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SKYVaricella Injection

SKYVaricella Injection

varicella-zoster vaccine

Manufacturer:

SK Bioscience

Distributor:

Biogenetech

Marketer:

Bionovel
Concise Prescribing Info
Contents
Live attenuated varicella-zoster virus (Oka/SK strain) ≥2,400 PFU
Indications/Uses
Prevention of varicella in childn 12 mth to 12 yr.
Dosage/Direction for Use
SC Inj 0.5 mL in deltoid region. 1st dose: Administer at 12-18 mth. 2nd dose: Administer at 4-6 yr. Varicella outbreak May administer 2nd dose before 4 yr but w/ at least 3 mth interval from 1st dose.
Contraindications
Hypersensitivity to gelatin or any other component of vaccine. History of anaphylactic/anaphylactoid reaction to neomycin. Primary & acquired immunodeficiency states due to acute & chronic leukemias, lymphoma, other conditions affecting bone marrow or lymphatic system, HIV/AIDS & cellular immune deficiencies. Immunosuppressive therapy. Active untreated TB; febrile resp disease or infections. Women of childbearing potential. Pregnancy.
Special Precautions
Anaphylactic/anaphylactoid reaction might occur. Defer vaccination in the presence of acute illness eg, fever >38°C. Reye's syndrome. Avoid close association w/ high-risk individuals eg, immunocompromised, pregnant women & newborn infants of mothers w/o documented history of chickenpox or lab evidence of prior infection for up to 6 wk following vaccination. Provide adequate treatment provisions including epinephrine inj (1:1000) for immediate use. Use w/in min interval of 3-11 mth after blood or plasma transfusion or Ig or varicella-zoster Ig administration. Avoid use of salicylates for 6 wk post-vaccination. Not to be given w/ Ig including varicella-zoster Ig concomitantly or 2 mth thereafter. Avoid pregnancy for 3 mth following vaccination. Not to be used during pregnancy. Nursing mothers. Not recommended in infant <12 mth. Not to be used in adults including elderly.
Adverse Reactions
Pain/tenderness, erythema/redness, induration/swelling; fever, somnolence/exhaustion, headache, whining/irritability, fatigue/malaise. Skin & SC tissue disorders, infections & infestations.
Drug Interactions
Concomitant use w/ salicylates; Ig or varicella-zoster Ig transfusion.
MIMS Class
Vaccines, Antisera & Immunologicals
ATC Classification
J07BK01 - varicella, live attenuated ; Belongs to the class of varicella viral vaccines.
Presentation/Packing
Form
SKYVaricella Injection vaccine inj
Packing/Price
((lyo)) 5 × 1's
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