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0.1% W/W POLYSORBATE 80 IN WATER FOR INJECTION

Active substance(s): NOT APPLICABLE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
0.1% w/w polysorbate 80 in Water for Injection –5ml, 10 ml
Solvent for parental use
Read all of this leaflet carefully before you start using this medicine.
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. Do not pass it on to others. It may harm them,
even if their symptoms are the same as yours.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.

In this leaflet:
1.
What 0.1% w/w polysorbate 80 in Water for Injection is and what it is used for
2.
Before you use 0.1% w/w polysorbate 80 in Water for Injection
3.
How to use 0.1% w/w polysorbate 80 in Water for Injection
4.
Possible side effects
5.
How to store 0.1% w/w polysorbate 80 in Water for Injection
6.
Further information

1.

WHAT 0.1% w/w polysorbate 80 in Water for Injection IS AND WHAT IT IS USED
FOR
Water for Injections with 0.1% Polysorbate 80
Used for reconstitution of the freeze-dried human plasma preparation Wilate.

2.

BEFORE YOU USE 0.1% w/w polysorbate 80 in Water for Injection

Do not use 0.1% w/w polysorbate 80 in Water for Injection
The product should not be used if the solution is not clear or if the container is damaged.
As for the product to be reconstituted.
Take special care with 0.1% w/w polysorbate 80 in Water for Injection
As for the product to be reconstituted.
Taking other medicines
As for the product to be reconstituted.
Using 0.1% w/w polysorbate 80 in Water for Injection with food and drink
As for the product to be reconstituted.
Pregnancy and breast-feeding

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As for the product to be reconstituted.
Driving and using machines
As for the product to be reconstituted.
Important information about some of the ingredients of 0.1% w/w polysorbate 80 in Water
for Injection
As for the product to be reconstituted.

3.

HOW TO USE 0.1% w/w polysorbate 80 in Water for Injection
For intravenous use.
As for the product to be reconstituted.

If you use more 0.1% w/w polysorbate 80 in Water for Injection than you should
As for the product to be reconstituted.
If you forget to use 0.1% w/w polysorbate 80 in Water for Injection
As for the product to be reconstituted.
If you stop using 0.1% w/w polysorbate 80 in Water for Injection
As for the product to be reconstituted.

4.

POSSIBLE SIDE EFFECTS
As for the product to be reconstituted.

5.

HOW TO STORE 0.1% w/w polysorbate 80 in Water for Injection
Store in refrigerator (2°C to 8°C) protected from light. Do not freeze
Shelf-life: 60 months
The product can be stored at room temperature (max. +25°C) for 1 month. In this case the
shelf-life expires 1 month after the product has been taken out of the refrigerator for the first
time. The new shelf-life has to be noted on the outer carton by the patient.

6.

FURTHER INFORMATION

What 0.1% w/w polysorbate 80 in Water for Injection contains

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Water for Injections with 0.1% Polysorbate 80; 5 ml, 10 ml
What 0.1% w/w polysorbate 80 in Water for Injection looks like and contents of the pack
0.1% w/w polysorbate 80 in Water for Injection is supplied in colourless Type I glass vials
20 ml, closed with bromobutyl rubber stoppers and covered with flip off cap.
The carton contains:
1 vial with 0.1% w/w polysorbate 80 in Water for Injection
1 equipment pack with the administration devices (1 disposable syringe, 1 transfer set
[1 double-ended needle and 1 filter needle], 1 infusion set)
2 alcohol swabs
and the package leaflet
0.1% w/w polysorbate 80 in Water for Injection is supplied in two pack sizes with the
following filling volumes: 5 ml and 10 ml.
Marketing Authorisation Holder and Manufacturer
Octapharma Ltd.
The Zenith Building
26 Spring Gardens
Manchester M2 1AB
United Kingdom
This leaflet was last approved in 03/2011.
PL 10673/0026

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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