natgillin/translations-raw huggingface dataset:
The combined storage time (reconstituted solution in vial and diluted solution in infusion bag; see section 6.6) at 25°C should not exceed 12 hours (or 24 at 2°C - 8°C).
Kombinirani čas shranjevanja (rekonstituirana raztopina v viali in razredčena raztopina v infuzijski vrečki: glejte poglavje 6. 6) pri 25 °C ne sme presegati 12 ur (ali 24 ur pri 2 °C - 8 °C).
From a microbiological point of view the product should be used immediately.
Z mikrobiološkega stališča je treba zdravilo uporabiti takoj.
If not used immediately, in-use storage times are the responsibility of the user and would not normally be longer than 24 hours at 2 to 8°C, unless reconstitution/ dilution has taken place in controlled and validated aseptic conditions.
Običajno naj ta čas ne bi bil daljši od 24 ur pri 2 do 8 °C, razen če je bila rekonstitucija/ razredčitev izvedena v nadzorovanih in validiranih aseptičnih pogojih.
12 6.4 Special precautions for storage
6. 4 Posebna navodila za shranjevanje
Store in a refrigerator at 2°C - 8°C.
Shranjujte v hladilniku pri 2 °C - 8 °C.
For storage conditions of the reconstituted diluted medicinal product see section 6.3.
Za pogoje shranjevanja rekonstituiranega razredčenega zdravila glejte poglavje 6. 3.
Single use 10 ml type 1 clear glass vials with type 1 rubber stoppers and aluminium closures with yellow plastic flip off caps.
Viale za enkratno uporabo, 10 ml, iz prozornega stekla tipa 1, z 1 gumijastim zamaškom in aluminijastimi zapirali z rumenimi plastičnimi dvižnimi zaporkami.
6.6 Special precautions for disposal and other handling
12 6. 6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom
A 50 mg/ ml concentration is obtained by reconstituting with 7 ml of sodium chloride 9 mg/ ml (0.9%) solution for injection, or water for injections.
Koncentracija 50 mg/ ml se doseže z rekonstitucijo s 7 ml raztopine natrijevega klorida 9 mg/ ml (0, 9%) za injiciranje ali z vodo za injekcije.
Aseptic technique should be used to reconstitute lyophilised Cubicin.
Za rekonstitucijo liofiliziranega zdravila Cubicin je treba uporabiti aseptično tehniko.
7 ml of either sodium chloride 9 mg/ ml solution for injection or water for injections should be slowly injected through the centre of the rubber stopper into the vial pointing the needle towards the wall of the vial.
Skozi sredino gumijastega zamaška je treba v vialo počasi injicirati 7 ml raztopine natrijevega klorida 9 mg/ ml za injiciranje ali vode za injekcije, pri tem naj bo igla usmerjena proti steni viale.
The vial should be gently rotated to ensure complete wetting of the product and then allowed to stand for 10 minutes.
Vialo je treba nežno obračati, da se zagotovi popolna navlažitev celotnega zdravila, in jo nato pustiti, da počiva 10 minut.
Finally the vial should be gently rotated/ swirled for a few minutes as needed to obtain a clear reconstituted solution.
Nazadnje je treba vialo nekaj minut nežno obračati/ vrteti, kolikor je potrebno da dobimo bistro rekonstituirano raztopino.
Vigorous shaking/ agitation should be avoided to prevent foaming of the product.
Izogibajte se močnemu stresanju, da se zdravilo ne začne peniti.
Reconstitution is typically complete within 15 minutes.
Običajno je rekonstitucija končana v 15 minutah.
The reconstituted solution should be checked carefully to ensure that the product is in solution and visually inspected for the absence of particulates prior to use.
Rekonstituirano raztopino je treba pazljivo preveriti in se prepričati, da je zdravilo v raztopini, pred uporabo pa je treba vizualno pregledati, da v njej ni vidnih delcev.
The reconstituted solution should then be diluted with sodium chloride intravenous infusion (typical volume 50 ml) and infused over 30 minutes as directed in section 4.2.
Rekonstituirano raztopino je treba nato razredčiti z natrijevim kloridom za intravensko infundiranje (običajni volumen 50 ml) in jo 30 minut infundirati, kot je predpisano v poglavju 4. 2.
19 January 2006
19 januar 2006
Cubicin 500 mg powder for concentrate for solution for infusion
Cubicin 500 mg prašek za koncentrat za raztopino za infundiranje
Each vial contains 500 mg daptomycin.
Vsaka viala vsebuje 500 mg daptomicina.
One ml provides 50 mg of daptomycin after reconstitution with 10 ml of sodium chloride 9 mg/ ml (0.9%) solution or water for injections.
En ml po rekonstituciji s 10 ml raztopine natrijevega klorida 9 mg/ ml (0, 9%) ali vode za injekcije vsebuje 50 mg daptomicina.
15 Due to limited clinical experience (see table and footnotes below) Cubicin should only be used in patients with any degree of renal insufficiency (Cr Cl < 80 ml/ min) when it is considered that the expected clinical benefit outweighs the potential risk.
14 Zaradi omejenega obsega kliničnih izkušenj se sme uporabljati zdravilo Cubicin pri bolnikih z ledvično insuficienco katerekoli stopnje (z očistkom kreatinina < 80 ml/ min) samo v primeru, da pričakovane klinične koristi pretehtajo tveganja (glejte spodnjo tabelo in opombe).
The response to treatment and renal function should be closely monitored in all patients with some degree of renal insufficiency) (see also sections 4.4 and 5.2).
Pri vseh bolnikih z ledvično insuficienco katerekoli stopnje je treba natančno spremljati odziv na zdravljenje in delovanje ledvic (glejte tudi poglavji 4. 4 in 5. 2).
16 4.3 Contraindications
15 4. 3 Kontraindikacije
In addition, dose regimens for daptomycin that might be appropriate for the treatment of enterococcal infections, with or without bacteraemia, have not been identified.
Poleg tega niso določili shem odmerjanja daptomicina, ki bi lahko bile primerne za zdravljenje enterokoknih okužb z bakteriemijo ali brez nje.
HMG-CoA reductase inhibitors, fibrates and ciclosporin). • Cubicin should not be administered to patients who are taking other medications associated with myopathy unless it is considered that the benefit to the patient outweighs the risk. • Patients should be reviewed regularly while on therapy for any signs or symptoms that might represent myopathy. • Any patient that develops unexplained muscle pain, tenderness, weakness or cramps should have CPK levels monitored every 2 days.
16 simptome, ki bi lahko predstavljali miopatijo. • Pri vsakem bolniku, pri katerem se razvijejo nepojasnjene bolečine v mišicah, občutljivost, oslabelost ali krči mišic, je treba raven CPK kontrolirati vsak drugi dan.
17 Peripheral Neuropathy Patients who develop signs or symptoms that might represent a peripheral neuropathy during therapy with Cubicin should be investigated and consideration should be given to discontinuation of daptomycin (see sections 4.8 and 5.3).
Periferna nevropatija Bolnike, pri katerih se med terapijo z zdravilom Cubicin pojavijo znaki ali simptomi, ki bi lahko predstavljali periferno nevropatijo, je potrebno pregledati in premisliti o prekinitvi uporabe daptomicina (glejte poglavji 4. 8 in 5. 3).
It is recommended that other medications associated with myopathy should if possible be temporarily discontinued during treatment with Cubicin unless the benefits of concomitant administration outweigh the risk.
17 drugih zdravil, povezanih z nastankom miopatij, razen v primeru, če so koristi sočasne uporabe večje od tveganja.
18 Daptomycin is primarily cleared by renal filtration and so plasma levels may be increased during co- administration with medicinal products that reduce renal filtration (e. g.
Daptomicin se primarno izloča z ledvično filtracijo, tako da lahko pri sočasni uporabi zdravil, ki zavirajo ledvično filtracijo (npr.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
18 V razvrstitvah pogostnosti so neželeni učinki navedeni po padajoči resnosti.
20 Post-Marketing Adverse reactions that have been reported Post-Marketing that are not listed above are:
Postmarketinško obdobje Neželeni učinki, o katerih so poročali v postmarketinškem obdobju:
Immune system disorders Hypersensitivity, manifested by isolated spontaneous reports including, but not limited to; pulmonary eosinophilia, vesicobullous rash with mucous membrane involvement and sensation of oropharyngeal swelling.
19 Bolezni imunskega sistema Preobčutljivosti, ki so bile opisane v posameznih poročanjih, so med drugim vključevale: pulmonalne eozinofilije, vezikulobulozne izpuščaje s prizadetostjo mukozne membrane in občutkom orofaringealne otekline.
21 Mechanisms of resistance Strains with decreased susceptibility to daptomycin have been reported especially during the treatment of patients with difficult-to-treat infections and/ or following administration for prolonged periods.
Mehanizmi rezistence Posebno pri zdravljenju bolnikov s hudimi okužbami, ki jih je težko zdraviti, in/ ali po dolgotrajnejšem zdravljenju so poročali o sevih z zmanjšano občutljivostjo za daptomicin.
22 Differences in Population
primerjalno skupine bolnikov
ITT (intention to treat) Population
ITT populacija (vsi bolniki predvideni za zdravljenje v študiji)
Failure of treatment due to persisting or relapsing Staphylococcus aureus infections was observed in 19/ 120 (15.8%) patients treated with Cubicin, 9/ 53 (16.7%) patients treated with vancomycin and 2/ 62 (3.2%) patients treated with an anti-staphylococcal semi-synthetic penicillin.
21 Neuspeh zdravljenja zaradi persistentne ali ponovne okužbe z bakterijo Staphylococcus aureus so opažali pri 19 od 120 bolnikov (15, 8%), zdravljenih z zdravilom Cubicin, pri 9 od 53 bolnikov (16, 7%), zdravljenih z vankomicinom, in pri 2 od 62 bolnikov (3, 2%), zdravljenih z antistafilokoknim polsintetičnim penicilinom.
23 Following intravenous administration, plasma clearance of daptomycin is approximately 7 to 9 ml/ h/ kg and its renal clearance is 4 to 7 ml/ h/ kg.
Po intravenskemu dajanju znaša plazemski očistek daptomicina približno 7 do 9 ml/ h/ kg in ledvični očistek 4 do 7 ml/ h/ kg.
Special populations
22 Posebne skupine bolnikov
24 The lowest observable effect level (LOEL) for myopathy in rats and dogs occurred at exposure levels of 0.8 to 2.3-fold the human therapeutic levels at 6 mg/ kg for patients with normal renal function.
Do najnižje koncentracije z opaznim učinkom (the lowest observable effect level - LOEL) za miopatijo je pri podganah in psih prišlo pri izpostavljenostih, ki so bile 0, 8 do 2, 3- kratniki terapevtskih koncentracij pri človeku pri odmerjanju 6 mg/ kg za bolnike z normalnim delovanjem ledvic.
Effects on peripheral nerves were observed at higher doses than those associated with skeletal muscle effects in adult rats and dogs, and were primarily related to plasma Cmax.
23 Učinke na periferne živce so opazili pri odmerkih, ki so bili višji od tistih, povezanih z vplivi na skeletne mišice pri podganah in psih, in so se nanašali predvsem na Cmax v plazmi.
25 For storage conditions of the reconstituted diluted medicinal product see section 6.3.
Za pogoje shranjevanja rekonstituiranega razredčenega zdravila glejte poglavje 6. 3.
Single use 10 ml type 1 clear glass vials with type 1 rubber stoppers and aluminium closures with blue plastic flip off caps.
Viale za enkratno uporabo, 10 ml, iz prozornega stekla tipa 1, z 1 gumijastim zamaškom in aluminijastimi zapirali z modrimi plastičnimi dvižnimi zaporkami.
6.6 Special precautions for disposal and other handling
24 6. 6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom
A 50 mg/ ml concentration is obtained by reconstituting with 10 ml of sodium chloride 9 mg/ ml (0.9%) solution for injection, or water for injections.
Koncentracija 50 mg/ ml se doseže z rekonstitucijo s 10 ml raztopine natrijevega klorida 9 mg/ ml (0, 9%) za injiciranje ali z vodo za injekcije.
10 ml of either sodium chloride 9 mg/ ml solution for injection or water for injections should be slowly injected through the centre of the rubber stopper into the vial pointing the needle towards the wall of the vial.
Skozi sredino gumijastega zamaška je treba v vialo počasi injicirati 10 ml raztopine natrijevega klorida 9 mg/ ml za injiciranje ali vode za injekcije, pri tem naj bo igla usmerjena proti steni viale.
Novartis Pharmaceuticals UK Limited Wimblehurst Road Horsham West Sussex, RH12 5AB United Kingdom
Novartis Pharmaceuticals UK Limited Wimblehurst Road Horsham West Sussex, RH12 5AB Velika Britanija
Pharmacovigilance system The MAH must ensure that the system of pharmacovigilance, as described in the amended version dated 4th December 06 presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
Sistem farmakovigilance Imetnik dovoljenja za promet z zdravilom mora vzpostaviti in zagotoviti delovanje sistema farmakovigilance preden je zdravilo dostopno na tržišču in dokler je trženo zdravilo v uporabi, kot je navedeno v modulu 1. 8. 1 dopolnjene verzije vloge za pridobitev dovoljenja za promet z zdravilom z dne 4. decembra 2006.
Risk Management Plan The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 2.1 dated 18th July 07 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
Načrt obvladovanja tveganja Imetnik dovoljenja za promet z zdravilom se zavezuje, da bo opravil raziskave in dodatne dejavnosti v okviru farmakovigilance, opisane v Farmakovigilančnem načrtu, kot je sprejeto v verziji 2. 1 Načrta obvladovanja tveganja z dne 18. julija 2007 v modulu 1. 8. 2 vloge za pridobitev dovoljenja za promet z zdravilom in vseh nadaljnjih dopolnilih Načrta obvladovanja tveganja, ki jih sprejme Odbor za zdravila za uporabo v humani medicini (CHMP).
31 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
29 PODATKI NA ZUNANJI OVOJNINI
Cubicin 350 mg powder for concentrate for solution for infusion daptomycin
Cubicin 350 mg prašek za koncentrat za raztopino za infundiranje daptomicin
33 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
31 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
34 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
32 PODATKI NA ZUNANJI OVOJNINI
Cubicin 500 mg powder for concentrate for solution for infusion daptomycin
Cubicin 500 mg prašek za koncentrat za raztopino za infundiranje daptomicin
36 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
34 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
INFORMATION FOR THE USER
36 NAVODILO ZA UPORABO
- If you have any further questions, ask your doctor, nurse or pharmacist.
- Če imate dodatna vprašanja, se posvetujte z zdravnikom, z medicinsko sestro ali s farmacevtom.
please tell your doctor, nurse or pharmacist.
omenjen v tem navodilu, obvestite svojega zdravnika, medicinsko sestro ali farmacevta.
What Cubicin is and what it is used for 2.
Kaj je zdravilo Cubicin in za kaj ga uporabljamo 2.
Before you are given Cubicin 3.
Kaj morate vedeti, preden vam dajo zdravilo Cubicin 3.
How Cubicin is given 4.
Kako dajemo zdravilo Cubicin 4.
How to store Cubicin 6.
Shranjevanje zdravila Cubicin 6.
WHAT CUBICIN IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO CUBICIN IN ZA KAJ GA UPORABLJAMO
The active substance in Cubicin powder for concentrate for solution for infusion is daptomycin.
Zdravilna učinkovina v Cubicin prašku za koncentrat za raztopino za infundiranje je daptomicin.
Daptomycin is an antibiotic that can stop the growth of certain bacteria.
Daptomicin je antibiotik, ki lahko zaustavi rast določenih bakterij.
Cubicin is used in adults to treat infections of the skin and the tissues below the skin.
Zdravilo Cubicin uporabljamo pri odraslih za zdravljenje okužb kože in tkiv pod kožo.
Depending on the type of infection(s) that you have, your doctor may also prescribe other antibiotics while you are receiving treatment with Cubicin.
Glede na to, kakšno vrsto okužb( e) imate, vam bo zdravnik poleg zdravila Cubicin morda predpisal še kak drug antibiotik.
BEFORE YOU ARE GIVEN CUBICIN
KAJ MORATE VEDETI, PREDEN VAM DAJO ZDRAVILO CUBICIN
You should not be given Cubicin If you are allergic (hypersensitive) to daptomycin or to sodium hydroxide.
Zdravila Cubicin ne smete dobiti Če ste alergični na (preobčutljivi za) daptomicin ali na natrijev hidroksid.
Take special care with Cubicin
Bodite posebno pozorni pri uporabi zdravila Cubicin
- If you have, or have previously had kidney problems.
- če imate ali ste imeli težave z ledvicami.
Your doctor may need to change the dose
Zdravnik bo morda moral prilagoditi odmerek zdravila
of Cubicin (see section 3 of this leaflet).
Cubicin (glejte poglavje 3 tega navodila).
- Occasionally, patients receiving Cubicin may develop tender or aching muscles or muscle
- občasno lahko pri bolnikih, ki dobivajo zdravilo Cubicin, pride do na dotik občutljivih ali
weakness (see section 4 of this leaflet for more information).
bolečih mišic ali šibkosti mišic (za več informacij glejte poglavje 4 tega navodila).
There is a possibility that your blood levels of Cubicin could be
Obstaja možnost, da bo raven zdravila Cubicin v vaši krvi višja kot pri osebah
higher than those found in persons of average weight and you may need careful monitoring in case of side effects.
z normalno telesno maso, zato vas bo treba skrbno spremljati glede pojava neželenih učinkov.
39 Tell your doctor if you develop any of the following symptoms:
37 Obvestite zdravnika, če pride do katerega od naslednjih simptomov:
- Any unusual tingling or numbness of the hands or feet, loss of feeling or difficulties with
- kakršnokoli nenavadno mravljinčenje ali odrevenelost v dlaneh in stopalih, izguba občutka ali
movements.
težave z gibanjem.
- Diarrhoea, especially if you notice blood.
- driska, posebno, če opazite zraven še kri.
The
- zdravilo Cubicin lahko moti laboratorijske teste, s katerimi izmerijo, kako dobro se strjuje vaša
results can suggest poor blood clotting when, in fact, there is no problem.
Izvidi lahko kažejo slabo strjevanje krvi, kadar se kri v resnici normalno strjuje.
Use in children The use of Cubicin in children has not been studied and is therefore not recommended.
Uporaba pri otrocih Uporabe zdravila Cubicin pri otrocih niso proučili, zato uporaba pri otrocih ni priporočena.
Use in elderly People over the age of 65 can be given the same dose as other adults, provided their kidneys are working well.
Uporaba pri starejših Ljudem, ki so stari več kot 65 let, se sme dajati enake odmerke kot drugim odraslim, če njihove ledvice delujejo normalno.
Taking other medicines Please tell your doctor, nurse or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Jemanje drugih zdravil Obvestite svojega zdravnika, medicinsko sestro ali farmacevta, če jemljete ali ste pred kratkim jemali katerokoli zdravilo, tudi če ste ga dobili brez recepta.
It is particularly important that you mention the following:
Posebno pomembno je, da omenite naslednja zdravila:
- Medicines called statins or fibrates (to lower cholesterol) or ciclosporin.
- zdravila, ki jih imenujemo statini ali fibrati (za zniževanje holesterola), ali ciklosporin.
It is possible that the
Možno
risk of side effects affecting the muscles may be higher when any of these medicines (and some others that can affect muscles) is taken during treatment with Cubicin.
je, da se bo pojavilo več neželenih učinkov na mišice, kadar ta zdravila (in še nekatera druga, ki vplivajo na mišice) jemljemo v času zdravljenja z zdravilom Cubicin.
Your doctor may decide not to give you Cubicin or to stop the other medicine for a while.
Vaš zdravnik se bo morda odločil, da vam ne bo predpisal zdravila Cubicin ali pa bo zdravljenje za nekaj časa prekinil.
- Pain killing medicines called non-steroidal anti-inflammatory drugs (NSAIDs) or COX-2
- zdravila proti bolečinam, ki se imenujejo nesteroidna protivnetna zdravila (NSAID) ali zaviralci
inhibitors (e. g. celecoxib).
COX- 2 (npr. celekoksib).
Pregnancy and breast-feeding Cubicin is not usually given to pregnant women.
Nosečnost in dojenje Zdravila Cubicin navadno ne dajemo nosečnicam.
Tell your doctor if you are pregnant, think you may be pregnant, or are planning to become pregnant.
Obvestite svojega zdravnika, če ste noseči, če mislite, da bi lahko bili noseči, ali če nameravate zanositi.
HOW CUBICIN IS GIVEN
KAKO DAJEMO ZDRAVILO CUBICIN
This dose is given directly into your blood stream (into a vein) over a period of about 30 minutes.
Odmerek prejmete direktno v krvni obtok (v veno) v času okrog 30 minut.
If your kidneys do not work well, you may receive Cubicin less often, e. g. once every other day.
Če vaše ledvice ne delujejo dobro, boste prejemali zdravilo Cubicin manj pogosto, na primer vsak drugi dan.
40 A course of treatment usually lasts for 1 to 2 weeks for skin infections.
38 Postopek zdravljenja običajno traja od 1 do 2 tednov pri okužbah kože.
Like all medicines, Cubicin can cause side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi zdravilo Cubicin neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
Some side effects are very rare (reported in less than 1 in 10,000 patients given Cubicin) A hypersensitivity reaction (serious allergic reaction including anaphylaxis) has been reported, in some cases during the infusion.
Nekateri neželeni učinki so zelo redki (o njih poročajo pri manj kot 1 od 10. 000 bolnikov, ki prejemajo zdravilo Cubicin) Poročali so, da je v nekaj primerih med infundiranjem prišlo do preobčutljivostne reakcije (resna alergijska reakcija, ki lahko vključuje anafilaksijo).
This serious allergic reaction needs immediate medical attention.
V primeru take resne alergijske reakcije je potrebna takojšnja zdravniška pomoč.
Tell your doctor or nurse straight away if you experience any of the following symptoms:
Če pride do katerega od naslednjih simptomov, takoj obvestite zdravnika ali medicinsko sestro:
- Chest pain or tightness
- bolečina ali stiskanje za prsnico,
- Rash with blistering, sometimes affecting the mouth and genitals
- izpuščaj z mehurčki, ki včasih prizadene usta ali spolovila,
- Swelling around throat
- otekanje okrog grla in žrela,
- Rapid or weak pulse
- hiter ali slaboten pulz,
- Wheezing
- piskajoče sopenje,
- Fever
- povišana telesna temperatura,
- Shivering or trembling
- tresenje ali drgetanje,
- Hot flushes
- navali vročine,
- Dizziness
- vrtoglavost,
- Fainting
- omedlevica,
- Metallic taste
- kovinski okus.
Tell your doctor if you experience unexplained muscle pain, tenderness, or weakness.
Svojemu zdravniku povejte, če občutite nepojasnjene bolečine v mišicah, občutljivost ali šibkost.
In very rare cases (reported in less than 1 in every 10,000 patients), muscle problems can be serious, including muscle breakdown (rhabdomyolysis), which can result in kidney damage.
V zelo redkih primerih (o katerih so poročali pri manj kot 1 od 10. 000 bolnikov), so lahko mišične težave resen zaplet, vključno z razpadanjem mišic (rabdomiolizo), ki lahko privede do okvare ledvic.
Cubicin may also cause other side effects:
Zdravilo Cubicin lahko povzroča tudi druge stranske učinke:
Some side effects are common (reported in more than 1 in 100 patients given Cubicin)
Nekateri neželeni učinki so pogosti (o njih poročajo pri več kot 1 od 100 bolnikov, ki prejemajo zdravilo Cubicin)
- Fungal infections such as thrush,
- glivične okužbe kot je ustni oprh ali gobice,
- Headache,
- glavobol,
- Diarrhoea, felling sick (nausea) or being sick (vomiting),
- driska, slabost (navzea) ali bruhanje,
- Skin rash,
- kožni izpuščaj,
- Pain, itchiness or redness at the site of infusion,
- bolečina, srbenje ali rdečina na mestu infundiranja,
- Blood testing showing higher levels of liver enzymes or creatine phosphokinase (CPK).
- izvidi preiskav krvi, ki kažejo zvišane vrednosti jetrnih testov ali kreatin- fosfokinaze (CPK).
Some side effects are uncommon (reported in more than 1 in 1,000 but less than 1 in 100 patients given Cubicin)
Nekateri neželeni učinki so občasni (o njih poročajo pri več kot 1 od 1. 000, a pri manj kot 1 od 100 bolnikov, ki prejemajo zdravilo Cubicin)
- Urinary tract infection,
- okužba sečil,
- Blood disorders (e. g increased number of small blood particles called platelets, which may
- bolezni krvi (na primer zvečano število majhnih krvnih ploščic, ki jih imenujemo trombociti in