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Xeomin 100 Units Vial Powder for Solution for Injection

*
Pharmacy Only: Prescription

  • Company:

    Merz Pharma UK Ltd

  • Status:

    No Recent Update

  • Legal Category:

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

  • Active Ingredient(s):

    Botulinum Toxin Type A

    *Additional information is available within the SPC or upon request to the company

Updated on 16 May 2022

File name

Xeomin 100 Licence_PA1907-001-002_11042022083322.pdf

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties

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

Updated on 16 November 2021

File name

Xeomin PIL-IE.pdf

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 2 - use in children and adolescents

Updated on 16 November 2021

File name

Xeomin 100 SPC - IE.pdf

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties

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

Updated on 20 July 2021

File name

XEOMIN powder for solution for injection PIL IE.pdf

Reasons for updating

  • New PIL for medicines.ie

Updated on 20 July 2021

File name

XEOMIN 100 units powder for solution for injection IE SPC.pdf

Reasons for updating

  • New SPC for medicines.ie

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

Updated on 03 November 2017

Reasons for updating

  • New SPC for new product

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

Updated on 03 November 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 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
  • Correction of spelling/typing errors
  • 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

$04.1indication has been changed from post stroke spasticity of upper limbpresenting with flexed wrist and clenched fist  to spasticity of the upperlimb$0$04.2updated recommended dosage table $0$04.2maximum daily dose updated$0$04.2 under"all indications" on last bullet point, addition of"localisation of the involved muscles with techniques such asElectromyographic guidance).$0$04.2 undermethod of administration, addition of statement "$0$0 $0$0All indications$0$0For instructions on reconstitution of the medicinal product beforeadministration and for instructions on disposal of the vials, seesection 6.6. After reconstitution, XEOMIN should be used for only oneinjection session and for only one patient.$0$04.4 underspasticity of the upper limb, addition of statement: New onset orrecurrent seizures have been reported, typically in patients who arepredisposed to experiencing these events. The exact relationship of theseevents to Botulinum toxin injection has not been established.$0$04.4 specialwarnings and precautions (changes highlighted in red)$0$0 $0$0Localised pain, inflammation, paraesthesia,hypoaesthesia, tenderness, swelling, oedema, erythema, itching, localisedinfection, haematoma, bleeding and/or bruising may be associated with the injection.$0$0Needle related pain and/or anxiety may result invasovagal responses, including transient symptomatic hypotension,nausea, tinnitus, and syncope.$0$0Toxin spread$0$0Undesirable effects related to spread of toxindistant from the site of administration have been reported very rarely to produce symptoms consistent withBotulinum toxin type A effects (exaggerated excessive muscle weakness,dysphagia, and aspiration pneumonitisa with a fataloutcome in some cases) (see section 4.4).$0$0Blepharospasm$0$0The following adverse reactions were reported withXEOMIN:$0$0 $0$0Skin and subcutaneous tissue disorders$0$0CommonUncommon:  Rash$0$0 $0$0Post-stroke sSpasticity of the upper limb$0$0The following adverse reactions were reported withXEOMIN:$0$0 $0$0Nervous system disorders$0$0UncCommon:Headache, dysaesthesia, hypoaesthesia$0$0 $0$0Gastrointestinal disorders$0$0Common:Dry mouth$0$0Uncommon:                 Dysphagia, nausea$0$0 $0$0Musculoskeletal and connective tissue disorders$0$0UncCommon:         Muscular weakness, painin extremity, myalgia$0$0Uncommon:Myalgia$0$0 $0$0General disorders andadministration site conditions$0$0Uncommon:Asthenia$0$0Common:Feeling hot,injection site pain$0$0Unknown:                    iInjectionsite pain$0$0 $0$05.1 $0$0Results of the clinical studies$0$0Non-inferiorityTherapeuticequivalence of XEOMIN efficacy ascompared to a the comparatorproduct Botox containingthe conventional Botulinumtoxin type A complex (onabotulinumtoxinA,(900 kD) was shown in twocomparative single-dosing Phase III studies, one in patients withblepharospasm (study MRZ 60201-0003, n=300) and one in patients with cervicaldystonia (study MRZ 60201-0013, n=463). Study results also suggest that XEOMINand this comparator product have a similar efficacy and safety profile inpatients with blepharospasm or cervical dystonia when used inwith adosing conversion ratio of 1:1 (see section  4.2) (see section 4.2).$0$0Under blepharospasm:$0$0XEOMIN has been investigated in aPhase III, randomised, double-blind, placebo-controlled, multi-centertrial in a total of 109 patients with blepharospasm. Patients had aclinical diagnosis of benign essential blepharospasm, with baseline JankovicRating Scale (JRS) Severity subscore ≥ 2, and a stable satisfactorytherapeutic response to previous administrations of Botox onabotulinumtoxinA(onabotulinumtoxinA Botox).$0$0 $0$0Under Spasticity of the upper limb$0$0addition and amendment of the following:$0$0 $0$0Another double-blind,placebo-controlled Phase III clinical trial enrolled a total of317 treatment-naïve patients with spasticity of the upper limb who were atleast three months post-stroke. During the Main Period a fixed total dose ofXEOMIN (400 units) was administered intramuscularly to the defined primarytarget clinical pattern chosen from among the flexed elbow, flexed wrist, orclenched fist patterns and to other affected muscle groups (n=210). Theconfirmatory analysis of the primary and co-primary efficacy variables atweek 4 post-injection demonstrated statistically significant improvementsin the responder rate of the Ashworth score, or changes from baseline in theAshworth score and the Investigator's Global Impression of Change.$0$0296 treated patientscompleted the Main Period and participated in the first Open-label Extension(OLEX) cycle. During the Extension Period patients received up to threeinjections. Each OLEX cycle consisted of a single treatment session(400 units of XEOMIN total dose, distributed flexibly among all affectedmuscles) followed by a 12 week observation period. The overall studyduration was 48 weeks.$0$0 $0$0Treatment of shouldermuscles was investigated inIn ana supportiveuncontrolled, open-label Phase III study which included 155 patientswith a clinical need for treatment of combined upper and lower limb spasticity. Thestudy protocol allowed for administration of doses up to 600 Uunits ofXEOMIN to the upper limb.  the safetyand efficacy of XEOMIN was investigatedfor the treatment of$0$0upper and lower limbspasticity due to different cerebral causes in 155 patients with aclinical need for a total body dose of 800 units. According to the numberof muscles/spastic patterns affected a maximum of 600 units per limb couldbe applied. This study showed a positive relationship between increasingdoses of XEOMIN of up to 800 units andimprovement of the patients’ condition as assessed by Ashworth Scale and otherefficacy variables without compromising the patients’ safety or thetolerability of XEOMIN.$0$0 $0$05.2 Pharmacokinetic Properties$0$0Botulinum neurotoxin type A has been shown to undergoretrograde axonal transport after intramuscular injection. However, retrogradetranssynaptic passage of active Botulinum neurotoxin type A into thecentral nervous system has not been found at therapeutically relevantdoses.$0$05.3     Preclinical safetydata$0$0Non-clinical data reveal nospecial hazard for humans based on conventional studies of cardiovascular and intestinal safety pharmacology.$0$0 $0$06.6 Special precuations fordisposal and other handling $0$0Updated dilution table$0$0 $0$0 $0

Updated on 01 November 2017

File name

PIL_17342_72.pdf

Reasons for updating

  • New PIL for new product

Updated on 22 July 2016

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.8 - Undesirable effects
  • Change to section 9 - Date of renewal of authorisation
  • 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

Section 1. LD50 Removed$0Section 2. Statement "one unit corresponds to..." has been removed.$0$0Section 4.8. General disorders and administration site conditions added under each indications$0$0Section 9. date updated$0$0section 10. date updated$0

Updated on 18 March 2014

Reasons for updating

  • New SPC for medicines.ie

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

Free text change information supplied by the pharmaceutical company

None provided