Description of Sera and Immunoglobulin – PST04211 Basic Pharmacology

NTA Level 4 • Semester 2 • PST04211

Description of Sera and Immunoglobulin

Basic Pharmacology • Source Session/Topic 45
Full source-text version: all educational wording from the extracted learning source is retained; only presenter/tutor metadata and web-layout noise are removed, while formatting is improved for readability.

Session 45: Description of Sera and Immunoglobulin

Total Session Time: 120 minutes

Prerequisites

• None

Learning Tasks

By the end of this session students are expected to be able to:

• List indications of Sera and Immunoglobulin
• List Contraindication of Sera and Immunoglobulin
• Describe dose, dosage and course of Sera and Immunoglobulin
• List side effects and adverse effects of Sera and Immunoglobulin
• Describe interaction and precaution of Sera and Immunoglobulin

Resources Needed:

• Flip charts, marker pens, and masking tape
• Black/white board and chalk/whiteboard markers
• Computer and projector
• Handout 32.1: Management of rabies for exposed individuals

SESSION OVERVIEW

Activity/

Step Time Content

Method

1 05 minutes Presentation Introduction, Learning Tasks

Presentation/

2 20 minutes Indications of Sera and Immunoglobulin

Buzzing

Presentation/

3 10 minutes Contraindication of Sera and Immunoglobulin

brainstorming

Dose, Dosage and Course of Sera and

4 40 minutes Presentation

Immunoglobulin

Presentation/ Side Effects and Adverse Effects of Sera and

5 20 minutes

brainstorming Immunoglobulin

Interaction and Precaution of Sera and

6 05minutes Presentation

Immunoglobulin

7 10 minutes Presentation Key Points

8 10 minutes Presentation Evaluation

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SESSION CONTENTS

STEP 1: Presentation of Session Title and Learning Tasks (5 minutes)

READ or ASK students to read the learning tasks and clarify

ASK students if they have any questions before continuing.

STEP 2: Indications of Sera and Immunoglobulin (20 minutes)

Activity: Buzzing (5 minutes)

ASK students to pair up and buzz on the following questions for 2 minutes

• What are Sera and Immunoglobulins?
• What are the indication of sera and immunoglobulins?

ALLOW few pairs to respond and let other pairs to add on points not mentioned

WRITE their response on the flip chart/board

CLARIFY and SUMMARIZE by using the content below

Definition

• Antisera

o Refers to purified and concentrated preparations of serum of horses actively

immunized against a specific antigen

o Example are Tetanus antitoxin (ATS), Gas gangrene antitoxin (AGS), Diphtheria

antitoxin (ADS), Antirabies serum (ARS) and Antisnake venom polyvalent

• Immunoglobulins (lGs)

o Refers to a separated human gamma globulins which carry the antibodies

o They are more efficacious than the corresponding antisera

o Example are normal human gamma globulin, Anti-D immunoglobulin, Tetanus

immunoglobulin, Rabies immuneglobulin and Hepatitis-B immunoglobulin

Indications

• Gamma – Globulins Injection

o Indications for its use are viral hepatitis A and B (prophylaxis), measles, mumps,

poliomyelitis and chickenpox (prophylaxis and modification of course of illness), and

has some beneficial action in burns

 It is especially valuable in agammaglobulinemia, premature infants and in patients

of leukemia or those undergoing immunosuppression

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• Anti-D(Rho) Immunoglobulin Injection

o Prevention of Rho(D) sensitisation to rhesus negative woman

• Anti-rabies Immunoglobulin Injection

o Post-exposure prophylaxis against rabies infection

• Activated Prothrombin

o Treatment of bleeding episodes

• Factor VII

o Treatment of bleeding episodes

• Snake venom polyvalent Antiserum injection

o Snake bite/Poisoning

• Tetanus Immunoglobulin

o Post-exposure prophylaxis and treatment of tetanus infection

 Indicated for prophylaxis in non-immunized persons receiving a contaminated

wound who are at high risk of developing tetanus

STEP 3: Contraindications of Sera and Immunoglobulin (10 minutes)

Activity: Brainstorming (5 minutes)

Ask students to brainstorm on the following question:

• What are the contraindications of sera and immunoglobulin?

ALLOW few students to respond

WRITE their responses on the flip chart/ board

CLARIFY and SUMMARISE by using the content below

• The immunoglobulins

o Patients with a history of allergic reactions after administration of human

immunoglobulin preparations

o Individuals with isolated immunoglobulin A (IgA) deficiency (individuals could have

an anaphylactic reaction to subsequent administration of blood products that contain

IgA)

• The antisera

o Patients with hypersensitivity to horse serum or any other component of the serum

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STEP 4: Dose, Dosage and Course of Sera and Immunoglobulin

(40 minutes)

• Gamma – Globulins Injection

o Available as Gamma – Globulins Injection I.V 500mg, 2.5g and 5g

o Hereditary haemolytic anaemia

 Immunoglobulin IgG 400mg/kg (IV) daily for 5 days

o Idiopathic thrombocytopenic Purpura (ITP) for the emergence of acute bleeding

caused by severe thrombocytopenia

 IV immunoglobulin may be given as a single dose infusion of 0.4-1.0g/kg

followed immediately platelets transfusion Splenectomy

• Anti-D(Rho) Immunoglobulin Injection
o Available as Anti-D(Rho) Immunoglobulin Injection 0.25 mg/ml in set of 5ml

o Dose by deep intramuscular injection, to rhesus-negative woman for prevention of

Rho(D) sensitisation;

 Following birth of rhesus-positive infant: 500 units immediately or within 72

hours

 For transplacental bleed of over 4mL fetal red cells: Extra 100–125units per mL

fetal red cells

 Following any potentially sensitising episode (e.g. stillbirth, abortion,

amniocentesis) up to 20 weeks‘ gestation . 250 units per episode (after 20 weeks,

500units) immediately or within 72 hours

 Antenatal prophylaxis 500 units given at weeks 28 and 34 of pregnancy; if infant

rhesus-positive, a further dose is still needed immediately or within 72 hours of

delivery

 Following Rho(D) incompatible blood transfusion 100–125 units per mL

transfused rhesus-positive red cells

• Anti-rabies Immunoglobulin Injection

o Available as Anti-rabies Immunoglobulin Injection 1000 IU/5ml ampoule

o Passive immunization of rabies

 Anti-rabies human immunoglobulin 20 IU/kg half the dose given parenterally and

the other half injected into and around the wound

o Active immunization of rabies

 Rabies immunoglobulin with the first dose (day 0) Tetanus toxoid vaccine

Refer students to Handout 31.1: Management of rabies for exposed individuals for

further reading

• Activated Prothrombin

o Treatment of bleeding episodes

o Activated Prothrombin Complex Concentrate (APCC) 50-100IU/kg every12-24hrs
• Factor VII

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o Available as Powder for reconstitution 2mg

o Treatment of bleeding episodes

o Recombinant factor VIIa 90 microgram per kg every 2-3 hrs or by continuous
infusion (at 20µg/kg/hr)
• Snake venom polyvalent Antiserum injection

o Available as Snake venom polyvalent Antiserum injection

Dose: 20ml i.v. (1 mil/min injection) repeated at 1 to 6 hourly intervals till symptoms

of envenomation disappear: up to 300 ml may be required in viper bites, while still
larger amounts (up to 900 ml) have been used in cobra bites
• Tetanus Immunoglobulin and tetanus antitoxin (antitetanic serum, ATS)

o Available as Tetanus Immunoglobulin (human) – ATS Injection 1,500 IU in vial;

Tetanus Immunoglobulin Tetanus Immunoglobulin (human) – ATS Injection 10,000

I.U in vial; Tetanus Immunoglobulin Tetanus Immunoglobulin (human) – ATS

Injection 100,000 I.U in vial and Tetanus Immunoglobulin Tetanus Immunoglobulin

(human) – ATS Injection 500,000 I.U in vial

o For prevention of further absorption of toxin form wound

 Human tetanus immunoglobulin: Adults & children 100 – 300 IU/kg IM stat

o Wound care

 Tetanus prophylaxis

 0.5 mL Tetanus toxoid and 1 mL Tetanus immunoglobulin (Depending on the

immunization protocol, see table 39.1)

Table 39.1: Protocol in Provision of Tetanus Prophylaxis

Patient Category Non-tetanus Prone Tetanus Prone

Immunized and booster Nil Nil

within 5 years

Immunized and 5 to 10 Nil TT

years since booster

Immunized and >10 years TT TT

Incomplete immunization TT and TIG TT and TIG

or unknown

TT = T. toxoid; TIG = Tetanus Immunoglobulin

PST 04211 Basic Pharmacology NTA Level 4 Semester 2 Facilitator Guide

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STEP 5: Side Effects and Adverse Effects of Sera and Immunoglobulin

(20 minutes)

Activity: Brainstorming (5 minutes)

Ask students to brainstorm on the following question:

• What are the side effects of sera and immunoglobulin?

ALLOW few students to respond

WRITE their responses on the flip chart/ board

CLARIFY and SUMMARISE by using the content below

• Antisera

o Immediate type of allergic reactions (urticaria, angioedema, respiratory distress and

anaphylaxis) can occur with any antiserum

o Serum sickness with fever, rash, joint pain, lymphadenopathy appearing 7-12 days

later is more frequent after large doses and repeated administration

o Local pain, erythema and arthus type reaction without constitutional symptoms may

also occur 7-70 days after i.m. injection

• Rabies immunoglobulin

o Side-effects

 Injection site swelling and pain; very rarely anaphylaxis; buccal ulceration,

glossitis, chest tightness, dyspnoea, tremor, dizziness, arthralgia, and facial

oedema

• Tetanus immunoglobulin

o Side effects

 Injection site swelling and pain; rarely anaphylaxis

• Anti-D(Rho) Immunoglobulin Injection

o Side-effects

 Nausea, vomiting, diarrhoea, abdominal pain; hypotension, hypertension,

headache, fever, malaise, asthenia, drowsiness, dizziness, back pain, arthralgia,

myalgia; pruritus, rash, sweating, injection site pain; rarely tachycardia,

anaphylaxis, dyspnoea, hypotension, and urticarial

• Snake venom polyvalent Antiserum injection

o Allergic reactions includes anaphylactic shock, to the serum are possible

PST 04211 Basic Pharmacology NTA Level 4 Semester 2 Facilitator Guide

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STEP 6: Interaction and Precaution of Sera and Immunoglobulin

(5 minutes)

• Precaution

o The immune globulins and antisera are administered cautiously during pregnancy

(Pregnancy Category C) and lactation and in children

• Interaction

o Antibodies in the immune globulin preparations may interfere with the immune

response to live virus vaccines

STEP 7: Key Points (10 minutes)

• Antisera

o Refers to purified and concentrated preparations of serum of horses actively

immunized against a specific antigen

• lmmunoglobulins (lGs)

o Refers to a separated human gamma globulins which carry the antibodies

o They are more efficacious than the corresponding antisera

• The immune globulins and antisera are administered cautiously during pregnancy

(Pregnancy Category C) and lactation and in children

• The immune globulins and antisera may interfere with the immune response to live virus

vaccines

STEP 8: Evaluation (10 minutes)

• What are the indications of Sera and Immunoglobulin?
• What are the contraindication of Sera and Immunoglobulin?
• What is the dose, dosage and course of Sera and Immunoglobulin?
• What are the side effects and adverse effects of Sera and Immunoglobulin?
• What is the interaction and precaution of Sera and Immunoglobulin?

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References

Ministry of Health and Social Welfare. 2013(2013). Standard Treatment Guidelines &

National Essential Medicines List Tanzania Mainland (4th ed.). Dar es salaam,

Tanzania government printers.

Robert, L. T., Albert, Gary C. Y, Gary R. Matzke, Barbara G. Wells, & L. Michael. (2014.)

Pharmacotherapy: A Pathophysiologic Approach (9th ed.). New York, McGraw-Hill

Education.

Sally S.R., & Jeanne C.S. (2000). Introductory Clinical Pharmacology (6th ed) New York,

Lippincott Williams and Wilkins.

School of Pharmaceutical sciences. (2011).Tanzania Pharmaceutical Handbook (2nd ed.).

Dar es Salaam, ARDHI University press.

The Royal Pharmaceutical Society of Great Britain. (2007). Martindale, the Extra

Pharmacopoeia (5TH ed). London, pharmaceutical press.

The Royal Pharmaceutical Society of Great Britain. (2009). British National Formulary

(59th ed). London, BMJ Group and RPS Publishing.

PST 04211 Basic Pharmacology NTA Level 4 Semester 2 Facilitator Guide

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Handout 32.1: Management of rabies for exposed individuals

Category Management

CATEGORY I No treatment

Touching or feeding animals, licks on

the skin

CATEGORY II After washing the wound with running water and

Nibbling of uncovered skin, minor soap for 15 minutes, administer antirabies vaccines

scratches or abrasions without 0.2ml (ID) in divided doses of 0.1 ml on deltoid on

bleeding, licks on broken skin one hand and another 0.1ml on the deltoid of the

second hand on days 0, 3, 14 and 28

OR

1 ml (IM) on deltoid muscle for days 0, 3,7,14, and

28 Note:

Children are given the same doses but vaccine is

administered on the lateral part of the thigh.

CATEGORY III After washing the wound with running water and

Single or multiple transdermal bites soap for 15 minutes, administer Rabies

or scratches with bleeding, Immunoglobulin (RIG) on day 0 40 IU/kg body
contamination of mucous membrane weight for Equine (ERIG) 20 IU/kg body weight for

with saliva from licks; exposure to Human (HRIG) Administer antirabies vaccines –

bat bites or scratches 0.2ml (ID) in divided doses of 0.1 ml on deltoid on

one hand and another 0.1ml on the deltoid of the

second hand on days 0, 3, 14 and 28

OR

1 ml (IM) on deltoid muscle for days 0, 3,7,14, and

28

Note 1: Children are given the same doses but

vaccine should be administered on the lateral part of

the thigh.

Note 2: The World Health Organization

recommends ID route of vaccination administration

because it is cost effective.

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