Rabies Vaccine Imovax; Wistar Rabies Virus Strain PM-1503-3M: 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 IMOVAX RABIES safely and effectively. See full prescribing information for IMOVAX RABIES.

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

IMOVAX RABIES (Rabies Vaccine)

Suspension for intramuscular injection

Initial U.S. Approval:

INGREDIENTS AND EXCIPIENTS

The Imovax Rabies Vaccine produced by Sanofi Pasteur SA is a sterile, stable, freeze-dried suspension of rabies virus prepared from strain PM-1503-3M obtained from the Wistar Institute, Philadelphia, PA.

The virus is harvested from infected human diploid cells, MRC-5 strain, concentrated by ultrafiltration and is inactivated by beta-propiolactone. One dose of reconstituted vaccine contains less than 100 mg human albumin, less than 150 mcg neomycin sulfate and 20 mcg of phenol red indicator. Beta-propiolactone, a residual component of the manufacturing process, is present in less than 50 parts per million.

The finished, freeze-dried vaccine is provided for intramuscular administration in a single dose vial containing no preservative. After reconstitution, immediately administer the full 1.0 mL amount of vaccine. If it cannot be administered promptly, discard.

The potency of one dose (1.0 mL) of Imovax Rabies vaccine is equal to or greater than 2.5 international units of rabies antigen.

INDICATIONS AND USAGE

Imovax Rabies is a vaccine indicated for pre-exposure and post-exposure prophylaxis against rabies. Imovax Rabies vaccine is approved for use in all age groups.

DOSAGE AND ADMINISTRATION

Parenteral drug products should be inspected for particulate matter and discoloration prior to administration, whenever solution and container permit. The syringe and its package should also be inspected prior to use for evidence of leakage, premature activation of the plunger, or a faulty tip seal. If evidence of such defects is observed, the product should not be used.

The package contains a vial of freeze-dried vaccine, a syringe containing 1.0 mL of diluent, a plunger for the syringe, and a sterile needle for reconstitution. Cleanse the vaccine vial stopper with a suitable germicide. Do not remove the stopper or the metal seal holding it in place. Attach the plunger and reconstitution needle to the syringe and reconstitute the freeze-dried vaccine by injecting the diluent into the vaccine vial. Gently swirl the contents until completely dissolved and withdraw the total contents of the vial into the syringe. Remove the reconstitution needle and discard. Attach a sterile needle of your choice that is suitable for intramuscular injection of your patient.

The supplied syringe is intended for single use only, must not be reused, and must be disposed of properly and promptly following its use.

To help avoid transmission of infectious diseases due to accidental needle sticks, needles should not be recapped but disposed of according to recommended guidelines.

The reconstituted vaccine should not be mixed with any other vaccine and should be used immediately.

DOSAGE FORMS AND STRENGTHS

Imovax Rabies vaccine is supplied in a tamper evident unit dose box with:

– One vial of freeze-dried vaccine containing a single dose (NDC 49281-248-58).

– One sterile syringe containing diluent (NDC 49281-249-01). A separate plunger is provided for insertion and use.

– One sterile disposable needle for reconstitution.

Packaged as NDC 49281-250-51.

CONTRAINDICATIONS

Do not administer to anyone with a known life-threatening systemic hypersensitivity reaction to any component of the vaccine.

WARNINGS AND PRECAUTIONS

Do not inject the vaccine into the gluteal area as administration in this area may result in lower neutralizing antibody titers. (11)

The product is provided in a single dose vial. Because the single dose vial contains no preservative, it is not to be used as a multidose vial for intradermal injection.

– IN ADULTS AND CHILDREN THE VACCINE SHOULD BE INJECTED INTO THE DELTOID MUSCLE. IN INFANTS AND SMALL CHILDREN, THE ANTEROLATERAL ASPECT OF THE THIGH MAY BE PREFERABLE.

– When a person with a history of hypersensitivity must be given rabies vaccine, antihistamines may be given. Epinephrine (1:1000) and other appropriate agents should be readily available to counteract anaphylactic reactions, and the person should be carefully observed after immunization.

– While the concentration of antibiotics in each dose of vaccine is extremely small, persons with known hypersensitivity to any of these agents, or any other component of the vaccine, could manifest an allergic reaction. While the risk is small, it should be weighed in light of the potential risk of contracting rabies.

ADVERSE REACTIONS

Once initiated, rabies prophylaxis should not be interrupted or discontinued because of local or mild systemic adverse reactions to rabies vaccine. Usually such reactions can be successfully managed with anti-inflammatory, antihistaminic, and antipyretic agents. (11)

Reactions after vaccination with HDCV have been observed. (13) In a study using five doses of HDCV, local reactions such as pain, erythema, swelling or itching at the injection site were reported in about 25% of recipients of HDCV, and mild systemic reactions such as headache, nausea, abdominal pain, muscle aches, and dizziness were reported in about 20% of recipients. (8)

Serious systemic anaphylactic or neuroparalytic reactions occurring during the administration of rabies vaccines pose a dilemma for the attending physician. A patient’s risk of developing rabies must be carefully considered before deciding to discontinue vaccination. Moreover, the use of corticosteroids to treat life-threatening neuroparalytic reactions carries the risk of inhibiting the development of active immunity to rabies. It is especially important in these cases that the serum of the patient be tested for rabies antibodies. Advice and assistance on the management of serious adverse reactions in persons receiving rabies vaccines may be sought from the local or state health department. (8)

DRUG INTERACTIONS

Corticosteroids, other immunosuppressive agents or treatments, and immunosuppressive illnesses can interfere with the development of active immunity and predispose the patient to developing rabies. Immunosuppressive agents should not be administered during post-exposure therapy, unless essential for the treatment of other conditions. When rabies post-exposure prophylaxis is administered to persons receiving steroids or other immunosuppressive therapy, it is especially important that serum be tested for rabies antibody to ensure that an adequate response has developed. (11)

USE IN SPECIFIC POPULATIONS

PREGNANCY

Pre-exposure

Pregnancy Category C: Animal reproduction studies have not been conducted with Imovax Rabies vaccine. It is also not known whether Imovax Rabies vaccine can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Imovax Rabies vaccine should be given to a pregnant woman only if potential benefits outweigh potential risks. If there is substantial risk of exposure to rabies, pre-exposure prophylaxis may also be indicated during pregnancy. (11)

Post-exposure

Because of the potential consequences of inadequately treated rabies exposure and limited data that indicate that fetal abnormalities have not been associated with rabies vaccination, pregnancy is not considered a contraindication to post-exposure prophylaxis. (11) (17)

USAGE IN NURSING MOTHERS

It is not known whether Imovax Rabies vaccine is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Imovax Rabies vaccine is administered to a nursing woman.

PEDIATRIC USE

Both safety and efficacy in children have been established.

Revision:

https://www.vaccineshoppe.com/image.cfm?doc_id=5983&image_type=product_pdf

http://naturalnewsreference.com/vaccine-insert-sheets/Rabies-Vaccine-Imovax-Wistar-Rabies-Virus-Strain-PM-1503-3M.pdf