Zimbabwe - English - Medicines Control Authority

aventis crop science - rabies prepared on vero cells (inactivated) - vaccine - 2.5iu

Kenya - English - Pharmacy and Poisons Board

sanofi pasteur s.a. 1541 avenue marcel mérieux, 69280 marcy,france - inactivated hepatitis a virus (gbm strain) … - suspension for injection in pre-filled syring - inactivated hepatitis a virus (gbm strain) … - viral vaccines: hepatitisvaccines

Kenya - English - Pharmacy and Poisons Board

sanofi pasteur s.a. 1541 avenue marcel mérieux, 69280 marcy… - inactivated hepatitis a virus (gbm strain) __80… - suspension for injection in pre-filled syring - inactivated hepatitis a virus (gbm strain) __80… - viral vaccines: hepatitisvaccines

Kenya - English - Pharmacy and Poisons Board

lg chem, ltd, e14 block lg science park, 70, magokjungang - inactivated poliovirus types 1, 2 and 3(sabin… - solution for injection - a single human dose (0.5 ml) of sabin inactivated… - poliomyelitis trivalent inactivated whole virus

Kenya - English - Pharmacy and Poisons Board

purified rabies antigen - injection - each dose of 1 ml contains not less than 2.5 iu - rabies inactivated whole virus

United States - English - NLM (National Library of Medicine)

bavarian nordic a/s - rabies virus strain flury lep antigen (propiolactone inactivated) (unii: fk894q51ye) (rabies virus strain flury lep antigen (propiolactone inactivated) - unii:fk894q51ye) -         rabavert is indicated for preexposure vaccination, in both primary series and booster dose, and for postexposure prophylaxis against rabies in all age groups.         usually an immunization series is initiated and completed with 1 vaccine product. no clinical studies have been conducted that document a change in efficacy or the frequency of adverse reactions when the series is completed with a second vaccine product. however, for booster immunization, rabavert was shown to elicit protective antibody level responses in persons tested who received a primary series with hdcv.4,11 preexposure vaccination: see table 1 and dosage and administration. preexposure vaccination consists of 3 doses of rabavert 1.0 ml given intramuscularly (deltoid region), 1 each on days 0, 7, and 21 or 281 (see also table 1 for criteria for preexposure vaccination).         preexposure vaccination does not eliminate the need for additional therapy after a known rabies exposure (see dosage and administration: postexposure prophylaxis of previously immunized persons).         preexposure vaccination should be offered to persons in high-risk groups, such as veterinarians, animal handlers, wildlife officers in areas where animal rabies is enzootic, certain laboratory workers, and persons spending time in foreign countries where rabies is endemic. persons whose activities bring them into contact with potentially rabid dogs, cats, foxes, skunks, bats, or other species at risk of having rabies should also be considered for preexposure vaccination. international travelers might be candidates for preexposure vaccination if they are likely to come in contact with animals in areas where dog rabies is enzootic and immediate access to appropriate medical care, including biologics, might be limited.27,28         preexposure vaccination is given for several reasons. first, it may provide protection to persons with inapparent exposure to rabies. second, it may protect persons whose postexposure therapy might be expected to be delayed. finally, although it does not eliminate the need for prompt therapy after a rabies exposure, it simplifies therapy by eliminating the need for globulin and decreasing the number of doses of vaccine needed. this is of particular importance for persons at high risk of being exposed in countries where the available rabies-immunizing products may carry a higher risk of adverse reactions.         in some instances, booster doses of vaccine should be administered to maintain a serum titer corresponding to at least complete neutralization at a 1:5 serum dilution by the rffit (table 1); each booster immunization consists of a single dose. see clinical pharmacology. serum antibody determinations to decide upon the need for a booster dose is suggested by acip and is considered cost effective. risk category and nature of risk typical populations preexposure prophylaxis recommendations continuous . virus present continuously, often in high concentrations. specific exposures likely to go unrecognized. bite, non-bite, or aerosol exposure. rabies research lab workers,b rabies biologics production workers. primary course. serologic testing every 6 months; booster vaccination if antibody titer is below acceptable level.b frequent . exposure usually episodic, with source recognized, but exposure might be unrecognized. bite, non-bite, or aerosol exposure. rabies diagnostic lab workers,b spelunkers, veterinarians and staff, and animal-control and wildlife workers in rabies enzootic areas. primary course. serologic testing every 2 years; booster vaccination if antibody titer is below acceptable level.c infrequent (greater than population-at-large). exposure nearly always episodic with source recognized. bite or non-bite exposure. veterinarians and animal control and wildlife workers in areas with low rabies rates. veterinary students. travelers visiting areas where rabies is enzootic and immediate access to appropriate medical care including biologics is limited. primary course. no serologic testing or booster vaccination.c rare (population-at-large). exposures always episodic with source recognized. bite or non-bite exposure. us population-at-large, including persons in rabies epizootic areas. no vaccination necessary. postexposure treatment: see table 2 and dosage and administration.         the following recommendations are only a guide. in applying them, take into account the animal species involved, the circumstances of the bite or other exposure, the immunization status of the animal, and presence of rabies in the region (as outlined below). local or state public health officials should be consulted if questions arise about the need for rabies prophylaxis.1 animal type evaluation and disposition of animal postexposure prophylaxis recommendations dogs, cats, and ferrets healthy and available for 10 days’ observation should not begin prophylaxis unless animal develops clinical signs of rabiesb rabid or suspected rabid immediately vaccinate unknown (e.g., escaped) consult public health officials skunks, raccoons, bats, foxes, and most other carnivores regarded as rabid unless animal proven negative by laboratory testsc consider immediate vaccination livestock, small rodents, lagomorphs (rabbits and hares), large rodents (woodchucks and beavers), and other mammals consider individually consult public health officials. bites of squirrels, hamsters, guinea pigs, gerbils, chipmunks, rats, mice, other small rodents, rabbits, and hares almost never require antirabies postexposure prophylaxis. in the us, the following factors should be considered before antirabies treatment is initiated. species of biting animal: wild terrestrial animals (especially skunks, raccoons, foxes, and coyotes) and bats are the animals most commonly infected with rabies and are the most important potential source of infection for both humans and domestic animals. unless a wild animal is tested and shown not to be rabid, postexposure prophylaxis should be initiated upon bite or non-bite exposure to the animals (see definition in “type of exposure” below). if treatment has been initiated and subsequent testing in a qualified laboratory shows the exposing animal is not rabid, postexposure prophylaxis can be discontinued.1         the likelihood of rabies in a domestic animal varies from region to region; hence, the need for postexposure prophylaxis also varies.1         small rodents (such as squirrels, hamsters, guinea pigs, gerbils, chipmunks, rats, and mice) and lagomorphs (including rabbits and hares) are almost never found to be infected with rabies and have not been known to transmit rabies to humans in the us. bites from large rodents such as woodchucks (including groundhogs) and beavers should be considered as possible rabies exposures, especially in regions where rabies is enzootic in raccoons.30 in all cases involving rodents, the state or local health department should be consulted before a decision is made to initiate antirabies postexposure prophylaxis.1 circumstances of biting incident: an unprovoked attack is more likely than a provoked attack to indicate the animal is rabid. bites inflicted on a person attempting to feed or handle an apparently healthy animal should generally be regarded as provoked. a currently vaccinated dog, cat, or ferret is unlikely to become infected with rabies.1         type of exposure: rabies is transmitted by introducing the virus into open cuts or wounds in skin or via mucous membranes. the likelihood of rabies infection varies with the nature and extent of exposure. two categories of exposure should be considered:         bite: any penetration of the skin by teeth. bites to highly innervated areas such as the face and hands carry the highest risk, but the site of the bite should not influence the decision to begin treatment. recent epidemiologic data suggest that even the very limited injury inflicted by a bat bite (compared with lesions caused by terrestrial carnivores) should prompt consideration of postexposure prophylaxis unless the bat is available for testing and is negative for evidence of rabies.1         non-bite: the contamination of open wounds, abrasions, mucous membranes, or theoretically, scratches with saliva or other potentially infectious material (such as neural tissue) from a rabid animal constitutes a non-bite exposure. in all instances of potential human exposures involving bats, and the bat is not available for testing, postexposure prophylaxis might be appropriate even if a bite, scratch, or mucous membrane exposure is not apparent when there is reasonable probability that such exposure might have occurred. postexposure prophylaxis can be considered for persons who were in the same room as the bat and who might be unaware that a bite or direct contact had occurred (e.g., a sleeping person awakens to find a bat in the room or an adult witnesses a bat in the room with a previously unattended child, mentally disabled person, or intoxicated person) and rabies cannot be ruled out by testing the bat. other contact by itself, such as petting a rabid animal and contact with blood, urine, or feces (e.g., guano) of a rabid animal, does not constitute an exposure and is not an indication for prophylaxis. because the rabies virus is inactivated by desiccation and ultraviolet irradiation, in general, if the material containing the virus is dry, the virus can be considered noninfectious. two cases of rabies have been attributed to probable aerosol exposures in laboratories, and 2 cases of rabies in texas could possibly have been due to airborne exposures in caves containing millions of bats.1 the only documented cases for rabies from human-to-human transmission occurred in 8 patients, including 2 in the us, who received corneas transplanted from persons who died of rabies undiagnosed at the time of death.1 stringent guidelines for acceptance of donor corneas have been implemented to reduce this risk.         bite and non-bite exposure from humans with rabies theoretically could transmit rabies, but no laboratory-diagnosed cases occurring under such situations have been documented. each potential exposure to human rabies should be carefully evaluated to minimize unnecessary rabies prophylaxis.1 postexposure treatment schedule: see also dosage and administration.         the essential components of rabies postexposure prophylaxis are prompt local treatment of wounds and administration of both hrig and vaccine. a complete course of postexposure treatment for previously unvaccinated adults and children consists of a total of 5 doses of vaccine, each 1.0 ml: one im injection (deltoid) on each of days 0, 3, 7, 14, and 28. for previously immunized adults and children, a total of 2 doses of vaccine, each 1.0 ml: one im injection (deltoid) on each of days 0 and 3. no hrig should be administered to previously vaccinated persons as it may blunt their rapid memory response to rabies antigen.         local treatment of wounds: immediate and thorough washing of all bite wounds and scratches with soap and water is an important measure for preventing rabies. in animal studies, thorough local wound cleansing alone has been shown to reduce markedly the likelihood of rabies. whenever possible, bite injuries should not be sutured to avoid further and/or deeper contamination. tetanus prophylaxis and measures to control bacterial infection should be given as indicated.1         postexposure prophylaxis of rabies: the regimen for postexposure prophylaxis depends on whether or not the patient has been previously immunized against rabies (see below). for persons who have not previously been immunized against rabies, the schedule consists of an initial im injection of hrig exactly 20 iu/kg body weight in total. if anatomically feasible, the full dose of hrig should be thoroughly infiltrated in the area around and into the wounds. any remaining volume of hrig should be injected intramuscularly at a site distant from rabies vaccine administration. hrig should never be administered in the same syringe or in the same anatomical site as the rabies vaccine. hrig is administered only once (for specific instructions for hrig use, see the product package insert). the hrig injection is followed by a series of 5 individual injections of rabavert (1.0 ml each) given intramuscularly on days 0, 3, 7, 14, and 28. postexposure rabies prophylaxis should begin the same day exposure occurred or as soon after exposure as possible. the combined use of hrig and rabavert is recommended by the cdc for both bite and non-bite exposures, regardless of the interval between exposure and initiation of treatment. in the event that hrig is not readily available for the initiation of treatment, it can be given through the seventh day after administration of the first dose of vaccine. hrig is not indicated beyond the seventh day because an antibody response to rabavert is presumed to have begun by that time.1 postexposure prophylaxis outside the united states: if postexposure treatment is begun outside the us with regimens or biologics that are not used in the us, it may be prudent to provide additional treatment when the patient reaches the us. state or local health departments should be contacted for specific advice in such cases.1 preexposure prophylaxis: hypersensitivity: history of anaphylaxis to the vaccine or any of the vaccine components constitutes a contraindication to preexposure vaccination with this vaccine. postexposure prophylaxis: in view of the almost invariably fatal outcome of rabies, there is no contraindication to postexposure prophylaxis, including pregnancy.1

New Zealand - English - Medsafe (Medicines Safety Authority)

merck sharp & dohme (new zealand) limited - measles vaccine 1000 tcid50 (at end of expiry); mumps vaccine 12500 tcid50 (at end of expiry); rubella vaccine 1000 tcid50 (at end of expiry) - suspension for injection - active: measles vaccine 1000 tcid50 (at end of expiry) mumps vaccine 12500 tcid50 (at end of expiry) rubella vaccine 1000 tcid50 (at end of expiry) excipient: dibasic potassium phosphate dibasic sodium phosphate monohydrate eagle minimum essential medium gelatin medium 199 monobasic potassium phosphate monobasic sodium phosphate monohydrate monosodium glutamate neomycin phenolsulfonphthalein sodium bicarbonate sorbitol sucrose water for injection - m-m-r ii is indicated for simultaneous vaccination against measles, mumps, and rubella in individuals 12 months of age or older.

New Zealand - English - Medsafe (Medicines Safety Authority)

merck sharp & dohme (new zealand) limited - hepatitis a vaccine 50 u/ml - suspension for injection - 50 u/ml - active: hepatitis a vaccine 50 u/ml excipient: aluminium as amorphous aluminium hydroxyphosphate sulphate borax sodium chloride water for injection - vaqta is indicated for active pre-exposure prophylaxis against disease caused by hepatitis a virus. primary immunisation should be given at least 2 weeks prior to expected exposure to hav. vaccination is recommended in children 12 months of age and older, adolescents, and adults who are at risk of contracting or spreading infection or who are at risk of life-threatening disease if infected, including but not limited to: · travellers to endemic or outbreak areas · frequently affected communities - members residing in any community with one or more recorded outbreaks within the last five years · daycare - children and staff of daycare centres as well as their parents, siblings, and other contacts · military personnel prior to departure for endemic or outbreak areas · persons for whom hepatitis a is an occupational hazard - health-care workers - staff and residents of orphanages, chronic care hospitals and mental health care facilities - sewage workers · haemophiliacs and other recipients of therapeutic blood products · persons who test positive for hepatitis c virus and have diagnosed liver disease · food handlers · consumers of high-risk foods e.g. raw shellfish · persons at increased risk of the disease due to their sexual practices - homosexually-active males - persons who repeatedly contract sexually transmitted diseases · human immunodeficiency virus (hiv)-infected adults · users of illicit injectable drugs vaqta will not prevent hepatitis caused by infectious agents other than hepatitis a virus.

Singapore - English - HSA (Health Sciences Authority)

glaxosmithkline pte ltd - measles virus (schwarz strain) (live attenuated); mumps virus (rit 4385 strain) (live attenuated); rubella virus (ra27/3 strain) (live attenuated) - injection, powder, for solution - min 1000 tcid50 - measles virus (schwarz strain) (live attenuated) min 1000 tcid50; mumps virus (rit 4385 strain) (live attenuated) min 5000 tcid50; rubella virus (ra27/3 strain) (live attenuated) min 1000 tcid50

European Union - English - EMA (European Medicines Agency)

glaxosmithkline biologicals s.a. - split influenza virus, inactivated, containing antigen: a/vietnam/1194/2004 (h5n1) like strain used (nibrg-14) - influenza, human; immunization; disease outbreaks - vaccines - active immunisation against h5n1 subtype of influenza a virus.this indication is based on immunogenicity data from healthy subjects from the age of 18 years onwards following administration of two doses of vaccine prepared from a/vietnam/1194/2004 nibrg-14 (h5n1) (see section 5.1).prepandemic influenza vaccine (h5n1) (split virion, inactivated, adjuvanted) glaxosmithkline biologicals 3.75 µg should be used in accordance with official guidance.