Material included in the package: • 1x10mlGM501Hyaluronidase• 5x1mlGM501Hyaluronidase

Material not included in the package:• Incubator(at37°C,noCO2)

• Petridishes

• Pipette suitable for denudation ofoocytes

• LAF-bench(ISO5environment)

• MineralOil(e.g.GM501MineralOil)

• Washingmedium(e.g.GM501Wash)

Product code:• 4HY0010 (1 x 10 ml)• 4HY0001-5 (5 x 1 ml)

Composition:• 80 IU/ml pharmaceutical grade

hyaluronidase from bovine originsolvedinHEPES-bufferedmedium,containing 4.00 g/liter human se-rumalbumin.

Intended use/Intended users:• GM501 Hyaluronidase is a ready-

to-use solution designed to fa-cilitate the mechanical removal ofcumulus cells. Hyaluronidase di-geststheextracellularmatrixinthecumulus-oocyte complex consist-ingofhyaluronicacid.

• TheintendedusersareIVFprofes-sionals (labtechnicians,embryolo-gistsormedicaldoctors).

pH(at37°C)7.30-7.60

Osmolality(mOsm/kg)270-290

Instructions for use:• GM501HyaluronidasecontainsHEPES;noCO2 incuba-

tion is required, justwarm itup to37°C (incubation inaCO2incubatorwilllowerthepHbelow7).

• Dependingonthedishes,100µl(micodrops)or400-600µl (center-/4-well) of GM501 Hyaluronidase should beusedfordenudation.

• Additionallyprepare3-5drops(100µl)ofwashingmedium(e.g.GM501Wash)foroocytewashing.

• The dishes should be covered with Mineral Oil (e.g.GM501MineralOil).

• PlacetheoocyteintheHyaluronidase(uptomax.5oo-cytes)forabout30seconds.

• Usingafinepipette,transferthepartiallydenudedoocytestothefirstwashingdrop.

• Removethecoronabyrepeatedlypipettingtheoocytes.

• Usetheotherdropstofurtherwashthedenudedoocyte.

Product specifications and quality control:• Allrawmaterialsareofhighestavailablepurity(European

Pharmacopoeiaand/orUSPstandard),ifapplicable.

• Acertificateofanalysis isavailable foreachbatchuponrequestfromourwebsitewithrespectivelotnumber.

• The MSDS for GM501 Hyaluronidase is available uponrequestandcanalsobedownloadedfromourwebsite.

• GM501 Hyaluronidase is manufactured and tested ac-cordingtothefollowingspecifications:

Precautions and warnings:• Standard measures to prevent infections resulting from

theuseofmedicinalproductspreparedfromhumanbloodorplasmaincludeselectionofdonors,screeningofindi-vidual donations and plasmapools for specificmarkersof infection and the inclusionof effectivemanufacturingstepsfortheinactivation/removalofviruses.Despitethis,whenmedicinalproductspreparedfromhumanbloodorplasma are administered, the possibility of transmittinginfectiveagentscannottotallybeexcluded.Thisalsoap-plies to unknown or emerging viruses and other patho-gens.Therearenoreportsofprovenvirustransmissionswithalbumin,manufacturedtoEuropeanPharmacopoeiaspecificationsbyestablishedprocesses.

• HandleallspecimensasifcapableoftransmittingHIVorhepatitis.Alwayswearprotectiveclothingwhenhandlingspecimens.

• Productdoesnotcontainanyantibiotics.Alwaysworkun-derstricthygienicconditions(e.g.LAF-bench,ISOClass5)toavoidpossiblecontamination.

• Onlyfortheintendeduse.

Pre-use checks:• Donotusetheproductifbottle,sealofthecontaineror

package isopenedordefectwhen theproduct isdeliv-ered.

• Donotusetheproductifitbecomesdiscoloured,cloudyorshowsanyevidenceofmicrobialcontamination.

GM501 Hyaluronidase GYNEMEDEN

Sterilitysterile-SAL10-3(SterilityAssuranceLevel)

Endotoxins(EU/ml)<1.00

MEA ≥ 80(1-cellassay,blastocystsafter96hin%)

For technical support:

GYNEMEDMedizinprodukteGmbH&Co.KG, LübeckerStraße9,23738Lensahn-Germany Phone:+49(0)436390329-0- Fax:+49(0)436390329-19 Email:info@gynemed.de- http: //www.gynemed.de

Gebrauchsanweisung:GM501_Hyaluronidase:Gebrauchsanweisung_GM501_Hyaluronidase_EN_Rev03_00.inddStand:2017-03-13

Bovine sourced Hyaluronidase:• ThePharmaceutical grade hyaluronidase used in this product is sourced from

bovinetestis.Itiscertifiednottocontainanyneuronaltissue(CertificateofSuit-ability/CEP).

• Hyaluronidaseissourcedfromanimalsdetermined„fitforhumanconsumption“andoriginatingfromcountrieswith„negligibleBSErisk“(ResolutionNo.18„Rec-ognitionoftheBovineSpongiformEncephalopathyRiskStatusofMemberCoun-tries(2014)“,adoptedbytheOIE).

• Accordingtothe„WHOguidelineonTransmissibleSpongiformEncephalopathiesinRelationtoBiologicalandPharmaceuticalProduct“,andaccordingtoECdirec-tive2004/C24/03„Noteforguidanceonminimisingtheriskoftransmittinganimalspongiformencephalopathyagentsviahumanandveterinarymedicinalproducts(EMA/410/01) adopted by the Committee for Proprietary Medicinal Products(CPMP)andbytheCommitteeforProprietaryMedicinalProducts(CVMP)“,testismaterialfrombovinesourceisclassifiedasa„CategoryC:Tissueswithnode-tectedinfectivity“product.

Storage instructions and stability:• Theshelflifeis12monthsfromtimeofmanufacture.

• Storebetween2-8°C.

• Donotfreezebeforeuse.

• Keepawayfrom(sun)light.

• Theproductcanbeusedsafelyupto7daysafteropening,whensterilecondi-tionsaremaintainedandtheproductsarestoredat2-8°C.

• Donotuseafterexpirydate.

• Stableaftertransport(max.5days)atelevatedtemperature(≤37°C)

Consultinstructionsforuse

Temperaturelimitation

Lotnumber

Useby

Cataloguenumber

Donotuseifpackageisdamaged

Sterilizedusingasepticprocessingtechniques(filtration)

Keepawayfrom(sun)light

GM501 Hyaluronidase GYNEMEDEN

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