Weuphoria

Weuphoria

vaccine, pneumococcal

Manufacturer:

Yuxi Walvax Biotechnology

Distributor:

Biovalys

Marketer:

Biovalys
Concise Prescribing Info
Contents
13-valent pneumococcal polysaccharide conjugate vaccine (PCV13-TT)
Indications/Uses
Elicits immune responses following immunization & for prevention of invasive disease caused by 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F & 23F) of Strep pneumoniae in infants & childn 6 wk to 5 yr.
Dosage/Direction for Use
IM Inj in anterolateral aspect of thigh in infants & deltoid muscle of upper arm in toddlers & childn. Administer at 4-dose series: Childn who have not received the vaccine Toddler 24 mth to 5 yr One 0.5 mL dose, 12-23 mth two 0.5 mL doses at least 2 mth apart, infant 7-11 mth three 0.5 mL doses (1st 2 doses at least 2 mth apart, 3rd dose after 1-yr birthday, separated from 2nd dose by at least 2 mth). Infant 3 mth Dose 1, 2, & 3: Administer at 3, 4, & 5 mth of age, respectively. Recommended dosing interval: 4 wk. Dose 4: Administer at approx 12-15 mth of age; 2 mth Dose 1: May be given as early as 6 wk of age; Dose 2: Administer at 4 mth; Dose 3: Administer at 6 mth. Recommended dosing interval: 8 wk. Dose 4: Administer at approx 12-15 mth of age.
Contraindications
Hypersensitivity to PCV13-TT or tetanus toxoid.
Special Precautions
Not to be given as IV or gluteal IM inj. Postpone vaccination in case of fever, acute disease, & acute attack of chronic disease. Not to be used as replacement for 23-valent pneumococcal polysaccharide vaccine in childn ≥24 mth w/ sickle cell disease, asplenia, HIV infection, chronic illness or immunocompromised; routine immunization of tetanus or tetanus-containing vaccine. Not guaranteed to protect all recipients against diseases caused by Strep pneumoniae. Appropriate monitoring, medical care & rescue measures in case of occurrence of rare hypersensitivity reactions during vaccination. Patients w/ thrombocytopenia, any coagulopathy or those receiving anticoagulants. Immunocompromised individuals eg, malignancy or nephrotic syndrome. Pregnancy & lactation. Monitor preterm infants at least 48 hr for potential risk of apnea during primary series.
Adverse Reactions
Fever, diarrhea; redness. Crying, cough, nausea/vomiting, fatigue/somnolence, allergic reaction; swelling, pain, induration.
MIMS Class
Vaccines, Antisera & Immunologicals
ATC Classification
J07AL02 - pneumococcus, purified polysaccharides antigen conjugated ; Belongs to the class of pneumococcal bacterial vaccines.
Presentation/Packing
Form
Weuphoria inj 0.5 mL
Packing/Price
1's
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