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For over 35 years RABIPUR has proven to protect to protect individuals from rabies

RABIPUR is the leading rabies vaccine providing rapid and robust protection.

 

RABIPUR is indicated for active immunisation against rabies in individuals of all ages.

View RABIPUR SmPC

Rabipur Rabies Vaccine
With rapid seroconversion and a robust immune response, RABIPUR offers protection against rabies for your patients, wherever they roam.

 

Persistence of Immunity

 

Rabipur Immunity
HDCV, Human diploid cell rabies vaccine; PCEV, primary chick-embryo cell culture vaccine.
The graph has been independently created from original data first published in Dreesen et al. Vaccine 1989.
Subjects received 3 doses of the rabies vaccine on days 0, 7 and 28 by intramuscular administration.
 
 

Clinical Experience with RABIPUR

  • The efficacy and safety of RABIPUR have been demonstrated extensively in more than 50 clinical trials worldwide

  • RABIPUR has demonstrated efficacy and tolerability in several populations:

    • Healthy adults and children 

    • Individuals bitten by laboratory-proven rabid animals

    • Malnourished children 

    • Immunocompromised individuals

  • Both PEP and PrEP regimens have proven to be immunogenic and well tolerated

  • Optimal protection is reached as early as 14 days after starting RABIPUR administration, both as pre- or post-exposure prophylaxis

What is RABIPUR?

  • A purified chick embryo cell-culture vaccine (PCECV) that contains inactivated rabies virus (strain Flury LEP)

  • Indicated for active immunisation against rabies in individuals of all ages

  • May be used as a pre-exposure prophylaxis vaccine (PrEP) as well as  for post-exposure prophylaxis (PEP)

  • RABIPUR has the longest shelf-life among other commercially available rabies vaccines

     

 

Following completion of the recommended primary immunisation schedule, an immune response indicative of rabies protection is achieved in almost all individuals.

 

Key Efficacy Findings

 

PrEP

  • Intramuscular RABIPUR administration resulted in achievement of adequate rabies virus neutralising antibody (RVNA) levels* in all subjects (2–37 years of age) by day 28
  • Adequate RVNA levels persisted for 2 years after PrEP with RABIPUR in all subjects (21–37 years of age)

PEP

  • RABIPUR administration resulted in an adequate RVNA concentration (defined as an RVNA concentration >0.5 IU/mL)1* in all subjects (2–78 years of age) by day 14, regardless of the immunisation regimen used†
  • Available data have demonstrated the immunogenicity of RABIPUR in several populations, including children from 12 months of age onwards and even malnourished children.


*WHO recommends a specific antibody level of 0.5 IU/mL as being proof of an adequate immune response after vaccination.  However there is no specific level of RVNA that is recognised as being ‘protective’ against rabies in humans. 
†Essen, Zagreb or intradermal regimens

 

Safety and Tolerability of RABIPUR

  • In clinical trials and in postmarketing surveillance, the most commonly reported adverse reactions were: headache, dizziness, rash, malaise, fatigue, asthenia, fever, injection site reactions – pain (30-85%) or induration (15-35%); most injection site reactions were not severe and resolved within 24 to 48 hours.

 

Common/Very common adverse events in clinical trials*

  • Very common: headache, dizziness, rash, malaise, fatigue, asthenia, fever, injection site reactions
  • Common: Lymphadenopathy, decreased appetite, nausea, vomiting, diarrhoea, abdominal pain / discomfort, urticaria, myalgia, arthralgia

*Very common = ≥1/10; common = ≥1/100

 

Special Warnings and Precautions for Use

  • A protective immune response may not be elicited in all individuals
  • In case of acute diseases requiring treatment, patients should not be vaccinated until at least 2 weeks after recovery
  • The presence of a minor infection should not result in the deferral of vaccination
  • Anaphylactic reactions including anaphylactic shock have occurred following RABIPUR vaccination. As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic event following the administration of the vaccine
  • Encephalitis and Guillain-Barré syndrome have been temporally associated with the use of RABIPUR. A patient's risk of developing rabies must be carefully considered, before deciding to discontinue immunisation
  • RABIPUR must under no circumstances be injected intraglutally or subcutaneously, as this may not reliably achieve an adequate immune response. Do not inject intravascularly
  • Anxiety-related reactions, including syncope or hyperventilation may occur as a psychogenic response to the needle injection. Appropriate measures must be taken in advance to prevent injuries in the event of fainting

 

Pregnancy or Breast-Feeding

  • Women who are pregnant or breastfeeding may receive RABIPUR for pre-exposure prophylaxis if it is considered that the potential benefit outweighs any possible risk to the foetus/child
  • RABIPUR may be administered to pregnant women when post-exposure prophylaxis is required

 

Contraindications

  • Pre-exposure prophylaxis (PrEP): Hypersensitivity to the active substance or to any of the components of the vaccine, including chicken eggs, chicken protein, bovine gelatin, neomycin, chlortetracycline and amphotericin B. Acute disease
  • Post-exposure prophylaxis (PEP): None

For more information on RABIPUR, please contact Bavarian Nordic.

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  • Giesen A et al. Expert Rev. Vaccines 2015;14(3):351–367.

  •  IQVIA MIDAS. Monthly data, 2018-2020, (accessed June 2020).

  •  RABIPUR Summary of Product Characteristics (updated 06 February 2020). Available at: https://www.medicines.org.uk/emc/product/2502/smpc, (accessed April 2020).

  •  Dreesen et al. Vaccine 1989;7:397–400.

  • Lumbiganon et al. Asian Pac J Allergy Immunol 1989;7:99–101.

  • Briggs et al. Vaccine 2000;19:1055–60.

  • Briggs et al. Bull World Health Organ 2000; 78: 693–8.

  •  Liu et al. Hum Vaccin 2011; 7: 220–4.

  • Rupprecht CE et al. In:. Plotkin, Walter A. Orenstein, Paul A. Offit, Kathryn M. Edwards, Plotkin's Vaccines (Seventh Edition), Elsevier, 2018, pp. 918-942.

  •  Vodopija et al. Vaccine 1986; 4: 245.

  • Kamoltham et al. Adv Prev Med 2011; 2011: 403201.

  • Pengsaa et al. Pediatr Infect Dis J 2009; 28: 335–7.

  •  Sampath et al. Vaccine 2005; 23: 1102–5.

  •  Sehgal et al. Indian Pediatr 1994; 31: 133–7.

  • Shanbag et al. Hum Vaccin 2008; 4: 365–9.

  •  Briggs et al. 2011. Available at: http://whqlibdoc.who.int/publications/2011/9789241501088_eng.pdf, (accessed April 2020).