natgillin/translations-raw huggingface dataset:
ANNEX II A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT E. SPECIFIC OBLIGATION TO COMPLETE POST-AUTHORISATION MEASURES FOR THE CONDITIONAL MARKETING AUTHORISATION 
A. IZDELOVALEC, ODGOVOREN ZA SPROŠČANJE SERIJ B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET Z ZDRAVILOM D. POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO
A standard package of reproduction toxicity studies was available. 
Na voljo so bile standardne študije o vplivu na sposobnost razmnoževanja.
No serious adverse reactions were observed in these subjects. 
Resnih neželenih učinkov pri teh osebah niso opazili.
Study 2 evaluated 230 male patients, ages 7 to 14 years. 
V študiji 2 so ocenili 230 moških bolnikov, starih od 7 do 14 let.
Percent Not 10% Worsened 
Odstotek brez 10-odstotnega poslabšanja
TRANSLARNA 10 mg/kg, 10 mg/kg, 20 mg/kg (N=57) Placebo (N=57) 
TRANSLARNA 10, 10, 20 mg/kg (n = 57) placebo (n = 57)
What Translarna is and what it is used for 
Kaj je zdravilo Translarna in za kaj ga uporabljamo
A lower ataluren dose should be considered. 
Razmisliti je treba o nižjem odmerku atalurena.
Magnesium stearate 
magnezijev stearat
Your dose of Translarna depends on your body weight. 
Odmerek zdravila Translarna, ki ga boste jemali, bo odvisen od vaše telesne mase.
If you have severe kidney problems (eGFR <30 ml/min) or if you are receiving dialisys because your kidneys do not work (end-stage renal disease) your doctor will established if treatment with Translarna is suitable for you. 
Če imate hude težave z ledvicami (eGFR < 30 ml/min) ali če se zdravite z dializo, ker vaše ledvice ne delujejo (končna stopnja ledvične odpovedi), bo vaš zdravnik presodil, če je zdravljenje z zdravilom
Kaplan-Meier Curve of Time to Persistent 10% 6MWD Worsening (Study 1) 
Kaplan-Meierjeva krivulja časa do persistentnega 10-odstotnega poslabšanja 6MWD
It is unknown whether ataluren/metabolites are excreted in human milk. 
Ni znano, ali se ataluren/presnovki izločajo v materino mleko.
Based on data in healthy volunteers, the relative bioavailability of ataluren is approximately 40% lower at steady-state than after the initial dose. 
Glede na podatke, pridobljene pri zdravih prostovoljcih, je relativna biološka uporabnost atalurena v stanju dinamičnega ravnovesja za približno 40 % manjša kot po začetnem odmerku.
In addition, at exposure much higher than in patients an increase of (rare) urinary bladder tumours was found. 
Poleg tega so pri izpostavljenosti, ki je bila veliko večja kot pri bolnikih, odkrili povečano število (redkih) tumorjev sečnega mehurja.
In addition, one case of malignant hibernoma was found at the highest dose in a 2-year rat carcinogenicity study. 
Poleg tega so en primer malignega hibernoma odkrili tudi pri največjem odmerku v 2-letni študiji rakotvornosti pri podganah.
One out of two 26-week rat repeat dose studies, initiated in 4-5 weeks old rats, showed a dose related increase of the incidence of malignant hibernoma, a rare tumour in rats. 
Ena od dveh 26-tedenskih študij s ponavljajočimi odmerki pri podganah, ki so jo začeli pri podganah, starih od 4-5 tednov, je pokazala z odmerkom povezano povečanje incidence malignega hibernoma, sicer redkega tumorja pri podganah.
Patients were randomised in a 1:1 ratio and received ataluren 40 mg/kg/day (n=115) or placebo (n=115) 3 times per day (morning, midday, and evening). 
Bolniki so bili randomizirani v razmerju 1 : 1 in so prejemali ataluren 40 mg/kg/dan (n = 115) ali placebo (n = 115) 3-krat na dan (zjutraj, popoldne in zvečer).
Study 1 evaluated 174 male patients, ages 5 to 20 years. 
V študiji 1 so ocenili 174 moških bolnikov, starih od 5 do 20 let.
The efficacy of Translarna in children aged 2 - 5 years has been established on extrapolation from patients aged >5years. 
Učinkovitost zdravila Translarna pri otrocih, starih od 2 do 5 let, je bila dokazana z ekstrapolacijo z bolnikov, starih > 5 let.
An updated RMP should be submitted: At the request of the European Medicines Agency; Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached. 
na zahtevo Evropske agencije za zdravila; ob vsakršni spremembi sistema za obvladovanje tveganj, zlasti kadar je tovrstna sprememba posledica prejema novih informacij, ki lahko privedejo do znatne spremembe razmerja med koristmi in tveganji, ali kadar je ta sprememba posledica tega, da je bil dosežen pomemben mejnik
The toxicity of the metabolite is unknown. 
Toksičnost presnovka ni znana.
The primary efficacy endpoint in both trials was change in 6 Minute Walk Distance (6MWD) at Week 48. 
Primarni opazovani dogodek učinkovitosti v obeh preskušanjih je bila sprememba v razdalji, prehojeni v 6 minutah (6MWD, 6 Minute Walk Distance) v 48. tednu.
Very common side effects (may affect more than 1 in 10 people): - Vomiting 
Zelo pogosti neželeni učinki (pojavijo se lahko pri več kot 1 od 10 bolnikov): - bruhanje.
Although ataluren is practically insoluble in water, ataluren is readily absorbed after oral administration as a suspension. 
Čeprav je ataluren skoraj netopen v vodi, se po peroralnem dajanju v obliki suspenzije zlahka absorbira.
Efficacy has not been demonstrated in non-ambulatory patients. 
Učinkovitost pri imobilnih bolnikih ni bila dokazana.
In a statistical based model the estimated mean difference was 13.0 meters (p=0.213), Figure 4. 
V statističnem modelu je bila ocenjena povprečna razlika 13,0 metra (p = 0,213), slika 4.
Treatment with Translarna should only be initiated by specialist physicians with experience in the management of Duchenne/Becker muscular dystrophy. 
Zdravljenje z zdravilom Translarna sme uvesti samo zdravnik specialist, ki ima izkušnje z zdravljenjem Duchennove/Beckerjeve mišične distrofije.
These data indicate no apparent drug-drug interaction between corticosteroids and ataluren, and no dose adjustments are required. 
Ti podatki kažejo, da ne prihaja do opaznega medsebojnega delovanja kortikosteroidov in atalurena, zato prilagajanje odmerkov ni potrebno.
In a 2-year rat carcinogenicity study, one case of hibernoma was found. 
V 2-letni študiji rakotvornosti pri podganah so odkrili en primer hibernoma.
Take each prepared dose immediately after preparation. 
Posamezen pripravljen odmerek vzemite takoj po pripravi.
The safety and efficacy of ataluren in patients aged 65 and older have not yet been established (see section 5.2). 
Starejši Varnost in učinkovitost atalurena pri bolnikih, starih 65 let ali več, še nista bili dokazani (glejte poglavje 5.2).
Potential interactions with other medicinal products 
Morebitno medsebojno delovanje z drugimi zdravili
Healthy volunteers receiving a single oral dose of 200 mg/kg of ataluren experienced transient, low-grade symptoms of headache, nausea, vomiting, and diarrhoea. 
Pri zdravih prostovoljcih, ki so prejeli enkratni peroralni odmerek atalurena 200 mg/kg, so se pojavili prehodni blažji simptomi, med katerimi so bili glavobol, slabost, bruhanje in driska.
The safety, pharmacokinetics and exploratory effectiveness of Translarna were assessed in an openlabel study in children between 2 and 5 years of age with nmDMD. 
Pediatrična populacija Varnost, farmakokinetiko in raziskovalno učinkovitost zdravila Translarna so ocenili v odprti študiji z otroki, starimi od 2 do 5 let, z nmDMD.
Therefore, caution should be exercised when ataluren is co-administered with medicinal products that are substrates of OAT1 or OATP1B3 because of the risk of increased concentration of these medicinal products (eg oseltamivir, aciclovir, captopril, furosemide, bumetanide, valsartan, pravastatin, rosuvastatin, atorvastatin, pitavastatin). 
Zato je pri sočasni uporabi atalurena z zdravili, ki so substrati OAT1 ali OATP1B3, potrebna previdnost, saj obstaja tveganje za zvišane koncentracije teh zdravil (to so npr. oseltamivir, aciklovir, kaptopril, furosemid, bumetanid, valsartan, pravastatin, rosuvastatin, atorvastatin in pitavastatin).
For example, you might take Translarna at 7:00 AM in the morning with breakfast, at 1:00 PM in the afternoon with lunch, and again at around 7:00 PM in the evening with dinner. 
Na primer: zdravilo Translarna lahko vzamete ob 7. uri zjutraj med zajtrkom, ob 13. uri popoldan med kosilom in nato še okoli 19. ure zvečer med večerjo.
An open-label study was performed including patients aged 2-5 years (n=14) to evaluate the PK and safety of ataluren. 
Izvedli so odprto študijo, v katero so bili vključeni bolniki, stari od 2 do 5 let (n = 14) za ovrednotenje farmakokinetike in varnosti atalurena.
Your doctor will test the levels of lipids (fats such as cholesterol and triglycerides) in your blood and your kidney function every 6 to 12 months. 
Zdravnik bo vsakih 6 do 12 mesecev preveril ravni lipidov (maščob, kot so holesterol in trigliceridi) v vaši krvi ter delovanje vaših ledvic.
In the ITT population, the hazard ratio for ataluren versus placebo was 0.75 (p=0.160), representing a 25% reduction in the risk of 10% 6MWD worsening. 
V populaciji ITT je bilo razmerje tveganja za ataluren v primerjavi s placebom 0,75 (p = 0,160), kar predstavlja 25-% zmanjšanje tveganja za 10-% poslabšanje v 6MWD.
Changes in lipid profile 
Spremembe ravni lipidov
The most common adverse reactions in the 2 placebo-controlled studies were vomiting, diarrhoea, nausea, headache, upper abdominal pain, and flatulence, all occurring in ≥5% of all ataluren-treated patients. 
Najpogostejši neželeni učinki v 2 s placebom kontroliranih študijah so bili bruhanje, driska, navzea, glavobol, bolečine v zgornjem delu trebuha in flatulenca, ki so se vsi pojavili pri ≥ 5 % bolnikov, zdravljenih z atalurenom.
If you forget to take Translarna 
Če ste pozabili vzeti zdravilo Translarna
Therefore, if treatment with intravenous aminoglycosides is necessary the treatment with Translarna should be stopped and can be resumed 2 days after administration of the aminoglycoside has ended. 
Če je torej potrebno zdravljenje z aminoglikozidi za intravensko uporabo, je treba zdravljenje z zdravilom Translarna prekiniti, ponovno pa se lahko uvede dva dneva po koncu uporabe aminoglikozidov.
- If you are receiving treatment with certain antibiotics, such as gentamicin, tobramycin, or streptomycin by injection into a vein. 
- če prejemate zdravljenje z določenimi antibiotiki, kot so gentamicin, tobramicin ali streptomicin, ki se dajejo z injiciranjem v veno.
Background incidence of this tumour type in rats as well as humans is very low and the mechanism causing these tumours in the rat studies (including its relation to ataluren treatment) is unknown. 
Izkušnje kažejo, da je incidenca te vrste tumorja pri podganah in pri ljudeh zelo majhna, mehanizem, ki je v študijah pri podganah povzročil omenjene tumorje, pa ni znan (niti njegova povezava s prejemanjem atalurena).
Since the mechanism by which ataluren increases nephrotoxicity of intravenous aminoglycosides is not known, concomitant use of other nephrotoxic medicinal products with ataluren is not recommended. 
Ker mehanizem, preko katerega ataluren poveča nefrotoksičnost aminoglikozidov za intravensko uporabo, ni znan, sočasna uporaba drugih nefrotoksičnih zdravil in atalurena ni priporočljiva.
Therefore, patients with severe renal impairment or end-stage renal disease should be treated with ataluren only if the anticipated clinical benefit outweighs the potential risk, and should be closely monitored for possible metabolite toxicity and decrease in efficacy. 
Zato je treba bolnike s hudo okvaro ledvic ali končno odpovedjo ledvic zdraviti z atalurenom le, če pričakovane klinične koristi pretehtajo tveganje, in treba jih je skrbno spremljati glede potencialne toksičnosti presnovka in zmanjšanja učinkovitosti.
There are no adequate data from the use of ataluren in pregnant women. 
O uporabi atalurena pri nosečnicah ni zadostnih podatkov.
The prepared dose should be mixed well before administration. 
Pripravljen odmerek je treba pred dajanjem dobro premešati.
Concomitant use of intravenous aminoglycosides (see sections 4.4 and 4.5). 
Sočasna uporaba aminoglikozidov za intravensko uporabo (glejte poglavji 4.4 in 4.5).
Sachets should only be opened at the time of dose preparation. 
Vrečice se lahko odprejo šele takrat, ko je čas za pripravo odmerka.
Based on a pharmacokinetic assessment conducted in groups with either mild, moderate or severe hepatic impairment versus a control group of healthy subjects, no dose adjustment is required for patients with any degree of hepatic impairment. 
Na podlagi farmakokinetične ocene, izvedene v skupinah z blagimi, zmernimi ali hudimi okvarami jeter v primerjavi s kontrolno skupino zdravih preiskovancev, prilagajanje odmerka pri bolnikih z nobeno stopnjo okvare jeter ni potrebno.
Caution should be exercised when ataluren is co-administered with medicinal products that are inducers of UGT1A9, or substrates of OAT1 or OAT3 (see section 4.5). 
Previdnost je potrebna, kadar se ataluren uporablja sočasno z zdravili, ki so induktorji UGT1A9 ali substrati OAT1 ali OAT3 (glejte poglavje 4.5).
Coadministration of corticosteroids (deflazacort, prednisone, or prednisolone) with ataluren did not affect the plasma concentrations of ataluren. 
Sočasna uporaba atalurena in kortikosteroidov (deflazakorta, prednizona ali prednizolona) ni vplivala na koncentracije atalurena v plazmi.
The presence of a nonsense mutation in the dystrophin gene should be determined by genetic testing (see section 4.4). 
Prisotnost nesmiselne mutacije gena za distrofin je treba potrditi z genetskimi preiskavami (glejte poglavje 4.4).
In a pharmacokinetic study in subjects with varying degrees of renal impairment, following a single dose administration, ataluren plasma exposure changed by -13%, 27%, and 61% for the mild, moderate and severe groups, respectively, and 46% for the end-stage renal disease group compared with the normal renal function group. 
V farmakokinetični študiji se je pri preiskovancih z različnimi stopnjami okvare ledvic po uporabi enkratnega odmerka plazemska izpostavljenost atalurenu spremenila za -13 %, 27 % in 61 % pri skupinah z blago, zmerno in hudo okvaro ter za 46 % pri skupini s končno odpovedjo ledvic v primerjavi s skupino z normalnim delovanjem ledvic.
However there were no apparent effects of gender on ataluren plasma exposure in other populations. 
Vendar pri drugih populacijah niso opazili, da bi spol vplival na izpostavljenost atalurenu v plazmi.
In rats and rabbits embryo-foetal toxicity (e.g. increased early resorptions, postimplantation loss, decreased viable foetuses) and signs of delayed development (increased skeletal variations) were found in the presence of maternal toxicity. 
Pri podganah in kuncih so opazili embriofetalno toksičnost (npr. večje število zgodnjih resorpcij in poimplantacijskih izgub ter manjše število živih zarodkov) ter znake zaostalosti v razvoju (večje število skeletnih sprememb), kadar je bila prisotna toksičnost pri materi.
The first dose should be taken in the morning, the second at midday, and the third in the evening. 
Prvi odmerek je treba vzeti zjutraj, drugega zgodaj popoldne in tretjega zvečer.
Studies in animals have shown reproductive toxicity only at doses that resulted in maternal toxicity (see section 5.3). 
Študije na živalih so pokazale vpliv na sposobnost razmnoževanja samo pri odmerkih, ki so povzročili toksičnost pri materi (glejte poglavje 5.3).
The efficacy and safety of Translarna were assessed in 2 randomised, double-blind, placebo-controlled, trials in nmDMD. 
Učinkovitost in varnost zdravila Translarna so ocenjevali v 2 randomiziranih, dvojno slepih, s placebom kontroliranih preskušanjih o nmDMD.
Almac Pharma Services 22 Seagoe Industrial Estate Craigavon BT63 5QD United Kingdom 
22 Seagoe Industrial Estate Craigavon BT63 5QD Velika Britanija
In a statistical based model the estimated mean difference was 31.7 meters (adjusted p=0.0367). 
Pri oceni statističnega modela je bila povprečna razlika 31,7 metra (prilagojena vrednost p = 0,0367).
Treatment should not be initiated in previously untreated patients with eGFR <30 ml/min (see sections 4.2 and 5.2). 
Zdravljenja ni dovoljeno začeti pri predhodno nezdravljenih bolnikih z eGFR < 30 ml/min (glejte poglavji 4.2 in 5.2).
The significance of these findings for humans is unknown. 
Pomen tega izsledka pri ljudeh ni znan.
Co-administration of rifampicin, a strong inducer of metabolic enzymes including UGT1A9, decreased ataluren exposure by 29%. 
Sočasna uporaba rifampicina, močnega induktorja presnovnih encimov, vključno z UGT1A9, zmanjša izpostavljenost atalurenu za 29 %.
Based on data from subjects ranging in age from 2 years to 57 years, there is no apparent effect of age on ataluren plasma exposure. 
Podatki, pridobljeni pri osebah, starih od 2 do 57 let, ne kažejo, da bi starost vplivala na izpostavljenost atalurenu v plazmi.
Adverse reactions were generally mild or moderate in severity, and no treatment-related serious adverse events were reported among ataluren-treated patients in these 2 studies. 
Na splošno so bili neželeni učinki po resnosti blagi ali zmerni; pri bolnikih, zdravljenih z atalurenom, v teh 2 študijah niso poročali o resnih neželenih učinkih.
Available pharmacodynamic/toxicological data in animals have shown excretion of ataluren/metabolites in milk (see section 5.3). 
Razpoložljivi farmakodinamični/toksikološki podatki pri živalih kažejo na izločanje atalurena/presnovkov v mleko (glejte poglavje 5.3).
The table below provides information on which sachet strength(s) to use in the preparation of the recommended dose by body weight range. 
V spodnji razpredelnici so podatki o jakosti(h) vrečic, ki jih je treba uporabiti za pripravo priporočenega odmerka glede na razpon telesne mase.
Exposure at the no observed adverse effect level (NOAEL) was similar to (rabbit) or 4 times (rat) the systemic exposure in humans (40 mg/kg/day). 
Izpostavljenost pri odmerku, pri katerem ni mogoče opaziti neželenih učinkov (NOAEL), je bila podobna (pri kuncih) sistemski izpostavljenosti človeka (40 mg/kg/dan) ali 4-krat večja (pri podganah).
These may affect your kidney function. 
To bi lahko vplivalo na delovanje ledvic.
Translarna is indicated for the treatment of Duchenne muscular dystrophy resulting from a nonsense mutation in the dystrophin gene, in ambulatory patients aged 2 years and older (see section 5.1). 
Zdravilo Translarna je indicirano za zdravljenje Duchennove mišične distrofije, ki je posledica nesmiselne mutacije gena za distrofin, pri mobilnih bolnikih, starih 2 leti ali več (glejte poglavje 5.1).
In particular do not take Translarna with the antibiotics gentamicin, tobramycin, or streptomycin given by injection. 
Zlasti ne jemljite zdravila Translarna skupaj z antibiotiki gentamicinom, tobramicinom ali streptomicinom, ki se dajejo z injiciranjem.
The European Medicines Agency will review new information on this medicine at least every year and this leaflet will be updated as necessary. 
Evropska agencija za zdravila bo vsaj enkrat letno ponovno pregledala nove podatke o zdravilu in posodobila povzetek glavnih značilnosti zdravila, če bo potrebno.
A higher frequency of malaise (7.1%), pyrexia (42.9%), ear infection (28.6%), and rash (21.4%) were reported in patients aged 2-5 years compared with patients 5 years of age and older. 
Pri bolnikih, starih od 2 do 5 let, so opazili večjo pogostnost splošnega slabega počutja (7,1 %), pireksije (42,9 %), okužbe ušesa (28,6 %) in izpuščaja (21,4 %) kot pri bolnikih, starih 5 let in več.
Ataluren enables ribosomal readthrough of mRNA containing such a premature stop codon, resulting in production of a full-length protein. 
Ataluren omogoči, da ribosomi podaljšajo translacijo mRNA, ki vsebuje tak prezgodnji zaključni kodon, zaradi česar lahko nastane beljakovina s polno dolžino.
Adverse reactions reported in >1 patient in the 40 mg/kg/day group at a frequency greater than that of the placebo group are presented by MedDRA System Organ Class, Preferred Term, and frequency. 
Neželeni učinki, o katerih so poročali pri > 1 bolnikov v skupini 40 mg/kg/dan in z večjo pogostnostjo kot v skupini s placebom, so predstavljeni po po organskih sistemih po MedDRA, prednostnih izrazih in pogostnosti.
26% worsening 
poslabšanje pri 26 % poslabšanje pri 44 %
The effect of ataluren on driving, on cycling, or on using machines has not been tested. 
Vpliv atalurena na sposobnost vožnje, kolesarjenja ali upravljanja strojev ni bil raziskan.
If you stop taking Translarna 
Če ste prenehali jemati zdravilo Translarna
Steady-state plasma concentrations are dose-proportional for ataluren doses between 10 and 50 mg/kg, and no accumulation is observed after repeated dosing. 
Plazemske koncentracije v stanju dinamičnega ravnovesja so sorazmerne z odmerkom pri odmerkih atalurena od 10 do 50 mg/kg, pri ponavljajočem se odmerjanju pa ne prihaja do kopičenja.
Duchenne muscular dystrophy is caused by genetic changes that result in an abnormality in a muscle protein called dystrophin which is needed for muscles to work properly. 
Duchennovo mišično distrofijo povzročijo genetske spremembe, ki so posledica anomalije mišične beljakovine, imenovane distrofin, ki je potrebna za pravilno delovanje mišic.
Patients who do not have a nonsense mutation should not receive ataluren. 
Bolniki brez nesmiselne mutacije ne smejo prejemati atalurena.
There were no apparent differences in either steady-state relative bioavailability or apparent clearance due to loss of ambulation. 
Opaznih razlik v relativni biološki uporabnosti v stanju dinamičnega ravnovesja ali navideznem očistku zaradi izgube mobilnosti ni bilo.
An increase in serum lipids, i.e. cholesterol and triglycerides, was observed. 
Opazili so povečanje vrednosti serumskih lipidov, tj. holesterola in trigliceridov.
General characteristics of ataluren after administration 
Splošne značilnosti atalurena po dajanju
atorvastatin lipid-lowering benzylpenicillin severe infections bumetanide treatment or prevention of congestive heart failure captopril treatment or prevention of congestive heart failure ciprofloxacin treatment of infections famotidine treatment of active duodenal ulcer, gastroesophageal reflux disease furosemide treatment or prevention of congestive heart failure methotrexate rheumatoid arthritis, psoriasis olmesartan essential hypertension in adults oseltamivir prevention of influenza phenobarbital sleep-inducing, prevention of seizures pitavastatin lipid-lowering pravastatin lipid-lowering rifampicin treatment for tuberculosis rosuvastatin lipid-lowering sitagliptin type 2 diabetes valsartan treatment or prevention of congestive heart failure Some of these medicines were not tested together with Translarna and your doctor may decide to monitor you closely. 
atorvastatin zniževanje ravni lipidov benzilpenicilin hude okužbe bumetanid zdravljenje ali preprečevanje kongestivnega srčnega popuščanja kaptopril zdravljenje ali preprečevanje kongestivnega srčnega popuščanja ciprofloksacin zdravljenje okužb famotidin zdravljenje aktivne razjede dvanajstnika ali gastroezofagealne refluksne bolezni furosemid zdravljenje ali preprečevanje kongestivnega srčnega popuščanja metotreksat revmatoidni artritis, luskavico olmesartan esencialno hipertenzijo pri odraslih oseltamivir preprečevanje gripe fenobarbital pomoč pri spanju, preprečevanje epileptičnih napadov pitavastatin zniževanje ravni lipidov pravastatin zniževanje ravni lipidov rifampicin zdravljenje tuberkuloze rosuvastatin zniževanje ravni lipidov sitagliptin sladkorno bolezen tipa 2
Paediatric patients with body weight ≥12 kg are treated as per the dosing recommendations by body weight range (see above dosing table). 
Pediatrična populacija Pediatrični bolniki s telesno maso ≥ 12 kg se zdravijo po priporočilih za odmerjanje in glede na razpon telesne mase (glejte zgornjo preglednico za odmerjanje).