Methotrexate Ebewe

Country: Նոր Զելանդիա

language: անգլերեն

source: Medsafe (Medicines Safety Authority)

active_ingredient:

Methotrexate 100 mg/mL

MAH:

Sandoz New Zealand Limited

INN:

Methotrexate 100 mg/mL

dosage:

100 mg/mL

pharmaceutical_form:

Concentrate for injection

composition:

Active: Methotrexate 100 mg/mL Excipient: Sodium hydroxide Water for injection

units_in_package:

Vial, glass, 500mg/5mL vial, 1 x 5 mL, 5 mL

class:

Prescription

prescription_type:

Prescription

manufactured_by:

Fermion Oy

therapeutic_indication:

Antineoplastic chemotherapy. Methotrexate has a broad spectrum of antineoplastic activity. It is indicated for the treatment of breast cancer and the palliation of acute and subacute lymphocytic leukaemia (greatest effect has been observed in palliation of acute lymphoblastic (stem cell) leukaemias). Methotrexate is now most commonly used for the maintenance of medicine induced remissions. High dose therapy. In high dose schedules, methotrexate may be effective alone or in combination therapy, in the treatment of epidermoid cancers of the head and neck, osteogenic sarcoma and bronchogenic carcinoma. Calcium folinate (leucovorin calcium) must be used in conjunction with high dose methotrexate therapy. Psoriasis chemotherapy. Methotrexate may be of value in the symptomatic control of severe, recalcitrant, disabling psoriasis that is not adequately responsive to other forms of treatment. However, due to the high risk associated with its use, methotrexate should be used after the diagnosis has been definitely established, as by biopsy and/or after dermatological consultation.

leaflet_short:

Package - Contents - Shelf Life: Vial, glass, 500mg/5mL vial, 1 x 5 mL - 5 mL - 24 months from date of manufacture stored at or below 25°C protect from light - Vial, glass, 1000mg/10mL vial, 1 x 10 mL - 10 mL - 24 months from date of manufacture stored at or below 25°C protect from light - Vial, glass, 5000mg/50mL vial, 1 x 50 mL - 50 mL - 24 months from date of manufacture stored at or below 25°C protect from light

authorization_date:

2004-07-26

PIL

Methotrexate Ebewe® CMI v1.0
1
METHOTREXATE EBEWE®
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
WARNING: Important safety information is provided in a boxed warning
in the full CMI. Read before using this medicine.
1.
WHY AM I USING METHOTREXATE EBEWE?
Methotrexate Ebewe contains the active ingredient methotrexate.
Methotrexate Ebewe is used to treat certain types of
cancers or severe psoriasis when the condition does not improve with
other medicines.
For more information, see Section 1. Why am I using Methotrexate
Ebewe? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE METHOTREXATE EBEWE?
Do not use if you have ever had an allergic reaction to methotrexate
or any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
Methotrexate Ebewe? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Methotrexate Ebewe and affect how it
works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE METHOTREXATE EBEWE?
•
The dose of medicine given to you will depend on the condition being
treated, your medical condition, your age, your size
and how well your kidneys and liver are working.
More instructions can be found in Section 4. How do I use Methotrexate
Ebewe? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING METHOTREXATE EBEWE?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
Methotrexate Ebewe.
•
You and your partner must use a reliable method of contraception
(birth control pills or condom)
during treatment with Methotrexate Ebewe and for at least 6 months for
females and 3 months for
males after stopping treatment.
•
Discuss wi

SPC

240229-Methotrexate Ebewe-ds-v1.0
Page 1 of 25
NEW ZEALAND DATA SHEET
METHOTREXATE EBEWE INJECTION CONCENTRATE (METHOTREXATE
BP)
WARNINGS
METHOTREXATE EBEWE (METHOTREXATE 100 MG/ML) IS RECOMMENDED
FOR INTRAVENOUS ADMINISTRATION ONLY.
METHOTREXATE
MUST
BE
USED
ONLY
BY
DOCTORS
EXPERIENCED
IN
ANTIMETABOLITE
CHEMOTHERAPY
OR
IN
THE
CASE
OF
NON-ONCOLOGICAL
CONDITIONS, BY A SPECIALIST DOCTOR.
BECAUSE
OF
THE
POSSIBILITY
OF
FATAL
OR
SEVERE
TOXIC
REACTIONS,
THE
PATIENT SHOULD BE FULLY INFORMED BY THE DOCTOR OF THE RISKS INVOLVED
AND SHOULD BE UNDER HIS CONSTANT SUPERVISION.
DEATHS HAVE BEEN REPORTED WITH THE USE OF METHOTREXATE.
IN THE TREATMENT OF PSORIASIS, METHOTREXATE USE SHOULD BE RESTRICTED
TO
SEVERE,
RECALCITRANT,
DISABLING
DISEASE
THAT
IS
NOT
ADEQUATELY
RESPONSIVE TO OTHER FORMS OF THERAPY, AND ONLY WHEN THE DIAGNOSIS HAS
BEEN ESTABLISHED, BY BIOPSY AND/OR AFTER APPROPRIATE CONSULTATION.
1.
Methotrexate may produce marked depression of the bone marrow,
anaemia, aplastic
anaemia, leucopenia, neutropenia, thrombocytopenia and bleeding.
2.
Methotrexate may be hepatotoxic, particularly at high dosage or with
prolonged
therapy. Liver atrophy, necrosis, cirrhosis, fatty changes and
periportal fibrosis have
been reported. Since changes may occur without previous signs of
gastrointestinal or
haematological toxicity, it is imperative that hepatic function be
determined prior to
initiation of treatment and monitored regularly throughout therapy.
Special caution is
indicated in the presence of pre-existing liver damage or impaired
hepatic function.
Concomitant use of methotrexate with other drugs with hepatotoxic
potential or
alcohol should be avoided.
3.
Malignant lymphomas, which may regress following withdrawal of
methotrexate,
may occur in patients receiving low dose methotrexate and, thus, may
not require
cytotoxic treatment. Discontinue methotrexate first and, if the
lymphoma does not
regress, appropriate treatment should be instituted.
4.
Potentially
fatal
opportunistic
infections,
especially
_Pneumocystis _
_jirovecii