DBL METHOTREXATE 500mg/20mL Injection

Land: Australië

Taal: Engels

Bron: Department of Health (Therapeutic Goods Administration)

Werkstoffen:

methotrexate, Quantity: 25 mg/mL

Beschikbaar vanaf:

Pfizer Australia Pty Ltd

farmaceutische vorm:

Injection, solution

Samenstelling:

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

Toedieningsweg:

Intravenous, Intramuscular, Intrathecal, Intraarterial

Eenheden in pakket:

1x500mg/20mL(E), 1x500mg/20mL

Prescription-type:

Not scheduled. Not considered by committee, (S4) Prescription Only Medicine

therapeutische indicaties:

Antineoplastic chemotherapy: Methotrexate has a broad spectrum of antineoplastic activity. It is indicated for the treatment of breast cancer, gestational choriocarcinoma, and in patients with chorioadenoma destruens and hydatidiform mole. Methotrexate may be used in combination with other chemotherapeutic agents for the palliative treatment of acute leukaemias, particularly acute lymphoblastic leukaemia. It may also be used in the treatment of Burkitt's lymphoma, advanced stages (III and IV, Peters' Staging System) of lymphosarcoma, especially in children, and in advanced cases of mycosis fungoides. 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 (see WARNING box): Methotrexate may be of value in the symptomatic control o

Product samenvatting:

Visual Identification: Yellow solution; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Autorisatie-status:

Registered

Autorisatie datum:

1994-01-31

Bijsluiter

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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 DBL METHOTREXATE INJECTION?
DBL Methotrexate Injection contains the active ingredient
methotrexate. DBL Methotrexate Injection is used to treat certain
types of
cancers, severe psoriasis or rheumatoid arthrtis when the condition
does not improve with other medicines.
For more information, see Section 1. Why am I using DBL Methotrexate
Injection? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE DBL METHOTREXATE INJECTION?
Do not use if you have ever had an allergic reaction to DBL
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
DBL Methotrexate Injection? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with DBL 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 DBL 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 DBL Methotrexate
Injection? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING DBL METHOTREXATE INJECTION?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
DBL Methotrexate.
•
You and your partner must use a reliable method of contraception
(birth control pills or condom)

Productkenmerken

Version: pfpmetxi10422
supersedes: pfpmetxi11021
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AUSTRALIAN
PRODUCT
INFORMATION
–
DBL™
METHOTREXATE
INJECTION
(METHOTREXATE)
WARNINGS
Methotrexate must only be used by physicians experienced in
anti-metabolite chemotherapy,
or in the case of non-oncological conditions, by a specialist
physician.
Patients should be fully informed of the risk of fatal or severe toxic
reactions involved with the
administration of methotrexate and should be under constant
supervision of the physician.
Deaths have been reported with the use of methotrexate. In the
treatment of psoriasis and
rheumatoid arthritis, methotrexate should be restricted to severe,
recalcitrant, disabling disease
which is not adequately responsive to other forms of therapy and only
when the diagnosis has
been established, by biopsy and/or after consultation.
1.
Methotrexate may produce depression of the bone marrow, anaemia,
aplastic anaemia,
leucopenia, neutropenia, thrombocytopenia and bleeding.
2. At high or prolonged doses, methotrexate may be hepatotoxic. Liver
atrophy, necrosis,
cirrhosis, fatty changes and periportal fibrosis have been reported.
Since changes may occur
without previous signs of gastro-intestinal 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
liver damage or impaired
hepatic function. Concomitant use of other drugs with hepatotoxic
potential and 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.
USE IN PREGNANCY
Category D. This category specifies drugs, which have c