natgillin/translations-raw huggingface dataset:
Rates lower than 320 mL/h are not recommended for commercial solutions.
Pri uporabi komercialnih raztopin so odsvetovane hitrosti, nižje od 320 ml/h.
− A pair of tongs (for Lutathera vial handling)
− klešče (za prijemanje viale zdravila Lutathera);
Excipient with known effect Each mL of solution contains 0.14 mmol (3.2 mg) of sodium.
En ml raztopine vsebuje 0,14 mmol (3,2 mg) natrija.
Tabulated list of adverse reactions The adverse reactions are listed in Table 7 according to the frequency and the MedDRA System Organ
Neželeni učinki so navedeni v preglednici 7 glede na pogostnost in organske sisteme MedDRA (SOC).
After administration of Lutathera
Po apliciranju zdravila Lutathera
Two hundred thirty-one (231) patients have been randomized to receive either Lutathera (n=117) or octreotide LAR (n=114).
(n = 117) ali oktreotida LAR (n = 114).
Includes Headache and migraine
Bolečina v ustih in žrelu
Acetic acid Sodium acetate Gentisic acid Ascorbic acid Pentetic acid Sodium chloride Sodium hydroxide Water for injections
6.1 Seznam pomožnih snovi ocetna kislina natrijev acetat gentizinska kislina askorbinska kislina pentetinska kislina natrijev klorid natrijev hidroksid voda za injekcije
Lutathera should always be infused through an intravenous catheter placed exclusively for its infusion.
Pravila za zaščito proti sevanju Zdravilo Lutathera je treba vedno infundirati po intravenskem katetru, ki je nameščen izključno za to infuzijo.
PFS and OS observed in the Erasmus phase I/II study in Dutch patients with GEP and bronchial NET - (FAS, N=360)
faze pri nizozemskih bolnikih z GEP in bronhialnimi NET - (FAS, N=360)
Volumetric activity at calibration time: 370 MBq/mL - {DD/MM/YYYY hh:mm UTC} Activity at infusion time: {Z} MBq - {DD/MM/YYYY hh:mm UTC}
Volumetrična aktivnost v času umerjanja: 370 MBq/ml - {DD/MM/LLLL uu:mm UTC} Aktivnost v času infundiranja: {Z} MBq - {DD/MM/LLLL uu:mm UTC}
Lutathera with sodium chloride 9 mg/mL (0.9%) solution for injection
Zdravilo Lutathera z natrijevim kloridom 9 mg/ml (0,9 %) raztopino za injiciranje 60
Pregnancy No studies on animal reproductive function have been conducted with lutetium (177Lu) oxodotreotide.
Izvedena ni bila nobena študija o sposobnosti za razmnoževanje na živalih z lutecijevim (177Lu) oksodotreotidom.
Low white blood cell count (leukopenia or neutropenia), muscle pain, temporal partial hair loss (alopecia), abdominal distension (feeling bloated), diarrhoea, dizziness, injection site reaction or swelling, disturbed taste, pain in the site of injection, headache, high or low blood pressure, peripheral oedema, abnormal results of renal blood test (increased creatinine), abdominal pain (general and upper), constipation, abnormal results of liver blood test, flushing and hot flushes, increased sugar level in the blood, fainting, renal failure (including acute injury), dehydration, heartburn (dyspepsia), blood in urine, abnormal results of urine test (presence of serum proteins), decrease in function of thyroid, shortness of breath, inflammation of stomach (gastritis), abnormally high amounts of bile pigment (bilirubin) in the blood (Hyperbilirubinemia), abnormal results of blood test (Hypomagnesaemia and hyponatraemia), influenza like illness, chills, bone marrow cancer (myelodysplastic syndrome), blood transfusion.
Pogosti (pojavijo se lahko pri največ 1 od 10 bolnikov): zmanjšano število belih krvnih celic (levkopenija ali nevtropenija), bolečina v mišicah, začasna delna izguba las in dlak (alopecija), napihnjenost trebuha (občutek napihnjenosti), driska, omotica, reakcija ali oteklina na mestu injiciranja, motnje okušanja, bolečina na mestu injiciranja, glavobol, visok ali nizek krvni tlak, periferni edem, nenormalni rezultati krvnih preiskav delovanja ledvic (zvišan kreatinin), bolečina v trebuhu (splošno in v zgornjem delu), zaprtje, nenormalni rezultati preiskav jetrne krvi, zardevanje in vročinski oblivi, zvišana raven sladkorja v krvi, omedlevica, ledvična odpoved (vključno z akutno poškodbo), dehidracija, zgaga (prebavne motnje), kri v urinu, nenormalni rezultati preiskav urina (prisotnost proteinov v serumu), zmanjšanje delovanja ščitnice, zasoplost, vnetje želodca (gastritis), nenormalno velika količina žolčnega barvila (bilirubina) v krvi
Hepatic impairment
Hepatični zastoj
Given the mechanism of action and the tolerance profile of Lutathera (see section 4.8), it is not recommended to start treatment in the following cases:
Glede na mehanizem delovanja in profil tolerance za zdravilo Lutathera (glejte poglavje 4.8)
Composition of the standard amino acid solution
Preglednica 1: Sestava standardne raztopine aminokislin Sestavina
NAME OF THE MEDICINAL PRODUCT Lutathera 370 MBq/mL solution for infusion
IME ZDRAVILA Lutathera 370 MBq/ml raztopina za infundiranje
If your partner is pregnant, extend this time to 15 days.
- spite v ločenih posteljah na razdalji najmanj 1 metra; če je vaša partnerica noseča, ta čas podaljšajte na 15 dni.
Clear, colourless to slightly yellow solution.
FARMACEVTSKA OBLIKA raztopina za infundiranje Bistra, brezbarvna do nekoliko rumena raztopina.
Genetic consultation is recommended if you wish to have children after treatment.
Če želite imeti po zdravljenju otroke, je priporočljivo genetsko svetovanje.
The pharmacokinetic profile of lutetium (177Lu) oxodotreotide in patients with severe hepatic impairment has not been studied,
Farmakokinetični profil lutecijevega (177Lu) oksodotreotida pri bolnikih s hudo jetrno okvaro ni bil raziskan, zato zdravljenje z zdravilom
Arginine content
Vsebnost arginina
Secondary hypothyroidism Hypothyroidism Diabetes mellitus
Hipotiroidizem Diabetes mellitus Karcinoidna kriza Hipotiroidizem
Genetic consultation is recommended if the patient wishes to have children after treatment.
Če želi bolnik po zdravljenju imeti otroke, je priporočljivo genetsko svetovanje.
For information on the use in patients with renal impairment, see section 4.2.
Za informacijo o uporabi pri bolnikih z ledvično okvaro glejte poglavje 4.2.
oxodotreotide through the proximal tubules, resulting in a significant reduction in the kidney radiation dose (see section 4.2).
Raztopina aminokislin bo pomagala zmanjšati reabsorpcijo lutecijevega (177Lu) oksodotreotida skozi proksimalne tubule, kar bo omogočilo pomembno zmanjšanje odmerka sevanja v ledvicah (glejte poglavje 4.2).
Based on the data collected during the Erasmus phase I/II and NETTER-1 phase III studies, lutetium (177Lu) oxodotreotide is primarily eliminated by renal excretion: about 60% of the medicinal product is eliminated in the urine within 24 hours, and about 65% within 48 hours following the administration.
oksodotreotid primarno izloča preko ledvic: približno 60 % zdravila se izloči v urin v 24 urah in približno 65 % v 48 urah po aplikaciji.
The infusion of the amino acid solution should start 30 minutes prior to start of Lutathera infusion.
Infundiranje raztopine aminokislin je treba začeti 30 minut pred začetkom infundiranja zdravila Lutathera.
Premedication with antiemetics should be injected 30 minutes before the start of amino acid solution infusion.
Premedikacijo z antiemetiki je treba injicirati 30 minut pred začetkom infuzije raztopine aminokislin.
Nevertheless, the general condition of the patient and the possible adverse reactions to treatment must be taken into account before driving or using machines.
Pred vožnjo ali upravljanjem strojev pa je treba vseeno upoštevati splošno stanje bolnika in možne neželene učinke zdravljenja.
Nephrotoxicity Lutetium (177Lu) oxodotreotide is excreted by the kidney.
Nefrotoksičnost Lutecijev (177Lu) oksodotreotid se izloča skozi ledvice.
Hyperglycaemia Dehydration Hypomagnesaemia Hyponatremia
Hiperglikemija Dehidracija Hipomagnezemija Hiponatriemija
− One vial of Lutathera
− ena viala zdravila Lutathera;
PFS = Progression free survival; OS = Overall survival * Includes Foregut, Midgut and Hindgut; **Foregut NETs other than bronchial and pancreatic
PFS (Progression Free Survival) = preživetje brez napredovanja bolezni; OS (Overal Survival) = stopnja preživetja
Conjunctivitis Respiratory tract infection Cystitis
Konjunktivitis Okužbe dihal Cistitis
Secondary malignant neoplasms
Sekundarni maligni tumorji
• Kidney failure with creatinine clearance < 30 mL/min
• odpoved ledvic z očistkom kreatinina < 30 ml/min.
Lutathera contains sodium
Zdravilo Lutathera vsebuje natrij.
PFS Kaplan Meier curves of patients with progressive midgut carcinoid tumourcut-off date 30 June 2016 (NETTER-1 phase III study; FAS, N=231)
Slika 4: PFS Kaplan Meier krivulje bolnikov s progresivnim karcinoidnim tumorjem v srednjem črevesju - končni datum za analizo 30. junij 2016 (študija NETTER 1 III. faze; FAS, N = 231)
This evidence confirms what has been previously observed in the Erasmus phase I/II study, in which HPLC analysis of a urine specimen collected 1 hour post administration of lutetium (177Lu) oxodotreotide from one patient receiving 1.85 MBq of lutetium (177Lu) oxodotreotide indicated that the main portion (91%) was excreted unchanged.
faze, v kateri je analiza HPLC vzorca urina, zbranega 1 uro po aplikaciji lutecijevega (177Lu) oksodotreotida od enega bolnika, ki je prejel 1,85
For additional details about the treatment of patient with renal impairment see Table 5 in section 4.2 and section 4.4.
Za dodatne informacije o zdravljenju bolnikov z blago do zmerno jetrno okvaro glejte preglednico 5 v poglavjih 4.2 in 4.4.
One mL of solution contains 370 MBq of lutetium (177Lu) oxodotreotide at the date and time of calibration.
En ml raztopine vsebuje 370 MBq lutecijevega (177Lu) oksodotreotida ob datumu in uri umerjanja.
Lethargy Syncope
Raztopina aminokislin
Lutathera 370 MBq/mL solution for infusion Lutetium (177Lu) oxodotreotide
Lutathera 370 MBq/ml raztopina za infundiranje lutecijev (177Lu) oksodotreotid
Elderly:
Starejši bolniki:
Discontinue Lutathera administrations in patients who have experienced or are at risk of any of the following conditions during treatment:
Preglednica 3: Merila za dokončno ukinitev zdravljenja z zdravilom Lutathera Ukinitev aplikacije zdravila Lutathera pri bolnikih, ki so imeli ali pa zanje v času zdravljenja obstaja tveganje za pojav naslednjega:
Abdominal cavity drainage Dialysis
Drenaža trebušne votline Dializa
How Lutathera is used
Kako uporabljati zdravilo Lutathera
Antiemetic premedication should be administered 30 minutes before start of amino acid solution infusion.
Premedikacijo z antiemetiki je treba aplicirati 30 minut pred začetkom infuzije raztopine aminokislin.
Hyperparathyroidism
Hipertenzija7
There is no relevant use of Lutathera in the paediatric population in the indication of treatment of GEP-NETs (excluding neuroblastoma, neuroganglioblastoma, phaeochromocytoma).
Pediatrična populacija Ni smotrne uporabe zdravila Lutathera pri pediatrični populaciji za indikacijo zdravljenja GEP-NET
PFS observed in the NETTER-1 phase III study in patients with progressive midgut carcinoid tumour - cut-off date 24 July 2015 (full analyses set (FAS), N=229)
Preglednica 8: vrednost PFS, opažena v študiji NETTER-1 III. faze pri bolnikih s progresivnim karcinoidnim tumorjem v srednjem črevesju - končni datum za analizo 24. julij 2015 (celotna skupina bolnikov (FAS), N=229)
The European Medicines Agency has waived the obligation to submit the results of studies with Lutathera in all subsets of the paediatric population in the treatment of GEP-NETs (excluding neuroblastoma, neuroganglioblastoma, phaeochromocytoma).
Lutathera za vse skupine pediatrične populacije pri zdravljenju GEP-NET (razen nevroblastoma,
PFS observed in the NETTER-1 phase III study in patients with progressive midgut carcinoid tumour - cut-off date 30 June 2016 (full analyses set (FAS), N=231)
Preglednica 9: vrednost PFS, opažena v študiji NETTER 1 III. faze pri bolnikih s progresivnim karcinoidnim tumorjem v srednjem črevesju - končni datum za analizo 30. junij 2016 (celotna skupina bolnikov (FAS), N = 231)
EXPIRY DATE EXP: {DD MM YYYY hh:mm UTC}
DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA EXP: {DD MM LLLL uu:mm UTC}
Breasts
Pireksija
For information on the use in patients with hepatic impairment, see section 4.2.
Za informacijo o uporabi pri bolnikih z jetrno insuficienco glejte poglavje 4.2.
Thrombocytopenia2 Lymphopenia3
Trombocitopenija2Limfopenija3 Anemija4
If you get any side effects talk to your nuclear medicine doctor.
Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom nuklearne medicine.
PFS Kaplan Meier curves of patients with progressive midgut carcinoid tumour - cutoff date 24 July 2015 (NETTER-1 phase III study; FAS, N=229)
Slika 3: PFS Kaplan Meier krivulje bolnikov s progresivnim karcinoidnim tumorjem v srednjem črevesju, - končni datum za analizo 24. julij 2015 (Študija NETTER-1 III. faze; FAS,
STATEMENT OF ACTIVE SUBSTANCE(S) One mL contains 370 MBq of lutetium (177Lu) oxodotreotide at calibration time.
NAVEDBA ENE ALI VEČ UČINKOVIN En ml vsebuje 370 MBq lutecijevega (177Lu) oksodotreotida v času umerjanja.
The co-administration of amino acid solution decreases the kidney uptake, enhancing the elimination of radioactivity (see section 4.4).
Sočasna aplikacija raztopine aminokislin zmanjša privzem v ledvicah, kar izboljša izločanje radioaktivnosti
Uncommon increased
Zvečanje vrednosti
• Haematology (Haemoglobin [Hb], white blood count, platelet count)
• hematologija (hemoglobin [Hb], število levkocitov in trombocitov).
PHARMACEUTICAL FORM Solution for infusion.
FARMACEVTSKA OBLIKA IN VSEBINA Raztopina za infundiranje Viala št .
Dry mouth
Trebušna slinavka
Upper Large Intestine Wall Heart Wall
Stena srca Ledvice Jetra
Wait 12 weeks after the date of surgery to administer Lutathera.
tednov po datumu kirurškega posega.
Acute myeloid leukaemia Acute leukaemia Chronic myelomonocytic leukaemia
Akutna mieloidna levkemija Akutna levkemija
Toxicological studies with rats have demonstrated that a single intravenous injection of up to 4,550 MBq/kg was well tolerated and no deaths were observed.
Toksikološke študije pri podganah so pokazale dobro prenašanje ene intravenske injekcije do
Unless your doctor has considered that the clinical benefit of the treatment overcomes the possible risks, you will not be given this medicine: - if you have received a previous external radiation therapy on more than 25% of your bone marrow - if you heart is seriously impaired - if you have seriously affected blood cell counts - if your liver is seriously impaired - if it appears that your tumour does not have sufficient somatostatin receptors
- če imate resno okvaro srca; - če imate resno prizadeto število krvnih celic; - če imate resno okvaro jeter; - če se izkaže, da tumor nima zadostnih somatostatinskih receptorjev.
Malaise
Konstipacija
NAME OF THE MEDICINAL PRODUCT Lutathera 370 MBq/mL solution for infusion Lutetium (177Lu) oxodotreotide
IME ZDRAVILA IN POT(I) UPORABE Lutathera 370 MBq/ml raztopina za infundiranje lutecijev (177Lu) oksodotreotid intravenska uporaba
Occurrence of an intercurrent disease (e.g. urinary tract infection), which according to the physician could increase the risks associated to Lutathera administration.
ki bi po mnenju zdravnika lahko povečale tveganja, povezana z aplikacijo zdravila Lutathera.
Dizziness Dysgeusia Headache10
Omotica Disgevzija Glavobol10 Letargija Sinkopa
Careful consideration of the activity to be administered is required since an increased radiation exposure is possible in these patients.
Ledvična okvara Pri teh bolnikih obstaja možnost povečane izpostavljenosti sevanju, zato je treba tehtno premisliti o aktivnosti, ki se jo aplicira.
Vial No.: {X}
: {X}
The following table summarises the required procedures during a treatment course with Lutathera using the gravity method:
Naslednja preglednica povzema zahtevane postopke med potekom zdravljenja z zdravilom Lutathera z gravitacijsko metodo: Preglednica 6: Postopek aplikacije antiemetika, raztopine aminokislin in zdravila Lutathera Aplicirana sredstva
Clavicle fracture
Zlom ključnice
Start time (min)
Čas začetka
Depending on the case, aspiration of extravasation fluid, sodium chloride 9 mg/mL (0.9%) solution for injection flush injection, or applying warm compresses or a heating pad to the infusion site to accelerate vasodilation should be considered.
Odvisno od posameznega primera je treba razmisliti o uporabi aspiracije ekstravazacijske tekočine, izpiranje z injekcijo natrijevega klorida 9 mg/ml (0,9 %)
Careful consideration of the activity to be administered to patients with hepatic impairment is required since an increased radiation exposure is possible in these patients.
Pri teh bolnikih obstaja možnost povečane izpostavljenosti sevanju, zato je treba pri bolnikih z jetrno okvaro tehtno premisliti o aktivnosti, ki se jo aplicira.
Gastrointestinal tube insertion Stent placement Abscess drainage Bone marrow harvest Polypectomy
Vstavitev žilne opornice Drenaža abscesa Odvzem kostnega mozga Polipektomija
Blood lactate dehydrogenase
Zvečanje vrednosti laktat dehidrogenaze v krvi Kateholamini v krvi
Fatigue1
Utrujenost1
Refractory cytopenia with unilineage dysplasia Nephrogenic anaemia Bone marrow failure Thrombocytopenic purpura
Refraktorna citopenija z displazijo ene celične linije Nefrogena anemija Odpoved kostnega mozga
Best response, ORR and DoR observed in the Erasmus phase I/II study in Dutch patients with GEP and bronchial NETs - (FAS, N=360)
Preglednica 10: Opažen najboljši odziv, ORR in DoR v študiji Erasmus I./II.
• The tubing line should be pre-filled with sodium chloride 9 mg/mL (0.9%) solution for injection and then connected with a venous catheter previously inserted to the patient's arm.
Postopek priključitve cevke na vialo zdravila Lutathera (glejte sliko 2): • Vod cevke je treba predhodno napolniti z natrijevim kloridom 9 mg/ml (0,9 %) raztopino za injiciranje in nato priključiti na venski kateter, predhodno vstavljen v bolnikovo roko.
Use of toilets
Jedilni pribor in kopalniški pripomočki
− Amino acid solution bag(s)
− vrečka(-e) z raztopino aminokislin;
Major surgery.
Večji kirurški poseg.
Blood creatinine increased GGT* increased ALAT** increased ASAT*** increased Blood ALP**** increased
Zvečanje vrednosti GGT* Zvečanje vrednosti
Physical disability
Telesna prizadetost
11 Includes injection site reaction, injection site hypersensibility, injection site induration, injection site swelling * Gamma-glutamyltransferase increased **Alanine amino transferase *** Aspartate amino transferase **** Alkaline phosphatase
** Alanin-aminotransferaza *** Aspartat-aminotransferaza **** Alkalin fosfataza
• Patient guide
Vodnik za bolnike
Overall, the results of the dosimetric analysis performed in the NETTER-1 phase III dosimetry substudy and in the Erasmus phase I/II study are in agreement and indicate that Lutathera dose regimen (4 administrations of 7,400 MBq) is safe.
faze skladni in kažejo, da je režim odmerjanja zdravila Lutathera (4 aplikacije po 7.400 MBq) varen.
• Bone metastasis;
- če imate metastaze v kosteh;
Bronchial Pancreatic Foregut** Midgut Hindgut
Bronhialni Pankreatski
Please see Table 5 in case of dose modifying toxicity.
v primeru toksičnosti, ki zahteva prilagoditev odmerka.
Lutetium-177 (177Lu) is a β- emitting radionuclide with a maximum penetration range in tissue of
Lutecij (177Lu) razpade z emisijo β- na stabilni hafnij
How Lutathera is stored
Shranjevanje zdravila Lutathera
Oropharyngeal pain Pleural effusion Sputum increased Choecking sensation
Plevralni izliv Povečano nastajanje izpljunka
Hepatobiliary disorders
Hemoragični ascites
Any other CTCAE grade 3 or grade 4 toxicity** possibly related to Lutathera.
Vsaka druga toksičnost CTCAE 3. ali 4.
Table 5.
Glejte preglednico 5
Biodistribution studies show that lutetium (177Lu)
faze in NETTER-1 III. faze, se lutecijev (177Lu)
Hindgut
Merilo
Hepatic congestion Hepatic failure
Zardevanje Vročinski obliv Hipotenzija
Acute kidney injury Haematuria Renal failure Proteinuria
Akutna poškodba ledvic Hematurija
Blood potassium decreased Blood urea increased Glycosylated haemoglobin increased
Zvečanje vrednosti glikiranega hemoglobina
Leukocyturia
Vranica
Do not give this medicine to children (under 12 years of age) because it does not work.
Ne dajajte tega zdravila otrokom ali mladostnikom (starim manj kot 12 let), ker ne deluje.
Krka, d.d., Novo mesto Šmarješka cesta 6
KRKA, d.d., Novo mesto - Locna Šmarješka cesta 6
None of these analyses were adequately sized to detect differences in outcome in poor metabolisers.
Nobena teh analiz ni imela zadostne velikosti za odkritje razlik v izidu pri slabih metabolizatorjih
- a planned surgery (including dental) in the next seven days.
- načrtovan kirurški poseg (tudi na zobeh) v naslednjih sedmih dneh;
The expiry date refers to the last day of that month.
Roka uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
Macrogol 3000
smukec makrogol 3000
Their frequency is defined using the following conventions: 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), not known (cannot be estimated from the available data).
Njihova pogostnost je navedena po naslednjem dogovoru: pogosti (≥1/100 do <1/10), občasni (≥1/1.000 do <1/100), redki (≥1/10.000 do <1/1.000), zelo redki (<1/10.000), neznani (ni mogoče oceniti iz razpoložljivih podatkov).
Clopidogrel has been evaluated for safety in more than 44,000 patients who have participated in clinical studies, including over 12,000 patients treated for 1 year or more.
Varnost klopidogrela so vrednotili pri več kot 44.000 bolnikih, ki so sodelovali v kliničnih študijah, vključno z več kot 12.000 bolniki, ki so se zdravili eno leto ali več.
Date of first authorisation: 28 October 2010 Date of latest renewal: 16 June 2015
Datum pridobitve dovoljenja za promet: 28.10.2010 Datum zadnjega podaljšanja: 16.06.2015
Excipients with known effect:
Pomožna snov z znanim učinkom:
Acetylsalicylic acid (ASA)
Acetilsalicilna kislina (ASA)
Do not use this medicine after the expiry date which is stated on the carton and on the blister, after EXP.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in pretisnem omotu poleg oznake EXP.
Some other medicines may influence the use of Clopidogrel HCS or vice versa.
Nekatera druga zdravila lahko vplivajo na jemanje zdravila Klopidogrel HCS in obratno.
Not applicable.
nista funkcionalna.
You should take Clopidogrel HCS for as long as your doctor continues to prescribe it.
Zdravilo Klopidogrel HCS morate jemati, dokler vam ga vaš zdravnik predpisuje.
This may cause stomach upset or diarrhoea.
To lahko povzroči želodčne motnje ali drisko.
This leaflet was last revised in <Month YYYY>.
Navodilo je bilo nazadnje revidirano dne < mesec LLLL>
However, clopidogrel and ASA have been administered together for up to one year (see section
Vendar pa so klopidogrel in ASA sočasno jemali do eno leto (glejte poglavje
-4.0%; CI: -22.5 to 11.7 [p=0.639]).
IZ: -22,5 do 11,7 /p = 0,639/).
The film-coated tablets are pink, round and slightly convex.
Filmsko obložente tablete so rožnate, okrogle in rahlo izbočene.
HCS bvba H. Kennisstraat 53 B-2650 Edegem Belgium
HCS bvba H. Kennisstraat 53 B-2650 Edegem Belgija
Side effects with frequency not known (frequency cannot be estimated from the available data): Hypersensitivity reactions with chest or abdominal pain.
Neželeni učinki z neznano pogostnostjo (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti): Preobčutljivostne reakcije z bolečinami v prsih ali trebuhu.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
Obvestite svojega zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katerokoli zdravilo, tudi če ste ga dobili brez recepta.
The ACTIVE-W and ACTIVE-A studies, separate trials in the ACTIVE program, included patients with atrial fibrillation (AF) who had at least one risk factor for vascular events.
Atrijska fibrilacija Študiji ACTIVE-W in ACTIVE-A, ločeni preskušanji v programu ACTIVE, sta vključili bolnike z atrijsko fibrilacijo (AF), ki so imeli vsaj en dejavnik tveganja za žilne dogodke.