FrancophonIA/ELRC3.0 huggingface dataset:
English: Secondary pharmacodynamics effects
Slovenian: Sekundarni farmakodinamični učinki
English: Minimum 1 hour dosing interval.
Slovenian: Najmanj enourni odmerni interval.
English: No pharmacokinetic data exist for sufentanil in paediatric patients.
Slovenian: Pediatrična populacija Farmakokinetični podatki za sufentanil pri pediatričnih bolnikih niso na voljo.
English: In both trials, the primary efficacy endpoint was the time-weighted sum of pain intensity difference (SPID) to baseline (measured on an 11-point NRS) over 12 hours (SPID12).
Slovenian: V obeh preskušanjih je bila primarni opazovani dogodek v 12 urah časovno tehtana vsota razlik v intenzivnosti bolečine (SPID) glede na izhodišče (izmerjeno po 11-stopenjski številčni ocenjevalni lestvici) v 12 urah (SPID12).
English: Depress the green Pusher to deliver the tablet to the patient's sublingual space and confirm tablet placement.
Slovenian: Pritisnite zeleno potiskalo, da vstavite tableto v bolnikov podjezični prostor, in se prepričajte, da je tableta nameščena.
English: Patients with moderate to severe hepatic or severe renal impairment should be monitored carefully for symptoms of sufentanil overdose (see section 4.9).
Slovenian: Bolnike z zmerno do hudo jetrno ali hudo ledvično okvaro je treba skrbno spremljati glede pojava simptomov prevelikega odmerjanja sufentanila (glejte poglavje 4.9).
English: Other medicines and Dzuveo Tell your doctor if you are taking, have recently taken or might take any other medicines.
Slovenian: Obvestite zdravnika, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
English: The most commonly reported adverse reactions seen in clinical trials and from post marketing experience with sufentanil containing products were nausea, vomiting and pyrexia (≥1/10 patients) (see section 4.4).
Slovenian: Neželeni učinki, o katerih so v kliničnih preskušanjih in v obdobju trženja zdravil, ki vsebujejo sufentanil, najpogosteje poročali, so bili slabost, bruhanje in zvišana telesna temperatura (≥1/10 bolnikov) (glejte poglavje 4.4).
English: NOTE: Avoid direct mucosal contact with the SDA tip.
Slovenian: OPOMBA: Izogibajte se neposrednemu stiku sluznice s konico aplikatorja.
English: - Difficulty urinating, strong smelling urine, pain urinating, kidney failure.
Slovenian: Težave pri odvajanju vode, močan vonj urina, bolečine pri uriniranju, odpoved ledvic.
English: By reporting side effects, you can help provide more information on the safety of this medicine.
Slovenian: O neželenih učinkih lahko poročate tudi neposredno na nacionalni center za poročanje, ki je naveden v Prilogi V S tem, ko poročate o neželenih učinkih, lahko prispevate k zagotovitvi več informacij o varnosti tega zdravila.
English: Sufentanil has major influence on the ability to drive and use machines.
Slovenian: 4.7 Vpliv na sposobnost vožnje in upravljanja strojev Sufentanil ima pomemben vpliv na sposobnost vožnje in upravljanja strojev.
English: Administer product immediately after opening pouch.
Slovenian: Zdravilo uporabite takoj po odprtju vrečke.
English: Mean (SEM) baseline intensity in these trials was 6.48 (0.21) for the 12-hour bunionectomy trial in the sufenatil-treated patients and 5.98 (0.30) for placebo-treated patients.
Slovenian: Povprečna (SEM) izhodiščna intenzivnost v teh preskušanjih je bila 6,48 (0,21) pri 12-urnem preskušanju po bunionektomiji pri bolnikih, zdravljenih s sufentanilom, in 5,98 (0,30) pri bolnikih, zdravljenih s placebom.
English: Pharmacokinetic/Pharmacodynamic Relationship
Slovenian: Razmerje med farmakokinetiko in farmakodinamiko
English: - High blood pressure or low blood pressure when standing up, skin flushing.
Slovenian: Visok ali nizek krvni tlak po vstajanju, pordelost kože.
English: If the decision to begin sufentanil is made, the patient should be closely monitored and a lower dose of the concomitant CNS depressant should be considered.
Slovenian: Ob odločitvi za uvedbo sufentanila je treba bolnika skrbno spremljati in razmisliti o manjšem odmerku zaviralca CŽS, ki ga bolnik sočasno jemlje.
English: Warnings and precautions
Slovenian: Opozorila in previdnostni ukrepi zgoraj).
English: Sufentanil is mainly metabolised in humans by the cytochrome P450-3A4 enzyme system (see section 4.5).
Slovenian: Sufentanil se pri človeku v glavnem presnavlja z encimskim sistemom citokroma P450-3A4 (glejte poglavje 4.5).
English: MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. IZDELOVALEC (IZDELOVALCI), ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE
English: These medicines must not be taken in the 2 weeks before or at the same time as Dzuveo is given.
Slovenian: Ta zdravila se ne smejo jemati 2 tedna pred začetkom jemanja zdravila Dzuveo in sočasno z njim.
English: Only limited data are available for the use of sufentanil in such patients.
Slovenian: Za uporabo sufentanila pri teh bolnikih so na voljo samo omejeni klinični podatki.
English: Steady-state clearance is 129.3 L/hr.
Slovenian: Očistek v stanju dinamičnega ravnovesja je 129,3 l/h.
English: Co-administration of sufentanil with a serotonergic agent, such as Selective Serotonin Reuptake Inhibitors (SSRIs), Serotonin Norepinephrine Reuptake Inhibitors (SNRIs), or Monoamine Oxidase Inhibitors (MAOIs), may increase the risk of serotonin syndrome, a potentially life threatening condition.
Slovenian: Sočasna uporaba sufentanila s serotoninergično učinkovino, kot so selektivni zaviralci ponovnega privzema serotonina (SSRI), zaviralci ponovnega privzema serotonina in noradrenalina (SNRI) ali zaviralci monoamin-oksidaze (MAOI), lahko poveča tveganje serotoninskega sindroma, morebitno smrtno nevarnega stanja.
English: Patients with a higher pain intensity at one hour after sufentanil treatment was initiated required more frequent redosing compared to patients with lower pain intensity scores at one hour.
Slovenian: Bolniki, ki so imeli eno uro po začetku zdravljenja s sufentanilom močnejšo bolečino, so v primerjavi z bolniki z manj močno bolečino po eni uri pogosteje potrebovali ponovni odmerek.
English: Dzuveo is to be administered by a healthcare professional in a medically monitored setting only.
Slovenian: Zdravilo Dzuveo mora dati zdravstveni delavec v medicinsko nadzorovanem okolju.
English: 5 x 1 sublingual tablet in a single dose applicator.
Slovenian: 5 × 1 podjezična tableta v aplikatorju z enkratnim odmerkom.
English: ≥1/10,000 to
Slovenian: (≥ 1/10 000 do < 1/1 000)
English: This route of administration results in higher absolute bioavailability than oral (swallowed) administration by avoiding intestinal and first-pass liver 3A4 enzyme metabolism.
Slovenian: Pri tej poti uporabe zdravila je bila dosežena večja absolutna biološka uporabnost kot pri peroralnem (zaužitje) dajanju, ker ni bilo presnove zdravila v črevesju in ob prvem prehodu skozi jetra z encimom 3A4.
English: Anaemia postoperative
Slovenian: Pooperacijska anemija
English: - is stored in the original package in order to protect from light and oxygen.
Slovenian: Shranjujte v originalni ovojnini za zagotovitev zaščite pred svetlobo in kisikom.
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to special and restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Slovenian: B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE Predpisovanje in izdaja zdravila je le na recept s posebnim in omejenim režimom (glejte Prilogo I:
English: Therefore, Dzuveo should be used with caution in such patients (see section 4.4).
Slovenian: Pri teh bolnikih je zato treba zdravilo Dzuveo uporabljati previdno (glejte poglavje 4.4).
English: Blue-coloured flat-faced tablet with round edges and a diameter of 3 mm.
Slovenian: Modro obarvana tableta z ravnima ploskvama, okroglimi robovi in s premerom 3 mm.
English: When ready to administer the medicine, tear open the slit-notched pouch across the top.
Slovenian: Ko bo bolnik pripravljen, da date zdravilo, vrečko odprite tako, da jo raztrgate pri zarezi na vrhu.
English: Sufentanil is primarily metabolised by the human cytochrome P450-3A4 enzyme.
Slovenian: Sufentanil se presnavlja predvsem s humanim citokromom P450-3A4.
English: The sublingual tablet will be given to you by a healthcare professional using the disposable single-dose applicator.
Slovenian: Podjezično tableto vam bo z uporabo aplikatorja za enkratno uporabo z enkratnim odmerkom dal zdravstveni delavec.
English: Tension headache
Slovenian: Tenzijski glavobol
English: Population pharmacokinetic analysis with weight as a covariate showed that patients with a higher BMI dosed more frequently.
Slovenian: Učinek ITM na odmerjanje Populacijska farmakokinetična analiza s telesno maso kot sočasno spremenljivko je pokazala, da so si bolniki z višjim ITM zdravilo odmerjali pogosteje.
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Slovenian: Od zdravstvenih delavcev se zahteva, da poročajo o katerem koli domnevnem neželenem učinku zdravila na nacionalni
English: Instruct the patient to not eat or drink and minimize talking for 10 minutes after receiving the tablet.
Slovenian: Bolniku naročite, naj vsaj deset minut po prejemu tablete ne je in ne pije ter čim manj govori.
English: The symptoms of overdose include severe breathing problems like slow and shallow breathing, loss of consciousness, extremely low blood pressure, collapse and muscle rigidity.
Slovenian: Če ste uporabili večji odmerek zdravila Dzuveo, kot bi smeli Simptomi prevelikega odmerjanja vključujejo hude težave z dihanjem, npr. počasno in plitvo dihanje, izgubo zavesti, zelo nizek krvni tlak, kolaps in togost mišic.
English: Lower pregnancy rates were noted following treatment of males suggesting the potential for an adverse effect on fertility in males.
Slovenian: Po tretiranju samcev so bili ugotovljeni nižji deleži brejosti, kar kaže na možnost škodljivega vpliva na plodnost pri samcih.
English: Hypotension Hypertension
Slovenian: Hipotenzija Hipertenzija
English: Withdrawal syndrome which may include symptoms such as agitation, anxiety, muscle aches, insomnia, sweating and yawning.
Slovenian: Odtegnitveni sindrom, ki lahko vključuje simptome, kot so vznemirjenost, tesnoba, bolečine v mišicah, nespečnost in zehanje.
English: Gastroesophageal reflux disease
Slovenian: Gastroezofagealna refluksna bolezen Peroralna hipestezija
English: Common side effects (may affect up to 1 in 10 people): - Inability or difficulty sleeping, feeling anxious or confused, dizziness.
Slovenian: Pogosti neželeni učinki (pojavijo se lahko pri največ 1 od 10 bolnikov): - Nezmožnost ali težave s spanjem, občutek tesnobe ali zmedenosti, omotica.
English: Very common side effects (may affect more than 1 in 10 people): Nausea or feeling sick, vomiting or being sick and generally feeling hot.
Slovenian: Zelo pogosti neželeni učinki (pojavijo se lahko pri več kot 1 od 10 bolnikov) Slabost ali občutek siljenja na bruhanje, bruhanje in na splošno občutek vročine.
English: Cardiovascular effects
Slovenian: Srčno-žilni učinki
English: Rescue analgesia was allowed in both studies, with a higher proportion of patients in the placebo group requiring rescue medication due to inadequate analgesia (64.8%, 100%; abdominal, bunionectomy) than in the sufentanil group (27.1%, 70.0%;.
Slovenian: V obeh študijah je bila dovoljena rešilna analgezija, pri čemer je rešilno zdravilo zaradi nezadostne analgezije potreboval večji delež bolnikov v skupini, zdravljeni s placebom (64,8 %, 100%;
English: - If you have any further questions, ask your doctor or pharmacist or nurse.
Slovenian: - Če imate dodatna vprašanja, se posvetujte z zdravnikom ali farmacevtom ali medicinsko sestro.
English: - Chest pain and breathing difficulties caused by a blood clot in lung, fluid in the lungs, wheezing.
Slovenian: Bolečina v prsnem košu in težave pri dihanju, ki jih povzroča krvni strdek v pljučih, tekočina v pljučih, piskanje.
English: Hypomagnesaemia Hypoproteinaemia Hyperkalaemia Diabetes mellitus Hyperglycaemia Hyperlipidaemia Hypophosphataemia Hypovolaemia
Slovenian: Hipomagneziemija Hipoproteinemija Hiperkaliemija Sladkorna bolezen Hiperglikemija Hiperlipidemija Hipofosfatemija Hipovolemija
English: The central volume of distribution after intravenous application of sufentanil is approximately 14 litres and the volume of distribution at steady state is approximately 350 litres.
Slovenian: Porazdelitev Centralni porazdelitveni volumen po intravenskem dajanju sufentanila je približno 14 litrov,
English: There are no or limited amount of data from the use of sufentanil in pregnant women.
Slovenian: Podatkov o uporabi sufentanila pri nosečnicah ni oziroma so omejeni.
English: Bronchitis Conjunctivitis infective Pharyngitis
Slovenian: Okužbeni konjunktivitis Faringitis
English: Primary pharmacodynamics effects
Slovenian: Primarni farmakodinamični učinki
English: In the abdominal surgery trial, mean baseline pain intensity was 5.61 (0.13) for sufentanil-treated patients and 5.48 (0.18) for placebo-treated patients.
Slovenian: Pri preskušanju po abdominalni operaciji je bila povprečna intenzivnost bolečine pri bolnikih, zdravljenih s sufentanilom, 5,61 (0,13), pri bolnikih, zdravljenih s placebom, pa 5,48 (0,18).
English: Patients using Dzuveo had a mean SPID12 score that was superior to patients using placebo (25.8 vs. 13.1) in abdominal surgery patients (p<0.001) and (5.93 vs. -6.7) in bunionectomy patients (p=0.005) respectively.
Slovenian: Bolniki, ki so uporabljali zdravilo Dzuveo, so imeli višjo povprečno oceno SPID12 kot bolniki, ki so uporabljali placebo, in sicer tako po abdominalni operaciji (25,8 v primerjavi s 13,1, p < 0,001) kot tudi po bunionektomiji (5,93 v primerjavi z −6,7, p = 0,005).
English: A population pharmacokinetic analysis of plasma sufentanil concentrations following usage of Dzuveo did not identify renal function as a significant covariate for clearance.
Slovenian: Pri populacijski farmakokinetični analizi plazemskih koncentracij sufentanila po uporabi zdravila Dzuveo se delovanje ledvic ni izkazalo kot pomembna sočasna spremenljivka očistka.
English: Patients with a higher pain intensity at one hour after Dzuveo treatment was initiated required more frequent redosing compared to patients with lower pain intensity scores at one hour.
Slovenian: Bolniki, ki so imeli eno uro po začetku zdravljenja z zdravilom Dzuveo močnejšo bolečino, so v primerjavi z bolniki z manj močno bolečino po eni uri od začetka zdravljenja pogosteje potrebovali ponovni odmerek.
English: 10 x 1sublingual tablet in a single-dose applicator.
Slovenian: 10 × 1 podjezična tableta v aplikatorju z enkratnim odmerkom.
English: Place the SDA tip under the tongue and aim at the floor of the patient's mouth.
Slovenian: Konico aplikatorja postavite pod jezik in jo usmerite proti dnu ustne votline.
English: 1 single-dose applicator containing 1 sublingual tablet.
Slovenian: En aplikator z enkratnim odmerkom, ki vsebuje eno podjezično tableto
English: Local tolerance Two local tolerance studies were conducted in the hamster cheek pouch with the sufentanil sublingual tablets.
Slovenian: S podjezičnimi tabletami sufentanila sta bili izvedeni dve študiji lokalne tolerance v lični vrečki pri hrčku.
English: Sufentanil should be administered with caution to patients with moderate to severe hepatic or severe renal impairment (see section 4.4).
Slovenian: Sufentanil je treba pri bolnikih z zmerno do hudo okvaro jeter ali hudo okvaro ledvic uporabljati previdno (glejte poglavje 4.4).
English: 4.4 Special warnings and precautions for use
Slovenian: 4.4 Posebna opozorila in previdnostni ukrepi Depresija dihanja
English: See section 6.6 for instructions regarding handling of the Dzuveo sublingual tablet and applicator.
Slovenian: Za navodila o ravnanju s podjezično tableto in aplikatorjem zdravila Dzuveo glejte poglavje 6.6.
English: Do not chew or swallow the tablet.
Slovenian: Tablete ne smete žvečiti ali pogoltniti.
English: However, due to the limited number of patients with severe renal impairment studied, Dzuveo should be used with caution in such patients (see section 4.4).
Slovenian: Vendar pa je treba zdravilo Dzuveo zaradi omejenega števila bolnikov s proučevano hudo okvaro ledvic pri teh bolnikih uporabljati previdno (glejte poglavje 4.4).
English: - Developing blisters, excessive sweating, rash, dry skinnumbness of mouth or face.
Slovenian: Pojav mehurjev, čezmerno potenje, izpuščaj, suha koža, odrevenelost ust ali obraza.
English: The incidence and degree of bradycardia and hypotension with sufentanil may be greater in patients on chronic calcium channel and/or beta blocker therapy.
Slovenian: Interakcija z zaviralci kalcijevih kanalčkov in/ali zaviralci adrenergičnih receptorjev beta Incidenca in stopnja bradikardije in hipotenzije pri zdravljenju s sufentanilom sta lahko večji pri bolnikih, ki se kronično zdravijo z zaviralci kalcijevih kanalčkov in/ali zaviralci adrenergičnih receptorjev beta.
English: - Vision disturbances, eye pain.
Slovenian: Motnje vida, bolečina v očesu.
English: - Dry mouth, flatulence (passing wind), constipation, indigestion or reflux.
Slovenian: Suha usta, napenjanje (vetrovi), zaprtost, prebavne motnje ali refluks.
English: - If you are allergic to sufentanil or any of the other ingredients of this medicine (listed in section
Slovenian: - če ste alergični na sufentanil ali katero koli sestavino tega zdravila (navedeno v poglavju 6); če imate resne težave s pljuči ali dihanjem.
English: Angina pectoris Atrial fibrillation
Slovenian: Bradikardija Angina pektoris Atrijska fibrilacija Ventrikularne ekstrasistole
English: Over 24 hours, the mean number of Dzuveo doses administered was 7.0 (210 micrograms/day).
Slovenian: V 24 urah je bilo povprečno število odmerkov zdravila Dzuveo 7,0
English: Marketing Authorisation Holder FGK Representative Service GmbH, Heimeranstr.
Slovenian: Imetnik dovoljenja za promet z zdravilom FGK Representative Service GmbH, Heimeranstr.
English: Uncommon side effects (may affect up to 1 in 100 people): - Inflammation of the lungs, eye redness and inflammation, inflammation of the throat.
Slovenian: Občasni neželeni učinki (pojavijo se lahko pri največ 1 od 100 bolnikov): Vnetje pljuč, rdeče in vneto oko, vnetje žrela.
English: Patients requested dosing with Dzuveo to maintain plasma sufentanil concentrations averaging 40- 50 pg/ml at 12 hours, with no effect based on age or body mass index (BMI), or mild to moderate renal or liver impairment.
Slovenian: do 50 pg/ml po 12 urah zahtevali odmerjanje zdravila Dzuveo, ne da bi bilo to odvisno od starosti ali indeksa telesne mase (ITM) ali blage do zmerne okvare ledvic ali jeter.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each sublingual tablet contains 30 micrograms of sufentanil (as citrate).
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena podjezična tableta vsebuje 30 mikrogramov sufentanila (v obliki citrata).
English: The pouch contains one clear plastic SDA with a single blue-coloured tablet housed in the tip, and an oxygen absorber packet.
Slovenian: Vrečka vsebuje en prozoren plastičen aplikator z enkratnim odmerkom z eno tableto modre barve, nameščeno v konici, in absorbent kisika.
English: Special populations
Slovenian: Starejše osebe
English: Anaphylactic shock
Slovenian: Anafilaktični šok
English: Based on the population pharmacokinetic analysis for Dzuveo, hepatic function was not identified as a significant covariate for clearance.
Slovenian: V populacijski farmakokinetični analizi zdravila Dzuveo se delovanje jeter ni izkazalo kot pomembna sočasna spremenljivka očistka.
English: Do Not Use if Pouch Seal is Broken.
Slovenian: Ne uporabljajte, če je tesnilo vrečke poškodovano.
English: Contents of the pouch are shown below:
Slovenian: Prikaz vsebine vrečke:
English: - This medicine may also cause changes in levels of red blood cells, white blood cells, calcium,
Slovenian: - To zdravilo lahko povzroči tudi spremembe v koncentraciji rdečih krvnih celic, belih krvnih celic, kalcija, albumina, kalija in natrija v krvi, ki jih je mogoče prepoznati samo s preiskavo krvi.
English: Tachycardia Sinus tachycardia
Slovenian: Tahikardija Sinusna tahikardija
English: Hyperhidrosis Hypoaesthesia facial Pruritus generalized Blister
Slovenian: Hiperhidroza Hipestezija obraza Generalizirani pruritus Mehur
English: Contents of the pack and other information
Slovenian: Shranjevanje zdravila Dzuveo Vsebina pakiranja in dodatne informacije
English: Lipoma
Slovenian: Lipom
English: NAME OF THE MEDICINAL PRODUCT Dzuveo 30 micrograms sublingual tablet
Slovenian: IME ZDRAVILA Dzuveo 30 mikrogramov podjezična tableta
English: Hepatic or renal impairment
Slovenian: Jetrna ali ledvična okvara
English: Dzuveo 30 micrograms sublingual tablets sufentanil
Slovenian: Dzuveo 30 mikrogramov podjezične tablete sufentanil
English: - If you get any side effects, talk to your doctor, or pharmacist or nurse.
Slovenian: - Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom ali farmacevtom ali medicinsko sestro.
English: - Keep this leaflet.
Slovenian: Zaklep zavrzite.
English: Pharyngolaryngeal pain
Slovenian: Hipoksija Faringolaringealna bolečina
English: Therefore, it should be used with caution in patients with previous or pre-existing bradyarrhythmias.
Slovenian: Srčno-žilni učinki Sufentanil lahko povzroči bradikardijo, zato ga je treba pri bolnikih s predhodnimi ali obstoječimi bradiaritmijami uporabljati previdno.
English: Appendix V
Slovenian: PRILOGA IV
English: Oxygen saturation decreased Body temperature increased
Slovenian: Povišana telesna temperatura
English: Procedural nausea Postoperative ileus Procedural vomiting Gastrointestinal stoma complication Procedural pain
Slovenian: Navzea ob posegu Pooperacijski ileus Bruhanje ob posegu Komplikacije z gastrointestinalno stomo
English: Headache Dizziness Somnolence Sedation
Slovenian: Glavobol Omotica Zaspanost Sedacija
English: Dzuveo passes into breast milk and can cause side effects in the breast-fed child. Breastfeeding is not recommended while you are taking Dzuveo.
Slovenian: Zdravilo Dzuveo prehaja v materino mleko in lahko povzroči neželene učinke pri dojenih otrocih.
English: Erythema
Slovenian: Irska
English: Calcium hydrogen phosphate Hypromellose Croscarmellose sodium Indigo carmine -E132 Stearic acid
Slovenian: 6.1 Seznam pomožnih snovi manitol (E421) kalcijev hidrogenfosfat hipromeloza premreženi natrijev karmelozat indigotin (E132) stearinska kislina magnezijev stearat
English: Each sublingual tablet contains 30 micrograms of sufentanil (as citrate).
Slovenian: Vsaka podjezična tableta vsebuje 30 mikrogramov sufentanila (v obliki citrata).
English: Musculoskeletal pain Musculoskeletal chest pain
Slovenian: Mišično-skeletna bolečina v prsnem košu Bolečina v okončini
English: Sufentanil has potential for abuse.
Slovenian: Možnost zlorabe in tolerance Pri sufentanilu obstaja možnost zlorabe.
English: Blood pressure increased Respiratory rate decreased Blood glucose increased Blood bilirubin increased Urine output decreased Aspartate aminotransferase increased
Slovenian: Zvišana raven bilirubina v krvi Zmanjšano izločanje urina
English: Sufentanil should be used with caution in patients with brain tumours.
Slovenian: Pri bolnikih z možganskimi tumorji je treba sufentanil uporabljati zelo previdno.
English: Back Pain
Slovenian: Bolečina v hrbtu
English: Patients should not eat or drink and should minimise talking for 10 minutes after each dose of sufentanil 30 mcg sublingual tablet.
Slovenian: Bolniki deset minut po vsakem odmerku 30-μg podjezične tablete sufentanila ne smejo jesti ali piti in naj bi čim manj govorili.
English: Respiratory arrest
Slovenian: Zastoj dihanja
English: Hypocalcaemia Hypoalbuminaemia Hypokalaemia Hyponatraemia
Slovenian: Hipokalciemija Hipoalbuminemija Hipokaliemija Hiponatriemija
English: A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturer(s) responsible for batch release Propak Health Ltd
Slovenian: Ime in naslov izdelovalca (izdelovalcev), odgovornega (odgovornih) za sproščanje serij
English: Dzuveo 30 micrograms sublingual tablet sufentanil
Slovenian: Dzuveo 30 mikrogramov podjezična tableta sufentanil