Cases of administration of more than the recommended dose (overdose) have been reported with STAMARIL.
3 years.
After reconstitution, the medicinal product must be used immediately.
-
- Severe hypersensitivity reactions (e.g., anaphylaxis) after a previous dose of any yellow fever vaccine.
- Age less than 6 months.
- 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 myasthenia gravis, thymoma, thymectomy).
- Symptomatic HIV infection.
- Asymptomatic HIV infection when accompanied by evidence of impaired immune function.
- Moderate or severe febrile illness or acute illness.
In the absence of compatibility studies, this vaccine must not be mixed with other medicinal products.
Powder:
Lactose
Sorbitol E420
L-Histidine hydrochloride
L-Alanine
Sodium chloride
Potassium chloride
Disodium phosphate dihydrate
Potassium dihydrogen phosphate
Calcium chloride
Magnesium sulphate
Solvent:
Sodium chloride
Water for injections
Powder and solvent for suspension for injection.
Before reconstitution, the powder is homogeneous, beige to orange beige, and the solvent is a limpid solution.
a. Summary of the safety profile
In all clinical studies, 4896 subjects (all ages) received STAMARIL.
In the most representative study in general population, the most frequently reported reactions (between 12% and 18% of subjects) were headache, asthenia, injection site pain and myalgia.
In the most representative study in toddler population, the most frequently reported reactions (between 32% and 35% of toddlers) were irritability, crying and appetite loss.
Adverse reactions usually occurred within the first three days following vaccination except pyrexia, which occurred between Day 4 and Day 14.
These reactions usually lasted for not more than 3 days.
Both local and systemic reactions were usually of mild intensity; however at least one severe injection site reaction was reported in 0.8% of subject in general population and in 0.3% of toddlers and at least one severe systemic reaction was reported in 1.4% of subjects in general population and 4.9% in toddlers.
Cases of serious adverse events such as severe hypersensitivity or anaphylactic reactions, neurotropic or viscerotropic disease (YEL-AND; YEL-AVD) have been reported from post-marketing experience (see subsections b. Tabulated list of adverse reactions and c. Description of selected adverse reactions).
b. Tabulated list of adverse reactions
The table below summarizes the frequencies of the adverse reactions that were recorded following vaccination with STAMARIL during clinical studies and worldwide post-marketing experience.
The adverse reactions 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 available data)
| System Organ Class | Frequency | Adverse reactions |
| Infections and infestations | Rare | Rhinitis |
| Very rare | YEL-AVD‡ | |
| Blood and Lymphatic System Disorders | Not known | Lymphadenopathy |
| Immune System Disorders | Not known | Anaphylactoid reaction including angioedema |
| Metabolism and nutrition disorders | Very common | Appetite loss* |
| Nervous System Disorders | Very common | Drowsiness*, Headache |
| Uncommon | Dizziness | |
| Very rare | YEL-AND‡ | |
| Not known | Paresthesia | |
| Gastrointestinal disorders | Very common | Vomiting†|
| Common | Nausea | |
| Uncommon | Abdominal pain | |
| Rare | Diarrhea | |
| Skin and Subcutaneous tissue Disorders | Common | Rash |
| Uncommon | Pruritus | |
| Not known | Urticaria | |
| Musculoskeletal and Connective Tissue Disorders | Very common | Myalgia |
| Common | Arthralgia | |
| General Disorders and Administration Site Conditions | Very common | Irritability*, Crying*, Pyrexia†, Asthenia, Injection site pain/tenderness |
| Common | Injection site erythema/redness, Injection site hematoma, Injection site induration; Injection site oedema/swelling | |
| Uncommon | Injection site papule | |
| Not known | Influenza-like illness |
*Specific to paediatric population, (see Section d. Paediatric population)
‡ For clinical features see Section c. Description of selected adverse reactions
†Very common in toddlers (see Section d. Paediatric population), Common in general population
c. Description of selected adverse reactions
Cases of neurotropic disease (known as YEL-AND), some of which have had a fatal outcome, have been reported to occur within 30 days following vaccination with STAMARIL, and other yellow fever vaccines. YEL-AND may manifest as high fever with headache that may progress to include one or more of confusion, lethargy, encephalitis, encephalopathy and meningitis. Other neurological signs and symptoms have been reported and include convulsion, Guillain-Barré syndrome and focal neurological deficits.
Cases of viscerotropic disease (known as YEL-AVD and formerly described as “Febrile Multiple Organ-System Failureâ€) have been reported following vaccination with STAMARIL, and other yellow fever vaccines, some of which have been fatal. In the majority of cases reported, the onset of signs and symptoms was within 10 days after the vaccination.
Initial signs and symptoms are non-specific and may include pyrexia, myalgia, fatigue, headache and hypotension, potentially progressing quickly to liver dysfunction with jaundice, muscle cytolysis, thrombocytopenia and acute respiratory and renal failure.
d. Paediatric population
The safety of STAMARIL in paediatric population has been studied through a clinical study performed in 393 toddlers aged 12 to 13 months which received STAMARIL and placebo concomitantly.
The safety profile was assessed during the first 4 weeks following vaccination.
The following most frequently reported adverse reactions specific to the paediatric population were reported as “very commonâ€: irritability (34.7%), appetite loss (33.7%), crying (32.1%) and drowsiness (22%).The other adverse reactions reported in toddlers were also reported from studies in general population:
- Injection site pain (17.6%), pyrexia (16.5%) and vomiting (17.1%) were reported as “very common†in toddlers. Pyrexia and vomiting were more frequently reported than in general population (see table in subsection b. Tabulated summary of adverse reactions).
- Injection site erythema (9.8%) and injection site swelling (4.4%) were reported as “common†in toddlers, like in general population, however with significantly higher frequencies compared to general population.
e. Other special population
Congenital or acquired immunodeficiency has been recognized as a potential risk factor for serious adverse events, including YEL-AND.
Age of more than 60 years has been recognized as a potential risk factor for YEL-AVD and YEL-AND.
Age below 9 months (including infants exposed to vaccine through breastfeeding) has been recognized as a potential risk factor for YEL-AND.
A medical history of thymus dysfunction has been recognized as a potential 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.
No non-clinical studies have been performed.
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).
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 recognized, yellow fever vaccines must be administered in an approved World Health Organization (WHO) vaccination centre and registered on an International Certificate of Vaccination. The validity period of this Certificate is established according to International Health Regulations (IHR) recommendations, and starts 10 days after primary vaccination and immediately after re-vaccination.
Pharmacotherapeutic group: Yellow Fever Vaccine (Live), ATC code: J07BL01
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. A neutralizing antibody titer of 1:10 is assumed to correlate with protection.
Protective immunity appears from about 10 days after vaccination, lasts at least 10 years and may be life-long.
In clinical studies in adults it has been shown that 28 days following vaccination with STAMARIL seroconversion rates of 93% and 100% were obtained.
Paediatric population
In a clinical study conducted in 337 toddlers aged 12 to 13 months the yellow fever seropositivity rates 28 days post injection of STAMARIL were 99.7% (98.5; 100.0) and the Geometric Mean Titers were 423 (375; 478). In another clinical study conducted in 30 children and adolescents aged 2 to 17 years a seroconversion rate of 90 to 100% was observed confirming results observed in earlier clinical studies.
No pharmacokinetic studies have been performed.
22 December 2017
STAMARIL, powder and solvent for suspension for injection in pre-filled syringe.
Yellow fever vaccine (Live).
Sanofi Pasteur Europe
14 Espace Henry Vallée
69007 Lyon
FRANCE
Distributed in the UK by:
Sanofi
One Onslow Street
Guildford
Surrey
GU1 4YS
Store in a refrigerator (2°C - 8°C).
Powder in vial (type I glass), with a stopper (chlorobutyl) and a flip-off cap (aluminium) + 0.5 ml of solvent in a pre-filled syringe (type I glass), with a plunger-stopper (halobutyl), and an attached needle and needle-shield (natural rubber or polyisoprene) - pack size of 1, 10 or 20.
Powder in vial (type I glass), with a stopper (chlorobutyl) and a flip-off cap (aluminium) + 0.5 ml of solvent in a pre-filled syringe (type I glass), with a plunger-stopper (halobutyl), and a tip-cap (chlorobromobutyl or styrene - butadiene) - pack size of 1 or 10.
Powder in vial (type I glass), with a stopper (chlorobutyl) and a flip-off cap (aluminium) + 0.5 ml of solvent in a pre-filled syringe (type I glass), with a plunger-stopper (halobutyl) and a tip cap (chlorobromobutyl or styrene - butadiene) with 1 or 2 separate needles attached in the blister - pack size of 1 or 10.
Not all pack sizes may be marketed.
PL 46602/0007
Pregnancy
No animal developmental and reproductive 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.
Breast-feeding
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.
Fertility
No animal fertility studies have been conducted with STAMARIL and no fertility data are available in humans.
After reconstitution, 1 dose (0.5 ml) contains:
Yellow fever virus1 17D-204 strain (live, attenuated)...................................... not less than 1000 IU
1 produced in specified pathogen-free chick embryos
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.
Syncope (fainting) can occur following, or even before, any vaccination as a psychogenic response to the needle injection.).
Pregnant and breast-feeding women
STAMARIL should not be used in pregnant and breast-feeding woman unless when clearly needed and following an assessment of the risks and benefits.
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 YEL-AND from which the infants recover.
As with any vaccine, vaccination with STAMARIL may not protect 100% of vaccinated individuals.
No studies on the effects on the ability to drive or use machines have been performed.
Posology
- Primary vaccination
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.
Adults: a single dose of 0.5 ml of the reconstituted vaccine.
Paediatric population
- Children aged 9 months and older: a single dose of 0.5 ml of the reconstituted vaccine.
- Children from 6 to 9 months of age: Vaccination against yellow fever is not recommended in children aged from 6 months up to 9 months except in specific circumstances and in accordance with available official recommendations , in which case the dose is the same as in children aged 9 months and older.
- Children under 6 months of age: STAMARIL is contraindicated in children less than 6 months of age.
Older people
The dose is the same as for adults. However due to a potentially higher risk of yellow fever vaccine-associated 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 significant and unavoidable risk of acquiring yellow fever infection.
- Re-vaccination
The duration of protection following administration of one single 0.5 ml dose of STAMARIL is expected to be at least 10 years and may be life-long.
Re-vaccination with one dose of 0.5 ml may be needed in some individuals who had an insufficient immune response after their primary vaccination. Re-vaccination may also be required, depending on official recommendations of local Health Authorities, as a condition of entry in some countries.
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 children less than 12 months of age, the anterolateral aspect of the thigh (or the deltoid muscle if muscle mass is adequate) in children 12 months through 35 months of age or the deltoid muscle in children from 36 months of age onwards and adults.
DO NOT INJECT INTRAVASCULARLY.
Precautions to be taken before handling or administering the medicinal product
For syringe without attached needle only: after removing the syringe tip cap, a needle should be firmly placed on the tip of the syringe and secured by rotating a quarter of a turn (90°).
The vaccine is reconstituted by adding the solvent provided in the pre-filled syringe to the vial of powder. The vial is shaken and, after complete dissolution, the suspension obtained is withdrawn into the same syringe for injection.
Before administration, the reconstituted vaccine should be vigorously shaken.
Use immediately after reconstitution.
After reconstitution the suspension is beige to pink beige, more or less opalescent.
Contact with disinfectants is to be avoided since they may inactivate the virus.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
03/09/2007
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).
This vaccine may be administered at the same time as measles vaccine if this is in accordance with official recommendations.
It may be administered at the same time as vaccines containing typhoid Vi capsular polysaccharide and/or inactivated hepatitis A virus.
It 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),.
It can induce false positive results with laboratory and/or diagnostic tests for other flavivirus related diseases such as dengue or Japanese encephalitis.
