Vimpat 10 mg/ml solution for infusion
*Company:
UCB (Pharma) Ireland LimitedStatus:
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 12 July 2022
File name
IE PIL - IV.pdf
Reasons for updating
- Change to section 2 - pregnancy, breast feeding and fertility
Updated on 12 July 2022
File name
IE PIL - IV.pdf
Reasons for updating
- Change to section 2 - pregnancy, breast feeding and fertility
Updated on 12 July 2022
File name
IE SPC - IV.pdf
Reasons for updating
- Change to section 4.6 - Pregnancy and lactation
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 08 March 2022
File name
ie-pil-vimpat-iv-clean.pdf
Reasons for updating
- Change to section 1 - what the product is used for
- 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 3 - how to take/use
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
- the extension of Vimpat indication as monotherapy and adjunctive therapy in the treatment of partial-onset seizures with or without secondary generalisation to patients down to 2 years of age (currently from 4 years of age)
- the extension of the shelf life after first opening of Vimpat UCB 10mg/mL syrup up to 6 months
Updated on 08 March 2022
File name
ie-spc-vimpat-iv-clean.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 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.3 - Preclinical safety data
- 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
- the extension of Vimpat indication as monotherapy and adjunctive therapy in the treatment of partial-onset seizures with or without secondary generalisation to patients down to 2 years of age (currently from 4 years of age)
- the extension of the shelf life after first opening of Vimpat UCB 10mg/mL syrup up to 6 months
Updated on 22 July 2021
File name
ie-pil-vimpat-iv.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Addition of “Dyskinesia “ as Uncommon Adverse reaction and change of local representative to United Kingdom (Northern Ireland).
Updated on 22 July 2021
File name
ie-spc-vimpat-iv.pdf
Reasons for updating
- 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
Addition of “Dyskinesia “ as Uncommon Adverse reaction
Updated on 02 December 2020
File name
Vimpat IV EN PIL.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 - how to take/use
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Extension of the Vimpat indication as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures (PGTCS) in patients with idiopathic generalized epilepsy (IGE) aged 4 years and older
Updated on 02 December 2020
File name
Vimpat IV EN SPC.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 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- 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 the Vimpat indication as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures (PGTCS) in patients with idiopathic generalized epilepsy (IGE) aged 4 years and older
Updated on 09 September 2019
File name
ie-vimpat-spc-IV-clean.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Update to Sodium information listed in Excipients warning in secion 4.4
Updated on 09 September 2019
File name
ie-vimpat-pil-IV-clean.pdf
Reasons for updating
- Change to section 2 - excipient warnings
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Update to Excipients Warning in Section 2 of the package leaflet
Updated on 13 August 2019
File name
PIL solution for infusion.pdf
Reasons for updating
- Change to section 2 - excipient warnings
- Change to section 4 - possible side effects
Updated on 13 August 2019
File name
ie solution for infusion SPC.pdf
Reasons for updating
- 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 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
warning of cardiac arrhythmia
Updated on 21 August 2018
File name
Vimpat 10mg_ml solution for infusion PIL.pdf
Reasons for updating
- Change to section 4 - possible side effects
Updated on 21 August 2018
File name
Vimpat 10 mg_ml solution for infusion SPC.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
update with paediatric additional data
Updated on 17 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 17 January 2018
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)
Free text change information supplied by the pharmaceutical company
Updated on 30 November 2017
File name
PIL_14073_900.pdf
Reasons for updating
- New PIL for new product
Updated on 30 November 2017
Reasons for updating
- Change to section 6 - date of revision
Updated on 12 October 2017
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 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- 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
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 4.1: updated to add the indication for use in adolescents and children from 4 years of age.
Section 4.2: updated to add information relating to paediatric population.
Section 4.4: updated to add information relating to paediatric population.
Section 4.6: update to Breastfeeding section (risk to newborns/infants).
Section 4.8: updated to add “convulsion” and to add information relating to paediatric population.
Section 5.1: updated to add information relating to paediatric population.
Section 5.2: updated to add information relating to paediatric population.
Section 5.3: updated to add information relating to paediatric population.
Section 6.6: updated to add information relating to product with particulate matter or discolouration.
Updated on 10 October 2017
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 4 - possible side effects
- Change to section 6 - date of revision
Updated on 29 March 2017
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
- 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
Hepatic impairment
A maximum dose of 300 mg/day is recommended for patients with mild to moderate hepatic impairment.
[..] Lacosamide should be administered to patients with severe hepatic impairment only when the expected therapeutic benefits are anticipated to outweigh the possible risks. The dose may need to be adjusted while carefully observing disease activity and potential side effects in the patient.
In section 4.8 (Undesirable effects) “Hepatic enzyme increased” has been added as Uncommon adverse reaction
In section 4.9 (Overdose) the text has been updated as follow:
Symptoms
Symptoms observed after an accidental or intentional overdose of lacosamide are primarily associated with CNS and gastrointestinal system.
• The types of adverse reactions experienced by patients exposed to doses above 400 mg up to 800 mg were not clinically different from those of patients administered recommended doses of lacosamide.
• Reactions reported after an intake of more than 800 mg are dizziness, nausea, vomiting, seizures (generalized tonic-clonic seizures, status epilepticus). Cardiac conduction disorders, shock and coma have also been observed. Fatalities have been reported in patients following an intake of acute single overdose of several grams of lacosamide.
Updated on 29 March 2017
Reasons for updating
- Change to section 3 - how to take/use
- Change to section 3 - overdose, missed or forgotten doses
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
- Change to other sources of information section
Updated on 22 March 2017
Reasons for updating
- Previous version of SPC reinstated
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 22 March 2017
Reasons for updating
- Previous version of PIL reinstated
Updated on 02 March 2017
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
- 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
Hepatic impairment
A maximum dose of 300 mg/day is recommended for patients with mild to moderate hepatic impairment.
[..] Lacosamide should be administered to patients with severe hepatic impairment only when the expected therapeutic benefits are anticipated to outweigh the possible risks. The dose may need to be adjusted while carefully observing disease activity and potential side effects in the patient.
In section 4.8 (Undesirable effects) “Hepatic enzyme increased” has been added as Uncommon adverse reaction.
In section 4.9 (Overdose) the text has been updated as follow:
Symptoms
Symptoms observed after an accidental or intentional overdose of lacosamide are primarily associated with CNS and gastrointestinal system.
• The types of adverse reactions experienced by patients exposed to doses above 400 mg up to 800 mg were not clinically different from those of patients administered recommended doses of lacosamide.
• Reactions reported after an intake of more than 800 mg are dizziness, nausea, vomiting, seizures (generalized tonic-clonic seizures, status epilepticus). Cardiac conduction disorders, shock and coma have also been observed. Fatalities have been reported in patients following an intake of acute single overdose of several grams of lacosamide
Updated on 28 February 2017
Reasons for updating
- Change to section 3 - how to take/use
- Change to section 3 - overdose, missed or forgotten doses
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
- Change to other sources of information section
Updated on 22 December 2016
Reasons for updating
- New individual SPC (was previously included in combined SPC)
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Change to section 4.1 - Addition of monotherapy inidication
Change to section 4.2 - Posology regarding the new indication
Change to section 4.4 - Special warnings and precaution fo use (cardiac rhythm and conduction)
Change to section 4.5 - Interaction with other with other medicinal products (eslcarbezine)
Change to section 4.8 - Undesiderable side effects
Change to section 5.1 - Pharmacodynamic properties (clinical efficacy and safety in monotherapy)
Change to section 5.2 - Pharmacokinetic properties (editiorial change)
Change to section 10 - Date of revision
Updated on 21 December 2016
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 2 - excipient warnings
- Change to section 3 - dose and frequency
- Change to section 6 - date of revision
- Change to information for healthcare professionals
Updated on 25 July 2014
Reasons for updating
- Change to side-effects
Updated on 10 January 2014
Reasons for updating
- Change to, or new use for medicine
- Change to warnings or special precautions for use
- Change to side-effects
- Change to drug interactions
- Change to information about drinking alcohol
- Change to information about pregnancy or lactation
- Change to dosage and administration
Updated on 13 December 2012
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
Updated on 17 April 2012
Reasons for updating
- Change to side-effects
Updated on 28 September 2011
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to name of manufacturer
Updated on 14 January 2011
Reasons for updating
- Change to side-effects
Updated on 16 September 2010
Reasons for updating
- Change of manufacturer
- Change to side-effects
Updated on 06 April 2010
Reasons for updating
- Correction of spelling/typing errors
Updated on 27 April 2009
Reasons for updating
- Change to warnings or special precautions for use
Updated on 03 February 2009
Reasons for updating
- New PIL for new product