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Quixidar (fondaparinux sodium) – Package leaflet - B01AX05

Updated on site: 09-Oct-2017

Medication nameQuixidar
ATC CodeB01AX05
Substancefondaparinux sodium
ManufacturerGlaxo Group Ltd.

PACKAGE LEAFLET: INFORMATION FOR THE USER

Quixidar 1.5 mg/0.3 ml solution for injection fondaparinux sodium

Read all of this leaflet carefully before you start using this medicine.

 

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 personally. Do not pass it on to others. It may harm

them, even if their symptoms seem to be the same as yours.

 

If any of the side effects get serious or if you notice any side effects not listed in this leaflet,

 

please tell your doctor or pharmacist.

authorised

In this leaflet:

1.

What Quixidar is and what it is used for

2.

Before you use Quixidar

3.

How to use Quixidar

4.

Possible side effects

5.

How to store Quixidar

6.

Further information

 

1.

WHAT QUIXIDAR IS AND WHAT IT IS USED FOR

 

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

Quixidar 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.

no

longer

 

Quixidar 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. Product

2. BEFORE YOU USE QUIXIDAR Do not use Quixidar:

if you are allergic (hypersensitive) to fondaparinux sodium or to any of the other ingredients of Quixidar

if you are bleeding excessively

if you have a bacterial heart infection

if you have very severe kidney disease.Medicinal

→ Tell your doctor if you think any of these applies to you. If they do, you must not use Quixidar.

Take special care with Quixidar:

Your doctor needs to know before you take Quixidar:

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

 

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

Using other medicines

authorised

 

Tell your doctor or pharmacist if you are taking any other medicines, or have recently taken any. This includes medicines you bought without a prescription. Some other medicines may affect the way that Quixidar works or be affected by Quixidar.

Pregnancy and breast feeding

Quixidar should not be prescribed to pregnant women unless clearly necessary. Breast-feeding is not recommended during treatment with Quixidar. If you are pregnant, think you might be, or if you are breast feeding:

→ tell your doctor or pharmacist.

Important information about some of the ingredientslongerof Quixidar

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

3. HOW TO USE QUIXIDAR

Always use Quixidar exactly as your doctor has told you. You should check with your doctor or

pharmacist if you are not sure.

 

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

 

 

 

no

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

How is Quixidar given

 

 

Quixidar 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 Quixidar into muscle.

 

 

 

Product

 

How long should Quixidar be taken for

 

You should continue Quixidar treatment for as long as your doctor has told you, since Quixidar

prevents development of a serious condition.

 

MedicinalIf you forget to take Quixidar

 

If you inject too much Quixidar

Contact your doctor or pharmacist for advice as soon as possible because of the increased risk of bleeding.

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 Quixidar 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 about how to use this product, ask your doctor or pharmacist.

4.POSSIBLE SIDE EFFECTS

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

These may affect up to 1 in 100 people treated with Quixidar.

authorised

Common side effects

 

These may affect more than 1 in 100 people treated with Quixidar.

 

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

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.longer

Rare side effects

These may affect up to 1 in every 1000 people treated with Quixidar.

allergic reaction

 

no

internal bleeding in the brain or abdomen

anxiety or confusion

headache

Product

fainting or dizziness, low blood pressure

 

drowsiness or tiredness

 

flushing

 

 

coughing

 

 

leg pain or stomach pain

 

diarrhoea or constipation

 

indigestion

 

 

Medicinal• Keep out of the reach and sight of children

wound infection

 

 

increase in bilirubin (a substance produced by the liver) in the blood

reduction in potassium in your blood.

 

If you get side effects

Tell your doctor or pharmacist if any of the side effects gets severe or troublesome, or if you notice any side effects not listed in this leaflet.

5. HOW TO STORE QUIXIDAR

Do not freeze

Quixidar does not need to be kept in the fridge.

Do not use Quixidar:

after the expiry date stated on the label and carton

Marketing Authorisation Holder and Manufacturer

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

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. FURTHER INFORMATION

What Quixidar contains

authorised

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.

 

Quixidar does not contain any animal products.

What Quixidar looks like and contents of the pack

Quixidar is a clear and colourless solution for injection. It is supplied in a pre-filled, single-use syringe fitted with an automatic 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 Authorization Holder:

no

longer

Glaxo Group Ltd, Greenford, Middlesex, UB6 0NN, United Kingdom

Manufacturer:

Product

 

 

 

 

 

Glaxo Wellcome Production, 1 rue de l'Abbaye, F-76960 Notre Dame de Bondeville, France.

This leaflet was last approved in

Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http://www.emea.europa.eu

Medicinal

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

België/Belgique/Belgien

GlaxoSmithKline s.a./n.v.

Tél/Tel: + 32 (0)2 656 21 11

България

ГлаксоСмитКлайн ЕООД

Teл.: + 359 2 953 10 34

Česká republika

GlaxoSmithKline s.r.o. Tel: + 420 222 001 111 gsk.czmail@gsk.com

Danmark

GlaxoSmithKline Pharma A/S Tlf: + 45 36 35 91 00 info@glaxosmithkline.dk

Deutschland

GlaxoSmithKline GmbH & Co. KG Tel.: + 49 (0)89 36044 8701 produkt.info@gsk.com

Eesti

GlaxoSmithKline Eesti OÜ

Tel: + 372 6676 900

Ελλάδα

Product

 

GlaxoSmithKline A.E.B.E.

Τηλ: + 30 210 68 82 100

España

 

GlaxoSmithKline, S.A.

 

Tel: + 34 902 202 700

 

Medicinal

 

es-ci@gsk.com

 

France

Laboratoire GlaxoSmithKline Tél.: + 33 (0)1 39 17 84 44 diam@gsk.com

Ireland

GlaxoSmithKline (Ireland) Limited

Tel: + 353 (0)1 4955000

Ísland

GlaxoSmithKline ehf. Sími: + 354 530 3700

Luxembourg/Luxemburg

GlaxoSmithKline s.a./n.v.

Belgique/Belgien

Tél/Tel: + 32 (0)2 656 21 11

nlinfo@gsk.com

authorised

Magyarország

 

GlaxoSmithKline Kft.

 

Tel.: + 36 1 225 5300

 

Malta

GlaxoSmithKline Malta

Tel: + 356 21 238131

Nederland

GlaxoSmithKline BV

Tel: + 31 (0)30 6938100

Norge

GlaxoSmithKline AS

Tlf: + 47 22 70 20 00

firmapost@gsk.no

Österreich

 

longer

GlaxoSmithKline Pharma GmbH

Tel: + 43 (0)1 97075 0

at.info@gsk.com

no

 

Polska

GSK Commercial Sp. z o.o.

Tel.: + 48 (0)22 576 9000

Portugal

GlaxoSmithKline – Produtos Farmacêuticos, Lda.

Tel: + 351 21 412 95 00

FI.PT@gsk.com

România

GlaxoSmithKline (GSK) S.R.L.

Tel: + 4021 3028 208

Slovenija

GlaxoSmithKline d.o.o. Tel: + 386 (0)1 280 25 00 medical.x.si@gsk.com

Slovenská republika

GlaxoSmithKline Slovakia s. r. o. Tel: + 421 (0)2 48 26 11 11 recepcia.sk@gsk.com

Italia

Suomi/Finland

GlaxoSmithKline S.p.A.

GlaxoSmithKline Oy

Tel: + 39 (0)45 9218 111

Puh/Tel: + 358 (0)10 30 30 30

 

Finland.tuoteinfo@gsk.com

Κύπρος

GlaxoSmithKline Cyprus Ltd Τηλ: + 357 22 89 95 01

Latvija

GlaxoSmithKline Latvia SIA Tel: + 371 7312687 lv-epasts@gsk.com

Lietuva

GlaxoSmithKline Lietuva UAB Tel: + 370 5 264 90 00 info.lt@gsk.com

Medicinal

Product

 

Sverige

GlaxoSmithKline AB Tel: + 46 (0) 8 638 93 00 info.produkt@gsk.com

United Kingdom

 

GlaxoSmithKline UK

 

Tel: + 44 (0)800 221441

customercontactuk@gsk.com

 

longer

authorised

no

 

 

 

Parts of the safety syringe

1Rigid needle guard

2Cap

3Plunger

4Finger-grip

5Security sleeve

Syringe BEFORE USE

Syringe AFTER USE

STEP BY STEP GUIDE TO USING QUIXIDAR

longer

 

Instructions for use

 

no

 

 

 

 

1. Wash your hands thoroughly with soap and water and dry them with

 

Product

 

 

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

the expiry date has not passed

the solution is clear and colourless and doesn’t contain particles

the syringe has not been opened or damaged

3. Sit or lie down in a comfortable position.

Choose a place in the lower abdominal (tummy) area, at least 5 cm below your belly button (picture A).

Alternate the left and right side of the lower abdominal area

Medicinalat each injection. This will help to reduce the discomfort at the injection site.

If injecting in the lower abdominal area is not possible, ask your nurse or doctor for advice.

Picture A

4. Clean the injection area with an alcohol wipe.

5. Hold the body of the syringe firmly in one hand.

Remove the cap that protects the plunger by pulling it off (picture B).

Discard the plunger cap.

authorised

a towel.

Picture B

6. Remove the needle guard, by first twisting it and then pulling it in a straight line away from the body of the syringe (picture C).

Discard the needle guard.

Important note

Do not touch the needle or allow it to touch any surface before the injection.

It is normal to see a small air bubble in this syringe. Do

not try to remove this air bubble before making the

injection - you may lose some of the medicine if you do. Picture C

7. Gently pinch the skin that has been cleaned to make a fold. Hold the fold between the thumb and the forefinger during the entire injection (picture D).

 

 

 

Picture D

8. Hold the syringe firmly by the finger grip.

 

 

Insert the full length of the needle at right angles into the skin

 

fold (picture E).

 

 

 

 

 

 

Picture E

 

 

longer

9. Inject ALL of the contents of the syringe by pressing

 

down on the plunger as far as it goes. This will activate the

 

automatic needle protection system (picture F).no

 

 

 

 

 

Picture F

10. Release the plunger

and the needle will automatically

 

withdraw from the skin and go back into the security sleeve

 

 

Product

 

 

where it will be locked permanently (picture G).

 

 

Medicinal

 

 

Picture G

 

 

 

Do not dispose of the used syringe in the household waste. Dispose of it pharmacist has instructed.

authorised

as your doctor or

PACKAGE LEAFLET: INFORMATION FOR THE USER

Quixidar 2.5 mg/0.5 ml solution for injection fondaparinux sodium

Read all of this leaflet carefully before you start using this medicine.

 

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 personally. Do not pass it on to others. It may harm

them, even if their symptoms seem to be the same as yours.

 

If any of the side effects get serious or if you notice any side effects not listed in this leaflet,

 

please tell your doctor or pharmacist.

 

authorised

In this leaflet:

 

1.

What Quixidar is and what it is used for

 

2.

Before you use Quixidar

 

3.

How to use Quixidar

 

4.

Possible side effects

 

5.

How to store Quixidar

 

 

 

6.

Further information

longer

 

antithrombotic agent).

 

1.

WHAT QUIXIDAR IS AND WHAT IT IS USED FOR

 

Quixidar is a medicine that helps prevent blood clots from forming in the blood vessels (an

Quixidar contains a synthetic substance callednofondaparinux 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.

Quixidar 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 some types of heart attack and severe angina (pain caused by narrowing of the arteries in the heart). Product

2. BEFORE YOU USE QUIXIDAR Do not use Quixidar:

if you are allergic (hypersensitive) to fondaparinux sodium or to any of the other ingredients of Quixidar

if you are bleeding excessively

if you have a bacterial heart infection

if you have very severe kidney disease.Medicinal

→ Tell your doctor if you think any of these applies to you. If they do, you must not use Quixidar.

Take special care with Quixidar:

 

Your doctor needs to know before you take Quixidar:

 

if you have a risk of uncontrolled bleeding (haemorrhage) including:

 

·

stomach ulcer

 

 

·

bleeding disorders

 

 

· recent bleeding in the brain (intracranial bleeding)

 

· recent surgery on the brain, spine or eye

 

if you have severe liver disease

authorised

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

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

Using other medicines

Tell your doctor or pharmacist if you are taking any other medicines, or have recently taken any. This includes medicines you bought without a prescription. Some other medicines may affect the way

Pregnancy and breast feeding

that Quixidar works or be affected by Quixidar. longer

Quixidar should not be prescribed to pregnant women unless clearly necessary. Breast-feeding is not recommended during treatment with Quixidar. If you are pregnant, think you might be, or if you are breast-feeding:

→ tell your doctor or pharmacist.

3. HOW TO USE QUIXIDAR

no

Important information about some of the ingredients of Quixidar

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

Always use Quixidar exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

The usual 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 Quixidar is given

Product

Quixidar 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. To treat some types of heart attack, a health professional may give the first dose into a

vein (intravenously).

Do not inject Quixidar into muscle.

Medicinal

 

How long Quixidar should be taken for

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

If you inject too much Quixidar

Contact your doctor or pharmacist for advice as soon as possible, because of the increased risk of bleeding.

If you forget to take Quixidar

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 Quixidar 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 about how to use this product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

 

 

authorised

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

Common side effects

 

These may affect more than 1 in 100 people treated with Quixidar.

 

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 Quixidar.

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.longer

Rare side effects

Product

These may affect up to 1 in 1000 people treated with Quixidar.

allergic reaction

 

internal bleeding in the brain or abdomen

anxiety or confusion

Medicinal

 

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

If you get side effects

→ Tell your doctor or pharmacist if any of the side effects gets severe or troublesome, or if you notice any side effects not listed in this leaflet.

Quixidar does not contain any animal products.
Disposal of syringes:

5. HOW TO STORE QUIXIDAR

Keep out of the reach and sight of children

Do not freeze

Quixidar does not need to be kept in a fridge.

Do not use Quixidar:

 

after the expiry date stated on the label and carton

authorised

 

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.

 

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. FURTHER INFORMATION

longer

What Quixidar contains

The active substance is 2.5 mg fondaparinux sodium in 0.5 ml solution for injection

The other ingredients are sodium chloride, water for injections, and hydrochloric acid and/or sodium hydroxide to adjust the pH.

What Quixidar looks like and contents of thenopack

Marketing Authorisation Holder and Manufacturer

Quixidar is a clear and colourless solution for injection. It is supplied in a pre-filled, single-use syringe fitted with an automaticProductsafety 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 Authorization Holder:

Glaxo Group Ltd, Greenford, Middlesex, UB6 0NN, United Kingdom

Manufacturer:

MedicinalGlaxo Wellcome Production, 1 rue de l'Abbaye, F-76960 Notre Dame de Bondeville, France.

This leaflet was last approved in

Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http://www.emea.europa.eu

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

België/Belgique/Belgien

GlaxoSmithKline s.a./n.v.

Tél/Tel: + 32 (0)2 656 21 11

България

ГлаксоСмитКлайн ЕООД

Teл.: + 359 2 953 10 34

Česká republika

GlaxoSmithKline s.r.o. Tel: + 420 222 001 111 gsk.czmail@gsk.com

Danmark

GlaxoSmithKline Pharma A/S Tlf: + 45 36 35 91 00 info@glaxosmithkline.dk

Deutschland

GlaxoSmithKline GmbH & Co. KG Tel.: + 49 (0)89 36044 8701 produkt.info@gsk.com

Eesti

GlaxoSmithKline Eesti OÜ

Tel: + 372 6676 900

Ελλάδα

Product

 

GlaxoSmithKline A.E.B.E.

Τηλ: + 30 210 68 82 100

España

 

GlaxoSmithKline, S.A.

 

Tel: + 34 902 202 700

 

Medicinal

 

es-ci@gsk.com

 

France

Laboratoire GlaxoSmithKline Tél.: + 33 (0)1 39 17 84 44 diam@gsk.com

Ireland

GlaxoSmithKline (Ireland) Limited

Tel: + 353 (0)1 4955000

Ísland

GlaxoSmithKline ehf. Sími: + 354 530 3700

Luxembourg/Luxemburg

GlaxoSmithKline s.a./n.v.

Belgique/Belgien

Tél/Tel: + 32 (0)2 656 21 11

nlinfo@gsk.com

authorised

Magyarország

 

GlaxoSmithKline Kft.

 

Tel.: + 36 1 225 5300

 

Malta

GlaxoSmithKline Malta

Tel: + 356 21 238131

Nederland

GlaxoSmithKline BV

Tel: + 31 (0)30 6938100

Norge

GlaxoSmithKline AS

Tlf: + 47 22 70 20 00

firmapost@gsk.no

Österreich

 

longer

GlaxoSmithKline Pharma GmbH

Tel: + 43 (0)1 97075 0

at.info@gsk.com

no

 

Polska

GSK Commercial Sp. z o.o.

Tel.: + 48 (0)22 576 9000

Portugal

GlaxoSmithKline – Produtos Farmacêuticos, Lda.

Tel: + 351 21 412 95 00

FI.PT@gsk.com

România

GlaxoSmithKline (GSK) S.R.L.

Tel: + 4021 3028 208

Slovenija

GlaxoSmithKline d.o.o. Tel: + 386 (0)1 280 25 00 medical.x.si@gsk.com

Slovenská republika

GlaxoSmithKline Slovakia s. r. o. Tel: + 421 (0)2 48 26 11 11 recepcia.sk@gsk.com

Italia

Suomi/Finland

GlaxoSmithKline S.p.A.

GlaxoSmithKline Oy

Tel: + 39 (0)45 9218 111

Puh/Tel: + 358 (0)10 30 30 30

 

Finland.tuoteinfo@gsk.com

Κύπρος

GlaxoSmithKline Cyprus Ltd Τηλ: + 357 22 89 95 01

Latvija

GlaxoSmithKline Latvia SIA Tel: + 371 7312687 lv-epasts@gsk.com

Lietuva

GlaxoSmithKline Lietuva UAB Tel: + 370 5 264 90 00 info.lt@gsk.com

Medicinal

Product

 

Sverige

GlaxoSmithKline AB

authorised

Tel: + 46 (0) 8 638 93 00 info.produkt@gsk.com

United Kingdom

GlaxoSmithKline UK

Tel: + 44 (0)800 221441

customercontactuk@gsk.com

no

longer

 

Parts of the safety syringe

1Rigid needle guard

2Cap

3Plunger

4Finger-grip

5Security sleeve

Syringe BEFORE USE

Syringe AFTER USE

STEP BY STEP GUIDE TO USING QUIXIDAR

longer

 

Instructions for use

 

no

 

 

 

 

1. Wash your hands thoroughly with soap and water and dry them with

 

Product

 

 

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

• the expiry date has not passed

• the solution is clear and colourless and doesn’t contain particles

• the syringe has not been opened or damaged

3. Sit or lie down in a comfortable position.

Choose a place in the lower abdominal (tummy) area, at least 5 cm below your belly button (picture A).

Alternate the left and right side of the lower abdominal area

Medicinalat each injection. This will help to reduce the discomfort at the injection site.

If injecting in the lower abdominal area is not possible, ask your nurse or doctor for advice.

Picture A

4. Clean the injection area with an alcohol wipe.

5. Hold the body of the syringe firmly in one hand.

Remove the cap that protects the plunger by pulling it off (picture B).

Discard the plunger cap.

authorised

a towel.

Picture B

6. Remove the needle guard, by first twisting it and then pulling it in a straight line away from the body of the syringe (picture C).

Discard the needle guard.

Important note

Do not touch the needle or allow it to touch any surface before the injection.

It is normal to see a small air bubble in this syringe. Do

not try to remove this air bubble before making the

injection - you may lose some of the medicine if you do. Picture C

7. Gently pinch the skin that has been cleaned to make a fold. Hold the fold between the thumb and the forefinger during the entire injection (picture D).

 

 

 

Picture D

8. Hold the syringe firmly by the finger grip.

 

 

Insert the full length of the needle at right angles into the skin

 

fold (picture E).

 

 

 

 

 

 

Picture E

 

 

longer

9. Inject ALL of the contents of the syringe by pressing

 

down on the plunger as far as it goes. This will activate the

 

automatic needle protection system (picture F).no

 

 

 

 

 

Picture F

10. Release the plunger and the needle will automatically

 

withdraw from the skin and go back into the security sleeve

 

 

Product

 

 

where it will be locked permanently (picture G).

 

 

Medicinal

 

 

Picture G

 

 

 

Do not dispose of the used syringe in the household waste. Dispose of it pharmacist has instructed.

authorised

as your doctor or

In this leaflet:
1. What Quixidar is and what it is used for 2. Before you use Quixidar
3. How to use Quixidar

4. Possible side effects

5. How to store Quixidar
6. Further information

PACKAGE LEAFLET

Quixidar 5 mg/0.4 ml solution for injection.

Quixidar 7.5 mg/0.6 ml solution for injection

Quixidar 10 mg/0.8 ml solution for injection

Fondaparinux sodium

Read all of this leaflet carefully before you start using this medicine.

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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 personally. Do not pass it on to others. It may harm

them, even if their symptoms seem to be the same as yours.

 

If any of the side effects get serious or if you notice any side effects not listed in this leaflet,

 

please tell your doctor or pharmacist.

 

longer 1. WHAT QUIXIDAR IS AND WHAT IT IS USED FOR

Quixidar is a medicine that treats or helps to prevent blood clots from forming in the blood

vessels (an antithrombotic agent).

no

 

Quixidar contains a synthetic substance called fondaparinux sodium. This stops a clotting factor Xa

Do not use Quixidar: Product

(“ten-A”) from working in the blood, and so prevents unwanted blood clots (thromboses) from forming in the blood vessels.

Quixidar is used to treat patients with a blood clot in the blood vessels of their legs (deep vein thrombosis) and/or lungs (pulmonary embolism).

2. BEFORE YOU USE QUIXIDAR

if you are allergic (hypersensitive) to fondaparinux sodium or to any of the other ingredients of Quixidar

if you are bleeding excessively

if you have a bacterial heart infection

if you have severe kidney disease.

Medicinal→ Tell your doctor if you think any of these applies to you. If they do, you must not use Quixidar.

Take special care with Quixidar:

Your doctor needs to know before you take Quixidar:

• if you have a risk 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

Important information about some of the ingredients of Quixidar

if you are 75 years old or older.

→ Tell your doctor if any of these applies to you.

Children

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

Using other medicines

Tell your doctor or pharmacist if you are taking any other medicines, or have recently taken any. authorised

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

Pregnancy and breast feeding

Quixidar should not be prescribed to pregnant women unless clearly necessary. Breast-feeding is not recommended during treatment with Quixidar. If you are pregnant, think you might be, or if you are breast feeding:

→ tell your doctor or pharmacist.

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

3. HOW TO USE QUIXIDAR

 

Below 50 kg

 

 

5 mglongeronce a day

 

Always use Quixidar exactly as your doctor has told you. You should check with your doctor or

 

pharmacist if you are not sure.

 

 

 

Your weight

 

 

Usual dose

 

Between 50 kg and 100 kg

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7.5 mg once a day

 

Over 100 kg

Product

 

10 mg once a day. This dose may be reduced to

 

 

the page.

 

7.5 mg once a day if you have moderate kidney

 

 

 

 

 

 

 

 

 

 

disease.

 

You should inject at about the same time each day.

 

How Quixidar is given

 

 

 

 

Quixidar is given by injection under the skin (subcutaneously) into a skin fold of the lower

 

 

abdominal area. They syringes are pre-filled with the exact dose you need. There are different

 

 

syringes for the 5 mg, 7.5 mg and 10 mg doses. For step-by-step instructions please see over

Medicinal

 

 

 

 

Do not inject Quixidar into muscle.

 

 

How long should Quixidar be taken for

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

If you inject too much Quixidar

Contact your doctor or pharmacist for advice as soon as possible, because of the increased risk of bleeding.

If you forget to take Quixidar

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 Quixidar without advice

If you stop the treatment before your doctor told you to, the blood clot may not be treated properly and you may also be at risk of developing a new blood clot in a vein of your leg or in the lung. Contact your doctor or pharmacist before stopping.

If you have any further questions about how to use this product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

 

 

 

 

 

 

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

Common side effects

 

 

 

 

 

These may affect more than 1 in 100 people treated with Quixidar.

 

bleeding (for example from an operation site, an existing stomach ulcer, nosebleed, bruising)

Uncommon side effects

 

 

 

 

These may affect up to 1 in 100 people treated with Quixidar.

 

swelling (oedema)

 

 

 

 

headache

 

 

 

 

 

pain

 

 

 

 

 

feeling sick or being sick (nausea or

vomiting)

 

 

low number of red blood cells (anaemia)

 

 

 

low number of platelets (blood cells necessary for blood clotting)

 

increase in some chemical (enzymes) produced by the liver

 

Rare side effects

 

 

 

 

 

These may affect up to 1 in every 1000 people treated with Quixidar.

 

allergic reaction

 

 

 

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internal bleeding in the brain, liver or abdomen

 

 

rash

Product

no

 

 

dizziness

 

 

pain and swelling at injection site

 

 

 

 

high number of platelets (blood cells necessary for blood clotting)

 

increase in the amount of non-protein nitrogen in the blood

 

If you get side effects

 

 

 

 

 

Tell your doctor or pharmacist if any of the side effects gets severe or troublesome, or if you

notice any side effects not listed in this leaflet.

 

 

 

Medicinalif you have opened a syringe and you do not use it straightaway.

 

5.

HOW TO STORE QUIXIDAR

 

 

 

 

Keep out of the reach and sight of children

 

 

Do not freeze

 

 

 

 

 

Quixidar does not have to be kept in the fridge.

 

 

Do not use Quixidar:

 

 

 

 

 

after the expiry date stated 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

 

 

 

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. FURTHER INFORMATION
What Quixidar contains
The active substance is:
5 mg fondaparinux sodium in 0.4 ml solution for injection
7.5 mg fondaparinux sodium in 0.6 ml solution for injection
10 mg fondaparinux sodium in 0.8 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.

Quixidar does not contain any animal products.

What Quixidar looks like and contents of the pack

Quixidar is a clear and colourless to slightly yellow solution for injection. It is supplied in a pre-filled syringe fitted with an automatic 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

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Marketing Authorization Holder:

 

Glaxo Group Ltd, Greenford, Middlesex, UB6 0NN, United Kingdom

Manufacturer:

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Glaxo Wellcome Production, 1 rue de l'Abbaye, F-76960 Notre Dame de Bondeville, France.

This leaflet was last approved in

Detailed information on this medicine is available on the European Medicines Agency (EMEA) web

site: http://www.emea.europa.eu

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Medicinal

Product

 

 

 

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

België/Belgique/Belgien

GlaxoSmithKline s.a./n.v.

Tél/Tel: + 32 (0)2 656 21 11

България

ГлаксоСмитКлайн ЕООД

Teл.: + 359 2 953 10 34

Česká republika

GlaxoSmithKline s.r.o. Tel: + 420 222 001 111 gsk.czmail@gsk.com

Danmark

GlaxoSmithKline Pharma A/S Tlf: + 45 36 35 91 00 info@glaxosmithkline.dk

Deutschland

GlaxoSmithKline GmbH & Co. KG Tel.: + 49 (0)89 36044 8701 produkt.info@gsk.com

Eesti

GlaxoSmithKline Eesti OÜ

Tel: + 372 6676 900

Ελλάδα

Product

 

GlaxoSmithKline A.E.B.E.

Τηλ: + 30 210 68 82 100

España

 

GlaxoSmithKline, S.A.

 

Tel: + 34 902 202 700

 

Medicinal

 

es-ci@gsk.com

 

France

Laboratoire GlaxoSmithKline Tél.: + 33 (0)1 39 17 84 44 diam@gsk.com

Ireland

GlaxoSmithKline (Ireland) Limited

Tel: + 353 (0)1 4955000

Ísland

GlaxoSmithKline ehf. Sími: + 354 530 3700

Luxembourg/Luxemburg

GlaxoSmithKline s.a./n.v.

Belgique/Belgien

Tél/Tel: + 32 (0)2 656 21 11

nlinfo@gsk.com

authorised

Magyarország

 

GlaxoSmithKline Kft.

 

Tel.: + 36 1 225 5300

 

Malta

GlaxoSmithKline Malta

Tel: + 356 21 238131

Nederland

GlaxoSmithKline BV

Tel: + 31 (0)30 6938100

Norge

GlaxoSmithKline AS

Tlf: + 47 22 70 20 00

firmapost@gsk.no

Österreich

 

longer

GlaxoSmithKline Pharma GmbH

Tel: + 43 (0)1 97075 0

at.info@gsk.com

no

 

Polska

GSK Commercial Sp. z o.o.

Tel.: + 48 (0)22 576 9000

Portugal

GlaxoSmithKline – Produtos Farmacêuticos, Lda.

Tel: + 351 21 412 95 00

FI.PT@gsk.com

România

GlaxoSmithKline (GSK) S.R.L.

Tel: + 4021 3028 208

Slovenija

GlaxoSmithKline d.o.o. Tel: + 386 (0)1 280 25 00 medical.x.si@gsk.com

Slovenská republika

GlaxoSmithKline Slovakia s. r. o. Tel: + 421 (0)2 48 26 11 11 recepcia.sk@gsk.com

Italia

Suomi/Finland

GlaxoSmithKline S.p.A.

GlaxoSmithKline Oy

Tel: + 39 (0)45 9218 111

Puh/Tel: + 358 (0)10 30 30 30

Κύπρος

GlaxoSmithKline Cyprus Ltd Τηλ: + 357 22 89 95 01

Latvija

GlaxoSmithKline Latvia SIA Tel: + 371 7312687 lv-epasts@gsk.com

Lietuva

GlaxoSmithKline Lietuva UAB Tel: + 370 5 264 90 00 info.lt@gsk.com

Medicinal

Product

 

Sverige

GlaxoSmithKline AB Tel: + 46 (0) 8 638 93 00 info.produkt@gsk.com

United Kingdom

 

GlaxoSmithKline UK

 

Tel: + 44 (0)800 221441

customercontactuk@gsk.com

 

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Parts of the safety syringe

1Rigid needle guard

2Cap

3Plunger

4Finger-grip

5Security sleeve

Syringe BEFORE USE

Syringe AFTER USE

STEP BY STEP GUIDE TO USING QUIXIDAR

longer

 

 

1.

Wash your hands thoroughly with soap and water and dry them with

2.

 

 

no

 

 

Remove the syringe from the carton and check that:

 

 

the expiry date has not passed

 

 

 

 

the solution is clear and colourless to slightly yellow and doesn’t

your nurse or doctor for Productadvice.

 

 

 

 

the syringe has not been opened or damaged

 

 

3.

Sit or lie down in a comfortable position.

 

 

 

Choose a place in the lower abdominal (tummy) area, at least

 

5 cm below your belly button (picture A).

 

 

 

Alternate the left and right side of the lower abdominal area

 

at each injection. This will help to reduce the discomfort at the

 

injection site.

 

 

 

If injecting in the lower abdominal area is not possible, ask

 

Medicinal

 

 

Picture A

 

 

 

 

 

4.

Clean the injection area with an alcohol wipe.

 

 

5.

Hold the body of the syringe firmly in one hand.

 

 

Remove the cap that protects the plunger by pulling it off

 

(picture B).

Discard the plunger cap.

Picture B

6. Remove the needle guard, by first twisting it and then pulling it in a straight line away from the body of the syringe (picture C).

authorised

a towel.

contain particles

Discard the needle guard.

Important note

Do not touch the needle or allow it to touch any surface before the injection.

It is normal to see a small air bubble in this syringe. Do not try to remove this air bubble before making the injection - you may lose some of the medicine if you do.

Picture C

7. Gently pinch the skin that has been cleaned to make a fold. Hold the fold between the thumb and the forefinger during the entire injection (picture D).

Picture D

9.

Inject ALL of the contents of the syringe by pressinglonger

8.

Hold the syringe firmly by the finger grip.

Insert the full length of the needle at right angles into the skin

fold (picture E).

Picture E

 

 

no

 

down on the plunger as far as it goes. This will activate the

 

automatic needle protection system (picture F).

 

 

 

Product

 

Picture F

 

 

 

10. Release the plunger and the needle will automatically

 

withdraw from the skin and go back into the security sleeve

 

where it will be locked permanently (picture G).

 

Medicinal

 

 

Picture G

 

 

 

Do not dispose of the used syringe in the household waste. Dispose of it pharmacist has instructed.

authorised

as your doctor or

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