Inovelon Oral Suspension

  • Name:

    Inovelon Oral Suspension

  • Company:
    info
  • Active Ingredients:

    Rufinamide

  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 15/07/20

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Summary of Product Characteristics last updated on medicines.ie: 15/7/2020

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Eisai Ltd

Eisai Ltd

Company Products

Medicine NameActive Ingredients
Medicine Name Fycompa 0.5 mg/ml oral suspension Active Ingredients Perampanel
Medicine Name Fycompa tablets Active Ingredients Perampanel
Medicine Name Gliadel Active Ingredients Carmustine
Medicine Name Halaven 0.44 mg/ml solution for injection Active Ingredients Eribulin mesylate
Medicine Name Inovelon Oral Suspension Active Ingredients Rufinamide
Medicine Name Inovelon Tablets Active Ingredients Rufinamide
Medicine Name Lenvima (lenvatinib) Active Ingredients Lenvatinib mesilate
Medicine Name Targretin Capsules Active Ingredients Bexarotene
Medicine Name Zebinix 200mg tablets Active Ingredients eslicarbazepine acetate
Medicine Name Zebinix 50 mg/ml Oral Suspension Active Ingredients eslicarbazepine acetate
Medicine Name Zebinix 800mg tablets Active Ingredients eslicarbazepine acetate
Medicine Name Zonegran 100 mg hard capsules Active Ingredients Zonisamide
Medicine Name Zonegran 25 mg hard capsules Active Ingredients Zonisamide
Medicine Name Zonegran 50 mg hard capsules Active Ingredients Zonisamide
1 - 0 of 14 items.Total: Infinity pages

When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 15 July 2020 SmPC

Reasons for updating

  • Improved presentation of SmPC

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 SmPC

Reasons for updating

  • Improved presentation of SmPC

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 PIL

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

Summary of changes

 Instructions for use of the syringe and adaptor changed

FROM

Instructions for use of the syringe and adaptor changed

TO

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.

 

 

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 2 July 2020 SmPC

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

SPC Section affected

Change

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

 

 

Section 10 Date of Revision of the Text

Amended to 26 May 2020

Updated on 2 July 2020 PIL

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 PIL

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 SmPC

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

SmPC Section

Changes

4.1          Therapeutic indications

The acronym (LGS) has been added after Lennox Gastaut syndrome.

 

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.

 

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.”

 

4.5          Interaction with other medicinal products and other forms of interaction

Several mentions of ‘b.i.d.’ amended to ‘twice daily’

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””

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.”

10.          DATE OF REVISION OF THE TEXT

 

 

Updated to 07/2019

Updated on 22 January 2019

Updated on 18 January 2019 PIL

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 SmPC

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 PIL

Reasons for updating

  • XPIL Updated

Updated on 13 August 2018 PIL

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 SmPC

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 4 December 2017 PIL

Reasons for updating

  • Change to section 6 - date of revision
  • Change to MA holder contact details
  • Improved presentation of PIL

Updated on 4 December 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 16 May 2017 PIL

Reasons for updating

  • Change to section 3 - how to take/use
  • Change to section 6 - date of revision

Updated on 25 January 2017 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 24 January 2017 PIL

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 2 August 2013 PIL

Reasons for updating

  • Addition of information on reporting a side effect.

Updated on 24 July 2013 PIL

Reasons for updating

  • Change to MA holder contact details

Updated on 10 December 2012 PIL

Reasons for updating

  • Change to MA holder contact details

Updated on 23 May 2012 PIL

Reasons for updating

  • New PIL for new product