FrancophonIA/ELRC3.0 huggingface dataset:
English: Guidance on prevention of medication errors with highstrength insulins
Croatian: Smjernice za prevenciju pogrešaka pri propisivanju inzulina velike jačine
English: • Pharmacists are encouraged to check that patients and carers are able to read the strength of insulin and the dose counter of the pen device before dispensing the medicine.
Croatian: • Ljekarnicima se preporučuje da provjere mogu li bolesnici i njegovatelji pročitati jačinu inzulina te očitati brojač doza uređaja s olovkom prije doziranja lijeka.
English: Patients and healthcare professionals are therefore advised to take extra care when using highstrength insulin medicines and to carefully follow the recommendations given below.
Croatian: Stoga se bolesnicima i zdravstvenim djelatnicima savjetuje da posebno pripaze pri uporabi lijekova s inzulinom velike jačine te da pozorno slijede preporuke navedene u nastavku.
English: • Ensure that electronic and paper systems used to prescribe and dispense these medicines facilitate correct selection of the medicine and avoid confusion with other medicines.
Croatian: • pobrinuti se da elektronički i papirnati sustavi za propisivanje i doziranje tih lijekova omogućuju točan odabir lijeka te onemogućuju zabunu s drugim lijekovima;
English: Therefore, when switching from insulin glargine 100 units/ml to Toujeo, this can be done on a unit to unit basis, but a higher Toujeo dose (approx. 10-18%) may be needed to achieve target ranges for plasma glucose level.
Croatian: Stoga se pri prijelazu s inzulina glargina 100 jedinica/ml na Toujeo to može provesti po načelu jedinica-zajedinicu, ali može biti potrebna veća doza lijeka Toujeo (o. 10 - 18 %) kako bi se postigle ciljne vrijednosti razine glukoze u plazmi.
English: • If you are using other types of insulin alongside your high-strength insulin, always check the strength on the packaging and the label of each type of insulin before every injection to avoid mixing them up.
Croatian: • Ako se koristite i drugim vrstama inzulina, a ne samo inzulinom velike jačine, uvijek provjerite jačinu navedenu na pakiranju i naljepnici svake vrste inzulina prije svake injekcije kako ih ne biste zabunom zamijenili.
English: Toujeo (insulin glargine 300 units/ml), although it is also a high-strength insulin, is not bioequivalent to insulin glargine 100 units/ml (such as Lantus) which means that these insulins are not interchangeable.
Croatian: Toujeo (inzulin glargin 300 jedinica/ml), iako također inzulin velike jačine, nije bioekvivalentan inzulin glarginu 100 jedinica/ml (kao što je Lantus), što znači da ti inzulini nisu međusobno zamjenjivi.
English: • Explain differences in the design of the package and the pre-filled pen for high-strength insulins and standard-strength insulins, especially if the patient has been transferred from standardstrength insulin to high-strength insulin.
Croatian: • Objasnite razlike u dizajnu pakiranja i unaprijed napunjene olovke između inzulina velike jačine i inzulina standardne jačine, osobito ako je bolesniku inzulin standardne jačine zamijenjen inzulinom velike jačine.
English: • If the concentration of insulin stated on your medicine pack is higher than 100 units/ml, you are using high-strength insulin.
Croatian: • Ako je koncentracija inzulina navedena na pakiranju lijeka veća od 100 jedinica/ml, koristite se inzulinom velike jačine.
English: • Ensure that storage arrangements for combination insulin medicines facilitate correct selection of the medicine and avoid confusion with other medicines.
Croatian: • pobrinuti se da rješenja za pohranjivanje kombiniranih inzulinskih lijekova omogućuju točan odabir lijeka te onemogućuju zabunu s drugim lijekovima.
English: Healthcare professionals must never use a syringe to withdraw insulin from a pre-filled pen otherwise severe overdose can result.
Croatian: Zdravstveni se djelatnici nikada ne smiju koristiti štrcaljkom za izvlačenje inzulina iz unaprijed napunjene olovke jer u suprotnome može doći do predoziranja.
English: • The insulin is supplied in a pre-filled pen and it should only be used with this device.
Croatian: • Inzulin se isporučuje kao unaprijed napunjena olovka te se treba upotrebljavati samo s tim uređajem.
English: In addition, healthcare professionals are encouraged to take the following precautions when storing and dispensing high strength insulins:
Croatian: Osim toga, zdravstvenim se djelatnicima preporučuje da pri pohranjivanju i doziranju inzulina velike jačine poduzmu sljedeće mjere opreza:
English: • If you are being transferred from standard strength insulin to high-strength insulin, your healthcare professional will highlight any differences in design between your high-strength insulin pen and other standard-strength insulin pens.
Croatian: • Ako vam je inzulin standardne jačine zamijenjen inzulinom velike jačine, zdravstveni djelatnik istaknut će vam sve razlike u dizajnu između olovke za inzulin velike jačine i drugih olovki za inzulin standardne jačine.
English: • When switching patients from standard-strength insulin to an insulin formulation that is not bioequivalent (such as Toujeo, insulin glargine 300 units/ml), switching can be done on a unit to unit basis, but the dose may need to be adjusted to achieve target ranges for plasma glucose level.
Croatian: • Pri prijelazu bolesnika s inzulina standardne jačine na inzulinski pripravak koji nije bioekvivalentan (kao što je Toujeo, inzulin glargin od 300 jedinica/ml) prijelaz se može provesti po načelu jedinica-za-jedinicu, ali možda će biti potrebno prilagoditi dozu kako bi se postigle ciljne vrijednosti razine glukoze u plazmi.
English: • You must never use a syringe to withdraw insulin from a pre-filled pen otherwise severe overdose may result.
Croatian: • Nikada se ne smijete koristiti štrcaljkom za izvlačenje inzulina iz unaprijed napunjene olovke jer bi u suprotnome moglo doći do predoziranja.
English: The strength of the insulin formulation should also be always included in the prescription.
Croatian: U liječničkom receptu uvijek treba bit navedena i jačina inzulinskog pripravka.
English: Examples of high-strength insulin formulations are Tresiba (200 units/ml insulin degludec) and Humalog (insulin lispro 200 units/ml).
Croatian: Tresiba (200 jedinica/ml inzulin degludek) i Humalog (inzulin lispro 200 jedinica /ml) primjeri su inzulinskih pripravaka velike jačine.
English: • The high-strength insulin is supplied in a pre-filled pen and it should only be used with this device.
Croatian: • Inzulin velike jačine isporučuje se kao unaprijed napunjena olovka te se treba upotrebljavati samo s tim uređajem.
English: • If you are being transferred from standard-strength insulin to a high-strength insulin you will usually be using the same number of units that you were when using the standard-strength insulin.1 This also applies if you are being transferred from a high-strength to a standard-strength insulin.
Croatian: • Ako vam je inzulin standardne jačine zamijenjen inzulinom velike jačine, najčešće ćete se koristiti jednakim brojem jedinica kao i tijekom uporabe inzulina standardne jačine.1
English: Call your doctor immediately.
Croatian: Odmah pozovite liječnika.
English: These items may sting your fingers if you touch them.
Croatian: Ove stvari mogu izazvati bockanje u prstima ako ih dodirnete.
English: Tell your doctor if you are taking, have recently taken or might take any other medicines.
Croatian: Obavijestite svog liječnika ako uzimate, ako ste nedavno uzimali ili ćete uzeti bilo koje druge lijekove.
English: No more than 4 patches should be used at the same time.
Croatian: Ne smije se primijeniti više od 4 naljepka odjednom.
English: No data are available following 30-minute treatments.
Croatian: Nema dostupnih podataka o 30-minutnom liječenju.
English: Keep in place for 30 or 60 minutes depending on the location of treatment.
Croatian: Ostavite ga na tom mjestu 30 ili 60 minuta ovisno o mjestu liječenja.
English: Do not touch your eyes, mouth or other sensitive areas.
Croatian: Nemojte dodirivati oči, usta ili druga osjetljiva područja.
English: Date of first authorisation: 15 May 2009 Date of latest renewal: 15 May 2014
Croatian: Datum posljednje obnove: 15. svibnja 2014.
English: There is no antidote to capsaicin.
Croatian: Nema antidota za kapsaicin.
English: 52078 Aachen Germany
Croatian: 52078 Aachen Njemačka
English: The safety and efficacy of Qutenza in children from birth to 18 years has not been established.
Croatian: Sigurnost i djelotvornost Qutenze u djece od rođenja do 18. godine nije ustanovljena.
English: Remove anaesthetic.
Croatian: Uklonite anestetik.
English: Latex gloves should NOT be worn as they do not provide adequate protection.
Croatian: Rukavice od lateksa NE SMIJU se nositi, jer ne pružaju odgovarajuću zaštitu.
English: Qutenza should be used with caution if you are pregnant.
Croatian: Qutenzu treba primjenjivati s oprezom ako ste trudni.
English: Qutenza is not recommended for treatment in patients under 18 years of age.
Croatian: Qutenza se ne preporučuje za liječenje bolesnika u dobi manjoj od 18 godina.
English: For all three aetiologies efficacy was maintained throughout the 12-week study period.
Croatian: Kod sve tri etiologije djelotvornost se održala tijekom svih 12 tjedana ispitivanja.
English: Do not attempt to remove the patch yourself.
Croatian: Nemojte pokušati sami ukloniti naljepak.
English: Your doctor or nurse will remove it for you.
Croatian: Liječnik ili medicinska sestra uklonit će ga umjesto Vas.
English: to < 1/10), uncommon (≥ 1/1,000 to < 1/100) and not known (cannot be estimated from the available data).
Croatian: često (≥ 1/100 i < 1/10), manje često (≥ 1/1000 i < 1/100) i nepoznato (ne može se procijeniti iz dostupnih podataka).
English: If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby ask your doctor for advice before taking this medicine.
Croatian: Ako ste trudni ili dojite, mislite da biste mogli biti trudni, ili planirate imati dijete, obratite se svom liječniku za savjet prije nego uzmete ovaj lijek.
English: Other medicines and Qutenza
Croatian: Drugi lijekovi i Qutenza
English: • because of the risk of accidental exposure, the use of nitrile gloves, a mask and protective glasses are recommended
Croatian: • zbog rizika od nehotičnog izlaganja, preporučuje se uporaba nitrilnih rukavica, maske i zaštitnih naočala
English: Qutenza acts locally on your skin and is not expected to influence other medicines.
Croatian: Qutenza djeluje lokalno na Vašu kožu pa se ne očekuje da će utjecati na druge lijekove.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, single-dose toxicity, and repeated-dose toxicity.
Croatian: Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije, toksičnosti jednokratne doze i toksičnosti ponovljenih doza.
English: TUBE OF CLEANSING GEL - LABEL
Croatian: TUBA S GELOM ZA ČIŠĆENJE - NALJEPNICA
English: Hair in treatment areas will be clipped.
Croatian: Dlake na području liječenja bit će podrezane.
English: If you experience very severe pain, ask your doctor to remove the patch.
Croatian: Ako osjetite vrlo jaku bol, zamolite liječnika da ukloni naljepak.
English: Qutenza contains capsaicin and belongs to a group of medicines called anaesthetics.
Croatian: Qutenza sadržava kapsaicin i pripada grupi lijekova zvanih anestetici.
English: Your doctor or nurse will remove the patches after 30 minutes if you're being treated for nerve pain on your feet or 60 minutes if you're being treated for nerve pain on other parts of your body.
Croatian: Liječnik ili medicinska sestra uklonit će flastere nakon 30 minuta ako se liječite zbog boli živca u stopalima ili 60 minuta ako se liječite zbog boli živca u drugim dijelovima tijela.
English: For instructions on handling and disposal of the treatment materials see section 6.6.
Croatian: Za upute za rukovanje i uklanjanje materijala uporabljenih za liječenje vidjeti dio 6.6.
English: These later-stage effects of capsaicin are frequently referred to as “desensitization” and are thought to underlie the pain relief.
Croatian: Ovi učinci kapsaicina u kasnijoj fazi često se nazivaju “desenzitizacija” i smatra se da čine osnovu uklanjanja boli.
English: Although neither statistically significant nor dose dependent, the Fertility Index and the number of pregnancies per number of rats in cohabitation were reduced in all capsaicin-treated groups.
Croatian: Iako nisu bili niti statistički značajni niti su ovisili o dozi, indeks plodnosti i broj trudnoća po broju štakora u kohabitaciji bili su smanjeni u svih skupina liječenih kapsaicinom.
English: Do not touch the patch with your hands.
Croatian: Nemojte dodirivati naljepak rukama.
English: Because of the pain, your blood pressure may go up and therefore, your doctor will measure your blood pressure several times during your treatment.
Croatian: Zbog boli Vam se može povisiti krvni tlak pa će Vam liječnik mjeriti krvni tlak nekoliko puta tijekom liječenja.
English: The painful area should be determined by the physician and marked on the skin.
Croatian: Bolno područje treba odrediti liječnik i označiti ga na koži.
English: A carcinogenicity study performed in mice indicates that capsaicin is not carcinogenic.
Croatian: Ispitivanja kancerogenosti provedena u miševa pokazuju da kapsaicin nije kancerogen.
English: The use of a mask and protective glasses is recommended, see section 4.2.
Croatian: Preporučuje se i uporaba maske i zaštitnih naočala (vidjeti dio 4.2).
English: What Qutenza is and what it is used for
Croatian: Što je Qutenza i za što se koristi
English: Available pharmacodynamic/toxicological data in animals have shown excretion of capsaicin/metabolites in milk (for details see 5.3).
Croatian: Dostupni farmakodinamički/toksikološki podaci u životinja dokazali su da se kapsaicin/metaboliti izlučuju u mlijeko (za detalje vidjeti 5.3).
English: If after that time you still have a lot of pain, please talk to your doctor.
Croatian: Ako nakon toga i dalje budete imali jake bolove, molimo obratite se svom liječniku.
English: Increased blood pressure
Croatian: Povišenje krvnog tlaka
English: If Qutenza is used longer than it should
Croatian: Ukoliko se lijek Qutenza primjenjuje duže nego što bi trebao
English: Do not remove release liner from the patch until ready for application.
Croatian: Nemojte uklanjati zaštitnu foliju s naljepka dok ne bude spreman za primjenu.
English: Disposal of used and unused Qutenza patches.
Croatian: Zbrinjavanje iskorištenih i neiskorištenih naljepaka Qutenza.
English: Supportive measures should be taken as clinically needed.
Croatian: Potporne mjere treba primijeniti po kliničkoj potrebi.
English: This educational programme will include: - recommendations regarding the general handling and disposal measures for Qutenza
Croatian: Taj program edukacije uključit će sljedeće: - preporuke za opće mjere pri rukovanju i zbrinjavanju Qutenze
English: Cleansing gel contains:
Croatian: Gel za čišćenje sadrži:
English: For painful diabetic peripheral neuropathy consistent and reproducible efficacy has been demonstrated with repeated treatments during a 52-week period.
Croatian: Kod bolne dijabetičke periferne neuropatije dokazana je konzistentna i reproducibilna djelotvornost kod ponovljenih liječenja tijekom perioda od 52 tjedna.
English: According to the EC Scientific Committee on Food, the average European oral intake of capsaicin is 1.5 mg/day (0.025 mg/kg/day for a 60 kg person) and the highest dietary exposure is 25 to 200 mg/day (up to 3.3 mg/kg/day for a 60 kg person).
Croatian: Prema Znanstvenom povjerenstvu za hranu Europske komisije, prosječni peroralni unos kapsaicina za Europu je 1,5 mg na dan (0,025 mg/kg na dan za osobu tjelesne težine 60 kg), a najviša prehrambena izloženost je 25 do 200 mg na dan (do 3,3 mg/kg na dan za osobu tjelesne težine 60 kg).
English: Injury, poisoning and procedural complications
Croatian: Ozljede, trovanja i prroceduralne komplikacije
English: o Frequency not known: frequency cannot be estimated from the available data
Croatian: Nepoznata učestalost: učestalost se ne može procijeniti iz dostupnih podataka
English: The cutaneous patch should be applied to the most painful skin areas (using up to a maximum of 4 patches).
Croatian: Naljepak za kožu treba primijeniti na najbolnija područja na koži (s time da se može uporabiti najviše 4 naljepka).
English: In this case, your doctor will use other measures to reduce your pain following Qutenza treatment.
Croatian: U tom će slučaju Vaš liječnik primijeniti druge mjere za ublažavanje bola nakon liječenja Qutenzom.
English: Capsaicin, or 6-nonenamide, N-[(4-hydroxy-3-methoxyphenyl) methyl]-8-methyl, (6E), is a highly selective agonist for the transient receptor potential vanilloid 1 receptor (TRPV1).
Croatian: Kapsaicin, ili 6-nonenamid, N-[(4-hidroksi-3-metoksifenil) metil]-8-metil, (6E), visoko je selektivni agonist prolaznog receptorskog potencijala vaniloidnog receptora 1 (TRPV1).
English: • administration of capsaicin should only be done under medical supervision
Croatian: • kapsaicin se smije primjenjivati samo pod medicinskim nadzorom
English: In clinical trials, patients were pre-treated with topical lidocaine (4%), lidocaine (2.5%)/prilocaine (2.5%) or with 50 mg of tramadol.
Croatian: U kliničkim ispitivanjima na bolesnicima se prethodno primijenio topikalni lidokain (4%), lidokain (2,5%)/prilokain (2,5%) ili 50 mg tramadola.
English: Capsaicin-induced alterations in cutaneous nociceptors are reversible and it has been reported and observed that normal function (the detection of noxious sensations) returns within weeks in healthy volunteers.
Croatian: Promjene u nociceptorima kože izazvane kapsaicinom su reverzibilne, a zabilježeno je i opaženo da se u zdravih dobrovoljaca normalna funkcija (detekcija štetnih osjeta) vraća unutar nekoliko tjedana.
English: The Qutenza patches should be removed gently and slowly by rolling them inward to minimize the risk of aerosolisation of capsaicin.
Croatian: Naljepke Qutenza treba ukloniti nježno i polako na način da ih se uvrće prema unutra kako bi se smanjio rizik od aerosolizacije kapsaicina.
English: What Qutenza looks like and contents of the pack
Croatian: Kako Qutenza izgleda i sadržaj pakiranja
English: • if you are allergic to capsaicin, chilli peppers or any other ingredients of this medicine (listed in section 6).
Croatian: • ako ste alergični na kapsaicin, čili papričice ili neki drugi sastojak ovog lijeka (naveden u dijelu
English: Qutenza treatments may be repeated every 90 days, as warranted by the persistence or return of pain.
Croatian: Liječenje Qutenzom može se ponavljati svakih 90 dana, ovisno o ustrajnosti ili povratu boli.
English: As a result of treatment-related increases in pain, transient increases in blood pressure (on average < 8.0 mm Hg) may occur during and shortly after the Qutenza treatment.
Croatian: Kao rezultat liječenja vezanog za povećanje boli može se pojaviti prolazno povišenje krvnog tlaka (u prosjeku za <8,0 mm Hg) tijekom i ubrzo nakon liječenja Qutenzom.
English: • administration of Qutenza in a well ventilated area to reduce the risk of occupational exposure - instructions regarding the administration of Qutenza - warnings and precautions, including the need:
Croatian: • primjena Qutenze u dobro prozračenoj prostoriji kako bi se smanjio rizik od profesionalne izloženosti - upute za primjenu Qutenze - upozorenja i mjere opreza, uključujući potrebu:
English: Adverse reactions were transient, self limiting and usually mild to moderate in intensity.
Croatian: Nuspojave su bile prolazne, samoograničavajuće i obično blagog do umjerenog intenziteta.
English: UAB “STADA - Nizhpharm - Baltija“ Leedu
Croatian: UAB “STADA - Nizhpharm - Baltija“
English: Damaged nerves in your skin may occur as a result of a variety of diseases such as shingles, HIV infection, diabetes, certain medicines and other conditions.
Croatian: Oštećenje živaca u Vašoj koži može nastati kao posljedica raznih bolesti poput herpes zostera, HIVinfekcije, dijabetesa, određenih lijekova i drugih stanja.
English: Pain in extremity
Croatian: Često bol u ekstremitetima
English: If you experience a lot of pain, your doctor will apply local cooling or give you medicine for pain.
Croatian: Ako će Vas jako boljeti, liječnik će primijeniti lokalne hladne obloge i dati Vam lijek protiv bolova.
English: The outer surface of the backing layer is imprinted with ‘capsaicin 8%'.
Croatian: Na vanjskoj površini potpornog sloja otisnuto je ‘capsaicin 8%'.
English: Do not use Qutenza on broken skin or open wounds.
Croatian: Nemojte stavljati Qutenzu na oštećenu kožu ili otvorene rane.
English: It may take between 1 to 3 weeks before you experience pain relief with Qutenza.
Croatian: Može potrajati između 1 do 3 tjedna dok ne osjetite ublažavanje boli sa Qutenzom.
English: There is no data in humans available on fertility.
Croatian: Nema dostupnih podataka u ljudi vezanih uz plodnost.
English: The active substance is capsaicin.
Croatian: Djelatna tvar je kapsaicin.
English: When using Qutenza, only very small amounts of the active substance may be present in the blood stream for a very short time.
Croatian: Za vrijeme primjene Qutenze, u krvotoku mogu vrlo kratko biti prisutne samo vrlo male količine djelatne tvari.
English: CARTON OF 1 OR 2 PATCHES
Croatian: KUTIJA S 1 ILI 2 NALJEPAKA
English: Your doctor or nurse will put them in a polyethylene bag before safely discarding them.
Croatian: Liječnik ili medicinska sestra stavit će ih u polietilensku vreću prije nego što ih odlože u otpad na siguran način.
English: Pharmacotherapeutic group: Anaesthetics, other local anaesthetics, ATC code: N01BX04
Croatian: Farmakoterapijska skupina: anestetici, drugi lokalni anestetici, ATK oznaka: N01BX04
English: To ensure Qutenza maintains contact to the treatment area, stretchable socks or rolled gauze may be used.
Croatian: Da bi se osiguralo da Qutenza ostane u dodiru s područjem liječenja, mogu se uporabiti rastezljive čarape ili namotana gaza.
English: No detectable levels of metabolites were observed in any subject.
Croatian: Nisu opažene mjerljive razine metabolita niti u jednog ispitanika.
English: These precautions should be taken to avoid unintentional contact with the patches or other materials that have come in contact with the treated areas.
Croatian: Ove mjere opreza treba poduzeti da se izbjegne slučajni kontakt s naljepcimaima ili drugim materijalom koji je bio u kontaktu s liječenim područjima.
English: Each patch is 14 cm x 20 cm (280 cm2) and consists of an adhesive side containing the active substance and an outer surface backing layer.
Croatian: Jedan naljepak ima dimenzije 14 cm x 20 cm (280 cm2) i sastoji se od ljepljive strane koja sadrži djelatnu tvar i vanjskog potpornog sloja.
English: Your doctor or nurse may wear gloves, and sometimes a mask and protective glasses, while handling the Qutenza patches.
Croatian: Liječnik ili medicinska sestra mogu nositi rukavice, a ponekad i masku i zaštitne naočale za vrijeme rukovanja naljepkom Qutenza.
English: A reproductive toxicology study in rats showed a reduction in the number and percent of motile sperm and the number of pregnancies (see section 5.3).
Croatian: Ispitivanja reproduktivne toksičnosti u štakora su pokazala smanjen broj i postotak pokretljivih spermija kao i broj trudnoća (vidjeti dio 5.3).
English: In addition, there have been reported cases of burns, including second degree burns, in patients treated with capsaicin patches (see section 4.8).
Croatian: Dodatno su zabilježeni i slučajevi opekotina, uključujući opekotine drugog stupnja, u bolesnika liječenih naljepcima s kapsaicinom (vidjeti dio 4.8.)
English: • to provide supportive treatment if patients experience increased pain during Qutenza administration
Croatian: • da se pruži potporno liječenje ako bolesnici osjete pojačanje bola tijekom primjene Qutenze
English: In patients reporting severe pain, the patch should be removed and the skin examined for chemical burn.
Croatian: U bolesnika koji prijave jaku bol treba ukloniti naljepak i pregledati kožu zbog moguće kemijske opekotine.
English: The other ingredients of the Qutenza cutaneous patch are:
Croatian: Ostali sastojci naljepka za kožu Qutenza su: