Subject: Temporary importation of Hartmann s (Compound Sodium Lactate) 1L from Spain to address manufacturing disruption in UK

Transcription

1 5 th September 2018 Subject: Temporary importation of Hartmann s (Compound Sodium Lactate) 1L from Spain to address manufacturing disruption in UK Dear Customer, In order to address shortages of critical drug products following a continued disruption in the supply of our IV Solutions, Baxter is coordinating with the MHRA to increase the availability of IV fluid in the UK, by temporarily importing product from its manufacturing facility in Spain. What you need to know and do This product is classified as licensed and is covered by a Batch Specific Variation approved by the MHRA. The imported product is identical to product you will have already been using, only the label copy is different. The labelling is in both English and French language. The bags are fully compatible with Baxter IV sets marketed in the UK. As with all IV solutions, it is important to check for leaks prior to use by squeezing the inner bag firmly. If leaks are found, discard solution as sterility may be impaired. Additionally, check to see that solution is clear and free of foreign matter. Discard the solution if solution is not clear. Do not remove from overwrap until ready for use. Do not reconnect partially used bags. The new code must be set up in ordering systems to facilitate ordering. More information is provided on page 2. Report all Adverse Events and Quality Defects as per your normal procedure. Further details are provided on page 2. Details of the product Product Name Size Product Code Pack Factor Batch Numbers Ringer Lactate Solution (Compound Sodium Lactate Hartmann s Solution) in Viaflo 1000 ml XE per box The batches involved are listed in Attachment 2 Effective immediately during this temporary period, Baxter will offer this product to an identified group of NHS Hospitals in England and Wales as an alternative to its UK Viaflo equivalent product FKE2324 Hartmann s (Compound Sodium Lactate) 1000ml. There are some key differences in the labeling between the UK marketed product and the imported product. Please see additional information at the end of this letter for: Attachment 1: Comparison Table of UK product vs imported product Attachment 2: FAQ document for customer use Baxter Healthcare Ltd Wallingford Road / Compton / Newbury / Berkshire / RG20 7QW / Great Britain T F Registered Office: Caxton Way / Thetford / Norfolk / IP24 3SE Registered in England No

2 Ordering In order to enable ease of ordering and invoicing, it is important that customers please set up the new code in their ordering systems. The new code will appear on purchase orders dated from 10th September onwards, when the imported stock will be ready to ship. Product Name Size Product Code Ringer Lactate Solution (Compound Sodium Lactate Hartmann s Solution) in Viaflo 1000 ml Pack Factor GTIN /EAN Code for Carton GTIN /EAN Code for Unit XE per box To place an order, please contact Baxter Customer Service on Reporting Adverse Events and Quality Defects Please report suspected adverse drug reactions (ADRs) to the MHRA through the Yellow Card Scheme. It is easiest and quickest to report ADRs online via the Yellow Cards website - Please ensure that any reports include details of the product code XE2324. Please report: all suspected ADRs that are serious or result in harm. Serious reactions are those that are fatal, life-threatening, disabling or incapacitating, those that cause a congenital abnormality or result in hospitalisation, and those that are considered medically significant for any other reason. When reporting please provide as much information as possible, including information about medical history, any concomitant medication, onset, treatment dates. Adverse Events relating to Baxter products can also be reported direct to Baxter Pharmacovigilance on , or by to vigilanceuk@baxter.com. Any drug product quality complaints (including suspected defective medicines) relating to Baxter products can be reported directly to the Baxter Country Quality Assurance Team on , or by to UK_SHS_QA_Complaints@baxter.com. Alternatively, please report directly to your Baxter Account Manager who will take the details and forward to the Baxter Country Quality Assurance Team. A copy of the UK approved leaflet is available via the Baxter Product Catalogue, within the Clinical Data section for Product Code FKE2324, or by calling the Marketing Authorization Holder on If you have any questions about the information contained in this letter, or the use of the imported product, please contact your Baxter Account Manager or Baxter Medical Information on Yours faithfully Victoria Franklin Product Manager UK & Ireland Baxter Fluid Systems

3 Attachment 1 Comparison Table of UK product vs Imported product UK Standard Product Product code FKE2324 Imported Product Product code XE2324 Bag label Carton label Product Name Licence Status Active Compound Sodium Lactate Solution for Infusion BP Synonyms: Ringer Lactate; Hartmann s Solution BP UK registered product under Marketing Authorisation PL00116/0330 Sodium 131 mmol/l, potassium 5 mmol/l, Calcium 2 mmol/l, chloride 111 mmol/l, lactate 29 mmol/l Ringer Lactate Solution (Compound Sodium Lactate - Hartmann s Solution) BP Covered by PL00116/0330 by Batch Specific Variation although the licence number is not on the labelling. Batch numbers 18H16E9C, 18H18E9P, 18H27E9M, 18H29E9J. Other batches may be added Sodium 131 mmol/l, potassium 5 mmol/l, Calcium 2 mmol/l, chloride 111 mmol/l, lactate 29 mmol/l Excipients Water for injections, EP Water for injections, EP Additional ph ph Information Osmolarity 278 mosmol/l Osmolarity 278 mosmol/l Labelled Storage temp. Container type No special precautions for storage Store below 25 C Both products may be stored at ambient temperatures. Product can be stored in the over pouch up to 40 C for a period of 14 weeks. See also FAQs Viaflo (polyolefin/polyamide co-extruded plastic) Supplied in an overwrap. Twist off port protector (white colour) Viaflo (polyolefin/polyamide co-extruded plastic) Supplied in an overwrap. Twist off port protector (white colour) Administration port closure Baxter Customer Services: Tel: Baxter Medical Information: v1.0 05/09/18

4 Bag Labels Carton Labels Baxter Healthcare Ltd Wallingford Road / Compton / Newbury / Berkshire / RG20 7QW / Great Britain T F Registered Office: Caxton Way / Thetford / Norfolk / IP24 3SE Registered in England No v1.0 05/09/18

5 Attachment 2 Compound Sodium Lactate Solution for Infusion BP (Synonyms: Ringer s lactate; Hartmann s solution) Frequently Asked Questions IMPORTANT: Due to the risk of coagulation precipitated by its calcium content, Compound Sodium Lactate solution must not be added to or administered simultaneously through the same tubing with citrate anticoagulated/preserved blood. Please refer to the Summary of Product Characteristics for full product details. This can be found at Is the replacement product licensed? Yes. The product is covered by the UK product license issued by the Medicines and Healthcare products Regulatory Authority (MHRA) under a batch specific variation to allow for the differences in the labelling from the normal UK product. The product is the same as UK approved product in all other respects. The batches approved by the MHRA are listed below. Note that this list will be updated as and when new batches become available. Batch Numbers Approved by the MHRA as of 5 th September H16E9C 18H18E9P 18H27E9M 18H29E9J What is the replacement product? Compound Sodium Lactate solution has several synonyms. These include Ringer s Lactate and Hartmann s solution. The manufacturing, the material of the bag and the electrolyte composition is the same as the UK approved product. The only difference is the label on the bag. The replacement product is intended for humanitarian aid use. What are the differences between the products? The only difference is the labelling on the primary bag and carton. All other aspects are the same as the Viaflo bags currently in use. Storage, handling and use of these bags of Hartmann s solution is the same as your current practice. The labelling for the imported product has a storage temperature of below 25 C. Solutions in the 1000ml Viaflo container can be stored in their over pouch to temperatures not exceeding 40 C for a period of 14 weeks but should be identified as having been stored at a higher temperature and should not be subsequently warmed. Are the imported bags of Hartmann s solution latex free? Baxter can confirm we do not use natural rubber latex components in the manufacture of products in Viaflo containers. Are the imported bags of Hartmann s solution DEHP free? Yes. The Viaflo bags do not contain di-ethlyhexyl phthalate (DEHP). P a g e 1 2 v1.0 05/09/18

6 Is the surface of the primary bag inside the overwrap sterile? Baxter Viaflex bags are sealed within their over pouch and then terminally sterilised using steam. Therefore, both the primary container and it s over pouch are considered sterilised. However, we cannot guarantee that the outer surface of the primary container will still be sterile when you open the over pouch as the over pouch may have been compromised during transport, storage and handling. Care should be taken when handling the products to minimise the risk of damage and the potential for contamination of the surface of the inner bag. Can I have a certificate of analysis? Yes. Please your request to servicecs@baxter.com, including details of the batch number(s) you require the certificate(s) for. When will the next delivery arrive? For details about specific orders and deliveries please refer to the local Commercial Business Manager or Customer Services on Are the Medicines and Healthcare products Regulatory Agency (MHRA) and Department of Health & Social Care (DHSC) aware? Baxter is working hard with the MHRA and the DHSC to ensure IV fluids continue to be supplied. The replacement product is covered by the UK product licence issued by the MHRA under a batch specific variation to allow for the differences in the labelling from the normal UK product. The product is the same as UK approved product in all other respects. Where can I find more information? For additional details regarding the use of Compound Sodium Lactate Solution for Infusion (Hartmann s solution) please contact Baxter Medical Information. Baxter Medical Information: For details about supply please contact Baxter Customer service or your local account manager. Baxter Customer Services: Tel: Baxter Healthcare Ltd Wallingford Road / Compton / Newbury / Berkshire / RG20 7QW / Great Britain T F Registered Office: Caxton Way / Thetford / Norfolk / IP24 3SE Registered in England No P a g e 2 2 v1.0 05/09/18