Medine.co.uk

0.1% W/W Polysorbate 80 In Water For Injection

SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

0.1% w/w polysorbate 80 in Water for Injection

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

Water for Injections with 0.1% Polysorbate 80; 5 ml, 10 ml For a full list of excipients, see section 6.1.

3    PHARMACEUTICAL FORM

Solvent for parental use

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

Used for reconstitution of the freeze-dried human plasma preparation Wilate.

4.2    Posology and method of administration

For intravenous use.

As for the product to be reconstituted.

4.3    Contraindications

As for the product to be reconstituted.

4.4    Special warnings and precautions for use

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.

4.5    Interaction with other medicinal products and other forms of interaction

As for the product to be reconstituted.

4.6    Fertility, pregnancy and lactation

As for the product to be reconstituted.

4.7    Effects on ability to drive and use machines

As for the product to be reconstituted.

4.8    Undesirable effects

As for the product to be reconstituted.

4.9    Overdose

As for the product to be reconstituted.

5    PHARMACOLOGICAL PROPERTIES

5.1    Pharmacodynamic properties

As for the product to be reconstituted.

5.2    Pharmacokinetic properties

As for the product to be reconstituted.

5.3    Preclinical safety data

As for the product to be reconstituted.

6    PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Water for Injections

Polysorbate 80

6.2 Incompatibilities

As for the product to be reconstituted.

6.3    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.

6.4    Special precautions for storage

Store in refrigerator (2°C to 8°C) protected from light. Do not freeze

6.5    Nature and contents of container

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.

6.6    Special precautions for disposal

Any unused product or waste material should be disposed of in accordance with local requirements.

7


MARKETING AUTHORISATION HOLDER

Octapharma Ltd.

The Zenith Building 26 Spring Gardens Manchester M2 1AB United Kingdom

8    MARKETING AUTHORISATION NUMBER(S)

PL 10673/0026

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

21/09/2007

10 DATE OF REVISION OF THE TEXT

16/06/2011