BIOLOGICS

Tyler

Written by Aafaqi
Faculty of Pharmacy BZU
 Biologics
Definition:
Any product obtained from a living plants or animals is known as biologic.
According to FDA
Any virus, therapeutic serum, toxin, antitoxin and their analogue that may be
viral vaccine, bacterial vaccine, immune serum, human blood or products derived
from blood used in diagnosis, prevention and treatment of diseases.
OR
A preparation such as drug, vaccine, antitoxin that is synthesized from living
organisms or their products as a diagnostic, preventive and therapeutic agent.
➢ Biologics have expiry date and storage conditions.
➢ They should be properly labelled with name.
➢ Biologics must have batch number, manufacture license number and
storage conditions.

Classifications of biologics:
• Antigen
• Antibody

Antigen:
Any substance that provokes immune system and causes immune response is
called antigen.
Categorical definition of antigens:
Biologically:
Biologically antigen is any substance or the material that when enters the
tissues of humans or other vertebrates causes production of antibodies.
Biological properties:
Immunogenicity:
It has the capacity to induce antibody formation or induce immune response.
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Specificity:
Antigen is specific to react with specific antibody. Specificity is governed by
small chemical sites on the antigen molecules called antigenic determinants.
Chemically:
Antigen are usually proteins however some high molecular polysaccharides are
antigenic.
Physically:
Antigen must possess a high molecular weight. A weight of more than 10,000
Dalton is required.
Hapten is the incomplete antigen having molecular weight less than 10,000
Dalton. It has no ability to produce immune response. It combines with host
protein and act as antigen.
The simplest form of an antigenic determinant present on a complex antigenic
molecule is called an epitope.

Antibody:
Any substance that is produced in response to antigen is called antibody.
Usually antibodies exist in human serum, other secretions and mucous
membrane. Specialized cells of the immune system can recognize the antigen and
are able to set off complex chain of events designed to kill these foreign invades.
Fractionation of human blood by electrophoresis give following four fractions
1. Albumin
2. 𝜶 globulin
3. 𝜷 globulin
4. 𝜸 globulin

Antibodies that exist in 𝛾 globulin fraction are known as Immunoglobulin.

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Classes of immunoglobulin:
1. IgG
It constitutes about 80% of the total antibodies. Its molecular weight is
1,50,000 Dalton and consists of only 1400 amino acids. It occurs in
tetrameric form having two identical halves which together form the Y-
linked shape. Each of the fork contain antigen binding site. It is the only
class of immunoglobin that can cross placenta.
2. IgM
it is also known as material antibody. It is the first antibody that is made by
fetus and the first immunoglobulin made by virgin B cells when it is
stimulated by antigen. It occurs in pentameric form
3. IgA (Alpha heavy chain)
It is predominant immunoglobulin that is found external bodily secretions
such as saliva, tears, GIT fluid, respiratory secretion (my also cause asthma).
4. IgD (Delta heavy chain)
It is present in lowest concentration primarily found on B cell surface where
it functions as a receptor for antigen.
5. IgE (Epsilon heavy chain)
It functions in allergic reactions. It is a hypersensitivity antibody and bound
with mast cell of the surface of tissue.

Immunity
Definition:
It is the state of having sufficient biological defense to avoid infection, disease
or other unwanted biological invasion. It is the capability of the body to resist
harmful microbes from entering it.
Types:
Innate immunity:
It is the natural resistance with which a person is born. It depends upon race,
genetic make-up. It can never be finished nor be increased

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Acquired immunity:
The immunity obtained either from the development of antibodies in response
to exposure an antigen as from vaccination or an attack of an infection, disease or
from the transmission of antibodies from mother to fetus through the placenta or
the injection of antiserum.
Types of acquired immunity:
• Active immunity (natural or artificial)
• Passive immunity (natural or artificial)
Active immunity:
It is produced by introducing antigenic substances.
Naturally acquired active immunity:
It is received by the body in natural manner. It occurs when exposure to antigen
is unintentional. It often follows a disease mumps, measles.
Artificially acquired active immunity:
It is received by the body through the administration of vaccine or toxoid that
act as antigen as exposure to antigen is intentional.
Passive immunity:
It is produced by injecting preformed antibodies from external to the body.
Naturally acquired passive immunity:
It develops when antibodies pass into the fetal circulation from mother blood.
Artificially acquired passive immunity:
It develops from the intentional injection of antibody rich serum into the
circulation.

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 Vaccines
Definition:
Vaccines may contain living, attenuated or killed viruses or bacteria and they
are used as inoculations to stimulate the production of antibodies and provide
immunity against one or several diseases.
Primary active immunity from vaccination develops more slowly than the
incubation period of most infections and must be induced prior to exposure to
the infectious agent; therefor the general action of vaccine should be considered
prophylactic.
Nonliving vaccines provide protection for only a limited time. Active immunization
with living agents is generally preferable to immunization with killed vaccines
because of a superior and more long-lived immune response. Active
immunization may cause fever, malaise and soreness at injection sites.
Use of vaccines is contraindicated under conditions in which the immune
response may be depressed such as during therapy involving corticosteroids,
antineoplastic agents, immunosuppressive agents or radiations in patients with
immunoglobulin deficiency and in patients with latent or active infections.

Viral vaccines
Poliomyelitis vaccines:
It is the sterile suspension of inactivated poliomyelitis virus of types 1,2 and 3.
Sometimes it is also called “Salk vaccine”, “Trivalent vaccine” or “Sabin vaccine”.
Polio is the very serious infection that cause paralysis of the muscles that enable
the body to walk and breath.
Types:
Type I (brunhilde) most often isolated from paralysis cases.
Type II (lansing) concerned in sporadic diseases.
Type III (leon) proved to be etiologic agent in less frequent epidemics.

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Types of polio vaccines:
• Polio vaccine by injection
• Oral polio vaccine
Discovery:
Landsteiner and Popper in 1908 first transmitted and isolated poliomyelitis
virus in monkeys. It was subsequently ascertained that monkeys that had survived
one attack of poliomyelitis were resistant to further attacks. Furthermore blood
serum from such monkeys neutralized the virus in vitro. During 1948 Dr. John F.
Enders and his associates originated a method of cultivating polio virus in vitro on
animal tissues other than nervous tissues. Then in 1953 Dr. Jonas Salk and his
coworkers perfected the roller-tissue method of polio virus culture as well as the
final detoxified form of polio vaccine.
Preparation:
➢ The virus strains are grown separately in primary cultures of Rhesus
monkey kidney tissues bathed by a complex nutrient fluid containing
more than 60 ingredients.
➢ After incubation the virus is harvested by decanting the nutrient fluid
that is clarified by filtration and formaldehyde 1:4000 is added.
➢ The formaldehyde treated virus is maintained at 36oC at pH 7 until all
viruses are killed.
➢ A series of teste is performed to ascertain that all viruses are inactivated.
➢ The formaldehyde is neutralized and a preservative is added.
➢ The 3 types of virus are then pooled and the resultant mixture is the
trivalent vaccine.
Dose:
The usual dose given S/C is 3 injections of 1ml,4 or more weeks apart and the
th
4 reinforcing dose of 1ml,6-12 months later.

Oral polio vaccine:

It was developed by Albert Sabin. It is also known as trivalent oral polio vaccine
or Sabin vaccine. The amount equal to 1 sugar grain is sufficient to produce
immunity.5% dose is given due to active virus.
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It consists of a mixture of live attenuated polio virus strains of all three polio virus
types.
Advantages:
➢ Ease of administration.
➢ Low cast and long-lasting immunity
➢ Can also be used when polio virus has formed colonies in the intestine.
Storage:
It is stored at -10oC.

Yellow fever vaccine:

The vaccine is used to treat yellow fever (yellow jack), black vomit. It is a serious
disease that is caused by yellow fever virus called Flavi. Fibricus is the causative
agent and its vector is Aedes mosquito.
Effects of fibricus:
• Fever and flue.
• Jaundice
• Liver, kidney and respiratory failure.
• Death
Preparation:
➢ Live attenuated stains of yellow fever virus are grown on the tissues of
domestic fowl Gallus domesticus.
➢ Virus is inoculated to its embryo and after sufficient growth suspended in
water.
➢ It is passed through aseptic process.
➢ The vaccine is passed through freeze drying (lyophilization) and packed into
the embryo. Liquid nitrogen is filled above the embryo and sealed.
➢ Before use it is reconstituted and made available in liquid form.
Dose:
Single dose of 0.5ml is given S/C. Sometimes a booster dose is given before visit
to countries where yellow fever virus is present such as Africa, Syria.

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Storage:
It is stored below 0 to maximum 5oC.After 5oC it becomes inactivated.

Rubeola/Measles and Rubella/German Measles vaccine:

Measles is caused by two strains of virus. Rubeola strain causes measles and
Rubella causes German measles. Both are two different diseases but have same
symptoms. It is highly effective vaccine.
It is considered as suspension of life.

Measles:
• Rubeola virus especially affect respiratory system.
• In severe case it can be life threatening.
• It results in red or reddish-brown rash.
Preparation:
The vaccine is prepared by Enders strain and Shachwartz strain and the culture
growth is carried out on avion embryo or mammalian kidney. Usually chicken
embryo is used for its preparation.

German measles:
• Rubella invades the lymph nodes, and eyes.
• It is benign or milder disease but pregnant women should be cautious.
• It results in red spots with white center known as Koplik spot in oral cavity.
Preparation:
The vaccine is prepared by CPV 77 viral strain and the culture growth is carried
out on duck embryo.
Contraindication:
It is not given to pregnant woman, feeding woman and children below 1 year age.
Dose:
➢ Rubeola vaccine single dose of 0.5ml S/C over 1 year children.
➢ Rubella vaccine single dose of 0.5ml S/C to children 1 year to puberty.

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Storage:
Storage conditions for both vaccines is 2-8oC.
Measles Mumps Rubeola (MMR) comes in common form and it is not trivalent.

Small pox vaccine:

Small pox vaccine is the living virus of vaccinia that is prepared from skin of
bovine calf or membrane of chicken embryo.
Preparation:
From calf:
➢ A healthy calf is taken that is not diseased and its belly is washed and hair
are removed.
➢ The belly is cut in such a way that the membrane serum comes out.
➢ The virus is inoculated and the skin is rubbed.
➢ When the maximum development of virus takes place, vesicles are formed.
➢ These vesicles are removed, triturated and suspended in glycerin or sorbitol
40%-60% (0.3% phenol as preservative).
From chicken:
➢ Freshly incubated eggs are taken.
➢ Pox virus suspension is introduced into the egg yolk and then the eggs are
incubated.
➢ When the maximum period of vaccine takes place then eggs are broken and
are mixed with water.
Dose:
1 capillary tube is injected to the multiple puncture at human body at the age of
7 years.
Storage:
• Liquid form is stored below 0oC.
• Dried form is stored at 2-8o.

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Rabies vaccine:
It is virus killed vaccine and also known as human diploid cell rabies vaccine
(HDCV). It is the sterile preparation of either the whole virion or sub-virion rabies
virus. It is obtained from the brain of rabbit or from duck embryo. It is more
effective as antibodies are produced at maximum 10th day because there is less
myelin sheath is eggs.
It is available in two forms
➢ Liquid form with 6 months expiry date.
➢ Dried form with 8 months expiry date.
Dose:
14 injections on consecutive basis are applied. Its action starts at minimum 10th
days. The usual pre-exposure dose is3 injections of 1ml.

Bacterial vaccines
It contains killed or attenuated strains of bacteria. Pathogenic bacteria grow in
isotonic 0.9% NaCl solution. Bacteria are killed by moist heat method and their
pathogenicity is removed by radiations. Bacterial smooth (S) strains are more
endogenic than rough (R) strains.
The concentration or activity is measured in No. of micro-organisms/ml.

Typhoid vaccine:
Typhoid is caused by Salmonella typhi that grows in intestine. Typhoid fever is
also known as enteric fever that’s why the vaccine is also called enteric vaccine.
The vaccine is prepared from the sterile suspension of Salmonella typhi and is
used for the production of active immunity.
Potency:
Its potency is 1 billion M.O/ml.
Dosage:
2 doses of 0.5ml 4 weeks apart and then 3rd dose of 0.5ml after every 3 years.
Depending upon condition the dosage schedule (not initial dose) can be changed.
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Cholera vaccine:
Cholera is caused by Vibrio cholera. Two strains of bacteria (Inaba and Ogawa)
are used but Inaba strain is used mostly.
Potency:
Its potency is 8 billion M.O/ml.
Dosage:
2 doses of 0.5ml 4 weeks apart and then 3rd dose after every 6 months.
Sometimes vaccine schedule is changed due to environmental conditions. The
person is first examined and then booster dose is given.
Storage:
It is stored at 2-8oC no longer than 18 months.

Pertussis vaccine (whooping cough):

It is caused by Bordetella pertussis that cause secretion in trachea but not
damage body organs. It is generally used in combination with diphtheria and
tetanus toxoid DTT or DTP.
Dosage:
2 doses of 0.5ml 4 weeks apart and then 3rd dose after 1 year S/C.
Adsorbed pertussis vaccine contains Al hydroxide and Al phosphate while the
concentration of Al is not more than 850𝜇g/ml. It is given IM.

BCG vaccine:
It is the suspension of living cells of a strain Mycobacterium tuberculosis also
known as bacillus of Calmette and Gverin and protects against tuberculosis. The
vaccine is also called TB vaccine (TB once considered as life threatening).The
vaccine is 70-80% effective against severe form of TB.
Dosage:
0.1ml I/C or 1 drop by multiple puncture method. It is given only if the
Tuberculosis test is negative and should be used 2 hour after reconstitution.

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Storage:
It can be stored at 5oC for 1 year.

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 Toxins
Definition:
Toxins are bacterial waste products that are considered poisonous to the
animal body.
Types:
1. Endotoxins
If toxins are produced and retain within the bacterial body they are called
endotoxins.
2. Exotoxins
If toxins are excreted from the bacterial cells producing them and are dissolved
in surrounding culture medium, they are called exotoxins.
Exotoxins are pathogenic in nature and cause diseases and vaccine production.

Preparation of exotoxin solution

To produce a solution of exotoxins commercially the highly virulent organisms are
used.
• Bacteria are grown in beef broth media and then killed by appropriate
means.
• The organisms are removed by filteration through a bacterial filter.
• This filtrate contains the toxins.

Use of exotoxin solution

Exotoxin solution can be used
• For diagnostic purpose:
The unprocessed or pure form of exotoxin is used for the diagnostic
purpose that either the person is susceptible to certain disease or not.

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 • For preparation of toxoids:
The unprocessed form is treated with 0.2% formaldehyde that reduces or
eliminates the toxic properties without affecting the antigenic properties.
These products, detoxified in this manner are called fluid toxoids and are
used to induce artificial active immunity in susceptible individuals.
5 times of the toxoid is injected guinea pigs. The first 3 injections are at the
intervals of 1-3 months while the 4th is after 6-12 months. If the symptoms of
toxicity appear then it is unprocessed. If no symptoms of toxicity appear then it is
processed. The toxoids alone and in combination with pertussis vaccine should be
stored at a temperature of between 2o-8oC for 2 years.
Adsorbed toxoid is prepared by precipitating or adsorbing the fluid toxoid with
alum, aluminum hydroxide or aluminum phosphate. Adsorbed toxoids result in a
slower release of the antigen from the site of injection. They are used to increase
the potency. Both fluid and adsorbed toxoids are used to produce active
immunity against diphtheria and tetanus. They are used alone and in
combination.
➢ Toxoids produce active immunity as they produce antigens.

Tetanus toxoid (fluid):

It is the sterile preparation of Clostridium tetani. Pathogenicity is diminished by
treating it with formaldehyde. It is stored at 2-8oC.Its expiry date is 2 years.
Usually 5 times of the dose (immunizing dose) is given to 4 guinea pigs individually
having weight 300-400g.If there is no symptoms of toxicity in 21 days then drug is
toxoid.1/3rd of immunizing dose is injected S/C to 10 guinea pigs and after it 6th
week 10 folds of the minimum lethal dose is injected. If in 10 days there is 80%
survival of pigs then toxoid has immunogenicity.
Dose:
For primary immunization 3 injections of 0.5ml given S/C or IM 4-8 weeks apart,
and the 4th dose of 0.5ml given 6-12 months after the 3rd injection. A booster dose
of 0.5ml is given every 10 years.

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Adsorbed tetanus toxoid:
It is the sterile suspension of tetanus toxoid adsorbed in alum, aluminum
sulfate, aluminum hydroxide. It release the drug in low concentration thus cause
active immunization against tetanus.
Dose:
For primary immunization 2 injections of 0.5ml given IM 4-8 weeks apart, and
the 3rd dose of 0.5ml given 6-12 months later. Booster dose is same as tetanus
toxoid(fluid).

Diphtheria tetanus toxoid (DTT):

It is the combination of diphtheria and tetanus toxoid. Diphtheria and tetanus
toxoids are mixed in such way that their ability to produce immunity remains
intact.
Dose:
Same as above.

Adsorbed diphtheria tetanus toxoid (suspension):

Equal quantity of diphtheria and tetanus toxoid is adsorbed in alum, aluminum
sulfate and aluminum hydroxide.
It is available in two forms
• For pediatric use (to children less than 6 years)
2 injections of 0.5ml given IM at intervals of 4-8 weeks. A reinforce dose is
given 6-12 months. Booster dose of 0.5ml at 5 years of age and then every
10 years there-after.
• For adult use
It contains same amount of tetanus as in DTT but only 10-25% of the
diphtheria toxoid as in adults immunity is produced against diphtheria
naturally.

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Diphtheria tetanus toxoid and pertussis vaccine(DTP):
It is the mixture of diphtheria and tetanus toxoid in which killed pertussis bacilli
is added. It produces active immunity.
Dose:
Same as above.

Adsorbed diphtheria tetanus toxoid and pertussis vaccine:

It produces active immunity in infants and children under 7 years of age against
diphtheria, tetanus and whooping cough.
Dose:
0.5ml dose at 4-8 weeks intervals IM at the age of 2-3 months with a reinforcing
dose given 1 year after the 3rd injection. Booster dose is 0.5ml when child is 4-6
years old.

Antitoxin:
An antitoxin is an antibody with the ability to neutralize a specific toxin.
Antitoxins are produced by certain animals, plants and bacteria in response to
toxin exposure. Although they are most effective in neutralizing toxins, they can
also kill bacteria and other micro-organisms.

Preparation of antitoxin
Antitoxins are prepared from animals usually horses that have been immunized
by repeated injections of specific bacterial exotoxins. The toxin in constantly
increasing doses induces the formation of antitoxin in the blood of the injected
animal. The first injection of toxin is injected to the animal. The second dose is
injected after 1 month and the third is injected after 2 months of the second
dose. In this way maximum production of antitoxins take place. The animal is
bled, the clot is permitted to form, and the clear serum is separated for

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processing. Depending upon the manufacturer either two methods of processing
is employed.
• Precipitation method
The method involves the series of precipitations using varying
concentrations of ammonium sulfate. During the process the euglobulin
and fibrinogen fractions are initially salted out followed by the pseudo-
globulin fraction, which contains the antitoxin. The latter fraction is re-
dissolved dialyzed and filtered.
• Pepsin method
The second method utilizes a pepsin solution to digest the plasma, thus removing
up to 80% of protein, however the loss of about 20% in antitoxin content occurs
also. The digested material is then treated with ammonium sulfate solution, re-
dissolved, dialyzed and filtered.
Antitoxins are standardized in terms of “antitoxin units”. The antitoxin unit for
diphtheria is 500 antitoxin unit/ml. Usually the expiry date is 5 years with 20%
extra antitoxins.

Use of antitoxins
Antitoxins are used for
• Cure purpose (1000-8000 antitoxin units/ml)
• Pro-phylactic purpose (1000 antitoxin units/ml)

Tetanus antitoxin:
It is the sterile, non-pyrogenic solution of the refined and concentrated
proteins, chiefly globulins, containing antitoxic antibodies obtained from the
blood serum or plasma of healthy horses that have been immunized against
tetanus toxin or toxoid. It has potency of not less than 400 antitoxin units/ml. It
should be stored at the temperature of 2-8oC.
It is available in two forms
Liquid form 20% excess of potency with 5 years expiry date.
Lyophilized form 10% excess of potency with 5 years expiry date.
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 Use:
• Tetanus antitoxin is employed in the diagnostic purpose (40000-
100000 antitoxin units/ml).
• It is used in prophylaxis of tetanus (1500-5000 antitoxin units/ml) IM
or S/C.
• Therapeutic dose is (50000-100000 antitoxin units/ml) IV.

Diphtheria antitoxin:
It is the sterile, non-pyrogenic solution of the refined and concentrated
proteins, chiefly globulins, containing antitoxin antibodies obtained from the
blood serum or plasma of healthy horses that have been immunized against
diphtheria toxin or toxoid. It has the potency of not less than 500 antitoxin
units/ml. It should be stored at the temperature of 2-8oC.The expiry date is 5
years with a 20% excess of potency.
Use:
Diphtheria antitoxin is a passive immunizing agent capable of inducing
passive immunity against diphtheria.
• The usual pro-phylactic dose is (1000-10000 antitoxin units/ml) IV or IM.
• The therapeutic dose is (20000-120000 antitoxin units/ml).

Botulism antitoxin:
It is the sterile, non-pyrogenic solution of the refined and concentrated
proteins, chiefly globulins, containing antitoxin antibodies obtained from the
blood serum or plasma of healthy horses that have been immunized against
the toxins produced by both type A and type B or type E strains of Clostridium
botulinum. The antitoxin contains not more than 20% of solids and should be
stored at the temperature of 2-8oC.The expiry date is 5 years.
Use:
It is classed as a passive immunizing agent to be used in treatment of
botulism 20000 antitoxin units IV repeated at 2-4 hours intervals.

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 Venoms
Definition:
Venoms are poisonous excretions produced by animals usually by reptiles
(snake, scorpion, spider).
They can be compared with the toxic waste products (exotoxins) of bacteria.
Venoms are mostly protein in nature having enzymatic and non-enzymatic toxic
effects. Chemical examination of the poisons of toads have revealed that both
skin and glandular secretions possess toxic substances called bufotoxins. The
chemical structure of bufotoxins are somewhat similar to those of the aglycones
of the cardiac glycosides; in fact the bufotoxins appear to have a similar
pharmacologic effect.
Mostly venoms are obtained from snakes.
• Snake venins or venoms are obtained by holding a poisonous snake over a
conical glass container covered with a sheet of thin rubber.
• The snake strikes the rubber and penetrate it with its fangs, whereupon the
semiliquid venom is ejected into the container.
Uses:
➢ Mixtures of venins from the poisonous snakes are prepared and used in the
preparation of polyvalent antivenins.
The life span of venom is 5 years.

Preparation of antivenins
Venoms are injected to horses for the production of antivenins.
In general, antivenins are prepared in the same manner as antitoxins. The specific
venom is injected into horses in gradually increasing doses until the blood titer
reaches the desired strength. The animal is then bled and the blood serum is
subjected to the required processing.

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Antivenin (Cortalidae) polyvalent:
It is the sterile, non-pyrogenic preparation derived by drying a frozen solution
of specific venom-neutralizing globulins obtained from the serum of healthy
horses immunized against venoms of 4 species of pit vipers Crotalus atrox, C.
adamanteus, C. terrifucus, Bothrops atrox.
It should be protected against exposure to excessive heat. The expiration date for
antivenin polyvalent with a 10% excess of potency is 5 years. It is the passive
immunizing agent used for treating snakebite of the species indicated. The
preferred route of administration is intravenous infusion as a 1:1 to 1:10 dilution
of antivenin in sodium chloride injection or 5% dextrose injection.

Antivenin (Micrurus fulvius):

It is the sterile, non-pyrogenic preparation derived by drying a frozen solution
of specific venom-neutralizing globulins obtained from the serum of healthy
horses immunized against venom of Micrurus fulvius.

Spider-bite antivenin:
Antivenin (Latrodectus mactans) or black widow spider antivenin is prepared
from the serum obtained from horses immunized against venom of black spider.
It is given IM or IV over a 15 minutes period when diluted in 10-50ml of saline
solution.

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 Antiserum
Definition:
Antiserum is a specific biologic employed to provide a supply of ready-made
antibodies to combat diseases. These are globulins that are gained from horses.
The therapeutic effectiveness of antiserum is based on their production of
artificial passive immunity.

Preparation of antiserum
Antiserum are prepared in a manner similar to that for antitoxins and antivenins
except that bacteria or viruses are used to stimulate the production of specific
antibodies like horses. Viral or bacterial cells found in vaccines when introduced
into the animal body in gradually increasing doses and are continued until the
proper antibody titer of the blood serum is achieved.
The destruction of the injected cells by phagocytes liberates antigenic materials
with the subsequent development of corresponding antibodies. Antiserum
against rabies is an example of immunizing agent.

Anti-rabies serum:
It is a sterile non-pyrogenic solution containing antiviral substances obtained
from the blood serum or plasma of healthy horses that has been immunized
against rabies.
Use and dose:
Injection of anti-rabies serum provides the patient with immediate protection
against rabies. It is available in containers of 100 units.
The usual single dose 1000 units/55 pounds of body weight is given IM.

Immune globulins:
Immune globulins are immunizing biologics that contain specific antibodies
derived from the blood of the humans who have been survived an attack of a
specific disease or who have been immunized in some other manner.

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Immune globulins can be obtained from the plasma or serum pool of a large
number of random donors or from a limited number of individuals.

Immune globulin/Immune serum/Gamma globulin:

It is the sterile non-pyrogenic solution of globulins and contains many
antibodies normally present in adult human blood. It has some prophylactic value
in chicken pox, hepatitis A, rubella and other diseases.
Use and dose:
It is a passive immunizing agent. It is also given to treat gamma globulin
deficiency for prevention of recurrent infection.
The dose is based on body weight and varies with the intended use. The usual IM
dose is 0.2ml/kg for measles prophylaxis,0.02ml/kg for prophylaxis against
hepatitis. It is injected IM in a dose of 1.3ml/kg followed in 3 or 4 weeks by
0.66ml/kg to be given every 3-4 weeks.
Immune globulin intravenous provides immediate antibody levels and used in the
treatment of immunodeficiency syndrome. The usual dose is 100-200mg/kg.

Pertussis immune globulin:

It is the sterile non-pyrogenic solution of globulins derived from the blood
plasma of adult human donors who have been immunized with pertussis vaccine.
Use and dose:
It is used in prophylaxis and treatment of pertussis.
The usual IM dose is 1.25-2.5ml repeated in 1 or two weeks as necessary. The
therapeutic dose range is same.

Tetanus immune globulin:

It is the sterile non-pyrogenic solution of globulins derived from the blood
plasma of adult human donors who have been immunized with tetanus toxoid.
It is especially useful for passive immunization against tetanus in an individual
with wounds that may have been contaminated with tetanus micro-organisms.

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Use and dose:
It is used in prophylaxis and treatment of tetanus.
The usual IM prophylactic dose is 250 units as a single injection. The therapeutic
dose range is 3000-6000 units.

Rabies immune globulin:

It is the sterile non-pyrogenic solution of anti-rabies gamma globulin
concentrated by cold alcohol fractionation from plasma of donors
hyperimmunized with rabies vaccine.
Use and dose:
It is recommended that rabies immune globulin be used in combination with
rabies vaccine as the best postexposure prophylaxis.
The usual dose is a single administration of 0.133ml/kg of body weight.

Hepatitis B immune globulin:

It is the sterile non-pyrogenic solution of immunoglobulin prepared from
pooled plasma obtained from donors with high titer of antibody to hepatitis B
surface antigen.
Use and dose:
It is used in prophylaxis postexposure following accidental exposure to hepatitis
B surface antigen.
Injection should be given IM not later than 7 days after exposure and the
recommended dose is 0.06ml/kg of body weight repeated 28-30 days after the
first dose.

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