Dailiport 5 mg Prolonged-release hard capsules

देश: आयरलैंड

भाषा: अंग्रेज़ी

स्रोत: HPRA (Health Products Regulatory Authority)

सक्रिय संघटक:

Tacrolimus

थमां उपलब्ध:

Rowex Ltd

ए.टी.सी कोड:

L04AD; L04AD02

INN (इंटरनेशनल नाम):

Tacrolimus

डोज़:

5 milligram(s)

फार्मास्यूटिकल फॉर्म:

Prolonged-release capsule, hard

चिकित्सीय क्षेत्र:

Calcineurin inhibitors; tacrolimus

प्राधिकरण का दर्जा:

Not marketed

प्राधिकरण की तारीख:

2020-01-17

सूचना पत्रक

PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
DAILIPORT 0.5 MG PROLONGED-RELEASE HARD CAPSULES
DAILIPORT 1 MG PROLONGED-RELEASE HARD CAPSULES
DAILIPORT 2 MG PROLONGED-RELEASE HARD CAPSULES
DAILIPORT 3 MG PROLONGED-RELEASE HARD CAPSULES
DAILIPORT 5 MG PROLONGED-RELEASE HARD CAPSULES
tacrolimus
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What Dailiport is and what it is used for
2. What you need to know before you take Dailiport
3. How to take Dailiport
4. Possible side effects
5. How to store Dailiport
6. Contents of the pack and other information
1. WHAT DAILIPORT IS AND WHAT IT IS USED FOR
Dailiport contains the active substance tacrolimus. It is an
immunosuppressant. Following your organ
transplant (liver, kidney), your body’s immune system will try to
reject the new organ. Dailiport is
used to control your body’s immune response, enabling your body to
accept the transplanted organ.
You may also be given Dailiport for an ongoing rejection of your
transplanted liver, kidney, heart or
other organ when any previous treatment you were taking was unable to
control this immune response
after your transplantation.
Dailiport is used in adults.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DAILIPORT
_ _
DO NOT TAKE DAILIPORT:
_ _

if you are allergic to tacrolimus or any of the other ingredients of
this medicine (listed in section 6)
_ _

if you are allergic to sirolimus or to any macrolide-antibiotic (e.g.
erythromycin, clarithromycin,
josamycin)

if you are allergic to peanut or

उत्पाद विशेषताएं

Health Products Regulatory Authority
07 July 2021
CRN00C6NP
Page 1 of 15
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Dailiport 5 mg Prolonged-release hard capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each prolonged-release hard capsule contains 5 mg of tacrolimus (as
monohydrate).
Each prolonged-release hard capsule contains 510 mg of lactose (as
monohydrate).
Each prolonged-release hard capsule contains 18.6 microgram of Sunset
yellow FCF (E110).
Each prolonged-release hard capsule contains 1.5 microgram of Allura
red AC (E129).
The printing ink used to mark the capsule contains trace amounts of:

Allura Red AC Aluminium Lake (E129) (14 %w/w of total printing ink
composition);

Sunset Yellow FCF Aluminium Lake (E110) (3%w/w of total printing ink
composition);

lecithin (soya) (0.99%w/w of total printing ink composition).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Prolonged-release hard capsule.
_ _
Gelatin capsule size 0 with a light brown body and a pink cap,
imprinted in black with "5 mg", containing white to yellowish
powder or compacted powder (length 21.4 – 22.0 mm).
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 patients.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Dailiport is a once-a-day oral formulation of tacrolimus. Dailiport
therapy requires careful monitoring by adequately qualified
and equipped personnel. This medicinal product should only be
prescribed, and changes in immunosuppressive therapy
initiated, by physicians experienced in immunosuppressive therapy and
the management of transplant patients.
Different oral formulations of tacrolimus should not be substituted
without clinical supervision. Inadvertent, unintentional or
unsupervised switching between different oral formulation of
tacrolimus with different release characteristic