natgillin/translations-raw huggingface dataset:
Activity: {Y}________MBq Cal.: {DD/MM/YYYY} 01h00 a.m. CET
Kal: {DD/MM/GGGG} 01h00 CET
You must inform the nuclear medicine doctor before the administration of medicines radiolabelled with Cuprymina if there is a possibility you might be pregnant, if you have missed your period or if you are breast-feeding.
Cupryminom ako postoji mogućnost da biste mogli biti trudni, ako Vam je izostala mjesečnica ili ako dojite.
The toxicological properties of Copper-64-labelled medicinal products prepared by radiolabelling with Cuprymina prior to administration will be dependent on the nature of the medicinal product to be radiolabelled.
Toksikološka svojstva lijekova obilježenih bakrom-64 pripremljenih radioobilježavanjem Cupryminom prije njegove primjene ovisit će o prirodi lijeka koji će biti radioobilježen.
Loc. Cavallino
Località Cavallino,
NAME OF THE MEDICINAL PRODUCT Cuprymina 925 MBq/mL radiopharmaceutical precursor, solution
NAZIV LIJEKA Cuprymina 925 MBq/ml radiofarmaceutski prekursor, otopina
Cuprymina is a radiopharmaceutical precursor.
4.1 Terapijske indikacije Cuprymina je radiofarmaceutski prekursor.
NAME OF THE MEDICINAL PRODUCT Cuprymina 925 MBq/mL radiopharmaceutical precursor, solution.
NAZIV LIJEKA Cuprymina 925 MBq/ml radiofarmaceutski prekursor, otopina.
One vial contains from 925 to 2,770 MBq (corresponding to 0.250.75 micrograms of copper-64).
Jedna bočica sadrži radioaktivnost u rasponu od 925 MBq do 2770 MBq što odgovara količini od 0,25-0,75 mikrograma bakra-64. (MBq: megaBekerel, Bekerel je mjerna jedinica za radioaktivnost)
Each mL of solution contains 925 MBq at calibration time (01h00 a.m. CET Central European Time), corresponding to at least 0.25 micrograms of copper-64.
Svaki ml otopine sadrži 925 MBq bakrovog (64Cu) klorida u vrijeme kalibracije (01h00 po srednje europskom vremenu [CET]), što odgovara najmanje 0,25 mikrograma bakra-64.
GENERAL CLASSIFICATION FOR SUPPLY Medicinal product subjects to medical prescription.
14. NAČIN IZDAVANJA LIJEKA Lijek se izdaje na recept.
For information on contraindications to particular Copper-64-labelled medicinal products prepared by radiolabelling with Cuprymina refer to the Summary of Product Characteristics/package leaflet of each particular medicinal product to be radiolabelled.
Za više informacija o kontraindikacijama za pojedine lijekove obilježene bakrom-64 pripravljene radioobilježavanjem Cupryminom pogledajte Sažetak opisa svojstava lijeka/uputu o svakom pojedinom lijeku koji treba biti radioobilježen.
Radiopharmaceuticals should be prepared by the user in a manner which satisfies both radiation safety and pharmaceutical quality requirements.
Način na koji ovlaštena osoba pripravlja radiofarmaceutik treba zadovoljavati i mjere zaštite od zračenja i zahtjeve u pogledu farmaceutske kvalitete.
For information concerning special warnings and special precautions for use of Copper-64-labelled medicinal products refer to the Summary of Product Characteristics/package leaflet of the medicinal product to be radiolabelled.
Za informacije o posebnim upozorenjima i posebnim mjerama opreza pri uporabi lijekova obilježenih bakrom-64 pogledajte Sažetak opisa svojstava lijeka/uputu o specifičnom lijeku koji će biti radioobilježen.
If you get any side effects, talk to your nuclear medicine doctor.
Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti svog liječnika, specijalistu nuklearne medicine.
The dosimetry table below is presented in order to evaluate the contribution of non-conjugated Copper64 to the radiation dose following the administration of Copper-64-labelled medicinal product or resulting from an accidental intravenous injection of Cuprymina.
64 dozi zračenja nakon primjene lijeka označenog bakrom-64 ili nakon nehotičnog intravenskog injiciranja Cuprymine.
How the medicine radiolabelled with Cuprymina is used
Ostali lijekovi i lijekovi radioobilježeni Cupryminom
Effects on ability to drive and to use machines following treatment by Copper-64-labelled medicinal products is specified in the Summary of Product Characteristics/package leaflet of the particular medicinal product to be radiolabelled.
4.7 Utjecaj na sposobnost upravljanja vozilima i rada sa strojevima Utjecaj lijekova obilježenih bakrom-64 na sposobnost upravljanja vozilima i rada sa strojevima nakon terapije je naveden u Sažetku opisa svojstava lijeka/uputu o konkretnom lijeku koji treba biti radioobilježen.
For information concerning interactions associated with the use of Copper-64-labelled medicinal products refer to the Summary of Product Characteristics/package leaflet of the radiolabelled medicinal product.
Za informacije o interakcijama povezanim s korištenjem lijekova obilježenih bakrom-64 pogledajte Sažetak opisa svojstava lijeka/uputu o radioobilježenom lijeku.
IT-62010 MONTECOSARO (MC) Italy
IT-62010 MONTECOSARO (MC) Italija
Cuprymina should be received, used and administered only by authorised persons in designated clinical settings.
Samo ovlaštene osobe smiju zaprimati, koristiti i primjenjivati Cupryminu u određenim kliničkim uvjetima.
62010 Montecosaro (MC) - Italy
62010 Montecosaro (MC) - Italija
Do not use this medicine after the expiry date and time which are stated on the label after EXP. Cuprymina will be stored in the original package that provides protection from radiation.
Cuprymina se ne smije koristiti nakon isteka datuma i vremena navedenog na naljepnici nakon kratice EXP za rok valjanosti.
The radiation dose received by the various organs following intravenous administration of a Copper-64labelled medicinal product is dependent on the specific molecule being radiolabelled.
Doza zračenja koju primaju različiti organi nakon intravenske primjene lijeka označenog bakrom-64
Cuprymina 925 MBq/mL radiopharmaceutical precursor, solution Copper (64Cu) chloride
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Cuprymina 925 MBq / ml radiofarmaceutski prekursor, otopina. bakrov (64Cu) klorid
62010 Montecosaro (MC) Italy
62010 Montecosaro (MC) Italija
The presence of free copper (64Cu) chloride in the body after an inadvertent administration of
Prisutnost slobodnog bakrovog (64Cu) klorida u organizmu nakon slučajne primjene Cuprymine će dovesti do povećane hepatotoksičnosti.
Fertility
Cavallino
Refer to the Summary of Product Characteristics/package leaflet of the particular medicinal product to be radiolabelled.
Pogledajte Sažetak opisa svojstava lijeka/uputu o lijeku za specifični lijek koji treba biti radioobilježen.
For more information concerning paediatric use of Copper-64-labelled medicinal products refer to the Summary of Product Characteristics/package leaflet of the radiolabelled medicinal product.
Za više informacija u vezi primjene radiofarmaceutskih proizvoda obilježenih bakrom-64 u pedijatriji pogledajte Sažetak opisa svojstava lijeka/uputu o lijeku za radioobilježeni lijek.
The surface dose
PRIMJENU LIJEKA
Copper (64Cu) chloride
- Djelatna tvar je bakrov (64Cu) klorid.
Further information concerning the effect on fertility of the use of Copper-64-labelled medicinal products is specified in the Summary of Product Characteristics of the medicinal product to be radiolabelled.
Dodatne informacije o učinku primjene lijekova obilježenih bakrom-64 na plodnost su navedene u
What Cuprymina is and what it is used for What you need to know before the medicine radiolabelled with Cuprymina is used How the medicine radiolabelled with Cuprymina is used Possible side effects
Što morate znati prije nego se primjeni lijek radioaktivno označen Cupryminom Lijek radioaktivno označen Cupryminom ne smije se koristiti:
(MBq: mega Becquerel, Becquerel is the unit in which radioactivity is measured) - The other ingredients are hydrochloric acid (0.1 N) and water for injections.
- Ostali sastojci su kloridna kiselina (0,1 M) i voda za injekcije.
SPARKLE S.r.l
ACOM S.r.l. SPARKLE S.r.l
- if you drink alcohol excessively (either every day or only from time to time).
- ako pijete pretjerane količine alkohola (svaki dan ili samo s vremena na vrijeme).
- if you have blood in your urine that your doctor has not checked.
- ako imate krv u mokraći, što Vaš liječnik nije provjerio.
Take Competact daily as prescribed.
Uzimajte Competact svakodnevno, kako je propisano.
Competact with alcohol
Competact s alkoholom
- if you have a severe infection or are dehydrated.
- ako imate tešku infekciju ili ste dehidrirani.
Individual cartons not to be sold separately.
Pojedinačne kutije ne smiju se prodavati zasebno.
Other medicines and Competact
Drugi lijekovi i Competact
Packs of 14, 28, 30, 50, 56, 60, 90, 98, 112, 180.
Pakiranja od 14, 28, 30, 50, 56, 60, 90, 98, 112, 180.
Talk to your doctor before stopping this treatment.
Razgovarajte s liječnikom prije nego što prekinete ovo liječenje.
Talk to your doctor or pharmacist before taking Competact (see also section 4).
Obratite se svom liječniku ili ljekarniku prije nego uzmete Competact (također pogledajte dio 4).
What Competact is and what it is used for
Što je Competact i za što se koristi
What you need to know before you take Competact Do not take Competact:
Što morate znati prije nego počnete uzimati Competact Nemojte uzimati Competact:
Your doctor will check whether Competact is working 3 to 6 months after you start taking it.
Liječnik će kod Vas provjeriti djelovanje lijeka Competact 3 do 6 mjeseci nakon što ga počnete uzimati.
Ask your doctor or pharmacist for more information if you are not sure how to recognise this.
Pitajte svog liječnika ili ljekarnika za više informacija ako niste sigurni kako prepoznati to stanje.
If you take more Competact than you should
Ako uzmete više lijeka Competact nego što ste trebali
What Competact is and what it is used for What you need to know before you take Competact How to take Competact
Što je Competact i za što se koristi Što morate znati prije nego počnete uzimati Competact Kako uzimati Competact
Contents of the pack and other information What Competact contains
Sadržaj pakiranja i druge informacije Što Competact sadrži
Pioglitazone and all active metabolites are extensively bound to plasma protein (> 99%).
Pioglitazon i svi djelatni metaboliti uglavnom su vezani za proteine plazme (> 99%).
- 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.
- ako imate posebni tip dijabetičke bolesti oka koja se zove makularni edem (oteknuće stražnjeg segmenta oka) razgovarajte sa svojim liječnikom ako primijetite bilo kakvu promjenu u svom vidu.
- if you recently had a heart attack, have severe circulatory problems including shock, or breathing difficulties.
- ako ste nedavno imali srčani udar, imate teške smetnje cirkulacije uključujući šok ili poteškoće s disanjem.
Before you start taking Competact you will have a blood sample taken to check your liver function.
Prije nego počnete uzimati Competact uzet će Vam uzorak krvi za provjeru funkcije jetre.
Competact is not recommended in pregnancy.
Competact se ne preporučuje u trudnoći.
It is recommended that you carry some sugar lumps, sweets, biscuits or sugary fruit juice.
Preporučuje se da sa sobom uvijek nosite kocku šećera, bombone, kekse ili slatki voćni sok.
If you wish to become pregnant, your doctor will advise you to discontinue this medicine.
Ako želite zatrudnjeti liječnik će Vam savjetovati da prestanete uzimati ovaj lijek.
Adults with normal renal function (GFR ≥ 90 mL/min)
Odrasli s normalnom funkcijom bubrega (GFR ≥ 90 ml/min)
In case of suspected symptoms, the patient should stop taking Competact and seek immediate medical attention.
U slučaju sumnje na simptome, bolesnik treba prestati uzimati Competact i odmah potražiti pomoć liječnika.
During treatment with Competact, your doctor will check your kidney function at least once a year or more frequently if you are elderly and/or if you have worsening kidney function.
Tijekom liječenja lijekom Competact, liječnik će Vam provjeravati funkciju bubrega najmanje jedanput godišnje ili češće ako ste starija osoba i/ili ako Vam se funkcija bubrega pogoršava.
Competact is contraindicated in patients with:
Competact je kontraindiciran u bolesnika s:
What Competact looks like and contents of the pack
Kako Competact izgleda i sadržaj pakiranja
EU/1/06/354/011 2x98 tablets
EU/1/06/354/011 2x98 tableta
Food had no effect on the AUC and Cmax of pioglitazone when Competact was administered to healthy volunteers.
Hrana nije utjecala na AUC i Cmax pioglitazona kad se Competact primijenio u zdravih dobrovoljaca.
Competact has no or negligible influence on the ability to drive and use machines.
Competact ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
The safety and efficacy of Competact in children and adolescents under 18 years of age have not been established.
Sigurnost i djelotvornost lijeka Competact u djece i adolescenata starosti do 18 godina nisu još ustanovljene.
If you take Competact with other medicines for diabetes, it is more likely that your blood sugar could fall below the normal level (hypoglycaemia).
Ako uzimate Competact s drugim lijekovima za šećernu bolest, veća je vjerojatnost da će Vam šećer u krvi pasti na vrijednosti ispod normalne razine (hipoglikemija).
If no adequate strength of Competact is available, individual monocomponents should be used instead of the fixed dose combination.
Ako nije dostupna odgovarajuća jačina lijeka Competact, potrebno je primijeniti pojedinačne komponente zasebno umjesto fiksne kombinacije.
Taking Competact with, or just after food, may reduce gastrointestinal symptoms associated with metformin.
Uzimanje lijeka Competact s hranom ili neposredno nakon obroka može smanjiti gastrointestinalne simptome povezane s metforminom.
Not known (frequency can not be estimated from the available data) - inflammation of the liver (hepatitis) - liver does not work as well as it should (changes in liver enzymes)
Nepoznato (učestalost se ne može procijeniti iz dostupnih podataka) - upala jetre (hepatitis) - jetra ne funkcionira onako dobro kako bi trebala (promjene jetrenih enzima)
If you have a serious allergic reaction, including hives and swelling of the face, lips, tongue, or throat that may cause difficulty in breathing or swallowing, stop taking this medicine and talk to your doctor immediately.
Ako imate ozbiljnu alergijsku reakciju, uključujući koprivnjaču, oticanje lica, usana, jezika ili grla, to može uzrokovati probleme s disanjem ili gutanjem pa prestanite uzimati ovaj lijek i obratite se odmah svom liječniku.
Do not use this medicine after the expiry date which is stated on the carton and the blister after “EXP”.
Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i blisteru iza “EXP”.
As Competact contains metformin hydrochloride,it must be discontinued at the time of surgery under general, spinal or epidural anesthesia.
Budući da Competact sadrži metformin hidroklorid, njegovu primjenu treba prekinuti u vrijeme kirurških zahvata pod općom, spinalnom ili epiduralnom anestezijom.
There have been no formal interaction studies for Competact.
Nisu provedena službena ispitivanja interakcija lijeka Competact.
Competact helps control the level of sugar in your blood when you have type 2 diabetes by helping your body make better use of the insulin it produces.
Competact pomaže kontrolirati razinu šećera u krvi kod šećerne bolesti tipa 2, tako što pomaže Vašem tijelu da bolje iskoristi inzulin koji se u tijelu proizvodi.
Small clinical trials have not revealed metformin to have malformative effects.
Mala klinička ispitivanja nisu pokazala da metformin ima malformacijske učinke.
Also, if you already have blurred vision and the symptoms get worse, talk to your doctor as soon as possible.
Također, ako već imate zamagljen vid i simptomi se pogoršavaju, što prije obavijestite svog liječnika.
- if you have a problem with your heart.
- ako imate tegobe sa srcem.
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.
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. de la Industria 30, 28108 Alcobendas, Madrid, Španjolska
- do not use Competact if you are breastfeeding or are planning to breast-feed (see section “Do not take Competact”).
- Nemojte uzimati Competact ako dojite ili planirate dojiti (vidjeti dio „Nemojte uzimati Competact“).
You may need more frequent blood glucose and kidney function tests, or your doctor may need to adjust the dose of Competact.
Možda ćete češće morati raditi pretrage glukoze u krvi ili testove funkcije bubrega ili će Vam liječnik trebati prilagoditi dozu lijeka Competact.
The European Medicines Agency has waived the obligation to submit the results of studies with Competact in all subsets of the paediatric population in type 2 diabetes mellitus.
Europska agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja lijeka Competact u svim podskupinama pedijatrijske populacije u tipu 2 šećerne bolesti.
Risk related to metformin
Rizik povezan s metforminom
Detailed information on this medicine is available on the European Medicines Agency website http://www.ema.europa.eu.
Detaljnije informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za lijekove http://www.ema.europa.eu
There may be an increased possibility of becoming pregnant because you may ovulate again when you take Competact.
Mogućnost trudnoće može biti povećana zato što Vam se, dok uzimate Competact, može vratiti ovulacija.
3 Visual disturbance has been reported mainly early in treatment and is related to changes in blood glucose due to temporary alteration in the turgidity and refractive index of the lens.
3 Poremećaj vida zabilježen je uglavnom na početku liječenja i povezan je s promjenama glukoze u krvi zbog privremene promjene turgidnosti i indeksa refrakcije leće.
- if you are going to have a certain type of X-ray with an injectable dye, talk to your doctor as you must stop taking Competact for a certain period of time before and after the examination.
- ako idete na određenu vrstu rendgenskog snimanja s ubrizgavanjem kontrastnog sredstva razgovarajte sa svojim liječnikom jer ćete morati prestati uzimati Competact na određeno vrijeme prije i nakon pregleda.
Animal studies have not revealed teratogenic effects.
Ispitivanja na životinjama nisu pokazala teratogene učinke.
Lactic acidosis is a serious reaction which may occur very rarely (< 1/10,000) (see section 4.4) and other reactions such as bone fracture, weight increase and oedema may occur commonly (≥ 1/100 to < 1/10) (see section 4.4).
Laktacidoza je ozbiljna reakcija koja može nastati vrlo rijetko (< 1/10 000) (vidjeti dio 4.4), a druge reakcije kao što su prijelomi kostiju, povećanje tjelesne težine i edemi mogu nastati često (≥ 1/100 do < 1/10) (vidjeti dio 4.4).
In controlled clinical trials, maximum metformin plasma levels (Cmax) did not exceed 4 µg/mL, even at maximum doses.
U kontroliranim kliničkim ispitivanjima, maksimalne razine metformina u plazmi (Cmax) nisu prelazile 4 µg/ml, čak i kod najviših doza.
Tablets should be swallowed with a glass of water.
Način primjene Tablete se trebaju progutati uz čašu vode.
At the usual metformin doses and dosing schedules, steady state plasma concentrations are reached within 24-48 h and are generally less than 1 µg/mL.
Kod uobičajenih doza metformina i rasporeda doziranja, dinamička ravnoteža koncentracije u plazmi postiže se u roku od 24-48 sati i općenito je manja od 1 µg/ml.
If you are following a special diet for diabetes, you should continue with this while you are taking Competact.
Ako se pridržavate posebne dijete za šećernu bolest, nastavite s takvom prehranom dok uzimate Competact.
Your doctor will decide when you must stop and when to restart your treatment with Competact.
Liječnik će odlučiti kada morate prekinuti i kada ćete nastaviti s liječenjem lijekom Competact.
Dose titration with pioglitazone (added to the optimal dose of metformin) should be considered before the patient is switched to Competact.
Titraciju doze pioglitazona (pridodanog optimalnoj dozi metformina) treba razmotriti prije nego što se bolesnika prebaci na Competact.
60 x 1 tablets
60 x 1 tableta
Stop taking Competact for a short time if you have a condition that may be associated with dehydration (significant loss of body fluids) such as severe vomiting, diarrhoea, fever, exposure to heat or if you drink less fluid than normal.
Prestanite nakratko uzimati Competact ako imate stanje koje može biti povezano s dehidracijom (značajan gubitak tjelesnih tekućina) kao što je jako povraćanje, proljev, vrućica, izloženost toplini ili ako pijete manje tekućine nego obično.
When starting or using such products in combination with Competact, close monitoring of renal function is necessary.
Kad se takvi lijekovi uvode ili primjenjuju u kombinaciji s Competact, potrebno je pažljivo praćenje funkcije bubrega.
If you experience symptoms of hypoglycaemia such as weakness, dizziness, increased sweating, fast heart-beating, vision disorders or difficulty in concentration, you should take some sugar to increase your blood sugar level again.
Ako iskusite simptome hipoglikemije poput slabosti, omaglice, pojačanog znojenja, ubrzanih otkucaja srca, smetnji vida ili poteškoća u koncentraciji, morate uzeti malo šećera kako biste ponovno povećali svoju razinu šećera u krvi.
If you need to have an injection of a contrast medium that contains iodine into your bloodstream, for example in the context of an X-ray or scan, you must stop taking Competact before or at the time of the injection.
Ako trebate dobiti injekciju kontrastnog sredstva koje sadrži jod u krvnu žilu, na primjer, u sklopu rendgenskog snimanja ili skeniranja, morate prestati uzimati lijek Competact prije ili u vrijeme injekcije.
Renal clearance of metformin is > 400 mL/min, indicating that metformin is eliminated by glomerular filtration and tubular secretion.
Bubrežni klirens metformina je >400 ml/min, što pokazuje da se metformin eliminira glomerularnom filtracijom i tubularnom sekrecijom.
In case of dehydration (severe diarrhoea or vomiting, fever, heat, reduced fluid intake), Competact should be temporarily discontinued and contact with a health care professional is recommended.
U slučaju dehidracije (teški proljev ili povraćanje, vrućica ili smanjen unos tekućine), potrebno je privremeno prekinuti primjenu Competact i preporučuje se obratiti se zdravstvenom radniku.
FOR CALENDARISED PACKS: 7 Tablet blister
ZA KALENDARSKA PAKIRANJA: blister sa 7 tableta blister sa 14 tableta
common common alanine aminotransferase increased9
često često povišena alanin aminotransferaza9
Eye disorders visual disturbance3
Poremećaji oka poremećaj vida3
They are supplied in aluminium/aluminium blisters in packs of 14, 28, 30, 50, 56, 60, 90, 98, 112, 180, multipacks of 196 (2 packs of 98) tablets or in aluminium/aluminium perforated unit dose blisters in packs of 60 x 1 tablets.
Isporučuju se u aluminij/aluminij blisterima u pakiranjima od 14, 28, 30, 50, 56, 60, 90, 98, 112, 180, višestrukim pakiranjima od 196 (2 pakiranja od 98) tableta ili u aluminij/aluminij perforiranim blisterima djeljivim na jedinične doze u pakiranjima od 60 x 1 tableta.
Multipack: 196 (2 packs of 98) film-coated tablets.
Višestruko pakiranje: 196 (2 pakiranja od 98) filmom obloženih tableta.
It is an anti-diabetic medicine used in adults to treat type 2 (non-insulin dependent) diabetes mellitus when treatment with metformin alone is not sufficient.
To je antidijabetički lijek koji se primjenjuje u odraslih za liječenje šećerne bolesti tipa 2 (neovisne o inzulinu) kad liječenje samo metforminom nije dovoljno.
ACE inhibitors may decrease the blood glucose levels.
ACE-inhibitori mogu sniziti razinu glukoze u krvi.
Some epidemiological studies have suggested a similarly increased risk of fracture in both men and women.
Neka epidemiološka ispitivanja ukazuju na jednako povećni rizik od lomova i kod muškaraca i kod žena.
You may take your tablets with or just after food to reduce the chance of an upset stomach.
Tablete možete uzeti uz obrok ili neposredno nakon obroka, jer to smanjuje mogućnost želučanih smetnji.