FrancophonIA/ELRC3.0 huggingface dataset:
English: Administer subcutaneously one dose (1ml) of the veterinary medicinal product according to the following regimen of vaccination.
Slovenian: En odmerek zdravila (1ml) za uporabo v veterinarski medicini dajte subkutano po naslednjem programu cepljenja.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Slovenian: DATUM ZADNJE ODOBRITVE NAVODIL ZA UPORABO
English: Live attenuated feline panleucopenia virus (strain LR 72)
Slovenian: Živ oslabljeni virus mačje panlevkopenije (sev LR 72)
English: Reconstitute one dose of lyophilisate with one dose (1ml) of suspension, shake gently and administer immediately.
Slovenian: En odmerek liofilizata rekonstituirajte z enim odmerkom (1ml) suspenzije, rahlo pretresite in takoj aplicirajte.
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. PROIZVAJALEC BIOLOŠKE UČINKOVINE IN PROIZVAJALEC ZDRAVILA, ODGOVOREN ZA SPROŠČANJE SERIJ
English: THE WORDS “KEEP OUT OF THE SIGHT AND REACH OF CHILDREN”
Slovenian: BESEDILO “ZDRAVILO SHRANJUJTE NEDOSEGLJIVO OTROKOM ”
English: The feline calicivirus and feline panleucopenia virus vaccine strains can spread.
Slovenian: Vakcinalni sevi kalicivirusa mačk in virusa mačje panlevkopenije se lahko širijo.
English: - feline viral rhinotracheitis to reduce clinical signs and viral excretion, - feline panleucopenia to prevent leucopenia and to reduce clinical signs, - feline leukaemia to prevent persistent viraemia and clinical signs of the related disease.
Slovenian: - virusnemu rinotraheitisu mačk za zmanjšanje kliničnih znakov in izločanja virusa, - panlevkopeniji mačk za preprečevanje levkopenije in zmanjšanje kliničnih znakov, - levkemiji mačk, za preprečevanje trajne viremije in kliničnih znakov povezane bolezni.
English: Minimum quantity of purified p45 FeLV-envelope antigen
Slovenian: Minimalna količina prečiščenega antigena ovojnice p45 FeLV 102 µg
English: 4.4 Special warnings for each target species
Slovenian: Posebna opozorila za vsako ciljno vrsto :
English: Active substance:
Slovenian: Pomožna snov:
English: Following a first booster vaccination one year after the primary vaccination course, a duration of immunity of 3 years has been demonstrated for the leukaemia component.
Slovenian: Po prvem poživilnem cepljenju leto po prvem krogu cepljenja je bilo za komponento levkemije dokazano trajanje tri leta.
English: Not all pack sizes may be marketed
Slovenian: Ni nujno, da so v prometu vsa navedena pakiranja
English: Name and address of the manufacturer responsible for batch release
Slovenian: Ime in naslov proizvajalca zdravila, odgovornega za sproščanje serij
English: Lyophilisate:
Slovenian: Liofilizat:
English: Live attenuated feline viral rhinotracheitis virus (strain F2)
Slovenian: Živ oslabljeni virus mačjega virusnega rinotraheitisa (sev F2)
English: EU/2/09/097/001-002
Slovenian: ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/09/097/001-002
English: Sodium chloride Disodium phosphate anhydrous Potassium dihydrogen phosphate Aluminium hydroxide gel Quillaja saponaria Water for injections
Slovenian: Natrijev hidrogenfosfat, brezvodni Kalijev dihidrogenfosfat Aluminijev hidroksid (gel) Quillaja saponaria Voda za injekcije
English: Visual aspect:
Slovenian: Videz:
English: Vaccine against feline viral rhinotracheitis, feline calicivirosis, feline panleucopenia and feline leukaemia.
Slovenian: Cepivo proti virusnemu rinotraheitisu mačk, kalicivirozi mačk, panlevkopeniji mačk in mačji levkemiji.
English: LYOPHILISATE VIAL
Slovenian: VIALA LIOFILIZATA
English: Suspension for LEUCOFELIGEN FeLV/RCP, for cats
Slovenian: Suspenzija za LEUCOFELIGEN FeLV/RCP za mačke
English: Only feline leukaemia virus (FeLV) negative cats should be vaccinated.
Slovenian: Cepijo se lahko samo mačke, ki nimajo virusa mačje levkemije (so FeLV negativne).
English: In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
Slovenian: Posebni previdnostni ukrepi, ki jih mora izvajati oseba, ki živalim daje zdravilo V primeru nenamernega samo-injiciranja se takoj posvetujte z zdravnikom in mu pokažite navodilo za uporabo ali ovojnino.
English: Do not use this veterinary medicinal product after the expiry date which is stated on the label after EXP.
Slovenian: Zdravila ne smete uporabljajte po datumu izteka roka uporabnosti navedenega na nalepki po EXP. Rok uporabnosti po rekonstrukciji v skladu z navodili: uporabite takoj.
English: LEUCOFELIGEN FeLV/RCP, lyophilisate for cats
Slovenian: LEUCOFELIGEN FeLV/RCP liofilizat za mačke
English: Live attenuated feline calicivirus (strain F9)
Slovenian: Živ oslabljeni mačji kalicivirus (sev F9)
English: - feline calicivirosis to reduce clinical signs, - feline viral rhinotracheitis to reduce clinical signs and viral excretion, - feline panleucopenia to prevent leucopenia and to reduce clinical signs,
Slovenian: - kalicivirozi mačk za zmanjšanje kliničnih znakov - virusnemu rinotraheitisu mačk za zmanjšanje kliničnih znakov in izločanja virusa - panlevkopeniji mačk za preprečevanje levkopenije in zmanjšanje kliničnih znakov - levkemiji mačk za preprečevanje trajne viremije in kliničnih znakov povezane bolezni.
English: Read the package leaflet before use Subcutaneous use
Slovenian: Pred uporabo preberite navodilo.
English: Following a first booster vaccination one year after the primary vaccination course, subsequent vaccinations can be performed at intervals of three years for the leukaemia component.
Slovenian: Za komponento levkemije se lahko po prvem poživilnem cepljenju leto po prvem krogu cepljenja izvede nadaljnja cepljenja v intervalih po tri leta.
English: LEUCOFELIGEN FeLV/RCP lyophilisate and suspension for suspension for injection for cats
Slovenian: LEUCOFELIGEN FeLV/RCP liofilizat in suspenzija za suspenzijo za injiciranje za mačke
English: Type I glass vial containing one dose (1 ml) of the adjuvanted liquid, with a 13 mm-diameter butyl elastomer stopper and set with an aluminium capsule.
Slovenian: Viala iz stekla tipa I, ki vsebuje en odmerek (1ml) tekočine z dodatki, z zamaškom iz butil elastomera, premera 13 mm, ter komplet z aluminijasto kapsulo.
English: A type I glass vial containing one dose (1 ml) of the adjuvanted liquid vaccine, with a 13 mm-diameter butyl elastomer stopper and set with an aluminium capsule.
Slovenian: Viala iz stekla tipa I, ki vsebuje en odmerek (1ml) tekočine cepiva z dodatki, z zamaškom iz butil elastomera, premera 13 mm in zaprta z aluminijasto zaporko.
English: Potassium hydroxide Lactose monohydrate Glutamic acid
Slovenian: Kalijev hidroksid Laktoza monohidrat Glutaminska kislina Kalijev dihidrogenfosfat Kalijev hidrogenfosfat Voda za injekcije Natrijev klorid
English: A type I glass vial containing one dose of freeze-dried attenuated live viral components with a butyl elastomer stopper.
Slovenian: Viala iz stekla tipa I, ki vsebuje en odmerek liofiliziranih oslabljenih živih virusnih komponent, z zamaškom iz butil elastomera.
English: Marketing authorisation holder and manufacturer responsible for the batch release:
Slovenian: Imetnik dovoljenja za promet z zdravilom in proizvajalec odgovoren za sproščanje serij: VIRBAC
English: Administer subcutaneously one dose (1 ml) of the veterinary medicinal product according to the following regimen of vaccination.
Slovenian: En odmerek zdravila za uporabo v veterinarski medicini dajte subkutano po naslednjem programu cepljenja.
English: PACKAGE LEAFLET: LEUCOFELIGEN FeLV/RCP lyophilisate and suspension for suspension for injection for cats
Slovenian: NAVODILO ZA UPORABO LEUCOFELIGEN FeLV/RCP liofilizat in suspenzija za suspenzijo za injiciranje za mačke
English: Excipient: Buffered isotonic solution to
Slovenian: Pomožna snov: Puferirana izotonična raztopina do
English: Lot {number}
Slovenian: Serija {številka}
English: ère avenue 2065 m LID 06516 Carros France
Slovenian: ère avenue 2065 m LID 06516 Carros Francija
English: Special precautions to be taken by the person administering the veterinary medicinal product to animals:
Slovenian: Posebni previdnostni ukrepi, ki jih mora izvajati oseba, ki živalim daje veterinarsko zdravilo: V primeru nenamernega samo-injiciranja se takoj posvetujte z zdravnikom in mu pokažite navodila za uporabo ali ovojnino.
English: DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
Slovenian: DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA
English: Disodium phosphate anhydrous
Slovenian: Natrijev hidrogenfosfat, brezvodni
English: This check should be repeated at intervals.
Slovenian: To preverjanje je treba ponavljati v presledkih.
English: Two-year clinical studies have shown maintenance of this effect.
Slovenian: Dvoletne klinične študije so pokazale vzdrževanje tega učinka.
English: if you drink alcohol excessively (either every day or only from time to time).
Slovenian: - če prekomerno uživate alkohol (bodisi dnevno ali občasno).
English: Absolute bioavailability is greater than 80%.
Slovenian: Absolutna biološka uporabnost je večja od 80%.
English: if you have blood in your urine that your doctor has not checked.
Slovenian: - če imate kri v urinu, ki ga zdravnik ni preiskal.
English: County Wicklow Ireland
Slovenian: County Wicklow Irska
English: The level of sugar in your blood or urine should be checked regularly.
Slovenian: Raven sladkorja v krvi ali urinu je treba redno preverjati.
English: The recommended dose is one tablet taken twice daily.
Slovenian: Priporočeni odmerek je ena tableta dvakrat na dan.
English: 28065 Cerano (NO) Italy
Slovenian: 28065 Cerano (NO) Italija
English: Date of first authorisation: 11 December 2007 Date of latest renewal: 10 November 2017
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM Datum prve odobritve: 11 december 2007 Datum zadnjega podaljšanja: 10 November 2017
English: The data presented during the current reporting period did not provide new information that would allow for further reduction, mitigation, or characterisation of these risks.
Slovenian: Podatki, predloženi v tekočem obdobju poročanja, niso zagotovili novih informacij, ki bi omogočale dodatno zmanjšanje, omilitev ali opredelitev teh tveganj.
English: Your doctor will take this into account when treating your diabetes.
Slovenian: Zdravnik bo to upošteval pri zdravljenju vaše sladkorne bolezni.
English: The potential risk for humans is unknown.
Slovenian: Možno tveganje za človeka ni znano.
English: If this applies to you, use appropriate contraception to avoid the possibility of an unplanned pregnancy.
Slovenian: Če se to nanaša na vas, vzemite primerno kontracepcijo, da preprečite možnost nenačrtovane nosečnosti.
English: However, this did not lead to an increase in mortality in this study.
Slovenian: Vendar to ni vodilo k povečanju smrtnosti v tej študiji.
English: if you have or have ever had bladder cancer.
Slovenian: - če imate ali ste kdaj imeli raka sečnega mehurja.
English: You should not use this medicine if you are pregnant.
Slovenian: Ne jemljite tega zdravila, če ste noseči.
English: Metformin may act via three mechanisms:
Slovenian: Metformin lahko deluje na tri načine:
English: The study population had an average age of 62 years; the average duration of diabetes was 9.5 years.
Slovenian: Starost študijske populacije je bila v povprečju 62 let; povprečno trajanje sladkorne bolezni je bilo 9,5 let.
English: Approximately half of the study population had at least two of the cardiovascular history entry criteria.
Slovenian: Približno polovica študijske populacije je ustrezala vsaj dvema vstopnima kriterijema kardiovaskularne anamneze.
English: Although in very rare cases fatal outcome has been reported, causal relationship has not been established.
Slovenian: Čeprav so v zelo redkih primerih poročali o smrtnem izidu, vzročna povezava ni bila ugotovljena.
English: A risk to the newborns/infants cannot be excluded.
Slovenian: Tveganja za dojenega novorojenčka/dojenčka ne moremo izključiti.
English: Pregnancy and breast-feeding - you must tell your doctor if you are pregnant, think you may be pregnant or are planning to have a baby.
Slovenian: Nosečnost in dojenje - Svojemu zdravniku morate povedati, če ste noseči, menite, da bi lahko bili noseči ali načrtujete zanositev.
English: The estimated volume of distribution in humans is 0.25 L/kg.
Slovenian: Porazdelitev Ocenjeni volumen porazdelitve pri človeku je 0,25 l/kg.
English: not known not known
Slovenian: neznana neznana
English: if you have a severe infection or are dehydrated.
Slovenian: - če imate hujšo okužbo ali ste dehidrirani.
English: Some epidemiological studies have suggested a similarly increased risk of fracture in both men and women.
Slovenian: Nekatere epidemiološke študije so pokazale podobno povečano tveganje za zlome tako pri moških kot ženskah.
English: Steady state is achieved after 4-7 days of dosing.
Slovenian: Stanje dinamičnega ravnovesja je doseženo po 4-7 dnevih odmerjanja.
English: As a consequence, the conditions or restrictions with regards to the safe and effective use of the medicinal product should be updated to remove the additional risk minimisation measures.
Slovenian: Zaradi tega je treba pogoje ali omejitve v zvezi z varno in učinkovito uporabo zdravila posodobiti tako, da se odpravijo dodatni ukrepi za zmanjševanje tveganj.
English: However patients who experience visual disturbance should be cautious when driving or using machines.
Slovenian: Vendar pa morajo biti bolniki, ki so imeli motnje vida, previdni pri vožnji ali upravljanju strojev.
English: Three of the six identified metabolites are active (M-II, M-III, and M-IV).
Slovenian: Trije od šestih znanih presnovkov so aktivni (M-II, M-III in M-IV).
English: The presence of microcrystals exacerbated the hyperplastic response but was not considered to be the primary cause of hyperplastic changes.
Slovenian: Prisotnost mikrokristalov je poslabšala hiperplastični odgovor, vendar se ne šteje za glavni vzrok nastalih hiperplastičnih sprememb.
English: The relevance of this finding is unknown.
Slovenian: Pomen te ugotovitve ni znan.
English: if you retain water (fluid retention) or have heart failure problems in particular if you are over 75 years old.
Slovenian: - če zadržujete vodo (zastajanje tekočine v telesu) ali imate težave s srčnim popuščanjem, zlasti če ste starejši od 75 let.
English: In particular, patients have experienced the following serious side effects:
Slovenian: Pri bolnikih so se pojavili zlasti naslednji resni neželeni učinki:
English: Tablets should be swallowed with a glass of water.
Slovenian: Tablete je treba pogoltniti s kozarcem vode.
English: On this basis M-IV contribution to efficacy is approximately three-fold that of pioglitazone, whilst the relative efficacy of M-II is minimal.
Slovenian: Na tej podlagi je delež učinkovitosti M-IV enak približno trikratniku deleža pioglitazona, medtem ko je relativna učinkovitost M-II minimalna.
English: Approximately one third of patients were receiving insulin in combination with metformin and/or a sulphonylurea.
Slovenian: Približno ena tretjina bolnikov je prejemala insulin v kombinaciji z metforminom in/ali sulfonilsečnino.
English: Women of childbearing potential / Contraception in males and females
Slovenian: Ženske v rodni dobi / Kontracepcija pri moških in ženskah
English: The maximum reported dose of 120 mg/day for four days, then 180 mg/day for seven days was not associated with any symptoms.
Slovenian: Najvišji poročani odmerek 120 mg/dan štiri dni, zatem pa 180 mg/dan sedem dni, ni bil povezan s kakršnimikoli simptomi.
English: Your blood sugar could fall below the normal level and can be increased by taking sugar.
Slovenian: Krvni sladkor lahko pade pod normalno raven in se lahko poveča z zaužitjem sladkorja.
English: Children and adolescents Use in children and adolescents under 18 years is not recommended.
Slovenian: Otroci in mladostniki Uporaba tega zdravila pri otrocih in mladostnikih, mlajših od 18 let, ni priporočljiva.
English: Takeda Ireland Limited, Bray Business Park, Kilruddery, County Wicklow, Ireland Delpharm Novara S.r.l., Via Crosa, 86, I-28065 Cerano (NO), Italy Lilly S.A., Avda.
Slovenian: Takeda Ireland Limited, Bray Business Park, Kilruddery, County Wicklow, Irska Delpharm Novara S.r.l., Via Crosa, 86, I-28065 Cerano (NO), Italija Lilly S.A., Avda.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Slovenian: Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu
English: 4 Gastrointestinal disorders occur most frequently during initiation of therapy and resolve spontaneously in most cases.
Slovenian: 4 Gastrointestinalne motnje se najpogosteje pojavijo ob začetku zdravljenja in v večini primerov spontano prenehajo.
English: Immune System Disorders hypersensitivity and allergic reactions1
Slovenian: Bolezni imunskega sistema preobčutljivost in alergijske reakcije1
English: The relevance to humans of the tumourigenic findings in the male rat cannot be excluded.
Slovenian: Pomena za ljudi glede tumorogenih ugotovitev pri samcih podgan ni mogoče izključiti.
English: At least once a year (more often if you are elderly or have kidney problems) your doctor will check that your kidneys are working normally.
Slovenian: Vsaj enkrat letno (pogosteje, če ste starejši ali imate težave z ledvicami) bo zdravnik preveril, če ledvice pravilno delujejo.
English: Absorption is not influenced by food intake.
Slovenian: Vnos hrane ne vpliva na absorpcijo.
English: In patients who fail to show an adequate response, pioglitazone should be discontinued.
Slovenian: Pri bolnikih, ki ne pokažejo ustreznega odziva, je treba pioglitazon ukiniti.
English: It is recommended that you carry some sugar lumps, sweets, biscuits or sugary fruit juice.
Slovenian: Priporočljivo je, da imate pri sebi nekaj kock sladkorja, bombone, piškote ali sladek sadni sok.
English: If you wish to become pregnant, your doctor will advise you to discontinue this medicine.
Slovenian: Če želite zanositi, vam bo zdravnik svetoval, da prenehate z jemanjem tega zdravila.
English: In animals, only a small amount of unchanged pioglitazone can be detected in either urine or faeces.
Slovenian: Pri živalih se lahko zazna samo majhno količino nespremenjenega pioglitazona v urinu ali blatu.
English: Many of these patients reported concurrent peripheral oedema.
Slovenian: Pri mnogih od teh bolnikov so poročali o sočasnem perifernem edemu.
English: de la Industria 30, 28108 Alcobendas, Madrid, Spain
Slovenian: de la Industria 30, 28108 Alcobendas, Madrid, Španija
English: Packs of 14, 28, 30, 50, 56, 60, 90, 98 and 180 tablets.
Slovenian: Pakiranja po 14, 28, 30, 50, 56, 60, 90, 98 in 180 tablet.
English: Patients and/or care-givers should be informed on the risk of lactic acidosis.
Slovenian: Bolnike in/ali negovalce je treba opozoriti na tveganje laktacidoze.
English: Pioglitazone and all active metabolites are extensively bound to plasma protein (> 99%).
Slovenian: Pioglitazon in vsi aktivni presnovki se v veliki meri vežejo na plazemske beljakovine (> 99%).
English: After initiation of therapy with pioglitazone, patients should be reviewed after 3 to 6 months to assess adequacy of response to treatment (e.g. reduction in HbA1c).
Slovenian: Po začetku zdravljenja s pioglitazonom je treba bolnike pregledati po 3 do 6 mesecih, da se oceni ustreznost odziva na zdravljenje (npr. zmanjšanje HbA1c).
English: Almost half of the patients had a previous myocardial infarction and approximately 20% had had a stroke.
Slovenian: Skoraj polovica bolnikov je predhodno doživela miokardni infarkt in približno 20% je doživelo kap.
English: The reports of oedema were generally mild to moderate and usually did not require discontinuation of treatment.
Slovenian: Edemi, o katerih so poročali, so bili v splošnem blagi do zmerni in običajno niso zahtevali prekinitve zdravljenja.
English: Do not take Glubrava: if you are allergic to pioglitazone, metformin or any of the other ingredients of this medicine (listed in section 6).
Slovenian: Ne jemljite zdravila Glubrava: - če ste alergični na pioglitazon, metformin ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: Do not use this medicine after the expiry date which is stated on the carton and the blister after “EXP”.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in pretisnem omotu poleg oznake “EXP”.
English: Linearity/non-linearity
Slovenian: Linearnost/Nelinearnost
English: In addition, increased fatty deposition and infiltration were observed.
Slovenian: Poleg tega so opažali povečano odlaganje in infiltracijo maščob.
English: Pioglitazone or placebo was added to existing antidiabetic and cardiovascular therapy for up to 3.5 years.
Slovenian: Pioglitazon ali placebo so dodajali k že obstoječemu antidiabetičnemu in kardiovaskularnemu zdravljenju v trajanju do 3,5 let.
English: This study showed an increase in reports of heart failure; however this did not lead to an increase in mortality in this study.
Slovenian: Ta študija je pokazala povečanje poročil srčnega popuščanja, vendar to ni vodilo k dvigu smrtnosti v tej študiji.
English: What Glubrava is and what it is used for
Slovenian: Kaj je zdravilo Glubrava in za kaj ga uporabljamo
English: The maximum daily dose of metformin should preferably be divided into 2-3 daily doses.
Slovenian: Najbolje je, da se največji dnevni odmerek metformina razdeli v 2 do 3 dnevne odmerke.
English: Tmax was delayed by food by approximately 1.9 h for pioglitazone and 0.8 h for metformin.
Slovenian: Tmax je bil zakasnjen za približno 1,9 ure pri pioglitazonu in za 0,8 ure pri metforminu.
English: if you have a special type of diabetic eye disease called macular oedema (swelling of the back of the eye), talk to your doctor if you notice any change to your vision.
Slovenian: - če imate posebno obliko diabetične očesne bolezni, imenovano makularni edem (otekanje zadnjega dela očesa), se pogovorite s svojim zdravnikom, če opazite spremembe vida.
English: GFR mL/min
Slovenian: GFR ml/min Metformin
English: In clinical studies, patients have taken pioglitazone at higher than the recommended highest dose of 45 mg daily.
Slovenian: V kliničnih študijah so bolniki jemali odmerek pioglitazona, ki je višji od najvišjega priporočenega odmerka 45 mg dnevno.
English: The safety profile seen in this study reflected the known adverse reactions seen with the individual products and did not suggest any new safety issues.
Slovenian: Varnostni profil v tej študiji je pokazal že znane neželene učinke na posamična zdravila in ni razkril novih težav z varnostjo.
English: The mean plasma elimination half-life of unchanged pioglitazone in man is 5 to 6 hours and for its total active metabolites 16 to 23 hours.
Slovenian: Povprečni razpolovni čas plazemskega izločanja nespremenjenega pioglitazona pri človeku je 5 do 6 ur in za njegove skupne aktivne presnovke 16 do 23 ur.
English: Based on the data presented, the risk minimisation measures in the approved product information are considered adequate for the listed safety concerns.
Slovenian: Na podlagi predloženih podatkov se ukrepi za zmanjševanje tveganj v odobrenih informacijah o zdravilu štejejo za ustrezne za navedene varnostne zadržke.
English: if you have a problem with your liver.
Slovenian: - če imate težave z jetri.
English: if you have heart failure or have had heart failure in the past.
Slovenian: - če imate srčno popuščanje ali ste imeli srčno popuščanje v preteklosti.
English: The safety and efficacy of Glubrava in children and adolescents under 18 years of age have not been established.
Slovenian: Varnost in učinkovitost zdravila Glubrava pri otrocih in mladostnikih, mlajših od 18 let, še nista bili dokazani.
English: However, in the case of metformin, in the fed state the mean AUC and Cmax were lower (13% and 28% respectively).
Slovenian: Vendar sta bila po obroku v primeru metformina povprečna AUC in Cmax nižja (13% in 28% v tem zaporedju).
English: If 3 to 6 months after starting Glubrava your sugar control is not improved, the medicine should be discontinued.
Slovenian: Če se po 3 do 6 mesecih po začetku jemanja zdravila Glubrava nadzor sladkorja ne izboljša, morate prenehati uporabljati zdravilo.