English
A B C D E F G H I J K L M N O P Q R S T U V W X Y Z

Quintanrix (diphtheria toxoid / tetanus toxoid /...) – Package leaflet - J07CA10

Updated on site: 09-Oct-2017

Medication nameQuintanrix
ATC CodeJ07CA10
Substancediphtheria toxoid / tetanus toxoid / inactivated Bordetella pertussis / hepatitis B surface antigen (rDNA) / Haemophilus influenzae type b polysaccharide
ManufacturerGlaxoSmithKline Biologicals S.A.
In this leaflet:
1. What Quintanrix is and what it is used for 2. Before your child receives Quintanrix
3. How Quintanrix is given
4. Possible side effects
5. Storing Quintanrix
6. Further information

 

 

PACKAGE LEAFLET

Read all of this leaflet carefully before your child starts receiving this medicine.

-

Keep this leaflet until your child has finished the complete vaccination course. You may need to

 

read it again.

authorised

 

 

-

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

-

This medicine has been prescribed for your child and should not be passed on to others.

Quintanrix powder and suspension for suspension for injection

Diphtheria, tetanus, pertussis (whole cell), hepatitis B (rDNA) and Haemophilus type b conjugate vaccine (adsorbed)

-

The active substances contained in 1 dose (0.5 ml) of Quintanrix are:

 

Diphtheria toxoid1

 

 

not less than 30 International Units

 

Tetanus toxoid1

 

no

not less than 60 International Units

 

Inactivated Bordetella pertussis 2

not less than 4 International Units

 

Hepatitis B surface antigen (rDNA) 2, 3

longer

10 micrograms

 

Haemophilus influenzae type b polysaccharide

 

 

 

(polyribosylribitol phosphate) 2

 

 

2.5 micrograms

 

conjugated to tetanus toxoid as a carrier

 

 

5-10 micrograms

 

 

Product

 

B-1330 Rixensart

 

1 adsorbed on aluminium hydroxide, hydrated

Total: 0.26 milligrams Al3+

 

2adsorbed on aluminium phosphate

 

Total: 0.40 milligrams Al3+

 

3 produced in Saccharomyces cerevisae cells by recombinant DNA technology

-

The other ingredients in the vaccine are: lactose, thiomersal (preservative), sodium chloride and

 

water for injections.

 

 

 

 

Marketing authorisation holder and Manufacturer: GlaxoSmithKline Biologicals s.a.

 

Medicinal

 

 

Rue de l’Institut 89

 

 

 

Belgium

 

 

 

 

 

 

1.

WHAT QUINTANRIX IS AND WHAT IT IS USED FOR

 

Quintanrix is a white slightly milky liquid obtained by mixing the vial containing the diphtheria (D), tetanus (T), whole cell pertussis (Pw) and hepatitis B (HBV) liquid (DTPw-HBV) with the vial containing the Haemophilus influenzae type b (HIB) powder. Both components are presented in a glass vial for 1 dose and must be mixed together before your child receives the vaccine.

Quintanrix is available in the following pack sizes:

- pack size of 1 vial of powder plus 1 vial of liquid

- pack size of 100 vials of powder plus 100 vials of liquid.

Not all pack sizes may be marketed.

Quintanrix is a vaccine used in children to prevent five infectious diseases: diphtheria, tetanus (lockjaw), pertussis (whooping cough), hepatitis B and Haemophilus influenzae type b (a type of bacteria). The vaccine works by causing the body to produce its own protection (antibodies) against

Diphtheria: Diphtheria mainly affects the airways and sometimes theauthorisedskin. Generally the airways become inflamed (swollen) causing severe breathing difficulties and sometimes suffocation. The bacteria also release a toxin (poison), which can cause nerve damage, heart problems, and even death.

Tetanus (Lockjaw): Tetanus bacteria enter the body through cuts, scratches or wounds in the skin. Wounds that are especially prone to infection are burns, fractures, deep wounds or wounds contaminated with soil, dust, horse manure/dung or wood splinters. The bacteria release a toxin (poison), which can cause muscle stiffness, painful muscle spasms, fits and even death. The muscle spasms can be strong enough to cause bone fractures of the spine.

Pertussis (Whooping cough): Pertussis is a highly infectious illness. The disease affects the airways causing severe spells of coughing that may interferelongerwith normal breathing. The coughing is often accompanied by a “whooping” sound, hence the common name “whooping cough”. The cough may last for 1-2 months or longer. Pertussis can also cause ear infections, bronchitis which may last a long time, pneumonia, fits, brain damage and even death.

Hepatitis B: Infection with the hepatitis B virus may cause the liver to become swollen (inflamed). The virus is found in body fluids such as blood, semen, vaginal secretions, or saliva (spit) of infected people. Signs of the disease may not be seen for 6 weeks to 6 months after infection. Sometimes people who have been infected dononot look or feel ill. Others have signs of mild flu, but some people can become very ill. They may be extremely tired, and have dark urine, pale faces, yellowish skin and/or eyes (jaundice), and other signs of the disease possibly requiring

hospitalisation.

Most adults fully recover Productfrom the disease. But some people, particularly children, who may not have shown signs of the disease can remain infected. They are called hepatitis B virus carriers. Hepatitis B carriers can infect others throughout their lives. Hepatitis B carriers are at risk of serious liver disease, such as cirrhosis (liver scarring) and liver cancer.

Haemophilus influenzae type b (HIB): HIB infection most frequently causes brain inflammation (swelling). There will be some type of serious complications such as: mental retardation, cerebral palsy, deafness, epilepsy or partial blindness. HIB infection also causes inflammation of the throat.

It occasionally causes death by suffocation. Less commonly, the bacteria can also infect the blood, heart,Medicinallungs, bones, joints, and tissues of the eyes and mouth.these infectious diseases.

In the following cases, Quintanrix should not be given to your child. You must tell your doctor:

if your child has experienced any health problems after previous administration of a vaccine.

In the following cases, your doctor can determine the right time and scheme of vaccination for your child. Tell your doctor:

if your child has previously had any allergic reaction to Quintanrix, or any ingredient contained

 

in this vaccine. The active substances and other ingredients in Quintanrix are listed at the

 

beginning of the leaflet. Signs of an allergic reaction may include itchy skin rash, shortness of

breath and swelling of the face or tongue.

 

if your child has previously had an allergic reaction to any vaccine against diphtheria, tetanus,

pertussis (whooping cough), hepatitis B or Haemophilus influenzae type b diseases.

if your child experienced problems of the nervous system (such as repetitive fits, decrease of

 

consciousness) within 7 days after previous vaccination with a vaccine against pertussis

(whooping cough) disease.

 

if your child has a severe infection with a high temperature (over 38°C). In these cases, the

 

vaccination will be postponed until your child has recovered. A minor infection such as a cold

should not be a problem, but talk to your doctor first.

authorised

if your child has any known allergies.

 

 

if after previously having Quintanrix or another vaccine against pertussis (whooping cough)

 

disease, your child had any problems, especially:

longer

 

 

 

 

A high temperature (over 40°C) within 48 hours of vaccination

 

A collapse (floppiness) or shock-like state within 48 hours of vaccination

 

Persistent crying lasting 3 hours or more within 48 hours of vaccination

Seizures/fits with or without a high temperature within 3 days of vaccination

if your child has a bleeding problem or bruises easily

if your child has a tendency to seizures/fits due to a fever, or if there is a history in the family of

this

 

 

if your child is taking any other medicine or has recently received any other vaccine. Your

 

doctor will be able to tell you what to do if Quintanrix is to be given with another vaccine or

 

medicine.

 

 

 

 

Product

 

 

Important information about some of the ingredientsno

of Quintanrix

This medicinal product contains thiomersal as a preservative and it is possible that your child may experience an allergic reaction. Tell you doctor if your child has any known allergies.

3. HOW QUINTANRIX IS GIVEN

Your child will receive a total of three injections with an interval of at least one month between each

The doctor or nurse will give Quintanrix as an injection into the muscle.

Your doctor will advise on the possible need for extra doses.

one. Each injection is given on a separate visit. The first injection can be given from the age of 6 weeksMedicinalonwards. You will be informed by the doctor or nurse when you should come back for subsequent injections.

If your child misses the visit scheduled for the second or third injection, talk to your doctor and arrange another visit as soon as possible.

Make sure your child finishes the complete vaccination course of three injections. If not, your child may not be fully protected against the diseases.

The vaccine should never be given into a vein.

4. POSSIBLE SIDE EFFECTS

Any vaccine can have some side effects.

Very common (more than 1 per 10 doses of vaccine): authorised

Pain, redness or swelling at the injection site

Fever (more than 37.5°C)

Irritability

Loss of appetite

Drowsiness

Common (less than 1 per 10 but more than 1 per 100 doses of vaccine):

Induration (hard lump)

Fever (more than 39°C)

Rare (less than 1 per 1000 but more than 1 per 10 000 doses of vaccine):

Bronchitislonger

Coughing

Vomiting

Collapse (floppiness) or periods of unconsciousness or lack of awareness

FitsplateletsSide effects that occurred during clinical trials with Quintanrix were as follows:

local or widespread rashes that may be itchy or blistering,no swelling of the eyes and face, difficulty in breathing or swallowing, a suddenProductdrop in blood pressure and loss of consciousness. Such reactions

As with all injectable vaccines, there is an extremely small risk of allergic reactions. These may be

may occur before leaving the doctor’s surgery. However, you should seek immediate treatment in any event.

If these events continue or become severe, tell your doctor.

This medicinal product contains thiomersal as a preservative and it is possible that your child may experience an allergic reaction.

5. STORING QUINTANRIX

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist. Do notMedicinalbe alarmed by this list of possible side effects. It is possible that your child will have no side effects from vaccination.

Store in a refrigerator (2°C – 8°C).

Store in the original package in order to protect from light.

Do not freeze. Freezing destroys the vaccine.

Keep out of the reach and sight of children.

Do not use after the expiry date stated on the pack. The date for last use corresponds to the last day of the month mentioned.

6. FURTHER INFORMATION

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

België/Belgique/Belgien

 

Luxembourg/Luxemburg

GlaxoSmithKline s.a./n.v.

 

GlaxoSmithKline s.a./n.v.

Tél/Tel: + 32 2 656 21 11

 

Tél/Tel: + 32 2 656 21 11

България

 

Magyarország

 

ГлаксоСмитКлайн ЕООД

 

GlaxoSmithKline Kft.

ул. Димитър Манов бл.10

 

Tel.: + 36-1-2255300

София 1408

 

 

 

Тел. + 359 2 953 10 34

 

 

 

Česká republika

 

Malta

 

GlaxoSmithKline s.r.o.

 

GlaxoSmithKline Malta

Tel: + 420 2 22 00 11 11

 

Tel: + 356 21 225736

gsk.czmail@gsk.com

 

 

authorised

 

 

 

Danmark

 

Nederland

 

GlaxoSmithKline Pharma A/S

GlaxoSmithKline BV

Tlf: + 45 36 35 91 00

 

Tel: + 31 (0)30 69 38 100

info@glaxosmithkline.dk

 

nlinfo@gsk.com

 

Deutschland

 

Norge

 

GlaxoSmithKline GmbH & Co. KG

GlaxoSmithKlinelonger

AS

Tel: + 49 (0)89 360448701

 

Tlf: + 47 22 70 20 00

produkt.info@gsk.com

 

firmapost@gsk.no

Eesti

Product

noÖsterreich

 

GlaxoSmithKline Eesti OÜ

GlaxoSmithKline Pharma GmbH.

Tel: +372 667 6900

estonia@gsk.com

at.info@gsk.com

 

Ελλάδα

Polska

 

Allen Φαρµακευτική Α.Ε

GlaxoSmithKline Pharmaceuticals S.A.

Tηλ: + 30 210 68 82 100

Tel.: + 48 (22) 576 9000

España

Portugal

 

GlaxoSmithKline S.A.

Smith Kline & French Portuguesa, Produtos

Tel: + 34 902 202 700

 

Farmacêuticos, Lda.

es-ci@gsk.com

 

Tel: + 351 21 412 95 00

 

 

FI.PT@gsk.com

 

France

 

România

 

Laboratoire GlaxoSmithKline

GlaxoSmithKline (GSK) SRL

Tél: + 33 1 39 17 84 44

 

Tel: +40 (0)21 3028 208

diam@gsk.com

 

 

 

Ireland

 

Slovenija

 

GlaxoSmithKline (Ireland) Ltd

GlaxoSmithKline d.o.o.

Medicinal

 

Tel: + 386 1 280 25 00

Tel: + 353 (0)1 4955000

 

gqq41253@glaxowellcome.co.uk

This leaflet was last approved on:
Italia
GlaxoSmithKline S.p.A. Tel:+ 39 04 59 21 81 11
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. +370 264 90 00 info.lt@gsk.com
Suomi/Finland authorised
GlaxoSmithKline Oy Puh/Tel: + 358 10 30 30 30 Finland.tuoteinfo@gsk.com
Sverige
GlaxoSmithKline AB
Tel: + 46 31 67 09 00 info.produkt@gsk.com
United Kingdom
GlaxoSmithKline UK Tel: + 44 (0)808 100 9997 customercontactuk@gsk.comlonger
Ísland
GlaxoSmithKline ehf. Tel: +354-530 3700
Slovenská republika
GlaxoSmithKline Slovakia s.r.o. Tel: + 421 (0)2 49 10 33 11 recepcia.sk@gsk.com

----------------------------------------------------------------------------------------------------------------------no

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

The DTPw-HBV component should be well shaken in order to obtain a homogeneous turbid white suspension and should be inspected visually for any foreign particulate matter and/or abnormal physical appearance. Any unused vaccine or waste material should be disposed of in accordance with local requirements.

Upon storage, a white depositProductand clear supernatant may be observed for the DTPw-HBV component. This does not constitute a sign of deterioration.

the powder is completely dissolved. The reconstituted vaccine is a homogeneous turbid white suspension.

The vaccine is reconstituted by withdrawing the contents of the vial containing the DTPw-HBV componentMedicinalby means of a syringe and by adding it to the vial containing the HIB powder. After the addition of the DTPw-HBV component to the HIB powder, the mixture should be well shaken until

Remove and discard the needle used for reconstitution and replace it with a second needle to administer the vaccine. After reconstitution, the vaccine should be injected promptly.

Quintanrix should not be given to subjects with hypersensitivity to the active substances or to any of the excipients.

Quintanrix is contra-indicated if the child has experienced an encephalopathy of unknown aetiology, occurring within 7 days following previous vaccination with pertussis containing vaccine. In these circumstances the vaccination course should be continued with diphtheria, tetanus, hepatitis B and HIB vaccines.

As with other vaccines, the administration of Quintanrix should be postponed in subjects suffering from acute severe febrile illness. The presence of a minor infection, such as a cold, is not a contraindication for vaccination.

If any of the following events occur in temporal relation to receipt of Quintanrix, the decision to give

 

 

authorised

subsequent doses of a vaccine containing the pertussis component should be carefully considered:

Temperature of ≥ 40.0 °C within 48 hours, not due to another identifiable cause.

Collapse or shock-like state (hypotonic-hyporesponsive episode) within 48 hours.

Persistent crying lasting ≥ 3 hours, occurring within 48 hours.

 

Convulsions with or without fever, occurring within 3 days.

 

There may be circumstances, such as a high incidence of pertussis, when the potential benefits outweigh possible risks.

As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic event following the administration of the vaccine.

Quintanrix is for deep intramuscular injection, preferably in the anterolateral thigh.

 

 

 

longer

Quintanrix should under no circumstances be administered intravascularly.

 

Product

no

 

Medicinal

 

 

 

 

 

In this leaflet:
1. What Quintanrix is and what it is used for 2. Before your child receives Quintanrix
3. How Quintanrix is given
4. Possible side effects
5. Storing Quintanrix
6. Further information

 

 

PACKAGE LEAFLET

Read all of this leaflet carefully before your child starts receiving this medicine.

-

Keep this leaflet until your child has finished the complete vaccination course. You may need to

-

read it again.

authorised

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

-

This medicine has been prescribed for your child and should not be passed on to others.

Quintanrix powder and suspension for suspension for injection, multidose

Diphtheria, tetanus, pertussis (whole cell), hepatitis B (rDNA) and Haemophilus type b conjugate vaccine (adsorbed)

-

The active substances contained in 1 doses (0.5 ml) of Quintanrix are:

 

Diphtheria toxoid1

 

not less than 30 International Units

 

Tetanus toxoid1

 

not less than 60 International Units

 

Inactivated Bordetella pertussis 2

not less than 4 International Units

 

Hepatitis B surface antigen (rDNA) 2, 3

longer

10 micrograms

 

Haemophilus influenzae type b polysaccharide

2.5 micrograms

 

(polyribosylribitol phosphate) 2

 

 

conjugated to tetanus toxoid as a carrier

 

5-10 micrograms

 

 

Product

Belgium

 

 

1 adsorbed on aluminium hydroxide, hydratedno

Total: 0.26 milligrams Al3+

 

2adsorbed on aluminium phosphate

Total: 0.40 milligrams Al3+

 

3 produced in Saccharomyces cerevisae cells by recombinant DNA technology

-

The other ingredients in the vaccine are: lactose, thiomersal (preservative), sodium chloride and

 

water for injections.

 

 

 

Marketing authorisation holder and Manufacturer: GlaxoSmithKline Biologicals s.a.

 

Medicinal

 

Rue de l’Institut 89

 

 

B-1330 Rixensart

1.

 

 

 

WHAT QUINTANRIX IS AND WHAT IT IS USED FOR

 

Quintanrix is a white slightly milky liquid obtained by mixing the vial containing the diphtheria (D), tetanus (T), whole cell pertussis (Pw) and hepatitis B (HBV) liquid (DTPw-HBV) with the vial containing the Haemophilus influenzae type b (HIB) powder. Both components are presented in a glass vial for 2 doses or for 10 doses and must be mixed together before your child receives the vaccine.

Quintanrix is available in the following pack sizes:

For 2 doses :

-pack size of 1 vial of powder plus 1 vial of liquid

-pack size of 100 vials of powder plus 100 vials of liquid

For 10 doses:

-pack size of 50 vials of powder plus 50 vials of liquid

Diphtheria: Diphtheria mainly affects the airways and sometimes theauthorisedskin. Generally the airways become inflamed (swollen) causing severe breathing difficulties and sometimes suffocation. The bacteria also release a toxin (poison), which can cause nerve damage, heart problems, and even death.

Tetanus (Lockjaw): Tetanus bacteria enter the body through cuts, scratches or wounds in the skin.

Wounds that are especially prone to infection are burns, fractures, deep wounds or wounds contaminated with soil, dust, horse manure/dung or woodlongersplinters. The bacteria release a toxin (poison), which can cause muscle stiffness, painful muscle spasms, fits and even death. The muscle spasms can be strong enough to cause bone fractures of the spine.

Pertussis (Whooping cough): Pertussis is a highly infectious illness. The disease affects the airways causing severe spells of coughing that may interfere with normal breathing. The coughing is often accompanied by a “whooping” sound, hence the common name “whooping cough”. The cough may last for 1-2 months or longer. Pertussis can also cause ear infections, bronchitis which may last a long time, pneumonia, fits, brain damage and even death.

Hepatitis B: Infection with the hepatitis B virusnomay cause the liver to become swollen (inflamed). The virus is found in body fluids such as blood, semen, vaginal secretions, or saliva (spit) of infected people. Signs of theProductdisease may not be seen for 6 weeks to 6 months after infection. Sometimes people who have been infected do not look or feel ill. Others have signs of mild flu, but some people can become very ill. They may be extremely tired, and have dark urine, pale faces, yellowish skin and/or eyes (jaundice), and other signs of the disease possibly requiring hospitalisation.

Most adults fully recover from the disease. But some people, particularly children, who may not have shown signs of the disease can remain infected. They are called hepatitis B virus carriers. Hepatitis B carriers can infect others throughout their lives. Hepatitis B carriers are at risk of serious liver disease, such as cirrhosis (liver scarring) and liver cancer.

HaemophilusMedicinalinfluenzae type b (HIB): HIB infection most frequently causes brain inflammation (swelling). There will be some type of serious complications such as: mental retardation, cerebral palsy, deafness, epilepsy or partial blindness. HIB infection also causes inflammation of the throat.

It occasionally causes death by suffocation. Less commonly, the bacteria can also infect the blood, heart, lungs, bones, joints, and tissues of the eyes and mouth.Not all pack sizes may be marketed.

bacteria than Haemophilus influenzae type b or against meningitis caused by other organisms.

2. BEFORE YOUR CHILD RECEIVES QUINTANRIX

In the following cases, Quintanrix should not be given to your child. You must tell your doctor:

if your child has experienced any health problems after previous administration of a vaccine.

 

 

 

 

authorised

if your child has previously had any allergic reaction to Quintanrix, or any ingredient contained

 

in this vaccine. The active substances and other ingredients in Quintanrix are listed at the

 

beginning of the leaflet. Signs of an allergic reaction may include itchy skin rash, shortness of

breath and swelling of the face or tongue.

 

 

 

if your child has previously had an allergic reaction to any vaccine against diphtheria, tetanus,

pertussis (whooping cough), hepatitis B or Haemophilus influenzae type b diseases.

if your child experienced problems of the nervous system (such as repetitive fits, decrease of

 

consciousness) within 7 days after previous vaccination with a vaccine against pertussis

(whooping cough) disease.

 

 

 

if your child has a severe infection with a high temperature (over 38°C). In these cases, the

 

vaccination will be postponed until your child has recovered. A minor infection such as a cold

should not be a problem, but talk to your doctor first.

 

if your child has any known allergies.

 

longer

 

 

 

 

 

 

In the following cases, your doctor can determine the right time and scheme of vaccination for

your child. Tell your doctor:

 

 

 

if after previously having Quintanrix or another vaccine against pertussis (whooping cough)

 

disease, your child had any problems, especially:

 

 

 

A high temperature (over 40°C) within 48 hours of vaccination

 

A collapse (floppiness) or shock-like state within 48 hours of vaccination

 

this

 

no

 

 

 

Persistent crying lasting 3 hours or more within 48 hours of vaccination

Seizures/fits with or without a high temperature within 3 days of vaccination

if your child has a bleeding problem or bruises easily

 

if your child has a tendency to seizures/fits due to a fever, or if there is a history in the family of

 

Product

 

 

 

if your child is taking any other medicine or has recently received any other vaccine. Your

doctor will be able to tell you what to do if Quintanrix is to be given with another vaccine or medicine.

Important information about some of the ingredients of Quintanrix

This medicinal product contains thiomersal as a preservative and it is possible that your child may experience an allergic reaction. Tell you doctor if your child has any known allergies.

3. MedicinalHOW QUINTANRIX IS GIVEN

Your child will receive a total of three injections with an interval of at least one month between each one. Each injection is given on a separate visit. The first injection can be given from the age of 6 weeks onwards. You will be informed by the doctor or nurse when you should come back for subsequent injections.

The doctor or nurse will give Quintanrix as an injection into the muscle.

Your doctor will advise on the possible need for extra doses.

If your child misses the visit scheduled for the second or third injection, talk to your doctor and arrange another visit as soon as possible.

Make sure your child finishes the complete vaccination course of three injections. If not, your child may not be fully protected against the diseases.

The vaccine should never be given into a vein.

4. POSSIBLE SIDE EFFECTS

Any vaccine can have some side effects.

Side effects that occurred during clinical trials with Quintanrix were as follows:

Very common (more than 1 per 10 doses of vaccine):

 

 

• Pain, redness or swelling at the injection site

 

 

• Fever (more than 37.5°C)

 

 

Irritability

 

 

 

Loss of appetite

 

 

 

Drowsiness

 

 

Common (less than 1 per 10 but more than 1 per 100 doses of vaccine):

 

Induration (hard lump)

 

authorised

 

• Fever (more than 39°C)

 

 

Rare (less than 1 per 1000

but more than 1 per 10 000 doses of vaccine):

 

Bronchitis

 

 

 

Coughing

 

 

 

Vomiting

 

 

 

• Collapse (floppiness) or periods of unconsciousness or lack of awareness

 

Fits

longer

 

Bleeding or bruising more easily than normal due to a drop in a type of blood cell called platelets

have been reported very rarely (less than 1 per 10,000 doses of vaccine) with the hepatitis B

component of Quintanrix.

no

As with all injectable vaccines, there is an extremely small risk of allergic reactions. These may be local or widespread rashes that may be itchy or blistering, swelling of the eyes and face, difficulty in breathing or swallowing, a sudden drop in blood pressure and loss of consciousness. Such reactions

may occur before leaving the doctor’s surgery. However, you should seek immediate treatment in any

event.

 

If these events continue or become severe, tell your doctor.

 

Product

This Medicinalmedicinal product contains thiomersal as a preservative and it is possible that your child may experience an allergic reaction.

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Do not be alarmed by this list of possible side effects. It is possible that your child will have no side effects from vaccination.

5. STORING QUINTANRIX

Store in a refrigerator (2°C – 8°C).

Store in the original package in order to protect from light.

Do not freeze. Freezing destroys the vaccine.

Keep out of the reach and sight of children.

Do not use after the expiry date stated on the pack. The date for last use corresponds to the last day of the month mentioned.

6. FURTHER INFORMATION

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

België/Belgique/Belgien

 

 

Luxembourg/Luxemburg

GlaxoSmithKline s.a./n.v.

 

 

GlaxoSmithKline s.a./n.v.

Tél/Tel: + 32 2 656 21 11

 

 

Tél/Tel: + 32 2 656 21 11

България

 

 

Magyarország

 

ГлаксоСмитКлайн ЕООД

 

 

GlaxoSmithKline Kft.

ул. Димитър Манов бл.10

 

 

Tel.: + 36-1-2255300

София 1408

 

 

 

authorised

Тел. + 359 2 953 10 34

 

 

 

Česká republika

 

 

Malta

 

 

 

GlaxoSmithKline s.r.o.

 

 

GlaxoSmithKline Malta

Tel: + 420 2 22 00 11 11

 

 

Tel: + 356 21 225736

gsk.czmail@gsk.com

 

 

 

 

Danmark

 

 

Nederland

 

GlaxoSmithKline Pharma A/S

 

GlaxoSmithKline BV

Tlf: + 45 36 35 91 00

 

no

Tel:longer+ 31 (0)30 69 38 100

info@glaxosmithkline.dk

 

nlinfo@gsk.com

 

Deutschland

 

Norge

 

GlaxoSmithKline GmbH & Co. KG

GlaxoSmithKline AS

Tel: + 49 (0)89 360448701

Product

 

Tlf: + 47 22 70 20 00

produkt.info@gsk.com

 

firmapost@gsk.no

 

Eesti

 

Österreich

 

GlaxoSmithKline Eesti OÜ

 

GlaxoSmithKline Pharma GmbH.

Tel: +372 667 6900

 

estonia@gsk.com

 

at.info@gsk.com

 

Ελλάδα

 

Polska

 

Allen Φαρµακευτική Α.Ε

 

GlaxoSmithKline Pharmaceuticals S.A.

Tηλ: + 30 210 68 82 100

 

 

Tel.: + 48 (22) 576 9000

España

 

 

Portugal

 

GlaxoSmithKline S.A.

 

 

Smith Kline & French Portuguesa, Produtos

Tel: + 34 902 202 700

 

 

Farmacêuticos, Lda.

es-ci@gsk.com

 

 

Tel: + 351 21 412 95 00

 

 

 

FI.PT@gsk.com

 

France

 

 

România

 

Laboratoire GlaxoSmithKline

 

GlaxoSmithKline (GSK) SRL

Tél: + 33 1 39 17 84 44

 

 

Tel: +40 (0)21 3028 208

diam@gsk.com

 

 

 

 

Medicinal

 

 

 

 

Ireland

 

 

Slovenija

 

GlaxoSmithKline (Ireland) Ltd

 

GlaxoSmithKline d.o.o.

 

 

 

 

Lietuva
GlaxoSmithKline Lietuva UAB Tel. +370 264 90 00 info.lt@gsk.com
Italia
GlaxoSmithKline S.p.A. Tel:+ 39 04 59 21 81 11
Κύπρος
GlaxoSmithKline Cyprus Ltd Τηλ: + 357 22 89 95 01
Latvija
GlaxoSmithKline Latvia SIA Tel: + 371 7312687 lv-epasts@gsk.com
Slovenská republika
GlaxoSmithKline Slovakia s.r.o. Tel: + 421 (0)2 49 10authorised33 11 recepcia.sk@gsk.com
Suomi/Finland
GlaxoSmithKline Oy Puh/Tel: + 358 10 30 30 30 Finland.tuoteinfo@gsk.com
Sverige
GlaxoSmithKline AB
Tel: + 46 31 67 09 00 info.produkt@gsk.com
UnitedlongerKingdom
GlaxoSmithKline UK Tel: + 44 (0)808 100 9997
customercontactuk@gsk.com
Ísland
GlaxoSmithKline ehf. Tel: +354-530 3700
Tel: + 386 1 280 25 00 gqq41253@glaxowellcome.co.uk
Tel: + 353 (0)1 4955000

This leaflet was last approved on:

no

----------------------------------------------------------------------------------------------------------------------

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

local requirements.

Product

Upon storage, a white deposit and clear supernatant may be observed for the DTPw-HBV component. This does not constitute a sign of deterioration.

The DTPw-HBV component should be well shaken in order to obtain a homogeneous turbid white suspension and should be inspected visually for any foreign particulate matter and/or abnormal

addition of the DTPw-HBV component to the HIB powder, the mixture should be well shaken until the powder is completely dissolved. The reconstituted vaccine is a homogeneous turbid white suspension.

physical appearance. Any unused vaccine or waste material should be disposed of in accordance with The vaccineMedicinalis reconstituted by withdrawing the contents of the vial containing the DTPw-HBV component by means of a syringe and by adding it to the vial containing the HIB powder. After the

Remove and discard the needle used for reconstitution and replace it with a second needle to administer the vaccine. After reconstitution, the vaccine should be injected promptly.

Quintanrix should not be given to subjects with hypersensitivity to the active substances or to any of the excipients.

Quintanrix is contra-indicated if the child has experienced an encephalopathy of unknown aetiology, occurring within 7 days following previous vaccination with pertussis containing vaccine. In these

circumstances the vaccination course should be continued with diphtheria, tetanus, hepatitis B and HIB vaccines.

As with other vaccines, the administration of Quintanrix should be postponed in subjects suffering

from acute severe febrile illness. The presence of a minor infection, such as a cold, is not a

contraindication for vaccination.

authorised

 

If any of the following events occur in temporal relation to receipt of Quintanrix, the decision to give subsequent doses of a vaccine containing the pertussis component should be carefully considered:

• Temperature of ≥ 40.0 °C within 48 hours, not due to another identifiable cause.

• Collapse or shock-like state (hypotonic-hyporesponsive episode) within 48 hours.

• Persistent crying lasting ≥ 3 hours, occurring within 48 hours.

• Convulsions with or without fever, occurring within 3 days.

There may be circumstances, such as a high incidence of pertussis, when the potential benefits outweigh possible risks.

As with all injectable vaccines, appropriate medical treatment and supervision should always be

readily available in case of a rare anaphylactic event following the administration of the vaccine.

 

 

 

longer

Quintanrix is for deep intramuscular injection, preferably in the anterolateral thigh.

Quintanrix should under no circumstances be administered intravascularly.

 

Product

no

 

Medicinal

 

 

 

 

 

Comments

A B C D E F G H I J K L M N O P Q R S T U V W X Y Z
  • Help
  • Get it on Google Play
  • About
  • Info on site by:

  • Presented by RXed.eu

  • 27558

    prescription drugs listed