FrancophonIA/ELRC3.0 huggingface dataset:
English: Injury, poisoning and procedural complications common procedural pain*, procedural site reaction* uncommon post procedural complication (*), contusion (*), wound dehiscence*, migration of implanted drug***, device breakage***
Croatian: Ozljede, trovanja i proceduralne komplikacije često bol uzrokovana postupkom*, reakcija na mjestu postupka* manje često postproceduralna komplikacija (*), kontuzija (*), dehiscencija rane *, migracija implantiranog lijeka***, lomljenje implantata***
English: Preparations for handling or administering the medicinal product
Croatian: Pripreme za rukovanje ili primjenu lijeka
English: White/Off-white to pale yellow, rod-shaped implant, 26.5 mm long and 2.4 mm in diameter.
Croatian: Bijeli/gotovo bijeli do blijedožuti implantat u obliku štapića, duljine 26,5 mm i promjera 2,4 mm.
English: • naltrexone, nalmefene, used to treat addiction They can block the effects of buprenorphine.
Croatian: • naltrekson, nalmefen, koji se primjenjuju za liječenje ovisnosti Mogu blokirati učinke buprenorfina.
English: Only a healthcare professional who is trained in the insertion of Sixmo should perform the procedure, using only the implant applicator, with the recommended local anaesthetic available.
Croatian: Ovaj postupak smije provoditi samo liječnik obučen za ugradnju implantata Sixmo, koristeći samo aplikator implantata, uz dostupan preporučeni lokalni anestetik.
English: Grasp the centre of the implant with the X-plant clamp(s) (Figure 17) and apply gentle traction.
Croatian: Hvataljkom (hvataljkama) X-plant uhvatite implantat po sredini (slika 17) i nježno ga povucite.
English: Opioids should be used with caution in patients with hypotension, prostatic hypertrophy or urethral stenosis.
Croatian: Opioide treba primjenjivati s oprezom u bolesnika s hipotenzijom, hipertrofijom prostate ili stenozom uretre.
English: If Sixmo implants are not immediately replaced upon removal, patients should be maintained on sublingual buprenorphine (2 to 8 mg/day), as clinically indicated, until Sixmo treatment is resumed.
Croatian: Ako se implantati Sixmo ne zamijene odmah nakon uklanjanja, bolesnike treba održavati na sublingvalnom buprenorfinu (2-8 mg na dan), kako je klinički indicirano, sve do nastavka liječenja implantatima Sixmo.
English: Metabolism and nutrition disorders common decreased appetite uncommon abnormal weight gain, dehydration, increased appetite
Croatian: Poremećaji metabolizma i prehrane često smanjeni apetit manje često abnormalno povećanje tjelesne težine, dehidracija, pojačan apetit
English: The implants will then be inserted under the skin in the inner side of the upper arm.
Croatian: Zatim će ugraditi implantate pod kožu s unutarnje stranje nadlaktice.
English: Follow steps 6 through 9 for the insertion of the three remaining implants through the same incision.
Croatian: Za ugradnju preostala tri implantata kroz istu inciziju slijedite korake 6 do 9.
English: Sixmo was shown to be noninferior to sublingual buprenorphine, the proportion of responders being 87.6% in the sublingual buprenorphine and 96.4% in the Sixmo group.
Croatian: Da je Sixmo neinferioran sublingvalnom buprenorfinu pokazao je udio bolesnika s odgovorom od 87,6% u skupini koja je primala sublingvalni buprenorfin i 96,4% u skupini koja je imala Sixmo,.
English: Instruct the patient that the pressure bandage can be removed after 24 hours and the adhesive bandage removed in three to five days, and to apply an ice pack on the arm for 40 minutes every two hours for the first 24 hours, then as needed.
Croatian: Bolesniku dajte uputu da ukloni kompresijski zavoj nakon 24 sata, a flaster nakon tri do pet dana te da tijekom prva 24 sata stavlja hladni oblog na ruku svaka dva sata i drži ga 40 minuta, a poslije po potrebi.
English: If implant(s) or implant fragment(s) are not removed during a removal attempt, the patient should undergo imaging for localisation as soon as is feasible with the subsequent removal attempt performed on the same day as localisation.
Croatian: Ako se implantat(i) ili dio (dijelovi) implantata ne uklone tijekom postupka uklanjanja, u bolesnika treba čim prije slikovnim tehnikama utvrditi mjesto na kojem se nalazi, s time da sljedeći postupak uklanjanja treba provesti istog dana kada i utvrđivanje mjesta implantata.
English: Retention in treatment was high in the Sixmo groups, with 65.7% and 64.0% of patients completing studies PRO-805 and PRO-806, respectively.
Croatian: Ostanak u liječenju bio je visok u skupinama koje su dobile Sixmo i ispitivanje je dovršilo 65,7% bolesnika u ispitivanju PRO-805 i njih 64,0% u ispitivanju PRO-806.
English: The treating physician should consider implant removal if:
Croatian: Kriteriji za prekid liječenja Nadležni liječnik treba razmotriti uklanjanje implantata:
English: Patients in all groups were allowed to use supplemental sublingual buprenorphine to control potential withdrawal symptoms/cravings according to pre-specified criteria.
Croatian: Bolesnici u svim skupinama smjeli su uzimati dodatni sublingvalni buprenorfin prema prethodno utvrđenim kriterijima radi kontrole mogućih simptoma ustezanja/žudnje za drogom.
English: • sleeplessness, anxiety, hostility, nervousness
Croatian: • nesanica, tjeskoba, neprijateljsko ponašanje, nervoza
English: The Sixmo PK was assessed in opioid-dependent patients treated with Sixmo in studies TTP-400-0201, PRO-810, PRO-805, PRO-806, PRO-807 and PRO-811.
Croatian: Sixmo procijenjena je u bolesnika s ovisnošću o opioidima liječenih implantatima Sixmo u ispitivanjima TTP-400-02-01, PRO-810, PRO-805, PRO-806, PRO-807 i PRO-811.
English: • sutures, such as 4-0 Prolene™ with an FS-2 cutting needle (may be absorbable)
Croatian: • kirurški konac, kao što je 4-0 Prolene™ s kirurškom iglom FS-2 (može biti resorptivni)
English: A number of cases of death due to respiratory depression have been reported while on buprenorphine, particularly when buprenorphine was used in combination with benzodiazepines (see section 4.5) or when buprenorphine was not used according to prescribing information.
Croatian: Respiratorna depresija i depresija središnjeg živčanog sustava (SŽS) Zabilježen je određeni broj smrtnih slučajeva zbog respiratorne depresije u bolesnika dok su primali buprenorfin, osobito kad se buprenorfin primjenjivao u kombinaciji s benzodiazepinima (vidjeti dio 4.5) ili kada se buprenorfin nije primjenjivao u skladu s informacijama za propisivanje.
English: • pain, such as abdominal pain, bone pain, muscle pain, chest pain, headache
Croatian: • bol, kao što je bol u trbuhu, bol u kostima, bol u mišićima, bol u prsnom košu, glavobolja
English: • iris scissors
Croatian: • iris škarice
English: Buprenorphine is a partial agonist at the µ (mu)-opioid receptor and chronic administration produces dependence of the opioid type.
Croatian: Ovisnost Buprenorfin je parcijalni agonist µ-opioidnih receptora pa njegova kronična primjena stvara opioidni tip ovisnosti.
English: Patients treated with CYP inhibitors (e.g. ritonavir, ketoconazole, itraconazole, troleandomycin, clarithromycin, nelfinavir, nefazodone, verapamil, diltiazem, amiodarone, amprenavir, fosamprenavir, aprepitant, fluconazole, erythromycin and grapefruit juice) should be monitored for signs and symptoms of toxicity or overdose (miosis, lip cyanosis, sedation, bradycardia, hypotension, respiratory depression).
Croatian: Bolesnike liječene inhibitorima CYP-a (kao što su ritonavir, ketokonazol, itrakonazol, troleandomicin, klaritromicin, nelfinavir, nefazodon, verapamil, diltiazem, amiodaron, amprenavir, fosamprenavir, aprepitant, flukonazol, eritromicin i sok od grejpfruta) treba pratiti zbog mogućih znakova i simptoma toksičnosti ili predoziranja (mioza, cijanoza usana, sedacija,
English: Caution is recommended when dosing patients with severe renal impairment (creatinine clearance < 30 mL/min) (see sections 4.2 and 5.2).
Croatian: Preporučuje se oprez kod primjene u bolesnika s teškim oštećenjem bubrežne funkcije (klirens kreatinina < 30 ml/min) (vidjeti dijelove 4.2 i 5.2).
English: In Studies PRO-805 and PRO-806, 62.0% and 39.5% of Sixmo-treated subjects required supplemental SL buprenorphine.
Croatian: U ispitivanjima PRO-805 i PRO-806, 62,0% odnosno 39,5% ispitanika liječenih implantatima
English: • have severe breathing problems
Croatian: • ako imate teške probleme s disanjem
English: Step 7: While holding the cannula in place, unlock the obturator and remove the obturator.
Croatian: Korak 7: Dok držite kanilu na mjestu postavljanja, oslobodite i izvucite opturator.
English: Medicines that inhibit the enzyme CYP3A4 may give rise to increased concentrations of buprenorphine.
Croatian: Inhibitori CYP3A Lijekovi koji inhibiraju enzim CYP3A4 mogu dovesti do povišenja koncentracija buprenorfina.
English: Skin and subcutaneous tissue disorders common hyperhidrosis uncommon cold sweat, dry skin, rash, skin lesion, ecchymosis*
Croatian: Poremećaji kože i potkožnog tkiva često hiperhidroza manje često hladan znoj, suha koža, osip, kožna lezija, ekhimoza*
English: Subcutaneous use
Croatian: sublingvalni buprenorfin
English: Instruct the patient that the pressure bandage can be removed after 24 hours and the adhesive bandage in three to five days.
Croatian: Bolesniku dajte uputu da ukloni kompresijski zavoj nakon 24 sata, a flaster nakon tri do pet dana.
English: While applying counter-traction to the skin, at a slight angle (no greater than 20 degrees), insert only the tip of the applicator into the subcutaneous space (depth of 3 to 4 mm below the skin), with the bevel-up stop marking on the cannula facing upwards and visible with the obturator locked fully into the cannula (Figure 5).
Croatian: Povlačeći kožu na suprotnu stranu, uvedite vršak aplikatora pod malim kutom (ne većim od 20 stupnjeva) u potkožni prostor (dubine 3-4 mm ispod kože), tako da urezana oznaka za zaustavljanje na držaču kanile gleda prema gore i da je vidljivo kako je opturator potpuno pričvršćen u kanili (slika 5).
English: • have severly reduced liver function
Croatian: • ako imate jako smanjenu funkciju jetre
English: Sixmo implants are intended to be in place for 6 months of treatment and provide a sustained delivery of buprenorphine.
Croatian: Implantati Sixmo predviđeni su da ostanu na mjestu ugradnje tijekom 6 mjeseci liječenja i osiguravaju kontinuirano otpuštanje buprenorfina.
English: A key secondary endpoint in Study PRO-806 was the difference in proportions of urine samples that were negative for opioids over 24 weeks for Sixmo versus sublingual buprenorphine.
Croatian: Ključna sekundarna mjera ishoda u ispitivanju PRO-806 bila je razlika u udjelu uzoraka mokraće koji su bili negativni na opioide tijekom 24 tjedna u skupini koja je imala ugrađen Sixmo naspram one koja je primala sublingvalni buprenorfin.
English: • enlarged prostate or narrowed urethra
Croatian: • povećanu prostatu ili suženu mokraćnu cijev
English: • mild or moderate liver problems
Croatian: • blage ili umjerene probleme s jetrom
English: Figure 1: Cumulative Distribution Function of the Percentage of Urine Samples Negative for Opioids in Weeks 1-16, Study PRO-805 (ITT)
Croatian: Slika 1: Kumulativna funkcija distribucije postotka uzoraka mokraće negativnih na opioide u razdoblju od 1. do 16. tjedna, ispitivanje PRO-805 (ITT)
English: Caution is recommended when dosing patients with severe renal impairment (creatinine clearance < 30 mL/min) (see sections 4.4 and 5.2).
Croatian: Preporučuje se oprez kod primjene u bolesnika s teškim oštećenjem bubrežne funkcije (klirens kreatinina < 30 ml/min) (vidjeti dijelove 4.4 i 5.2).
English: • Benzodiazepines: This combination may result in death due to respiratory depression of central origin.
Croatian: “azepam” Ta kombinacija može dovesti do smrti zbog depresije disanja.
English: Prescription opioids * For 1 patient (0.8%) primary opioid of abuse was “other”.
Croatian: Medijan dobi (raspon), godine Primarni opioid zlouporabe, n (%) heroin opioidni lijekovi koji se izdaju na recept * Za 1 bolesnika (0,8%) primarni opioid zlouporabe bilo je “ostalo”.
English: ITT=intent-to-treat Buprenorphine was not included in urine toxicology assessments.
Croatian: Buprenorfin nije bio uključen u toksikološke analize mokraće.
English: • While using Sixmo, situations may arise where you need acute pain treatment or anaesthesia.
Croatian: Sixmo mogu nastati situacije u kojima će Vam biti potrebno liječenje bola ili anestezija.
English: • Other CNS depressants: Other opioid derivatives (e.g. methadone, analgesics and antitussives), certain antidepressants, sedative H1-receptor antagonists, barbiturates, anxiolytics other than benzodiazepines, neuroleptics, clonidine and related substances: these combinations increase CNS depression.
Croatian: određeni antidepresivi, sedativni antagonisti H1-receptora, barbiturati, anksiolitici koji ne pripadaju skupini benzodiazepina, neuroleptici, klonidin i slične tvari: te kombinacije pojačavaju depresiju SŽS-a.
English: Table 3: Percentage of Opioid-Negative Urine Samples for Weeks 1 to 16 and Weeks 17 to 24,
Croatian: Tablica 3: Postotak uzoraka mokraće negativnih na opioide od 1. do 16. tjedna i od 17. do 24.
English: Step 16: After removal of each implant, confirm that the entire 26.5 mm long implant has been removed by measuring its length.
Croatian: Korak 16: Nakon uklanjanja pojedinog implantata, provjerite da je isti uklonjen u cjelini tako što ćete mu izmjeriti duljinu, koja iznosi 26,5 mm.
English: • dry mouth, wind, indigestion, bloody stool
Croatian: • suha usta, vjetrovi, probavne smetnje, krvava stolica
English: • The other ingredient is ethylene vinyl acetate copolymer.
Croatian: • Drugi sastojak je etilenvinilacetat kopolimer.
English: • changes in blood levels increased enzyme levels: aspartate aminotransferase, gamma-glutamyltransferase, blood lactate dehydrogenase, lipase, amylase decreased enzyme levels: alkaline phosphatase increased bicarbonate level increased bilirubin level - a yellow breakdown substance of the blood pigment increased glucose level decreased cholesterol level decreased haematocrit - the percentage of blood cells on the blood volume decreased haemoglobin - the red blood cell pigment, increased mean cell haemoglobin increase in certain white blood cell count: monocyte, neutrophils decreased cell count: platelets, red blood cells, lymphocytes
Croatian: • promjene na krvnim pretragama - povišene razine enzima: aspartat aminotransferaze, gama-glutamiltransferaze, laktat dehidrogenaze u krvi, lipaze, amilaze - snižene razine enzima: alkalne fosfataze - povišena razina bikarbonata - povišena razina bilirubina - žute tvari koja nastaje razgradnjom krvnog pigmenta - povišena razina glukoze - snižena razina kolesterola - sniženi hematokrit - postotak volumena krvi koji otpada na krvne stanice - sniženi hemoglobin - pigment u crvenim krvnim stanicama, povišena srednja vrijednost staničnog hemoglobina - povećan broj određenih bijelih krvnih stanica: monocita, neutrofila - sniženi broj stanica: krvnih pločica, crvenih krvnih stanica, limfocita
English: Improper insertions or infections may lead to protrusion or expulsion.
Croatian: Neispravna ugradnja ili infekcije mogu dovesti do protruzije ili do izbacivanja implantata.
English: Patients who discontinue treatment with Sixmo should be switched back to their previous dose of sublingual buprenorphine within 12 to 24 hours following removal of the Sixmo implants (i.e. the dose from which they were transferred prior to starting Sixmo treatment).
Croatian: Prekid liječenja Bolesnici koji prekinu liječenje implantatom Sixmo trebaju se, unutar 12-24 sata od uklanjanja implantata Sixmo, vratiti na dozu sublingvalnog buprenorfina koju su prethodno uzimali (tj. na dozu koju su uzimali neposredno prije nego što su prebačeni na liječenje implantatom Sixmo).
English: Blood and lymphatic system disorders uncommon lymphadenopathy, neutropenia
Croatian: Poremećaji krvi i limfnog sustava manje često limfadenopatija, neutropenija
English: Naloxone may be of value for the management of buprenorphine overdose.
Croatian: Nalokson može biti koristan u zbrinjavanju predoziranja buprenorfinom.
English: Figure 2: Cumulative Distribution Function of the Percentage of Urine Samples Negative for Opioids in Weeks 1-24 (co-primary endpoint 1), Study PRO-806 (ITT Population)
Croatian: Slika 2: Kumulativna funkcija distribucije postotka uzoraka mokraće negativnih na opioide u razdoblju od 1. do 24. tjedna (1. primarna mjera ishoda), ispitivanje PRO-806 (ITT populacija)
English: How to store Sixmo
Croatian: Kako primjenjivati Sixmo
English: Apply the sterile fenestrated drape to the patient's arm (Figure 4).
Croatian: Prekrijte ruku bolesnika sterilnom prekrivkom s otvorom (slika 4).
English: Risk of serious complications of insertion and removal of implants Rare but serious complications including nerve damage and migration resulting in embolism and death may result from improper insertion of drug implants (see section 4.4).
Croatian: Rijetke, ali ozbiljne komplikacije uključujući oštećenje živca i migraciju implantata s posljedičnom embolijom i smrću mogu biti rezultat neispravne ugradnje implantata s lijekom (vidjeti dio 4.4).
English: • sedation
Croatian: • sedaciju
English: Patients receiving Sixmo should be closely monitored for signs of toxicity if combined with potent CYP3A4 inhibitors (e.g. protease inhibitors like ritonavir, nelfinavir or indinavir, or azole antifungals such as ketoconazole and itraconazole, or macrolide antibiotics).
Croatian: Sixmo kombinira s potentnim inhibitorima CYP3A4 (npr. inhibitorima proteaze kao što su ritonavir, nelfinavir ili indinavir ili azolnim antimikoticima kao što su ketokonazol i itrakonazol ili makrolidnim antibioticima).
English: • infection, such as viral infection (e.g. flu)
Croatian: • infekcija, kao što je virusna infekcija (npr. gripa) • kašalj, nedostatak zraka
English: 4 years.
Croatian: 6.3 Rok valjanosti 4 godine.
English: After removal of the implant, the doctor will apply a sterile gauze with a pressure bandage to minimize bruising.
Croatian: Nakon uklanjanja implantata, liječnik će staviti sterilnu gazu s kompresijskim zavojem da bi smanjio podljev.
English: In each of the two studies, the proportion of subjects requiring supplemental SL BPN was significantly higher in the placebo group than in the Sixmo group (90.9% and 66.7% of subjects, with mean days of use per week of 2.17 and 1.27, in PRO-805 and PRO-806, respectively).
Croatian: Sixmo značajno viši u skupini koja je dobila placebo nego u skupini koja je dobila Sixmo (90,9% odnosno 66,7% ispitanika, uz srednju vrijednost broja dana uporabe tjedno od 2,17 odnosno 1,27 u ispitivanjima PRO-805 i PRO-806).
English: • alcohol pad
Croatian: • alkoholni tupfer
English: Implant kit: 4 Sixmo implants with 1 applicator
Croatian: Implantacijski set: 4 implantata Sixmo s 1 aplikatorom 6.6 Posebne mjere za zbrinjavanje
English: Priorities are the re-establishment of a patient and protected airway and institution of assisted ventilation, if needed.
Croatian: Na prvom je mjestu ponovna uspostava prohodnosti i zaštite dišnih putova i, po potrebi, uvođenje potpomognute ventilacije.
English: • other medicines that depress the brain or spinal cord, as these reduce alertness, making driving and using machines hazardous other opioid derivatives such as methadone, strong painkillers and cough suppressants certain medicines to treat depressions medicines called antihistamines used to treat allergic reactions, sleep disturbances, cold; or prevent and treat nausea and vomiting medicines to treat epilepsy or to sedate, with active substance names mostly ending with “tal” medicines to treat anxiety, other than those described in the first bullet point medicines to treat mental or anxiety disorders, with sedative effects, called neuroleptics clonidine: a medicine to treat high blood pressure and high eye pressure
Croatian: • druge lijekove s depresornim učinkom na funkciju mozga ili leđne moždine jer smanjuju budnost, zbog čega je opasno upravljati vozilima i strojevima druge opioidne derivate poput metadona, jakih analgetika i lijekova protiv kašlja određene lijekove za liječenje depresije lijekove pod nazivom antihistaminici koji se primjenjuju za liječenje alergijskih reakcija, poremećaja spavanja, prehlade; ili za sprječavanje i liječenje mučnine i povraćanja lijekove za liječenje epilepsije ili za sedaciju, s djelatnim tvarima čiji nazivi većinom završavaju na “tal”
English: Keep this medicine out of the sight and reach of children.
Croatian: Kako čuvati Sixmo Lijek čuvajte izvan pogleda i dohvata djece.
English: Figure 3: Plasma buprenorphine concentrations after insertion of Sixmo (concentrations up to day 28 are based on study PRO-810, while concentrations after day 28 are based on studies PRO-805, PRO-806, PRO-807 and PRO-811)
Croatian: Slika 3: Koncentracije buprenorfina u plazmi nakon ugradnje implantata Sixmo (koncentracije do 28. dana temelje se na ispitivanju PRO-810, dok se koncentracije nakon 28. dana temelje na ispitivanjima PRO-805, PRO-806, PRO-807 i PRO-811)
English: Opioids have been shown to increase intracholedochal pressure, and should be used with caution in patients with dysfunction of the biliary tract.
Croatian: Pokazalo se da opioidi povećavaju tlak u žučovodu pa se moraju primjenjivati s oprezom u bolesnika s poremećenom funkcijom žučnih putova.
English: Place the implant in a glass jar with a lid. Store it safely away from others, especially children.
Croatian: Spremite je na sigurno mjesto izvan dohvata drugih, osobito djece.
English: • If the expelled implant is not intact, the healthcare professional should palpate the insertion location to identify the location of any remaining partial implant.
Croatian: • Ako nije izbačen cijeli implantat, liječnik treba palpacijom mjesta ugradnje utvrditi gdje se nalazi preostali dio implantata.
English: Buprenorphine should be used cautiously when co-administered with:
Croatian: Buprenorfin se ne smije primjenjivati zajedno s:
English: Sixmo implants must be inserted, removed, and patients monitored by a healthcare professional familiar with the procedure, with experience in the management of opioid addiction.
Croatian: Sixmo implantate mora ugraditi i ukloniti, a bolesnika pratiti liječnik koji je upoznat s postupkom i ima iskustva u liječenju ovisnosti o opioidima.
English: Step 4: Lift the edge of the incision opening with the toothed forceps.
Croatian: Korak 4: Podignite rub otvora incizije kirurškom pincetom.
English: Apply an ice pack on the arm for 40 minutes every two hours for the first 24 hours, then as needed.
Croatian: 24 sata stavlja hladni oblog na ruku svaka dva sata i drži ga 40 minuta, a poslije po potrebi.
English: Follow steps 15 and 16 for the removal of the remaining implants through the same incision.
Croatian: Za uklanjanje preostalih implantata kroz istu inciziju slijedite korake 15 i 16.
English: • latex, talc-free sterile gloves
Croatian: • sterilne rukavice od lateksa, bez talka
English: • pain affecting muscles and skeleton, neck, limbs, joints
Croatian: • bol u mišićima i kostima, vratu, udovima, zglobovima
English: • hot flush, bruising, dilation of blood vessels
Croatian: • navale vrućine, modrice, širenje krvnih žila
English: Nervous system disorders common headache, dizziness, somnolence, hypertonia**, syncope** uncommon hypoaesthesia, migraine, depressed level of consciousness, hypersomnia, paraesthesia, tremor
Croatian: Poremećaji živčanog sustava često glavobolja, omaglica, somnolencija, hipertonija**, sinkopa** manje često hipoestezija, migrena, snižena razina svijesti, hipersomnija, parestezija, tremor
English: Buprenorphine is extensively metabolized in the liver.
Croatian: Oštećenje jetrene funkcije Buprenorfin se opsežno metabolizira u jetri.
English: Appropriate precautions, such as the conduct of patient follow-up visits according to the patient's needs and the treating physician's clinical judgement, should be taken during Sixmo treatment.
Croatian: Sixmo moraju se provoditi odgovarajuće mjere opreza, kao što su kontrolni pregledi bolesnika prema njihovim potrebama i kliničkoj procjeni liječnika koji provodi liječenje.
English: • consistency in compliance with clinic visit requirements
Croatian: • dosljedno pridržavanje obaveze redovitih posjeta liječniku