FLUAD

Valsts: Izraēla

Valoda: angļu

Klimata pārmaiņas: Ministry of Health

Aktīvā sastāvdaļa:

A/CALIFORNIA/7/2009 (H1N1)PDM09-LIKE VIRUS; A/HONG KONG/4801/2014 (H3N2) - LIKE VIRUS; B/BRISBANE/60/2008 - LIKE VIRUS

Pieejams no:

NEOPHARM SCIENTIFIC LTD

ATĶ kods:

J06BB07

Zāļu forma:

SUSPENSION FOR INJECTION

Kompozīcija:

B/BRISBANE/60/2008 - LIKE VIRUS 15 MCG / 0.5 ML; A/HONG KONG/4801/2014 (H3N2) - LIKE VIRUS 15 MCG / 0.5 ML; A/CALIFORNIA/7/2009 (H1N1)PDM09-LIKE VIRUS 15 MCG / 0.5 ML

Ievadīšanas:

I.M

Receptes veids:

Required

Ražojis:

SEQIRUS VACCINES LTD, UK

Ārstniecības grupa:

VACCINIA IMMUNOGLOBULIN

Ārstniecības joma:

VACCINIA IMMUNOGLOBULIN

Ārstēšanas norādes:

Active immunisation against influenza in the elderly (65 years of age and over), especially for those with an infreased risk of associated complications (i.e. patients affected by underlying chronic diseases including diabetes, cardiovascular and respiratory diseases).

Autorizācija datums:

2015-12-31

Lietošanas instrukcija

העדוה
העדוה
לע
לע
הרמחה
הרמחה
(
(
עדימ
עדימ
ןולעב )תוחיטב
ןולעב )תוחיטב
ל
ל
אפור
אפור
ןכדועמ(
ןכדועמ(
05.2013
05.2013
)
) :ךיראת
03.08 .2015
םש
רישכת
תילגנאב
רפסמו
:םושירה
33057-00 -1 44 - 88 FLUAD
םש
לעב
םושירה :
NEOPHARM SCIENTIFIC LTD
ספוט
הז
דעוימ
טורפל
תורמחהה
דבלב
!
תורמחהה
תושקובמה
קרפ
ןולעב
טסקט
יחכונ
טסקט
שדח
4.4
SPECIAL WARNINGS
AND PRECAUTIONS
FOR USE
4.4
SPECIAL
WARNINGS
AND
SPECIAL
PRECAUTIONS FOR USE
As with all injectable vaccines, appropriate
medical treatment and supervision should
always be readily available in case an
anaphylactic event occurs following the
administration of the vaccine
.
The vaccine (FLUAD) should under no
circumstances be administered
intravascularly or subcutaneously
.
Antibody response in patients with
endogenous or iatrogenic
immunosuppression may be insufficient
.
A protective response may not be elicited in
all vaccinees
.
4.4
SPECIAL
WARNINGS
AND
SPECIAL
PRECAUTIONS FOR USE
As with all injectable vaccines, appropriate
medical treatment and supervision should
always be readily available in case an
anaphylactic event occurs following the
administration of the vaccine
.
The vaccine (FLUAD) should under no
circumstances be administered
intravascularly or subcutaneously
.
ANXIETY-RELATED REACTIONS, INCLUDING
VASOVAGAL REACTIONS (SYNCOPE),
HYPERVENTILATION OR STRESS-RELATED
REACTIONS, CAN OCCUR FOLLOWING, OR EVEN
BEFORE, ANY VACCINATION AS A PSYCHOGENIC
RESPONSE TO THE NEEDLE INJECTION. THIS CAN
BE ACCOMPANIED BY SEVERAL NEUROLOGICAL
SIGNS SUCH AS TRANSIENT VISUAL DISTURBANCE,
PARAESTHESIA AND TONIC-CLONIC LIMB
MOVEMENTS DURING RECOVERY. IT IS
IMPORTANT THAT PROCEDURES ARE IN PLACE TO
AVOID INJURY FROM FAINTS
.
Antibody response in patients with
endogenous or iatrogenic
immunosuppression may be insufficient
.
A protective response may not be elicited in
all vaccinees
.
4.5
INTERACTIONS WITH
OTHER

Produkta apraksts

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT_ _
FLUAD
, suspension for injection in pre-filled syringe
Influenza Vaccine, Surface Antigen, Inactivated, Adjuvanted with
MF59C.1
(2017/2018 SEASON)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Influenza virus surface antigens (haemagglutinin and neuraminidase
)*,
of strains
:
A/Michigan/45/2015 (H1N1)pdm09 – like strain
(A/Singapore/GP1908/2015, IVR-180)
15 micrograms HA**
A/Hong Kong/4801/2014 (H3N2) – like strain
(A/Hong Kong/4801/2014, NYMC X-263B)
15 micrograms HA**
B/Brisbane/60/2008 – like strain (B/Brisbane/60/2008, wild type)
15 micrograms HA **
*propagated in fertilized hens’ eggs from healthy chicken flocks and
adjuvanted with MF59C.1
**haemagglutinin
Adjuvant: MF59C.1 which is an exclusive adjuvant: 9.75 mg squalene,
1.175 mg polysorbate 80, 1.175 mg
sorbitan trioleate, 0.66 mg sodium citrate, 0.04 mg citric acid, water
for injection.
For one dose of 0.5 ml
This vaccine complies with the WHO recommendations (Northern
Hemisphere) and EU decision for the
2017/2018 season.
Fluad may contain traces of eggs such as ovalbumin or chicken
proteins, kanamycin and neomycin sulphate,
formaldehyde, cetyltrimethylammonium bromide (CTAB) and barium
sulphate which are used during the
manufacturing process (see section 4.3).
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Suspension for injection in pre-filled syringe.
The vaccine appears as a milky-white suspension.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Active immunisation against influenza in the elderly (65 years of age
and over), especially for those with
an increased risk of associated complications.
The use of Fluad should be based on official recommendations.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
A single 0.5 ml dose should be administered by intramuscular injection
into the deltoid muscle. Due to the
presence of the adjuvant, the injection should be carried out by using
a 1 inch needle.
Method of administration
For instructions for pre