ARGANOVA 100 mg/ml CONCENTRATE FOR INFUSION SOLUTION

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Arganova 100 mg/ml concentrate for solution for infusion

argatroban monohydrate

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 any further questions, ask your doctor or pharmacist.
• If you experience any side effects, talk to your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

Contents of the pack

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

1. What is Arganova and what is it used for

Arganova is an anticoagulant (a medicine that helps prevent the formation of blood clots in your bloodstream). It works by blocking the action of thrombin, a substance present in the blood that is important for its coagulation.

Arganova is used if you have a disorder known as type II heparin-induced thrombocytopenia (type II HIT). If you have type II HIT, you are at risk of forming blood clots in your circulation, which can cause heart attacks, strokes, respiratory problems, and problems with blood flow to your limbs. Arganova can prevent these problems or prevent them from getting worse.

2. What you need to know before you use Arganova

Do not use Arganova

You will not be given Arganova:

• If you have uncontrolled bleeding.
• If you are allergic (hypersensitive) to argatroban or any of the other components of Arganova.
• If you have severe liver failure.

Warnings and precautions

Arganova will be administered to you with special caution in the following cases:

• If you have an increased risk of bleeding.
• If you have recently been given injections or infusions of other anticoagulants, such as heparin.
• If you have any liver disease.

Children and adolescents

It is not recommended to give this medicine to children or adolescents as the effective and safe dose of Arganova has not been established.

Use of Arganova with other medicines

Tell your doctor or pharmacist if you are using or have recently used other medicines, including those obtained without a prescription.

The combined use with other anticoagulant or thrombolytic medicines may increase the risk of bleeding.

As Arganova contains ethanol, it may affect the action of other medicines that contain metronidazole (for infections) or disulfiram (for alcoholism).

Pregnancy, breastfeeding, and fertility

If you are pregnant, breastfeeding, think you may be pregnant, or plan to become pregnant, ask your doctor for advice before Arganova is administered to you.

As a precaution, it is recommended to avoid the use of Arganova during pregnancy.

Avoid breastfeeding while using Arganova. Also, see the section "Arganova contains alcohol".

Driving and using machines

As Arganova contains alcohol, you should not drive a vehicle or use machines during treatment. (See also "Arganova contains alcohol").

Arganova contains alcohol

This product contains 50% ethanol (alcohol), which corresponds to an amount of 400 mg/ml before dilution, which corresponds to 0.5% by volume after dilution according to the instructions. Therefore, the daily dose may contain up to 5 ml (4 g) of alcohol, equivalent to 100 ml of beer or 40 ml of wine.

This medicine may be harmful to people with alcoholism.

The alcohol content should be taken into account in the case of pregnant or breastfeeding women, children, and high-risk groups, such as patients with liver disease, epilepsy, or brain damage. See also "Pregnancy, breastfeeding, and fertility".

If you have an addiction to alcohol, consult your doctor or pharmacist before taking this medicine.

It is unlikely that the amount of alcohol in this medicine will have any noticeable effect on adults or adolescents. The amount of alcohol in this medicine may alter the effect of other medicines. Consult your doctor or pharmacist if you are taking other medicines. As this medicine is usually administered slowly over several hours, the effects of alcohol may be less.

Arganova contains sorbitol

This medicine contains 750 mg of sorbitol in each vial (2.5 ml), equivalent to 300 mg/ml.

Sorbitol is a source of fructose. If you have hereditary fructose intolerance (HFI), a rare genetic disease, you should not receive this medicine. Patients with HFI cannot break down fructose, which can cause serious side effects. Consult your doctor before receiving this medicine if you have HFI.

3. How to use Arganova

Arganova will always be administered to you by a healthcare professional. Arganova will be administered intravenously (into a vein) as a continuous infusion. The doctor will decide the dose and duration of treatment.

4. Possible side effects

Like all medicines, Arganova can cause side effects, although not everybody gets them.

The most common side effect is bleeding.Significant bleeding may occur in approximately 5% of patients, and minor bleeding in about 39%.

Tell your doctor immediatelyif you experience any of the following symptoms:

? bleeding or bruising

? blood in urine or stools

? vomiting or coughing up blood

? black stools

? difficulty breathing

? cold sweats

? dry mouth

? dilated pupils or weak and rapid pulse

These symptoms may indicate that you have bleeding.

Common side effects(may affect up to 1 in 10 users)

? anemia

? blood clots

? bleeding, including small and numerous bleeding spots on the skin and mucous membranes (purpura)

? nausea

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

? infections, such as urinary tract infections

? changes in blood test results

? blood clots

? loss of appetite

? low blood sugar levels

? low sodium levels in the blood

? confusion

? dizziness

? fainting

? headache

? stroke

? muscle disorders

? speech disorders

? vision problems

? deafness

? heart attacks

? fluid around the heart

? irregular heartbeat

? rapid heartbeat

? low blood pressure

? high blood pressure

? venous inflammation

? shock

? decreased oxygen supply to tissues

? breathing difficulties

? fluid around the lungs

? hiccups

? blood when coughing or in vomit or stools

? constipation

? diarrhea

? stomach inflammation

? difficulty swallowing

? tongue disorders

? liver function abnormalities

? jaundice (yellowing of the skin and eyes)

? changes in liver function blood tests

? rash, including hives

? itching

? increased sweating

? hair loss

? muscle weakness

? muscle pain

? kidney failure

? fever

? pain

? fatigue

? reaction at the injection site

? swelling of the legs

? increased wound suppuration

? abnormal test results

Unknown(frequency cannot be estimated from available data)

? Cases of bleeding in the brain have been reported

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines Agency's online platform: www.notificaRAM.es.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Arganova

Keep out of the sight and reach of children.

Store the vial in the outer packaging to protect it from light.

Do not refrigerate or freeze.

Reconstituted solutions should not be exposed to direct sunlight.

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

Diluted solution: its chemical and physical stability has been demonstrated for use up to 14 days at temperatures of 25 °C and 2 °C to 8 °C in a 9 mg/ml (0.9%) sodium chloride infusion solution or 50 mg/ml (5%) glucose solution or in an intravenous infusion preparation of sodium lactate.

From a microbiological point of view, the product should be used immediately. If not used immediately, the storage times and conditions during use are the responsibility of the user and should not normally exceed 24 hours at a temperature of 2 °C to 8 °C, unless the dilution has been performed under validated and controlled aseptic conditions.

Do not use Arganova after the expiry date stated on the carton or vial after EXP. The expiry date is the last day of the month stated.

6. Contents of the pack and other information

Composition of Arganova

The active substance of Arganova is argatroban monohydrate.

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

The other ingredients are:

anhydrous ethanol

sorbitol (E-420i)

water for injections.

Appearance and packaging

This medicine is a clear, colorless or pale yellow solution for infusion. Each vial contains 2.5 ml of the solution and the vials are packaged in cardboard boxes of 1 or 6 vials.

Not all pack sizes may be marketed.

Marketing authorization holder

Ethypharm, 194, Bureaux de la Colline, Bâtiment D, 92213 Saint-Cloud cedex, France.

Manufacturer

Tjoapack Netherlands B.V., Nieuwe Donk 9, Etten-Leur, 4879AC, Netherlands.

Fisiopharma, Nucleo Industriale, 84020 Palomonte (SA), Italy

You can obtain further information on this medicine from the local representative of the marketing authorization holder:

Aguettant Ibérica S.L.

Baldiri Reixac, 4-8, Torre I, 08028 Barcelona

Spain

Tel: +34 93 403 37 80

This medicine is authorized in the Member States of the European Economic Area under the following names:

This leaflet was approved in:03/2021

This information is intended only for healthcare professionals.

Instructions for use, handling, and disposal

Arganova should be diluted in a 9 mg/ml (0.9%) sodium chloride infusion solution or 50 mg/ml (5%) glucose solution or in an intravenous infusion preparation of sodium lactate to a final concentration of 1 mg/ml. The vial should be discarded if the solution is cloudy or contains any insoluble precipitate.

Each 2.5 ml vial should be diluted 100 times by mixing it with 250 ml of diluent. Each vial is for single use. 250 mg (2.5 ml) is used per 250 ml of diluent or 500 mg (5 ml) per 500 ml of diluent.

The reconstituted solution is mixed by inverting the diluent bag or bottle repeatedly for one minute. The diluted solution should be clear and practically free from visible particles. During reconstitution, the solution may show a slight, transient turbidity due to the formation of microprecipitates that dissolve rapidly when mixed. The pH of the reconstituted intravenous solution, following the instructions, is 3.2-7.5.

It is not necessary to avoid exposure to sunlight with measures such as protecting intravenous lines with aluminum foil. No significant loss of potency has been observed after simulated administration of the solution through intravenous lines.

Disposal of unused medicine and all materials that have come into contact with it should be done in accordance with local regulations.