Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Prograf 0.5 mg capsules
Capsule content:
Lactose monohydrate
Magnesium stearate hydroxypropyl methylcellulose
Croscarmellose sodium
Capsule shell:
Titanium dioxide (E 171)
Ferric oxide yellow (E 172)
Gelatin

Printing ink of capsule shell: Shellac glaze, lecithin (soya), simeticone, ferric oxide red (E 172), hydroxypropyl cellulose.

Prograf 1 mg capsules
Capsule content:
Lactose monohydrate hydroxypropyl methylcellulose
Croscarmellose sodium
Magnesium stearate

Capsule shell:
Titanium dioxide (E 171)
Gelatin
Printing ink of capsule shell: Shellac glaze, lecithin (soya), simeticone, ferric oxide red (E 172), hydroxypropyl cellulose.

Prograf 5 mg capsules
Capsule content:
Lactose monohydrate hydroxypropyl methylcellulose
Croscarmellose sodium
Magnesium stearate

Capsule shell:
Titanium dioxide (E 171)
Ferric oxide red (E 172)
Gelatin
Printing ink of capsule shell: Shellac, titanium dioxide (E 171), propylene glycol.

6.2   Incompatibilities

Tacrolimus is not compatible with PVC. Tubing, syringes and other equipment used to prepare or administer a suspension of Prograf capsule contents should not contain PVC.

6.3   Shelf life

The expiry date of the product is indicated on the packaging materials.
After opening the aluminium wrapper: 12 months.
6.4   Special precautions for storage
Store below 25°C.
Store in the original package in order to protect from moisture.
Capsules should be taken immediately following removal from the blister.

6.5   Nature and contents of container

PVC/PVDC/Aluminium blisters. Ten capsules per blister. Five or ten blisters with a desiccant, in an aluminium wrapper.

Prograf 0.5 mg capsules
Ten capsules per strip. Five or ten blister strips with one desiccant in one aluminium wrapper.
Pack sizes: 50 and 100 capsules in blisters.
Prograf 1 mg capsules
Ten capsules per strip. Five or ten blister strips with one desiccant in one aluminium wrapper.
Pack sizes: 50 and 100 capsules in blisters.
Prograf 5 mg capsules
Ten capsules per strip. Five blister strips with one desiccant in one aluminium wrapper.
Pack sizes: 50 and 100 capsules in blisters.

Not all pack sizes may be marketed.
6.6 Special precautions for disposal and other handling

Based on immunosuppressive effects of tacrolimus, inhalation or direct contact with skin or mucous membranes by the formulations for injection, powder or granule contained in tacrolimus products should be avoided during preparation. If such contact occurs, wash the skin and flush the affected eye or eyes.

7.    LICENCE HOLDER AND MANUFACTURER

Licence Holder:
Astellas Pharma International B.V.
21 Ha’melacha Street, Rosh Ha’ayin, 4809157, Israel.
Manufacturer:
Astellas Ireland Co. Ltd.,
Killorglin, Ireland