Senin, 27 Agustus 2018
Confirmation Receipt motu
Dear Healthcare Professional, We are writing to inform you of the following: Summary • Some vials of dantrolene sodium for intravenous use may contain visible particles after reconstitution. These particles are crystals of dantrolene sodium. • All newly released packs of dantrolene sodium are being supplied with one blunt filter needle per via l (a BD Blunt Fill Needle with 5 micron filter 18 G 40 mm). • R econstituted dantrolene sodium from newly released stock must be drawn up with this blunt filter needle to remove the undissolved crystals prior to administration to patients. • If the solution i s not filtered, the administered crystals may result in an increased risk of injection site reactions including erythema, rash, swelling, localized pain, thrombophlebitis, and tissue necrosis . • Filtering does not affect the amount of intravenous dantrolene in solution; no reduction in efficacy of the filtered solution is anticipated . • Existing stock is not affected and does not require filtering. • Stickers with filtering instructions are included with this letter. Place these stickers on to emergenc y toolkits for the treatment of malignant hyperthermia. Further Information Dantrolene sodium is indicated for the treatment of malignant hyperthermia. Due to a manufacturing issue, some vials of dantrolene sodium may contain undissolved dantrolene sodium crystals after reconstitution. The emergency measures outlined in this letter are to ensure continued supply of dantrolene sodium until the manufacturing problem is resolved. These measures apply immediately and until further notice. John Sample Sample City Sample Pharmaceuticals Sample Town SA44 9LE 123 Sample Street To addressee only Norgine Pharmaceuticals Limited Norgine House, Widewater Place, Moorhall Road, Harefield, Uxbridge UB9 6NS, UK Tel: +44 (0)1895 826600 Fax: +44 (0)1895 825865 www.norgine.com Registered in England & Wales No: 03527131 Norgine UK Letterhead.indd 1 14/03/2014 11:53 1. Reconstitute the vial with 60 mL of water for injection. 2. Filter the reconstituted product with a blunt fill needle when drawing the solution up into the syringe. Use a BD Blunt Fill Needle with 5 micron filter 18 G 40 mm (p rovided with newly released stock). 3. Remove the blunt fill needle from the syringe before attaching the syringe to an intravenous cannula or giving set. Discard the blunt fill needle and product vial in an approved sharps collector. 4. Administer the dantrole ne sodium solution immediately once reconstituted. 5. Use a new filter needle with every vial of dantrolene sodium. Reconstitution should be performed in accordance with local infection control guidelines. Dose The use of the filter does not reduce the amount of intravenous dantrolene in solution; therefore no reduction in efficacy of the filtered solution is anticipated. Intravenous dantrolene should be administered as currently recommended. The product information states that the initial dantrolen e sodium dose should be 1 mg/kg . If the physiological and metabolic abnormalities persist or reappear, this dose may be repeated up to a cumulative dose of 10 mg/kg. If a relapse or recurrence occurs, dantrolene sodium should be re -administered at the last e ffective dose. Risk of skin reactions Dantrolene sodium is known to be associated with a risk of injection site reactions including erythema, rash, swelling, localized pain, thrombophlebitis, and tissue necrosis. This risk may be increased if the filter is not used to remove the particles from affected vials prior to administration to patients. Therefore, please use the filter needles provided to draw up reconstituted dantrolene sodium solution. Please be vigilant for and report any injection site reactio ns. Call for Reporting Healthcare professionals should report adverse reactions and medication errors in accordance with the Yellow Card Scheme Website : www.mhra.gov.uk/yellowcard . Should you have any questions or require additional information, please call 0080012002222 . This information has been approved for distribution by the EMA (European Medicines Agency), the MHRA and Norgine. Yours Sincerely Dear LEA CAASPP Coordinator: The 2017–18 California Science Test (CAST ) Test Administrator Survey is now available on the CAST Web page on the CAASPP Portal Web site. Your feedback from this year's survey of the fi eld test administration provid es guidance on future test administration procedures and identifies areas where addit ional training resources may be needed. The survey will take approximately fiv e minutes to complete. Please share this e-mail with t he test administrators at your L EA and schools so they will have access to the survey after they have administered the CAST. Questions about the CAST and all other topics r egarding the 201 7–18 CAASPP administration should be directed to the California Technical Assistance Center by phone at 800-955-2954 or by e-mail at caltac@ets.org . Sincerely, California Technical Assistance Center Phone: 800-955-2954 Fax: 800-541-8455 E-mail: caltac@ets.org Web site: http://www.caaspp.org/
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