Prograf 5 mg/ml concentrate for solution for infusion

Nazione: Irlanda

Lingua: inglese

Fonte: HPRA (Health Products Regulatory Authority)

Principio attivo:

Tacrolimus

Commercializzato da:

Astellas Pharma Co. Limited

Codice ATC:

L04AD; L04AD02

INN (Nome Internazionale):

Tacrolimus

Dosaggio:

5 milligram(s)/millilitre

Forma farmaceutica:

Concentrate for solution for infusion

Tipo di ricetta:

Product subject to prescription which may not be renewed (A)

Area terapeutica:

Calcineurin inhibitors; tacrolimus

Stato dell'autorizzazione:

Marketed

Data dell'autorizzazione:

1996-02-16

Foglio illustrativo

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
PROGRAF 5 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION
Tacrolimus
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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, pharmacist or
nurse.
-
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, pharmacist or nurse.
This includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Prograf is and what it is used for
2.
What you need to know before you use Prograf
3.
How to use Prograf
4.
Possible side effects
5.
How to store Prograf
6.
Contents of the pack and other information
1.
WHAT PROGRAF IS AND WHAT IT IS USED FOR
Prograf belongs to a group of medicines called immunosuppressants.
Following your organ transplant
(e.g. liver, kidney, heart), your body’s immune system will try to
reject the new organ. Prograf is used
to control your body’s immune response enabling your body to accept
the transplanted organ.
Prograf is often used in combination with other medicines that also
suppress the immune system.
You may also be given Prograf for an ongoing rejection of your
transplanted liver, kidney, heart or
other organ or if any previous treatment you were taking was unable to
control this immune response
after your transplantation.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE PROGRAF
DO NOT USE PROGRAF
-
If you are allergic (hypersensitive) to tacrolimus or to any
antibiotic belonging to the subgroup
of macrolide antibiotics (e.g. erythromycin, clarithromycin,
josamycin).
-
If you are allergic (hypersensitive) to any of the other ingredients
of Prograf (listed in section 6)
- in particular polyoxyethylene hydrogenated castor oil or similar
substances.
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist or nu

Scheda tecnica

Health Products Regulatory Authority
15 May 2023
CRN00DKQF
Page 1 of 18
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Prograf 5 mg/ml concentrate for solution for 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 transplant