Perla® Resources
Perla® Resources
Perla®is an extracellular solution [8,9] with polyethylene glycol [10–13] and contains medicinal substances : trimetazidine, tacrolimus and carvedilol [14–17].
The solution has an osmolality of 290 mOsm/kg, a pH of 7,4 at 20°C. Perla® is supplied in 1L or 2 L bags.
Composition
Component | Quantity / L | Function |
Lactobionic acid | 35.83 g | Osmotic agent |
Polyethylene glycol (PEG 35000) | 1.0 g | Oncotic agent |
Raffinose pentahydrate | 17.83 g | Osmotic agent |
Magnesium sulfate heptahydrate | 1,23 | Ionic agent |
Potassium dihydrogen phosphate | 3.40 g | Buffer |
Trimetazidine dihydrochloride | 0.34 mg | Protective agent [1–3] |
Tacrolimus monohydrate | 4.11 mg | Protective agent [4,5] |
Carvedilol | 4.06 mg | Protective agent [6,7] |
Ethanol, anhydrous | 0.50 mL | Solvent |
Sodium hydroxide | qsp pH 7.4 | Ionic agent and pH adjustment |
Water for injections | qsp 1 L | Solvent |
Composition
Component | Quantity / L | Function |
Lactobionic acid | 35.83 g | Osmotic agent |
Polyethylene glycol (PEG 35000) | 1.0 g | Oncotic agent |
Raffinose pentahydrate | 17.83 g | Osmotic agent |
Magnesium sulfate heptahydrate | 1,23 | Ionic agent |
Potassium dihydrogen phosphate | 3.40 g | Buffer |
Trimetazidine dihydrochloride | 0.34 mg | Protective agent [1–3] |
Tacrolimus monohydrate | 4.11 mg | Protective agent [4,5] |
Carvedilol | 4.06 mg | Protective agent [6,7] |
Ethanol, anhydrous | 0.50 mL | Solvent |
Sodium hydroxide | qsp pH 7.4 | Ionic agent and pH adjustment |
Water for injections | qsp 1 L | Solvent |
Main features
Perla® Cold Preservation Solution is a sterile, non-pyrogenic solution intended for hypothermic preservation, flushing and storage of human organs (kidney and livers).
Perla® is indicated in liver and kidney preservation in abdominal transplantation procedures.
Perla® is intended to washout / flushing of the organ, allowing the graft protection during cold ischemia by removing blood, cooling down the organ to reduce metabolism and protection of Ischemia / Reperfusion Injury at the time of organ removal from the donor in preparation for storage, transportation and eventual transplantation into the recipient.
Perla® must be cooled to 2° to 6 °C prior to use.
Perla® is not intended for continuous machine perfusion.
Regulatory
CE-marked Class III. Not approved in other countries.
Registration and Distribution agreements are currently in process in various countries.
Safety and Clinical Performances
For Safety and Clinical Performances, please contact clinical.support@adlifesol.com
Information - IFU
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*Mandatory information – ALS is GDPR compliant.
Bibliography
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2-Faure JP, Baumert H, Han Z, Goujon JM, Favreau F, Dutheil D, et al. Evidence for a protective role of trimetazidine during cold ischemia: targeting inflammation and nephron mass. Biochem Pharmacol. 1 déc 2003;66(11):2241‑50. doi:10.1016/j.bcp.2003.07.011
3-Mosbah IB, Casillas-Ramírez A, Xaus C, Serafín A, Roselló-Catafau J, Peralta C. Trimetazidine: Is it a promising drug for use in steatotic grafts? World J Gastroenterol WJG. 14 févr 2006;12(6):908‑14. doi:10.3748/wjg.v12.i6.908 PubMed PMID: 16521219; PubMed Central PMCID: PMC4066156.
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