Prograf 5mg/1ml solution for infusion ampoules

国: イギリス

言語: 英語

ソース: MHRA (Medicines & Healthcare Products Regulatory Agency)

有効成分:

Tacrolimus

から入手可能:

Astellas Pharma Ltd

ATCコード:

L04AD02

INN（国際名）:

Tacrolimus

投薬量:

5mg/1ml

医薬品形態:

Solution for infusion

投与経路:

Intravenous

クラス:

No Controlled Drug Status

処方タイプ:

Valid as a prescribable product

製品概要:

BNF: 08020200; GTIN: 5390332111143

情報リーフレット

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 PRECAUTION

製品の特徴

OBJECT 1
PROGRAF 5MG/ML CONCENTRATE FOR SOLUTION FOR
INFUSION
Summary of Product Characteristics Updated 02-Oct-2015 | Astellas
Pharma Ltd
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.
METHOD OF ADMINI