Prograf 1mg capsules

Land: Verenigd Koninkrijk

Taal: Engels

Bron: MHRA (Medicines & Healthcare Products Regulatory Agency)

Werkstoffen:

Tacrolimus

Beschikbaar vanaf:

Abacus Medicine Ltd

ATC-code:

L04AD02

INN (Algemene Internationale Benaming):

Tacrolimus

Dosering:

1mg

farmaceutische vorm:

Oral capsule

Toedieningsweg:

Oral

klasse:

No Controlled Drug Status

Prescription-type:

Caution - AMP level prescribing advised

Product samenvatting:

BNF: 08020200; GTIN: 08719923001804

Bijsluiter

PROGRAF
® 1 MG CAPSULES
(tacrolimus)
PATIENT INFORMATION LEAFLET
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.
This medication is available using the above name but will be referred
to as
Prograf throughout the following leaflet.
This medicine is available in other strengths. This leaflet also
contains
information regarding other strengths of Prograf.
WHAT IS IN THIS LEAFLET
1. What Prograf is and what it is used for
2. What you need to know before you take Prograf
3. How to take 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 TAKE PROGRAF
DO NOT TAKE PROGRAF
- If you are allergic (hypersensitive) to tacrolimus or any of the
other
ingredients of Prograf (listed in Section 6).
- If you are allergic (hypersensitive) to any antibiotic belonging to
the subgroup
of macrolide antibiotic

Productkenmerken

PRODUCT SUMMARY
1.
NAME OF THE MEDICINAL PRODUCT
Not applicable
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Not applicable
3.
PHARMACEUTICAL FORM
Not applicable
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Not applicable
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Not applicable
4.3.
CONTRAINDICATIONS
Not applicable
4.4.
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Not applicable
4.5.
INTERACTIONS WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
Not applicable
4.6.
PREGNANCY AND LACTATION
Not applicable
4.7.
EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
Not applicable
4.8.
UNDESIRABLE EFFECTS
Not applicable
4.9.
OVERDOSE
Not applicable
5.
PHARMACOLOGICAL PROPERTIES
5.1.
PHARMACODYNAMIC PROPERTIES
Not applicable
5.2.
PHARMACOKINETIC PROPERTIES
Not applicable
5.3.
PRECLINICAL SAFETY DATA
Not applicable
6.
PHARMACEUTICAL PARTICULARS
6.1.
LIST OF EXCIPIENTS
Not applicable
6.2.
INCOMPATIBILITIES
Not applicable
6.3.
SHELF LIFE
Not applicable
6.4.
SPECIAL PRECAUTIONS FOR STORAGE
Not applicable
6.5.
NATURE AND CONTENTS OF CONTAINER
Not applicable
6.6.
INSTRUCTION FOR USE AND HANDLING (, AND DISPOSAL)
Not applicable
No Data Held
ADMINISTRATIVE DATA
7.
Marketing Authorisation Holder
Not applicable
8.
MARKETING AUTHORISATION NUMBER
Not applicable
9.
DATE OF FIRST AUTHORISATION/RENEWAL OF AUTHORISATION
Not applicable
10.
DATE OF (PARTIAL) REVISION OF TEXT
Not applicable