Exembol Multidose100 mg/ml concentrate for solution for infusion

Exembol Multidose 100 mg/ml concentrate for solution for infusion

argatroban monohydrate

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.

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.

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.

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:

• 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 (may affect up to 1 in 10 people):

• anaemia
• blood clotting
• bleeding, including numerous small bleedings in skin and mucus membranes (purpura)
• nausea

Uncommon side effects (may affect up to 1 in 100 people):

• 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.

Not known (frequency cannot be estimated from the available data).

• Cases of bleeding into the brain have been reported.

Keep out of the sight and reach of children.

Keep vial in the outer carton in order to protect from light.

Do not refrigerate or freeze.

Diluted solutions should not be exposed to direct sunlight.

Solutions should not be used if they are cloudy or contain any particles.

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.

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 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.

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

United Kingdom :

This medicinal product is authorised in the Member States of the EEA under the following names:

Austria Argatra Multidose

Finland Novastan

France Arganova

Germany Argatra Multidose

Italy Novastan Multidose

Netherlands Arganova Multidose

Sweden Novastan Multidos

United Kingdom Exembol Multidose