Summary of Product Characteristics. Methotrexate 2.5 tablets. Last updated 15.4.16. Available via xxx.xxxxxxxxx.xxx.xx accessed 14/8/172.
Summary of Product Characteristics. The SCA must be used inconjuction with the NHS Fife Policy and Procedures for the Shared Care of Medicines, available at:-
Summary of Product Characteristics. Arava 10mg, 20mg and 100mg Tablets (Sanofi-aventis), last updated: 22/11/2011. Available to access at: xxxx://xxx.xxxxxxxxx.xxx.xx/EMC/medicine/7480/SPC/Arava+10%2c+20+and+100mg+Tablets/ 2. Chakravarty K et al. BSR/BHPR guideline for disease-modifying anti-rheumatic drug (DMARD) therapy in consultation with the British Association of Dermatology. Rheumatology 2008; 47: 924-5. Available to access at: xxxx://xxxxxxxxxxxx.xxxxxxxxxxxxxx.xxx/content/suppl/2008/05/31/kel216a.DC1/kel216b.pdf Undertake baseline tests
Summary of Product Characteristics. (Zebinix®) Eisai Ltd. Accessed Nov 2017.
Summary of Product Characteristics. Azathioprine. Last updated 21.10.16. Available via xxx.xxxxxxxxx.xxx.xx accessed 14/8/2018
Summary of Product Characteristics. “Therapeutic indications”
Summary of Product Characteristics. Cinacalcet (Mimpara®) Amgen Ltd. Last updated August 2017. Available xxxx://xxx.xxxxxxxxx.xxx.xx accessed 2/7/19 2. NICE TA 117 Cinacalcet for the treatment of secondary hyperparathyroidism in patients with end stage renal disease on maintenance dialysis therapy. January 2007 xxxx://xxx.xxxx.xxx.xx/guidance/ta117 3. NICE Guideline 132 Hyperparathyroidism (primary): diagnosis, assessment and initial management. 23 May 2019. xxxxx://xxx.xxxx.xxx.xx/guidance/NG132
Summary of Product Characteristics. NEORAL® soft gelatin capsules and oral solution; Novartis (last updated August 2011) Available to access at: xxxx://xxx.xxxxxxxxx.xxx.xx/EMC/medicine/1307/SPC/Neoral+Soft+Gelatin+Capsules%2c+Neoral+Ora l+Solution/ 2. Chakravarty K et al. BSR/BHPR guideline for disease-modifying anti-rheumatic drug (DMARD) therapy in consultation with the British Association of Dermatology. Rheumatology 2008; 47: 924-5. Available to access at: xxxx://xxxxxxxxxxxx.xxxxxxxxxxxxxx.xxx/content/suppl/2008/05/31/kel216a.DC1/kel216b.pdf 1 Confirmation of diagnosis and identification of suitable patients 2 Request agreement of shared care with primary care prescriber 3 Initiation of appropriate therapy 4 Discussion of risks and benefits with patients, outline possible side effects 5 Monitoring requirements and appropriate dose adjustments (if relevant to specific drug) Before Treatment FBC (including differential white cell count & platelets) Electrolytes & Creatinine (check twice, two weeks apart) 24 hr Creatinine Clearance Liver function tests (LFT’s) Fasting lipids Blood Pressure (BP) should be 140/90 on 2 separate occasions 2 weeks apart prior to treatment. Hypertension should be treated and controlled before starting treatment. Urine testing for protein and blood Dermatology indications require a skin examination During treatment (first three months) Every TWO weeks: U&E’s, Serum creatinine &, if possible, BP Every FOUR weeks: FBC (as above) & LFT’s During treatment (after three months) Serum creatinine, U&E monthly FBC and LFT’s 3 monthly BP at each clinic or primary care prescriber visit Blood lipids 6 monthly Patients should be re-evaluated at 6 months and treatment continued only if benefits outweigh risks. The consultant will stop, or advise to stop, ciclosporin treatment if any of the following occur: WBC<4.0x109/l OR Neutrophils<2.0x109/l OR Platelets<150X109/l - withhold until FBC normal Abnormal bruising or sore throat - withhold until FBC normal Significant rise in lipids - specialist should advise Rise in ALT, AST or ALK PHOS 2x upper limit of reference range - withhold until LFT’s normal If serum creatinine levels rise 30% above patients own baseline - repeat in 1 week. If still raised >30% - withhold and seek specialist advice. A dose reduction may suffice. Rise in K+ above upper limit of normal - withhold and seek specialist advice. Ciclosporin should be stopped if treated hypertension remains uncontrolled (>140/90, on 2 occasions, two weeks apart)...
Summary of Product Characteristics. Cinacalcet (Mimpara®) Amgen Ltd. Last updated August 2017. Available xxxx://xxx.xxxxxxxxx.xxx.xx accessed 2/7/19
Summary of Product Characteristics. This document/These documents shall be provided by the Sponsor to the Investigator and shall be attached to the documents about the Clinical Trial. Changes, if any, to this document/to these documents shall be notified by the Sponsor to the Ethics Committee and the Institute;
