Tetanus Vaccine

Uses and Administration

Tetanus vaccines are used for active immunisation against tetanus.

For primary immunisation combined tetanus vaccines, usually diphtheria, tetanus, and pertussis vaccines (Refer to) or diphtheria, tetanus, pertussis, poliomyelitis, and Haemophilus influenzae vaccines (Refer to), are used. For discussion of immunisation schedules, see under Vaccines, Refer to . In adults requiring primary immunisation combined vaccines such as diphtheria and tetanus vaccines (Refer to) or diphtheria, tetanus, and poliomyelitis vaccines (Refer to) are used.

In children who complete the primary course in infancy, reinforcing doses are given at school entry (about 4 to 6 years) and in adolescence using the recommended appropriate combined vaccines. In adults, a reinforcing dose is desirable 10 years later with a further dose after a further 10 years.

Tetanus vaccines should be part of wound management if primary immunisation is incomplete or boosters are not up-to-date. For tetanus-prone wounds, tetanus immunoglobulin (see Refer to) may also be required. Tetanus vaccine and tetanus immunoglobulin may be given at the same time, but not at the same site. In the event of injury in non-immunised persons or if immunisation status is uncertain, the opportunity is usually taken to start a course of primary immunisation. Since this provides no immediate protection, prophylactic treatment with tetanus immunoglobulin is recommended for tetanus-prone wounds. Suitable antibacterial therapy may also be given (see Refer to ).

(last reviewed 2010-09-03; last modified 2010-06-11)

References.

(last reviewed 2010-09-03; last modified 2010-09-01)

References

1. WHO. Tetanus vaccines: WHO position paper.Wkly Epidem Rec. 2006; 75: 198–208. online

Neonatal tetanus

In 1989 WHO adopted a resolution to eliminate neonatal tetanus after estimates revealed that worldwide (but excluding China) it was the cause of 800 000 neonatal deaths each year, a figure representing about 50% of all such deaths in developing countries. Control of neonatal tetanus may be achieved by ensuring adequate hygiene during delivery and by ensuring protective immunity of the mother in late pregnancy. However, by mid-2000 there were 57 countries that had still not eliminated maternal and neonatal tetanus and WHO, UNICEF, and UNFPA agreed to set a target date of 2005 for elimination (defined as a rate of neonatal tetanus below 1 in 1000 live births at district level). However, by the end of 2007, 47 countries were still considered to have not achieved elimination.

Tetanus vaccine is given to all women of child-bearing age as part of WHO's Expanded Programme on Immunization. For pregnant women, 2 doses of vaccine should be given, the second dose at least 4 weeks after the first and at least 2 weeks before delivery; this may provide the newborn infant with about 80% protection against tetanus. For all women of child-bearing age, 3 doses of vaccine, with at least 4 weeks between the first two doses and 6 to 12 months between the second and third doses, provide 95 to 98% protection for at least 5 years. Fourth and fifth doses, each at least one year after the previous dose, prolong the immunity for 10 and 20 years respectively.

(last reviewed 2010-09-03; last modified 2017-04-19)

Reinforcing doses in adults

Although the current recommendation in the UK is that 5 doses of tetanus vaccine (as a 3-dose primary course in infancy and 2 reinforcing doses at pre-school and in adolescence) is sufficient to produce satisfactory long-term protection in most circumstances, there has been concern about immunity in the elderly, and in particular women. Routine primary immunisation against tetanus was introduced in the UK in 1961, so individuals born before that year would not have been immunised in infancy, and unless they had been in the armed forces, may never have received a full primary course. Unless there is a clear immunisation history immunity to tetanus may be difficult to assess. It is also recommended in the UK that travellers to areas where medical attention may not be accessible, and who had the last dose of vaccine more than 10 years previously, should receive a booster even if they have had 5 doses previously.

Studies in the USA,1 Australia,2 and Austria3 have shown that at least half of healthy people over 50 years of age did not have adequate circulating tetanus antibodies. However, the level of circulating antibodies in the absence of an antigen challenge may not be an appropriate measure of the immune status. The low incidence of clinical tetanus in adults provides circumstantial evidence of an adequate inducible antibody response on exposure to tetanus despite a decline in antibody concentrations with increasing age.4,5 Conversely, there have been reports of tetanus occurring despite high antibody concentrations.6,7 There have been calls for the introduction of regular booster injections in adults,3,7-9 as is standard practice in the USA or alternatively a single booster in late middle age10,11 or giving a primary course to elderly persons who have never received one.1

(last reviewed 2010-09-03; last modified 2006-06-19)

References

1. Gergen PJ, et al.. A population-based serologic survey of immunity to tetanus in the United States.N Engl J Med. 1995; 332: 761–6. PubMed

2. Heath TC, et al.. Tetanus immunity in an older Australian population.Med J Aust. 1996; 164: 593–6. PubMed

3. Steger MM, et al.. Vaccination against tetanus in the elderly: do recommended vaccination strategies give sufficient protection?Lancet. 1996; 348: 762. PubMed

4. Bowie C. Tetanus toxoid for adults—too much of a good thing.Lancet. 1996; 348: 1185–6. PubMed

5. Baily G. Are the elderly inadequately protected against tetanus?Lancet. 1996; 348: 1389–90. PubMed

6. Passen EL, Andersen BR. Clinical tetanus despite a 'protective' level of toxin-neutralising antibody.JAMA. 1986; 255: 1171–3. PubMed

7. Bowman C, et al.. Tetanus toxoid for adults.Lancet. 1996; 348: 1664. PubMed

8. Rethy LA, Rethy L. Can tetanus boosting be rejected?Lancet. 1997; 349: 359–60. PubMed

9. Sehgal R. Tetanus toxoid for adults.Lancet. 1997; 349: 573. PubMed

10. Balestra DJ, Littenberg B. Tetanus immunization in adults.JAMA. 1994; 272: 1900. PubMed

11. Gardner P, LaForce FM. Protection against tetanus.N Engl J Med. 1995; 333: 599. PubMed

Adverse Effects, Treatment and Precautions

Adverse Effects and Precautions

As for vaccines in general, Refer to .

Local reactions, usually after the use of adsorbed vaccines, and mild systemic reactions may occur. The incidence and severity of reactions increases with the number of doses given.

Anaphylaxis and neurological reactions have been reported rarely.

Although vaccination is usually postponed in patients suffering from an acute febrile illness, tetanus vaccine should be given to such patients in the presence of a tetanus-prone wound.

With the exception of the first booster dose of tetanus vaccine (which is usually given before school entry and about 3 years after the primary course), further boosters should not generally be given at intervals of less than 10 years because of an increased risk of severe local reactions.

(last reviewed 2010-09-03; last modified 2006-06-01)

Effects on the nervous system

Neuropathies have been reported rarely with tetanus vaccination. Optic neuritis and myelitis occurred1 in an 11-year-old girl after a routine booster dose. Corticosteroids and immunoglobulin were given, and both vision and muscle power were restored after 11 months. Acute transverse myelitis was reported2 in a 50-year-old man who received a tetanus vaccine and immunoglobulin after an injury. Neurological deficits were unchanged after 1 month despite use of corticosteroids. Other causes could not be ruled out in either case. Brachial neuritis that developed in 2 infants after immunisation with diphtheria, tetanus, and pertussis vaccine was attributed to the tetanus component.3

(last reviewed 2010-09-03; last modified 2006-06-01)

References

1. Topaloglu H, et al.. Optic neuritis and myelitis after booster tetanus toxoid vaccination.Lancet. 1992; 339: 178–9. PubMed

2. Read SJ, et al.. Acute transverse myelitis after tetanus toxoid vaccination.Lancet. 1992; 339: 1111–12. PubMed

3. Hamati-Haddad A, Fenichel GM. Brachial neuritis following routine childhood immunization for diphtheria, tetanus, and pertussis (DTP): report of two cases and review of the literature.Pediatrics. 1997; 99: 602–3. PubMed

Guillain-Barré syndrome

For a discussion on the relationship between tetanus-containing vaccines and Guillain-Barré syndrome, see Diphtheria and Tetanus Vaccines, Refer to .

(last reviewed 2010-09-03; last modified 2006-04-28)

Porphyria

The Drug Database for Acute Porphyria, compiled by the Norwegian Porphyria Centre (NAPOS) and the Porphyria Centre Sweden, classifies tetanus vaccine as not porphyrinogenic; it may be used as a drug of first choice and no precautions are needed.1

(last reviewed 2010-09-03; last modified 2011-11-08)

References

1. The Drug Database for Acute Porphyria. Available at: Link (accessed 02/11/11)

Pregnancy

No connection has been found between use of tetanus vaccine during pregnancy and either congenital malformations1 or spontaneous abortion.2

(last reviewed 2010-09-03; last modified 2006-04-26)

References

1. Silveira CM, et al.. Safety of tetanus toxoid in pregnant women: a hospital-based case-control study of congenital anomalies.Bull WHO. 1995; 73: 605–8. PubMed

2. Catindig N, et al.. Tetanus toxoid and spontaneous abortions: is there epidemiological evidence of an association?Lancet. 1996; 348: 1098–9. PubMed

Interactions

As for vaccines in general, Refer to .

Tetanus immunoglobulins will neutralise tetanus toxoid and should not be injected into the same site or in the same syringe as a tetanus vaccine.

(last reviewed 2010-09-03; last modified 2006-05-04)

Preparations: Single-Ingredient

The following preparations list represents a compilation of all available salt forms or related substances for this drug product.

The symbol ¤ denotes a preparation which is discontinued or no longer actively marketed.

ARGENTINA: Tetanol; Tetavax;AUSTRALIA: Tet-Tox¤;AUSTRIA: T-Immun¤; Tanrix¤; Te Anatoxal¤; Tetanol;BELGIUM: Anatoxal Te¤; Tetamer¤; Tevax¤;BRAZIL: Tetavax¤;CHILE: Tetatox; Tetavax;CZECH REPUBLIC: Alteana¤; Tetanol; Tetavax; Vacteta;FRANCE: Tetavax¤;GERMANY: T-Immun¤; T-Medevax¤; T-Rix¤; T-Vaccinol¤; T-Wellcovax¤; Tet-Aktiv¤; Tetamun SSW¤; Tetanol; Tetasorbat SSW¤; Tetavax¤;GREECE: Anatoxal-Te-Berna¤; Imovax Tetano; Tetanol¤; Tetavax; Vaccin Tetanique Pasteur;HONG KONG: Te Anatoxal¤; Tetatox; Tetavax;INDIA: Anti-Tet (ATS); Bett;ITALY: Anatetall; H-Atetal¤; Imovax Tetano; Tanrix¤; Tetanol¤; Tetatox¤;MALAYSIA: Te Anatoxal¤; Tetavax¤; TT Vaccine;MEXICO: Tetamyn¤; Tetanol; Tetinox; Toxanal¤;NETHERLANDS: Tetavax¤;NORWAY: Tetavax;NEW ZEALAND: Te Anatoxal¤; Tet-Tox¤;PHILIPPINES: Anatetall¤; Imatet; T-Vac; Te Anatoxal¤; Tet-vac; Tetavax¤; Tetliv; Tetox;PORTUGAL: Anatoxal Te¤;SOUTH AFRICA: Tetavax;SINGAPORE: Te Anatoxal¤; Tetavax;SPAIN: Alutoxoide T¤; Anatoxal Tedi¤; Tetanibys¤; Vac Antitet¤; Vac Antitetanica¤;SWITZERLAND: Anatoxal Te¤; Tetanol pur¤;THAILAND: Anatetall; Bio-TT; Te Anatoxal¤; Tetana; Tetavax; TT Vaccine;TURKEY: Anatetall¤; Tetavax;UNITED KINGDOM: Clostet¤; Tetavax¤;UNITED STATES: Te Anatoxal;

Preparations: Pharmacopoeial

The following preparations list represents a compilation of all available salt forms or related substances for this drug product.

Ph. Eur.: Tetanus Vaccine (Adsorbed);

Therapeutic Use

• Vaccines Immunoglobulins and Antisera

Last Updated 1/21/20

Sanofi Pasteur Ltd. English Package Insert

Thailand TETAVAX 1C 17/51

Version: 12-2010

TETAVAX

ADSORBED TETANUS VACCINE

Suspension for injection in single dose

Read all of this leaflet carefully before you start using this medicinal product.

It contains important information for your treatment.

• If you have any further questions, ask your doctor or pharmacist.

• Keep this leaflet. You may need to read it again.

• If you need more information or advice, ask your doctor or pharmacist.

• You must contact a doctor if your symptoms worsen or do not improve.

• If any of the side effects gets serious, or if you notice any side effects not listed in this

leaflet, please tell your doctor or pharmacist.

1. WHAT TETAVAX IS AND WHAT IT IS USED FOR

This vaccine is an anti-infectious medicinal product indicated in the prevention of tetanus.

PERSONS INFECTED WITH THE HUMAN IMMUNODEFICIENCY VIRUS (HIV):

According to W.H.O. recommendations, any person infected with HIV, symptomatic or

asymptomatic, should be immunized with the TETAVAX vaccine according to the usual

schedule.

2. BEFORE YOU USE TETAVAX

Do not use TETAVAX in the following cases:

• If you are allergic to any of the vaccine components.

• If you experienced allergic reactions or neurological disorder after a previous vaccine

injection.

• If you have fever or an acute disease or chronic progressive illness, vaccination should be

postponed.

IF YOU HAVE DOUBTS, IT IS IMPORTANT THAT YOU ASK YOUR DOCTOR OR

PHARMACIST FOR ADVICE.

Take special care with TETAVAX:

Inform your doctor:

• If you suffer from immunodeficiency or if you follow an immunosuppressive treatment.

• If you are allergic or if you have already experienced an abnormal reaction during a

previous vaccine administration.

• If you received a tetanus vaccine in the previous five years.

• If you presented with Guillain-Barre syndrome (abnormal sensitivity, paralysis) or brachial

neuritis (paralysis, diffuse pain in arm and shoulder) following receipt of prior tetanus

toxoid containing vaccine (vaccine against tetanus), the decision to give any further

vaccine containing tetanus toxoid should be carefully evaluated by your doctor.

Using other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other

medicines, including medicines obtained without a prescription.

Pregnancy and lactation

Pregnancy

If needed, the vaccine may be administered during pregnancy.

Ask your doctor or pharmacist for advice before taking any medicine.

Lactation

Ask your doctor or pharmacist for advice before taking any medicine.

Important information about some of the ingredients of TETAVAX: Potassium

3. HOW TO USE TETAVAX

Dosage

Post-tetanus exposure prophylactic vaccination

The recommended schedule below should be complied with:

PATIENT COMPLETELY IMMUNISED

Time since last booster dose TYPE OF

WOUND

PATIENT NOT IMMUNISED OR

PARTIALLY IMMUNISED

5 to 10 years > 10 years

Minor - clean Begin or complete vaccination:

Tetanus toxoid, 1 dose of 0.5 ml None Tetanus toxoid:

1 dose of 0.5 ml

Major - clean

or tetanus -

prone

In one arm:

Human tetanus immunoglobulin, 250

I.U.*

In the other arm:

Tetanus toxoid**: 1 dose of 0.5 ml

Tetanus toxoid:

1 dose of 0.5 ml

In one arm:

Human tetanus

immunoglobulin,

250 I.U.*

In the other arm:

Tetanus toxoid**:

1 dose of 0.5 ml*

Tetanus-prone

Delayed or

incomplete

debridement

In one arm:

Human tetanus immunoglobulin, 500

I.U.*

In the other arm:

Tetanus toxoid**: 1 dose of 0.5 ml

Antibiotic therapy

Tetanus toxoid:

1 dose of 0.5 ml

Antibiotic therapy

In one arm:

Human tetanus

immunoglobulin,

500 I.U.*

In the other arm:

Tetanus toxoid**

1 dose of 0.5 ml*

Antibiotic therapy

* Use different syringes, needles and injection sites.

** Complete the vaccination according to the vaccination schedule.

Neonatal tetanus prophylaxis

Women of childbearing age or pregnant women that have not yet been immunised must have

2 successive injections at least 4 weeks apart; the first one shall preferably be administered

90 days or more before birth.

Primary immunisation: 2 successive injections one or two months apart followed by a booster

6 to 12 months after the second injection.

Booster injection: 1 dose10 years after primary immunisation and every 10 years thereafter.

Route of administration

Shake before injection until a homogeneous suspension is obtained.

It is preferable to administer the vaccine by the intramuscular route in order to minimize local

reactions. The deep subcutaneous route may also be used. The intradermal route should not

be used.

4. POSSIBLE SIDE EFFECTS

Like all medicines, TETAVAX can cause side effects, although not everybody gets them.

The reported side effects are as follows:

• Swelling of lymph nodes.

• Allergic or hypersensitivity reactions: urticaria, swelling (oedema).

• Skin reaction: itching (pruritus), skin redness (erythema).

• Headache, malaise.

• Hypotension.

• Muscle and joint pain.

• Injection site reactions such as pain, rash, induration or oedema within 48 hours and

persisting 1 to 2 days. These reactions may sometimes be accompanied with nodules and,

exceptionally, with uninfected abscesses.

• Transient fever, malaise.

The possible side effect (i.e. those which were not directly reported with TETAVAX but with

other vaccines containing or several constituents of TETAVAX) are as follows:

• Guillain-Barre syndrome (abnormal sensitivity, paralysis) and brachial neuropathy

(paralysis, diffuse pain in arm and shoulder) following receipt of prior tetanus toxoid

containing vaccine.

In babies born very prematurely (at or before 28 weeks of gestation) longer gaps than normal

between breaths may occur for 2-3 days after vaccination.

If any other side effects gets serious, or if you notice any side effects not listed in this leaflet,

please tell your doctor or pharmacist.

5. HOW TO STORE TETAVAX

Keep out of the reach and sight of children.

Do not use TETAVAX after the expiry date which is stated on the label, carton.

Store between +2°C to +8°C (in a refrigerator). Do not freeze.

After opening: the product should be used immediately.

Medicines should not be disposed of via wastewater or household waste.

Ask your pharmacist how to dispose of medicines no longer required. These measures will

help to protect the environment.

6. FURTHER INFORMATION

What TETAVAX contains

The active substance is:

One dose (0.5 ml) contains:

Tetanus toxoid …………………………………………..≥ 40 I.U.

Adsorbed on hydrated aluminum hydroxide …………0.6 mg Al

The other ingredients are:

A buffer solution containing sodium chloride, disodium dihydrate phosphate, monopotassium

phosphate and water for injections.

What TETAVAX looks like and contents of the pack

This medicinal product is a suspension for injection in single doses. Box of 20 ampoules or

box of 1 prefilled syringe.

This leaflet was last approved in 12/2010.