ADVAGRAF 3 MG

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

TACROLIMUS AS MONOHYDRATE

Available from:

ASTELLAS PHARMA INTERNATIONAL B.V., ISRAEL

ATC code:

L04AD02

Pharmaceutical form:

CAPSULES PROLONGED RELEASE

Composition:

TACROLIMUS AS MONOHYDRATE 3 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

ASTELLAS IRELAND CO. LTD, IRELAND

Therapeutic area:

TACROLIMUS

Therapeutic indications:

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

Authorization date:

2019-11-30

Patient Information leaflet

1
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS REGULATIONS
(PREPARATIONS)-1986
THE MEDICINE IS DISPENSED WITH A DOCTOR’S PRESCRIPTION ONLY
ADVAGRAF
5 MG
PROLONGED RELEASE CAPSULES
ADVAGRAF
3 MG
PROLONGED RELEASE CAPSULES
ADVAGRAF
1 MG
PROLONGED RELEASE CAPSULES
ADVAGRAF
0.5 MG
PROLONGED RELEASE CAPSULES
COMPOSITION:
Tacrolimus
(as monohydrate)
5 mg
Tacrolimus
(as monohydrate)
3 mg
Tacrolimus
(as monohydrate)
1 mg
Tacrolimus
(as monohydrate)
0.5 mg
READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE.
This leaflet contains concise information about the medicine. If you
have additional questions,
refer to the doctor or pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them,
even if their medical condition appears to be similar.
This medicine is not intended for children or adolescents under the
age of 18.
1. WHAT IS THE MEDICINE USED FOR?
Prevention of graft rejection after a kidney or liver transplant.
Treatment of graft rejection after a kidney or liver transplant, when
there is resistance to other
immunosuppressive drugs.
THERAPEUTIC GROUP: immunosuppressant.
2. BEFORE USING THE MEDICINE:
DO NOT USE THE MEDICINE:
•
If you are sensitive (allergic) to tacrolimus or to any of the
additional ingredients
that the medicine contains.
•
If you are sensitive (allergic) to sirolimus or to antibiotics of the
macrolide family
(such as erythromycin, clarithromycin, josamycin).
SPECIAL WARNINGS FOR USING THE MEDICINE:
Prograf and Advagraf contain both the active substance, tacrolimus.
However, Advagraf is
taken once daily, whereas Prograf is taken twice daily. This is
because Advagraf capsules
allow for a prolonged release (more slow release over a longer period)
of tacrolimus.
Advagraf and Prograf are not interchangeable.
You must update the doctor or the pharmacist in the following cases:
•
If you are taking a medicine in the list appearing in the next section
(“if you are taking
or have recently taken medicines…”).
•
If you have or

Summary of Product characteristics

1
1.
NAME OF THE MEDICINAL PRODUCT
Advagraf 0.5 mg prolonged-release hard capsules.
Advagraf 1 mg prolonged-release hard capsules.
Advagraf 3 mg prolonged-release hard capsules.
Advagraf 5 mg prolonged-release hard capsules.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Advagraf 0.5 mg: Each prolonged-release hard capsule contains 0.5 mg
tacrolimus (as monohydrate).
Advagraf 1 mg: Each prolonged-release hard capsule contains 1 mg
tacrolimus (as monohydrate).
Advagraf 3 mg: Each prolonged-release hard capsule contains 3 mg
tacrolimus (as monohydrate).
Advagraf 5 mg: Each prolonged-release hard capsule contains 5 mg
tacrolimus (as monohydrate).
Excipients with known effect:
Advagraf 0.5 mg: Each capsule contains 51.09 mg lactose.
Advagraf 1 mg: Each capsule contains 102.17 mg lactose.
Advagraf 3 mg: Each capsule contains 306.52 mg lactose.
Advagraf 5 mg: Each capsule contains 510.9 mg lactose.
The printing ink used to mark the capsule contains trace amounts of
soya lecithin (0.48% of total printing
ink composition).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Prolonged-release hard capsule.
Advagraf 0.5 mg: Gelatin capsules imprinted in red with “0.5 mg”
on the light yellow capsule cap and
“

647” on the orange capsule body, containing white powder.
Advagraf 1 mg: Gelatin capsules imprinted in red with “1 mg” on
the white capsule cap and “

677” on
the orange capsule body, containing white powder.
Advagraf 3 mg: Gelatin capsules imprinted in red with “3 mg” on
the orange capsule cap and “

637” on
the orange capsule body, containing white powder.
Advagraf 5 mg: Gelatin capsules imprinted in red with “5 mg” on
the greyish red capsule cap and
“

687” on the orange capsule body, containing white powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Prophylaxis of transplant rejection in adult kidney or liver allograft
recipients.
Treatment of allograft rejection resistant to treatment with other
immunosuppressive medicinal products
in adult k