Document: Novastan Multidos concentrate for solution for infusion ENG PL change

• Novastan Multidos concentrate for solution for infusion PL
• Novastan Multidos concentrate for solution for infusion ENG PL

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Package leaflet: Information for the user

Novastan Multidos 100 mg/ml concentrate for solution for infusion

argatroban monohydrate

Read all of this leaflet carefully before you start using this medicinebecause it contains

important information for you.

• Keep this leaflet. You may need to read it again.

• If you have any further questions, ask your doctor.

• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

In this leaflet:

1. What Novastan Multidos is and what it is used for

Novastan Multidos 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.

Novastan Multidos 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. Novastan Multidos can prevent these problems or prevent them from becoming worse.

2. What you need to know before you use Novastan Nultidos

Do not use Novastan Multidos

Novastan Multidos 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 Novastan Multidos

• If you have severely impaired liver function

Warnings and precautions

Novastan Multidos 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

Children and Adolescents

It is not advised to give this medicine to children or adolescents as the safe or effective dose of Novastan Mutlidos has not been clearly established.

Other medicines and Novastan Multidos

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 Novastan Multidos 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 or breast-feeding, think you may be pregnant or are planning to have a baby, you should askyour doctor for advice before Novastan Multidos is given to you.

As a precautionary measure,it is preferable to avoid the use of Novastan Multidos during pregnancy.

Avoid breast-feeding while you are being given Novastan Multidos(see also “Novastan Multidos contains alcohol”).

Driving and using machines

Since Novastan Multidos contains alcohol you should not drive a car or use machines in connection with the treatment. (see also “Novastan Multidos contains alcohol”).

Novastan Multidos contains alcohol

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.

Novastan Multidos contains sorbitol

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

3. How to use Novastan Multidos

Novastan Multidos will always be given to you by medical personnel. Novastan Multidos 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, Novastan Multidos 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 to1 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 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).

Casesof bleeding into the brain have been reported.

If you experience side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system (see below). By reporting side effects you can help provide more information on the safety of this medicine.

<To be completed nationally>

5. How to store Novastan Multidos

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 a controlled and validated aseptic conditions.

Do not use Novastan Multidos 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. Contents of the pack and other information

What Novastan Multidos contains

The active substance is argatroban monohydrate 100 mg/ml.

1 ml concentrate for solution for infusion contains 100 mg argatroban monohydrate.

1 Vial with 2.5 ml concentrate for solution for infusion contains 250 mg argatroban monohydrate.

The other ingredients are anhydrous ethanol, sorbitol and water for injections.

What Novastan Multidos 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:

<To be completed nationally>

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

Italy Novastan Multidose

Netherlands Arganova Multidose

Norway Novastan

Sweden Novastan Multidos

United Kingdom Exembol Multidose

This leaflet was last approved in: 2016-07-15

The following information is intended for healthcare professionals only..

Instructions for use, handling and disposal

Novastan Multidos 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 50mg (0.5ml) concentrate for solution for infusion per 50ml 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 Novastan Multidos 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.