natgillin/translations-raw huggingface dataset:
151 133 (88, 1) 140 123 (87, 9) 59 54 (91, 5) 51 49 (96, 1) 48 41 (85, 4) 44 35 (79, 5) 23 19 (82, 6) 17 14 (82, 4) 9 8 (88, 9) 7 6 (85, 7)
89 (90.8) 123 (87.9) 49 (96.1) 35 (79.5) 14 (82.4) 6 (85.7)
† Raten for micafungin minus raten for liposomalt amphotericin B og dobbeltsidet 95% konfidensinterval, som viser forskellen i total succesrate er baseret på tilnærmelse til normalfordeling. ‡ Tilpasset neutropene status; primært endpoint. § Børnepopulation er ikke beregnet til at blive undersøgt for non- inferioritet. ¶ Klinisk effekt blev også observeret (< 5 patienter) hos følgende Candida arter:
† Micafungin rate minus the liposomal amphotericin B rate, and 2-sided 95% confidence interval for the difference in overall success rate based on large sample normal approximation. ‡ Adjusted for neutropenic status; primary endpoint. § The paediatric population was not sized to test for non-inferiority. ¶ Clinical efficacy was also observed (< 5 patients) in the following Candida species:
C. guilliermondii, C. famata, C. lusitaniae, C. utilis, C. inconspicua og C. dubliniensis.
C. guilliermondii, C. famata, C. lusitaniae, C. utilis, C. inconspicua and C. dubliniensis.
Candidiasis i øsofagus:
Oesophageal Candidiasis:
I en randomiseret, dobbeltblind undersøgelse med micafungin versus fluconazol som førstevalgsbehandling af candidiasis i øsofagus, modtog 518 patienter mindst én enkeltdosis forsøgsmedicin.
In a randomised, double-blind study of micafungin versus fluconazole in the first-line treatment of oesophageal candidiasis, 518 patients received at least a single dose of study drug.
En endoskopisk grad på 0 (endoskopisk heling) ved slutningen af behandlingen blev observeret hos 87, 7% (228/ 260) og 88, 0% (227/ 258) af patienterne i micafungin - og fluconazolgrupperne, henholdvis (95% KI for forskellen:
An endoscopic grade of 0 (endoscopic cure) at the end of treatment was observed for 87.7% (228/260) and 88.0% (227/258) of patients in the micafungin and fluconazole groups, respectively (95% CI for difference:
Den nedre grænse for konfidensintervallet på 95% lå over den prædefinerede non- inferioritetsmargin på - 10%, og viste derfor non- inferioritet.
The lower limit of the 95% CI was above the predefined non-inferiority margin of -10%, proving non-inferiority.
Typen og forkomsten af bivirkningerne var ens for de to behandlingsgrupper.
The nature and incidence of adverse events were similar between treatment groups.
Micafungin var mere effektiv end fluconazol til at forhindre invasive svampeinfektioner i en patientergruppe med højere risiko for at udvikle en systemisk svampeinfektion (patienter der gennemgår en hæmatopoetisk stamcelletransplantation [HSCT] i en randomiseret, dobbeltblind multicenterundersøgelse).
Micafungin was more effective than fluconazole in preventing invasive fungal infections in a population of patients at high risk of developing a systemic fungal infection (patients undergoing haematopoietic stem cell transplantation [HSCT] in a randomised, double-blind, multicentre study).
Behandlingssucces blev defineret som ingen påvist, mulig eller mistænkt systemisk svampeinfektion ved slutningen af behandlingen og ingen påvist, mulig eller mistænkt systemisk svampeinfektion ved slutningen af undersøgelsen.
Treatment success was defined as the absence of a proven, probable, or suspected systemic fungal infection through the end of therapy and absence of a proven or probable systemic fungal infection through the end of study.
De fleste patienter (97%, N=882) havde neutropeni ved baseline (< 200 neutrofile/ μL).
Most patients (97%, N=882) had neutropenia at baseline (< 200 neutrophils/µL).
Der var en fast daglig dosis på 50 mg (1, 0 mg/ kg) med micafungin og 400 mg (8 mg/ kg) med fluconazol.
There was a fixed daily dose of 50 mg (1.0 mg/kg) for micafungin and 400 mg (8 mg/kg) for fluconazole.
Behandlingssucces var signifikant højere for micafungin end for fluconazol (1, 6% versus 2, 4% påviste infektioner).
The rate of treatment success was statistically significantly higher for micafungin than fluconazole (1.6% versus 2.4% breakthrough infections).
Påviste Aspergillus- infektioner blev observeret hos 1 versus 7 patienter og påvist, eller mulig udvikling af Candida- infektioner blev observeret i henholdsvis 4 versus 2 patienter i micafungin - og fluconazol- grupperne.
Breakthrough Aspergillus infections were observed in 1 versus 7 patients, and proven or probable breakthrough Candida infections were observed in 4 versus 2 patients in the micafungin and fluconazole groups, respectively.
Andre påviste infektioner var forårsaget af Fusarium (1 og 2 patienter, henholdsvis) og Zygomycetes (1 og 0 patienter, henholdvis).
Other breakthrough infections were caused by Fusarium (1 and 2 patients, respectively) and Zygomycetes (1 and 0 patients, respectively).
Absorption Micafungin gives intravenøst.
Absorption Micafungin is an intravenously administered medication.
Farmakokinetik af micafungin er liniær over et dagligt dosisinterval på 12, 5- 200 mg og 3- 8 mg/ kg.
Pharmacokinetics are linear over the daily dose range of 12.5 mg to 200 mg and 3 mg/kg to 8 mg/kg.
Ved gentagen indgift af micafungin nås stabil tilstand sædvanligvis efter 4- 5 dage uden tegn på systemisk akkumulering.
There is no evidence of systemic accumulation with repeated administration and steady-state is generally reached within 4 to 5 days.
Fordeling Efter intravenøs indgift mindskes koncentrationer af micafungin bieksponentielt.
Distribution Following intravenous administration concentrations of micafungin show a biexponential decline.
I systemisk cirkulation er micafungin ekstensivt plasmabundet (> 99%) primært til albumin.
10 In systemic circulation, micafungin is highly bound to plasma protein (> 99%), primarily to albumin.
Bindingen til albumin er uafhængig af koncentrationen af micafungin (10- 100 μg/ ml).
Binding to albumin is independent of micafungin concentration (10-100 µg/ml).
18- 19 liter.
The volume of distribution at steady state (Vss) was approximately 18-19 litres.
10 Metabolisme Uforandret micafungin er det vigtigste cirkulationsstof i systemisk cirkulation.
Metabolism Unchanged micafungin is the principal circulating compound in systemic circulation.
Af disse er M- 1 (katekolform), M- 2 (metoxyform af M- 1) og M- 5 (hydroxylering ved sidekæde) set i den systemiske cirkulation af micafungin.
Micafungin has been shown to be metabolised to several compounds; of these M-1 (catechol form), M-2 (methoxy form of M-1) and M-5 (hydroxylation at the side chain) of micafungin have been detected in systemic circulation.
Eksponering til disse metabolitter er lav, og metabolitterne bidrager ikke til den samlede effekt af micafungin.
Exposure to these metabolites is low and metabolites do not contribute to the overall efficacy of micafungin.
10- 17 timer og er konstant i doser op til 8 mg/ kg og efter enkelt og gentagen administration.
Elimination and excretion The mean terminal half-life is approximately 10-17 hours and stays consistent across doses up to 8 mg/kg and after single and repeated administration.
Clearance er uafhængig af dosis efter enkelt og gentagen indgift.
Total clearance was 0.15-0.3 ml/min/kg in healthy subjects and adult patients and is independent of dose after single and repeated administration.
Efter indgift af enkelt intravenøs dosis af 14C- micafungin (25 mg) til raske personer genfindes 11, 6% i urinen og 71, 0% i fæces efter 28 dage.
Following a single intravenous dose of 14C-micafungin (25 mg) to healthy volunteers, 11.6% of the radioactivity was recovered in the urine and 71.0% in the faeces over 28 days.
Disse data indikerer, at elimination af micafungin primært er ikke- renal.
These data indicate that elimination of micafungin is primarily non-renal.
I plasma fandt man kun sporkoncentrationer af metabolitterne M- 1 og M- 2, mens M- 5, den mere udtalte metabolit, fandtes i en mængde svarende til 6, 5% af den oprindelige substans.
In plasma, metabolites M-1 and M-2 were detected only at trace concentrations and metabolite M-5, the more abundant metabolite, accounted for a total of 6.5% relative to parent compound.
Specielle populationer Børn:
Special populations Paediatric patients:
Hos pædiatriske patienter var værdierne af AUC proportionale med dosis over et interval på 0, 5 - 4 mg/ kg.
In paediatric patients AUC values were dose proportional over the dose range of 0.5-4 mg/kg.
1, 3 gange større end hos ældre børn (12- 17 år).
Clearance was influenced by age, with mean values of clearance in younger children (2-11 years) being approximately 1.3 -fold greater than those in older children (12-17 years).
Ældre børn havde gennemsnitsclearanceværdier svarende til de værdier, man fandt hos voksne.
Older children had mean clearance values similar to those determined in adult patients.
5 gange større end hos voksne.
Mean clearance in premature infants (gestational age approximately 26 weeks) is approximately 5-fold greater than in adults.
Når farmakokinetikken af micafungin indgives som én enkelt 1- times infusion på 50 mg, svarer den hos ældre (66- 78 år) til, hvad man finder hos yngre voksne (20- 24 år).
When administered as a single 1-hour infusion of 50 mg the pharmacokinetics of micafungin in the elderly (aged 66-78 years) were similar to those in young (20-24 years) subjects.
Dosisjustering er ikke nødvendig for de ældre.
No dose adjustment is necessary for the elderly.
I en undersøgelse foretaget på patienter med moderat nedsat leverfunktion (Child- Pugh- score 7- 9) adskilte farmakokinetikken for micafungin sig ikke signifikant fra den hos raske forsøgspersoner (n=8).
In a study performed in patients with moderate hepatic impairment (Child-Pugh score 7-9), (n=8), the pharmacokinetics of micafungin did not significantly differ from those in healthy subjects (n=8).
Farmakokinetikken af micafungin er ikke blevet undersøgt hos patienter med svært nedsat leverfunktion.
The pharmacokinetics of micafungin has not been studied in patients with severe hepatic insufficiency.
Svært nedsat nyrefunktion (Glomerular Filtration Rate [GFR] < 30 ml/ min) påvirkede ikke farmakokinetikken af micafungin signifikant.
Severe renal impairment (Glomerular Filtration Rate [GFR] < 30 ml/min) did not significantly affect the pharmacokinetics of micafungin.
Køn/ race:
Gender/Race:
Køn og race (hvid, sort og orientalsk) påvirkede ikke de farmakokinetiske parametre for micafungin signifikant.
Gender and race (Caucasian, Black and Oriental) did not significantly influence the pharmacokinetic parameters of micafungin.
Når FAH blev observeret efter behandlling i 13 uger eller mere, var der stadig efter en 13- ugers seponeringsperiode FAH, som udviklede sig til hepatocellulære tumorer efter en behandlingsfri periode, som strakte sig over resten af rotternes levetid.
FAH recorded after treatment for 13 weeks or longer persisted after a 13-week withdrawal period and developed into hepatocellular tumours following a treatment free period which covered the life span of rats.
Der er ikke udført standard carcinogenicitetsundersøgelser, men udviklingen af FAH blev vurderet hos hunrotter efter 20 og 18 måneder efter afsluttet behandling, der havde varet henholdsvis 3 og 6 måneder.
In both studies
Dette sås såvel i højdosisgruppen med 32 mg/ kg/ day som i lavdosisgruppen (forskellen var dog ikke statistisk signifikant).
11 increased incidences/numbers of hepatocellular tumours were observed after the 18 and 20 month treatment free period in the high dose group of 32 mg/kg/day as well as in a lower dose group (although not statistically significant).
11 Toksikologien for micafungin efter gentagen intravenøs dosering hos rotter og/ eller hunde viste bivirkninger i lever, urinveje, røde blodlegemer og mandlige kønsorganer.
The toxicology of micafungin following repeated intravenous dosing in rats and/or dogs showed adverse responses in liver, urinary tract, red blood cells, and male reproductive organs.
Eksponeringsniveauerne hvor, disse bivirkninger forekommer (NOAEL), lå i samme område som ved klinisk eksponering eller lavere.
The exposure levels at which these effects did not occur (NOAEL) were in the same range as the clinical exposure or lower.
I gentagne toksicitetsundersøgelser på rotter var symptomerne på levertoksicitet forhøjede niveauer af leverenzymer og degenerative forandringer af hepatocytter, som blev ledsaget af symptomer på kompenserende regenerering.
In repe ated dose toxicity studies in rat signs of hepatotoxicity consisted of increased liver enzymes and degenerative changes of hepatocytes which were accompanied by signs of compensatory regeneration.
Der blev ikke observeret degenerative ændringer af hepatocyterne.
In dog, liver effects consisted of increased weight and centrilobular hypertrophy, no degenerative changes of hepatocytes were observed.
I en anden 26 ugers undersøgelse var forekomsten af hyperplasi af overgangsepitelet i urinblæren betydelig lavere.
In a second 26-week study hyperplasia of transitional cells in the urinary bladder occurred with a much lower incidence.
5. 1).
The duration of micafungin dosing in these rat studies (6 months) exceeds the usual duration of micafungin dosing in patients (see section 5.1).
Ved gentagne doseringsforsøg på hunde blev der ikke observeret hæmolytisk anæmi.
In repeat dose studies in dogs, haemolytic anaemia was not observed.
I reproduktions - og udviklingstoksicitetsundersøgelser blev der observeret reduceret fødselsvægt hos hundehvalpe.
In reproductive and developmental toxicity studies, reduced birth weight of the pups was noted.
Hos kaniner forekom der en abort ved 32 mg/ kg/ dag.
One abortion occurred in rabbits at 32 mg/kg/day.
Hanrotter i intravenøs behandling i 9 uger viste vakuolisering i bitestiklernes duktale epitelceller, forøget bitestikkelvægt og reduceret antal sædceller (med 15%).
Male rats treated intravenously for 9 weeks showed vacuolation of the epididymal ductal epithelial cells, increased epididymis weights and reduced number of sperm cells (by 15%), however, in studies of 13 and 26 weeks duration these changes did not occur.
Der blev ikke observeret nedsat fertilitet hos hverken hanner eller hunner i de respektive fertilitets - og tidlige fosterundersøgelser af rotter.
No impairment of male or female fertility was observed in the fertility and early embryonic development study in rats.
En af testene var en in vitro- undersøgelse ” Unscheduled DNA Synthesis ” med hepatocytter fra rotter.
Micafungin was not mutagenic or clastogenic when evaluated in a standard battery of in vitro and in vivo tests, including an in vitro study on unscheduled DNA synthesis using rat hepatocytes.
Laktosemonohydrat Citronsyre, vandfri (til pH- justering) Natriumhydroxid (til pH- justering)
Lactose monohydrate Citric acid anhydrous (to adjust the pH) Sodium hydroxide (to adjust the pH)
6. 2 Uforligeligheder
12 6.2 Incompatibilities
6. 6.
This medicinal product must not be mixed or co-infused with other medicinal products except those mentioned in section 6.6.
Uåbnet hætteglas:
3 years.
3 år 12 Rekonstitueret koncentrat i hætteglas:
Reconstituted concentrate in vial:
Der er vist kemisk og fysisk stabilitet i op til 48 timer ved 25°C efter rekonstitution med natriumklorid 9 mg/ ml (0, 9%) til infusionvæske, opløsning eller glukose 50 mg/ ml (5%) til infusionsvæske, opløsning.
Chemical and physical in-use stability has been demonstrated for up to 48 hours at 25°C when reconstituted with sodium chloride 9 mg/ml (0.9%) solution for infusion or glucose 50 mg/ml (5%) solution for infusion.
Der er vist kemisk og fysisk stabilitet i 96 timer ved 25°C, hvis opløsningen beskyttes mod lys, og hvis den er fortyndet med natriumklorid 9 mg/ ml (0, 9%) til infusionsvæske, opløsning eller glukose 50 mg/ ml (5%) til infusionsvæske, opløsning.
Chemical and physical in-use stability has been demonstrated for 96 hours at 25°C when protected from light when diluted with sodium chloride 9 mg/ml (0.9%) solution for infusion or glucose 50 mg/ml (5%) solution for infusion.
Hvis de ikke anvendes straks, er opbevaringstid og opbevaringsbetingelser før anvendelsen brugerens ansvar og bør ikke overstige 24 timer ved 2 - 8°C, med mindre rekonstitution og fortynding sker under kontrollerede og validerede aseptiske forhold.
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless the reconstitution and dilution have taken place in controlled and validated aseptic conditions.
10 ml Type I- hætteglas med isobutylen- isopren (teflonlamineret) prop med "flip- off cap".
10 ml Type I glass vial with an isobutylene-isoprene (Teflon-laminated) rubber stopper and a flip-off cap.
Hætteglasset er pakket i UV- beskyttende film.
The vial is wrapped with an UV-protective film.
Ikke anvendt lægemiddel samt affald heraf bør destrueres i henhold til de lokale retningslinier.
Any unused product or waste material should be disposed of in accordance with local requirements.
5 ml natriumklorid 9 mg/ ml (0, 9%) infusionsvæske, opløsning eller glukose 50 mg/ ml (5%) infusionvæske, opløsning (udtaget fra 100 ml flaske/ pose) bør aseptisk og langsomt injiceres i hvert hætteglas langs siden af indervæggen.
Five ml of sodium chloride 9 mg/ml (0.9%) solution for infusion or glucose 50 mg/ml (5%) solution for infusion (taken from a 100 ml bottle/bag) should be aseptically and slowly injected into each vial along the side of the inner wall.
Kassér derfor ubrugt rekonstitueret koncentrat med det samme.
The refore, please discard unused reconstituted concentrate immediately.
Alt rekonstitueret koncentrat bør udtages fra hvert hætteglas og returneres til den infusionsflaske/ pose, hvorfra det oprindeligt blev udtaget.
All of the reconstituted concentrate should be withdrawn from each vial and returned into the infusion bottle/bag from which it was originally taken.
Den fortyndede infusion bør anvendes straks.
The diluted infusion solution should be
Der er vist kemisk og fysisk stabilitet i 96 timer ved 25°C, hvis opløsningen beskyttes mod lys, og er fortyndet som ovenfor beskrevet.
Chemical and physical in-use stability has been demonstrated for 96 hours at 25°C when protected from light and diluted as described above.
Infusionsflasken/ posen bør vendes forsigtigt, når den fortyndede opløsning indgives, men for at undgå skumdannelse må den IKKE rystes.
The infusion bottle/ bag should be gently inverted to disperse the diluted solution but NOT agitated in order to avoid foaming.
Infusionsflasken / - posen med den fortyndede opløsning bør anbringes i en uigennemsigtig pose for at beskytte mod lys.
The infusion bottle/bag containing the diluted infusion solution should be inserted into a closable opaque bag for protection from light.
13 Tilberedning af infusionsvæske, opløsning
Preparation of the solution for infusion
Mycamine Hætteglas, der skal bruges (mg/ hætteglas)
Mycamine vial to be used (mg/vial)
Mængde natriumchlorid (0, 9%) eller glucose (5%), der skal tilsættes til hvert hætteglas
Volume of sodium chloride (0.9%) or glucose (5%) to be added per vial
Standardinfusion (fyldt op til 100 ml) Slutkoncentration
Standard infusion (added up to 100 ml) Final concentration
50 100 150 200
150
5 ml 5 ml 5 ml 5 ml
10 ml
ca.
200
5 ml (10 mg/ ml) ca.
2 x 100
5 ml (20 mg/ ml) ca.
5 ml
10 ml ca.
approx.
Yderligere information om dette lægemiddel er tilgængelig på Det europæiske Lægemiddelagenturs (EMEAs) hjemmeside http: // www. emea. europa. eu /
Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http://www.emea.europa.eu/.
Efter rekonstitution vil hver ml 20 mg micafungin (som natriumsalt).
After reconstitution each ml contains 20 mg micafungin (as sodium).
Hvert 100 mg hætteglas indeholder 200 mg laktose.
Each 100 mg vial contains 200 mg lactose.
Officielle/ nationale vejledninger vedrørende rigtig brug af antimykotika bør tages med i vurderingen.
Consideration should be given to official/national guidance on the appropriate use of antifungal agents.
Dosering af Mycamine afhænger af patientens vægt, som vist i følgende tabeller:
15 The dose regimen of Mycamine depends on the body weight of the patient as given in the following tables:
15 Brug hos voksne, unge ≥ 16 år og hos ældre
Use in adults, adolescents ≥ 16 years of age and elderly
100 mg/ dag * 150 mg/ dag 50 mg/ dag
100 mg/day* 150 mg/day 50 mg/day
2 mg/ kg/ dag * 3 mg/ kg/ dag 1 mg/ kg/ dag
2 mg/kg/day* 3 mg/kg/day 1 mg/kg/day
* Hvis patientens respons er utilstrækkelig, f. eks. hvis kulturerne giver negative resultater, eller den kliniske tilstand ikke forbedres, kan dosis øges til 200 mg/ dag hos patienter, der vejer > 40 kg eller 4 mg/ kg/ dag hos patienter, som vejer ≤ 40 kg.
*If the patient’s response is inadequate, e.g. persistence of cultures or if clinical condition does not improve, the dose may be increased to 200 mg/day in patients weighing > 40 kg or 4 mg/kg/day in patients ≤ 40 kg.
100 mg/ dag * 50 mg/ dag
100 mg/day* 50 mg/day
2 mg/ kg/ dag * 1 mg/ kg/ dag
2 mg/kg/day* 1 mg/kg/day
* Hvis patientens respons er utilstrækkelig, f. eks. hvis kulturerne giver negative resultater, eller den kliniske tilstand ikke forbedres, kan dosis øges til 200 mg/ dag hos patienter, der vejer > 40 kg eller 4 mg/ kg/ dag hos patienter, som vejer ≤ 40 kg.
*If the patient’s response is inadequate, e.g. persistence of cultures or if clinical condition does not improve, the dose may be increased to 200 mg/day in patients weighing > 40 kg or 4 mg/kg/day in patients weighing ≤ 40 kg.
5. 2).
Gender/Race No dose adjustment is necessary based on gender or race (see section 5.2).
4. 3 Kontraindikationer 16 Overfølsomhed over for det aktive stof eller over for et eller flere af hjælpestofferne.
16 4.3 Contraindications
4. 4 Særlige advarsler og forsigtighedsregler vedrørende brugen
Hypersensitivity to the active substance or to any of the excipients.
For at mindske risikoen for adaptiv regenerering og mulig dannelse af levertumorer anbefales der tidlig seponering ved signifikante og vedvarende forhøjede værdier af ALAT/ ASAT.
To minimise the risk of adaptive regeneration and potentially subsequent liver tumour formation, early discontinuation in the presence of significant and persistent elevation of ALT/AST is recommended.
Micafunginbehandling bør først gives efter nøje vurdering af risk/ benefit - forholdet, især af patienter med svært nedsat leverfunktion eller kroniske leversygdomme med præneoplastiske tilstande, som f. eks, fremskreden leverfibrose, cirrose, viral hepatit, neonatal leversygdom eller medfødte enzymdefekter eller hos patienter, som samtidig får behandling, som har hepatotoksiske og/ eller genotoksiske egenskaber.
Micafungin treatment should be conducted on a careful risk/benefit basis, particularly in patients having severe liver function impairment or chronic liver diseases known to represent preneoplastic conditions, such as advanced liver fibrosis, cirrhosis, viral hepatitis, neonatal liver disease or congenital enzyme defects, or receiving a concomitant therapy including hepatotoxic and/or genotoxic properties.
Patienter, som udvikler kliniske symptomer eller har laboratorieprøver, som viser hæmolyse under behandling med micafungin, bør overvåges nøje, for at man kan følge en mulig forværring af disse tilstande, og vurdere risk/ benefit - forholdet med henblik på at fortsætte behandlingen.
Patients who develop clinical or laboratory evidence of haemolysis during micafungin therapy should be monitored closely for evidence of worsening of these conditions and evaluated for the risk/benefit of continuing micafungin therapy.
17 itrakonazol, sirolimus og nifedipin viste en let øgning i forbindelse med micafungin (henholdsvis 22%, 21% og 18%).
17 Exposure (AUC) of itraconazole, sirolimus and nifedipine was slightly increased in the presence of micafungin (22%, 21% and 18% respectively).
Fordele og ulemper ved amning af barnet afvejes med fordelene for moderen ved at forsætte med behandlingen.
A decision on whether to continue/discontinue breast-feeding or to continue/discontinue therapy with Mycamine should be made taking into account the benefit of breast-feeding to the child and the benefit of Mycamine therapy to the mother.