FrancophonIA/ELRC3.0 huggingface dataset:
English: <Invented Name> should be initiated by physicians with experience in the diagnosis and treatment of atopic dermatitis.
Slovenian: {Lastniško ime} naj uvedejo zdravniki, ki imajo izkušnje z diagnosticiranjem in zdravljenjem atopijskega dermatitisa.
English: Infants
Slovenian: Dojenčki
English: Based on the minimal extent of pimecrolimus absorption after topical application of <Invented Name> (see Section 5.2 “Pharmacokinetic properties”), the potential risk for humans is considered limited.
Slovenian: Zaradi minimalnega obsega absorpcije pimekrolimusa po lokalni uporabi {Lastniško ime} (glejte poglavje 5.2 “Farmakokinetične lastnosti”) je mogoče sklepati, da je možnost tveganja za ljudi omejena.
English: 1% w/w Cream
Slovenian: 1% w/w krema
English: HOW TO APPLY <INVENTED NAME> CREAM
Slovenian: KAKO UPORABLJATI KREMO <LASTNIŠKO IME>
English: Rare side-effects, reported in between 1 in 1000 and 1 in 10,000 people include: Flushing, rash, burning, itching or swelling shortly after drinking alcohol.
Slovenian: Redki neželeni učinki, o katerih poročajo od pri 1 od 1.000 ljudi do pri 1 od 10.000 ljudi, vključujejo: pordečitev obraza, izpuščaj, pečenje, srbenje ali otekanje kmalu po zaužitju alkohola; alergične kožne reakcije (npr. otekanje, srbenje ali rdečina).
English: 10 mg/ 1g Cream
Slovenian: 10 mg/ 1g krema
English: In the oral embryotoxicity study in rabbits, a higher resorption rate associated with maternal toxicity was observed at 20 mg/kg/day (= 7 times the maximum human exposure after dermal application); the mean number of live fetuses was not affected.
Slovenian: Pri raziskavi embriotoksičnosti ob peroralni uporabi pri kuncih je bila ugotovljena večja hitrost resorpcije, povezana s toksičnostjo za mater, pri 20 mg/kg/dan (= 7 kratna največja izpostavljenost pri človeku po uporabi na koži).
English: GROUNDS FOR AMENDMENT OF THE SUMMARIES OF PRODUCT CHARACTERISTICS AND PACKAGE LEAFLETS
Slovenian: PODLAGA ZA DOPOLNITEV POVZETKOV GLAVNIH ZNAČILNOSTI ZDRAVILA IN NAVODIL ZA UPORABO ZDRAVILA
English: The active substance of <Invented Name> Cream is pimecrolimus.
Slovenian: Kaj vsebuje krema <Lastniško ime> Zdravilna učinkovina v kremi <Lastniško ime> je pimekrolimus.
English: This may include intolerance to topical corticosteroids, lack of effect of topical corticosteroids and use on the face and neck where prolonged intermittent treatment with topical corticosteroids may be inappropriate.
Slovenian: To lahko vključuje neprenašanje lokalnih kortikosteroidov, pomanjkljiv učinek lokalnih kortikosteroidov in pa uporabo na obrazu in vratu, kjer je dolgotrajno zdravljenje v presledkih z lokalno uporabljenimi kortikosteroidi lahko neprimerno.
English: How long to apply <Invented Name>
Slovenian: Kako dolgo uporabljati kremo <Lastniško ime>
English: Emollients can be applied immediately after using <Invented Name>.
Slovenian: Emoliente lahko nanesete takoj po uporabi {Lastniško ime}.
English: The MAHs should provide, if available, the immune status and serology data when reporting individual tumours to Regulatory Authorities and in the regular PSURs.
Slovenian: Status bolnikov HIV, HTLV-1 za T-celične limfome in EVB status za B-celične limfome Imetniki dovoljenja za promet z zdravilom morajo, če je le-to na voljo, priskrbeti imunski status in serološke podatke, kadar o posameznih tumorjih poročajo regulatornim organom in v rednih posodobljenih poročilih o varnosti (PSUR).
English: Endpoint Criteria
Slovenian: Kriteriji
English: Data in humans
Slovenian: Podatki pri ljudeh
English: <Invented Name> also contains propylene glycol, which may cause skin irritation.
Slovenian: {Lastniško ime} vsebuje tudi propilenglikol, ki lahko povzroča draženje kože.
English: The use of <Invented Name> under occlusion has not been studied in patients.
Slovenian: Pri bolnikih uporaba {Lastniško ime} pod okluzivnim zavojem ni bila raziskana.
English: <Invented Name> should not be applied to potentially malignant or pre-malignant skin lesions.
Slovenian: {Lastniško ime }se ne sme nanašati na potencialno maligne ali predmaligne spremembe na koži.
English: <Invented Name> has no photocarcinogenic potential in animals (see section 5.3.
Slovenian: Pri živalih {Lastniško ime} nima fotokancerogenega delovanja (glejte poglavje 5.3 “Predklinični podatki o varnosti”).
English: However, a link to the treatment with Elidel Cream has not been confirmed or refuted on the available evidence so far.
Slovenian: Vendar na podlagi do zdaj zbranih dokazov povezanost z zdravljenjem z <Lastniško ime> ni bila niti potrjena niti ovržena.
English: The other ingredients of <Invented Name> Cream are: medium chain triglycerides, oleyl alcohol, propylene glycol, stearyl alcohol, cetyl alcohol, mono-and di-glycerides, sodium cetostearyl sulphate, benzyl alcohol, citric acid anhydrous, sodium hydroxide, purified water.
Slovenian: Pomožne snovi v kremi <Lastniško ime> so: srednjeverižni trigliceridi, oleilalkohol, propilenglikol, stearilalkohol, cetilalkohol, monogliceridi in digliceridi, natrijev cetilsulfat in stearilsulfat, benzilalkohol, brezvodna citronska kislina, natrijev hidroksid, prečiščena voda.
English: You can use moisturisers (emollients) with <Invented Name> .
Slovenian: Skupaj z <Lastniško ime> lahko uporabljate sredstva za vlaženje kože (emoliente).
English: Stop the treatment and consult your doctor if no improvement occurs after 6 weeks or if your eczema gets worse.
Slovenian: Če v 6 tednih ne pride do izboljšanja ali če se ekcem poslabša, prekinite zdravljenje in se posvetujte s svojim zdravnikom.
English: Do not bath, shower or swim right after applying <Invented Name> .
Slovenian: Takoj po mazanju z <Lastniško ime> se ne prhajte ali kopajte in ne plavajte.
English: Post marketing: Cases of malignancy, including cutaneous and other types of lymphoma, and skin cancers, have been reported in patients using pimecrolimus cream (See Section 4.4) .
Slovenian: Postmarketinške izkušnje: Pri bolnikih, ki so uporabljali kremo s pimekrolimusom, so poročali o primerih maligne bolezni, vključno s kožnim in drugimi oblikami limfoma, ter kožnega raka (glejte poglavje 4.4).
English: Common side-effects, reported in between 1 in 10 and 1 in 100 people include: Irritation, itching and reddening of the skin at the application site.
Slovenian: Pogosti neželeni učinki, o katerih poročajo od pri 1 od 10 ljudi do pri 1 od 100 ljudi, vključujejo: draženje, srbenje, pordečitev kože na mestu uporabe; okužbe kože (npr. folikulitis).
English: 6.6 Instructions for use and handling
Slovenian: OZNAČEVANJE IN NAVODILO ZA UPORABO
English: You should not use <Invented Name> if you are pregnant.
Slovenian: Če ste noseči, <Lastniško ime> ne smete uporabljati.
English: Therefore if you develop painful sores anywhere on your body, tell your doctor immediately.
Slovenian: Zato takoj opozorite zdravnika, če opazite boleče rane na koži kjerkoli po telesu.
English: Elidel cream 1% 1% Cream 30 g
Slovenian: Elidel cream 1% 1% krema 30 g
English: <Invented Name> should be applied thinly to the affected areas twice daily.
Slovenian: {Lastniško ime} se tanko nanese na prizadete predele kože dvakrat dnevno.
English: 1% Cream 15 g
Slovenian: 1% krema 15 g
English: 10mg in 1g
Slovenian: 10mg v 1g krema
English: Cases of malignancies, including cutaneous and other types of lymphoma, and skin cancers have been reported in patients using pimecrolimus cream (see section 4.8).
Slovenian: Pri bolnikih, ki so uporabljali kremo s pimekrolimusom, so poročali o primerih maligne bolezni, vključno s kožnim in drugimi oblikami limfoma, ter kožnega raka (glejte poglavje 4.8).
English: Elidel cream 1% 1% Cream 15 g
Slovenian: Elidel cream 1% 1% krema 15 g
English: • The treatment should be intermittent and not continuous.
Slovenian: Zdravljenje mora potekati s presledki in ne neprekinjeno.
English: <{(Invented) name and associated names (see Annex I) strength pharmaceutical form}> <[See Annex I - To be completed nationally]> [For referral procedures]
Slovenian: <Lastniško ime> 1% krema <{(Lastniško) ime in povezana imena (glejte Dodatek I) jakost farmacevtska oblika}> <[Glejte Dodatek I - Izpolni država članica]>
English: <[To be completed nationally]> <[See Annex I - To be completed nationally]> [For referral procedures]
Slovenian: <[glejte Dodatek I - Izpolni država članica]>
English: 1% Cream 60 g
Slovenian: 1% krema 60 g
English: <Invented Name> should not be applied to areas affected by acute cutaneous viral infections (herpes simplex, chicken pox).
Slovenian: {Lastniško ime} ne smete nanašati na predele z akutnimi kožnimi virusnimi okužbami (herpes simpleks, norice).
English: <Invented Name> cream is available in tubes of 15 g, 30 g, 60 g and 100 g. The cream is used to treat signs and symptoms of mild or moderate eczema (e.g. redness and itch) in children (aged 2 years and above), teenagers and adults When used to treat early signs and symptoms it can prevent progression to severe flare-ups.
Slovenian: Krema se uporablja za zdravljenje znakov in simptomov blagega ali zmernega ekcema (kot sta rdečina in srbenje) pri otrocih (starih 2 leti ali več), mladostnikih in odraslih.
English: Elidel 1% Cream 1% w/w Cream
Slovenian: Elidel 1% Cream 1% w/w krema
English: Medium chain triglycerides, Oleyl alcohol, Propylene glycol, Stearyl alcohol, Cetyl alcohol, Monoand di-glycerides, Sodium cetostearyl sulphate, Benzyl alcohol, Citric acid anhydrous, Sodium hydroxide, Purified water
Slovenian: SEZNAM POMOŽNIH SNOVI srednjeverižni trigliceridi, oleilalkohol, propilenglikol, stearilalkohol, cetilalkohol, monogliceridi in digliceridi, natrijev cetilsulfat in stearilsulfat, benzilalkohol, brezvodna citronska kislina, natrijev hidroksid, prečiščena voda
English: Effects on reproductive organs and altered sex hormone functions were seen in male and female rats in repeated dose toxicity studies after oral administration of 10 or 40 mg/kg/day (= 20 to 60 times the maximum human exposure after dermal application).
Slovenian: Pri raziskavah toksičnosti ponavljajočih se odmerkov po peroralni uporabi 10 ali 40 mg/kg/dan (= 20 do 60 kratna največja izpostavljenost pri človeku po uporabi na koži) so bili ugotovljeni učinki na spolne organe in spremenjeno delovanje spolnih hormonov pri podganjih samcih in samicah.
English: B-1800 Vilvoorde Belgium
Slovenian: Novartis Pharma N.V.Medialaan 40 B-1800 Vilvoorde Belgija
English: 1% Cream 30 g
Slovenian: 1% krema 30 g
English: 10 mg/g
Slovenian: 10 mg/g krema
English: 1% Cream 100 g
Slovenian: 1% krema 100 g
English: <Invented Name> is not approved for children younger than 2 years of age.
Slovenian: Bodite posebno pozorni pri uporabi kreme <Lastniško ime> Krema <Lastniško ime> ni odobrena za uporabo pri otrocih, ki so mlajši od 2 let.
English: <This medicine has been authorised under “exceptional circumstances”.
Slovenian: <To zdravilo je v državah članicah Evropskega gospodarskega prostora (EEA) odobreno pod naslednjimi imeni:>
English: Read all of this leaflet carefully before you start using <Invented Name> cream - Keep this leaflet.
Slovenian: Pred začetkom uporabe kreme <Lastniško ime> natančno preberite navodilo.
English: Do not apply <Invented Name> to the breasts if breast-feeding.
Slovenian: Če dojite, <Lastniško ime> ne nanašajte na dojke.
English: Measuring off label use of patients with AD and less than the age of 2 The MAHs should measure the off-label use of pimecrolimus in patients of less than 2 years.
Slovenian: Imetniki dovoljenja za promet z zdravilom morajo preverjati uporabo pimekrolimusa, ki ni v skladu z odobrenimi indikacijami, pri bolnikih, ki so stari manj kot dve leti.
English: • Replace the cap on the tube.
Slovenian: • Odprite tubo.
English: Read the following information before you use <Invented Name> cream.
Slovenian: Preden uporabite <Lastniško ime>, preberite naslednje informacije.
English: MARKETING AUTHORISATION HOLDER [To be completed nationally]
Slovenian: NAČIN IZDAJANJA ZDRAVILA [Izpolni država članica]
English: STORING <INVENTED NAME> CREAM
Slovenian: SHRANJEVANJE KREME <LASTNIŠKO IME>
English: Elidel 1 % cream 1 % Cream
Slovenian: Elidel 1 % cream 1 % krema
English: PARTICULARS TO APPEAR ON <THE OUTER PACKAGING> <AND> <THE IMMEDIATE PACKAGING>
Slovenian: Izgled zdravila <Lastniško ime> in vsebina pakiranja
English: Elidel 1% Krém 1% Cream
Slovenian: Elidel 1% Krém 1% krema
English: 1 % Cream
Slovenian: 1% krema
English: 1% Cream
Slovenian: 1 % krema
English: Skin infections such as impetigo (a bacterial skin infection), herpes simplex (cold sores), herpes zoster (shingles), herpes simplex dermatitis (eczema herpeticum), molluscum contagiosum (a viral skin infection), warts and furuncles (boils).
Slovenian: Občasni neželeni učinki, o katerih poročajo od pri 1 od 100 ljudi do pri 1 od 1.000 ljudi, vključujejo: okužbe kože, kot so impetigo (bakterijska okužba kože), herpes simpleks (herpes), herpes zoster (pasovec), herpes simpleks dermatitis (herpetični ekcem), molluscum contagiosum (virusna okužba kože), bradavice in furunkli (turi); reakcije na mestu uporabe kot so izpuščaj, bolečina, občutek zbadanja, rahlo luščenje kože, suha koža, otekanje in slabšanje simptomov ekcema.
English: Elidel cream 1% 1% Cream
Slovenian: Elidel cream 1% 1% krema
English: If you are hypersensitive (allergic) to pimecrolimus or any of the other ingredients of <Invented Name> cream.
Slovenian: Ne uporabljajte kreme <Lastniško ime>: - če ste alergični na (preobčutljivi za) pimekrolimus ali katerokoli sestavino kreme <Lastniško ime>; - če je vaš imunski sistem oslabljen (ste imunokompromitirani).
English: 1% cream Cream
Slovenian: 1% krema krema
English: Case reports of malignancies (including cutaneous T-Cell lymphoma (CTCL) and skin cancer) have been received during the clinical development and post-marketing experience in association with the use of topical pimecrolimus.
Slovenian: Med kliničnim razvojem in v obdobju zbiranja postmarketinških izkušenj so v zvezi z lokalno uporabo pimekrolimusa zabeležili primere malignih obolenjih (vključno s kožnim T-celičnim limfomom (CTLC) in kožnim rakom).
English: Member State Marketing Authorisation Holder
Slovenian: ŠTEVILKA DOVOLJENJA ZA PROMET
English: Tell your doctor immediately if you have a severe reaction to <Invented Name> .
Slovenian: Če pride do hude reakcije na <Lastniško ime>, takoj opozorite zdravnika.
English: <Invented Name> was less effective than 0,1% triamcinolone acetonide cream (for trunk and extremities) plus 1% hydrocortisone acetate cream (for face, neck and intertriginous areas) in the long-term treatment (52 weeks) of adults with moderate to severe atopic dermatitis.
Slovenian: Pri dolgotrajnem zdravljenju (52 tednov) odraslih z zmernim do težkim atopijskim dermatitisom je bil {Lastniško ime} manj učinkovit od kreme z 0,1% triamcinolonacetonidom (za trup in ude) plus kreme z 1% hidrokortizonacetatom (za obraz, vrat in intertriginozne predele).
English: “Preclinical Safety Data”).
Slovenian: PODATKI NA ZUNANJI OVOJNINI {VRSTA/TIP}
English: Avoid excessive exposure to sunlight, sun lamps and tanning beds during treatment with <Invented Name> .
Slovenian: Med zdravljenjem z <Lastniško ime> se izogibajte prekomernemu izpostavljanju sončni svetlobi, ultravijoličnim svetilkam in sončenju v solariju.
English: Mono-and di-glycerides Sodium cetostearyl sulphate Benzyl alcohol Citric acid anhydrous Sodium hydroxide Purified water
Slovenian: monogliceridi in digliceridi, natrijev cetilsulfat in stearilsulfat, benzilalkohol, brezvodna citronska kislina, natrijev hidroksid, prečiščena voda
English: EXPIRY DATE [For terms on Batch number and Expiry date see Appendix IV]
Slovenian: DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA EXP: {MM/LLLL}
English: PSURs
Slovenian: Ciper
English: METHOD AND ROUTE(S) OF ADMINISTRATION Topical administration.
Slovenian: POSTOPEK IN POT(I) UPORABE ZDRAVILA za dermalno uporabo
English: Long term treatment should be intermittent and not continuous.
Slovenian: Pri dolgotrajnem zdravljenju uporabljajte kremo s presledki (intermitentno) in ne neprekinjeno.
English: Date of last revision: 2 November 2004 <Invented Name> Cream: PL 00101/0659
Slovenian: Datum zadnje revizije navodila: <Lastniško ime> krema:
English: BEFORE YOU USE <INVENTED NAME> CREAM
Slovenian: KAJ MORATE VEDETI, PREDEN BOSTE UPORABILI KREMO <LASTNIŠKO IME>
English: <Invented Name> should only be applied to areas affected with atopic dermatitis.
Slovenian: {Lastniško ime} se sme nanašati samo na z atopijskim dermatitisom prizadete predele kože.
English: The patient or caregiver should stop using <Invented Name> when signs and symptoms resolve.
Slovenian: Ko znaki in simptomi izzvenijo, naj bolnik ali negovalec preneha uporabljati {Lastniško ime}.
English: Only in case of a flare of severe disease not controlled by <Invented Name>, treatment with medium potency topical corticosteroids was initiated.
Slovenian: Zdravljenje s srednje močnimi kortikosteroidi je bilo uvedeno samo v primeru izbruha bolezni, ki ga {Lastniško ime} ni obvladal.
English: Rarely, cases of malignancy, including lymphomas and skin cancers, have been reported in patients using Elidel .
Slovenian: Še redkeje so pri bolnikih, ki so uporabljali <Lastniško ime> poročali o primerih malignih bolezni, ki vključujejo limfome in kožne rake.
English: The MAHs should continue the submission of 6-monthly PSURs.
Slovenian: Redna posodobljena poročila o varnosti (PSUR-ji) Imetniki dovoljenja za promet z zdravilom morajo nadaljevati s pošiljanjem 6-mesečnih rednih posodobljenih poročil o varnosti.
English: Caution should be exercised when <Invented Name> is administered to breastfeeding women.
Slovenian: Pri zdravljenju doječih mater z {Lastniško ime} je potrebna previdnost.
English: 2100 U
Slovenian: 2100 E
English: 1 vial + 1 vial + 2 vial adapters + 1 syringe + 1 infusion set + 2 alcohol swabs +1 sterile swab + 1 plaster
Slovenian: 1 viala + 1 viala + 2 adapterja za viale + 1 brizga + 1 komplet za infundiranje z iglo + 2 alkoholni blazinici + 1 sterilni netkani tampon + 1 samolepilni obliž
English: Powder: 2100 U Solvent: 20 ml
Slovenian: Prašek: 2100 E Vehikel: 20 ml
English: 2100 U Powder and solvent for solution for injection
Slovenian: 2100 E prašek in vehikel za pripravo raztopine za injiciranje
English: Solvent: vial (glass)
Slovenian: Prašek: viala (steklana) Vehikel: viala (steklana)
English: 2100 U Powder for solution for injection
Slovenian: 2100 E prašek za pripravo raztopine za injiciranje viala (steklana)
English: Pregnancy and breast-feeding - If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Slovenian: Nosečnost in dojenje - Če ste noseči, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom, preden vzamete to zdravilo.
English: Do not take Icandra - if you are allergic to vildagliptin, metformin or any of the other ingredients of this medicine (listed in section 6).
Slovenian: Ne jemljite zdravila Icandra - če ste alergični na vildagliptin, metformin ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: The amount of Icandra that people have to take varies depending on their condition.
Slovenian: Koliko zdravila Icandra morajo ljudje jemati, je odvisno od njihovega stanja.
English: If no adequate strength of Icandra is available, individual monocomponents should be used instead of the fixed dose combination.
Slovenian: Če ni na voljo ustrezna jakost zdravila Icandra, je treba namesto fiksne kombinacije uporabiti posamične monokomponente.
English: The following statements reflect the pharmacokinetic properties of the individual active substances of Icandra.
Slovenian: Naslednje trditve opisujejo farmakokinetične lastnosti posameznih učinkovin zdravila Icandra.
English: Food does not affect the extent and rate of absorption of vildagliptin from Icandra.
Slovenian: Hrana ne vpliva na obseg in hitrost absorpcije vildagliptina iz zdravila Icandra.
English: Do not stop taking Icandra unless your doctor tells you to.
Slovenian: Ne prenehajte jemati zdravila Icandra, če vam tega ne naroči zdravnik.
English: What Icandra is and what it is used for
Slovenian: Kaj je zdravilo Icandra in za kaj ga uporabljamo
English: Your doctor will tell you exactly the dose of Icandra to take.
Slovenian: Zdravnik vam bo natančno povedal, kolikšen odmerek zdravila Icandra morate jemati.
English: During treatment with Icandra, your doctor will check your kidney function at least once a year or more frequently if you are elderly and/or have worsening renal function.
Slovenian: Med zdravljenjem z zdravilom Icandra bo zdravnik vsaj enkrat letno preveril delovanje ledvic, če pa ste starejša oseba in/ali se vam delovanje ledvic slabša, pa še pogosteje.
English: The safety and efficacy of Icandra in children and adolescents (< 18 years) have not been established.
Slovenian: Varnost in učinkovitost zdravila Icandra pri otrocih in mladostnikih (< 18 let) nista bili dokazani.
English: You may need more frequent blood glucose and kidney function tests or your doctor may need to adjust the dosage of Icandra.
Slovenian: Morda boste morali pogosteje opravljati preiskave glukoze v krvi in delovanja ledvic, zdravnik pa bo morda moral prilagoditi odmerek zdravila Icandra.
English: Icandra may cause a very rare, but very serious side effect called lactic acidosis, particularly if your kidneys are not working properly.
Slovenian: Zdravilo Icandra lahko povzroči zelo redek, a zelo resen neželeni učinek, imenovan laktacidoza, zlasti če ledvice ne delujejo pravilno.
English: Taking Icandra with or just after food may reduce gastrointestinal symptoms associated with metformin (see also section 5.2).
Slovenian: Jemanje zdravila Icandra s hrano ali takoj po njej lahko ublaži gastrointestinalne simptome, ki so povezani z jemanjem metformina (glejte tudi poglavje 5.2).
English: Icandra with alcohol
Slovenian: Zdravilo Icandra skupaj z alkoholom
English: Your doctor will discuss with you the potential risk of taking Icandra during pregnancy.
Slovenian: Zdravnik vam bo pojasnil možna tveganja zaradi jemanja zdravila Icandra med nosečnostjo.
English: Animal studies of up to 13-week duration have been conducted with the combined substances in Icandra.
Slovenian: Na živalih so opravili 13 tednov trajajoče študije s kombinacijo učinkovin v zdravilu Icandra.
English: Stop taking Icandra for a short time if you have a condition that may be associated with dehydration (significant loss of body fluids) such as severe vomiting, diarrhoea, fever, exposure to heat or if you drink less fluid than normal.
Slovenian: Za kratek čas prenehajte jemati zdravilo Icandra, če imate stanje, ki je lahko povezano z dehidracijo (znatna izguba telesnih tekočin), kot je hudo bruhanje, driska, zvišana telesna temperatura, izpostavljenost vročini ali če pijete manj tekočine, kot običajno.
English: If pancreatitis is suspected, vildagliptin should be discontinued; if acute pancreatitis is confirmed, vildagliptin should not be restarted.
Slovenian: Če obstaja sum na pankreatitis, je potrebno prenehati z jemanjem vildagliptina, če pa je diagnoza akutnega pankreatitisa potrjena, bolnik ne sme ponovno začeti z jemanjem vildagliptina.
English: If you take too many Icandra tablets, or if someone else takes your tablets, talk to a doctor or pharmacist immediately.
Slovenian: Če ste vzeli večji odmerek zdravila Icandra, kot bi smeli Če ste vzeli preveč tablet zdravila Icandra ali če kdo drug vzame vaše tablete, se takoj obrnite na zdravnika ali farmacevta.
English: Avoid excessive alcohol intake while taking Icandra since this may increase the risk of lactic acidosis (please see section “Warnings and precautions”).
Slovenian: Med jemanjem zdravila Icandra ne uživajte čezmernih količin alkohola, saj lahko to poveča tveganje za laktacidozo (glejte poglavje “Opozorila in previdnostni ukrepi”).
English: Icandra is not a substitute for insulin in insulin-requiring patients and should not be used in patients with type 1 diabetes.
Slovenian: Zdravilo Icandra ne more nadomestiti zdravljenja z insulinom pri bolnikih, ki potrebujejo insulin, in se ga ne sme uporabljati pri bolnikih z diabetesom tipa 1.
English: There are no adequate data from the use of Icandra in pregnant women.
Slovenian: Ni zadostnih podatkov o uporabi zdravila Icandra pri nosečnicah.