Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS

6.1   List of excipients
Lactose (each vial contains 690 mg lactose)
Dimyristoyl phosphatidylcholine
Phosphatidylglycerol (Egg)
L-ascorbic acid 6-palmitate
Butylated hydroxytoluene

6.2   Incompatibilities

Visudyne precipitates in sodium chloride solution. Do not use normal sodium chloride solutions or other parenteral solutions.

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.

6.3   Shelf life

Shelf-life in the sealed vial
The expiry date of the product is indicated on the packaging materials.

Shelf-life after reconstitution and dilution

Chemical and physical in-use stability has been demonstrated for 4 hours at 25°C. From a microbiological point of view, the medicinal product should be used immediately. If not used immediately, the in-use storage time and conditions prior to use are the responsibility of the user and 
VIS API-NOT OCT18 CL V8                            11                            Ref: EU SmPC July 2018 would normally not last longer than 4 hours below 25°C protected from light.

6.4   Special precautions for storage

Store below 25°C.
Keep the vial in the outer carton in order to protect from light.
For storage conditions after reconstitution and dilution of the medicinal product, see section 6.3.
6.5   Nature and contents of container

15 mg of powder for solution for infusion in a single-use glass vial (type I), sealed with bromobutyl stopper and aluminium flip-off cap.

Pack containing 1 vial.

6.6   Special precautions for disposal and other handling
Reconstitute Visudyne in 7.0 ml water for injections to produce 7.5 ml of a 2.0 mg/ml solution.
Reconstituted Visudyne is an opaque dark green solution. It is recommended that reconstituted Visudyne be inspected visually for particulate matter and discoloration prior to administration. For a dose of 6 mg/m2 body surface (see section 4.2) dilute the required amount of Visudyne solution in dextrose 50 mg/ml (5%) solution for infusion to a final volume of 30 ml. Do not use sodium chloride solution (see section 6.2). Use of a standard infusion line filter with hydrophilic membranes (such as polyethersulfone) of a pore size of not less than 1.2 μm is recommended.

The vial and any unused portion of reconstituted solution should be discarded after single use.

If material is spilled, it should be contained and wiped up with a damp cloth. Eye and skin contact should be avoided. Use of rubber gloves and eye protection is recommended. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

7.    Manfacturer:

PAR Sterile Products LLC, Michigan, USA for Novartis Pharma AG, Basel, Switzerland 
8.    Registration Holder:

Novartis Israel Ltd., 36 Shacham St., Petach-Tikva