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RABIES VACCINE BP > 2.5 IU/ML POWDER AND SOLVENT FOR SUSPENSION FOR INJECTION

Active substance(s): INACTIVATED RABIES VIRUS STRAIN PM/WI 38 1503-3M / INACTIVATED RABIES VIRUS STRAIN PM/WI 38 1503-3M / INACTIVATED RABIES VIRUS STRAIN PM/WI 38 1503-3M

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Rabies Vaccine BP ≥ 2.5 IU/ml, Powder and solvent for suspension for injection

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
After reconstitution, 1 dose (1ml) contains:
Rabies virus* (inactivated, strain PM/WI 38 1503-3M)……..≥2.5 IU
*produced in human diploid MRC-5 cells
For a full list of excipients, see section 6.1

3

PHARMACEUTICAL FORM
Powder and solvent for suspension for injection
The powder is pinkish beige to orangey yellow.
The solvent is a clear, colourless solution.

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
For prophylactic immunisation against rabies. Treatment of patients following
suspected rabies contact.

4.2

Posology and method of administration
Administer by intramuscular injection. The vaccine should be administered
into the deltoid region. For instructions on the reconstitution of the vaccine
before administration, see section 6.6.
Pre-exposure prophylaxis
One injection of 1 millilitre given each day on days 0, 7 and 28.
The earliest day that the 3rd dose can be given to achieve effective immune
status is day 21.

For those at regular and continuing risk, a single reinforcing dose of vaccine
should be given at 1 year after the primary course has been completed. Further
doses should be given at three- to five-year intervals thereafter.
For travellers at intermittent risk of exposure, booster doses may be given in
line with official recommendations.
The need for serology testing to detect the presence of rabies virus-neutralising
antibodies (≥0.5 IU/ml) should be assessed and conducted, if appropriate, in
accordance with official recommendations.
Post-exposure prophylaxis
Post-exposure treatment should begin as soon as possible after the suspected
contact. Immediate wound toilet is important to reduce the risk of infection,
followed by the administration of the vaccine and passive immunisation if
indicated; this should be carried out in accordance with official
recommendations.
(i)
In persons known to have adequate prophylaxis:
In the event of contact with a suspected rabid animal, two further
boosters should be given, one on day 0 and one on day 3.
(ii)
In persons with no, or possibly inadequate, prophylaxis:
The first injection of rabies vaccine (day 0) should be given as soon as
possible after the suspected contact and followed by four further doses
on days 3, 7, 14, and 30 (the earliest that the 5th dose can be given is
day 28 as per WHO recommendations). The use of Rabies
Immunoglobulin should be considered in unimmunised or
incompletely immunised subjects or those with uncertain immune
status in accordance with official recommendations and/or expert
advice. The treatment schedule may be stopped if the animal concerned
is found conclusively to be free of rabies.
Subjects with incomplete prophylaxis or unknown history of immunisation
should be treated as non-immune.

4.3

Contraindications
Pre Exposure
Known systemic hypersensitivity reaction to any component of Rabies
Vaccine BP or
after previous administration of the vaccine or a vaccine containing the same
components as Rabies Vaccine BP.
Vaccination must be postponed in case of febrile and/or acute disease.
Post Exposure
Since declared rabies infection generally results in death, there are no
contraindications to post exposure vaccination.

4.4

Special warnings and precautions for use
In subjects with a history of allergy there may be an increased risk of sideeffects and this possibility should be taken into account.
As with all vaccines, appropriate facilities and medication such as epinephrine
(adrenaline) should be readily available for immediate use in case of
anaphylaxis or hypersensitivity following injection.
The vaccine may contain traces of neomycin and betapropiolactone which are
used during the manufacturing process. Caution must be exercised when the
vaccine is administered to subjects with hypersensitivity to betapropiolactone,
neomycin, and other antibiotics of the same class.
If Rabies Immunoglobulin is indicated in addition to Rabies Vaccine BP, then
it must be administered at a different anatomical site to the vaccination site.
Rabies Vaccine BP should not be administered to patients with bleeding
disorders such as haemophilia or thrombocytopenia, or to persons on
anticoagulant therapy unless the potential benefit clearly outweighs the risk of
administration. If the decision is taken to administer Rabies Vaccine BP in
such persons, it should be given with caution with steps taken to avoid the risk
of haematoma formation following injection.
The potential risk of apnoea and the need for respiratory monitoring for 48-72
h should be considered when administering the primary immunisation series to
very premature infants (born ≤ 28 weeks of gestation) and particularly for
those with a previous history of respiratory immaturity. As the benefit of
vaccination is high in this group of infants, vaccination should not be withheld
or delayed.
Anxiety-related reactions, including vasovagal reactions (syncope),
hyperventilation or stress-related reactions can occur following, or even
before, any vaccination as a psychogenic response to the needle injection. This
can be accompanied by several neurological signs such as transient visual
disturbance and paraesthesia. It is important that procedures are in place to
avoid injury from faints.

4.5

Interaction with other medicinal products and other forms of interaction
Corticosteroids and immunosuppressive treatments may interfere with
antibody
production and cause the failure of the vaccination. It is therefore advisable to
perform a neutralising antibody assay 2 – 4 weeks after the last injection.
Administration of an additional dose should be considered if the antibody titre
is less
than 0.5 IU/ml (using an RFFIT analysis – Rapid Fluorescent Focus Inhibition
Test).

4.6

Fertility, Pregnancy and lactation
Data on limited number of exposed pregnancies do not allow a conclusion on
the
potential risk of Rabies HDCV for pregnancy or for the health of the
foetus/newborn
child. Due to the severity of disease, pregnancy is not considered a
contraindication
to post exposure prophylaxis. If there is substantial risk of exposure to rabies,
preexposure
prophylaxis may also be indicated during pregnancy.
Due to the severity of the disease, breast feeding is not considered a
contraindication
and treatment must not be discontinued. It is not known whether this vaccine
is
excreted in human breast milk, thus no recommendation on
continuation/discontinuation of breastfeeding can be made.

4.7

Effects on ability to drive and use machines
No adverse effects reported.

4.8

Undesirable effects
Adverse reaction information is derived from clinical trials and worldwide
post- marketing experience.
Two randomised controlled trials where Rabies Vaccine BP has been studied
in both children (n=199) using pre-exposure schedule (3 doses, IM) and adults
(n=124) using the post exposure schedule (5 doses, IM) have been selected to
represent safety clinical data.
Within each system organ class the adverse reactions are ranked under
headings of frequency, using the following convention:
Very common (>1/10)
Common (>1/100, <1/10)
Uncommon (>1/1000, <1/100)
Not known (cannot be estimated from the available data because only reported
post marketing and not in clinical trials)
The most frequent adverse reactions are injection site pain and headache.
• Blood and lymphatic system disorders
o Very common: lymphadenopathy
• Immune system disorders
o Common: allergic reactions with skin disorders such as urticaria,
rash and pruritus, or respiratory manifestations such as dyspnoea
and wheezing. Angioedema.

o Not known: anaphylactic and serum sickness type reactions,
oedema
These reactions have been associated with the presence of
betapropiolactone-altered human albumin (including the production of
IgE antibodies in the vaccine).
Allergic reactions occurred more frequently among persons receiving
booster than primary vaccination. Further information on allergic
reactions see section 4.4.
• Nervous system disorders
o Very common: headache
o Common: dizziness
o Not known: encephalitis, convulsion, Guillain-Barré Syndrome,
paresis, neuropathy, paraesthesia
• Gastrointestinal disorders
o Very common: nausea, diarrhoea
o Common: abdominal pain, vomiting
• Musculoskeletal and connective tissue disorders
o Very common: myalgia, arthralgia
• General disorders and administration site conditions
o Very common: injection site reactions including pain, erythema,
induration and injection site pruritus. Malaise, chills
o Common: injection site bruising, pyrexia
o Not known: asthenia
Additional information on special populations:
Apnoea in very premature infants (≤ 28 weeks of gestation) (see section 4.4).
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal
product is important. It allows continued monitoring of the benefit/risk balance
of the medicinal product. Healthcare professionals are asked to report any
suspected adverse reactions via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard.

4.9

Overdose
Not applicable.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
The vaccine is a lyophilised, stabilised suspension of inactivated Wistar rabies
virus
strain PM/WI 38-1503-3M, cultured in human diploid cells (MRC5) and
inactivated
by beta-propiolactone.

5.2

Pharmacokinetic properties
Not applicable.

5.3

Preclinical safety data
None stated.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Human albumin solution.
Solvent: Water for Injections (1 millilitre).

6.2

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

6.3

Shelf life
3 years
Once reconstituted, the vaccine must be used immediately.

6.4

Special precautions for storage
Store between +2°C and +8°C in a refrigerator. Do not freeze.

6.5

Nature and contents of container
Powder:
Single dose (Ph Eur type 1 glass) vial with elastomeric stopper (chlorobutyl)
and

aluminium overcap.
Solvent:
1.0 ml disposable syringe (type I glass) with a plunger-stopper(elastomer) with
attached needle and needle-guard (elastomer).
1.0 ml disposable syringe (type 1 glass) with a plunger-stopper
(chlorobromobutyl)
without needle and with a tip- cap (chlorobromobutyl). Up to two separate
needles
(for each syringe) may be included in the pack.
1.0 ml disposable syringe (type I glass) with a plunger-stopper (elastomer)
with
attached needle and needle shield (grey elastomer).
Pack of 1 vial and 1 prefilled syringe.
Not all pack 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
prefilled syringe and rotated through 90 degrees.
Reconstitute the freeze-dried vaccine by introducing the solvent provided in
the prefilled
syringe into the vial of powder. Shake carefully until complete suspension of
the powder is obtained. Following reconstitution, the suspension will be a
pinkish
colour and free from particles. Withdraw the suspension from the vial into the
syringe
prior to intramuscular injection.
Shake well immediately before use.
Use immediately after reconstitution.
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 46602/0004

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
7 November 1994

10

DATE OF REVISION OF THE TEXT
22/03/2017

11

DOSIMETRY (IF APPLICABLE)
N/A

12

INSTRUCTIONS FOR PREPARATION OF
RADIOPHARMACEUTICALS (IF APPLICABLE)
N/A

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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