PROGRAF 5 MG

Country: Իսրայել

language: անգլերեն

source: Ministry of Health

active_ingredient:

TACROLIMUS

MAH:

ASTELLAS PHARMA INTERNATIONAL B.V., ISRAEL

ATC_code:

L04AA05

pharmaceutical_form:

CAPSULES

composition:

TACROLIMUS 5 MG

administration_route:

PER OS

prescription_type:

Required

manufactured_by:

ASTELLAS IRELAND CO. LTD, IRELAND

therapeutic_group:

TACROLIMUS

therapeutic_area:

TACROLIMUS

therapeutic_indication:

Prophylaxis of transplant rejection in liver kidney or heart allograft recipients. Treatment of allograft rejection resistant to treatment with other immunosuppressive medicinal products.

authorization_date:

2012-10-31

PIL

PATIENT LEAFLET IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986
The medicine is dispensed with a doctor’s prescription only
PROGRAF
® CAPSULES
PROGRAF
® 0.5 MG
PROGRAF
® 1 MG
PROGRAF
® 5 MG
CAPSULES
CAPSULES
CAPSULES
COMPOSITION
Each capsule contains:
Tacrolimus 0.5 mg
Tacrolimus 1 mg
Tacrolimus 5 mg
For information regarding inactive ingredients and allergens, see
section 2 - “Important information about some ingredients of the
medicine” and section 6 - “Additional information”.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THE MEDICINE. This
leaflet contains concise information about the medicine. If you have
additional questions, refer to the doctor or the pharmacist.
This medicine has been prescribed for your treatment. Do not pass it
on to others. It may harm them even if it seems to you that their
medical condition is similar.
1. WHAT IS THE MEDICINE INTENDED FOR?
Prophylaxis of transplant rejection in liver, kidney or heart
allograft recipients.
Treatment of allograft rejection resistant to treatment with other
immunosuppressive drugs.
Prograf belongs to a group of medicines that suppress the immune
system. Following organ transplant (such as liver, kidney and heart)
your body’s immune system will try to reject the new organ. Prograf
is
used for modulation of your body’s immune reaction and allows your
body to accept the transplanted organ.
THERAPEUTIC CLASS: immunosuppressive agents.
2. BEFORE USING THE MEDICINE
DO NOT REPLACE WITH ANOTHER TACROLIMUS PREPARATION, UNLESS THE DOCTOR
FROM THE TRANSPLANT CLINIC YOU ARE TREATED IN APPROVES THAT.
DO NOT USE THIS MEDICINE IF:
• You are sensitive (allergic) to tacrolimus or to any of the other
ingredients this medicine contains (see section 6 – “Additional
information”).
• You are sensitive (allergic) to any antibiotic of the macrolide
group (e.g. erythromycin, clarithromycin, josamycin).
SPECIAL WARNINGS REGARDING THE USE OF THE MEDICINE
FOR YOUR ATTENTION, IT IS IMPORTANT TO ASCERTAIN THAT YOU ALWAYS
RECEIV

SPC

Prograf Capsules MF 11/2022 Notification
SUMMARY OF PRODUCT CHARACTERISTICS
PROGRAF
® 0.5 MG
PROGRAF
® 1 MG
PROGRAF
® 5 MG
IMPORTANT!
In order to ensure the continuity of different products of tacrolimus
in individual patients it should be
emphasized that if patients are changed from one tacrolimus product to
another it should be done only
with specific counselling and tight monitoring from their
transplantation specialist.
1.
NAME OF THE MEDICINAL PRODUCT
Prograf 0.5 mg
Prograf 1 mg
Prograf 5 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Prograf 0.5 mg capsules
Each capsule contains 0.5 mg of tacrolimus.
Excipient with known effect: 62.85 mg of lactose monohydrate.
The printing ink used to mark the capsule contains trace amounts of
soya lecithin (0.48% of total
printing ink composition).
Prograf 1 mg capsules
Each capsule contains 1 mg of tacrolimus.
Excipient with known effect: 61.35 mg of lactose monohydrate.
The printing ink used to mark the capsule contains trace amounts of
soya lecithin (0.48% of total
printing ink composition).
Prograf 5 mg capsules
Each capsule contains 5 mg of tacrolimus.
Excipient with known effect: 123.60 mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Prograf 0.5 mg capsules
Capsule, hard
Light yellow hard gelatin capsules imprinted in red with “0.5 mg”
and “[f] 607”, containing white
powder.
Prograf 1 mg capsules
Capsule, hard
Opaque white hard gelatin capsules imprinted in red with “1 mg”
and “[f] 617”, containing white
powder.
Prograf 5 mg capsules
Capsule, hard
Opaque greyish red hard gelatin capsules imprinted in white with “5
mg” and “[f] 657”, containing
white powder.
Prograf Capsules MF 11/2022 Notification
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Prophylaxis of transplant rejection in liver, kidney or heart
allograft recipients.
Treatment
of allograft rejection resistant to
treatment with
other immunosuppressive medicinal
products.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Prograf thera