FLUQUADRI SH

Valsts: Indonēzija

Valoda: indonēziešu

Klimata pārmaiņas: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Aktīvā sastāvdaļa:

HAEMAGGLUTININ A/MICHIGAN/45/2015 X-275 (H1N1); HAEMAGGLUTININ B/BRISBANE/60/2008 (VICTORIA LINEAGE); HAEMAGGLUTININ B/PHUKET/3073/20-13 (YAMAGATA LINEAGE); HAEMAGLUTININ A/HONGKONG/4801/2014 X-263B (H3N2)

Pieejams no:

AVENTIS PHARMA - Indonesia

SNN (starptautisko nepatentēto nosaukumu):

HAEMAGGLUTININ A/MICHIGAN/45/2015 X-275 (H1N1); HAEMAGGLUTININ B/BRISBANE/60/2008 (VICTORIA LINEAGE); HAEMAGGLUTININ B/PHUKET/3073/20-13 (YAMAGATA LINEAGE); HAEMAGLUTININ A/HONGKONG/4801/2014 X-263B (H3N2)

Deva:

30 UG HA TOTAL PER 0.25 ML DOS

Zāļu forma:

CAIRAN INJEKSI

Vienības iepakojumā:

DUS, 5 SYRINGE @ 0.25 ML (1 DOSIS)

Ražojis:

SANOFI PASTEUR - USA

Autorizācija datums:

2017-05-15

Produkta apraksts

FLUQUADRI SH
Quadrivalent Influenza Vaccine
Types A and B
2017 Formula
FULL PRESCRIBING INFORMATION:
INDICATION AND USAGE
FluQuadri is an activated quadrivalent influenza vaccine indicated for
the prevention of influenza
disease caused by influenza types A and B viruses contained in the
vaccine in children (6 months
to 9 years old), adult with high risk factor (>18 years old), and
elderly (>60 years old)
COMPOSITION:
Per 0.25 mL contains:
Hemagglutinin A/Michigan/45/2015 X-275 (H1N1) 7.5 mcg, hemagglutinin
A/Hongkong/4801/2014 X-263B (H3N2) 7.5 mcg.
Hemagglutinin B/Phuket/3073/2013 (Yamagata lineage) 7.5 mcg, and
hemagglutinin
B/Brisbane/60/2008 (Victoria lineage) 7.5 mcg
Per 0.5 mL contains:
Hemagglutinin A/Michigan/45/2015 X-275 (H1N1) 15 mcg, hemagglutinin
A/Hongkong/4801/2014 X-263B (H3N2) 15 mcg.
Hemagglutinin B/Phuket/3073/2013 (Yamagata lineage) 15 mcg, and
hemagglutinin
B/Brisbane/60/2008 (Victoria lineage) 15 mcg
The vaccine complies with the W.H.O. recommendations (Southern
Hemisphere) for the 2017
season.
DOSAGE AND ADMINISTRATION
FOR INTRAMUSCULAR USE ONLY
DOSE AND SCHEDULE
The dose and schedule for FluQuadri are presented in Table 1.
TABLE 1: DOSE AND SCHEDULE FOR FLUQUADRI
Age
Dose
Schedule
6 months through 35 months
One or two doses*, 0.25 mL each
If 2 doses, administer at least 1
month apart
36 months through 8 years
One or two doses*, 0.5 mL each
If 2 doses, administer at least 1
month apart
9 years and older
One dose, 0.5 mL
-
*1 or 2 dose depends on vaccination history and local or national
recommendations
“.” Indicates information is not applicable
ADMINISTRATION
Inspect FluQuadri visually for particulate matter and/or discoloration
prior to administration. If
either of these conditions exist, the vaccine should not be
administered.
Before administering a dose of vaccine, shake the prefilled syringe to
uniformly distribute the
suspension before administering each dose.
Aseptic technique must be used. Use a separate, sterile syringe and
needle, or a sterile disposable
unit, for each individ