Summary of Product Characteristics (SmPC) - 0.1% w/w Polysorbate 80 in water for injection
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
27/11/2024
10 DATE OF REVISION OF THE TEXT
27/11/2024