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Nottinghamshire Area Prescribing Committee
Joint Formulary
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 Formulary Chapter 10: Musculoskeletal and joint diseases - Full Chapter
10.01.03  Expand sub section  Drugs which suppress the rheumatic disease process
10.01.03  Expand sub section  Gold
10.01.03  Expand sub section  Penicillamine
10.01.03  Expand sub section  Antimalarials
10.01.03  Expand sub section  Drugs affecting the immune response to top
Cytotoxic Drug Azathioprine
(rheumatology)
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Formulary
Amber 1
 
Link  Notts APC: Azathioprine Shared Care Protocol - Prescribing information sheet
Link  Notts APC: Rheumatology DMARDs - shared care monitoring summary
Link  Notts APC: Rheumatology Overarching Shared Care Protocol
Link  UKMI Q&A: Can mothers breast feed while taking azathioprine?
   
Ciclosporin
(Rhematology)
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Formulary
Amber 1

See also section 8.2.2

  • MHRA specify that ciclosporin must be prescribed and dispensed by brand as bioavailability differences exist between brands.
  • Capimune® is preferred brand for new patients at SFH. For advice on switching see BNF
  • Relative prices of different brands [Hospital price][GP price]
  • Neoral liquid is equivalent to Neoral capsules. If changing from any other preparation contact Medicines Information for assistance.
 
Link  Notts APC: Ciclosporin Shared Care Protocol - Prescribing information sheet
Link  Notts APC: Rheumatology Overarching Shared Care Protocol
Link  Notts APC: Rheumatology DMARDs - shared care monitoring summary
Link  NUH Lite Bite: Importance of Maintaining Brand for Certain Medicines
Link  SFH Drug levels information - compilation table
Link  SFH: IV drugs which need special giving sets
Link  Therapeutic Drug Monitoring in Adults at NUH
   
Leflunomide
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Formulary
Amber 1
Tablet
 
Link  Notts APC: Leflunomide Shared Care Protocol - Prescriber information sheet
Link  Notts APC: Rheumatology DMARDs - shared care monitoring summary
Link  Notts APC: Rheumatology Overarching Shared Care Protocol
Link  HCP letter: risk of hepatotoxicity, haemotoxicity, infections,& birth defects
   
Cytotoxic Drug Methotrexate
(rheumatology)
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Formulary
Amber 1
Homecare

Tablet 2.5mg
Tablet 10mg - Restricted for paediatric use only.
Injection- secondary care only (as prefilled syringes/pens)

  • Cytotoxic, do not crush and disperse in water, liquid may be obtained if required.
  • Tablets classified Amber 1 when used ONCE weekly in line with Shared Care Protocol (see below). Twice weekly dosing (for any indication) is classified red.
  • SFH: Zlatal® syringes used first line, Metoject® available for patient's who are either needlephobic or unable to inject the syringe due to dexterity issues. Nordimet® pen available for patients unable to use Metoject® pen.
  • NUH: Metoject® injection available for paediatric patients - routinely supplied via homecare (prescribe by brand and generic name).
  • Available through homecare for NUH patients. Please contact pharmacy medicines homecare team for further information
 
Link  Notts APC: Methotrexate Shared Care Protocol - Prescribing information sheet
Link  Notts APC: Rheumatology DMARDs - shared care monitoring summary
Link  Notts APC: Rheumatology Overarching Shared Care Protocol
Link  NUH Lite Bite: Methotrexate for non-cancer use
Link  NUH Lite Bite: Safer use of weekly oral methotrexate
Link  NUH: Methotrexate education video
Link  SFH methotrexate policy - see medicines policy section 4.5.1
Link  SFH: Methotrexate 'never event' bulletin
Link  UKMI Q&A: Methotrexate and alcohol guidance
Link  NICE Q&A: Interaction between methotrexate and penicillins
Link  NUH: Medicines Matters Bulletin: Safer Use of Weekly oral Methotrexate
Link  NUH: Safety Bulletin: Oral Methotrexate for non cancer treatment
   
Abatacept (Orencia®)
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Restricted Drug Restricted
Red
High Cost Medicine
Infusion
  • By IV infusion in the treatment of rheumatoid arthritis in line with NICE TA195 and after the failure of conventional disease-modifying anti-rheumatic drugs in line with NICE TA375.
  • Can also be used via the subcutaneous route for Homecare patients (contact the HCD team for more details).
  • Approved in accordance with NICE TA373 and NHS England clinical commissioning policy for the treatment of juvenile idiopathic arthritis in people 6 years and older.  
  • Link  Link to reviews
    Link  Clinical Commissioning Statement: Biologics for Juvenile Idiopathic Arthritis
    Link  Clinical Commissioning Statement (Appendix)
    Link  NICE TA373: Abatacept, adalimumab, etanercept and tocilizumab for treating juvenile idiopathic arthritis
    Link  NICE TA375: Rheumatoid arthritis not previously treated with DMARDs or after conventional DMARDs only have failed
    Link  SFH: Information about IV filters
    Link  SFH: Protocol for IV abatacept in rheumatology patients
       
    Adalimumab
    (rheumatology)
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    Restricted Drug Restricted
    Red
    High Cost Medicine
    Homecare

    Injection SC

    • Restricted for RA and psoriatic arthritis in line with NICE guidance - rheumatology consultants only.
    • In accordance with NICE TA373 and NHS England clinical commissioning for the treatment of juvenile idiopathic arthritis in people 2 years and older.
    • Approved in accordance with NICE TA383 for ankylosing spondylitis and non-radiographic axial spondyloarthritis
    • In accordance with NICE TA375 for the treatment of adults with severe rheumatoid arthritis.
    • NUH only:As per commissioning policy for children with severe refractory uveitis

    Available through homecare for NUH patients.  Please contact pharmacy medicines homecare team for further information.

    NUH and SFH

    • Biosimilar Imraldi® is the first line option for new patients
    • Biosimilar Amgevita® can be used second line in those who are unable to tolerate Imraldi®
     
    Link  Link to reviews
    Link  Clinical Commissioning Statement: Biologics for Juvenile Idiopathic Arthritis
    Link  Clinical Commissioning Statement (Appendix)
    Link  Interim Clinical Commissioning Policy: Adalimumab for Children with Severe Refractory Uveitis
    Link  MHRA: Tuberculosis risk—screen patients before starting treatment
    Link  NICE TA195: Rheumatoid arthritis - after failure of a TNF inhibitor
    Link  NICE TA199: Psoriatic arthritis
    Link  NICE TA373: Abatacept, adalimumab, etanercept and tocilizumab for treating juvenile idiopathic arthritis
    Link  NICE TA375: Rheumatoid arthritis not previously treated with DMARDs or after conventional DMARDs only have failed
    Link  NICE TA383: TNF-alpha inhibitors for ankylosing spondylitis and non-radiographic axial spondyloarthritis
    Link  SFH Homecare information
       
    Anakinra (Kineret®)
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    Restricted Drug Restricted
    Red
    High Cost Medicine
    Homecare

    Injection
    Restricted for indications below and RA at NUH only. For use by rheumatology and immunology specialists only.

    • NUH approval for immunology use in:
      - TRAPS (TNF Receptor Associated Periodic Syndrome)
      - Cryopyrin Associated Periodic Syndromes: (1) CINCA (Chronic Infantile Neurologic Cutaneous Articular syndrome - also known as NOMID) (2) Muckle-Wells Syndrome.
      - HIDS (Hyperimmunoglobulinaemia D Syndrome)
      - DIRA (Deficiency of Interleukin-1 Receptor Antagonist)
      - Still’s Disease
      - Schnitzler’s Syndrome
    • NUH approval as per NHSE commissioning policy E03/P/d for the treatment of Juvenile Idiopathic Arthritis (JIA)
    • Available through homecare for NUH patients. Please contact pharmacy medicines homecare team for further information
     
    Link  Link to reviews
    Link  Clinical Commissioning Policy Statement: Biologic Therapies for the treatment of Juvenile Idiopathic Arthritis (JIA)
    Link  NHS England: Suggested Treatment Flow-chart for JIA (Appendix A)
       
    Certolizumab Pegol (Cimzia®)
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    Restricted Drug Restricted
    Red
    High Cost Medicine

    Injection- secondary care only

    • Approved in accordance with NICE TA375 for the treatment of rheumatoid arthritis. Restricted to adult rheumatology consultants.
    • Approved in accordance with NICE TA383 for ankylosing spondylitis and non-radiographic axial spondyloarthritis
    • Approved in accordance with NICE TA415 for treating rheumatoid arthritis after inadequate response to a TNF-alpha inhibitor

    Nottingham NHS Treatment Centre:

    • Approved in accordance with NICE TA445 for treating active psoriatic arthritis after inadequate response to DMARDs
    • Approved in accordance with NICE TA574 for treating moderate to severe plaque psoriasis

    Not routinely commissioned in paediatrics - IFR approval must be sought before treatment initiation.

    Patient access scheme exists whereby manufacturer funds the cost of the first 12 weeks of treatment. Managed by Healthcare at Home as long as the first 12 weeks are prescribed on one prescription. After that smaller quantities may be prescribed at a time if appropriate.

     
    Link  Link to reviews
    Link  MHRA: Tuberculosis risk—screen patients before starting treatment
    Link  NICE TA375: Rheumatoid arthritis not previously treated with DMARDs or after conventional DMARDs only have failed
    Link  NICE TA383: TNF-alpha inhibitors for ankylosing spondylitis and non-radiographic axial spondyloarthritis
    Link  NICE TA415: Certolizumab pegol for treating rheumatoid arthritis after inadequate response to a TNF-alpha inhibitor
    Link  NICE TA445:Certolizumab pegol and secukinumab for treating active psoriatic arthritis after inadequate response to DMARDs
    Link  NICE TA574: Certolizumab pegol for treating moderate to severe plaque psoriasis
       
    Cytotoxic Drug Cyclophosphamide
    (Rheumatology)
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    Formulary
    Red
    Tablets, Infusion.
  • Liquid (unlicensed special) may be made specially in hospital production units if required. At SFH do NOT send patients to retail pharmacies for supplies 
  • Link  SFH: Cyclophsphamide in rheumatology patients
       
    Etanercept (Benepali®)
    (Biosimilar)
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    Restricted Drug Restricted
    Red

    Injection

    • Erelzi®, Benepali® and Enbrel® should not be used interchangeably. Ensure all prescriptions and communications specify brand.

    Nottingham NHS Treatment Centre only:

    • Restricted for adult rheumatology consultants, for the treatment of rheumatoid arthritis, psoriatic arthritis, axial spondylitis and plaque psoriasis, only in line with NICE guidance.
    • In accordance with NICE TA375 for the treatment of adults with severe rheumatoid arthritis.
    • Erelzi®, Benepali® and Enbrel® should not be used interchangeably. Ensure all prescriptions and communications specify brand.

    NUH Only (unlicensed indications):

    • Tumor necrosis factor receptor-1 associated periodic syndrome (TRAPS)
    • Graft versus Host Disease (GVHD), clinical haematology
     
    Link  NICE TA35: Adult psoriasis
    Link  Benepali Patient Alert Card
    Link  MHRA: Tuberculosis risk—screen patients before starting treatment
    Link  NICE TA195: rheumatoid arthritis after the failure of a TNF inhibitor
    Link  NICE TA199: Psoriatic arthritis
    Link  NICE TA375: Rheumatoid arthritis not previously treated with DMARDs or after conventional DMARDs only have failed
    Link  NICE TA383: TNF-alpha inhibitors for ankylosing spondylitis and non-radiographic axial spondyloarthritis
       
    Etanercept (Enbrel®)
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    Restricted Drug Restricted
    Red
    High Cost Medicine
    Homecare

    Injection

    • Restricted for adult rheumatology consultants only in line with NICE guidance
    • In accordance with NICE TA373 and NHS England clinical commissioning policy for the treatment of juvenile idiopathic arthritis in people 2 years and older.
    • Approved in accordance with NICE TA383 for ankylosing spondylitis and non-radiographic axial spondyloarthritis
    • Approved in accordance with NICE TA375 for the treatment of adults with severe rheumatoid arthritis.
    • Erelzi®, Benepali® and Enbrel® should not be used interchangeably. Ensure all prescriptions and communications specify brand.
    • Available through homecare for NUH patients. Please contact pharmacy medicines homecare team for further information
     
    Link  Link to reviews
    Link  Appendix to Clinical Commissioning Statement (NHS England E03/P/d)
    Link  Clinical Commissioning Statement: Biologics for Juvenile Idiopathic Arthritis
    Link  MHRA: Tuberculosis risk—screen patients before starting treatment
    Link  NICE TA35: Adult psoriasis
    Link  NICE TA195: Rheumatoid arthritis after the failure of a TNF inhibitor
    Link  NICE TA199: Psoriatic arthritis
    Link  NICE TA373: Abatacept, adalimumab, etanercept and tocilizumab for JIA
    Link  NICE TA375: Rheumatoid arthritis not previously treated with DMARDs or after conventional DMARDs only have failed
    Link  NICE TA383: TNF-alpha inhibitors for ankylosing spondylitis and non-radiographic axial spondyloarthritis
    Link  SFH Homecare information
       
    Etanercept (Erelzi®)
    (Biosimilar)
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    Restricted Drug Restricted
    Red
    Injection
    SFH only:
  • Restricted for adult rheumatology consultants, for the treatment of rheumatoid arthritis, psoriatic arthritis, axial spondylitis and plaque psoriasis, only in line with NICE guidance.
  • In accordance with NICE TA375 for the treatment of adults with severe rheumatoid arthritis.
  • Erelzi®, Benepali® and Enbrel® should not be used interchangeably. Ensure all prescriptions and communications specify brand.
     
  • Link  MHRA: Tuberculosis risk—screen patients before starting treatment
    Link  NICE TA195: rheumatoid arthritis after the failure of a TNF inhibitor
    Link  NICE TA199: Psoriatic arthritis
    Link  NICE TA35: Adult psoriasis
    Link  NICE TA375: Rheumatoid arthritis not previously treated with DMARDs or after conventional DMARDs only have failed
    Link  NICE TA383: TNF-alpha inhibitors for ankylosing spondylitis and non-radiographic axial spondyloarthritis
       
    Golimumab (Simponi®)
    (Rheumatology)
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    Restricted Drug Restricted
    Red
    High Cost Medicine

    Injection
    Approved in accordance with:

    • NICE TA220 for psoriatic arthritis
    • NICE TA375 for rheumatoid arthritis
    • NICE TA383 for ankylosing spondylitis
    • NICE TA497 for non-radiographic axial spondyloarthritis
      – rheumatology consultants only.
     
    Link  Link to reviews
    Link  MHRA: Tuberculosis risk—screen patients before starting treatment
    Link  NICE TA220: psoriatic arthritis
    Link  NICE TA375: Rheumatoid arthritis not previously treated with DMARDs or after conventional DMARDs only have failed
    Link  NICE TA383: TNF-alpha inhibitors for ankylosing spondylitis and non-radiographic axial spondyloarthritis
    Link  NICE TA497: Golimumab for treating non-radiographic axial spondyloarthritis
       
    Infliximab (Remicade®)
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    Restricted Drug Restricted
    Red
    High Cost Medicine
    Infusion
    Restricted for use in line with NICE guidance(consultant decision)
    Classifed red for rheumatoid arthritis & Crohns disease
  • Approved in accordance with:
    NICE TA375 for rheumatoid arthritis
    NICE TA383 for ankylosing spondylitis
  • NUH approved as per NHSE commissioning policy E03/P/d for the treatment of Juvenile Idiopathic Arthritis (JIA)
     
  • Link  Link to reviews
    Link  MHRA: Tuberculosis risk—screen patients before starting treatment
    Link  NICE TA195: Rheumatoid arthritis (after failure of a TNF inhibitor)
    Link  NICE TA199: Psoriatic arthritis
    Link  NICE TA375: Rheumatoid arthritis not previously treated with DMARDs or after conventional DMARDs only have failed
    Link  NICE TA383: TNF-alpha inhibitors for ankylosing spondylitis and non-radiographic axial spondyloarthritis
    Link  SFH: Information about IV filters
    Link  SFHT: Infliximab protocol in rheumatology patients
    Link  UKMI: Biosimilars - New Developments
    Link  Clinical Commissioning Policy Statement: Biologic Therapies for the treatment of Juvenile Idiopathic Arthritis (JIA)
    Link  NHS England: Suggested Treatment Flow-chart for JIA (Appendix A)
       
    Rituximab  (MabThera®)
    (Rheumatology)
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    Restricted Drug Restricted
    Red
    High Cost Medicine

    Infusion
    Note: a staged switch from MabThera® to the biosimilar Truxima® is currently in progress. Please check which brand should be used as per indication before prescribing.

    NUH and Nottingham NHS Treatment Centre:

    See entry for biosimilar rituximab (Truxima®)

    SFH:
    Restricted for

    • Existing rheumatology patients who have received rituximab (MabThera®)
    • NB: NEW rheumatology patients who have previously not received rituximab - see Rituximab Truxima®
      Rituximab must be prescribed by brand, i.e. either Truxima® or MabThera® in line with guidance for biosimilar switch programmes.
     
    Link  Link to reviews
    Link  NICE TA195: Rheumatoid arthritis - after failure of a TNF inhibitor
    Link  SFH: Rituximab in rheumatology patients
       
    Rituximab (Truxima®)
    (Rheumatology - biosimilar)
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    Restricted Drug Restricted
    Red
    High Cost Medicine

    Infusion (biosimilar)
    Note: a staged switch from MabThera® to the biosimilar Truxima® is currently in progress. Please check which brand should be used as per indication before prescribing.

    Restricted for

    NUH and Nottingham NHS Treatment Centre:

    • Rheumatoid Arthritis - see NICE guidance
    • SLE vasculitis refractory to first line therapies- NUH only
    • [ANCA]-associated vasculitis in accordance with the commissioning policy (A13/P/a) and NICE TA308.
    • In line with NHSE commissioning policy (16057/P) for immunoglobulin G4-related disease
    • NUH approval as per NHSE commissioning policy E03/P/d for the treatment of Juvenile Idiopathic Arthritis (JIA)- NUH only

    SFH: 

    • NEW rheumatology patients who have previously not received rituximab, in line with NHS England commissioning policies
    • Existing rheumatology patients who have received rituximab (MabThera®) – see Rituximab MabThera®
      Rituximab must be prescribed by brand, i.e. either Truxima® or MabThera® in line with guidance for biosimilar switch programmes.
     
    Link  Clinical Commissioning Policy Statement: Biologic Therapies for the treatment of Juvenile Idiopathic Arthritis (JIA)
    Link  NHS England: Rituximab for ANCA-associated vasculitis in adults
    Link  NHS England: Rituximab for immunoglobulin G4-related disease
    Link  NHS England: Suggested Treatment Flow-chart for JIA (Appendix A)
    Link  NICE TA195: Rheumatoid arthritis - after failure of a TNF inhibitor
    Link  SFH: Rituximab in rheumatology patients
       
    Tocilizumab (RoActemra®)
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    Restricted Drug Restricted
    Red
    High Cost Medicine

    Infusion

    • Approved for IV infusion in accordance with NICE TA375 for the treatment of moderate to severe active rheumatoid arthritis in combination with methotrexate.
    • Can also be used via the subcutaneous route for Homecare patients (contact the HCD team for more details).
    • In accordance with NICE TA373 and NHS England clinical commissioning policy for the treatment of juvenile idiopathic arthritis in people 2 years and older.
    • NHS Treatment Centre: Approved in accordance with NICE TA518 for treating giant cell arteritis
     
    Link  Link to reviews
    Link  MHRA: rare risk of serious liver injury including cases requiring transplantation (2019)
    Link  Appendix to Clinical Commissioning Policy Statement (NHS England E03/P/d)
    Link  Clinical Commissioning Statement: Biologics for Juvenile Idiopathic Arthritis
    Link  NICE TA247:Tocilizumab in RA
    Link  NICE TA373: Abatacept, adalimumab, etanercept and tocilizumab for treating juvenile idiopathic arthritis
    Link  NICE TA375: Rheumatoid arthritis not previously treated with DMARDs or after conventional DMARDs only have failed
    Link  NICE TA518: Tocilizumab for treating giant cell arteritis
    Link  SFH: Protocol for IV tocilizumab in rheumatology patients
       
    10.01.03  Expand sub section  Cytokine modulators
    10.01.03  Expand sub section  Sulfasalazine
     ....
    Key
    note Notes
    Section Title Section Title (top level)
    Section Title Section Title (sub level)
    First Choice Item First Choice item
    Non Formulary Item Non Formulary section
    Restricted Drug
    Restricted Drug
    Unlicensed Drug
    Unlicensed
    Track Changes
    Display tracking information
    click to search medicines.org.uk
    Link to adult BNF
    click to search medicines.org.uk
    Link to children's BNF
    click to search medicines.org.uk
    Link to SPCs
    SMC
    Scottish Medicines Consortium
    Cytotoxic Drug
    Cytotoxic Drug
    CD
    Controlled Drug
    High Cost Medicine
    High Cost Medicine
    Cancer Drugs Fund
    Cancer Drugs Fund
    NHSE
    NHS England
    Homecare
    Homecare
    CCG
    CCG

    Traffic Light Status Information

    Status Description

    Grey

    Grey / Non-Formulary: Medicines, which the Nottinghamshire APC has actively reviewed and does not recommend for use at present due to limited clinical and/or cost effective data.
    Grey / Non-Formulary (undergoing assessment): Work is ongoing and will be reviewed at a future APC meeting.
    Grey / Non-Formulary (no formal assessment): APC has not formally reviewed this medicine or indication because it had never been requested for formulary inclusion. Often used for drugs new to market.
      

    Red

    Medicines which should normally be prescribed by specialists only. eg hospital only.
    For patients already receiving prescriptions in primary care - continue. No new patients to receive prescriptions in primary care.
      

    Amber 1

    Medicines that should be initiated by a specialist and prescribed by primary care prescribers only under a shared care protocol, once the patient has been stabilised.
    Prior agreement must be obtained by the specialist from the primary care provider before prescribing responsibility is transferred. The shared care protocol must have been agreed by the relevant secondary care trust Drugs and Therapeutics Committee(s) (DTC) and approved by the Nottinghamshire APC.
      

    Amber 2

    Medicines suitable to be prescribed in primary care / general practice after specialist* recommendation or initiation.
    A supporting prescribing guideline may be requested which must have been agreed by the relevant secondary care trust DTCs and approved by the Nottinghamshire APC.
    *Specialist is defined by the APC as a clinician who has undertaken an appropriate formal qualification or recognised training programme within the described area of practice
      

    Amber 3

    Primary care/ non specialist may initiate as per APC guideline.
    The supporting prescribing guideline must have been agreed by the relevant secondary care trust D&TC(s) and approved by the Nottinghamshire APC.
      

    Green

    Medicines suitable for routine use within primary care.
    Can be initiated within primary care within their licensed indication, in accordance with nationally recognised formularies, for example the BNF, BNF for Children, Medicines for Children or Palliative Care Formulary. Primary care prescribers take full responsibility for prescribing.   

    OTC

      

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