Cocav (Lyophilisate) Instructions for Use

Marketing Authorization Holder

Microgen NPO, JSC (Russia)

ATC Code

J07BG01 (Rabies virus inactivated whole)

Active Substance

Rabies vaccine (USP Pharmacopoeia)

Dosage Form

Cocav

Lyophilisate for preparation of solution for intramuscular administration 2.5 IU/1 dose: amp. 5 pcs. in set with solvent

Dosage Form, Packaging, and Composition

Lyophilisate for preparation of solution for intramuscular administration is a porous mass of white color; it is hygroscopic.

	1 dose
Rabies vaccine	Not less than 2.5 IU

Excipients: human albumin 5 mg, sucrose 75 mg, gelatin 10 mg.

Solvent: water for injections.

2.5 IU – ampoules (5) in a set with solvent 1 ml amp. (5 pcs.) – cardboard packs.

Clinical-Pharmacological Group

Vaccine for the prevention of rabies

Pharmacotherapeutic Group

MIBP-vaccine

Pharmacological Action

The vaccine induces the development of humoral and cellular immunity against rabies, providing a protective level of specific antibodies with a maximum rise by day 45.

Cocav, Purified concentrated inactivated cultural rabies vaccine, lyophilisate for preparation of solution for intramuscular administration, is a preparation containing the rabies vaccine virus, strain “Vnukovo-32”, grown in a primary culture of Syrian hamster kidney cells, inactivated by ultraviolet rays, concentrated and purified by ultrafiltration.

Indications

therapeutic and prophylactic immunization: contact and bites of people by animals sick with rabies, animals suspected of having rabies, wild or unknown animals;
prophylactic immunization: for prophylactic purposes, persons with a high risk of rabies infection are immunized (laboratory workers working with the street rabies virus; veterinary workers; gamekeepers, hunters, foresters; persons engaged in animal capture and maintenance, and other professional groups).

ICD codes

Open the list of ICD codes

ICD-10 code	Indication
Z24.2	Need for immunization against rabies

ICD-11 code	Indication
QC01.2	Need for immunization against rabies

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

The contents of the ampoule with the vaccine should be dissolved in 1.0 ml of water for injections. The dissolution time should not exceed 5 minutes. The dissolved vaccine is a transparent or slightly opalescent liquid from colorless to light yellow. Storage of the dissolved vaccine for more than 5 minutes is not allowed.

The dissolved vaccine is administered slowly intramuscularly into the deltoid muscle of the shoulder; for children under 5 years old – into the upper part of the anterolateral surface of the thigh.

Administration of the vaccine into the gluteal region is not allowed.

Provision of anti-rabies assistance

Anti-rabies assistance consists of local treatment of wounds, scratches, abrasions, places of saliva contact and subsequent administration of the Cocav rabies vaccine for prophylaxis or, if indicated, combined administration of anti-rabies immunoglobulin (RIG) and the Cocav rabies vaccine for prophylaxis. The interval between the administration of RIG and Cocav is no more than 30 minutes.

Local treatment of wounds Local treatment of wounds (bites, scratches, abrasions) and places of saliva contact should begin immediately or as soon as possible after the bite or injury. It consists of copious washing for several minutes (up to 15 minutes) of the wound surface with water and soap or another detergent, or, in the absence of soap or detergent, the injury site is washed with a stream of water. After this, the edges of the wound should be treated with 70% ethyl alcohol or a 5% alcohol solution of iodine.

Suturing of wounds should be avoided if possible. Suturing is indicated exclusively in the following cases:

For extensive wounds – several guiding skin sutures after preliminary treatment of the wound;
For cosmetic reasons (applying skin sutures to facial wounds);
Ligation of bleeding vessels to stop external bleeding.

If there are indications for the use of anti-rabies immunoglobulin, it is used immediately before suturing (see section Dose of anti-rabies immunoglobulin (RIG)).

After local treatment of wounds (injuries), therapeutic and prophylactic immunization is started immediately.

Therapeutic and prophylactic immunization

A detailed Scheme of therapeutic and prophylactic immunization and notes to the scheme are presented below in the “Scheme of therapeutic and prophylactic vaccinations with the Cocav rabies vaccine for prophylaxis and anti-rabies immunoglobulin (RIG)”.

All persons exposed to the risk of rabies infection are subject to therapeutic and prophylactic immunization. If there are indications for combined treatment, then RIG is administered first and, no more than 30 minutes later, Cocav is administered.

Anti-rabies immunoglobulin (RIG) is prescribed as early as possible after contact with a rabid animal or an animal suspected of having rabies, a wild or unknown animal.

Before the administration of heterologous (equine) anti-rabies immunoglobulin, it is necessary to check the individual sensitivity of the patient to horse proteins (see “Instructions for use of liquid anti-rabies immunoglobulin from horse serum”). Heterologous anti-rabies immunoglobulin is administered no later than 3 days after the bite.

Before the administration of homologous (human) anti-rabies immunoglobulin, individual sensitivity is not checked. Homologous anti-rabies immunoglobulin is administered no later than 7 days after the bite.

Dose of anti-rabies immunoglobulin (RIG). Heterologous (equine) anti-rabies immunoglobulin is prescribed at a dose of 40 IU per 1 kg of body weight. The volume of administered heterologous anti-rabies immunoglobulin should not exceed 20 ml. Homologous (human) anti-rabies immunoglobulin is prescribed at a dose of 20 IU per 1 kg of body weight.

Administration of RIG. As much as possible of the recommended dose of RIG should be infiltrated into the tissues around the wound and into the depth of the wound. The unused part of the drug dose is administered deeply intramuscularly into a site different from the administration of the anti-rabies vaccine.

Scheme of therapeutic and prophylactic vaccinations with the Cocav rabies vaccine for prophylaxis and anti-rabies immunoglobulin (RIG)

Damage Category	Nature of Contact	Data on the Animal	Treatment
1	No damage to the skin, no saliva contact with the skin, no saliva contact with mucous membranes.	Rabid	Not prescribed
2	Saliva contact with intact skin, abrasions, scratches, superficial bites of the trunk, upper and lower extremities (except head, face, neck, hands, fingers of hands and feet), inflicted by domestic and agricultural animals.	If within 10 days of observation the animal remains healthy, then treatment is stopped (i.e., after the 3rd injection). If the absence of rabies in the animal is laboratory proven, then treatment is stopped from the moment the absence of rabies is established. In all other cases, when 10-day observation of the animal is impossible (killed, died, ran away, etc.), treatment is continued according to the indicated scheme.	Prescribe treatment immediately: Cocav 1.0 ml on days 0, 3, 7, 14, 30, 90
3	Any saliva contact with mucous membranes, any bites to the head, face, neck, hands, fingers of hands and feet, genitals; single or multiple deep lacerated wounds inflicted by domestic or agricultural animals. Any saliva contact and damage inflicted by wild carnivorous animals, bats and rodents.	If it is possible to observe the animal and it remains healthy for 10 days, then treatment is stopped (i.e., after the third injection). If the absence of rabies in the animal is laboratory proven, then treatment is stopped from the moment the absence of rabies is established. In all other cases, when observation of the animal is impossible, treatment is continued according to the indicated scheme.	Start combined treatment immediately with anti-rabies immunoglobulin: RIG on day 0 (see Dose of anti-rabies immunoglobulin (RIG) and rabies vaccine for prophylaxis: Cocav 1.0 ml on days 0, 3, 7, 14, 30 and 90

Notes to the Scheme of therapeutic and prophylactic vaccinations with the Cocav rabies vaccine for prophylaxis and anti-rabies immunoglobulin (RIG)

1. Doses and schemes of therapeutic and prophylactic immunization are the same for children and adults.

2. The course of therapeutic and prophylactic immunization is prescribed regardless of the time the victim seeks anti-rabies help, even several months after contact with a rabid animal, an animal suspected of having rabies, a wild or unknown animal.

3. For persons who have previously received a full course of therapeutic and prophylactic or prophylactic vaccinations, and no more than 1 year has passed since its completion, three injections of the Cocav rabies vaccine for prophylaxis, 1.0 ml each, are prescribed on days 0, 3, 7; if a year or more has passed or an incomplete course of immunization was conducted, then vaccinations are carried out in accordance with the provided “Scheme of therapeutic and prophylactic vaccinations with the Cocav rabies vaccine for prophylaxis and anti-rabies immunoglobulin (RIG)”.

4. After a course of therapeutic and prophylactic or prophylactic immunization, the vaccinated person is issued a certificate (certificate of prophylactic vaccinations) indicating the type and series of the preparations, the course of vaccinations and the presence of post-vaccination reactions.

5. The vaccinated person should know: he is prohibited from consuming any alcoholic beverages during the entire course of vaccinations and for 6 months after its completion. Overwork, hypothermia, and overheating should also be avoided during the entire course of vaccinations.

6. Glucocorticosteroids and immunosuppressants can lead to the ineffectiveness of vaccine therapy. Therefore, in cases of vaccination while taking corticosteroids and immunosuppressants, determination of the titer of virus-neutralizing antibodies is mandatory. In the absence of virus-neutralizing antibodies, an additional course of vaccine administration is carried out according to the scheme on days 0, 7 and 30.

Prophylactic immunization

The vaccine is administered intramuscularly into the deltoid muscle of the shoulder, 1.0 ml on days 0, 7 and 30. Revaccination is carried out once, in a dose of 1.0 ml after one year and then every three years.

Scheme of prophylactic immunization

Primary immunization	Three injections on days 0, 7 and 30, 1.0 ml each
First revaccination after 1 year	One injection, 1.0 ml
Subsequent revaccinations every 3 years	One injection, 1.0 ml

Prophylactic immunization of contingents at increased risk of rabies infection is carried out in vaccination rooms of medical and preventive institutions, where the “Certificate of Prophylactic Vaccinations” is filled out and issued, which includes all necessary information (names, series, doses, frequency and dates of receipt of the preparations).

Precautions for use.

The preparation in ampoules with damaged integrity, labeling, as well as with changed color and transparency, with an expired shelf life, or improper storage is not suitable for use. Opening of ampoules and the vaccination procedure are carried out with strict adherence to the rules of asepsis. The vaccinated person should be under medical supervision for at least 30 minutes. Places for vaccination should be equipped with anti-shock therapy means.

Adverse Reactions

1. Administration of the vaccine may be accompanied by a local or general reaction. The local reaction is characterized by slight swelling, hyperemia, redness, itching, soreness at the injection site, and enlargement of regional lymph nodes. The general reaction may manifest as malaise, headache, weakness, increased body temperature, systemic allergic reactions (generalized rash, Quincke’s edema). Symptomatic therapy and the use of hyposensitizing agents are recommended.

The development of neurological symptoms is possible; such a patient should be urgently hospitalized.

2. After the administration of anti-rabies immunoglobulin from horse serum, complications may be observed: a local allergic reaction occurring on the 1st-2nd day after administration; serum sickness, which most often occurs on the 6th-8th day; anaphylactic shock. In case of anaphylactic reactions, emergency care is required and subsequent observation in a specialized institution. In case of development of an anaphylactoid reaction, a solution of epinephrine, norepinephrine, ephedrine is administered. The frequency, method of application and dose of the administered drugs depend on the severity of the shock and blood pressure indicators.

When symptoms of serum sickness appear, parenteral administration of H1 histamine receptor blockers (antihistamines), glucocorticosteroids, and calcium preparations is recommended.

Contraindications

There are no contraindications for therapeutic and prophylactic immunization. Pregnancy is not a contraindication.

Contraindications for prophylactic immunization

Acute infectious and non-infectious diseases, chronic diseases in the stage of exacerbation or decompensation – vaccinations are carried out no earlier than one month after recovery (remission);
Systemic allergic reactions to previous administration of the Cocav vaccine (generalized rash, Quincke’s edema, etc.);
Pregnancy.

Use in Pregnancy and Lactation

The use of the drug is possible only for therapeutic and prophylactic purposes for vital indications.

Special Precautions

During the treatment period, patients should avoid driving vehicles and other activities requiring high concentration and speed of psychomotor reactions.

Information is absent.

Overdose

Not established.

Drug Interactions

During the course of therapeutic and prophylactic vaccination, vaccination with other drugs is prohibited. After the end of rabies vaccination, vaccinations with other vaccines are allowed no earlier than after 2 months.

Prophylactic vaccination is carried out no earlier than 1 month after vaccination against another infectious disease.

During the course of therapeutic and prophylactic immunization, the prescription of immunosuppressants and corticosteroids is carried out only for vital indications.

Storage Conditions

At a temperature of 2 to 8°C (46.4°F) in a place inaccessible to children.

Shelf Life

Shelf life – 1.5 years.

Dispensing Status

For medical and preventive institutions.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.

Medical Disclaimer

Medixlife (Author)

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