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Synagis (palivizumab) – Package leaflet - J06BB16

Updated on site: 10-Oct-2017

Medication nameSynagis
ATC CodeJ06BB16
Substancepalivizumab
ManufacturerAbbVie Ltd  

Package leaflet: Information for the user

Synagis 50 mg powder and solvent for solution for injection

Palivizumab

Read all of this leaflet carefully before your child is given this medicine because it contains important information for you and your child.

Keep this leaflet. You may need to read it again.

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

If any of the side effects get serious, or if you notice that your child has any side effects not listed in this leaflet, please tell your doctor or pharmacist. See section 4

What is in this leaflet

1.What Synagis is and what it is used for

2.What you need to know before Synagis is given to your child

3.How will my child receive Synagis

4.Possible side effects

5.How to store Synagis

6.Contents of the pack and other information

1.What Synagis is and what it is used for

Synagis contains an active ingredient called palivizumab which is an antibody that works specifically against a virus called respiratory syncytial virus, RSV.

Your child is at high risk of getting an illness caused by a virus called respiratory syncytial virus (RSV).

Children who are more likely to get severe RSV disease (high risk children) include babies born prematurely (35 weeks or less) or babies born with certain heart or lung problems.

Synagis is a medicine to help protect your child from getting severe RSV illness

2. What you need to know before Synagis is given to your child

Your child should not be given Synagis

If he/she is allergic to palivizumab or any of the other ingredients of this medicine (listed in section 6). Signs and symptoms of a severe allergic reaction could include:

severe rash, hives, or itching skin

swelling of the lips, tongue, or face

closing of the throat, difficulty swallowing

difficult, rapid, or irregular breathing

bluish colour of skin, lips, or under fingernails

muscle weakness or floppiness

a drop in blood pressure

unresponsiveness

Warnings and precautions

Take special care with Synagis

if your child is unwell. Please tell your doctor if your child is unwell, as the use of Synagis may need to be delayed.

if your child has any bleeding disorders as Synagis is usually injected into the thigh.

Other medicines and Synagis

Synagis is not known to interact with other medicines. However, you should inform your doctor of all medicines your child is currently taking before starting Synagis.

3.How will my child receive Synagis

How often will Synagis be given to my child?

Synagis should be given to your child at a dose of 15 mg/kg body weight once a month for as long as the risk of RSV infection remains. For your child’s best protection, it is necessary to take the doctor’s advice about when to return for additional doses of Synagis.

If your child is to have a heart operation (cardiac bypass surgery), he or she may be given an extra dose of Synagis after the operation. Your child can then go back to the original planned injection.

How will my child receive Synagis?

Synagis will be given by injection to your child into a muscle, usually in the outer part of the thigh.

What should you do if your child misses an injection of Synagis?

If your child misses an injection, you should contact your doctor as soon as possible. Each injection of Synagis can only help protect your child for about one month before another injection is needed.

Always use this medicine exactly as your doctor or pharmacist has told you. If you are not sure about how this product will be given to your child, ask your doctor or pharmacist.

4.Possible side effects

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

Synagis may cause serious side effects including:

severe allergic reactions, such reactions may be life-threatening or fatal (see "Your child should not be given Synagis" for a list of signs and symptoms).

unusual bruising or groups of tiny red spots on the skin.

Call your doctor or get medical help right away if your child has any of the serious side effects listed above after receiving any dose of Synagis.

Additional side effects

Very common (affects at least 1 user in 10):

rash

fever

Common (affects 1 to 10 users in 100):

pain, redness or swelling at the injection site

a pause in breathing or other breathing difficulties

Uncommon (affects less than 1 user in 100):

fits

hives

Reporting of side effects

If your child gets any side effects, talk to your doctor. 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.How to store Synagis

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the label. The expiry date refers to the last day of that month.

Store in a refrigerator. (2ºC-8°C)

After reconsititution use within 3 hours.

Do not freeze.

Keep the vial in the carton in order to protect from light.

6. Contents of the pack and other information

What Synagis contains

-The active substance is palivizumab. 50 mg per vial, providing 100 mg/ml of palivizumab when reconstituted as recommended.

-The other ingredients are, - for the powder: histidine, glycine and mannitol.

-for the solvent: water for injections.

What Synagis looks like and contents of the pack

Synagis is presented as a powder and solvent for solution for injection (50 mg of powder in vial) + 1 ml of solvent in ampoule - Pack size of 1.

Synagis is a white to off-white cake.

Marketing Authorisation holder

AbbVie Ltd

Maidenhead

SL6 4UB

United Kingdom

Manufacturer

AbbVie S.r.l.

04011 Campoverde di Aprilia (Latina) Italy

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

België/Belgique/Belgien

Lietuva

AbbVie SA

AbbVie UAB

Tél/Tel: +32 10 477811

Tel: +370 5 205 3023

България

Luxembourg/Luxemburg

АбВи ЕООД

AbbVie SA

Тел.:+359 2 90 30 430

Belgique/Belgien

 

Tél/Tel: +32 10 477811

Česká republika

Magyarország

AbbVie s.r.o.

AbbVie Kft.

Tel: +420 233 098 111

Tel.:+36 1 455 8600

Danmark

Malta

AbbVie A/S

V.J.Salomone Pharma Limited

Tlf: +45 72 30-20-28

Tel: +356 22983201

Deutschland

Nederland

AbbVie Deutschland GmbH & Co. KG

AbbVie B.V.

Tel: 00800 222843 33 (gebührenfrei)

Tel: +31 (0)88 322 2843

 

Eesti

Norge

AbbVie Biopharmaceuticals GmbH Eesti filiaal

AbbVie AS

Tel: +372 623 1011

Tlf: +47 67 81 80 00

Ελλάδα

Österreich

AbbVie ΦΑΡΜΑΚΕΥΤΙΚΗ Α.Ε.

AbbVie GmbH

Τηλ: +30 214 4165 555

España

Polska

AbbVie Spain, S.L.U.

AbbVie Polska Sp. z o.o.

Tel: +34 9 1 384 09 10

Tel.: +48 22 372 78 00

France

Portugal

AbbVie

AbbVie, Lda.

Tél: +33 (0) 1 45 60 13 00

Tel: +351 (0)21 1908400

Hrvatska

România

AbbVie d.o.o.

AbbVie S.R.L.

Tel: +385 (0)1 5625 501

Tel: +40 21 529 30 35

Ireland

Slovenija

AbbVie Limited

AbbVie Biofarmacevtska družba d.o.o.

Tel: +353 (0)1 4287900

Tel: +386 (1)32 08 060

Ísland

Slovenská republika

Vistor hf.

AbbVie s.r.o.

Tel: +354 535 7000

Tel: +421 2 5050 0777

Italia

Suomi/Finland

AbbVie S.r.l.

AbbVie Oy

Tel: +39 06 928921

Puh/Tel: +358 (0)10 2411 200

Κύπρος

Sverige

Lifepharma (Z.A.M.) Ltd

AbbVie AB

Τηλ: +357 22 34 74 40

Tel: +46 (0)8 684 44 600

Latvija

United Kingdom

AbbVie SIA

AbbVie Ltd

Tel: +371 67605000

Tel: +44 (0)1628 561090

This leaflet was last revised in

 

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

The following information is intended for medical or healthcare professionals only:

Administrator’s Instructions

The 50 mg vial contains an overfill to allow the withdrawal of 50 mg when reconstituted if following the directions described below.

To reconstitute, remove the tab portion of the vial cap and clean the rubber stopper with 70% ethanol or equivalent

Slowly add 0.6 ml of water for injections along the inside wall of the vial to minimise foaming. After the water is added, tilt the vial slightly and gently rotate the vial for 30 seconds.

Do not shake the vial.

Palivizumab solution should stand at room temperature for a minimum of 20 minutes until the solution clarifies. Palivizumab solution does not contain a preservative and should be administered within 3 hours of preparation. Single-use vial. Any remaining contents should be discarded after use.

When reconstituted as recommended the final concentration is 100 mg/ml.

Palivizumab should not be mixed with any medicinal products or diluents other than water for injections.

Palivizumab is administered once a month intramuscularly, preferably in the anterolateral aspect of the thigh. The gluteal muscle should not be used routinely as an injection site because of the risk of damage to the sciatic nerve. The injection should be given using standard aseptic technique. Injection volumes over 1 ml should be given as a divided dose.

When using Palivizumab 100 mg/mL, the volume (expressed in mL) of Palivizumab to be administered at one-monthly intervals = [patient weight in kg] multiplied by 0.15

For example, for a baby with a body weight of 3 kg, the calculation becomes:

(3 x 0.15) mL = 0.45 mL palivizumab per month

Package leaflet: Information for the user

Synagis 100 mg powder and solvent for solution for injection

Palivizumab

Read all of this leaflet carefully before your child is given this medicine because it contains important information for you and your child.

Keep this leaflet. You may need to read it again.

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

If any of the side effects get serious, or if you notice that your child has any side effects not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

What is in this leaflet

1.What Synagis is and what it is used for

2.What you need to know before Synagis is given to your child

3.How will my child receive Synagis

4.Possible side effects

5.How to store Synagis

6.Contents of the pack and other information

1. What Synagis is and what it is used for

Synagis contains an active ingredient called palivizumab which is an antibody that works specifically against a virus called respiratory syncytial virus, RSV.

Your child is at high risk of getting an illness caused by a virus called respiratory syncytial virus (RSV).

Children who are more likely to get severe RSV disease (high risk children) include babies born prematurely (35 weeks or less) or babies born with certain heart or lung problems.

Synagis is a medicine to help protect your child from getting severe RSV illness.

2. What do you need to know before Synagis is given to your child

Your child should not be given Synagis

If he/she is allergic to palivizumab or any of the other ingredients of this medicine (listed in Section 6). Signs and symptoms of a severe allergic reaction could include:

severe rash, hives, or itching skin

swelling of the lips, tongue, or face

closing of the throat, difficulty swallowing

difficult, rapid, or irregular breathing

bluish colour of skin, lips, or under fingernails

muscle weakness or floppiness

a drop in blood pressure

unresponsiveness

Warnings and precautions

Take special care with Synagis

if your child is unwell. Please tell your doctor if your child is unwell, as the use of Synagis may need to be delayed.

if your child has any bleeding disorders as Synagis is usually injected into the thigh.

Other medicines and Synagis

Synagis is not known to interact with other medicines. However, you should inform your doctor of all medicines your child is currently taking before starting Synagis.

3. How will my child receive Synagis

How often will Synagis be given to my child?

Synagis should be given to your child at a dose of 15 mg/kg body weight once a month for as long as the risk of RSV infection remains. For your child’s best protection, it is necessary to take the doctor’s advice about when to return for additional doses of Synagis.

If your child is to have a heart operation (cardiac bypass surgery), he or she may be given an extra dose of Synagis after the operation. Your child can then go back to the original planned injections.

How will my child receive Synagis?

Synagis will be given by injection to your child into a muscle, usually in the outer part of the thigh.

What should you do if your child misses an injection of Synagis?

If your child misses an injection, you should contact your doctor as soon as possible. Each injection of Synagis can only help protect your child for about one month before another injection is needed.

Always use this medicine exactly as your doctor or pharmacist has told you. If you are not sure about how this product will be given to your child, ask your doctor or pharmacist.

4. Possible side effects

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

Synagis may cause serious side effects including:

severe allergic reactions, such reactions may be life-threatening or fatal (see “Your child should not be given Synagis” for a list of signs and symptoms).

unusual bruising or groups of tiny red spots on the skin.

Call your doctor or get medical help right away if your child has any of the serious side effects listed above after receiving any dose of Synagis.

Additional side effects

Very common (affects at least 1 user in 10):

rash

fever

Common (affects 1 to 10 users in 100):

pain, redness or swelling at the injection site

a pause in breathing or other breathing difficulties

Uncommon (affects less than 1 users in 100):

fits

hives

Reporting of side effects

If your child gets any side effects, talk to your doctor. 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. How to store Synagis

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the label. The expiry date refers to the last day of that month

Store in a refrigerator. (2ºC-8°C)

After reconstitution use within 3 hours.

Do not freeze.

Keep the vial in the carton in order to protect form light.

6. Contents of the pack and other information

What Synagis contains

-The active substance is palivizumab. 100 mg per vial, providing 100 mg/ml of palivizumab when reconstituted as recommended.

-The other ingredients are, - for the powder: histidine, glycine and mannitol.

-for the solvent: water for injections.

What Synagis looks like and contents of the pack

Synagis is presented as a powder and solvent for solution for injection (100 mg of powder in vial) + 1 ml of solvent in ampoule - Pack size of 1.

Synagis is a white to off-white cake.

Marketing Authorisation holder

AbbVie Ltd

Maidenhead

SL6 4UB

United Kingdom

Manufacturer

AbbVie S.r.l.

04011 Campoverde di Aprilia (Latina) Italy

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

België/Belgique/Belgien

Lietuva

AbbVie SA

AbbVie UAB

Tél/Tel: +32 10 477811

Tel: +370 5 205 3023

България

Luxembourg/Luxemburg

АбВи ЕООД

AbbVie SA

Тел.:+359 2 90 30 430

Belgique/Belgien

 

Tél/Tel: +32 10 477811

Česká republika

Magyarország

AbbVie s.r.o.

AbbVie Kft.

Tel: +420 233 098 111

Tel.:+36 1 455 8600

Danmark

Malta

AbbVie A/S

V.J.Salomone Pharma Limited

Tlf: +45 72 30-20-28

Tel: +356 22983201

Deutschland

Nederland

AbbVie Deutschland GmbH & Co. KG

AbbVie B.V.

Tel: 00800 222843 33 (gebührenfrei)

Tel: +31 (0)88 322 2843

 

Eesti

Norge

AbbVie Biopharmaceuticals GmbH Eesti filiaal

AbbVie AS

Tel: +372 623 1011

Tlf: +47 67 81 80 00

Ελλάδα

Österreich

AbbVie ΦΑΡΜΑΚΕΥΤΙΚΗ Α.Ε.

AbbVie GmbH

Τηλ: +30 214 4165 555

España

Polska

AbbVie Spain, S.L.U.

AbbVie Polska Sp. z o.o.

Tel: +34 9 1 384 09 10

Tel.: +48 22 372 78 00

France

Portugal

AbbVie

AbbVie, Lda.

Tél: +33 (0) 1 45 60 13 00

Tel: +351 (0)21 1908400

Hrvatska

România

AbbVie d.o.o.

AbbVie S.R.L.

Tel: +385 (0)1 5625 501

Tel: +40 21 529 30 35

Ireland

Slovenija

AbbVie Limited

AbbVie Biofarmacevtska družba d.o.o.

Tel: +353 (0)1 4287900

Tel: +386 (1)32 08 060

Ísland

Slovenská republika

Vistor hf.

AbbVie s.r.o.

Tel: +354 535 7000

Tel: +421 2 5050 0777

Italia

Suomi/Finland

AbbVie S.r.l.

AbbVie Oy

Tel: +39 06 928921

Puh/Tel: +358 (0)10 2411 200

Κύπρος

Sverige

Lifepharma (Z.A.M.) Ltd

AbbVie AB

Τηλ: +357 22 34 74 40

Tel: +46 (0)8 684 44 600

Latvija

United Kingdom

AbbVie SIA

AbbVie Ltd

Tel: +371 67605000

Tel: +44 (0)1628 561090

This leaflet was last approved in

 

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

The following information is intended for medical or healthcare professionals only:

Administrator’s Instructions

The 100 mg vial contains an overfill to allow the withdrawal of 100 mg when reconstituted if following the directions described below.

To reconstitute, remove the tab portion of the vial cap and clean the rubber stopper with 70% ethanol or equivalent

Slowly add 1.0 ml of water for injections along the inside wall of the vial to minimise foaming. After the water is added, tilt the vial slightly and gently rotate the vial for 30 seconds.

Do not shake the vial.

Palivizumab solution should stand at room temperature for a minimum of 20 minutes until the solution clarifies. Palivizumab solution does not contain a preservative and should be administered within 3 hours of preparation. Single-use vial. Any remaining contents should be discarded after use.

When reconstituted as recommended the final concentration is 100 mg/ml.

Palivizumab should not be mixed with any medicinal products or diluents other than water for injections.

Palivizumab is administered once a month intramuscularly, preferably in the anterolateral aspect of the thigh. The gluteal muscle should not be used routinely as an injection site because of the risk of damage to the sciatic nerve. The injection should be given using standard aseptic technique. Injection volumes over 1 ml should be given as a divided dose.

When using Palivizumab 100 mg/mL, the volume (expressed in mL) of Palivizumab to be administered at one-monthly intervals = [patient weight in kg] multiplied by 0.15

For example, for a baby with a body weight of 3 kg, the calculation becomes:

(3 x 0.15) mL = 0.45 mL palivizumab per month

Package leaflet: Information for the user

Synagis 100 mg/ml solution for injection

Palivizumab

Read all of this leaflet carefully before your child is given this medicine because it contains important information for you and your child.

Keep this leaflet. You may need to read it again.

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

If any of the side effects get serious, or if you notice that your child has any side effects not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

What is in this leaflet

1.What Synagis is and what it is used for

2.What you need to know before Synagis is given to your child

3.How will my child receive Synagis

4.Possible side effects

5.How to store Synagis

6.Contents of the pack and other information

1. What Synagis is and what it is used for

Synagis contains an active ingredient called palivizumab which is an antibody that works specifically against a virus called respiratory syncytial virus, RSV.

Your child is at high risk of getting an illness caused by a virus called respiratory syncytial virus (RSV).

Children who are more likely to get severe RSV disease (high-risk children) include babies born prematurely (35 weeks or less) or babies born with certain heart or lung problems.

Synagis is a medicine to help protect your child from getting severe RSV illness.

2. What you need to know before Synagis is given to your child

Your child should not be given Synagis

If he/she is allergic to palivizumab or any of the other ingredients of this medicine (listed in section 6). Signs and symptoms of a severe allergic reaction include:

severe rash, hives, or itching skin

swelling of the lips, tongue, or face

closing of the throat, difficulty swallowing

difficult, rapid, or irregular breathing

bluish colour of skin, lips, or under fingernails

muscle weakness or floppiness

a drop in blood pressure

unresponsiveness

Warnings and precautions

Take special care with Synagis

if your child is unwell. Please tell your doctor if your child is unwell, as the use of Synagis may need to be delayed.

if your child has any bleeding disorders as Synagis is usually injected into the thigh.

Other medicines and Synagis

Synagis is not known to interact with other medicines. However, you should inform your doctor of all medicines your child is currently taking before starting Synagis.

3. How will my child receive Synagis

How often will Synagis be given to my child?

Synagis should be given to your child at a dose of 15 mg/kg body weight once a month for as long as the risk of RSV infection remains. For your child’s best protection, it is necessary to take the doctor’s advice about when to return for additional doses of Synagis.

If your child is to have a heart operation (cardiac bypass surgery), he or she may be given an extra dose of Synagis after the operation. Your child can then go back to the original planned injections.

How will my child receive Synagis?

Synagis will be given by injection to your child into a muscle, usually in the outer part of the thigh.

What should you do if your child misses an injection of Synagis?

If your child misses an injection, you should contact your doctor as soon as possible. Each injection of Synagis can only help protect your child for about one month before another injection is needed.

Always use this medicine exactly as your doctor or pharmacist has told you. If you are not sure about how this product will be given to your child, ask your doctor or pharmacist.

4. Possible side effects

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

Synagis may cause serious side effects including:

severe allergic reactions, such reactions may be life threatening or fatal (see "Your child should not be given Synagis" for a list of signs and symptoms).

unusual bruising or groups of tiny red spots on the skin.

Call your doctor or get medical help right away if your child has any of the serious side effects listed above after receiving any dose of Synagis.

Additional side effects

Very common (affects at least 1 user in 10):

rash

fever

Common (affects 1 to 10 users in 100):

pain, redness or swelling at the injection site

a pause in breathing or other breathing difficulties

Uncommon (affects less than 1 user in 100):

fits

hives

Reporting of side effects

If your child gets any side effects, talk to your doctor. 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. How to store Synagis

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the label. The expiry date refers to the last day of that month.

Store in a refrigerator (2ºC to 8ºC).

Do not freeze.

Keep the vial in the carton in order to protect from light.

6. Contents of the pack and other information

What Synagis contains

-The active substance is palivizumab. One ml of Synagis solution for injection contains 100 mg of palivizumab.

-Each 0.5 ml vial contains 50 mg of palivizumab.

-Each 1 ml vial contains 100 mg of palivizumab.

-The other ingredients are histidine, glycine and water for injections.

What Synagis looks like and contents of the pack

Synagis solution for injection is a clear or slightly opalescent solution and is available in vials of either 0.5 ml or 1 ml.

Pack size of 1.

Marketing Authorisation holder

AbbVie Ltd

Maidenhead

SL6 4UB

United Kingdom

Manufacturer

AbbVie S.r.l.

04011 Campoverde di Aprilia (Latina) Italy

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

België/Belgique/Belgien

Lietuva

AbbVie SA

AbbVie UAB

Tél/Tel: +32 10 477811

Tel: +370 5 205 3023

България

Luxembourg/Luxemburg

АбВи ЕООД

AbbVie SA

Тел.:+359 2 90 30 430

Belgique/Belgien

 

Tél/Tel: +32 10 477811

Česká republika

Magyarország

AbbVie s.r.o.

AbbVie Kft.

Tel: +420 233 098 111

Tel.:+36 1 455 8600

Danmark

Malta

AbbVie A/S

V.J.Salomone Pharma Limited

Tlf: +45 72 30-20-28

Tel: +356 22983201

Deutschland

Nederland

AbbVie Deutschland GmbH & Co. KG

AbbVie B.V.

Tel: 00800 222843 33 (gebührenfrei)

Tel: +31 (0)88 322 2843

 

Eesti

Norge

AbbVie Biopharmaceuticals GmbH Eesti filiaal

AbbVie AS

Tel: +372 623 1011

Tlf: +47 67 81 80 00

Ελλάδα

Österreich

AbbVie ΦΑΡΜΑΚΕΥΤΙΚΗ Α.Ε.

AbbVie GmbH

Τηλ: +30 214 4165 555

España

Polska

AbbVie Spain, S.L.U

AbbVie Polska Sp. z o.o.

Tel: +34 9 1 384 09 10

Tel.: +48 22 372 78 00

France

Portugal

AbbVie

AbbVie, Lda.

Tél: +33 (0) 1 45 60 13 00

Tel: +351 (0)21 1908400

Hrvatska

România

AbbVie d.o.o.

AbbVie S.R.L.

Tel + 385 (0)1 5625 501

Tel: +40 21 529 30 35

Ireland

Slovenija

AbbVie Limited

AbbVie Biofarmacevtska družba d.o.o.

Tel: +353 (0)1 4287900

Tel: +386 (1)32 08 060

Ísland

Slovenská republika

Vistor hf.

AbbVie s.r.o.

Tel: +354 535 7000

Tel: +421 2 5050 0777

Italia

Suomi/Finland

AbbVie S.r.l.

AbbVie Oy

Tel: +39 06 928921

Puh/Tel: +358 (0)10 2411 200

Κύπρος

Sverige

Lifepharma (Z.A.M.) Ltd

AbbVie AB

Τηλ.: +357 22 34 74 40

Tel: +46 (0)8 684 44 600

Latvija

United Kingdom

AbbVie SIA

AbbVie Ltd

Tel: +371 67605000

Tel: +44 (0)1628 561090

This leaflet was last revised in

 

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

The following information is intended for medical or healthcare professionals only:

Administrator’s Instructions

Palivizumab should not be mixed with any medicinal products or diluents.

Both the 0.5 ml and 1 ml vials contain an overfill to allow the withdrawal of 50 mg or 100 mg respectively.

Do not dilute the product.

Do not shake the vial.

To administer, remove the tab portion of the vial cap and clean the stopper with 70 % ethanol or equivalent. Insert the needle into the vial and withdraw into the syringe an appropriate volume of solution. Palivizumab solution for injection does not contain a preservative, is for single use and should be administered immediately after drawing the dose into the syringe.

Any unused product or waste material should be disposed of in accordance with local requirements.

Palivizumab is administered once a month intramuscularly, preferably in the anterolateral aspect of the thigh. The gluteal muscle should not be used routinely as an injection site because of the risk of damage to the sciatic nerve. The injection should be given using standard aseptic technique.

Injection volumes over 1 ml should be given as a divided dose.

When using Palivizumab 100 mg/mL, the volume (expressed in mL) of Palivizumab to be administered at one-monthly intervals = [patient weight in kg] multiplied by 0.15

For example, for a baby with a body weight of 3 kg, the calculation becomes:

(3 x 0.15) mL = 0.45 mL palivizumab per month.

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