SKYCELLFLU QUADRIVALENT PREFILLED SYRINGE 0.5ML

Maa: Singapore

Kieli: englanti

Lähde: HSA (Health Sciences Authority)

Aktiivinen ainesosa:

Influenza virus (NH) A/Guangdong-Maonan/SWL1536/2019, CNIC-1909 (H1N1); Influenza virus (NH) A/Hong Kong/2671/2019, NIB-121 (H3N2); Influenza virus (NH) B/Phuket/3073/2013; Influenza virus (NH) B/Washington/02/2019

Saatavilla:

AJ BIOLOGICS PTE. LTD.

ATC-koodi:

J07BB02

Lääkemuoto:

INJECTION

Koostumus:

Influenza virus (NH) A/Guangdong-Maonan/SWL1536/2019, CNIC-1909 (H1N1) 15mcg/0.5ml; Influenza virus (NH) A/Hong Kong/2671/2019, NIB-121 (H3N2) 15mcg/0.5ml; Influenza virus (NH) B/Phuket/3073/2013 15mcg/0.5ml; Influenza virus (NH) B/Washington/02/2019 15mcg/0.5ml

Antoreitti:

INTRAMUSCULAR

Prescription tyyppi:

Prescription Only

Valmistaja:

SK bioscience Co., Ltd. (L House)

Valtuutuksen tilan:

ACTIVE

Valtuutus päivämäärä:

2019-08-16

Valmisteyhteenveto

170×490mm(2P)
Revised on 04 Mar 2021
(Ver.005)
7) Post Marketing Experience
①
During this 4-year post marketing surveillance (PMS), among 655
subjects on adults aged 19 years and older, adverse events
w
ere reported by 6.87% (45/655 subjects, 69 cases) regardless the
causal relationship with the vaccine. No serious adverse
events or serious adverse drug reactions were reported. In addition,
unexpected adverse events and unexpected adverse drug
reactions are shown below according to its frequency.
Unexpected adverse events
regardless the causal
relationship with the vaccine
were reported by 1.68%
(11/655 subjects, 16 cases)
②
At the point of re-examination, integrated assessment of adverse
events in SKYCellflu was conducted from re-examination
reports to MFDS and adverse events from spontaneous reports compared
with all reported events in all licensed vaccines in
Korea (1989-March 31, 2020). Among the statistically significant
adverse events reported on this vaccine compared to those
reported on all other vaccines the following are newly identified.
However, this does not mean that the causal relationship between
the component of this vaccine and the following adverse events has
been proved.
• General disorders and administration site conditions: Chills,
Vaccination site bruising
Uncommon
(0.1 to <5%)
_Respiratory, thoracic, and _
_mediastinal disorders_
Unexpected adverse drug
reactions that causal relationship
with the vaccine could not be
excluded were reported by 0.76%
(5/655 subjects, 6 cases)
_Nervous system disorders_
_General disorders and _
_administration site conditions_
_Infections and Infestations_
_Gastrointestinal disorders_
_Injury, poisoning and _
_procedural complications_
Cough, Oropharyngeal pain,
Respiratory disorder, Rhinitis allergic
Cough, Oropharyngeal pain
Dizziness Dizziness
Influenza like illness Influenza like illness
Acute sinusitis, Tonsillitis, Tracheobronchitis
Gastritis
Contusion, Skin abrasion,
Thermal burn