RabAvert, Rabies Vaccine: patient information, prescribing information, ingredients, manufacturer, adverse reactions and side effects

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use RabAvert safely and effectively. See full prescribing information for RabAvert.

See full insert sheet at this link at the Natural News Reference website.

RabAvert, Rabies Vaccine

Suspension for Intramuscular Injection

Initial US Approval:

INGREDIENTS AND EXCIPIENTS

RabAvert, Rabies Vaccine, produced by Novartis Vaccines and Diagnostics GmbH 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 < 1µg, 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.

INDICATIONS AND USAGE

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 one 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).

DOSAGE AND ADMINISTRATION

The individual dose for adults, children, and infants is 1 mL, given intramuscularly. 496 In adults, administer vaccine by IM injection into the deltoid muscle. In small children and infants, administer vaccine into the anterolateral zone of the thigh. The gluteal area should be 498 avoided for vaccine injections, since administration in this area may result in lower neutralizing antibody titers. Care should be taken to avoid injection into or near blood vessels and nerves. 500 After aspiration, if blood or any suspicious discoloration appears in the syringe, do not inject but discard contents and repeat procedure using a new dose of vaccine, at a different site.

DOSAGE FORMS AND STRENGTHS

– 1 vial of freeze-dried vaccine containing a single dose

– 1 disposable pre-filled syringe of Sterile Diluent for reconstitution (1 mL)

– 1 small needle for injection (25 gauge, 1 inch) and 1 long needle for reconstitution (21 gauge, 1 ½ inch)

CONTRAINDICATIONS

In view of the almost invariably fatal outcome of rabies, there is no contraindication to postexposure prophylaxis, including pregnancy (1).

Hypersensitivity

History of anaphylaxis to the vaccine or any of the vaccine components constitutes a

contraindication to preexposure vaccination with this vaccine.

In the case of postexposure prophylaxis, if an alternative product is not available, the patient should be vaccinated with caution with the necessary medical equipment and emergency supplies available and observed carefully after vaccination. A patient’s risk of acquiring rabies must be carefully considered before deciding to discontinue vaccination. Advice and assistance on the

management of serious adverse reactions for persons receiving rabies vaccines may be sought from the state health department or CDC.

WARNINGS AND PRECAUTIONS

Anaphylaxis, encephalitis including death, meningitis, neuroparalytic events such as encephalitis, transient paralysis, Guillain-Barre Syndrome, myelitis, and retrobulbar neuritis; and multiple sclerosis have been reported to be temporally associated with the use of RabAvert. See Precautions and Adverse Events sections. A patient’s risk of developing rabies must be carefully considered, however, before deciding to discontinue immunization.

RABAVERT MUST NOT BE USED SUBCUTANEOUSLY OR INTRADERMALLY

DO NOT INJECT INTRAVASCULARLY.

ADVERSE REACTIONS

In very rare cases, neurological and neuroparalytical events have been reported in temporal association with administration of RabAvert (see also Warnings section). These include cases of hypersensitivity (see Contraindications, Warnings, and Precautions sections).

The most commonly occurring adverse reactions are injection site reactions, such as injection site erythema, induration and pain; flu-like symptoms, such as asthenia, fatigue, fever, headache, myalgia and malaise; arthralgia, dizziness, lymphadenopathy, nausea, and rash.

USE IN SPECIFIC POPULATIONS

Pregnancy

Pregnancy Category C. Animal reproductive studies have not been conducted with RabAvert. It is also not known whether RabAvert can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. RabAvert should be given to a pregnant woman only if clearly needed. The ACIP has issued recommendations for use of rabies vaccine in pregnant women (1)

Nursing Mothers

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 prophylaxis. If the risk of exposure to rabies is substantial, preexposure vaccination might also be indicated during nursing.

Pediatric Use

Children and infants receive the same dose of 1 mL, given IM, as do adults.

Only limited data on the safety and efficacy of RabAvert in the pediatric age group are available. However, in three studies some preexposure and postexposure experience has been gained (12, 19, 26; see also Clinical Studies in Clinical Pharmacology section).

Geriatric Use

Clinical studies of RabAvert did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.

Revised:

https://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM312931.pdf

http://naturalnewsreference.com/vaccine-insert-sheets/RabAvert-Rabies%20Vaccine.pdf