PARACETAMOL KABI SOLUTION FOR INFUSION 10MGML

Pajjiż: Singapor

Lingwa: Ingliż

Sors: HSA (Health Sciences Authority)

Ingredjent attiv:

Paracetamol

Disponibbli minn:

FRESENIUS KABI (SINGAPORE) PTE LTD

Kodiċi ATC:

N02BE01

Għamla farmaċewtika:

INFUSION, SOLUTION

Kompożizzjoni:

Paracetamol 10mg/ml

Rotta amministrattiva:

INTRAVENOUS

Tip ta 'preskrizzjoni:

Prescription Only

Manifatturat minn:

FRESENIUS KABI AUSTRIA GMBH (PLANT GRAZ)

L-istatus ta 'awtorizzazzjoni:

ACTIVE

Data ta 'l-awtorizzazzjoni:

2018-03-08

Karatteristiċi tal-prodott

KEEP MEDICAMENT OUT OF THE REACH OF CHILDREN
PARACETAMOL KABI 10 MG/ML
SOLUTION FOR INFUSION
COMPOSITION
1 ml contains 10 mg paracetamol.
Each 50 ml vial contains 500 mg paracetamol.
Each 100 ml vial contains 1000 mg paracetamol.
Also contains cysteine, mannitol, water for injections.
_Distribution _
The volume of distribution of paracetamol is approximately 1 l/kg.
Paracetamol is not extensively bound to plasma
proteins (about 10 %). Twenty minutes following infusion of 1 g
paracetamol, significant concentrations of paracetamol
(about 1.5 µg/ml) were observed in the cerebrospinal fluid.
_Biotransformation _
Paracetamol is mainly metabolised in the liver following two major
hepatic pathways: conjugation with glucuronic
acid and sulphuric acid. At doses that exceed the therapeutic dose,
the latter route is rapidly saturated. A small
fraction (less than 4 %) is metabolised by cytochrome P450 to a
reactive intermediate (N-acetyl benzoquinone imine)
which, with normal dosing, is rapidly detoxified by reduced
glutathione and eliminated in the urine after conjugation
with cysteine and mercapturic acid. However, in the event of massive
overdose, the quantity of this toxic metabolite
is increased.
_ Elimination_
The metabolites of paracetamol are mainly excreted in the urine. 90 %
of the dose administered is excreted within 24
hours, mainly as glucuronide (60-80 %) and sulphate (20- 30 %)
conjugates. Less than 5 % is eliminated unchanged.
Plasma half-life is 2.7 hours and total body clearance is 18 l/h.
Newborn infants, infants and children
The pharmacokinetic parameters of paracetamol observed in infants and
children are similar to those observed in
adults, except for the plasma half-life that is slightly shorter (1.5
to 2 hours) than in adults. In newborn infants, the
plasma half-life is longer than in infants, i.e. around 3.5 hours.
Newborn infants, infants and children up to 10 years
excrete significantly less glucuronide and more sulphate conjugates
than adults.
PRODUCT DESCRIPTION
Solution for infusion
Clear and s