Hospira Methotrexate Injection

দেশ: নিউ জিলণ্ড

ভাষা: ইংরেজি

সূত্র: Medsafe (Medicines Safety Authority)

সক্রিয় উপাদান:

Methotrexate 25 mg/mL (as methotrexate sodium)

থেকে পাওয়া:

Pfizer New Zealand Limited

ডোজ:

7.5 mg/0.3mL

ফার্মাসিউটিকাল ফর্ম:

Solution for injection

রচনা:

Active: Methotrexate 25 mg/mL (as methotrexate sodium) Excipient: Sodium chloride Sodium hydroxide Water for injection

প্রেসক্রিপশন টাইপ:

Prescription

থেরাপিউটিক ইঙ্গিত:

Methotrexate may be of value in the symptomatic control of server, 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.

পণ্য সারাংশ:

Package - Contents - Shelf Life: Syringe, glass, Type I glass syringe in PET blister tray, in outer carton - 1 dose units - 24 months from date of manufacture stored at or below 25°C protect from light - Syringe, glass, Type I glass syringe in PET blister tray, in outer carton - 4 dose units - 24 months from date of manufacture stored at or below 25°C protect from light - Syringe, glass, Type I glass syringe in PET blister tray, in outer carton - 6 dose units - 24 months from date of manufacture stored at or below 25°C protect from light - Syringe, glass, Type I glass syringe in PET blister tray, in outer carton - 12 dose units - 24 months from date of manufacture stored at or below 25°C protect from light - Syringe, glass, Type I glass syringe in PET blister tray, in outer carton - 24 dose units - 24 months from date of manufacture stored at or below 25°C protect from light

অনুমোদন তারিখ:

2018-10-25

তথ্য লিফলেট

METHOBLASTIN
®
PFS
1
METHOBLASTIN® PFS
(METHOTREXATE)
_methotrexate (meth-o-TREX-ate) _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about METHOBLASTIN®
PFS. It does not contain all the
available information. It does not
take the place of talking to your
doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking
METHOBLASTIN® PFS against the
benefits they expect it will have for
you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT
METHOBLASTIN®
PFS IS USED FOR
This medicine is used to treat:
•
severe psoriasis (a skin condition)
•
severe rheumatoid arthritis (a
chronic inflammatory condition)
when these conditions do not
improve with other medicines.
The medicine contains methotrexate,
which belongs to a family of
medicines called antimetabolites. It
may also be called a chemotherapy
medicine.
The medicine works by blocking an
enzyme needed by the body cells to
live. This interferes with the growth
of some cells that are growing
rapidly in psoriasis. In rheumatoid
arthritis, this medicine reduces the
overactivity of the immune system
leading to less pain, swelling and
damage to the joints.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
This medicine is/is not addictive.
It is only available with a doctor's
prescription.
BEFORE YOU USE
METHOBLASTIN®
PFS
_WHEN YOU MUST NOT USE IT _
DO NOT USE THE MEDICINE IF YOU HAVE
AN ALLERGY TO:
•
any medicine containing
methotrexate
•
any of the ingredients listed at the
end of this leaflet.
Some of the symptoms of an allergic
reaction may include:
•
shortness of breath
•
wheezing or difficulty breathing
•
swelling of the face, lips, tongue
or other parts of the body
•
rash, itching or hives on the skin.
DO NOT USE THE MEDICINE IF YOU
HAVE:
•
sev

পণ্য বৈশিষ্ট্য

Version: pfdmetbi10720
Supersedes: pfdmetbi10620
Page 1 of 23
NEW ZEALAND DATA SHEET-
METHOBLASTIN
® PFS_ _
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 carinii_
pneumonia, may
occur with methotrexate therapy.
5.
USE IN PREGNANCY
Category D. This category specifies drugs, which have caused an
increased incidence of
huma