Rabavert

RabAvert product presentation is listed in Table 3 below:

TABLE 3: RABAVERT PRODUCT PRESENTATION

CAUTION: Federal law prohibits dispensing without a prescription.

Storage

RabAvert should be stored protected from light at 2°C to 8°C (36°F to 46°F). After reconstitution the vaccine is to be used immediately. The vaccine may not be used after the expiration date given on package and container.

REFERENCES

1. CDC. Recommendations of the Advisory Committee on Immunization Practices (ACIP). Human Rabies Prevention - United States, 1999. Morbidity and Mortality Weekly Report Recommendations and Report, January 8, 1999, Vol.48, RR-1, pg 1.1-21.

4. Dreesen DW, et al. Two-year comparative trial on the immunogenicity and adverse effects of purified chick embryo cell rabies vaccine for preexposure immunization. Vaccine. 1989; 7: 397-400.

11. Bijok U, et al. Clinical trials in healthy volunteers with the new purified chick embryo cell rabies vaccine for man. J Commun Dis. 1984; 16: 61-69.

27. Centers for Disease Control and Prevention. Health Information for International Travel, 2003-2004 (The Yellow Book). Atlanta: US Department of Health and Human Services, Public Health Service, 2003. Internet version at: http://www.cdc.gov/travel/yb

28. World Health Organization. International Travel and Health, 2002. Geneva, Switzerland. Internet version at: http://www.who.int/ith

29. CDC and NIH. Biosafety in microbiological and biomedical laboratories. 3rd. ed. Washington, D.C. HHS Publication no. (CDC) 93-8395, Washington, DC: US Department of Health and Human Services, 1993.

30. Krebs JW, et al. Rabies surveillance in the United States in 2001. J Am Vet Med Assoc. 2002; 221:1690-1701.

Manufactured by: Novartis Vaccines and Diagnostics GmbH, D-35006 Marburg, Germany. Distributed by: Novartis Vaccines and Diagnostics, Inc. 350 Massachusetts Ave. Cambridge, MA. Revised: Nov 2013

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known whether RabAvert is excreted in animal or human milk, but many drugs are excreted in human milk. Although there are no data, because of the potential consequences of inadequately treated rabies exposure, nursing is not considered a contraindication to postexposure vaccination. If the risk of exposure to rabies is substantial, pre-exposure vaccination might also be indicated during nursing.

In deciding to use a vaccine, the risks of taking the vaccine must be weighed against the good it will do. This is a decision you and your doctor will make. For this vaccine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of rabies vaccine in children.

Geriatric

No information is available on the relationship of age to the effects of rabies vaccine in geriatric patients.

Pregnancy

Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this vaccine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Receiving this vaccine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Chloroquine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this vaccine. Make sure you tell your doctor if you have any other medical problems, especially:

• Illness with fever, severe—The symptoms of the condition may be confused with the possible side effects of the vaccine.

• Immune system problems—May decrease the useful effects of the vaccine.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

• Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• confusion
• cough
• difficulty in moving
• difficulty swallowing
• fast heartbeat
• feeling of discomfort
• inflammation of joints
• irritability
• lack or loss of strength
• muscle pain, stiffness, or weakness
• paralysis or severe weakness of legs
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• rash
• seizures
• shortness of breath
• skin rash, hives, or redness
• stiffness of arms, legs, or neck
• swollen, painful, or tender lymph glands in the neck, armpit, or groin
• tightness in chest
• unusual tiredness
• vomiting

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Chills
• dizziness
• fever
• general feeling of discomfort or illness
• headache
• itching, pain, redness, or swelling at the injection site
• muscle or joint aches
• nausea
• stomach or abdominal pain

• Bruising at the injection site
• diarrhea

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

• If you need to store RabAvert at home, talk with your doctor, nurse, or pharmacist about how to store it.

RabAvert, Rabies Vaccine, produced by Novartis Vaccines and Diagnostics GmbH & Co. KG is a sterile freeze-dried vaccine obtained by growing the fixed-virus strain Flury LEP in primary cultures of chicken fibroblasts. The strain Flury LEP was obtained from American Type Culture Collection as the 59th egg passage. The growth medium for propagation of the virus is a synthetic cell culture medium with the addition of human albumin, polygeline (processed bovine gelatin) and antibiotics. The virus is inactivated with β-propiolactone, and further processed by zonal centrifugation in a sucrose density-gradient. The vaccine is lyophilized after addition of a stabilizer solution which consists of buffered polygeline and potassium glutamate. One dose of reconstituted vaccine contains less than 12 mg polygeline (processed bovine gelatin), less than 0.3 mg human serum albumin, 1 mg potassium glutamate and 0.3 mg sodium EDTA. Small quantities of bovine serum are used in the cell culture process. Bovine components originate only from the United States, Australia and New Zealand. Minimal amounts of chicken protein may be present in the final product; ovalbumin content is less than 3 ng/dose (1 mL), based on ELISA. Antibiotics (neomycin, chlortetracycline, amphotericin B) added during cell and virus propagation are largely removed during subsequent steps in the manufacturing process. In the final vaccine, neomycin is present at < 1 μg, chlortetracycline at < 20 ng, and amphotericin B at < 2 ng per dose. RabAvert is intended for intramuscular (IM) injection. The vaccine contains no preservative and should be used immediately after reconstitution with the supplied Sterile Diluent for RabAvert (Water For Injection). The potency of the final product is determined by the NIH mouse potency test using the US reference standard. The potency of one dose (1.0 mL) RabAvert is at least 2.5 IU of rabies antigen. RabAvert is a white, freeze-dried vaccine for reconstitution with the diluent prior to use; the reconstituted vaccine is a clear to slightly opaque, colorless suspension.

1. CDC. Recommendations of the Advisory Committee on Immunization Practices (ACIP). Human Rabies Prevention – United States, 1999. Morbidity and Mortality Weekly Report Recommendations and Report, January 8, 1999, Vol.48, RR-1, pg1.1-21.
2. Smith JS, Yager, PA & Baer, GM. A rapid reproducible test for determining rabies neutralizing antibody. Bull WHO. 1973; 48: 535-541.
3. Eighth Report of the WHO Expert Committee on Rabies. WHO Technical Report Series, no. 824; 1992.
4. Dreesen DW, et al. Two-year comparative trial on the immunogenicity and adverse effects of purified chick embryo cell rabies vaccine for preexposure immunization. Vaccine. 1989; 7: 397-400.
5. Dreesen, DW. Investigation of antibody response to puified chick embryo cell tissue culture vaccine (PCECV) or human diploid cell culture vaccine (HDCV) in healthy volunteers. Study synopsis 7USA401RA, September 1996 – December 1996 (unpublished).
6. Nicholson KG, et al. Preexposure studies with purified chick embryo cell culture rabies vaccine and human diploid cell vaccine: serological and clinical responses in man. Vaccine. 1987; 5: 208-210.
7. Vodopija I, et al. An evaluation of second generation tissue culture rabies vaccines for use in man: a four-vaccine comparative immunogenicity study using a preexposure vaccination schedule and an abbreviated 2-1-1 postexposure schedule. Vaccine. 1986; 4: 245-248.
8. Wasi C, et al. Purified chick embryo cell rabies vaccine (letter). Lancet. 1986; 1: 40.
9. Wasi C. Rabies prophylaxis with purified chick embryo (PCEC) rabies vaccine. Protocol 8T--201RA, 1983 - 1984 (unpublished).
10. Wasi C. Personal communication to Behringwerke AG, 1990.
11. Bijok U, et al. Clinical trials in healthy volunteers with the new purified chick embryo cell rabies vaccine for man. J Commun Dis. 1984; 16: 61-69.
12. Lumbiganon P, et al. Preexposure vaccination with purified chick embryo cell rabies vaccines in children. Asian Pacific J Allergy Immunol 1989; 7: 99-101.
13. Vodopija I. Post-exposure rabies prophylaxis with purified chick embryo cell (PCEC) rabies vaccine. Protocol 7YU-201RA, 1983-1985 (unpublished).
14. John J. Evaluation of purified chick embryo cell culture (PCEC) rabies vaccine, 1987 (unpublished).
15. Tanphaichitra D, Siristonpun Y. Study of the efficacy of a purified chick embryo cell vaccine in patients bitten by rabid animals. Intern Med. 1987; 3: 158-160.
16. Thongcharoen P, et al. Effectiveness of new economical schedule of rabies postexposure prophylaxis using purified chick embryo cell tissue culture rabies vaccine. Protocol 7T--301IP, 1993 (unpublished).
17. Ljubicic M, et al. Efficacy of PCEC vaccines in post-exposure rabies prophylaxis. In: Vodopija, Nicholson, Smerdel & Bijok (eds.): Improvements in rabies post-exposure treatment (Proceedings of a meeting in Dubrovnik, Yogoslavia). Zagreb Institute of Public Health 1985.17.
18. Madhusudana SN, Tripathi KK. Post exposure studies with human diploid cell rabies vaccine and purified chick embryo cell vaccine: Comparative Serological Responses in Man. Zbl Bakt 1989; 271: 345-350.
19. Sehgal S, et al. Ten year longitudinal study of efficacy and safety of purified chick embryo cell vaccine for pre- and postexposure prophylaxis of rabies in Indian population. J Commun Dis. 1995; 27: 36-43.
20. Sehgal S, et al. Clinical evaluation of purified chick embryo cell antirabies vaccine for postexposure treatment. J Commun Dis. 1988; 20: 293-300.
21. Fishbein DB, et al. Administration of human diploid-cell rabies vaccine in the gluteal area. N Engl J Med 1988; 318: 124-125.
22. Shill M, et al. Fatal rabies encephalitis despite appropriate postexposure prophylaxis. A case report. N Engl J Med 1987; 316: 1257-1258.
23. Wilde H, et al. Failure of rabies postexposure treatment in Thailand. Vaccine 1989; 7: 49-52.
24. Kuwert EK, et al. postexposure use of human diploid cell culture rabies vaccine. Dev Biol Stand 1977; 37: 273-286.
25. Hemachudha T, et al. Additional reports of failure to respond to treatment after rabies exposure in Thailand. Clin Infect Dis 1999; 28: 143-144.
26. Lumbiganon P, Wasi C. Survival after rabies immunisation in newborn infant of affected mother. Lancet 1990; 336: 319-320.
27. Centers for Disease Control and Prevention. Health Information for International Travel, 2003-2004 (The Yellow Book). Atlanta: US Department of Health and Human Services, Public Health Service, 2003. Internet version at: http://www.cdc.gov/travel/yb
28. World Health Organization. International Travel and Health, 2002. Geneva, Switzerland. Internet version at: http://www.who.int/ith
29. CDC and NIH. Biosafety in microbiological and biomedical laboratories. 3rd. ed. Washington, D.C. HHS Publication no. (CDC) 93-8395, Washington, DC: US Department of Health and Human Services, 1993.
30. Krebs JW, et al. Rabies surveillance in the United States in 2001. J Am Vet Med Assoc. 2002; 221: 1690-1701.

Manufactured by:
Novartis Vaccines and Diagnostics GmbH & Co. KG,
D-35006 Marburg, Germany
US License No. 1754

Distributed by:
Novartis Vaccines and Diagnostics, Inc.
Emeryville, CA. 94608, USA

Rev. 10/06

Rabies Vaccine

RabAvert

Single Dose Vial. Rx Only • Intramuscular Use Only

Potency ≥ 2.5 IU/mL

Mfg. by: Novartis Vaccines and Diagnostics GmbH & Co. KG,

D-35006 Marburg, Germany

Dist. by: Novartis Vaccines and Diagnostics, Inc., Emeryville,

CA 94608, USA • US Lic. No. 1754 • NDC# 63851-501-01