natgillin/translations-raw huggingface dataset:
Severe cutaneous adverse reactions (SCARs), including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported with the use of EXJADE (see section 4.4).
Pri uporabi zdravila EXJADE so poročali o hudih kožnih neželenih reakcijah (SCAR), med drugim o Stevens-Johnsonovem sindromu (SJS), toksični epidermalni nekrolizi (TEN) in reakcijah na zdravilo z eozinofilijo in sistemskimi simptomi (DRESS) (glejte poglavje 4.4).
In a 5-year observational study in which 267 children aged 2 to <6 years (at enrollment) with transfusional haemosiderosis received deferasirox, there were no clinically meaningful differences in the safety and tolerability profile of Exjade in paediatric patients aged 2 to <6 years compared to the overall adult and older paediatric population, including increases in serum creatinine of >33% and above the upper limit of normal on ≥2 consecutive occasions (3.1%), and elevation of alanine aminotransferase (ALT) greater than 5 times the upper limit of normal (4.3%).
V 5-letni opazovalni študiji, v kateri je deferasiroks prejemalo 267 otrok, ki so bili ob vključitvi stari od 2 do manj kot 6 let in so imeli transfuzijsko hemosiderozo, ni bilo klinično pomembnih razlik v profilih varnosti in prenašanja zdravila Exjade med pediatričnimi bolniki v starosti od 2 do manj kot 6 let in celotno populacijo odraslih ter starejših pediatričnih bolnikov.
EXJADE granules demonstrate higher bioavailability compared to the EXJADE dispersible tablet formulation.
Zdravilo EXJADE v obliki zrnc ima večjo biološko uporabnost v primerjavi z zdravilom EXJADE v obliki disperzibilnih tablet.
Exjade 360 mg film-coated tablets deferasirox
Exjade 360 mg filmsko obložene tablete deferasiroks
In case of switching from dispersible tablets to granules, the dose of the granules should be 30% lower than the dose of the dispersible tablets, rounded to the nearest whole sachet.
V primeru prehoda z disperzibilnih tablet na zrnca mora biti odmerek pri zrncih za 30 % nižji od prejšnjega odmerka v obliki disperzibilnih tablet, in sicer naj bo odmerek zaokrožen na najbližjo jakost cele vrečice.
• Each sachet of EXJADE 180 mg granules contains 180 mg deferasirox.
• Ena vrečica zdravila EXJADE 180 mg zrnca vsebuje 180 mg deferasiroksa.
EXJADE 125 mg dispersible tablets EU/1/06/356/001
EXJADE 125 mg disperzibilne tablete EU/1/06/356/001
10 mg/kg/day ≥5 mg Fe/g dw or >800 µg/l
10 mg/kg/dan ≥5 mg Fe/g suhe teže ali
EXJADE 125 mg dispersible tablets
EXJADE 125 mg disperzibilne tablete
While no increase in renal adverse events was observed after dose escalation of EXJADE dispersible tablets to doses above 30 mg/kg in clinical studies, an increased risk of renal adverse events with granule doses above 21 mg/kg cannot be excluded.
Čeprav v kliničnih študijah zdravila EXJADE v obliki disperzibilnih tablet po postopnem zviševanju odmerkov nad 30 mg/kg niso opažali povečanega obsega ledvičnih neželenih dogodkov, pri uporabi zdravila v obliki zrnc v odmerkih nad 21 mg/kg ni mogoče izključiti povečanega tveganja za ledvične neželene dogodke.
Each dispersible tablet contains 125 mg of deferasirox.
Ena disperzibilna tableta vsebuje 125 mg deferasiroksa.
It is recommended that hyperammonaemic encephalopathy be considered and ammonia levels measured in patients who develop unexplained changes in mental status while on Exjade therapy.
Pri bolnikih, pri katerih v času zdravljenja z zdravilom Exjade pride do nepojasnjenih sprememb duševnega stanja, je priporočeno upoštevati možnost, da gre za hiperamoniemično encefalopatijo, in jim meriti koncentracijo amonijaka.
Exjade 180 mg film-coated tablets deferasirox
Exjade 180 mg filmsko obložene tablete deferasiroks
• Each sachet of EXJADE 360 mg granules contains 360 mg deferasirox.
• Ena vrečica zdravila EXJADE 360 mg zrnca vsebuje 360 mg deferasiroksa.
Each tablet contains 360 mg of deferasirox.
Ena tableta vsebuje 360 mg deferasiroksa.
• Each dispersible tablet of EXJADE 125 mg contains 125 mg deferasirox.
Ena disperzibilna tableta zdravila EXJADE 125 mg vsebuje 125 mg deferasiroksa.
EXJADE 500 mg dispersible tablets
EXJADE 500 mg disperzibilne tablete
Multipack: 300 (10 packs of 30) film-coated tablets
filmsko obložene tablete Skupno pakiranje: 300 (10 pakiranj po 30) filmsko obloženih tablet
EXJADE 250 mg dispersible tablets
EXJADE 250 mg disperzibilne tablete
Light blue, ovaloid, biconvex film-coated tablet with bevelled edges and imprints (NVR on one face and 90 on the other).
Svetlo modra ovalna bikonveksna filmsko obložena tableta z zaobljenimi robovi in vtisnjenima oznakama (NVR na eni in 90 na drugi strani).
EXJADE 500 mg dispersible tablets EU/1/06/356/005
EXJADE 500 mg disperzibilne tablete EU/1/06/356/005
• Obligation to conduct post-authorisation measures
• Dodatni ukrepi za zmanjševanje tveganj
• Each film-coated tablet of EXJADE 90 mg contains 90 mg deferasirox.
Ena filmsko obložena tableta zdravila EXJADE 90 mg vsebuje 90 mg deferasiroksa.
White to slightly yellow, round, flat tablets with bevelled edges and imprints (NVR on one face and J 125 on the other).
Bele do nekoliko rumenkaste, okrogle, ploščate tablete z zaobljenimi robovi in vtisnjenima oznakama (NVR na eni in J 125 na drugi strani).
• Each film-coated tablet of EXJADE 180 mg contains 180 mg deferasirox.
Ena filmsko obložena tableta zdravila EXJADE 180 mg vsebuje 180 mg deferasiroksa.
White to slightly yellow, round, flat tablets with bevelled edges and imprints (NVR on one face and J 250 on the other).
Bele do nekoliko rumenkaste, okrogle, ploščate tablete z zaobljenimi robovi in vtisnjenima oznakama (NVR na eni in J 250 na drugi strani).
Exjade 90 mg film-coated tablets deferasirox
Exjade 90 mg filmsko obložene tablete deferasiroks
Magnesium stearate Silica, colloidal anhydrous Poloxamer
Jedro tablete: mikrokristalna celuloza krospovidon povidon magnezijev stearat brezvoden koloidni silicijev dioksid poloksamer
• Each sachet of EXJADE 90 mg granules contains 90 mg deferasirox.
• Ena vrečica zdravila EXJADE 90 mg zrnca vsebuje 90 mg deferasiroksa.
In patients in whom LIC was not assessed and serum ferritin is ≤2,000 µg/l, dosing should not exceed 10 mg/kg.
Pri bolnikih brez izmerjene koncentracije železa v jetrih in s koncentracijo feritina v serumu ≤2.000 µg/l odmerek ne sme preseči 10 mg/kg.
White to slightly yellow, round, flat tablets with bevelled edges and imprints (NVR on one face and J 500 on the other).
Bele do nekoliko rumenkaste, okrogle, ploščate tablete z zaobljenimi robovi in vtisnjenima oznakama (NVR na eni in J 500 na drugi strani).
5-10 mg/kg/day Up to 40 mg/kg/day Decrease 3.5 - 7 mg/kg/day 5-10 mg/kg/day
3,5 - 7 mg/kg/dan 5-10 mg/kg/dan zniževanje 3,5 - 7 mg/kg/dan 5-10 mg/kg/dan <7 mg Fe/g suhe teže ali
Each tablet contains 180 mg of deferasirox.
Ena tableta vsebuje 180 mg deferasiroksa.
Each dispersible tablet contains 250 mg of deferasirox.
Ena disperzibilna tableta vsebuje 250 mg deferasiroksa.
Exjade 180 mg granules deferasirox
Exjade 180 mg zrnca deferasiroks peroralna uporaba
An initial daily dose of 30 mg/kg may be considered for patients who require reduction of elevated body iron levels and who are also receiving more than 14 ml/kg/month of packed red blood cells (approximately >4 units/month for an adult).
Začetni dnevni odmerek 30 mg/kg je lahko primeren za bolnike, pri katerih je treba znižati zvišano raven železa v organizmu in pri tem prejemajo več kot 14 ml/kg/mesec koncentriranih eritrocitov (približno >4 enote/mesec pri odraslem).
Each tablet contains 90 mg of deferasirox.
Ena tableta vsebuje 90 mg deferasiroksa.
• Each film-coated tablet of EXJADE 360 mg contains 360 mg deferasirox.
Ena filmsko obložena tableta zdravila EXJADE 360 mg vsebuje 360 mg deferasiroksa.
Each dispersible tablet contains 500 mg of deferasirox.
Ena disperzibilna tableta vsebuje 500 mg deferasiroksa.
• Each dispersible tablet of EXJADE 500 mg contains 500 mg deferasirox.
Ena disperzibilna tableta zdravila EXJADE 500 mg vsebuje 500 mg deferasiroksa.
What EXJADE is used for
Za kaj uporabljamo zdravilo EXJADE
Exjade 360 mg granules deferasirox
Exjade 360 mg zrnca deferasiroks peroralna uporaba
Exjade 360 mg granules in sachet deferasirox
Exjade 360 mg zrnca v vrečici deferasiroks
EXJADE 250 mg dispersible tablets EU/1/06/356/003
EXJADE 250 mg disperzibilne tablete EU/1/06/356/003
Exjade 180 mg granules in sachet deferasirox
Exjade 180 mg zrnca v vrečici deferasiroks
EXJADE 125 mg dispersible tablets deferasirox
EXJADE 125 mg disperzibilne tablete deferasiroks
Deafness Respiratory, thoracic and mediastinal disorders Uncommon:
Bolezni dihal, prsnega koša in mediastinalnega prostora občasni:
EXJADE 90 mg film-coated tablets Each film-coated tablet contains 90 mg deferasirox.
KAKOVOSTNA IN KOLIČINSKA SESTAVA EXJADE 90 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 90 mg deferasiroksa.
• Each dispersible tablet of EXJADE 250 mg contains 250 mg deferasirox.
Ena disperzibilna tableta zdravila EXJADE 250 mg vsebuje 250 mg deferasiroksa.
Each sachet contains 360 mg of deferasirox.
Ena vrečica vsebuje 360 mg deferasiroksa.
Exjade 90 mg granules deferasirox
Exjade 90 mg zrnca deferasiroks peroralna uporaba
Lactose monohydrate Crospovidone type A Cellulose, microcrystalline Povidone
6.1 Seznam pomožnih snovi laktoza monohidrat krospovidon tipa A mikrokristalna celuloza povidon natrijev lavrilsulfat brezvoden koloidni silicijev dioksid magnezijev stearat
EXJADE 500 mg dispersible tablets deferasirox
EXJADE 500 mg disperzibilne tablete deferasiroks
Exjade 90 mg granules in sachet deferasirox
Exjade 90 mg zrnca v vrečici deferasiroks
Magnesium stearate
Delovanje jeter
In patients treated with doses >21 mg/kg/day
3,5 - 7 mg/kg pri bolnikih, ki prejemajo odmerke >21 mg/kg/dan
• The usual daily dose for EXJADE dispersible tablets at the start of the treatment for patients receiving regular blood transfusions is 20 mg per kilogram body weight.
• Za bolnike, ki prejemajo redne transfuzije krvi, je običajni dnevni odmerek zdravila EXJADE v obliki disperzibilnih tablet na začetku zdravljenja 20 mg na kilogram telesne mase.
Each sachet contains 180 mg of deferasirox.
Ena vrečica vsebuje 180 mg deferasiroksa.
EXJADE contains lactose
PODATKI NA ZUNANJI OVOJNINI
• The usual daily dose for EXJADE film-coated tablets at the start of the treatment for patients receiving regular blood transfusions is 14 mg per kilogram body weight.
• Za bolnike, ki prejemajo redne transfuzije krvi, je običajni dnevni odmerek zdravila EXJADE v obliki filmsko obloženih tablet na začetku zdravljenja 14 mg na kilogram telesne mase.
It is recommended that serum ferritin be monitored every month to assess the patient's response to therapy and to minimise the risk of overchelation (see section 4.4).
Za oceno bolnikovega odziva na zdravljenje in za zmanjšanje tveganja za prekomerno kelacijo je priporočeno vrednost feritina v serumu spremljati vsak mesec (glejte poglavje 4.4).
Each sachet contains 90 mg of deferasirox.
Ena vrečica vsebuje 90 mg deferasiroksa.
1, urticaria erythema multiforme
1, aktuni pankreatitis
Table 1 Recommended doses for transfusional iron overload
Preglednica 1 Priporočeni odmerki pri preobremenitvi z železom zaradi transfuzij filmsko obložene tablete/zrnca disperzibilne tablete transfuzije feritin v serumu začetni odmerek
EXJADE 125 mg dispersible tablets Each dispersible tablet contains 125 mg deferasirox.
KAKOVOSTNA IN KOLIČINSKA SESTAVA EXJADE 125 mg disperzibilne tablete Ena disperzibilna tableta vsebuje 125 mg deferasiroksa.
1, anaemia aggravated neutropenia
1, poslabšanje anemije nevtropenija Bolezni imunskega sistema neznana pogostnost:
The recommended initial daily dose of EXJADE dispersible tablets in patients with non-transfusion-dependent thalassaemia syndromes is 10 mg/kg body weight.
Pri bolnikih, ki imajo katerega od sindromov talasemije, neodvisnih od transfuzij, je priporočen začetni odmerek zdravila EXJADE v obliki disperzibilnih tablet 10 mg/kg telesne mase.
• The usual daily dose for EXJADE film-coated tablets at the start of the treatment for patients not receiving regular blood transfusions is 7 mg per kilogram body weight.
• Za bolnike, ki ne prejemajo rednih transfuzij krvi, je običajni dnevni odmerek zdravila EXJADE v obliki filmsko obloženih tablet na začetku zdravljenja 7 mg na kilogram telesne mase.
An initial daily dose of 10 mg/kg may be considered for patients who do not require reduction of body iron levels and who are also receiving less than 7 ml/kg/month of packed red blood cells (approximately <2 units/month for an adult).
Začetni dnevni odmerek 10 mg/kg je lahko primeren za bolnike, pri katerih ni treba znižati ravni železa v organizmu in prejemajo manj kot 7 ml/kg/mesec koncentriranih eritrocitov (približno
• The usual daily dose for EXJADE dispersible tablets at the start of the treatment for patients not receiving regular blood transfusions is 10 mg per kilogram body weight.
• Za bolnike, ki ne prejemajo rednih transfuzij krvi, je običajni dnevni odmerek zdravila EXJADE v obliki disperzibilnih tablet na začetku zdravljenja 10 mg na kilogram telesne mase.
The recommended initial daily dose of EXJADE film-coated tablets in patients with non-transfusion-dependent thalassaemia syndromes is 7 mg/kg body weight.
Pri bolnikih, ki imajo katerega od sindromov talasemije, neodvisnih od transfuzij, je priporočen začetni odmerek zdravila EXJADE v obliki filmsko obloženih tablet 7 mg/kg telesne mase.
Do not swallow whole or chew.
Ne pogoltnite cele tablete in je ne žvečite.
Table 2 Recommended doses for non-transfusion-dependent thalassaemia syndromes
Preglednica 2 Priporočeni odmerki pri sindromih talasemije, ki niso odvisni od transfuzij filmsko obložene tablete/zrnca disperzibilne tablete koncentracija železa v jetrih*
EXJADE 250 mg dispersible tablets deferasirox
EXJADE 250 mg disperzibilne tablete deferasiroks
• The usual daily dose for EXJADE granules at the start of the treatment for patients receiving regular blood transfusions is 14 mg per kilogram body weight.
• Za bolnike, ki prejemajo redne transfuzije krvi, je običajni dnevni odmerek zdravila EXJADE v obliki zrnc na začetku zdravljenja 14 mg na kilogram telesne mase.
• The usual daily dose for EXJADE granules at the start of the treatment for patients not receiving regular blood transfusions is 7 mg per kilogram body weight.
• Za bolnike, ki ne prejemajo rednih transfuzij krvi, je običajni dnevni odmerek zdravila EXJADE v obliki zrnc na začetku zdravljenja 7 mg na kilogram telesne mase.
The recommended initial daily dose of EXJADE granules in patients with non-transfusion-dependent thalassaemia syndromes is 7 mg/kg body weight.
Pri bolnikih, ki imajo katerega od sindromov talasemije, neodvisnih od transfuzij, je priporočen začetni odmerek zdravila EXJADE v obliki zrnc 7 mg/kg telesne mase.
Monitoring your EXJADE treatment
Shranjevanje zdravila EXJADE
EU/1/06/356/010 294 (3 packs of 98) dispersible tablets
294 (3 pakiranja po 98) disperzibilnih tablet
What EXJADE looks like and contents of the pack EXJADE is supplied as film-coated tablets.
Zdravilo EXJADE je na voljo v obliki filmsko obloženih tablet.
In patients treated with doses greater than 30 mg/kg, dose reductions in steps of 5 to 10 mg/kg should be considered when control has been achieved (e.g. serum ferritin levels persistently below 2,500 µg/l and showing a decreasing trend over time).
Ko bolniki, ki se zdravijo z odmerki nad 30 mg/kg, dosežejo urejenost (na primer koncentracijo feritina v serumu vztrajno pod 2.500 µg/l skupaj s trendom zniževanja s časom), je treba razmisliti o postopnem zniževanju odmerka v korakih po 5 do 10 mg/kg.
Granules in sachet (granules)
• tesnoba (anksioznost)
- if you experience difficulty thinking, remembering information, or solving problems, being less alert or aware or feeling very sleepy with low energy (signs of a high level of ammonia in your blood, which may be associated with liver or renal problems, see also section 4 “Possible side effects”).
Pred začetkom jemanja zdravila EXJADE se posvetujte z zdravnikom ali farmacevtom: - če imate težave z ledvicami ali z jetri, - če imate težave s srcem zaradi preobremenitve z železom, - če opazite izrazito zmanjšanje izločanja urina (znak težav z ledvicami), - če dobite hud izpuščaj, če začnete težko dihati, postanete omotični ali začnete otekati pretežno v obraz in grlo/žrelo (znaki hude alergične reakcije, glejte tudi poglavje 4 “Možni neželeni učinki”), - če opazite kombinacijo katerih koli izmed naslednjih simptomov: izpuščaj, rdeča koža,
Deferasirox
Učinkovina je deferasiroks.
Cases of serious hypersensitivity reactions (such as anaphylaxis and angioedema) have been reported in patients receiving deferasirox, with the onset of the reaction occurring in the majority of cases within the first month of treatment (see section 4.8).
Poročali so o primerih resnih preobčutljivostnih reakcij (kot sta anafilaksija in angioedem) pri bolnikih, ki so prejemali deferasiroks.
Before initiation of therapy
- ko je dosežen cilj zdravljenja
The CHMP opinion will now be sent to the European Commission for a legally binding decision applicable in all EU Member States.
Mnenje CHMB bo posredovano Evropski komisiji v sprejetje pravno zavezujočega sklepa, ki bo veljal v vseh državah članicah EU.
Healthcare professionals will also receive a letter in the coming weeks reminding them of the problem.
Zdravstveni delavci bodo v naslednjih tednih prejeli dopis, v katerem bodo opozorjeni na težavo.
More information about Noxafil can be found on the Agency's website: ema.europa.eu/Find_medicine.
Več informacij o zdravilu Noxafil je na voljo na spletni strani agencije: ema.europa.eu/Find_medicine.
This review was conducted by EMA's Committee for Medicinal Products for Human Use (CHMP) in the context of a procedure known as a ‘type II variation'.
Ta pregled je opravil Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji EMA v okviru postopka, znanega kot „sprememba tipa II“.
• Noxafil is a medicine used to treat serious infections caused by fungi, when other medicines cannot be used or are not effective.
• Noxafil je zdravilo, ki se uporablja za zdravljenje resnih okužb, ki jih povzročajo glive, kadar se druga zdravila ne smejo uporabljati ali niso učinkovita.
• Patients who have any concerns about their medicine should speak to their pharmacist or the prescriber.
• Bolniki, ki imajo kakršne koli pomisleke o svojem zdravilu, naj se posvetujejo s farmacevtom ali zdravnikom, ki jim je predpisal zdravilo.
It is used when other medicines do not work or cannot be given, to treat adults with the serious fungal infections invasive aspergillosis, fusariosis, chromoblastomycosis, mycetoma, or coccidioidomycosis.
Uporablja se, kadar druga zdravila niso učinkovita ali se ne smejo dajati, za zdravljenje odraslih z resnimi glivičnimi okužbami, kot so invazivna aspergiloza, fuzarioza, kromomikoza, micetom ali kokcidioidomikoza.
• When the medicine is given by mouth, it can be given either as tablets or a liquid, but the dose needed when using the tablets (how much and how often) is different from the one needed when using the liquid.
• Kadar se zdravilo daje peroralno, se lahko daje bodisi v obliki tablet bodisi tekočine, vendar je odmerjanje pri uporabi tablet (koliko in kako pogosto) drugačno kot pri uporabi tekočine.
It is also used in patients with weakened immune systems (such as transplant patients) to treat thrush (fungal infection of the throat or mouth due to Candida) or prevent invasive fungal infections.
Uporablja se tudi pri bolnikih z oslabljenim imunskim sistemom (npr. pri bolnikih po transplantaciji) za zdravljenje soora (okužbe v grlu ali ustih, ki jo povzroča gliva Candida) ali za preprečevanje invazivnih glivičnih okužb.
Prescriptions should indicate which dose form is intended
Na receptu mora biti navedeno, katera farmacevtska oblika je predvidena
• The usual dose of tablets is three tablets (300 mg) twice a day on the first day, then 300 mg once a day.
• Običajni odmerek tablet so tri tablete (300 mg) dvakrat na dan prvi dan, nato pa 300 mg enkrat na dan.
Noxafil, a medicine for serious fungal infections, is available by mouth as tablets (100 mg) and oral suspension (40 mg/ml), but the recommended doses for the two forms are different.
Noxafil, zdravilo za resne glivične okužbe, je na voljo za peroralno jemanje v obliki tablet (100 mg) in peroralne suspenzije (40 mg/ml), vendar se priporočena odmerka med tema formulacijama razlikujeta.
• Patients should not switch between taking Noxafil tablets and Noxafil oral suspension without talking to their doctor or pharmacist first as it may result in a decreased effectiveness or an increased risk of side effects.
• Bolniki ne smejo zamenjevati tablet in peroralne suspenzije zdravila Noxafil, ne da bi se najprej posvetovali z zdravnikom ali farmacevtom, saj se lahko zmanjša učinkovitost ali poveča tveganje za neželene učinke.
Noxafil is an antifungal medicine containing the active substance posaconazole, a member of the group of triazole antifungals.
Noxafil je protiglivično zdravilo, ki vsebuje zdravilno učinkovino posakonazol, ki spada v skupino triazolnih protiglivičnih zdravil.
It contains the active substance posaconazole.
Vsebuje zdravilno učinkovino posakonazol.
Prescribers are advised to make clear which form is intended when they write a prescription, and pharmacists should ensure that the correct form is dispensed.
Zdravnikom, ki predpisujejo zdravilo, svetujemo, naj v receptu jasno navedejo, katero formulacijo predpisujejo, farmacevti pa morajo poskrbeti, da pravo formulacijo tudi izdajo.
Doses of the liquid (200 mg, one 5-ml spoonful) are taken three or four times a day.
Zdravilo v obliki tekočine (200 mg, ena 5-ml žlica) se jemlje trikrat ali štirikrat na dan.
• Medication errors have been reported following erroneous switching, resulting in over- or underdosage and consequent dose-related toxicity or lack of efficacy.
• Po zmotni zamenjavi so poročali o napakah pri uporabi zdravila, kar je privedlo do premajhnega ali prevelikega odmerjanja in posledične toksičnosti, povezane z odmerkom, ali neučinkovitosti.
Some patients have mistakenly received oral solution instead of tablets, leading to underdosing and to a potential lack of effect.
Nekateri bolniki so po pomoti prejeli peroralno suspenzijo namesto tablet, kar je privedlo do premajhnega odmerjanja in možne neučinkovitosti.
• There have been cases where patients were provided with the wrong form of the medicine, and so took the wrong dose, resulting either in side effects or in the medicine not being effective.
• Obstajajo primeri bolnikov, ki so prejeli napačno formulacijo zdravila in so tako jemali napačen odmerek, zato so imeli bodisi neželene učinke bodisi zdravilo ni bilo učinkovito.
• Noxafil tablets and oral suspension are not interchangeable due to the differences between these two formulations in the frequency of dosing, administration with food and plasma drug concentration achieved.
• Tablete in peroralna suspenzija zdravila Noxafil niso zamenljive, saj se formulaciji razlikujeta po pogostnosti odmerjanja, dajanjem s hrano in doseženimi koncentracijami učinkovine v plazmi.
It is available as a solution for infusion (drip) into a vein, but also as tablets and oral suspension for use by mouth.
Na voljo je kot raztopina za infundiranje (kapalno infuzijo) v veno ter v obliki tablet in peroralne suspenzije za jemanje skozi usta.
The recommended oral dosage is 300 mg once a day with the tablets (after a loading dose of 300 mg twice daily on day 1) and 200 mg three to four times a day (600 to 800 mg daily) with the oral suspension.
Za tablete je priporočeni peroralni odmerek 300 mg enkrat na dan (po polnilnem odmerku 300 mg dvakrat na dan prvi dan), pri peroralni suspenziji pa 200 mg trikrat do štirikrat na dan (600 do 800 mg na dan).
• It is important that the dosage form as well as the relevant dose be specified on the prescription, and that pharmacists ensure the correct oral dosage form is dispensed.
• Pomembno je, da sta na receptu navedena farmacevtska oblika in ustrezni odmerek ter da farmacevt izda pravilno formulacijo.