Summary of Product Characteristics Updated 08-Sep-2020 | Sanofi Pasteur
1 produced in specified pathogen-free chick embryos
Excipients with known effects:
This product contains approximately 8 mg of sorbitol (E420) per dose.
For the full list of excipients, see Section 6.1.
Powder and solvent for suspension for injection.
Before reconstitution, the powder is homogeneous, beige to orange beige, and the solvent is a clear and colorless solution.
Posology• Primary vaccinationThe 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 (see Section 4.4), 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 (see Section 4.3).
Older peopleThe 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 (see Sections 4.4 and 4.8).• Re-vaccinationThe 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 administrationIt 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 productFor instructions on reconstitution of the medicinal product before administration, see Section 6.6.
In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
The tip caps of the prefilled syringes contain a natural rubber latex derivative, which may cause allergic reactions in latex sensitive individuals.
Excipients with known effect
STAMARIL contains less than 1 mmol sodium (23 mg) per dose that is to say essentially “sodium free”.STAMARIL contains less than 1 mmol potassium (39 mg) per dose that is to say essentially “potassium free”.
STAMARIL contains approximately 8 mg of sorbitol (E420) per dose.
PregnancyNo 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-feedingAs 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.).
FertilityNo animal fertility studies have been conducted with STAMARIL and no fertility data are available in humans.
a. Summary of the safety profileIn 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 reactionsThe 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
|Infections and infestations||Rare|| |
|Very rare|| |
|Blood and Lymphatic System Disorders||Not known|| |
|Immune System Disorders||Not known|| |
Anaphylactoid reaction including angioedema
|Metabolism and nutrition disorders||Very common|| |
|Nervous System Disorders||Very common|| |
|Very rare|| |
|Not known|| |
|Gastrointestinal disorders||Very common|| |
|Skin and Subcutaneous tissue Disorders||Common|| |
|Not known|| |
|Musculoskeletal and Connective Tissue Disorders||Very common|| |
|General Disorders and Administration Site Conditions||Very common|| |
Irritability*, Crying*, Pyrexia, Asthenia, Injection site pain/tenderness
Injection site erythema/redness, Injection site hematoma, Injection site induration; Injection site oedema/swelling
Injection site papule
|Not known|| |
c. Description of selected adverse reactionsCases 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 (see Section 4.4).Cases of viscerotropic disease (known as YEL-AVD and formerly described as Febrile Multiple Organ-System Failure) 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 (see Section 4.4).
d. Paediatric populationThe 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 common: 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 populationCongenital or acquired immunodeficiency has been recognized as a potential risk factor for serious adverse events, including YEL-AND (See Sections 4.3 and 4.4).Age of more than 60 years (see Section 4.4) 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) (see Section 4.4) has been recognized as a potential risk factor for YEL-AND.A medical history of thymus dysfunction (see Sections 4.3 and 4.4) has been recognized as a potential risk factor for YEL-AVD.
Reporting of suspected adverse reactionsReporting 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 or search for MHRA Yellow Card in the Google Play or Apple App Store.
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 (styrene - butadiene) – pack size of 1 or 10. The tip caps of the prefilled syringes contain a natural rubber latex derivative.
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 (styrene - butadiene) with 1 or 2 separate needles attached in the blister – pack size of 1 or 10. The tip caps of the prefilled syringes contain a natural rubber latex derivative.
Not all pack sizes may be marketed.
17th August 2020
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