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Xeomin 50 Units 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 be renewed (B)

  • 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 50 Licence_PA1907-001-001_11042022083323.pdf

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 16 November 2021

File name

Xeomin 50 SPC - IE.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 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties

Legal category:Product subject to medical prescription which may be renewed (B)

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 20 July 2021

File name

XEOMIN 50 units powder for solution for injection IE.pdf

Reasons for updating

  • New SPC for medicines.ie

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 20 July 2021

File name

XEOMIN 50 units powder for solution for injection IE.pdf

Reasons for updating

  • New SPC for medicines.ie

Legal category:Product subject to medical prescription which may be renewed (B)

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 02 November 2017

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 02 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 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

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

4.1 indication has been changed from post stroke spasticity of upper limb presenting with flexed wrist and clenched fist  to spasticity of the upper limb$04.2 updated recommended dosage table $0$04.2 maximum daily dose updated$0$04.2 under "all indications" on last bullet point, addition of "localisation of the involved muscles with techniques such as Electromyographic guidance).$0$04.2 under method of administration, addition of statement "$0$0$0$0$0All indications$0For instructions on reconstitution of themedicinal product before administration and for instructions on disposal of thevials, see section 6.6. After reconstitution, XEOMIN should be used foronly one injection session and for only one patient.$0$04.4 under spasticity of the upper limb, addition of statement: New onset or recurrent seizures have beenreported, typically in patients who are predisposed to experiencing theseevents. The exact relationship of these events to Botulinum toxin injection hasnot been established.$0$0$04.6 special warnings and precautions (changes highlighted in red)$0$0$0$0$0$0$0$0Localisedpain, inflammation, paraesthesia, hypoaesthesia, tenderness, swelling, oedema,erythema, itching, localised infection, haematoma, bleeding and/or bruising maybe associated with the injection.$0$0Needle relatedpain and/or anxiety may result in vasovagal responses, including transientsymptomatic hypotension, nausea, tinnitus, andsyncope.$0$0Toxin spread$0$0$0$0Undesirable effectsrelated to spread of toxin distant from the site of administration have beenreported very rarely to producesymptoms consistent with Botulinum toxin type A effects (exaggerated excessive muscle weakness,dysphagia, and aspiration pneumonitisawith a fatal outcome in some cases) (seesection 4.4).$0$0Blepharospasm$0$0$0$0Thefollowing adverse reactions were reported with XEOMIN:$0$0$0$0$0Skin andsubcutaneous tissue disorders$0$0$0$0CommonUncommon:               Rash$0$0$0$0$0Post-stroke sSpasticity of the upper limb$0$0Thefollowing adverse reactions were reported with XEOMIN:$0$0 $0$0Nervoussystem disorders$0$0UncCommon:               Headache, dysaesthesia,hypoaesthesia$0$0 $0$0Gastrointestinal disorders$0$0Common:                     Dry mouth$0$0Uncommon:                 Dysphagia, nausea$0$0 $0$0Musculoskeletal and connectivetissue disorders$0$0UncCommon:               Muscularweakness, pain in extremity, myalgia$0$0Uncommon:                 Myalgia$0$0 $0$0General disorders and administration site conditions$0$0Uncommon:                 Asthenia$0$0Common:                     Feeling hot, injection site pain$0$0Unknown:                    iInjection sitepain$0$0$0$0$05.1 $0$0Results of the clinical studies$0$0$0$0Non-inferiorityTherapeutic equivalence ofXEOMIN efficacy as compared to a the comparatorproduct Botox containingthe conventional Botulinumtoxin type A complex (onabotulinumtoxinA,(900 kD)was shown in two comparative single-dosing Phase III studies, one inpatients with blepharospasm (study MRZ 60201-0003, n=300) and one in patientswith cervical dystonia (study MRZ 60201-0013, n=463). Study results alsosuggest that XEOMIN and this comparator product have a similar efficacy andsafety profile in patients with blepharospasm or cervical dystonia when used inwith a dosing conversion ratio of 1:1 (see section  4.2) (see section 4.2).$0$0Under blepharospasm:$0$0XEOMINhas been investigated in a Phase III, randomised, double-blind,placebo-controlled, multi-center trial in a total of 109 patients withblepharospasm. Patients had a clinical diagnosis of benign essentialblepharospasm, with baseline Jankovic Rating Scale (JRS) Severity subscore ≥ 2,and a stable satisfactory therapeutic response to previous administrations of Botox onabotulinumtoxinA (onabotulinumtoxinA Botox).$0$0$0$0$0Under Spasticity of the upper limb$0$0addition and amendment of the following:$0$0$0$0$0Another double-blind, placebo-controlledPhase III clinical trial enrolled a total of 317 treatment-naïvepatients with spasticity of the upper limb who were at least three monthspost-stroke. During the Main Period a fixed total dose of XEOMIN (400 units)was administered intramuscularly to the defined primary target clinical patternchosen from among the flexed elbow, flexed wrist, or clenched fist patterns andto other affected muscle groups (n=210). The confirmatory analysis of theprimary and co-primary efficacy variables at week 4 post-injectiondemonstrated statistically significant improvements in the responder rate ofthe Ashworth score, or changes from baseline in the Ashworth score and theInvestigator's Global Impression of Change.$0$0296 treated patients completed theMain Period and participated in the first Open-label Extension (OLEX) cycle.During the Extension Period patients received up to three injections. Each OLEXcycle consisted of a single treatment session (400 units of XEOMIN totaldose, distributed flexibly among all affected muscles) followed by a 12 weekobservation period. The overall study duration was 48 weeks.$0$0 $0$0Treatmentof shoulder muscles was investigated inIn ana supportiveuncontrolled, open-label Phase III studywhich included155 patients with a clinical need fortreatment of combined upper and lower limb spasticity.The study protocol allowed for administration of dosesup to 600 Uunitsof XEOMIN to the upper limb. the safety and efficacy of XEOMIN wasinvestigated for the treatment of $0$0$0$0upper and lowerlimb spasticity 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 betweenincreasing doses of XEOMIN of up to 800 unitsand improvement of the patients’ condition as assessed by AshworthScale and other efficacy variables without compromising the patients’ safety orthe tolerability of XEOMIN. $0$0$0$05.2 Pharmacokinetic Properties$0$0Botulinumneurotoxin type A has been shown to undergo retrograde axonal transportafter intramuscular injection. However, retrograde transsynaptic passage ofactive Botulinum neurotoxin type A into the central nervous system has notbeen found at therapeuticallyrelevant doses.$0$05.3     Preclinical safety data$0$0Non-clinicaldata reveal no special hazard for humans based on conventional studies ofcardiovascular and intestinal safetypharmacology.$0$0$0$0$06.6 Special precuations for disposal and other handling $0$0Updated dilution table$0$0$0$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 be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 1: LD50 removed$0section 2: LD50 removed, "one unit corresponds to..." statement removed$0$0Section 4.8 under each condition, General disorders and administration site conditions added$0$0Section 9: Date of first authorisation/renewal of the authorisation updated$0$0Section 10: date of revision of the text updated$0

Updated on 18 March 2014

Reasons for updating

  • New SPC for medicines.ie

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

None provided