Corporate Office

Indian Immunologicals Ltd.

Road # 44, Jubilee Hills Hyderabad - 500033 Andhra Pradesh, India E-mail: info@indimmune.com Tel : +91 40 23544585 +91 40 23544593 +91 9948298322 +91 9948298422

IIL is a wholly owned subsidiary of National Dairy Development Board and was set up in 1983, under the Operation Flood programme, to meet the growing demand for Foot and Mouth Disease (FMD) vaccine in India. The objective of setting up IIL was to make FMD vaccine available to farmers at an affordable price. The technology to manufacture FMD vaccine was obtained from M/s. Wellcome Foundation Limited, United Kingdom. Subsequently IIL developed several vaccines for various species of animals through its own R&D efforts and launched them in the Indian market. IIL also markets a full range of animal health products. IIL manufactures a wide range of veterinary biologicals, animal health products and feed additives required by the veterinary profession. It has also entered the human biological segment with a vaccine plant to produce purified vero cell rabies vaccine. Manufacturing Units IIL has a modern plant at Hyderabad that has an installed production capacity of 25 million quadrivalent doses of FMD vaccine. The plant is certified under WHO GMP guidelines and is also ISO 9002 approved. It is the largest plant in Asia and the second largest plant in the world. IIL is among the top 10 animal health companies and the largest exporter of veterinary biologicals in Asia. Raksha FMD vaccine is its largest selling brand. IIL also exports its products to several countries in Asia, Middle East and Africa. IIL operates a facility in Ooty to manufacture HRV. This plant was set up in 1997 at the specific request of the government of India so that our country can phase out the use of the older and unsafe sheep brain vaccine (also termed nerve tissue vaccine NTV) with the modern tissue culture vaccine. IIL sells the product under the brand name Abhayrab. The vaccine is sold through its network of Abhay Clinics.

With the success of Abhayrab and Abhay Clinics, IIL embarked on building a new vaccine facility in Hyderabad, at a cost of Rs. 42 crores, to manufacture various other human vaccines such as Diphtheria, Pertussis, Tetanus, Recombinant Hepatitis B, Hepatitis A and Measles. This plant will also produce combination vaccine against these diseases. Structure of Organisation IIL is a board-managed company. The chairman of NDDB, Ms. Namrata Patel, who also heads the board of IIL. There are 6 members in the board and Mr. K.V. Balsubramaniam is the managing director. There are around 540 employees and 20 core scientists plus other support staff, says Mr. Balsubramaniam. Operations IIL has divided its domestic operations into three strategic business units: Institution (Government, Co-operatives/Milk-unions), Livestock and Petlife, the last two divisions focus on prescription and retail markets while the former caters to institutional business. The Livestock Division focusses on livestock customer segment, which comprises of cattle, buffalo, sheep, goat, swine as well as camels, horses and donkey. The customers of these products are farm veterinarians, para-veterinarians, dairy farms, shepherds and camel herd owners. The pet segment is one of the fastest growing segment of the veterinary pharma industry. In order to serve the pet practitioners better and to be part of this growing industry, IIL has recently started the Petlife SBU. The Petlife SBU focuses on the pet clinics and hospitals in metros and urban areas. Distribution Channel The products are marketed through a network of 500 odd distributors. The sales professionals are equipped with technical information on the products and detail these to vets and paravets. These sales professionals also conduct demonstrations and film shows in the countryside to create awareness among the farmers towards livestock health and protection from diseases. We are mainly into two major markets animals and humans. For animals we are selling to the government then to cooperative dairies and the third to the traders be it wholesalers or retailers, says Mr. Balsubramaniam. Human vaccines are sold to government hospitals and district hospitals and through Abhay Clinics. Distribution channel is common to both. We have our main depot at Hyderabad and apart from that we have 19 more depots at different places. Then we have CMD agents and along with that we have a field force to generate sales, he adds.

Purified Vero Cell Rabies Vaccine

Rabies Vaccine I.P Human (Cell Culture) Purified Inactivated Rabies Vaccine prepared on Vero Cells for the prophylactic or PostExposure Treatment (PET)

Composition per single dose: Freeze-dried vaccine: One immunizing dose contains the protective activity of equal to or greater than 2.5 International Units (IU) even after exposure at 37 degree centigrade for one month. Rabies Virus (L.Pasteur 2061/Vero) propagated on Vero cell line, inactivated with betapropiolactone. Thiomersol @ 0.015% added as preservative Maltose.q.s. per immunizing dose Human Serum Albumin ..q.s. per immunizing dose. Sodium Chloride (0.9%) for Injection I.P.- 0.5 ml.

The antibiotics Neomycin, Kanamycin and Polymyxin - B sulphate used in the cell and virus cultures are eliminated to the greatest extent during purification procedures and cannot be detected in the final vaccine.

INDICATIONS: For active immunization against rabies both for prophylaxis and post-bite therapy in all age group of humans For prophylactic immunization of all high-risk group of persons such as Veterinarians, Municipal workers, Medical and Paramedical personnel, Forest and zoo personnel, Hunters, Laboratory personnel working with suspected rabies materials and pet owners. For immunization against rabies after exposure (after contact with a rabid or suspected rabid animal)

-----------------------------------------------------------------------------------------------------------------DOSAGE: Prophylaxis: Three immunizing doses on 0,7 and 28 days followed by the first booster after one year and subsequently in every three years Post exposure: Six immunizing doses on post exposure days 0,3,7,14,28 and 90 (0 day being the day of the first vaccination).

-----------------------------------------------------------------------------------------------------------------ADMINISTRATION:

a. Reconstitute the freeze dried vaccine with the diluent supplied in the ampoule. b. Administer the reconstituted vaccine (entire quantity of the vial) by deep intramuscular route in the deltoid region or in small children, into the anterolateral region of the thigh muscle. The reconstituted vaccine should be used immediately and not to be stored for administration later.

-----------------------------------------------------------------------------------------------------------------CONTRAINDICATIONS: In principle, there are no contraindications for administering the vaccine as the high risk of death in rabies outweighs all other considerations, specially in case of post-bite therapy.

-----------------------------------------------------------------------------------------------------------------CAUTIONS: 1. Concurrent use of immunosuppressive agents like corticosteroids shall be avoided as it may hamper in the development of protective antibodies. 2. In case of severe bites, local infiltration of the wounds with antirabies immunoglobulins is recommended. 3. Delay in the commencement of post-bite therapy, incomplete and irregular therapy can cause failure of protection.

-----------------------------------------------------------------------------------------------------------------STORAGE: To be stored at temperature between 2 and 8 degrees centigrade. Do not store the vaccine in deep freezer.

-----------------------------------------------------------------------------------------------------------------PRESENTATION: The vaccine is supplied as a single dose vial in a mono-carton with the diluent for reconstitution along with disposable syringe and needle.

Rabies Antiserum I.P

COMPOSITION: Each 5 ml vial contains: Equine anti rabies immunoglobulin fragments .. Not less than 1500 IU. Chloro-m-Cresol I.P........................................... Not more than 0.25%v/v.

-----------------------------------------------------------------------------------------------------------------PHARMACEUTICAL FORM Solution for injection by intramuscular or subcutaneous route 5ml vial, 1500IU

-----------------------------------------------------------------------------------------------------------------THERAPEUTIC INDICATIONS: AbhayRIG provides passive immunization against rabies. AbhayRIG is for prevention of rabies in patients at risk of being exposed to rabies after contact with a rabid animal or an animal presumed to be rabid. AbhayRIG itself does not constitute an anti rabies treatment and should always be used in conjunction with rabies vaccine. CONTRA-INDICATIONS: Should be used with extreme caution in subject with a history of allergic symptoms or hypersensitivity to horse serum. In case of doubt, it is essential to ask your doctor or pharmacist for advice.

-----------------------------------------------------------------------------------------------------------------SPECIAL WARNINGS AND PRECAUTIONS FOR USE: Despite the high degree of purification of the serum, it is recommended to perform a skin test before administering heterologus serum. The skin test consists of a intradermal injection of 0.1ml of 1:10 dilution of AbhayRIG on the outside of the forearm so as to obtain an orange ring type appearance (3 mm diameter induration). An equivalent intradermal injection of physiological saline solution is used as control. The observations made 15 minutes after intradermal injection is considered to be positive if erythrema (>6mm), local oedema or a systemic reaction is observed and the control is negative. A positve test result is not a formal contra-indication for the use of serotherapy, but it should be considered as a warning. A negative test is not an absolute guarantee for the absence of an immediate allergic type reaction.

-----------------------------------------------------------------------------------------------------------------DRUG INTERACTIONS: Rabies prevention requires simultaneous administration of antirabies immunoglobulin and vaccine. Anti rabies vaccine should be inoculated in different parts of the body contra-laterally if possible. In this case interference is minimized. AbhayRIG should not be administered in the same syringe as the vaccine.

------------------------------------------------------------------------------------------------------------------

PREGNANCY AND LACTATION: The safety of AbhayRIG when used during pregnancy has not been established in clinical trials in human beings. Considering the lethal risk associated with rabies, pregnancy is not a contra-indication to the administration of antirabies treatment subsequent to exposure to rabid animal. Table : Guide for Post Exposure Treatment ( WHO recommendation for post exposure treatment Type of contact with suspected or confirmed domestic or wild animals or animals unavailable for observation Touching or feeding of animals Licks on intact skin Touching or feeding of animals Licks on intact skin

Category

Recommended treatment

I II

None, if reliable case history is available Administer vaccine immediately Stop treatment if animal remains healthy throughout an observation period of 10 days/** Or, if the animal is euthanised and found to be negative for rabies by appropriate laboratory technique

III

Single or multiple transdermal bites or scratches Contamination of mucous membrane with saliva (i.e. licks)

Administer rabies immunoglobulin and vaccine immediately** Stop treatment if animal remains healthy throughout an observation period of 10 days,*** Or, if the animal is euthanised and found to be negative for rabies by appropriate laboratory technique.

** If an apparently healthy dog or cat in or from a low risk area is placed under observation it may be justified to delay specific treatment *** This observation applies only to dogs and cats

-----------------------------------------------------------------------------------------------------------------IMPORTANT NOTES:

Action

Results Helps reduce the viral load by physically removing virus particles (with running water) and subsequently by inactivating some of the remaining virions by chemical disruption. This simple action, if promptly carried out, can significantly reduce the risk of developing rabies Alcohol or other disinfectants lead to further inactivation of the remaining virions by chemical disruption

Washing the wound copiously with soap and water

Application of 70% alcohol, tincture of Iodine, povidine iodine or any other suitable disinfectant (after all traces of soap have been removed)

Proper infiltration of the wound with Rabies Immunoglobulin (RIG) of Human or Equine origin. As much as anatomically feasible should be infiltrated into and around the wound and the remaining if any to be injected (by intramuscular route only) in the deltoid region away from the site of vaccine administration.

RIG is a specific rabies-virus-neutralising antibody that immediately neutralizes the rabies virus on contact. Once the viruses are coated with antibody, they cannot adsorb onto and enter the nerve endings. This results in a further reduction (and in some cases complete obliteration) of the inoculated virus, even in deeper tissues where the soap or alcohol may not have reached. Potent cell culture vaccines when administered according to the approved schedules result in systemic production of anti-rabies antibodies after a lag period of 7 to 14 days. These circulating antibodies reach the wound site through the systemic circulation and are able to neutralize any remaining virus particles.

Administration of a potent cell culture vaccine as per the recognized Schedules

-----------------------------------------------------------------------------------------------------------------FIRST-AID TREATMENT: All the areas of the body and the bite or scratch site which may be infected with rabies virus should be immediately and thoroughly washed with soap or detergent with running water and 70% alcohol or an iodine preparation is applied. AbhayRIG should be injected as soon as possible in case of suspected exposure.

-----------------------------------------------------------------------------------------------------------------DOSAGE AND ADMINISTRATION OF ABHAYRIG: For Prevention of rabies, combined immunoglobulin and rabies vaccine treatment is recommended for all Category III exposure as per WHO classification of Exposure. The recommended dose of AbhayRIG is 40 IU/Kg. of body weight infiltrated in and around the wound as much as anatomically feasible. Administer the remainder of the dose, if any by deep intramuscular injection at a site separate from that used for the vaccine. Ensure that the wound has been adequately infiltrated with immunoglobulin locally before suturing, if suturing is necessary. The first dose of the vaccine should be inoculated at the same time as that of AbhayRIG, but at a different site on the body. In no cases should the dosage of AbhayRIG be exceeded because immunoglobulin may partially suppress active production of antibodies. Children and adults receive the same dose of 40 IU/Kg of body weight. Incase the volume of AbhayRIG is low or insufficient for infiltration in case of a child or in case of large bite site then it can be diluted in normal saline.When indicated, begin anti-tetanus treatment and administer antimicrobial drugs to control infections other than rabies. Discard any unused portion.

-----------------------------------------------------------------------------------------------------------------UNDESIRABLE EFFECTS: Immediate or delayed hypersensitive type reactions may be developed on administration of AbhayRIG. The observed immediate reactions are anaphylactoid reactions with hypotension, dyspnea, urticaria. Delayed reactions consist of inflammatory reaction, fever, pruritis, rash or urticaria, adenopathy and arthralagia. Inform your doctor or pharmacist if you experience any undesirable

effect.

-----------------------------------------------------------------------------------------------------------------STORAGE CONDITIONS : Store at a temperature between 2*C and 8*C in a refrigerator. DO NOT FREEZE.

-----------------------------------------------------------------------------------------------------------------PRESENTATION : Vials of 5 ml, Each vial contains 300IU/ml of equine anti-rabies immunoglobulin.

Measles, Mumps, Rubella Vaccine EP

------------------------------------------------------------------------------------------------------------------Composition 1 dose of 0.5 ml contains -Measles virus, Edmonston Zagreb, HDC -Mumps virus, L-Zagreb, CF not less than 1000 CCID50 not less than 5000 CCID50

-Rubella virus, RA27/3, HDC Inactive ingredients

not less than 1000 CCID50

-Sorbitol, gelatine, L-arginine HCI, maltose, sodium chloride, lactalbumin hydrolysate, L-alanine.

------------------------------------------------------------------------------------------------------------------Properties The vaccine is prepared by propagation of live attenuated viruses; measles (Edmonston Zagreb strain) and rubella virus (RA27/3 strain) grown in human diploid cells (HDC) and mumps (L-Zagreb strain) grown in cell cultures of chick fibroblasts (CF) derived from chick embryo of specified pathogen free flocks (SPF). Lyophilized vaccine is dissolved with water for injection provided. Due to small differences in pH values, the dissolved vaccine is a clear yellow to clear pink. The production and control of measles, mumps and rubella vaccine (live) complies to the respective monograph of current European Pharmacopoeia. ------------------------------------------------------------------------------------------------------------------Indications The vaccine is indicated for active immunization against measles, mumps and rubella the vaccine should be used at an age when passive protection through the mothers antibodies is lost in children, the immunization against measles, mumps and rubella should be obligatory, indicated in children at twelve months of age or older. Immunization is also indicated in children up to 18 months of age or older, if they have not received immunization against these diseases. The second dose of MMR vaccine should be routinely administered at the age of 6 to 7 years. Persons with history of measles, mumps and rubella are also subject to immunization. ------------------------------------------------------------------------------------------------------------------Contraindications -pregnancy; -acute -febrile infectious diseases; state;

-immune deficiency; primary (congenital) and secondary (caused by a malignant disease or drug use such as antimetabolites, corticosteroids, alkylating agents and radiations); -with in three moths following blood plasma transfusion, or immunoglobulin therapy (or after even longer period, if greater doses have been used), i .e. Within six months after exsanguinotransfusion; -hypersensitivity to vaccine ingredients; Although grown in primary culture of chick fibroblasts, there is no evidence of allergic reactions in immunized persons allergic to chicken or chicken feathers. Diarrhoea or benign acute diseases of the upper respiratory tract, as well as seropositivity to HIV are not contraindicated to vaccination against measles, mumps and rubella. -------------------------------------------------------------------------------------------------------------------

Precautions -a through case history should precede immunization

-in case the vaccinations have not been administered at the same time, a period of at least one month should expire between two immunizations with live virus vaccines -tuberculin skin tests (Mantoux test) should be done before, or least 2 months after administration of measles, mumps and rubella vaccine, because of a possible occurrence of a transient inhibition of cellular immunity -children prone to infectious disease should be immunized, like in asthma, cystic fibrosis, celiac disease, chronic lung disease congenital heart diseases, Downs syndrome, stable neurological conditions, malnutrition, as well as premature infants regardless of the degree of prematurity -Antishock therapy should be used in case possible anaphylactic reaction!

------------------------------------------------------------------------------------------------------------------Pregnancy an lactation The vaccine must not be used in pregnancy. Conception should be avoided for two months after vaccination, because of the presence of the virus in the body. As the excretion of the active substances (viruses) in the milk has been described in the literature, the vaccination during lactation should be avoided. ------------------------------------------------------------------------------------------------------------------Adverse effects

Local Transient pain and irritation (edema, indurations and erythema) at the site of injection General The most frequent reaction to vaccination with live attenuated morbilla virus are increased body temperature following approximately one week after vaccination and skin rash.. increased body temperature, parotid swelling and skin rash appear in rear cases as reactions to the mumps component adds side effects to rubella components, arthralgia and arthritis appear to be associated with the age of the immunized persons, that is they are reported in up to 2% of girls 6 to 12 and 13 to 16 years of age, in relation to 25% of girls and women 20 to 24 years of age. There are data available in relation to the incidents of side effects upon the administration of the second dose of vaccine; a higher risk of side effects is recorded in the age group of 11 to 12 years than in the age group 6 to 7 years of age. ------------------------------------------------------------------------------------------------------------------Dosage and administration The lyophilized vaccine should be diluted immediately prior to use! 0.5 ml water for injection should be taken as diluents for one dose of vaccine. 2.5 ml water for injection should be taken as diluents for five doses of vaccine. A certain amount of diluents should be withdrawn via a sterile needle into the sterile syringe. To obtain a prescribed suspension the diluents should be injected into a vial of lyophilized vaccine and agitated gently in order to avoid the formation of foam. In multiple dose vial, a new sterile needle and the syringe should be used for each (0.5 ml) per dose

The vaccine should be heated to body temperature prior to vaccination (by holding in closed fist); the vaccine should not come into contact with disinfectants. The usual 0.5 ml dose should be injected subcutaneously into the upper arm in the region of the deltoid muscle. From the microbiological point of view the reconstituted vaccine should be used as soon as possible. Should the vaccine not be used immediately the person administering the vaccine should be responsible for its proper storage and labeling. Reconstituted vaccine should be kept at temperatures o between 2 and 8 C and used within 8 hours, expect instances where the vaccine has been opened and dissolved in controlled and validated aseptic conditions. ----------------------------------------------------------------------------------------------------------------- -Drug interactions Vaccine against measles, mumps and rubella may be used simultaneously with other live virus vaccines, (vaccine against polio, hepatitis B and yellow fever) and bacterial vaccines in vaccines against diphtheria, tetanus and Pertussis). Other commercially individual vaccines should not be mixed in the same syringe in the measles, mumps and rubella vaccine (expanded program of immunization of the world health organization) ------------------------------------------------------------------------------------------------------------------Storage Store
o

the

vaccine

at

to

8 C

protected

from

light.

------------------------------------------------------------------------------------------------------------------Shelf-life The expiry

dated

of

the

vaccine

is

indicated

on

the

package.

------------------------------------------------------------------------------------------------------------------Presentation -50 vials with as 5 doses of vaccine in a box and 50 ampoules with 2.5 of water for injection in a box.

Hepatitis B vaccine I.P. (r DNA)

----------------------------------------------------------------------------------------------------------------------

------------------------------------------------------------------------------------------------------------------Description Elovac- B (Recombinant Hepatitis B vaccine) is a noninfectious recombinant DNA vaccine. It is a sterile suspension of purified major surface antigen of Hepatitis B virus (HBV). The hepatitis B surface antigen (HBsAg) is produced from cultures of genetically engineered Pichia pastoris, containing the gene that codes for the HBsAg. The HBsAg protein released by disruption of Pichia pastoris cells is purified by various physiochemical methods. The purified antigen is adsorbed on aluminum hydroxide gel to get bulk vaccine. The vaccine does not contain any material of human or animal origin. Elovac- B is commercially available as a sterile suspension, ready to use for I.M. injection. The vial must be shaken well before administration. Pediatric & Adolescent dose: Each 0.5mL dose contains 10mcg of hepatitis B surface antigen (purified) adsorbed on 0.25mg aluminum as aluminum hydroxide and 0.025 mg of Thiomersal as preservative. Adult dose: Each 1 mL adult dose contains 20 mcg of hepatitis B surface antigen (purified) adsorbed on 0.5 mg aluminum as aluminum hydroxide and 0.05mg of Thiomersal as preservative. ------------------------------------------------------------------------------------------------------------------Indications and clinical use Elovac - B vaccine is indicated for immunization against infection caused by all known subtypes of Hepatitis B virus. Routine vaccination is recommended for all new born, infants, children and adolescents.Vaccination of defined high risk populations is recommended for persons older than eighteen years of age. High-risk populations

1.

People who have a job that involves contact with human blood (Ex: Health care personnel, Military personnel etc.) 2. Travelers to areas of high endemicity i.e. where > 4% of the population are infected. 3. Injectable drug abusers 4. Patients who may require multiple blood transfusions or are at a risk of receiving unsafe transfusions or blood products. 5. Persons originating from areas of high endemicity 6. Persons who have sex with someone infected with HBV 7. Persons who have sex with more than one partner 8. Men who have sex with men 9. People who live in the same house with someone who has chronic HBV infection 10. Infants born to HBV positive mothers.

------------------------------------------------------------------------------------------------------------------Contraindications Elovac - B should not be administered to any person who has experienced a hypersensitivity reaction to any component of any Hepatitis B recombinant DNA vaccine. Elovac - B should not be administered to subjects with severe febrile infections. ------------------------------------------------------------------------------------------------------------------Warnings Elovac - B may not prevent infection, if the vaccinee, at the time of immunization was harboring an unrecognized Hepatitis B infection. Not all vaccinees respond in the same manner to a given vaccine. The immune response may be dependant up on many factors. Some are mentioned below. Age over 40 years, Gender: Male, Smokers, Obese individuals, patients with immuno-deficiency diseases or those receiving immuno - suppressive therapy or those who received the vaccine on the gluteal region, may have an unsatisfactory antibody titre. Hence adequate anti-HBs antibody titres may not be obtained after a primary course of immunization. In such persons additional doses of the vaccine may be required. The vaccine does not prevent infection by hepatitis A, hepatitis C, hepatitis D, hepatitis E or other pathogens known to infect the liver. Pregnancy: Adequate human and animal data on use during pregnancy is not available. Hepatitis B vaccine should be used during pregnancy only when definitely indicated, and the possible benefits outweigh the possible risks to the fetus. However as with all inactivated viral vaccines we dont anticipate any harm to the fetus. Lactation: Adequate human and animal data on use during lactation is not available. Caution should be exercised when hepatitis B vaccine is administered to lactating women. Patients who develop symptoms suggestive of Hypersensitivity after an injection should not receive further injections of the vaccine. Interchangeability with other Hepatitis B vaccines Elovac- B can be used, for primary vaccination as well as for booster doses. Even if the person has been vaccinated by any other Hepatitis B vaccine, the subsequent vaccination series may be continued using Elovac- B

------------------------------------------------------------------------------------------------------------------Precautions -Caution and care should be exercised in administering the Vaccine to individuals with severe compromised cardiopulmonary status as systemic reaction could pose a significant risk. -As with any injectable vaccine, epinephrine should be available for use in case of anaphylaxis or anaphylactic reaction. -The vaccine should be well shaken before use. In presence of minor infection Elovac- B to be used only when clearly needed and the possible advantage outweighs the risks. ------------------------------------------------------------------------------------------------------------------Adverse reactions Elovac B is generally well tolerated. Most Common adverse reactions: Injection site: Mild soreness, indurations, erythema. Uncommon adverse reactions classified by body system: SYSTEMIC: Fatigue, low-grade fever and malaise. SKIN AND APPENDAGES: Rash, pruritis and urticaria MUSCULOSKELETAL SYSTEM: Arthralgia, myalgia DIGESTIVE SYSTEM: Nausea, vomiting, diarrhoea and abdominal pain. HEPATOBILIARY SYSTEM: Abnormal liver function tests. NERVOUS SYSTEM: Dizziness, and paresthesia. Extremely rare adverse reactions classified by body system: SYSTEMIC: Anaphylaxis, serum sickness, angioedema and erythema multiforme. MUSCULOSKELETAL SYSTEM: Arthritis CVS: Syncope, Hypotension. NERVOUS SYSTEM: Neuropathy, neuritis (including Guillain- Barre syndrome, optic neuritis), encephalitis and meningitis. RESPIRATORY SYSTEM: Bronchoconstriction like symptoms. LYMPHOID SYSTEM: Lymphadenopathy. ------------------------------------------------------------------------------------------------------------------Drug interactions No suspected drug interactions influencing the efficacy of the vaccine have been reported. Elovac - B vaccine can be administered concomitantly with DPT, TT,DT and OPV if required. Elovac - B vaccine can be given together with measles mumps-rubella vaccines Haemophilus influenza b vaccine, hepatitis A vaccine and BCG vaccine Different injections should be given at different sites using separate needles and syringes. ------------------------------------------------------------------------------------------------------------------Dosage and administration Preparation for Administration: Elovac- B is presented as a ready to use suspension. The vaccine should be shaken well to obtain a homogenous turbid white suspension.

The vaccine should be used as supplied and no dilution is necessary. The vaccine should be inspected visually for particulate material or discolouration prior to administration. Sterile needle and syringe should be used for withdrawal of vaccine. Aseptic techniques should be followed. Any vaccine remaining in a single dose vial should be discarded

Dosage: NEONATES, AND CHILDREN TILL THE AGE OF 18 YEARS :The recommended dose of Elovac-B is 10 mcg of antigen protein in 0.5mL suspension. ADULTS 19 YEARS OF AGE AND OLDER: The recommended dose of Elovac- B is 20 mcg of antigen protein in 1 mL suspension Elovac- B SHOULD NEVER BE GIVEN INTRAVENOUSLY. Elovac- B should be injected intramuscularly in the anterolateral thigh, for neonates and infants. Elovac- B is to be injected intramuscularly in the deltoid of adults. Elovac- B must not be administered in the gluteal region as the immune response may be lower. Elovac- B may be administered subcutaneously in patients with severe bleeding tendencies (e.g. hemophiliacs). Immunization Regimen Primary immunization with Elovac- B consists of three intramuscular doses. The second dose given one month after the first and the third dose administered at least four months after the second dose of Elovac- B Immunization Schedule 1 dose Given on a fixed date this is the FIRST DOSE nd 2 dose 4-10 weeks after the FIRST DOSE rd 3 dose 4-20 weeks after the SECOND dose st A booster dose is recommended 12 months after the 1 dose. A second booster dose may be required after 8 years in the high risk population if the antibody titre falls below 10mIU/mL. Immunization in special situations Known/presumed exposure to HBV First dose of hepatitis B vaccine can be administered simultaneously with hepatitis B immunoglobulin, which however must be given at a separate injection site. Neonates Born to HBV carrier Mothers First dose of hepatitis B vaccine can be administered simultaneously with hepatitis B immunoglobulin, which must be given at separate injection site. The immunization should start immediately after birth and preferably use 0,1 and 2 months schedule. Chronic Haemodialysis Patients The recommended dosage of hepatitis B vaccine is 40mcg (2mL) using a 0,1,2, 6 months vaccination schedule. Anti HBs surveillance every 3-6 months is warranted so as to maintain the accepted protective levels of 10mIU/mL. ------------------------------------------------------------------------------------------------------------------Over dosage : Not known
st

Action and clinical pharmacology Elovac- B generates specific protective immune response against HBsAg. For protection against HBV infection the anti-HBsAg titre (Anti HBs antibodies) should be more than or equal to 10 mIU/mL. ------------------------------------------------------------------------------------------------------------------Storage and stability When stored at 2-8 c the product is stable till the date of expiry printed on the label. 'Do not store in the freezer.' 'Store in its original package.' ------------------------------------------------------------------------------------------------------------------Special handling instructions The product must never be frozen, must always be shaken well before withdrawing into syringe, safe open vial practices must be followed. After withdrawal from the vial the vaccine must be administered immediately. ------------------------------------------------------------------------------------------------------------------Dosage forms, composition and packaging Elovac- B multidose vials in packs of 1, and 20mcg/mL dose Elovac- B monodose vials in packs of 12, 10mcg/dose and 20mcg/dose