POLIO SABIN ONE AND THREE

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

POLIOMYELITIS VIRUS TYPE 1; POLIOMYELITIS VIRUS TYPE 1; POLIOMYELITIS VIRUS TYPE 3

Available from:

GLAXO SMITH KLINE (ISRAEL) LTD

ATC code:

J07BF01

Pharmaceutical form:

SUSPENSION

Composition:

POLIOMYELITIS VIRUS TYPE 3 NLT 10^6.0 CCID50; POLIOMYELITIS VIRUS TYPE 1 NLT 10^5.8 CCID50; POLIOMYELITIS VIRUS TYPE 1 NLT 10^6.0 CCID50

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

GLAXO SMITH KLINE BIOLOGICALS S.A

Therapeutic area:

POLIOMYELITIS ORAL, MONOVALENT LIVE ATTENUATED

Therapeutic indications:

Active immunisation against poliomyelitis infection caused by types 1 and 3 poliomyelitis viruses at any age after receiving at least one dose of IPV.

Authorization date:

2019-10-31

Patient Information leaflet

ל ןולעב )תוחיטב עדימ ( הרמחה לע העדוה
ל ןולעב )תוחיטב עדימ ( הרמחה לע העדוה
ל ןולעב )תוחיטב עדימ ( הרמחה לע העדוה
אפור
אפור
אפור
ןכדועמ(
ןכדועמ(
ןכדועמ(
.102.50
.102.50
.102.50
)
)
) ךיראת :
5102.
21
תילגנאב רישכת םש
:
ONE AND THREE
SABIN
POLIO
םושירה רפסמ
:
34035
-
84
-
152
םושירה לעב םש
:
GLAXOSMITHKLINE (ISRAEL) LTD
! דבלב תורמחהה טורפל דעוימ הז ספוט
אפורל ןולעב
אפורל ןולעב
אפורל ןולעב
ה תורמחהה
תושקובמ
ןולעב קרפ
יחכונ טסקט
שדח טסקט
FERTILITY,
PREGNANCY
AND LACTATION
Pregnancy
There is limited data,and even no data, on the use in
the pregnant woman of live attenuated poliomyelitis
virus from Sabin strains of Type 1 (LSc, 2ab) and of
Type 3 (Leon 12a, 1b). Animal studies are
insufficient to allow conclusions to be drawn about
the toxicity on reproductions (see section 5.3).
Pregnancy
There is limited data,and even no data, on the use in the
pregnant woman of live attenuated poliomyelitis virus
from Sabin strains of Type 1 (LSc, 2ab) and of Type 3
(Leon 12a, 1b). Animal studies are insufficient to allow
conclusions to be drawn about the toxicity on
reproductions (see section 5.3). Polio Sabin One and
Three (oral) is not recommended during pregnancy or
in woman of childbearing age who do not use
contraception.
UNDESIRABLE
EFFECTS
Fever, vomiting and diarrhoea have been observed
after immunisation with the Polio Sabin One and Three
(oral). Allergic/anaphylactoid reactions have been
described after immunisation with GlaxoSmithKline
Biological's trivalent oral poliomyelitis vaccine.
General disorders and administration site
condition
Very rare Fever
Gastrointestinal disorders
Very rare Diarrhoea, vomiting
Immune system disorders
Very rare Allergic/anaphylactoid reactions
Infections and infestations
Very rare Vaccine-associated paralysis תושקובמה תורמחהה ת

Summary of Product characteristics

_The format of this leaflet was determined by the Ministry of Health
and its content was checked and approved in February 2016 _
_ _
POLIO SABIN
™ ONE AND THREE
1.
NAME OF THE MEDICINAL PRODUCT
Polio Sabin One and Three
Suspension for oral administration, multidose.
Poliomyelitis bivalent vaccine type 1 and 3 (live attenuated)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One dose (0.1 ml) contains:
Polio virus type 1 (LSc, 2ab strain) live attenuated*
.................................. not less than 10
6.0
CCID
50
Polio virus type 3 (Leon, 12a,1b strain) live attenuated*
............................ not less than 10
5.8
CCID
50
*produced on a culture of human diploid cells
The vaccine is presented in a multidose pack. See section 6.5 for the
number of doses per vial.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Suspension for oral administration.
Clear, yellowish pink suspension for oral administration.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Active immunization against poliomyelitis infection caused by types 1
and 3 poliomyelitis viruses at any age
after receiving at least one dose of IPV.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
In a multidose vial, the immunizing dose consists of two drops.
The vaccination schedule must be in accordance with official
recommendations.
Method of administration
Polio Sabin One and Three (oral) is presented ready for use and is for
oral administration only.
Under no circumstances can the oral vaccine be injected.
The vaccine can be administered alone or together with beverages or
foods (syrup, milk, bread, sugar cube)
provided that these do not contain substances that may inactivate the
viruses, such as preservatives.
Since the vaccine has a slightly bitter, salty taste, it can be given
in syrup or on a sugar cube, particularly when
it is given to young children.
For breast-fed infants, the vaccine should be administered preferably
two hours before or after breast-feeding
in order to avoid any interference with the antibodies pres