Tetanus vaccine
| 1. NAME |
| 1.1 Substance |
| 1.2 Group |
| 1.3 Synonyms |
| 1.4 Identification numbers |
| 1.4.1 CAS number |
| 1.4.2 Other numbers |
| 1.5 Brand names, Trade names |
| 1.6 Manufacturers, Importers |
| 2. SUMMARY |
| 2.1 Main risks and target organs |
| 2.2 Summary of clinical effects |
| 2.3 Diagnosis |
| 2.4 First aid measures and management principles |
| 3. PHYSICO-CHEMICAL PROPERTIES |
| 3.1 Origin of the substance |
| 3.2 Chemical structure |
| 3.3 Physical properties |
| 3.3.1 Properties of the substance |
| 3.3.2 Properties of the locally available formulation |
| 3.4 Other characteristics |
| 3.4.1 Shelf-life of the substance |
| 3.4.2 Shelf-life of the locally available formulation |
| 3.4.3 Storage conditions |
| 3.4.4 Bioavailability |
| 3.4.5 Specific properties and composition |
| 4. USES |
| 4.1 Indications |
| 4.2 Therapeutic dosage |
| 4.2.1 Adults |
| 4.2.2 Children |
| 4.3 Contraindications |
| 5. ROUTES OF ENTRY |
| 5.1 Oral |
| 5.2 Inhalation |
| 5.3 Dermal |
| 5.4 Eye |
| 5.5 Parenteral |
| 5.6 Other |
| 6. KINETICS |
| 6.1 Absorption by route of exposure |
| 6.2 Distribution by route of exposure |
| 6.3 Biological half-life by route of exposure |
| 6.4 Metabolism |
| 6.5 Elimination by route of exposure |
| 7. PHARMACOLOGY AND TOXICOLOGY |
| 7.1 Mode of action |
| 7.1.1 Toxicodynamics |
| 7.1.2 Pharmacodynamics |
| 7.2 Toxicity |
| 7.2.1 Human data |
| 7.2.1.1 Adults |
| 7.2.1.2 Children |
| 7.2.2 Relevant animal data |
| 7.2.3 Relevant in vitro data |
| 7.3 Carcinogenicity |
| 7.4 Teratogenicity |
| 7.5 Mutagenicity |
| 7.6 Interactions |
| 7.7 Main adverse effects |
| 8. TOXICOLOGICAL ANALYSES AND BIOMEDICAL INVESTIGATIONS |
| 8.1 Material sampling plan |
| 8.1.1 Sampling and specimen collection |
| 8.1.1.1 Toxicological analyses |
| 8.1.1.2 Biomedical analyses |
| 8.1.1.3 Arterial blood gas analysis |
| 8.1.1.4 Haematological analyses |
| 8.1.1.5 Other (unspecified) analyses |
| 8.1.2 Storage of laboratory samples and specimens |
| 8.1.2.1 Toxicological analyses |
| 8.1.2.2 Biomedical analyses |
| 8.1.2.3 Arterial blood gas analysis |
| 8.1.2.4 Haematological analyses |
| 8.1.2.5 Other (unspecified) analyses |
| 8.1.3 Transport of laboratory samples and specimens |
| 8.1.3.1 Toxicological analyses |
| 8.1.3.2 Biomedical analyses |
| 8.1.3.3 Arterial blood gas analysis |
| 8.1.3.4 Haematological analyses |
| 8.1.3.5 Other (unspecified) analyses |
| 8.2 Toxicological Analyses and Their Interpretation |
| 8.2.1 Tests on toxic ingredient(s) of material |
| 8.2.1.1 Simple Qualitative Test(s) |
| 8.2.1.2 Advanced Qualitative Confirmation Test(s) |
| 8.2.1.3 Simple Quantitative Method(s) |
| 8.2.1.4 Advanced Quantitative Method(s) |
| 8.2.2 Tests for biological specimens |
| 8.2.2.1 Simple Qualitative Test(s) |
| 8.2.2.2 Advanced Qualitative Confirmation Test(s) |
| 8.2.2.3 Simple Quantitative Method(s) |
| 8.2.2.4 Advanced Quantitative Method(s) |
| 8.2.2.5 Other Dedicated Method(s) |
| 8.2.3 Interpretation of toxicological analyses |
| 8.3 Biomedical investigations and their interpretation |
| 8.3.1 Biochemical analysis |
| 8.3.1.1 Blood, plasma or serum |
| 8.3.1.2 Urine |
| 8.3.1.3 Other fluids |
| 8.3.2 Arterial blood gas analyses |
| 8.3.3 Haematological analyses |
| 8.3.4 Interpretation of biomedical investigations |
| 8.4 Other biomedical (diagnostic) investigations and their interpretation |
| 8.5 Overall Interpretation of all toxicological analyses and toxicological investigations |
| 8.6 References |
| 9. CLINICAL EFFECTS |
| 9.1 Acute poisoning |
| 9.1.1 Ingestion |
| 9.1.2 Inhalation |
| 9.1.3 Skin exposure |
| 9.1.4 Eye contact |
| 9.1.5 Parenteral exposure |
| 9.1.6 Other |
| 9.2 Chronic poisoning |
| 9.2.1 Ingestion |
| 9.2.2 Inhalation |
| 9.2.3 Skin exposure |
| 9.2.4 Eye contact |
| 9.2.5 Parenteral exposure |
| 9.2.6 Other |
| 9.3 Course, prognosis, cause of death |
| 9.4 Systematic description of clinical effects |
| 9.4.1 Cardiovascular |
| 9.4.2 Respiratory |
| 9.4.3 Neurological |
| 9.4.3.1 CNS |
| 9.4.3.2 Peripheral nervous system |
| 9.4.3.3 Autonomic nervous system |
| 9.4.3.4 Skeletal and smooth muscle |
| 9.4.4 Gastrointestinal |
| 9.4.5 Hepatic |
| 9.4.6 Urinary |
| 9.4.6.1 Renal |
| 9.4.6.2 Other |
| 9.4.7 Endocrine and reproductive systems |
| 9.4.8 Dermatological |
| 9.4.9 Eye, ear, nose, throat: local effects |
| 9.4.10 Haematological |
| 9.4.11 Immunological |
| 9.4.12 Metabolic |
| 9.4.12.1 Acid-base disturbances |
| 9.4.12.2 Fluid and electrolyte disturbances |
| 9.4.12.3 Others |
| 9.4.13 Allergic reactions |
| 9.4.14 Other clinical effects |
| 9.4.15 Special risks |
| 9.5 Other |
| 9.6 Summary |
| 10. MANAGEMENT |
| 10.1 General principles |
| 10.2 Relevant laboratory analyses |
| 10.2.1 Sample collection |
| 10.2.2 Biomedical analysis |
| 10.2.3 Toxicological analysis |
| 10.2.4 Other investigations |
| 10.3 Life supportive procedures and symptomatic/specific treatment |
| 10.4 Decontamination |
| 10.5 Elimination |
| 10.6 Antidote treatment |
| 10.6.1 Adults |
| 10.6.2 Children |
| 10.7 Management discussion |
| 11. ILLUSTRATIVE CASES |
| 11.1 Case reports from literature |
| 11.2 Internally extracted data on cases |
| 11.3 Internal cases |
| 12. Additional information |
| 12.1 Availability of antidotes |
| 12.2 Specific preventive measures |
| 12.3 Other |
| 13. REFERENCES |
| 14. AUTHOR(S), REVIEWER(S), DATE(S) (INCLUDING UPDATES), COMPLETE ADDRESS(ES) |
PHARMACEUTICALS
1. NAME
1.1 Substance
Tetanus vaccine
1.2 Group
Biological immunological agent.
1.3 Synonyms
Adsorbed Tetanus vaccine (BP)
Pasteur Tetanus vaccine (France)
Tetanol (France, Germany)
Tetanus Toxoid (USP) and Tetanus Toxoid adsorbed (USP)
Tetanus vaccine (BP)
1.4 Identification numbers
1.4.1 CAS number
1.4.2 Other numbers
1.5 Brand names, Trade names
Tetanol (Germany)
Tetavax (UK)
Te Anatoxin Berne (Switzerland)
Tetanus toxoid adsorbed puragated (USA)
1.6 Manufacturers, Importers
Behring (Germany)
Merieux (UK)
Wellcome (UK)
Servier (UK)
Slavo (USA)
Lederle (USA)
Wyeth-Ayerst (USA)
2. SUMMARY
2.1 Main risks and target organs
Main risk is adverse reactions which may be local or involve
multiple organs.
2.2 Summary of clinical effects
Local effects: Local reactions at injection site include
tenderness, erythema, induration, warmth and oedema. Rarely,
the local reactions may become extensive as a result of
hypersensitivity. The incidence of reactions increases with
the 2nd and 3rd injections, but the reactions are generally
not severe.
Systemic effects: transient fever, malaise, generalized aches
and pains, rash, generalized urticaria or pruritus,
lymphadenopathy, tachycardia and hypotension. More rarely, a
severe anaphylactic reaction may occur. Neurological disorders
include cochlear lesions, brachial plexus neuropathies,
paralysis of radial or recurrent nerves, accommodation paresis,
EEG disturbances. Dysphagia and polyradiculoneuropathy have
been reported.
2.3 Diagnosis
Diagnosis is based on occurrence of local and/or systemic
reactions following the parenteral administration of the
vaccine.
2.4 First aid measures and management principles
Immediate allergic reactions should be controlled with
antihistamines, and anaphylaxis with the administration of
epinephrine 1:1000 (see Treatment protocol).
3. PHYSICO-CHEMICAL PROPERTIES
3.1 Origin of the substance
Tetanus vaccine is prepared from tetanus toxin produced by the
growth of the bacterium Clostridium tetani. The toxin is
converted to tetanus formol toxoid by treatment with
formaldehyde solution. In addition, for tetanus toxoid
adsorbed or adsorbed tetanus vaccine, aluminium phosphate or
aluminium potassium sulphate is used as a mineral adjuvant to
adsorb the tetanus antigens. This prolongs and enhances the
antigenic properties by retarding the rate of absorption of
the injected toxoid into the body. [There are slight
variations of the production methods used by different
manufacturers but all products must meet the established
potency of 5 to 7.5 Lf units/0.5 ml dose].
3.2 Chemical structure
Not relevant.
3.3 Physical properties
3.3.1 Properties of the substance
Tetanus vaccine is a clear, colourless to
brownish yellow or slightly turbid liquid, free from
evident lumps or particles, having a characteristic
odour or an odour of formaldehyde.
Tetanus toxoid adsorbed (USP) or Adsorbed tetanus vaccine
(BP): Turbid, white, slightly grey or slightly pink
suspension, free from evident lumps after shaking.
3.3.2 Properties of the locally available formulation
Pasteur tetanus vaccine is a preparation containing
purified tetanus toxoid adsorbed onto aluminium
hydroxide. Each 0.5 ml dose contains: purified tetanus
toxoid (1 vaccination dose q.s. 0.5 ml); aluminium
hydroxide (expressed as aluminium) (2.25 mg maximum);
thiomersal (preservative) (0.05 mg maximum); isotonic
sodium chloride solution corresponding to at least 40
immunizing international units.
One dose (0.5 ml) of Behring Preparation contains
adsorbed tetanus vaccine (tetanol) (75 IU); aluminium
hydroxide (1.5 mg) and sodium p-ethyl-mercuri-mercapto-
benzol-sulphate (0.025 mg) as preservative.
3.4 Other characteristics
3.4.1 Shelf-life of the substance
The expiry date of tetanus toxoid and tetanus toxoid
adsorbed is not later than 5 years after the date of
issue from the manufacturers cold storage or one year
when the manufacturer's cold storage was at 5°C.
3.4.2 Shelf-life of the locally available formulation
Not less than 5 years from the date on which the potency
test was begun.
3.4.3 Storage conditions
Tetanus vaccine or adsorbed tetanus vaccine should be
stored in a refrigerator at a temperature ranging
between +2 and +8 °C; it should be used on or before
the date of expiry given on the pack. It must not be
frozen and should be protected from light.
3.4.4 Bioavailability
One hundred percent.
3.4.5 Specific properties and composition
Not relevant.
4. USES
4.1 Indications
Tetanus vaccines are used for active immunization
against tetanus. The main objective of tetanus
immunization is to prevent the severe complications (or
death), which arise from the potent exotoxin elaborated
by Clostridium tetanus. Unless otherwise
contraindicated, all infants of 6 to 8 weeks of age or
older, all children, and all adults should be immunized
against tetanus with the primary series of tetanus
vaccine and a booster injection every 10 years
throughout their lives, including:
- Adults: Especially those of 50 years of age and
older. In recent years, approximately two-thirds of persons
contracting tetanus have been in this age group.
- Persons with uncertain histories of complete primary courses
of vaccination with tetanus vaccine or immunizing agents
containing tetanus toxoid.
- Travellers
- Persons at increased risk of receiving lacerations and
abrasions through their occupation or recreational activities.
- Persons with known hypersensitivity to horse serum or with
asthma or other allergies. This is to minimize the possible
need for passive immunization with tetanus antitoxin (TAT) of
animal origin (usually horse) if a wound is received. Although
human tetanus immune globulin (TIG) is usually used for passive
immunization, TAT of animal origin may still be used in certain
areas of the world and risks causing adverse reactions in
hypersensitive patients.
- Pregnant women who are not immunized or inadequately immunized
and who may deliver their infants in conditions of poor hygiene
thereby exposing their infants to neonatal tetanus.
- Those recovering from tetanus. Since an injection of TAT or
TIG does not confer immunity, immunization with tetanus vaccine
should be initiated or continued at the time of recovery from the
illness.
- Persons who are injured may require emergency tetanus
prophylaxis depending on the number of primary immunizations,
the timing of any boosters, and the type of wound received.
The active immunization of children is not discussed
further in this monograph.
When a single entity vaccine is used, adsorbed tetanus
vaccine (BP) or tetanus toxoid adsorbed (USP) are the
vaccines of choice for primary immunization because
greater antigenic stimulation and longer lasting
immunity are achieved than with the tetanus toxoid (USP)
or tetanus vaccine (BP). For wounds, tetanus toxoid
(fluid) USP may be used as emergency prophylaxis of
tetanus.
4.2 Therapeutic dosage
4.2.1 Adults
The dosage of tetanus vaccine/tetanus toxoid is the same
for all persons, infants, children and adults.
4.2.2 Children
(See 4.2.1)
- Tetanus toxoid adsorbed (injection)
A primary vaccination course of tetanus toxoid adsorbed
consists of 3 doses each of 0.5 ml (not less than 40
units for adsorbed vaccine or not less than 14 Lf for
non-adsorbed vaccine).
Usual adult and adolescent dose: Intramuscular, 0.5 ml.
First dose: at initial visit
Second dose: 4 to 8 weeks after the first dose
Third dose: 6 to 14 months after the second dose
Booster doses: every 10 years.
- Tetanus Vaccine/Toxoid (Fluid) (Injection)
Usual adult and adolescent dose: Intramuscular or
subcutaneous 0.5 ml (US, UK, Zimbabwe) or 1 ml (Canada).
First dose: at initial visit
Second dose: 4 to 8 weeks after the first dose
Third dose: 4 to 8 weeks after the second dose
Fourth dose: 6 to 12 months after the third dose
Booster doses: every 10 years.
N.B. In other countries the strength of the vaccine,
dosages and schedules may differ slightly from that
outlined above. Immunization against tetanus forms part
of the World Health Organization's Expanded Programme on
Immunization, which recommends the treatment schedules.
4.3 Contraindications
Tetanus vaccine and adsorbed tetanus vaccine are
contraindicated in individuals who have had a prior systemic
hypersensitivity reaction to either vaccine.
- The US Public Health Service Immunizations Practices
Advisory Committee states that tetanus toxoid and tetanus
toxoid adsorbed are contraindicated in individuals who
experienced a neurological reaction after a previous dose
of a tetanus toxoid-containing preparation.
- Routine administration of the vaccines is contraindicated
in patients having acute respiratory disease because
routine primary or booster immunization should not be
administered until the symptoms of the patient's illness
have abated; however, emergency tetanus prophylaxis for
wounds should be administered as usual. Minor illness,
such as upper respiratory tract infection, does not
preclude administration of tetanus toxoid.
- The vaccine should not be administered during an outbreak
of poliomyelitis; elective immunization of patients over
the age of 6 months with tetanus toxoid should be deferred
during an outbreak of poliomyelitis.
- Tetanus vaccine is contraindicated in individuals with
tetanus infection. Tetanus toxoid should not be used to
treat a tetanus infection, for which tetanus antitoxin,
preferably tetanus immune globulin (TIG), should be used
instead; vaccination with tetanus toxoid should begin
after recovery.
5. ROUTES OF ENTRY
5.1 Oral
No data available.
5.2 Inhalation
No data available.
5.3 Dermal
During sensitivity testing and desensitization
5.4 Eye
Conjunctival test.
5.5 Parenteral
Intramuscular, subcutaneous and intravenous injection.
5.6 Other
No data available.
6. KINETICS
6.1 Absorption by route of exposure
Not relevant.
6.2 Distribution by route of exposure
Not relevant.
6.3 Biological half-life by route of exposure
Not relevant.
6.4 Metabolism
Not relevant.
6.5 Elimination by route of exposure
Not relevant.
7. PHARMACOLOGY AND TOXICOLOGY
7.1 Mode of action
7.1.1 Toxicodynamics
Not relevant.
7.1.2 Pharmacodynamics
Following intramuscular injection of tetanus toxoid
adsorbed or either intramuscular or subcutaneous
injection of tetanus toxoid, an antigen response is
induced in the immunized patient causing the formation
of antibodies to tetanus toxins (USP DI 1990).
7.2 Toxicity
7.2.1 Human data
7.2.1.1 Adults
Local reactions are more common in adults than
in children and an incidence in adults of 1 - 2%
has been reported (Martindale, 1982).
7.2.1.2 Children
Local reactions are more common in adults than
in children and an incidence in adults of 1 - 2%
has been reported (Martindale, 1982).
7.2.2 Relevant animal data
Not relevant.
7.2.3 Relevant in vitro data
Not relevant.
7.3 Carcinogenicity
No data available.
7.4 Teratogenicity
There is no evidence that tetanus toxin is teratogenic. In
general, waiting until the second trimester is a reasonable
precaution to minimise any theoretical concern (PDR, 1992).
7.5 Mutagenicity
No data available.
7.6 Interactions
No data available.
7.7 Main adverse effects
Common adverse effects include redness or hard lump at
injection site, which may persist for a few days.
Hypersensitivity to reinforcing doses of tetanus toxoid has
been described (Dittmann, 1988), especially in individuals who
are sensitive to the mercury in thiomersal. Slight local
reactions such as induration, erythema and tenderness seem to
be more common with the adsorbed type of vaccine. If
aluminium adsorbed toxoid is given subcutaneously, a small
granuloma may occur due to deposition of material at the
injection site. Intramuscular injection of tetanus toxoid is
generally better tolerated and the product can best be
injected into a large muscle (gluteal) (Dittmann, 1988).
Anaphylactic reactions may occur rarely and can be sudden and
severe. These include difficulty in breathing or swallowing;
hives and itching, especially of the soles or palms;
reddening of skin, especially around the ears, swelling of
the eyes, the face, of the inside of the nose; unusual
tiredness or weakness. Adverse neurological effects include
confusion, fever over 39.4°C (103 °F), severe or continuing
headache, seizures, excessive sleepiness, unusual
irritability and severe or continuing vomiting.
Lymphadenopathy (swelling of glands and armpit). Swelling,
blistering, or pain at injection site, which may be severe
and extensive.
Allergic reactions of the delayed and the cell-mediated type
occur occasionally and include pain, tenderness, itching, or
swelling at injection site, chills, fever, irritability or
unusual tiredness.
A nodule or sterile abscess at the injection site, probably
caused by the aluminium content of tetanus toxoid adsorbed,
may persist for several weeks. Skin rash has also been
reported (McEvoy, 1988; USP DI 1990).
8. TOXICOLOGICAL ANALYSES AND BIOMEDICAL INVESTIGATIONS
8.1 Material sampling plan
8.1.1 Sampling and specimen collection
8.1.1.1 Toxicological analyses
8.1.1.2 Biomedical analyses
8.1.1.3 Arterial blood gas analysis
8.1.1.4 Haematological analyses
8.1.1.5 Other (unspecified) analyses
8.1.2 Storage of laboratory samples and specimens
8.1.2.1 Toxicological analyses
8.1.2.2 Biomedical analyses
8.1.2.3 Arterial blood gas analysis
8.1.2.4 Haematological analyses
8.1.2.5 Other (unspecified) analyses
8.1.3 Transport of laboratory samples and specimens
8.1.3.1 Toxicological analyses
8.1.3.2 Biomedical analyses
8.1.3.3 Arterial blood gas analysis
8.1.3.4 Haematological analyses
8.1.3.5 Other (unspecified) analyses
8.2 Toxicological Analyses and Their Interpretation
8.2.1 Tests on toxic ingredient(s) of material
8.2.1.1 Simple Qualitative Test(s)
8.2.1.2 Advanced Qualitative Confirmation Test(s)
8.2.1.3 Simple Quantitative Method(s)
8.2.1.4 Advanced Quantitative Method(s)
8.2.2 Tests for biological specimens
8.2.2.1 Simple Qualitative Test(s)
8.2.2.2 Advanced Qualitative Confirmation Test(s)
8.2.2.3 Simple Quantitative Method(s)
8.2.2.4 Advanced Quantitative Method(s)
8.2.2.5 Other Dedicated Method(s)
8.2.3 Interpretation of toxicological analyses
8.3 Biomedical investigations and their interpretation
8.3.1 Biochemical analysis
8.3.1.1 Blood, plasma or serum
8.3.1.2 Urine
8.3.1.3 Other fluids
8.3.2 Arterial blood gas analyses
8.3.3 Haematological analyses
8.3.4 Interpretation of biomedical investigations
8.4 Other biomedical (diagnostic) investigations and their
interpretation
8.5 Overall Interpretation of all toxicological analyses and >
toxicological investigations 8.6 References
9. CLINICAL EFFECTS
9.1 Acute poisoning
9.1.1 Ingestion
Not relevant
9.1.2 Inhalation
No data available.
9.1.3 Skin exposure
Not relevant.
9.1.4 Eye contact
Not relevant.
9.1.5 Parenteral exposure
Local and systemic reactions may occur after
ultramuscular administration.
9.1.6 Other
No data available.
9.2 Chronic poisoning
9.2.1 Ingestion
Not relevant.
9.2.2 Inhalation
No data available.
9.2.3 Skin exposure
No data available.
9.2.4 Eye contact
No data available.
9.2.5 Parenteral exposure
No data available.
9.2.6 Other
No data available.
9.3 Course, prognosis, cause of death
Local reactions such as erythema, induration, oedema and
redness are usually self-limiting and need no special
treatment. Nodules or sterile abcesses may eventually appear
at the site of administration. In case of severe adverse
reactions, e.g. anaphylaxis, appropriate emergency treatment
is imperative as it constitutes a life-threatening effect.
9.4 Systematic description of clinical effects
9.4.1 Cardiovascular
Tachycardia and hypotension
9.4.2 Respiratory
Respiratory manifestations of anaphylaxis, for example
bronchospasm, have been reported as a manifestation of
anaphylaxis.
9.4.3 Neurological
9.4.3.1 CNS
Neurological disorders reported include
convulsions, cochlear lesions, paralysis of
radial or recurrent nerves, accommodation
paresis and EEG disturbances.
9.4.3.2 Peripheral nervous system
A case of peripheral neuropathy with paralysis
of the right radial nerve has been reported in a
medical student a few hours after administration
of tetanus vaccine. Various mono
- and polyneuropathies including Gillain-Barre
Syndrome have been reported following the
administration of tetanus antigens (PDR 1992).
9.4.3.3 Autonomic nervous system
No data available.
9.4.3.4 Skeletal and smooth muscle
No data available.
9.4.4 Gastrointestinal
Dysphagia may occur
9.4.5 Hepatic
No data available.
9.4.6 Urinary
9.4.6.1 Renal
No data available.
9.4.6.2 Other
No data available.
9.4.7 Endocrine and reproductive systems
No data available.
9.4.8 Dermatological
Skin rash, generalized urticaria or pruritus as
manifestations of allergic reactions.
9.4.9 Eye, ear, nose, throat: local effects
Reddening and swelling as manifestations of allergic
reactions.
9.4.10 Haematological
No data available.
9.4.11 Immunological
No data available.
9.4.12 Metabolic
9.4.12.1 Acid-base disturbances
No data available.
9.4.12.2 Fluid and electrolyte disturbances
No data available.
9.4.12.3 Others
No data available.
9.4.13 Allergic reactions
Allergic and anaphylactoid reactions have been reported
(US DI 1990) [see section 7.7].
9.4.14 Other clinical effects
No data available
9.4.15 Special risks
Pregnancy: No data available.
Breast feeding: No problems have been documented.
Enzyme deficiency: No data available.
9.5 Other
No data available.
9.6 Summary
10. MANAGEMENT
10.1 General principles
Management principles consist of the control of anaphylactic
reactions and its life-threatening effects. Minor reactions
to the vaccine are usually self-limiting and do not require
special treatment. Anti-histamines may be used is required.
10.2 Relevant laboratory analyses
10.2.1 Sample collection
Not relevant
10.2.2 Biomedical analysis
Not relevant
10.2.3 Toxicological analysis
Not relevant
10.2.4 Other investigations
Not relevant
10.3 Life supportive procedures and symptomatic/specific
treatmentAn antihistamine may be indicated for mild allergic
reactions. For anaphylactic reactions, adrenaline
(epinephrine) with maintenance of vital functions is
necessary.
Adult dosage: If anaphylaxis occurs, give 0.2 to 0.5 mg of
adrenaline intramuscularly or subcutaneously; the dose
should be repeated every 10 to 15 min as needed and if
necessary increased up to a maximum of 1 mg per dose. If
anaphylactic shock occurs, give 0.5 mg of adrenaline
intramuscularly or subcutaneously, followed by slow
intravenous administration of adrenaline or 0.0025 to 0.005
mg. The dose may be repeated every 5 to 15 min as needed.
Children's dosage: If anaphylaxis occurs, give adrenaline
0.01 mg per kg body weight or 0.3 mg per square metre of
body surface, up to a maximum of 0.5 mg per dose, by
subcutaneous injection; repeat every 15 min for two doses,
then every 4 h as needed. If anaphylactic shock occurs,
give 0.3 mg adrenaline intramuscularly or intravenously;
repeat every 15 min for 3 or 4 doses, if necessary.
10.4 Decontamination
Not relevant
10.5 Elimination
Not relevant
10.6 Antidote treatment
10.6.1 Adults
10.6.2 Children
10.7 Management discussion
Not relevant
11. ILLUSTRATIVE CASES
11.1 Case reports from literature
A 24-year-old woman developed anaphylactic shock and died 30
min after an injection of tetanus vaccine. Previous
injections with the vaccine had been well tolerated
(Martindale, 1989).
11.2 Internally extracted data on cases
To be completed by the centre
11.3 Internal cases
To be completed by the centre
12. Additional information
12.1 Availability of antidotes
Not relevant
12.2 Specific preventive measures
The existence of any contraindication to immunization should
be determined prior to administration of the vaccine
12.3 Other
No data available
13. REFERENCES
Briggs CG, Freeman RK, Yaffe SJ (1986). Tetanus/Diphtheria
toxoids (adult). Drugs in pregnancy and lactation. A reference
guide to foetal and neonatal risk. Second edition. Williams &
Wilkins, Baltimore, 423 t.
Dittman S (1988) Immunological preparations. In: Dukes MNG.
Meyler's side effects of drugs, 11th edition, Elsevier, Amsterdam,
668-692.
McEvoy GK (1988) Serums, Toxoids and Vaccines: Tetanus
antitoxin. American Hospital Formulary Service Drug Information
88. The American Society of the Hospital Pharmacists, Montgomery
Avenue, Bethesda, 1871-1969.
PDR Physician's Desk Reference (1993), 46th Edition Medical
Economics Data, USA.
Reynolds JEF (1989) Immunological agents: Tetanus antitoxins.
Martindale, the Extra Pharmacopoeia. The Pharmaceutical Press,
London, 1155-1183.
The United States Pharmacopoeial Convention Inc. (1990) Tetanus
toxoid. USP Drug Information for Health Care Professionals.
Vol. IB, 2580-2583.
Zink GL (1990) Immunizing agents and diagnostic antigens. In:
Osol Arthur, Remington's Pharmaceutical Sciences, 16th Edition,
Mack Publishing Company, Easton, Pennsylvania, 1324-1340.
14. AUTHOR(S), REVIEWER(S), DATE(S) (INCLUDING UPDATES), COMPLETE
ADDRESS(ES)
Author: Dr O.J. Kasilo
Drug and Toxicology Information Service (DaTIS),
Department of Pharmacy
University of Zimbabwe Medical School
P.O.Box A178
Avondale
Harare
Zimbabwe.
Author: Dr C.F.B. Nhachi
Department of Clinical Pharmacology and Toxicology
University of Zimbabwe Medical School
P.O.Box A178
Avondale
Harare
Zimbabwe.
Tel: 263-4-790233/791631, Ext. 228
Telex: 265801 UNIV ZW
Fax: 263-4-303-292
Reviewer:
Finalized and updated at the IPCS, May 1994.