Methotrexate 50mg/2ml solution for injection vials

Land: Bretland

Tungumál: enska

Heimild: MHRA (Medicines & Healthcare Products Regulatory Agency)

Virkt innihaldsefni:

Methotrexate sodium

Fáanlegur frá:

Pfizer Ltd

ATC númer:

L01BA01

INN (Alþjóðlegt nafn):

Methotrexate sodium

Skammtar:

25mg/1ml

Lyfjaform:

Solution for injection

Stjórnsýsluleið:

Intramuscular; Intraarterial; Intravenous

Tegund:

No Controlled Drug Status

Gerð lyfseðils:

Valid as a prescribable product

Vörulýsing:

BNF: 08010300; GTIN: 5015997441151

Upplýsingar fylgiseðill

Page 1 of 6
PACKAGE LEAFLET: INFORMATION FOR THE USER
METHOTREXATE 25 MG/ML INJECTION
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

If any of the side effects gets serious, or if you notice any side
effects not listed in
this leaflet, please tell your doctor.
IN THIS LEAFLET:
1. What Methotrexate Injection is and what it is used for
2. Before you are given Methotrexate Injection
3. How you are given Methotrexate Injection
4. Possible side effects
5. How to store Methotrexate Injection
6. Further information
1. WHAT METHOTREXATE INJECTION IS AND WHAT IT IS USED FOR
Methotrexate Injection is an anti-metabolite medicine (medicine which
affects how the
body’s cells grow) and immunosuppressant (medicine which reduces the
activity of the
immune system).
Methotrexate is used in large doses (on its own or in combination with
other medicines)
to treat certain types of cancer such as breast cancer. In smaller
doses it can be used to
treat severe psoriasis (a skin disease with thickened patches of
inflamed red skin, often
covered by silvery scales), when it has not responded to other
treatments.
2. BEFORE YOU ARE GIVEN METHOTREXATE INJECTION
YOU WILL NOT BE GIVEN METHOTREXATE INJECTION IF YOU

ARE ALLERGIC (HYPERSENSITIVE) TO METHOTREXATE OR ANY OF THE OTHER
INGREDIENTS OF
METHOTREXATE INJECTION

have significant kidney or liver problems

have been told you have (or think you have) a blood disorder such as
low levels of
white blood cells, red blood cells (anaemia) or platelets

have any infection

your immune system is not working as well as it should
Tell your doctor if any of the above applies to you before this
medicine is used.
TAKE SPECIAL CARE WITH METHOTREXATE INJECTION IF YOU

have a stomach ulcer or ulcerative colitis (inflammation and
ulceration of the gut)

have an infection

have mild kidney problems

have a medical condition which

Vara einkenni

OBJECT 1
METHOTREXATE 25 MG/ML INJECTION
Summary of Product Characteristics Updated 10-May-2018 | Hospira UK
Ltd
1. Name of the medicinal product
Methotrexate 25 mg/ml Injection
2. Qualitative and quantitative composition
Each ml of solution contains 25 mg methotrexate (sodium salt formed
_in situ_)
Each vial of 2 ml of solution contains 50 mg methotrexate (sodium salt
formed _in situ_)
Each vial of 10 ml of solution contains 250 mg methotrexate (sodium
salt formed _in situ_)
Each vial of 20 ml of solution contains 500 mg methotrexate (sodium
salt formed _in situ_)
Each vial of 40 ml of solution contains 1 g methotrexate (sodium salt
formed _in situ_)
For excipients, see 6.1.
3. Pharmaceutical form
Solution for Injection
Vials containing a clear yellow solution
4. Clinical particulars
4.1 Therapeutic indications
Methotrexate is indicated in the treatment of neoplastic disease, such
as trophoblastic neoplasms and
leukaemia, and the symptomatic treatment of severe recalcitrant
disabling psoriasis which is not
adequately responsive to other forms of therapy.
4.2 Posology and method of administration
ADULTS AND CHILDREN
ANTINEOPLASTIC CHEMOTHERAPY
Methotrexate is active orally and parenterally. Methotrexate Injection
may be given by the intramuscular,
intravenous, intraarterial or intrathecal routes.
NOTE: ONLY THE 50 MG/2 ML PRESENTATION SHOULD BE USED FOR THE
INTRATHECAL ROUTE OF ADMINISTRATION
TO PREVENT ACCIDENTAL OVERDOSE.
Dosage is related to the patient's body weight or surface area.
Methotrexate has been used with beneficial
effect in a wide variety of neoplastic diseases, alone and in
combination with other cytotoxic agents.
CHORIOCARCINOMA AND SIMILAR TROPHOBLASTIC DISEASES
Methotrexate is administered orally or intramuscularly in doses of
15-30 mg daily for a 5 day course.
Such courses may be repeated 3-5 times as required, with rest periods
of one or more weeks interposed
between courses until any manifesting toxic symptoms subside.
The effectiveness of therapy can be evaluated by 24 hours quantitative
an