natgillin/translations-raw huggingface dataset:
2.2 ml (172.5/ 43.1 mg) 2.3 ml (184/ 46 mg) 2.9 ml (230/ 57.5 mg) 3.6 ml (287.5/ 71.9 mg) 3.7 ml (299/ 74.8 mg) 4.0 ml (322/ 80.5 mg) 4.3 ml (345/ 86.3 mg) 5 ml (402.5/ 100.6 mg)
4, 0 ml (322/ 80, 5 mg) 4, 3 ml (345/ 86, 3 mg)
1 soft capsule (133.3/ 33.3 mg) 2 soft capsules (266.6/ 66/ 6 mg) 2 soft capsules (266.6/ 66/ 6 mg) 2 soft capsules (266.6/ 66/ 6 mg) 2 soft capsules (266.6/ 66/ 6 mg) 3 soft capsules (400/ 100 mg) 3 soft capsules (400/ 100 mg) 3 soft capsules (400/ 100 mg)
3 mehke kapsule (400/ 100 mg) 3 mehke kapsule (400/ 100 mg)
* Body surface area can be calculated with the following equation
* Telesno površino lahko izračunamo po enačbi
Kaletra is not recommended for use in children below 2 years of age due to insufficient data on safety and efficacy (see section 5.1).
Otroci do 2. leta starosti: zaradi nezadostnih podatkov o varnosti in učinkovitosti uporabe zdravila Kaletra pri otrocih pod 2 letoma ni priporočljiva (glejte poglavje 5. 1).
Paediatric patients should switch from Kaletra oral solution to soft capsules as soon as they are able to swallow the capsule formulation (see section 4.4).
Pediatrični bolniki morajo s peroralne raztopine Kaletra preiti na mehke kapsule, čim zmorejo pogoltniti pripravek v kapsulah (glejte poglavje 4. 4 Posebna opozorila in previdnostni ukrepi).
(see section 5.2).
Okvara jeter: pri s HIV okuženih bolnikih z blago do zmerno jetrno okvaro so opazili za približno 30% večjo izpostavljenost lopinavirju, vendar ni pričakovati, da bi to bilo klinično pomembno (glejte poglavje 5. 2).
No dose adjustment is necessary in patients with renal impairment.
Okvara ledvic: pri bolnikih z okvaro ledvic odmerka ni treba prilagoditi.
4.3 Contraindications
25 4. 3 Kontraindikacije
24 caution on parenterally administered midazolam, see section 4.5), triazolam, cisapride, pimozide, amiodarone, ergot alkaloids (e. g. ergotamine, dihydroergotamine and ergonovine and methylergonovine) and vardenafil.
Med takšna zdravila spadajo astemizol, terfenadin, peroralni midazolam (za previdnost pri uporabi parenteralnega midazolama glejte poglavje 4. 5), triazolam, cisaprid, pimozid, amiodaron in alkaloidi ergot (npr. ergotamin, dihidroergotamin, ergonovin in metilergonovin) in vardenafil.
Herbal preparations containing St John’ s wort (Hypericum perforatum) must not be used while taking lopinavir and ritonavir due to the risk of decreased plasma concentrations and reduced clinical effects of lopinavir and ritonavir (see section 4.5).
Med jemanjem lopinavirja in ritonavirja se ne sme uporabljati zeliščnih pripravkov šentjanževke (Hypericum perforatum), ker obstaja tveganje za zmanjšanje koncentracije lopinavirja in ritonavirja v plazmi in zmanjšanje njunih kliničnih učinkov (glejte poglavje 4. 5).
Kaletra oral solution is contraindicated in children below the age of 2 years, pregnant women, patients with hepatic or renal failure and patients treated with disulfiram or metronidazole due to the potential risk of toxicity from the excipient propylene glycol (see section 4.4).
Zaradi možnih toksičnih učinkov pomožne snovi propilenglikola je peroralna raztopina Kaletra kontraindicirana pri otrocih, mlajših od 2 let, nosečnicah, bolnikih z odpovedjo jeter ali ledvic in pri bolnikih, zdravljenih z disulfiramom ali metronidazolom (glejte poglavje 4. 4).
Particular caution should be paid to patients with high values at baseline and with history of lipid disorders.
Lipidne motnje je treba obravnavati, kot je klinično primerno.
25 Pancreatitis should be considered if clinical symptoms (nausea, vomiting, abdominal pain) or abnormalities in laboratory values (such as increased serum lipase or amylase values) suggestive of pancreatitis should occur.
Na pankreatitis je treba pomisliti, če se pojavijo klinični simptomi (navzeja, bruhanje, bolečine v trebuhu) ali nenormalne laboratorijske vrednosti (npr. zvišanje serumske lipaze ali amilaze), ki nakazujejo pankreatitis.
Patients who exhibit these signs or symptoms should be evaluated and Kaletra therapy should be suspended if a diagnosis of pancreatitis is made (see section 4.8).
Če se diagnoza pankreatitisa potrdi, je treba zdravljenje z zdravilom Kaletra prekiniti (glejte poglavje 4. 8).
New onset diabetes mellitus, hyperglycaemia or exacerbation of existing diabetes mellitus has been reported in patients receiving protease inhibitors.
Pri bolnikih, ki so dobivali zaviralce proteaz, so opisani novonastal diabetes mellitus, hiperglikemija ali poslabšanje obstoječega diabetesa mellitusa.
In some of these the hyperglycaemia was severe and in some cases also associated with ketoacidosis.
Pri nekaterih je bila hiperglikemija huda in v nekaterih primerih povezana tudi s ketoacidozo.
Many patients had confounding medical conditions some of which required therapy with agents that have been associated with the development of diabetes mellitus or hyperglycaemia.
Številni bolniki so imeli dodatne bolezni in nekatere teh so zahtevale zdravljenje z zdravili, ki so povezana s pojavom diabetesa mellitusa ali hiperglikemije.
Fat redistribution & metabolic disorders
Prerazporeditev maščevja in presnovne motnje
A connection between visceral lipomatosis and protease inhibitors (PIs) and lipoatrophy and nucleoside reverse transcriptase inhibitors (NRTIs) has been hypothesised.
Domnevajo, da obstaja povezava med visceralno lipomatozo in zaviralci proteaz (ZP) ter lipoatrofijo ter nukleozidnimi zaviralci reverzne transkriptaze.
PR interval prolongation
27 Podaljšanje intervala PR
Kaletra is likely to increase plasma concentrations of medicinal products that are primarily
Zdravilo Kaletra pogosto zveča plazemsko koncentracijo zdravil, ki se v prvi vrsti presnavljajo s CYP3A.
The HMG-CoA reductase inhibitors simvastatin and lovastatin are highly dependent on CYP3A for metabolism, thus concomitant use of Kaletra with simvastatin or lovastatin is not recommended due to an increased risk of myopathy including rhabdomyolysis.
Presnova zaviralcev reduktaze HMG- CoA simvastatina in lovastatina je močno odvisna od CYP3A, zato hkratna uporaba zdravila Kaletra s simvastatinom ali lovastatinom ni priporočljiva, ker obstaja večje tveganje za miopatijo, vključno z rabdomiolizo.
Caution must also be exercised and reduced doses should be considered if Kaletra is used concurrently with rosuvastatin or with atorvastatin, which is metabolised to a lesser extent by CYP3A4.
Previdnost je potrebna tudi pri hkratni uporabi zdravila Kaletra z rosuvastatinom ali z atorvastatinom, ki se v manjši meri presnavlja s CYP3A4; razmisliti je treba o zmanjšanju odmerkov.
If treatment with an HMG-CoA reductase inhibitor is indicated, pravastatin or fluvastatin is recommended (see section 4.5).
Če je indicirano zdravljenje z zaviralcem reduktaze HMG - CoA, sta priporočljiva pravastatin ali fluvastatin (glejte poglavje 4. 5).
Indeed, Kaletra could increase concentrations of the co-administered medicinal products and this may result in an increase of their associated cardiac adverse events.
Zdravilo Kaletra lahko dejansko zveča koncentracijo hkrati uporabljenih zdravil, to pa lahko zveča njihove neželene kardialne učinke.
Rifampicin in combination with Kaletra causes large decreases in lopinavir concentrations which may in turn significantly decrease the lopinavir therapeutic effect.
Rifampicina v kombinaciji z zdravilom Kaletra povzroči veliko zmanjšanje koncentracij lopinavirja s posledičnim pomembnim zmanjšanjem terapevtskega učinka lopinavirja.
Patients taking the oral solution, particularly those with renal impairment or with decreased ability to metabolise propylene glycol (e. g. those of Asian origin), should be monitored for adverse reactions potentially related to propylene glycol toxicity (i. e. seizures, stupor, tachycardia, hyperosmolarity, lactic acidosis, renal toxicity, haemolysis) (see section 4.3).
Bolnike, ki uporabljajo peroralno raztopino, zlasti tiste z okvaro ledvic ali slabšo zmožnostjo za presnovo propilenglikola (npr. tiste azijskega porekla), je treba nadzirati glede neželenih učinkov, ki so lahko povezani s toksičnostjo propilenglikola (t. j. konvulzivnih napadov, stuporja, tahikardije, hiperosmolarnosti, laktacidoze, ledvične toksičnosti, hemolize) (glejte poglavje 4. 3).
Besides propylene glycol as described above, Kaletra oral solution contains alcohol (42% v/ v) which is potentially harmful for those suffering from liver disease, alcoholism, epilepsy, brain injury or disease as well as for pregnant women and children.
Poleg propilenglikola, kot je opisano zgoraj, vsebuje peroralna raztopina Kaletra alkohol (42% v/ v), ki lahko škoduje bolnikom z boleznijo jeter, alkoholizmom, epilepsijo, možgansko okvaro ali boleznijo ter nosečnicam in otrokom.
Kaletra oral solution contains up to 0.8 g of fructose per dose when taken according to the dosage recommendations.
To
This may be unsuitable in hereditary fructose intolerance.
28 utegne biti neprimerno v primeru podedovane intolerance za fruktozo.
Kaletra oral solution contains up to 0.3 g of glycerol per dose.
Peroralna raztopina Kaletra vsebuje do 0, 3 g glicerola na odmerek.
Furthermore, polyoxol 40 hydrogenated castor oil and potassium present in Kaletra oral solution may cause only at high inadvertent doses gastrointestinal upset.
Poleg tega lahko makrogolglicerol hidroksistearat 40 in kalij, ki ju vsebuje peroralna raztopina Kaletra, le v velikih, nenamernih odmerkih povzročita prebavne motnje.
27 4.5 Interaction with other medicinal products and other forms of interaction
4. 5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij
Kaletra has been shown in vivo to induce its own metabolism and to increase the biotransformation of some medicinal products metabolised by cytochrome P450 enzymes and by glucuronidation.
In vivo je bilo dokazano, da zdravilo Kaletra inducira svojo lastno presnovo in zvečuje biotransformacijo nekaterih zdravil, ki se presnavljajo z encimi citokroma P450 in z glukuronidacijo.
Nucleoside/ Nucleotide reverse transcriptase inhibitors (NRTIs):
Nukleozidni/ nukleotidni zaviralci reverzne transkriptaze (NRTI – Nucleoside/ Nucleotide reverse transcriptase inhibitors):
Zidovudine and Abacavir:
Zidovudin in abakavir:
Kaletra induces glucuronidation, therefore Kaletra has the potential to reduce zidovudine and abacavir plasma concentrations.
Zdravilo Kaletra inducira glukuronidacijo, zato lahko zmanjša koncentracijo zidovudina in abakavirja v plazmi.
However, based on clinical experience, Kaletra dose increase to 533/ 133 mg twice daily (~6.5 ml) may be considered when co-administered with nevirapine, particularly for patients in whom reduced lopinavir susceptibility is likely.
29 povečanje odmerka zdravila Kaletra na 533/ 133 mg (~ 6, 5 ml) dvakrat na dan, zlasti pri bolnikih, pri katerih je verjetno, da so manj občutljivi za lopinavir.
Efavirenz: when used in combination with efavirenz and two nucleoside reverse transcriptase inhibitors in multiple protease inhibitor-experienced patients, increasing the dose of Kaletra 33.3% from 400/ 100 mg (3 capsules) twice daily to 533/ 133 mg (4 capsules) twice daily yielded similar lopinavir plasma concentrations as compared to historical data of Kaletra 400/ 100 mg (3 capsules) twice daily.
Efavirenz: ko so zdravilo Kaletra uporabili v kombinaciji z efavirenzem in dvema nukleozidnima zaviralcema reverzne transkriptaze pri bolnikih, izkušenih z več zaviralci proteaz, je zvečanje njenega odmerka za 33, 3% – od 400/ 100 mg (3 kapsule) dvakrat na dan na 533/ 133 mg (4 kapsule) dvakrat na dan – povzročilo podobno plazemsko koncentracijo lopinavirja kot po preteklih podatkih zdravilo Kaletra 400/ 100 mg (3 kapsule) dvakrat na dan.
Dosage increase of Kaletra from 400/ 100 mg (5 ml) twice daily to 533/ 133 mg (~6.5 ml) twice daily should be considered when co-administered with efavirenz.
V primeru sočasne uporabe z efavirenzem je treba razmisliti o zvečanju odmerjanja zdravila Kaletra s 400/ 100 mg (5 ml) dvakrat na dan na 533/ 133 mg (~ 6, 5 ml) dvakrat na dan.
Caution is warranted since this dosage adjustment might be insufficient in some patients.
Potrebna je previdnost, kajti ta prilagoditev odmerjanja ne zadošča za vse bolnike.
28 Co-administration with other HIV protease inhibitors (PIs):
Sočasna uporaba z drugimi zaviralci proteaz (ZP) HIV:
Amprenavir: the concomitant use of Kaletra with amprenavir 750 mg twice daily, resulted in an increase in amprenavir AUC by 70% and of Cmin by 4.6-fold, relative to amprenavir 1200 mg twice daily alone.
Amprenavir: sočasna uporaba zdravila Kaletra s 750 mg amprenavirja dvakrat na dan je v primerjavi s 1200 mg samega amprenavirja dvakrat na dan zvečala AUC amprenavirja za 70% in Cmin za 4, 6- krat.
Co-administration of increased doses of fosamprenavir 1400 mg twice daily with lopinavir/ ritonavir 533/ 133 mg twice daily to protease inhibitor-experienced patients resulted in a higher incidence of gastrointestinal adverse events and elevations in triglycerides with the combination regimen without increases in virological efficacy, when compared with standard doses of fosamprenavir/ ritonavir.
Ob tem se virološka učinkovitost v primerjavi s standardnimi odmerki fosamprenavirja/ ritonavirja ni povečala.
Saquinavir: saquinavir 800 mg twice daily co-administered with Kaletra produces an increase of saquinavir AUC by 9.6-fold relative to saquinavir 1200 mg three times daily given alone.
30 Sakvinavir: sakvinavir 800 mg dvakrat na dan doseže ob sočasni uporabi z zdravilom Kaletra 9, 6- krat večjo AUC kot sakvinavir sam v odmerku 1200 mg trikrat na dan.
29 Other medicinal products:
Druga zdravila:
(bepridil, systemic lidocaine and quinidine): concentrations may be increased when co-administered with Kaletra.
Antiaritmiki (bepridil, sistemski lidokain in kinidin): med sočasno uporabo z zdravilom Kaletra se njihova koncentracija lahko zveča.
Bupropion: in healthy volunteers, the AUC and Cmax of bupropion and of its active metabolite, hydroxybupropion, were decreased by about 50% when co-administered with lopinavir/ ritonavir capsules 400/ 100 mg twice daily at steady-state.
Med sočasno uporabo kapsul lopinavirja/ ritonavirja 400/ 100 mg dvakrat na dan sta se AUC in Cmax bupropiona in njegovega aktivnega presnovka hidroksibupropiona pri zdravih prostovoljcih v stanju dinamičnega ravnovesja zmanjšali za okoli 50%.
However, it is unknown whether the combination of lopinavir/ ritonavir causes a similar increase in trazodone exposure.
Ni znano, ali lahko tudi kombinacija lopinavir/ ritonavir podobno poveča izpostavljenost trazodonu.
Caution is warranted and therapeutic drug monitoring of digoxin concentrations, if available, is recommended in case of co-administration of Kaletra and digoxin.
Posebna previdnost je potrebna
Particular caution should be used when prescribing Kaletra in patients taking digoxin as the acute inhibitory effect of ritonavir on Pgp is expected to significantly increase digoxin levels.
31 pri predpisovanju zdravila Kaletra bolnikom, ki jemljejo digoksin, kajti pričakovati je treba, da akutno zaviralno delovanje ritonavirja na PgP občutno zviša koncentracijo digoksina.
Kaletra oral solution contains alcohol which can produce disulfiram-like reactions when co-administered with disulfiram or other medicinal products that produce this reaction.
Disulfiram, metronidazol: peroralna raztopina Kaletra vsebuje alkohol, ki lahko izzove reakcijo, podobno disulfiramski, če je uporabljena hkrati z disulfiramom ali drugimi zdravili, ki povzročajo to reakcijo.
Since increased concentrations of HMG-CoA
Pri zaviralcih reduktaze HMG- CoA, ki so zelo odvisni od presnove s CYP3A4 (npr. lovastatin in simvastatin), je med sočasno uporabo z zdravilom Kaletra treba pričakovati izrazito zvečanje njihove koncentracije v plazmi.
30 reductase inhibitors may cause myopathy, including rhabdomyolysis, the combination of these medicinal products with Kaletra is not recommended.
Zvečana koncentracija zaviralcev reduktaze HMG- CoA lahko povzroči miopatijo, vključno z rabdomiolizo, zato njihovo kombiniranje z zdravilom Kaletra ni priporočljivo.
Dexamethasone: may induce CYP3A4 and may decrease lopinavir concentrations.
Deksametazon: lahko inducira CYP3A4 in zmanjša koncentracijo lopinavirja.
Ketoconazole and itraconazole: may have serum concentrations increased by Kaletra.
Zdravilo Kaletra lahko zveča njuno koncentracijo v serumu.
31 Rifampicin: co-administration of Kaletra with rifampicin is not recommended.
Rifampicin: sočasna uporaba zdravila Kaletra in rifampicina ni priporočljiva.
The Kaletra dose should be titrated upward only after rifampicin has been initiated (see section 4.4).
Dvigajoče titriranje odmerka zdravila Kaletra se lahko prične šele po začetku jemanja rifampicina (glejte poglavje 4. 4).
St John’ s wort: serum levels of lopinavir and ritonavir can be reduced by concomitant use of the herbal preparation St John’ s wort (Hypericum perforatum).
Šentjanževka: sočasna uporaba zeliščnih pripravkov šentjanževke (Hypericum perforatum) lahko zmanjša koncentracijo lopinavirja in ritonavirja v serumu.
Fluticasone propionate (interaction with ritonavir): in a clinical study where ritonavir 100 mg capsules twice daily were co − administered with 50 μ g intranasal fluticasone propionate (4 times daily) for seven days in healthy subjects, the fluticasone propionate plasma levels increased significantly, whereas the intrinsic cortisol levels decreased by approximately 86% (90% confidence interval 82 − 89%).
Flutikazonpropionat (interakcija z ritonavirjem): pri zdravih osebah, ki so med klinično študijo 7 dni sočasno prejemale ritonavir v obliki 100 mg kapsul dvakrat dnevno in flutikazonpropionat v odmerku 50 µg intranazalno (4- krat dnevno), so ugotovili, da so se vrednosti flutikazonpropionata v plazmi znatno povečale, intrinzične vrednosti kortizola pa zmanjšale za približno 86% (90% interval zaupanja; 82- 89%).
Systemic corticosteroid effects including Cushing's syndrome and adrenal suppression have been reported in patients receiving ritonavir and inhaled or intranasally administered fluticasone propionate; this could also occur with other corticosteroids metabolised via the P450 3A pathway eg budesonide.
Pri bolnikih, ki so prejemali ritonavir in inhalacijske ali intranazalne oblike flutikazonpropionata, so poročali o pojavu sistemskih kortikosteroidnih učinkov, vključno s
HIV-infected women must not breast-feed their infants under any circumstances to avoid transmission of HIV.
S HIV okužene ženske nikakor ne smejo dojiti, da ne pride do prenosa HIV na otroka.
Kaletra oral solution contains approximately 42% v/ v alcohol.
Peroralna raztopina Kaletra vsebuje približno 42% v/ v alkohola.
Combination antiretroviral therapy has been associated with metabolic abnormalities such as hypertriglyceridaemia, hypercholesterolaemia, insulin resistance, hyperglycaemia and hyperlactataemia (see section 4.4).
Kombinirano protiretrovirusno zdravljenje je bilo povezano s presnovnimi nepravilnostmi, npr. hipertrigliceridemijo, hiperholesterolemijo, odpornostjo proti insulinu, hiperglikemijo in hiperlaktatemijo (glejte poglavje 4. 4).
In HIV-infected patients with severe immune deficiency at the time of initiation of combination antiretroviral therapy (CART), an inflammatory reaction to asymptomatic or residual opportunistic infections may arise (see section 4.4).
34 Pri s HIV okuženih bolnikih s hudo imunsko pomanjkljivostjo lahko ob uvedbi kombiniranega protiretrovirusnega zdravljenja (CART - "combination antiretroviral therapy") nastane vnetna reakcija na asimptomatične ali rezidualne oportunistične okužbe (glejte poglavje 4. 4).
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness: very common > 1/ 10, common > 1/ 100 ,< 1/10, uncommon > 1/ 1000, < 1/ 100.
V razvrstitvah pogostnosti so neželeni učinki navedeni po padajoči resnosti: zelo pogosto > 1/ 10, pogosto > 1/ 100, < 1/ 10, občasno > 1/ 1. 000, < 1/ 100.
33 Undesirable effects in clinical studies in adult patients Infections and infestations
Infekcijske in parazitske bolezni
Otitis media, bronchitis, sinusitis, furunculosis, bacterial infections, viral infection
vnetje srednjega ušesa, bronhitis, sinuzitis, furunkuloza, bakterijska okužba, virusna okužba
Hypergonadism male, Cushing syndrome, hypothyroidism
moški hipogonadizem, Cushingov sindrom, hipotiroidizem
Avitminosis, dehydration, oedema, increased appetite, lactic acidosis, obesity, anorexia, diabetes mellitus, hyperglycaemia, hypocholesteramia
avitaminoza, dehidracija, edemi, zvečan apetit, laktacidoza, debelost, anoreksija, diabetes mellitus, hiperglikemija, hipoholesteremija
Abnormal dreams, agitation, anxiety, confusion, depression, dyskinesia, emotional lability, decreased libido, nervousness, abnormal thinking
nenormalne sanje, agitiranost, anksioznost, zmedenost, depresija, diskinezija, čustvena labilnost, zmanjšan libido, živčnost, nenormalno mišljenje
Dizziness, amnesia, ataxia, encephalopathy, facial paralysis, hypertonia, neuropathy, peripheral neuritis, somnolence, tremor, taste perversion, migraine, extrapyramidal syndrome
omotica, amnezija, ataksija, encefalopatija, paraliza obraza, hipertonija, nevropatija, periferni nevritis, zaspanost, tremor, motnje okusa, migrena, amnezija, ekstrapiramidni sindrom
Eye disorder Ear and labyrinth disorders Cardiac disorders Vascular disorders
Ušesne bolezni, vključno z motnjami labirinta
Abnormal vision, eye disorder Tinnitus Palpitation, lung oedema, myocardial infarc1 Hypertension, thrombophlebitis, vasculitis, varicose vein, deep thrombophlebitis, vascular disorder
hipertenzija, tromboflebitis, vaskulitis, varikozne vene, globoka flebotromboza, žilna motnja
Respiratory, thoracic and mediastinal disorders
35 Bolezni dihal, prsnega koša in mediastinalnega prostora
Abdomen enlarged, constipation, dry mouth, dysphagia, entercolitis, eructation, oesophagitis, faecal incontinence, gastritis, gastroenteritis, haemorrhagic colitis, mouth ulcerations, panreatitis2, sialadenitis, stomatitis, ulcerative stomatitis, peridontitis
zvečanje trebuha, zaprtje, suha usta, disfagija, enterokolitis, spahovanje, ezofagitis, fekalna inkontinenca, gastritis, gastroenteritis, hemoragični kolitis, razjede v ustih, pankreatitis2, sialadenitis, stomatitis, ulcerativni stomatitis, periodontitis
Cholecystitis, hepatitis, hepatomegaly, liver fatty deposit, liver tenderness
holecistitis, hepatitis, hepatomegalija, maščobni jetrni depoziti, jetrna občutljivost
Alopecia, dry skin, eczema, exfoliative dermatitis, maculopapular rash, nail disorder, Pruritis, seborrhoea, skin discoloration, skin ulcer, face oedema, sweating, skin striae
alopecija, suha koža, ekcem, eksfoliacijski dermatitis, makulopapularen izpuščaj, nepravilnosti nohtov, srbenje, diseboreja, sprememba barve kože, razjeda na koži, edem obraza, znojenje, kožne strije
34 Musculoskeletal and connective tissue disorder
Bolezni mišično- skeletnega sistema in vezivnega tkiva
Arthralgia, arthosis, myalgia, back pain, joint disorder
artralgije, artroza, mialgije, bolečine v hrbtu, sklepna bolezen
Kidney calculus, urine abnormality, albuminuria, hypercalcinuria, hypericaemia
ledvični kamni, nenormalnosti urina, albuminurija, hiperkalciurija, hiperurikemija
Asthemia, pain
astenija, bolečine
Chest pain, chest pain substernal, chills, fever, flu syndrome, malaise, peripheral oedema, drug interaction
bolečine v prsih, bolečine v prsih substernalno, mrzlica, zvišana telesna temperatura, gripozni sindrom, splošno slabo počutje, periferni edemi, interakcije z zdravili
Very common (Grade 3or 4)
zelo pogosto (3. ali 4. stopnje)
This event had a fatal outcome.
Ta dogodek je imel smrten izid.
Decreased glucose tolerance, weight gain, weight loss, increased bilirubin, hormone level altered, lab test abnormal
zmanjšana toleranca za glukozo, zvečanje telesne mase, hujšanje, zvišan bilirubin, spremenjen hormonski nivo, nenormalen lab. test
See section 4.4: pancreatitis and lipids
glejte poglavje 4. 4: pankreatitis in
Paediatric patients
36 Pediatrični bolniki
Constipation, vomiting, pancreatitis*
zaprtje, bruhanje, pankreatitis *
Rash, dry skin
izpuščaj, suha koža