natgillin/translations-raw huggingface dataset:
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. Kaplan Meierove krivulje za PFS u bolesnika s progresivnim karcinoidnim tumorom srednjeg crijeva - datum prestanka prikupljanja podataka 30. lipnja 2016 (ispitivanje faze III NETTER-1; FAS, N=231)
The pharmacokinetic profile of lutetium (177Lu) oxodotreotide in patients with severe hepatic impairment has not been studied,
Farmakokinetički profil lutecijeva (177Lu) oksodotreotida u bolesnika s teškim oštećenjem funkcije jetre nije proučavan, pa se ne preporučuje liječenje Lutatherom kod tih bolesnika.
Antiemetic premedication should be administered 30 minutes before start of amino acid solution infusion.
Premedikaciju antiemeticima potrebno je primijeniti 30 minuta prije početka infuzije otopine aminokiselina.
The absence of inhibition or significant induction of the human CYP450 enzymes, the absence of specific interaction with P-glycoprotein (efflux transporter) as well as OAT1, OAT3, OCT2, OATP1B1, OATP1B3, OCT1 and BCRP transporters in pre-clinical studies suggest that Lutathera has a low probability of causing significant other drug-drug interactions.
P-glikoproteinom (efluksni transporter) kao i s OAT1, OAT3, OCT2, OATP1B1, OATP1B3, OCT1 i
You can also report side effects directly via the national reporting system:
Nuspojave možete prijaviti izravno putem nacionalnog sustava za prijavu nuspojava: navedenog u Dodatku V.
Any other CTCAE grade 3 or grade 4 toxicity** possibly related to Lutathera.
Bilo koja druga toksičnosti CTCAE** stupnja 3.
Leukopenia5 Neutropenia6
Neutropenija6
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)
Tablica 9. PFS zabilježen u ispitivanju faze III NETTER-1 u bolesnika s progresivnim karcinoidnim tumorom srednjeg crijeva - datum prestanka prikupljanja podataka 30. lipnja 2016. (potpuni skup podataka za analizu (FAS), N=231)
Ear and labyrinth
Poremećaji uha i labirinta
Kidneys
Vrtoglavica
Amino acid solution
Metabolička acidoza
Gallbladder Wall Lower Large Intestine Wall Small Intestine Stomach Wall
Stijenka donjeg dijela debelog crijeva
Biodistribution studies show that lutetium (177Lu)
Farmakokinetički profil lutecijeva (177Lu)
− One vial of Lutathera
Jedna bočica lijeka Lutathera
Vial No.: {X}
Bočica br.: {X}
For information on the use in patients with hepatic impairment, see section 4.2.
Informacije o uporabi u bolesnika s oštećenjem funkcije bubrega potražite u dijelu 4.2.
Pancreas
Pankreatični
PFS = Progression free survival; OS = Overall survival * Includes Foregut, Midgut and Hindgut; **Foregut NETs other than bronchial and pancreatic
* Uključuje prednje, srednje i stražnje crijevo; **NET-ovi prednjeg crijeva osim bronhijalnih i pankreatičnih
Abdominal cavity drainage Dialysis
Drenaža abdominalne šupljine Dijaliza
2 Includes Thrombocytopenia and Platelet count decreased Includes Lymphopenia and Lymphocyte count decreased 4 Includes Anaemia and Haemoglobin decreased
Uključuje asteniju i umor 2 Uključuje trombocitopeniju i snižen broj trombocita
Arginine content
Sadržaj arginina
EXPIRY DATE EXP: {DD MM YYYY hh:mm UTC}
ROK VALJANOSTI Rok valjanosti: {DD MM GGGG hh:mm UTC}
• Kidney failure with creatinine clearance < 30 mL/min
• Zatajenje bubrega s klirensom kreatinina < 30 mL/min 4.4.
STATEMENT OF ACTIVE SUBSTANCE(S) One mL contains 370 MBq of lutetium (177Lu) oxodotreotide at calibration time.
Jedan mL sadrži 370 MBq lutecijeva (177Lu) oksodotreotida u vrijeme kalibracije.
Secondary hypothyroidism Hypothyroidism Diabetes mellitus
Hipotireoza Dijabetes melitus Karcinoidna kriza Hiperparatiroidizam
NAME OF THE MEDICINAL PRODUCT Lutathera 370 MBq/mL solution for infusion Lutetium (177Lu) oxodotreotide
Uputa o lijeku: Informacije za korisnika Lutathera 370 MBq/mL otopina za infuziju lutecijev (177Lu) oksodotreotid
General warning
Generalizirani pruritus
Orthostatic hypotension Phlebitis
Ortostatska hipotenzija Flebitis
Oropharyngeal pain Pleural effusion Sputum increased Choecking sensation
Povećanje količine sputuma Osjećaj gušenja
Solution for infusion
Preporuke za otpad
Start time (min)
Vrijeme početka
Lutetium-177 (177Lu) is a β- emitting radionuclide with a maximum penetration range in tissue of
Lutecij (177Lu) se raspada β- emisijom u stabilni hafnij
Deaths
Umor1
Injection site mass Chest discomfort Chest pain Pyrexia
Masa na mjestu injekcije Nelagoda u prsištu Bol u prsištu Pireksija
Acute prerenal failure Renal impairment
Akutno prerenalno zatajenje Oštećenje funkcije bubrega
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Lutathera 370 MBq/mL solution for infusion
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Lutathera 370 MBq/mL otopina za infuziju lutecijev (177Lu) oksodotreotid
Thrombocytopenia2 Lymphopenia3
Trombocitopenija2 Limfopenija3
Administration of Lutathera and conduct of the procedure Lutathera is administered directly into a vein.
Lutathera se primjenjuje izravno u venu.
Gastrointestinal tube insertion Stent placement Abscess drainage Bone marrow harvest Polypectomy
Umetanje gastrointestinalne cijevi Postavljanje stenta Drenaža apscesa
Refractory cytopenia with unilineage dysplasia Nephrogenic anaemia Bone marrow failure Thrombocytopenic purpura
Refraktorna citopenija s displazijom jedne krvotvorne loze Nefrogena anemija Zatajenje koštane srži
Storage of the vial
Korištenje zahoda
Hyperparathyroidism
Sekundarna hipotireoza
Hindgut
Nuspojave
Lethargy Syncope
Otopina aminokiselina
What Lutathera contains - The active substance is lutetium (177Lu) oxodotreotide.
- Djelatna tvar je lutecijev (177Lu) oksodotreotid.
- If you get any side effects, talk to your nuclear medicine doctor.
- Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika specijalista nuklearne medicine.
Osmolarity
Osmolarnost
Specification of commercially available amino acid solutions Characteristic
Opis odabranih nuspojava Toksičnost za koštanu srž
BATCH NUMBER Batch:
BROJ SERIJE Serija:
Fertility
Hematohezija
Acute kidney injury Haematuria Renal failure Proteinuria
Akutna ozljeda bubrega Hematurija
Upper Large Intestine Wall Heart Wall
Stijenka gornjeg dijela debelog crijeva
Breasts
Parestezija
• The infusion set should be connected to the bag of sodium chloride 9 mg/mL (0.9%) solution for injection and pre-filled by opening the clamp.
• Komplet za infuziju trebao bi biti povezan s vrećicom otopine natrijeva klorida 9 mg/mL
Dizziness Dysgeusia Headache10
Omaglica Disgeuzija Glavobolja10 Letargija Sinkopa
Contact your nuclear medicine doctor if you have any questions.
Ako imate pitanja, obratite se svojemu liječniku specijalistu nuklearne medicine.
Major or some specific adverse reactions to Lutathera.
ili 4. eventualno povezana s lijekom Lutathera.
− Amino acid solution bag(s)
− Vrećica/e s otopinom aminokiselina − Antiemetici
Haematocrit decreased Protein urine
Zatajenje bubrega Proteinurija
Osteogenic Cells Skin
Crvena koštana srž Osteogene stanice Koža
Taste disturbances,
NAVOĐENJE DJELATNE (IH) TVARI
Do not give this medicine to children (under 12 years of age) because it does not work.
Nemojte dati ovaj lijek djeci (mlađoj od 12 godina) jer ne djeluje.
Always take this medicine exactly as your doctor or pharmacist has told you.
Uvijek uzimajte ovaj lijek točno onako kako su Vam rekli Vaš liječnik ili ljekarnik.
Contact your doctor immediately if you experience:
Odmah se obratite svom liječniku ako primijetite:
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenija Za sve informacije o ovom lijeku obratite se lokalnom predstavniku nositelja odobrenja za stavljanje lijeka u promet:
• If you are allergic to clopidogrel or any of the other ingredients of this medicine (listed in section 6).
• ako ste alergični na klopidogrel ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
The active metabolite is formed mostly by
Aktivni metabolit nastaje većinom putem
The ACTIVE-A study included patients who could not receive VKA therapy because they were unable or unwilling to receive the treatment.
Studija ACTIVE-A uključivala je bolesnike koji nisu mogli primati terapiju VKA zbog toga što nisu bili podobni ili nisu željeli primati terapiju.
Contact your doctor or the nearest hospital emergency department because of the increased risk of bleeding.
Odmah se morate javiti liječniku ili u najbliži odjel hitne medicinske pomoći zbog povećanog rizika od krvarenja.
• Adults and elderly (over 65 years) Clopidogrel should be given as a single daily dose of 75 mg.
• Odrasli i starije osobe (u dobi iznad 65 godina) Klopidogrel se daje u jednokratnoj dnevnoj dozi od 75 mg.
You should take Clopidogrel HCS for as long as your doctor continues to prescribe it.
Lijek Klopidogrel HCS trebate uzimati sve dok Vam ga liječnik propisuje.
Some other medicines may influence the use of Clopidogrel HCS or vice versa.
Neki lijekovi mogu utjecati na djelovanje lijeka Klopidogrel HCS i obratno.
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).
<1/100); rijetke (≥1/10 000, <1/1000); vrlo rijetke (<1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka).
-4.0%; CI: -22.5 to 11.7 [p=0.639]).
ASK (RRR = -4,0%; CI: -22,5 do 11,7 [p=0,639]).
• Your doctor may order blood tests.
• liječnik će možda odrediti da Vam se naprave pretrage krvi.
Date of first authorisation: 28 October 2010 Date of latest renewal: 16 June 2015
Datum posljednje obnove odobrenja: 16. lipnja 2015
What Clopidogrel HCS is and what it is used for
Što je Klopidogrel HCS i za što se koristi
In the long-term safety follow-up of this study, 26 patients with the shunt still in place at one year of age received clopidogrel up to 18 months of age.
dugotrajnoj nastavnoj studiji o sigurnosti primjene, 26 bolesnika koji su još uvijek imali šant nakon godinu dana starosti, primali su klopidogrel do 18 mjeseci starosti.
In the myocardial infarction subgroup, most of the patients received ASA for the first few days following the acute myocardial infarction.
U podskupini s infarktom miokarda većina je bolesnika prvih nekoliko dana nakon akutnog infarkta miokarda primala
- a planned surgery (including dental) in the next seven days.
- nedavnog kirurškog zahvata (uključujući stomatološke zahvate), - planiranog kirurškog zahvata (uključujući stomatološke zahvate) u sljedećih sedam dana.
Clopidogrel HCS contains clopidogrel and belongs to a group of medicines called antiplatelet medicinal products.
Klopidogrel HCS sadrži klopidogrel i pripada skupini lijekova koji se nazivaju antitrombocitni lijekovi.
While you are taking Clopidogrel HCS:
Dok uzimate Klopidogrel HCS:
Other alleles associated with absent or reduced metabolism are less frequent and include CYP2C19*4, *5, *6, *7, and *8.
Ostali aleli povezani sa odsutnim ili smanjenim metabolizmom uključuju CYP2C19*4, *5, *6, *7 i *8, ali oni su manje zastupljeni.
What Clopidogrel HCS is and what it is used for What you need to know before you take Clopidogrel HCS How to take Clopidogrel HCS Possible side effects
Što je Klopidogrel HCS i za što se koristi Što morate znati prije nego počnete uzmati Klopidogrel HCS Kako uzimati Klopidogrel HCS
CYP2C19 with contributions from several other CYP enzymes, including CYP1A2, CYP2B6 and CYP3A4.
CYP2C19 uz sudjelovanje nekoliko drugih CYP enzima, uključujući CYP1A2, CYP2B6 i CYP3A4.
There was no evidence of carcinogenic effect when clopidogrel was administered for 78 weeks to mice and 104 weeks to rats when given at doses up to 77 mg/kg per day (representing at least 25 times the exposure seen in humans receiving the clinical dose of 75 mg/day).
Nije bilo dokaza o kancerogenim učincima kad se klopidogrel davao miševima 78 tjedana i štakorima 104 tjedna u dozama do 77 mg/kg na dan (što predstavlja barem 25 puta veću izloženost nego u ljudi koji primaju kliničku dozu od 75 mg/dan).
Pharmacotherapeutic group: platelet aggregation inhibitors excl. heparin, ATC Code: B01AC04.
Farmakoterapijska skupina: inhibitori agregacije trombocita izuzev heparina, ATK oznaka: B01AC04.
How to store Clopidogrel HCS Contents of the pack and other information
Kako čuvati Klopidogrel HCS Sadržaj pakiranja i druge informacije
What Clopidogrel HCS looks like and contents of the pack
Kako Klopidogrel HCS izgleda i sadržaj pakiranja
Your doctor should have prescribed Clopidogrel HCS plus acetylsalicylic acid if you cannot take ‘oral anticoagulants' and you do not have a risk of major bleeding.
Liječnik Vam treba propisati Klopidogrel HCS i acetilsalicilatnu kiselinu ako ne možete uzimati oralne antikoagulanse te nemate rizik od velikog krvarenja.
In a relative bioavailability study in adults, the constituted solution of clopidogrel showed a similar extent and slightly higher rate of absorption of the main circulating (inactive) metabolite compared to the authorised tablet.
U relativnoj studiji bioraspoloživosti lijeka u odraslih, konstituirana otopina klopidogrela pokazala je sličan raspon i neznatno veću brzinu apsorpcije glavnog cirkulirajućeg (inaktivnog) metabolita, u usporedbi s tabletom.
For the 28x1 tablets pack size, you can check the day on which you last took a tablet of Clopidogrel HCS by referring to the calendar printed on the blister.
Na pakiranju od 28x1 tableta možete pomoću kalendara otisnutog na blisteru provjeriti dan kada ste zadnji put uzeli tabletu Klopidogrel HCS.
Clopidogrel HCS 75 mg
Klopidogrel HCS 75 mg
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VANJSKO PAKIRANJE
It also contains hydrogenated castor oil.
Također sadrži: hidrogenirano ricinusovo ulje.
HCS bvba, H. Kennisstraat 53, B 2650 Edegem, Belgium
Kennisstraat 53, B 2650 Edegem, Belgija
Jaundice; severe abdominal pain with or without back pain; fever, breathing difficulties sometimes associated with cough; generalised allergic reactions (for example, overall sensation of heat with sudden general discomfort until fainting); swelling in the mouth; blisters of the skin; skin allergy; sore mouth (stomatitis); decrease in blood pressure; confusion; hallucinations; joint pain; muscular pain; changes in taste or loss of taste of food.
Žutica; jaka bol u trbuhu s bolovima u leđima ili bez njih; vrućica, teškoće pri disanju, ponekad povezane s kašljem; generalizirane alergijske reakcije (primjerice, sveukupni osjećaj vrućine s iznenadnom općom nelagodom do nesvjestice); oticanje u ustima; mjehurići na koži; kožne alergijske reakcije; upala u usnoj šupljini (stomatitis); pad krvnoga tlaka; zbunjenost; halucinacije; bol u zglobovima; bol u mišićima, poremećaj okusa ili gubitak osjeta okusa hrane.
The safety and efficacy of clopidogrel have been evaluated in 5 double-blind studies involving over 88,000 patients: the CAPRIE study, a comparison of clopidogrel to ASA, and the CURE, CLARITY, COMMIT and ACTIVE-A studies comparing clopidogrel to placebo, both medicinal products given in combination with ASA and other standard therapy.
Sigurnost primjene i djelotvornost klopidogrela procijenjena je u 5 dvostrukoslijepih studija koje su uključivale više od 88 000 bolesnika: studija CAPRIE, u kojoj su uspoređivani klopidogrel i ASK, te studije CURE, CLARITY, COMMIT i ACTIVE-A, u kojima je uspoređivano djelovanje klopidogrela u odnosu na placebo, a obje su terapije davane u kombinaciji s ASK i drugom standardnom terapijom.
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.
Fibrilacija atrija Studije ACTIVE-W i ACTIVE-A, zasebna ispitivanja u programu ACTIVE, uključivale su bolesnike s fibrilacijom atrija (FA) koji su imali najmanje jedan faktor rizika za krvožilne događaje.
If you become pregnant while taking Clopidogrel HCS, consult your doctor immediately as it is recommended not to take clopidogrel while you are pregnant.
Ako zatrudnite za vrijeme uzimanja lijeka Klopidogrel HCS, odmah se posavjetujte s liječnikom jer nije preporučeno uzimati klopidogrel za vrijeme trudnoće.
An occasional use of acetylsalicylic acid (no more than 1,000 mg in any 24 hour period) should generally not cause a problem, but prolonged use in other circumstances should be discussed with your doctor.
1000 mg u 24 sata) općenito ne izaziva probleme, ali o produljenom uzimanju u drugim okolnostima morate razgovarati s liječnikom.
In a randomised, double-blind, parallel-group study (CLARINET), 906 paediatric patients (neonates and infants) with cyanotic congenital heart disease palliated with a systemic-to-pulmonary arterial shunt were randomised to receive clopidogrel 0.2 mg/kg (n=467) or placebo (n=439) along with concomitant background therapy up to the time of second stage surgery.
U randomiziranoj, dvostrukoslijepoj studiji s paralelnim skupinama (CLARINET), 906 pedijatrijskih bolesnika (novorođenčad i dojenčad) s cijanotičnom kongenitalnom bolešću srca ublaženom sistemsko-plućnim arterijskim šantom, bilo je randomizirano u skupinu koje je primala klopidogrel u dozi od 0,2 mg/kg (n=467) ili placebo (n=439) zajedno s istodobnom popratnom terapijom sve do drugog operativnog zahvata.
Acetylsalicylic acid (ASA)
Acetilsalicilatna kiselina (ASK)
Clopidogrel HCS contains hydrogenated castor oil
Klopidogrel HCS sadrži hidrogenirano ricinusovo ulje
You should have been told that ‘oral anticoagulants' are more effective than acetylsalicylic acid or the combined use of Plavix and acetylsalicylic acid for this condition.
Trebalo Vam je biti rečeno da su za ovo stanje 'oralni antikoagulansi' učinkovitiji od acetilsalicilatne kiseline ili kombinirane primjene lijeka
No substantial differences in active metabolite exposure and mean inhibition of platelet aggregation (IPA) were observed between ultrarapid, extensive and intermediate metabolisers.
Nisu opažene značajne razlike u izloženosti aktivnom metabolitu i prosječnoj vrijednosti inhibicije agregacije trombocita (IAT) između ultrabrzih, brzih i umjerenih metabolizatorima.
Patients should be followed carefully for any signs of bleeding including occult bleeding, especially during the first weeks of treatment and/or after invasive cardiac procedures or surgery.
uključujući okultno krvarenje, i to poglavito tijekom prvih tjedana liječenja i/ili nakon invazivnih kardioloških postupaka ili kirurških zahvata.
In a clinical study conducted in healthy volunteers, the concomitant administration of clopidogrel and naproxen increased occult gastrointestinal blood loss.
U jednoj kliničkoj studiji provedenoj na zdravim dobrovoljcima, istodobna primjena klopidrogela i naproksena povećala je gubitak krvi okultnim krvarenjem iz probavnog trakta.
The CYP2C19*1 allele corresponds to fully functional metabolism while the CYP2C19*2 and CYP2C19*3 alleles are nonfunctional.
CYP2C19*1 alel odgovara potpuno funkcionalnom metabolizmu, dok su CYP2C19*2 i CYP2C19*3
If you have experienced severe chest pain (unstable angina or heart attack), your doctor may give you 300 mg of Clopidogrel HCS (4 tablets of 75 mg) once at the start of treatment.
Ako ste imali jake bolove u prsištu (nestabilna angina ili srčani udar), liječnik Vam u početku liječenja može jednokratno dati 300 mg lijeka Klopidogrel HCS (4 tablete od po 75 mg).
However, concomitant administration of 500 mg of ASA twice a day for one day did not significantly increase the prolongation of bleeding time induced by clopidogrel intake.
istodobna primjena 500 mg ASK dva puta na dan tijekom jednog dana nije značajno produljila vrijeme krvarenja već produljeno uzimanjem klopidogrela.
In a clinical study conducted in healthy subjects, clopidogrel did not necessitate modification of the heparin dose or alter the effect of heparin on coagulation.
U jednoj kliničkoj studiji provedenoj na zdravim ispitanicima, primjena klopidogrela nije iziskivala promjenu doze heparina, niti je mijenjala učinak heparina na koagulaciju.
Other concomitant therapy
Ostala istodobna terapija
After the 300 mg/75 mg dose regimen, antiplatelet responses were decreased in the poor metabolisers with mean IPA (5 μM ADP) of 24% (24 hours) and 37% (Day 5) as compared to IPA of 39% (24 hours) and 58% (Day 5) in the extensive metabolisers and 37% (24 hours) and 60% (Day 5) in the intermediate metabolisers.
Nakon režima doziranja od 300 mg/75 mg, antitrombocitni odgovor bio je smanjen u slabih metabolizatora sa srednjom vrijednosti IAT (5 μM ADP) od 24% (nakon 24 sata) te 37% (na dan 5), u usporedbi s vrijednostima IAT-e od 39% (24 sata) i 58% (dan 5) u brzih metabolizatora te 37% (24 sata) i 60% (dan 5) u umjerenih metabolizatora.
These occurred at doses representing at least 25 times the exposure seen in humans receiving the clinical dose of 75 mg/day and were a consequence of an effect on hepatic metabolising enzymes.
One su se javljale pri dozama koje su odgovarale barem 25 puta većoj od izloženosti od one u bolesnika koji su primali kliničku dozu od 75 mg klopidogrela na dan i bile su posljedice učinka na jetrene metaboličke enzime.
Other medicines and Clopidogrel HCS
Drugi lijekovi i Klopidogrel HCS
If you forget to take a dose of Clopidogrel HCS, but remember within 12 hours of your usual time, take your tablet straightaway and then take your next tablet at the usual time.
Ako zaboravite uzeti jednu dozu lijeka Klopidogrel HCS, ali se toga sjetite u roku od 12 sati, odmah uzmite tabletu, a sljedeću tabletu uzmite u uobičajeno vrijeme.
In patients who were enrolled in the trial on the sole basis of a recent myocardial infarction, clopidogrel was numerically inferior, but not statistically different from ASA (RRR =
U bolesnika koji su u studiju uključeni samo zbog nedavnog infarkta miokarda, klopidogrel je bio brojčano slabiji, ali se statistički nije razlikovao od
Due to the risk of bleeding and haematological adverse reactions, blood cell count determination and/or other appropriate testing should be promptly considered whenever clinical symptoms suggestive of bleeding arise during the course of treatment (see section 4.8).
Zbog opasnosti od krvarenja i hematoloških nuspojava, potrebno je odmah provjeriti krvnu sliku i/ili druge relevantne nalaze kad god se tijekom liječenja pojave klinički znakovi koji ukazuju na krvarenje
Mean peak plasma levels of unchanged clopidogrel (approximately 2.2-2.5 ng/ml after a single 75 mg oral dose) occurred approximately 45 minutes after dosing.
Srednje vršne razine nepromijenjenog klopidogrela u plazmi (oko 2,2 - 2,5 ng/ml nakon jednokratne oralne doze od 75 mg), postižu se otprilike 45 minuta nakon uzimanja lijeka.
- signs of liver problems such as yellowing of the skin and/or the eyes (jaundice), whether or not associated with bleeding which appears under the skin as red pinpoint dots, and/or confusion (see section 2 ‘Warnings and precautions').
- znakove oštećenja funkcije jetre kao što su žuta boja kože ili očiju (žutica), bez obzira na to jesu li povezani s krvarenjem koje se pojavljuje kao crvene točkice ispod kože i/ili zbunjenošću (vidjeti dio 2 "Upozorenja i mjere opreza");
Headache, stomach ulcer, vomiting, nausea, constipation, excessive gas in stomach or intestines, rashes, itching, dizziness, sensation of tingling and numbness.
Glavobolja, čir želuca, povraćanje, mučnina, zatvor, povećano stvaranje plinova u želucu ili crijevima, osip, svrbež, omaglica, osjećaj trnaca i utrnulosti.
Major bleeding was mostly of extracranial origin in both groups (5.3% in the clopidogrel + ASA group; 3.5% in the placebo +ASA group), mainly from the gastrointestinal tract (3.5% vs. 1.8%).
Velika su krvarenja su najčešće bila ekstrakranijalnog porijekla u obje skupine (5,3% u skupini klopidogrel + ASK; 3,5% u skupini placebo + ASK), uglavnom iz probavnog trakta (3,5% naspram 1,8%).
HCS bvba H. Kennisstraat 53 B-2650 Edegem Belgium
Kennisstraat 53 B-2650 Edegem Belgija