natgillin/translations-raw huggingface dataset:
There are some medicines that should not be taken with CRIXIVAN with or without ritonavir (see Do not take CRIXIVAN) or that require dosage changes of that medicine or CRIXIVAN (e. g., itraconazole, ketoconazole, cyclosporine, nevirapine, delavirdine and efavirenz).
101 istočasno ali odmerek zdravila CRIXIVAN (npr. itrakonazol, ketokonazol, ciklosporin, nevirapin, delavirdin in efavirenz).
100 Consult your doctor before taking certain cholesterol– lowering medicines (e. g., atorvastatin, rosuvastatin, pravastatin, fluvastatin), antifungals (e. g., fluconazole), anticonvulsants (e. g., phenobarbital, phenytoin, carbamazepine), steroids (e. g., dexamethasone), protease inhibitors (e. g., amprenavir, saquinavir), medicines for impotence (e. g., sildenafil), blood thinners (e. g., warfarin), calcium channel blockers (e. g., amlodipine, felodipine– class of medicinal products used for the treatment of hypertension and some specific heart disorders), sedative agents (e. g. midazolam administered by injection), antidepressants (e. g., venlafaxine), oral contraceptives (e. g. "the Pill"), medicines for asthma (e. g., theophylline) or any other medicines.
Z zdravnikom se posvetujte preden jemljete določena zdravila za zniževanje holesterola (npr. atorvastatin, rosuvastatin, pravastatin, fluvastatin), antimikotike (npr. flukonazol), antiepileptike (npr. fenobarbital, fenitoin, karbamazepin), steroide (npr. deksametazon), zaviralce proteaze (npr. amprenavir, sakvinavir), zdravila za impotenco (npr. sildenafil), zdravila za redčenje krvi (npr. varfarin), zaviralce kalcijevih kanalov (npr. amlodipin, felodipin – razred zdravil, ki se uporabljajo za zdravljenje povišanega krvnega tlaka in nekaterih specifičnih okvar srca), pomirjevala (npr. midazolam dan z injekcijo), antidepresive (npr. venlafaksin), peroralna kontracepcijska sredstva (npr. » tabletke «), zdravila proti astmi (npr. teofilin) ali katerokoli drugo zdravilo.
If CRIXIVAN cannot be taken without food, a low– fat light meal, such as dry toast with jam or fruit conserve, juice and coffee with skimmed or low– fat milk and sugar, or a light meal such as corn flakes with skimmed or low– fat milk and sugar is acceptable.
Če ga ne morete vzeti brez hrane, je primeren lahek obrok z malo maščobami, kot je prepečenec z marmelado ali konzervirano sadje, sok ter kava s posnetim mlekom oziroma z mlekom z malo maščobami in sladkorjem ali lahek obrok, kot so koruzni kosmiči s posnetim mlekom oziroma z mlekom z malo maščobami in sladkorjem.
It is not known whether CRIXIVAN is harmful to an unborn baby when taken by a pregnant woman.
Ni znano ali je CRIXIVAN, če ga jemlje noseča ženska, škodljiv za nerojenega otroka.
The dose for children and adolescents will be determined by the doctor.
102 Za otroke in mladostnike bo odmerek določil zdravnik.
For all dosages, use a combination of the 100– mg, 200– mg or 400– mg hard capsules, as appropriate.
Za vse odmerke uporabite primerno kombinacijo 100- mg, 200- mg ali 400- mg trdih kapsul.
101 CRIXIVAN must be taken at regular intervals of 8 hours for full effectiveness and either 1 hour before or 2 hours after a meal.
Za popolno učinkovitost morate CRIXIVAN jemati vsakih 8 ur in sicer eno uro pred obrokom ali dve uri po njem.
Nervous system disorders:
103 Bolezni živčevja:
Very common: nausea; vomiting; diarrhoea; an uncomfortable feeling in the stomach or belching after eating Common: wind; dry mouth; acid regurgitation Not known: inflammation of the pancreas 102 Skin and subcutaneous tissue disorders:
Zelo pogosti: siljenje na bruhanje, bruhanje, driska, nelagoden občutek v želodcu ali spahovanje po jedi Pogosti: vetrovi, suha usta, refluks kisline Pogostost ni znana: vnetje trebušne slinavke
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
104 Če katerikoli neželeni učinek postane resen ali če opazite katerikoli neželeni učinek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika ali farmacevta.
103 Store CRIXIVAN in the original bottle.
CRIXIVAN shranjujte v originalni plastenki.
corresponding to 200 mg of indinavir.
200 mg indinavirja.
The capsules are printed with printing ink containing indigo carmine (E 132).
Kapsule so potiskane s črnilom, ki vsebuje titanov dioksid (E 171) in indigo karmin (E 132).
CRIXIVAN 200 mg hard capsules are supplied in HDPE bottles with a polypropylene cap and a foil induction cap containing 180, 270 or 360 capsules.
V eni plastenki je 180, 270 ali 360 kapsul.
The capsules are semi-translucent white and coded CRIXIVANTM 200 mg in blue.
Kapsule so polprozorne, bele, z oznako CRIXIVANTM 200 mg v modri barvi.
България Мерк Шарп и Доум България ЕООД Тел.: +359 2 819 3740 info-msdbg@merck. com
105 България Мерк Шарп и Доум България ЕООД Тел.: +359 2 819 3740 info- msdbg@ merck. com
Ι talia Merck Sharp & Dohme (Italia) S. p. A.
106 Suomi/ Finland Ιtalia MSD Finland Oy Merck Sharp & Dohme (Italia) S. p. A.
INFORMATION FOR THE USER
107 NAVODILO ZA UPORABO
CRIXIVAN 400 mg hard capsules indinavir
CRIXIVAN 400 mg trde kapsule indinavir
encainide, flecanide, propafenone, quinidine, fusidic acid, clozapine, clorazepate, diazepam, estazolam, and flurazepam.
enkainid, flekanid, propafenon, kinidin, fusidno kislino, klozapin, klorazepat, diazepam, estazolam in flurazepam; 108
- if you are intolerant to lactose because each hard capsule contains 149.6 mg lactose (anhydrous).
Svojega zdravnika obvestite: • o vseh zdravstvenih težavah, ki ste jih imeli v preteklosti ali jih imate, vključno z boleznijo jeter zaradi ciroze; • če imate težave z ledvicami (vključno z bolečino v hrbtu z ali brez krvi v urinu); • če imate alergije; • če imate povišan holesterol, in če jemljete zdravila za zniževanje holesterola, imenovana statini; • če imate sladkorno bolezen; • če imate hemofilijo; • če ne prenašate laktoze, saj ena trda kapsula vsebuje 149, 6 mg laktoze (brezvodne).
There are some medicines that should not be taken with CRIXIVAN with or without ritonavir (see Do not take CRIXIVAN) or that require dosage changes of that medicine or CRIXIVAN (e. g., itraconazole, ketoconazole, cyclosporine, nevirapine, delavirdine and efavirenz).
109 istočasno ali odmerek zdravila CRIXIVAN (npr. itrakonazol, ketokonazol, ciklosporin, nevirapin, delavirdin in efavirenz).
108 Consult your doctor before taking certain cholesterol– lowering medicines (e. g., atorvastatin, rosuvastatin, pravastatin, fluvastatin), antifungals (e. g., fluconazole), anticonvulsants (e. g., phenobarbital, phenytoin, carbamazepine), steroids (e. g., dexamethasone), protease inhibitors (e. g., amprenavir, saquinavir), medicines for impotence (e. g., sildenafil), blood thinners (e. g., warfarin), calcium channel blockers (e. g., amlodipine, felodipine– class of medicinal products used for the treatment of hypertension and some specific heart disorders), sedative agents (e. g. midazolam administered by injection), antidepressants (e. g., venlafaxine), oral contraceptives (e. g. "the Pill"), medicines for asthma (e. g., theophylline) or any other medicines.
Z zdravnikom se posvetujte preden jemljete določena zdravila za zniževanje holesterola (npr. atorvastatin, rosuvastatin, pravastatin, fluvastatin), antimikotike (npr. flukonazol), antiepileptike (npr. fenobarbital, fenitoin, karbamazepin), steroide (npr. deksametazon), zaviralce proteaze (npr. amprenavir, sakvinavir), zdravila za impotenco (npr. sildenafil), zdravila za redčenje krvi (npr. varfarin), zaviralce kalcijevih kanalov (npr. amlodipin, felodipin – razred zdravil, ki se uporabljajo za zdravljenje povišanega krvnega tlaka in nekaterih specifičnih okvar srca), pomirjevala (npr. midazolam dan z injekcijo), antidepresive (npr. venlafaksin), peroralna kontracepcijska sredstva (npr. » tabletke «), zdravila proti astmi (npr. teofilin) ali katerokoli drugo zdravilo.
The dose for children and adolescents will be determined by the doctor.
110 Za otroke in mladostnike bo odmerek določil zdravnik.
109 CRIXIVAN must be taken at regular intervals of 8 hours for full effectiveness and either 1 hour before or 2 hours after a meal.
Za popolno učinkovitost morate CRIXIVAN jemati vsakih 8 ur in sicer eno uro pred obrokom ali dve uri po njem.
It is important for adults to drink at least 1.5 litres (approximately.
Za odrasle je pomembno, da med jemanjem zdravila CRIXIVAN vsak dan popijejo vsaj 1, 5 litra tekočine.
48 fluid ounces) of liquids during each day while taking CRIXIVAN to help reduce the risk of forming kidney stones.
S tem se zmanjša možnost nastanka ledvičnih kamnov.
Nervous system disorders:
111 Bolezni živčevja:
110 Skin and subcutaneous tissue disorders:
Bolezni kože in podkožja:
Common: pain on urination Not known: infection of the kidneys, decreased kidney function, loss of renal function.
Pogosti: boleče uriniranje Pogostost ni znana: okužba ledvic, zmanjšana funkcija ledvic, prenehanje delovanja ledvic
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
112 Če katerikoli neželeni učinek postane resen ali če opazite katerikoli neželeni učinek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika ali farmacevta.
111 Store CRIXIVAN in the original bottle.
CRIXIVAN shranjujte v originalni plastenki.
corresponding to 400 mg of indinavir.
400 mg indinavirja.
The capsules are printed with printing ink containing titanium dioxide (E 171), indigo carmine (E 132) and iron oxide (E 172).
Kapsule so potiskane s črnilom, ki vsebuje titanov dioksid (E 171), indigo karmin (E 132) in železov oksid (E172).
What CRIXIVAN look like and content of the pack CRIXIVAN 400 mg hard capsules are supplied in HDPE bottles with a polypropylene cap and a foil induction cap containing 18, 90 or 180 capsules.
V eni plastenki je 18, 90 ali 180 kapsul.
The capsules are semi-translucent white and coded CRIXIVANTM 400 mg in green.
Kapsule so polprozorne, bele, z oznako CRIXIVANTM 400 mg v zeleni barvi.
България Мерк Шарп и Доум България ЕООД Тел.: +359 2 819 3740 info-msdbg@merck. com
113 България Мерк Шарп и Доум България ЕООД Тел.: +359 2 819 3740 info- msdbg@ merck. com
Ι talia Merck Sharp & Dohme (Italia) S. p. A.
114 Suomi/ Finland Ιtalia MSD Finland Oy Merck Sharp & Dohme (Italia) S. p. A.
114
115
It explains how the Committee for Medicinal products for Human Use (CHMP) assessed the studies performed, to reach their recommendations on how to use the medicine.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil opravljene študije, na podlagi česar je oblikoval priporočila glede uporabe zdravila.
If you need more information about your medical condition or your treatment, read the Package Leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Če potrebujete več informacij o vašem zdravstvenem stanju ali zdravljenju, preberite Navodila za uporabo (ki so prav tako del EPAR) ali se posvetujte s svojim zdravnikom ali s farmacevtom.
Cubicin is a powder that is made up into a solution for infusion (drip into a vein).
Zdravilo Cubicin je prašek za pripravo raztopine za infundiranje (dajanje v veno).
Cubicin is used to treat adults with the following bacterial infections: • complicated infections of the skin or in the layers of flesh under the skin (soft tissues), • right-sided infective endocarditis (infection of the lining or the valves of the right side of the heart) caused by the bacterium Staphylococcus aureus.
Zdravilo Cubicin se uporablja za zdravljenje naslednjih bakterijskih okužb pri odraslih: • zapletene okužbe kože ali plasti pod kožo (mehkih tkiv), • infektivni endokarditis desne strani (okužba zaklopk na desni strani srca), ki ga je povzročila bakterija Staphylococcus aureus.
The decision to treat this type of infection with Cubicin should be based on the likelihood that the medicine will work against the infection and on advice from an expert, • bacteraemia (infection of the blood) caused by Staphylococcus aureus, associated with either of the two infections above.
Podlaga za odločitev o zdravljenju te vrste okužbe z zdravilom Cubicin naj bo verjetnost, da bo zdravilo delovalo proti okužbi ter nasvet strokovnjaka. • bakteremija (okužba krvi), ki jo povzroča Staphylococcus aureus, povezana s katero od zgoraj omenjenih okužb.
Cubicin powder is made up into a solution and is given by intravenous infusion by a doctor or a nurse over 30 minutes.
CUBICIN v obliki praška se pripravi v raztopino, ki jo zdravnik ali medicinska sestra daje z intravensko infuzijo okoli 30 minut.
For skin or soft tissue infections without bacteraemia, the recommended dose is 4 mg per kilogram body weight given once every 24 hours for seven to 14 days or until the infection is cleared.
Za okužbe kože ali mehkega tkiva brez bakteremije je priporočeni odmerek 4 mg na kilogram telesne mase in se daje enkrat vsakih 24 ur sedem do 14 dni oziroma dokler okužba ni odpravljena.
For endocarditis and for skin or soft tissue infection with bacteraemia, the recommended dose is 6 mg/ kg every 24 hours.
Za endokarditis ali za okožbe kože oziroma mehkega tkiva z bakteremijo je priporočeni odmerek 6mg/ kg vsakih 24 ur.
Cubicin at a lower dose should only be used in patients who have problems with their kidneys if the benefit of treatment is greater than its potential risk.
Zdravilo Cubicin v manjših odmerkih se uporablja samo pri bolnikih, ki imajo težave z ledvicami, če so koristi zdravljenja večje od možnih tveganj.
Depending on the type of infection being treated and whether or not a patient has more than one infection, other antibiotics may be given during treatment with Cubicin.
Glede na vrsto okužbe, ki jo zdravimo, ter tega ali ima bolnik več kot eno okužbo ali ne, se med zdravljenjem z zdravilom Cubicin lahko dajejo tudi drugi antibiotiki.
The active substance in Cubicin, daptomycin, is an antibiotic.
Zdravilna učinkovina zdravila Cubicin je daptomicin, ki je antibiotik.
It can stop the growth of certain types of bacteria, by binding to the membrane around each bacterial cell and upsetting the essential functions that keep the cell alive.
Ta lahko ustavi rast določenih vrst bakterij tako, da se veže na membrano okrog posamezne bakterijske celice in s tem prepreči bistvene funkcije, ki omogočajo preživetje celice.
The full list of bacteria against which Cubicin is active can be found in the Summary of Product Characteristics (also part of the EPAR).
Za seznam bakterij, proti katerim zdravilo Cubicin učinkuje, glejte Povzetek glavnih značilnosti zdravila (ki je prav tako del EPAR).
(44-20) 74 18 84 00 Fax (44-20) 74 18 85 45 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged How has Cubicin been studied?
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 85 45 E- mail: mail@ emea. eu. int http: // www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Kako je bilo zdravilo Cubicin raziskano?
Cubicin has been studied in two large studies involving 1,118 patients with complicated skin and soft tissue infections (mainly wound infections and major abscesses) and in one study involving 246 patients with bacteraemia caused by Staphylococcus aureus, including 35 patients with right-sided infective endocarditis.
Zdravilo Cubicin so preučevali v okviru dveh velikih študij, v katerih je sodelovalo 1118 bolnikov z zapletenimi oblikami okužbe kože in mehkih tkiv (predvsem okužbami ran in večjimi ognojki) ter v eni študiji z 246 bolniki z bakteremijo zaradi Staphylococcus aureus, od katerih jih je 35 imelo infektivni endokarditis desne strani.
In all three studies, Cubicin was compared to standard treatments with other antibiotics used for such infections (either vancomycin or one of the penicillins, including oxacillin, cloxacillin, flucloxacillin and nafcillin).
V vseh treh študijah so zdravilo Cubicin primerjali s standardnim zdravljenjem z drugimi antibiotiki, ki se uporabljajo za take okužbe (bodisi vankomicinom ali enim od penicilinov, vključno z oksacilinom, kloksacilinom, flukloksacilinom in nafcilinom).
The trials looked at cure and clinical improvement of the infections, after seven to 12 days in the studies of skin and soft-tissue infections, and, in the study of bacteraemia, after a length of time determined by each patient ’ s diagnosis and susceptibility of the bacteria causing their infection to the medicines being used.
V preizkušanjih so spremljali zdravljenje in klinično izboljšanje okužb po sedmih do 12 dneh v študijah okužb kože in mehkih tkiv, v študiji bakteremije pa po obdobju, določenem za vsakega bolnika posebej glede na njegovo diagnozo in občutljivost bakterije, ki povzroča njegovo okužbo, na uporabljena zdravila.
What benefit has Cubicin shown during the studies?
Kakšne koristi je zdravilo Cubicin izkazalo med raziskavami?
Cubicin was as effective as the standard treatments.
Zdravilo Cubicin je bilo enako učinkovito kot standardna zdravljenja.
In the studies of skin and soft tissue infections, the clinical success rates at seven to 12 days after the last injection for Cubicin were 67% in one study and 85% in the other.
V študijah okužb kože in mehkih tkiv je bila stopnja uspešnega kliničnega odziva sedem do 12 dni po zadnji injekciji v eni študiji 67%, v drugi pa 85%.
These rates reflect differences between the two studies in the range of types of patients and infections that were being treated in each.
Te stopnje odražajo razlike med obema študijama z vidika tipa bolnikov in okužb, ki so jih zdravili v posameznih študijah.
For the treatment of bacteraemia in patients with right-sided infective endocarditis, 8 (42%) of the 19 patients given Cubicin were treated successfully, compared with 7 (44%) of the 16 given standard treatment.
Pri zdravljenju bakteremije pri bolnikih z infektivnim endokarditisom desne strani je bilo 8 (42%) od 19 bolnikov uspešno ozdravljenih, v primerjavi s 7 (44%) od 16 bolnikov, ki so prejemali standardno zdravljenje.
However, there was insufficient evidence to support the use of Cubicin to treat bacteraemia in patients who did not have either right-sided infective endocarditis or complicated skin and soft- tissue infections.
Kljub temu ni bilo dovolj dokazov v podporo uporabi zdravila Cubicin za zdravljenje bakteremije pri bolnikih, ki niso imeli bodisi infektivnega endokarditisa desne strani bodisi zapletenih okužb kože ali mehkih tkiv.
The most common side effects with Cubicin (seen in more than 1 patient in 10) are infections caused by fungi (moulds and yeasts), headache, nausea (feeling sick), vomiting, diarrhoea, rash, infusion site reactions, abnormal liver tests and raised levels in the blood of an enzyme called CPK (a marker of muscle damage).
Najpogostejši neželeni učinki zdravila Cubicin (opaženi pri več kot 1 bolniku od 10) so bile glivične okužbe (plesni in kvasovke), glavobol, navzeja (občutek slabosti), bruhanje, driska, izpuščaj, reakcije na mestu infundiranja, nenormalni jetrni testi ter povišane ravni krvnega encima, imenovanega CPK (označevalec poškodb mišic).
For the full list of all side effects reported with Cubicin, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Cubicin, glejte Navodilo za uporabo.
Cubicin should not be used in people who may be hypersensitive (allergic) to daptomycin or the other ingredient (sodium hydroxide).
Zdravila Cubicin ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) daptomicin ali katero koli drugo sestavino zdravila (natrijev hidroksid).
Caution is needed when it is given to patients with kidney problems and the dose may need to be reduced.
Previdnost je potrebna pri dajanju zdravila bolnikom, ki imajo težave z ledvicami in bo odmerek morda potrebno zmanjšati.
All patients must have their CPK levels measured at regular intervals, particularly if they have any known risk factors for muscle damage.
Vsem bolnikom je potrebno v rednih presledkih meriti raven CPK, še posebej če pri njih obstajajo znani dejavniki tveganja za poškodbe mišic.
For the full list of precautions, see the Package Leaflet.
Za celoten seznam previdnostnih ukrepov glejte Navodilo za uporabo.
Why has Cubicin been approved?
Zakaj je bilo zdravilo CUBICIN odobreno?
The Committee for Medicinal Products for Human Use (CHMP) decided that Cubicin’ s benefits are greater than its risks for the treatment of adults with complicated skin and soft-tissue infections and right-sided infectious endocarditis, and with bacteraemia due to Staphylococcus aureus associated with either of these infections.
Odbor za zdravila za uporabo v humani medicini (CHMP) je sklenil, da so koristi zdravila Cubicin pri zdravljenju odraslih bolnikov z zapletenimi okužbami kože in mehkih tkiv ter infektivnim endokarditisom desne strani ter bakteremijo zaradi bakterije Staphylococcus aureus, ki je povezana s katero koli od teh okužb, večje od z njim povezanih tveganj.
The Committee recommended that Cubicin be given marketing authorisation.
Odbor je priporočil, da se za zdravilo Cubicin odobri dovoljenje za promet.
Which measures are being taken to ensure the safe use of Cubicin?
Kateri ukrepi se izvajajo za zagotovitev varne uporabe zdravila Cubicin?
The company that makes Cubicin will carry out further studies with Cubicin to investigate whether it has an effect on the muscle, and to look at its safety and effectiveness in patients with kidney disease and in the elderly.
Družba, ki izdeluje zdravilo Cubicin, bo izvedla nadaljnje študije, s katerimi bo raziskala, ali zdravilo vpliva na mišice, ter preučila njegovo varnost in učinkovitost pri bolnikih z ledvičnimi obolenji ter pri starejših.
Other information about Cubicin:
Druge informacije o zdravilu Cubicin:
The European Commission granted a marketing authorisation valid throughout the European Union for Cubicin on 23 January 2006.
Evropska komisija je dovoljenje za promet z zdravilom Cubicin, veljavno po vsej Evropski uniji, odobrila dne 23. januarja 2006.
The marketing authorisation holder is Novartis Europharm Limited.
Imetnik dovoljenja za promet je družba Novartis Europharm Limited.
The full EPAR for Cubicin can be found here.
Celotno javno poročilo o oceni zdravila (EPAR) za zdravilo Cubicin je na voljo tukaj.
(concentration)
Vsebina (koncentracija)
Powder for concentrate for solution for infusion
Prašek za koncentrat za pripravo raztopine za infundiranje
Vial (glass)
Viala
Cubicin 350 mg powder for concentrate for solution for infusion
Cubicin 350 mg prašek za koncentrat za raztopino za infundiranje
Each vial contains 350 mg daptomycin.
Vsaka viala vsebuje 350 mg daptomicina.
One ml provides 50 mg of daptomycin after reconstitution with 7 ml of sodium chloride 9 mg/ ml (0.9%) solution or water for injections.
En ml po rekonstituciji s 7 ml raztopine natrijevega klorida 9 mg/ ml (0, 9%) ali vode za injekcije vsebuje 50 mg daptomicina.
Powder for concentrate for solution for infusion.
Prašek za koncentrat za raztopino za infundiranje
A pale yellow to light brown lyophilised powder.
Bledo rumen do svetlo rjav liofiliziran prašek
Cubicin is indicated for the treatment of the following infections in adults (see sections 4.4 and 5.1).
Cubicin je indiciran za zdravljenje naslednjih okužb pri odraslih (glejte poglavji 4. 4 in 5. 1):
- Complicated skin and soft-tissue infections (cSSTI).
- zapletene okužbe kože in mehkih tkiv;
- Right-sided infective endocarditis (RIE) due to Staphylococcus aureus.
- infektivni endokarditis desne strani zaradi bakterije Staphylococcus aureus.
It is recommended that
Pri odločitvi o
the decision to use daptomycin should take into account the antibacterial susceptibility of the organism and should be based on expert advice.
Odločitev naj temelji na presoji strokovnjaka.
See sections 4.4 and 5.1.
Glejte poglavji 4. 4 in 5. 1;
- Staphylococcus aureus bacteraemia (SAB) when associated with RIE or with cSSTI.
- bakteriemija z bakterijo Staphylococcus aureus (SAB) v povezavi z infektivnim endokarditisom
Daptomycin is active against Gram positive bacteria only (see section 5.1).
Daptomicin deluje samo proti po Gramu pozitivnim bakterijam (glejte poglavje 5. 1).