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REVAXIS SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE

Active substance(s): DIPHTHERIA TOXOID ADSORBED PURIFIED / POLIOMYELITIS INACTIVATED VIRUS TYPE 1 / POLIOMYELITIS INACTIVATED VIRUS TYPE 2 / POLIOMYELITIS INACTIVATED VIRUS TYPE 3 / TETANUS TOXOID ADSORDED PURIFIED / DIPHTHERIA TOXOID ADSORBED PURIFIED / POLIOMYELITIS INACTIVATED V

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
REVAXIS
Suspension for injection in pre-filled syringe
Diphtheria, tetanus and poliomyelitis (inactivated) vaccine (adsorbed, reduced
antigen(s) content)

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose (0.5 ml) contains:
Active ingredients:
Purified diphtheria toxoid

not less than 2 IU* (5 Lf)

Purified tetanus toxoid

not less than 20 IU* (10 Lf)

Inactivated poliomyelitis virus type 1**

40 D antigen units***

Inactivated poliomyelitis virus type 2**………………..……………... 8 D
antigen units***
Inactivated poliomyelitis virus type 3**…………………………….…32 D
antigen units***
aluminium hydroxide as adsorbant…………………………………… 0.35
mg (as aluminium)
For a full list of excipients, see section 6.1
*
As lower confidence limit (p = 0.95) of activity measured according to
the assay described in the European Pharmacopoeia.
**

Produced in Vero cells.

*** Or equivalent antigenic quantity determined by a suitable
immunochemical method

3

PHARMACEUTICAL FORM
Suspension for injection in pre-filled syringe.
The vaccine has a cloudy white appearance.

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
REVAXIS is indicated for active immunisation against diphtheria, tetanus and
poliomyelitis in children from six years of age, adolescents and adults as a
booster following primary vaccination.
REVAXIS is not intended for primary immunisation.

4.2

Posology and method of administration
Posology
The dose for children from the age of six years, adolescents and adults is 0.5
ml.
REVAXIS should be administered in accordance with official
recommendations and/or local practice regarding the use of vaccines that
provide reduced (adult) dose diphtheria toxoid plus tetanus toxoid in
combination with inactivated poliomyelitis viruses.
REVAXIS may be used as a booster following primary immunisation with
inactivated or oral poliomyelitis vaccines (IPV or OPV). There are no clinical
data available regarding the use of REVAXIS in individuals with an
incomplete, or no, history of a primary series of diphtheria and tetanus toxoids
or of vaccinations against poliomyelitis.
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. REVAXIS may therefore be used in subjects with tetanus-prone
injuries if concomitant vaccination against diphtheria and poliomyelitis is
desirable.
Method of Administration
REVAXIS is for intramuscular injection only. The recommended injection site
is the deltoid region.
REVAXIS must not be administered by intradermal or intravascular routes.
Under certain conditions (e.g. bleeding disorders) REVAXIS may be
administered as a deep subcutaneous injection.
For further instructions for use see section 6.6.

4.3

Contraindications
Hypersensitivity to diphtheria, tetanus or poliomyelitis vaccines or to any
other ingredient of the vaccine.
Hypersensitivity to neomycin, streptomycin or polymyxin B. These are used
during production and traces may remain in the vaccine.

Acute severe febrile illness. The presence of a minor infection is not a
contraindication.
Neurological complications following an earlier immunisation against
diphtheria and/or tetanus.

4.4

Special warnings and precautions for use
As for all vaccines, appropriate medical treatment should be readily available
for immediate use in case of an anaphylactic reaction following vaccination.
REVAXIS should under no circumstances be administered intravascularly.
The intradermal or subcutaneous routes must not be used either.
The immunogenicity of the vaccine could be reduced in immunosuppressed
subjects. Where possible, vaccination should be postponed until immune
function has recovered. However, vaccination of subjects with chronic
immunodeficiency, such as AIDS, is recommended even if the antibody
response might be limited.
REVAXIS must be administered with caution to subjects with
thrombocytopenia or a bleeding disorder since bleeding may occur following
an intramuscular administration to such subjects.
In order to minimise the risk of adverse events, REVAXIS should not be
administered to subjects who completed a primary vaccination course or
received a booster of a vaccine containing diphtheria or tetanus toxoids within
the previous five years.
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.

4.5

Interaction with other medicinal products and other forms of interaction
REVAXIS may be administered at the same time as other vaccines or
immunoglobulins provided that the injections are made at separate site.
Subjects who are taking immunosuppressive agents may not respond to
REVAXIS (see section 4.4).

4.6

Pregnancy and lactation
The effect of REVAXIS on embryo-foetal development has not been assessed
in animals. No teratogenic effect of vaccines containing diphtheria or tetanus
toxoids, or inactivated poliovirus has been observed following use in pregnant
women. However, this vaccine should not be administered to pregnant women
unless it is considered urgent to boost immunity.

REVAXIS may be administered to breastfeeding women.

4.7

Effects on ability to drive and use machines
Vertigo has been reported following vaccination.

4.8

Undesirable effects
The adverse events are ranked under headings of frequency using the
following convention:
Very common:
(≥1/10)
Common:
(≥1/100 to <1/10)
Uncommon: (≥1/1,000 to <1/100)
Rare:
(≥1/10,000 to <1/1,000)
Very rare:
(<1/10,000), not known (cannot be estimated from the available
data)
Data from pre-approval clinical studies
In clinical studies, the most common events occurring after vaccine
administration were local injection site reactions (pain, erythema, induration
and oedema) reported by 65 to 80% of subjects in each trial. These usually had
their onset within the 48 hours following vaccination and persisted for 1 to 2
days. These reactions are sometimes accompanied by injection site nodules.
Blood and lymphatic system disorders:
Uncommon: lymphadenopathy
Nervous system disorders
Common:
headache
Ear and labyrinth disorders
Common:
vertigo
Gastrointestinal disorders
Common:
nausea / vomiting
Musculoskeletal and connective tissue disorders
Uncommon: myalgia
Rare:
arthralgia
General disorders and administration site conditions

Very common:
local reactions (injection site pain, injection site
erythema,
injection
site
induration,
injection site oedema and injection site nodule)
Common:
pyrexia
Uncommon: malaise

Data from post-marketing surveillance:
Based on spontaneous reporting, the following additional adverse events have
been reported during the commercial use of REVAXIS.
These events have been very rarely reported, however exact incidence rates
cannot precisely be calculated.
Nervous system disorders
Convulsions, Guillain Barre syndrome, brachial neuritis, transient paresthesia
and hypoesthesia of the vaccinated limb, vasovagal syncope
Gastrointestinal disorders
Abdominal pain, diarrhoea
Skin and subcutaneous tissue disorders
allergic-type reactions such as urticaria, various types of rash, and face
oedema
Musculskelettal and connective tissue disorders
Pain in vaccinated limb
General disorders and administration site conditions
Large injection site reaction (>50 mm), including extensive limb swelling
from the injection site beyond one or both joints have been reported.These
reactions start within 24-72 hours after vaccination, may be associated with
erythema, warmth, tenderness or pain at the injection site and resolve
spontaneously
within
3-5
days.
Pallor, asthenia, usually occurring and resolving within a few days, chills,
influenza-like symptoms, mostly the same day as the vaccination
Immune system disorder:
systemic allergic / anaphylactic reactions including shock

4.9

Overdose
Not documented.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
Pharmacotherapeutic group: Vaccine against diphtheria, tetanus and
poliomyelitis
ATC code: J07CA01
During clinical studies, the immunogenicity of REVAXIS was evaluated in
661 healthy subjects aged six to 78 years. In subjects vaccinated within ten
years of a previous dose of diphtheria/tetanus/poliomyelitis vaccine, more than
99% achieved protective antibody levels for diphtheria, tetanus and
poliomyelitis (types 1, 2 and 3) one month after receiving REVAXIS .
In a clinical study carried out in 113 healthy subjects aged 40 to 78 years who
received their last vaccination against diphtheria, tetanus and poliomyelitis
more than ten years ago, REVAXIS elicited a satisfactory booster response.
Antibody persistence over a two-year period was assessed in 113 healthy
adults. Two years after receiving a dose of REVAXIS the proportions of
subjects with protective titres against diphtheria, tetanus and poliomyelitis
(types 1, 2 and 3) were 100%, 94.7% and 100% respectively. In a clinical
study in 151 healthy children aged six to nine years, antibody titres at one
month after a dose of REVAXIS were approximately three-fold higher than
those seen in the healthy adults at two years post-dose. Therefore, it may be
anticipated that antibody levels in children would be at least as good as those
observed in adults at two years post-dose.

5.2

Pharmacokinetic properties
Evaluation of pharmacokinetic properties is not required for vaccines.

5.3

Preclinical safety data
Preclinical data reveal no special hazard for humans based on conventional
studies of safety, specific toxicity and compatibility of ingredients.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Phenoxyethanol
Formaldehyde
Medium 199*
Water for injections
* Medium 199 is a complex medium of amino acids, mineral salts, vitamins,
polysorbate 80 and other substances diluted in water for injections.

6.2

Incompatibilities
In the absence of compatibility studies, the vaccine must not be mixed with
other medicinal products.

6.3

Shelf life
3 years

6.4

Special precautions for storage
Store in a refrigerator (2°C to 8°C).
Do not freeze. Discard the vaccine if it has been frozen.

6.5

Nature and contents of container
0.5 ml of suspension in pre-filled syringe (0.5 ml, type I glass) with a plungerstopper (bromochlorobutyl or bromobutyl or chlorobutyl) and attached needle
and needle-guard (natural rubber or polyisoprene elastomer).
0.5 ml of suspension in pre-filled syringe (0.5 ml, type I glass) with a plungerstopper (bromochlorobutyl or bromobutyl or chlorobutyl) and tip-cap
(bromochlorobutyl or synthetic isoprene-bromobutyl), without needle.
Packs of 1, 10 and 20 syringes.
0.5 ml of suspension in pre-filled syringe (0.5 ml, type I glass) with a plungerstopper (bromochlorobutyl or bromobutyl or chlorobutyl) and tip-cap
(bromochlorobutyl or synthetic isoprene-bromobutyl), with 1 or 2 separate
needles (for each syringe).
Packs of 1 and 10 syringes.
Not all pack sizes and presentations may be marketed.

6.6

Special precautions for disposal
For needle free syringes, the needle should be pushed firmly on to the end of
the pre-filled syringe and rotated through 90 degrees.
The vaccine’s normal appearance is a cloudy white suspension that may
sediment during storage. Shake the pre-filled syringe well to distribute
uniformly the suspension before administering the vaccine.
Parenteral biological products should be inspected visually for extraneous
particulate matter and/or discolouration prior to administration. In the event of
either being observed, discard the vaccine.
Any unused product or waste material should be disposed of in accordance
with local requirements.

7

MARKETING AUTHORISATION HOLDER

Sanofi Pasteur Europe
2 Avenue Pont Pasteur
69007 Lyon
FRANCE
Distributed in the UK by:
Sanofi
One Onslow Street
Guildford
Surrey
GU1 4YS

8

MARKETING AUTHORISATION NUMBER(S)
PL 46602/0006

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
11/02/2008

10

DATE OF REVISION OF THE TEXT
02/03/2017

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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