Paracetamol Uni-Pharma 10mg/ml Solution for Infusion

国家: 英国

语言: 英文

来源: myHealthbox

有效成分:

Paracetamol

可用日期:

SALF SpA Laboratorio Farmacologico

ATC代码:

N02BE01

INN（国际名称）:

Paracetamol

剂量:

10mg

药物剂型:

Solution for infusion

给药途径:

intravenous route

每包单位数:

Boxes of 1, 10, 20, 50 bags

处方类型:

POM - Prescription Only Medicine

厂商:

Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories S.A.

治疗组:

OTHER ANALGESICS AND ANTIPYRETICS

疗效迹象:

It is indicated for the shortterm treatment of moderate pain, especially following surgery and for 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.

授权状态:

Authorised

授权日期:

2015-05-18

资料单张

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
PARACETAMOL UNI-PHARMA 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.
-
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 side effects, talk to your doctor. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Paracetamol Uni-Pharma 10 mg/ml Solution
for Infusion is and what it is used
for
2.
What you need to know before you
use Paracetamol Uni-Pharma 10 mg/ml Solution
for Infusion
3.
How to
use Paracetamol Uni-Pharma 10 mg/ml Solution for Infusion
4.
Possible side effects
5.
How to
store Paracetamol Uni-Pharma 10 mg/ml Solution for Infusion
6.
Contents of the pack and other information
1.
WHAT PARACETAMOL UNI-PHARMA 10 MG/ML SOLUTION FOR INFUSION 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 <
INVENTED NAME >10 MG/ML SOLUTION FOR
INFUSION
DO NOT USE PARACETAMOL UNI-PHARMA 10 MG/ML SOLUTION FOR INFUSION

if you are allergic (hypersensitive) to
paracetamol or to any of the other ingredients of
this medicine (listed in section 6)

if you are allergic (hypersensitive) to propacetamol (another analgesic for infusion and
a precursor of paracetamol)

if you suffer from a severe liver disease.
WARNINGS AND PRECAUTIONS
Talk to

产品特点

SUMMARY OF PRODUCT CHARACTERISTICS 

1 
NAME OF THE MEDICINAL PRODUCT 
Paracetamol Uni-Pharma 10 mg/ml Solution for Infusion 

2 
QUALITATIVE AND QUANTITATIVE COMPOSITION 
Each ml of solution for infusion contains 10 mg paracetamol. 
Each 100 ml bag solution for
infusion contains 1000 mg paracetamol. 
Excipients with known effect: Sodium 250 mg/100 ml. 
For a full list of excipients, see Section 6.1. 

3 PHARMACEUTICAL 
FORM 
Solution for infusion. 
Clear, colourless to slightly yellowish solution. 
pH: 4.5 – 6.0 during shelf-life 
Osmolarity: approximately 290mOsmol/l 

4 CLINICAL 
PARTICULARS 

4.1 THERAPEUTIC 
INDICATIONS 
_Paracetamol Uni-Pharma 10 mg/ml Solution for
Infusion_ is indicated for the short-
term treatment
of moderate pain, especially following surgery and for 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 route. 
The 100 ml bag is restricted to adults, adolescents
and children weighing more 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 _
_UNI-PHARMA _
_10 MG/ML _
_SOLUTION FOR _
_INFUSION _PER 
ADMINISTRATION 
BASED ON 
UPPER WEIGHT 
LIMITS OF GROUP 
(ML)** 
MAXIMUM 
DAILY DOSE 
* 
> 33 KG TO 
≤50KG 
15 mg/kg 
1.5mL/kg 
75 mL 
60mg/kg 
not 
exceeding 
3g 
>50KG WITH 
ADDITIONAL 
RISK FACTORS 
FOR 
HEPATOTOXICITY 
1g 100mL 
100mL 
3g 
>50 KG AND NO 
ADDITIONAL 
RISK FACTORS 
FOR 
HEPATOTOXICITY 
1g 100mL 
100mL 
4g 
*Maximum daily dose: The maximum daily dose as presented in
the table above is 
for patients that are not re