PARACETAMOL ALTAN 10 MGML

Land: Ísrael

Tungumál: enska

Heimild: Ministry of Health

Virkt innihaldsefni:

PARACETAMOL

Fáanlegur frá:

PROPHARM LTD

ATC númer:

N02BE01

Lyfjaform:

SOLUTION FOR INFUSION

Samsetning:

PARACETAMOL 10 MG / 1 ML

Stjórnsýsluleið:

I.V

Gerð lyfseðils:

Required

Framleitt af:

S.C. INFOMED FLUIDS S.R.L, ROMANIA

Lækningarsvæði:

PARACETAMOL

Ábendingar:

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

Leyfisdagur:

2019-12-11

Vara einkenni

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Paracetamol ALTAN 10 mg/ml
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml solution for infusion contains 10 mg paracetamol.
Each 50 ml bag contains 500 mg paracetamol. Each
100 ml bag contains 1000 mg paracetamol.
EXCIPIENTS WITH KNOWN EFFECT:
One 50 mL bag contains 39.7 mg sodium (1.75 mmol) and 1.65 g glucose.
One 100 mL bag contains 79.4 mg sodium (3.5 mmol) and 3.30 g glucose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for infusion.
The solution is clear and colorless or faintly straw -brown colored
solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Paracetamol ALTAN is indicated for the short-term treatment of
moderate pain, especially following
surgery, and for the short-term treatment of fever, when intravenous
administration 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 use.
The 100 ml infusion bag is restricted to adults, adolescents and
children weighing more than 33 kg.
The 50 ml infusion bag is adapted 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 ALTAN 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
*PRETERM NEWBORN INFANTS:
No safety and efficacy data are available for premature newborn
infants (see also section 5.2).
**Patients weighin