THE NERVOUS SYSTEM

The nervous system is the most complex and delicate of all the body systems. At the
center of the nervous system is brain. The brain sends and receives messages through
a network of nerves. This network can be explained as similar to road network
The spinal cord is thick bundle of nerves, which runs down the center of the spine.
Along the spinal cord smaller bunches of nerves branch out. From these bundles,
smaller bundles of nerves branch out again. Finally, individual nerves branch out to
every part of the body.
This network of brain allows the brain to communicate with every part of the body.
Nerves transmit information as electrical impulses from area of the body to another.
Some nerves carry information to the brain. This allows us to see, hear, smell, taste and
touch. Other nerves carry information from the brain to the muscles to control our body’s
movement.

NERVOUS SYSTEM

CENTRAL PERIPHERAL

BRAIN SPINAL CORD SOMATIC AUTONOMIC

SYMPATHETIC PARASYMPATHETIC

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The Nervous System is divided into –
• Peripheral nervous system (PNS)
• Central nervous system (CNS)

The PNS consists of –

• Sensory neurons running from stimulus receptors that inform the CNS of the
stimuli.
• Motor neurons running from the CNS to the muscles and glands- called effectors-
that take action.

The PNS is subdivided into the -

• Somatic nervous system and
• Autonomic nervous system

The CNS consists of –

• Spinal cord
• Brain

Somatic nervous system:

The somatic nervous system consist of-
• Peripheral nerve fibers that send sensory information to the central nervous
system
• Motor nerve fibers that project to skeletal muscles.
All our conscious awareness of the external environment and all our motor activity to
cope with it operate through the somatic nervous system.

Autonomic nervous system:

The autonomic nervous system consists of sensory neurons and motor neurons that
run between the central nervous system and various internal organs such as –
• Heart
• Lungs
• Viscera
• Glands (both exocrine & endocrine)
It is responsible for monitoring conditions in the internal environment and bringing about
appropriate changes in them.

The autonomic nervous system has subdivisions-

Sympathetic nervous system
Parasympathetic nervous system.

In peripheral nervous system depending on the impulse transmission neurons are

functionally divided into:
• Sensory (afferent) neuron – carries impulses from sense organs to CNS.
Motor (efferent) neuron – carries impulses from CNS to effector organ.

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 • Cranial neuron – connects the brain with periphery
Spinal neuron – connects the spinal cord with the periphery.
• Somatic neuron – connects the skin or muscle with the CNS
Visceral neuron – connects the internal organs with the CNS.

NEURON

A neuron is a nerve cell, the functional unit of the nervous system.

Structure of neuron:

A neuron has three parts:

• Dendrite: The bushy branching extension of the neuron that receives messages
and conduct impulses from the cell body.
• Cell body/ soma: Contains ribosomes, mitochondria and subcellular parts for the
metabolic work of cells.
• Axon: The extension of a neuron, ending in branching terminal fibers through
which messages are passed on to other neuron, muscles or glands.
Axons are wrapped in a myelin sheath.

Myelin sheath: it is an electrical insulator that serves to speed the conduction of nerve
impulses. Myelin sheath is formed from plasma membranes of specialized glial cells
known as Schwann cells in the PNS and of Oligodendrocytes in CNS.

Node of Ranvier: The myelin insulation does not cover the entire axon. There are
breaks in the wrapping. These breaks are called nodes of ranvier. The distance
between these nodes is between 0.2 & 2mm.
Signals jumping from node to node travel hundreds of times faster than signals
travelling along the surface of the axon. This allows your brain to communicate with
your toes in a few thousands of a second.

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Types of Neuron:
There are 3 types of neurons required to transmit impulses.
• Sensory neuron: Typically have a long dendrite and short axon, and carry
messages from sensory receptors to the CNS.
• Motor neurons: Have a long axon and short dendrites and transmit messages
from the CNS to the muscles or to glands.
• Interneurons: Are found only in the CNS that internally communicate &
intervene between the sensory inputs and motor inputs.

Synapse:
The junction between a nerve cell and another cell is called a synapse. Messages travel
within the neuron as an electrical action potential.
Synaptic cleft: the space between the two cells is known as the synaptic cleft.

Neurotransmitters:
• Are chemical messengers that traverse the synaptic cleft between the neurons.
• Neurotransmitters are stored in small synaptic vesicles clustered at the tip of the
axon.
• When released by sending neuron, neurotransmitters travel across the synapse
and bind to receptor site on the receiving neuron, thereby influencing whether it
will generate a neural impulse.
• Neurotransmitters can be excitatory or inhibitory.
The major neurotransmitters are –
• Dopamine
• Serotonin
• Nor epinephrine (and epinephrine)
• Gamma-amino butyric acid (GABA)

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 • Acetylcholine
IMMUNITY SYSTEM

 The immune system is a complex of organs, all of which work together to clear
infection from the body.

 Located at Blood, Lymph Nodes, Spleen, Liver, Thymus, Bone Marrow, Tonsils,
Lungs and Intestines.

 Absence or improper functioning of Immune system leads to Immunodeficiencies.

 Improper functioning of the Immune System to produce Antibodies against a

human’s own tissues/cells is called Autoimmune disorders.
The Immune System

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 IMMUNITY

ACTIVE PASSIVE

Natural Artificial Natural Artificial

After infection vaccination mother to child IVIG

THE 3 TIER FUNCTION

TIER 1: Physical and chemical barriers through skin and mucus secretions.

TIER 2: Inflammation and blood clotting through Leukocytes and Macrophages.

Leukocytes consists of Neutrophils and Eosinophils.Macrophages are WBC’s which are
phagocytic in nature, present in blood that ingests microbes and antigens.

Blood

Plasma (52-62%) Cells (38-48%)

Water (92%) Protein (7%) RBC WBC Platelets

Albumin Globulin Fibrinogen

(54%) (38%) (7%)

Alpha Beta Gamma

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 WBC

GRANULOCYTES AGRANULOCYTES

LYMPHOCYTE MONOCYTE
EOSINOPHIL NEUTROPHIL
BASOPHIL

B LYMPHOCYTE T LYMPHOCYTE

PLASMA MEMORY MEMORY HELPER KILLER

SUPPRESSOR

3rd TIER

 Consists Lymphocytes.
 Divided into 2 types, the T and B-Lymphocytes.
 T Lymphocytes are the one that mature at the THYMUS.
 B Lymphocytes mature at BONE MARROW

LYMPHOCYTES FROM BONE MARROW

BONE MARROW MATURING THYMUS MATURING

B LYMPHOCYTE T LYMPHOCYTE

T LYMPHOCYTES

 Helper T- Cell Mediated immunity

 Killer T- Inactivate cells carrying antigen
 Suppressor T- Moderates intensity of immunity.
 Memory T- Helps in increasing Killer T, activates Lymphocytes and amplifies
immune response.

B – LYMPHOCYTES 2 Types
Plasma B and Memory B
Plasma B cells produce Antibodies or Immunoglobulins to kill the bacteria/virus,
Promote phagocytosis and form Antigen/Antibody complex.

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Memory B cells for response to another encounter with the same antigen.
HOW IMMUNE SYSTEM WORKS?

 Virus+Macrophage (WBC)=consumes it.

 Displays the pieces of the virus, the antigen on its surface.
 Helper T recognizes the antigen and combines with the macrophage to release
Interleukins, Tumor Necrosis Factor that communicates to Killer T cells to multiply
and plasma B cells to produce Antibodies.
 Killer T cells kills the cells with antigens preventing spreading.
 Meanwhile antibodies produced by B cells binds to antigens and kills them.
 Finally the activated T and B cells are suppressed by the Suppressor T cells.
 Memory B cells carries the memory of the antigen to respond in future to the same
antigen.

ANTIBODY DIAG

ANTIBODY

 Y shaped made of 2 identical light and heavy chains/Highly Antigen Specific.

 2 Parts
Fab--Antigen binding Fragment
Fc--Crystallizing Fragment.
 Depending on the structure of antigen, antibodies with different binding sites are
produced.
 It means IgG.

ABNORMAL IMMUNE REACTIONS

 Sometimes when the immune system malfunctions and the body misinterprets the
body tissues as foreign and attacks them.
 E.g. GBS, ITP, PID, MG Etc.

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Autoimmune Disorders
Autoimmune disorders affect the nervous system. Autoimmune disorders occurs when
body's natural defense mistakenly attacks body's own tissue.
It can affect any part of the nervous system.
Since neurons are affected, conduction capacity of nervous system goes down.
Products like GENEXGLOB, Succimed and Myestin are used in the treatment of
Autoimmune disorders

Neurological Disorders:
CNS - Multiple Sclerosis, Spasticity of skeletal muscles related to spinal cord. PNS -
Guillain Barre Syndrome, CIDP, Multifocal Motor Neuropathy.

Neuromuscular Junctional Disorder:

Myasthenia Gravis

THERAPY CHOICES
 Immuno Suppression--Through Glucocorticosteroids
 Immunosupplementation/Modulation--Through IVIG preparations.
 Plasmapheresis--Cleaning or washing of the whole body fluid to remove the faulty
antibody containing plasma and replace with fresh plasma through centrifugation.
 Physiotherapy

IMMUNOGLOBULINS
 Immunoglobulins (Antibodies) are Proteins produced by Plasma cells which control
immune response by binding with Antigen
 On the basis of structure and biological activity, Immunoglobulins are divided into
IgG, IgM, IgA, IgD and IgE.
 Ig -- Immunoglobulins/Gammaglobulins.
 Used to treat Autoimmune disorders and Primary Immunodeficiencies..

IgG
 Most active Immunoglobulin.
 Monomeric in nature.
 Formed on exposure to antigen.
 Only Ig type to cross placenta.
 Made of two light and two heavy chains of polypeptides.
 Major constituent of IVIG preparations.
IgM
 Cyclic pentamer
 Referred to as polymer also.
 First kind of Immunoglobulin to be produced in an immune response before IgG.
 IgM enriched preparations are also of therapeutic value for some other indications.

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IgA

 Immunoglobulin of Alimentary canal.

 Also found in Respiratory tracts.
 Secreted by Salivary and Respiratory tracts.
 Increase of IgA can cause Respiratory failure.
 Not a preferred ingredient in IVIG preparations.
 Increased IgA is increased RISK.

IgD
 Present very less in human body.
 Major Immunoglobulin on the surface of B-Lymphocytes.
 Plays an important role in Antigen recognition.
 Structure resembles, IgG

IgE
 Present in traces in serum.
 Involved in Anaphylactic and hypersensitivity reaction.
 Links Antigen to mast cells, which release histamine.

MECHANISM OF ACTION

2 TYPES.

1. In ACCQUIRED IMMUNODEFICIENCIES, direct and restores the IgG levels.

2. In AUTOIMMUNE disorders, less clear mechanism, but 4 hypothesis proposed.

In general affects, function and production of Antibodies.

MODE OF ACTION 4 HYPOTHESIS

1. ANTI IDIOTYPE: IVIG antibodies clear the pathogenic antibodies.

2. Fc RECEPTOR BLOCKADE: The Fc part of the malfunctioning Antibody forms a

complex with the IVIG antibody and takes it to Macrophage and is destroyed.

3. CYTOKINE NETWORK: Cytokines are proteins, that modulate immune system,

involving T-lymphocyte. IVIG contains cytokines, which modulates the immune system.

4. INCREASED CATABOLISM: Following high doses of IVIG catabolism increases in

body, so breakdown of pathogenic IgG happens to attain the normal level of IgG in the
body.

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IgG levels / pharmacokinetics

 Minimum desirable: 500mg/Dl.

 Mild to moderate IgG deficiency: 300 -400mg/Dl
 IgG replacement advised when levels < 200mg/Dl.
 Pharmacokinetics: Directly infused by IV route and so 100% bioavailability. Direct
increase of plasma concentration. Maintained in serum.

Autoimmune Disorders

Autoimmune disorders arise when the body’s natural defenses (the immune system)
mistakenly attacks the body’s own tissue. It can affect any part of the nervous system.
Neurons are affected and therefore the conduction capacity of nervous system goes
down

Autoimmune disorders of the nervous system:

Neurological disorders:
CNS: multiple sclerosis, spasticity of skeletal muscles related to spinal cord.
PNS: Guillain Barre Syndrome, CIDP, and, Multifocal Motor Neuropathy.
Neuromuscular junctional diorders: Myasthenia Gravis.

Guillain Barre Syndrome (GBS):

• It is also called Acute Inflammatory Demyelinating Polyneuropathy.

• It is typically characterized by the rapid onset of muscle weakness and often,

paralysis of the legs, arms and breathing muscles takes place.

• The nerves of the GBS patient are attacked by the body's own defense system.
• As a result of this Autoimmune attack, the nerve insulation (myelin) and sometimes
even the covered conducting part of the nerve (axon) are damaged.

• It can strike at any age and both sexes are equally prone to the disorder.

• The syndrome is rare, however, affecting only about one person in 100,000.

• Onset is mostly after viral and bacterial infection.

• OUTCOME: 30 % of affected people may have residual weakness. 3 % suffer from
relapse of muscle weakness.

Chronic Inflammatory Demyelinating Polyneuropathy (CIDP):

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• It is a neurological disorder characterized by slowly progressive weakness and
sensory dysfunction of the legs and arms.

• It is caused by damage to the myelin sheath of the peripheral nerves.

• Although it can occur at any age and in both genders, CIDP is more common in
young adults, and in men more so than women.
• Cause: Idiopathic. 60 % of patients suffer from a throat infection or intestinal
infection, Influenza/ stress symptoms in previous 2 weeks.

• 80 % of patients show total recovery between 3 to 12 months stay & therapy in

hospital.
• Recurrent GBS turns to CIDP.

Multiple sclerosis:

• A disorder of the Central Nervous System (brain and spinal cord), which is
characterized by decreased nerve function due to myelin loss and secondary axonal
damage.
• It is a disease of the “White matter” tissue.
• The white matter is made up of nerve fibers, which are responsible for transmitting
communication signals both internally within the CNS and between the CNS and the
nerves supplying rest of the body.
• In people affected by MS, patches of damage called plaques or lesion appear in
seemingly random areas of the CNS white matter.
• At the site of a lesion, a nerve insulating material, called myelin, is lost.
• Affects mostly women between age 20 and 40.

Multifocal Motor Neuropathy:

It is a progressive muscle disorder characterized by muscle weakness in the hands

• It affects men much more than women.

• An early and accurate diagnosis allows patients to recover quickly.

• More than 80 % patients rapidly improve with high dose of IVIG.

Kawasaki Disease:
• Cause: Idiopathic. (Assumed to start from an infection or from exposure to some
toxins). Some doctors think it may be caused by a virus or bacteria.

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• Occurrence: Children under age 5. 1-2 yr. of age mostly. Asian children are more
prone.
• Most children recover completely.
• Arthritis, meningitis and rarely death is also seen.

Primary Immunodeficiency (PID):

• PID’s are caused by intrinsic defects in the cells of the immune system and are often
caused by inherited genetic defects.

• There are more than 80 PID diseases. Usually inherited.

• Patients with primary Immunodeficiency disorders are susceptible to infections that,

if left untreated, may be fatal.

• The primary immunodeficiencies appear to affect males and females about equally.

• These are sometimes life threatening and complex and vary considerably in nature,
incidence and severity.

• Affected people are sometimes completely unable to fight off infection and have to
have replacement Immunoglobulin therapy and use antibiotics all their lives.

Inflammatory Myopathies:

• A group of muscle diseases involving the inflammation and degeneration of skeletal

muscle tissues.

• They are thought to be autoimmune disorders.

• In Inflammatory Myopathies, inflammatory cells surround, invade, and destroy

normal muscle fibers as though they were defective or foreign to the body. This
eventually results in discernible muscle weakness.

Types Of Myopathies:
1) Dermatomyositis
2) Polymyositis
3) Inclusion Body Myositis.

Dermatomyositis:
• The most easily recognized of the inflammatory myopathies due to its distinctive
rash. T- cell attacks the muscle fiber.

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• Rash occurs as a patchy, dusky, reddish rash on the eyelids, cheeks, and bridge of
the nose, and on the back or upper chest, elbows, knees and knuckles followed by
muscle weakness.
Myasthenia Gravis:

Epidemiology and etiology:

In Latin Myasthenia Gravis (MG) means grave muscle weakness. MG is a relatively

uncommon disease, affecting only 1 in 25,000. There is a bimodal incidence, with
women in their teens and early 20's and men in their 40's to 50's being most commonly
affected. The overall female to male ratio is approximately 3:2.
• MG is an autoimmune disease in which antibodies are formed against the
neuromuscular junction. Acetylcholine travels through the neuromuscular junction
and binds to acetylcholine receptors, which are activated and generate a muscle
contraction.

• In MG, faulty antibodies block, alter, or destroy the acetylcholine receptors at the
neuromuscular junction which prevents the muscle contraction from occurring
• These antibodies are produced by the body's own immune system. Thus, MG is an
autoimmune disease.

These autoantibodies cause disease via two mechanisms:

1) A decrease in functional Acetylcholine (Ach-R) receptor due to competitive inhibition,

2) Destruction of ACh-R due to autoantibody binding and subsequent complement

mediated reaction. These autoantibodies can be measured in the serum, and while
useful in diagnosing disease presence, they correlate poorly with disease severity
and therefore not routinely used to guide decisions in therapy. Instead, clinical exam
findings and resistance to drug regimens are most often used as markers of disease
severity.

Signs and Symptoms:

In early stages MG primarily affects muscles that control eye movement (extraocular
muscles) and those that control facial expression, chewing and swallowing. If untreated,
the disorder may affect muscles that control breathing (respiration), causing acute
respiratory failure (myasthenia crisis).

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Normal neuromuscular junction versus neuromuscular junction in MG

Types of MG:

MG can be classified according to which skeletal muscles are affected

1) Generalized MG: weakness in the trunk arms and legs.
2) Ocular MG: weakness in muscles that control eye movement.
3) Congenital MG: develops at or shortly after birth and causes generalized
symptoms.
4) Transient neonatal MG: is a temporary condition that develops in 10-205 of
infants born to mothers who have MG.

Treatment of MG:
MG is the most treatable neuromuscular disorder. The choice of treatment depends on
several factors, including, age, overall health, severity of disease, and rate of disease
progression.

Medications:
Anticholinesterase medications such as neostigmine and pyridostigmine usually
prescribed. These drugs prevent ACh destruction and increase the accumulation of ACh
at neuromuscular junctions, improving the ability of the muscles to contract.
Side effects include excessive salivation, involuntary muscle twitching (fasciculation),
abdominal pain, nausea, and diarrhea. A drug called kaolin may be used with
anticholinesterase medications to reduce gastrointestinal side effects.

Corticosteroids (e.g., prednisone) suppress the antibodies that block AChR at the
neuromuscular junction and may be used in conjunction with anticholinesterase.
Corticosteroids improve symptoms within a few weeks and once improvement
stabilizes, the dose is slowly decreased.
A low dosage may be used indefinitely to treat MG; however,
Side effects such as gastric ulcers, osteoporosis (bone thinning), weight gain, high
blood sugar (hyperglycemia), and increased risk for infection may develop over the long
term.
Immunosuppressants such as azathioprine and cyclophosphamide are used to treat
generalized MG when other medications fail to reduce symptoms.

15
Side effects may be severe and include low white blood cell count (leukopenia), liver
dysfunction, nausea, vomiting, and hair loss.
Immunosuppressants are not used to treat congenital MG because this condition is not
the result of an immune system malfunction.

Other Treatments
Plasmapheresis, or plasma exchange, is used to modify the immune system
malfunction. It can be used to treat severe worsening of symptoms (exacerbations) or in
preparation for surgery (thymectomy).
In this procedure, blood is removed from the body and blood cells are separated from
the liquid portion of the blood (plasma). Then, AChR antibodies are removed and blood
cells are diluted with artificial plasma (usually a solution of saline and sterilized human
albumin protein) and infused back into the body.
Typically, 2 to 3 liters of plasma is removed and replaced during a single treatment,
which takes several hours. Most patients undergo several sessions over the course of 2
weeks or more. Plasmapheresis improves MG symptoms within days and improvement
lasts 6–8 weeks.
Risks include low blood pressure, dizziness, blurred vision, and formation of blood clots
(thrombosis).
Thymectomy is surgical removal of the thymus gland. It is usually performed on
patients with a tumor of the thymus (thymoma) and patients younger than age 55 with
generalized MG. Benefits of Thymectomy develop gradually and most improvement
occurs years after the procedure is performed.

Prognosis
Symptoms of myasthenia gravis usually progress to maximum severity within 3 years.
After 3 years, patients usually stabilize or improve. Infants with transient neonatal MG
may develop acute respiratory failure within a few weeks after birth.
Advances in medical care have reduced the mortality rate from respiratory failure in MG
patients to approximately 3%. Patients over the age of 40, those with a short history of
severe disease and those with thymoma have a worse prognosis.

Prevention
Myasthenia gravis cannot be prevented, but avoiding the following triggers may help
patients prevent exacerbations:
• Emotional stress
• Exposure to extreme temperatures
• Fever
• Illness (e.g., respiratory infection, pneumonia, tooth abscess)
• Low levels of potassium in the blood (hypokalemia; caused by diuretics, frequent
vomiting)
• Medications (e.g., muscle relaxants, anticonvulsants, certain antibiotics)
• Overexertion

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 GENEXGLOB

• Human Immunoglobulin (pH4) for Intravenous Injection

• 1gm/20ml, 2.5g/50ml, 5.0g/100ml.

• Maltose base.

• The truly next generation IVIG

• When it comes to IVIG Nobody knows purity as we do.

Now also Australian patented.

CONVENTIONAL MANUFACTURING

SOLVENT DETERGENT: Not sufficiently effective against non-lipid-enveloped viruses

such as HAV, B19 (Parvovirus).

ETHANOL FRACTIONATION: Inactivation is virus specific. Inadequate to remove HCV.

GENEXGLOB incorporates a combination of processes that ensures a preparation of
utmost purity patented in US and Australia.

PURIFICATION PROCESSES

 12 purification processes
 2 Viral inactivation steps
 7 viral elimination processes.
 Eliminates even trace virus and viral sub proteins unlike conventional processes.
 The double viral inactivation techniques are Pasteurisation and Low pH method.

VIRAL INACTIVATION

PASTEURISATION: Maintaining 60 deg C for 10 Hrs.

Low pH method: Incubation for 21 days at low pH 4.0

Two methods are the superior most in the existing viral inactivation techniques.
The unique manufacturing processes results in the safest and purest IVIG.

SURPASSING STANDARDS
 According to BP any IVIG should have >95% IgG, But GENEXGLOB has 100%
IgG.

17
 >90% should be the Monomer/Dimer content according to BP, but GENEXGLOB
has 100% Monomer/Dimer content.
 Total protein content according to BP should be > 30G/L, But GENEXGLOB has
53.6 G/L protein content.

PRESERVATIVES

 GENEXGLOB is a preservative free preparation.

 Sometimes preservatives are found to protect potentially dangerous viral proteins.
 Preservative free preparations are safer at higher doses.

UNIQUE SELLING POINTS

 Developed by a revolutionary new technology, patented in USA and in Australia.

 Human beings can produce 18 billion different antibodies.
Minimum 10,000 donors required to produce plasma with 90% antibody variety.
 DONOR SELECTION: 10,600 healthy volunteers, screened as per WHO norms,
including screening after window period.
 Plasmapheresis is completely automatic and is done in collaboration with Baxter -
USA.
 Plasma pooling and storage is done according to European standards.
 Extra screening of pooled plasma is done to eliminate potentially dangerous
contaminants.
 These are stringent donor selection, plasma collection and pooling methods.
 IVIG of the highest purity--99.9% IgG and so better efficacy.
 Only IVIG brand in the market to offer least IgA 0.1% or just 5 mcg/ml.
 Stable at room temperature for 24 months. But recommended storage is between 2
to 8’C.
 Ready to use solution saves dissolution time
 Ready to use solution prevents polymerization
 Certified by GMP--Good Manufacturing Practices.
 Certified by ISO 9002--International Organization for Standards.
 Certified by BPCR--Blood Products Control Regulation.
 In all stages from plasma collection to finished products
 EXTENDED PATIENT COMPLIANCE: because
 Processed at low pH 4.0 Prevents aggregation and ideal for patients with acid/base
problems.
 No anti-complementary activity and so no danger of serum sickness.
 Processed at low pKa levels and so no risk of hypotension.
 Sucrose free base ideal for patients with diabetes and renal impairment
 One piece-moulded ready to hang glass vial offers ease of administration, saves
time and prevents breakage due to slipping.
 Collaboration with Baxter for plasma collection, Fuji for ultra filtration and Bosch for
automatic filling

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LABELLED INDICATIONS IN INDIA

 Primary Immunodeficiencies.
 Kawasaki Syndrome.
 Idiopathic Thrombocytopenic Purpura.
 Bone Marrow Transplantation.
 Chronic B cells Lymphocytic Leukemia.
 Pediatric HIV 1 infection.

DOSAGE

GBS: 400mg/Kg/daily/5 days.

MS: 400mg/Kg/daily/5 days.
ITP: 400mg/Kg/daily/5 days.
Kawasaki Syndrome: 400mg/Kg/day/5 days.
PID: 100-200 upto 400mg/Kg/month for 4 months.
Pediatric HIV: 400mg/kg/every 28 days.
Empirical Dose: 2G/Kg
Maintenance dose: 800-1000mg/Kg/2-6 weeks

ADMINISTRATION

IV/IM route
GENEXGLOB is administered by only IV route.
Infusion rate: 0.01 to 0.02 ml/kgBwt/Min for 30 min. If well tolerated increase upto 0.08
ml/kg/min.
Infused through separate line.
Not compatible with saline.
5% Dextrose can be used.

CONTRAINDICATIONS / DRUG INTERACTIONS

 Contraindicated in Patients who have had anaphylactic reactions

 Contraindicated in Patients with IgA deficiencies.
 Antibodies may interfere with response to live attenuated virus vaccines such as
measles, mumps, rubella and varicella. So such vaccines should be administered
atleast after the last administration of IVIG

TARGET CUSTOMERS

 Neurologists

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 Pediatric Neurologists
 Infectious specialists
 Burns units
 Intensivists
 Physicians
 Dermatologists
 Rheumatologists

MYTHS AND FACTS

 GENEXGLOB is not FDA approved, it is USA patented.

 This unique process of manufacturing is patented and cannot be copied by any other
manufacturer.
 Protein content is close to 100% and Monomer, Dimer content is 100%.
 IgG is Monomer.
 IgA is Dimer.
 Baxter, Fuji and Bosch are employed in the manufacturing of GENEXGLOB as they
are leaders in plasma collection, filtration and filling processes.
 GMP, ISO and BPCR are the certifications that we have received.
 We follow WHO norms for selecting the donors and European standards for storage
of the pooled plasma.

RIVALS

NORGLOBIN / CLARIS:

 98% IgG content

 IgA present but not quantified
 Source is China.
 Base: 10% Maltose.
 Single viral inactivation by pH method.
 Protein content is 98%

GAMMA IV / BSV

 Protein content 98% ready to use.

 Not less than 90% of it is Monomer.
 Traces of IgA, IgM are present.
 Sub-Packed in India.
 IgA 2mg/Ml
 Single viral inactivation by pH method.
 KOREAN SOURCE
 Maltose base.

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VERGLOB / SUN

 90 % IgG
 Manufactured by Ethanol Fractionation.
 Lyophilised/Chances of trace virus survival.
 Dextrose 50% base.
 Single viral inactivation by PEG treatment.
 % IgA /IgM data not available.
 KOREAN SOURCE.

OTHERS

 Octagam from Octapharma

 Intraglobin F from Biotest
 Endobulin from Baxter
 Other companies like Wockhardt, and other MNC players expected to enter the field
within next 6 months.OBJECTIONS AND SOLUTIONS

OBJECTIONS AND SOLUTIONS

 USFDA Approved? NO BUT USA AND AUSTRALIAN PATENTED. Patency
includes the passing the tests of the pharmacopeia of those countries.
 I USE QUALITY PRODUCTS? We follow 12/7/2 viral inactivation and purification
techniques/certified by ISO, GMP and BPCR/donor selection is according to WHO
standards/Storage according to European standards/only brand with 99.9% IgG in
Market.
 Donor pool? Our donor pool is from China. But ours is the only product that follows
WHO guidelines for donor selection.
 Double screening of the plasma is done for safety. 12/7/2 viral safety methods.
 Asian immunity is considered to be the first of its quality in the international varieties
because the profile consists a broad variety of IgG for the best immunity.

 IVIG preparations cause renal impairment or Nephrotoxicity?

 GENEXGLOB does not cause any such effects because GENEXGLOB is

SUCROSE FREE.
 Sucrose causes Nephrotoxicity. It was the text book brand that has led to this
confusion.
 GENEXGLOB has Maltose base and so absolutely no chances of Nephrotoxicity.
SAFER IN-PATIENTS WITH DIABETES AND RENAL COMPROMISE.

 PRESERVATIVE FREE?

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 GENEXGLOB follows such a stringent manufacturing process that makes it possible
to be presented without a preservative. Also safer for patients at higher doses.
 12/7/2 viral purification processes ensures utmost purity and stability.
 Also preservatives are sometimes found to protect potentially dangerous viral
contaminants.

COMPARISON
Corticosteroids suppress the immune system by masking the production of faulty
antibodies and so the damage is reduced.

Cost of therapy less when compared to IVIG.

Other infections may not show up and may be dangerous since the antigen*antibody
reaction is suppressed by these agents.

PLASMAPHERESIS: Fluid part of the blood, plasma is removed through cell separator,
cells injected back with fresh normal plasma into the body and the plasma containing
faulty antibodies is discarded.

An anticoagulant is also used.

Similar to the procedure of Dialysis.

Risks/Disadvantages: Time consuming, Catheter puncture, Risk of infections, Profuse

bleeding, Hypotension, abdominal cramps.

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