Pfizer (Australia) METHOTREXATE 500mg/20mL injection BP vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

methotrexate, Quantity: 500 mg

Available from:

Pfizer Australia Pty Ltd

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: water for injections; sodium chloride; hydrochloric acid; sodium hydroxide

Administration route:

Intravenous, Intramuscular, Intrathecal

Units in package:

20mL x 1

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Antineoplastic chemotherapy - Treatment of breast cancer, gestational choriocarcinoma and in patients with chorioadenoma destruens and hydatidiform mole. Palliation of acute and subacute lymphocytic and meningeal leukaemia. Greatest effect has been observed in palliation of acute lymphoblastic (stem cell) leukaemia. In combination with corticosteroids, methotrexate may be used for induction of remission. The drug is now most commonly used for the maintenance of induced remissions. Methotrexate is also effective in the treatment of the advanced stages (III and IV, Peters Staging System) of lymphosarcoma, particularly in children and in advanced cases of mycosis fungoides. High dose therapy - The use of very high doses is made possible by vials for injection containing 500 mg and 1000 mg (See Precautions). Diseases treated with these doses administered in the form of single-drug or combination therapy, include osteogenic sarcoma, acute leukaemia, bronchogenic carcinoma and epidermoid carcinoma of the head and n

Product summary:

Visual Identification: Clear yellow solution free from visible particulate matter.; Container Type: Vial; Container Material: PP; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

1994-01-19

Patient Information leaflet

PFIZER (AUSTRALIA) METHOTREXATE INJECTION
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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 PFIZER METHOTREXATE INJECTION?
Pfizer Methotrexate Injection contains the active ingredient
methotrexate. Pfizer Methotrexate Injection 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 Pfizer
Methotrexate Injection? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE PFIZER METHOTREXATE INJECTION?
Do not use if you have ever had an allergic reaction to Pfizer
Methotrexate Injection 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
Pfizer Methotrexate Injection? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Pfizer Methotrexate Injection 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 PFIZER METHOTREXATE INJECTION?
•
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 Pfizer Methotrexate
Injection? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING PFIZER METHOTREXATE INJECTION?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
Pfizer Methotrexate.
•
You and your partner must use a reliable meth

Summary of Product characteristics

Version: pfpmetti10422
Supersedes: pfpmetti10821
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AUSTRALIAN
PRODUCT
INFORMATION
–
PFIZER
(AUSTRALIA)
METHOTREXATE
INJECTION BP (METHOTREXATE)
WARNINGS
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 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
other drugs with
hepatotoxic potential (including 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_
pneumonia,
may occur with methotrexate therapy.
5. Vaccination with a live