Arixtra

Italy

Brand name Arixtra

Form solution for injection

Active substance / Dosage

FONDAPARINUX SODIUM

Prescription type Prescription only

ATC code

B01AX05

Registration number 035606

Manufacturer Viatris Healthcare Limited

Table of Contents

Package leaflet: Information for the user
Arixtra 1.5 mg/0.3 ml injection solution
2. What you need to know before using Arixtra
3. How to use Arixtra
4. Possible side effects
5. How to store Arixtra
6. Package contents and other information
2. Remove the syringe from the carton and check that:
3. Sit down or lie down in a comfortable position.
4. Clean the injection site with an alcohol swab.
6. Gently pinch the disinfected skin area to
7. Hold the syringe firmly between your fingers.
8. Inject ALL the contents of the syringe by pushing the
Package leaflet: Information for the user
Arixtra 2.5 mg/0.5 ml injectable solution
2. What you should know before using Arixtra
3. How to use Arixtra
4. Possible side effects
5. How to store Arixtra
6. Package Contents and Other Information
2. Remove the syringe from the carton and check that:
3. Sit or lie down in a comfortable position.
4. Clean the injection site with an alcohol swab.
6. Gently pinch the disinfected skin area to
7. Hold the syringe firmly between your fingers.
8. Inject ALL the contents of the syringe by pushing the
Package leaflet: Information for the user
Arixtra 5 mg/0.4 ml injection solution, 7.5 mg/0.6 ml injection solution, 10 mg/0.8 ml injection solution
2. What you need to know before using Arixtra
3. How to use Arixtra
4. Possible side effects
5. How to store Arixtra
6. Package contents and other information
2. Remove the syringe from the carton and check that:
4. Clean the injection site with an alcohol swab.
6. Gently pinch the disinfected skin area to
7. Hold the syringe firmly between your fingers.
8. Inject ALL of the contents of the syringe by pushing the

Package leaflet: Information for the user

Arixtra 1.5 mg/0.3 ml injection solution

fondaparinux sodium
Please read this leaflet carefully before using this medicine because it contains important
information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it may be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
Contents of this leaflet:

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

1. What Arixtra is and what it is used for
Arixtra is a medicine that helps prevent blood clots from forming in blood vessels ( antithrombotic agent ).
Arixtra contains a substance called fondaparinux sodium. It works by inhibiting the activity of coagulation factor Xa ("ten-A") in the blood, thereby preventing the formation of blood clots ( thrombosis ) in blood vessels.
Arixtra is used for:

preventing the formation of blood clots in the blood vessels of the legs or lungs after orthopedic surgery (such as hip or knee surgery) or after abdominal surgery;
preventing the formation of blood clots during and immediately after a period of limited mobility due to an acute illness;
treatment of blood clots in the superficial veins of the legs ( superficial venous thrombosis ).

2. What you need to know before using Arixtra

Do not use Arixtra:

if you are allergic to fondaparinux sodium or to any of the other ingredients of this medicine (listed in section 6);
if you have active bleeding;
if you have a bacterial infection of the heart;
if you have severe kidney disease. → Tell your doctor if you think any of these situations apply to you. In such cases, do not use Arixtra.

Take special care with Arixtra:
Talk to your doctor or pharmacist before using Arixtra:

if you have previously experienced complications during treatment with heparin or with heparin-like medicines that caused a decrease in platelets (heparin-induced thrombocytopenia);
if you are at risk of uncontrolled bleeding ( bleeding ), including:
. gastric ulcer
. bleeding disorders
. recent cerebral haemorrhage ( intracranial bleeding )
. recent surgery on the brain, spinal cord, or eyes;
if you have severe liver disease;
if you have kidney disease;
if you are 75 years of age or older;
if you weigh less than 50 kg. → Tell your doctor if you think any of these situations apply to you.

Children and adolescents
The use of Arixtra has not been studied in children and adolescents under 17 years of age.

Other medicines and Arixtra
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This includes medicines purchased without a prescription. Some other medicines may affect how Arixtra works, or may be affected by Arixtra.

Pregnancy and breastfeeding
Arixtra should not be prescribed to pregnant women unless clearly necessary.
Breastfeeding is not recommended during treatment with Arixtra. If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before using this medicine.

Arixtra contains sodium
Each dose of this medicine contains less than 23 mg of sodium and is therefore essentially "sodium-free".

The Arixtra syringe contains latex
The needle cover of the syringe contains latex, which may cause allergic reactions in individuals sensitive to latex.
➔ Tell your doctor if you are allergic to latex before receiving treatment with Arixtra.

3. How to use Arixtra

Use this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

The recommended dose is 2.5 mg once daily, to be injected at approximately the same time each day.
If you have kidney disease, the dose may be reduced to 1.5 mg once daily.

How Arixtra is administered

Arixtra is administered by subcutaneous injection into a skin fold in the lower abdominal area. The syringes are pre-filled with the exact required dose. The syringes for the 2.5 mg and 1.5 mg doses are different. For step-by-step "Instructions for use", see the reverse side of the leaflet.
Do not inject Arixtra into the muscle.

How long Arixtra should be used
You must continue Arixtra treatment for the entire duration prescribed by your doctor, as Arixtra prevents the development of serious conditions.

If you inject too much Arixtra
Contact your doctor or pharmacist as soon as possible for advice, as this increases the risk of bleeding.

If you forget to take Arixtra

Inject the missed dose as soon as you remember. Do not inject a double dose to make up for the forgotten dose.
If you are unsure what to do, consult your doctor or pharmacist.

Do not stop using Arixtra without medical advice
If you stop treatment earlier than prescribed by your doctor, you are at risk of developing a blood clot in a vein of the legs or in the lungs. Contact your doctor or pharmacist before stopping treatment.

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Conditions requiring immediate medical help
Severe allergic reactions (anaphylaxis): these are very rare in people taking Arixtra (up to 1
person in 10,000). Symptoms include:

swelling, sometimes of the face or mouth ( angioedema ), causing difficulty in swallowing or breathing
collapse. ➔ Contact your doctor immediately if you experience any of these symptoms. Stop taking Arixtra.

Common side effects
May affect more than 1 in 100 people treated with Arixtra:

bleeding (for example, at the surgical site, from a pre-existing stomach ulcer, nosebleeds, bleeding from gums, blood in urine, coughing up blood, bleeding from eyes, bleeding into joint spaces, internal bleeding in the uterus)
localized accumulation of blood (in any organ/tissue of the body)
anaemia (a reduction in the number of red blood cells)
bruising.

Uncommon side effects
May affect up to 1 in 100 people treated with Arixtra:

swelling ( edema )
feeling unwell or nausea or vomiting
headache
pain
chest pain
shortness of breath
skin redness or itching
fluid leakage from a surgical wound
fever
decrease or increase in the number of platelets (blood components necessary for clotting)
increase in certain substances ( enzymes ) produced by the liver.

Rare side effects
May affect up to 1 in 1,000 people treated with Arixtra:

allergic reactions (including itching, swelling, rash)
internal bleeding in the brain, liver, or abdomen
anxiety or confusion
fainting or dizziness, low blood pressure
drowsiness or fatigue
hot flushes
cough
leg pain or stomach pain
diarrhoea or constipation
indigestion
pain and swelling at the injection site
wound infections
increased bilirubin (a substance produced by the liver) in the blood
increased blood urea nitrogen levels
decreased potassium levels in the blood
upper abdominal pain or heartburn.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system listed in Annex V.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Arixtra

Keep this medicine out of the sight and reach of children.
Store below 25°C. Do not freeze.
Arixtra must not be stored in the refrigerator.

Do not use this medicine:

after the expiry date stated on the label and carton
if you notice the presence of particles in the solution, or if the solution has an unusual colour
if you notice that the syringe is damaged
if you have opened a syringe and do not use it immediately.

Disposal of syringes:
Do not dispose of any medicine or syringe via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer used. This will help protect the environment.

6. Package contents and other information

What Arixtra contains

The active substance is 1.5 mg of fondaparinux sodium in 0.3 ml of injectable solution.
The excipients are sodium chloride, water for injections, and hydrochloric acid and/or sodium hydroxide for pH adjustment (see section 2).

Arixtra does not contain any animal-derived products.
Description of the appearance of Arixtra and contents of the pack
Arixtra is a clear, colourless injectable solution. It is supplied in a pre-filled, single-use syringe, complete with a safety system designed to protect against accidental needlestick injuries after use. It is available in packs of 2, 7, 10 and 20 pre-filled syringes (not all pack sizes may be marketed).
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Viatris Healthcare Limited, Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland
Manufacturers:
Aspen Notre Dame de Bondeville, 1 rue de l’Abbaye, F-76960 Notre Dame de Bondeville, France
Mylan Germany GmbH, Zweigniederlassung Bad Homburg v. d. Höhe, Benzstrasse 1,
61352 Bad Homburg v. d. Höhe, Germany
For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
België/Belgique/Belgien Lietuva
Viatris Viatris UAB
Tél/Tel: + 32 (0)2 658 61 00 Tel: +370 5 205 1288
България Luxembourg/Luxemburg
Майлан ЕООД Viatris
Тел.: +359 2 44 55 400 Tél/Tel: + 32 (0)2 658 61 00
(Belgique/Belgien)
Česká republika Magyarország
Viatris CZ s.r.o. Viatris Healthcare Kft.
Tel: + 420 222 004 400 Tel.: + 36 1 465 2100
Danmark Malta
Viatris ApS V.J. Salomone Pharma Ltd
Tlf.: +45 28 11 69 32 Tel: + 356 21 22 01 74
Deutschland Nederland
Viatris Healthcare GmbH Mylan Healthcare BV
Tel: +49 800 0700 800 Tel: +31 (0)20 426 3300
Eesti Norge
Viatris OÜ Viatris AS
Tel: + 372 6363 052 Tlf: + 47 66 75 33 00
Ελλάδα Österreich
Viatris Hellas Ltd Viatris Austria GmbH
Τηλ: +30 2100 100 002 Tel: +43 1 86390
España Polska
Viatris Pharmaceuticals, S.L. Viatris Healthcare Sp. z o.o.
Tel: +34 900 102 712 Tel.: + 48 22 546 64 00
France Portugal
Viatris Santé Viatris Healthcare, Lda.
Tél: + 33 4 37 25 75 00 Tel: + 351 21 412 72 00
Hrvatska România
Viatris Hrvatska d.o.o. BGP Products SRL
Tel: +385 1 23 50 599 Tel: +40 372 579 000
Ireland Slovenija
Viatris Limited Viatris d.o.o.
Tel: +353 1 8711600 Tel: + 386 1 23 63 180
Ísland Slovenská republika
Icepharma hf. Viatris Slovakia s.r.o.
Sími: +354 540 8000 Tel: +421 2 32 199 100
Italia Suomi/Finland
Viatris Italia S.r.l. Viatris Oy
Tel: + 39 (0) 2 612 46921 Puh/Tel: +358 20 720 9555
Κύπρος Sverige
CPO Pharmaceuticals Limited Viatris AB
Τηλ: +357 22863100 Tel: + 46 (0)8 630 19 00
Latvija
Viatris SIA
Tel: +371 676 055 80
This leaflet was last updated on
Other sources of information
More detailed information about this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu
Types of safety syringes
There are two types of safety syringes used for Arixtra, designed to protect against accidental needlestick injuries after injection. One type of syringe is equipped with an automatic needle protection system and the other type with a manual needle protection system.
Parts of the syringes:
 Needle cap
 Plunger
 Grip
Safety shield
Figure 1. Syringe with an automatic needle protection system

Technical diagram of a medical device with four numbered parts showing the plunger, central body, and the

Syringe with a manual needle protection system
Figure 2. Syringe with a manual needle protection system Figure 3. Syringe with a manual needle protection system showing the safety shield covering the needle AFTER USE

Two hands hold a syringe horizontally while a gray arrow and the number 4 indicate the piston sliding to the right

Technical diagram of a syringe with identifying numbers: 1 the

STEP-BY-STEP GUIDE TO USING ARIXTRA
Instructions for use
These instructions apply to both types of syringes (automatic and manual needle protection systems).
Where instructions differ for each syringe type, this is clearly indicated.

Wash your hands thoroughly with soap and water, then dry them with a towel.

2. Remove the syringe from the carton and check that:

the expiry date has not been exceeded
the solution is clear, colourless, and contains no particles
the syringe has not been opened or damaged

Schematic drawing of a man sitting on a chair and a standing male body with the

3. Sit down or lie down in a comfortable position.

Choose a site in the lower abdominal area, at least 5
cm below the navel (Figure A).
Alternate between the left and right sides of the lower abdominal area
for each injection. This will help reduce discomfort at the
injection site.
If injection in the lower abdominal area is not possible,
consult your nurse or doctor for advice.
Figure A

4. Clean the injection site with an alcohol swab.

Two hands hold a syringe while a curved arrow indicates the rotational movement of the cap for drug preparation

Remove the needle cover by first rotating it (Figure B1) and then pulling it straight off the syringe barrel (Figure B2). Discard the needle cover. Important note
- Do not touch the needle and ensure it does not come into contact with any other surfaces before the injection.
- It is normal to have a small air bubble in the syringe. Do not attempt to remove small air bubbles before performing the injection to ensure you do not waste any product.

Figure B1

Two hands hold a syringe with needle pointing toward the

Figure B2

Black and white drawing showing a hand holding the skin taut above an area of the

6. Gently pinch the disinfected skin area to

form a skin fold. Hold the skin fold between your thumb and index finger
throughout the injection (figure C).
Figure C

A hand holds a syringe to inject a drug while the

7. Hold the syringe firmly between your fingers.

Insert the full length of the needle perpendicularly (at a 90° angle) into the skin fold (Figure D).
Figure D

A hand presses down a pen-like medical device onto the skin while the

8. Inject ALL the contents of the syringe by pushing the

plunger down completely to the end (figure E).
Figure E

Syringe with automatic system

Release the plunger, and the needle will automatically retract into the safety shield, where it will remain permanently enclosed (figure F).

Figure F
Syringe with manual system

After the injection, hold the syringe in one hand while keeping the safety shield steady. With the other hand, grasp the handle and firmly pull it backward. This unlocks the shield. Slide the shield along the syringe barrel until it clicks into place over the needle. This is shown in figure 3 at the beginning of these instructions. Do not dispose of the used syringe in household waste. Dispose of the used syringe according to the instructions provided by your doctor or pharmacist.

Package leaflet: Information for the user

Arixtra 2.5 mg/0.5 ml injectable solution

fondaparinux sodium
Please read this leaflet carefully before using this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4. Contents of this leaflet:

1. What Arixtra is and what it is used for
Arixtra is a medicine that helps prevent blood clots from forming in blood vessels ( antithrombotic agent ).
Arixtra contains a synthetic substance called fondaparinux sodium. It works by inhibiting the activity of coagulation factor Xa ("ten-A") in the blood, thereby preventing the formation of blood clots ( thrombosis ) in blood vessels.
Arixtra is used for:

preventing the formation of blood clots in the blood vessels of the legs or lungs after orthopedic surgery (such as hip or knee surgery) or after abdominal surgery;
preventing the formation of blood clots during and immediately after a period of limited mobility due to an acute illness;
the treatment of certain types of heart attack or severe angina (chest pain caused by narrowing of the heart arteries);
the treatment of blood clots in blood vessels close to the skin surface in the legs ( superficial venous thrombosis ).

2. What you should know before using Arixtra

Do not use Arixtra:

if you are allergic to fondaparinux sodium or to any of the excipients of this medicine (listed in section 6);
if you have significant bleeding;
if you have a bacterial infection of the heart (bacterial endocarditis);
if you have severe kidney disease. → Tell your doctor if you think any of these situations apply to you. In such cases, do not use Arixtra.

Take special care with Arixtra:
Talk to your doctor or pharmacist before taking Arixtra:

if you have previously experienced complications during treatment with heparin or heparin-like medicines that caused a decrease in platelets (heparin-induced thrombocytopenia);
if you are at risk of uncontrolled bleeding (haemorrhage), including:
. gastric ulcer
. bleeding disorders
. recent intracranial haemorrhage (bleeding in the brain)
. recent surgery on the brain, spinal cord, or eyes;
if you have severe liver disease;
if you have kidney disease;
if you are 75 years of age or older;
if you weigh less than 50 kg. → Tell your doctor if you think any of these situations apply to you.

Children and adolescents
The use of Arixtra has not been studied in children and adolescents under 17 years of age.

Other medicines and Arixtra
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This includes medicines obtained without a prescription. Some other medicines may affect the way Arixtra works or may be affected by Arixtra.

Pregnancy and breastfeeding
Arixtra should not be prescribed to pregnant women unless clearly necessary.
Breastfeeding is not recommended during treatment with Arixtra. If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before using this medicine.

Arixtra contains sodium
Each dose of this medicine contains less than 23 mg of sodium and is therefore essentially "sodium-free".

The Arixtra syringe may contain latex
The needle cover of the syringe may contain latex, which has the potential to cause allergic reactions in latex-sensitive individuals.
→ Inform your doctor if you are allergic to latex before being treated with Arixtra.