VAXIGRIP

Israel - English - Ministry of Health

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Active ingredient:
A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE VIRUS; A/SINGAPORE/INFIMH-16-0019/2016 (H3N2) - LIKE VIRUS; B/COLORADO/06/2017- LIKE VIRUS (B/VICTORIA/2/87 LINEAGE); B/PHUKET/3073/2013 - LIKE VIRUS (B/YAMAGATA/16/88 LINEAGE)
Available from:
MEDICI MEDICAL LTD, ISRAEL
ATC code:
J07BB01
Pharmaceutical form:
SUSPENSION FOR INJECTION
Composition:
B/PHUKET/3073/2013 - LIKE VIRUS (B/YAMAGATA/16/88 LINEAGE) 15 MCG/DOSE; A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE VIRUS 15 MCG/DOSE; A/SINGAPORE/INFIMH-16-0019/2016 (H3N2) - LIKE VIRUS 15 MCG/DOSE; B/COLORADO/06/2017- LIKE VIRUS (B/VICTORIA/2/87 LINEAGE) 15 MCG/DOSE
Administration route:
I.M, DEEP S.C.
Prescription type:
Required
Manufactured by:
SANOFI PASTEUR, FRANCE
Therapeutic group:
INFLUENZA, INACTIVATED, WHOLE VIRUS
Therapeutic area:
INFLUENZA, INACTIVATED, WHOLE VIRUS
Therapeutic indications:
For the prevention of influenza.
Authorization number:
031 05 21760 00
Authorization date:
2012-11-30

Documents in other languages

Patient Information leaflet Patient Information leaflet - Hebrew

27-01-2021

אפורל ןולעב )תוחיטב עדימ ( הרמחה לע העדוה אפורל ןולעב )תוחיטב עדימ ( הרמחה לע העדוה אפורל ןולעב )תוחיטב עדימ ( הרמחה לע העדוה

ןכדועמ( ןכדועמ( ןכדועמ(

.102.50

.102.50

.102.50

)

)

)

רשוא

61.6

_______________ ךיראת

05.06.16

________

ש

םושירה רפסמו תילגנאב רישכת ם

____

____

031 -05 -21760 -00

_

VAXIGRIP

םושירה לעב םש

_

מ"עב לקידמ יצידמ

___________________________________

! דבלב תורמחהה טורפל דעוימ הז ספוט

תושקובמה תורמחהה

ןולעב קרפ

יחכונ טסקט

שדח טסקט

2

.

Qualitive and Quantitive

composition

יוניש

בכרה

21.6-21.7

A/California/7/2009 (H1N1)pdm09– like virus

….15 micrograms HA**

A/Hong Kong/4801/2014 (H3N2) -like virus

15 micrograms HA**

B/Brisbane/60/2008 –like virus

15 micrograms HA**

4.1

Terapeutic indications

תפסות

טסקט

VAXIGRIP is indicated in adults and children from 6

months of age.

4.2

Posology and method of

תפסות

ןוכדעו

טסקט

Posology

Adults: 0.5 ml.

administration

Paediatric population

Children aged 36 months onwards: 0.5 ml.

Children aged 6 to 35 months: 0.25 ml. Clinical data

are limited. See Section 6.6 for more information on

administration of the 0.25 ml dose.

A 0.5 ml dose may be given, if this is required by

national recommendations.

For children aged less than 9 years who have not

previously been vaccinated, a second dose should be

given after an interval of at least 4 weeks.

Children aged less than

6 months: the safety and

efficacy of VAXIGRIP in children aged less than 6

months

have

been

established.

data

available.

Method of administration

administered

intramuscular

deep

subcutaneous route.

For adults and children from 36 months of age: the preferred

site for intramuscular injection is the deltoid muscle.

35 months of age: the preferred site

For children from 12 to

for intramuscular injection is the anterolateral aspect of the

thigh (or the deltoid muscle if muscle mass is adequate).

For children from 6 to 11 months of age: the preferred

site

intramuscular

injection

anterolateral

aspect of the thigh.

Precautions

to

be

taken

before

handling

or

administering the medicinal product.

instructions

preparation

medicinal

product before administration, see Section 6.6.

4.3

Contraindications

ןוכדע טסקט

Hypersensitivity to the active substances, to any of the

excipients listed in Section 6.1 or to any component

that may be present as traces such as eggs

(ovalbumin, chicken proteins), neomycin,

formaldehyde and octoxinol-9.

Vaccination should be postponed in case of moderate or

severe febrile disease or acute disease

414

תפסות

טסקט

As with other vaccines administered intramuscularly

the vaccine should be administered with caution to

subjects with thrombocytopenia or bleeding disorders

since

bleeding

occur

following

intramuscular

administration to these subjects.

As with any vaccine, vaccination with VAXIGRIP may

not protect 100% of susceptible subjects

Interference with serological testing

תושקובמה תורמחהה תונמוסמ ובש ,ןולעה ב"צמ בוהצ עקר לע

1

ונמוס תורמחה רדגב םניאש םייוניש )ןולעב(

םוקימב םייוניש אלו יתוהמ ןכות קר ןמסל שי .הנוש עבצב .טסקטה

וה 111111ךיראתב ינורטקלא ראודב רבע

05/06/16

111111111

4.8

Undesirable effects

ןוכדע

טסקט

ףרוצמה ןולעב

4.9

Overdose

ןוכדע

טסקט

Cases

administration

more

than

recommended dose (overdose) have been reported

with

VAXIGRIP.

When

adverse

reactions

were

reported,

information

consistent

with

known safety profile of VAXIGRIP described in Section

4.8.

1

NAME OF THE MEDICINAL PRODUCT

VAXIGRIP, suspension for injection in prefilled syringe.

Influenza vaccine (split virion, inactivated).

2

QUALITATIVE AND QUANTITATIVE COMPOSITION

Split influenza virus*, inactivated containing antigens equivalent to the following strains:

A/California/7/2009 (H1N1)pdm09– like virus ….15 micrograms HA**

A/Hong Kong/4801/2014 (H3N2) -like virus 15 micrograms HA**

B/Brisbane/60/2008 –like virus 15 micrograms HA**

per 0.5 ml dose.

propagated in fertilized hens’ eggs from healthy chicken flocks

haemagglutinin

This vaccine complies with the WHO recommendations (Northern Hemisphere) and EU decision for the 2016-2017 season.

For a full list of excipients, see section 6.1 .

VAXIGRIP may contain traces of eggs, such as ovalbumin, traces of neomycin, of formaldehyde and of octoxinol-9, which are used during the manufacturing

process (see Section 4.3.).

3

PHARMACEUTICAL FORM

Suspension for injection in prefilled syringe.

The vaccine, after shaking gently, is a slightly whitish and opalescent liquid.

4

CLINICAL PARTICULARS

4.1 Therapeutic indications

For the prevention of influenza.

VAXIGRIP is indicated in adults and children from 6 months of age.

The use of VAXIGRIP should be based on official recommendations.

4.2 Posology and method of administration

Posology

Adults: 0.5 ml.

Paediatric population

Children aged 36 months onwards: 0.5 ml.

Children aged 6 to 35 months: 0.25 ml. Clinical data are limited. See Section 6.6 for more information on administration of the 0.25 ml dose.

A 0.5 ml dose may be given, if this is required by national recommendations.

For children aged less than 9 years who have not previously been vaccinated, a second dose should be given after an interval of at least 4 weeks.

Children aged less than 6 months: the safety and efficacy of VAXIGRIP in children aged less than 6 months have not been established. No data are available.

Method of administration

To be administered via intramuscular or deep subcutaneous route.

For adults and children from 36 months of age: the preferred site for intramuscular injection is the deltoid muscle.

For children from 12 to 35 months of age: the preferred site for intramuscular injection is the anterolateral aspect of the thigh (or the deltoid muscle if muscle mass

is adequate).

For children from 6 to 11 months of age: the preferred site for intramuscular injection is the anterolateral aspect of the thigh.

Precautions to be taken before handling or administering the medicinal product.

For instructions for preparation of the medicinal product before administration, see Section 6.6.

4.3 Contraindications

Hypersensitivity to the active substances, to any of the excipients listed in Section 6.1 or to any component that may be present as traces such as eggs, (ovalbu-

min, chicken proteins),neomycin, formaldehyde and octoxinol -9.

Immunisation shall be postponed in patients with febrile illness or acute disease.

4.4 Special warnings and precautions for use

As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of an anaphylactic reaction , although

rare,following the administration of the vaccine.

VAXIGRIP should under no circumstances be administered intravascularly.

As with other vaccines administered intramuscularly the vaccine should be administered with caution to subjects with thrombocytopenia or bleeding disorders since

bleeding may occur following intramuscular administration to these subjects.

As with any vaccine, vaccination with VAXIGRIP may not protect 100% of susceptible subjects

Antibody response in patients with congenital or acquired immunosuppression may be insufficient.

Interference with serological testing

4.5 Interaction with other medicinal products and other forms of interaction

VAXIGRIP may be given at the same time as other vaccines. However injections

should be carried out on separate limbs. It should be noted that the adverse reactions may be intensified.

The immunological response may be diminished if the patient is undergoing immunosuppressant treatment.

Following influenza vaccination, false positive results in serology tests using the ELISA method to detect antibodies against HIV1, Hepatitis C and especially

HTLV1 have been observed. The Western Blot technique disproves the false-positive ELISA test results. The transient false positive reactions could be due to the

IgM response by the vaccine.

4.6 Pregnancy and lactation

Pregnancy

Inactivated influenza vaccines can be used in all stages of pregnancy. Larger datasets on safety are available for the second and third trimester, compared with

the first trimester, however, data from worldwide use of Inactivated influenza vaccines do not indicate any adverse foetal and maternal outcomes attributable to the

vaccine.

Breastfeeding

VAXIGRIP may be used during Breastfeeding

Fertility

No fertility data are available.

4.7 Effects on ability to drive and use machines

The vaccine has no or negligible influence on the ability to drive and use machines.

4.8 Undesirable effects

a. Summary of the safety profile

In recent clinical trials approximately 10,000 subjects from 6 months of age received VAXIGRIP.

Depending on immunization history and the age of the children, the dosage and the number of doses were different (see Paediatric population in subsection b.

Tabulated list of adverse reactions).

Solicited reactions usually occurred within the first 3 days following VAXIGRIP, resolved spontaneously within 1 to 3 days after onset. Most of the solicited adverse

reactions were of mild to moderate intensity.

The most frequently reported solicited adverse reaction within 7 days following injection of VAXIGRIP was injection site pain in all population except in children

aged 6 to 35 months in whom irritability was the most frequently reported.

The most frequently reported solicited systemic adverse reaction within 7 days following injection of VAXIGRIP was headache in adults, elderly and children aged

9 to 17 years and malaise in children aged 3 to 8 years.

Solicited adverse reactions were generally less frequent in elderly than in adults.

b. Tabulated list of adverse reactions

The data below summarize the frequencies of the adverse reactions that were recorded following vaccination with VAXIGRIP during clinical trials and worldwide

post-marketing experience.

Adverse events are ranked under headings of frequency using the following convention:

Very common (≥1/10);

Common (≥1/100 to <1/10);

Uncommon (≥1/1,000 to <1/100);

Rare (≥1/10,000 to <1/1,000);

Very rare (<1/10,000);

Not known: cannot be estimated from available data.

Adult and elderly

ADVERSE REACTIONS

FREQUENCY

Blood and Lymphatic System Disorders

Lymphadenopathy

Uncommon

Transient thrombocytopenia

Not known

Immune System Disorders

Allergic reactions such as swelling face

urticaria

prurit, generalized prurit

erythema, general-

ized erythema

rash

Rare

Severe allergic reactions such as dyspnoea, angioedema, shock

Not known

Nervous System Disorders

Headache

Very common

Dizziness

somnolence

Uncommon

Hypoaesthesia

paresthesia

neuralgia

brachial radiculitis

Rare

Convulsions, neurological disorders such as encephalomyelitis, neuritis, Guillain Barré syndrome

Not known

Vascular disorders

Vasculitis such as Henoch-Schonlein purpura, with transient renal involvement in certain cases

Not known

Gastrointestinal Disorders

Diarrhoea, nausea

Uncommon

Skin and Subcutaneous System Disorders

Sweating increased

Common

Musculoskeletal and Connective Tissue Disorders

Myalgia

Very common

Arthralgia

Common

General Disorders and Administration Site Conditions

Injection site pain/tenderness, injection site erythema/redness, injection site oedema/swelling, injection

site induration, malaise

, asthenia

, injection site pruritus

Very common

Fever, shivering/rigors, injection site ecchymosis

Common

Flu-like syndrome

, injection site warmth

, injection site discomfort

Uncommon

Rare in elderly

Reported during clinical trials in elderly

Reported during clinical trials in adults

Common in elderly

Not known in adults

Not known in elderly

Paediatric population

Depending on immunization history, children aged 6 months to 8 years received one or two doses of VAXIGRIP. Children aged 6 to 35 months received the 0.25 ml

formulation, and children from 3 years of age received the 0.5 ml formulation.

Children/adolescents aged 3 to 17 years:

The safety profile presented below is based on data from more than 300 children aged 3 to 8 years and around 70 children/adolescents aged 9 to 17 years.

In children aged 3 to 8 years, the most frequently reported solicited reactions within 7 days following injection of VAXIGRIP were as follows: injection site pain/ten-

derness (56.3%), malaise (27.3%), myalgia (25.5%) and injection site erythema/redness (23.4%).

In children/adolescents aged 9 to 17 years, the most frequently reported solicited reactions within 7 days following injection of VAXIGRIP were as follows: injection

site pain/tenderness (54.5% to 70.6%), cephalalgia (22.4% to 23.6%), myalgia (12.7% to 17.6%) and injection site erythema/redness (5.5% to 17.6%).

5.2 Pharmacokinetic properties

Not applicable.

5.3 Preclinical safety data

Not applicable.

6

PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Buffer solution:

Sodium chloride

Potassium chloride

Disodium phosphate dihydrate

Potassium dihydrogen phosphate

Water for injections

6.2 Incompatibilities

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

6.3 Shelf life

1 year.

6.4 Special precautions for storage

Store in a refrigerator (2°C – 8°C). Do not freeze. Keep the syringe in the outer carton in order to protect from light.

6.5 Nature and contents of container

0.5 ml of suspension in prefilled syringe (type I glass) with attached needle, equipped with a plunger stopper (elastomer chlorobromobutyl or chlorobutyl or bromo-

butyl) – pack size of 1, 10, 20 or 50.

0.5 ml of suspension in prefilled syringe (type I glass) without needle, equipped with a plunger stopper (elastomer chlorobromobutyl or chlorobutyl or bromobutyl)

and a tip cap (chlorobromobutyl) – pack size of 1, 10, 20 or 50.

6.6 Special precautions for disposal and other handling

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

The vaccine should not be used if foreign particles are present in the suspension.

The vaccine should be brought to reach room temperature before use.

Shake before use. Inspect visually prior to administration.

Instructions for the administration of a dose of 0.25 ml in children aged 6 to 35 months

When one dose of 0.25 ml is indicated, in order to eliminate half of the volume of the 0.5 ml syringe: the syringe should be held in an upright position and the

plunger stopper should be pushed until it reaches the fine black line printed on the syringe. The remaining volume of 0.25 ml should be injected. See also Section

4.2.

Manufacturer:

SANOFI PASTEUR SA 2, avenue Pont Pasteur 69007 Lyon, France

License Holder:

Medici Medical Ltd., 3 Hamachshev St., Netanya

The format of this leaflet was determined by the Ministry of Health and its content was checked and approved at June 2016.

PI-124.06

ADVERSE REACTIONS

FREQUENCY

Blood and Lymphatic System Disorders

Transient thrombocytopenia, lymphadenopathy

Not known

Immune System Disorders

Urticaria

Not known

Allergic reactions such as pruritus, rash erythematous, dyspnoea, angioedema, shock

Not known

Metabolism and nutrition Disorders

Decreased appetite, anorexia

Very common

Psychiatric Disorders

Crying abnormal, irritability

Very common

Insomnia

Common

Nervous System Disorders

Drowsiness

Very common

Paresthesia, convulsions, neurological disorders such as encephalomyelitis

Not known

Vascular disorders

Vasculitis such as Henoch-Schonlein purpura, with transient renal involvement in certain cases

Not known

Gastrointestinal Disorders

Diarrhoea

Very common

Vomiting

Common

General Disorders and Administration Site Conditions

Injection site pain/tenderness, injection site erythema/redness, injection site oedema/swelling, injection

site induration, fever

Very common

Injection site pruritus

injection site ecchymosis

Common

Reported within 3 days after injection of VAXIGRIP

c. Other special populations

Although only a limited number of subjects with co-morbidities were enrolled, studies conducted in renal transplant patients, asthmatic patients, or children aged

6 months to 3 years with medical conditions being at especially high risk of developing serious flu-related complications showed no major differences in terms of

safety profile of VAXIGRIP in these populations.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the

medicinal product.

Any suspected adverse events should be reported to the Ministry of Health according to the National Regulatorybyusinganonlineform http://forms.gov.il/globaldata/

getsequence/getsequence.aspx?formType=AdversEffectMedic@moh. gov.il

4.9 Overdose

Cases of administration of more than the recommended dose (overdose) have been reported with VAXIGRIP. When adverse reactions were reported, the informa-

tion was consistent with the known safety profile of VAXIGRIP described in Section 4.8.

5

PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: INFLUENZA VACCINE

ATC code: J07BB02

An antibody immune response is generally obtained within 2 to 3 weeks. The duration of postvaccinal induced immunity varies but is usually 6-12 months.

Reported during clinical trials in children aged 3 to 8 years

Reported during clinical trials in children/adolescents aged 9 to 17 years

Common in children/adolescents aged 9 to 17 years

Very common in children/adolescents aged 9 to 17 years

Not known in children/adolescents aged 9 to 17 years

Children aged 6 to 35 months:

The safety profile presented below is based on data from around 50 children aged 6 to 35 months.

In one clinical trial, the most frequently reported solicited reactions within 3 days following injection of VAXIGRIP were as follows: injection site pain (23.5%), irrita-

bility (23.5%), fever (20.6%) and abnormal crying (20.6%).

In another trial, the most frequently reported solicited reactions within 7 days following injection of VAXIGRIP were as follows:

irritability (60%), fever (50%), decreased appetite (35%) and abnormal crying (30%).

The data below summarize the frequencies of the adverse reactions that were recorded in children aged 6 to 35 months within

3 or 7 days following one or two 0.25 ml doses of VAXIGRIP during these two clinical trials and worldwide post-marketing experience:

ADVERSE REACTIONS

FREQUENCY

Blood and Lymphatic System Disorders

Lymphadenopathy

Uncommon

Transient thrombocytopenia

Not known

Immune System Disorders

Urticaria

Uncommon

Allergic reactions such as pruritus, rash erythematous, dyspnoea, angioedema, shock

Not known

Nervous System Disorders

Cephalalgia

Very common

Dizziness

Common

Neuralgia, paresthesia, convulsions, neurological disorders, such as encephalomyelitis, neuritis and

Guillain Barré syndrome

Not known

Vascular disorders

Vasculitis such as Henoch-Schonlein purpura, with transient renal involvement in certain cases

Not known

Gastrointestinal Disorders

Diarrhoea

Uncommon

Musculoskeletal and Connective Tissue Disorders

Myalgia

Very common

General Disorders and Administration Site Conditions

Injection site pain/tenderness, injection site erythema/redness, injection site oedema/swelling, injection

site induration

, malaise

Very common

Fever, shivering/rigors

injection site ecchymosis, injection site discomfort

injection site pruritus

Common

Injection site warmth

injection site haemorrhage

Uncommon

The data below summarize the frequencies of the adverse reactions that were recorded in children/adolescents aged 3 to 17 years following vaccination with

VAXIGRIP during clinical trials and worldwide post-marketing experience.

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