PARACETAMOL S.A.L.F 10 MGML

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

PARACETAMOL

Available from:

RAZ PHARMACEUTICS LTD, ISRAEL

ATC code:

N02BE01

Pharmaceutical form:

SOLUTION FOR INFUSION

Composition:

PARACETAMOL 10 MG / 1 ML

Administration route:

I.V

Prescription type:

Required

Manufactured by:

S.A.L.F. S.P.A. LABORATORIO FARMACOLOGICO, ITALY

Therapeutic area:

PARACETAMOL

Therapeutic indications:

Paracetamol 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.

Authorization date:

2020-11-25

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
PARACETAMOL S.A.L.F 10 MG/ML
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml of solution for infusion contains 10 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, colorless solution or slightly
colored from amber-yellow to pink-pale orange
(perception may vary).
pH 4.8 – 5.2
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications
PARACETAMOL S.A.L.F 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 hyperthermia 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.
_Posology:_
The dose to be administered depends 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)
* 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.
The minimum interval between each administration in
patients with severe renal insufficiency must be at least 6
hours.
No more than 4 doses to be given in 24 hours.
Severe renal insufficiency:
It is recommended, when giving paracetamol to patients
with severe renal impairment (creatinine clearance ≤ 30
m