natgillin/translations-raw huggingface dataset:
It is considered unlikely that Axumin will affect your ability to drive or to use machines.
Verjetnost, da bo zdravilo Axumin vplivalo na vašo sposobnost za vožnjo ali upravljanje strojev, naj bi bila majhna.
Please refer to the SmPC [SmPC should be included in the box]
[povzetek mora biti priložen v škatli]
GE Healthcare Ltd, Amersham HP7 9LL, UK Advanced Accelerator Applications, 50100, La Almunia-Zaragoza, Spain Advanced Accelerator Applications, 407014, Meldola (FC), Italy Advanced Accelerator Applications, 92210 Saint Cloud, France
GE Healthcare Ltd, Amersham HP7 9LL, Velika Britanija Advanced Accelerator Applications, 50100, Zaragoza, Španija Advanced Accelerator Applications, 407014, Meldola (FC), Italija Advanced Accelerator Applications, 92210 Saint Cloud, Francija
Axumin has not been studied in patients with renal or hepatic impairment.
Zdravila Axumin niso preučevali pri bolnikih z okvaro ledvic ali jeter.
N True positive n (%) False positive n (%) True negative n (%) False negative n (%) Sensitivity [95% CI] Specificity [95% CI] Positive likelihood ratio [95% CI] Negative likelihood ratio [95% CI]
[95 % IZ] Pozitivno razmerje verjetnosti [95 % IZ] Negativno razmerje verjetnosti [95 % IZ]
Radiopharmaceuticals should be received, used and administered only by authorised persons in designated clinical settings.
Prevzem, uporaba in dajanje radiofarmakov smejo potekati samo v ustreznem kliničnem okolju, uporabljati in dajati pa jih sme samo pooblaščeno osebje.
Mechanism of action Fluciclovine (18F) is a synthetic amino acid which is transported across mammalian cell membranes by amino acid transporters such as LAT-1 and ASCT2.
[18F]fluciklovin je sintetična aminokislina, ki jo prenašalci aminokislin, kot sta LAT-1 in ASCT2, prenašajo skozi celične membrane sesalcev.
Method of administration Axumin is for intravenous use.
Zdravilo Axumin je za intravensko uporabo.
The recommended activity for an adult is 370 MBq fluciclovine (18F).
Priporočena aktivnost za odrasle je 370 MBq [18F]fluciklovina.
Fluorine (18F) decays to stable oxygen (18O) with a half-life of 110 minutes by emitting a positronic radiation of maximum energy of 634 keV, followed by photonic annihilation radiations of 511 keV.
Fluor (18F) z oddajanjem pozitronskega sevanja z največjo energijo 634 keV, čemur sledi fotonsko anihilacijsko sevanje s 511 keV, razpade na stabilni kisik (18O) z razpolovnim časom 110 minut.
What Axumin is and what it is used for
Kaj je zdravilo Axumin in za kaj ga uporabljamo
Seibersdorf Labor GmbH, 2444 Seibersdorf, Austria Norsk medisinsk syklotronsenter AS, 0372 Oslo, Norway Advanced Accelerator Applications, 13005 Marseille, France Nucleis SA, 4000 Liège, Belgium
Seibersdorf Labor GmbH, 2444 Seibersdorf, Avstrija Norsk medisinsk syklotronsenter AS, 0372 Oslo, Norveška Advanced Accelerator Applications, 13005 Marseille, Francija Nucleis SA, 4000 Liège, Belgija
Storage of radiopharmaceuticals should be in accordance with national regulation on radioactive materials.
Shranjevanje radiofarmacevtskih izdelkov mora biti skladno z lokalnimi predpisi o radioaktivnih snoveh.
Interpretation of fluciclovine (18F) images and limitations of use Fluciclovine (18F) images should be interpreted by appropriately trained personnel.
Razlaga slik, izdelanih z [18F]fluciklovinom, in omejitve pri uporabi Slike, izdelane z [18F]fluciklovinom, mora razlagati ustrezno usposobljeno osebje.
PET scanning should begin from 3-5 minutes (target 4 minutes) after completion of the injection; an acquisition time of 3 minutes per bed position is recommended.
Slikanje PET je treba začeti 3-5 minut (najbolje 4 minute) po koncu injiciranja;
PET images with fluciclovine (18F) should be interpreted visually.
Slike PET, izdelane z [18F]fluciklovinom, je treba razlagati vizualno.
The MAH shall ensure that in each Member State where Axumin is marketed, all Healthcare professionals who are expected to use Axumin have access to self-training educational material in order to reduce the risk of PET imaging interpretation errors.
Za namenom zmanjševanja tveganja za napake pri razlaganju slik PET mora imetnik dovoljenja za promet z zdravilom zagotoviti, da imajo v vsaki državi članici, v kateri se zdravilo Axumin trži, vsi zdravstveni delavci, za katere se pričakuje, da bodo uporabljali zdravilo Axumin, dostop do izobraževalnega gradiva za samostojno usposabljanje.
What you need to know before Axumin is used Axumin must not be used:
Kaj morate vedeti, preden boste uporabili zdravilo Axumin Ne uporabljajte zdravila Axumin:
Axumin contains sodium
Zdravilo Axumin vsebuje natrij
Suspicion of cancer in sites typical for prostate cancer recurrence is based on fluciclovine (18F) uptake in comparison with tissue background.
Sum na raka na mestih, značilnih za ponovitev raka prostate, temelji na privzemu [18F]fluciklovina v primerjavi z okoliškimi tkivi.
Axumin should only be used when the injection volume is greater than 0.5 mL (approximately 2 hours after time of calibration for Axumin 1600 MBq/mL and 4 hours after time of calibration for Axumin 3200 MBq/mL).
Zdravilo Axumin se sme uporabiti samo takrat, ko je volumen injiciranja večji od 0,5 ml (približno 2 uri po času umerjanja za zdravilo Axumin 1600 MBq/ml in 4 ure po času umerjanja za zdravilo
Administration procedures should be carried out in a way to minimise risk of contamination of the medicinal product and irradiation of the operators.
Zdravilo je treba dajati tako, da se zmanjša tveganje za kontaminacijo zdravila in obsevanje osebja.
Total body
Maternica Celotno telo
Fluciclovine (18F) distributes immediately following administration to the liver (14% of administered activity), pancreas (3%), lung (7%), red bone marrow (12%) and heart wall (4%).
(3 %), pljuča (7 %), rdeči kostni mozeg (12 %) in srčno steno (4 %).
What Axumin looks like and contents of the pack
Izgled zdravila Axumin in vsebina pakiranja
Radiation protection precautions in accordance with national regulations must therefore be taken.
Zato je treba upoštevati nacionalne predpise glede previdnostnih ukrepov za zaščito pred sevanjem.
Adverse reactions were reported commonly (≥ 1/100 to < 1/10) during clinical trials.
Preglednica neželenih učinkov V kliničnih preskušanjih so pogosto poročali o neželenih učinkih (pri ≥ 1/100 do < 1/10 bolnikih).
How Axumin is stored 6.
Shranjevanje zdravila Axumin 6.
Pharmacodynamic effects At the chemical concentrations used for diagnostic examinations, fluciclovine (18F) does not appear to have any pharmacodynamic activity.
Farmakodinamični učinki Ni videti, da bi [18F]fluciklovin pri kemijskih koncentracijah, ki se uporabljajo za diagnostične preiskave, imel kakršno koli farmakodinamično aktivnost.
If the integrity of this vial is compromised, the medicinal product should not be used.
Če se poseg v vialo ne more izključiti, se zdravilo ne sme uporabiti.
Effect of blood PSA level on the patient-based diagnostic performance of fluciclovine (18F) PET-CT at BED-001 Emory
Vpliv ravni PSA na diagnostično učinkovitost slikanja PET-CT z [18F]fluciklovinomv študiji BED-001 Emory
Pharmacotherapeutic group: Other diagnostic radiopharmaceuticals for tumour detection, ATC code:
Farmakoterapevtska skupina: drugi radiodiagnostiki za tumorje, oznaka ATC: V09IX12.
Elderly No dose adjustment required.
Prilagajanje odmerkov ni potrebno.
The Patient-based diagnostic performance of fluciclovine (18F) PET-CT by blood PSA level is shown in Table 2.
Diagnostična učinkovitost slikanja PET-CT z [18F]fluciklovinom glede na krvno raven PSA je prikazana v preglednici 2.
Red bone marrow Osteogenic cells Skin
Osteogene celice Koža
Using the findings of other relevant imaging modalities and clinical follow-up as reference standard in the recruited population, patient-based sensitivity and specificity of fluciclovine (18F) PET-CT for detection of prostate/prostate bed recurrences were 94.7% (89/94) (95%CI: 88.0-98.3%) and 54.8% (17/31) (95%CI:36-72.7%), respectively.
[18F]fluciklovinom na podlagi bolnika za odkrivanje ponovitev raka na prostati/ležišču prostate 94,7 % (89/94) (95 % IZ: 88,0-98,3 %) oziroma 54,8 % (17/31) (95 % IZ:36-72,7 %).
- The active substance is fluciclovine (18F).
- Učinkovina je [18F]fluciklovin.
Images should only be interpreted by readers trained in the interpretation of PET images with fluciclovine (18F).
Slike sme razlagati samo osebje, usposobljeno za razlago slik PET z [18F]fluciklovinom.
Talk to your nuclear medicine doctor if you are under 18 years old.
Če ste mlajši od 18 let, se pogovorite s specialistom nuklearne medicine.
A PET scan with fluciclovine (18F) should be administered by appropriately qualified healthcare professionals.
Slikanje s pozitronsko emisijsko tomografijo (PET) z [18F]fluciklovinom morajo opraviti ustrezno usposobljeni zdravstveni delavci.
Chemical and physical in-use stability has been demonstrated for Axumin 1600 MBq/mL for 8 hours and for Axumin 3200 MBq/mL for 10 hours.
Dokazano je, da je zdravilo Axumin 1600 MBq/ml kemijsko in fizikalno stabilno 8 ur in zdravilo Axumin 3200 MBq/ml 10 ur.
ANNEX II A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET Z
Axumin 3200 MBq/mL solution for injection 10 hours from the time of calibration (ToC)
Axumin 3200 MBq/ml raztopina za injiciranje 10 ur od časa umerjanja (ToC, time of calibration)
Image interpretation errors can occur with PET with fluciclovine (18F) (see section 5.1).
Pri pozitronski emisijski tomografiji lahko pride do napak pri razlagi slik PET, izdelanih z [18F]fluciklovinom (glejte poglavje 5.1).
For larger lesions, uptake equal to or greater than bone marrow is considered suspicious for cancer.
Pri večjih lezijah kaže na verjetnost raka privzem, enak ali večji od privzema v kostni mozeg.
Talk to your nuclear medicine doctor before you are given Axumin if you: - have kidney problems - are on a low sodium diet (see section "Axumin contains sodium").
- imate težave z ledvicami; - se morate držati diete z malo natrija (glejte poglavje »Zdravilo Axumin vsebuje natrij«).
The medicinal product may be diluted with sodium chloride 9 mg/mL (0.9%) solution for injection by up to a factor of 8.
Zdravilo se lahko razredči z 0,9-odstotno (9 mg/ml) raztopino natrijevega klorida za injiciranje, tako da je volumen končne raztopine za do 8-krat večji.
Fluciclovine is not metabolised in vivo.
Fluciklovin se ne presnavlja in vivo.
For small lesions (<1 cm diameter) focal uptake greater than blood pool should be considered suspicious for cancer.
Pri majhnih lezijah (s premerom < 1 cm) kaže na verjetnost raka žariščni privzem, ki je večji kot v ožilju.
The activity of fluciclovine (18F) has to be measured with an activimeter immediately prior to injection.
Tik pred injiciranjem je treba z merilnikom aktivnosti izmeriti aktivnost [18F]fluciklovina.
Axumin 1600 MBq/mL solution for injection 8 hours from the time of calibration (ToC)
Axumin 1600 MBq/ml raztopina za injiciranje 8 ur od časa umerjanja (ToC, time of claibration)
How Axumin is used
Kako uporabljati zdravilo Axumin
Axumin 1600 MBq/mL solution for injection Axumin 3200 MBq/mL solution for injection
Axumin 1600 MBq/ml raztopina za injiciranje Axumin 3200 MBq/ml raztopina za injiciranje
Axumin is for multidose use.
Zdravilo Axumin je namenjeno za večkratno uporabo (več odmerkov).
It should be recommended to the patient that they do not undertake any significant exercise for at least a day before the fluciclovine (18F) scan.
Bolniku je treba odsvetovati večjo telesno dejavnost vsaj en dan pred slikanjem z uporabo
Fluciclovine (18F) uptake is not specific for prostate cancer and may occur with other types of cancer, prostatitis and benign prostatic hyperplasia.
Privzem [18F]fluciklovina ni specifičen za raka prostate in se lahko pojavi pri drugih vrstah raka,
The adult effective dose resulting from the administration of the recommended activity of 370 MBq of fluciclovine (18F) is 8.2 mSv.
Efektivni odmerek za odrasle po aplikaciji priporočene aktivnosti 370 MBq [18F]fluciklovina je
Renal/Hepatic impairment The pharmacokinetics in patients with renal or hepatic impairment have not been characterised.
Farmakokinetike pri bolnikih z okvaro ledvic ali jeter niso opredelili.
Fluciclovine (18F) PET-CT was restricted to the abdomino-pelvic region.
Slikanje PET-CT s fluciklovinom [18F] je bilo omejeno na območje trebuha in medenice.
88.6% for all three readers while specificity ranged from 17.2-53.6%.
Občutljivost [18F]fluciklovina na podlagi bolnika je bila višja od 88,6 % za vse tri razlagalce, medtem ko je bila specifičnost v razponu 17,2
The PSA value may affect the diagnostic performance of fluciclovine (18F) PET. (see section 5.1, Pharmacodynamic properties).
[18F]fluciklovina (glejte poglavje 5.1 Farmakodinamične lastnosti).
Concentrated hydrochloric acid Sodium hydroxide Water for injections
FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi natrijev citrat koncentrirana klorovodikova kislina natrijev hidroksid voda za injekcije
Volume: {xx.x} mL
Prostornina: {xx,x} ml
True positive (%) False positive (%) True negative (%) False negative (%) Sensitivity [95% CI] Specificity [95% CI]
Resnično pozitivni Lažno pozitivni Resnično negativni Lažno negativni
Each multidose vial contains 1 to 10 mL of solution, corresponding to 3200 to 32000 MBq at the date and time of calibration (ToC).
Ena večodmerna viala vsebuje od 1 do 10 ml raztopine, kar ustreza od 3200 MBq do 32.000 MBq ob datumu in uri umerjanja (ToC, time of calibration).
After administration of Axumin you should:
Pred prejemom zdravila Axumin ne smete:
Patient and region based diagnostic performance of fluciclovine 18F PET vs histopathology
Diagnostična uspešnost slikanja PET z [18F]fluciklovinom na podlagi bolnika in telesnega predela v primerjavi s histopatologijo
Axumin is administered intravenously as an injection into your vein followed by a flush of sodium chloride solution to ensure that you receive the full dose.
Temu sledi izpiranje z raztopino natrijevega klorida, ki zagotovi, da dobite celoten odmerek.
Axumin 3200 MBq/mL solution for injection fluciclovine (18F)
Axumin 3200 MBq/ml raztopina za injiciranje [18F]fluciklovin
Paediatric population There is no relevant use of fluciclovine (18F) in the paediatric population.
[18F]fluciklovin ni namenjen za uporabo pri pediatrični populaciji.
Each multidose vial contains 1 to 10 mL of solution, corresponding to 1600 to 16000 MBq at the date and time of calibration (ToC).
Ena večodmerna viala vsebuje od 1 do 10 ml raztopine, kar ustreza od 1600 do 16.000 MBq [18F]fluciklovina ob datumu in uri umerjanja (ToC, time of calibration).
Axumin 3200 MBq/mL solution for injection
Axumin 3200 MBq/ml raztopina za injiciranje
Advanced Accelerator Applications, 13005 Marseille, France Nucleis SA, 4000 Liège, Belgium
Nucleis SA, 4000 Liège, Belgija.
Axumin 1600 MBq/mL solution for injection fluciclovine (18F)
Axumin 1600 MBq/ml raztopina za injiciranje [18F]fluciklovin intravenska uporaba
The detection of prostate cancer recurrence in prostate/prostate bed, regional lymph nodes, bone, soft tissue and non-regional lymph nodes by fluciclovine (18F) PET has been reported.
Pri slikanju PET z [18F]fluciklovinom so poročali o odkritju ponovitve raka prostate v prostati/ležišču prostate, regionalnih bezgavkah, kosteh, mehkem tkivu in neregionalnih bezgavkah.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING SHIELD LABEL
NALEPKA NA ŠČITNIKU
Axumin 1600 MBq/mL solution for injection
Axumin 1600 MBq/ml raztopina za injiciranje
Parosmia
Slikanje
- avoid any close contact with young children and pregnant women for the 12 hours following the injection - urinate frequently in order to eliminate the product from your body.
- 12 ur po injiciranju ne bodite v tesnih stikih z majhnimi otroki in nosečnicami;
V09IX12.
8,2 mSv.
How Axumin is stored
Shranjevanje zdravila Axumin
Testes
ZDRAVILA
Axumin 1600 MBq/mL solution for injection One vial contains 1 to 10 mL of solution, corresponding to 1600 to 16000 MBq at calibration time.
Axumin 1600 MBq/ml raztopina za injiciranje Ob datumu in uri umerjanja (ToC-time of calibration) en ml raztopine vsebuje 1600 MBq [18F]fluciklovina.
If you get any side effects talk to your nuclear medicine doctor.
Če imate kakršna koli vprašanja, se obrnite na specialista nuklearne medicine.
Each mL of solution contains 1600 MBq fluciclovine (18F) at date and time of calibration (ToC).
En ml raztopine vsebuje 1600 MBq [18F]fluciklovina ob datumu in uri umerjanja (ToC, time of calibration).
Each mL of solution for injection contains 1600 MBq of fluciclovine (18F) at date and time of calibration (ToC).
En ml raztopine za injiciranje vsebuje 1600 MBq [18F]fluciklovina ob datumu in uri umerjanja (ToC).
Each mL of solution contains 3200 MBq of fluciclovine (18F) at the date and time of calibration (ToC).
En ml raztopine vsebuje 3200 MBq [18F]fluciklovina ob datumu in uri umerjanja (ToC, time of claibration).
Extraprostatic (pelvic and distal recurrence)
(medenična in distalna ponovitev)
An additional study BED002 conducted a blinded read of fluciclovine (18F) PET-CT images from the
[95 % IZ] Specifičnost [95 % IZ] V dodatni študiji BED002 so izvedli slepo razlaganje slik PET-CT, izdelanih z [18F]fluciklovinom, iz podatkov podskupine Emory v študiji BED001 s 3 razlagalci slik.
Axumin 3200 MBq/mL solution for injection One vial contains 1 to 10 mL of solution, corresponding to 3200 to 32000 MBq at calibration time.
Ena viala vsebuje od 1 do 10 ml raztopine, kar ustreza od 3200 do 32.000 MBq ob času umerjanja.
Tabulated list of adverse reactions
Organski sistem po MedDRA NEŽELENI UČINKI
The activity per vial ranges from 1600 MBq to 16000 MBq at the date and time of calibration.
Aktivnost na vialo ob datumu in uri umerjanja se giblje med 1600 MBq in 16.000 MBq.
Each mL of solution contains 3200 MBq fluciclovine (18F) at date and time of calibration (ToC).The activity per vial ranges from 3200 MBq to 32000 MBq at the date and time of calibration.
Ob datumu in uri umerjanja (ToC, time of calibration) se aktivnost na vialo giblje med 3200 in 32.000 MBq.
Norsk medisinsk syklotronsenter AS, 0372 Oslo, Norway.
Seibersdorf Labor GmbH, 2444 Seibersdorf, Avstrija Norsk medisinsk syklotronsenter AS, 0372 Oslo, Norveška Advanced Accelerator Applications, 13005 Marseille, Francija.
The full EPAR for Clopidogrel Krka 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) za zdravilo Klopidogrel Krka je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The European Commission granted a marketing authorisation valid throughout the European Union for Clopidogrel Krka on 23 September 2009.
Evropska komisija je dovoljenje za promet z zdravilom Klopidogrel Krka, veljavno po vsej Evropski uniji, izdala 23. septembra 2009.
This is a summary of the European public assessment report (EPAR) for Clopidogrel Krka.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Klopidogrel Krka.
Clopidogrel Krka clopidogrel
Klopidogrel Krka klopidogrel
What measures are being taken to ensure the safe and effective use of Clopidogrel Krka?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Klopidogrel Krka?
What are the benefits and risks of Clopidogrel Krka?
Kakšne so koristi in tveganja, povezani z zdravilom Klopidogrel Krka?
This means that Clopidogrel Krka is similar to a ‘reference medicine' already authorised in the European Union (EU) called Plavix.
To pomeni, da je podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Plavix.
The standard dose is one 75-mg tablet once a day.
Običajni odmerek zdravila je ena 75-miligramska tableta na dan.
In acute coronary syndrome and atrial fibrillation, Clopidogrel Krka is used together with aspirin, the dose of which should not be higher than 100 mg.
Pri akutnem koronarnem sindromu in atrijski fibrilaciji se zdravilo Klopidogrel Krka uporablja skupaj z aspirinom, katerega odmerek ne sme biti višji od 100 mg.
It is used in those patients who have at least one risk factor for vascular events such as a heart attack or stroke, cannot take vitamin K antagonists (other medicines that prevent blood clots) and are at low risk of bleeding.
Uporablja se pri tistih bolnikih, ki imajo vsaj en dejavnik tveganja za vaskularne dogodke, kot je srčni napad ali možganska kap, ki ne smejo jemati antagonistov vitamina K (drugega zdravila, ki preprečuje krvne strdke) in pri katerih je tveganje za krvavitve majhno.
Clopidogrel Krka can be started between a few days and 35 days after the attack;
Zdravilo Klopidogrel Krka se lahko začne jemati nekaj dni po napadu do 35 dni po njem;
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Clopidogrel Krka have been included in the summary of product characteristics and the package leaflet.
Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Klopidogrel Krka upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
It is not intended to provide practical advice on how to use Clopidogrel Krka.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
For more information about treatment with Clopidogrel Krka, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Klopidogrel Krka preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
The European Medicines Agency concluded that, in accordance with EU requirements, Clopidogrel Krka has been shown to have comparable quality and to be bioequivalent to Plavix.
Evropska agencija za zdravila je zaključila, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Klopidogrel Krka primerljivo raven kakovosti kot referenčno zdravilo Plavix ter da mu je biološko enakovredno.
Clopidogrel Krka is available as tablets containing 75 mg clopidogrel.
Zdravilo Klopidogrel Krka je na voljo v obliki tablet, ki vsebujejo 75 mg klopidogrela.
Because Clopidogrel Krka is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Ker je zdravilo Klopidogrel Krka generično zdravilo in je biološko enakovredno referenčnemu zdravilu, so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
Clopidogrel Krka is used to prevent problems caused by blood clots in adults who have:
Zdravilo Klopidogrel Krka se uporablja za preprečevanje težav, ki jih povzročajo krvni strdki pri odraslih:
What is Clopidogrel Krka and what is it used for?
Kaj je zdravilo Klopidogrel Krka in za kaj se uporablja?
Clopidogrel Krka is a ‘generic medicine'.
Zdravilo Klopidogrel Krka je „generično zdravilo“.
For practical information about using Clopidogrel Krka, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Klopidogrel Krka naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
• recently had an ischaemic stroke (stroke caused by failure of the blood supply to part of the brain).
• ki so nedavno utrpeli ishemično kap (kap, ki jo povzroči pomanjkljiva oskrba določenega dela možganov s krvjo).
Because Clopidogrel Krka is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Plavix.
Ker je zdravilo Klopidogrel Krka generično zdravilo, so bile študije pri ljudeh omejene na preskuse za ugotavljanje, ali je biološko enakovredno referenčnemu zdravilu Plavix.
Other information about Clopidogrel Krka
Druge informacije o zdravilu Klopidogrel Krka
Clopidogrel Krka can be started between seven days and six months after the stroke;
Zdravilo Klopidogrel Krka se lahko začne jemati od sedem dni po kapi do šest mesecev po njej;