FrancophonIA/ELRC3.0 huggingface dataset:
English: • Suliqua is available in two pre filled pens containing different strengths of lixisenatide, and different dose ranges: Both pre filled pens contain insulin glargine in a strength of 100 units/ml Suliqua 10-40 pen allows daily doses between 10 and 40 dose steps of Suliqua to be given (strength: insulin glargine 100 units/ml and lixisenatide 50 mcg/ml; dose range: 10 to 40 units of insulin glargine in combination with 5 to 20 mcg lixisenatide) Suliqua 30-60 pen allows daily doses between 30 and 60 dose steps of Suliqua to be given (strength: insulin glargine 100 units/ml and lixisenatide 33 mcg/ml; dose range: 30 to 60 units insulin glargine in combination with 10 to 20 mcg lixisenatide)
Croatian: • Suliqua je dostupna u dvije napunjene brizgalice koje sadrže različite jačine liksisenatida i različite raspone doza: Obje napunjene brizgalice sadrže inzulin glargin jačine 100 jedinica/ml Suliqua 10-40 brizgalica omogućava primjenu dnevnih doza između 10 i 40 odmjernih koraka lijeka Suliqua (jačina: inzulin glargin 100 jedinica/ml i liksisenatid 50 µg/ml; raspon doza: 10-40 jedinica inzulina glargina u kombinaciji s 5-20 µg liksisenatida) Suliqua 30-60 brizgalica omogućava primjenu dnevnih doza između 30 i 60 odmjernih koraka lijeka Suliqua (jačina: inzulin glargin 100 jedinica/ml i liksisenatid 33 µg/ml; raspon doza: 30-60 jedinica inzulina glargina u kombinaciji s 10-20 µg liksisenatida)
English: • Test your blood sugar level and, if it is high and as agreed with your doctor or nurse, test your urine for ketones as soon as you notice any of the above signs
Croatian: • Čim se pojavi bilo koji od navedenih znakova, što prije provjerite razinu šećera u krvi i ako je visoka, i kao što je dogovoreno s Vašim liječnikom ili medicisnkom sestrom, provjerite prisutnost ketona u mokraći.
English: • if there are particles in the Suliqua.
Croatian: • ako se u njemu nalaze čestice.
English: STEP 3: Do a safety test Always do a safety test before each injection to:
Croatian: KORAK 3: Napravite test sigurnosti Prije svake injekcije uvijek napravite test sigurnosti kako biste: provjerili da igla i brizgalica ispravno rade bili sigurni da ćete primijeniti točnu dozu lijeka
English: Suliqua 100 units/ml + 50 micrograms/ml pre-filled pen:
Croatian: Suliqua 100 jedinica/ml + 50 mikrograma/ml napunjena brizgalica:
English: • You change the area where you inject Suliqua.
Croatian: • ako promijenite područje u koje injicirate lijek Suliqua, npr. s bedra na nadlakticu.
English: Insulin glargine has not been studied in diabetes patients with hepatic impairment.
Croatian: Inzulin glargin nije ispitivan u bolesnika sa šećernom bolešću i oštećenjem funkcije jetre.
English: Suliqua should not be used during breast-feeding.
Croatian: Suliqua se ne smije primijenjivati tijekom dojenja.
English: Patients [n (%)] reaching HbA1c <7% at week 30* Fasting plasma glucose (mmol/L) Baseline (mean)
Croatian: Broj bolesnika (%) koji su dosegli vrijednost HbA1c <7% u 30. tjednu* Razina glukoze u plazmi natašte (mmol/l) Početna razina (srednja vrijednost) Kraj ispitivanja (srednja vrijednost)
English: • Suliqua 100 units/ml + 50 micrograms/ml pre-filled pen delivers dose steps from 10-40 units of insulin glargine in combination with 5-20 mcg lixisenatide (Suliqua (10-40) pen).
Croatian: • Suliqua 100 jedinica/ml + 50 mikrograma/ml napunjena brizgalica može isporučiti dozu u odmjernim koracima od 10-40 jedinica inzulina glargina u kombinaciji sa 5-20 mikrograma liksisenatida. (Suliqua (10-40) brizgalica)
English: • Throw away your used pen as instructed by your pharmacist or local authority.
Croatian: Upotrijebljenu brizgalicu zbrinite sukladno uputama ljekarnika ili lokalnog nadležnog tijela.
English: AUC was comparable while there was a small decrease in Cmax of lixisenatide of 22-34% compared with separate simultaneous administration of insulin glargine and lixisenatide, which is not likely to be clinically significant.
Croatian: Iako je bilo prisutno malo smanjenje Cmax liksisentida od 22-34% u odnosu na zasebnu istodobnu primjenu inzulina glargina i liksisentida koje se ne smatra klinčki značajnim, površina ispod krivulje (AUC) je bila usporediva.
English: Before using Suliqua, the instructions for use included in the package leaflet must be read carefully.
Croatian: Upute za uporabu koje dolaze s uputom o lijeku moraju se pažljivo pročitati prije uporabe lijeka Suliqua.
English: Do not inject a dose greater than 60 dose steps.
Croatian: Nemojte injicirati dozu koja je veća od 60 odmjernih koraka.
English: Warning signs of hypoglycaemia
Croatian: Upozoravajući simptomi hipoglikemije
English: In patients with hepatic impairment, insulin requirements may be diminished due to reduced capacity for gluconeogenesis and reduced insulin metabolism.
Croatian: Međutim, u bolesnika sa oštećenjem funkcije jetre potreba za inzulinom može biti smanjena zbog smanjenog kapaciteta za glukoneogenezu i smanjenog metabolizma inzulina.
English: Nervous system disorders
Croatian: Poremećaji živčanog sustava omaglica glavobolja
English: Do not inject a dose lower than 30 dose steps.
Croatian: Nemojte injicirati dozu koja je niža od 30 odmjernih koraka.
English: How to store Suliqua
Croatian: Kako primjenjivati lijek Suliqua
English: Do not inject a dose lower than 10 dose steps.
Croatian: Nemojte injicirati dozu koja je niža od 10 odmjernih koraka.
English: If a dose greater than 40 dose steps is needed, your doctor will prescribe a different strength.
Croatian: Vaš liječnik će Vam propisati drugu jačinu lijeka ako Vam je potrebna veća doza od 40 odmjernih koraka.
English: Suliqua Insulin glargine
Croatian: Suliqua brizgalica
English: throughout the day.
Croatian: Vrlo često
English: Comparison versus lixisenatide [95% confidence interval]*
Croatian: Usporedba naspram liksisenatida [95% interval pouzdanosti]*
English: Each Suliqua pen contains 3 ml of solution
Croatian: Jedna Suliqua brizgalica sadrži 3 ml otopine.
English: This will change the way it works and may cause your blood sugar to become too low.
Croatian: Primjena u venu promijenit će način na koji lijek djeluje te može uzrokovati prenisku razinu šećera u krvi.
English: • Too low blood sugar (hypoglycaemia).
Croatian: • prenizak šećer u krvi (hipoglikemija).
English: • if you are allergic to insulin glargine or lixisenatide or to any of the other ingredients of this medicine (listed in section 6).
Croatian: Nemojte primjenjivati lijek Suliqua: - ako ste alergični na inzulin glargin ili liksisenatid ili bilo koji drugi sastojak ovoga lijeka
English: Keep these Instructions For Use for future reference.
Croatian: Sačuvajte ove Upute za uporabu jer će Vam možda ponovno zatrebati.
English: • You lose carbohydrates from being sick (vomiting) or diarrhoea.
Croatian: • Gubite ugljikohidrate zbog povraćanja ili proljeva.
English: 2 hour PPG (mmol/L)**
Croatian: Postprandijalna razina glukoze u plazmi 2 sata nakon obroka (mmol/L)* *
English: • Do not use your pen if there is still no medicine coming out of the needle tip.
Croatian: - zatim ponovite test sigurnosti (KORAK 3) Nemojte upotrijebiti brizgalicu ako lijek i dalje ne izlazi kroz vrh igle.
English: The Suliqua 100 units/ml + 33 microgams/ml pre-filled SoloStar pen:
Croatian: Suliqua 100 jedinica/ml + 33 mikrograma/ml SoloStar napunjena brizgalica:
English: Plunger* Dose window Dose pointer
Croatian: Prozorčić za prikaz doze
English: The insulin glargine/lixisenatide ratio has no relevant impact on the PK of insulin glargine and lixisenatide in Suliqua.
Croatian: Omjer inzulina glargina i liksisenatida nema značajan učinak na farmakokinetiku inzulina glargina i liksisenatida u lijeku Suliqua.
English: Do not inject a dose higher than 40 dose steps.
Croatian: Nemojte injicirati dozu koja je veća od 40 odmjernih koraka.
English: • Switch from basal insulin
Croatian: • prijelaz s bazalnog inzulina
English: • Add-on to metformin [insulin naïve]
Croatian: • dodatak metforminu [bolesnici koji prethodno nisu primjenjivali inzulin]
English: • Do not use this pen if you need a daily dose less than 10 dose steps or if you need more than 40 dose steps.
Croatian: • Nemojte koristiti ovu brizgalicu ako Vam je potrebna dnevna doza manja od 10 ili viša od 40 odmjernih koraka.
English: Suliqua 100 units/ml + 50 microgram/ml solution for injection in a pre-filled pen Each pre-filled pen contains 300 units of insulin glargine* and 150 micrograms lixisenatide in 3 ml solution.
Croatian: Suliqua 100 jedinica/ml + 50 mikrograma/ml otopina za injekciju u napunjenoj brizgalici Jedna napunjena brizgalica sadrži 300 jedinica inzulina glargina* i 150 mikrograma liksisenatida u 3 ml otopine.
English: Therapy with basal insulin or oral glucose lowering medicinal product other than metformin should be discontinued prior to initiation of Suliqua.
Croatian: Prije uvođenja lijeka Suliqua potrebno je prekinuti liječenje bazalnim inzulinom ili oralnim lijekovima za snižavanje glukoze u krvi, osim metformina.
English: • Provide patients with the patient guide prior to prescribing or dispensing Suliqua.
Croatian: • Prije propisivanja ili izdavanja lijeka Suliqua potrebno je bolesnicima dati Vodič za bolesnike
English: 2 hour PPG (mmol/L)** Baseline (mean) End of study (mean)
Croatian: Postprandijalna razina glukoze u plazmi nakon 2 sata(mmol/L)* * Početna vrijednost (srednja vrijednost) Kraj ispitivanja (srednja vrijednost)
English: • Suliqua is available in two pre-filled pens containing two different strengths of lixisenatide, and different dose ranges: Both pre-filled pens contain insulin glargine in a strength of 100 units/ml Suliqua 10-40 pen allows daily doses between 10 and 40 dose steps of Suliqua to be given (strength: insulin glargine 100 units/ml and lixisenatide 50 mcg/ml; dose range: 10 to 40 units of insulin glargine in combination with 5 to 20 mcg lixisenatide) Suliqua 30-60 pen allows daily doses between 30 and 60 dose steps of Suliqua to be given (strength: insulin glargine 100 units/ml and lixisenatide 33 mcg/ml; dose range: 30 to 60 units insulin glargine in combination with 10 to 20 mcg lixisenatide)
Croatian: • Suliqua je dostupna u dvije napunjene brizgalice koje sadrže dvije različite jačine liksisenatida i različite raspone doza: Obje napunjene brizgalice sadrže inzulin glargin jačine 100 jedinica/ml Suliqua 10-40 brizgalica omogućuje primjenu dnevne doze lijeka Suliqua od 10 do 40 odmjernih koraka (jačina: inzulin glargin 100 jedinica/ml i liksisenatid 50 μg/ml; raspon doza: 10 do 40 jedinica inzulina glargina u kombinaciji sa 5 do 20 μg liksisenatida).
English: 5x 3 mL pens
Croatian: 5 brizgalica x 3 ml
English: Lixisenatide Suliqua Insulin glargine
Croatian: Liksisenatid Suliqua Inzulin glargin
English: Documented symptomatic or severe hypoglycaemic adverse reactions
Croatian: Zabilježene nuspojave simptomatske ili teške hipoglikemije Bolesnici koji nisu primjenjivali inzulin Prijelaz s bazalnog inzulina
English: Use in elderly patients (65 years and over) If you are 65 years or older, talk to your doctor as you may need a lower dose.
Croatian: Ako imate 65 ili više godina, razgovarajte sa svojim liječnikom jer ćete možda trebati nižu dozu.
English: Do not store with attached needle.
Croatian: Nemojte čuvati brizgalicu s pričvršćenom iglom.
English: Suliqua 100units/ml + 33 microgram/ml solution for injection in a pre-filled pen Each pre-filled pen contains 300 units of insulin glargine and 100 micrograms Lixisenatide in 3 ml solution.
Croatian: Suliqua 100 jedinica/ml + 33 mikrograma/ml otopina za injekciju u napunjenoj brizgalici Jedna napunjena brizgalica sadrži 300 jedinica inzulin glargina i 100 mikrograma liksisenatida u 3 ml otopine.
English: • Read the instructions in your package leaflet carefully before using Suliqua.
Croatian: • Pažljivo pročitajte uputu o lijeku prije nego počnete primjenjivati lijek Suliqua.
English: Add-on to metformin [insulin naïve]
Croatian: Dodatak metforminu [bolesnici koji prethodno nisu primjenjivali inzulin]
English: Nausea Diarrhoea Vomiting
Croatian: Poremećaji probavnog sustava mučnina proljev povraćanje dispepsija bol u abdomenu
English: If your blood sugar is too low, follow the guidance for hypoglycaemia (see information in the box at the end of this leaflet).
Croatian: Ako Vam je šećer u krvi prenizak, slijedite upute za slučaj hipoglikemije (vidjeti uokvireni tekst na kraju ove upute o lijeku).
English: Number (%) of patients achieving HbA1c< 7.0% with no body weight gain at week 30
Croatian: Bolesnici [n (%)] koji su dosegli vrijednost HbA1c <7% u 30. tjednu*
English: Each pen contains 300 units insulin glargine and 150 micrograms lixisenatide in 3 ml of solution.
Croatian: Jedna brizgalica sadrži 300 jedinica inzulina glargina i 150 mikrograma liksisenatida u 3 ml otopine.
English: 10x 3 mL pens
Croatian: 10 brizgalica x 3 ml
English: Mean body weight (kg) Baseline (mean)
Croatian: Srednja vrijednost tjelesne težine (kg) Početna vrijednost (srednja vrijednost)
English: Each ml contains 100 units of insulin glargine and 33 micrograms lixisenatide.
Croatian: Jedan ml sadrži 100 jedinica inzulina glargina i 33 mikrograma liksisenatida.
English: The mean BMI at baseline was 31.7 kg/m2 with 63.4% of patients having a BMI ≥30 kg/m2.
Croatian: Srednja vrijednost ITM u početku bila je 31,7 kg/m sa 63,4% bolesnika kojima je ITM ≥30 kg/m 2. Srednje trajanje šećerne bolesti bilo je otprilike 9 godina.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Suliqua 100 units/mL + 50 mcg/mL solution for injection insulin glargine + lixisenatide
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Suliqua 100 jedinica/ml + 50 μg/ml injekcija inzulin glargin + liksisenatid Za potkožnu primjenu
English: Each pen contains 300 units of insulin glargine and 100 micrograms lixisenatide in 3 mL solution.
Croatian: Jedna brizgalica sadrži 300 jedinica inzulina glargina i 100 mikrograma liksisenatida u 3 ml otopine.
English: If your blood sugar level falls too much you may pass out (become unconscious).
Croatian: Ako Vam se razina šećera u krvi previše snizi, možete izgubiti svijest.
English: Suliqua 100 units/ml + 50 micrograms/ml solution for injection in a pre-filled pen Suliqua 100 units/ml + 33 micrograms/ml solution for injection in a pre-filled pen
Croatian: Suliqua 100 jedinica/ml + 50 mikrograma/ml otopina za injekciju u napunjenoj brizgalici Suliqua 100 jedinica/ml + 33 mikrograma/ml otopina za injekciju u napunjenoj brizgalici
English: • Tiredness
Croatian: • mučnina
English: • in a vein.
Croatian: • u venu.
English: Handling needles
Croatian: Prijavljivanje nuspojava
English: • The needle can puncture the cap if it is recapped at an angle.
Croatian: Igla može probušiti zatvarač ako je zatvorite pod kutem.
English: • Do not use this pen if you need a single daily dose that is less than 10 dose steps, or more than 40 dose steps.
Croatian: Nemojte koristiti ovu brizgalicu ako Vam je potrebna pojedinačna dnevna doza manja od 10 ili veća od 40 odmjernih koraka.
English: • Stomachache
Croatian: • omaglica
English: Fatigue Injection site reactions
Croatian: Opći poremećaji i reakcije na mjestu primjene umor reakcije na mjestu injekcije
English: • Do not use this pen if you need a daily dose less than 30 dose steps or if you need more than 60 dose steps.
Croatian: Nemojte koristiti ovu brizgalicu ako Vam je potrebna pojedinačna dnevna doza manja od 30 ili veća od 60 odmjernih koraka.
English: Proportion difference versus insulin glargine [95% confidence interval] (p-value)
Croatian: Razlika naspram inzulina glargina [95% interval pouzdanosti] (p-vrijednost)
English: Suliqua 100 units/ml + 33 micrograms/ml solution for injection in a pre-filled pen Insulin glargine + lixisenatide
Croatian: Suliqua 100 jedinica/ml + 33 mikrograma/ml otopina za injekciju u napunjenoj brizgalici inzulin glargin + liksisenatid
English: Baseline (mean; post run-in phase) End of treatment (mean)
Croatian: Početna vrijednost (srednja vrijednost; nakon uvodnog razdoblja) Kraj ispitivanja (srednja vrijednost)
English: In patients with renal impairment, however, insulin requirements may be diminished due to reduced insulin metabolism.
Croatian: Međutim, u bolesnika sa oštećenjem funkcije bubrega potreba za inzulinom može biti smanjena zbog smanjenog metabolizma inzulina.
English: Each mL contains 100 units of insulin glargine and 50 micrograms lixisenatide.
Croatian: Jedan ml sadrži 100 jedinica inzulina glargina i 50 mikrograma liksisenatida.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Suliqua 100 units/mL +33 mcg/mL solution for injection insulin glargine + lixisenatide
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Suliqua 100 jedinica/ml + 33 μg/ml injekcija inzulin glargin + liksisenatid Za potkožnu primjenu.
English: In patients with renal impairment, insulin requirements may be diminished due to reduced insulin metabolism.
Croatian: U bolesnika s oštećenjem funkcije bubrega, potrebe za inzulinom mogu biti smanjene zbog smanjenog metabolizma inzulina.
English: Suliqua 100 units/ml + 50 micrograms/ml solution for injection in a pre-filled pen Insulin glargine + lixisenatide
Croatian: Suliqua 100 jedinica/ml + 50 mikrograma/ml otopina za injekciju u napunjenoj brizgalici inzulin glargin + liksisenatid
English: Proportion difference vs. lixisenatide [95% confidence interval]*
Croatian: Razlika udjela naspram liksisenatida [95% interval pouzdanosti]*
English: 3x 3 mL pens
Croatian: 3 brizgalice x 3 ml
English: Dose selector
Croatian: Držač uloška
English: NAME OF THE MEDICINAL PRODUCT Suliqua 100 units/mL + 50 micrograms/mL solution for injection in a pre-filled pen Suliqua 100 units/mL + 33 micrograms/mL solution for injection in a pre-filled pen insulin glargine + lixisenatide
Croatian: Suliqua 100 jedinica/ml + 50 mikrograma/ml otopina za injekciju u napunjenoj brizgalici Suliqua 100 jedinica/ml + 33 mikrograma/ml otopina za injekciju u napunjenoj brizgalici inzulin glargin + liksisenatid
English: Product name
Croatian: NAZIV LIJEKA
English: Each dose step of Suliqua contains 1 unit of insulin glargine and 0.5 micrograms of lixisenatide,.
Croatian: Jedan odmjerni korak lijeka Suliqua sadrži 1 jedinicu inzulina glargina i 0,5 mikrograma liksisenatida.
English: A. Grip the widest part of the outer needle cap. Keep the needle straight and guide it into the outer needle cap back.
Croatian: Držite iglu ravno i uvedite ju natrag u vanjski zatvarč igle.
English: Some medicines such as antibiotics, oral contraceptives, statins (medicines like atorvastatin to lower cholesterol) acid resistant tablets or capsules that should not stay too long in your stomach may need to be taken at least one hour before or four hours after your Suliqua injection.
Croatian: želučanootporne tablete ili kapsule koji se ne smiju predugo zadržavati u želucu možda ćete morati uzeti najmanje jedan sat prije ili četiri sata nakon injekcije lijeka Suliqua.
English: • Each dose step you dial contains 1 unit of insulin glargine and 0.5 micrograms of lixisenatide.
Croatian: • Jedan odmjerni korak koji odaberete sadrži 1 jedinicu inzulina glargina i 0,5 mikrograma liksisenatida.
English: Proportion difference vs. insulin glargine [95% confidence interval] (p-value)
Croatian: Usporedba naspram inzulina glargina [95% interval pouzdanosti] (p-vrijednost)
English: Suliqua 100 units/ml + 50 micrograms/ml solution for injection in a pre-filled pen
Croatian: Suliqua 100 jedinica/ml + 50 mikrograma/ml otopina za injekciju u napunjenoj brizgalici (10
English: Each dose step contains 1 unit of insulin glargine and 0.33 micrograms of lixisenatide.
Croatian: Jedan odmjerni korak sadrži 1 jednicu inzulin glargina i 0,33 mikrograma liksisenatida.
English: See the box at the end of this leaflet for more information.
Croatian: Za dodatne informacije pogledajte uokviren tekst na kraju ove upute o lijeku.
English: Each pen contains 3 ml of solution
Croatian: Jedna brizgalica sadrži 3 ml otopine.
English: Insulin glargine
Croatian: Inzulin glargin Liksisenatid
English: LS change from baseline (mean) Difference versus insulin glargine [95% confidence interval] (p-value)
Croatian: Promjena od početne vrijednosti dobivena metodom najmanjih kvadrata (srednja vrijednost) Razlika naspram inzulina glargina [95% interval pouzdanosti] (p-vrijednost)
English: Each dose step contains 1 unit of insulin glargine and 0.5 micrograms of lixisenatide.
Croatian: Jedan odmjerni korak sadrži 1 jednicu inzulin glargina i 0,5 mikrograma liksisenatida.
English: Zinc chloride
Croatian: Inzulin glargin
English: • Each dose step of Suliqua you dial contains 1 unit of insulin glargine and 0.33 micrograms of lixisenatide.
Croatian: • Jedan odmjerni korak koji odaberete sadrži 1 jedinicu inzulina glargina i 0,33 mikrograma liksisenatida.
English: Switch from basal insulin
Croatian: Prijelaz s bazalnog inzulina
English: 30 dose steps (30 units/10 mcg)* * units insulin glargine (100 units/ml) / mcg lixisenatide
Croatian: *jedinice inzulina glargina (100 jedinica/ml) / µg liksisenatida
English: LS difference versus lixisenatide (mean) [95%CI] (p-value)
Croatian: Razlika dobivena metodom najmanjih kvadrata naspram liksisenatida (srednja vrijednost) [95%IP] (p-vrijednost)
English: Store the pen away from direct heat or direct light.
Croatian: Čuvajte brizgalicu zaštićenu od izravnog izvora topline i svjetlosti.
English: Check your blood sugar and eat more food to prevent your blood sugar getting too low (hypoglycaemia).
Croatian: Da biste spriječili prenisku razinu šećera u krvi, kontrolirajte razinu šećera u krvi i uzimajte više hrane.
English: Concentrated hydrochloric acid (for pH adjustment) Sodium hydroxide (for pH adjustment) Water for injections
Croatian: FARMACEUTSKI PODACI 6.1 Popis pomoćnih tvari glicerol 85% metionin metakrezol koncentrirana kloridna kiselina (za podešavanje pH) natrijev hidroksid (za podešavanje pH) voda za injekcije
English: After concomitant administration of lixisenatide 20 mcg and digoxin 0.25 mg at steady state, the AUC of digoxin was not affected.
Croatian: Nakon istodobne primjene liksisenatida u dozi od 20 µg i digoksina u dozi od 0,25 mg u stanju dinamičke ravnoteže, AUC digoksina nije promijenjen. tmax digoksina odgodio se za 1,5 sati, a Cmax smanjio se za 26%.
English: Suliqua 100 units/ml + 33 micrograms/ml solution for injection in a pre-filled pen INSTRUCTIONS FOR USE
Croatian: Suliqua 100 jedinica/mL + 33 mikrograma/mL otopina za injekciju u napunjenoj brizgalici (30
English: Upper arms Stomach Thighs
Croatian: Mjesta za injiciranje nadlaktice trbuh bedra
English: Magyarország SANOFI-AVENTIS Zrt., Tel.: +36 1 505 0050
Croatian: Hrvatska sanofi-aventis Croatia d.o.o. Tel: +385 1 600 34 00
English: Get to know your pen
Croatian: Upoznajte svoju brigalicu
English: • a new sterile needle (see STEP 2).
Croatian: • nova sterilna igla (pogledajte KORAK 2) • neprobojan spremnik za upotrijebljene igle i brizgalice (pogledajte Odlaganje brizgalice)
English: • Do not reuse needles.
Croatian: Nemojte ponovo upotrijebiti istu iglu.
English: Origanum dictamnus L., herba
Croatian: Origanum dictamnus L., zelen
English: What are the HMPC conclusions on its medicinal uses?
Croatian: Koji su zaključci HMPC-a o njezinoj medicinskoj uporabi?
English: When used for skin problems the infusion may be used in those above the age of 12 years for up to two weeks; if symptoms last longer than this, advice should be sought from a qualified healthcare practitioner.
Croatian: Ako se koristi za probleme s kožom, Oparak se može koristiti u osoba starijih od 12 godina do dva tjedna; ako simptomi traju dulje od toga, potrebno je potražiti savjet kvalificiranog zdravstvenog djelatnika.
English: Dittany of Crete herb EMA/HMPC/441263/2013
Croatian: Zelen kretskog mravinca EMA/HMPC/441263/2013
English: In its assessment the HMPC took into account the well documented and longstanding use of dittany of Crete for these conditions.
Croatian: U svojoj ocjeni HMPC je uzeo u obzir dobro dokumentiranu i dugotrajnu primjenu kretskog mravinca za ta stanja.
English: It also considered published experimental studies and reports which supported the plausibility of the use of dittany of Crete herb in the approved indications.
Croatian: Također je razmotrio objavljena eksperimentalna ispitivanja i izvještaje koji govore u prilog vjerodostojnosti uporabe zeleni kretskog mravinca za odobrene indikacije.