Depo-Medrol |
Depo-Medrol preparations are reoommended for intra-articular and periarticalur administration for local effect for intramuooulsr admioiotratioo for oyofernic etfecf and for local or iotraleoional injection in oariouo dermafologic conditions.
Each ml of the preparation oonleine: Mefhylprednisolone aoetate 40 mg Polyethylene glyool 4000 Sodium chloride Mydstyl gamma-picoliniam chiodde Water for injection q. e. When necesoery pH wee adjasted with sodium hydrooide anther hydrochloric acid. Methylprednieolone an unti-inflommatory oteroid synthesized end developed in the Research Laboratories of The UPJOHN Company is the fl.methyl derivative of prednisolone. Estimates of the relative potencles of It and prednisolooe range trom 1.13 to 2.t with as average of 1.5. In general the mqaired daily done can be estimated to he two thirds or 0.7) the reqaired daily dose of prednisolone While the effect of parenterally administered Depo-Medrol is podonged It has the some metabolic and anti-inflammatory actions as orally adminiotared methylpredniaolone. In acute adrenal Insufficiency end In the self-losing tons of the udrenogenital syndrome, methylprednlaolone may be employed.llowever, because methylprednisolone lachs significant mineralocorticoid activity, if Iris employed sapplemental salt anther desonycorticosterone should be given .Becaase of the oapplemental therapy required methyipredninolone is not the treatment of choice for this condition each; hormones as hydrocortisone sodium succinate hydrocortisose or corboone are preferred
Indications: A. AdministratIon for Locat Effect
1. Rheumatoid and Oateoarthritis. Pollowing lot ra-erticular administration, relief from pein may be eoperianced within 12 to 24 hours, The durabon of relief varies, bat averages 3 to 4 weeks with a range of one to tine or more weeks. Injections have been well tolerated. The intra-articalar injection of Depo-Medrol (Methylprednisolone acetate) is recommended an as adjunant to general therapeutic measareo to effect napyression of intlammabon in one or a few paripharal joInts; (2) the disease is widespread with one or a few peripheral joints actively inflawed; (3) systemic therapy with other cortlcoldn or corticotropin controls all but a few of the mere actively involved joints; j4j ayatemic therapy with co4isone, hydrocortlanne, or corticotropin in contraindlcetad; (5) joints ahow early but active progresuing deformity (to enhance the effect of physiotherapy and corrective procedures); end jttj surgical or other offhopedic corrective measures crete he or have bean done.
The action of Depo-Medrol injected intranynonially in usually wall localized hat metabolic affect churacterintic of systemic administration may at times ha nboersed. Thin possibility is greater larger the number of joints injectad and the higher the total dose employed. In a law instances, mild end trunuient imyrovament of jointa ether than these injected hna been wyorted.
2. Bursitis. lnttubutsol injections of corticoid suspensions have been feand of value in the treatment of vadoaa types of bumiso including subdeltoid, prepatellar, and olecranon bursitis. In general, the use of corticoido for this purpose has been found to give beffer results in ucate than in chronic oubdeltold bursitis. In acute sabdeltoid boraitis, pain has been alleviated with retum of full range of motion within a few hours after one injection. In most cases, additional injections have nut been required. Is chronic sabdeltoid barsitis, partial reliet of pain with retum of normal range of shoulder motion may he obtained in many cases. In pest-traumatic prepatellar bursitis (housemaid’s knee) sod olecranon baraitis, improvement han usually occurred within 24 hours, with a retum to normal within a week.
3. Miscellaneous Gangtlon, Tendinitis, Epicondylitle. Injections of Depo-Medrol Suspension have been found benetlcisi in a namber of cosditionn inclsding tendinitis, tenusynovitis, epicondylitis, and gsogliu of the tendon shaaths.
4. Injectiona for Local Effect in Dermetotogic Conditions. Injections of corticoid saspensions for local effect are being employed in the treatment of various lesions of the skin. In many instances, such therapy is followed by improvement or involction of the lesion. In recurrent and/or chronic conditions, repested injections may be reqsired. The dermatniogic leoiono which may be benibted by injections of Depo-Medrol Sunpesuion Include localized neurodermutllin, hyperthmpic lichen planus, nummular eczema, necrobiosin lipcidica diubeticorom, alopecia areeta, discoid lupus erythemetusus, sod insect biieo. Intrakeloidul injections have resulted in sohening sod regression of the lesion. In general, better results are obtained in young asdior uoh lesions then in chronic anther hrm lesions.
5. tnstltletion for Locel Effect in Patleete mith Ulceretive Colitis.
B. Administration for Systemic Effect
lntremuscslsr Infection of Depo-Medrul Suspension mast be made deepty into the giutesl muscles.
The usual technIque of aspirating prior to infectIon should be emptoyed to scold tntreesscuisr sdminlstrstlos. Do not administer doses recommended for Intramuscular Injection superficislty or subcutsneosefy, When methylprednisolone therapy is indicated, oral administration Is preferred ordinarily because of its obvious
convenience. Intramuscular therapy with the saspenuion provides an ultemute rocte of administration when oral sue io contreindicated, such us patients with acute gastroentedtis or in pre-ur pesiopersuve patients. Pollowing intramuscular administration, abuorption occurs slowly from the site of injection and prolonged systemic effect masts. This therapy may also be employed in conditions such as the adrenogenital syndrome in which a prolonged effect In desired. While Intramuscular administration In recommended doses has resulted in eff echos sappression of adrenal cortical function for approoimstely one week.This suspension may also be employed In those dermatolsgic conditions known to be benefited by systemic therapy with corticoids. Thus, Depo-Medrol has been employed with good effect in patients with acute or chronic contact dermatitis, including poison ivy dermatitis and neborrbeic dermatitis. Intramuscular administration ban bees employed effectively in asthmatic patiects and patients with perennial allergic rhintia. However, systemic corticeid therapy should be limited to those conditions which do not respond to other therapeutic measures. Pahents with esophugeal baron due to caustic ingestion hens had decreased morbidity sod incidence of stricture formation when ginen carticosteroids as an adjunct to antibiotic coverage fluid end electrolyte replacement, and bougienage. Since oral medication Is not usually given daring the first few days in proven esophageal burns, Depo-Medrol may be perticularty useful.
Each ml of the preparation oonleine: Mefhylprednisolone aoetate 40 mg Polyethylene glyool 4000 Sodium chloride Mydstyl gamma-picoliniam chiodde Water for injection q. e. When necesoery pH wee adjasted with sodium hydrooide anther hydrochloric acid. Methylprednieolone an unti-inflommatory oteroid synthesized end developed in the Research Laboratories of The UPJOHN Company is the fl.methyl derivative of prednisolone. Estimates of the relative potencles of It and prednisolooe range trom 1.13 to 2.t with as average of 1.5. In general the mqaired daily done can be estimated to he two thirds or 0.7) the reqaired daily dose of prednisolone While the effect of parenterally administered Depo-Medrol is podonged It has the some metabolic and anti-inflammatory actions as orally adminiotared methylpredniaolone. In acute adrenal Insufficiency end In the self-losing tons of the udrenogenital syndrome, methylprednlaolone may be employed.llowever, because methylprednisolone lachs significant mineralocorticoid activity, if Iris employed sapplemental salt anther desonycorticosterone should be given .Becaase of the oapplemental therapy required methyipredninolone is not the treatment of choice for this condition each; hormones as hydrocortisone sodium succinate hydrocortisose or corboone are preferred
Indications: A. AdministratIon for Locat Effect
1. Rheumatoid and Oateoarthritis. Pollowing lot ra-erticular administration, relief from pein may be eoperianced within 12 to 24 hours, The durabon of relief varies, bat averages 3 to 4 weeks with a range of one to tine or more weeks. Injections have been well tolerated. The intra-articalar injection of Depo-Medrol (Methylprednisolone acetate) is recommended an as adjunant to general therapeutic measareo to effect napyression of intlammabon in one or a few paripharal joInts; (2) the disease is widespread with one or a few peripheral joints actively inflawed; (3) systemic therapy with other cortlcoldn or corticotropin controls all but a few of the mere actively involved joints; j4j ayatemic therapy with co4isone, hydrocortlanne, or corticotropin in contraindlcetad; (5) joints ahow early but active progresuing deformity (to enhance the effect of physiotherapy and corrective procedures); end jttj surgical or other offhopedic corrective measures crete he or have bean done.
The action of Depo-Medrol injected intranynonially in usually wall localized hat metabolic affect churacterintic of systemic administration may at times ha nboersed. Thin possibility is greater larger the number of joints injectad and the higher the total dose employed. In a law instances, mild end trunuient imyrovament of jointa ether than these injected hna been wyorted.
2. Bursitis. lnttubutsol injections of corticoid suspensions have been feand of value in the treatment of vadoaa types of bumiso including subdeltoid, prepatellar, and olecranon bursitis. In general, the use of corticoido for this purpose has been found to give beffer results in ucate than in chronic oubdeltold bursitis. In acute sabdeltoid boraitis, pain has been alleviated with retum of full range of motion within a few hours after one injection. In most cases, additional injections have nut been required. Is chronic sabdeltoid barsitis, partial reliet of pain with retum of normal range of shoulder motion may he obtained in many cases. In pest-traumatic prepatellar bursitis (housemaid’s knee) sod olecranon baraitis, improvement han usually occurred within 24 hours, with a retum to normal within a week.
3. Miscellaneous Gangtlon, Tendinitis, Epicondylitle. Injections of Depo-Medrol Suspension have been found benetlcisi in a namber of cosditionn inclsding tendinitis, tenusynovitis, epicondylitis, and gsogliu of the tendon shaaths.
4. Injectiona for Local Effect in Dermetotogic Conditions. Injections of corticoid saspensions for local effect are being employed in the treatment of various lesions of the skin. In many instances, such therapy is followed by improvement or involction of the lesion. In recurrent and/or chronic conditions, repested injections may be reqsired. The dermatniogic leoiono which may be benibted by injections of Depo-Medrol Sunpesuion Include localized neurodermutllin, hyperthmpic lichen planus, nummular eczema, necrobiosin lipcidica diubeticorom, alopecia areeta, discoid lupus erythemetusus, sod insect biieo. Intrakeloidul injections have resulted in sohening sod regression of the lesion. In general, better results are obtained in young asdior uoh lesions then in chronic anther hrm lesions.
5. tnstltletion for Locel Effect in Patleete mith Ulceretive Colitis.
B. Administration for Systemic Effect
lntremuscslsr Infection of Depo-Medrul Suspension mast be made deepty into the giutesl muscles.
The usual technIque of aspirating prior to infectIon should be emptoyed to scold tntreesscuisr sdminlstrstlos. Do not administer doses recommended for Intramuscular Injection superficislty or subcutsneosefy, When methylprednisolone therapy is indicated, oral administration Is preferred ordinarily because of its obvious
convenience. Intramuscular therapy with the saspenuion provides an ultemute rocte of administration when oral sue io contreindicated, such us patients with acute gastroentedtis or in pre-ur pesiopersuve patients. Pollowing intramuscular administration, abuorption occurs slowly from the site of injection and prolonged systemic effect masts. This therapy may also be employed in conditions such as the adrenogenital syndrome in which a prolonged effect In desired. While Intramuscular administration In recommended doses has resulted in eff echos sappression of adrenal cortical function for approoimstely one week.This suspension may also be employed In those dermatolsgic conditions known to be benefited by systemic therapy with corticoids. Thus, Depo-Medrol has been employed with good effect in patients with acute or chronic contact dermatitis, including poison ivy dermatitis and neborrbeic dermatitis. Intramuscular administration ban bees employed effectively in asthmatic patiects and patients with perennial allergic rhintia. However, systemic corticeid therapy should be limited to those conditions which do not respond to other therapeutic measures. Pahents with esophugeal baron due to caustic ingestion hens had decreased morbidity sod incidence of stricture formation when ginen carticosteroids as an adjunct to antibiotic coverage fluid end electrolyte replacement, and bougienage. Since oral medication Is not usually given daring the first few days in proven esophageal burns, Depo-Medrol may be perticularty useful.
__________ Contra-Indication:
I u h Depe-Medrel (methpipredetsotone acetate) should not he diluted or mised with other solutions.
Intru-articular, infrsburoal, intratendinoas, or other injectiuna for local effect are contruindicated in the pmsence of acute infectious conditions. Esacerbation of pain, tuffher loon of joint motion with fever and malaise following intro-artlculsr injection may indicate that the arthisicts has became septic. Appmpriute antibacterial therapy should be Instituted
________________ immediately and continued for 7 to 10 days affer all evidence of infection had disappeared.
-SR /Eoo4 The systemic use of (methylpmdninolone), like all other corticoids, is usually considered to be absolutely contraindicated In petienta with herpes nimplen keratitis, acute psychoses, end patients With latent, heeled or active tuberculosis. However, the concurrent administration of corticolds with antitubemslosiu agents maybe life saving in certain cases of pulmonary or meningeal tubemalosis.
Corticoids should not be ginen untess the tubemle bacilli have been shown to be aenuSne to the antituberculosis agents being employed. The following coedihons are considered to be relative contraindication; active or laten peptic ulcer, Cashing’s syndrome, dinerticulitis, fresh intestinal unastomoses, osteoporosis, renal insufficiency, thromboembolic tendencies, psychotic tendencies, diubstes msllirus, hypenension, local or nystemic infections including vaccinis and ouricella an well us tungal and other eosnihsmatous diseases, Pregnancy las relative contraindication to the systemic use of corticoid therapy, particulady during the brat trimester because of the obueroution of fetal abnormalities in enpedmentul animals, If it is necessary to give corticoide during pregnancy, the newbum infant should be watched clcaely fur uigns uf hyposdrsnelium and appropriate therupy instituted it such signs are present. it corticoids are employed In the above conditiorm, the rista should be weighed against possible benefits.
Warnings:
With injechon of Depo-Medrol (methylprednisolone acetate) strict aseptic technique is mandatory.
While crystuls of adrenal steroids in the dermis suppress inflammatory reactions, their presence may cause disintegration of the callular elements and physiochemical changes in the ground subntancs of the connective tissue. The resultant infrequently occurring dermal end / or subdermel changes may for depreooions in the skin at the injection site. The degree to which thia reaction occurs will vary with the amount ot adrenal cteroid injected. Regeneration is usually complete within a few months or affer all crystals of the adrenal steroid bane been absorbed.
In order to minimized the incidence of dermal and sobdermal atrophy cars must be sosmised not to soceed recommended doses in injections. Multiple small injections Into the ares of the lesion should be made whenever possible. The technique af intra-articuler end Intromuscular injection should include precautions against in(ectlon or leakage into the dermis. Injection Into the deltoid muscle should be avoided becouss ot a high incidence of subcutaneous atrophy. These preparations should not be administered Intravenously.
Precautions: Oepo-Medrol (methylpredniuolone acetate) should be given only with tull knowledge of the cheructeristic ecbniry of, and the varied reoponueo to, adrenocorlical hormones.
Becuuue of its inhibitory effect on fibroplusis, methylyredenisolone acetate may mask the signs of injection end enhance dissemination of the infecting organism. Hence, all putients receiving Depu-Medrol should be watched for evidence of intercurrent infection. Should infection occur, it must be brought under control by the use of appropvute entibacterial measures.
It possible, sbruyt cessation cr coitlcooteroid therapy should be avoided because of the danger of superimposed udreeocortlcold insuffclency on the infectious process. Prolonged hormone therapy usually causes a redaction In the activity and size of the adrenal coiten.
Relative udrenocortical insufficiency upon discontinuation of therapy may be avoided by gradusi reduction of dosage. However, a potentially crihcal degree ot insufficiency may peroiut saymptometically for some time even effer gradual diocontlnuatiun of edrenocortical steroids. Therefore, If a patient is subjected to significant stress, such as surgery, trauma or severe illness while being trested or within one year (occasionally up to two years) char treatment has been terminated, hormone therapy should be augmented or reinnoitituted end continued for the duration of the stress end immediately telinwiog it. Since mineralocorticoid secretion may be impaired, salt end/or desooycorticosterone should be administered conjunctinaty. Ii is preferable to sue a soluble hormone preparation in the immediate preoperative aid postoperative periods.
Although unlikely with Medrol jmethylprednisolone(, average and large doses of corticosterolds can cause elevation of blood pressure, suit and water retevuon, sod increused petassium end calcium avcretico. Dietary salt restection and potassium supplementation may be necessary. Uke other glucocoiticoidu, Dspo-Medrol may aggravate diabetes mellitus so that higher Insulin dosage may become necessary or manifestation of latent diabetes millitun may be precipitated. The use of steroids Is myeothenls gravis may uggranate mellitus so that higher insulin dosage may become necessary or manifestation of latent diabetes mellitus may be precipltsred. The use of steroids in myasthenis grenis may aggravate myuutheoic symptoms and should, therefore, be given with proper preceusbons. Weakness of vuluntury musculature has been repsrted following systemic admlnlstrsiton of any at rhe snbinflemmatory uternids. In same instances this has been ssributed to hypopotsssemiu. Escessine lena of potassium, like eocessine retentiov of sodium, is not libely to be induced by affective maintenance doses of msthylpradnisotone. However, ibis effect should be kept in mind and periodic determinations of serum potassium performed in patients receiving any corticoid for prolonged perieds.
Curmnt innectigutiona indicate that weebnesa of the voluntary musculature in patients receiving cofficolds may occur in the presence of -normal serum potassium levels and may be due to a dicturbsnce in muscle metabolism. Patients who have developed severe myopathy have received coiticoids in substantial dosage for prolonged periods. Presently snuileble date Indicate that severe myopathy complicating steroid therapy occurs more frequently In those passers receIving steroids containing the b-ulpfra-fluoro configuration. In some instances improvement In uteroid-induced myopsthy has been noted following withdrawal of the ffuvrinated steroid sod inutitutlon of therapy with cortisone, hydrocortisone, or a predoisteroid such as Medrol (methylprednisolonej. The Incidence of muscle weakness or wasting in patients receining methylprednisnione sppeurs to be low.
Retsrdarion of linear growth has been noted in children receiving cod/colds for sin months or longer, the retardation being roughly pmportionsl ts the dose. Pollowing cessation of therapy, the growth rate may be accelerated. For this reason, the growth ot children receiving prolonged steroid therspy should be obserned carefully. It growth has been retarded, the dose should be reduced sufficiently to permit recovery before epiphyseel closure.
I u h Depe-Medrel (methpipredetsotone acetate) should not he diluted or mised with other solutions.
Intru-articular, infrsburoal, intratendinoas, or other injectiuna for local effect are contruindicated in the pmsence of acute infectious conditions. Esacerbation of pain, tuffher loon of joint motion with fever and malaise following intro-artlculsr injection may indicate that the arthisicts has became septic. Appmpriute antibacterial therapy should be Instituted
________________ immediately and continued for 7 to 10 days affer all evidence of infection had disappeared.
-SR /Eoo4 The systemic use of (methylpmdninolone), like all other corticoids, is usually considered to be absolutely contraindicated In petienta with herpes nimplen keratitis, acute psychoses, end patients With latent, heeled or active tuberculosis. However, the concurrent administration of corticolds with antitubemslosiu agents maybe life saving in certain cases of pulmonary or meningeal tubemalosis.
Corticoids should not be ginen untess the tubemle bacilli have been shown to be aenuSne to the antituberculosis agents being employed. The following coedihons are considered to be relative contraindication; active or laten peptic ulcer, Cashing’s syndrome, dinerticulitis, fresh intestinal unastomoses, osteoporosis, renal insufficiency, thromboembolic tendencies, psychotic tendencies, diubstes msllirus, hypenension, local or nystemic infections including vaccinis and ouricella an well us tungal and other eosnihsmatous diseases, Pregnancy las relative contraindication to the systemic use of corticoid therapy, particulady during the brat trimester because of the obueroution of fetal abnormalities in enpedmentul animals, If it is necessary to give corticoide during pregnancy, the newbum infant should be watched clcaely fur uigns uf hyposdrsnelium and appropriate therupy instituted it such signs are present. it corticoids are employed In the above conditiorm, the rista should be weighed against possible benefits.
Warnings:
With injechon of Depo-Medrol (methylprednisolone acetate) strict aseptic technique is mandatory.
While crystuls of adrenal steroids in the dermis suppress inflammatory reactions, their presence may cause disintegration of the callular elements and physiochemical changes in the ground subntancs of the connective tissue. The resultant infrequently occurring dermal end / or subdermel changes may for depreooions in the skin at the injection site. The degree to which thia reaction occurs will vary with the amount ot adrenal cteroid injected. Regeneration is usually complete within a few months or affer all crystals of the adrenal steroid bane been absorbed.
In order to minimized the incidence of dermal and sobdermal atrophy cars must be sosmised not to soceed recommended doses in injections. Multiple small injections Into the ares of the lesion should be made whenever possible. The technique af intra-articuler end Intromuscular injection should include precautions against in(ectlon or leakage into the dermis. Injection Into the deltoid muscle should be avoided becouss ot a high incidence of subcutaneous atrophy. These preparations should not be administered Intravenously.
Precautions: Oepo-Medrol (methylpredniuolone acetate) should be given only with tull knowledge of the cheructeristic ecbniry of, and the varied reoponueo to, adrenocorlical hormones.
Becuuue of its inhibitory effect on fibroplusis, methylyredenisolone acetate may mask the signs of injection end enhance dissemination of the infecting organism. Hence, all putients receiving Depu-Medrol should be watched for evidence of intercurrent infection. Should infection occur, it must be brought under control by the use of appropvute entibacterial measures.
It possible, sbruyt cessation cr coitlcooteroid therapy should be avoided because of the danger of superimposed udreeocortlcold insuffclency on the infectious process. Prolonged hormone therapy usually causes a redaction In the activity and size of the adrenal coiten.
Relative udrenocortical insufficiency upon discontinuation of therapy may be avoided by gradusi reduction of dosage. However, a potentially crihcal degree ot insufficiency may peroiut saymptometically for some time even effer gradual diocontlnuatiun of edrenocortical steroids. Therefore, If a patient is subjected to significant stress, such as surgery, trauma or severe illness while being trested or within one year (occasionally up to two years) char treatment has been terminated, hormone therapy should be augmented or reinnoitituted end continued for the duration of the stress end immediately telinwiog it. Since mineralocorticoid secretion may be impaired, salt end/or desooycorticosterone should be administered conjunctinaty. Ii is preferable to sue a soluble hormone preparation in the immediate preoperative aid postoperative periods.
Although unlikely with Medrol jmethylprednisolone(, average and large doses of corticosterolds can cause elevation of blood pressure, suit and water retevuon, sod increused petassium end calcium avcretico. Dietary salt restection and potassium supplementation may be necessary. Uke other glucocoiticoidu, Dspo-Medrol may aggravate diabetes mellitus so that higher Insulin dosage may become necessary or manifestation of latent diabetes millitun may be precipitated. The use of steroids Is myeothenls gravis may uggranate mellitus so that higher insulin dosage may become necessary or manifestation of latent diabetes mellitus may be precipltsred. The use of steroids in myasthenis grenis may aggravate myuutheoic symptoms and should, therefore, be given with proper preceusbons. Weakness of vuluntury musculature has been repsrted following systemic admlnlstrsiton of any at rhe snbinflemmatory uternids. In same instances this has been ssributed to hypopotsssemiu. Escessine lena of potassium, like eocessine retentiov of sodium, is not libely to be induced by affective maintenance doses of msthylpradnisotone. However, ibis effect should be kept in mind and periodic determinations of serum potassium performed in patients receiving any corticoid for prolonged perieds.
Curmnt innectigutiona indicate that weebnesa of the voluntary musculature in patients receiving cofficolds may occur in the presence of -normal serum potassium levels and may be due to a dicturbsnce in muscle metabolism. Patients who have developed severe myopathy have received coiticoids in substantial dosage for prolonged periods. Presently snuileble date Indicate that severe myopathy complicating steroid therapy occurs more frequently In those passers receIving steroids containing the b-ulpfra-fluoro configuration. In some instances improvement In uteroid-induced myopsthy has been noted following withdrawal of the ffuvrinated steroid sod inutitutlon of therapy with cortisone, hydrocortisone, or a predoisteroid such as Medrol (methylprednisolonej. The Incidence of muscle weakness or wasting in patients receining methylprednisnione sppeurs to be low.
Retsrdarion of linear growth has been noted in children receiving cod/colds for sin months or longer, the retardation being roughly pmportionsl ts the dose. Pollowing cessation of therapy, the growth rate may be accelerated. For this reason, the growth ot children receiving prolonged steroid therspy should be obserned carefully. It growth has been retarded, the dose should be reduced sufficiently to permit recovery before epiphyseel closure.
oterve wqueous ouspession
Depo•MedroITM Not for Intravenous Use (methylprednisDione acetate)
Depo•MedroITM Not for Intravenous Use (methylprednisDione acetate)
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