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Vacunas Finlay S.A

Last Update:    Copyright © 2005 Finlay Instutute. Center for Vaccines Research and Production


Intramuscular injection

COMPOSITION: vax-SPIRAL® is a trivalent vaccine containing a trivalent whole-cell suspension of Leptospira interrogans including serogroups Canicola serovar canicola, Icterohaemorragiae serovar copenhageni and Pomona serovar mozdok, inactivated with formaldehyde, adsorbed onto aluminium hydroxide gel with the addition of 0.01% thiomersal as preservative. Each 0.5 ml contains:

  Inactivated canicola whole cells   50-80 x 106 células
  Inactivated copenhageni whole cells    50-80 x 106 células
  Inactivated mozdok whole cells   50-80 x 106 células
  Aluminium hydroxide gel   1,0 mg
  Thiomersal   0,05 mg
  Phosphate saline buffer     c.s.  

INDICATIONS: The trivalent leptospirosis vaccine is indicated for active immunization against leptospirosic disease caused by serogroups serogroups Canicola serovar canicola, Icterohaemorragiae serovar copenhageni and Pomona serovar mozdok. Its use is recommended in adults with occupational risk of acquiring the disease, as is the case of workers in rice and sugarcane plantations, in the sewage, miners, veterinaries, animal breeders, workers in slaughterhouses, fish farms, farmers and in the army. Also persons in risk of exposition to waters contaminated by urine from domestic and wild animals, bathers and people camping outdoors in infected areas. Its use is also recommended in persons inhabiting risk zones due to the association of elements such as those: infested by rodents, humid soils, history of morbility and the presence and coexistence of domestic and and/or affective animals.

CONTRAINDICATIONS: Hypersensitivity to any vaccine component. As other vaccines, this one should not be administered in persons with acute febrile diseases, infectious and acute allergic processes, unbalanced chronic diseases, history of immunosupresive treatment in the previous six months or some form of immune compromise. Do not administer to pregnant women.

WARNINGS: Sterile syringes and needles should be used for individually administering a dose to each patient, to prevent transmission of hepatitis B, HIV or other infectious agents. Once the vial is punctured if it is maintained at refrigerator temperature (2 to 8 °C, DO NOT FREEZE) the contents may be used for a period of 24 hours

PRECAUTIONS: In all vaccination centres an appropriate pharmaceutical (adrenaline 1/1000) should be ready in case an anaphylactic reaction should appear.


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