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REVAXIS

Manufacturer
SANOFI
Label last updated
06 Jan 2025
Source
Official SmPC ↗

Booster vaccine against diphtheria, tetanus and polio for children from 6 years, adolescents and adults. Not for primary immunisation.

42 findings, each with the section of the label it comes from.

Ingredients and materials

  • Purified diphtheria toxoid, not less than 2 IU (5 Lf) per 0.5 ml doses.2
  • Purified tetanus toxoid, not less than 20 IU (10 Lf) per doses.2
  • Inactivated poliomyelitis virus types 1, 2 and 3, cultivated on Vero cells (a laboratory-grown monkey kidney cell line)s.2
  • Aluminium hydroxide as an adsorbent, 0.35 mg as aluminium, present as an adjuvants.2
  • Phenoxyethanol, a preservative, and anhydrous ethanol (alcohol)s.6.1
  • Formaldehyde, used during manufactures.6.1
  • Medium 199: amino acids including phenylalanine, mineral salts, vitamins, polysorbate 80, hydrochloric acid and/or sodium hydroxides.6.1
  • Phenylalanine, 10 micrograms per dose, declared because it may be harmful in people with phenylketonuria (PKU)s.2, 4.4
  • Contains 2 mg of alcohol (ethanol) per 0.5 ml doses.4.4
  • Trace residues of neomycin, streptomycin and polymyxin B from production; allergy to any of these is a contraindications.4.3
  • Declared essentially potassium-free and sodium-free (less than 1 mmol each per dose)s.4.4

Manufacture, storage and handling

  • Shelf life 3 yearss.6.3
  • Store at 2C to 8C, do not freeze, discard the vaccine if it has been frozens.6.4
  • Must not be mixed with other medicinal products; no compatibility studies exists.6.2
  • Intramuscular injection only; the intradermal and intravascular routes must not be useds.4.2
  • Discard if extraneous particulate matter or discolouration is seens.6.6

Safety findings

  • Licensed only as a booster from six years of age; it is not intended for primary immunisations.4.1
  • No clinical data exist on use in people with an incomplete or absent primary course of diphtheria, tetanus or polio vaccinations.4.2
  • Not studied in people with tetanus-prone injuries; use there is inferred from Td vaccine datas.4.2
  • Contraindicated in hypersensitivity to the vaccines or excipients, and to neomycin, streptomycin or polymyxin Bs.4.3
  • Contraindicated in acute severe febrile illness, and after neurological complications following an earlier diphtheria or tetanus immunisations.4.3
  • Should not be given to anyone who completed a primary course or had a diphtheria or tetanus booster within the previous five yearss.4.4
  • If Guillain-Barre syndrome or brachial neuritis followed a previous tetanus toxoid vaccine, the decision to give any tetanus toxoid vaccine must weigh potential benefits against possible riskss.4.4
  • Immunogenicity may be reduced in immunosuppressed subjects; vaccination should be postponed where possible until immune function recoverss.4.4
  • Caution with thrombocytopenia or bleeding disorders because bleeding may follow intramuscular injection; may be given deep subcutaneously insteads.4.2, 4.4
  • Pregnancy: the effect on embryo-foetal development has not been assessed in animals; the vaccine should not be given to pregnant women unless it is considered urgent to boost immunitys.4.6
  • Breastfeeding: may be administereds.4.6
  • Fertility: no fertility studies were performeds.4.6
  • Local injection site reactions were reported by 65 to 80 per cent of subjects in each trials.4.8
  • Post-marketing reports include anaphylactic reactions including shock, convulsions, Guillain-Barre syndrome and brachial neuritis, all at frequency not knowns.4.8
  • Because events are reported voluntarily from a population of uncertain size, frequency cannot be reliably estimated and a causal relationship cannot always be establisheds.4.8

Evidence and claims

  • Immunogenicity was evaluated in 661 healthy subjects aged six to 78 years: in those vaccinated within ten years of a previous dose, more than 99 per cent achieved protective antibody levels one month after the boosters.5.1
  • A booster response was assessed in 113 healthy subjects aged 40 to 78 whose last dose was more than ten years earliers.5.1
  • Antibody persistence over two years in 113 adults: protective titres against diphtheria 100 per cent, tetanus 94.7 per cent, polio 100 per cents.5.1
  • In 151 children aged six to nine, antibody titres one month after a dose were about three-fold higher than in adults at two years, so levels in children 'may be anticipated' to be at least as goods.5.1
  • The measured outcome is antibody levels above a threshold, not prevention of diseases.5.1
  • Preclinical data reveal no special hazard for humans based on conventional studies of safety, specific toxicity and compatibility of ingredientss.5.3
  • Overdose: not documenteds.4.9

Document and licensing

  • Marketing authorisation holder: Sanofi Winthrop Industrie, France; distributed in the UK by Sanofis.7
  • First authorised 3 June 2003, latest renewal 4 April 2008s.9
  • Text last revised 4 January 2025s.10
  • Suspected reactions are reported through the MHRA Yellow Card schemes.4.8

Every line above is a summary of a statement in the manufacturer's own label, with the section number it comes from. Nothing has been added from any other source. The full list of flagged sentences is below, as it came out of the document.

Listed ingredients

Section 2 - qualitative and quantitative composition source ↗

Each dose (0.5 ml) contains:
 Active ingredients:
 Purified diphtheria toxoid ……………………………………………… not less than 2 IU^1 (5 Lf)
 Purified tetanus toxoid ………………………………………………… not less than 20 IU^1 (10 Lf)
 Inactivated poliomyelitis virus type 1^2………………..……………...29 D antigen units^3
 Inactivated poliomyelitis virus type 2^2………………..……………...7 D antigen units^3
 Inactivated poliomyelitis virus type 3^2…………………………….…26 D antigen units^3
 aluminium hydroxide as adsorbant…………………………………… 0.35 mg (as aluminium)
 ^1 As lower confidence limit (p = 0.95) of activity measured according to the assay described in the European Pharmacopoeia.
 ^2 Cultivated on Vero cells. 
 ^3 These antigen quantities are strictly the same as those previously expressed as 40-8-32 D-antigen units, for virus type 1, 2 and 3 respectively, when measured by another suitable immunochemical method.
 Excipient with known effect:Each dose (0.5 ml) contains approximately 10 μg of phenylalanine.
 For the full list of excipients, see section 6.1

What these are, in plain English

  • diphtheria toxoid - A diphtheria toxin that has been treated so it can no longer cause disease but still trains the immune system.
  • tetanus toxoid - A tetanus toxin that has been treated so it can no longer cause disease but still trains the immune system.
  • aluminium - An aluminium salt. It is an adjuvant: it makes the immune system respond more strongly to the vaccine. Aluminium in vaccines has been used since the 1930s.
  • vero - VERO cells: a laboratory-grown line of kidney cells originally taken from an African green monkey in 1962. Cells, not animal tissue, and they are not present in the finished vaccine.
  • phenylalanine - An amino acid. People with the inherited condition phenylketonuria (PKU) have to limit it, which is why it is declared.

Other ingredients (excipients)

Section 6.1 source ↗

  • Phenoxyethanol2-phenoxyethanol, a preservative that stops bacteria growing in a multi-dose container. Also used in cosmetics.
  • Ethanol anhydrousAlcohol, used as a solvent and to help inactivate viruses during manufacture.
  • FormaldehydeA chemical used to inactivate (kill) viruses or bacteria during manufacture. It is then removed, and only trace amounts can remain.
  • Acetic acid and/or sodium hydroxide (for pH adjustment)The acid in vinegar, used to adjust the acidity.
  • Medium 199*A standard laboratory nutrient mixture (salts, vitamins, amino acids, sugars) that cells are grown in. Its residues are diluted out almost entirely.
  • Water for injectionsPurified water to the standard used for injected medicines. It is the liquid the other ingredients are dissolved in.
  • * Medium 199 is a complex medium of amino acids including phenylalanine, mineral salts, vitamins, polysorbate 80, hydrochloric acid and/or sodium hydroxide (for pH adjustment) and other substances diluted in water for injections.A standard laboratory nutrient mixture (salts, vitamins, amino acids, sugars) that cells are grown in. Its residues are diluted out almost entirely.
Audit trail: every flagged sentence in the document (9)

These are the sentences the mechanical filter pulled out, in the document's own words, grouped by section. They are what the briefing above was built from, kept here so you can check nothing was left out. Some are fragments and some are technical, which is why the briefing exists.

4.2 Posology and method of administration

  1. Although REVAXIS has not been studied in subjects with tetanus-prone injuries, studies have shown that it induces similar tetanus antitoxin titres to Td vaccine.

    Section 4.2 Posology and method of administration source ↗

    In plain English

    • has not been studied - No trial has been run for this group or this situation.

    No data / not studied matched: has not been studied

  2. REVAXIS must not be administered by intradermal or intravascular routes.

    Section 4.2 Posology and method of administration source ↗

    Not recommended, contraindicated or restricted matched: must not be administered

4.3 Contraindications

  1. Hypersensitivity to diphtheria, tetanus or poliomyelitis vaccines or to any of the excipients listed in section 6.1.Hypersensitivity to neomycin, streptomycin or polymyxin B.

    Section 4.3 Contraindications source ↗

    In plain English

    • hypersensitivity - An allergic-type reaction, from a mild rash up to a severe reaction.

    Trace residues and process chemicals matched: neomycin

4.4 Special warnings and precautions for use

  1. The intradermal route must not be used either.

    Section 4.4 Special warnings and precautions for use source ↗

    Not recommended, contraindicated or restricted matched: must not be used

  2. If Guillain-Barré syndrome or brachial neuritis has occurred following receipt of prior vaccine containing tetanus toxoid, the decision to give any vaccine containing tetanus toxoid should be based on careful consideration of the potential benefits and possible risks.

    Section 4.4 Special warnings and precautions for use source ↗

    In plain English

    • toxoid - A bacterial toxin that has been treated so it can no longer cause harm but still trains the immune system.

    Rare or very rare serious events matched: brachial

4.6 Fertility, pregnancy and lactation

  1. The effect of REVAXIS on embryo-foetal development has not been assessed in animals.

    Section 4.6 Fertility, pregnancy and lactation source ↗

    Animal, human or cell-line derived materialNo data / not studied matched: foetal, not been assessed

4.8 Undesirable effects

  1. Not known (cannot be estimated from the available data

    Section 4.8 Undesirable effects source ↗

    In plain English

    • not known - The label's lowest band: the number of cases is too small, or the reporting too patchy, to work out how often it happens.

    No data / not studied matched: not known

  2. Because events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to vaccine exposure.

    Section 4.8 Undesirable effects source ↗

    In plain English

    • uncertain - The evidence does not settle the question.

    Limited, insufficient or inconclusive matched: uncertain

6.1 List of excipients

  1. * Medium 199 is a complex medium of amino acids including phenylalanine, mineral salts, vitamins, polysorbate 80, hydrochloric acid and/or sodium hydroxide (for pH adjustment) and other substances diluted in water for injections.

    Section 6.1 List of excipients source ↗

    Trace residues and process chemicals matched: polysorbate

Read the whole document at the source ↗