Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - arixtra

Document Subject

Generated Narrative: MedicinalProductDefinition mp3762e897869ef821659a1e76148e806a

identifier: http://ema.europa.eu/identifier/EU/1/02/206/005-008

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Arixtra 1.5 mg/0.3 ml solution for injection, pre-filled syringe.

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

part

part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-3762e897869ef821659a1e76148e806a

identifier: http://ema.europa.eu/identifier/EU/1/02/206/005-008

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - arixtra

Attesters

What is in this leaflet:

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

Arixtra is a medicine that helps prevent blood clots from forming in the blood vessels (an antithrombotic agent).

Arixtra contains a synthetic substance called fondaparinux sodium. This stops a clotting factor Xa ( ten-A ) from working in the blood, and so prevents unwanted blood clots (thromboses) from forming in the blood vessels.

Arixtra is used to:

• prevent the formation of blood clots in the blood vessels of the legs or lungs after orthopaedic surgery (such as hip or knee surgery) or abdominal surgery
• prevent the formation of blood clots during and shortly after a period of restricted mobility due to acute illness.
• treat blood clots in blood vessels that are near the surface of the skin of the legs (superficial- vein thrombosis).

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 are bleeding excessively
• if you have a bacterial heart infection
• if you have very severe kidney disease. Tell your doctor if you think any of these applies to you. If they do, you must not use Arixtra.

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

• if you have previously had complications during treatment with heparin or heparin-like medicines causing a fall in the number of blood platelets (heparin-induced thrombocytopenia)
• if you have a risk of uncontrolled bleeding (haemorrhage) including:

stomach ulcer

bleeding disorders

recent bleeding into the brain (intracranial bleeding)

recent surgery on the brain, spine or eye

• if you have severe liver disease
• if you have kidney disease
• if you are 75 years old or older
• if you weigh less than 50 kg. Tell your doctor if any of these applies to you.

Children and adolescents Arixtra has not been tested in children and adolescents under the age of 17 years.

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 you bought without a prescription. Some other medicines may affect the way that Arixtra works or be affected by Arixtra.

Pregnancy and breast-feeding Arixtra should not be prescribed to pregnant women unless clearly necessary. Breast-feeding is not recommended during treatment with Arixtra. If you are pregnant, or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Arixtra contains sodium This medicinal product contains less than 23 mg of sodium in each dose and therefore is essentially sodium-free.

Arixtra syringe contains latex The syringe needle shield contains latex that has the potential to cause allergic reactions in latex sensitive individuals.
Tell your doctor if you are allergic to latex before being treated with Arixtra.

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The recommended dose is 2.5 mg once a day, injected at about the same time each day.

If you have kidney disease, the dose may be reduced to 1.5 mg once a day.

How Arixtra is given

• Arixtra is given by injection under the skin (subcutaneously) into a skin fold of the lower abdominal area. The syringes are pre-filled with the exact dose you need. There are different syringes for the 2.5 mg and 1.5 mg doses. For step-by-step instructions please see over the page
• Do not inject Arixtra into muscle.

How long should Arixtra be taken for You should continue Arixtra treatment for as long as your doctor has told you, since Arixtra prevents development of a serious condition.

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

If you forget to take Arixtra

• Take the dose as soon as you remember. Do not inject a double dose to make up for a forgotten dose.
• If you are not sure what to do, ask your doctor or pharmacist.

Don t stop using Arixtra without advice
If you stop the treatment before your doctor told you to, you are at risk of developing a blood clot in a vein of your leg or lung. Contact your doctor or pharmacist before stopping.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

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

Conditions you need to look out for Severe allergic reactions (anaphylaxis): These are very rare in people (up to 1 in 10,000) taking Arixtra. Signs include:

• swelling, sometimes of the face or mouth (angioedema), causing difficulty in swallowing or breathing
• collapse.

Contact a doctor immediately if you get these symptoms. Stop taking Arixtra.

Common side effects These may affect more than 1 in 100 people treated with Arixtra.

• bleeding (for example from an operation site, an existing stomach ulcer, nosebleed, gums)
• anaemia (a reduction in the number of red blood cells).

Uncommon side effects
These may affect up to 1 in 100 people treated with Arixtra.

• bruising or swelling (oedema)
• feeling sick or being sick (nausea or vomiting)
• chest pain
• breathlessness
• rash or itchy skin
• oozing from operation wound site
• fever
• reduction or increase in the number of platelets (blood cells necessary for blood clotting)
• increase in some chemicals (enzymes) produced by the liver.

Rare side effects These may affect up to 1 in every 1000 people treated with Arixtra.

• allergic reaction (including itching, swelling, rash)
• internal bleeding in the brain or abdomen
• anxiety or confusion
• headache
• fainting or dizziness, low blood pressure
• drowsiness or tiredness
• flushing
• coughing
• leg pain or stomach pain
• diarrhoea or constipation
• indigestion
• wound infection
• increase in bilirubin (a substance produced by the liver) in the blood
• reduction in potassium in your blood.

Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

• Keep this medicine out of the sight and reach of children
• Store below 25 C. Do not freeze
• Arixtra does not need to be kept in the fridge.

Do not use this medicine:

• after the expiry date shown on the label and carton
• if you notice any particles in the solution, or if the solution is discoloured
• if you notice that the syringe is damaged
• if you have opened a syringe and you do not use it straightaway.

Disposal of syringes: Do not throw away any medicines or syringes via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.

What Arixtra contains

• The active substance is 1.5 mg fondaparinux sodium in 0.3 ml solution for injection

• The other ingredient(s) are sodium chloride, water for injections, and hydrochloric acid and/or sodium hydroxide to adjust the pH (see section 2).

Arixtra does not contain any animal products.

What Arixtra looks like and contents of the pack Arixtra is a clear and colourless solution for injection. It is supplied in a pre-filled, single-use syringe fitted with a safety system to help prevent needle stick 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: Mylan IRE Healthcare Limited, Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland

Manufacturer: 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. H he, Benzstrasse 1, 61352 Bad Homburg v. d. H he, Germany

For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.

Belgi /Belgique/Belgien Mylan EPD bvba/sprl
Tel: + 32 (0)2 658 61

: +359 2 44 55 esk republika Viatris CZ s.r.o. Tel: + 420 222 004 Lietuva Mylan Healthcare UAB Tel: +370 5 205 1Luxembourg/Luxemburg Mylan EPD bvba/sprl
Tel: + 32 (0)2 658 61 (Belgique/Belgien)

Magyarorsz g Mylan EPD Kft Tel: + 36 1 465 2Danmark Viatris ApS Tel: +45 28 11 69 Malta V.J. Salomone Pharma Ltd Tel: + 356 21 22 01 Deutschland Viatris Healthcare GmbH Tel: +49 800 0700 Nederland Mylan Healthcare BV
Tel: +31 (0)20 426 3Eesti BGP Products Switzerland GmbH Eesti filiaal
Tel: + 372 6363 Norge Viatris AS Tel: + 47 66 75 33
BGP . . . . : +30 210 9891 sterreich Mylan sterreich GmbH Tel: +43 1 86Espa a Viatris Pharmaceuticals, S.L.U. Tel: +34 900 102 Polska Mylan Healthcare Sp. z o.o. Tel: + 48 22 546 64 France Viatris Sant
T l.: + 33 (0)4 37 25 75 Portugal
BGP Products, Unipessoal, Lda. Tel: + 351 21 412 72 Hrvatska Mylan Hrvatska d.o.o. Tel: +385 1 23 50 Rom nia BGP Products SRL Tel: +40 372 579 Ireland Mylan Ireland Limited Tel: +353 1 8711Slovenija Viatris d.o.o. Tel: + 386 1 23 63 sland Icepharma hf. Slovensk republika Viatris Slovakia s.r.o. Simi: +354 540 8Tel: +421 2 32 199 Italia Mylan Italia S.r.l. Tel: + 39 02 612 46Suomi/Finland Viatris Oy Puh/Tel: +358 20 720 9
Varnavas Hadjipanayis Ltd
: +357 2220 7Sverige Viatris AB
Tel: + 46 855 522 Latvija Mylan Healthcare SIA Tel: +371 676 055 United Kingdom (Northern Ireland)
Mylan IRE Healthcare Limited +353 18711This leaflet was last revised in {MM/YYYY}.

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: