Tacni 0.5mg capsules

Quốc gia: Vương quốc Anh

Ngôn ngữ: Tiếng Anh

Nguồn: MHRA (Medicines & Healthcare Products Regulatory Agency)

Thành phần hoạt chất:

Tacrolimus

Sẵn có từ:

Teva UK Ltd

Mã ATC:

L04AD02

INN (Tên quốc tế):

Tacrolimus

Liều dùng:

500microgram

Dạng dược phẩm:

Oral capsule

Tuyến hành chính:

Oral

Lớp học:

No Controlled Drug Status

Loại thuốc theo toa:

Caution - AMP level prescribing advised

Tóm tắt sản phẩm:

BNF: 08020200; GTIN: 5017007058519

Tờ rơi thông tin

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.
1. What Tacni is and what it is used for
2. What you need to know before you take Tacni
3. How to take Tacni
4. Possible side effects
5. How to store Tacni
6. Contents of the pack and other information
WHAT TACNI IS AND WHAT IT IS USED FOR
Tacni is an immunosuppressant. Following your organ transplant (e.g.
liver, kidney, heart), your body’s
immune system will try to reject the new organ.
Tacni is used to control your body’s immune response enabling your
body to accept the transplanted
organ.
Tacni is often used in combination with other medicines that also
suppress the immune system.
You may also be given Tacni 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.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE Tacni
DO NOT TAKE TACNI
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).
WARNINGS AND PRECAUTIONS
Talk to your doctor before taking Tacni
-
if you are taking any medicines mentioned below under ‘Other
medicines and Tacni’ .
-
if you have or have had liver problems
-
if you have diarrhoea for more than one day
-
if you need to receive any vaccinations
Your doctor may need to adjust your dose of Tacni.
You should keep in regular contact with your doctor. From time to
time, your

Đặc tính sản phẩm

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Tacni 0.5mg hard capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Tacni 0.5 mg hard capsule contains 0.5 mg tacrolimus
Excipient with known effect:
Each Tacni 0.5 mg hard capsule contains 109.1 mg lactose anhydrous
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Capsules, hard.
Ivory cap and ivory body hard shell capsules with white powder.
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
Tacni 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 transplanted patients.
Inadvertent, unintentional or unsupervised switching of immediate- or
prolonged-
release formulations of tacrolimus is unsafe. This can lead to graft
rejection or
increased incidence of side effects, including under- or
over-immunosuppression, due
to clinically relevant differences in systemic exposure to tacrolimus.
Patients should
be maintained on a single formulation of tacrolimus with the
corresponding daily
dosing regimen; alterations in formulation or regimen should only take
place under
the close supervision of a transplant specialist (see sections 4.4 and
4.8). Following
conversion to any alternative formulation, therapeutic drug monitoring
must be
performed and dose adjustments made to ensure that systemic exposure
to tacrolimus
is maintained.
GENERAL CONSIDERATIONS
The recommended initial dosages presented below are intended to act
solely as a
guideline. Tacrolimus dosing should primarily be based on clinical
assessments of
rejection and tolerability in each patient individually aided by blood
level monitori