Paracetamol Kabi 10 mg/ml solution for infusion (50ml vial/bag)

Ülke: Malta

Dil: İngilizce

Kaynak: Medicines Authority

Aktif bileşen:

PARACETAMOL

Mevcut itibaren:

Fresenius Kabi Italia S.r.l Via Camagre 41, 37063 Isola della Scala (Vr) , Italy

ATC kodu:

N02BE01

INN (International Adı):

PARACETAMOL 10 mg/ml

Farmasötik formu:

SOLUTION FOR INFUSION

Kompozisyon:

PARACETAMOL 10 mg/ml

Reçete türü:

POM

Terapötik alanı:

ANALGESICS

Ürün özeti:

Licence number in the source country: NOT APPLICAPABLE

Yetkilendirme durumu:

Authorised

Yetkilendirme tarihi:

2021-08-19

Bilgilendirme broşürü

1.3.1 SPC, LABELLING AND PACKAGE LEAFLET
palen-paracetamolkabi-dcp-Jan 2020
-clean
1
PACKAGE LEAFLET: INFORMATION FOR THE USER
PARACETAMOL KABI 10 MG/ML SOLUTION FOR INFUSION
Paracetamol
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any of the side effects, talk to your doctor or pharmacist.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Paracetamol Kabi is and what it is used for
2.
What you need to know before you use Paracetamol Kabi
3.
How to use Paracetamol Kabi
4.
Possible side effects
5.
How to store Paracetamol Kabi
6.
Contents of the pack and other information
1.
WHAT PARACETAMOL KABI IS AND WHAT IT IS USED FOR
This medicine is an analgesic (it relieves pain) and an antipyretic
(it lowers fever).
It is indicated
-
for the short-term treatment of moderate pain, especially following
surgery, and
-
for the short-term treatment of fever.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE PARACETAMOL KABI
DO NOT USE PARACETAMOL KABI
-
if you are
ALLERGIC
(hypersensitive)
TO PARACETAMOL
or any of the other ingredients of
Paracetamol Kabi (listed in section 6).
-
if you are
ALLERGIC
(hypersensitive)
TO PROPACETAMOL
(another pain killer and a precursor of
paracetamol).
-
if you suffer from a
SEVERE LIVER DISEASE
.
WARNINGS AND PRECAUTIONS
Talk to your doctor before using Paracetamol Kabi.
TAKE SPECIAL CARE WITH PARACETAMOL KABI
-
if you suffer from a
LIVER OR KIDNEY DISEASE
, or from
ALCOHOL ABUSE
.
-
if you suffer from a inherited liver function disorder called
MEULENGRACHT GILBERT'S SYNDROME
.
-
if you suffer from
GLUCOSE-6-PHOSPHATE DEHYDROGENASE DEFICIENCY.
-
if you are taking
OTHER MEDICINES CONTA

Ürün özellikleri

1.3.1 SPC, LABELLING AND PACKAGE LEAFLET
Page 1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Paracetamol Kabi 10 mg/ml solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml contains 10 mg paracetamol.
Each 10 ml ampoule contains 100 mg paracetamol.
Each 50 ml vial or bag contains 500 mg paracetamol.
Each 100 ml vial or bag contains 1000 mg paracetamol.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for infusion
Clear and slightly yellowish solution.
The solution is iso-osmotic, and its pH is between 5.0 and 7.0.
4.
CLINICAL PARTICULARS
4.1
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.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Intravenous use.
The 100 ml vial or bag is restricted to adults, adolescents and
children weighing more than 33 kg.
The 10 ml ampoule and the 50 ml vial or bag 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):
1.3.1 SPC, LABELLING AND PACKAGE LEAFLET
Page 2
PATIENT WEIGHT
DOSE PER
ADMINISTRATION
VOLUME PER
ADMINISTRATION_ _
MAXIMUM
VOLUME OF
PARACETAMOL
KABI 10 MG/ML
SOLUTION FOR
INFUSION 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 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 a