natgillin/translations-raw huggingface dataset:
What you need to know before you take Xagrid Do not take Xagrid
Kaj morate vedeti, preden boste vzeli zdravilo Xagrid Ne jemljite zdravila Xagrid
If treatment is initiated, the benefits and risks of treatment with anagrelide must be monitored regularly and the need for ongoing treatment evaluated periodically.
Če začnemo z zdravljenjem, moramo redno spremljati koristi in tveganja zdravljenja z anagrelidom in v rednih presledkih vrednotiti potrebo po aktualnem zdravljenju.
• If you have any problems with your liver or kidneys.
• če imate težave z jetri ali ledvicami.
In vitro studies of human megakaryocytopoiesis established that anagrelide's inhibitory actions on platelet formation in man are mediated via retardation of maturation of megakaryocytes, and reducing their size and ploidy.
In vitro študije človeške megakariocitopoeze so pokazale, da se zaviralno delovanje anagrelida na tvorbo krvnih ploščic pri ljudeh odvija prek upočasnitve razvoja megakariocitov ter zmanjšanja njihove velikosti in ploidnosti.
The safety of anagrelide has been examined in 4 open label clinical studies.
Varnost anagrelida so proučevali v štirih odprtih kliničnih študijah, z vsem sodelujočim znanim zdravilom.
Do not use this medicine after the expiry date which is stated on the carton and bottle label after EXP.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in etiketi steklenice poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
If you take more Xagrid than you should
Če ste vzeli večji odmerek zdravila Xagrid, kot bi smeli
Repeated dose toxicity
Toksičnost po ponavljajočem se odmerjanju
• If you have further questions, ask your doctor or pharmacist.
• Če imate dodatna vprašanja, se posvetujte z zdravnikom ali farmacevtom.
The most commonly reported adverse reactions associated with anagrelide were headache occurring at approximately 14%, palpitations occurring at approximately 9%, fluid retention and nausea both occurring at approximately 6% and diarrhoea occurring at 5%.
Najpogosteje zabeleženi neželeni učinki, povezani z anagrelidom, so bili glavobol, ki se je pojavil pri približno 14 % bolnikov, palpitacije so se pojavile pri približno 9 % bolnikov, zastajanje tekočine in slabost sta se pojavila pri približno 6 % bolnikov in driska pri 5 odstotkih bolnikov.
This contains a drying agent to keep the capsules dry.
V njem je sredstvo za sušenje, ki skrbi, da ostanejo kapsule suhe.
The platelet count will increase within 4 days of stopping treatment with anagrelide and will return to pre-treatment levels within 10 to 14 days, possibly rebounding above baseline values.
Število krvnih ploščic bo v štirih dneh po prenehanju zdravljenja z anagrelidom naraslo, po 10 do 14 dneh pa se bo vrnilo na raven pred zdravljenjem, lahko se zviša celo nad izhodiščne vrednosti.
Essential thrombocythaemia is a condition which occurs when the bone marrow produces too many of the blood cells known as platelets.
Esencialna trombocitemija je bolezen, do katere pride, ko kostni mozeg proizvaja preveliko število krvnih celic, ki jih poznamo kot krvne ploščice.
Following oral administration of anagrelide in man, at least 70% is absorbed from the gastrointestinal tract.
Po peroralni uporabi anagrelida pri človeku se iz prebavnega trakta vsrka vsaj 70 %.
Keep the sealed container in the bottle.
Zatesnjeni vsebnik naj ostane v plastenki.
Uterine adenocarcinomas, of epigenetic origin, could be related to an enzyme induction of CYP1 family.
Maternični adenokarcinom epigenetskega izvora bi lahko bil povezan z indukcijo encima iz družine CYP1.
Maternally toxic doses of anagrelide in rats and rabbits were associated with increased embryo resorption and foetal mortality.
Toksični odmerki anagrelida pri brejih podganah in kuncih so povezani z zvišanim vsrkavanjem zarodka in zvišano umrljivostjo ploda.
In combination with acetylsalicylic acid (a substance present in many medicines used to relieve pain and lower fever, as well as to prevent blood clotting, also known as aspirin), there is an increased risk of major haemorrhages (bleeding) (see section “Other medicines and Xagrid”).
V kombinaciji z acetilsalicilno kislino (snov, ki je prisotna v številnih zdravilih, ki se uporabljajo za blaženje bolečin in zniževanje zvišane telesne temperature, pa tudi za preprečevanje strjevanja krvi, ki je znana tudi pod imenom aspirin) obstaja povečano tveganje za velike krvavitve (hemoragijo) (glejte poglavje „Druga zdravila in zdravilo Xagrid“).
In case of overdose, close clinical supervision of the patient is required; this includes monitoring of the platelet count for thrombocytopenia.
V primeru prevelikega odmerka je potreben strog klinični nadzor bolnika; to vključuje spremljanje števila krvnih ploščic zaradi trombocitopenije.
Pharmacokinetic data from fasting elderly patients with ET (age range 65 - 75 years) compared to fasting adult patients (age range 22 - 50 years) indicate that the Cmax and AUC of anagrelide were 36% and 61% higher respectively in elderly patients, but that the Cmax and AUC of the active metabolite, 3-hydroxy anagrelide, were 42% and 37% lower respectively in the elderly patients.
Farmakokinetični podatki, pridobljeni od starejših teščih bolnikov z ET (starostni okvir 65 - 75 let) v primerjavi s teščimi odraslimi bolniki (starostni okvir 22 - 50 let), kažejo, da sta bili vrednosti Cmax in AUC anagrelida za 36 % in 61 % višji pri starejših bolnikih, vrednosti Cmax in AUC aktivnega presnovka 3-hidroksi anagrelida pa sta bili pri starejših bolnikih za 42 % in 37 % nižji.
Each hard capsule contains lactose monohydrate (53.7 mg) and anhydrous lactose (65.8 mg).
Ena trda kapsula vsebuje laktozo monohidrat (53,7 mg) in brezvodno laktozo (65,8 mg).
Serious cardiovascular adverse events including cases of torsade de pointes, ventricular tachycardia, cardiomyopathy, cardiomegaly and congestive heart failure have been reported (see section 4.8).
Poročali so o resnih kardiovaskularnih neželenih učinkih, vključno s primeri torsade de pointes, prekatne tahikardije, kardiomiopatije, kardiomegalije in kongestivnega popuščanja srca (glejte poglavje 4.8).
Anagrelide is primarily metabolised by CYP1A2 to form, 3-hydroxy anagrelide, which is further metabolised via CYP1A2 to the inactive metabolite, 2-amino-5, 6-dichloro-3, 4-dihydroquinazoline.
Anagrelid se v glavnem metabolizira s CYP1A2, da nastane 3-hidroksi anagrelid, ki ga CYP1A2 še nadalje presnovi v neaktivni presnovek 2-amino-5, 6-dikloro-3, 4-dihidrokinazolin.
Evidence of similar in vivo actions was observed in bone marrow biopsy samples from treated patients.
Dokaze podobnega in vivo delovanja so opazili pri biopsiji vzorcev kostnega mozga, ki so jih odvzeli zdravljenim bolnikom.
In an open-label clinical study in 8 children and 10 adolescents (including patients who were anagrelide treatment naïve or who had been receiving anagrelide for up to 5 years pre-study), median platelet counts were decreased to controlled levels after 12 weeks of treatment.
V odprti klinični študiji pri 8 otrocih in 10 mladostnikih (vključno z bolniki, ki prej niso prejemali anagrelida ali ki so pred študijo prejemali anagrelid do 5 let dolgo) se je mediana koncentracija krvnih ploščic po 12 tednih zdravljenja zmanjšala na kontrolirane vrednosti.
• At the doses recommended for use in the treatment of essential thrombocythaemia, anagrelide may potentiate the effects of other medicinal products that inhibit or modify platelet function e.g. acetylsalicylic acid.
• Pri priporočenih odmerkih pri zdravljenju esencialne trombocitemije utegne anagrelid okrepiti učinke drugih zdravil, ki zavirajo ali spreminjajo funkcijo krvnih ploščic, npr. učinke acetilsalicilne kisline.
What Xagrid is and what it is used for What you need to know before you take Xagrid How to take Xagrid
Kaj je zdravilo Xagrid in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Xagrid Kako jemati zdravilo Xagrid Možni neželeni učinki
In male rats, anagrelide at oral doses up to 240 mg/kg/day (>1000 times a 2mg/day dose, based on body surface area) was found to have no effect on fertility and reproductive performance.
Pri samcih podgan so ugotovili, da anagrelid v peroralnih odmerkih do 240 mg/kg/dan (>1000-kratnik odmerka 2 mg/dan na podlagi velikosti telesne površine) ne vpliva na plodnost in sposobnost razmnoževanja.
Therefore Xagrid is not recommended during pregnancy.
Zato uporaba zdravila Xagrid med nosečnostjo ni priporočljiva.
Therapy requires close clinical supervision of the patient which will include a full blood count (haemoglobin and white blood cell and platelet counts), assessment of liver function (ALT and AST), renal function (serum creatinine and urea) and electrolytes (potassium, magnesium and calcium).
Terapija zahteva natančen klinični nadzor bolnika, kar vključuje tudi popolno analizo krvi (ugotavljanje količine hemoglobina, števila belih krvničk in krvnih ploščic), oceno delovanja jeter (ALT in AST), oceno delovanja ledvic (serumski kreatinin in sečnina) in elektrolite (kalij, magnezij in kalcij).
Cardiovascular
Kardiovaskularno
The usual starting dose of Xagrid is 1 mg. You take this dose as one capsule of 0.5 mg twice a day, for at least a week.
Ta odmerek jemljete tako, da jemljete eno kapsulo po 0,5 mg dvakrat na dan vsaj en teden.
It is known that CYP1A2 is inhibited by several medicinal products, including fluvoxamine and enoxacin, and such medicinal products could theoretically adversely influence the clearance of anagrelide.
Znano je, da CYP1A2 zavirajo številna zdravila, med drugim tudi fluvoksamin in enoksacin, in ta zdravila utegnejo teoretično neugodno vplivati na očistek anagrelida Spodbujevalci CYP1A2
The precise mechanism by which anagrelide reduces blood platelet count is unknown.
Natančni mehanizem, s katerim anagrelid zmanjša število krvnih ploščic v krvi, ni znan.
• Anagrelide demonstrates some limited inhibitory activity towards CYP1A2 which may present a theoretical potential for interaction with other co-administered medicinal products sharing that clearance mechanism e.g. theophylline.
• Anagrelid kaže nekatere omejene zaviralne lastnosti napram CYP1A2, kar utegne predstavljati teoretično možnost za medsebojno delovanje z drugimi zdravili, ki so uporabljeni istočasno in ki si delijo ta mehanizem očistka, npr. teofilin.
Therefore it is recommended that patients with moderate or severe hepatic impairment are not treated with anagrelide.
Zato je priporočljivo, da bolnikov z zmerno ali zelo oslabljenimi jetri ne zdravimo z anagrelidom.
However, hepatic metabolism represents the major route of anagrelide clearance and liver function may therefore be expected to influence this process.
Vendar predstavlja jetrna presnova glavno pot, po kateri se razgrajuje anagrelid in delovanje jeter tako morda vpliva na ta potek.
• Medicines used to treat heart disorders, for example, milrinone, enoximone, amrinone, olprinone and cilostazol;
• zdravila, ki se uporabljajo za zdravljenje motenj srca, npr. milrinon, enoksimon, amrinon, olprinon in cilostazol;
• Acetylsalicylic acid (a substance present in many medicines used to relieve pain and lower fever, as well as to prevent blood clotting, also known as aspirin);
• acetilsalicilna kislina (snov, ki je prisotna v številnih zdravilih, ki se uporabljajo za blaženje bolečin in zniževanje zvišane telesne temperature, pa tudi za preprečevanje strjevanja krvi, ki je znana tudi pod imenom aspirin);
Caution should be taken when using anagrelide in patients with known risk factors for prolongation of the QT interval, such as congenital long QT syndrome, a known history of acquired QTc prolongation, medicinal products that can prolong QTc interval and hypokalaemia.
Kadar uporabljamo anagrelid pri bolnikih z znanimi dejavniki tveganja za podaljšanje intervala QT, na primer s prirojenim sindromom dolgega intervala QT, z znano anamnezo pridobljenega podaljšanja intervala QTc, pri uporabi zdravil, ki lahko podaljšajo interval QTc, in pri hipokaliemiji, je potrebna previdnost.
• If you were born with or have family history of prolonged QT interval (seen on ECG, electrical recording of the heart), or you are taking other medicines that result in abnormal ECG changes or if you have low levels of electrolytes e.g. potassium, magnesium or calcium (see section “Other medicines and Xagrid”);
• če ste se rodili s podaljšanim intervalom QTc oziroma imate podaljšan interval QTc v družinski anamnezi (vidno na EKG posnetku, električnem posnetku srca) ali pa jemljete druga zdravila, pri katerih bi lahko prišlo do nenormalnih sprememb na EKG posnetku oziroma če imate nizke vrednosti elektrolitov, n.pr.
Xagrid (on the outer carton only)
PODATKI V BRAILLOVI PISAVI Xagrid (samo na zunanji ovojnini)
Anagrelide, at higher than recommended doses, has been shown to produce reductions in blood pressure with occasional instances of hypotension.
Anagrelid je pri višjih odmerkih od priporočenih povzročilo padec krvnega tlaka z občasnimi primeri hipotenzije.
Xagrid is a medicine which interferes with the development of platelets.
Zdravilo Xagrid je zdravilo, ki ovira razvoj krvnih ploščic.
High-density polyethylene (HDPE) bottles with child-resistant closures and desiccant containing 100 capsules.
Plastenke iz polietilena visoke gostote (HDPE) s pokrovom, ki otrokom onemogoča odpiranje, in sušilnim sredstvom, ki vsebujejo po100 kapsul.
Xagrid is indicated for the reduction of elevated platelet counts in at risk essential thrombocythaemia (ET) patients who are intolerant to their current therapy or whose elevated platelet counts are not reduced to an acceptable level by their current therapy.
Zdravilo Xagrid je indicirano za zmanjšanje povečanega števila krvnih ploščic pri bolnikih, ki so izpostavljeni tveganju za pojav esencialne trombocitemije (ET) in ki se ne odzivajo na trenutno zdravljenje, ali pri bolnikih, katerih povišano število krvnih ploščic se s trenutnim načinom zdravljenja ni zmanjšalo na sprejemljivo raven.
• a platelet count > 1000 x 10
• število krvnih ploščic, ki je višje od 1000 x 10
Among them, the incidence of adrenal phaeochromocytomas was increased relative to control in males at all dose levels (≥ 3 mg/kg/day) and in females receiving 10 mg/kg/day and above.
Pojav nadledvičnega feokromocitoma je bil pogostejši v zvezi s kontrolo pri samcih pri vseh odmerkih (≥ 3 mg/kg/dan) in pri samicah, ki so prejemale 10 mg/kg/dan in več.
• Lung inflammation (signs include fever, coughing, difficulty breathing, wheezing; which causes scaring of the lungs) (allergic alveolitis, including interstitial lung disease, pneumonitis);
• vnetje pljuč (znaki vključujejo zvišano telesno temperaturo, kašelj, oteženo dihanje,sopenje; ki povzroči brazgotinjenje pljuč) (alergijski alveolitis, vključno z intersticijsko boleznijo pljuč,
Like all medicines, Xagrid can cause side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi to zdravilo neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
• If you have moderate or severe liver problems;
• če imate zmerne ali hude težave z jetri;
Xagrid should not be taken by pregnant women.
Zdravila Xagrid nosečnice ne bi smele jemati.
What Xagrid looks like and contents of the pack
Izgled zdravila Xagrid in vsebina pakiranja
Very common side effects: may affect more than 1 in 10 people
Zelo pogosti neželeni učinki: (pojavijo se pri več kot 1 od 10 bolnikov glavobol.
Capsule contents: povidone (E1201); crospovidone; lactose, anhydrous; lactose monohydrate; cellulose, microcrystalline (E460) and magnesium stearate.
Vsebina kapsule: povidon (E1201), krospovidon; laktoza, brezvodna; laktoza monohidrat; celuloza, mikrokristalna (E460) in magnezijev stearat.
Hard capsule.
FARMACEVTSKA OBLIKA Trda kapsula.
Concomitant use of anagrelide with other PDE III inhibitors such as milrinone, amrinone, enoximone, olprinone and cilostazol is not recommended.
Hkratna uporaba anagrelida z drugimi zaviralci PDE III, kot so milrinon, amrinon, enoksimon, olprinon in cilostazol, ni priporočljiva.
Capsule shell: gelatin and titanium dioxide (E171).
Ovojnica kapsule: želatina in titanov dioksid (E171).
Do not crush or dilute the contents in a liquid.
Ne sme jih zdrobiti ali raztopiti njihove vsebine v tekočini.
They were observed in females receiving 30 mg/kg/day, corresponding to 572 times the human AUC exposure after a 1 mg twice daily dose.
Opazili so jih pri samicah, ki so prejemale 30 mg/kg/dan, kar je enako 572-kratniku AUC po odmerjenem 1 mg dvojnega dnevnega odmerka.
In the later study 3660 patients who received anagrelide at a mean dose of approximately 2 mg/day were assessed for safety.
V zadnji študiji so glede varnosti ocenjevali 3660 bolnikov, ki so prejemali anagrelid v povprečnem odmerku približno 2 mg dnevno.
In clinical development, dizziness was commonly reported.
Pri kliničnem razvoju so pogosto poročali o omotici.
Lactose is an ingredient in this medicine.
Sestavina tega zdravila je laktoza.
The lowest dose in males (3 mg/kg/day) corresponds to 37 times the human AUC exposure after a 1 mg twice daily dose.
Najmanjši odmerek pri samcih (3 mg/kg/dan) je enak 37-kratniku AUC pri ljudeh po odmerjenem 1 mg dvojnega dnevnega odmerka.
In 3 of the studies 942 patients who received anagrelide at a mean dose of approximately 2 mg/day were assessed for safety.
V treh študijah so glede varnosti ocenjevali 942 bolnikov, ki so prejemali anagrelid pri povprečni vrednosti približno 2 mg dnevno.
Dizziness has been reported by some patients taking Xagrid.
Pri nekaterih bolnikih, ki so jemali zdravilo Xagrid, so poročali o omotici.
• Oral contraceptives: If you experience bad diarrhoea whilst taking this medicine, it may reduce how well the oral contraceptive works and use of an extra method of contraception is recommended (e.g condom).
Če dobite pri jemanju tega zdravila močno drisko, se lahko zmanjša učinkovitost delovanja peroralne kontracepcije, zato je priporočljiva uporaba dodatne kontracepcijske metode (n.pr.
Tell your doctor if you are breast-feeding or if you are planning to breast-feed your baby.
Povejte zdravniku, če dojite otroka ali če ga nameravate začeti dojiti.
Printing ink: shellac; strong ammonium solution; potassium hydroxide (E525); black iron oxide (E172).
Tiskarsko črnilo: šelak; močna raztopina amoniaka; kalijev hidroksid (E525); črni železov oksid (E172).
• If you have moderate or severe kidney problems.
• če imate zmerne ali hude težave z ledvicami.
All patients should be monitored regularly during treatment (e.g. ECG or echocardiography) for evidence of cardiovascular effects that may require further cardiovascular examination and investigation.
z EKG ali ehokardiografijo) znake kardiovaskularnih učinkov, zaradi katerih bi utegnila biti potrebna nadaljnja kardiovaskularna preiskava in pregled.
In a pre- and post-natal development study in female rats, anagrelide at oral doses of ≥10 mg/kg produced a non-adverse increase in gestational duration.
Anagrelid je v študiji prenatalnega in postnatalnega razvoja pri samicah podgan pri peroralnih odmerkih ≥10 mg/kg povzročil neškodljivo podaljšanje trajanja brejosti.
Typically cytoreductive therapy is considered in high risk paediatric patients.
Pri pediatričnih bolnikih z velikim tveganjem pride v poštev tipično citoreduktivno zdravljenje.
Strong ammonium solution Potassium hydroxide (E525) Black iron oxide (E172)
Tiskarsko črnilo šelak močna raztopina amoniaka kalijev hidroksid (E525) črni železov oksid (E172)
The mean recovery of 2-amino-5, 6-dichloro-3, 4-dihydroquinazoline in urine is approximately 18-35% of the administered dose.
V urinu prestrežemo povprečno približno 18-35 % danega odmerka v obliki 2-amino-5,6-dikloro-3, 4-dihidrokinazolina.
Povidone (E1201) Lactose, anhydrous Lactose monohydrate Cellulose, microcrystalline (E460) Crospovidone
Vsebina kapsule povidon (E1201) laktoza, brezvodna laktoza monohidrat celuloza, mikrokristalna (E460) krospovidon magnezijev stearat
Post-marketing case reports of intentional overdose with anagrelide have been received.
Po začetku trženja zdravila so bili zabeleženi primeri, ko so bolniki namerno vzeli prevelik odmerek anagrelida.
The no observed effect level (NOEL) for male dogs (0.3mg/kg/day) corresponds to 0.1, 0.1, and 1.6-fold the AUC in humans for anagrelide at 2mg/day, and the metabolites BCH24426 and RL603, respectively.
Raven brez vidnih učinkov (no observed effect level (NOEL)) za samce psov (0,3 mg/kg/dan) ustreza 0,1-, 0,1- oziroma 1,6-kratniku AUC pri ljudeh za anagrelid pri odmerku 2 mg/dan oziroma za presnovka BCH24426 in RL603.
Following repeated oral administration of anagrelide in dogs, subendocardial haemorrhage and focal myocardial necrosis was observed at 1mg/kg/day or higher in males and females with males being more sensitive.
Pri psih so, po ponavljajočem se peroralnem dajanju anagrelida, opazili pri odmerku 1 mg/kg/dan ali več subendokardialne krvavitve in fokalno miokardialno nekrozo tako pri samcih kot pri samicah, pri čemer so bili samci občutljivejši.
You must stop breast-feeding if you are taking Xagrid.
Če jemljete zdravilo Xagrid, morate prenehati z dojenjem.
• Other medicines used to treat conditions affecting the platelets in your blood, e.g. clopidogrel;
• druga zdravila, ki se uporabljajo za zdravljenje bolezni, ki vplivajo na trombocite, n.pr.
Therefore, the potential risks of the concomitant use of anagrelide with acetylsalicylic acid should be assessed, particularly in patients with a high risk profile for haemorrhage before treatment is initiated.
Zato je treba pri bolnikih z ET pred začetkom zdravljenja ugotoviti morebitna tveganja ob hkratni uporabi anagrelida z acetilsalicilno kislino, še posebej pri bolnikih z velikim tveganjem za krvavitve.
How to take Xagrid
Kako jemati zdravilo Xagrid
• Inflammation of the liver, symptoms include nausea, vomiting, itching, yellowing of the skin and eyes, discoloration of stool and urine (hepatitis);
• vnetje jeter, simptomi vključujejo navzeo, bruhanje, srbenje, rumeno obarvanje kože in oči,
A pre-treatment cardiovascular examination, including a baseline ECG and echocardiography is recommended for all patients prior to initiating therapy with anagrelide.
Pred uvedbo zdravljenja z anagrelidom za vse bolnike priporočajo kardiovaskularni pregled, ki vključuje izhodiščni EKG posnetek in ehokardiografijo.
In a paediatric registry study, median platelet counts were reduced from diagnosis and maintained for up to 18 months in 14 paediatric ET patients (4 children, 10 adolescents) with anagrelide treatment.
V pediatrični registrski študiji se je pri 14 pediatričnih bolnikih z ET (4 otroci, 10 mladostnikov), ki so se zdravili z anagrelidom, mediana koncentracija trombocitov od postavitve diagnoze zmanjšala in se nato vzdrževala do 18 mesecev dolgo.
In female rats increases in pre- and post-implantation losses and a decrease in the mean number of live embryos was observed at 30 mg/kg/day.
Pri podganjih samicah so pri odmerku 30 mg/kg/dan opazili zvečanje predugnezditvenih in pougnezditvenih izgub in zmanjšanje povprečnega števila živih zarodkov.
The NOEL (10mg/kg/day) to this effect was 143, 12 and 11-fold higher than the AUC in humans administered a dose of anagrelide 2 mg/day, and the metabolites BCH24426 and RL603, respectively.
NOEL (10 mg/kg/dan) za ta učinek je bila 143-, 12- oziroma 11-krat višja kot AUC pri ljudeh, ki so jim dajali odmerek anagrelida 2 mg/dan oziroma presnovka BCH24426 in RL603.
Care should also be taken in populations that may have a higher maximum plasma concentration (Cmax) of anagrelide or its active metabolite, 3-hydroxy-anagrelide, e.g. hepatic impairment or use with CYP1A2 inhibitors (see section 4.5).
Previdnost je potrebna tudi pri skupinah bolnikov, ki utegnejo imeti višjo maksimalno plazemsko koncentracijo (Cmax) anagrelida ali njegovega aktivnega presnovka 3-hidroksi-anagrelida, n.pr.
• a history of thrombo-haemorrhagic events.
• že doživeti trombohemoragični primeri.
Xagrid 0.5 mg hard capsules.
IME ZDRAVILA Xagrid 0,5 mg trde kapsule.
The potential risks and benefits of anagrelide therapy in a patient with impairment of renal function should be assessed before treatment is commenced (see section 4.3).
Morebitna tveganja in koristi ob zdravljenju z anagrelidom pri bolnikih s poslabšanim delovanjem ledvic je treba oceniti pred začetkom zdravljenja (glejte poglavje 4.3).