a Novartis company

What is EBETREX?
Information about EBETREX pre-filled syringes
for patients and carers.

Dear Patient,
Your doctor has prescribed EBETREX (active
substance: Methotrexate) for the treatment of your
medical condition.

Foreword

Methotrexate is an efficacious, well-proven drug with a good safety

profile and has become the cornerstone in the doctors armory to treat
rheumatoid arthritis.
The information contained here will provide you with answers to the
most frequently asked questions regarding the use of EBETREX prefilled
syringes.
As with all drugs, there is a possibility of side effects and it is important
the patient understands these and any concerns they may have are
addressed. No guidebook is a substitute for your physicians experience
and individual advice and you always should contact your physician to
discuss concerns or issues arising from your EBETREX treatment.
Please accept my sincere good wishes for a successful course of
treatment.
Yours sincerely,
Primarius Burkhard Leeb, MD
State Hospital Stockerau, Austria

EBETREX is administered only once a week by injection under the

skin (subcutaneously).

How and when do I use

the EBETREX
pre-filled syringe?

Injection by your doctor or healthcare professional

In consultation with your doctor or healthcare professional a
suitable day will be arranged for your injection.
Self-injection
If you are comfortable with performing self-injection and prefer
this option, you will be instructed clearly on what to do. Before
undertaking self-injection unsupervised, you will have practised selfinjection with EBETREX under your doctors / nurses supervision.
Essential Information
You should ensure you wash your hands before you start.
We recommend using the abdomen or thigh regions for selfinjection.
To avoid skin irritations, use a different injection site every week.
You should be try to be relaxed when injecting EBETREX pre-filled
syringes.
Abdomen:

Keep a minimum distance of at least approximately

5 cm from the navel, and do not inject above the
lowermost rib.

Thigh:

Keep a distance of at least approximately 5 cm

from the knee and from the groin.

Handling
Instruction

Take out the inner package,

containing the pre-filled
syringe
and
cannula
(needle) package. Open
the inner package by
pulling the corner flap. Take
out the pre-filled syringe.

Now, open the cannula

packaging by pulling the
flap. Do not touch the
round sterile opening. To
avoid this, keep hold of the
bottom end of the cannula
packaging.

Remove (twist) the grey

rubber cap from the
syringe without touching
the opening of the pre-filled
syringe.

Attach the cannula, with

its protective packaging,
on to the syringe and fix it
(clockwise). Put the syringe
in a readily accessible
place.

Place the syringe back

into the inner-package.
The yellow solution will be
unable to escape.

Choose an injection site.

Wipe the injection site

with the alcohol pad,
using circular motion.
Once wiped, do not touch
this area again before
injecting.

Pull the protective packaging from the cannula. Put

aside the cannula protective packaging.

Do not touch the sterile

cannula. If this should
happen, ask your doctor
or pharmacist about using
another cannula. With
two fingers, form a skin
fold and puncture it almost
vertically.

10

Push the cannula completely

into the skin fold. Then,
slowly push the plunger
down and inject all the fluid
underneath the skin.

11

Carefully
remove
the
cannula and dab the
injection site with a swab.
Do not rub, as this will cause
irritation at the injection
site.

12

Dispose of the used syringes

in a special sharps bin
available on prescription.

How do I dispose of
EBETREX pre-filled
syringes?

n Methotrexate must not be discarded into waste water.

n Used EBETREX pre-filled syringes should be discarded
in appropriate sharp bins. Sharp bins are available on

prescription from your GP or healthcare professional.

n Keep your sharps bin in a safe place during use and

when awaiting collection.
n The bin should never be filled more than two-thirds of
its total capacity.
n Collection services for full sharps bins vary from area
to area.
n People who have a requirement for the disposal of
syringes should seek advice in the first instance from
their local Health Centre, Health Visitor or their local
pharmacy.

What do I do about my
EBETREX injection when
travelling?

This question arises in particular when holidays abroad have

been planned. In this case, you will need to ask your doctor for
a suitably signed and dated certificate to confirm the necessity of
your therapy. You may be required to present this certificate when
passing through security controls.
In particular, keep in mind the following points:
n Please pay attention to storage conditions. Leave the pre-filled
syringes in the original packaging (box) to protect from light
and store in temperature range between 0C and 25C.
n Take along additional syringes in case your stay should be
extended.
When travelling by air:
n Keep the boxed product in your hand luggage during the flight
(the temperatures of an aircraft cargo bay will fall far below
0C).

In accordance with EU Regulation 829/2008 it is permitted

to carry liquid pharmaceutical products on board of an aircraft.
The regulation states that the passenger may be required to
demonstrate authenticity of the product. The doctor certificate
and original packaging serves this purpose.

Important
Information

Pregnancy and EBETREX

Methotrexate can cause deformities in the unborn child. During
treatment with EBETREX, strict contraception is absolutely essential.
This requirement applies to both men and women.
In women of childbearing age, pregnancy must be excluded prior to
beginning treatment. Women of childbearing age must use reliable
contraception for at least 4 weeks prior to starting treatment, and
medical advice on appropriate methods of contraception should
be sought if necessary.
Men using EBETREX should use condoms when having sexual
intercourse with a partner of child bearing age.
After discontinuation of EBETREX, patients should wait for at least 6
months before considering having children.
If you think you are pregnant, contact your doctor
immediately.
For parents with children receiving treatment:
The need for reliable contraception should be emphasized with
adolescent patients receiving treatment (i.e. those with juvenile
idiopathic arthritis).
For carers and relatives
Pregnant carers or pregnant relatives should not be involved in
the administration of EBETREX pre-filled syringes as unintentional
contact with methotrexate (e. g. through a needle injury) might
cause deformities in the unborn child.
Breast-feeding is strictly prohibited during therapy
with EBETREX.

Please bear this in

mind during your
treatment with
EBETREX

The information contained here provides patients who are selfadministrating EBETREX with the most important instructions for use.
However, it is not intended to replace individual discussions and
training from your specialist nurse / doctor.

Please read the Patient Information Leaflet and observe your

doctors instructions carefully. If you have any further questions
relating to EBETREX please contact your care team.

Do not hesitate to consult your doctor/care team if you are

concerned about your EBETREX treatment and inform them
immediately if you experience any unusual symptoms relating to
the use of this product.

SANDOZ
EBEWE Pharma Ges.m.b.H. Nfg.KG
Mondseestrasse 114866 Unterach Austria
Phone +43 7665 8123-0
www.sandoz.com

a Novartis company
IMMUNO/A/04/2011/6