1.5 mg / 0.3 ml solution for injection 
fondaparinux sodium

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

– Save this information, you may need to read it again.

– If you have any further questions, ask your doctor or pharmacist.

– This medicine has been prescribed for you only. Do not give it to others. It may harm them, even if they show symptoms similar to yours.

– If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

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 packaging 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 the blood vessels ( an antithrombotic agent ).

Arixtra contains a synthetically produced substance called fondaparinux sodium. It prevents coagulation factor Xa “to-A” from acting in the blood and thus prevents unwanted blood clots ( thrombosis ) from forming in the blood vessels.

Arixtra is used to:

  • prevent the formation of blood clots in the veins of the legs or lungs after orthopedic surgery (such as hip and knee joint surgery) or after abdominal surgery
  • prevent the formation of blood clots during and shortly after a period of reduced mobility due to acute illness
  • treat 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 any of the other ingredients of this medicine (listed in section 6)
  • if you bleed heavily
  • if you have a bacterial infection in the heart
  • if you have very serious kidney disease.

→ Tell your doctor if any of these apply to you. If it does, do not use Arixtra.

Warnings and cautions

Talk to your doctor or pharmacist before using Arixtra:

  • if you have a history of complications during treatment with heparin or heparin-like medicines that have caused a decrease in platelet count(heparin-induced thrombocytopenia )
  • if you are at risk of uncontrolled bleeding that includes:
    • gastric ulcer
    • bleeding disorder
    • recent cerebral hemorrhage ( intracranial hemorrhage)
    • recently undergone surgery in the brain, spine or
  • if you have severe liver disease
  • if you have kidney disease
  • if you are 75 years or older
  • if you weigh less than 50 kg.→ Tell your doctor if any of these apply to you.

Children and young people

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 also includes over-the-counter medications. Some other medicines may affect the effect of Arixtra or 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, 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 excipients

Arixtra contains sodium

This medicine contains less than 23 mg sodium per dose and is therefore considered sodium-free .

The syringe for Arixtra contains latex

The needle cover of the syringe contains latex which can cause allergic reactions in people sensitive to latex.

→ Tell your doctor if you are allergic to latex before you are treated with Arixtra.

3. How to use Arixtra

Always use this medicine exactly as your doctor or pharmacist has told you.

Ask your doctor or pharmacist if you are unsure. 

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

How Arixtra is given

  • Arixtra is given as an injection under the skin ( subcutaneously ) into a fold of skin in the lower abdomen. The syringe is pre-filled with exactly the dose you need. There are different syringes for doses are 2.5 mg and 1.5 mg. Step-by-step instruction is included in the package leaflet.
  • Inject not Arixtra into muscle.

How long to use Arixtra

You should continue treatment with Arixtra for as long as your doctor prescribes as Arixtra prevents the development of serious medical conditions.

If you inject too much Arixtra

Contact your doctor or pharmacist for advice as soon as possible, as there is an increased risk of bleeding.

If you forget to use Arixtra

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

Do not stop using Arixtra without the advice

If you stop treatment earlier than your doctor has told you, there is a risk of a blood clot forming in a vein in your leg or lung. Contact your doctor or pharmacist before stopping treatment.

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

4. Possible side effects

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

Conditions that you need to watch out for

Severe allergic reactions ( anaphylaxis ): These are very rare in people (up to one in 10,000) treated with Arixtra. Signs of this include:

  • swelling, sometimes on the face or mouth ( angioedema ), which may make it difficult to swallow or breathe
  • fainting.
  • Contact a doctor immediately if you get these symptoms. Stop using Arixtra.

Common side effects are

These may occur in more than 1 in 100 people treated with Arixtra

  • bleeding (eg at the surgical site, an existing stomach ulcer, or nosebleeds)
  • anemia (decreased number of red blood cells ).

Uncommon side effects are

These can occur in up to 1 in 100 people treated with Arixtra

  • bruising or swelling ( edema ) 
  • nausea, vomiting
  • chest pain
  • respiratory distress
  • skin rash or itching
  • exuding wounds at the surgical site
  • fever
  • decreased or increased platelet count (ie blood cells needed for blood clotting)
  • elevated liver enzyme values.

Rare side effects are

These can occur in up to 1 in 1,000 people treated with Arixtra

  • allergic reactions (including itching, swelling, and rash)
  • bleeding inside the brain or abdomen
  • anxiety or confusion
  • headache
  • fainting or dizziness, low blood pressure
  • drowsiness or fatigue
  • redness
  • cough
  • leg pain or abdominal pain
  • diarrhea or constipation
  • indigestion
  • wound infection
  • elevated bilirubin levels in the blood (a substance produced in the liver)
  • the decrease in potassium in the blood.

Reporting of side effects

If you get any 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 to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. 

5. How to store Arixtra

  • Keep this medicine out of the sight and reach of children
  • Store below 25 ° C. Do not freeze
  • Arixtra does not need to be stored in the refrigerator.
    Do not use this medicine:
  • after the expiry date which is stated on the label and carton
  • if you see any particles in the solution or if the solution is discolored
  • if you see that the syringe is damaged
  • if you have opened a syringe but do not intend to use it immediately.

Disposal of syringes:

Medicines and syringes should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substance is 1.5 mg fondaparinux sodium in 0.3 ml solution for injection.
  • The other ingredients 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 products.

What the medicine looks like and the contents of the pack

Arixtra is a clear and colorless solution for injection that comes in pre-filled syringes equipped with a safety system that helps prevent needle stick injuries after use. Arixtra is available in packs of 2, 7, 10, and 20 pre-filled syringes (not all pack sizes may be marketed).

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder:

Aspen Pharma Trading Limited, 3016 Lake Drive, Citywest Business Campus, Dublin 24, Ireland

Manufacturer:

Aspen Notre Dame de Bondeville, 1 rue de l’Abbaye, F-76960 Notre Dame de Bondeville, France.

Contact the representative of the marketing authorization holder to find out more about this medicine:

Belgium / Belgique / BelgienAspen Pharma Trading LimitedTel: 0032 24009864aspenmedinfo@professionalinformation.co.uk Luxembourg / LuxemburgAspen Pharma Trading LimitedTel: 0035 227861279aspenmedinfo@professionalinformation.co.uk
BulgariaAspen Pharma Trading LimitedTel: 00359 24917582aspenmedinfo@professionalinformation.co.uk HungaryAspen Pharma Trading LimitedTel .: 003 618480681aspenmedinfo@professionalinformation.co.uk
Czech RepublicAspen Pharma Trading LimitedTel: 00420 228880774aspenmedinfo@professionalinformation.co.uk MaltaAspen Pharma Trading LimitedTel: 00356 21497982aspenmedinfo@professionalinformation.co.uk
DenmarkAspen Pharma Trading LimitedTel: 0045 78772887 aspenmedinfo@professionalinformation.co.uk The NetherlandsAspen Pharma Trading LimitedTel: 0031 207095007aspenmedinfo@professionalinformation.co.uk
GermanyAspen Germany GmbHTel .: 0049 3056796862aspenmedinfo@professionalinformation.co.uk NorwayAspen Pharma Trading LimitedTel: 0047 21984376aspenmedinfo@professionalinformation.co.uk
EestiAspen Pharma Trading LimitedTel: 003531 6308400aspenmedinfo@professionalinformation.co.uk AustriaAspen Pharma Trading LimitedTel: 0043 19284015aspenmedinfo@professionalinformation.co.uk
GreeceAspen Pharma Trading Limited.:Ηλ: 0030 2111768477aspenmedinfo@professionalinformation.co.uk PolandAspen Pharma Trading LimitedTel .: 0048 221253376aspenmedinfo@professionalinformation.co.uk
SpainAspen Pharmacare España SLAvenida Diagonal, 512Planta Interior 1, Office 408006 BarcelonaTel: 0034 952010137aspenmedinfo@professionalinformation.co.uk PortugalAspen Pharma Trading LimitedTel: 00351 300501243aspenmedinfo@professionalinformation.co.uk
FranceAspen FranceTel .: + 33 (0) 1 39177000aspenmedinfo@professionalinformation.co.uk RomaniaAspen Pharma Trading Limited.Tel: 0040 316301169aspenmedinfo@professionalinformation.co.uk
CroatiaAspen Pharma Trading LimitedTel: 00385 17776395aspenmedinfo@professionalinformation.co.uk SloveniaAspen Pharma Trading LimitedTel: 003861 18888201aspenmedinfo@professionalinformation.co.uk
IrelandAspen Pharma Trading LimitedTel: 003531 6308400aspenmedinfo@professionalinformation.co.uk Slovak RepublicAspen Pharma Trading LimitedTel: 00421 233329930aspenmedinfo@professionalinformation.co.uk
IcelandAspen Pharma Trading Limited.Phone: 003531 6308400aspenmedinfo@professionalinformation.co.uk Finland / FinlandAspen Pharma Trading LimitedPuh / Tel: 00358 974 790 156aspenmedinfo@professionalinformation.co.uk
ItalyAspen Pharma Trading LimitedTel: 0039 0687502429aspenmedinfo@professionalinformation.co.uk
ΚύπροςAspen Pharma Trading Limited:Ηλ: 00357 25030922aspenmedinfo@professionalinformation.co.uk United KingdomAspen Pharma Trading LimitedTel: +44 (0) 1748 828 391aspenmedinfo@professionalinformation.co.uk
LatviaAspen Pharma Trading LimitedTel: 00371 66163124aspenmedinfo@professionalinformation.co.uk LiechtensteinAspen Pharma Trading LimitedTel: 0049 3056796862aspenmedinfo@professionalinformation.co.uk
LithuaniaAspen Pharma Trading LimitedTel: 00370 5 214 0291aspenmedinfo@professionalinformation.co.uk

Muhammad Nadeem

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