live varicella vaccine, lyophilization

Drug name Lyophilized, Live Attenuated Varicella Vaccine Compositions and form Compositions: Lyophilized, live attenuated varicella virus: Oka strain, not less than 2000 PFU, 5 mg-Mannicol, 12.5 mg-Dextran, 25 mg-Sucrose, 10 mg-Trehalose, 5 mg-Albumin, per dose. A lyophilized preparation (with appropriate stabilizer) of the live attenuated varicella-zoster virus (Oka strain) obtained by propagation of the virus in human diploid cell culture. This product is white fluey pellet in the glass vial. Clear colorless suspension of the vaccine after dissolution Therapeutic indications Healthy, varicella-susceptible subjects from the age of 12 months Effects and purposes Following vaccination, the body stimulated can generate the immuno-activity against varicella-zoster virus for preventing from varicella. Specification 0.5 ml vaccine of a single dose for one subject contains at least 2000 PFU of varicella live virus. Complete suspension of lyophilized pellet per vial contains 0.5 ml vaccine. Immune procedures and dosage (1) Transfer the diluent into the glass vial of the lyophilized pellet following the instructions. Shake well to ensure complete dissolution of the pellet for use. (2) Apply 0.5 ml suspension for subcutaneous injection at the deltoid area of the upper arm. (3) Alcohol and other disinfectors can cause the attenuated virus inactive, thus the vaccine should be applied just after ensuring completely volatilization of the disinfector away from skin. Undesirable side effects Very low overall reactogenicity in all the age groups studied. Reactions at the site of injection are usually mild and temporary. In a clinical trial involving 600 infants and children, it was observed that papulo-vesicular eruptions appeared in less than 4% of all vaccinees and fever (axillary temperature over 37.5 °C) happened in less than 5% of cases. There is no obvious difference using this product contrasted with the import vaccine. Contraindications (1) Contraindicated in subjects with known hypersensitivity to any constituent of this product including neomycin. (2) Contraindicated in women subjects during pregnancy. (3) Contraindicated in subjects suffering from serious diseases (acute or chronic infection), fever and any terminal immune disease. (4) Contraindicated in subjects treated with steroidal drug. (5) Contraindicated in subjects with a total lymphocyte count of less than 1200 per mm3 or presenting other signs of cellular immunodeficiency. (6) Contraindicated in subjects with known history of congenital immune disease or having closely touched with the family member who has a history of this disease. (7) The effects of this product will be cut down for use of whole blood, plasma or immunoglobulin within 5 months before vaccination or within 3 weeks after vaccination. (8) Avoid the use of salicylate within 6 weeks following vaccination of this product. Special precautions (1) It is advisable to have a solution of epinephrine available in the case of anaphylactic reaction. (2) Generally speaking, it is advisable for the vaccine to be kept under medical supervision for 30 minutes following vaccination of this product. (3) Transmission of vaccinal virus only occurs in extremely rare cases. All vaccinees who might contract with varicella virus, especially who appear skin reactions after inoculated, should avoid contacting with one who is a pregnant woman (especially less than 3 months pregnancy), or a patient with leucocythemia susceptible with serious varicella virus, or a patient being treated with immunosuppressant. (4) Administrated hypodermically, not intradermally and never, under any circumstances, intravenously. (5) Avoid any disinfector to contact the vaccine of this product during opening the vaccine vials and carrying the injection. (6) Not allow to administrate injection in conditions of incomplete dissolution of this product, cracked glass vial and unclear label of glass vial. (7) Dissolving with the diluent, the suspension of this product should be used within 30 minutes. (8) Women of child-bearing age can be vaccinated only if appropriately contraceptive measures have been taken for at least 3 months following vaccination. (9) Avoid administration of other vaccines within one month following vaccination of this product. (10) Patients with leucocythemia, tumor or immunodeficiency should be restrainedly used under doctors’ guidance. (11) Attenuated live vaccine not recommended to be used during epidemic seasons. Storage Stored in a refrigerator and transported in dark (between 2 °C and 8 °C). Packaging The packing material contacting the pellet of this product directly is 2 ml vial made of borosilicate glass. One vial per dose and one dose per kit accompanied by one vial of sterilized diluent for injection of vaccination. Validity period 36 months Production Standard “Pharmacopoeia of People's Republic of China” Vol. 3, 2010 and the official standard of this product registration