Skip to content
SPC Logo

Stamaril

Last Updated on eMC 23-Mar-2017 View document  | Sanofi Pasteur Contact details

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC.  For each version, we show the dates it was published on the eMC and the reasons for change.

Updated on 23-Mar-2017 and displayed until Current

Reasons for adding or updating:

  • Change of distributor

Date of revision of text on the SPC: 10-Mar-2017

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Type IB variation to add Sanofi as distributor in UK

Updated on 17-Jan-2017 and displayed until 23-Mar-2017

Reasons for adding or updating:

  • Company name change or merger

Date of revision of text on the SPC: 30-Nov-2016

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Sanofi Pasteur MSD company name changed to Sanofi Pasteur

Updated on 03-Feb-2016 and displayed until 17-Jan-2017

Reasons for adding or updating:

  • 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 - Fertility, 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
  • 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

Date of revision of text on the SPC: 25-Jan-2016

Legal Category:POM

Black Triangle (CHM): NO

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 12/2015



 

 

Updated on 18-Sep-2013 and displayed until 03-Feb-2016

Reasons for adding or 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

Date of revision of text on the SPC: 21-Aug-2013

Legal Category:POM

Black Triangle (CHM): NO

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 08/2013

Updated on 22-Dec-2010 and displayed until 18-Sep-2013

Reasons for adding or updating:

  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.6 - Pregnancy and Lactation

Date of revision of text on the SPC: 01-Nov-2010

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

4.4 update of transmission
4.8 update on lacation-not to be given in nursing mothers

Updated on 13-May-2010 and displayed until 22-Dec-2010

Reasons for adding or updating:

  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 10 date of revision of the text

Date of revision of text on the SPC: 01-Apr-2010

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Plunger stopper: Replacement of chlorobromobutyl by halobutyl

Tip cap: Addition of .styrene - butadiene.

Updated on 07-Apr-2008 and displayed until 13-May-2010

Reasons for adding or updating:

  • Change to section 1 -Name of the Medicinal product
  • Change to section 6. 6 - Instructions for use, handling and disposal
  • Change to section 10 date of revision of the text

Date of revision of text on the SPC: 01-Sep-2007

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Change to section 1 – description of pharmaceutical form updated in line with SPC guidelines, ‘Powder and solvent for suspension for injection in pre-filled syringe’

Change to section 6.6 – minor changes to the wording of the instructions for use to improve clarity.

Change to section 10 – date of review changed to 03/09/2007

Updated on 13-Aug-2007 and displayed until 07-Apr-2008

Reasons for adding or updating:

  • Improved Electronic Presentation

Updated on 11-Dec-2006 and displayed until 13-Aug-2007

Reasons for adding or updating:

  • Change to section 1 -Name of the Medicinal product
  • 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 4.9 - Overdose
  • Change to section 5 - Pharmacological Properties
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 5.3 - Preclinical Safety Data
  • 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. 4 - Special Precautions for Storage
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 6. 6 - Instructions for use, handling and disposal
  • Change to section 7 - Marketing Authorisation Holder

Date of revision of text on the SPC: 01-Jul-2006

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 1, 2, 3, 4, 5, 6 - Harmonisation of wording across Europe and alignment with QRD template.

 

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 14-Nov-2005 and displayed until 11-Dec-2006

Reasons for adding or updating:

  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 6. 6 - Instruction for Use/Handling

Updated on 27-Sep-2005 and displayed until 14-Nov-2005

Reasons for adding or updating:

  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 10 (date of (partial) revision of the text

Updated on 25-Sep-2003 and displayed until 27-Sep-2005

Reasons for adding or updating:

  • Correction of spelling/typing errors

Updated on 17-Sep-2002 and displayed until 25-Sep-2003

Reasons for adding or updating:

  • New SPC for new product

Updated on 07-Aug-2002 and displayed until 04-Sep-2002

Reasons for adding or updating:

  • New SPC for new product

Company contact details

Sanofi Pasteur

Company image
Address

1 Onslow Street, Guildford, Surrey, GU1 4YS, UK

Fax

+44 (0)1483 535 432

Medical Information e-mail
Telephone

+44 (0)1483 505 515

Medical Information Direct Line

+44 (0)845 372 7101

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?

Active ingredients

yellow fever vaccine

Legal categories

POM - Prescription Only Medicine

This site uses cookies. By continuing to browse the site you are agreeing to our policy on the use of cookies. Continue