PEDIACEL

Israel - English - Ministry of Health

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Active ingredient:
DIPHTHERIA TOXOID; FILAMENTOUS HAEMAGGLUTININ (FHA); FIMBRAE TUPES 2 + 3 (FIM); PERTACTIN (PRN); PERTUSSIS TOXOID VACCINE; POLIOVIRUS TYPE 1; POLIOVIRUS TYPE 2; POLIOVIRUS TYPE 3; PRP OF HAEMOPHILUS INFL. TYPE B; TETANUS TOXOID
Available from:
MEDICI MEDICAL LTD, ISRAEL
ATC code:
J07CA
Pharmaceutical form:
SUSPENSION FOR INJECTION
Composition:
PERTACTIN (PRN) 3 MCG ML; DIPHTHERIA TOXOID 15 LF ML; TETANUS TOXOID 5 LF ML; PERTUSSIS TOXOID VACCINE 20 MCG ML; FILAMENTOUS HAEMAGGLUTININ (FHA) 20 MCG ML; FIMBRAE TUPES 2 + 3 (FIM) 5 MCG ML; POLIOVIRUS TYPE 1 40 DU ML; POLIOVIRUS TYPE 2 8 DU ML; POLIOVIRUS TYPE 3 32 DU ML; PRP OF HAEMOPHILUS INFL. TYPE B 10 MCG ML
Administration route:
I.M
Prescription type:
Not required
Manufactured by:
SANOFI PASTEUR LTD, CANADA
Therapeutic group:
BACTERIAL AND VIRAL VACCINES, COMBINED
Therapeutic indications:
Pediacel is indicated for immunization of children at or above the age of 2 months and as a booster in children up to their 7th birthday against diphtheria, tetanus, whooping cough, poliomyelitis and invasive Haemophilus influenzae type b disease. In infants, three infectons are to be given intramuscularly at 2, 4 and 6 months of age followed by a booster at 18 months of age. Children who have had pertusis, tetanus, diphtheria or haemophilus influenzae type b invasive disease should still be immunized since these clinical infections do not always confer immunity. Children who have had natural pertussis can continue to receive pertussis - containing vaccines. Human immunodeficiency virus (HIV) infected persons HIV- infected individuals, both asymptomatic and symptomatic, should be immunized with Pediacel vaccine according to standard schedules.
Authorization number:
141 01 31746 00
Authorization date:
2014-06-30

העדוה העדוה

לע לע

הרמחה הרמחה

עדימ ( עדימ (

ב

ב

ןולעב )תוחיט ןולעב )תוחיט

אפורל אפורל

ךיראת

____

01.01.13

__________________

םש

רישכת

____תילגנאב

PEDIACEL

רפסמ

___םושיר

141

-

01

-

31746

-

00

_____________

םש

לעב

מ"עב לקידמ י'צידמ_ __:םושירה

______________________________

םיטרפ

לע

םי/יונישה

םי/שקובמה קרפ

ןולעב טסקט

יחכונ טסקט

שדח

WARNING AND

PRECAUTION

Pediatric

The potential risk of apnea and the need for respiratory

monitoring for 48 - 72 hours should be considered when

administering the primary immunization series to very

premature infants (born

28 weeks of gestation) and

particularly for those with a previous history of

respiratory immaturity. As the benefit of vaccination is

high in this group of infants, vaccination should not

be withheld or delayed

ADVERSE REACTIONS

Psychiatric

Disorders

screaming

Psychiatric Disorders

Irritability , screaming

ADVERSE REACTIONS

Nervous System Disorders

Somnolence

ADVERSE REACTIONS

הרבעה

לש

טסקטה

Vascular Disorders

Edematous reactions affecting one or both

lower limbs have occurred following

vaccination with H. influenza type b

containing vaccines. When this reaction

occurs, it does so mainly after primary

injections and is observed within the first few

hours following vaccination. Associated

symptoms may include cyanosis, redness,

transient purpura and severe crying. All

events resolved spontaneously without

sequelae within 24 hours

Pallor

ADVERSE REACTIONS

טסקט

שדח

Respiratory, Thoracic and Mediastinal

Disorders

Apnea

ADVERSE REACTIONS

General Disorders and Administration Site

Conditions

High fever (>40.5°C), injection site mass,

pallor, somnolence, asthenia, irritability and

listlessness

Large injection site reactions (>50 mm)

including

extensive limb swelling which may

extend from the injection site beyond one or

both joints, have been reported in children

following PEDIACEL

administration. These

reactions usually start within 24 - 72 hours

after vaccination, may be associated with

erythema, warmth, tenderness or pain at the

injection site and resolve spontaneously

within 3 to 5 days. The risk appears to be

dependent on the number of prior doses of

acellular pertussis containing vaccine, with a

greater risk following the 4

and 5

doses

הרבעה

לש

טסקטה

Edematous reactions affecting one or both

lower limbs have occurred following

vaccination with H. influenza type b

containing vaccines. When this reaction

occurs, it does so mainly after primary

injections and is observed within the first few

hours following vaccination. Associated

symptoms may include cyanosis, redness,

transient purpura and severe crying. All

events resolved spontaneously without

sequelae within 24 hours

DOSAGE

FORMS,

COMPOSITION

AND

PACKAGING

Composition

Active Ingredients

Diphtheria Toxoid 15 Lf (≥ 30 UI )

Tetanus Toxoid 5 Lf (≥ 40 UI )

Other Ingredients

Excipients

Aluminum Phosphate (adjuvant) 1.5 mg (0.33+-

0.03 mg)

phenoxyethanol 0.6% v/v (3.33 mg)

Polysorbate 80 ≤0.1% w/v

(by calculation )

<

(10ppm)

PEDIACEL

®

Diphtheria and Tetanus Toxoids and Acellular

Pertussis Vaccine Adsorbed Combined with

Inactivated Poliomyelitis Vaccine and Haemophilus b

Conjugate Vaccine (Tetanus Protein - Conjugate)

Intramuscular injection. Suspension for injection.

DESCRIPTION

PEDIACEL

[Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine

Adsorbed Combined with Inactivated Poliomyelitis Vaccine and Haemophilus b

Conjugate Vaccine (Tetanus Protein - Conjugate)] is a sterile, uniform, cloudy,

white to off-white suspension of diphtheria and tetanus toxoids and acellular

pertussis vaccine adsorbed separately on aluminum phosphate combined with

inactivated poliomyelitis vaccine (vero cell origin) types 1, 2 and 3 (IPV), and

H. influenzae type b capsular polysaccharide (polyribosylribitol phosphate,

PRP) covalently bound to tetanus protein, and suspended in water for injection.

The acellular pertussis vaccine is composed of 5 purified pertussis antigens

(PT, FHA, PRN and FIM).

INDICATIONS AND CLINICAL USE

PEDIACEL

is indicated for primary immunization of infants from the

age of 2 months and in children up to 6 years of age (prior to their

7th birthday) against diphtheria, tetanus, pertussis (whooping cough),

poliomyelitis and invasive H. influenzae type b disease. (See DOSAGE

ADMINISTRATION.)

Currently, Haemophilus b conjugate vaccines are not recommended for

infants younger than 2 months of age.

Children who have had pertussis, tetanus, diphtheria or H. influenzae type b

(Hib) invasive disease should still be immunized since these clinical infections

do not always confer immunity.

Human Immunodeficiency Virus (HIV)-infected persons, both asymptomatic

and symptomatic, should be immunized against diphtheria, tetanus, pertussis,

poliomyelitis and H. influenzae type b, according to standard schedules.

PEDIACEL

is not to be used for the treatment of diseases caused by

Corynebacterium diphtheriae, Clostridium tetani, Bordetella pertussis, poliovirus

or Haemophilus influenzae type b infections.

Pediatrics

PEDIACEL

is not indicated for persons less than 2 months or to persons

7 years of age or older.

Geriatrics

PEDIACEL

is not indicated for use in adult and elderly populations.

CONTRAINDICATIONS

Hypersensitivity

Known systemic hypersensitivity reaction to any component of PEDIACEL

or a life-threatening reaction after previous administration of the vaccine

or a vaccine containing one or more of the same components are

contraindications to vaccination. Because of uncertainty as to which

component of the vaccine may be responsible, none of the components

should be administered. Alternatively, such persons may be referred to an

allergist for evaluation if further immunizations are considered.

Acute Neurological Disorders

The following events are contraindications to administration of any pertussis-

containing vaccine, including PEDIACEL

Encephalopathy (e.g., coma, decreased level of consciousness, prolonged

seizures) within 7 days of a previous dose of a pertussis-containing vaccine

that is not attributable to another identifiable cause.

Progressive neurologic disorder, including infantile spasms, uncontrolled

epilepsy, progressive encephalopathy. Pertussis vaccine should not be

administered to persons with such conditions until a treatment regimen

has been established and the condition has stabilized.

WARNINGS AND PRECAUTIONS

General

Before administration of PEDIACEL

, health-care providers should inform

the parent or guardian of the recipient to be immunized of the benefits and

risks of immunization, inquire about the recent health status of the recipient,

review the recipient’s history concerning possible hypersensitivity to the

vaccine or similar vaccine, previous immunization history, the presence of any

contraindications to immunization and comply with any local requirements

with respect to information to be provided to the parent or guardian before

immunization and the importance of completing the immunization series.

It is extremely important that the parent or guardian be questioned

concerning any symptoms and/or signs of an adverse reaction after a

previous dose of vaccine. (See CONTRAINDICATIONS and ADVERSE

REACTIONS.)

The rates and severity of adverse events in recipients of tetanus toxoid are

influenced by the number of prior doses and level of pre-existing antitoxins.

As with any vaccine, PEDIACEL

may not protect 100% of vaccinated

individuals.

Vaccines that contain Hib antigen do not provide protection against infections

with other types of H. influenzae, or against meningitis of other origin.

Under no circumstances can the tetanus protein contained in conjugate

vaccines containing tetanus toxoid as protein carrier be used to replace

the usual tetanus vaccination.

Sudden infant death syndrome (SIDS) has occurred in infants following

administration of DTaP vaccines. By chance alone, some cases of SIDS can

be expected to follow receipt of PEDIACEL

Administration Route Related Precautions: Do not administer

PEDIACEL

by intravascular injection; ensure that the needle does not

penetrate a blood vessel.

Intradermal or subcutaneous routes of administration are not to be utilized.

PEDIACEL

should not be administered into the buttocks.

Granuloma or sterile abscess at the injection site has been reported with

a product containing the same antigens.

Febrile or Acute Disease: Vaccination should be postponed in cases of

acute or febrile disease. However, a disease with low-grade fever should

not usually be a reason to postpone vaccination.

If any of the following events occur within the specified period after

administration of a whole-cell pertussis vaccine or a vaccine containing an

acellular pertussis component, the decision to administer PEDIACEL

should

be based on careful consideration of potential benefits and possible risks.

Temperature of

40.5°C within 48 hours, not attributable to another

identifiable cause;

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

48 hours;

Persistent crying lasting

3 hours within 48 hours;

Convulsions with or without fever within 3 days.

Hematologic

Because any intramuscular injection can cause an injection site

hematoma in persons with any bleeding disorders, such as hemophilia or

thrombocytopenia, or in persons on anticoagulant therapy, intramuscular

injections with PEDIACEL

should not be administered to such persons

unless the potential benefits outweigh the risk of administration. If the

decision is made to administer any product by intramuscular injection to

such persons, it should be given with caution, with steps taken to avoid the

risk of hematoma formation following injection.

Immune

The possibility of allergic reactions in persons sensitive to components

of the vaccine should be evaluated. Hypersensitivity reactions may occur

following the use of PEDIACEL

even in persons with no prior history of

hypersensitivity to the product components. Cases of allergic or anaphylactic

reaction have been reported after receiving some preparations containing

diphtheria and tetanus toxoids and/or pertussis antigens.

As with all other products, epinephrine hydrochloride solution (1:1,000)

and other appropriate agents should be available for immediate use in

case an anaphylactic or acute hypersensitivity reaction occurs. Health-care

providers should be familiar with current recommendations for the initial

management of anaphylaxis in non-hospital settings, including proper

airway management.

Immunocompromised persons (whether from disease or treatment)

may not obtain the expected immune response. If possible, consideration

should be given to delaying vaccination until after the completion of any

immunosuppressive treatment. Nevertheless, vaccination of persons with

chronic immunodeficiency such as HIV infection is recommended even if

the antibody response might be limited.

Neurologic

A review by the US Institute of Medicine (IOM) found evidence for a causal

relation between tetanus toxoid and both brachial neuritis and Guillain-

Barré syndrome (GBS). If GBS occurred within 6 weeks of receipt of prior

vaccine containing tetanus toxoid, the decision to give PEDIACEL

or any

vaccine containing tetanus toxoid should be based on careful consideration

of potential benefits and possible risks.

A few cases of demyelinating diseases of the central nervous system,

peripheral mononeuropathies, and cranial mononeuropathies have been

reported following vaccines containing tetanus and/or diphtheria toxoids,

although the IOM concluded that the evidence is inadequate to accept or

reject a causal relation between these conditions and vaccination.

For infants or children at higher risk for seizures than the general population,

an appropriate antipyretic may be administered (in the dosage recommended

in its prescribing information) at the time of vaccination with a vaccine

containing an acellular pertussis component (including PEDIACEL

) and for

the following 24 hours, to reduce the possibility of post-vaccination fever.

Hypotonic-hyporesponsive episodes (HHEs) rarely follow vaccination with

whole-cell pertussis containing DTP vaccines and occur even less commonly

after acellular pertussis-containing DTP vaccines and DT vaccines. A history

of HHEs is not a contraindication to the use of acellular pertussis vaccines

but recommends caution in these cases.

Pregnant Women

The vaccine should not be administered to pregnant women.

Nursing Women

The vaccine should not be administered to nursing women.

ADVERSE REACTIONS

Clinical Trial Adverse Reactions

Because clinical trials are conducted under widely varying conditions,

adverse reaction rates observed in the clinical trials of a vaccine cannot be

directly compared to rates in the clinical trials of another vaccine and may

not reflect rates observed in practice. The adverse reaction information

from clinical trials does, however, provide a basis for identifying the adverse

events that appear to be related to vaccine use and for approximating

rates of those events.

2027984-315

350mm

132mm

Insert Dimensions:

350 mm x 132 mm

Final Fold Dimensions:

35 mm x 66 mm = +/– 2 mm

Packaging System:

Marchessini

Pharma Code Dimensions:

Sanofi codes read left to right

First read is 8 mm from left edge

Stock: Finch Opaque - 40m

Document #: D002609

Version #: 1.0

Effective Date: 15 February 2007

66mm

35mm

DIELINE D80-124MQ

Eyespot

AP CODE

FIRST

READ

15mm

15mm

Eyespot

GLUE

BLANK

(Eyespots)

BLANK

GLUE

BLANK

8mm

5mm

12mm

5mm

12mm

PEDIACEL

®

Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed

Combined with

Inactivated Poliomyelitis Vaccine and Haemophilus b

Conjugate Vaccine (Tetanus Protein - Conjugate)

FPO

FPO

Colours: Text Black

Logo Black (60%)

Part Number: 2027984

Pharma Code: 82 9

Font: GillSans

Product ID: 315

Date: 21 May 2010

Initials: BM

PEDIACEL

5 x 1 dose vials

Israel

PEDIACEL®

Diphtheria and Tetanus Toxoids and Acellular

Pertussis Vaccine Adsorbed Combined with

Inactivated Poliomyelitis Vaccine and Haemophilus b

Conjugate Vaccine (Tetanus Protein – Conjugate)

Intramuscular injection. Suspension for injection.

DESCRIPTION

PEDIACEL®[Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed Combined

with Inactivated Poliomyelitis Vaccine and Haemophilus b Conjugate Vaccine (Tetanus Protein –

Conjugate)] is a sterile, uniform, cloudy, white to off-white suspension of diphtheria and tetanus

toxoids and acellular pertussis vaccine adsorbed separately on aluminum phosphate combined

with inactivated poliomyelitis vaccine (vero cell origin) types 1, 2 and 3 (IPV), and H. influenzae

type b capsular polysaccharide (polyribosylribitol phosphate, PRP) covalently bound to tetanus

protein, and suspended in water for injection. The acellular pertussis vaccine is composed of 5

purified pertussis antigens (PT, FHA, PRN and FIM).

INDICATIONS AND CLINICAL USE

PEDIACEL® is indicated for primary immunization of infants from the age of 2 months and in

children up to 6 years of age (prior to their 7th birthday) against diphtheria, tetanus, pertussis

(whooping cough), poliomyelitis and invasive H. influenzae type b disease. (See DOSAGE AND

ADMINISTRATION.)

In infants, three infectons are to be given intramuscularly at 2, 4 and 6 months of age followed

by a booster at 18 months of age.

Currently, Haemophilus b conjugate vaccines are not recommended for infants younger than

2 months of age.

Children who have had pertussis, tetanus, diphtheria or H. influenzae type b (Hib) invasive

disease should still be immunized since these clinical infections do not always confer immunity.

Children who have had natural pertussis can continue to receive pertussis – containing vaccines.

Human Immunodeficiency Virus (HIV)-infected persons, both asymptomatic and symptomatic,

should be immunized against diphtheria, tetanus, pertussis, poliomyelitis and H. influenzae type

b, according to standard schedules.

PEDIACEL® is not to be used for the treatment of diseases caused by Corynebacterium diphtheriae,

Clostridium tetani, Bordetella pertussis, poliovirus or Haemophilus influenzae type b infections.

Pediatrics

PEDIACEL® is not indicated for persons less than 2 months or to persons 7 years of age or older.

Geriatrics

PEDIACEL® is not indicated for use in adult and elderly populations.

CONTRAINDICATIONS

Hypersensitivity

Known systemic hypersensitivity reaction to any component of PEDIACEL® or a life-threatening

reaction after previous administration of the vaccine or a vaccine containing one or more of

the same components are contraindications to vaccination. Because of uncertainty as to which

component of the vaccine may be responsible, none of the components should be administered.

Alternatively, such persons may be referred to an allergist for evaluation if further immunizations

are considered.

Acute Neurological Disorders

The following events are contraindications to administration of any pertussis-containing vaccine,

including PEDIACEL®:

Encephalopathy (e.g., coma, decreased level of consciousness, prolonged seizures) within 7

days of a previous dose of a pertussis-containing vaccine that is not attributable to another

identifiable cause.

Progressive neurologic disorder, including infantile spasms, uncontrolled epilepsy, progressive

encephalopathy. Pertussis vaccine should not be administered to persons with such conditions

until a treatment regimen has been established and the condition has stabilized.

WARNINGS AND PRECAUTIONS

General

Before administration of PEDIACEL®, health-care providers should inform the parent or guardian

of the recipient to be immunized of the benefits and risks of immunization, inquire about

the recent health status of the recipient, review the recipient’s history concerning possible

hypersensitivity to the vaccine or similar vaccine, previous immunization history, the presence of

any contraindications to immunization and comply with any local requirements with respect to

information to be provided to the parent or guardian before immunization and the importance

of completing the immunization series.

It is extremely important that the parent or guardian be questioned concerning any symptoms

and/or signs of an adverse reaction after a previous dose of vaccine. (See CONTRAINDICATIONS

and ADVERSE REACTIONS )

The rates and severity of adverse events in recipients of tetanus toxoid are influenced by the

number of prior doses and level of pre-existing antitoxins.

As with any vaccine, PEDIACEL® may not protect 100% of vaccinated individuals.

Vaccines that contain Hib antigen do not provide protection against infections with other types

of H. influenzae, or against meningitis of other origin.

Under no circumstances can the tetanus protein contained in conjugate vaccines containing

tetanus toxoid as protein carrier be used to replace the usual tetanus vaccination.

Sudden infant death syndrome (SIDS) has occurred in infants following administration of DTaP

vaccines. By chance alone, some cases of SIDS can be expected to follow receipt of PEDIACEL®.

Administration Route Related Precautions: Do not administer PEDIACEL® by intravascular

injection; ensure that the needle does not penetrate a blood vessel.

Intradermal or subcutaneous routes of administration are not to be utilized.

PEDIACEL® should not be administered into the buttocks.

Granuloma or sterile abscess at the injection site has been reported with a product containing

the same antigens.

Febrile or Acute Disease: Vaccination should be postponed in cases of acute or febrile disease.

However, a disease with low-grade fever should not usually be a reason to postpone vaccination.

If any of the following events occur within the specified period after administration of a whole-

cell pertussis vaccine or a vaccine containing an acellular pertussis component, the decision

to administer PEDIACEL® should be based on careful consideration of potential benefits and

possible risks.

Temperature of ≥40.5°C (105°F) within 48 hours, not attributable to another identifiable

cause;

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

Persistent crying lasting ≥3 hours within 48 hours;

Convulsions with or without fever within 3 days.

Hematologic

Because any intramuscular injection can cause an injection site hematoma in persons with any

bleeding disorders, such as hemophilia or thrombocytopenia, or in persons on anticoagulant

therapy, intramuscular injections with PEDIACEL® should not be administered to such persons

unless the potential benefits outweigh the risk of administration. If the decision is made to

administer any product by intramuscular injection to such persons, it should be given with caution,

with steps taken to avoid the risk of hematoma formation following injection.

Immune

The possibility of allergic reactions in persons sensitive to components of the vaccine should

be evaluated. Hypersensitivity reactions may occur following the use of PEDIACEL® even in

persons with no prior history of hypersensitivity to the product components. Cases of allergic

or anaphylactic reaction have been reported after receiving some preparations containing

diphtheria and tetanus toxoids and/or pertussis antigens.

As with all other products, epinephrine hydrochloride solution (1:1,000) and other appropriate

agents should be available for immediate use in case an anaphylactic or acute hypersensitivity

reaction occurs. Health-care providers should be familiar with current recommendations for the

initial management of anaphylaxis in non-hospital settings, including proper airway management.

Immunocompromised persons (whether from disease or treatment) may not obtain the expected

immune response. If possible, consideration should be given to delaying vaccination until after

the completion of any immunosuppressive treatment. Nevertheless, vaccination of persons

with chronic immunodeficiency such as HIV infection is recommended even if the antibody

response might be limited.

Neurologic

A review by the US Institute of Medicine (IOM) found evidence for a causal relation between

tetanus toxoid and both brachial neuritis and Guillain-Barré syndrome (GBS). If GBS occurred within

6 weeks of receipt of prior vaccine containing tetanus toxoid, the decision to give PEDIACEL®

or any vaccine containing tetanus toxoid should be based on careful consideration of potential

benefits and possible risks.

A few cases of demyelinating diseases of the central nervous system, peripheral mononeuropathies,

and cranial mononeuropathies have been reported following vaccines containing tetanus and/

or diphtheria toxoids, although the IOM concluded that the evidence is inadequate to accept or

reject a causal relation between these conditions and vaccination.

For infants or children at higher risk for seizures than the general population, an appropriate

antipyretic may be administered (in the dosage recommended in its prescribing information) at

the time of vaccination with a vaccine containing an acellular pertussis component (including

PEDIACEL®) and for the following 24 hours, to reduce the possibility of post-vaccination fever.

Hypotonic-hyporesponsive episodes (HHEs) rarely follow vaccination with whole-cell pertussis

containing DTP vaccines and occur even less commonly after acellular pertussis-containing

DTP vaccines and DT vaccines. A history of HHEs is not a contraindication to the use of acellular

pertussis vaccines but recommends caution in these cases.

Pregnant Women

The vaccine should not be administered to pregnant women.

Nursing Women

The vaccine should not be administered to nursing women.

Pediatric

The potential risk of apnea and the need for respiratory monitoring for 48 - 72 hours should

be considered when administering the primary immunization series to very premature infants

(born ≤28 weeks of gestation) and particularly for those with a previous history of respiratory

immaturity. As the benefit of vaccination is high in this group of infants, vaccination should not

be withheld or delayed.

ADVERSE REACTIONS

Clinical Trial Adverse Reactions

Because clinical trials are conducted under widely varying conditions, adverse reaction rates

observed in the clinical trials of a vaccine cannot be directly compared to rates in the clinical

trials of another vaccine and may not reflect rates observed in practice. The adverse reaction

information from clinical trials does, however, provide a basis for identifying the adverse events

that appear to be related to vaccine use and for approximating rates of those events.

In a randomized, controlled clinical trial conducted in Canada, 339 infants were immunized with

PEDIACEL® at 2, 4 and 6 months of age. In addition, 301 of these children were immunized as

toddlers at 18 months. Injection site reactions were generally mild. Up to one third of children

receiving PEDIACEL® experienced some degree of redness, swelling or tenderness around the

injection site. The frequency of solicited injection site and systemic reactions observed in a

clinical trial within 24 hours of any dose of PEDIACEL® given at 2, 4, 6 and 18 months of age

are presented below.

Very Common:

≥10%

Common:

≥1% and <10%

Gastrointestinal Disorders

Common: Diarrhea, vomiting.

General Disorders and Administration Site Conditions

Very Common: Injection site tenderness, swelling, redness, fever (≥38.0°C), crying, eating less,

fussiness, less active.

Data from Post-Marketing Experience

The following additional adverse events have been spontaneously reported during the post-

marketing use of PEDIACEL® worldwide. Because these events are reported voluntarily from

a population of uncertain size, it is not always possible to reliably estimate their frequency or

establish a causal relationship to vaccine exposure.

Immune System Disorders

Hypersensitivity, anaphylactic reaction (such as urticaria, angioedema).

Psychiatric Disorders

Irritability , screaming.

Nervous System Disorders

Convulsion (with or without fever), prolonged or unusual high-pitched crying, hypotonic

hyporesponsive episode (infant appears pale, hypotonic [limp] and unresponsive to parents).

To date, this condition has not been associated with any permanent sequelae Somnolence

Vascular Disorders

Pallor

Respiratory, Thoracic and Mediastinal Disorders

Apnea

Skin and Subcutaneous Tissue Disorders

Erythema, rash.

Musculoskeletal, Connective Tissue and Bone Disorders

Pain in vaccinated limb.

General Disorders and Administration Site Conditions

High fever (>40.5°C), injection site mass, , asthenia, and listlessness.

Large injection site reactions (>50 mm) including extensive limb swelling which may extend

from the injection site beyond one or both joints, have been reported in children following

PEDIACEL® administration. These reactions usually start within 24 - 72 hours after vaccination,

may be associated with erythema, warmth, tenderness or pain at the injection site and resolve

spontaneously within 3 to 5 days. The risk appears to be dependent on the number of prior doses

of acellular pertussis containing vaccine, with a greater risk following the 4th and 5th doses.

Edematous reactions affecting one or both lower limbs have occurred following vaccination

with H. influenza type b containing vaccines. When this reaction occurs, it does so mainly after

primary injections and is observed within the first few hours following vaccination. Associated

symptoms may include cyanosis, redness, transient purpura and severe crying. All events resolved

spontaneously without sequelae within 24 hours.

DRUG INTERACTIONS

Vaccine-Drug Interactions

Immunosuppressive treatments may interfere with the development of the expected immune

response. (See WARNINGS AND PRECAUTIONS.)

Concomitant Vaccine Administration

Administering the most widely used live and inactivated vaccines during the same patient visit

has produced seroconversion rates and rates of adverse reactions similar to those observed

when the vaccines are administered separately. Vaccines administered simultaneously should

be given using separate syringes at separate sites. Simultaneous administration is suggested,

particularly when there is concern that a person may not return for subsequent vaccination.

PEDIACEL® should not be mixed in the same syringe with other parenterals.

Vaccine-Laboratory Test Interactions

Antigenuria has been detected in some instances following administration of a vaccine containing

Hib antigen. Therefore, urine antigen detection may not have definite diagnostic value in suspected

H. influenzae type b disease within two weeks of immunization.

DOSAGE AND ADMINISTRATION

Recommended Dose

1 dose = 0.5 mL

The immunization schedule with PEDIACEL® should follow local recommendations. As a guide,

PEDIACEL® may be administered as a 4-dose series starting as early as 2 months of age with 3

doses at an interval of 2 months between each dose, followed by a booster dose approximately

6 to 12 months after the third dose.

Whenever feasible, PEDIACEL® should be used for all 4 doses in the vaccination series as there

are no clinical data to support the use of PEDIACEL® with any other licensed acellular pertussis

combination vaccine in a mixed sequence.

Premature infants whose clinical condition is satisfactory should be immunized with full doses of

vaccine at the same chronological age and according to the same schedule as full-term infants,

regardless of birth weight.

Fractional doses (doses <0.5 mL) should not be given. The effect of fractional doses on the safety

and efficacy has not been determined.

PEDIACEL® should not be administered to persons less than 2 months or to persons 7 years of

age or older. (See INDICATIONS AND CLINICAL USE.)

Administration

Inspect for extraneous particulate matter and/or discolouration before use. If these conditions

exist, the product should not be administered.

Shake the vial well until a uniform, cloudy, suspension results. Cleanse the vial stopper with

a suitable germicide prior to withdrawing the dose. Do not remove either the stopper or the

metal seal holding it in place.

Aseptic technique must be used. Use a separate, sterile syringe and needle, or a sterile disposable

unit, for each individual patient to prevent disease transmission. Needles should not be recapped

but should be disposed of according to biohazard waste guidelines.

Before injection, the skin over the site to be injected should be cleansed with a suitable germicide.

Administer the total volume of 0.5 mL intramuscularly (I.M.). In infants younger than 1 year, the

anterolateral aspect of the thigh provides the largest muscle and is the preferred site of injection.

In older children, the deltoid muscle is usually large enough for injection.

STORAGE AND STABILITY

Store at 2° to 8°C (35° to 46°F). Do not freeze. Discard product if exposed to freezing.

Do not use after expiration date.

DOSAGE FORMS, COMPOSITION AND PACKAGING

Dosage Forms

PEDIACEL® is supplied as a sterile, uniform, cloudy, white to off-white suspension in a vial.

Composition

Each single dose (0.5 mL) contains:

Active Ingredients

Diphtheria Toxoid (D) adsorbed

15 Lf (≥ 30 UI )

Tetanus Toxoid (T) adsorbed

5 Lf (≥ 40 UI )

Acellular Pertussis

Pertussis Toxoid adsorbed(PT)

20 µg

Filamentous Haemagglutinin adsorbed (FHA)

20 µg

Pertactin (PRN) adsorbed

3 µg

Fimbriae Types 2 and 3 (FIM) adsorbed

5 µg

Inactivated Poliomyelitis Vaccine

Type 1 (Mahoney)

40 D-antigen units

Type 2 (MEF1)

8 D-antigen units

Type 3 (Saukett)

32 D-antigen units

Purified Capsular

Polysaccharide (PRP) of Haemophilus influenzae

Type b covalently bound to 20 µg of Tetanus Protein

10 µg

Other Ingredients

Excipients

Aluminum Phosphate (adjuvant)

1.5 mg (0.33+- 0.03 mg)

2-phenoxyethanol

0.6% v/v (3.33 mg)

Polysorbate 80

≤0.1% w/v (by calculation

Manufacturing Process Residuals

Bovine serum albumin, neomycin, polymyxin B, streptomycin and formaldehyde are present

in trace amounts.

Packaging

PEDIACEL® is supplied in 0.5 mL single dose glass vials.

The vials are made of Type 1 glass.

The container closure system for PEDIACEL® is free of latex (natural rubber).

PEDIACEL® is available in a package of:

1 single dose vial

5 single dose vials

Manufactured by:

License Holder:

Sanofi Pasteur Limited

Medici Ltd.

Toronto, Ontario, Canada

8 Tzoran St. Netanya ,Israel

Registration Number: 141013174600

The format of this leaflet was determined by the Ministry of Health and its content was checked

and approved in June 2013

PI-117.02

R4-112Export

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