VACCINE MANAGEMENT Recommendations for Storage and Handling of Selected Biologicals November 2007 Department of Health and Human Services Centers for Disease Control and Prevention Contents DT, Td . 3 DTaP, DTaP/Hib, DTaP/HepB/IPV,Tdap 4 Hepatitis Vaccines: Hepatitis A, Hepatitis B, Hepatitis A/B, Hepatitis B/Hib 5 Hib 6 HPV 7 IPV 8 TIV 9 LAIV 10 MMR, MR, Measles Virus Vaccine, Mumps Virus Vaccine, Rubella Virus Vaccine 11 MMRV 12 MCV 13 MPSV 14 PCV 15 PPV 16 Rotavirus Vaccine 17 Varicella (Chickenpox) Vaccine 18 Zoster (Shingles) Vaccine 19 Manufacturer Quality Control Office Telephone Numbers 20 DT: Diphtheria, Tetanus Toxoids—Pediatric Td: Tetanus, Diphtheria Toxoids—Adult Shipping Requirements Should be shipped in insulated container. Maintain temperature at 35° – 46°F (2° – 8°C). Do not freeze or expose to freezing temperatures. Condition upon Arrival Should not have been frozen or exposed to freezing temperatures. Refrigerate upon arrival. If you have questions about the condition of the material at the time of delivery, you should 1) immediately place material in recommended storage; and 2) then follow your state health department immunization program policy and contact either the Manufacturer’s Quality Control office or the immunization program for guidance. Storage Requirements Refrigerate immediately upon arrival. Store at 35° – 46°F (2° – 8°C). Do not freeze or expose to freezing temperatures. Shelf Life Check expiration date on vial or manufacturer-filled syringe. Instructions for Use Inspect visually for extraneous particulate matter and/or discoloration. If these conditions exist, the vaccine should not be used. Shake vial or manufacturer-filled syringe well before use. Discard vaccine if it cannot be resuspended with thorough agitation. Shelf Life after Opening Single-Dose Vials: The vaccine should be administered shortly after withdrawal from the vial. Multidose Vials: Withdraw single dose of vaccine into separate sterile needle and syringe for each immunization. The vaccine should be administered shortly after withdrawal from the vial. Unused portions of multidose vials may be refrigerated at 35° – 46°F (2° – 8°C) and used until expired, if not contaminated or unless otherwise stated in the manufacturer’s product information. Manufacturer-Filled Syringes: The vaccine should be administered shortly after the needle is attached to the syringe. Special Instructions Rotate stock so that the earliest dated material is used first. Note: All vaccine materials should be disposed of using medical waste disposal procedures. Contact the state health department for details. DTaP: Diphtheria Toxoid, Tetanus Toxoid, Acellular Pertussis Vaccine—Pediatric DTaP/Hib: Diphtheria Toxoid, Tetanus Toxoid, Acellular Pertussis Vaccine Combined with Haemophilus influenzae type b Conjugate Vaccine*—Pediatric DTaP/HepB/IPV: Diphtheria Toxoid, Tetanus Toxoid, Acellular Pertussis Vaccine, Hepatitis B Vaccine, Inactivated Polio Vaccine—Pediatric Tdap: Tetanus Toxoid, Diphtheria Toxoid, Acellular Pertussis Vaccine—Adult Shipping Requirements Should be shipped in insulated container. Maintain temperature at 35° – 46°F (2° – 8°C). Do not freeze or expose to freezing temperatures. Condition upon Arrival Should not have been frozen or exposed to freezing temperatures. Refrigerate upon arrival. If you have questions about the condition of the material at the time of delivery, you should 1) immediately place material in recommended storage; and 2) then follow your state health department immunization program policy and contact either the Manufacturer’s Quality Control office or the immunization program for guidance. Storage Requirements Refrigerate immediately upon arrival. Store at 35° – 46°F (2° – 8°C). Do not freeze or expose to freezing temperatures. Shelf Life Check expiration date on vial, or manufacturer-filled syringe. Instructions for Reconstitution* or Use Inspect visually for extraneous particulate matter and/or discoloration. If these conditions exist, the vaccine should not be used. Shake vial or manufacturer-filled syringe well before use. Discard vaccine if it cannot be resuspended with thorough agitation. Shelf Life after Reconstitution* or Opening Single-Dose Vials: The vaccine should be administered shortly after withdrawal from the vial. Manufacturer-Filled Syringes: The vaccine should be administered shortly after the needle is attached to the syringe. Special Instructions Rotate stock so that the earliest dated material is used first. Note: All vaccine materials should be disposed of using medical waste disposal procedures. Contact the state health department for details. * DTaP/Hib (TriHIBit®) is ActHIB® (sanofi pasteur) reconstituted with Tripedia® (sanofi pasteur). Once reconstituted, this combination vaccine must be used within 30 minutes or discarded. The only DTaP vaccine that can be used to reconstitute ActHIB® is Tripedia®. No other brand of DTaP is approved for this use. Hepatitis Vaccines: Hepatitis A, Hepatitis B, Hepatitis A/B, Hepatitis B/Haemophilus influenzae type b Shipping Requirements Should be shipped in insulated container. Maintain temperature at 35° – 46°F (2° – 8°C). Do not freeze or expose to freezing temperatures. Condition upon Arrival Should not have been frozen or exposed to freezing temperatures. Refrigerate upon arrival. If you have questions about the condition of the material at the time of delivery, you should 1) immediately place material in recommended storage; and 2) then follow your state health department immunization program policy and contact either the Manufacturer’s Quality Control office or the immunization program for guidance. Storage Requirements Refrigerate immediately upon arrival. Store at 35° – 46°F (2° – 8°C). Do not freeze or expose to freezing temperatures. Shelf Life Check expiration date on vial or manufacturer-filled syringe. Instructions for Use Inspect visually for extraneous particulate matter and/or discoloration. If these conditions exist, the vaccine should not be used. Shake vial or manufacturer-filled syringe well before use. Discard vaccine if it cannot be resuspended with thorough agitation. Shelf Life after Opening Single-Dose Vials: The vaccine should be administered shortly after withdrawal from the vial. Manufacturer-Filled Syringes: The vaccine should be administered shortly after the needle is attached to the syringe. Special Instructions Rotate stock so that the earliest dated material is used first. Note: All vaccine materials should be disposed of using medical waste disposal procedures. Contact the state health department for details. Hib: Haemophilus influenzae type b Conjugate Vaccine Shipping Requirements Should be shipped in insulated container. Maintain temperature at 35° – 46°F (2° – 8°C). Do not freeze or expose to freezing temperatures. Condition upon Arrival Should not have been frozen or exposed to freezing temperatures. Refrigerate upon arrival. If you have questions about the condition of the material at the time of delivery, you should 1) immediately place material in recommended storage; and 2) then follow your state health department immunization program policy and contact either the Manufacturer’s Quality Control office or the immunization program for guidance. Storage Requirements Vaccine: Refrigerate immediately upon arrival. Store at 35° – 46°F (2° – 8°C). Do not freeze or expose to freezing temperatures. Diluent: May be refrigerated or stored at room temperature (68° – 77°F [20° – 25°C]). Do not freeze or expose to freezing temperatures. Shelf Life Check expiration date on vial. Instructions for Reconstitution* or Use Inspect visually for extraneous particulate matter and/or discoloration. If these conditions exist, the vaccine should not be used. Shake vial well before use. Discard vaccine if it cannot be resuspended with thorough agitation. Shelf Life after Reconstitution* or Opening Single-Dose Vials: The vaccine should be administered shortly after withdrawal from the vial. Special Instructions Rotate stock so that the earliest dated material is used first. Note: All vaccine materials should be disposed of using medical waste disposal procedures. Contact the state health department for details. * ActHIB® (sanofi pasteur) reconstituted with 0.4% sodium chloride diluent should be used within 24 hours after reconstitution. If sanofi pasteur DTaP-Tripedia® is used to reconstitute ActHIB®, the TriHibit® vaccine must be used within 30 minutes of reconstitution. Only sanofi pasteur DTaP-Tripedia® or the diluent shipped with the product may be used to reconstitute the sanofi pasteur ActHIB® product. No other brand of DTaP is licensed for use in reconstitution of ActHIB®. HPV: Human Papillomavirus Vaccine Shipping Requirements Should be shipped in insulated container. Maintain temperature at 35° – 46°F (2° – 8°C). Do not freeze or expose to freezing temperatures. Condition upon Arrival Should not have been frozen or exposed to freezing temperatures. Refrigerate upon arrival. If you have questions about the condition of the material at the time of delivery, you should 1) immediately place material in recommended storage; and 2) then follow your state health department immunization program policy and contact either the Manufacturer’s Quality Control office or the immunization program for guidance. Storage Requirements Refrigerate immediately upon arrival. Store at 35° – 46°F (2° – 8°C). Do not freeze or expose to freezing temperatures. Protect from light at all times. Shelf Life Check expiration date on vial or manufacturer-filled syringe. Instructions for Use Inspect visually for extraneous particulate matter and/or discoloration. If these conditions exist, the vaccine should not be used. Shake vial or manufacturer-filled syringe well before use. Discard vaccine if it cannot be resuspended with thorough agitation. Shelf Life after Opening Single-Dose Vials: The vaccine should be administered shortly after withdrawal from the vial. Manufacturer-Filled Syringes: The vaccine should be administered shortly after the needle is attached to the syringe. Special Instructions Rotate stock so that the earliest dated material is used first. Note: All vaccine materials should be disposed of using medical waste disposal procedures. Contact the state health department for details. IPV: Inactivated Polio Vaccine Shipping Requirements Should be shipped in insulated container. Maintain temperature at 35° – 46°F (2° – 8°C). Do not freeze or expose to freezing temperatures. Condition upon Arrival Should not have been frozen or exposed to freezing temperatures. Refrigerate upon arrival. If you have questions about the condition of the material at the time of delivery, you should 1) immediately place material in recommended storage; and 2) then follow your state health department immunization program policy and contact either the Manufacturer’s Quality Control office or the immunization program for guidance. Storage Requirements Refrigerate immediately upon arrival. Store at 35° – 46°F (2° – 8°C). Do not freeze or expose to freezing temperatures. Shelf Life Check expiration date on vial or manufacturer-filled syringe. Instructions for Use Inspect visually for extraneous particulate matter and/or discoloration. If these conditions exist, the vaccine should not be used. Shake vial or manufacturer-filled syringe well before use. Discard vaccine if it cannot be resuspended with thorough agitation. Shelf Life after Opening Multidose Vials: Withdraw single dose of vaccine into separate sterile needle and syringe for each immunization. The vaccine should be administered shortly after withdrawal from the vial. Unused portions of multidose vials may be refrigerated at 35° – 46°F (2° – 8°C) and used until expired, if not contaminated or unless otherwise stated in the manufacturer’s product information. Manufacturer-Filled Syringes: The vaccine should be administered shortly after the needle is attached to the syringe. Special Instructions Rotate stock so that the earliest dated material is used first. Note: All vaccine materials should be disposed of using medical waste disposal procedures. Contact the state health department for details. TIV: Trivalent Inactivated Influenza Vaccine Shipping Requirements Should be shipped in insulated container. Maintain temperature at 35° – 46°F (2° – 8°C). Do not freeze or expose to freezing temperatures. Condition upon Arrival Should not have been frozen or exposed to freezing temperatures. Refrigerate upon arrival. If you have questions about the condition of the material at the time of delivery, you should 1) immediately place material in recommended storage; and 2) then follow your state health department immunization program policy and contact either the Manufacturer’s Quality Control office or the immunization program for guidance. Storage Requirements Refrigerate immediately upon arrival. Store at 35° – 46°F (2° – 8°C). Do not freeze or expose to freezing temperatures. Protect Fluarix® and FluLaval™ from light at all times by storing in original package. Shelf Life Formulated for use during current influenza season. Check expiration date on vial or manufacturer-filled syringe. Instructions for Use Inspect visually for extraneous particulate matter and/or discoloration. If these conditions exist, the vaccine should not be used. Shake vial or manufacturer-filled syringe well before use. Discard vaccine if it cannot be resuspended with thorough agitation. Shelf Life after Opening Single-Dose Vials: The vaccine should be administered shortly after withdrawal from the vial. Multidose Vials: Withdraw single dose of vaccine into separate sterile needle and syringe for each immunization. The vaccine should be administered shortly after withdrawal from the vial. Unused portions of multidose vials may be refrigerated at 35° – 46°F (2° – 8°C) and used until expired, if not contaminated or unless otherwise stated in the manufacturer’s product information. Manufacturer-Filled Syringes: The vaccine should be administered shortly after the needle is attached to the syringe. Special Instructions Rotate stock so that the earliest dated material is used first. Note: All vaccine materials should be disposed of using medical waste disposal procedures. Contact the state health department for details. LAIV: Live Attenuated Influenza Vaccine Shipping Requirements Initially shipped to authorized distributors in the frozen state 5°F (-15°C). Shipped from the distributor to healthcare facilities in the refrigerated state at 35° – 46°F (2° – 8°C). Condition upon Arrival Refrigerate upon arrival. If you have questions about the condition of the material at the time of delivery, you should 1) immediately place material in recommended storage; and 2) then follow your state health department immunization program policy and contact either the Manufacturer’s Quality Control office or the immunization program for guidance. Storage Requirements Refrigerate immediately upon arrival. Store at 35° – 46°F (2° – 8°C). Do not freeze or expose to freezing temperatures. (If LAIV is inadvertently frozen, the vaccine should be moved immediately to the refrigerator and may be used until the expiration date printed on the package.) Shelf Life Formulated for use during current influenza season. Check expiration date on package. Instructions for Use LAIV is a colorless to pale yellow liquid and is clear to slightly cloudy; some particulates may be present but do not affect the use of the product. After removal of the sprayer from the refrigerator, remove the rubber tip protector. Follow manufacturer’s instructions to deliver ½ dose into one nostril. Then remove the dose-divider clip and deliver the remainder of the dose into the other nostril. Shelf Life after Opening Single-Dose Sprayer: The vaccine should be administered shortly after removal from the refrigerator. Special Instructions Rotate stock so that the earliest dated material is used first. Note: All vaccine materials should be disposed of using medical waste disposal procedures. Contact the state health department for details. MMR: Measles/Mumps/Rubella Vaccine, MR: Measles/Rubella Vaccine, Measles Virus Vaccine, Mumps Virus Vaccine, Rubella Virus Vaccine Shipping Requirements Vaccine: Should be shipped in insulated container. Must be shipped with refrigerant. Maintain temperature at 50°F (10°C) or less. If shipped with dry ice, diluent must be shipped separately. Diluent: May be shipped with vaccine, but do not place in container with dry ice. Condition upon Arrival Maintain at 50°F (10° C) or less. Do not use warm vaccine. Refrigerate upon arrival. If you have questions about the condition of the material at the time of delivery, you should 1) immediately place material in recommended storage; and 2) then follow your state health department immunization program policy and contact either the Manufacturer’s Quality Control office or the immunization program for guidance. Storage Requirements Vaccine: Refrigerate immediately upon arrival. Store at 35° – 46°F (2° – 8°C). Protect from light at all times, since such exposure may inactivate the vaccine viruses. Diluent: May be refrigerated or stored at room temperature (68° – 77°F [20° – 25°C]). Do not freeze or expose to freezing temperatures. Note: MMR vaccine may be stored in the refrigerator or freezer. Shelf Life Check expiration date on vial. Instructions for Reconstitution and Use Reconstitute just before use according to the manufacturer’s instructions. Use only the diluent supplied to reconstitute the vaccine. Shelf Life after Reconstitution, Thawing or Opening Single-Dose Vials: After reconstitution, use immediately or store at 35° – 46°F (2° – 8°C) and protect from light. Discard if not used within 8 hours of reconstitution. Multidose vials: Withdraw single dose of reconstituted vaccine into separate sterile needle and syringe for each immunization. The vaccine dose should be administered shortly after withdrawal from vial. Unused portions of multidose vials may be refrigerated at 35° – 46°F (2° – 8°C), but must be discarded if not used within 8 hours after reconstitution. Special Instructions Rotate stock so that the earliest dated material is used first. Note: All vaccine materials should be disposed of using medical waste disposal procedures. Contact the state health department for details. MMRV: Measles/Mumps/Rubella/Varicella Vaccine Shipping Requirements Vaccine: Should be shipped in insulated container. Must be shipped with dry ice only, at 5°F (-15°C) or colder. Should be delivered within 2 days. Diluent: May be shipped with vaccine, but do not place in container with dry ice. Condition upon Arrival Should be frozen. Vaccine should remain at 5°F (-15°C) or colder until arrival at the healthcare facility. Dry ice should still be present in the shipping container when vaccine is delivered. If you have questions about the condition of the material at the time of delivery, you should 1) immediately place material in recommended storage; and 2) then follow your state health department immunization program policy and contact either the Manufacturer’s Quality Control office or the immunization program for guidance. Storage Requirements Vaccine: Freeze immediately upon arrival. Maintain vaccine in a continuously frozen state at 5°F (-15°C) or colder. No freeze/thaw cycles are allowed with this vaccine. Vaccine should only be stored in freezers or refrigerator/freezers with separate external doors and compartments. Acceptable storage may be achieved in standard household freezers purchased in the last 10 years, and standard household refrigerator/freezers with a separate, sealed freezer compartment. "Dormitory-style units" are not appropriate for the storage of MMRV vaccine. Do not store lyophilized vaccine in the refrigerator. If lyophilized vaccine is inadvertently stored in the refrigerator, it should be used within 72 hours. Lyophilized vaccine stored at 35° – 46°F (2° – 8°C) which is not used within 72 hours should be discarded. Protect the vaccine from light at all times since such exposure may inactivate the vaccine viruses. In order to maintain temperatures of 5°F (-15°C) or colder, it will be necessary in most refrigerator/freezer models to adjust the temperature dial down to the coldest setting. This may result in the refrigerator compartment temperature being lowered as well. Careful monitoring of the refrigerator temperature will be necessary to avoid freezing killed or inactivated vaccines. Diluent: May be refrigerated or stored at room temperature (68° – 77°F [20° – 25°C]). Do not freeze or expose to freezing temperatures. Shelf Life Check expiration date on vial. Instructions for Reconstitution and Use Reconstitute just before use according to the manufacturer’s instructions. Use only the diluent supplied to reconstitute the vaccine. Shelf Life after Reconstitution, Thawing or Opening Single-Dose Vials: Discard reconstituted vaccine if it is not used within 30 minutes of reconstitution. Do not freeze reconstituted vaccine. Special Instructions Rotate stock so that the earliest dated material is used first. If this vaccine is stored at a temperature warmer than 5°F (-15°C), it will result in a loss of potency and a reduced shelf life. If a power outage or some other situation occurs that results in the vaccine storage temperature rising above the recommended temperature, the healthcare provider should contact Merck, the vaccine manufacturer, at 1-800-MERCK-90 for an evaluation of the product potency before using the vaccine. Note: All vaccine materials should be disposed of using medical waste disposal procedures. Contact the state health department for details. MCV: Meningococcal Conjugate Vaccine Shipping Requirements Should be shipped in insulated container. Maintain temperature at 35° – 46°F (2° – 8°C). Do not freeze or expose to freezing temperatures. Condition upon Arrival Should not have been frozen or exposed to freezing temperatures. Refrigerate upon arrival. If you have questions about the condition of the material at the time of delivery, you should 1) immediately place material in recommended storage; and 2) then follow your state health department immunization program policy and contact either the Manufacturer’s Quality Control office or the immunization program for guidance. Storage Requirements Refrigerate immediately upon arrival. Store at 35° – 46°F (2° – 8°C). Do not freeze or expose to freezing temperatures. Protect from light at all times. Shelf Life Check expiration date on vial or manufacturer-filled syringe. Instructions for Use Inspect visually for extraneous particulate matter and/or discoloration. If these conditions exist, the vaccine should not be used. Shake vial or manufacturer-filled syringe well before use. Discard vaccine if it cannot be resuspended with thorough agitation. Shelf Life after Opening Single-Dose Vials: The vaccine should be administered shortly after withdrawal from the vial. Manufacturer-Filled Syringes: The vaccine should be administered shortly after the needle is attached to the syringe. Special Instructions Rotate stock so that the earliest dated material is used first. Note: All vaccine materials should be disposed of using medical waste disposal procedures. Contact the state health department for details. MPSV: Meningococcal Polysaccharide Vaccine Shipping Requirements Should be shipped in insulated container. Maintain temperature at 35° – 46°F (2° – 8°C). Do not freeze or expose to freezing temperatures. Condition upon Arrival Should not have been frozen or exposed to freezing temperatures. Refrigerate upon arrival. If you have questions about the condition of the material at the time of delivery, you should 1) immediately place material in recommended storage; and 2) then follow your state health department immunization program policy and contact either the Manufacturer’s Quality Control office or the immunization program for guidance. Storage Requirements Vaccine: Refrigerate immediately upon arrival. Store at 35° – 46°F (2° – 8°C). Do not freeze or expose to freezing temperatures. Diluent: May be refrigerated or stored at room temperature (68° – 77°F [20° – 25°C]). Do not freeze or expose to freezing temperatures. Shelf Life Check expiration date on vial. Instructions for Reconstitution and Use Reconstitute just before using according to the manufacturer’s instructions. Use only the diluent supplied to reconstitute the vaccine. Shelf Life after Reconstitution or Opening Single-Dose Vials: Use within 30 minutes of reconstitution. Multidose Vials: Unused portions of multidose vials may be refrigerated at 35° – 46°F (2° – 8°C) and used up to 35 days after reconstitution. Special Instructions Rotate stock so that the earliest dated material is used first. Note: All vaccine materials should be disposed of using medical waste disposal procedures. Contact the state health department for details. PCV: Pneumococcal Conjugate Vaccine Shipping Requirements Should be shipped in insulated container. Maintain temperature at 35° – 46°F (2° – 8°C). Do not freeze or expose to freezing temperatures. Condition upon Arrival Should not have been frozen or exposed to freezing temperatures. Refrigerate upon arrival. If you have questions about the condition of the material at the time of delivery, you should 1) immediately place material in recommended storage; and 2) then follow your state health department immunization program policy and contact either the Manufacturer’s Quality Control office or the immunization program for guidance. Storage Requirements Refrigerate immediately upon arrival. Store at 35° – 46°F (2° – 8°C). Do not freeze or expose to freezing temperatures. Shelf Life Check expiration date on vial or manufacturer-filled syringe. Instructions for Use Inspect visually for extraneous particulate matter and/or discoloration. If these conditions exist, the vaccine should not be used. Shake vial or manufacturer-filled syringe well before use. Discard vaccine if it cannot be resuspended with thorough agitation. Shelf Life after Opening Single-Dose Vials: The vaccine should be administered shortly after withdrawal from the vial. Manufacturer-Filled Syringes: The vaccine should be administered shortly after the needle is attached to the syringe. Special Instructions Rotate stock so that the earliest dated material is used first. Note: All vaccine materials should be disposed of using medical waste disposal procedures. Contact the state health department for details. PPV: Pneumococcal Polysaccharide Vaccine Shipping Requirements Should be shipped in insulated container. Maintain temperature at 35° – 46°F (2° – 8°C). Do not freeze or expose to freezing temperatures. Condition upon Arrival Should not have been frozen or exposed to freezing temperatures. Refrigerate upon arrival. If you have questions about the condition of the material at the time of delivery, you should 1) immediately place material in recommended storage; and 2) then follow your state health department immunization program policy and contact either the Manufacturer’s Quality Control office or the immunization program for guidance. Storage Requirements Refrigerate immediately upon arrival. Store at 35° – 46°F (2° – 8°C). Do not freeze or expose to freezing temperatures. Shelf Life Check expiration date on vial. Instructions for Use Inspect visually for extraneous particulate matter and/or discoloration. If these conditions exist, the vaccine should not be used. Shake vial or manufacturer-filled syringe well before use. Discard vaccine if it cannot be resuspended with thorough agitation. Shelf Life after Opening Single-Dose Vials: The vaccine should be administered shortly after withdrawal from the vial. Multidose Vials: Withdraw single dose of vaccine into separate sterile needle and syringe for each immunization. The vaccine should be administered shortly after withdrawal from the vial. Unused portions of multidose vials may be refrigerated at 35° – 46°F (2° – 8°C) and used until expired, if not contaminated or unless otherwise stated in the manufacturer’s product information. Special Instructions Rotate stock so that the earliest dated material is used first. Note: All vaccine materials should be disposed of using medical waste disposal procedures. Contact the state health department for details. Rotavirus Vaccine Shipping Requirements Should be shipped in insulated container. Maintain temperature at 35° – 46°F (2° – 8°C). Do not freeze or expose to freezing temperatures. Condition upon Arrival Should not have been frozen or exposed to freezing temperatures. Refrigerate upon arrival. If you have questions about the condition of the material at the time of delivery, you should 1) immediately place material in recommended storage; and 2) then follow your state health department immunization program policy and contact either the Manufacturer’s Quality Control office or the immunization program for guidance. Storage Requirements Refrigerate immediately upon arrival. Store at 35° – 46°F (2° – 8°C). Do not freeze or expose to freezing temperatures. Protect from light at all times, since such exposure may inactivate the vaccine viruses. Shelf Life Check expiration date on package. Instructions for Use Each dose is supplied in a container consisting of a squeezable plastic, latex-free dosing tube with a twist-off cap, allowing for direct oral administration. The dosing tube is contained in a pouch. Remove the dosing tube from the pouch, screw the cap clockwise to puncture the tube, and screw the cap off counter-clockwise so that the liquid can be squeezed from the tube during oral administration of the vaccine. Shelf Life after Opening Pouched Single-Dose Tubes: The vaccine should be administered shortly after withdrawal from the refrigerator. The dosing tube should not be returned to the refrigerator once the screw cap has been removed. Special Instructions Rotate stock so that the earliest dated material is used first. Note: All vaccine materials should be disposed of using medical waste disposal procedures. Contact the state health department for details. Varicella (Chickenpox) Vaccine Shipping Requirements Vaccine: Should be shipped in insulated container. Must be shipped with dry ice only, at 5°F (-15°C) or colder. Should be delivered within 2 days. Diluent: May be shipped with vaccine, but do not place in container with dry ice. Condition upon Arrival Should be frozen. Vaccine should remain at 5°F (-15°C) or colder until arrival at the healthcare facility. Dry ice should still be present in the shipping container when vaccine is delivered. If you have questions about the condition of the material at the time of delivery, you should 1) immediately place material in recommended storage; and 2) then follow your state health department immunization program policy and contact either the Manufacturer’s Quality Control office or the immunization program for guidance. Storage Requirements Vaccine: Freeze immediately upon arrival. Maintain vaccine in a continuously frozen state at 5°F (-15°C) or colder. No freeze/thaw cycles are allowed with this vaccine. Vaccine should only be stored in freezers or refrigerator/freezers with separate external doors and compartments. Acceptable storage may be achieved in standard household freezers purchased in the last 10 years, and standard household refrigerator/freezers with a separate, sealed freezer compartment. "Dormitory-style units" are not appropriate for the storage of varicella vaccine. Do not store lyophilized vaccine in the refrigerator. If lyophilized vaccine is inadvertently stored in the refrigerator, it should be used within 72 hours. Lyophilized vaccine stored at 35° – 46°F (2° – 8°C) which is not used within 72 hours, should be discarded. Protect the vaccine from light at all times since such exposure may inactivate the vaccine virus. In order to maintain temperatures of 5°F (-15°C) or colder, it will be necessary in most refrigerator/freezer models to turn the temperature dial down to the coldest setting. This may result in the refrigerator compartment temperature being lowered as well. Careful monitoring of the refrigerator temperature will be necessary to avoid freezing killed or inactivated vaccines. Diluent: May be refrigerated or stored at room temperature (68° – 77°F [20° – 25°C]). Do not freeze or expose to freezing temperatures. Shelf Life Check expiration date on vial. Instructions for Reconstitution and Use Reconstitute just before use according to the manufacturer’s instructions. Use only the diluent supplied to reconstitute the vaccine. Shelf Life after Reconstitution, Thawing or Opening Single-Dose Vials: Discard reconstituted vaccine if it is not used within 30 minutes of reconstitution. Do not freeze reconstituted vaccine. Special Instructions Rotate stock so that the earliest dated material is used first. If this vaccine is stored at a temperature warmer than 5°F (-15°C), it will result in a loss of potency and a reduced shelf life. If a power outage or some other situation occurs that results in the vaccine storage temperature rising above the recommended temperature, the healthcare provider should contact Merck, the vaccine manufacturer, at 1-800-9-VARIVAX for an evaluation of the product potency before using the vaccine. Note: All vaccine materials should be disposed of using medical waste disposal procedures. Contact the state health department for details. Zoster (Shingles) Vaccine Shipping Requirements Vaccine: Should be shipped in insulated container. Must be shipped with dry ice only, at 5°F (-15°C) or colder. Should be delivered within 2 days. Diluent: May be shipped with vaccine, but do not place in container with dry ice. Condition upon Arrival Should be frozen. Vaccine should remain at 5°F (-15°C) or colder until arrival at the healthcare facility. Dry ice should still be present in the shipping container when vaccine is delivered. If you have questions about the condition of the material at the time of delivery, you should 1) immediately place material in recommended storage; and 2) then follow your state health department immunization program policy and contact either the Manufacturer’s Quality Control office or the immunization program for guidance. Storage Requirements Vaccine: Freeze immediately upon arrival. Maintain vaccine in a continuously frozen state at 5°F (-15°C) or colder. No freeze/thaw cycles are allowed with this vaccine. Vaccine should only be stored in freezers or refrigerator/freezers with separate external doors and compartments. Acceptable storage may be achieved in standard household freezers purchased in the last 10 years, and standard household refrigerator/freezers with a separate, sealed freezer compartment. "Dormitory-style units" are not appropriate for the storage of zoster vaccine. Do not store lyophilized vaccine in the refrigerator. Protect the vaccine from light at all times since such exposure may inactivate the vaccine virus. In order to maintain temperatures of 5°F (-15°C) or colder, it will be necessary in most refrigerator/freezer models to turn the temperature dial down to the coldest setting. This may result in the refrigerator compartment temperature being lowered as well. Careful monitoring of the refrigerator temperature will be necessary to avoid freezing killed or inactivated vaccines. Diluent: May be refrigerated or stored at room temperature (68° – 77°F [20° – 25°C]). Do not freeze or expose to freezing temperatures. Shelf Life Check expiration date on vial. Instructions for Reconstitution and Use Reconstitute just before use according to the manufacturer’s instructions. Use only the diluent supplied to reconstitute the vaccine. Shelf Life after Reconstitution, Thawing or Opening Single-Dose Vials: Discard reconstituted vaccine if it is not used within 30 minutes of reconstitution. Do not freeze reconstituted vaccine. Special Instructions Rotate stock so that the earliest dated material is used first. If this vaccine is stored at a temperature warmer than 5°F (-15°C), it will result in a loss of potency and a reduced shelf life. If a power outage or some other situation occurs that results in the vaccine storage temperature rising above the recommended temperature, the healthcare provider should contact Merck, the vaccine manufacturer, at 1-800-MERCK-90 for an evaluation of the product potency before using the vaccine. Note: All vaccine materials should be disposed of using medical waste disposal procedures. Contact the state health department for details. Manufacturer Quality Control Office Telephone Numbers Manufacturer/Distributor sanofi pasteur www.sanofipasteur.us Talecris Biotherapeutics www.talecrisusa.com/ Centers for Disease Control and Prevention Drug Service www.cdc.gov/ncidod/srp/drugs/drug-service.html Novartis www.novartis-vaccines.com/products/index.shtml GlaxoSmithKline www.gsk.com/ Massachusetts Biological Labs MedImmune, Inc. www.medimmune.com Merck www.merckvaccines.com Nabi Biopharmaceuticals www.nabi.com Wyeth www.wyeth.com Telephone Number 800-822-2463 800-520-2807 404-639-3670 800-244-7668 866-475-8222 (customer support) 888-825-5249 (customer support) 617-474-3000 617-983-6400 877-358-6478 800-637-2590 800-635-1766 800-999-9384 Products DTaP, DTaP-Hib, DT, Td, Tdap, TT, Hib, Influenza (TIV), IPV, MCV4, MPSV4 HBIG, IGIM, RIG, TIG Distributor for Diphtheria antitoxin Influenza (TIV) DTaP, DTaP-HepB-IPV,Tdap, HepA, HepB, HepA-HepB, Influenza (TIV) Td, IGIM, TT Influenza (LAIV) Hib, Hib-HepB, HepA, HepB, HPV, Measles, Mumps, Rubella, MMR, MMRV, PPV23, Rotavirus, Varicella, Zoster HBIG Hib, PCV7 http://www.cdc.gov/vaccines/pubs/downloads/bk-vac-mgt.txt