ARIXTRA 5 mg/0.4 mL Injectable Solution, Prefilled Syringe
How to use ARIXTRA 5 mg/0.4 mL Injectable Solution, Prefilled Syringe
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This page provides general information and does not replace a doctor’s consultation. Always consult a doctor before taking any medication. Seek urgent medical care if symptoms are severe.
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Introduction
Package Leaflet: Information for the User
Arixtra 5 mg/0.4 ml Solution for Injection
Arixtra 7.5 mg/0.6 ml Solution for Injection
Arixtra 10 mg/0.8 ml Solution for Injection
sodium fondaparinux
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.
- This medicine has been prescribed for you only.Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
- If you get any side effects,talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
Contents of the pack:
- What is Arixtra and what is it used for
- What you need to know before you use Arixtra
- How to use Arixtra
- Possible side effects
- Storage of Arixtra
- Contents of the pack and further information
1. What is Arixtra and what is it used for
Arixtra is a medicine used to treat or help prevent the formation of blood clots in blood vessels (an antithrombotic agent).Arixtra contains a synthetic substance called sodium fondaparinux. This stops the effect of coagulation factor Xa in the blood and thus prevents the formation of unwanted blood clots (thrombi) in blood vessels.
Arixtra is used to treat adults who have blood clots in the blood vessels of their legs (deep vein thrombosis)and/or lungs (pulmonary embolism).
2. What you need to know before you use Arixtra
Do not use Arixtra:
- Tell your doctorif you think any of these situations apply to you. If so, you must notuse Arixtra.
Arixtra.
Warnings and precautions:
Talk to your doctor or pharmacist before you start using Arixtra:
- stomach ulcer
- bleeding disorders
- recent bleeding in the brain(intracranial haemorrhage)
- recent brain, spinal or eye surgery;
- Tell your doctorif any of these situations apply to you.
Children and adolescents
Arixtra has not been tested in children and adolescents under 17 years of age.
Using Arixtra with other medicines
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines, including those obtained without a prescription.
The use of other medicines may affect how Arixtra works or be affected by Arixtra.
Pregnancy and breast-feeding
Arixtra should not be given to pregnant women unless clearly necessary. Breast-feeding is not recommended during treatment with Arixtra. If you are pregnant, or think you might be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
Arixtra contains sodium
This medicine contains less than 23 mg of sodium per dose; it is essentially “sodium-free”.
The Arixtra syringe contains latex
The needle protector of the syringe contains latex, which may cause allergic reactions in people sensitive to latex.
Tell your doctorif you are allergic to latex before being treated with Arixtra.
3. How to use Arixtra
Follow exactly the instructions of administration of this medicine given by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist.
Your weight | Normal dose |
Less than 50 kg | 5 mg once a day |
Between 50 and 100 kg | 7.5 mg once a day |
More than 100 kg | 10 mg once a day. This dose may be reduced to |
7.5 mg once a day if you have moderate kidney disease. | |
It should be injected at approximately the same time each day.
How to administer Arixtra
- Arixtra is given by injection under the skin (subcutaneously) in a skin fold of the lower abdominal area. The syringes are pre-filled with the exact dose that you need. There are different syringes for the 5 mg, 7.5 mg and 10 mg doses.For a detailed description of how to use Arixtra, see the end of this leaflet.
- Do notinject Arixtra into a muscle (intramuscularly).
For how long should you use Arixtra
You should use Arixtra for the period of time that your doctor has told you, as Arixtra prevents you from having a serious illness.
If you inject more Arixtra than you should
Contact your doctor or pharmacist immediately because there is an increased risk of bleeding.
If you forget to use Arixtra
- Administer the dose as soon as you remember. Do not inject a double dose to make up for forgotten doses.
- In case of doubt,contact your doctor or pharmacist.
If you stop using Arixtra
If you stop treatment before your doctor has told you to, the blood clot may not have been treated properly and you may be at risk of developing a new blood clot in a vein in your leg or in the lung. Before stopping treatment, contactyour doctor or pharmacist.
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.
Symptoms to look out for
Severe allergic reactions(anaphylaxis): are very rare (up to 1 in 10,000) in patients using Arixtra. The symptoms include:
- swelling, sometimes of the face or mouth (angioedema), which can cause difficulty in swallowing or breathing
- collapse.
- Contact a doctor immediatelyif you experience these symptoms. Stop using Arixtra.
Common side effects
These may affect more than 1 in 100 patientstreated with Arixtra.
- bleeding(e.g. from the area where the operation was performed, from a stomach ulcer, nosebleeds, blood in the urine, coughing up blood, eye bleeding, bleeding into joints, internal bleeding in the uterus)
- localised accumulation of blood(in any organ or body tissue)
- anaemia(reduction in the number of red blood cells)
- bruising
Uncommon side effects
These may affect up to 1 in 100 patientstreated with Arixtra.
- swelling (oedema)
- headache
- pain
- chest pain
- difficulty breathing
- skin rash or itching
- wound secretion
- fever
- feeling or being sick (nausea or vomiting)
- reduction or increase in the number of platelets (blood cells needed for clotting) increase in some chemicals (enzymes) produced by the liver
Rare side effects
These may affect up to 1 in 1,000 patientstreated with Arixtra.
- allergic reaction
- internal bleeding in the brain, liver or abdomen
- anxiety or confusion
- fainting or dizziness, low blood pressure
- sleepiness or tiredness
- flushing
- cough
- pain and inflammation at the injection site
- wound infection
- increase in blood of the amount of non-protein nitrogen
- leg pain or stomach pain
- indigestion
- diarrhoea or constipation
- increase in bilirubin (a substance produced by the liver) in the blood
- reduction of potassium in the blood
- pain around the top of the stomach or heartburn
If you experience side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet.
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.
5. Storage of Arixtra
- Keep this medicine out of the sight and reach of children.
- Store below 25°C. Do not freeze.
- It is not necessary to store Arixtra in the refrigerator.
Do not use this medicine:
- after the expiry date which is stated on the label and carton.
- if you notice the presence of particles or a change in the colour of the solution.
- if the syringe is damaged.
- if the syringe has been opened and is not to be used immediately.
Disposal of syringes
Medicines or syringes should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines or syringes no longer required. This will help protect the environment.
6. Container Contents and Additional Information
Arixtra Composition
The active ingredient:
- 5 mg of fondaparinux sodium in 0.4 ml of injectable solution
- 7.5 mg of fondaparinux sodium in 0.6 ml of injectable solution
- 10 mg of fondaparinux sodium in 0.8 ml of injectable solution
The other components are sodium chloride, water for injectable preparations, and hydrochloric acid and/or sodium hydroxide to adjust the pH (see section 2).
Arixtra does not contain any animal products.
Product Appearance and Container Contents
Arixtra is a clear and colorless or slightly yellowish injectable solution. It is presented in a pre-filled syringe for single use, equipped with a safety system that helps prevent accidental needlesticks after use.
It is presented in packs of 2, 7, 10, and 20 pre-filled syringes. Only some pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
Viatris Healthcare Limited, Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland
Manufacturer:
Aspen Notre Dame de Bondeville, 1 rue de l'Abbaye, F-76960 Notre Dame de Bondeville, France.
Date of Last Revision of this Leaflet:
Other Sources of Information
Detailed information on this medicinal product is available on the European Medicines Agency website http://www.ema.europa.eu
You can request more information about this medicinal product by contacting the local representative of the marketing authorization holder.
België/Belgique/Belgien Viatris Tél/Tel: + 32 (0)2 658 61 00 България Вятрис Тел.: +359 2 44 55 400 Ceská republika Viatris CZ s.r.o. Tel: + 420 222 004 400 | Lietuva Viatris UAB Tel: +370 5 205 1288 Luxembourg/Luxemburg Viatris Tél/Tel: + 32 (0)2 658 61 00 (Belgique/Belgien) Magyarország Viatris Healthcare Kft.Tel.: + 36 1 465 2100 |
Danmark Viatris ApS Tlf: +45 28 11 69 32 | Malta V.J. Salomone Pharma Ltd Tel: + 356 21 22 01 74 |
Deutschland Viatris Healthcare GmbH Tel: +49 800 0700 800 | Nederland Mylan Healthcare BV Tel: +31 (0)20 426 3300 |
Eesti Viatris OÜ Tel: + 372 6363 052 | Norge Viatris AS Tlf: + 47 66 75 33 00 |
Ελλάδα Viatris Hellas Ltd Τηλ: +30 2100 100 002 | Österreich Mylan Österreich GmbH Tel: +43 1 86390 |
España Viatris Pharmaceuticals, S.L. Tel: +34 900 102 712 | Polska Mylan Healthcare Sp. z o.o. Tel.: + 48 22 546 64 00 |
France Viatris Santé Tél: + 33 (0)4 37 25 75 00 | Portugal Viatris Healthcare, Lda. Tel: + 351 21 412 72 00 |
Hrvatska Viatris Hrvatska d.o.o. Tel: +385 1 23 50 599 | România BGP Products SRL Tel: +40 372 579 000 |
Ireland Mylan Ireland Limited Tel: +353 1 8711600 | Slovenija Viatris d.o.o. Tel: + 386 1 23 63 180 |
Ísland Icepharma hf Sími: +354 540 8000 | Slovenská republika Viatris Slovakia s.r.o. Tel: +421 2 32 199 100 |
Italia Viatris Italia S.r.l. Tel: + 39 02 612 46921 | Suomi/Finland Viatris Oy Puh/Tel: +358 20 720 9555 |
Κύπρος Varnavas Hadjipanayis Ltd Τηλ: +357 2220 7700 | Sverige Viatris AB Tel: + 46 (0)8 630 19 00 |
Latvija Viatris SIA Tel: +371 676 055 80 | United Kingdom (Northern Ireland) Mylan IRE Healthcare Limited +353 18711600 |
Drawing 3. Syringe with a manualneedle protection system with the safety cap covering the needle AFTER USE
USE
Types of Safety Syringes:
There are two types of safety syringes for Arixtra, designed to protect against accidental needlesticks after use. One type of syringe has an automaticneedle protection system and the other has a manualsystem.
Syringe Components:
- Needle protector
? Plunger
? Grip zone (with fingers)
- Needle safety cap
Drawing 1.Syringe with an automaticneedle protection system
Syringe with a manualneedle protection system
Drawing 2. Syringe with a manualneedle protection system
DESCRIPTION OF ARIXTRA USE MODEInstructions for Use
These instructions apply to both types of syringes (with automatic and manual needle protection systems).
When there is a different instruction between syringes, it will be specified clearly.
- Wash your handscarefully with water and soap and dry them with a towel.
- Remove the syringe from the packaging and check that:
- the expiration date has not passed
- the solution is clear and colorless and does not contain particles
- the syringe has not been opened or damaged
- Sit or lie down in a comfortable position.Select a point in the lower abdomen (belly), at least 5 cm below the navel (drawing A).
For each injection, alternate the left and right sidesof the lower abdomen. This will help reduce discomfort at the injection site.
If injection in the lower abdomen is not possible, ask your doctor.
Drawing A
- Clean the injection area with a swab or cotton ball soaked in alcohol.
- Remove the needle protector: first by twisting (drawing
B1) and then by pulling out from the syringe body (drawing B2).
Discard the needle protector.
Important Note
- Do not touch the needleand prevent it from coming into contact with any surface before injection.
- It is normal to find a small air bubble in the syringe. Do not try to eliminate this air bubblebefore applying the injectionas you may lose part of the medication.
- Gently pinch the skinthat you previously cleaned until a fold is formed. Hold the fold between your thumb and index finger throughout the injection (drawing C).
- Hold the syringe firmlyby the grip zone. Insert the needle into the skin fold at a right angle (drawing D).
Drawing B1
Drawing B
Drawing C
Drawing D
- Inject the entire contents of the syringeby pressing the plunger down to the maximum (drawing E).
Drawing E
Syringe with automatic system
- Release the plungerand the needle will automatically move from the skin into a safety cap where it will be permanently locked (drawing F).
Drawing F
Syringe with manual system
- After injection, hold the syringe by the needle safety cap with the fingers of one hand, grasp the grip zone with the fingers of the other hand, and pull back. This action releases the cap. Slide the cap along the syringe body until it is locked in a position that covers the needle, as shown in drawing 3.
Do not dispose of the used needlein the trash can.Dispose of it following the instructions given by your doctor or pharmacist.
- Country of registration
- Average pharmacy price164.86 EUR
- Active substance
- Prescription requiredYes
- Manufacturer
- This information is for reference only and does not constitute medical advice. Always consult a doctor before taking any medication. Oladoctor is not responsible for medical decisions based on this content.
- Alternatives to ARIXTRA 5 mg/0.4 mL Injectable Solution, Prefilled SyringeDosage form: INJECTABLE, 1.5 mgActive substance: fondaparinuxManufacturer: Viatris Healthcare LimitedPrescription requiredDosage form: INJECTABLE, 2.5 mgActive substance: fondaparinuxManufacturer: Viatris Healthcare LimitedPrescription requiredDosage form: INJECTABLE, 7.5 mgActive substance: fondaparinuxManufacturer: Viatris Healthcare LimitedPrescription required
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