FrancophonIA/ELRC3.0 huggingface dataset:
English: In an interaction study with healthy volunteers, co-administration of clopidogrel (300 mg loading dose), a CYP2C8 inhibitor, increased repaglinide exposure (AUC0-∞) 5.1-fold and continued administration (75 mg daily dose) increased repaglinide exposure (AUC0-∞) 3.9-fold.
Croatian: U ispitivanju interakcija u zdravih dobrovoljaca, istodobna primjena klopidogrela (udarna doza od 300 mg), inhibitora CYP2C8, povećala je izloženost repaglinidu (AUC0-∞) 5,1 puta, a nakon kontinuirane primjene (dnevna doza od 75 mg) povećala se izloženost repaglinidu (AUC0-∞) 3,9 puta.
English: EU/1/09/530/011 30 tablets EU/1/09/530/012 90 tablets EU/1/09/530/013 120 tablets EU/1/09/530/014 270 tablets EU/1/09/530/015 360 tablets
Croatian: EU/1/09/530/011 30 tableta EU/1/09/530/012 90 tableta EU/1/09/530/013 120 tableta EU/1/09/530/014 270 tableta EU/1/09/530/015 360 tableta
English: In an interaction study in healthy volunteers, co-administration of 250 mg clarithromycin, a potent mechanism based inhibitor of CYP3A4, slightly increased the repaglinide (AUC) by 1.4-fold and Cmax by 1.7-fold and increased the mean incremental AUC of serum insulin by 1.5-fold and the maximum concentration by 1.6-fold.
Croatian: Istodobna primjena 250 mg klaritromicina, snažnog inhibitora CYP3A4, u ispitivanju interakcija provedenom na zdravim dobrovoljcima neznatno je povećala AUC repaglinida 1,4 puta i Cmax 1,7 puta te povećala srednju vrijednost AUC inzulina u serumu 1,5 puta i maksimalnu koncentraciju 1,6 puta.
English: Repaglinide Teva 2 mg tablets Microcrystalline cellulose (E460) Meglumine
Croatian: Repaglinid Teva 2 mg tablete celuloza, mikrokristalična (E460)
English: Repaglinide Teva 1 mg tablets Microcrystalline cellulose (E460) Meglumine
Croatian: Repaglinid Teva 1 mg tablete celuloza, mikrokristalična (E460)
English: EU/1/09/530/006 30 tablets EU/1/09/530/007 90 tablets EU/1/09/530/008 120 tablets EU/1/09/530/009 270 tablets EU/1/09/530/010 360 tablets
Croatian: EU/1/09/530/006 30 tableta EU/1/09/530/007 90 tableta EU/1/09/530/008 120 tableta EU/1/09/530/009 270 tableta EU/1/09/530/010 360 tableta
English: • Visual disturbances
Croatian: • zatvor • smetnje vida
English: Hypoglycaemia Repaglinide, like other insulin secretagogues, is capable of producing hypoglycaemia.
Croatian: Repaglinid, kao i drugi lijekovi koji potiču izlučivanje inzulina, može izazvati hipoglikemiju.
English: In an interaction study with healthy volunteers, co-administration of deferasirox (30 mg/kg/day, 4 days), a moderate inhibitor of CYP2C8 and CYP3A4, and repaglinide (single dose, 0.5 mg) resulted in an increase in repaglinide systemic exposure (AUC) to 2.3-fold (90% CI [2.03-2.63]) of control, a 1.6-fold (90% CI [1.42-1.84]) increase in Cmax, and a small, significant decrease in blood glucose values.
Croatian: 4 dana), umjerenog inhibitora CYP2C8 i CYP3A4 i repaglinida (pojedinačna doza od 0,5 mg) rezultirala je povećanjem sistemske izloženosti repaglinidu (AUC) za 2,3 puta (90% CI [2,03-2,63]) u odnosu na kontrolnu skupinu, povećanjem Cmax za 1,6 puta (90% CI [1,42-1,84]) i malim, ali značajnim sniženjem razine glukoze u krvi.
English: Common (may affect up to 1 in 10 patients)
Croatian: Često (mogu se javiti u do 1 na 10 bolesnika)
English: Repaglinide Teva 0.5 mg tablets Microcrystalline cellulose (E460) Meglumine
Croatian: Repaglinid Teva 0,5 mg tablete celuloza, mikrokristalična (E460)
English: In a study conducted in healthy volunteers, the concomitant administration of repaglinide (a single dose of 0.25 mg) and ciclosporin (repeated dose at 100 mg) increased repaglinide AUC and Cmax about 2.5-fold and 1.8-fold respectively.
Croatian: U ispitivanju provedenom na zdravim dobrovoljcima, istodobna primjena repaglinida (pojedinačna doza od 0,25 mg) i ciklosporina (ponovljena doza od 100 mg) povećala je AUC repaglinida otprilike
English: EU/1/09/530/001 30 tablets EU/1/09/530/002 90 tablets EU/1/09/530/003 120 tablets EU/1/09/530/004 270 tablets EU/1/09/530/005 360 tablets
Croatian: EU/1/09/530/001 30 tableta EU/1/09/530/002 90 tableta EU/1/09/530/003 120 tableta EU/1/09/530/004 270 tableta EU/1/09/530/005 360 tableta
English: The use of repaglinide might be associated with an increased incidence of acute coronary syndrome (e.g. myocardial infarction), see sections 4.8 and 5.1.
Croatian: (primjerice, infarkt miokarda), vidjeti dijelove 4.8 i 5.1.
English: • ACE-inhibitors (used to treat heart conditions).
Croatian: • ACE inhibitore (koriste se za liječenje bolesti srca)
English: Warnings and precautions Talk to your doctor before taking Repaglinide Teva:
Croatian: Obratite se svom liječniku prije nego uzmete Repaglinid Teva: • Ako imate problema s jetrom.
English: Repaglinide Teva should be taken with caution.
Croatian: Potreban je oprez pri uzimanju lijeka Repaglinid Teva.
English: Repaglinide Teva 1 mg tablets Each tablet contains 1 mg of repaglinide.
Croatian: Svaka tableta sadrži 1 mg repaglinida.
English: • have frequent hypos,
Croatian: • imate česte hipoglikemije
English: - The other ingredients are: microcrystalline cellulose (E460), meglumine, poloxamer 188, povidone K-30, calcium hydrogen phosphate anhydrous, colloidal silicon dioxide anhydrous, polacrilin potassium, maize starch, magnesium stearate, indigo carmine aluminium (E132) (0.5 mg tablet only), iron oxide yellow (E172) (1 mg tablet only), iron oxide red (E172) (2 mg tablet only)
Croatian: bezvodni kalcijev hidrogenfosfat, koloidni bezvodni silicijev dioksid, polakrilinkalij, kukuruzni škrob, magnezijev stearat, indigo carmine aluminium (E132) (samo u tabletama od 0,5 mg), žuti željezov oksid (E172) (samo u tabletama od 1 mg), crveni željezov oksid (E172) (samo u tabletama od 2 mg).
English: Repaglinide Teva 2 mg tablets Each tablet contains 2 mg of repaglinide.
Croatian: Svaka tableta sadrži 2 mg repaglinida.
English: NAME OF THE MEDICINAL PRODUCT Repaglinide Teva 0.5 mg tablets Repaglinide
Croatian: NAZIV LIJEKA Repaglinid Teva 0,5 mg tablete repaglinid
English: How to store Repaglinide Teva
Croatian: Moguće nuspojave Kako čuvati Repaglinid Teva
English: NAME OF THE MEDICINAL PRODUCT Repaglinide Teva 0.5 mg tablets Repaglinide Teva 1 mg tablets Repaglinide Teva 2 mg tablets
Croatian: NAZIV LIJEKA Repaglinid Teva 0,5 mg tablete Repaglinid Teva 1 mg tablete
English: NAME OF THE MEDICINAL PRODUCT Repaglinide Teva 2 mg tablets Repaglinide
Croatian: NAZIV LIJEKA Repaglinid Teva 2 mg tablete repaglinid
English: NAME OF THE MEDICINAL PRODUCT Repaglinide Teva 1 mg tablets Repaglinide
Croatian: NAZIV LIJEKA Repaglinid Teva 1 mg tablete repaglinid
English: INFORMATION IN BRAILLE Repaglinide Teva 0.5 mg tablets
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Repaglinid Teva 0,5 mg tablete
English: INFORMATION IN BRAILLE Repaglinide Teva 1 mg tablets
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Repaglinid Teva 1 mg tablete
English: Repaglinide Teva 0.5 mg tablet is a light blue to blue, capsule shaped tablet, debossed with "93" on one side and “210” on the other side of the tablet.
Croatian: Repaglinid Teva 0.5 mg tableta je svijetloplava do plava tableta oblika kapsule, s utisnutom oznakom „93“ na jednoj strani te „210“ na drugoj strani tablete.
English: INFORMATION IN BRAILLE Repaglinide Teva 2 mg tablets
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Repaglinid Teva 2 mg tablete
English: • Itraconazole, ketokonazole (antifungal medicines).
Croatian: • itrakonazol, ketokonazol (koriste se za liječenje gljivica) • gemfibrozil (koristi se za snižavanje povišenih masnoća u krvi)
English: How to store Repaglinide Teva Contents of the pack and other information
Croatian: Sadržaj pakiranja i druge informacije Što Repaglinid Teva sadrži
English: Repaglinide Teva 1 mg tablet is a yellow to light yellow, capsule shaped tablet, debossed with "93" on one side and “211” on the other side of the tablet.
Croatian: Repaglinid Teva 1 mg tableta je žuta do svijetložuta tableta oblika kapsule, s utisnutom oznakom „93“ na jednoj strani te „211“ na drugoj strani tablete.
English: Repaglinide Teva is used to control type 2 diabetes in adults as an add-on to diet and exercise: treatment is usually started if diet, exercise and weight reduction alone have not been able to control (or lower) your blood sugar.
Croatian: S liječenjem se obično započinje kada se samo dijetom, tjelovježbom i smanjenjem tjelesne težine ne može postići zadovoljavajuća regulacija (ili snižavanje) razine šećera u krvi.
English: Repaglinide Teva 2 mg tablet is a mottled peach, capsule shaped tablet, debossed with "93" on one side and “212” on the other side of the tablet.
Croatian: Repaglinid Teva 2 mg tableta je išarana tableta boje breskve, oblika kapsule, s utisnutom oznakom „93“ na jednoj strani te „212“ na drugoj strani tablete.
English: Pharmacotherapeutic group: Drugs used in diabetes, other blood glucose lowering drugs, excl. insulins, ATC code: A10BX02
Croatian: 5.1 Farmakodinamička svojstva Farmakoterapijska skupina: lijekovi za liječenje šećerne bolesti, drugi lijekovi za snižavanje razine glukoze u krvi, osim inzulina.
English: Repaglinide Teva 0.5 mg tablets Repaglinide Teva 1 mg tablets Repaglinide Teva 2 mg tablets Repaglinide
Croatian: Repaglinid Teva 0,5 mg tablete repaglinid
English: 6.5 Nature and contents of container Alu/Alu blisters.
Croatian: 6.5 Vrsta i sadržaj spremnika
English: Repaglinide Teva is not recommended.
Croatian: Uzimanje lijeka Repaglinid Teva se ne preporučuje jer nije ispitivan u tim dobnim skupinama.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 0.5 mg of repaglinide.
Croatian: Svaka tableta sadrži 0,5 mg repaglinida.
English: Abdominal pain, diarrhoea Common Vomiting, constipation Very rare Nausea
Croatian: Bol u abdomenu, proljev
English: Combination with insulin secretagogues
Croatian: Kombinacija s metforminom
English: Maintenance
Croatian: PROMET
English: Repaglinide Teva 2 mg tablets Mottled peach, capsule shaped tablet, debossed with "93" on one side and “212” on the other side.
Croatian: Išarana tableta boje breskve, oblika kapsule, s utisnutom oznakom „93“ na jednoj strani te „212“ na drugoj strani tablete.
English: A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturers responsible for batch release Teva Pharmaceutical Works Private Limited Company Pallagi ut 13
Croatian: Naziv i adresa proizvođača odgovornih za puštanje serije lijeka u promet
English: Magnesium stearate
Croatian: NAVOĐENJE DJELATNE TVARI
English: *See next section below
Croatian: *Vidjeti sljedeći odjeljak ispod
English: Tell your doctor what happened.
Croatian: Obavijestite liječnika što se dogodilo.
English: Repeat step 5 three times.
Croatian: Ponovite 5. korak tri puta.
English: Blow your nose if you feel you need to.
Croatian: Ispuhnite nos ako osjećate da je potrebno.
English: Elderly (older than 65 years)
Croatian: Stariji bolesnici (u dobi iznad 65 godina)
English: The patient should be instructed how to do this correctly.
Croatian: Bolesnika se mora uputiti kako to učiniti pravilno.
English: It is very important to follow your doctor's instructions.
Croatian: Veoma je važno da se pridržavate liječnikovih uputa.
English: • Do not change the dose yourself.
Croatian: • Ne mijenjajte dozu sami.
English: • not knowing where you are (disorientated)
Croatian: • ne znate gdje se nalazite (dezorijentiranost)
English: • difficulty in speaking
Croatian: • teškoće s govorom
English: The relevance of these findings to humans is unknown.
Croatian: Važnost ovog nalaza za ljude nije poznata.
English: Abuse potential and tolerance
Croatian: Mogućnost zlouporabe i tolerancija
English: Patients should be carefully monitored until an effective dose is reached.
Croatian: Bolesnike se mora pažljivo nadzirati dok se ne postigne djelotvorna doza.
English: The main pharmacokinetic parameters are shown in the following table.
Croatian: Glavni farmakokinetički parametri prikazani su u sljedećoj tablici.
English: • you suffer a severe blow to the head
Croatian: • ako ste pretrpjeli snažan udarac u glavu
English: Sit down with your head upright.
Croatian: Sjednite držeći glavu uspravno.
English: Coma is also known to occur.
Croatian: Poznato je da može nastupiti i koma.
English: <1/1,000); very rare (<1/10,000); unknown (cannot be estimated from available data)).
Croatian: vrlo rijetko (< 1/10 000); nepoznato (ne može se procijeniti iz dostupnih podataka)).
English: • changes in blood cells (detected by laboratory tests)
Croatian: • promjene krvnih stanica (ustanovljene laboratorijskim pretragama)
English: The safety and efficacy of PecFent in children and adolescents aged below 18 years have not yet been established.
Croatian: Sigurnost i djelotvornost lijeka PecFent u djece i adolescenata mlađih od 18 godina nisu još ustanovljene.
English: micrograms micrograms micrograms micrograms micrograms
Croatian: mikrograma mikrograma mikrograma mikrograma mikrograma
English: One hundred of these patients continued treatment for up to 26 months in an extension phase.
Croatian: Od tih bolesnika, njih stotinu nastavilo je liječenje do 26 mjeseci u fazi produžetka ispitivanja.
English: If this happens, do not drive or use any tools or machines.
Croatian: Ako se to dogodi, ne vozite ili ne rukujte alatima ili strojevima.
English: Call an ambulance or ask someone else to call one straight away if you:
Croatian: Odmah pozovite hitnu pomoć ili zamolite nekog drugog da to učini ako:
English: Dose increase should be undertaken with caution.
Croatian: Povećanje doze se mora provoditi s oprezom.
English: Patients should not use more than 4 doses per day.
Croatian: Bolesnici ne smiju primijeniti više od 4 doze na dan.
English: Your doctor may need to check the dose.
Croatian: Liječnik će možda trebati provjeriti dozu.
English: PecFent is not approved for use in children under 18 years of age.
Croatian: PecFent nije odobren za primjenu u djece mlađe od 18 godina.
English: Bottles contain:
Croatian: Bočice sadrže:
English: This will tilt the bottle slightly (Figure 5).
Croatian: Time ćete bočicu neznatno nagnuti (slika 5).
English: Contents of the pack and other information What PecFent contains
Croatian: Sadržaj pakiranja i druge informacije Što PecFent sadrži
English: • The counter will stay on the number “8”.
Croatian: • Brojač će ostati na broju „8”.
English: Of the patients entering the titration phase, only 7 (6.1 %) were unable to be titrated to an effective dose due to lack of efficacy and 6 (5.3 %) withdrew due to adverse events.
Croatian: Od bolesnika koji su ušli u fazu titracije samo njih 7 (6,1%) nije bilo moguće titrirati na djelotvornu dozu zbog nedostatka djelotvornosti, a 6 bolesnika (5,3%) povučeno je zbog štetnih događaja.
English: L. Molteni & C. dei F.lli Alitti Società di Esercizio S.p.A Strada Statale 67 Tosco Romagnola, Fraz.
Croatian: Molteni & C. dei F.lli Alitti Società di Esercizio S.p.A Strada Statale 67 Tosco Romagnola, Fraz.
English: If this occurs, patients should be advised to discontinue their decongestant.
Croatian: Ako se to dogodi, bolesnike se mora savjetovati da prekinu primjenu dekongestiva.
English: The risk of side effects increases if you are taking medicines such as certain antidepressants or antipsychotics.
Croatian: Rizik od nuspojava povećava se ako uzimate lijekove kao što su neki antidepresivi ili antipsihotici.
English: Your doctor will tell you how many sprays (1 or 2) you should use to treat your breakthrough pain episode.
Croatian: Liječnik će Vam reći koliko potisaka morate primijeniti (1 ili 2) za liječenje epizode probijajuće boli.
English: Date of first authorisation: 31 August 2010 Date of latest renewal: 17 July 2015
Croatian: Datum posljednje obnove odobrenja: 17 srpanj 2015
English: Therefore it is not possible to definitively separate the effects of PecFent alone.
Croatian: Stoga nije moguće jasno odvojiti učinke samog PecFenta.
English: This will go up to the number 2 when the spray is used again.
Croatian: Broj će se povećati do broja 2 kada ponovno upotrijebite sprej.
English: Granatieri - 50018 Scandicci (FI) Italy
Croatian: Granatieri - 50018 Scandicci (FI) Italija
English: • Do not use PecFent if you are pregnant or might get pregnant, unless your doctor has told you to.
Croatian: • Ne primjenjujte PecFent ako ste trudni ili biste mogli zatrudnjeti, osim ako Vam je to rekao liječnik.
English: Kyowa Kirin Holdings B.V. Bloemlaan 2,
Croatian: Kyowa Kirin Holdings B.V.
English: The 2 spray bottle cannot be re-primed and once both doses are used, or if longer than 5 days since priming, the bottle and contents should be discarded as described in section 6.6.
Croatian: Bočica sa 2 potiska ne može se ponovno aktivirati, a jednom kada su iskorištene obje doze, ili kada je proteklo više od 5 dana od aktiviranja, bočicu i njezin sadržaj treba baciti onako kako je opisano u dijelu 6.6.
English: For 8 spray bottle: 1, 4 or 12 bottles.
Croatian: Za bočicu sa 8 potisaka: 1, 4 ili 12 bočica.
English: Keep out of the sight and reach of children (Figure 6)
Croatian: Čuvati izvan pogleda i dohvata djece (slika 6).
English: Serotonin Syndrome
Croatian: Serotoninski sindrom
English: • change in taste
Croatian: • promjena okusa
English: • seeing or hearing things that are not really there (hallucinations/delirium), feeling confused
Croatian: • vidite ili čujete ono što ne postoji (halucinacije/delirij), osjećaj smetenosti
English: • The counter will stay on the number “2”.
Croatian: • Brojač će ostati na broju ”2”.
English: • you have problems with your heart especially slow heart rate
Croatian: • ako imate tegobe sa srcem, posebno sa sporim otkucajima srca
English: Of the 355 patients treated in the open-label treatment phase, 90 % required no increase in dose.
Croatian: Od 355 bolesnika liječenih u fazi liječenja otvorenog tipa, za 90% bolesnika nije bilo potrebno povećavati dozu.
English: PecFent should not be disposed of via wastewater or household waste.
Croatian: PecFent se ne smije bacati u otpadne vode ili kućni otpad.
English: It should be noted that although statistically significant increases in Cmax levels were seen following a second dose of PecFent given either one or two hours after the initial dose, this increase is not considered to be large enough to suggest that clinically concerning accumulation or over-exposure would occur, providing a wide safety margin for the recommended dose interval of four hours.
Croatian: Mora se napomenuti da iako su opažena statistički značajna povećanja razina Cmax nakon druge doze PecFenta primijenjenog jedan ili dva sata poslije početne doze, to se povećanje ne smatra dovoljno velikim da bi ukazivalo da će se dogoditi klinički zabrinjavajuće nakupljanje ili prevelika izloženost, što daje široku sigurnosnu granicu za preporučeni dozni interval od četiri sata.
English: Less than 7 % of an administered dose of fentanyl is excreted unchanged in the urine and only about 1 % is excreted unchanged in the faeces.
Croatian: Manje od 7% primijenjene doze fentanila izlučuje se nepromijenjeno u mokraći, a samo oko 1% izlučuje se nepromijenjeno u stolici.
English: The plasma protein binding of fentanyl is 80 - 85 %.
Croatian: Na proteine plazme veže se 80 - 85% fentanila.
English: • you have low blood pressure or a low amount of fluid in your circulation
Croatian: • ako imate nizak krvni tlak ili malu količinu tekućine u optoku
English: To prime the bottle, please follow the instructions below:
Croatian: Da biste aktivirali bočicu, slijedite ove upute:
English: Never try to fix the nasal spray yourself or take it apart.
Croatian: Nikada ne pokušavajte sprej za nos popraviti sami i nikada ga ne pokušavajte rastaviti.
English: It can increase the risk of getting serious side effects.
Croatian: Time biste mogli povećati rizik od pojave ozbiljnih nuspojava.
English: If you have not been using these medicines you must not use PecFent, because it may increase the risk that breathing could become dangerously slow and/or shallow, or even stop.
Croatian: Ako niste uzimali ove lijekove ne smijete uzeti PecFent jer može povećati rizik od opasnog usporavanja disanja i/ili plitkog disanja ili čak potpunog prestanka disanja.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and carcinogenicity.
Croatian: Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije, toksičnosti ponovljenih doza, genotoksičnosti i kancerogenosti.
English: Date of priming: ……….
Croatian: Datum aktivacije: ……….
English: Its primary therapeutic actions are analgesia and sedation.
Croatian: Njegovi su primarni terapijski učinci analgezija i sedacija.
English: Further findings at maternally toxic doses in F1 pups were delayed physical development, sensory functions, reflexes and behaviour.
Croatian: Daljnji nalazi pri dozama toksičnim za majku u F1 mladunaca bili su odgođen tjelesni razvoj, senzorne funkcije, refleksi i ponašanje.
English: Other medicines and PecFent
Croatian: Drugi lijekovi i PecFent
English: • Do not drive or use tools or machines until you know how this medicine makes you feel.
Croatian: • Nemojte voziti ni rukovati alatima ili strojevima dok ne saznate kako na Vas djeluje ovaj lijek.
English: [8 spray bottle:]
Croatian: [Bočica sa 8 potisaka:]
English: It is more than 90 % eliminated by biotransformation to N-dealkylated and hydroxylated inactive metabolites.
Croatian: Više od 90% fentanila eliminira se biotransformacijom u N-dealkilirane i hidroksilirane neaktivne metabolite.
English: In absence of adequate pain control, the possibility of hyperalgesia, tolerance and progression of underlying disease should be considered (see section 4.4).
Croatian: U slučaju da se ne postigne odgovarajuća kontrola boli, potrebno je razmotriti mogućnost razvoja hiperalgezije, tolerancije i progresije osnovne bolesti (vidjeti dio 4.4).
English: In the PecFent clinical trial programme, 104 (26.1%) of patients were over 60 years of age, 67 (16.8%) over 65 years and 15 (3.8%) over 75 years.
Croatian: U programu kliničkog ispitivanja PecFenta, 104 (26,1%) bolesnika bila su starija od 60 godina, 67 (16,8%) ih je bilo starije od 65 godina, a 15 (3,8%) od 75 godina.
English: Patients receiving PecFent concomitantly with moderate or strong CYP3A4 inhibitors should be carefully monitored for an extended period of time.
Croatian: Bolesnike koji uzimaju PecFent zajedno s umjerenim ili jakim inhibitorima CYP3A4 mora se pažljivo nadzirati dulje vremensko razdoblje.
English: Coadministration with medicinal products that induce 3A4 activity may reduce the efficacy of PecFent.
Croatian: Istodobna primjena s lijekovima koji induciraju aktivnost 3A4 može umanjiti djelotvornost PecFenta.
English: • Breakthrough pain comes on suddenly.
Croatian: • Probijajuća bol nastupa naglo.
English: Breathe in gently through your nose and out through your mouth.
Croatian: Lagano udahnite kroz nos i izdahnite na usta.
English: What PecFent looks like and contents of the pack
Croatian: Kako PecFent izgleda i sadržaj pakiranja
English: • feeling depressed, worried, slow or nervous
Croatian: • depresivno, zabrinuto, usporeno ili nervozno raspoloženje
English: Fentanyl may produce bradycardia.
Croatian: Fentanil može izazvati bradikardiju.
English: Point it inwards towards the wall of your nose.
Croatian: Usmjerite je prema unutrašnjoj stijenci nosa.
English: Educational material for patients should highlight the following:
Croatian: Edukacijski materijal za bolesnika treba isticati sljedeće:
English: • PecFent that has passed the expiry date or is no longer required may still contain enough medicine to be harmful to other people, especially children.
Croatian: • PecFent kojem je istekao rok valjanosti ili Vam više nije potreban, može i dalje sadržavati dovoljno lijeka da našteti drugim ljudima, a osobito djeci.
English: Some changes that can be seen include an increase in serum prolactin, and decreases in plasma cortisol and testosterone.
Croatian: Neke od promjena koje se mogu opaziti uključuju povišeni prolaktin u serumu i sniženi kortizol i testosteron u plazmi.
English: If you no longer have breakthrough pain, talk to your doctor before stopping PecFent and follow his/her advice.
Croatian: Ako Vam se više ne događa nastup probijajuće boli, obratite se liječniku prije nego što prestanete primjenjivati PecFent i slijedite njegov/njezin savjet.