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EXEMBOL 100 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION

Active substance(s): ARGATROBAN MONOHYDRATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

P0075/PLT561

EXEMBOL

®

Exembol 100 mg/ml concentrate for solution for infusion
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 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.

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

1. WHAT EXEMBOL IS AND WHAT IT IS USED FOR
Exembol 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.
Exembol 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 can prevent these problems or prevent them from becoming worse.

2. BEFORE YOU USE EXEMBOL
Do not use Exembol
Exembol 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 in Exembol.
• If you have severely impaired liver function.
Take special care with Exembol
Exembol 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 contains ethanol, this can influence the effect of other medicines
containing metronidazol (for infections) or disulfiram (for alcoholism).
Pregnancy and breast-feeding
If you are pregnant, your doctor will only give you Exembol if it is absolutely
necessary. Avoid breast-feeding while you are being given Exembol.
Driving and using machines
Since Exembol 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”).
Important information about some of the ingredients of Exembol
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 contain up to 5 ml (4 g) of alcohol, corresponding
to 100 ml beer or 40 ml wine. This may be harmful for those suffering from liver disease,
alcoholism or epilepsy, brain injury or disease as well as for pregnant and nursing
women and their children. This may also influence the effect of other medicines.
This medicine contains sorbitol. If you are intolerant to certain sugars you must tell
your doctor.

3. HOW TO USE EXEMBOL
Exembol will always be given to you by medical personnel. Exembol 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
Like all medicines, Exembol can cause side effects, although not everybody gets them.
The most common side-effects are bleeding. Major bleeding can occur in
approximately 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:
• 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.
These symptoms could indicate that you are experiencing bleeding problems.
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 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
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.
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 diluted 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 controlled and validated aseptic
conditions.
Do not use Exembol 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 contains
The active substance is argatroban monohydrate 100 mg/ml. The other ingredients
are anhydrous ethanol, sorbitol and water for injections.
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.
What Exembol 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 the 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, United Kingdom.
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
Denmark
Novastan
France

Arganova
Germany
Argatra
Iceland

Novastan
Italy

Novastan
Netherlands
Arganova
Norway

Novastan
Spain

Arganova
Sweden

Novastan
United Kingdom
Exembol
This leaflet was last revised in: 06-2014

The following information is only for doctors and medical personnel.
Instructions for use, handling and disposal
Exembol 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.
Each 2.5 ml vial should be diluted 100-fold by mixing with 250 ml of diluent. The
vial is for single use only. Use 250 mg (2.5 ml) per 250 ml of diluent or 500 mg (5 ml)
per 500 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.
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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