CONTENTS

Equine antirabies immune globulin (ERIG).

PRESENTATION

Vial 5 mL (soln for inj) x 1's.

DESCRIPTION

Each mL of vial contains F(ab')2 fragments of equine antirabies immune globulin (200-400 iu). It also contains the following ingredients: Polysorbate 80, sodium chloride, water for injections and hydrochloric acid or sodium hydroxide to adjust the pH between 6 and 7.

INDICATIONS

Seroprophylaxis (ie, prevention by injecting antibodies) of rabies in subjects suspected to be exposed to the rabies virus, particularly in the event of severe exposure (eg, multiple severe bites located on the face, head, neck, hands when the domestic or wild animal responsible either cannot be examined, or is infected or suspected to be infected by the rabies virus) or bites to young children.

Favirab is to be administered exclusively in association with rabies vaccination, according to the recommendations of the WHO expert committee on rabies (1992; 824; 61) (see Dosage & Administration).

Sole Exception: Any subject who has been immunized with rabies vaccine and show confirmed rabies antibody titres must only receive rabies vaccine/Verorab.

CONTENTS

Equine antirabies immune globulin (ERIG).

PRESENTATION

Vial 5 mL (soln for inj) x 1's.

DESCRIPTION

Each mL of vial contains F(ab')2 fragments of equine antirabies immune globulin (200-400 iu). It also contains the following ingredients: Polysorbate 80, sodium chloride, water for injections and hydrochloric acid or sodium hydroxide to adjust the pH between 6 and 7.

INDICATIONS

Seroprophylaxis (ie, prevention by injecting antibodies) of rabies in subjects suspected to be exposed to the rabies virus, particularly in the event of severe exposure (eg, multiple severe bites located on the face, head, neck, hands when the domestic or wild animal responsible either cannot be examined, or is infected or suspected to be infected by the rabies virus) or bites to young children.

Favirab is to be administered exclusively in association with rabies vaccination, according to the recommendations of the WHO expert committee on rabies (1992; 824; 61) (see Dosage & Administration).

Sole Exception: Any subject who has been immunized with rabies vaccine and show confirmed rabies antibody titres must only receive rabies vaccine/Verorab.

DOSAGE & ADMINISTRATION

It is important to perform a quick local treatment of wounds caused by biting or scratching liable to be contaminated with the rabies virus, irrespective of the time since the contact took place.

The recommended first-aid measures consist of immediately washing and cleaning the wound thoroughly with water and soap or with other substances with a proven vivicidal action on rabies virus.

Favirab must be injected as soon after exposure as possible.

Adults and Children: Recommended Dose: 40 iu/kg body weight. However, for children, particularly in the case of multiple wounds, it has been proposed to dilute the dose 2-3 times in 0.9% NaCl solution to obtain a sufficient quantity of equine rabies immune globulin to infiltrate the wound(s) correctly.

In no cases, should the recommended dosage be exceeded because immune globulin may partially suppress the active production of antibodies induced by the vaccine.

Favirab must be injected slowly by the IM route.

If anatomically feasible, as much as possible, the dose should be infiltrated around and into the wounds. The remainder of the dose should be administered IM (into the gluteal region) in a single injection.

Wounds in certain anatomical sites (fingertips) should be infiltrated with care so as to prevent a local increase in pressure in the tissue (compartment syndrome).

The WHO Expert committee on rabies (1992; 824: 61) has issued the following therapeutic recommendations: See table.

For post-exposure (after potential rabies exposure) prevention of rabies, combined Favirab-rabies vaccine treatment is recommended, although experience indicates that vaccine alone could be sufficient for minor exposure (category II).

The 1st dose of vaccine should be inoculated at the same time as Favirab. If Favirab is not available when the rabies vaccine is administered, it can be administered up to the 7th or 8th day after the 1st dose of vaccine. After this period, the active response produced by the vaccine is considered to have taken place.

When indicated, administer anti-tetanus treatment and antimicrobial drugs to control infections other than rabies.

OVERDOSAGE

If the recommended dosage is not strictly observed (overdosage), there is a risk of immunosuppressive interference (suppression of immune defenses) with rabies vaccine.

Consult a physician or pharmacist immediately.

CONTRAINDICATIONS

Known history of allergic symptoms to horse proteins (see Precautions). Nevertheless, the lethal risk associated with rabies overcomes any potential contraindication.

PRECAUTIONS

Favirab must only be administered in a rabies control centre, under medical supervision.

Do not administer Favirab IV (due to a risk of shock ie, sudden collapse with drop in blood pressure). Consequently, make sure that the needle has not penetrated a blood vessel.

In the event of a known history of allergic symptoms to horse proteins, a human antirabies immune globulin is preferable.

If human antirabies immune globulin is not available, administer Favirab without delay under reinforced medical supervision in order to prevent a possible anaphylactic shock reaction (see Side Effects).

In the event of allergic or systemic allergic reactions, stop the injection immediately.

In the event of shock, treatment of the state of shock must be established.

Given the heterologous (non-human origin) nature of Favirab, the risk of anaphylactic-type undesirable effects should always be assessed:

In order to detect if patients are presensitized to heterologous proteins, they must be questioned in detail on their history of allergies, paying particular attention to previous injections of heterologous (non-human) proteins and possible reactions.

Particular attention should also be paid to animal contact allergies (particularly to horses) or to food allergies.

A skin test consisting of an intradermal injection with a 1/10 dilution of Favirab (about 0.1 mL) on the front of the forearm so as to obtain an orange peel-type appearance (3-mm diameter induration) can be performed. An equivalent intradermal injection of physiological saline solution is used as a control. The reading is made 15 min later. The reaction is considered to be positive if there is erythema (rash) (>6 mm) or local oedema or a systemic (generalized) reaction occurs while the control remains negative. However, a negative test result is not an absolute guarantee of the absence of a severe immediate or delayed-type allergic reaction. Irrespective of whether the test is performed, or irrespective of the result, particularly for identified at-risk subjects, Favirab must only be injected under medical supervision (see Side Effects).

Favirab is to be administered exclusively in association with rabies vaccination, according to the recommendations of the WHO expert committee on rabies (1992; 824; 61) (see Dosage & Administration).

Only Exception: Subjects who have received previous immunization with rabies vaccine and show confirmed rabies neutralizing antibody titres.

Wounds in certain anatomical sites (fingertips) should be infiltrated with care so as to prevent a local increase in pressure in the tissue (compartment syndrome).

Use in pregnancy: The safety of Favirab during pregnancy has not been established in clinical trials in humans. Given the lethal risk associated with rabies, pregnancy is not a contraindication to the administration of antirabies treatment subsequent to exposure. However if the choice is available, human antirabies immune globulin is preferable.

SIDE EFFECTS

Undesirable effects occurring after the use of heterologous (non-human) proteins are observed in <10% of subjects. They essentially consist of immediate- or delayed-type allergic reactions.

The immediate reactions observed are anaphylactic reactions with hypotension, dyspnea (breathing problems) and urticaria. In rare cases (<1 case in 10,000), more severe reactions eg, Quincke's oedema (sudden swelling of face and neck of allergic origin) or anaphylactic shock may take place.

Delayed-type, serum sickness-like reactions (illness due to an allergic reaction) reported after the administration of heterologous (non-human) proteins may occur about 6 days after the beginning of treatment. They consist of an inflammatory reaction occasionally accompanied by clinical symptoms eg, fever, pruritus, erythema (rash) or urticaria, adenopathy (increase in lymph gland size) and arthralgia (joint pains).

INTERACTIONS

Favirab should not be administered in repeated doses. Once the vaccine treatment has been started, repeating injections of Favirab may reduce the protective efficacy that must be guaranteed by the vaccine.

For treatments associating Favirab and rabies vaccine, the rabies vaccine should be injected in a contralateral anatomic site (ie, on opposite side) using a different syringe from Favirab.

As a general rule, corticosteroids liable to attenuate the immune response should be avoided.

Inform the doctor or pharmacist if patient is taking or has taken any other medicinal product, even in the case of nonprescription medicinal products.

List of Excipients With a Known Effect: Sodium chloride [<1 mmole (or 23 mg) of sodium per dosage unit].

STORAGE

Store between 2°C and 8°C (in a refrigerator).

Shelf-Life: 24 months.