FrancophonIA/ELRC3.0 huggingface dataset:
English: Stop using Emgality and tell your doctor or seek medical help immediately if you notice any signs of a serious allergic reaction.
Slovenian: Če opazite znake resne alergijske reakcije, nemudoma prenehajte uporabljati zdravilo Emgality in se posvetujte z zdravnikom ali poiščite zdravniško pomoč.
English: Emgality may be stored unrefrigerated for single period up to 7 days when stored at temperatures up to 30 °C.
Slovenian: Zdravilo Emgality lahko hranite zunaj hladilnika za enkratno obdobje največ 7 dni pri temperaturah do 30 °C.
English: N
Slovenian: V
English: Package leaflet: Information for the patient Emgality 120 mg solution for injection in pre-filled syringe galcanezumab This medicine is subject to additional monitoring.
Slovenian: Navodilo za uporabo Emgality 120 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku galkanezumab Za to zdravilo se izvaja dodatno spremljanje varnosti.
English: Injection Button
Slovenian: Zavrzite injekcijsko brizgo
English: Very common side effects (may affect more than 1 in 10 people): - Injection site pain - Injection site reactions (e.g. red skin, itching, bruising, swelling)
Slovenian: - bolečina na mestu injiciranja - reakcije na mestu injiciranja (npr. pordela koža, srbenje, modrice, oteklina)
English: In patients who failed one or more prophylactic treatments for efficacy reasons, the treatment difference for the reduction of mean monthly MHDs observed between galcanezumab 120 mg and placebo was -3.54 days (p < 0.001) and between galcanezumab 240 mg and placebo -1.37 days (p < 0.05).
Slovenian: Razlika med zdravljenjema pri bolnikih, ki so se neuspešno zdravili z enim ali več profilaktičnimi zdravili zaradi neučinkovitosti, glede zmanjšanja povprečnega mesečnega števila MHD med 120 mg galkanezumaba in placebom -3,54 dneva (p < 0,001) ter med 240 mg galkanezumaba in placebom1,37 dneva (p < 0,05).
English: L-histidine hydrochloride monohydrate Polysorbate 80
Slovenian: L-histidinijev klorid monohidrat polisorbat 80 natrijev klorid voda za injekcije
English: Compared with placebo-treated patients, patients treated with galcanezumab 120 mg or 240 mg had significantly greater mean decreases from baseline in the number of monthly MHDs at at the first month and at all subsequent months up to month 3 (see Figure 2).
Slovenian: V primerjavi z bolniki, zdravljenimi s placebom, so imeli bolniki, zdravljeni s 120 mg ali 240 mg galkanezumaba, po prvem mesecu in vseh naslednjih mesecih do tretjega meseca, značilno večje povprečno zmanjšanje števila MHD na mesec od izhodišča (glejte sliko 2).
English: Emgality
Slovenian: Urtikarija
English: Renal impairment/hepatic impairment
Slovenian: Okvara ledvic/okvara jeter
English: You will know your injection is complete when you can see the grey plunger.
Slovenian: ko boste lahko videli sivi bat.
English: A. It is normal to have air bubbles in the pen.
Slovenian: O. Zračni mehurčki v injekcijskem peresniku so normalen pojav.
English: Top
Slovenian: Vrh
English: The medicine inside should be clear.
Slovenian: Zdravilo v injekcijski brizgi mora biti bistro.
English: The pre-filled syringe is for total use only.
Slovenian: Napolnjeno injekcijsko brizgo je treba uporabiti v celoti.
English: Q. What if I unlocked the pen and pressed the teal injection button before I twisted off the base cap?
Slovenian: V. Kaj če odklenem injekcijski peresnik in pritisnem modro zeleni gumb za injiciranje,
English: For subcutaneous use
Slovenian: Način uporabe subkutana uporaba
English: • You should see the teal plunger rod show through the syringe body when the injection is complete as shown.
Slovenian: • morate skozi telo injekcijske brizge videti modro zeleni potisni bat; • morate sivi bat brizge potisniti do konca brizge.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION
Slovenian: NAČIN IN POT(I) UPORABE ZDRAVILA
English: • Do not continue to use the syringe
Slovenian: • Injekcijske brizge ne uporabljajte naprej.
English: Expiration Date
Slovenian: DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA
English: Parts of the Emgality Syringe
Slovenian: Deli injekcijskega peresnika Emgality
English: Grey Syringe Plunger
Slovenian: Modro zeleni gumb za injiciranje
English: Read the “Instructions for Use” for the syringe carefully before using Emgality.
Slovenian: Pred uporabo zdravila Emgality natančno preberite „Navodila za uporabo“ injekcijske brizge.
English: 2 Insert
Slovenian: PRILOGA I
English: No pharmacokinetic drug interactions are expected based on the characteristics of galcanezumab.
Slovenian: Na podlagi lastnosti galkanezumaba ni pričakovati farmakokinetičnih interakcij z drugimi zdravili.
English: Do not share or reuse your pen.
Slovenian: Svoje injekcijske brizge ne delite z drugimi in je ne uporabite ponovno.
English: Serious allergic reaction may occur rarely (may affect up to 1 in 1,000 people) and the signs may include: - difficulty breathing or swallowing, - low blood pressure, which can cause dizziness or light-headedness, - swelling of the neck, face, mouth, lips, tongue or throat which may develop rapidly, - severe itching of the skin, with a red rash or raised bumps.
Slovenian: - otekanje vratu, obraza, ust, ustnic, jezika ali grla, kar se lahko razvije hitro,
English: Needle
Slovenian: MHD
English: MSQ Role Function Restrictive Domain Responders
Slovenian: Merila izidov po navedbah bolnikovb Področje omejevanja funkcioniranja v sklopu MSQ
English: EU/1/18/1330/003 (1 pre-filled syringe) EU/1/18/1330/004 (3 pre-filled syringes) EU/1/18/1330/006 (2 pre-filled syringes)
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/18/1330/003 (1 napolnjena injekcijska brizga) EU/1/18/1330/004 (3 napolnjene injekcijske brizge) EU/1/18/1330/006 (2 napolnjeni injekcijski brizgi)
English: It is normal to have air bubbles in the syringe.
Slovenian: Zračni mehurčki v injekcijski brizgi so normalen pojav.
English: Emgality 120 mg injection galcanezumab Subcutaneous use
Slovenian: Emgality 120 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku galkanezumab subkutana uporaba
English: EVOLVE-1 - Episodic Migraine
Slovenian: Učinkovitost in merila izidov po navedbah bolnikov EVOLVE 1 - epizodna migrena EVOLVE 2 - epizodna migrena Emgality placebo
English: EU/1/18/1330/001 (1 pre-filled pen) EU/1/18/1330/002 (3 pre-filled pens) EU/1/18/1330/005 (2 pre-filled pens)
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/18/1330/001 (1 napolnjeni injekcijski peresnik) EU/1/18/1330/002 (3 napolnjeni injekcijski peresniki) EU/1/18/1330/005 (2 napolnjena injekcijska peresnika)
English: When you dispose of the syringe and the sharps disposal container:
Slovenian: Odlaganje injekcijskega peresnika in vsebnika za odstranjevanje ostrih odpadkov: • Polnega vsebnika za ostre odpadke ne reciklirajte.
English: • Remove the pen from your skin.
Slovenian: • Umaknite injekcijski peresnik s kože.
English: • Ask your doctor, pharmacist or nurse about how to dispose of medicines you no longer use.
Slovenian: • O načinu odlaganja zdravila, ki ga ne uporabljate več, se posvetujte z zdravnikom,
English: Emgality 120 mg solution for injection in pre-filled syringe galcanezumab
Slovenian: Emgality 120 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku galkanezumab
English: Constipation
Slovenian: Odmerjanje
English: Each pre-filled syringe contains 120 mg of galcanezumab
Slovenian: Ena napolnjena injekcijska brizga vsebuje 120 mg galkanezumaba.
English: Thumb Pad
Slovenian: Pokrovček podnožja
English: Solution for injection.
Slovenian: Za injiciranje uporabite nov injekcijski peresnik.
English: Each pre-filled syringe contains 120 mg of galcanezumab in 1 mL.
Slovenian: En napolnjen injekcijski peresnik vsebuje 120 mg galkanezumaba v 1 ml raztopine.
English: Each pre-filled syringe contains 120 mg of galcanezumab in 1 mL solution.
Slovenian: Ena napolnjena injekcijska brizga vsebuje 120 mg galkanezumaba v 1 ml raztopine.
English: How to store Emgality
Slovenian: Shranjevanje zdravila Emgality
English: Emgality 120 mg solution for injection in pre-filled syringe
Slovenian: IME ZDRAVILA Emgality 120 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku
English: The solution is clear and colourless to slightly yellow.
Slovenian: FARMACEVTSKA OBLIKA raztopina za injiciranje (injekcija) Raztopina je bistra in brezbarvna do rahlo rumena.
English: The syringe is encased in a disposable, single-dose pen.
Slovenian: Injekcijska brizga je vložena v enoodmerni injekcijski peresnik za enkratno uporabo.
English: N = 220 N = 450
Slovenian: 240 mg n = 273
English: 1 mL of solution in a type I clear glass single-dose syringe.
Slovenian: En ml raztopine v injekcijski brizgi iz prozornega stekla tipa I. Injekcijska brizga je vložena v enoodmerni injekcijski peresnik za enkratno uporabo.
English: Based on a population PK analysis, the apparent clearance of galcanezumab was approximately 0.008 L/hour and the half life of galcanezumab was 27 days.
Slovenian: 0,008 l/h, razpolovna doba galkanezumaba pa 27 dni.
English: MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Slovenian: IZDELOVALEC (IZDELOVALCI) BIOLOŠKE
English: No effects on fertility parameters such as oestrous cycle, sperm analysis, or mating and reproductive performance were observed in rats that were administered galcanezumab (exposures approximately 4 to 20 times the human exposure at 240 mg).
Slovenian: Pri podganah, ki so prejemale galkanezumab (približno od 4- do 20-krat večje izpostavljenosti, kot je izpostavljenost pri človeku pri 240 mg odmerku), niso opazili učinkov na parametre plodnosti, kot so estrusni cikel, analiza sperme ali parjenje in sposobnost razmnoževanja.
English: Each pre-filled pen contains 120 mg of galcanezumab
Slovenian: En napolnjen injekcijski peresnik vsebuje 120 mg galkanezumaba.
English: Emgality may be stored unrefrigerated for a single period up to 7 days when stored at temperatures up to 30 °C
Slovenian: Zdravilo Emgality lahko hranite zunaj hladilnika največ enkrat za obdobje 7 dni pri temperaturah do
English: The relevance of this finding is unknown.
Slovenian: Pomen tega izsledka ni znan.
English: Teva Sweden AB
Slovenian: Sverige Teva Sweden AB
English: Two-year clinical studies have shown maintenance of this effect.
Slovenian: Dveletne klinične študije so pokazale, da se ta učinek ohrani.
English: If this applies to you, use appropriate contraception to avoid the possibility of an unplanned pregnancy.
Slovenian: Če to velja za vas, uporabite ustrezno kontracepcijo, da boste preprečili nenačrtovano nosečnost.
English: - if you have blood in your urine that your doctor has not checked.
Slovenian: - če imate kri v urinu, vaš zdravnik pa tega še ni raziskal.
English: 220 Hafnarfjörður Iceland
Slovenian: 220 Hafnarfjörđur Islandija
English: This is to check that your liver is working normally.
Slovenian: S tem bo kontroliral, da vam jetra delujejo normalno.
English: This is the diabetes that usually develops in adulthood.
Slovenian: To je sladkorna bolezen, ki se po navadi pojavi v odrasli dobi.
English: Your doctor will take this into account when treating your diabetes.
Slovenian: Zdravnik bo to pri zdravljenju vaše sladkorne bolezni upošteval.
English: - if you have a problem with your liver or heart.
Slovenian: - če imate težave z jetri ali srcem.
English: Three of the six identified metabolites are active (M-II, M-III, and M-IV).
Slovenian: Aktivni so trije od šestih ugotovljenih presnovkov (M-II, M-III in M-IV).
English: Steady state is achieved after 4-7 days of dosing.
Slovenian: Stanje dinamičnega ravnovesja je doseženo po 4 do 7 dneh uporabe.
English: • Periodic Safety Update Reports
Slovenian: • Redno posodobljena poročila o varnosti zdravila
English: Use in children under 18 years is not recommended.
Slovenian: Otroci in mladostniki Uporaba pri otrocih, mlajših od 18 let, ni priporočljiva.
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: Največji priporočeni odmerek 120 mg na dan štiri dni in potem 180 mg na dan sedem dni ni bil povezan z nobenimi simptomi.
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 odziv, vendar je ne ocenjujejo za glavni vzrok hiperplastičnih sprememb.
English: However, this did not lead to an increase in mortality in this study.
Slovenian: Vendar to v tej študiji ni povzročilo večje umrljivosti.
English: This check may be repeated at intervals.
Slovenian: To preiskavo boste morda morali v presledkih ponavljati.
English: The safety and efficacy of pioglitazone in children and adolescents under 18 years of age have not been established.
Slovenian: Varnost in učinkovitost pioglitazona pri otrocih in mladostnikih, mlajših od 18 let, nista ugotovljeni.
English: It is recommended that you carry some sugar lumps, sweets, biscuits or sugary fruit juice.
Slovenian: Zato je priporočljivo, da imate pri sebi nekaj kock sladkorja, bonbone, piškote ali sadni sok, ki vsebuje sladkor.
English: Not known (frequency cannot be estimated from the available data) - increase in liver enzymes - allergic reactions
Slovenian: Ni znano (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti) - zvišanje jetrnih encimov - alergijske reakcije
English: Glidipion has no or negligible effect on the ability to drive and use machines.
Slovenian: Glidipion nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji.
English: However, the marketing authorisation holder shall submit periodic safety update reports for this medicinal product if the product is included in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Slovenian: Kljub temu naj imetnik dovoljenja za promet z zdravilom odda redno posodobljena poročila o varnosti za to zdravilo v skladu z zahtevami določenimi na seznamu referenčnih datumov Unije (seznam EURD) opredeljen v členu 107c(7) Direktive 2001/83/ES in objavljen na evropskem spletnem portalu o zdravilih.
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Slovenian: Obvestite svojega zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katerokoli drugo zdravilo.
English: In particular, patients have experienced the following serious side effects:
Slovenian: Še zlasti so se bolnikom pojavljali naslednji neželeni učinki:
English: However patients who experience visual disturbance should be cautious when driving or using machines.
Slovenian: Vendar pa morajo biti bolniki, ki se jim pojavi motnja vida, previdni, če vozijo ali upravljajo s stroji.
English: Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland
Slovenian: Reykjavíkurvegi 76-78 220 Hafnarfjörđur Islandija
English: Patients should be advised to adhere strictly to a calorie-controlled diet.
Slovenian: Bolnikom je treba naročiti, naj se strogo držijo kalorično kontrolirane diete.
English: However if you miss a dose, just carry on with the next dose as normal.
Slovenian: A če ste pozabili vzeti odmerek, zgolj nadaljujte z naslednjim, kot po navadi.
English: The study population had an average age of 62 years; the average duration of diabetes was 9.5 years.
Slovenian: Povprečna starost bolnikov v populaciji študije je bila 62 let in povprečno trajanje sladkorne bolezni 9,5 leta.
English: Pioglitazone and all active metabolites are extensively bound to plasma protein (> 99%).
Slovenian: Pioglitazon in vsi njegovi aktivni presnovki so v veliki meri vezani na beljakovine v plazmi (> 99 %).
English: In addition, increased fatty deposition and infiltration were observed.
Slovenian: Poleg tega so opažali tudi povečano odlaganje in infiltracijo maščob.
English: Absorption is not influenced by food intake.
Slovenian: Uživanje hrane ne vpliva na absorpcijo.
English: Your weight should be checked at regular intervals; if your weight increases, inform your doctor.
Slovenian: Redno morate kontrolirati telesno maso; če se vam poveča, obvestite zdravnika.
English: Talk to your doctor before you start to take this medicine: - if you retain water (fluid retention) or have heart failure problems and in particular if you are over 75 years old.
Slovenian: Pred začetkom jemanja tega zdravila morate zdravniku povedati: - če vam zastaja voda (zastajanje tekočine) ali imate težave s srčnim popuščanjem, še zlasti, če ste starejši od 75 let.
English: If you experience any of these, especially if you are over the age of 65, seek medical advice straight away.
Slovenian: Če se vam pojavi kateri od teh, morate takoj poiskati zdravniški nasvet, še zlasti, če ste starejši od 65 let.
English: These patients may be at risk of pregnancy.
Slovenian: Pri takšnih bolnicah lahko obstaja tveganje, da zanosijo.
English: Pioglitazone tablets are taken orally once daily with or without food.
Slovenian: Tablete pioglitazona je treba jemati peroralno enkrat na dan s hrano ali brez nje.
English: If ALT levels remain > 3 X the upper limit of normal, therapy should be discontinued.
Slovenian: Če raven ALT ostaja > 3-kratno zgornjo normalno mejo, je treba zdravljenje prekiniti.
English: Your blood sugar could fall below the normal level and can be increased by taking sugar.
Slovenian: Krvni sladkor vam lahko pade pod normalno raven; znova ga lahko zvišate tako, da zaužijete sladkor.
English: Talk to your doctor before stopping this treatment.
Slovenian: Posvetujte se z zdravnikom, preden prenehate jemati to zdravilo.
English: You may also experience a reduction in blood count (anaemia).
Slovenian: Pojavi se vam lahko tudi zmanjšanje števila rdečih krvnih celic (anemija).
English: TEVA Pharmaceuticals Slovakia s.r.oTel:
Slovenian: Slovenská republika TEVA Pharmaceuticals Slovakia s.r.oTel:
English: Pioglitazone or placebo was added to existing antidiabetic and cardiovascular therapy for up to 3.5 years.
Slovenian: Pioglitazon ali placebo so dodali že obstoječemu antidiabetičnemu in kardiovaskularnemu zdravljenju za obdobje do 3,5 leta.
English: • This educational pack is aimed at strengthening awareness of important identified risks of bladder cancer and heart failure and the overall recommendations intended to optimise the benefit-risk margin at the patient level.
Slovenian: • Namen izobraževalnega gradiva je okrepiti ozaveščenost o pomembnih ugotovljenih tveganjih za raka sečnega mehurja in srčno popuščanje ter o splošnih priporočilih za izboljšanje meje koristi in tveganja na ravni bolnika.
English: Signs and symptoms include blood in your urine, pain when urinating or a sudden need to urinate.
Slovenian: Med znaki in simptomi so kri v urinu, bolečine pri uriniranju ali nenadna potreba po uriniranju.
English: Approximately half of the study population had at least two of the cardiovascular history entry criteria.
Slovenian: Približno polovica bolnikov v populaciji študije je ustrezala vsaj dvema meriloma kardiovaskularne anamneze za vključitev.
English: Pioglitazone is indicated as second or third line treatment of type 2 diabetes mellitus as described below:
Slovenian: Pioglitazon je indiciran kot drugi ali tretji izbor za zdravljenje sladkorne bolezni tipa 2, kot je opisano spodaj:
English: Prior to distribution of the prescriber guide in each Member State, the MAH must agree the content and format of the educational material, together with a communication plan, with the national competent authority.
Slovenian: Imetnik dovoljenja za promet mora pred distribucijo vodnika za predpisovanje v vsaki posamezni državi članici s pristojnim nacionalnim organom uskladiti vsebino in obliko izobraževalnega gradiva, vključno s komunikacijskim načrtom.
English: Thus free (unbound) pioglitazone concentration is unchanged.
Slovenian: Zato koncentracija prostega (nevezanega) pioglitazona ni spremenjena.
English: Frequencies are defined as: 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); very rare
Slovenian: Pogostnosti so opredeljene takole: 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), zelo redki (< 1/10.000), ni znano (ni mogoče oceniti na podlagi podatkov, ki so na voljo).
English: The reports of oedema were generally mild to moderate and usually did not require discontinuation of treatment.
Slovenian: Edemi so bili v splošnem blagi do zmerni in po navadi niso zahtevali prekinitve zdravljenja.
English: There are no adequate human data to determine the safety of pioglitazone during pregnancy.
Slovenian: Pri človeku ni dovolj podatkov za ugotovitev varnosti uporabe pioglitazona med nosečnostjo.
English: This leaflet was last revised in {MM/YYYY}.
Slovenian: Navodilo je bilo nazadnje revidirano
English: The European Medicines Agency has waived the obligation to submit the results of studies with pioglitazone in all subsets of the paediatric population in Type 2 Diabetes Mellitus.
Slovenian: Evropska agencija za zdravila je odstopila od obveze za predložitev rezultatov študij s pioglitazonom za vse skupine pediatrične populacije pri sladkorni bolezni tipa 2.
English: No information is available from dialysed patients, therefore pioglitazone should not be used in such patients.
Slovenian: Informacij o dializiranih bolnikih ni, zato se pioglitazona pri takšnih bolnikih ne sme uporabljati.
English: • Caution in use in the elderly in light of age related risks (in particular bladder cancer, fractures and heart failure).
Slovenian: • Previdnosti pri uporabi pri starejših bolnikih v luči tveganj, povezanih s starostjo (zlasti raka sečnega mehurja, zlomov in srčnega popuščanja).
English: - if you have a special type of diabetic eye disease called macular oedema (swelling of the back of the eye).
Slovenian: - če imate posebno vrsto diabetične bolezni očesa, imenovano edem makule (oteklost na zadnji strani očesa).
English: • Patient selection criteria including that Pioglitazone should not be used as first line therapy and emphasising the need for regular review of treatment benefit.
Slovenian: • Merilom za izbiro bolnikov; vključeno mora biti dejstvo, da se pioglitazona ne sme predpisovati kot zdravila prve izbire, in poudarjena mora biti potreba po rednem ocenjevanju koristi zdravljenja.
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 zdravilana na nacionalni center za poročanje, ki je naveden v Prilogi V.
English: This is similar to that seen in a sulphonylurea active comparator group.
Slovenian: To je podobno kot v primerjalni skupini s sulfonilsečnino.
English: Pioglitazone is contraindicated in patients with:
Slovenian: Pioglitazon je kontraindiciran pri bolnikih s:
English: The relevance of such a mechanism in humans is unclear and pioglitazone should not be used in pregnancy.
Slovenian: Pomen takega mehanizma pri človeku ni jasen in pioglitazona se med nosečnostjo ne sme uporabljati.
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 uvedbi zdravljenja s pioglitazonom je treba bolnike po 3 do 6 mesecih kontrolirati za oceno ustreznosti odziva na zdravljenje (npr. znižanje HbA1c).
English: These findings were observed across species at plasma concentrations ≤ 4 times the clinical exposure.
Slovenian: Te izsledke so opažali v različnih živalskih vrstah pri plazemskih koncentracijah, ki so bile ≤ 4-krat večje od klinične izpostavljenosti.
English: Many of these patients reported concurrent peripheral oedema.
Slovenian: Številni od teh bolnikov so navajali sočasne periferne edeme.
English: Symptomatic and general supportive measures should be taken in case of overdose.
Slovenian: V primeru prevelikega odmerjanja je treba uporabiti splošne podporne ukrepe in simptomatsko zdravljenje.
English: Take Glidipion daily as prescribed.
Slovenian: Zdravilo Glidipion vzemite vsak dan, kot je predpisano.