BIOLOGICS

CONTENTS:
ANTITOXINS
VENOMS AND ANTIVENINS
ANTISERUMS
IMMUNE GLOBULINS
BIOLOGICS RELATED TO

HUMAN BLOOD

PRECAUTION

No antitoxin, antivenin, or antiserum prepared

from horse serum should be given without
careful inquiring on patients prior exposure to
horse serum or hypersensitivity reaction when in
proximity to horses.
Have a syringe of epinephrine injection (1:1000)
and a tourniquet available before administration
Perform sensitivity tests:
Skin test 0.02mL of 1:100 dilution of the
product
Eye test- a drop of 1:100 dilution of the
product into the conjunctival sac

ANTITOXINS

Prepared from

the blood of animals that

have been immunized by repeated
injections of specific bacterial exotoxins
2 methods of preparation:

Precipitations using varying

concentrations of ammonium sulfate

Utilization of pepsin solution

Standardized in terms of antitoxin units.

ANTITOXINS
DIPHTHERIA ANTITOXIN
TETANUS ANTITOXIN
BOTULISM ANTITOXIN

DIPHTHERIA

Diphtheria (Greek (diphthera)pair of

leather scrolls")
an upper respiratory tract illness characterized
by sore throat, low fever, and an adherent
membrane (a pseudomembrane) on the tonsils,
pharynx, and/or nasal cavity.
A milder form of diphtheria can be restricted to
the skin.
Causative agent: Corynebacterium diphtheriae (
aerobic Gram-positive bacterium)
A contagious disease spread by direct physical
contact or breathing the aerosolized secretions
of infected individuals.

DIPHTHERIA

DIPHTHERIA ANTITOXIN
A sterile, non-pyrogenic soln of the refined

and conc. proteins, chiefly globulins,

containing antitoxic antibodies obtained
from the blood serum or plasma of healthy
horses that have been immunized against
diphtheria toxin or toxoid.
Potency: NLT 500 antitoxin units per mL
Storage: 2-5C
Exp date: not later than 5 years

DIPHTHERIA ANTITOXIN

Passive immunizing agent against diphtheria

Curative agent
Prophylactic dose:

Therapeutic dose:

1000 to 10,000 units (IV/IM)

20,000 to 120,000 units

Added contents:

0.22% phenol (preservative)

Sodium chloride
Other horse proteins

TETANUS
Also called

lockjaw
A medical condition characterized by a
prolonged contraction of skeletal muscle
fibers.
Causative agent: Clostridium tetani
(Gram-positive, obligate anaerobic
bacterium )
Toxin: tetanospasmin

An infant suffering from neonatal

tetanus

Lock-jaw in a patient suffering from

tetanus

TETANUS ANTITOXIN
A sterile, non-pyrogenic soln of the refined

and conc. 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.
Potency: NLT 400 antitoxin units
Storage: 2-8C
Exp date: not later than 5 years

TETANUS ANTITOXIN
Employed in the treatment and

prophylaxis of tetanus.
Passive immunizing agent for the
treatment of tetanus

For those who had two or less injections of

tetanus toxoid and;
Those who had tetanus-prone injuries that are
more than 24 hours old.

Curative agent

TETANUS ANTITOXIN

Prophylactic dose:

Therapeutic dose:

1,500 to 5,000 units (IM/SC)

50,000 to 100,000 or more with at least part of the
dose given IV

Added contents:

30 to 50 mmol/L phenol or 30 mmol/L tricresol

(preservatives)
Sodium chloride
Glycerol (stabilizer)

BOTULISM
comes from

the Latin botulus, meaning

sausage
neuroparalytic illness resulting from the
action of a potent toxin produced by
Clostridium botulinum

BOTULISM ANTITOXIN
A sterile, non-pyrogenic

soln of the refined

and conc. proteins, chiefly globulins,
containing antitoxic antibodies obtained from
the blood serum or plasma of healthy horses
that have been immunized against the toxins
produced by both the type A and B and/ or
type E strains of Clostridium botulinum.
Contains NMT 20% of solids
Potency: NLT 400 antitoxin units
Storage: 2-8C
Exp date: not later than 5 years

BOTULISM ANTITOXIN
Multivalent antitoxin
Classed as a passive immunizing agent

for the treatment of botulism

Dose: 20,000 units IV at 2-4 hr intervals,
as necessary
Not available commercially but can be
obtained from the Centers for Disease
Control (CDC)

VENOMS AND ANTIVENINS

Venoms

Poisonous excretions produced by animals

Snake venins or venoms

Obtained by holding a poisonous snake over a

colonical glass container covered with a sheet
of thin rubbber

Polyvalent antivenins (Anti-snakebite

serums)

Mixtures of venins from poisonous snakes of a

locality, country, or continent

VENOMS AND ANTIVENINS

ANTIVENIN (Crotalidae) POLYVALENT

ANTIVENIN (Micrurus fulvius)

SPIDER- BITE ANTIVENIN

NOTE:
The location of antivenins for rare species and names
and telephone numbers of experts on venomous bites
can be obtained at any hour from the OKLAHOMA CITY
POISON CONTROL CENTER

Milking a snake for the production

of antivenom

ANTIVENIN (CROTALIDAE)
POLYVALENT
North and South American anti-

snakebite serum
A sterile, non-pyrogenic prepn
derived by drying a frozen soln of
specific venom- neutralizing globulins
obtained from the serum of healthy
horses immunized against venoms of
4 spp of pit vipers

ANTIVENIN (CROTALIDAE)
POLYVALENT

Pit vipers:

Crotalus atrox (Western diamondback)

C. adamanteus (Florida diamondback)

C. durissus terrificus (South American

rattlesnake)

Bothrops atrox (South American fer-de-lance)

Standardized by biologic assay on mice in terms
of venom neutralization.
Storage: Protect from exposure to excessive heat

ANTIVENIN (CROTALIDAE)
POLYVALENT
Exp date: with 10% excess of potency, not

more than 5 years after the date of issue

Passive immunizing agent used for
treating snakebite of the Crotalidae
species
Preferred route of admin: IV infusion

1:1 to 1:10 dilution of antivenin in NaCl

injection or 5% dextrose injection
Pregnancy Risk Factor: C

ANTIVENIN (CROTALIDAE)
POLYVALENT
Should be used within 4-6 hours of

snakebite
Should not be taken with blood thinners
(ASA)
Added contents:

Thimerosal, phenol
Papain, chymopapain, bromelain (OVANEfrom sheep plasma)

Crotalus atrox (Western

diamondback)

Crotalus adamanteus (Florida

diamondback)

Crotalus durissus terrificus (South

American rattlesnake)

Bothrops atrox (South American

fer-de-lance)

ANTIVENIN (Micrurus fulvius)

North American coral snake antivenin

A sterile, non-pyrogenic prepn derived by drying
a frozen soln of specific venom- neutralizing
globulins obtained from the serum of healthy
horses immunized with the venum of Micrurus
fulvius, the EASTERN CORAL SNAKE
Also neutralizes the venom of M. fulvius tenere
(Texas coral snake) but NOT the venom of
Micruriodes euryxanthus (Arizona or Sonoran
coral snake)

ANTIVENIN (Micrurus fulvius)

Added contents:

0.25% phenol and 0.005% thimerosal

DRUG INTERACTIONS:

Beta-blockers: May increase severity of

anaphylaxis.
Opioid analgesics: Use of morphine and
other narcotics which depress respiration are
contraindicated.
Sedatives: Use with extreme caution.

Micruroides euryxanthus (Arizona

or Sonoran coral snake)

SPIDER-BITE ANTIVENIN
Antivenin

(Latrodectus mactans) or black

widow spider antivenin
Prepared from the serum obtained from
horses immunized against the venom of
the black widow spider
Available in lyophilized form
Recommended as specific treatment of
the effects of venom from the black widow
spider bites.

SPIDER-BITE ANTIVENIN
Thimerosal (mercury derivative) 1:10,000

is added as a preservative
May be given IM/IV over a 15 min period
when diluted in 10 to 15 mL of saline
solution

(Latrodectus mactans) or Black

widow spider antivenin

ANTISERUMS
Biologics prepared in the manner similar

to that for antitoxins and antivenins except

that bacteria or viruses are used to
stimulate the production of specific
antibodies in a healthy animal
Therapeutic effectiveness of antiserums is
based on their production of artificial
passive immunity

ANTIRABIES SERUM
A sterile, nonpyrogenic solution containing

antiviral substances obtained from the

blood serum or plasma of a healthy horse
that has been immunized against rabies
by means of a vaccine
Provides immediate protection against
rabies
Exp date: not later than two years after the
date of manufacture

ANTIRABIES SERUM
Available in containers of 1000 units
Usual single dose:

NLT 1000 units/55 lb of body weight (IM)

IMMUNE GLOBULINS
Immunizing biologics that contain specific

antibodies derived from the blood of

humans who have survived an attack of a
specific disease or who have been
immunized in some other manner
May be obtained from the plasma or
serum pool of a large number of donors or
from a limited number of individuals who
have been hyperimmunized against a
specific antigenic material

IMMUNE GLOBULINS
Storage: 2-8C
Exp date: NMT 3 years after the date of

issue
Offer rapid protection (artificial passive
immunity)
Administered intramuscularly
Live virus vaccinations should be
administered 2 wk. before or 3 mo. after
immune globulin admin

IMMUNE GLOBULINS
IMMUNE GLOBULIN INTRAMUSCULAR
IMMUNE GLOBULIN INTRAVENOUS
PERTUSSIS IMMUNE GLOBULIN
TETANUS

IMMUNE GLOBULIN
RABIES IMMUNE GLOBULIN
HEPA B IMMUNE GLOBULIN
VARICELLA- ZOSTER IMMUNE
GLOBULIN
RH0(D) IMMUNE GLOBULIN
LYMPHOCYTE IMMUNE GLOBULIN

IMMUNE GLOBULIN
Immune serum globulin (human), Immune

globular intramuscular, or Gamma

globulins
A sterile, nonpyrogenic soln of globulins
and contains many antibodies normally
present in adult human blood
Prepared by pooling approx equal
amounts of material from at least 1000
individuals

IMMUNE GLOBULIN
INTRAMUSCULAR
Passive
immunizing agent
Measles prophylaxis: 0.2 mL/ kg
Hepa A prophylaxis: 0.02 mL/ kg
Given to treat immune globulin deficiency

for the prevention of recurrent infection

1.3 mL/ kg followed in 3 to 4 weeks by

0.66 mL/kg, to be given every 3 to 4
weeks

IMMUNE GLOBULIN
INTRAVENOUS
(IGIV)
Provides immediate antibody levels
whereas intramuscular administration
involves a 2 to 5 day delay before
adequate serum levels are attained
Used in the treatment of
immunodeficiency syndrome
Usual dose:

100 to 200 mg/ kg once a month (IV)

PERTUSSIS IMMUNE
GLOBULIN
Pertussis immune
globulin (human)

A sterile, nonpyrogenic soln of globulins derived

from the blood plasma of adult human donors
who have previously been immunized with
pertussis vaccine
Used in the prophylaxis and treatment of
pertussis
Prophylactic dose:

1.25 to 2.5 mL, repeated in 1 or 2 weeks as

necessary (IM); therapeutic: repeated in 1 or 2 days

TETANUS IMMUNE
GLOBULIN
Tetanus immune
globulin (human)

Sterile, nonpyrogenic soln of globulins derived

from the blood plasma of adult human donors
who have been immunized with tetanus toxoid
Passive immunizing agent against tetanus for
individuals with wounds that may have been
contaminated with tetanus microorg
Intended particularly for persons who have not
previously received tetanus toxoid for active
immunization

TETANUS IMMUNE
GLOBULIN
Employed in
the prophylaxis and
treatment of tetanus
Usual prophylactic dose:

250 units as a single injection

Therapeutic dose range:

3000 to 6000 units

RABIES IMMUNE
GLOBULIN
Sterile, nonpyrogenic
soln of antirabies

gamma globulin concentrated by cold

alcohol fractionation from plasma of donors
hyperimmunized with rabies vaccine
Indicated for rapid passive protection
against rabies in persons suspected of
exposure to rabies
Immunity to rabies develops approximately
one week after administration

RABIES IMMUNE
GLOBULIN
Recommended
to be used in combination
with rabies vaccine as best postexposure
prophylaxis
Usual dose: 0.133mL/ kg of body weight at
the time of the first vaccine dose

HEPA B IMMUNE
GLOBULIN
Sterile, nonpyrogenic
soln of
immunoglobulin prepared from pooled
plasma obtained from donors with high
titers of antibody to hepatitis B surface
(HBs) antigen
Indicated for postexposure prophylaxis
following accidental exposure to hepatitis
B surface antigen

HEPA B IMMUNE
GLOBULIN
Injections should
be given intramuscularly
not later than 7 days after exposure
Recommended dose:

0.06 mL/ kg, repeated 28 to 30 days after the

first dose.

VARICELLA- ZOSTER
IMMUNE
GLOBULIN
The
fraction of human plasma, primarily
immunoglobulin G, found in routine
screening of normal volunteer blood
donors
It has its greatest effectiveness when
administered within 96 hours of exposure
to the varicella virus
Its use is restricted to susceptible
immunodeficient individuals

VARICELLA- ZOSTER
IMMUNE
GLOBULIN
Dose range:
125 units/ kg of body weight up to a
maximum

Up to a maximum of 625 units

administered by deep IM injection in the
gluteal muscle or in another large
muscle mass

RH0 (D) IMMUNE

GLOBULIN
Sterile, nonpyrogenic
concentrated soln of

globulins derived from human blood plasma

containing antibody to the erythrocyte factor RH 0
(D)
Recommended for admin to unsensitized RH0negative women who give birth to RH0 (D) or
Du- positive infants
Administered within 72 hr of Rh- incompatible
delivery, miscarriage, abortion, or transfusion

RH0 (D) IMMUNE

GLOBULIN
Usual dose:
300mcg of antibody(1 vial),
IM
Neutralizes any antigen introduced into
the mother
Prevents sensitization

LYMPHOCYTE IMMUNE
GLOBULIN

Antithymocyte globulin (equine)

Lymphocyte selective immunosuppressant

Prepared by immunizing horses with

thymus cells and then isolating the equine

gamma globulin
Indicated for use in organ transplant
Usual adult dose: 10 to 30 mg per kg a
day, intravenous infusion

BIOLOGICS RELATED TO
HUMAN
BLOOD
WHOLE BLOOD

WHOLE BLOOD
RED BLOOD CELLS
ANTIHEMOPHILIC DERIVATIVES

ALBUMIN HUMAN
PLASMA PROTEIN FRACTION
RADIO- IODINATED SERUM ALBUMINS

ANTIHEMOPHILIC FACTOR
ANTIHEMOPHILIC FACTOR IX COMPLEX

IODINATED 125I ALBUMIN INJECTION

IODINATED 131I ALBUMIN INJECTION

THROMBIN

WHOLE BLOOD

Whole blood (human)

Blood that has been withdrawn from a selected
donor under rigid aseptic conditions
Store at a constant temp of between 1-6C
Exp date:

21 days after the date of bleeding

(Anticoagulant:citrate dextrose soln or citrate
phosphate dextrose soln)
35 days after the date of bleeding (Anticoagulant:
citrate phosphate dextrose adenine soln)
48 days after the date of bleeding( anticoagulant:
heparin)

WHOLE BLOOD
Used as a blood replenisher
Administered intravenously, usu in a

volume of 1 unit or 500mL, as necessary

RED BLOOD CELLS

Whole blood from

which plasma has been

removed
Prepared any time during the dating
period of the whole blood
Derived by centrifugation or undisturbed
sedimentation
Contains a portion of the plasma sufficient
to ensure optimal cell preservation

RED BLOOD CELLS

Contains cryophylactic substance if it is

used for extended manufacturers storage

at - 65C or colder
Exp date:

Frozen RBC- not later than that of the whole

blood
Frozen RBC stored at - 65C or colder- not
later than 3 years after the date of collection

RED BLOOD CELLS

Used as blood replenisher
Particularly useful in cases of anemia

when additional volume of plasma is

undesirable
Usual dose: I unit of whole blood

ANTIHEMOPHILIC
DERIVATIVES

Available for control of two types of

hemophilia
Available in a lyophilized form and are
standardized for antihemophilic properties
Administered intravenously
Offer an advantage of reducing the
volume of fluid that must be injected

ANTIHEMOPHILIC FACTOR

Sterile, freeze-dried concentrate of human

antihemophilic factor (prepared from the factor
VIII- rich cryoprotein fraction of human venous
plasma)
For use in therapy of hemophilia A (Classic
hemophilia) by accelerating the abnormally slow
clotting time
Stored at temp bet 2-8C
Exp date: not later than 1 or 2 years from the
date of manufacture or date of issue

ANTIHEMOPHILIC FACTOR
Dose: 10-20 AHF units per kg of body

weight, 1 to 2 times a day, IV

1 AHF unit- activity present in 1mL of
normal pooled human plasma less than 1
hour old

ANTIHEMOPHILIC FACTOR IX
COMPLEX

Dried plasma fraction comprising

coagulation factors:

IX (plasma thromboplastin component)

II (prothrombin)
VII (proconvertin)
X (Stuart- Prower factor)

ANTIHEMOPHILIC FACTOR IX
COMPLEX

Indicated to prevent dangerous bleeding

episode or to perform surgery whenever

one or more of these specific coagulation
factors is absent in the blood of the patient
Dose depends on the patient and the
circumstances

ALBUMIN HUMAN
Normal Serum Albumin (Human)
Sterile, non- pyrogenic prepn of serum

albumin obtained by fractionating

materials from healthy, human donors.
Tested for the absence of Hepa B surface
antigen
NLT 96% of its total protein is albumin
25g of serum albumin per 100mL,
osmotically equiv to 500mL

ALBUMIN HUMAN
5g equiv to 100mL, of normal human

plasma
Blood volume supporter
Usual dose: vol equiv to 25g of albumin,
IV

PLASMA PROTEIN FRACTION

Plasma Protein Fraction (Human)
Sterile soln of selected CHON derived by

fractionating material from healthy human

donors
Tested for the absence of Hepa B surface
antigen
Contains NLT 4.5g and NMT 5.5g CHON
per 100mL

NLT 83% is albumin

NMT 17% is alpha and beta globulins

PLASMA PROTEIN FRACTION

Blood volume supporter
Usual dose: 250 to 500 mL by IV infusion

at a rate not exceeding 10mL per minute

RADIO- IODINATED SERUM

ALBUMINS

Preparations containing serum

albumin
that has been iodinated using mild
conditions with either 125I or 131I
Iodination is controlled to introduce not
more than 1 gram- atom of iodine for each
gram- molecule (60,000g) of albumin
Sterile, buffered, isotonic solutions
prepared to contain NLT 10mg of radioiodinated normal human albumin per mL

RADIO- IODINATED SERUM

ALBUMINS

Must be labeled to indicate the

radioactivity expressed in microcuries or

millicuries per mL, at a specified time

RADIO- IODINATED SERUM

ALBUMINS
Iodinated 125I
albumin injection

Iodinated 131I albumin

injection

USE

Diagnostic aid for

determining blood
vol and cardiac
output

Diagnostic aid
for determining blood
vol and cardiac
output

Usual dose

5 microcuries IV

5 microcuries IV

Radioactive
half- life (days)

60

8.08 days

Exp date (days)

120

30

THROMBIN
Sterile protein substance prepared from

prothrombin of bovine origin through

interaction with added thromboplastin in
the presence of calcium
Activity is expressed in units
Available as lyophilized solid
Exp date: NMT 3 years
Should be used within a few hours after
preparation

THROMBIN
Local haemostatic
Applied topically
Useful for dental surgery, laryngeal and

nasal surgery, plastic surgery and skin

grafting procedures
May be applied as:

Powder
Soln ( 100- 2000 NIH units per mL in NaCl
irrigation or SWFI)