METHOTREXATE

Main information

  • Trade name:
  • METHOTREXATE INTAS methotrexate 1000mg/10mL injection vial
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • METHOTREXATE INTAS methotrexate 1000mg/10mL injection vial
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 213735
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

213735

METHOTREXATE INTAS methotrexate 1000mg/10mL injection vial

ARTG entry for

Medicine Registered

Sponsor

Accord Healthcare Pty Ltd

Postal Address

Level 24 570 Bourke Street,Melbourne, VIC, 3000

Australia

ARTG Start Date

10/10/2014

Product category

Medicine

Status

Active

Approval area

Drug Safety Evaluation Branch

Conditions

Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Registered or Listed Therapeutic Goods

Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Standard Conditions Applying to Registered

or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Products

1. METHOTREXATE INTAS methotrexate 1000mg/10mL injection vial

Product Type

Single Medicine Product

Effective date

28/09/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

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.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Vial

Glass Type I Clear

2 Years

Store below 25

degrees Celsius

Not recorded

Protect from Light

Pack Size/Poison information

Pack Size

Poison Schedule

1 vial

(S4) Prescription Only Medicine

Components

1. medicine product

Dosage Form

Injection, solution

Route of Administration

Intraarterial

Intrathecal

Intravenous

Intramuscular

Visual Identification

A yellow to orange clear solution in a glass vial

Active Ingredients

Methotrexate

100 mg/mL

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 26.11.2017 at 10:52:59 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

29-6-2018

Medicines Safety Update, Volume 9, Number 2, June 2018

Medicines Safety Update, Volume 9, Number 2, June 2018

Oral methotrexate dosing, medicines associated with a risk of neuropsychiatric adverse events, and clozapine and gastrointestinal effects

Therapeutic Goods Administration - Australia

5-3-2012

Danish Pharmacovigilance Update, 16 February 2012

Danish Pharmacovigilance Update, 16 February 2012

Among the topics covered in this issue of Danish Pharmacovigilance Update are: Risk of overdose with methotrexate in the treatment of rheumatoid arthritis as well as intensified monitoring of heart rate and blood pressure in connection with treatment with Gilenya.

Danish Medicines Agency

24-5-2018

Jylamvo (Therakind Ltd)

Jylamvo (Therakind Ltd)

Jylamvo (Active substance: methotrexate) - PSUSA - Modification - Commission Decision (2018)3263 of Thu, 24 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/2014/201706

Europe -DG Health and Food Safety

18-5-2018

Nordimet (Nordic Group B.V.)

Nordimet (Nordic Group B.V.)

Nordimet (Active substance: methotrexate) - PSUSA - Modification - Commission Decision (2018)3155 of Fri, 18 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/2014/201706

Europe -DG Health and Food Safety