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.

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