FrancophonIA/ELRC3.0 huggingface dataset:
English: Haemorrhagic events, including major haemorrhagic events can occur (see section 4.8).
Croatian: Mogu nastupiti događaji krvarenja, uključujući događaje većeg krvarenja (vidjeti dio 4.8).
English: Cobimetinib is a substrate of P-gp in vitro.
Croatian: Kobimetinib je supstrat P-glikoproteina in vitro.
English: Cobimetinib plus Vemurafenib (n = 247)
Croatian: Kobimetinib plus vemurafenib (n = 247)
English: Photosensitivity has been observed with a higher frequency in the Cotellic plus vemurafenib arm vs placebo plus vemurafenib arm (47% vs 35%).
Croatian: Fotoosjetljivost je primijećena s većom učestalošću u skupini liječenoj lijekom Cotellic plus vemurafenibom nego u onoj koja je primala placebo plus vemurafenib (47% naspram 35%).
English: What you need to know before you take Cotellic Do not take Cotellic: · if you are allergic to cobimetinib or any of the other ingredients of this medicine (listed in section 6).
Croatian: · ako ste alergični na kobimetinib ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
English: · Keep this medicine out of the sight and reach of children.
Croatian: Kako čuvati Cotellic · Lijek čuvajte izvan pogleda i dohvata djece.
English: Caution should be exercised if a moderate CYP3A inhibitor is co-administered with Cotellic.
Croatian: Potreban je oprez ako se istodobno s lijekom Cotellic primjenjuje umjeren inhibitor CYP3A.
English: · Eye problems
Croatian: · Očne tegobe
English: If during treatment the QTc exceeds 500 msec, please refer to the vemurafenib SmPC sections 4.2 and
Croatian: Ako se tijekom liječenja QTc interval produlji na više od 500 ms, vidjeti dijelove 4.2 i 4.4 Sažetka opisa svojstava lijeka za vemurafenib.
English: Within each frequency grouping, ADRs are presented in order of decreasing severity and were reported according to NCICTCAE v 4.0 (common toxicity criteria) for assessment of toxicity in Study GO28141.
Croatian: Unutar svake kategorije učestalosti nuspojave su navedene u padajućem nizu prema težini, a prijavljene su u skladu s verzijom 4.0 kriterija Zajedničkih terminoloških kriterija za nuspojave nacionalnog instituta za rak (engl.
English: Vemurafenib dosing can be continued when Cotellic treatment is modified.
Croatian: Primjena vemurafeniba može se nastaviti nakon prilagodbe doze lijeka Cotellic.
English: Duration of Response (DoR) Median DoR (months) (95% CI) for median NE = Not evaluable a
Croatian: Medijan trajanja odgovora (mjeseci) 95% CI za medijan
English: Ejection fraction decreased, Blood bilirubin increased
Croatian: Povišena vrijednost GGT-a Povišena vrijednost bilirubina u krvi
English: The effects of Cotellic in people younger than 18 years old are not known.
Croatian: Učinci lijeka Cotellic u osoba mlađih od
English: Significant improvement in OS was observed in patients assigned to the Cotellic plus vemurafenib arm compared to the placebo plus vemurafenib arm (Figure 1).
Croatian: U skupini bolesnika kojima je bilo dodijeljeno liječenje lijekom Cotellic plus vemurafenibom primijećeno je značajno poboljšanje ukupnog preživljenja u usporedbi sa skupinom koja je primala placebo plus vemurafenib (Slika 1).
English: Serous retinopathy (fluid accumulation within the layers of the retina) has been observed in patients treated with MEK-inhibitors, including Cotellic (see section 4.8).
Croatian: U bolesnika liječenih MEK inhibitorima, uključujući Cotellic, primijećena je serozna retinopatija (nakupljanje tekućine unutar slojeva mrežnice) (vidjeti dio 4.8).
English: No dose adjustment is recommended in patients with mild or moderate renal impairment based on population pharmacokinetic analysis (see section 5.2).
Croatian: Prema populacijskoj farmakokinetičkoj analizi, ne preporučuje se prilagođavati dozu u bolesnika s blagim ili umjerenim oštećenjem bubrežne funkcije (vidjeti dio 5.2).
English: Toxicity studies in rats and dogs identified generally reversible degenerative changes in the bone marrow, gastrointestinal tract, skin, thymus, adrenal gland, liver, spleen, lymph node, kidney, heart, ovary, and vagina at plasma exposures below clinical efficacious levels.
Croatian: Ispitivanja toksičnosti na štakorima i psima ukazala su na načelno reverzibilne degenerativne promjene u koštanoj srži, probavnom sustavu, koži, timusu, nadbubrežnim žlijezdama, jetri, slezeni,
English: All patients restarting treatment with a dose reduction of Cotellic should have LVEF measurements taken after approximately 2 weeks, 4 weeks, 10 weeks and 16 weeks, and then as clinically indicated.
Croatian: nakon približno 2 tjedna, 4 tjedna, 10 tjedana i 16 tjedana, a zatim sukladno kliničkoj indikaciji.
English: Increased blood bilirubin Other laboratory abnormalities Increased blood CPK
Croatian: Ostala odstupanja u laboratorijskim vrijednostima Povišena vrijednost CPK-a u krvi
English: Each film-coated tablet contains cobimetinib hemifumarate equivalent to 20 mg cobimetinib.
Croatian: Jedna filmom obložena tableta sadrži 20 mg kobimetiniba u obliku kobimetinib hemifumarata.
English: Serous retinopathy can be managed with treatment interruption, dose reduction or with treatment discontinuation (see Table 1 in section 4.2).
Croatian: Serozna retinopatija može se zbrinuti privremenim prekidom primjene, smanjenjem doze ili trajnom obustavom liječenja (vidjeti Tablicu 1 u dijelu 4.2).
English: and ≥ 10%
Croatian: naspram 9%).
English: Asymptomatic increases in blood CPK levels were observed with a higher frequency in the Cotellic plus vemurafenib arm vs placebo plus vemurafenib arm in Study GO28141 (see section 4.2 and 4.4).
Croatian: Povišene vrijednosti kreatin fosfokinaze u krvi U ispitivanju GO28141A, asimptomatska povišenja vrijednosti CPK-a u krvi primijećena su s većom učestalošću u skupini liječenoj lijekom Cotellic plus vemurafenibom nego u onoj koja je primala placebo plus vemurafenib (vidjeti dijelove 4.2 i 4.4).
English: Cotellic in combination with vemurafenib in patients who have progressed on a BRAF inhibitor There are limited data in patients taking the combination of Cotellic with vemurafenib who have progressed on a prior BRAF inhibitor.
Croatian: Cotellic u kombinaciji s vemurafenibom u bolesnika koji su doživjeli progresiju bolesti tijekom liječenja BRAF inhibitorom
English: Includes both chorioretinopathy and retinal detachment events indicative of serous retinopathy (see section 4.4) b Combined figure includes reports of photosensitivity reaction, sunburn, solar dermatitis, actinic elastosis
Croatian: Ukupan broj uključuje prijavljene slučajeve reakcija fotoosjetljivosti, sunčanih opeklina, solarnog dermatitisa i aktiničke elastoze
English: Respiratory, thoracic and mediastinal disorders
Croatian: Poremećaji dišnog sustava, prsišta i sredoprsja pneumonitis
English: The OS p-value (0.0050) crossed the pre-specified boundary (p value <0.0499) f The data cut-off date for this updated PFS analysis and the secondary endpoints of ORR, BOR and DoR is 16 January 2015.
Croatian: Završni datum prikupljanja podataka za ovu ažuriranu analizu PFS-a i sekundarne mjere ishoda - ORR, najbolji ukupan odgovor i trajanje odgovora - bio je 16. siječnja 2015.
English: The following convention has been used for the classification of frequency:
Croatian: Za određivanje učestalosti korištene su sljedeće kategorije: vrlo često ≥ 1/10
English: Hypertension, Haemorrhage*
Croatian: Krvožilni poremećaji hipertenzija, krvarenje*
English: Name and address of the manufacturer responsible for batch release
Croatian: PROIZVOĐAČ(I) ODGOVORAN(NI) ZA PUŠTANJE SERIJE LIJEKA U PROMET Naziv i adresa proizvođača odgovornog za puštanje serije lijeka u promet
English: Liver laboratory abnormalities can occur when Cotellic is used in combination with vemurafenib and with vemurafenib as a single agent (please refer to its SmPC).
Croatian: Odstupanja u laboratorijskim vrijednostima jetrenih parametara Odstupanja u laboratorijskim vrijednostima jetrenih parametara mogu nastupiti kada se Cotellic primjenjuje u kombinaciji s vemurafenibom kao i kod monoterapije vemurafenibom (vidjeti Sažetak opisa svojstava lijeka za vemurafenib).
English: Mild to moderate renal impairment does not influence cobimetinib exposure based on the population pharmacokinetic analysis.
Croatian: Prema populacijskoj farmakokinetičkoj analizi, blago do umjereno oštećenje bubrežne funkcije ne utječe na izloženost kobimetinibu.
English: NAME OF THE MEDICINAL PRODUCT Cotellic 20 mg film-coated tablets cobimetinib
Croatian: Cotellic 20 mg filmom obložene tablete kobimetinib
English: · Muscle problems
Croatian: · Mišićne tegobe
English: Grade (CTC-AE)*
Croatian: Tablica 1 Preporučene prilagodbe doze lijeka Cotellic Stupanj (CTC-AE)*
English: · Diarrhoea
Croatian: · ošamućenost
English: Cotellic dosing can be continued without modification.
Croatian: Liječenje lijekom Cotellic može se nastaviti bez prilagodbe doze.
English: Strong CYP3A inhibitors include, but are not limited to ritonavir,
Croatian: Snažni inhibitori CYP3A uključuju, između ostalih,
English: Recommended Cotellic dose modification
Croatian: Prilagodba preporučene doze lijeka Cotellic
English: Clinical judgment should be applied when considering restarting Cotellic treatment.
Croatian: Kada se razmatra ponovno uvođenje liječenja lijekom Cotellic, treba se voditi kliničkom procjenom.
English: Rash events may occur with either Cotellic or vemurafenib treatment.
Croatian: Osip se može javiti i kod liječenja lijekom Cotellic i kod liječenja vemurafenibom.
English: Patients ≥65 years were more likely to experience serious adverse events (SAEs) and experience AEs leading to discontinuation of cobimetinib than those <65 years.
Croatian: Vjerojatnost nastupa ozbiljnih nuspojava i nuspojava koje su zahtijevale prekid liječenja kobimetinibom bila je veća u bolesnika u dobi od ≥ 65 godina nego u onih u dobi od < 65 godina.
English: Progression-free survival (PFS) as assessed by the investigator (INV) was the primary endpoint.
Croatian: Primarna mjera ishoda bilo je preživljenje bez progresije bolesti (engl. progression-free survival, PFS)
English: Manage Grade 4 liver laboratory abnormalities with treatment interruption, dose reduction or with treatment discontinuation of both Cotellic and vemurafenib (see section 4.2).
Croatian: smanjenjem doze ili trajnom obustavom liječenja i lijekom Cotellic i vemurafenibom (vidjeti dio 4.2).
English: If rhabdomyolysis is diagnosed, Cotellic treatment should be interrupted and CPK levels and other symptoms monitored until resolution.
Croatian: Ako se dijagnosticira rabdomioliza, liječenje lijekom Cotellic treba privremeno prekinuti, a vrijednosti
English: All Grades Grades 3-4 All Grades Grades 3-4
Croatian: Svi stupnjevi stupanj
English: Carcinogenicity studies have not been conducted with cobimetinib.
Croatian: 5.3 Neklinički podaci o sigurnosti primjene Nisu provedena ispitivanja kancerogenosti kobimetiniba.
English: ): Avoid concurrent use of strong CYP3A inhibitors during treatment with cobimetinib.
Croatian: Interakcije između lijekova: Inhibitori CYP3A Tijekom liječenja lijekom Cotellic treba izbjegavati istodobnu primjenu snažnih inhibitora CYP3A.
English: The median time to first onset was 6.1 months in the Cotellic plus vemurafenib arm.
Croatian: Medijan vremena do nastupa prvih nuspojava ≥ 3. stupnja iznosio je 0,6 mjeseci u skupini koja je primala Cotellic plus vemurafenib i 0,8 mjeseci u skupini koja je primala placebo plus vemurafenib.
English: Assessed and confirmed by the investigator (INV) using RECIST v1.1 b Stratified analysis by geographic region and metastasis classification (disease stage)
Croatian: Response Evaluation Criteria In Solid Tumors, RECIST) Stratificirana analiza prema geografskim regijama i klasifikaciji metastaza (stadiju bolesti) Koris teći Clopper-Pearsonovu metodu
English: Photosensitivityb, Rash, Rash maculo-papular, Dermatitis acneiform, Hyperkeratosis**
Croatian: Poremećaji kože i potkožnog tkiva fotoosjetljivostb, osip, makulopapularni osip, akneiformni dermatitis, hiperkeratoza**
English: The safety of Cotellic in combination with vemurafenib has been evaluated in 247 patients with advanced BRAF V600 mutated melanoma in Study GO28141.The median time to onset for the first Grade ≥3 adverse events was 0.6 months in the Cotellic plus vemurafenib arm vs 0.8 months in the placebo plus vemurafenib arm.
Croatian: Sigurnost lijeka Cotellic u kombinaciji s vemurafenibom ocjenjivala se u 247 bolesnika s uznapredovalim melanomom s mutacijom BRAF V600 u ispitivanju GO28141.
English: (or 40-49%
Croatian: (ili 40 - 49% i apsolutno smanjenje za ≥ 10% u odnosu na početnu vrijednost)
English: Increased AST
Croatian: Povišena vrijednost AST-a
English: Dose modification advice for left ventricular dysfunction Permanent discontinuation of Cotellic treatment should be considered if cardiac symptoms are attributed to Cotellic and do not improve after temporary interruption.
Croatian: Ako se srčane nuspojave pripisuju lijeku Cotellic i ako se ne poboljšaju nakon privremenog prekida primjene lijeka, potrebno je razmotriti trajnu obustavu liječenja lijekom Cotellic.
English: No dedicated fertility studies in animals have been performed with cobimetinib.
Croatian: Nisu provedena posebna ispitivanja utjecaja kobimetiniba na plodnost životinja.
English: Tell your doctor, pharmacist or nurse if you notice any of the following side effects: Very common (may affect more than 1 in 10 people) · increased skin sensitivity to sunlight · skin rash · feeling sick (nausea) · fever · chills · increased liver enzymes (shown in blood tests) · abnormal blood test results related to creatine phosphokinase, an enzyme found mainly in heart, brain and skeletal muscle · vomiting · skin rash with a flat discoloured area or raised bump like acne · high blood pressure · anaemia (a low level of red blood cells) · bleeding · abnormal thickening of the skin.
Croatian: · kožni osip praćen promjenom boje neuzdignutih područja na koži ili uzdignutim kvržicama nalik na akne · visok krvni tlak · anemija (niska vrijednost crvenih krvnih stanica) · krvarenje · neuobičajeno zadebljanje kože
English: Decrease in LVEF from baseline has been reported in patients receiving Cotellic (see section 4.8).
Croatian: U bolesnika liječenih lijekom Cotellic prijavljeno je smanjenje LVEF-a u odnosu na početnu vrijednost (vidjeti dio 4.8).
English: · If you get any side effects, talk to your doctor, pharmacist or nurse.
Croatian: · Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika, ljekarnika ili medicinsku sestru.
English: Avoid taking Cotellic with grapefruit juice.
Croatian: Cotellic s hranom i pićem Izbjegavajte uzimati Cotellic sa sokom od grejpa jer on može povećati količinu lijeka Cotellic u krvi.
English: In patients who were naive to BRAF inhibitor therapy, the median overall survival was 28.5 months (95% CI 23.3-34.6).
Croatian: 28,5 mjeseci (95% CI: 23,3 - 34,6).
English: Asymptomatic
Croatian: Asimptomatski
English: This is available without prescription.
Croatian: Lijek se izdaje na recept
English: Decrease in LVEF from baseline has been reported in patients receiving Cotellic (see section 4.4).
Croatian: U bolesnika liječenih lijekom Cotellic prijavljeno je smanjenje LVEF-a u odnosu na početnu vrijednost (vidjeti dio 4.4).
English: No pharmacokinetic trial in subjects with renal impairment has been conducted.
Croatian: Nije provedeno nijedno farmakokinetičko ispitivanje u ispitanika s oštećenjem bubrežne funkcije.
English: Common (may affect up to 1 in 10 people) · some types of skin cancer such as basal cell carcinoma, cutaneous squamous cell carcinoma and keratoacanthoma · dehydration, when your body does not have enough fluid · decreased levels of phosphate or sodium (shown in blood tests) · increased sugar level (shown in blood tests) · increased liver pigment (called “bilirubin”) in the blood.
Croatian: Često (mogu se javiti u do 1 na 10 osoba) · neke vrste raka kože, kao što su karcinom bazalnih stanica, planocelularni karcinom kože i keratoakantom
English: Manufacturer Roche Pharma AG Emil-Barell-Strasse 1 79639 Grenzach-Wyhlen Germany
Croatian: Roche Pharma AG Emil-Barell-Strasse 1
English: Vemurafenib treatment can be continued when Cotellic treatment is modified, if clinically indicated.
Croatian: Cotellic može se nastaviti bez prilagodbe doze, ako je to klinički indicirano.
English: Your doctor should examine your eyes if you have any new or worsening problems with your sight while you are taking Cotellic.
Croatian: Ako se tijekom liječenja lijekom Cotellic pojave nove ili pogoršaju postojeće vidne tegobe, liječnik bi Vam trebao pregledati oči.
English: Renal impairment
Croatian: · Jetrene tegobe
English: Talk to your doctor, pharmacist or nurse before taking Cotellic if you have: · bleeding or are taking any medications that may cause bleeding · an eye problem · heart problems · liver problems · muscle problems.
Croatian: Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego uzmete Cotellic ako imate:
English: Dose adjustment is not recommended for mild to moderate renal impairment based on the results of the population pharmacokinetic analysis.
Croatian: Prema rezultatima populacijske farmakokinetičke analize, ne preporučuje se prilagođavati dozu u bolesnika s blagim do umjerenim oštećenjem bubrežne funkcije.
English: Cases of Grade ≥3 and serious diarrhoea have been reported in patients treated with Cotellic.
Croatian: U bolesnika liječenih lijekom Cotellic prijavljeni su slučajevi proljeva ≥ 3. stupnja i ozbiljnog proljeva.
English: Major haemorrhagic events (including intracranial and gastrointestinal tract haemorrhage) were reported in the post-marketing setting.
Croatian: Nakon stavljanja lijeka u promet prijavljeni su događaji većeg krvarenja (uključujući intrakranijalno i gastrointestinalno krvarenje).
English: Interrupt treatment for 4 weeks
Croatian: 4 tjedna
English: · Bleeding
Croatian: · povraćanje krvi
English: Strong CYP3A inhibitors (see section 4.4.
Croatian: Snažni inhibitori CYP3A (vidjeti dio 4.4): Tijekom liječenja kobimetinibom potrebno je izbjegavati istodobnu primjenu snažnih inhibitora CYP3A.
English: B. PACKAGE LEAFLET
Croatian: · zamagljen vid
English: Musculoskeletal and connective tissue disorders
Croatian: Poremećaji mišićno koštanog sustava i vezivnog tkiva rabdomioliza***
English: Liver laboratory abnormalities, specifically ALT, AST, and ALP have been observed in patients treated with Cotellic in combination with vemurafenib (see section 4.4).
Croatian: U bolesnika liječenih lijekom Cotellic plus vemurafenibom primijećena su odstupanja u laboratorijskim vrijednostima jetrenih parametara, osobito vrijednostima ALT-a, AST-a i ALP-a (vidjeti dio 4.4).
English: Serous retinopathy
Croatian: Primjena lijeka
English: Interrupt treatment for 2 weeks
Croatian: Privremeno prekinuti liječenje dok se ne postigne
English: 12 September 2013
Croatian: 12. rujna 2013.
English: The European Commission issued a decision on 12 September 2013.
Croatian: Europska komisija izdala je Odluku dana 12. rujna 2013.
English: What is Targocid?
Croatian: Što je Targocid?
English: Targocid is authorised in the EU via national procedures.
Croatian: Targocid je odobren u EU-u putem nacionalnih postupaka.
English: The amount of the medicine in the blood should be measured to ensure that effective levels have been reached.
Croatian: Količina lijeka u krvi treba se mjeriti kako bi se osiguralo da su postignute djelotvorne razine.
English: Outcome of a procedure under Article 30 of Directive 2001/83/EC
Croatian: Direktive 2001/83/EC
English: This prevents the bacteria from building their cell walls, and eventually kills them.
Croatian: Na ovaj način sprječava bakterije da izgrađuju svoje stanične stijenke, te ih naposljetku ubija.
English: Targocid is also available in the EU under other trade names: Targosid, Teicomid.
Croatian: Targokid je također dostupan i u EU-u pod drugim trgovačkim nazivima: Targosid, Teicomid.
English: The Committee also harmonised other sections of the SmPC, including sections 4.3 (contraindications), 4.5 (interactions with other medicines), 4.6 (use in pregnancy and breast feeding), 4.8 (undesirable effects), 5.1 (pharmacodynamic properties), 5.2 (pharmacokinetic properties) and 5.3 (preclinical safety data).
Croatian: Povjerenstvo je također uskladilo ostale odjeljke SmPC-a, uključujući i odjeljke 4.3 (kontraindikacije), 4.5 (interakcije s drugim lijekovima), 4.6 (primjena u trudnoći i tijekom dojenja), 4.8 (nuspojave), 5.1 (farmakodinamička svojstva), 5.2 (farmakokinetička svojstva) i 5.3 (pretklinički podaci o sigurnosti).
English: On 30 May 2013, the European Medicines Agency completed a review of Targocid.
Croatian: Dana 30. svibnja 2013., Europska agencija za lijekove završila je pregled lijeka Targocid.
English: It works by attaching to the surface of bacteria.
Croatian: Djeluje tako što se vezuje za površinu bakterije.
English: The CHMP agreed that Targocid should be used by injection or infusion to treat the following infections in adults and children:
Croatian: CHMP suglasan je da se Targocid treba koristiti injekcijom ili infuzijom za liječenje sljedećih infekcija u odraslih i djece:
English: • bacteraemia (bacterial infection in the blood) resulting from any of the above.
Croatian: • bakteremija (bakterijska infekcija u krvi) koja je rezultat bilo čega prethodno spomenutog.
English: Targocid should be used to treat severe infections where standard antibiotic treatment is not suitable.
Croatian: Targocid se treba koristiti za liječenje teških infekcija u slučajevima kada standardno liječenje antibioticima nije primjereno.
English: The Committee asked the company that markets the medicine to submit a risk management plan for the safe use of Targocid, including a study to monitor the safety of the increased initial dose recommendations (12 mg per kg body-weight twice daily).
Croatian: Povjerenstvo je zatražilo tvrtku koja stavlja lijek u promet da dostavi plan za upravljanje rizikom za sigurnosnu primjenu lijeka Targocid, uključujući i ispitivanje za nadziranje sigurnosti preporuka za povećane početne doze (12 mg po kg tjelesne mase dva puta na dan).
English: Why was Targocid reviewed?
Croatian: Zašto je proveden pregled lijeka Targocid?
English: The Committee also agreed on specific dose ranges for adults and children (from birth) for the various infections.
Croatian: Povjerenstvo je također usuglasilo specifične raspone doze za odrasle osobe i djecu (od rođenja) za različite infekcije.
English: It is used by injection or infusion (drip) to treat serious bacterial infections.
Croatian: Primjenjuje se injekcijom ili infuzijom (drip) za liječenje ozbiljnih bakterijskih infekcija.
English: The Committee did not recommend the use of Targocid to prevent infections.
Croatian: Povjerenstvo nije preporučilo primjenu lijeka Targocid za sprječavanje infekcija.
English: Since Targocid is only effective against certain kinds of bacteria, it should be used in combination with other antibiotics if necessary, and in line with official recommendations on antibiotic use.
Croatian: S obzirom da je Targocid djelotvoran jedino protiv određene vrste bakterija, mora se koristiti u kombinaciji s drugim antibioticima ako je potrebno i u skladu sa službenim preporukama o uporabi antibiotika.
English: These include the fact that Targocid may cause serious life-threatening hypersensitivity (allergic) reactions which require immediate cessation of the medicine and emergency treatment; care is needed in patients who are allergic to another antibiotic, vancomycin, as they may be at greater risk.
Croatian: Iste uključuju činjenicu da Targocid može uzrokovati ozbiljne po život opasne reakcije preosjetljivosti (alergije) koje zahtijevaju trenutni prekid uzimanja lijeka i hitno liječenje; skrb je potrebna u slučaju bolesnika koji su alergični na drugi antibiotik, vankomicin, s obzirom da su oni izloženi većem riziku.
English: Patients should be particularly carefully monitored if given higher initial doses (12 mg per kg body-weight twice daily).
Croatian: Bolesnici se moraju posebice pažljivo nadzirati ako primaju više početne doze (12 mg po kg tjelesne mase dva puta na dan).