FrancophonIA/ELRC3.0 huggingface dataset:
English: Powder and solvent for solution for injection.
Slovenian: Prašek in vehikel za raztopino za injiciranje
English: - The active substance is human coagulation factor X. One vial contains nominally 250 IU or 500 IU
Slovenian: - Zdravilna učinkovina je humani koagulacijski faktor X. Ena viala vsebuje nazivno količino 250 i.e. ali
English: Some patients with a shortage of factor X may develop inhibitors (antibodies) to factor X during treatment.
Slovenian: Pri nekaterih bolnikih s pomanjkanjem faktorja X se lahko med zdravljenjem razvijejo zaviralci (protitelesa) faktorja X. To bi lahko pomenilo, da zdravljenje ne bo ustrezno delovalo.
English: Back pain
Slovenian: Bolečine v hrbtu
English: Required dose (IU) = body weight (kg) x desired factor X rise (IU/dL) x 0.5
Slovenian: Potrebni odmerek (i.e.) = telesna masa (kg) x želeni dvig faktorja X (i.e./dl) x 0,5
English: Pharmacokinetic (PK) parameters were calculated from plasma factor X:C (one-stage clotting assay) activity measurements after subtraction of the pre-dose value.
Slovenian: Farmakokinetične (FK) parametre so izračunali iz meritev aktivnosti faktorja X:C
English: Step 6: Immediately invert the vial of solution, which will be drawn into the syringe.
Slovenian: 6. korak: Takoj obrnite vialo z raztopino, ki jo bo potegnilo v injekcijsko brizgo.
English: Step 4: The solvent will be pulled into the powder vial by the vacuum contained within it.
Slovenian: 4. korak: Vehikel bo stekel v vialo s praškom zaradi vakuuma v viali z zdravilom.
English: - if the dissolved powder and solvent form a gel or a clot (if this happens please tell your healthcare provider, reporting the batch number printed on the vial).
Slovenian: - če se vehikel ni prenesel v vialo (to pomeni, da v viali ni bilo vakuuma, zato praška ne smete uporabiti); - če raztopljeni prašek in vehikel tvorita gel ali strdek (v tem primeru obvestite svojega zdravstvenega delavca in sporočite številko serije, ki je odtisnjena na viali).
English: The vials should be brought to room temperature (not above 30oC) prior to the removal of the snap-off cap closure from the powder vial.
Slovenian: Preden odstranite snemno zaporko z viale praška, morate viale ogreti na sobno temperaturo (ne več kot 30 oC).
English: Solvent vial: 2.5 mL or 5 mL solution in a type I glass vial sealed with a halobutyl rubber stopper and an overseal.
Slovenian: Viala z vehiklom: 2,5 ml ali 5 ml raztopine v viali iz stekla tipa I, zaprti z zamaškom iz halobutilne gume in tesnilom.
English: Keep container in the outer carton in order to protect it from light.
Slovenian: Vsebnik shranjujte v zunanji škatli za zagotovitev zaščite pred svetlobo.
English: Coagadex contains approximately 100 IU/mL human coagulation factor X after reconstitution with 2.5 mL (250 IU) or 5 mL (500 IU) sterilised water for injections.
Slovenian: Ena viala vsebuje nazivno količino 250 i.e. ali 500 i.e. humanega koagulacijskega faktorja X. Zdravilo Coagadex vsebuje približno 100 i.e./ml humanega koagulacijskega faktorja X po rekonstituciji z 2,5 ml (250 i.e.) ali 5 ml (500 i.e.) sterilizirane vode za injekcije.
English: Solvent vial: water for injections.
Slovenian: Viala z vehiklom: voda za injekcije.
English: What Coagadex looks like and contents of the pack
Slovenian: Izgled zdravila Coagadex in vsebina pakiranja
English: Quantity of Coagadex
Slovenian: Količina zdravila Coagadex
English: All were treated with a single infusion of Coagadex; mean and median doses 31.7 IU/kg (range 24.6 to 38.8 IU/kg) and all recorded efficacy ratings were categorized as excellent.
Slovenian: Vsi so bili zdravljeni z enkratno infuzijo zdravila Coagadex; povprečni in mediani odmerek sta bila 31,7 i.e./kg (razpon od 24,6 i.e./kg do
English: Sodium Content
Slovenian: Vsebnost natrija
English: Coagadex contains sodium
Slovenian: Zdravilo Coagadex vsebuje natrij
English: Draw air into the syringe by pulling the plunger to the volume of water added.
Slovenian: Povlecite zrak v injekcijsko brizgo s potegom bata na volumen dodane sterilizirane vode.
English: Step 5
Slovenian: 5. korak
English: • Peel back the top of the transfer device package but leave the device in the package.
Slovenian: • Odlepite zgornji del pakiranja pribora za prenos vehikla, vendar pustite pribor v embalaži.
English: For on-demand control of bleeding in children aged less than 12 years: 30 IU/kg Coagadex should be injected when the first sign of bleeding occurs.
Slovenian: Za obvladovanje krvavitev po potrebi pri otrocih, starih manj kot 12 let: Ob pojavu prvega znaka krvavitve je treba injicirati 30 i.e./kg zdravila Coagadex.
English: Keep the vial in the outer carton to protect from light.
Slovenian: Vialo shranjujte v zunanji ovojnini za zagotovitev zaščite pred svetlobo.
English: Coagadex is supplied with the amount of solvent as shown in the table.
Slovenian: 5 ml Zdravilu Coagadex je priložena količina vehikla, ki je prikazana v tabeli.
English: No pharmacokinetic studies have been conducted but there is no anticipated effect of age on the pharmacokinetic profile of Coagadex.
Slovenian: Farmakokinetičnih študij niso opravili, vendar ne pričakujemo učinka starosti na farmakokinetični profil zdravila Coagadex.
English: • Disconnect the filled syringe from the device.
Slovenian: • Odstranite napolnjeno injekcijsko brizgo s pribora.
English: - Solvent: water for injections.
Slovenian: - Vehikel: voda za injekcije.
English: The following adverse reactions have been reported in clinical studies involving 27 patients treated with
Slovenian: Tabelarični seznam neželenih učinkov V kliničnih študijah, ki so vključevale 27 bolnikov, zdravljenih z zdravilom Coagadex, so poročali o naslednjih neželenih učinkih.
English: Vaccination against hepatitis A and B in patients who regularly or repeatedly receive human plasma-derived Factor X products may be warranted.
Slovenian: Pri bolnikih, ki redno ali večkrat prejemajo zdravila s faktorjem X, pridobljenim iz človeške plazme, bo morda potrebno cepljenje proti hepatitisu A in B.
English: Connect the syringe to the clear part of the transfer device and push the air into the vial.
Slovenian: Priključite injekcijsko brizgo na prozorni del pribora za prenos vehikla in potisnite zrak v vialo.
English: Your medicine must only be dissolved in the solvent provided with the product.
Slovenian: Zdravilo lahko raztopite le v vehiklu, ki je priložen zdravilu.
English: How to use Coagadex
Slovenian: Kako uporabljati zdravilo Coagadex
English: Step 5: Separate the empty solvent vial and blue part from the clear part by unscrewing anti-clockwise.
Slovenian: 5. korak: Odstranite prazno vialo vehikla in modri del s prozornega dela, tako da ju obračate v nasprotni smeri vrtenja urinega kazalca.
English: When to inject Coagadex
Slovenian: Kdaj je treba injicirati zdravilo Coagadex
English: human coagulation factor X. - The other ingredients are: citric acid, disodium phosphate dihydrate, sodium chloride,
Slovenian: 500 i.e. humanega koagulacijskega faktorja X. - Druge sestavine zdravila so: citronska kislina, dinatrijev fosfat dihidrat, natrijev klorid, natrijev hidroksid in saharoza (za dodatne informacije o sestavinah glejte poglavje 2).
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL 250 IU
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH OZNAKA NA VIALI 250 i.e.
English: No pharmacokinetic studies have been conducted but there is no anticipated effect of gender or renal function on the pharmacokinetic profile of Coagadex.
Slovenian: Farmakokinetičnih študij niso opravili, vendar ne pričakujemo učinka spola ali delovanja ledvic na farmakokinetični profil zdravila Coagadex.
English: Do not use a double dose to make up for a forgotten dose.
Slovenian: Če ste pozabili uporabiti zdravilo Coagadex Ne vzemite uporabite dvojnega odmerka, če ste pozabili vzeti prejšnji odmerek.
English: Coagadex 250 IU Coagadex 500 IU
Slovenian: Coagadex 250 i.e. Coagadex 500 i.e.
English: No pharmacokinetic studies have been conducted but there is no anticipated effect of gender or hepatic function on the pharmacokinetic profile of Coagadex.
Slovenian: Farmakokinetičnih študij niso opravili, vendar ne pričakujemo učinka spola ali delovanja jeter na farmakokinetični profil zdravila Coagadex.
English: Powder vial containing white or off-white powder.
Slovenian: prašek in vehikel za raztopino za injiciranje Viala s praškom vsebuje bel ali umazano bel prašek.
English: 1 vial 500 IU human coagulation factor X powder for solution for injection 1 vial 5 mL water for injections
Slovenian: 1 viala s 500 i.e. humanega koagulacijskega faktorja X, prašek za raztopino za injiciranje 1 viala s 5 ml vode za injekcije
English: • The solvent will be pulled into the powder vial by the vacuum contained within it.
Slovenian: • Vehikel bo stekel v vialo s praškom zaradi vakuuma v viali z zdravilom.
English: 1 vial 250 IU human coagulation factor X powder for solution for injection 1 vial 2.5 mL water for injections
Slovenian: 1 viala z 250 i.e. humanega koagulacijskega faktorja X, prašek za raztopino za injiciranje 1 viala z 2,5 ml vode za injekcije
English: 1 vial 250 IU powder 1 vial 2.5 mL water for injections 1 Transfer Device (Mix2Vial)
Slovenian: 1 viala z 250 i.e., prašek 1 viala z 2,5 ml vode za injekcije 1 pribor za prenos vehikla (Mix2Vial)
English: Renal impairment No dose adjustment is necessary.
Slovenian: Odmerka ni treba prilagajati.
English: Hypersensitivity or allergic reactions (which may include angioedema, burning and stinging at the infusion site, chills, flushing, generalised urticaria, headache, hives, hypotension, lethargy, nausea, restlessness, tachycardia, tightness of the chest, tingling, vomiting, wheezing) have been observed rarely with treatment of other haemophilias and may in some cases have progressed to severe anaphylaxis (including shock).
Slovenian: navzeo, nemir, tahikardijo, stiskanje v prsih, mravljinčenje, bruhanje, sopenje) so redko opazili pri zdravljenju drugih hemofilij in so v določenih primerih lahko napredovale v hudo anafilaksijo (vključno s šokom).
English: It is recommended that post-infusion plasma factor X levels are measured for each patient before and after surgery, to ensure that haemostatic levels are obtained and maintained.
Slovenian: Za doseganje in vzdrževanje hemostatskih ravni je priporočljivo, da se za vsakega bolnika pred operativnim postopkom in po njem izmerijo ravni faktorja X v plazmi po infundiranju.
English: • Connect the syringe to the clear part of the transfer device and push the air in the syringe into the vial.
Slovenian: • Priključite injekcijsko brizgo na prozorni del pribora za prenos vehikla in potisnite zrak iz injekcijske brizge v vialo.
English: If you get any side effects, talk to your doctor, pharmacist or nurse.
Slovenian: - Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: 1 vial 500 IU powder 1 vial 5 mL water for injections 1 Transfer Device (Mix2Vial)
Slovenian: 1 viala s 500 i.e., prašek 1 viala s 5 ml vode za injekcije 1 pribor za prenos vehikla (Mix2Vial)
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON 500 IU
Slovenian: PODATKI NA ZUNANJI OVOJNINI ŠKATLA 500 i.e.
English: Peel back the top of the transfer device package but leave the device in the package.
Slovenian: Odlepite zgornji del pakiranja pribora za prenos vehikla, vendar pustite pribor v embalaži.
English: For major surgery, a median of 13 infusions (range 2 to 15 infusions) and a median cumulative dose of 181 IU/kg (range 45 to 210 IU/kg) were required to maintain haemostasis.
Slovenian: infuzij (od 2 do 15 infuzij) in mediani kumulativni odmerek 181 i.e./kg (od 45 do 210 i.e./kg).
English: Factor X is converted from its inactive form to the active form (factor Xa) by the cleavage of a 52-residue peptide from the heavy chain.
Slovenian: Faktor X se iz svoje neaktivne oblike pretvori v aktivno obliko (faktor Xa) s cepljenjem
English: If you get any of these contact your doctor.
Slovenian: Če se kateri koli od teh neželenih učinkov pojavi pri vas, se posvetujte z zdravnikom.
English: Step 2: Place the blue end of the transfer device on the solvent vial and push straight down until the spike penetrates the rubber stopper and snaps into place.
Slovenian: 2. korak: Postavite modri konec pribora za prenos vehikla na vialo vehikla in ga potisnite naravnost navzdol, da bo konica prebodla gumijasti zamašek in se zaskočila na svoje mesto.
English: The mean (CV%) half-life of human coagulation factor X was 30.3 (22.8) hr and clearance was 1.35 (21.7) mL/kg/hr.
Slovenian: Srednja (CV %) razpolovna doba človeškega koagulacijskega faktorja X je znašala 30,3 (22,8) ur, očistek pa
English: For secondary prophylaxis against re-bleeding or short-term prophylaxis prior to anticipated physical activity or dental appointments: 25 IU/kg Coagadex should be injected and repeated as required.
Slovenian: Za sekundarno preprečevanje ponovnih krvavitev ali za kratkotrajno preprečevanje krvavitve pred pričakovano fizično aktivnostjo ali zobozdravstvenimi posegi: injicirati je treba odmerek 25 i.e./kg zdravila
English: Systemic exposure to FX:C at the Repeat PK visit (at least 6 months later) was equivalent to that at baseline, since repeat/baseline ratios for all PK parameters were within the range of 90% to 110%.
Slovenian: enakovredna tisti ob izhodišču, saj so bila razmerja ponovljeni/izhodiščni za vse parametre farmakokinetike v razponu od 90 % do 110 %.
English: Method of administration Intravenous use.
Slovenian: Intravenska uporaba
English: Coagadex should not be used as an antidote to the effects of direct oral anti-coagulants (DOACs) in patients who do not have factor X deficiency.
Slovenian: Teh protitrombotičnih zdravil se ne sme uporabljati pri bolnikih s pomanjkanjem faktorja X. Zdravila Coagadex ne smete uporabljati kot antidota za učinke neposrednih peroralnih zdravil za zaviranje strjevanja krvi pri bolnikih, ki nimajo pomanjkanja faktorja X.
English: Hypersensitivity reactions, allergic reactions, and anaphylaxis have not been reported in Coagadex clinical trials.
Slovenian: V kliničnih preskušanjih zdravila Coagadex niso poročali o preobčutljivostnih reakcijah, alergijskih reakcijah in anafilaksiji.
English: Talk to your doctor, pharmacist or nurse before using Coagadex:
Slovenian: Pred začetkom uporabe zdravila Coagadex se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro:
English: Signs of these may include skin rash (including hives), tingling, flushing, nausea, vomiting, headache, cough, wheezing, tightness of the chest, chills, fast heart rate, dizziness, lethargy, restlessness, swelling of the face, tightness of the throat, discomfort at the site of injection.
Slovenian: zbadanje, eritem), mrzlico, kašljem, omotico, povišano telesno temperaturo, zardevanjem, generalizirano urtikarijo, glavobolom, koprivnico, hipotenzijo, letargijo, bolečinami mišično-skeletnega sistema, navzeo, pruritusom, izpuščajem, nemirom, tahikardijo, tiščanjem v prsih, mravljinčenjem, bruhanjem, sopenjem.
English: • back pain
Slovenian: • bolečina v hrbtu
English: Prophylaxis of Bleeding Episodes
Slovenian: Profilaksa epizod krvavitev
English: Despite these measures, when medicines prepared from human blood or plasma are administered, the possibility of passing on an infection cannot be totally excluded.
Slovenian: Kljub tem ukrepom ni mogoče povsem izključiti prenosa okužbe ob dajanju zdravil, pripravljenih iz človeške krvi ali plazme.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON 250 IU
Slovenian: PODATKI NA ZUNANJI OVOJNINI ŠKATLA 250 i.e.
English: Routine prophylaxis was started with unit doses of 40-50 IU/kg and during the first 6 weeks trough levels of Factor X were measured to adjust the dosage regimen to maintain a trough level of at least 5 IU/dL.
Slovenian: V prvih 6 tednih so merili najnižje ravni faktorja X in skladno s tem prilagajali režim odmerjanja za vzdrževanje najnižje ravni vsaj 5 i.e./dl.
English: • Immediately invert the vial of solution, which will be drawn into the syringe.
Slovenian: • Takoj obrnite vialo z raztopino, ki jo bo potegnilo v injekcijsko brizgo.
English: • Separate the empty solvent vial and blue part from the clear part by unscrewing anti-clockwise.
Slovenian: • Odstranite prazno vialo vehikla in modri del s prozornega dela, tako da ju obračate v nasprotni smeri vrtenja urinega kazalca.
English: Certain anticoagulants including those blocking a blood clotting factor (factor Xa) should not be used in patients with factor X deficiency receiving Coagadex due to a risk of blood clots.
Slovenian: Xa) se pri bolnikih s pomanjkanjem faktorja X, ki prejemajo zdravilo Coagadex, ne sme uporabljati zaradi tveganja za nastanek krvnih strdkov.
English: - careful selection of blood and plasma donors to make sure those at risk of carrying infections are excluded, - the testing of each donation and pools of plasma for signs of virus/infections, - the inclusion of steps in the processing of the blood or plasma that can inactivate or remove viruses.
Slovenian: - vključitev korakov, ki lahko inaktivirajo ali odstranijo viruse, v obdelavo krvi ali plazme.
English: Frequencies have been evaluated according to the following convention: very common (≥1/10 subjects); common (≥1/100 to <1/10).
Slovenian: (≥1/10 bolnikov); pogosti (≥1/100 do <1/10 bolnikov).
English: Coagadex to raise plasma factor X levels to 70-90 IU/dL.
Slovenian: v plazmi na 70-90 i.e./dl.
English: 1 solvent vial of 5 mL water for injections
Slovenian: 1 pribor za prenos vehikla 1 vialo z vehiklom s 5 ml vode za injekcije
English: 1 solvent vial of 2.5 mL water for injections
Slovenian: 1 pribor za prenos vehikla 1 vialo z vehiklom z 2,5 ml vode za injekcije
English: Coagadex 500 IU powder and solvent for solution for injection human coagulation factor X
Slovenian: Coagadex 500 i.e. prašek in vehikel za raztopino za injiciranje humani koagulacijski faktor X
English: What you need to know before you use Coagadex 3.
Slovenian: Kaj je zdravilo Coagadex in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Coagadex Kako uporabljati zdravilo Coagadex
English: Coagadex 250 IU powder and solvent for solution for injection human coagulation factor X
Slovenian: Coagadex 250 i.e. prašek in vehikel za raztopino za injiciranje humani koagulacijski faktor X
English: In adults and adolescents at least 12 years of age, the expected in vivo peak increase in factor X level expressed as IU/dL (or % of normal) can be estimated using the following formulae:
Slovenian: Pri odraslih in mladostnikih, starih 12 let ali več, je pričakovani največji dvig ravni faktorja X in vivo,
English: Dose (IU) = body weight (kg) x desired factor X rise (IU/dL or % of normal) x 0.5 OR Increase in factor X level (IU/dL or % of normal) = [total dose (IU)/body weight (kg)] x 2
Slovenian: Odmerek (i.e.) = telesna masa (kg) x želeni dvig faktorja X (i.e./dl ali % običajne vrednosti) x 0,5
English: The study in young children (see section 5.1) measured incremental recovery at 30 min (IR30min) after the first dose and after the last dose in the study (approximately 6 months later) (see section 5.1) Combining IR30min values for FX:C at the baseline visit (n=9) and the Repeat PK assessment (n=9) gave an overall geometric mean IR of 1.74 (range 1.3-2.2) IU/dL per IU/kg administered (n=9).
Slovenian: V študiji pri mladih otrocih (glejte poglavje 5.1) so merili prirastno zvečanje aktivnosti 30 minut (IR30min) po prvem odmerku in po zadnjem odmerku v študiji (približno 6 mesecev pozneje) (glejte poglavje 5.1).
English: Infusion site pain
Slovenian: Bolečina na mestu infundiranja
English: Place the clear end of the transfer device on the powder vial and push straight down until the spike penetrates the rubber stopper and snaps into place.
Slovenian: Položite prozorni konec pribora za prenos vehikla na vialo s praškom in ga potisnite naravnost navzdol, da bo konica prebodla gumijasti zamašek in se zaskočila na svoje mesto.
English: • Place the blue end of the transfer device on the solvent vial and push straight down until the spike penetrates the rubber stopper and snaps into place.
Slovenian: • Postavite modri konec pribora za prenos vehikla na vialo z vehiklom in ga potisnite naravnost navzdol, da bo konica prebodla gumijasto zaporko in se zaskočila na svoje mesto.
English: Coagadex 500 IU
Slovenian: Coagadex 500 i.e.
English: Coagadex 250 IU
Slovenian: coagadex 250 i.e.
English: coagadex 250 iu
Slovenian: Coagadex 250 i.e.
English: • tiredness
Slovenian: • utrujenost
English: • Place the clear end of the transfer device on the powder vial and push straight down until the spike penetrates the rubber stopper and snaps into place.
Slovenian: • Položite prozorni konec pribora za prenos vehikla na vialo s praškom in ga potisnite naravnost navzdol, da bo konica prebodla gumijasto zaporko in se zaskočila na svoje mesto.
English: How to store Coagadex
Slovenian: Shranjevanje zdravila Coagadex
English: The following side effects have been reported with Coagadex.
Slovenian: Pri zdravljenju z zdravilom Coagadex so poročali o naslednjih neželenih učinkih.
English: In a clinical study of Coagadex in subjects with severe or moderate factor X deficiency (basal FX:C <5 IU/dL), the pharmacokinetics of Coagadex were assessed in 16 subjects after administration of a nominal dose of 25 IU/kg.
Slovenian: FX:C < 5 i.e./dl) so ocenjevali farmakokinetiko zdravila Coagadex po dajanju nominalnega odmerka
English: Dose (IU) = body weight (kg) x desired factor X rise (IU/dL or % of normal) x 0.6 OR Increase in factor X level (IU/dL or % of normal) = [total dose (IU)/body weight (kg)] x 1.7
Slovenian: ALI Dvig ravni faktorja X (i.e./dl ali % običajne vrednosti) = [skupni odmerek (i.e.)/telesna masa (kg)] x 2
English: Contents of the pack and other information
Slovenian: Shranjevanje zdravila Coagadex Vsebina pakiranja in dodatne informacije
English: Coagadex 250 IU powder and solvent for solution for injection.
Slovenian: Coagadex 250 i.e. prašek in vehikel za raztopino za injiciranje Coagadex 500 i.e. prašek in vehikel za raztopino za injiciranje
English: Reconstitution time is less than 2 minutes.
Slovenian: Čas priprave je manj kot 2 minuti.
English: Date of first authorisation: 23 August 2012 Date of the latest renewal: 24 April 2017
Slovenian: Datum prve odobritve: 23. avgust 2012 Datum zadnjega podaljšanja: 24.april 2017
English: Resistant (R>)
Slovenian: Rezistentni (R >)
English: Dry powder: 3 years
Slovenian: Suhi prašek: 3 leta
English: A risk to the newborns/infants cannot be excluded.
Slovenian: Tveganja za novorojenčka/dojenčka ni možno izključiti.
English: Calculated using the Cockcroft-Gault formula for adults.
Slovenian: Izračunano z uporabo Cockcroft-Gaultove formule za odrasle.
English: Renal changes were not reversible but were reduced in severity following a 4 week recovery period.
Slovenian: Ledvične spremembe niso bile reverzibilne, se je pa njihova izrazitost zmanjšala po 4-tedenskem obdobju okrevanja.
English: The chemical and physical in-use stability has been demonstrated for up to 24 hours at 2-8 °C.
Slovenian: Kemična in fizikalna stabilnost med uporabo sta dokazani do 24 ur pri temperaturi od 2 - 8°C.
English: In this situation, you should not take medicines that stop or slow bowel movement.
Slovenian: V takšnih okoliščinah ne smete jemati zdravil, ki ustavijo ali upočasnijo gibanje črevesa.
English: The hospital will dispose of any waste materials safely.
Slovenian: V bolnišnici bodo varno odstranili kakršen koli odpadni material.
English: Overall, the safety profile in these 227 patients was similar to that observed in the adult population.
Slovenian: V celoti je bil varnostni profil pri teh 227 bolnikih podoben kot so ga zabeležili v odrasli skupini bolnikov.
English: Frequency categories are derived according to the following conventions: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), not known (cannot be estimated from the available data).
Slovenian: Kategorije pogostnosti so opredeljene po naslednjem dogovoru: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov).