Methotrexate Sandoz

Land: Nieuw-Zeeland

Taal: Engels

Bron: Medsafe (Medicines Safety Authority)

Werkstoffen:

Methotrexate 20 mg/mL

Beschikbaar vanaf:

Sandoz New Zealand Limited

INN (Algemene Internationale Benaming):

Methotrexate 20 mg/mL

Dosering:

20 mg/mL

farmaceutische vorm:

Injection with diluent

Samenstelling:

Active: Methotrexate 20 mg/mL Excipient: Sodium chloride Sodium hydroxide Water for injection

Eenheden in pakket:

Syringe, glass, Clear type 1 glass with bromo-butyl plunger, 7.5mg, 0.375 mL

klasse:

Prescription

Prescription-type:

Prescription

Geproduceerd door:

Fermion Oy

therapeutische indicaties:

- Active rheumatoid arthritis in adult patients where treatment with disease modifying antirheumatic drugs (DMARDs) is indicated. - Polyarthritic forms of severe, active juvenile idiopathic arthritis (JIA) when the response to nonsteroidal anti-inflammatory drugs (NSAIDs) has been inadequate - Severe forms of psoriasis vulgaris, particularly of the plaque type, which cannot be sufficiently treated with conventional therapy such as phototherapy, PUVA, and retinoids, and severe psoriatic arthritis.

Product samenvatting:

Package - Contents - Shelf Life: Syringe, glass, Clear type 1 glass with bromo-butyl plunger, 7.5mg - 0.375 mL - 24 months from date of manufacture stored at or below 25°C protect from light - Syringe, glass, Clear type 1 glass with bromo-butyl plunger, 10mg - 0.5 mL - 24 months from date of manufacture stored at or below 25°C protect from light - Syringe, glass, Clear type 1 glass with bromo-butyl plunger, 12.5 mg - 0.625 mL - 24 months from date of manufacture stored at or below 25°C protect from light - Syringe, glass, Clear type 1 glass with bromo-butyl plunger, 15mg - 0.75 mL - 24 months from date of manufacture stored at or below 25°C protect from light - Syringe, glass, Clear type 1 glass with bromo-butyl plunger, 17.5 mg - 0.875 mL - 24 months from date of manufacture stored at or below 25°C protect from light - Syringe, glass, Clear type 1 glass with bromo-butyl plunger, 20mg - 1 mL - 24 months from date of manufacture stored at or below 25°C protect from light - Syringe, glass, Clear type 1 glass with bromo-butyl plunger, 22.5 mg - 1.125 mL - 24 months from date of manufacture stored at or below 25°C protect from light - Syringe, glass, Clear type 1 glass with bromo-butyl plunger, 25mg - 1.25 mL - 24 months from date of manufacture stored at or below 25°C protect from light - Syringe, glass, Clear type 1 glass with bromo-butyl plunger, 27.5 mg - 1.375 mL - 24 months from date of manufacture stored at or below 25°C protect from light - Syringe, glass, Clear type 1 glass with bromo-butyl plunger, 30mg - 1.5 mL - 24 months from date of manufacture stored at or below 25°C protect from light - Syringe, glass, Clear type 1 glass with bromo-butyl plunger, 40mg - 2 mL - 24 months from date of manufacture stored at or below 25°C protect from light

Autorisatie datum:

2011-01-05

Bijsluiter

Methotrexate Sandoz®
1
METHOTREXATE SANDOZ®
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 METHOTREXATE SANDOZ?
Methotrexate Sandoz contains the active ingredient methotrexate (as
disodium). Methotrexate Sandoz is used to treat
inflammatory conditions, including severe psoriasis, and active
rheumatoid arthritis.
For more information, see Section 1. Why am I using Methotrexate
Sandoz? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE METHOTREXATE SANDOZ?
Do not use if you have ever had an allergic reaction to Methotrexate
Sandoz 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 Methotrexate
Sandoz? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Methotrexate Sandoz 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 METHOTREXATE SANDOZ?
•
Methotrexate Sandoz is given as a ONCE WEEKLY injection under the skin
(subcutaneous).
•
You may decide together with your doctor on a suitable weekday each
week to receive your injection.
More instructions can be found in Section 4. How do I use Methotrexate
Sandoz? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING METHOTREXATE SANDOZ?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
Methotrexate Sandoz.
•
Ensure you and your partner are using a reliable method of
contraception during, and at least for six
months after treatment with Methotrexate Sandoz.
•
Tell your doctor if you develop an infection or you noti

Productkenmerken

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Page 1 of 22
NEW ZEALAND DATA SHEET
METHOTREXATE SANDOZ (METHOTREXATE)
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.
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 caused an
increased incidence of
human foe