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EXEMBOL MULTIDOSE 100 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION

Active substance(s): ARGATROBAN MONOHYDRATE

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Important information about some of the ingredients of
Exembol Multidose
This product contains 400 mg/ml or 50% by volume of alcohol
(ethanol) before dilution, which corresponds to 0.5% by volume
after dilution in accordance with the instructions. The daily dose may
therefore contain up to 5 ml (4 g) of alcohol, corresponding to
100 ml beer or 40 ml wine. This may be harmful for persons suffering
from liver disease, alcoholism or epilepsy as well as for pregnant and
nursing women and their children. This may also influence the effect
of other medicines.

P0000/PMPLT000

PACKAGE LEAFLET:
Information for the user

Exembol Multidose 100 mg/ml concentrate for
solution for infusion

This medicine contains sorbitol. If you are intolerant to certain sugars,
you must tell your doctor.

argatroban monohydrate
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.
• If any of the side effects get serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor. See
section 4.

3. How to use Exembol Multidose
Exembol Multidose will always be given to you by medical personnel.
Exembol Multidose will be given to you intravenously (into a vein) by
continuous infusion. The doctor will decide the dose and how long
you will be treated.

4. Possible side effects

In this leaflet:
1. What Exembol Multidose is and what it is used for
2. Before you use Exembol Multidose
3. How to use Exembol Multidose
4. Possible side effects
5. How to store Exembol Multidose
6. Further information

Like all medicines, Exembol Multidose can cause side effects, although
not everybody gets them.
The most common side-effects are bleeding. Major bleeding can
occur in about 5% of patients and minor bleeding in about 39% of
patients. You must tell your doctor immediately if you experience
any of the following symptoms:

1. What Exembol Multidose is and what it is
used for

• Bleeding or bruising • blood in urine or stools • vomiting or
coughing up blood • black stools • difficulty in breathing • cold
sweaty skin • dry mouth • dilated pupils and/or weak rapid pulse.

Exembol Multidose is an anticoagulant (a drug that helps to prevent
blood clots from forming in your blood circulation). It works by
blocking the action of thrombin, a substance in your blood that is
important in blood clotting.

These symptoms could indicate that you are experiencing bleeding
problems.

Exembol Multidose is used if you are suffering from a disorder known
as heparin-induced thrombocytopenia type II (HIT type II). If you have
HIT type II, you are at risk of developing blood clots in your blood
circulation that can cause heart attacks, stroke, breathing problems
and problems with the blood supply to your limbs. Exembol Multidose
can prevent these problems or prevent them from becoming worse.

2. Before you use Exembol Multidose
Do not use Exembol Multidose
Exembol Multidose will not be given to you:
• If you have uncontrolled bleeding
• If you are allergic (hypersensitive) to argatroban or to any of the
other ingredients of Exembol Multidose
• If you have severely impaired liver function
Take special care with Exembol Multidose
Exembol Multidose will be given to you with special care:
• If there is an increased risk of bleeding
• If you have recently had injections or infusions of other
anticoagulants such as heparin
• If you have liver disease



Using other medicines
Please tell your doctor if you are taking or have recently taken any
other medicines, including medicines obtained without prescription.
Combined use with other blood thinning or blood clot dissolving
medicines can increase the risk of bleeding.
Because Exembol Multidose contains ethanol, this can influence the
effect of other medicines containing metronidazole (for infections) or
disulfiram (for alcoholism).

Common side effects (affects more than 1 user in 100):
• Anaemia • blood clotting • bleeding, including numerous small
bleedings in skin and mucus membranes (purpura) • nausea
Uncommon side effects (affects more than 1 user in 1,000):
• Infections such as urinary tract infection • changes in blood
values • blood clotting • lack of appetite • low blood sugar levels
• low sodium levels in the blood • confusion • dizziness • fainting
• headache • stroke • muscle disorders • speech disorder • vision
problems • deafness • heart attack • fluid in the heart sac • abnormal
heart rhythm • fast heartbeat • low blood pressure • high blood
pressure • inflammation of veins • shock • reduced oxygen supply to
the tissues • breathing difficulties • fluid around the lungs • hiccup
• blood in cough, vomit or stools • constipation • diarrhoea • stomach
inflammation • difficulty in swallowing • tongue disorder • abnormal
liver function • jaundice (yellowing of the skin and eyes) • changes in
blood tests for liver function • rash including including nettle rash
• itching,• increased sweating • hair loss • muscle weakness
• muscle pain • kidney failure • fever • pain • tiredness • injection site
reactions • swelling of the legs • increased wound drainage
• abnormal laboratory results.
If you experience side effects, talk with your doctor or pharmacist.
This includes any possible side effects not listed in this leaflet. You
may also report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard. By reporting adverse events you can
help to increase information on the safety of medicines.

5. How to store Exembol Multidose
Keep out of the reach and sight of children.
Keep vial in the outer carton in order to protect from light.
Do not freeze.
Diluted solutions should not be exposed to direct sunlight.
Solutions should not be used if they are cloudy or contain any
particles.

Pregnancy and breast-feeding
If you are pregnant, your doctor will only give you Exembol Multidose
if it is absolutely necessary. Avoid breast-feeding while you are being
given Exembol Multidose.

After opening, before dilution: Chemical and physical stability has
been demonstrated in use following multiple needle entries and
product withdrawal for 28 days at both 25ºC and at 2 to 8ºC.

Driving and using machines
Since Exembol Multidose contains alcohol you should not drive a
car or use machines in connection with the treatment. (see also
“Important information about some of the ingredients of Exembol
Multidose).

Diluted solution: chemical and physical in-use stability has been
demonstrated for up to 14 days at 25ºC and 2 to 8ºC in sodium
chloride 9 mg/ml (0.9%) solution for infusion, glucose 50 mg/ml
(5%) solution for infusion, or sodium lactate intravenous infusion
compound.

From a microbiological point of view, the product should be used
immediately. If not used immediately, in-use storage times and
conditions prior to use are the responsibility of the user and would
normally not be longer than 24 hours at 2-8°C, unless dilution has
taken place in a controlled and validated aseptic conditions.
Do not use Exembol Multidose after the expiry date which is stated
on the carton/vial after “EXP”. The expiry date refers to the last day
of that month.

6. Further INFORMATION
What Exembol Multidose contains
The active substance is argatroban monohydrate 100 mg/ml.
1 ml concentrate for solution for infusion contains argatroban as
100 mg argatroban monohydrate.

1 vial with 2.5 ml concentrate for solution for infusion contains
argatroban as 250 mg argatroban monohydrate.
The other ingredients are anhydrous ethanol, sorbitol and water for
injections

What Exembol Multidose looks like and contents of the pack
This medicinal product is a clear colourless to pale yellow concentrate
for solution for infusion. Each vial contains 2.5 ml of solution and the
vials are packed in cardboard boxes of 1 or 6 vials.
Not all pack sizes may be marketed.
Marketing authorisation holder
Mitsubishi Tanabe Pharma Europe Ltd, Dashwood House, 69 Old
Broad Street, London, EC2M 1QS, United Kingdom.
Manufacturer
Penn Pharmaceutical Services Limited, Tredegar, Gwent NP22 3AA,
UK.
Information can be obtained from:
Mitsubishi Medical Information,
Mitsubishi Tanabe Pharma Europe Ltd, Dashwood House, 69 Old
Broad Street, London, EC2M 1QS, United Kingdom.
Telephone number: 0207 382 9000
Email address: medinfo@mt-pharma-eu.com
This medicinal product is authorised in the Member States of
the EEA under the following names:
Austria
Argatra Multidose
Denmark
Novastan Multidose
Finland
Novastan
France
Arganova
Germany
Argatra Multidose
Iceland
Novastan Multidose
Italy

Novastan Multidose
Netherlands
Arganova Multidose
Norway
Novastan
Sweden
Novastan Multidose
United Kingdom Exembol Multidose
This leaflet was last revised in: 10-2014

The following information is only for doctors and medical
personnel.
Instructions for use, handling and disposal
Exembol Multidose should be diluted in sodium chloride 9 mg/ml
(0.9%) solution for infusion, glucose 50 mg/ml (5%) solution for
infusion, or Sodium Lactate Intravenous Infusion Compound to a final
concentration of 1 mg/ml. If the solution is cloudy, or if an insoluble
precipitate is noted, the vial should be discarded.
Following multiple needle entries and product withdrawals, the vials
maintain microbial, chemical and physical stability for up to 28 days
at 25ºC and at 2 to 8ºC. Other in-use storage times and conditions are
the responsibility of the user.
The 100 mg/ml concentrate for solution for infusion should be diluted
100-fold by mixing with diluent. For a starting infusion rate of
0.5 microgram/kg/min, use 50 mg (0.5 ml) concentrate for solution for
infusion per 50 ml of diluent.

The constituted solution must be mixed by repeated inversion of the
diluent bag or bottle for one minute. The diluted solution should be
clear and practically free from visible particles. Upon preparation, the
solution may show slight but brief haziness due to the formation of
microprecipitates that rapidly dissolve upon mixing. The pH of the
intravenous solution prepared as recommended is 3.2-7.5.
Multiple use of Exembol Multidose applies to the 100 mg/ml
concentrate for solution for infusion in its original container. The
diluted solution should be used immediately. Any unused solution
should be discarded.
Light resistant measures such as foil protection for intravenous lines
are not necessary. No significant potency losses have been noted
following simulated delivery of the solution through intravenous
tubing.
Any unused product or waste material should be disposed of in
accordance with local requirements.

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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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