FrancophonIA/ELRC3.0 huggingface dataset:
English: Pulmonary embolism (1.3%) (G3/4: 1.1%)a
Slovenian: Žilne bolezni vročinski valovi pljučna embolija (1,3 %) (G3/4: 1,1 %)a globoka venska tromboza
English: Uncommon side effects (may affect up to 1 in 100 people) are:
Slovenian: Občasni neželeni učinki (lahko se pojavijo pri največ 1 od 100 bolnikov) so:
English: Eribulin is embryotoxic, foetotoxic, and teratogenic in rats.
Slovenian: Podatkov o uporabi eribulina pri nosečnicah ni. Eribulin je pri podganah embriotoksičen, fetotoksičen in teratogen.
English: Oropharyngeal pain Epistaxis
Slovenian: PODATKI NA ZUNANJI OVOJNINI
English: The pharmacokinetic properties are not dose or time dependent in the range of eribulin doses of 0.22 to 3.53 mg/m2.
Slovenian: Farmakokinetične lastnosti eribulina v razponu odmerka 0,22 do
English: Alanine aminotransferase increased (7.6%) (G3/4: 1.9%)d
Slovenian: stopnje: 1,4 %)d zvišanje alaninaminotransferaze (7,6 %)
English: Median (months) Hazard Ratio (95% CI)
Slovenian: Število dogodkov Mediana (meseci) Razmerje tveganja (95-% CI)a
English: Dose reduction recommendations Adverse reaction after previous HALAVEN administration Recommended dose of eribulin
Slovenian: Priporočila za zmanjšanje odmerka Neželeni učinki po predhodnem dajanju zdravila HALAVEN
English: Gamma glutamyl transferase increased (1.7%) (G3/4: 0.9%)d
Slovenian: stopnje: 1,9 %)d zvišanje gamaglutamiltransferaze (1,7 %) (3./4.
English: Peripheral neuropathyc (35.9%) (G3/4: 7.3%) Headache (17.5%) (G3/4: 0.7%)
Slovenian: Bolezni živčevja periferna nevropatijac (35,9 %) (3./4.
English: Hyperhidrosis Palmar plantar erythrodysaesthesia (1.0%) (G3/4: 0.1%)d
Slovenian: stopnje: 0,1 %)d bolezni nohtov nočno potenje suha koža eritem hiperhidroza palmarno-plantarna eritrodisestezija (1,0 %)
English: Gastrooesophageal reflux disease Abdominal distension
Slovenian: stopnje: 0,3 %)d gastroezofagealna refluksna bolezen distenzija trebuha razjede v ustih pankreatitis
English: (22.5%) (G3/4: 0.7%)d Hypokalaemia (6.8%) Decreased appetite (G3/4: 2.0%)
Slovenian: stopnje: 0,7 %)d hipokaliemija (6,8 %) (3./4.
English: HER2 Negative
Slovenian: Parameter učinkovitosti negativni glede na HER2
English: Mucosal
Slovenian: kapecitabin
English: Study 301 Overall Survival ITT Population
Slovenian: Študija 301 - celokupno preživetje populacije z namenom zdravljenja
English: Dose delays during therapy
Slovenian: Preložitev odmerka med zdravljenjem
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT Contains 0.88 mg eribulin in 2 ml
Slovenian: 2 ml Vsebuje 0,88 mg eribulina v 2 ml.
English: Thrombocytopenia (4.2%) (G3/4: 0.7%)
Slovenian: stopnje: 4,4 %)a trombocitopenija (4,2 %) (3./4.
English: Lacrimation increased (5.8%) (G3/4: 0.1%)
Slovenian: Očesne bolezni obilnejše solzenje (5,8 %) (3./4.
English: Neutropenic sepsis (0.2%) (G3/4: 0.2%)a
Slovenian: stopnje: 0,2 %)a septični šok stopnje: 0,2 %)a
English: Fatigue/Asthenia (53.2%) (G3/4 : 7.7%) Pyrexia (21.8%) (G3/4: 0.7%)
Slovenian: stopnje: pireksija (21,8 %) (3./4.
English: 6 vials of 3 ml
Slovenian: 3 ml viala
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each 2 ml vial contains eribulin mesilate equivalent to 0.88 mg eribulin
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena 2 ml viala vsebuje količino eribulinijevega mesilata, ki ustreza 0,88 mg eribulina.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION One ml contains eribulin mesilate equivalent to 0.44 mg eribulin.
Slovenian: En mililiter vsebuje 0,44 mg eribulina v obliki eribulinijevega mesilata.
English: Unchanged eribulin was the major circulating species in plasma following administration of 14C
Slovenian: Po dajanju 14C-eribulina bolnikom je bila glavna cirkulirajoča oblika v plazmi nespremenjeni eribulin.
English: Dry mouth Dyspepsia (6.5%) (G3/4: 0.3%)d
Slovenian: stopnje: 1,0 %)d suha usta dispepsija (6,5 %) (3./4.
English: Urinary tract infection (8.5%) (G3/4: 0.7%) Pneumonia (1.6%) (G3/4: 1.0%) Oral candidiasis Oral herpes Upper respiratory tract infection Nasopharyngitis Rhinitis
Slovenian: stopnje: 1,0 %) ustna kandidiaza ustni herpes okužba zgornjih dihal nazofaringitis rinitis herpes zoster sepsa (0,5 %) (3./4.
English: Bone pain (6.7%) (G3/4: 1.2%) Muscle spasms (5.3%) (G3/4: 0.1%)
Slovenian: stopnje: 1,2 %) mišični spazmi (5,3 %)
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each 3 ml vial contains eribulin mesilate equivalent to 1.32 mg eribulin
Slovenian: IME ZDRAVILA HALAVEN 0,44 mg/ml raztopina za injiciranje eribulin NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena 3 ml viala vsebuje količino eribulinijevega mesilata, ki ustreza 1,32 mg eribulina.
English: Hypoaesthesia Lethargy Neurotoxicity
Slovenian: stopnje: 0,4 %)d hipoestezija letargija nevrotoksičnost
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Vial 3 ml vial
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
English: Sepsis (0.5%) (G3/4: 0.5%)a
Slovenian: stopnje: 0,5 %)
English: Common side effects (may affect up to 1 in 10 people) are:
Slovenian: Pogosti neželeni učinki (lahko se pojavijo pri največ 1 od 10 bolnikov) so:
English: Eisai Ltd. Τηλ: + 44 (0)208 600 1400
Slovenian: Τηλ: + 44 (0)208 600 1400 (Ηνωµένο Βασίλειο)
English: Constipation (22.3%) (G3/4: 0.7%)d
Slovenian: stopnje: 0,7 %)d driska (18,7 %) (3./4.
English: You may exceed this limit by programming only one bolus within 10 minutes.
Slovenian: To mejo lahko presežete, če programirate samo en bolus v 10 minutah.
English: • who are elderly,
Slovenian: • so starejši,
English: You must also make sure you get enough carbohydrates.
Slovenian: Poskrbeti morate tudi, da dobite dovolj ogljikovih hidratov.
English: The pump system will also be programmed and tested prior to your leaving the hospital.
Slovenian: Sistem črpalke bodo tudi programirali in preizkusili, preden boste odšli iz bolnišnice.
English: ATC Code: A10AB01.
Slovenian: Oznaka ATC: A10AB01.
English: These medicines are used for mental problems that affect how you think, feel or act.
Slovenian: Ta zdravila se uporabljajo za duševne težave, ki vplivajo na vaše mišljenje, čustvovanje ali ravnanje.
English: in adolescents who have not reached adult size.
Slovenian: - pri mladostnikih, ki še niso dosegli odrasle velikosti.
English: • If you forget the dose before a meal:
Slovenian: • Če pozabite uporabiti odmerek pred obrokom:
English: • unaccustomed, increased or prolonged physical activity,
Slovenian: • nevajena, večja ali dolgotrajnejša telesna dejavnost,
English: • alcohol consumption,
Slovenian: • pitje alkohola,
English: This can be verified by checking the insulin daily history on the PPC at each visit.
Slovenian: To je mogoče preveriti s pregledom zgodovine dnevne porabe insulina na PPC na vsakem obisku.
English: These materials shall contain content closely similar to the mock-ups provided in the currently approved risk management plan annexes.
Slovenian: Vsebina teh materialov bo zelo podobna maketam, ki jih vsebujejo trenutno odobrene priloge načrta za obvladovanje tveganj.
English: • Information on the risk management plan, the safety concerns and the risk minimisation measures
Slovenian: • Informacije o načrtu obvladovanja tveganja, varnostnih problemih in ukrepih za zmanjšanje tveganja.
English: The PPC prompts you with messages on the screen.
Slovenian: PPC vas opozori z obvestilom na zaslonu.
English: The MAH shall ensure that the training programme for centres includes the following key elements:
Slovenian: MAH bo poskrbel, da bo program usposabljanja za centre vključeval naslednje ključne elemente:
English: Concerning incompatibility with other insulins, see section 6.2.
Slovenian: Glede inkompatibilnosti z drugimi insulini, glejte poglavje 6.2.
English: There is no experience with Insuman Implantable in children and adolescents below 18 years.
Slovenian: Z zdravilom Insuman Implantable ni izkušenj pri otrocih in mladostnikih, mlajših od 18 let.
English: Based on your needs, you may need to replace your insulin earlier.
Slovenian: Glede na vaše potrebe se lahko zgodi, da boste morali insulin nadomestiti že prej.
English: • The potential for surgical and clinical complications and how to respond in the event any such complications arise.
Slovenian: • Možnostih za kirurške in klinične zaplete ter kako se odzvati, če se takšni zapleti pojavijo.
English: Do not extend this period of time.
Slovenian: Tega obdobja ne podaljšujte.
English: Your SoloStar is designed to work accurately and safely.
Slovenian: SoloStar je izdelan za natančno in varno delovanje.
English: All procedures must be performed under sterile conditions.
Slovenian: Vse postopke je treba opraviti v sterilnih pogojih.
English: All procedures should be performed using sterile technique.
Slovenian: Vse postopke je treba opraviti z uporabo sterilne tehnike.
English: Dose adjustment may also be required, for example, if:
Slovenian: Prilagoditev odmerka je lahko potrebna tudi na primer:
English: Alarms in your PPC will let you know if your reservoir level is getting low.
Slovenian: Alarmi v vašem PPC vas bodo opozorili, ko se bo količina v rezervoarju dovolj zmanjšala.
English: Date of first authorisation: 21 February 1997 Date of latest renewal: 21 February 2007
Slovenian: Datum prve odobritve: 21. februar 1997 Datum zadnjega podaljšanja: 21. februar 2007
English: No evidence of toxic effects was found.
Slovenian: Dokazov o toksičnih učinkih niso odkrili.
English: • missed meals,
Slovenian: • izpuščeni obroki,
English: Hyperglycaemia can become serious and lead to a serious condition (ketoacidosis).
Slovenian: Hiperglikemija lahko postane resna in povzroči resno stanje (ketoacidozo).
English: These limitations are necessary to provide some control over patients' ability to program their insulin regimens and to avoid the possibility of overdosing.
Slovenian: Te omejitve so potrebne, da omogočijo nekaj nadzora nad možnostjo bolnikov za programiranje njihove insulinske sheme in za preprečitev možnosti prevelikega odmerjanja.
English: • inadequate food intake,
Slovenian: • nezadostno uživanje hrane,
English: • improved insulin sensitivity (e.g., by removal of stress factors),
Slovenian: • izboljšana občutljivost za insulin (npr. zaradi odstranitve stresnih dejavnikov),
English: Skin erosion
Slovenian: Erozija kože
English: Be careful when you start or stop taking another medicine.
Slovenian: Bodite pazljivi, ko začnete ali nehate jemati kakšno drugo zdravilo.
English: If you need to deliver one additional bolus, press “SEL” and then “ACT”.
Slovenian: Če morate dati en dodaten bolus, pritisnite "SEL" in nato "ACT”.
English: Any unused insulin should be disposed of in accordance with local requirements and should not be reused.
Slovenian: Neporabljeni insulin je treba zavreči v skladu z lokalnimi predpisi in se ga ne sme znova uporabiti.
English: The time between two refill procedures cannot exceed 45 days for insulin in-use stability reasons.
Slovenian: Čas med dvema ponovnima polnjenjema ne sme preseči 45 dni zaradi stabilnosti insulina med uporabo.
English: This can be reduced by continuously wearing an abdominal binder until the capsule has formed (about 1 month) and limiting patient activities immediately following device implant.
Slovenian: To je mogoče zmanjšati s stalnim nošenjem trebušnega pasu, dokler ne nastane kapsula (približno 1 mesec), in z omejitvijo bolnikovih dejavnosti takoj po vsaditvi pripomočka.
English: The mean pharmacokinetic profile is shown in figure 1.
Slovenian: Povprečni farmakokinetični profil prikazuje slika 1.
English: This procedure should always be scheduled in advance of PPC “low reservoir” or “empty reservoir” messages with the patient.
Slovenian: Ta postopek je treba z bolnikom vedno načrtovati še prej, preden PPC pokaže sporočili "skoraj prazen rezervoar" ("low reservoir") ali "prazen rezervoar" ("empty reservoir").
English: This applies, for example, when changing from:
Slovenian: To na primer velja pri prehodu:
English: Other routes of administration (e.g. injection) are contraindicated.
Slovenian: Druge poti uporabe (npr. injiciranje) so kontraindicirane.
English: The MAH shall ensure that all centres are adequately supplied with the following in the appropriate national language(s):
Slovenian: MAH bo poskrbel, da bodo vsi centri ustrezno oskrbljeni z naslednjimi gradivi v ustreznem nacionalnem jeziku:
English: o You need to carry the completed Patient Emergency Information Card with you always.
Slovenian: o Vedno morate imeti pri sebi izpolnjeno izkaznico bolnika za nujne primere.
English: The reservoir is completely filled (approximately 15 ml or 6,000 units of Insuman Implantable), independently of the patients needs.
Slovenian: Rezervoar je treba popolnoma napolniti (približno 15 ml ali 6.000 enot insulina Insuman Implantable), ne glede na bolnikove potrebe.
English: • an animal insulin (especially a bovine insulin) to human insulin,
Slovenian: • z živalskega insulina (zlasti govejega insulina) na humani insulin,
English: Mean HbA1c value at baseline was 8.1%.
Slovenian: Povprečen izhodiščni HbA1c je bil 8,1 %.
English: Before initial pump implantation, 72.4% of these patients had been treated by continuous subcutaneous insulin infusion (CSII) and 17.8% by subcutaneous multi-injection.
Slovenian: Pred prvo vsaditvijo črpalke je bilo 72,4 % teh bolnikov zdravljenih z stalnim podkožnim infundiranjem insulina (CSII - continuous subcutaneous insulin infusion) in 17,8 % z večkratnim podkožnim injiciranjem.
English: Following the change from an animal insulin to human insulin, dose reduction may be required in particular in patients who:
Slovenian: Po prehodu z živalskega na humani insulin je lahko znižanje odmerka potrebno še zlasti pri bolnikih, ki:
English: It is recommended to perform the rinse procedure every 6 months or as necessary based on the refill accuracy criterion.
Slovenian: Postopek izpiranja je priporočljivo opraviti na 6 mesecev, ali kot je potrebno glede na merilo točnosti ponovnega polnjenja.
English: • Skin and allergic reactions
Slovenian: • Kožne in alergijske reakcije
English: In clinical studies and during marketed use, the frequency varies with patient population and dose regimens.
Slovenian: V kliničnih preskušanjih in med marketinško uporabo se je pogostnost razlikovala glede na populacijo bolnikov in sheme odmerjanja.
English: • Patients' responsibilities regarding insulin treatment as well as refill frequency and maintenance of the pump as outlined in the key messages in the patient information leaflet;
Slovenian: • Bolnikovih odgovornostih glede zdravljenja z insulinom, pogostnosti ponovnega polnjenja in vzdrževanja črpalke, kot je orisano v ključnih sporočilih v navodilu za uporabo.
English: • one human insulin preparation to another,
Slovenian: • s pripravka enega humanega insulina na drugega,
English: • Patient selection criteria
Slovenian: • Merila za izbiro bolnikov.
English: If the rinse procedure fails to restore the stroke volume and accurate delivery, an extended rinse procedure needs to be performed.
Slovenian: Če izpiranje ne obnovi pulznega volumna in točnega dovajanja, je treba izvesti razširjeni postopek izpiranja.
English: Diagnostic procedures must be performed to check if the problem is due to the pump or catheter.
Slovenian: Opraviti je treba diagnostične postopke, da bi ugotovili, ali je vzrok težav črpalka ali kateter.
English: These include patients:
Slovenian: Med takšne spadajo bolniki, ki:
English: A stroke volume of between 0.42 μl to 0.58 μl without backflow is indicative of a catheter occlusion.
Slovenian: Pulzni volumen od 0,42 do 0,58 µl brez povratnega toka kaže na zaporo katetra.
English: The refill procedure should be performed every 40 to 45 days.
Slovenian: Ponovno polnjenje je treba izvajati na 40 do 45 dni.
English: Intraperitoneal use
Slovenian: intraperitonealna uporaba
English: • Warnings and precautions when using an implantable pump
Slovenian: • Opozorila in previdnostni ukrepi pri uporabi implantabilne črpalke.
English: Otherwise stroke volume values outside this range or the detection of backflow is indicative of a pump problem.
Slovenian: Sicer pa pulzni volumen zunaj tega območja ali odkritje povratnega toka kaže na težavo s črpalko.
English: Reservoir refilling must be performed by trained and qualified personnel in accordance with the instructions provided by the pump manufacturer.
Slovenian: Ponovno polnjenje rezervoarja mora opraviti izurjeno in usposobljeno osebje v skladu z navodili izdelovalca črpalke.
English: The study included 168 patients with type 1 diabetes mellitus, previously treated with the semi-synthetic human insulin.
Slovenian: V študijo je bilo vključenih 168 bolnikov s sladkorno boleznijo tipa 1, predhodno zdravljenih s polsinteznim humanim insulinom.
English: • were already controlled with relatively low blood glucose levels,
Slovenian: • so že urejeni z razmeroma nizko koncentracijo glukoze v krvi,
English: The amount of insulin is constantly monitored through the PPC which communicates with the pump via radio waves.
Slovenian: Količino insulina nenehno nadzira PPC, ki s črpalko komunicira preko radijskih valov.
English: Elderly population (≥65 years old)
Slovenian: Starejša populacija (≥ 65 let)
English: Refilling the pump is a sterile procedure which must be carried out in the hospital or clinic.
Slovenian: Ponovno polnjenje črpalke je sterilen postopek, ki ga je treba opraviti v bolnišnici ali ambulanti.
English: Therefore, the safety and efficacy of Insuman Implantable (intraperitoneal use) have not been established in paediatric patients.
Slovenian: Zato varnost in učinkovitost zdravila Insuman Implantable (za intraperitonealno uporabo) pri pediatričnih bolnikih nista ugotovljeni.
English: Inform your doctor if you are planning to become pregnant, or if you are already pregnant.
Slovenian: Obvestite zdravnika, če nameravate zanositi ali če ste noseči.
English: • suffering from a psychiatric illness,
Slovenian: • imajo psihiatrične bolezni,
English: • Skin erosion: the movements of the pump can erode your skin
Slovenian: • Erozija kože: premikanje črpalke lahko povzroči erozijo kože
English: Please refer to section 6.6 and the Physician's Manual, which describe how to diagnose potential pump system problems that may cause insulin under-delivery, and how to correct and prevent under-delivery.
Slovenian: Glejte poglavje 6.6 v priročniku za zdravnika, ki opisuje, kako diagnosticirati možne težave s črpalnim sistemom, ki lahko povzročijo nezadostno dovajanje insulina, in kako odpraviti in preprečiti nezadostno dovajanje.
English: • The patient reports an increase in insulin use to maintain euglycaemia.
Slovenian: • bolnik navaja večjo porabo insulina za vzdrževanje evglikemije.
English: • Change of the pump due to malfunction
Slovenian: • Sprememba črpalke zaradi okvare
English: The pump is not connected to a glucose meter.
Slovenian: Črpalka ni povezana z merilnikom glukoze.
English: Side effects reported uncommonly (may affect up to 1 in 100 people) • Severe allergic reaction with low blood pressure (shock)
Slovenian: Občasno opisani neželeni učinki (pojavijo se lahko pri največ 1 od 100 bolnikov) • Huda alergijska reakcija z nizkim krvnim tlakom (šok)
English: The patient should only be released once blood glucose levels are stable and within the safe range.
Slovenian: Bolnika se sme odpustiti šele, ko je koncentracija glukoze v krvi stabilna in v varnem območju.
English: Due to the size of the pump, adolescents who have not reached the adult size must not be implanted.
Slovenian: Zaradi velikosti črpalke se le-te ne sme vsaditi mladostnikom, ki še niso dosegli odrasle velikosti.
English: Should pump performance change, the patient would be able to detect a change in blood glucose levels.
Slovenian: Če se delovanje črpalke spremeni, bo bolnik lahko odkril spremembo v koncentraciji glukoze v krvi.
English: Your doctor will tell you how to manage your blood glucose levels.
Slovenian: Zdravnik vam bo povedal, kako obvladati krvni sladkor.
English: • the patient's life-style changes,
Slovenian: • če se spremeni bolnikov življenjski slog,
English: If the flush procedure is unsuccessful, catheter replacement surgery is usually performed.
Slovenian: Če postopek izpiranja ni uspešen, se po navadi kirurško zamenja kateter.
English: • If you forget to have your pump refilled:
Slovenian: • Če pozabite opraviti ponovno polnjenje črpalke:
English: • At the request of the European Medicines Agency; • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Slovenian: • ob vsakršni spremembi sistema za obvladobvanje tveganj, zlasti kadar je tovrstna sprememba posledica prejema novih informacij, ki lahko privedejo do znatne spremembe razmerja med koristmi in tveganji, ali kadar je ta sprememba posledica tega, da je bil dosežen pomemben mejnik (farmakovigilančni ali povezan z zmanjšanjem tveganja)
English: During the refill procedure it is important to fill out the refill worksheet and to calculate refill accuracy to evaluate system function.
Slovenian: Med ponovnim polnjenjem je pomembno izpolniti delovni list o ponovnem polnjenju in izračunati točnost ponovnega polnjenja za oceno delovanja sistema.
English: At study initiation, half of the patients were switched to Insuman Implantable, while the other half remained on the semi-synthetic human insulin.
Slovenian: Na začetku študije je polovica bolnikov prešla na zdravilo Insuman Implantable, druga polovica pa je ostala na polsinteznem humanem insulinu.
English: Medtronic MiniMed Implantable Pump and the PPC, including rinsing procedures and instructions as to how to handle messages, alarms and routine warnings issued by the PPC;
Slovenian: MiniMed Implantable Pump in PPC, vključno s postopki za izpiranje in navodili za ravnanje v odziv na sporočila, alarme in rutinska opozorila, ki jih da PPC.
English: During a refill procedure, never push in the refill syringe plunger to fill the pump.
Slovenian: Med ponovnim polnjenjem nikoli ne pritiskajte bata polnilne brizge, da bi napolnili črpalko.
English: Failure to do this may cause permanent damage to the pump.
Slovenian: Če postopek ni opravljen tako, lahko trajno poškoduje črpalko.
English: No clinical symptoms, macroscopically visible changes or irritations in the abdominal cavity were observed.
Slovenian: Opazili niso nobenih kliničnih simptomov, makroskopsko vidnih sprememb ali draženja v trebušni votlini.
English: The risk of skin erosion at the pump implantation site can be reduced by selecting an appropriate implant site, maintaining good sterile technique during the implant procedure, prophylactic antibiotic therapy and by continuously wearing an abdominal binder until the capsule has formed (about 1 month) (see section 4.8).
Slovenian: Tveganje za erozijo kože na mestu vsaditve črpalke je mogoče zmanjšati z izbiro ustreznega mesta za vsaditev, vzdrževanjem dobre sterilne tehnike med postopkom vsaditve, profilaktično uporabo antibiotika in stalno nošnjo trebušnega pasu, dokler ne nastane kapsula (približno 1 mesec) (glejte poglavje 4.8).
English: The MAH shall ensure that all patients receive training in the following key elements regarding the Insuman Implantable Pump 400 IU/ml:
Slovenian: MAH bo poskrbel, da bodo vsi bolniki deležni usposabljanja o naslednjih ključnih elementih, ki zadevajo črpalko za zdravilo Insuman Implantable 400 i.e./ml:
English: Patients who plan to reside at or travel (other than by pressurised commercial aircraft) at elevations above 2439 meters (8000 feet) or to dive below 7.6 meters (25 feet) should be informed on the actions to be taken.
Slovenian: Bolnike, ki nameravajo prebivati ali potovati (razen v potniških letalih pod tlakom) na višino nad 2439 metrov, ali se potapljati globlje od 7,6 metra, je treba seznaniti s tem, kako morajo ukrepati.
English: The label on the insulin vial should be checked before use to make sure this is the correct insulin for the intended route of administration.
Slovenian: Pred uporabo je treba preveriti nalepko na viali insulina in se tako prepričati, da je to pravi insulin za predvideno pot uporabe.