natgillin/translations-raw huggingface dataset:
Tremor, Peripheral sensorimotor neuropathy, Dyskinesia*, Cerebellar coordination and balance disturbances*, Memory loss (exc dementia)*, Encephalopathy*, Posterior Reversible Encephalopathy Syndrome#, Neurotoxicity, Seizure disorders*, Post herpetic neuralgia, Speech disorder*, Restless legs syndrome, Migraine, Sciatica, Disturbance in attention, Reflexes abnormal*, Parosmia
smetnje koordinacije i ravnoteže u malom mozgu *, gubitak pamćenja (isključujući demenciju)*, encefalopatija*, sindrom posteriorne reverzibilne encefalopatije#, neurotoksičnost,
The reconstituted solution must be inspected visually for particulate matter and discolouration prior to administration.
Prije primjene pripremljenu otopinu treba vizualno pregledati na prisutnost čestica i promijenu boje.
Cerebral haemorrhage*, Haemorrhage intracranial (inc subarachnoid)*, Brain oedema, Transient ischaemic attack, Coma, Autonomic nervous system imbalance, Autonomic neuropathy, Cranial palsy*, Paralysis*, Paresis*, Presyncope, Brain stem syndrome, Cerebrovascular disorder, Nerve root lesion, Psychomotor hyperactivity, Spinal cord compression, Cognitive disorder NOS, Motor dysfunction, Nervous system disorder NOS, Radiculitis, Drooling, Hypotonia
sindrom moždanog debla, cerebrovaskularni poremećaj, lezije korjena živca, psihomotorna hiperaktivnost, kompresija kralježnične moždine, nespecificirani kognitivni poremećaj, motorna disfunkcija, nespecificirani poremećaj živčanog sustava,
• Infections including urinary tract infections, the flu, herpes virus infections, ear infection and cellulitis
• upala srčane ovojnice ili tekućina oko srca • infekcije, uključujući infekcije mokraćnih putova, gripa, infekcije virusom herpesa, infekcija uha i celulitis • krvave stolice ili krvarenje iz sluznica, npr. iz usta, rodnice
• Joint or muscle stiffness, sense of heaviness, pain in your groin
• ukočenost zglobova ili mišića, osjećaj težine, bol u preponama • gubitak kose i neuobičajena tekstura dlake
In a drug-drug interaction study assessing the effect of omeprazole, a potent CYP2C19 inhibitor, on the pharmacokinetics of bortezomib (injected intravenously), there was no significant effect on the pharmacokinetics of bortezomib based on data from 17 patients.
na farmakokinetiku bortezomiba (primijenjenog intravenski), nije bilo značajnog učinka na farmakokinetiku bortezomiba na temelju podataka o 17 bolesnika.
Bortezomib Accord is used for the treatment of mantle cell lymphoma (a type of cancer affecting the lymph nodes) in patients 18 years or older in combination with the medicines rituximab, cyclophosphamide, doxorubicin and prednisone, for patients whose disease has not been previously treated and for whom blood stem cell transplantation is unsuitable.
Accord se primjenjuje u liječenju limfoma plaštenih stanica (vrsta raka koji zahvaća limfne čvorove) u bolesnika starosti 18 godina ili starijih u kombinaciji s lijekovima rituksimabom,
One hundred and thirty patients (≥ 18 years of age) with multiple myeloma who previously had at least partial response on a bortezomib-containing regimen were retreated upon progression.
Otvoreno isptivanje faze II s jednom skupinom, MMY-2036 (RETRIEVE), bilo je provedeno kako bi se utvrdile djelotvornost i sigurnost ponovljenog liječenja bortezomibom na stotinu i trideset bolesnika (≥ 18 godina starosti) s multiplim mijelomom koji su prethodno imali barem parcijalan odgovor na režim koji je uključivao bortezomib bili su ponovno liječeni nakon progresije.
Rhabdomyolysis, Temporomandibular joint syndrome, Fistula, Joint effusion, Pain in jaw, Bone disorder, Musculoskeletal and connective tissue infections and inflammations*, Synovial cyst
izljev u zglobovima, bol u čeljusti, poremećaj kostiju, infekcije i upale mišićno koštanog sustava i vezivnog tkiva*, sinovijalna cista
Muscle twitching, Joint swelling, Arthritis*, Joint stiffness, Myopathies*,Sensation of heaviness
hiperhidroza, noćno znojenje, dekubitalni ulkus#, akne*, mjehur*, poremećaj pigmentacije*
Rest Period
ROK VALJANOSTI
Bortezomib Accord is administered via intravenous or subcutaneous injection at the recommended dose of 1.3 mg/m2 body surface area twice weekly for two weeks on days 1, 4, 8, and 11 in a 28-day treatment cycle.
Accord se primjenjuje putem intravenske ili supkutane injekcije pri preporučenoj dozi od 1,3 mg/m2 površine tijela, dva puta tjedno tijekom dva tjedna, 1., 4., 8. i 11. dana, u ciklusu liječenja od 28 dana.
A hazard ratio < 1 indicates an advantage for BzR-CAP. c Based on Kaplan-Meier product limit estimates.
< 1 ukazuje na prednost za BzR-CAP.
Pancreatitis acute, Peritonitis*, Tongue oedema*, Ascites, Oesophagitis, Cheilitis, Faecal incontinence, Anal sphincter atony, Faecaloma*, Gastrointestinal ulceration and perforation*, Gingival hypertrophy, Megacolon, Rectal discharge, Oropharyngeal blistering*, Lip pain, Periodontitis, Anal fissure, Change of bowel habit, Proctalgia, Abnormal faeces
heilitis, nemogućnost kontroliranja stolice, atonija analnog sfinktera, fekalom*, gastrointestinalna ulceracija i perforacija*, gingivalna hipertrofija, megakolon, rektalni iscjedak,
Bortezomib Accord 1 mg powder for solution for injection Each 6 ml vial of Bortezomib Accord must be carefully reconstituted with 1 ml of sodium chloride 9 mg/ml (0.9%) solution for injection, by using a syringe of the appropriate size, without removing the vial stopper.
Bortezomib Accord 1 mg prašak za otopinu za injekciju Bočicu od 6 ml lijeka Bortezomib Accord se mora pažljivo rekonstituirati pomoću 1 ml 0,9%-tne
• to report any adverse event, or medication error experienced with the administration of
• važnost prijave štetnih događaja ili medikacijskih pogrešaka kod primjene lijeka Bortezomib
Hypermagnesaemia*, Acidosis, Electrolyte imbalance*, Fluid overload, Hypochloraemia*, Hypovolaemia, Hyperchloraemia*, Hyperphosphataemia*, Metabolic disorder, Vitamin B complex deficiency, Vitamin B12 deficiency, Gout, Increased appetite, Alcohol intolerance
preopterećenje tekućinom, hipokloremija*, hipovolemija, hiperkloremija*, hiperfosfatemija*, poremećaj metabolizma,
Bortezomib Accord 3.5 mg powder for solution for injection Each 10 ml vial of Bortezomib Accord must be carefully reconstituted with 3.5 ml of sodium chloride 9 mg/ml (0.9%) solution for injection, by using a syringe of the appropriate size, without removing the vial stopper.
Bortezomib Accord 3,5 mg prašak za otopinu za injekciju Bočicu od 10 ml lijeka Bortezomib Accord se mora pažljivo rekonstituirati pomoću 3,5 ml 0,9%-tne
Date of latest renewal: 19 June 2014
Datum posljednje obnove: 19. lipnja 2014.
• If you have an infection or a fever.
• ako imate infekciju ili vrućicu.
Be aware that the desired effect is not achieved if you stop taking Repaglinide Teva.
Imajte na umu da željeni učinak nije postignut ako prestanete uzimati Repaglinid Teva.
Your body's response to Repaglinide Teva may change if you take other medicines, especially these:
Reakcija tijela na Repaglinid Teva može se promijeniti ako uzimate druge lijekove, posebice ove:
• If you eat more than usual.
• ako jedete više nego obično.
If you forget to take Repaglinide Teva If you miss a dose, take the next dose as usual - do not double the dose.
Ako zaboravite uzeti dozu, uzmite sljedeću dozu kao obično - nemojte uzeti dvostruku dozu.
Hungary (Headquarters: 4042 Debrecen, Pallagi út 13)
Mađarska (Glavno sjedište: 4042 Debrecen, Pallagi út 13)
Repaglinide Teva with alcohol
Repaglinid Teva s alkoholom
Do not take more Repaglinide Teva than your doctor has recommended.
Nemojte uzeti više lijeka Repaglinid Teva nego što Vam je preporučio liječnik.
You should not take Repaglinide Teva if you are pregnant or you are planning to become pregnant.
Ne smijete uzimati Repaglinid Teva ako ste trudni ili planirate trudnoću.
Repaglinide Teva may not be suitable for you.
Repaglinid Teva Vam možda neće odgovarati.
Children and adolescents Do not take this medicine if you are under 18 years of age.
Nemojte uzimati ovaj lijek ako ste mlađi od 18 godina.
The most frequent side effect is hypoglycaemia which may affect up to 1 in 10 patients (see If you get a hypo in section 2).
Najčešća nuspojava je hipoglikemija koja se može javiti u do 1 na 10 bolesnika (pogledajte dio Ako dobijete hipoglikemiju u dijelu 2).
Repaglinide has no direct influence on the ability to drive and use machines but may cause hypoglycaemia.
Repaglinid nema izravnog učinka na sposobnost upravljanja vozilima i rada sa strojevima, ali može uzrokovati hipoglikemiju.
What Repaglinide Teva is and what it is used for
Što je Repaglinid Teva i za što se koristi
• If you take other medicines or suffer from liver or kidney problems (see other sections of
• ako uzimate druge lijekove ili imate problema s jetrom ili bubrezima (pogledajte ostale odjeljke dijela 2.
Substances that inhibit OATP1B1 may likewise have the potential to increase plasma concentrations of repaglinide, as has been shown for ciclosporin (see below).
Tvari koje inhibiraju OATP1B1 mogu isto tako imati potencijal da povećaju koncentraciju repaglinida u plazmi, kao što je zamijećeno za ciklosporin
• If you exercise more than usual.
• ako vježbate više nego obično.
Method of administration Repaglinide should be taken before main meals (i.e. preprandially).
Repaglinid je potrebno uzimati prije glavnih obroka (tj. preprandijalno).
Other medicines and Repaglinide Teva
Drugi lijekovi i Repaglinid Teva
Combination with metformin Combination treatment with metformin is associated with an increased risk of hypoglycaemia.
Kombinirana terapija s metforminom povezana je s povećanim rizikom od hipoglikemije.
• Steroids (anabolic steroids and corticosteroids - used for anemia or to treat inflammation).
• steroide (anaboličke steroide i kortikosteroide - koriste se za liječenje anemije ili za liječenje upale)
• Beta blockers (used to treat high blood pressure or heart conditions).
• beta-blokatore (koriste se za liječenje povišenog krvnog tlaka ili bolesti srca)
Repaglinide Teva should not be taken if you have a severe liver disease (see Do not take Repaglinide Teva).
Repaglinid Teva ne smijete uzimati ako imate tešku bolest jetre (vidjeti Nemojte uzimati Repaglinid Teva).
30 tablets 90 tablets 120 tablets 270 tablets 360 tablets
30 tableta 90 tableta 120 tableta 270 tableta 360 tableta
Pharmachemie BV Swensweg 5, 2031 GA Haarlem The Netherlands
Pharmachemie BV Swensweg 5, 2031 GA Haarlem Nizozemska
What Repaglinide Teva looks like and contents of the pack
Kako Repaglinid Teva izgleda i sadržaj pakiranja
In addition to the usual self-monitoring by the patient of blood and/or urinary glucose, the patient's blood glucose must be monitored periodically by the physician to determine the minimum effective dose for the patient.
Osim uobičajene samokontrole glukoze u krvi i/ili urinu, potrebno je da liječnik povremeno provjerava razinu glukoze u krvi bolesnika kako bi mogao odrediti minimalnu učinkovitu dozu za bolesnika.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 29 June 2009
Datum prvog odobrenja: 29. lipnja 2009
What you need to know before you take Repaglinide Teva).
Što morate znati prije nego počnete uzimati Repaglinid Teva).
• Deferasirox (used to reduce chronic iron overload).
• deferasiroks (koristi se za snižavanje kroničnog preopterećenja željezom)
• Hypersensitivity (such as rash, itchy skin, reddening of the skin, swelling of the skin)
• preosjetljivost (kao što je osip, svrbež kože, crvenilo kože, oticanje kože)
Repaglinide Teva is available in pack sizes of 30, 90, 120, 270 and 360 tablets.
Repaglinid Teva je dostupan u veličinama pakiranja od 30, 90, 120, 270 i 360 tableta.
The warning signs of a hypo may come on suddenly and can include: cold sweat; cool pale skin; headache; rapid heart beat; feeling sick; feeling very hungry; temporary changes in vision; drowsiness; unusual tiredness and weakness; nervousness or tremor; feeling anxious; feeling confused; difficulty in concentrating.
Znakovi koji upozoravaju na hipoglikemiju mogu nastupiti iznenada i mogu obuhvaćati: hladan znoj, hladnu blijedu kožu, glavobolju, ubrzane otkucaje srca, mučninu, osjećaj jake gladi, privremene promjene vida, omamljenost, neuobičajen umor i slabost, nervozu ili nevoljno drhtanje, osjećaj tjeskobe, osjećaj smetenosti, poteškoće s koncentracijom.
• Salicylates (e.g. aspirin).
• salicilate (primjerice aspirin)
Alcohol can change the ability of Repaglinide Teva to reduce the blood sugar.
Alkohol može izmijeniti učinkovitost lijeka Repaglinid Teva u snižavanju razine šećera u krvi.
• Clarithromycin, trimethoprim, rifampicin (antibiotic medicines).
• klaritromicin, trimetoprim, rifampicin (vrste antibiotika)
When symptoms of hypoglycaemia have disappeared or when blood sugar levels are stabilised continue Repaglinide Teva treatment.
Kad simptomi hipoglikemije nestanu ili Vam se stabilizira razina šećera u krvi, nastavite terapiju lijekom Repaglinid Teva.
• Clopidogrel (prevents blood clots).
• klopidogrel (sprječava zgrušavanje krvi)
Merckle GmbH Ludwig-Merckle-Straße 3, 89143 Blaubeuren-Weiler Germany
Merckle GmbH Ludwig-Merckle-Straße 3, 89143 Blaubeuren-Weiler
What you need to know before you take Repaglinide Teva
Što morate znati prije nego počnete uzimati Repaglinid Teva
As hypoglycaemia in this study was avoided through increased calorie intake, a relative overdose may result in an exaggerated glucose-lowering effect with development of hypoglycaemic symptoms (dizziness, sweating, tremor, headache etc.).
Budući da je pojava hipoglikemije u ovom ispitivanju izbjegnuta povećanim unosom kalorija, relativno predoziranje može dovesti do pretjeranog snižavanja razine glukoze u krvi uz pojavu simptoma hipoglikemije (omaglica, znojenje,
• Ciclosporin (used to suppress the immune system).
• ciklosporin (koristi se za supresiju imunološkog sustava)
Pack sizes: 30, 90, 120, 270 and 360 tablets.
Veličine pakiranja: 30, 90, 120, 270 i 360 tableta.
If you stop taking Repaglinide Teva
Ako prestanete uzimati Repaglinid Teva
• Danazol (used to treat breast cysts and endometriosis).
• danazol (koristi se za liječenje cista na dojci i endometrioze)
• Nonsteroidal anti-inflammatory drugs (NSAID) (a type of painkillers).
• nesteroidne protuupalne lijekove (NSAIL) (vrsta lijekova protiv bolova)
Repaglinide was shown not to be teratogenic in animal studies.
Ispitivanja na životinjama su pokazala da repaglinid nije teratogen.
• Monoamine oxidase inhibitors (MAOI) (used to treat depression).
• inhibitore monoamino oksidaze (MAO inhibitore) (koriste se za liječenje depresije)
Brampton Road Hampden Park Eastbourne, East Sussex BN22 9AG, United Kingdom
Brampton Road Hampden Park Eastbourne, East Sussex BN22 9AG, Ujedinjeno Kraljevstvo
If you take gemfibrozil (used to lower increased fat levels in the blood) you should not take Repaglinide Teva.
Ako uzimate gemfibrozil (koristi se za snižavanje povišene razine masnoća u krvi) ne smijete uzimati
Keep this medicine out of the sight and reach of children.
Kako čuvati Repaglinid Teva Ovaj lijek čuvajte izvan pogleda i dohvata djece.
Repaglinide pharmacokinetics are characterised by a mean absolute bioavailability of 63% (CV 11%).
Farmakokinetika repaglinida karakterizirana je srednjom apsolutnom bioraspoloživošću od 63%
Do not use this medicine after the expiry date which is stated on the carton and blister foil after EXP.
Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i blisteru iza oznake ‘Rok valjanosti'.
The amount of Repaglinide Teva, food or exercise may need to be adjusted.
Možda će biti potrebno uskladiti dozu lijeka Repaglinid Teva, prehranu ili tjelovježbu.
• Octreotide (used to treat cancer).
• oktreotid (koristi se za liječenje karcinoma)
• Oral contraceptives (birth control pills).
• oralne kontraceptive (tablete za sprječavanje začeća)
How to take Repaglinide Teva
Kako uzimati Repaglinid Teva
Metabolism and nutrition disorders
Poremećaji metabolizma i prehrane Hipoglikemija
You can take Repaglinide Teva with metformin, another medicine for diabetes, if your doctor prescribes it.
Repaglinid Teva možete uzimati u kombinaciji s metforminom, drugim lijekom protiv šećerne bolesti, ako ga liječnik propiše.
Repaglinide Teva is not recommended in patients with moderate liver disease.
Repaglinid Teva se ne preporučuje u bolesnika koji imaju srednje tešku bolest jetre.
Repaglinide has been shown to lower the blood sugar, which helps to prevent complications from your diabetes.
Repaglinid snižava razinu šećera u krvi i time pomaže u sprječavanju komplikacija šećerne bolesti.
In the case of concomitant use with other active substances refer to sections 4.4 and 4.5 to assess the dosage.
U slučaju istodobne primjene s drugim djelatnim tvarima doziranje treba procijeniti na temelju navedenog u dijelovima 4.4 i 4.5. 4.3 Kontraindikacije
• Phenytoin, carbamazepine, phenobarbital (used to treat epilepsy).
• fenitoin, karbamazepin, fenobarbital (koriste se za liječenje epilepsije)
• Sympathomimetics (used to treat asthma).
• simpatomimetike (koriste se za liječenje astme)
Based on the experience with repaglinide and with other hypoglycaemic medicinal products the following adverse reactions have been seen: Frequencies are defined as: common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000) and not known (cannot be estimated from the available data).
Učestalost je definirana kao: često (≥1/100 do <1/10); manje često (≥1/1000 do <1/100); rijetko (≥1/10 000 do
Repaglinide Teva is an oral antidiabetic medicine containing repaglinide which helps your pancreas produce more insulin and thereby lower your blood sugar (glucose).
Repaglinid Teva je lijek protiv šećerne bolesti za primjenu kroz usta, a sadrži repaglinid koji pomaže gušterači da stvori više inzulina te tako snizi razinu šećera (glukoze) u krvi.
• If you take too little Repaglinide Teva.
• ako uzmete premalo lijeka Repaglinid Teva.
The following substances may reduce the hypoglycaemic effect of repaglinide: Oral contraceptives, rifampicin, barbiturates, carbamazepine, thiazides, corticosteroids, danazol, thyroid hormones and sympathomimetics.
oralni kontraceptivi, rifampicin, barbiturati, karbamazepin, tiazidi, kortikosteroidi, danazol, hormoni štitnjače i simpatomimetici.
Repaglinide Teva can also be given with metformin, another medicine for diabetes.
Repaglinid Teva se može primjenjivati i u kombinaciji s metforminom, drugim lijekom protiv šećerne bolesti.
• If you are allergic to repaglinide or any of the other ingredients in this medicine (listed in section 6).
Nemojte uzimati Repaglinid Teva • ako ste alergični na repaglinid ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
One epidemiological study suggested an increased risk of acute coronary syndrome in repaglinide treated patients as compared to sulfonylurea treated patients (see sections 4.4 and 4.8).
U jednom epidemiološkom ispitivanju primijećen je povećan rizik razvoja akutnog koronarnog sindroma u bolesnika liječenih repaglinidom u usporedbi s bolesnicima liječenih sulfonilurejom
The recommended starting dose is 0.5 mg. One to two weeks should elapse between titration steps (as determined by blood glucose response).
Između svakog koraka titracije doze trebalo bi proći jedan do dva tjedna (na temelju mjerenja odgovora razine glukoze u krvi).
• If you take too much Repaglinide Teva.
• ako uzmete previše lijeka Repaglinid Teva.
• Thiazides (diuretics or ‘water pills').
• tiazide (diuretici ili lijekovi za izmokravanje)
The blood glucose-lowering effect of oral hypoglycaemic medicinal products decreases in many patients over time.
Kombinacija s lijekovima koji potiču izlučivanje inzulina Učinak oralnih antidijabetika na snižavanje razine glukoze u krvi u mnogih bolesnika se s vremenom smanjuje.
If patients are transferred from another oral hypoglycaemic medicinal product, the recommended starting dose is 1 mg.
Ako su bolesnici prethodno bili liječeni drugim oralnim antidijabetikom, preporučena početna doza je
Marketing Authorisation Holder Teva B.V.
ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Teva B.V.
Data from animal studies investigating effects on embryofetal and offspring development as well as excretion in milk is described in section 5.3.
Podaci o učincima na embriofetalni razvoj i razvoj mladunčadi te izlučivanju u majčino mlijeko dobiveni u ispitivanjima na životinjama opisani su u dijelu 5.3. 4.7 Utjecaj na sposobnost upravljanja vozilima i rada sa strojevima
• have few or no warning signs of hypos.
• imate malo znakova hipoglikemije ili oni izostaju.
Seven days pre-treatment with rifampicin (600 mg), followed by co-administration of repaglinide (a single dose of 4 mg) at day seven resulted in a 50% lower AUC (effect of a combined induction and inhibition).
Prethodna terapija rifampicinom (600 mg) tijekom 7 dana, a potom dodavanje repaglinida (pojedinačna doza od 4 mg) sedmoga je dana rezultirala 50% nižom AUC
Repaglinide Teva 2 mg tablets EU/1/09/530/011-015
Repaglinid Teva 2 mg tablete EU/1/09/530/011-015
NAME OF THE MARKETING AUTHORISATION HOLDER Teva B.V.
Nositelj odobrenja za stavljanje lijeka u promet Teva B.V.
Repaglinide Teva 1 mg tablets EU/1/09/530/006-010
Repaglinid Teva 1 mg tablete EU/1/09/530/006-010
You should not take Repaglinide Teva if you are breast-feeding.
Ne smijete uzimati Repaglinid Teva ako dojite.
Repaglinide Teva 0.5 mg tablets EU/1/09/530/001-005
Repaglinid Teva 0,5 mg tablete EU/1/09/530/001-005
If you take more Repaglinide Teva than you should If you take too many tablets, your blood sugar may become too low, leading to a hypo.
Ako uzmete previše tableta, može doći do prevelikog pada razine šećera u krvi, što vodi u hipoglikemiju.
Repaglinide Teva 0.5 mg tablets Each tablet contains 0.5 mg of repaglinide.
Repaglinid Teva 0,5 mg tablete Svaka tableta sadrži 0,5 mg repaglinida.
• Thyroid products (used to treat low levels of thyroid hormones).
• hormone štitnjače (koriste se za liječenje niske razine hormona štitnjače)
In an interaction study with healthy volunteers, co-administration of clopidogrel (300 mg loading dose), a CYP2C8 inhibitor, increased repaglinide exposure (AUC0-∞) 5.1-fold and continued administration (75 mg daily dose) increased repaglinide exposure (AUC0-∞) 3.9-fold.
U ispitivanju interakcija u zdravih dobrovoljaca, istodobna primjena klopidogrela (udarna doza od 300 mg), inhibitora CYP2C8, povećala je izloženost repaglinidu (AUC0-∞) 5,1 puta, a nakon kontinuirane primjene (dnevna doza od 75 mg) povećala se izloženost repaglinidu (AUC0-∞) 3,9 puta.
EU/1/09/530/011 30 tablets EU/1/09/530/012 90 tablets EU/1/09/530/013 120 tablets EU/1/09/530/014 270 tablets EU/1/09/530/015 360 tablets
EU/1/09/530/011 30 tableta EU/1/09/530/012 90 tableta EU/1/09/530/013 120 tableta EU/1/09/530/014 270 tableta EU/1/09/530/015 360 tableta
In an interaction study in healthy volunteers, co-administration of 250 mg clarithromycin, a potent mechanism based inhibitor of CYP3A4, slightly increased the repaglinide (AUC) by 1.4-fold and Cmax by 1.7-fold and increased the mean incremental AUC of serum insulin by 1.5-fold and the maximum concentration by 1.6-fold.
Istodobna primjena 250 mg klaritromicina, snažnog inhibitora CYP3A4, u ispitivanju interakcija provedenom na zdravim dobrovoljcima neznatno je povećala AUC repaglinida 1,4 puta i Cmax 1,7 puta te povećala srednju vrijednost AUC inzulina u serumu 1,5 puta i maksimalnu koncentraciju 1,6 puta.
Repaglinide Teva 2 mg tablets Microcrystalline cellulose (E460) Meglumine
Repaglinid Teva 2 mg tablete celuloza, mikrokristalična (E460)
Repaglinide Teva 1 mg tablets Microcrystalline cellulose (E460) Meglumine
Repaglinid Teva 1 mg tablete celuloza, mikrokristalična (E460)
EU/1/09/530/006 30 tablets EU/1/09/530/007 90 tablets EU/1/09/530/008 120 tablets EU/1/09/530/009 270 tablets EU/1/09/530/010 360 tablets
EU/1/09/530/006 30 tableta EU/1/09/530/007 90 tableta EU/1/09/530/008 120 tableta EU/1/09/530/009 270 tableta EU/1/09/530/010 360 tableta
• Visual disturbances
• zatvor • smetnje vida
Hypoglycaemia Repaglinide, like other insulin secretagogues, is capable of producing hypoglycaemia.
Repaglinid, kao i drugi lijekovi koji potiču izlučivanje inzulina, može izazvati hipoglikemiju.