SKYCellflu Quadrivalent Prefilled Syringe 0.5ml

Valsts: Malaizija

Valoda: angļu

Klimata pārmaiņas: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Aktīvā sastāvdaļa:

INACTIVATED,INFLUENZA VIRUS TYPE A (H1N1); INACTIVATED,INFLUENZA VIRUS TYPE A (H3N2); INACTIVATED,INFLUENZA VIRUS TYPE B (B/YAMAGATA); INACTIVATED,INFLUENZA VIRUS TYPE B (B/VICTORIA)

Pieejams no:

AJ BIOLOGICS SDN. BHD.

SNN (starptautisko nepatentēto nosaukumu):

INACTIVATED,INFLUENZA VIRUS TYPE A (H1N1); INACTIVATED,INFLUENZA VIRUS TYPE A (H3N2); INACTIVATED,INFLUENZA VIRUS TYPE B (B/YAMAGATA); INACTIVATED,INFLUENZA VIRUS TYPE B (B/VICTORIA)

Vienības iepakojumā:

10 Pre-Filled Syringes; 5 Pre-Filled Syringes; 1 Pre-Filled Syringes; 10 Pre-Filled Syringes

Ražojis:

SK bioscience Co., Ltd.

Lietošanas instrukcija

Not Applicable

Produkta apraksts

[A/Guangdong-Maonan/SWL1536/2019, CNIC-1909 (H1N1)] (In-house)
[A/Hong Kong/2671/2019, NIB-121 (H3N2)] (In-house)
[B/Washington/02/2019]
6 months of age and older.
Aged 6 months through
8 years
6) Safety of SKYCellflu Quadrivalent
®
was assessed in a study with 449 children 6 months through 35 months
of age, 255 pediatric
and adolescent subjects 3 through 18 years of age, and 802 adults ≥
19 years of age, and followings were reported for adverse
reactions. 701 out of 1,506 (46.55%) subjects developed adverse
reactions after vaccination. The incidence rate was 50.11% in
children 6 through 35 months of age, 46.27% in pediatric and
adolescent subjects 3 through 18 years of age, 49.00% in adult 19
through 59 years of age, and 26.14% in subjects ≥ 60 years of age.
Solicited adverse reactions observed during the 7-day period after
SKYCellflu Quadrivalent
®
vaccination are shown below.
0.00%
0.00%
0.00%
6 through 35
months of age(N=449)
25.68%
24.77%
14.54%
6.11%
14.10%
11.61%
7.57%
1.84%
0.57%
12.60%
10.39%
2.39%
2.15%
-
-
-
-
-
16.26%
12.69%
7.57%
-
20.27%
27.39%
10.69%
1
2
3
4
4
5
5
6
(N=1,506)
2
2.15%
120Ⅹ310mm(2P)
Unsolicited adverse reactions observed during the 21-day (adults) or
28-day (children and adolescents) period after SKYCellflu
Quadrivalent
®
vaccination were reported in 35 out of 1,506 (2.32%) subjects. Adverse
reactions related to respiratory system
in 14 subjects (0.93%) was most frequently observed. Adverse reactions
observed during the study period are shown below.
(Uncommon: 0.1 to <5%, Rare: <0.1%)
Paresthesia
Eye discharge
Nasopharyngitis, Upper respiratory
tract infection, Rhinorrhea
Pharyngitis, Cough, Herpangina
_Gastrointestinal disorders_
_Respiratory system_
_General disorder and _
_administration site condition _
_Skin and subcutaneous tissue _
_Musculoskeletal system _
_Nervous system _
_Sensory organ_
Diarrhea
Dyspepsia, Vomiting, Decreased appetite
Pyrexia
Injection site pruritus/Injection site
warmth
Rash
Eczema, Viral rash
Myalgia
1
Reported in subjects ≥12 years of age(N=6