RAPAMUNE 1 MG TABLETS

Country: ইস্রায়েল

ভাষা: ইংরেজি

সূত্র: Ministry of Health

সক্রিয় উপাদান:

SIROLIMUS

থেকে পাওয়া:

PFIZER PHARMACEUTICALS ISRAEL LTD

এটিসি কোড:

L04AA10

ফার্মাসিউটিকাল ফর্ম:

COATED TABLETS

রচনা:

SIROLIMUS 1 MG

প্রশাসন রুট:

PER OS

প্রেসক্রিপশন টাইপ:

Required

Manufactured by:

PFIZER IRELAND PHARMACEUTICALS

Therapeutic area:

SIROLIMUS

থেরাপিউটিক ইঙ্গিত:

Rapamune is indicated for the prophylaxis of organ rejection in adult patients at low to moderate immunological risk receiving a renal transplant. It is recommended that Rapamune be used initially in combination with cyclosporine microemulsion and corticosteroids for 2 to 3 months. Rapamune may be continued as maintenance therapy with corticosteroids only if cyclosporine can be progressively discontinued.

অনুমোদন তারিখ:

2014-10-31

তথ্য লিফলেট

Rapamune 1mg coated tablets PIL CC technical change 22 March 2022
English
1
2022-0076905
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS) -
1986
This medicine is dispensed with a doctor’s prescription only
RAPAMUNE
®
1 MG TABLETS
COATED TABLETS
Each tablet contains: sirolimus 1 mg
Inactive ingredients and allergens: See section 2 under ‘Important
information about
some of this medicine’s ingredients’ and section 6 ‘Further
information’.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THIS MEDICINE.
This leaflet contains
concise information about this medicine. If you have any further
questions, consult
your doctor or pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others. It may harm
them, even if it seems to you that their medical condition is similar
to yours.
1.
WHAT IS THIS MEDICINE INTENDED FOR?
Rapamune
®
is intended to suppress the immune system. This medicine is intended
for prevention of transplant rejection in patients receiving a kidney
transplant.
THERAPEUTIC GROUP:
selective immunosuppressant.
2.
BEFORE USING THIS MEDICINE
DO NOT USE THIS MEDICINE IF:
• You are sensitive (allergic) to the active ingredient or to any of
the other
ingredients in this medicine (see section 6).
SPECIAL WARNINGS REGARDING USE OF THE MEDICINE
BEFORE TREATMENT WITH RAPAMUNE
®
, TELL YOUR DOCTOR IF:
• you are pregnant
–
see the section ‘Pregnancy, breastfeeding, and fertility’.
• you have impaired liver function or have had a disease which may
have affected
your liver. Your dose may need to change and you may need additional
blood tests.
• you have problems with your immune system. Rapamune
®
, like other
immunosuppressive medicines, may decrease your body’s immune
resistance, and
may increase your risk of developing cancer of the lymphoid tissues
and skin.
• you have a body mass index (BMI) greater than 30
(weight[kg]/height
2
[m
2
]). You
may be at increased risk of abnormal wound knitting and scabbing.
• you are at high risk for t

পণ্য বৈশিষ্ট্য

Rapamune coated tablets 1 mg LPD 12 Feb 2019
2016-0016968, 2016-0018383, 2015-0014015, 20190048434
1
1. NAME OF THE MEDICINAL PRODUCT
RAPAMUNE 1 MG
COATED TABLETS
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each coated tablet contains 1 mg sirolimus.
Excipients with known effect:
Each tablet contains 86.4 mg of lactose monohydrate and 215.8 mg of
sucrose.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Coated tablet (tablet).
White-coloured, triangular-shaped coated tablet marked “RAPAMUNE 1
mg” on one side.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Rapamune is indicated for the prophylaxis of organ rejection in adult
patients at low to
moderate immunological risk receiving a renal transplant. It is
recommended that Rapamune
be used initially in combination with ciclosporin microemulsion and
corticosteroids for 2 to 3
months. Rapamune may be continued as maintenance therapy with
corticosteroids only if
ciclosporin microemulsion can be progressively discontinued (see
sections 4.2 and 5.1).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Treatment should be initiated by and remain under the guidance of an
appropriately qualified
specialist in transplantation.
Posology
_ _
_Initial therapy (2 to 3 months post-transplantation) _
The usual dose regimen for Rapamune is a 6 mg single oral loading
dose, administered as
soon as possible after transplantation, followed by 2 mg once daily
until results of therapeutic
monitoring of the medicinal product are available (see
_Therapeutic monitoring of the _
_medicinal product and dose adjustment_
). The Rapamune dose should then be individualised
to obtain whole blood trough levels of 4 to 12 ng/mL (chromatographic
assay). Rapamune
therapy should be optimised with a tapering regimen of steroids and
ciclosporin
microemulsion. Suggested ciclosporin trough concentration ranges for
the first 2-3 months
after transplantation are 150-400 ng/mL (monoclonal assay or
equivalent technique) (see
section 4.5
_)_
.
To minimise variability, Rapamune should be