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STAMARIL POWDER AND SOLVENT FOR SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE

Active substance(s): YELLOW FEVER VIRUS 17D/AB237 STRAIN / YELLOW FEVER VIRUS 17D/AB237 STRAIN / YELLOW FEVER VIRUS 17D/AB237 STRAIN

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1.

NAME OF THE MEDICINAL PRODUCT

STAMARIL
Powder and solvent for suspension for injection in pre-filled syringe.
Yellow fever vaccine (Live).

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
After reconstitution, 1 dose (0.5 ml) contains:
Yellow fever virus1 17 D-204 strain (live, attenuated)
1

not less than 1000 IU

produced in specified pathogen-free chick embryos

For a full list of excipients, see section 6.1.

3.

PHARMACEUTICAL FORM

Powder and solvent for suspension for injection.
The powder is beige to orange beige; the solvent is clear and colourless.

4.

CLINICAL PARTICULARS

4.1

Therapeutic indications

STAMARIL is indicated for active immunization against yellow fever in persons:
travelling to, passing through or living in an endemic area,
travelling to any country that requires an International Certificate of Vaccination for entry
(which may or may not depend on the previous itinerary).
handling potentially infectious materials (e.g. laboratory personnel).
See sections 4.2, 4.3 and 4.4 regarding the minimum age for vaccination of children under
special circumstances and guidance for vaccination of other specific patient populations.
In order to comply with vaccine regulations and to be officially recognised, yellow fever
vaccines must be administered in an approved World Health Organization (WHO)
vaccination centre and registered on an International Certificate of Vaccination. This

certificate is valid for 10 years from the 10th day after vaccination and immediately after revaccination.

4.2

Posology and method of administration

Posology:
Primary vaccination
Adults and children aged 9 months and over: A single dose of 0.5 ml of reconstituted vaccine.
Children under 9 months of age: The vaccine must not be given to children less than 6
months old (see section 4.3). Vaccination against yellow fever is not usually recommended in
children aged from 6 months up to 9 months except in specific circumstances and in
accordance with available official recommendations (see section 4.4), in which case the dose
is the same as in older children and adults.
The vaccine should be given at least 10 days before entering an endemic area since protective
immunity may not be achieved until at least this time has elapsed.
Elderly
The dose is the same as for adults. However due to a higher risk of yellow fever vaccineassociated severe and potentially fatal disease in persons from 60 years of age, the vaccine
should only be given when it is considered that there is a considerable and unavoidable risk of
acquiring yellow fever infection (see sections 4.4 and 4.8).
Re-vaccination:
Re-vaccination with one dose of 0.5 ml is recommended every 10 years in persons considered
to be at risk of exposure.
International Health Regulations require re-vaccination, using the same dose as for primary
vaccination, at intervals of 10 years in order to retain a valid certificate.
Method of administration:
It is preferable that the vaccine is injected by the subcutaneous route
Intramuscular injection may be performed if this is in accordance with applicable official
recommendations.
For intramuscular use the recommended injection sites are the anterolateral aspect of the thigh
in the infants and toddlers (6 months up to 2 years of age) and the deltoid muscle in older
children and adults.
DO NOT INJECT INTRAVASCULARLY
See section 6.6. for instructions on reconstitution

4.3

Contraindications

Hypersensitivity reaction to eggs, chicken proteins or to any component of STAMARIL
Serious hypersensitivity reactions (e.g., anaphylaxis) after a previous dose of any yellow
fever vaccine.
Immunosuppression, whether congenital, idiopathic or as a result of treatment with
systemic steroids (greater than the standard dose of topical or inhaled steroids),
radiotherapy or cytotoxic drugs.
History of thymus dysfunction (including thymoma, thymectomy)
Symptomatic HIV infection
Asymptomatic HIV infection when accompanied by evidence of impaired immune
function (see section 4.4).
Age less than 6 months (see sections 4.2 and 4.4).
Current severe febrile illness.

4.4
Special warnings and precautions for use
As with all injectable vaccines, appropriate medical treatment and supervision should always
be readily available in case of anaphylaxis or other severe hypersensitivity reaction following
administration of the vaccine.
STAMARIL should be administered only to persons who are/will be at risk of infection with
yellow fever virus or who must be vaccinated to comply with international health regulations.
Before considering administration of yellow fever vaccine, care should be taken to identify
those who might be at increased risk of adverse reactions following vaccination (see section
4.3 and below).
Yellow fever vaccine associated neurotropic disease
Very rarely, yellow fever vaccine-associated neurotropic disease (YEL-AND) has been
reported following vaccination, with sequelae or with fatal outcome in some cases (see
section 4.8). Clinical features have appeared within one month of vaccination and include
high fever with headache that may progress to include one or more of the following:
confusion, encephalitis/encephalopathy, meningitis, focal neurological deficits, or Guillain
Barr syndrome. To date, those affected have been primary vaccinees. The risk appears to be
higher in those aged over 60 years, although cases have been also reported in younger persons
or following transmission from nursing mothers to the infants.
Yellow fever vaccine-associated viscerotropic disease
Very rarely, yellow fever vaccine-associated viscerotropic disease (YEL-AVD) resembling
fulminant infection by wild-type virus has been reported following vaccination (see section
4.8). The clinical presentation may include fever, fatigue, myalgia, headache, hypotension,
progressing to one or more of metabolic acidosis, muscle and liver cytolysis,
lymphocytopenia and thrombocytopenia, renal failure and respiratory failure. The mortality
rate has been around 60%. To date, all cases of YEL-AVD have been in primary vaccinees
with onset within 10 days of vaccination. The risk appears to be higher in those aged over 60
years although cases have also been reported in younger persons. Disease of the thymus gland
has also been recognised as a potential risk factor (see section 4.3 and section 4.8).
Immunosuppressed persons
STAMARIL must not be administered to immunosuppressed persons (see section 4.3).
If the immunosuppression is temporary, vaccination should be delayed until the immune
function has recovered. In patients who have received systemic corticosteroids for 14 days or
more, it is advisable to delay vaccination until at least one month after completing the course.


HIV infection

STAMARIL must not be administrated to persons with symptomatic HIV infection or with
asymptomatic HIV infection when accompanied by evidence of impaired immune function
(see section 4.3). However, there are insufficient data at present to determine the
immunological parameters that might differentiate persons who could be safely vaccinated
and who might mount a protective immune response from those in whom vaccination could
be both hazardous and ineffective. Therefore, if an asymptomatic HIV-infected person cannot
avoid travel to an endemic area available official guidance should be taken into account when
considering the potential risks and benefits of vaccination.
Children born to HIV positive mothers
Children aged at least 6 months (see sections 4.2 and 4.3 and below) may be vaccinated if it is
confirmed that they are not infected with HIV.
HIV infected children aged at least 6 months who are potentially in need of protection against
yellow fever should be referred to a specialist paediatric team for advice on whether or not to
vaccinate.
Age
Children aged 6 to 9 months
STAMARIL must not be administered to children before the age of 6 months (see section
4.3). Children aged from 6 months up to 9 months should only be vaccinated under special
circumstances (e.g. during major outbreaks) and on the basis of current official advice.
Persons aged 60 years and older
Some serious and potentially fatal adverse reactions (including systemic and neurological
reactions persisting more than 48 hours, YEL-AVD and YEL-AND) appear to occur at higher
frequencies after the age of 60 years. Therefore, the vaccine should only be given to those
who have a considerable risk of acquiring yellow fever (see above and section 4.8).
Because intramuscular injection can cause injection site haematoma, STAMARIL should not
be given by the intramuscular route to persons with any bleeding disorder, such as
haemophilia or thrombocytopenia, or to persons on anticoagulant therapy. The subcutaneous
route of administration should be used instead.
Patients with rare hereditary problems of fructose intolerance should not take this vaccine.
Transmission
There are very few reports suggesting that transmission of Yellow Fever vaccine virus may
occur from nursing mothers, who received Yellow Fever vaccine postpartum, to the infant.
Following transmission the infants may develop yellow fever vaccine associated neurotropic
disease (YEL-AND) from which the infants recover (see section 4.6).
4.5

Interaction with other medicinal products and other forms of interaction

STAMARIL must not be mixed with any other vaccine or medicinal product in the same
syringe.
If there is a need to administer another injectable vaccine(s) at the same time as STAMARIL
each vaccine should be injected into a separate site (and preferably a separate limb).
STAMARIL may be administered at the same time as measles vaccine if this is in
accordance with official recommendations.
STAMARIL may be administered at the same time as vaccines containing typhoid Vi
capsular polysaccharide and/or inactivated hepatitis A virus.
STAMARIL must not be administered to persons who are receiving immunosuppressant
therapy (e.g., cytotoxic agents, systemic steroids, greater than standard dose of topical or
inhaled steroids or other agents). See section 4.3.

4.6

Pregnancy and lactation

Pregnancy
No animal reproduction studies have been conducted with STAMARIL and the potential risk
for humans is unknown. Data on a limited number of exposed pregnancies indicate no adverse
effects of STAMARIL on pregnancy or the health of the fetus/newborn child. Nevertheless,
STAMARIL should be given to pregnant women only when clearly needed and only after
careful consideration of the potential risks and benefits.
Lactation
As there is a probable risk of transmission of the vaccine virus strain to the infants from
breast-feeding mothers, STAMARIL should not be given to nursing mothers unless when
clearly needed such as during an outbreak control, and following an assessment of the risks
and benefits (see section 4.4.).
4.7

Effects on ability to drive and use machines

No studies on the effects on the ability to drive or use machine have been performed.

4.8

Undesirable effects

Data from clinical studies
Across clinical studies, the most common adverse reactions occurring after vaccine
administration were local reactions, reported in approximately 16% of subjects.
The following adverse events are from one clinical study in which 106 healthy adult
subjects received STAMARIL.
The adverse events are ranked under headings of frequency, using the following
convention:


Very common: 10%



Common: 1% and 10%



Uncommon: 0.1% and 1%

Nervous system disorders
Very common: Headache
Gastro-intestinal system disorders
Common:

Nausea, Diarrhoea, Vomiting

Uncommon:

Abdominal pain

Musculo-skeletal and connective tissue disorders
Common:

Myalgia

Uncommon:

Arthralgia

General disorders and administration site conditions

Very common: Local reactions (including pain, redness, haematoma, induration,
swelling)
Common:

Pyrexia, Asthenia

Data from post-marketing experience
The following additional adverse events have been reported during post marketing
experience with STAMARIL. They are based on spontaneous reporting therefore the
frequencies are unknown.
Blood and lymphatic system disorders
Lymphadenopathy
Immune system disorders
Anaphylaxis, Angioedema
Nervous system disorders
Cases of neurotropic disease (known as YEL-AND), some of which have had a fatal
outcome, have been reported following yellow fever vaccination (see section 4.4).
YEL-AND may manifest as high fever with headache that may progress to include
one or more of confusion, lethargy, encephalitis, encephalopathy and meningitis (see
section 4.4).
Other neurological signs and symptoms have been reported and include convulsion,
Guillain-Barr syndrome and focal neurological deficits.
Skin and subcutaneous tissue disorders
Rash, Urticaria
General disorders and administration site conditions
Cases of viscerotropic disease (known as YEL-AVD and formerly described as
Febrile Multiple Organ-System Failure ) have been reported following yellow fever
vaccination some of which have been fatal (see section 4.4). YEL-AVD may manifest
as fever, fatigue, myalgia, headache and hypotension progressing to one or more of
metabolic acidosis, muscle and liver cytolysis, lymphocytopenia and
thrombocytopenia, renal and respiratory failure.
Additional information on special population
Congenital or acquired immunodeficiency has been identified as a risk factor for
neurotropic disease (See sections 4.3 and 4.4).
Age of more than 60 years (see section 4.4) has been identified as a risk factor for
YEL-AVD and YEL-AND. A medical history of thymic disease (see sections 4.3 and
4.4) has been identified as a risk factor for YEL-AVD.
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

No case of overdose has been reported.

5.

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties

Pharmacotherapeutic group: Yellow Fever Vaccine (Live)
ATC code: J07B L1
STAMARIL is a live attenuated yellow fever virus vaccine. As with other live attenuated
viral vaccines, there is a sub-clinical infection in healthy recipients that results in the
production of specific B and T cells and the appearance of specific circulating antibody.
Protective immunity appears from about 10 days after injection. Although International
Health Regulations require re-vaccination at intervals of 10 years in order to retain a valid
certificate, some degree of immunity likely persists for more than 10 years.

5.2

Pharmacokinetic properties

No pharmacokinetic studies have been performed.

5.3

Preclinical safety data

Pre-clinical data reveal no special hazard for humans.

6.

PHARMACEUTICAL PARTICULARS

6.1

List of excipients

Powder:
Lactose
Sorbitol E420
L-histidine hydrochloride
L-alanine
Sodium chloride
Potassium chloride
Disodium phosphate
Monopotassium phosphate
Calcium chloride
Magnesium sulphate

Solvent:
Sodium chloride
Water for injections.

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.
After reconstitution, the medicinal product must be used immediately.

6.4

Special precautions for storage

Store in a refrigerator (2 C 8 C). Do not freeze. Keep the vial in the outer carton in order to
protect from light.
For storage conditions of the reconstituted medicinal product, see section 6.3

6.5.

Nature and contents of container
Powder in vial (type I glass), with stopper (chlorobutyl) and flip-off cap (aluminium)
+ 0.5 ml of solvent in pre-filled syringe (type I glass), with a plunger-stopper
(halobutyl), attached needle and needle-shield (natural rubber or polyisoprene) pack
size of 1, 10 or 20.
Powder in vial (type I glass), with stopper (chlorobutyl) and flip-off cap (aluminium)
+ 0.5 ml of solvent in pre-filled syringe (type I glass), with a plunger-stopper
(halobutyl), and tip-cap (chlorobromobutyl or styrene butadiene) pack size of 1 and
10.
Powder in vial (type I glass), with stopper (chlorobutyl) and flip-off cap (aluminium)
+ 0.5 ml of solvent in pre-filled syringe (type I glass), with a plunger-stopper
(halobutyl) and tip cap (chlorobromobutyl or styrene butadiene) with 1 or 2 separate
needles attached in the blister pack size of 1 and 10.

Not all pack sizes or presentations may be marketed.

6.6

Special precautions for disposal

For syringe without attached needle only: after removing the syringe tip cap, the
needle should be firmly placed on the tip of the syringe and secured by rotating a
quarter of a turn (90 ).
The powder is reconstituted by adding the solvent provided in the pre-filled syringe to
the vial. The vial is shaken and, after complete dissolution, the suspension obtained
is withdrawn into this same syringe for injection.
Before administration, the reconstituted vaccine should be shaken vigorously.
Use immediately after reconstitution.
After reconstitution the suspension is beige to pink beige.
Contact with disinfectants is to be avoided since they may inactivate the virus.
Any unused product or waste material should be disposed of, preferably by heat
inactivation or incineration, in accordance with local requirements.

7.

MARKETING AUTHORISATION HOLDER

Sanofi Pasteur MSD Limited
Mallards Reach
Bridge Avenue
Maidenhead
Berkshire
SL6 1QP
8.

MARKETING AUTHORISATION NUMBER(S)

PL 6745/0087

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
03/09/2007

10

DATE OF REVISION OF THE TEXT
21/08/2013

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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