natgillin/translations-raw huggingface dataset:
Dafiro HCT is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is a newborn, or was born prematurely.
Če želite dojiti, bo zdravnik za vas izbral drugo zdravilo, še posebno če je vaš otrok še novorojenček ali je bil rojen prezgodaj.
Dafiro HCT 5 mg/160 mg/12.5 mg film-coated tablets Dafiro HCT 10 mg/160 mg/12.5 mg film-coated tablets Dafiro HCT 5 mg/160 mg/25 mg film-coated tablets Dafiro HCT 10 mg/160 mg/25 mg film-coated tablets Dafiro HCT 10 mg/320 mg/25 mg film-coated tablets
Dafiro HCT 5 mg/160 mg/12,5 mg filmsko obložene tablete Dafiro HCT 10 mg/160 mg/12,5 mg filmsko obložene tablete Dafiro HCT 5 mg/160 mg/25 mg filmsko obložene tablete Dafiro HCT 10 mg/160 mg/25 mg filmsko obložene tablete Dafiro HCT 10 mg/320 mg/25 mg filmsko obložene tablete
Tabulated list of adverse reactions
Tabelaričen pregled neželenih učinkov
Very rare (may affect up to 1 in 10,000 people):
Zelo redki (pojavijo se pri največ 1 od 10.000 bolnikov):
Amlodipine/Valsartan/Hydrochlorothiazide
Amlodipin/valsarta/hidroklorotiazid
Caution, including more frequent monitoring of blood pressure, is recommended in elderly patients, particularly at the maximum dose of Dafiro HCT, 10 mg/320 mg/25 mg, since available data in this patient population are limited.
Pri starejših bolnikih je priporočena previdnost, kar vključuje bolj pogosto merjenje krvnega tlaka, zlasti pri uporabi najvišjega odmerka zdravila Dafiro HCT 10 mg/320 mg/25 mg, saj je za to skupino bolnikov na voljo le malo podatkov.
Caution is advised in patients with heart failure and coronary artery disease, particularly at the maximum dose of Dafiro HCT, 10 mg/320 mg/25 mg, since available data in these patient populations is limited.
Pri bolnikih s srčnim popuščanjem in koronarno boleznijo je priporočena previdnost, zlasti pri uporabi najvišjega odmerka zdravila Dafiro HCT 10 mg/320 mg/25 mg, saj je pri teh skupinah bolnikov na voljo le malo podatkov.
Medicinal product subject to medical prescription.
Predisovanje in izdaja zdravila je le na recept.
• inflammation of blood vessels with symptoms such as rash, purplish-red spots, fever (vasculitis)
• vnetje krvnih žil s simptomi, kot so izpuščaj, vijolično-rdeče pike, zvišana telesna temperatura
Caution is advised in patients with heart failure and coronary artery disease, particularly at the maximum dose of Dafiro HCT, 10 mg/320 mg/25 mg.
Pri bolnikih s srčnim popuščanjem in koronarno boleznijo je priporočena previdnost, zlasti pri uporabi najvišjega odmerka zdravila Dafiro HCT 10 mg/320 mg/25 mg.
• disorder in passing urine
• motnje uriniranja
Angioedema, including swelling of the larynx and glottis, causing airway obstruction and/or swelling of the face, lips, pharynx, and/or tongue, has been reported in patients treated with valsartan.
Pri bolnikih, ki so prejemali valsartan, so poročali o angioedemu, vključno z otekanjem grla in glasilk, ki povzroči obstrukcijo dihalnih poti in/ali otekanje obraza, ustnic, žrela in/ali jezika.
Rare (may affect up to 1 in 1,000 people):
Redki (pojavijo se pri največ 1 od 1.000 bolnikov):
Dafiro HCT 5 mg/160 mg/12.5 mg film-coated tablets Dafiro HCT 10 mg/160 mg/12.5 mg film-coated tablets Dafiro HCT 5 mg/160 mg/25 mg film-coated tablets Dafiro HCT 10 mg/160 mg/25 mg film-coated tablets Dafiro HCT 10 mg/320 mg/25 mg film-coated tablets amlodipine/valsartan/hydrochlorothiazide
Dafiro HCT 5 mg/160 mg/12,5 mg filmsko obložene tablete Dafiro HCT 10 mg/160 mg/12,5 mg filmsko obložene tablete Dafiro HCT 5 mg/160 mg/25 mg filmsko obložene tablete Dafiro HCT 10 mg/160 mg/25 mg filmsko obložene tablete Dafiro HCT 10 mg/320 mg/25 mg filmsko obložene tablete amlodipin/valsartan/hidroklorotiazid
If you have accidentally taken too many Dafiro HCT tablets, talk to a doctor immediately.You may require medical attention.
Če ste vzeli večji odmerek zdravila Dafiro HCT, kot bi smeli Če ste nehote vzeli preveč tablet zdravila Dafiro HCT, se takoj posvetujte z zdravnikom.
Multipack: 280 (4 packs of 70x1) film-coated tablets.
Skupno pakiranje: 280 (20 škatel po 14) filmsko obloženih tablet Skupno pakiranje: 280 (4 škatle po 70x1) filmsko obloženih tablet
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM Datum prve odobritve: 4. november 2009
How to take Dafiro HCT
Kako jemati zdravilo Dafiro HCT
Dafiro HCT should be discontinued immediately in patients who develop angioedema and should not be re-administered.
Bolnikom, pri katerih pride do angioedema, je treba zdravilo Dafiro HCT takoj ukiniti.
You should never take Dafiro HCT again.
Ti bolniki ne smejo več prejemati zdravila Dafiro HCT.
if you have experienced swelling, particularly of the face and throat, while taking other medicines (including angiotensin converting enzyme inhibitors).
če vam je bilo slabo (bruhanje ali driska); če je v času jemanja drugih zdravil (kar vključuje tudi zaviralce angiotenzinske konvertaze) pri vas prišlo do otekanja, zlasti v obraz in grlo oziroma žrelo.
Grapefruit and grapefruit juice should not be consumed by people who are prescribed Dafiro HCT.
Zdravilo Dafiro HCT skupaj s hrano, pijačo in alkoholom Ljudje, ki jim je zdravnik predpisal zdravilo Dafiro HCT, ne smejo uživati grenivk in grenivkinega soka.
• skin discolouration
• obarvanost kože
There is limited experience with the use of Dafiro HCT, particulary at the maximum dose, in patients with heart failure and coronary artery disease.
Pri bolnikih s srčnim popuščanjem in koronarno boleznijo je le malo izkušenj z uporabo zdravila Dafiro HCT, zlasti z uporabo najvišjega odmerka.
Very common (may affect more than 1 in 10 people):
Zelo pogosti (pojavijo se pri več kot 1 od 10 bolnikov)
Dafiro HCT 10 mg/320 mg/25 mg film-coated tablets
Dafiro HCT 10 mg/320 mg/25 mg filmsko obložene tablete
What Dafiro HCT looks like and contents of the pack Dafiro HCT 5 mg/160 mg/12.5 mg film-coated tablets are white, oval tablets with “NVR” on one side and “VCL” on the other side.
Izgled zdravila Dafiro HCT in vsebina pakiranja Dafiro HCT 5 mg/160 mg/12,5 mg filmsko obložene tablete so bele ovalne tablete z oznako “NVR” na eni strani in “VCL” na drugi.
• increased number of times of passing urine
• zvečana pogostnost uriniranja
Hypromellose, substitution type 2910 (3 mPa.s) Macrogol 4000
Obloga hipromeloza, substitucijski tip 2910 (3 mPa.s) titanov dioksid (E171) makrogol 4000 smukec
• stiffness
• vrtoglavost
Reversible increases in serum lithium concentrations and toxicity have been reported during concomitant administration of lithium with ACE inhibitors, angiotensin II receptor antagonists including valsartan or thiazides.
Med sočasno uporabo litija in zaviralcev angiotenzinske konvertaze, antagonistov angiotenzinskih receptorjev tipa II, vključno z valsartanom ali tiazidov, so poročali o reverzibilnem povečanju koncentracije litija v serumu in povečanju njegovih toksičnih učinkov.
• weakness
• oslabelost
• visual impairment
• motnje okušanja
An increased risk of non-melanoma skin cancer (NMSC) [basal cell carcinoma (BCC) and squamous cell carcinoma (SCC)] with increasing cumulative dose of hydrochlorothiazide exposure has been observed in two epidemiological studies based on the Danish National Cancer Registry.
Dve epidemiološki študiji, izvedeni na podlagi podatkov registra raka za Dansko, sta pokazali, da zaradi izpostavljenosti povečanemu kumulativnemu odmerku hidroklorotiazida obstaja povečano tveganje za razvoj nemelanomskega kožnega raka (bazalnoceličnega karcinoma in ploščatoceličnega karcinoma).
What Dafiro HCT contains
Kaj vsebuje zdravilo Dafiro HCT
• purple skin patches
• vijolične kožne lise
if you had an allergic reaction to other high blood pressure medicines or diuretics (a type of medicine also known as “water tablets”), especially if you suffer from asthma and allergies if you have been sick (vomiting or diarrhoea).
Če imate to bolezen, uporaba zdravila Dafiro HCT za vas ni priporočena; če imate bolezen, ki se imenuje sistemski eritematozni lupus (ki ga kratko imenujemo tudi “lupus” ali s kratico “SLE”); če imate sladkorno bolezen (visoko raven sladkorja v krvi); če imate visoke ravni holesterola ali trigliceridov v krvi; če imate po izpostavljanju soncu kožne reakcije, npr izpuščaj; če ste že imeli alergijsko reakcijo na druga zdravila za uravnavanje visokega krvnega tlaka ali na diuretike (skupino zdravil, ki jim pravimo tudi “tablete za odvajanje vode”), zlasti če imate astmo ali alergije;
Multipack: 280 (20 packs of 14) film-coated tablets.
280 filmsko obloženih tablet (skupno pakiranje, 20 škatel po 14 tablet)
Amlodipine, valsartan and hydrochlorothiazide exhibit linear pharmacokinetics.
Farmakokinetike amlodipina, valsartana in hidroklorotiazida so linearne.
Uncommon (may affect up to 1 in 100 people):
Občasni (pojavijo se pri največ 1 od 100 bolnikov):
• decrease in blood platelets which may result in unusual brusing or easy bleeding (red blood cell damage)
• znižanje števila trombocitov, kar lahko povzroči večjo nagnjenost k podplutbam ali krvavitvam
(haemolytic anaemia)
(poškodba rdečih krvnih celic)
Protect your skin from sun exposure and UV rays while taking Dafiro HCT.
Med jemanjem zdravila Dafiro HCT zaščitite kožo pred izpostavljenostjo soncu in UVžarkom.
Non cardiac chest pain
• bolečina v prsih
Pack sizes: 56, 98 or 280 film-coated tablets Multipacks of 280 tablets, comprising 4 cartons, each containing 70 tablets.
Skupna pakiranja po 280 tablet, ki vsebujejo 4 škatle, od katerih vsaka vsebuje 70 tablet.
Dafiro HCT 10 mg/320 mg/25 mg film-coated tablets are brown-yellow, oval tablets with “NVR” on one side and “VFL” on the other side.
Dafiro HCT 10 mg/320 mg/25 mg filmsko obložene tablete so rjavo rumene ovalne tablete z oznako “NVR” na eni strani in “VFL” na drugi.
Amlodipine dose recommendations have not been established in patients with mild to moderate hepatic impairment.
Pri bolnikih z blago do zmerno okvaro jeter priporočljivega odmerka amlodipina niso ugotavljali.
Dafiro HCT 10 mg/320 mg/25 mg film-coated tablets amlodipine/valsartan/hydrochlorothiaziade
Dafiro HCT 10 mg/320 mg/25 mg filmsko obložene tablete amlodipin/valsartan/hidroklorotiazid
No dose adjustment of Dafiro HCT is required for patients with mild to moderate renal impairment (GFR ≥30 ml/min/1.73 m
Pri bolnikih z blago do zmerno okvaro ledvic (GFR ≥30 ml/min/1,73 m 2) odmerka zdravila Dafiro
Dafiro HCT 5 mg/160 mg/25 mg film-coated tablets are yellow, oval tablets with “NVR” on one side and “VEL” on the other side.
Dafiro HCT 5 mg/160 mg/25 mg filmsko obložene tablete so rumene ovalne tablete z oznako “NVR” na eni strani in “VEL” na drugi.
Dafiro HCT 5 mg/160 mg/12.5 mg film-coated tablets
Dafiro HCT 5 mg/160 mg/12,5 mg filmsko obložene tablete
Dafiro HCT 10 mg/160 mg/12.5 mg film-coated tablets are pale yellow, oval tablets with “NVR” on one side and “VDL” on the other side.
Dafiro HCT 10 mg/160 mg/12,5 mg filmsko obložene tablete so bledo rumene ovalne tablete z oznako “NVR” na eni strani in “VDL” na drugi.
Dafiro HCT 10 mg/160 mg/12.5 mg film-coated tablets
Dafiro HCT 10 mg/160 mg/12,5 mg filmsko obložene tablete
Common Uncommon Orthostatic hypotension Uncommon
Bolezni imunskega sistema preobčutljivost zelo redki pogostnost neznana zelo redki
Common (may affect up to 1 in 10 people):
Pogosti (pojavijo se pri največ 1 od 10 bolnikov):
Dafiro HCT 5 mg/160 mg/25 mg film-coated tablets
Dafiro HCT 5 mg/160 mg/25 mg filmsko obložene tablete
Dafiro HCT 10 mg/160 mg/25 mg film-coated tablets
Dafiro HCT 10 mg/160 mg/25 mg filmsko obložene tablete
Dafiro 10 mg/320 mg/25 mg film-coated tablets The active substances of Dafiro HCT are amlodipine (as amlodipine besylate), valsartan and hydrochlorothiazide.
Dafiro HCT 10 mg/320 mg/25 mg filmsko obložene tablete Učinkovine v zdravilu Dafiro HCT so amlodipin (v obliki amlodipinijevega besilata), valsartan in hidroklorotiazid.
• abdominal discomfort
• slaba prebava
• dizziness
• zadihanost
Dafiro HCT 10 mg/160 mg/25 mg film-coated tablets are brown-yellow, oval tablets with “NVR” on one side and “VHL” on the other side.
Dafiro HCT 10 mg/160 mg/25 mg filmsko obložene tablete so rjavo rumene ovalne tablete z oznako “NVR” na eni strani in “VHL” na drugi.
Titanium dioxide (E171) Iron oxide, yellow (E172) Iron oxide, red (E172)
Obloga hipromeloza, substitucijski tip 2910 (3 mPa.s) makrogol 4000 smukec titanov dioksid (E171) rumeni železov oksid (E172) rdeči železov oksid (E172)
The other ingredients are cellulose microcrystalline; crospovidone (type A); silica, colloidal anhydrous; magnesium stearate; hypromellose (substitution type 2910 (3 mPa.s)), macrogol 4000, talc, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172).
Druge sestavine zdravila so mikrokristalna celuloza, krospovidon (tipa A), brezvoden koloidni silicijev dioksid, magnezijev stearat, hipromeloza (substitucijski tip 2910 (3 mPa.s)), makrogol 4000, smukec, titanov dioksid (E171), rumeni železov oksid (E172), rdeči železov oksid (E172).
Dafiro HCT is contraindicated in patients with severe renal impairment, anuria or undergoing dialysis (see section 4.3).
Pri bolnikih s hudo okvaro ledvic, z anurijo in pri bolnikih na dializi je uporaba zdravila Dafiro HCT kontraindicirana (glejte poglavje 4.3).
Caution required with concomitant use
Način uporabe peroralna uporaba
• dry mouth
• vročinski oblivi
• indigestion
• omotičnost
Dafiro HCT 5 mg/160 mg/25 mg film-coated tablets amlodipine/valsartan/hydrochlorothiaziade
Dafiro HCT 5 mg/160 mg/25 mg filmsko obložene tablete amlodipin/valsartan/hidroklorotiazid
Dafiro HCT 5 mg/160 mg/25 mg film-coated tablets The active substances of Dafiro HCT are amlodipine (as amlodipine besylate), valsartan and hydrochlorothiazide.
Dafiro HCT 5 mg/160 mg/25 mg filmsko obložene tablete Učinkovine v zdravilu Dafiro HCT so amlodipin (v obliki amlodipinijevega besilata), valsartan in hidroklorotiazid.
Dafiro HCT 10 mg/160 mg/25 mg film-coated tablets amlodipine/valsartan/hydrochlorothiaziade
Dafiro HCT 10 mg/160 mg/25 mg filmsko obložene tablete amlodipin/valsartan/hidroklorotiazid
Dafiro HCT 10 mg/160 mg/12.5 mg film-coated tablets The active substances of Dafiro HCT are amlodipine (as amlodipine besylate), valsartan and hydrochlorothiazide.
Dafiro HCT 10 mg/160 mg/12,5 mg filmsko obložene tablete Učinkovine v zdravilu Dafiro HCT so amlodipin (v obliki amlodipinijevega besilata), valsartan in hidroklorotiazid.
• pain
• zadah
Dafiro HCT 5 mg/160 mg/12.5 mg film-coated tablets The active substances of Dafiro HCT are amlodipine (as amlodipine besylate), valsartan and hydrochlorothiazide.
Dafiro HCT 5 mg/160 mg/12,5 mg filmsko obložene tablete Učinkovine v zdravilu Dafiro HCT so amlodipin (v obliki amlodipinijevega besilata), valsartan in hidroklorotiazid.
Talk to your doctor or pharmacist before taking Dafiro HCT if you have a low level of potassium or magnesium in your blood (with or without symptoms such as muscle weakness, muscle spasms, abnormal heart rhythm).
Pred začetkom jemanja zdravila Dafiro HCT se posvetujte z zdravnikom ali farmacevtom če imate v krvi nizke ravni kalija ali magnezija (s simptomi, kot so šibkost mišic, mišični krči in nepravilen srčni ritem, ali brez teh simptomov); če imate v krvi nizke ravni natrija (s simptomi, kot so utrujenost, zmedenost, trzanje mišic in napadi krčev, ali brez teh simptomov); če imate v krvi visoko raven kalcija (s simptomi, kot so slabost, bruhanje, zapeka, bolečine v trebuhu, pogosto uriniranje, žeja, šibkost in trzanje mišic, ali brez teh simptomov); če imate težave z ledvicami, če so vam presadili ledvico ali so vam povedali, da imate zoženje ledvičnih arterij; če imate težave z jetri; če imate ali ste imeli kdaj prej srčno popuščanje ali koronarno bolezen, zlasti če vam je zdravnik predpisal najvišji odmerek zdravila Dafiro HCT (10 mg/320 mg/25 mg); če ste preživeli srčni infarkt.
• fainting
• omedlevica
The other ingredients are cellulose microcrystalline; crospovidone (type A); silica, colloidal anhydrous, magnesium stearate, hypromellose (substitution type 2910 (3 mPa.s)), macrogol 4000, talc, yellow iron oxide (E172).
Druge sestavine zdravila so mikrokristalna celuloza, krospovidon (tipa A), brezvoden koloidni silicijev dioksid, magnezijev stearat, hipromeloza (substitucijski tip 2910 (3 mPa.s)), makrogol 4000, smukec, rumeni železov oksid (E172).
Dafiro HCT 10 mg/160 mg/25 mg film-coated tablets The active substances of Dafiro HCT are amlodipine (as amlodipine besylate), valsartan and hydrochlorothiazide.
Dafiro HCT 10 mg/160 mg/25 mg filmsko obložene tablete Učinkovine v zdravilu Dafiro HCT so amlodipin (v obliki amlodipinijevega besilata), valsartan in hidroklorotiazid.
Dafiro HCT 5 mg/160 mg/12.5 mg film-coated tablets amlodipine/valsartan/hydrochlorothiaziade
Dafiro HCT 5 mg/160 mg/12,5 mg filmsko obložene tablete amlodipin/valsartan/hidroklorotiazid
Dafiro HCT 10 mg/160 mg/12.5 mg film-coated tablets amlodipine/valsartan/hydrochlorothiaziade
Dafiro HCT 10 mg/160 mg/12,5 mg filmsko obložene tablete amlodipin/valsartan/hidroklorotiazid
• hair loss
• srbeča koža
The other ingredients are cellulose microcrystalline; crospovidone (type A); silica, colloidal anhydrous; magnesium stearate; hypromellose (substitution type 2910 (3 mPa.s)), macrogol 4000, talc, titanium dioxide (E171).
Druge sestavine zdravila so mikrokristalna celuloza, krospovidon (tipa A), brezvoden koloidni silicijev dioksid, magnezijev stearat, hipromeloza (substitucijski tip 2910 (3 mPa.s)), makrogol 4000, smukec, titanov dioksid (E171).
Each film-coated tablet contains 10 mg amlodipine (as amlodipine besylate), 160 mg valsartan and 25 mg hydrochlorothiazide.
Ena filmsko obložena tableta vsebuje 10 mg amlodipina (v obliki amlodipinijevega besilata), 160 mg valsartana in 25 mg hidroklorotiazida.
Each film-coated tablet contains 5 mg amlodipine (as amlodipine besylate), 160 mg valsartan and 25 mg hydrochlorothiazide.
Ena filmsko obložena tableta vsebuje 5 mg amlodipina (v obliki amlodipinijevega besilata), 160 mg valsartana in 25 mg hidroklorotiazida.
The other ingredients are cellulose microcrystalline; crospovidone (type A); silica, colloidal anhydrous, magnesium stearate, hypromellose (substitution type 2910 (3 mPa.s)), macrogol 4000, talc, titanium dioxide (E171), yellow iron oxide (E172).
Druge sestavine zdravila so mikrokristalna celuloza, krospovidon (tipa A), brezvoden koloidni silicijev dioksid, magnezijev stearat, hipromeloza (substitucijski tip 2910 (3 mPa.s)), makrogol 4000, smukec, titanov dioksid (E171), rumeni železov oksid (E172).
Each film-coated tablet contains 10 mg amlodipine (as amlodipine besylate), 160 mg valsartan and 12.5 mg hydrochlorothiazide.
Ena filmsko obložena tableta vsebuje 10 mg amlodipina (v obliki amlodipinijevega besilata), 160 mg valsartana in 12,5 mg hidroklorotiazida.
EU/1/09/574/032 56 x 1 film-coated tablet (unit dose) EU/1/09/574/033 98 x 1 film-coated tablet (unit dose) EU/1/09/574/034 280 x 1 film-coated tablet (unit dose)
Dafiro HCT 10 mg/320 mg/25 mg filmsko obložene tablete EU/1/09/574/049-060
Each film-coated tablet contains 5 mg amlodipine (as amlodipine besylate), 160 mg valsartan and 12.5 mg hydrochlorothiazide.
Ena filmsko obložena tableta vsebuje 5 mg amlodipina (v obliki amlodipinijevega besilata), 160 mg valsartana in 12,5 mg hidroklorotiazida.
if you experience dizziness and/or fainting during treatment with Dafiro HCT, tell your doctor as soon as possible.
V tem primeru zdravila Dafiro HCT nikoli več ne smete več jemati; če med zdravljenjem z zdravilom Dafiro HCT pride do omotičnosti in/ali izgube zavesti, čimprej obvestite zdravnika; če se vam poslabša vid ali vas začne boleti oko.
• weight decrease
• zmanjšanje telesne mase
Cutaneous lupus erythematosus-like reactions, reactivation of cutaneous lupus erythematosus
Ušesne bolezni, vključno z motnjami labirinta tinitus vrtoglavica
• chest pain
• bolezen jeter
• anticholinergic agents (medicines used to treat a variety of disorders such as gastrointestinal cramps, urinary bladder spasm, asthma, motion sickness, muscular spasms, Parkinson's disease and as an aid to anaesthesia);
• mišičnih relaksantov (zdravil za sproščanje mišic, ki jih uporabljajo med operacijami); nitroglicerina in drugih nitratov ter učinkovin, ki jih imenujemo “vazodilatatorji”; drugih zdravil za zdravljenje visokega krvnega tlaka, vključno z metildopo; rifampicina (ki ga uporabljamo za zdravljenje npr. tuberkuloze), eritromicin, klaritromicin (antibiotiki); šentjanževke; dantrolen (zdravilo v infuziji pri hudih odstopanjih telesne temperature); vitamina D in kalcijevih soli.
Dafiro HCT should be discontinued if hypercalcaemia develops during treatment.
Če pride med zdravljenjem do razvoja hiperkalciemije, je treba uporabo zdravila Dafiro HCT prekiniti.
Dafiro HCT with food, drink and alcohol
Shranjevanje zdravila Dafiro HCT Vsebina pakiranja in dodatne informacije
• anxiety
• nespečnost
Withdrawal period
Pakiranje
The full EPAR and risk management plan summary for Pemetrexed Lilly can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) in povzetek načrta obvladovanja tveganj za zdravilo Pemetrexed Lilly sta na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The medicine can only be obtained with a prescription and should only be given under the supervision of a doctor who is qualified in the use of chemotherapy.
Izdaja zdravila je le na recept, daje pa se lahko samo pod nadzorom zdravnika, ki je usposobljen za uporabo kemoterapije.
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Pemetrexed Lilly has been shown to be comparable to Alimta.
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da je bilo v skladu z zahtevami EU dokazano, da je zdravilo Pemetrexed Lilly primerljivo z zdravilom Alimta.
This is a summary of the European public assessment report (EPAR) for Pemetrexed Lilly.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Pemetrexed Lilly.
What measures are being taken to ensure the safe and effective use of Pemetrexed Lilly?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Pemetrexed Lilly?
Pemetrexed Lilly is a cancer medicine used to treat two types of lung cancer:
Pemetrexed Lilly je zdravilo proti raku, ki se uporablja za zdravljenje dveh vrst pljučnega raka:
This means that Pemetrexed Lilly is similar to a ‘reference medicine' already authorised in the European Union (EU) called Alimta.
To pomeni, da je podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Alimta.
The Committee recommended that Pemetrexed Lilly be approved for use in the EU.
Priporočil je, da se zdravilo Pemetrexed Lilly odobri za uporabo v EU.
Because Pemetrexed Lilly is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.
Ker je zdravilo Pemetrexed Lilly generično zdravilo, so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Pemetrexed Lilly, including the appropriate precautions to be followed by healthcare professionals and patients.
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila Pemetrexed Lilly in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
What are the benefits and risks of Pemetrexed Lilly?
Kakšne so koristi in tveganja, povezani z zdravilom Pemetrexed Lilly?
A risk management plan has been developed to ensure that Pemetrexed Lilly is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Pemetrexed Lilly je bil pripravljen načrt obvladovanja tveganj.
Pemetrexed Lilly is a ‘generic medicine'.
Zdravilo Pemetrexed Lilly je „generično zdravilo“.