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REOPRO 2MG/ML SOLUTION FOR INJECTION OR INFUSION

Active substance(s): ABCIXIMAB

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Read all of this leaflet carefully
before you start using this medicine
because it contains important
information for you.

- Keep this leaflet. You may need to read it
again.
- If you have further questions, ask your
doctor.
- If you get any of side effects, talk to your
doctor. This includes any possible side
effects not listed in this leaflet. See section 4.

What is in this leaflet

1. What ReoPro is and what it is used for
2. What you need to know before you are
given ReoPro
3. How to use ReoPro
4. Possible side effects
5. How to store ReoPro
6. Contents of the pack and other
information

1. What ReoPro is and what it is
used for
What ReoPro is?

The active ingredient, abciximab, is a ‘murine
monoclonal antibody’. Monoclonal antibodies
are proteins that recognise and bind to other
unique proteins. ReoPro belongs to a group
of medicines known as antithrombotics and
binds to proteins in your blood to help to
prevent blood clots.

What is ReoPro used for?

ReoPro is used when you undergo an
operation known as angioplasty (see “What
is an angioplasty operation?” below) for the
following purposes:
• ReoPro is used (together with heparin and
acetylsalicylic acid) to prevent the formation
of blood clots in the heart during or after an
angioplasty operation.
• ReoPro is also used (together with heparin
and acetylsalicylic acid) to lower the short
term risk of getting a heart attack before an
angioplasty operation, which is planned to
take place within the next 1-month. This is
for patients who have chest pain due to low
blood supply to the heart (unstable angina)
and have not responded to the usual therapy.

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What is an angioplasty operation?

An angioplasty operation aims to open
blocked arteries around the heart. A doctor will
carefully guide a special instrument through an
artery (which is usually in the groin) to reduce
or remove the blockage.
There are three types of angioplasty
operations where ReoPro can be used:
• Using an inflatable balloon to compress an
artery blockage (balloon angioplasty)
• Using a cutting device to open a blocked
artery (atherectomy)
• Inserting an expandable metal sheath to
keep an artery open (stent)

2. What you need to know before
you are given ReoPro
Do not use ReoPro

Your doctor will review your medical history to
see if you are at an increased risk for any side
effects associated with being given ReoPro.
To prevent risks of increased bleeding ReoPro
must not be given:
• if you have internal bleeding
• if you have had a stroke within the last two
years
• if you have had any head, spinal surgery
(or trauma) or other major surgery in the last
two months
• if you have brain cancer
• if you have serious bleeding problems or
have very low amounts of platelets in your
blood
• if you have uncontrolled high blood pressure
• if you have an abnormal bulge in one of your
blood vessels (aneurysm)
• if you have serious problems with your liver
• if you are on dialysis for kidney failure
ReoPro must not be given if you are allergic
(hypersensitive):
• to abciximab, to any of the other ingredients
of ReoPro or to a group of medicines known
as ‘murine monoclonal antibodies’.
• to a protein called papain (or to papaya fruit
which contains papain). Papain is used in
the production of ReoPro and very small
amounts may be present.
If you think that you fit into any of
the categories described above, it is important
that you discuss it with your doctor. ReoPro
must not be given in these situations.

Warnings and precautions

Talk to your doctor before using ReoPro
• if you are taking blood-thinning medicines or
any other medicines that affect blood clotting
or blood platelets (see “Using other
medicines” section).

The following information is intended for
healthcare professionals only:

• if you have previously received ReoPro,
since this could be associated with higher
risk of reduction in blood platelets or allergic
reactions (hypersensitivity).
• if you have serious problems with your
kidneys, since this may put you at risk of
increased bleeding. In this case, your doctor
might monitor your blood frequently.
• if you are more than 65 years of age (see
“Adults over 65 years of age” section).

Instructions for use and handling
1. Calculate the number of ReoPro vials
needed. The recommended dose of ReoPro
is a 0.25 mg/kg intravenous bolus
immediately followed by a 0.125 μg/kg/min
(to a maximum of 10 μg/min) continuous
intravenous infusion.
2. Parenteral medicinal products should be
inspected visually for particulate matter prior
to administration. Preparations of ReoPro
containing visibly opaque particles should
NOT be used.

If you think that you fit into any of the
categories described above, it is important
that you discuss it with your doctor.

Adults over 65 years of age

3. As with all parenteral medicinal products,
aseptic procedures should be used during
the administration of ReoPro.

In patients who are over 65 years of age,
ReoPro should be given with caution, because
of risks of increased bleeding.

4. Preparation of Bolus Injection: Withdraw the
necessary amount of ReoPro for the bolus
injection into a syringe. Filter the bolus
injection using a sterile non-pyrogenic, low
protein binding 0.2 / 0.22 μm or 5.0 μm
syringe filter. The bolus should be
administered over one (1) minute.

Other medicines and ReoPro

Tell your doctor if you have been given bloodthinning medicines, or any other medicines
that affect blood clotting (‘anticoagulants’) or
blood platelets (‘anti-platelet medicines’). It is
particularly important that you tell your doctor
if ‘thrombolytic’ medicines have been given to
unblock your arteries. Being given ReoPro
together with these medicines may put you at
risk of increased bleeding.

5. Preparation of intravenous infusion:
Withdraw the necessary amount of ReoPro
for the continuous infusion into a syringe.
Inject into an appropriate container of sterile
sodium chloride 9 mg/ml (0.9%) solution for
injection or 5% glucose solution and infuse
at the calculated rate via a continuous
infusion pump. The continuous infusion
should be filtered either upon admixture
using a sterile, non-pyrogenic low protein
binding 0.2 / 0.22 μm or 5.0 μm syringe filter
or upon administration using an in-line,
sterile, non-pyrogenic, low protein-binding
0.2 μm or 0.22 μm filter. Discard the unused
portion at the end of the infusion period.

Tell your doctor if you are taking, have recently
taken or might take any other medicines.

Pregnancy and breast-feeding

ReoPro should not be given during pregnancy
unless clearly necessary, since the effect of
ReoPro on pregnant women or unborn
children is not known.
Breast-feeding must be stopped before being
given ReoPro, since it is not known whether
ReoPro is secreted in breast milk.

6. No incompatibilities have been shown with
intravenous infusion fluids or commonly
used cardiovascular medicinal products.
Nevertheless, it is recommended that
ReoPro be administered in a separate
intravenous line whenever possible and not
mixed with other medicinal products.

3. How to use ReoPro
Your nurse or doctor will inject ReoPro liquid
from a syringe into one of your veins. This is
known as a ‘bolus injection’.
After you have had the injection, your nurse,
doctor or pharmacist will put more diluted
ReoPro liquid into a bag which is connected by
a tube to a needle which goes into one of your
veins. This is known as a ‘drip’ or ‘infusion’.
Depending on your condition ReoPro will be
given to you as follows:
• If you are about to undergo an angioplasty
operation, your doctor will give you the bolus
injection 10 to 60 minutes before the
operation begins. After the bolus
injection your doctor will start the
infusion. The infusion will continue
for 12 hours after the operation
is
completed.

7. No incompatibilities have been observed
with glass bottles or polyvinyl chloride bags
or administration sets.
8. Any unused medicinal product or waste
material should be disposed of in
accordance with local requirements.

£

abciximab

GB - 33226C

2 mg/mL solution
for injection or infusion

GB - 33226C

®

ReoPro®

ReoPro

ReoPro®

Package leaflet: Information for the user

• If you have unstable angina (chest pain due
to low blood supply to the heart) and are
scheduled for an angioplasty operation,
your doctor will give you the bolus injection
up to 24 hours before the scheduled
operation. After the bolus injection your
doctor will start the infusion. The infusion will
continue for 12 hours after the operation is
completed.

• Build up of blood around the heart. Symptoms
may include rapid heartbeat, chest pain,
shortness of breath, sweating or fatigue.
• Serious restriction in breathing capacity.
Symptoms may include shortness of breath,
rapid and shallow breathing.
• Bleedings in the lungs. Symptoms may
include coughing blood, wheezing, rapid
breathing, airway obstruction.

Dosage

Please also tell your doctor if you notice
any of the following side effects:

Your doctor will calculate the dose of ReoPro
to give to you as follows:
• The dose of the bolus injection will be based
on your body weight. The dose is
0.25 milligrams for every kilogram of your
body weight.
• The infusion dose will also be based on your
body weight. The dose is 0.125 micrograms
per kilogram per minute up to a maximum of
10 micrograms per minute.

After the operation

After the angioplasty operation your doctor or
nurse will gently press a dressing on the artery
to stop any bleeding. Total bed rest is required
by the patient and the leg on which the
angioplasty has been performed must be kept
in a straight position for at least 6 to 8 hours.
You will also be carefully observed by your
doctor and nurse and your blood pressure and
pulse will be measured several times. Regular
blood tests will also be performed to monitor
your blood cell count.

4. Possible side effects
Like all medicines, this medicine can cause
side effects, although not everybody gets
them. Cases of fatal bleeding have been rarely
reported.
Please tell your doctor immediately if you
notice any of the following side effects,
as your doctor will need to take immediate
action and discontinue your treatment:
Common (affecting less than 1 person in 10):
• Bleeding in the stomach or intestines.
Symptoms may include vomiting blood,
blood in faeces or black faeces.
Uncommon (affecting less than 1 person in 100):
• Bleeding in the skull. Symptoms may include
pain in the head; speech, visual or hearing
difficulties; numbness or lack of feeling;
problems with movement or balance.
• Rare (affecting less than 1 person in
1,000):Allergic reactions (including
hypersensitivity and anaphylactic reactions).
Symptoms may include skin rash; itchy and
swollen skin; difficulty in breathing, dizziness.

£
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Common (affecting less than 1 person in 10):
• Low blood platelet count. Symptoms may
include easy or excessive bruising, bleeding
under the skin, bleeding from nose or gums.
• Headache
• Slow heart rate
• Bleeding (may include bruising, purple skin
rash, nose bleed, vaginal bleeding, blood in
urine or faeces)
• Swelling of arms and legs
• Nausea or vomiting
• Back pain
• Chest pain
• Fever
• Pain at the injection site
• Pain in the abdomen
Rare (affecting less than 1 person in 1,000):
• Very low blood pressure. Symptoms include
dizziness or feeling faint.

Reporting of side effects

If you get any side effects, talk to your doctor.
This includes any side effects not listed in this
leaflet. You can also report side effects directly
via UK: www.mhra.gov.uk/yellowcard or
Ireland: IMB Pharmacovigilance,
Earlsfort Terrace, IRL - Dublin 2.
Tel: +353 1 6764971, Fax: +353 1 6762517,
Website: www.imb.ie,
e-mail: imbpharmacovigilance@imb.ie
By reporting side effects you can help provide
more information on the safety of this medicine.

5. How to store ReoPro
Your doctor or other healthcare professionals
will take care of handling and storing ReoPro
according to the following instructions:
• Keep this medicine out of the reach and
sight of children.
• Store in a refrigerator (2°C - 8°C).
• Do not freeze.
• Do not shake.
• Do not use this medicine after the expiry
date which is stated on the carton and vial
label after the letters EXP. The expiry date
refers to the last day of that month.
• Do not use this medicine if you notice
discolouring of the liquid or opaque particles
in the liquid.

6. Contents of the pack and
other information
What ReoPro contains

• ReoPro 2 mg/mL is supplied as a solution for
injection or infusion containing 10 milligrams
of abciximab (active ingredient) dissolved in
5 millilitres of water for injection.
• The other ingredients are disodium
phosphate dihydrate, sodium dihydrogen
phosphate monohydrate, sodium chloride
and polysorbate 80.

What ReoPro looks like and
contents of the pack

• ReoPro 2 mg/mL pack contains a labelled
glass vial filled with colourless and clear
ReoPro liquid.
Marketing Authorisation Holder and
Manufacturer
Janssen Biologics B.V.
Einsteinweg 101
2333 CB Leiden
The Netherlands.
For any additional information about this
medicine, please contact the local
representative of the Marketing Authorisation
Holder.
Eli Lilly and Company Limited
Lilly House
Priestley Road
Basingstoke RG24 9NL
United Kingdom
Tel: + 44-(0)-1256-315-000
This leaflet was last revised in July 2013.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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