TICOVAC Description

(tick-borne encephalitis vaccine,whole virus, inactivated)

11 DESCRIPTION

TICOVAC (tick-borne encephalitis vaccine) is a sterile, off-white, homogenous, opalescent suspension for intramuscular injection. TICOVAC is prepared from tick-borne encephalitis (TBE) virus propagated in chick embryo fibroblast (CEF) cells. The harvested virus suspension is inactivated by treatment with formaldehyde, purified by sucrose gradient centrifugation and adsorbed onto aluminum hydroxide. TICOVAC is available in a 0.5 mL adult presentation and a 0.25 mL pediatric presentation.

Each 0.5 mL dose is formulated to contain 2.4 microgram (µg) TBE inactivated virus, 0.5 mg human serum albumin, 0.35 mg aluminum hydroxide, 3.45 mg sodium chloride, 0.22 mg dibasic sodium phosphate, and 0.045 mg of monobasic potassium phosphate. From the manufacturing process, each 0.5 mL may also contain formaldehyde (≤5 µg), sucrose (≤15 mg), protamine sulfate (≤0.5 µg), and trace amounts of chick protein and DNA from CEF cells, neomycin and gentamicin. The 0.25 mL dose of TICOVAC contains the same components as the 0.5 mL dose in half of the quantities.

TICOVAC is formulated without preservatives.

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Description

11 DESCRIPTION

TICOVAC (tick-borne encephalitis vaccine) is a sterile, off-white, homogenous, opalescent suspension for intramuscular injection. TICOVAC is prepared from tick-borne encephalitis (TBE) virus propagated in chick embryo fibroblast (CEF) cells. The harvested virus suspension is inactivated by treatment with formaldehyde, purified by sucrose gradient centrifugation and adsorbed onto aluminum hydroxide. TICOVAC is available in a 0.5 mL adult presentation and a 0.25 mL pediatric presentation.

Each 0.5 mL dose is formulated to contain 2.4 microgram (µg) TBE inactivated virus, 0.5 mg human serum albumin, 0.35 mg aluminum hydroxide, 3.45 mg sodium chloride, 0.22 mg dibasic sodium phosphate, and 0.045 mg of monobasic potassium phosphate. From the manufacturing process, each 0.5 mL may also contain formaldehyde (≤5 µg), sucrose (≤15 mg), protamine sulfate (≤0.5 µg), and trace amounts of chick protein and DNA from CEF cells, neomycin and gentamicin. The 0.25 mL dose of TICOVAC contains the same components as the 0.5 mL dose in half of the quantities.

TICOVAC is formulated without preservatives.

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