PFZ Methotrexate Tablet 2.5mg

Country: মাল্যাশিয়া

ভাষা: ইংরেজি

সূত্র: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

সক্রিয় উপাদান:

METHOTREXATE

থেকে পাওয়া:

PFIZER (MALAYSIA) SDN. BHD.

INN (International Name):

METHOTREXATE

প্যাকেজ ইউনিট:

30 Tablets

Manufactured by:

Excella GmbH

তথ্য লিফলেট

Pfizer Confidential
_ _
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
PFZ METHOTREXATE
® TABLET
Methotrexate (2.5 mg)
PLD Title
: Methotrexate (PFZ METHOTREXATE
®
)Tablet
PLD Date
: 2114 June May 20193082305 FebruarJanuaryyAprilAugust 202210
Country
: Malaysia
Reference Ddocument
: METHOTREXATE Tablet Malaysia LPD, dated 010 21 FebruaryMayJanuary
2021018
Reason for cCchange
: PfLEET Numbero: 2020-0061147 (O), To remove product owner
informationTo develop PLD
based on effective Malaysia LPD (10 January 2018) and new template
: :To update label as per BOH commentsTo amend serial number and MAL
number
: PfLEET Number 2020-0061675 (D) - To include rheumatoid arthritis
(RA) indication
: To update serial number
: To amend as per BOH recommendation
:To update serial number as per BOH request
Pfizer Confidential
_ _
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
PFZ METHOTREXATE
® TABLET
Methotrexate (2.5 mg)
1
WHAT IS IN THIS LEAFLET
1.
What METHOTREXATE is
used for
2.
How METHOTREXATE works
3.
Before you use
METHOTREXATE
4.
How to use METHOTREXATE
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
METHOTREXATE
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Rerevision
10.11.
Serial Number
WHAT METHOTREXATE IS USED
FOR
METHOTREXATE is used alone or
in combination with other anticancer
agents to treat various cancers.
METHOTREXATE is also indicated
in the symptomatic control of severe
psoriasis when other treatments are
not responsive.
METHOTREXATE can also be
usedis now the most popular drug for
the treatment of can be used in
Rheumatoid arthritis (RA) in
adutsadults. that is joint pain.
HOW METHOTREXATE WORKS
METHOTREXATE works by
blocking an enzyme process in cells
that is required for cell growth.
This interferes with the growth of
some cells that are growing rapidly in
psoriasis or ,rheumatoid arthritis and
cancer.
The precise mechanism of
METHOTREXATE in treating
rheumatoid arthritis is uncertain.
METHOTREXATE either taken
alone or with other medicines

পণ্য বৈশিষ্ট্য

1
METHOTREXATE
TABLETS
1.
NAME OF THE MEDICINAL PRODUCT
PFZ Methotrexate Tablet 2.5 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Methotrexate Tablets contain 2.5 mg of Methotrexate
3.
PHARMACEUTICAL FORM
Round, convex, yellow in colour, approximately 6.35 ± 0.1 mm in
diameter, engraved with ‘2.5’ on one
side and scored in half on the other side and engraved with a block
letter ‘M’ above the score and ‘I’
below.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
The following are representative indications. Locally approved
indications may differ.
Methotrexate is a cytotoxic drug used for antineoplastic chemotherapy
and in certain nonmalignant
conditions.
ANTI-NEOPLASTIC CHEMOTHERAPY
Methotrexate is indicated for the treatment of gestational
choriocarcinoma, and in patients with
chorioadenoma destruens and hydatidiform mole.
Methotrexate is indicated for the palliation of acute lymphocytic
leukemia. It is also indicated in the
treatment and prophylaxis of meningeal leukemia. Greatest effect has
been observed in palliation of
acute lymphoblastic (stem-cell) leukemias in children. In combination
with other anticancer drugs or
suitable agents Methotrexate may be used for induction of remission,
but it is most commonly used, as
described in the literature, in the maintenance of induced remissions.
Methotrexate may be used alone or in combination with other anticancer
agents in the management of
breast cancer, epidermoid cancers of the head and neck, and lung
cancer, particularly squamous cells
and small cell types.
Methotrexate is also effective in the treatment of the advanced stages
(III and IV, Peters Staging
System) of lymphosarcoma, particularly in those cases in children; and
in advanced cases of mycosis
fungoides.
PSORIASIS CHEMOTHERAPY (SEE SECTION 4.4)
Because of high risk attending its use, Methotrexate is only indicated
in the symptomatic control of
severe, recalcitrant, disabling psoriasis which is not adequately
responsive to other forms of therapy,
but only when the diagnosis has been est