Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS

6.1   List of excipients
Backing layer low-density pigmented polyethylene outer layer polyester inner layer

Middle layer polyisobutylene/polybutene adhesive crospovidone,
non-woven polyester fabric,
lauryl lactate.
Release Liner

Third layer polyethylene terephthalate (PET) film polydimethylsiloxane coating.

6.2   Incompatibilities

Not applicable.
6.3   Special precautions for storage

Do not store above 25°C.

Store in the original package in order to protect from light and moisture.
Do not store in the refrigerator or freezer.
6.4   Nature and contents of container

Primary packaging material
A sachet is composed of four layers: a low-density polyethylene film (innermost layer), an aluminium foil, a low-density polyethylene film, and an outer layer of bleached paper.

Secondary packaging material
Sachets are packaged in a cardboard carton.
Every carton has 3, 9 EVRA transdermal patches in individual foil-lined sachets.
Sachets are wrapped per three in a transparent perforated plastic film and packed in a cardboard carton.

6.5   Special precautions for disposal and other handling

The patch should be applied immediately upon removal from the protective sachet.
To prevent interference with the adhesive properties of EVRA, no creams, lotions or powders should be applied to the skin area where the EVRA transdermal patch is to be applied.

After use the transdermal patch still contains substantial quantities of active ingredients.
Remaining hormonal active ingredients of the transdermal patch may have harmful effects if reaching the aquatic environment. Therefore, the used transdermal patch should be discarded carefully. The disposal label from the outside of the sachet should be peeled open. The used transdermal patch should be placed within the open disposal label so that the sticky surface covers the shaded area on the sachet. The disposal label should then be closed sealing the used transdermal patch within. Any unused medicinal product or waste material should be disposed of in accordance with local requirements. Used transdermal patches should not be flushed down the toilet nor placed in liquid waste disposal systems.

Expiry date/shelf life: The expiry date of the product is indicated on the packaging materials.

7. Registration Holder:

Trima Israel Pharmacetical Products Maabarot Ltd., Maabarot 4023000, Israel.

8. Manufacturer:
Gedeon Richter Plc, Budapest, Hungary.