STAMARIL
*Company:
Sanofi PasteurStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 03 February 2021
File name
105_ie_smpc_2021-01-28_DEHxxxxWS479_VarII PI+RMP effectiveness.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 6.5 - Nature and contents of container
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 03 February 2021
File name
105_uk-ie_pil_2020-12-22_DEHxxxxWS479_VarII PI+RMP effectiveness.pdf
Reasons for updating
- Change to Section 1 - what the product is
- Change to section 1 - what the product is used for
- Change to section 2 - what you need to know - contraindications
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - use in children and adolescents
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 2 - driving and using machines
- Change to section 2 - excipient warnings
- Change to section 3 - dose and frequency
- Change to section 3 - use in children/adolescents
- Change to section 3 - how to take/use
- Change to section 3 - duration of treatment
- Change to section 3 - overdose, missed or forgotten doses
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
- Change to section 6 - what the product contains
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - marketing authorisation holder
- Change to section 6 - marketing authorisation number
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 24 September 2020
File name
105_ie_smpc_FRHxxxxWS187_VarIB 0.4 NaCl Diluent + CCDS update.pdf
Reasons for updating
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 03 September 2020
File name
105_ie_smpc_FRHxxxxWS187_VarIB 0.4 NaCl Diluent + CCDS update.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- Change to section 4.2 - Posology and method of administration
- Change to section 4.8 - Undesirable effects
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 6.5 - Nature and contents of container
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 03 September 2020
File name
105_uk-ie_pil_FRHxxxxWS187_VarIB 0.4 NaCl Diluent + CCDS update.pdf
Reasons for updating
- Change to section 2 - what you need to know - contraindications
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - use in children and adolescents
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 2 - driving and using machines
- Change to section 2 - excipient warnings
Updated on 05 September 2019
File name
uk-ie-stamaril-pil-distributor address change-clean.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Section 6: Distributor address change
Section 6: Date of revision
Updated on 05 January 2018
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 05 January 2018
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 04 January 2018
File name
PIL_10945_86.pdf
Reasons for updating
- New PIL for new product
Updated on 04 January 2018
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 23 March 2017
Reasons for updating
- Change of distributor details
Updated on 17 January 2017
Reasons for updating
- Company name change or merger
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 16 January 2017
Reasons for updating
- Company name change or merger
Updated on 03 February 2016
Reasons for updating
- Change to section 4.9 - Overdose
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.3 - Preclinical safety data
- Change to section 6.1 - List of excipients
- Change to section 6.4 - Special precautions for storage
- Change to section 6.5 - Nature and contents of container
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 10 - Date of revision of the text
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.7 - Effects on ability to drive and use machines
- Change to section 4.8 - Undesirable effects
- Change to Section 4.8 – Undesirable effects - how to report a side effect
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
In section 2: Removal of excipient with known effect 'sorbitol' to be in line with the Quality Review of Documents (QRD) template.
In section 3: Revised section with further detail: 'Before reconstitution, the powder is homogeneous, beige to orange beige, and the solvent is a limpid solution'.
In section 4.1: Includes the statement '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 (see Section 4.2)'. The following has been deleted 'This certificate is valid for 10 years from the 10th day after vaccination and immediately after re-vaccination'.
In section 4.2:
Under primary vaccination it is now stated that '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'.
Paediatric population statement has been added to include – 'Children aged 9 months and older: a single dose of 0.5 ml of the reconstituted vaccine. Children under 6 months of age: STAMARIL is contraindicated in children less than 6 months of age (see Section 4.3)'.
The revaccination section has been revised to include: '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'. The following has been deleted: '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'.
The method of administration has been revised to state 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.
In section 4.3: Myasthenia gravis has been added to the history of thymus dysfunction bullet point. Current severe febrile illness has been amended to read 'moderate or severe febrile illness or acute illness'
In section 4.4: Deletion of the sentence 'patients with rare hereditary problems of fructose intolerance should not take this vaccine'. Addition of instructions regarding syncope (fainting) and regarding procedures being in place to prevent injury from faints and manage syncopal reactions. Inclusion of sentence 'As with any vaccine, vaccination with STAMARIL may not protect 100% of vaccinated individuals'.
This statement has moved from 4.2 'DO NOT INJECT INTRAVASCULARLY. 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'.
Addition of '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 (see Section 4.6)'.
Amendment of Yellow Fever Vaccine-Associated Neurotropic Disease (YEL-AND) to read as 'Very rarely, YEL-AND has been reported following vaccination, with sequelae or with fatal outcome in some cases (see Section 4.8). To date most of cases of YEL-AND have been reported in primary vaccinees with an onset within 30 days of vaccination. The risk appears to be higher in those aged over 60 years, and below 9 months of age (including infants exposed to vaccine through breastfeeding) although cases have been also reported in other age groups. Congenital or acquired immunodeficiency has also been recognized as a potential risk factor (see Section 4.3)'.
In section 4.5: Addition of 'it can induce false positive results with laboratory and/or diagnostic tests for other flavivirus related diseases such as dengue or Japanese encephalitis'.
In section 4.6: Addition of a 'fertility' section which states 'No animal fertility studies have been conducted with STAMARIL and no fertility data are available in humans'.
In section 4.8: Tabulated format to include all adverse reactions. 'Events' replaced with 'reactions'. Transient moderate leucopenia removed in Section 4.8 of the SmPC and in Section 4 of the leaflet.
Paediatric population now includes data following a clinical study performed in 393 toddlers aged 12 to 13 months which received STAMARIL and placebo concomitantly.
In addition age below 9 months (including infants exposed to vaccine through breastfeeding) has been recognized as a potential risk factor for YEL-AND.
In section 4.9 Now includes further information on cases of administration of more than the recommended dose (overdose) that have been reported with STAMARIL. When adverse reactions were reported, the information was consistent with the known safety profile of STAMARIL.
In section 5.1: Addition of 'vaccination, lasts at least 10 years and may be life-long.' Also includes '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 data has been included and revision of ATC code from J07BL1 to J07BL01, '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'.
In section 5.3: Amended statement to No non-clinical studies have been performed.
In section 6.1: Revised list of excipients: Disodium phosphate now reads Disodium phosphate dihydrate & Monopotassium phosphate now reads Potassium dihydrogen phosphate.
In section 6.4: Amended to 'Keep the vial of powder and the syringe of solvent' for harmonization of the information.
In section 6.6: Addition of the phrase 'more or less opalescent' to describe the colour of the solution upon reconstitution. Removal of using 'heat inactivation or incineration' to dispose of vaccine.
In section 10: date of revision 01/2016
Updated on 03 February 2016
Reasons for updating
- Change to warnings or special precautions for use
- Change of contraindications
- Change to side-effects
- Change to information about pregnancy or lactation
- Change to further information section
- Change to dosage and administration
- Change to improve clarity and readability
Updated on 18 September 2013
Reasons for updating
- Change to side-effects
- Change to further information section
- Change to date of revision
Updated on 11 September 2013
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 2: LD50 units replaced by IU removal of 'The statistically determined lethal dose in 50% of animals'
Section 4.8: addition of national reporting system
Section 10: date of revision updated from 11/2010 to September 2013
Updated on 22 December 2010
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.6 - Pregnancy and lactation
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Lactation update in section 4.6
Updated on 13 May 2010
Reasons for updating
- Change to section 6.5 - Nature and contents of container
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Plunger stopper: Replacement of chlorobromobutyl by halobutyl
Tip cap: Addition of styrene - butadiene.
Updated on 06 November 2008
Reasons for updating
- Change due to user-testing of patient information
- Change to date of revision
Updated on 26 August 2008
Reasons for updating
- Change to dosage and administration
- Change to date of revision
Updated on 28 November 2007
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 6.5 - Nature and contents of container
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 9 - Date of renewal of authorisation
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 1 - updated pharmaceutical form to include description of container
Section 6.5 – minor editorial changes to the text
Section 6.6 – minor editorial changes to the text
Section 9 – changed date of last renewal to 26th June 2007
Updated on 27 February 2007
Reasons for updating
- Improved electronic presentation
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 12 February 2007
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 7: Changed the address of the Marketing Authorisation Holder to Sanofi Pasteur MSD Limited, Block A, Second Floor,
Section 10: Changed the date of the revision of the text to January 2007
Updated on 12 February 2007
Reasons for updating
- Change to MA holder contact details
Updated on 05 January 2007
Reasons for updating
- No reasons supplied
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 1, 2, 3, 4, 5, 6 - Harmonisation of wording across
Section 4.2 - Inserted details on:
▪ administration to adults and children aged > 9 months, infants aged 6-9 months and the elderly
▪ re-vaccination
▪ method of administration.
Section 4.3 - Updated and re-worded contraindications.
Section 4.4 - Updated/added information on:
▪ Association of vaccine with neurotropic and viscerotropic disease
▪ Administration to immunosuppressed and HIV infected persons, children born to HIV positive mothers, children aged 6-9 months and persons aged>60 years
▪ Administration via intramuscular injection
▪ Patients with hereditary problems of fructose intolerance should not take this vaccine.
Section 4.6 - Added information on pregnancy and lactation
Section 4.8 - Re-organised text
Section 9 - Changed to '7th September 1999/7th September 2004'
Updated on 13 December 2006
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 1, 2, 3, 4, 5, 6 - Harmonisation of wording across
Section 4.2 - Inserted details on:
▪ administration to adults and children aged > 9 months, infants aged 6-9 months and the elderly
▪ re-vaccination
▪ method of administration.
Section 4.3 - Updated and re-worded contraindications.
Section 4.4 - .
Updated/added information on:
▪ Association of vaccine with neurotropic and viscerotropic disease
▪ Administration to immunosuppressed and HIV infected persons, children born to HIV positive mothers, children aged 6-9 months and persons aged>60 years
▪ Administration via intramuscular injection
▪ Patients with hereditary problems of fructose intolerance should not take this vaccine.
Section 4.6 - Added information on pregnancy and lactation
Section 4.8 - Re-organised text
Added effects include: nausea, diarrhoea, vomiting, neurotropic disease and viscerotropic disease.
Section 10 - Change date of revision of text to July 2006
Updated on 13 December 2006
Reasons for updating
- Improved electronic presentation
Updated on 26 May 2006
Reasons for updating
- New PIL for medicines.ie
Updated on 20 March 2006
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
- Change to section 6.1 - List of excipients
- Change to section 6.2 - Incompatibilities
- Change to section 6.3 - Shelf life
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 9 - Date of renewal of authorisation
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 14 November 2005
Reasons for updating
- Change to section 6.5 - Nature and contents of container
- Change to section 6.6 - Special precautions for disposal and other handling
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 08 August 2005
Reasons for updating
- Change to section 10 - Date of revision of the text
- Change to section 7 - Marketing authorisation holder
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 06 August 2004
Reasons for updating
- New SPC for medicines.ie
Legal category:Product subject to medical prescription which may not be renewed (A)