلد: ماليزيا

اللغة: الإنجليزية

المصدر: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

العنصر النشط:

Paracetamol

متاح من:

FRESENIUS KABI MALAYSIA SDN. BHD

INN (الاسم الدولي):

Paracetamol

الوحدات في الحزمة:

100 ml X 10vial Vials; 100ml X 12vial Vials; 100ml X 20vial Vials

المصنعة من قبل:

Fresenius Kabi Deutschland GmbH

خصائص المنتج

PACKAGE LEAFLET: INFORMATION FOR THE USER
PARACETAMOL KABI 10 MG/ML
SOLUTION FOR INFUSION
COMPOSITION
1 ml contains 10 mg paracetamol.
DESCRIPTION
Solution for infusion
Clear and slightly yellowish solution.
The solution is iso-osmotic and its pH is between 5.0 and 7.0.
THERAPEUTIC INDICATIONS
Paracetamol Kabi 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.
POSOLOGY AND METHOD OF ADMINISTRATION
Intravenous use
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 up to 33 kg.
Posology
Dosing based on patient weight (please see the dosing table here
below):
PATIENT WEIGHT
DOSE
PER
ADMINISTR
A
TION
VOLUME
PER
ADMINISTRATION
MAXIMUM
VOLUME
OF
PARACETAMOL
KABI
10
MG/ML
SOLUTION
FOR
INFUSION
PER
ADMINI-
STRATION 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 AND 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 INFANTS: No safety and efficacy data are available
for pre-term newborn infants (_SEE _
_SECTION _
_PHARMACOKINETIC PROPERTIES)_._ _
**MAXIMUM DAILY DOSE: The maximum daily dose as presented in the table
above is for patients that
are not
receiving other paracetamol containing products and should be adjusted
accordingly taking such
products into
account.
***PATIENTS WEIGHING LESS WILL REQUIRE SMALLER VOLUMES.
THE MINIMUM INTERVAL BETWEEN EACH ADMINISTRATION MUST BE AT LEAST 4
HOURS IN PATIENTS