Inovelon Oral Suspension
*Company:
Eisai LtdStatus:
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 14 December 2023
File name
ROI Inovelon Oral Suspension PIL Nov 2023.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 6 - what the product contains
- Change to section 6 - date of revision
Updated on 14 December 2023
File name
ROI Inovelon Oral Suspension SmPC Nov 2023.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 6.1 - List of excipients
- 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 23 January 2023
File name
ROI Inovelon OS SmPC_Mar 2021.pdf
Reasons for updating
- Document format updated
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 13 September 2021
File name
Inovelon OS PIL_ROI July 2021.pdf
Reasons for updating
- XPIL Created
Updated on 22 July 2021
File name
ROI Inovelon Oral Suspension PIL_07 2020.pdf
Reasons for updating
- Change to other sources of information section
Updated on 30 March 2021
File name
ROI Inovelon OS PIL_Mar 2021.pdf
Reasons for updating
- Change to section 6 - manufacturer
Updated on 30 March 2021
File name
ROI Inovelon OS SmPC_Mar 2021.pdf
Reasons for updating
- Other
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 15 July 2020
File name
ROI Inovelon Oral Suspension SmPCs_26 05 2020.pdf
Reasons for updating
- Improved presentation of SPC
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Minor formatting changes
Updated on 15 July 2020
File name
ROI Inovelon tablets SmPC_26 05 2020.pdf
Reasons for updating
- Improved presentation of SPC
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Minor formatting changes
Updated on 15 July 2020
File name
ROI Inovelon Oral Suspension PIL_07 2020.pdf
Reasons for updating
- Change to section 3 - how to take/use
- Change to date of revision
Free text change information supplied by the pharmaceutical company
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Instructions for use of the syringe and adaptor changed FROM |
Instructions for use of the syringe and adaptor changed TO |
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Shake well before use. 1. Push down and turn cap to open bottle 2. Insert adaptor into the neck of the bottle until a tight seal is made 3. Push plunger of syringe completely down 4. Insert the syringe into the opening of the adaptor as far as possible. 5. Turn upside down and withdraw the prescribed amount of Inovelon from the bottle. 6. Turn upright and remove the syringe 7. Leave the adaptor in place and replace cap on bottle. Wash the syringe with clean water and dry thoroughly.
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1. Shake well before use. 2. Push down (1) and turn cap (2) to open bottle 3. Insert adaptor into the neck of the bottle until a tight seal is made 4. Push plunger of syringe completely down 5. Insert the syringe into the opening of the adaptor as far as possible. 6. Turn upside down and withdraw the prescribed amount of Inovelon from the bottle. 7. Turn upright and remove the syringe. 8. Leave the adaptor in place and replace cap on bottle. 9. After dose administration, separate barrel and plunger, and fully immerse both components in HOT soapy water. 10. Immerse the barrel and plunger in water to remove any residual detergent, shake off excess water and leave components to air dry. Do not wipe dry the dispensers. 11. Do not clean and reuse the syringe after 40 uses, or if the markings on the syringe wash off. |
Updated on 02 July 2020
File name
Inovelon oral suspension ROI SmPC clean 00112020.pdf
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
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SPC Section affected |
Change |
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Section 7 Marketing Authorisation Holder |
Change of MAH address details:
From :
Eisai GmbH Lyoner Straße 36 60528 Frankfurt am Main Germany
Amended to:
Eisai GmbH Edmund-Rumpler-Straße 3 60549 Frankfurt am Main Germany
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Section 10 Date of Revision of the Text |
Amended to 26 May 2020 |
Updated on 02 July 2020
File name
Inovelon oral suspension ROI PIL clean 00112020.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 16 August 2019
File name
ROI Inovelon oral suspension PIL_07 2019.pdf
Reasons for updating
- Change to section 6 - date of revision
- Correction of spelling/typing errors
- Change to improve clarity and readability
Updated on 15 August 2019
File name
ROI Inovelon oral suspension SmPC_07 2019.pdf
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- 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 5.1 - Pharmacodynamic properties
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 10 - Date of revision of the text
- Correction of spelling/typing errors
- Change to improve clarity and readability
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
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SmPC Section |
Changes |
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4.1 Therapeutic indications |
The acronym (LGS) has been added after Lennox Gastaut syndrome.
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4.2 Posology and method of administration |
Under Posology The following headings have been amended in this section:
Use in children from 1 year to less than 4 years of age (numerals 1 and 4 replace the words ‘one’ and ‘four’ respectively)
Use in children 4 years of age or older and less than 30 kg (numeral 4 replaces the word ‘four’)
Use in adults, adolescents and children 4 years of age or older of 30 kg or over (numeral 4 replaces the word ‘four’)
‘ml’ replaces ‘mL’ throughout Use in children from 1 year to less than 4 years of age
ORAL SUSPENSION SmPC ONLY Under Method of administration The following text has been added:
The prescribed dose of Inovelon oral suspension can be administered via an enteral feeding tube. Follow the manufacturer’s instructions for the feeding tube to administer the medicine. To ensure adequate dosing, after administration of the oral suspension, the enteral feeding tube must be flushed at least once with 1 ml of water.
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4.4 Special warnings and precautions for use |
Under Hypersensitivity reactions The acronym (AED) has been added after ‘antiepileptic drug’
The word ‘As’ has replaced ‘Because’ in the following sentence: “As the disorder is variable in its expression, other organ system signs and symptoms not noted here may occur.”
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4.5 Interaction with other medicinal products and other forms of interaction |
Several mentions of ‘b.i.d.’ amended to ‘twice daily’ |
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5.1 Pharmacodynamic properties |
Under Clinical experience The word ‘As’ has replaced ‘Because’ in the following sentence: “As it is difficult for caregivers to precisely separate tonic and atonic seizures, the international expert panel of child neurologists agreed to group these seizure types and call them tonic–atonic seizures or “drop attacks”” |
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6.6 Special precautions for disposal and other handling
ORAL SUSPENSION SmPC ONLY |
ORAL SUSPENSION SmPC ONLY
The following text has been added: “Nasogastric tube (NG): Polyvinyl chloride (PVC) tube of not greater than 40 cm in length and diameter of tube 5 Fr. To ensure adequate dosing, after administration of the oral suspension, the enteral feeding tube must be flushed at least once with 1 ml of water.” |
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10. DATE OF REVISION OF THE TEXT
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Updated to 07/2019 |
File name
ROI PIL Oral Suspension_Nov2018.pdf
Updated on 18 January 2019
File name
ROI PIL Oral Suspension_Nov2018.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 18 January 2019
File name
ROI Inovelon SmPC Oral Suspension November 2018.pdf
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)
Updated on 12 September 2018
File name
ROI PIL Oral Suspension_Aug2018.pdf
Reasons for updating
- XPIL Updated
Updated on 13 August 2018
File name
ROI PIL Oral Suspension_Aug2018.pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 2 - what you need to know - warnings and precautions
- 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 6 - date of revision
Updated on 13 August 2018
File name
ROI Inovelon SmPC Oral Suspension August 2018.pdf
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- 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 6.6 - Special precautions for disposal and other handling
- 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
Extension of indication to include the treatment of seizures associated with Lennox Gastaut syndrome in patients 1 year of age and older as adjunctive therapy. As a consequence sections 4.1, 4.2, 4.5, 5.1 and 5.2. were updated accordingly.
Updated on 04 December 2017
File name
PIL_15384_803.pdf
Reasons for updating
- New PIL for new product
Updated on 04 December 2017
Reasons for updating
- Change to section 6 - date of revision
- Change to MA holder contact details
- Improved presentation of PIL
Updated on 16 May 2017
Reasons for updating
- Change to section 3 - how to take/use
- Change to section 6 - date of revision
Updated on 25 January 2017
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 24 January 2017
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 2 - excipient warnings
- Change to section 3 - how to take/use
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
- Correction of spelling/typing errors
Updated on 02 August 2013
Reasons for updating
- Addition of information on reporting a side effect.
Updated on 24 July 2013
Reasons for updating
- Change to MA holder contact details
Updated on 10 December 2012
Reasons for updating
- Change to MA holder contact details
Updated on 23 May 2012
Reasons for updating
- New PIL for new product