B|BRAUN Effective

B. Braun Melsungen AG
Division Hospital Care
CoE Pharmaceuticals
34209 Melsungen
Germany

Contact: Dr. Christian Maaß

To whom it may concern Fon: +49 151 10253308

Email: christian.maass@bbraun.com
Internet: http://www.bbraun.de

Date: April 4th, 2023

Letter of Declaration

We,

B.Braun Melsungen AG
Carl-Braun-Strasse 1 Postal Address:
34212 Melsungen 34209
Germany Melsungen

herewith declare that the medicinal product Mannitol 20% in Ecoflac® Plus should be stored between
20 °C and 30 °C. Literature data confirm that the solubility of mannitol at 25 °C is 216 g/L1 which is only
slightly above the concentration of mannitol in Mannitol 20%.

When Mannitol 20% is stored under conditions recommended above but rather close to 20 °C, precipitation
might occur over time. The precipitate can be redissolved by warming the product at up to 50 °C in a water
bath or warming cabinet.

Apart from the described process for redissolving precipitated mannitol, all measures should be undertaken
to store the product in the recommended temperature range (this includes temperature-controlled storage
in a warming cabinet at up to 30 °C).

For administration of Mannitol 20% use an infusion system with filter.

Do not use a microwave for warming the product.

Yours faithfully,

B. Braun Melsungen AG

i.V. i.A.

See electronic signature See electronic signature

Joan Gil Bejar Christian Maaß

Director Global PPLCM Manager Global PPLCM &

1
Clinical Trial Supply
National Library of Medicine (https://pubchem.ncbi.nlm.nih.gov/compound/6251#section=Flash-Point; 2023-04-04)
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Vorsitzende des Aufsichtsrats: Vorstand: Sitz der Gesellschaft: Melsungen Hausanschrift:
Dr. Annette Beller Markus Strotmann Reg. Gericht: B. Braun Melsungen AG
(Vorsitzender) Amtsgericht Fritzlar Carl-Braun-Straße 1
Priv.-Doz. Dr. Stefan Ruppert HRB 11 000 34212 Melsungen
Jürgen Stihl WEEE-Reg.-Nr. DE 42690900 Deutschland
Document No.: LoD-Excursion-0259 - Version: 2.0 - Document ID: BB-PPLCM-002087 Print Date: 2023-04-06 10:05 (CET)
 Document Control
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& Signature Page
B|BRAUN

Title: LoD_Mannitol 20%_0259_EP_Excursion Initiator: Alina ? Roman

This document is signed electronically in compliance with the B. Braun electronic signature policies and
procedures by following persons:

UserName: Maass, Christian (maaschde)

Title: HC-RA-DE08P - Manager PPLCM & Clinical Supply
Date: Wednesday, 05 April 2023, 15:26 W. Europe Daylight Time
Meaning: Document signed as Author
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UserName: Gil Bejar, Juan (gilbjode)

Title: HC-LC-DE08P - Director Global PPLCM - CoE Pharmaceuticals
Date: Wednesday, 05 April 2023, 19:38 W. Europe Daylight Time
Meaning: Approve Document
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Document No.: LoD-Excursion-0259 - Version: 2.0 - Document ID: BB-PPLCM-002087 Print Date: 2023-04-06 10:05 (CET)