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Clodrosome-Clodronate Encapsulated Liposomes_ Package Insert Encapsula Nanosciences_2012

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This file is the package insert for Clodrosome-Clodronate encapsulated liposomes manufactured by Encapsula NanoSciences in United States of America. Clodrosome is used for macrophage and monocyte depletion. The formulation is for research purposes ONLY and it is used in laboratory animal models.

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Clodrosome-Clodronate Encapsulated Liposomes_ Package Insert Encapsula Nanosciences_2012

  1. 1. Encapsula Nano S ciences Product Information Version: 02/15/12 Clodrosome® Macrophage Depletion Kit Refrigerate at 4°C - DO NOT FREEZEKit Contents: 1. Clodrosome® Liposomal Clodronate Suspension - 5 ml in glass vial Contains: Clodronate ((dichloro-phosphono-methyl)phosphonate) Disodium Salt 5 mg/ml L-α-Phosphatidylcholine 18.8 mg/ml Cholesterol 4.2 mg/ml Suspended in Phosphate Buffered Saline at pH 7.4 2. Encapsome® Control Liposome Suspension - 5 ml in glass vial Contains: L-α-Phosphatidylcholine 18.8 mg/ml Cholesterol 4.2 mg/ml Suspended in Phosphate Buffered Saline at pH 7.4 See page 2 for Product Handling and AdministrationReceipt and Storage: Brief Product Description:Inspect package for signs of exposure to extreme Clodrosome is a multilamellar liposome suspension inconditions (excess heat, excess moisture, freezing, etc.) which clodronate is encapsulated in the aqueousand ensure that vials are intact. If packaging is seriously compartments of the liposomes. Encapsome is formu-damaged or otherwise suspect, immediately report lated and prepared identically to Clodrosome exceptdamage to courier (usually Federal Express at that clodronate is not added to the liposomes. The1.800.463.3339), then contact ENS to arrange a replace- liposomes are filtered through 2 μm polycarbonatement delivery. membranes to ensure that larger particles, which may be toxic to animals, are removed from the suspension. BothClodrosome and Encapsome should always be stored at are prepared and packaged under sterile conditions.in the dark at 4°C, except when brought to room temp-erature for brief periods prior to animal dosing. DO NOT When animals or cells are treated with Clodrosome,FREEZE. If the suspension is frozen, clodronate can be phagocytic cells recognize the liposomes as invadingreleased from the liposomes thus limiting its effective- foreign particles and proceed to remove the liposomesness in depleting macrophages. ENS is not responsible from the local tissue or serum via phagocytosis. Thefor results generated by frozen product. liposomes then release clodronate into the cytosol resulting in cell death. Unencapsulated clodronateFor General Information: cannot cross the cell membrane to initiate cell death.We invite and encourage Clodrosome users and scien-tists interested in Clodrosome to visit our website to Encapsome contol liposomes are recognized andlearn more about the behavior of Clodrosome as well as phagocytosed by the same mechanism as Clodrosome.its numerous applications in research. All liposomes, Since the control liposomes do not contain clodronate,including controls (no active agent), solicit some level of the phagocytic cells are not killed. However, phagocytesimmune system response when administered to animals. do respond to the ingestion of control liposomes byAlways take this into account when planning experi- cytokine secretion, temporary suspension of phagocyticments and interpreting the results. activity and other responses described in the literature. Further details, including descriptive animations and a literature database, are available at www.clodrosome.comVersion: 02/15/12 Page 1 of 2
  2. 2. Encapsula Nano S ciences Clodrosome® Macrophage Depletion Kit Product Information Animals systemically dosed with Clodrosome will become immune-compromised immune-compromised. Ensure that treated animals are handled and housed using appropriate protocols.Handling: Administration to Animals:“Product” refers to both Clodrosome and Encapsome If personnel performing intravenous injections, are notunless otherwise noted. experienced in, or familiar with, precautions for injecting larger volumes (~10% animal weight in ml), viscousThe product must be removed from the vial using sterile liquids or particulate suspensions, consider having extratechnique. Do not use if sterility is compromised. This is animals available in case serious injection-relatedparticularly important if a single vial is accessed multiple adverse events occur. Dose control animals first totimes over several weeks. The product should not be become familiar with large volume injections.used more than 60 days after receipt, even if unopened. Within hours after systemic administration of Clodro-Liposomes may settle when left undisturbed for more some, animals begin to loose important components ofthan a few hours. Immediately prior to use, in order to their immune system. Standard animal handling andensure a homogeneous liposome suspension, slowly housing protocols are not suitable for immune-invert the vial several times until the suspension appears compromised animals. Even when such precautions arehomogeneous by visual inspection. Vigorous or erratic taken, monitor the general health of each animal forshaking will not damage the liposomes, but may induce opportunistic infections unrelated to the experimentalfoaming and bubble formation making it more difficult protocol. There is no inherant toxicity to the product atto accurately measure the desired dosage. the recommended dose levels.It is important to become familiar with the gross physi- Please become familiar with the handling instructionscal appearance of the product in the vial. Individual (at left) prior to dosing animals.particles should not be visible. Flocculates or precipitateswhich are not dispersed by gentle, but thorough, mixing When dosing intravenously, use standard precautionsindicate that the product may have been compromised. for dosing larger volumes to animals including theDo not use the product if its appearance is suspect in any following:way. • Warm product to room temperature prior to dosing. • Ensure that all air bubbles are removed from theClodrosome is a viscous suspension due to the relatively syringe prior to dosing; intravenous injection of airhigh ratio of the liposomes’ internal aqueous volume bubbles may result in air emboli which can kill orcompared to the bulk aqueous phase outside the seriously injure animals.liposome. Therefore, extra care must be taken in order to• remove accurate volumes from the vial by syringe, • Inject product at a slow, steady rate of no more than• accurately measure small volumes for bench work, 1 ml/min; decrease infusion rate if animals display any• and avoid injecting air bubbles into animals. atypical reactions such as unusual agitation.A commonly reported problem when dosing the Infusion-related adverse reactions usually involve theproduct intravenously into animals is apparently related animal gasping for air or other seizure-like movements.to air emboli resulting from the coincidental injection of Animals often recover with no apparent permanentair bubbles (see Administration...). injury, but any potential effects on experimental results must be assessed by the researcher. There are currently literature reports on more than 25 different methods or sites for administration of Clodro- some to animals. Please go to www.clodrosome.com for more details and references for these methods.NOT FOR USE IN HUMANS. FOR RESEARCH ONLY.These materials are produced for use in research laboratories by, or under the technical Manufactured and Distributed bysurpervision of, research personnel experienced in their safe handling and application. Encapsula NanoSciences LLCPlease consult the MSDS for further safety information. Never use these products in 441 Donelson Pike, Suite 345humans or animals other than those maintained in a licensed research facility. Nashville, TN 37214 800.401.5140Clodrosome® and Encapsome® are registered trademarks with the US Patent and Trademark Office. www.encapsula.com© Copyright 2012 Encapsula NanoSciences LLC. All rights reserved. Information subject to change without notice. Please go to www.clodrosome.com for the most current information.Version: 02/15/12 Page 2 of 2

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