PROGRAF AMPOULES

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

TACROLIMUS

Available from:

ASTELLAS PHARMA INTERNATIONAL B.V., ISRAEL

ATC code:

L04AA05

Pharmaceutical form:

CONCENTRATE FOR SOLUTION FOR INFUSION

Composition:

TACROLIMUS 5 MG/ML

Administration route:

I.V

Prescription type:

Required

Manufactured by:

ASTELLAS IRELAND CO. LTD, IRELAND

Therapeutic group:

TACROLIMUS

Therapeutic area:

TACROLIMUS

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.

Authorization date:

2022-10-31

Patient Information leaflet

_ _
_ _
_ :ךיראת_
_לירפא_
_ _
_2019_
_ _ ה/דבכנ ת/חקור ,ה/אפור העידומ עבט תרבח
לע
ולעב םיאבה םינוכדעה
ן
אפורל
:רישכתה לש
_ _
PROGRAF AMPOULES, CONCENTRATE FOR SOLUTION FOR I.V. INFUSION
ידירו ךות יוריעל תזכורמ הסימת תולופמא
ףרגורפ
CONTAINS: TACROLIMUS 5MG/ML
אפורל ןולעב םינוכדע
------------------------------------------------------------------------------------------------------------ :םושירה תדועתב הרשואש יפכ היוותה
Prophylaxis of transplant rejection in liver kidney or heart allograft
recipients.
Treatment of allograft rejection resistant to treatment with other
immunosuppressive
medicinal products.
ל ןולעהש עידוהל וננוצרב
אפור
כדוע
ן תופסות( דבלב םיירקיעה םינוכדעה םילולכ
ןלהלש טוריפב , תונמוסמ
םודאב :)קוחמ טסקטכ עדימ תורסהו
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
[...]
Eye disorders
Eye disorders, sometimes progressing to loss of vision, have been
reported in patients treated with
tacrolimus. Some cases have reported resolution on switching to
alternative immunosuppression.
Patients should be advised to report changes in visual acuity, changes
in colour vision, blurred vision,
or visual field defect, and in such cases, prompt evaluation is
recommended with referral to an
ophthalmologist as appropriate.
Infections including opportunistic infections
Patients treated with immunosuppressants, including Prograf, are at
increased risk for infections
including opportunistic infections (bacterial, fungal, viral and
protozoal) such as BK virus associated
nephropathy and JC virus associated progressive multifocal
leukoencephalopathy (PML). Patients are
also at an increased risk of infections with viral hepatitis (for
example, hepatitis B and C reactivation
and de novo infection, as well as hepatitis E, which may become
chronic). These infections are often
related

Summary of Product characteristics

Prograf Ampoules MF 11/2022 Notification
SUMMARY OF PRODUCT CHARACTERISTICS
PROGRAF
® AMPOULES
1.
NAME OF THE MEDICINAL PRODUCT
Prograf Ampoules
5 mg/ml concentrate for solution for I.V. infusion.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml concentrate for solution for infusion contains 5 mg of
tacrolimus.
Excipients with known effect: 200 mg of polyoxyethylene hydrogenated
castor oil and 638 mg of dehydrated alcohol.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for solution for infusion
The concentrate is a clear colourless solution.
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 therapy requires careful monitoring by adequately qualified
and equipped personnel. The medicinal product should
only be prescribed, and changes in immunosuppressive therapy
initiated, by physicians experienced in immunosuppressive
therapy and the management of transplant patients.
GENERAL CONSIDERATIONS
The recommended initial dosages presented below are intended to act
solely as a guideline. Prograf dosing should primarily
be based on clinical assessments of rejection and tolerability in each
patient individually aided by blood level monitoring
(see below for recommended target whole blood trough concentrations).
If clinical signs of rejection are apparent, alteration
of the immunosuppressive regimen should be considered.
Prograf can be administered intravenously or orally. In general,
dosing may commence orally; if necessary, by administering
the capsule contents suspended in water, via nasogastric tubing.
Prograf is routinely administered in conjunction with other
immunosuppressive agents in the initial post-operative period.
The Prograf dose may vary depending upon the immunosuppressive regimen
chosen.
POSOLOGY
DOSAGE RECOMMENDATIONS - LIVER TRANS