METHOTREXATE ACCORD methotrexate 50mg/2mL injection vial

País: Australia

Idioma: inglés

Fuente: Department of Health (Therapeutic Goods Administration)

Ingredientes activos:

methotrexate, Quantity: 25 mg/mL

Disponible desde:

Accord Healthcare Pty Ltd

Designación común internacional (DCI):

Methotrexate

formulario farmacéutico:

Injection, solution

Composición:

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

Vía de administración:

Intraarterial, Intramuscular, Intravenous, Intrathecal

Unidades en paquete:

1 vial

tipo de receta:

(S4) Prescription Only Medicine

indicaciones terapéuticas:

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 of severe, recalcitrant, disabling psoriasis which 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 dermatologic consultation.

Resumen del producto:

Visual Identification: A yellow to orange clear solution in a glass vial; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 18 Months; Container Temperature: Store below 25 degrees Celsius

Estado de Autorización:

Licence status A

Fecha de autorización:

2014-10-10

Información para el usuario

Methotrexate Accord – version 5.0
1
METHOTREXATE ACCORD
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.
1.
WHY AM I BEING GIVEN METHOTREXATE ACCORD?
Methotrexate Accord contains the active ingredient methotrexate.
Methotrexate Accord belongs to a group of medicines
known as antineoplastic or cytotoxic agents.
Methotrexate Accord is used to treat some types of cancers. It may
also be used in severe psoriasis when these conditions do
not improve with other medicines.
For more information, see Section 1. Why am I using Methotrexate
Accord?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I AM GIVEN METHOTREXATE ACCORD?
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 am
given Methotrexate Accord?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines and methotrexate may interfere with each other and may
affect how well each medicine works.
A list of these medicines is in Section 3. What if I am taking other
medicines?
in the full CMI.
4.
HOW WILL I BE GIVEN METHOTREXATE ACCORD?
Methotrexate Accord will be given to you by a doctor or a nurse as an
injection into a muscle, a vein, an artery or into the
spine.
More instructions can be found in Section 4. How will I be given
Methotrexate Accord?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE BEING GIVEN METHOTREXATE ACCORD?
THINGS YOU
SHOULD DO
•
Be sure to keep all your doctor's appointments
•
Use an effective method of birth control while you are being treated
with methotrexate or for at
least 6 months after stopping treatment
•
If you or your partner becomes pregnant while you are being treated
with methotrexate, or for up
to 6 months

Ficha técnica

Page 1 of 23
AUSTRALIAN PRODUCT INFORMATION
METHOTREXATE ACCORD (METHOTREXATE) SOLUTION FOR
INJECTION
WARNING
Methotrexate must only be used by physicians experienced in
anti-metabolite 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 constant
supervision of the physician.
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 and only
when the diagnosis has been
established, by biopsy and/or after 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 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 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
carinii pneumonia, may occur
with methotrexate therapy.
5.
USE IN PREGNANCY
Category D. This category specifies drugs, which have caused an