METHOTREXATE EBEWE methotrexate concentrated injection 5000mg/50mL vial

Nchi: Australia

Lugha: Kiingereza

Chanzo: Department of Health (Therapeutic Goods Administration)

Viambatanisho vya kazi:

methotrexate, Quantity: 5000 mg

Inapatikana kutoka:

Sandoz Pty Ltd

INN (Jina la Kimataifa):

Methotrexate

Dawa fomu:

Injection, concentrated

Tungo:

Excipient Ingredients: sodium hydroxide; water for injections

Njia ya uendeshaji:

Intravenous

Vitengo katika mfuko:

1 vial

Dawa ya aina:

(S4) Prescription Only Medicine

Matibabu dalili:

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 drug 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 sarcoma. Calcium folinate (leucovorin calcium) must be used in conjunction with high dose methotrexate therapy.,Psoriasis Chemotherapy (See WARNINGS box and Section 4.4 Special warnings and precautions for use).:,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 diagnosis has been definitely established , as by biopsy and/or after dermatological consultation.

Bidhaa muhtasari:

Visual Identification: Clear yellow solution; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Idhini hali ya:

Registered

Idhini ya tarehe:

2005-07-18

Taarifa za kipeperushi

Methotrexate Ebewe

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 and 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
Ebewe 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
after you stop treatment.
•
Discuss with your doctor how much water or fl

Tabia za bidhaa

220708-Methotrexate EBEWE-pi
Page 1 of 24
AUSTRALIAN PRODUCT INFORMATION
METHOTREXATE EBEWE
®
(METHOTREXATE) CONCENTRATED INJECTION
VIAL
WARNINGS
METHOTREXATE EBEWE (METHOTREXATE 100 MG/ML) IS RECOMMENDED
FOR INTRAVENOUS ADMINISTRATION ONLY.
Methotrexate
must
be
used
only
by
physicians
experienced
in
antimetabolite
chemotherapy, or in the case of non-oncological conditions, by a
specialist physician.
Because of the possibility of fatal or severe toxic reactions the
patient should be fully
informed by the physician 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 should be restricted to
severe, recalcitrant,
disabling disease which is not adequately responsive to other forms of
therapy, but 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
medicines 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