natgillin/translations-raw huggingface dataset:
Anagrelide is an inhibitor of cyclic AMP phosphodiesterase III and because of its positive inotropic effects, a pre- treatment cardiovascular examination (including further investigation such as echocardiography, electrocardiogram) is recommended.
Anagrelid je zaviralec ciklične AMP fosfodiesteraze III in zaradi pozitivnih inotropnih učinkov pred zdravljenjem priporočamo pregled srca in ožilja (vključno z nadaljnjimi preiskavami kot npr. ehokardiografija, elektrokardiogram).
Patients should be monitored during treatment for evidence of cardiovascular effects that may require further cardiovascular examination and investigation.
Pri pacientih je treba med zdravljenjem spremljati znake kardiovaskularnih učinkov, zaradi katerih bi utegnila biti potrebna nadaljnja kardiovaskularna preiskava in pregled.
(see section 5.1) limited data are available on the use of anagrelide in the paediatric population and anagrelide should be used in this patient group with caution.
(glejte poglavje 5. 1) o uporabi anagrelida pri otroški populaciji je na voljo le malo podatkov, zato ga je pri tej skupini pacientov treba uporabljati previdno.
3 Clinically relevant interactions: anagrelide is an inhibitor of cyclic AMP phosphodiesterase III (PDE III).
Klinično pomembne interakcije: anagrelid je zaviralec ciklične AMP fosfodiesteraze III (PDE III).
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Pacienti z redkimi prirojenimi motnjami, kot so galaktozna intoleranca, Lappovo pomanjkanje laktaze ali malabsorpcija glukoze in galaktoze, tega zdravila ne smejo jemati.
Limited pharmacokinetic and/ or pharmacodynamic studies investigating possible interactions between anagrelide and other medicinal products have been conducted.
Opravili so omejene farmakokinetične in/ ali farmakodinamične raziskave, v katerih so preiskovali možna medsebojna delovanja anagrelida in drugih zdravil.
Drug interactions: effects of other substances on anagrelide • Anagrelide is primarily metabolised by CYP1A2.
Medsebojna delovanja z zdravili: učinki drugih snovi na anagrelid • Anagrelid se v glavnem metabolizira s CYP1A2.
It is known that CYP1A2 is inhibited by several medicinal products, including fluvoxamine and omeprazole, and such medicinal products could theoretically adversely influence the clearance of anagrelide. • In vivo interaction studies in humans have demonstrated that digoxin and warfarin do not affect the pharmacokinetic properties of anagrelide.
Znano je, da CYP1A2 zavirajo številna zdravila, med drugim tudi fluvoksamin in omeprazol, in ta zdravila utegnejo teoretično neugodno vplivati na očistek anagrelida. • In vivo raziskave medsebojnega delovanja pri ljudeh so pokazale, da digoksin in varfarin ne vplivata na farmakokinetične lastnosti anagrelida.
Drug interactions: effects of anagrelide on other substances • 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. • Anagrelide is an inhibitor of PDE III.
Medsebojna delovanja z zdravili: učinki anagrelida na druge snovi • 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. • Anagrelid je zaviralec PDE III.
The effects of medicinal products with similar properties such as the inotropes milrinone, enoximone, amrinone, olprinone and cilostazol may be exacerbated by anagrelide. • In vivo interaction studies in humans have demonstrated that anagrelide does not affect the pharmacokinetic properties of digoxin or warfarin. • At the doses recommended for use in the treatment of essential thrombocythaemia, anagrelide may theoretically potentiate the effects of other medicinal products that inhibit or modify platelet function e. g. acetylsalicylic acid. • A clinical interaction study performed in healthy subjects showed that co-administration of repeat-dose anagrelide 1mg once daily and acetylsalicylic acid 75mg once daily may enhance the anti-platelet aggregation effects of each drug compared with administration of acetylsalicylic acid alone.
Anagrelid utegne poslabšati učinke zdravil s podobnimi lastnostmi, kot so inotropna zdravila milrinon, enoksimon, amrinon, olprinon in cilostazol. • In vivo študije medsebojnega delovanja pri ljudeh so pokazale, da anagrelid ne vpliva na farmakokinetične lastnosti digoksina in varfarina. • Pri priporočenih odmerkih pri zdravljenju esencialne trombocitemije utegne anagrelid teoretično okrepiti učinke drugih zdravil, ki zavirajo ali spreminjajo funkcijo krvnih ploščic, npr. učinke acetilsalicilne kisline. • Študija kliničnega medsebojnega delovanja, opravljena pri zdravih osebah, je pokazala, da lahko sočasno dajanje ponavljajočih se enomiligramskih odmerkov anagrelida in acetilsalicilne kisline v odmerku 75 mg enkrat na dan zveča antiagregacijske učinke posameznega zdravila v primerjavi z dajanjem samo acetilsalicilne kisline.
Therefore, due to the lack of data in ET patients, 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. • Anagrelide may cause intestinal disturbance in some patients and compromise the absorption of hormonal oral contraceptives.
Zato je zaradi pomanjkanja podatkov pri bolnikih z ET treba pred začetkom zdravljenja ugotoviti morebitna tveganja ob hkratni uporabi anagrelida z acetilsalicilno kislino, še posebej pri bolnikih z velikim tveganjem za krvavitve. • Anagrelid utegne pri nekaterih pacientih povzročiti črevesne motnje in poslabšati absorpcijo hormonskih peroralnih kontracepcijskih sredstev.
Food interactions: • Food delays the absorption of anagrelide but does not significantly alter systemic exposure. • The effects of food on bioavailability are not considered clinically relevant to the use of anagrelide.
Medsebojno delovanje s hrano: • Hrana upočasni absorpcijo anagrelida, a ne spremeni bistveno sistemske izpostavljenosti. • Učinki hrane na biološko uporabnost niso klinično relevantni za uporabo anagrelida.
4 Use of Xagrid during pregnancy is not recommended.
4 Uporabe Xagrida med nosečnostjo ne priporočamo.
If Xagrid is used during pregnancy, or if the patient becomes pregnant while using the drug, she should be advised of the potential risk to the foetus.
V primeru uporabe Xagrida med nosečnostjo ali če pacientka v času uporabe zdravila zanosi, je nosečnico treba seznaniti z morebitnim tveganjem za zarodek.
Women of child-bearing potential should use adequate birth-control measures during treatment with anagrelide.
Ženske v rodni dobi morajo med zdravljenjem z anagrelidom poskrbeti za učinkovito zaščito pred zanositvijo.
Lactation:
Dojenje.
It is not known whether anagrelide hydrochloride is excreted in milk.
Ni znano, ali se anagrelidijev klorid izloča v mleku.
Since many medicinal products are excreted in human milk and because of the potential for adverse reactions in breast-feeding infants, mothers should discontinue breast-feeding when taking Xagrid.
Ker se številna zdravila izločajo v človeškem mleku in ker obstaja možnost, da pride do neželenih reakcij pri dojenih otrocih, bi morale matere prenehati z dojenjem, ko jemljejo Xagrid.
Patients are advised not to drive or operate machinery while taking Xagrid if dizziness is experienced.
V primeru omotice ob jemanju Xagrida naj pacienti ne vozijo ali upravljajo s stroji.
In 3 of the studies 942 patients who received anagrelide at a mean dose of approximately 2mg/ day were assessed for safety.
V treh študijah so glede varnosti ocenjevali 942 pacientov, ki so prejemali anagrelid pri povprečni vrednosti približno 2 mg dnevno.
In these studies 22 patients received anagrelide for up to 4 years.
V teh študijah je 22 pacientov anagrelid prejemalo do 4 leta.
In the later study 3660 patients who received anagrelide at a mean dose of approximately 2mg/ day were assessed for safety.
V zadnji študiji so glede varnosti ocenjevali 3660 pacientov, ki so prejemali anagrelid v povprečnem odmerku približno 2 mg dnevno.
In this study 34 patients received anagrelide for up to 5 years.
V tej študiji je 34 pacientov anagrelid prejemalo do 5 let.
The most commonly reported drug related adverse reactions 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 zdravilom, so bili glavobol, ki se je pojavil pri približno 14% pacientov, palpitacije so se pojavile pri približno 9% pacientov, zastajanje tekočine in slabost sta se pojavila pri približno 6% pacientov in driska pri 5 odstotkih pacientov.
Gradual dose titration may help diminish these effects (see section 4.2).
Postopna titracija odmerka utegne pomagati pri zmanjšanju teh učinkov (glejte poglavje 4. 2).
The following convention was used for frequency of adverse drug reactions: very common (> 1/ 10); common (> 1/ 100 ,< 1/10); uncommon (> 1/1 ,000, < 1/100); rare (> 1/10,000, < 1/ 1,000); not known (cannot be estimated from the available data).
Zelo pogosto (> 1/ 10); pogosto (> 1/ 100, < 1/ 10); občasno (> 1/ 1000, < 1/ 100); redko (> 1/ 10000, < 1/ 1000); ni znano (ni mogoče oceniti na podlagi razpoložljivih podatkov).
Blood and lymphatic system disorders Common:
Bolezni krvi in limfatičnega sistema Pogosto:
Anaemia Thrombocytopenia, pancytopenia, ecchymosis, haemorrhage
anemija trombocitopenija, pancitopenija, ekhimoza, krvavitev.
Metabolism and nutrition disorders Common:
Presnovne in prehranske motnje Pogosto:
Fluid retention Oedema, weight loss Weight gain
zastajanje tekočine edem, izguba telesne mase pridobivanje telesne mase
Headache Common:
Bolezni živčevja Zelo pogosto: glavobol Pogosto:
Dizziness Paraesthesia, insomnia, depression, confusion, hypoaesthesia, nervousness, dry mouth, amnesia
vrtoglavica parestezija, nespečnost, depresija, zmedenost, hipestezija, nervoza, suha usta, izguba spomina
Somnolence, abnormal coordination, dysarthria, migraine
dremavica, nenormalna koordinacija, disartrija, migrenski glavobol
Special senses
Posebni čuti
Vision abnormal, tinnitus, diplopia
nenormalen vid, tinitus, diplopija
Cardiac disorders Common:
Srčne bolezni Pogosto:
5 Uncommon:
5 Občasno:
Congestive heart failure, hypertension, arrhythmia, atrial fibrillation, supraventricular tachycardia, ventricular tachycardia, syncope
kongestivna srčna odpoved, hipertenzija, aritmija, atrijska fibrilacija, supraventrikularna tahikardija, ventrikularna tahikardija, omedlevica
Angina pectoris, myocardial infarction, cardiomegaly, cardiomyopathy, pericardial effusion, vasodilatation, postural hypotension
angina pektoris, miokardni infarkt, kardiomegalija, kardiomiopatija, perikardni izliv, vazodilatacija, posturalna hipotenzija
Respiratory and thoracic disorders Uncommon:
Bolezni dihal, prsnega koša in mediastinalnega prostora Občasno:
Dyspnoea, epistaxis, pleural effusion, pneumonia Pulmonary hypertension, pulmonary infiltrates Allergic alveolitis
dispneja, epistaksa (krvavitev iz nosu), plevralni izliv, pljučnica Pljučna hipertenzija, pljučni infiltrati Alergični alveolitis
Gastrointestinal disorders Common:
Pogosto:
Nausea, diarrhoea, abdominal pain, flatulence, vomiting Dyspepsia, anorexia, pancreatitis, constipation, gastrointestinal haemorrhage, gastrointestinal disorder
slabost, driska, bolečine v trebuhu, vetrovi, bruhanje prebavne motnje, anoreksija, vnetje trebušne slinavke, zaprtje, gastrointestinalna krvavitev, gastrointestinalne motnje
Colitis, gastritis, gingival bleeding
kolitis, gastritis, krvavitev dlesni
Hepatobiliary disorders Uncommon:
Bolezni jeter, žolčnika in žolčevodov Občasno:
Skin and subcutaneous tissue Common:
Bolezni kože in podkožja Pogosto:
Rash Alopecia, skin discoloration, pruritus Dry skin
izpuščaji izpadanje las, razbarvanje kože, pruritus suha koža
Musculoskeletal and connective tissue disorders Uncommon:
Bolezni mišično- skeletnega sistema in vezivnega tkiva Občasno:
Myalgia, arthralgia, back pain
mialgija, artralgija, bolečine v križu
Uncommon:
Urogenitalne bolezni Občasno:
Impotence Nocturia, renal failure
impotenca nokturija, ledvična odpoved
Investigations Rare:
Redko:
Fatigue Chest pain, weakness, chills, malaise, fever Asthenia, pain, flu-like syndrome
utrujenost bolečina v prsih, šibkost, mrzlica, bolehnost, vročica splošna oslabelost, bolečina, gripi podobni sindrom
There have been a small number of post-marketing case reports of intentional overdose with anagrelide.
Po začetku trženja zdravila je bilo zabeleženih nekaj primerov, ko so pacienti namerno vzeli prevelik odmerek anagrelida.
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 pacienta; to vključuje spremljanje števila krvnih ploščic zaradi trombocitopenije.
Dosage should be decreased or stopped, as appropriate, until the platelet count returns to within the normal range.
Odmerek je treba zmanjšati ali prekiniti dajanje, kot je primernejše, dokler se število krvnih ploščic ne povrne v normalno območje.
Xagrid, at higher than recommended doses, has been shown to produce reductions in blood pressure with occasional instances of hypotension.
Xagrid je pri višjih odmerkih od priporočenih povzročil padec krvnega tlaka z občasnimi primeri hipotenzije.
A single 5mg dose of anagrelide can lead to a fall in blood pressure usually accompanied by dizziness.
Enkraten 5 mg odmerek anagrelida utegne povzročiti padec krvnega tlaka, ki ga ponavadi spremlja omotica.
ATC Code:
Farmakoterapevtska skupina: oznaka ATC:
L01XX35 (Other Antineoplastic Agents)
L01XX35 (Druga zdravila z delovanjem na novotvorbe (citostatiki))
The specific mechanism of action by which anagrelide reduces platelet count is not yet fully understood although it has been confirmed that anagrelide is platelet selective from in vitro and in vivo study information.
Specifični mehanizem delovanja, s katerim anagrelid zmanjša število krvnih ploščic, še ni povsem znan, čeprav je bilo iz informacij in vitro in in vivo študij potrjeno, da je anagrelid selektiven do krvnih ploščic.
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.
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 pacientom.
The safety and efficacy of anagrelide as a platelet lowering agent have been evaluated in four open- label, non-controlled clinical trials (study numbers 700-012, 700-014, 700-999 and 13970-301) including more than 4000 patients with myeloproliferative disorders (MPDs).
Varnost in učinkovitost anagrelida kot sredstva za zniževanja krvnih ploščic so ovrednotili v štirih odprtih, nekontroliranih študijah, z vsem sodelujočim znanim zdravilom (številke študij 700- 012, 700 - 014, 700- 999 in 13970- 301), ki so vključevale več kot 4000 pacientov z mieloproliferativno boleznijo (MPD).
In patients with essential thrombocythaemia complete response was defined as a decrease in platelet count to ≤ 600 x 109/ l or a ≥ 50% reduction from baseline and maintenance of the reduction for at least 4 weeks.
Pri pacientih z esencialno trombocitemijo je bil popoln odziv opredeljen kot zmanjšanje števila krvnih ploščic na ≤600 x109/ l ali ≥50% zmanjšanje od prvotne vrednosti in ohranitev zmanjšanja vsaj štiri tedne.
In studies 700- 012, 700-014, 700-999 and study 13970-301 the time to complete response ranged from 4 to 12 weeks.
V študijah 700- 012, 700- 014, 700- 999 in študiji 13970- 301 so za dosego popolnega odziva potrebovali od 4 do 12 tednov.
An open label clinical study with a 3 month treatment period did not raise any safety concerns for anagrelide in 17 children/ adolescent patients with ET (age range 7-14 years) compared to 18 adult patients.
Med odprto klinično študijo s 3 mesečnim obdobjem zdravljenja niso zaznali skrbi zaradi varnosti anagrelida pri 17 otrocih adolescentih pacientih s ET (starih od 7+14 let) v primerjavi z 18 odraslimi bolniki.
Earlier during clinical development a limited number (12) of children (age range 5 - 17 years) with essential thrombocythaemia were treated with anagrelide.
V zgodnejši fazi kliničnega razvoja je bilo omejeno število otrok (12) (starih od 5+ 17 let) z esencialno trombocitemijo zdravljenih z anagrelidom.
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%.
In fasted subjects, peak plasma levels occur about 1 hour after a 0.5mg dose; the plasma half- life is short, approximately 1.3 hours.
Pri osebah, ki so bile tešče, se najvišja plazemska koncentacija doseže približno 1 uro po 0, 5 mg odmerku; razpolovna doba v plazmi je kratka, približno 1, 3 ure.
Dose proportionality has been found in the dose range 0.5mg to 2mg.
Ugotovljena sorazmernost odmerka je v razponu od 0, 5 mg do 2 mg.
Anagrelide is primarily metabolised by CYP1A2; less than 1% is recovered in the urine as anagrelide.
Anagrelid se v glavnem metabolizira s CYP1A2; v seču ga manj kot 1% najdemo kot anagrelid.
Two major urinary metabolites, 2-amino-5, 6-dichloro-3, 4-dihydroquinazoline and N-(5,6-dichloro- 3,4-dihydroquinazalin-2-yl)-2-oxoacetamide have been identified.
Ugotovili so dva glavna sečna presnovka, 2- amino- 5, 6- dikloro- 3, 4- dihidrokvinazolin in N - (5, 6 - dikloro- 3, 4- dihidrokvinazolin- 2- il) - 2- oksoacetamid.
The mean recovery of 2-amino-5, 6-dichloro-3, 4-dihydroquinazoline in urine is approximately 18-35% of the administered dose.
Srednja rekuperacija 2- amino- 5, 6- dikloro- 3, 4 - dihidrokvinazolina v seču je približno 18- 35% danega odmerka.
Pharmacokinetic data from healthy subjects established that food decreases the Cmax of anagrelide by 14%, but increases the AUC by 20%.
Farmakokitetični podatki pridobljeni pri zdavih osebah so dokazali, da hrana zmanjša Cmax analgrelida za 14%, vendar zveča AUC vrednost za 20%.
Food had a more significant effect on the active metabolite and decreased the Cmax by 29%, although it had no effect on the AUC.
Hrana je imela pomemben učinek na aktivni metabolit in je zmanjšala Cmax za 29%, čeprav ni imela vpliva na AUC.
As expected from its half-life, there is no evidence for anagrelide accumulation in the plasma.
Kot je pričakovano glede na razpolovno dobo, ni dokazov, da bi se anagrelid kopičil v plazmi.
Additionally these results show no evidence of auto-induction of the anagrelide clearance.
Poleg tega ti izsledki ne vsebujejo dokazov o samoinduciranju očistka anagrelida.
7 Special populations
7 AUC, anagrelida manjša pri otrocih\ adolescentih v primerjavi z odraslimi.
There was also a trend to lower exposure to the active metabolite.
Obstajal je tudi trend, da bi zmanjšali izpostavljenost aktivnemu metabolitu.
These observations may be a reflection of more efficient metabolic clearance in younger subjects.
Ta opazovanja morda odražajo bolj učinkovit metabolni očistek pri mlajših pacientih.
Elderly 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, 2- amino-5, 6-dichloro-3, 4-dihydroquinazoline, were 42% and 37% lower respectively in the elderly patients.
Starejši 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 2- amino- 5, 6- dikloro- 3, 4- dihidrokvinazolina pa sta bili pri starejših bolnikih za 42% in 37% nižji.
These differences were likely to be caused by lower presystemic metabolism of anagrelide to 2-amino-5, 6-dichloro-3, 4-dihydroquinazoline in the elderly patients.
Te razlike so najverjetneje posledica manjše predsistemske presnove anagrelida v 2- amino - 5, 6- dikloro- 3, 4- dihidrokvinazolin pri starejših bolnikih.
Repeated dose toxicity.
Toksičnost po ponavljajočem odmerjanju.
Following repeated administration of anagrelide, at doses of 1mg/ kg/ day or higher, subendocardial haemorrhage and focal myocardial necrosis occurred in dogs.
Pri psih sta se pri ponavljajočem dajanju anagrelida v odmerku 1 mg na kilogram dnevno ali celo več pojavili subendokardialna krvavitev in osrednja miokardialna nekroza.
Reproductive toxicology.
Reproduktivna toksikologija.
Maternally toxic doses of anagrelide (60 mg/ kg/ day and above) in rats and rabbits were associated with increased embryo resorption and foetal mortality.
Toksični odmerki anagrelida (60 mg na kg dnevno in več) pri brejih podganah in zajcih so povezani s povišanim vsrkavanjem zarodka in povišano umrljivostjo le- tega.
Mutagenic and carcinogenic potential.
Mutageni in karcinogeni potenical.
In a two-year rat carcinogenicity study, non-neoplastic and neoplastic findings were observed and related or attributed to an exaggerated pharmacological effect.
V dvoletni raziskavi karcinogenosti pri podganah, so opazovali ne- neoplastične in neoplastične ugotovitve ter jih povezali ali pripisovali prekomernemu farmakološkemu učinku.
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.
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.
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.
Currently, there is no clinical evidence that these findings are of relevance to human use.
Trenutno ni kliničnih dokazov, da so ta odkritja relevantna pri uporabi zdravila pri človeku.
Capsule contents Povidone (E1201) Anhydrous lactose Lactose monohydrate Microcrystalline cellulose (E460) Crospovidone Magnesium stearate
Vsebina kapsule povidon (E1201) brezvodna laktoza laktoza monohidrat mikrokristalna celuloza (E460) krospovidon magnezijev stearat
Capsule shell Gelatin Titanium dioxide (E171)
Ovojnica kapsule želatina titanov dioksid (E171)
8 Printing ink Shellac Strong ammonium solution Potassium hydroxide (E525) Black iron oxide (E172)
8 kalijev hidroksid (E525) črni železov oksid (E172)
No special precautions for storage
Za shranjevanje ni posebnih navodil.
High-density polyethylene (HDPE) bottles containing desiccant with child-resistant closures containing 100 capsules
Steklenice iz polietilena visoke gostote (HDPE) s 100 kapsulami s sušilnim sredstvom in pokrovom, ki otrokom onemogoča odpiranje.
Shire Pharmaceutical Contracts Ltd Hampshire International Business Park Chineham Basingstoke Hampshire RG24 8EP United Kingdom
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