FrancophonIA/ELRC3.0 huggingface dataset:
English: Store below 30°C.
Slovenian: površine podnožja.
English: Inhaled human insulin has a faster onset of activity than subcutaneously administered fast-acting human insulin.
Slovenian: Humani insulin za inhaliranje začne hitreje delovati kot subkutano apliciran hitrodelujoč humani insulin.
English: An approximately 40% higher bioavailability of three 1 mg unit dose blisters compared to one 3 mg unit dose blister was observed in healthy subjects.
Slovenian: Pri zdravih preiskovancih je bila biološka uporabnost treh 1-mg pretisnih omotov za enkratni odmerek približno 40 % večja kot enega 3-mg pretisnega omota za enkratni odmerek.
English: Do not refrigerate or freeze.
Slovenian: Zdravila ne shranjujte v hladilniku in ga ne zamrzujte.
English: It is important to follow your doctor's instructions exactly.
Slovenian: Pomembno je, da zdravnikova
English: The 1 mg blister is printed with green ink and has one raised dot on the protruding end of each The 3 mg blister is printed with blue ink and has three raised dots on the protruding end of each
Slovenian: 3 mg pretisni omot ima oznako, natisnjeno z modro barvo, in po tri izbočene točke na vrhu
English: Insulin Release Unit Chamber Release Button (not visible)
Slovenian: in modra ročica črni obroč napis Exubera sivi gumb gumb za sprostitev komore (ni viden)
English: The effect of hepatic impairment on the absorption of inhaled human insulin has not been studied (see section 4.2).
Slovenian: Učinka okvar jeter na absorpcijo humanega insulina za inhaliranje niso proučevali (glejte poglavje
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton/Unit dose blisters (60, 90, 270)
Slovenian: PODATKI NA ZUNANJI OVOJNINI Škatla / enoodmerni pretisni omoti (60, 90, 270)
English: A 3 mg blister of inhaled insulin is approximately equivalent to 8 IU of subcutaneously injected fast-acting human insulin.
Slovenian: 3-mg pretisni omot inhaliranega insulina ustreza približno 8 i.e. subkutano injiciranega hitrodelujočega humanega insulina.
English: Close monitoring of blood glucose concentrations and dose titration as appropriate are recommended when inhaled human insulin is used in these patients.
Slovenian: Pri uporabi humanega insulina za inhaliranje pri teh bolnikih priporočajo natančno spremljanje koncentracij glukoze v krvi in titriranje odmerka.
English: Thoroughly rinse the soap out of the chamber and mouthpiece with warm water.
Slovenian: Komoro in ustnik temeljito splaknite s toplo
English: EXUBERA should only be breathed in through your mouth and should only be taken with your
Slovenian: Zdravilo EXUBERA smete vdihniti samo skozi usta in samo z insulinskim inhalatorjem.
English: Inhaled human insulin is absorbed as rapidly as fast-acting insulin analogues and more rapidly than subcutaneously administered fast-acting human insulin in healthy subjects and in subjects with type 1 or type 2 diabetes (see Figure 4).
Slovenian: Pri zdravih preiskovancih in preiskovancih z diabetesom tipa 1 ali 2 se humani insulin za inhaliranje absorbira enako hitro kot hitrodelujoči insulinski analogi in hitreje kot subkutano aplicirani hitrodelujoči humani insulin (glejte sliko 4).
English: Once you start treatment, your doctor will check your lung function again after 6 months and at other times to see how well you are tolerating
Slovenian: Nato bo čez 6 mesecev in pozneje še večkrat znova preveril delovanje pljuč, da oceni, kako dobro prenašate zdravilo EXUBERA.
English: BEFORE YOU TAKE EXUBERA
Slovenian: KAJ MORATE VEDETI, PREDEN BOSTE VZELI ZDRAVILO EXUBERA
English: Refraction abnormalities of the eye may occur upon initiation of insulin therapy.
Slovenian: Po uvedbi zdravljenja z insulinom se lahko pojavijo refrakcijske očesne nenormalnosti.
English: Bioavailability of inhaled human insulin relative to subcutaneously administered fast-acting human insulin was comparable to those in younger
Slovenian: Biološka uporabnost humanega insulina za inhaliranje glede na subkutano injicirani hitrodelujoči humani insulin je bila primerljiva s tisto pri mlajših odraslih bolnikih z diabetesom tipa 2.
English: Push the IRU gently into the base.
Slovenian: Nežno potisnite nastavek za sproščanje insulina v podnožje.
English: please tell your doctor or pharmacist.
Slovenian: Če ste glede česarkoli negotovi, se obrnite na svojega zdravnika, medicinsko sestro ali farmacevta.
English: A 1 mg blister of EXUBERA gives you about the same insulin dose as 3 IU of subcutaneously injected fast-acting insulin human.
Slovenian: Z 1-mg pretisnim omotom zdravila EXUBERA dobite približno toliko insulina kot s podkožnim injiciranjem 3 i.e. hitrodelujočega humanega insulina.
English: Comparator INH Washout
Slovenian: GmbH & Co.
English: If your blood sugar is too high (hyperglycaemia) Your blood sugar level may be too high, if for example: - you have not taken enough insulin, or if it has become less effective, e.g. through incorrect storage, - you are doing less physical exercise, you are under stress (emotional distress, excitement), or if you have an injury, operation, feverish illness or certain other diseases, - you are taking or have taken certain other medicines (see section 2, “Taking other medicines”).
Slovenian: - ste telesno manj aktivni, ste pod stresom (čustvena stiska, razburjenje) ali če imate poškodbo, operacijo, vročinsko bolezen ali katero od določenih drugih bolezni, - jemljete ali ste jemali nekatera druga zdravila (glejte poglavje 2 “Jemanje drugih zdravil”).
English: Please also read the “Instructions for Use” of the inhaler at the end of the package leaflet carefully before taking EXUBERA.
Slovenian: Preden začnete jemati zdravilo EXUBERA, tudi natančno preberite “Navodilo za uporabo insulinskega inhalatorja”, ki je na koncu tega navodila.
English: NAME OF THE MEDICINAL PRODUCT EXUBERA 3 mg inhalation powder pre-dispensed Insulin human
Slovenian: IME ZDRAVILA EXUBERA 3 mg prašek za inhaliranje, odmerjen
English: A 1 mg blister of inhaled insulin is approximately equivalent to 3 IU of subcutaneously injected fastacting human insulin.
Slovenian: 1-mg pretisni omot inhaliranega insulina ustreza približno 3 i.e. subkutano injiciranega hitrodelujočega humanega insulina.
English: • A pack containing 180 x 1 of 3 mg PVC/Aluminium perforated unit dose blisters (6 pouches) and 2 spare Insulin Release Units (IRU)
Slovenian: • pakiranje, ki vsebuje 180 x 1 3-mg perforiran pretisni omot za enkratni odmerek iz PVC/aluminija (6 vrečk) in 2 rezervna nastavka za sproščanje insulina (Insulin release unitIRU)
English: Reattach the chamber to the base.
Slovenian: Komoro potisnite nazaj na
English: What EXUBERA is and what it is used for
Slovenian: Kaj je zdravilo EXUBERA in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo EXUBERA
English: A 3 mg blister of EXUBERA gives you about the same insulin dose as 8 IU of subcutaneously injected fast-acting insulin human.
Slovenian: Z 3-mg pretisnim omotom zdravila EXUBERA dobite približno toliko insulina kot s podkožnim injiciranjem 8 i.e. hitrodelujočega humanega insulina.
English: NAME OF THE MEDICINAL PRODUCT EXUBERA 1 mg inhalation powder pre-dispensed.
Slovenian: IME ZDRAVILA EXUBERA 1 mg prašek za inhaliranje, odmerjen
English: Please talk to your doctor if you have problems administering EXUBERA or controlling your blood glucose.
Slovenian: Če imate težave z uporabo zdravila EXUBERA ali z obvladovanjem krvnega sladkorja, se posvetujte z zdravnikom.
English: Intrasubject variability of time to peak insulin concentrations was less for inhaled human insulin than for subcutaneous fast-acting human insulin in subjects with type 1 or 2 diabetes.
Slovenian: Pri preiskovancih z diabetesom tipa 1 in 2 je bila intraindividualna variabilnost časa do največje koncentracije insulina ob uporabi insulina za inhaliranje manjša kot ob subkutani uporabi hitrodelujočega humanega insulina.
English: Hold the black ring at the bottom of the base and use it to pull the base out of the chamber.
Slovenian: Vtaknite kazalec v črni obroč na spodnjem delu inhalatorja in ga povlecite, s čimer boste
English: An explanation for the differences in bioavailability appears to be the different energy to mass ratio between the 1 and 3 mg unit blisters since with less powder in the blister the inhaler is more efficient in breaking up or de-agglomerating the powder leading to a larger proportion of smaller aerodynamic particle sizes for the 1 mg blister
Slovenian: Razlaga različne biološke uporabnosti je verjetno različno razmerje med energijo in maso pri 1-mg in 3-mg pretisnih omotih za enkratni odmerek.
English: Dyspnoea Productive Cough Throat Irritation Dry Throat
Slovenian: Infekcijske in parazitske bolezni faringitis dispneja produktivni kašelj, vnetje žrela suho žrelo,
English: Read all of this leaflet carefully before starting to use your insulin inhaler
Slovenian: Navodilo za uporabo insulinskega inhalatorja Preden začnete uporabljati insulinski inhalator, natančno preberite navodilo!
English: • A pack containing 270 x 1 of 3 mg PVC/Aluminium perforated unit dose blisters (9 pouches) and 6 spare Insulin Release Units (IRU)
Slovenian: • pakiranje, ki vsebuje 270 x 1 3-mg perforiran pretisni omot za enkratni odmerek iz PVC/aluminija (9 vrečk) in 6 rezervnih nastavkov za sproščanje insulina (Insulin release unit
English: • A pack containing 270 x 1 of 1 mg PVC/Aluminium perforated unit dose blisters (9 pouches) and 6 spare Insulin Release Units (IRU)
Slovenian: • pakiranje, ki vsebuje 270 x 1 1-mg perforiran pretisni omot za enkratni odmerek iz PVC/aluminija (9 vrečk) in 6 rezervnih nastavkov za sproščanje insulina (Insulin release unit
English: • A pack containing 90 x 1 of 3 mg PVC/Aluminium perforated unit dose blisters (3 pouches) and 2 spare Insulin Release Units (IRU)
Slovenian: • pakiranje, ki vsebuje 90 x 1 3-mg perforiran pretisni omot za enkratni odmerek iz PVC/aluminija (3 vrečke) in 2 rezervna nastavka za sproščanje insulina (Insulin release unitIRU)
English: Do not get the inside of the IRU wet.
Slovenian: Notranjosti nastavka za sproščanje insulina ne smete zmočiti.
English: • A pack containing 60 x 1 of 1 mg PVC/Aluminium perforated unit dose blisters (2 pouches) and 2 spare Insulin Release Units (IRU)
Slovenian: • pakiranje, ki vsebuje 60 x 1 1-mg perforiran pretisni omot za enkratni odmerek iz PVC/aluminija (2 vrečki) in 2 rezervna nastavka za sproščanje insulina (Insulin release unit
English: Use within 3 months of opening.
Slovenian: Delovanje traja približno 6 ur.
English: (Seen in less than 1 in 10 but more than 1 in 100 patients) Commonly reported side effects are mild to moderate shortness of breath (dyspnoea), productive cough, throat irritation and dry throat.
Slovenian: Neželeni učinki, o katerih bolniki pogosto poročajo, so blaga do zmerna kratka sapa (dispneja), kašelj z izkašljevanjem izmečka, vnetje žrela in suho žrelo.
English: Number of 1 mg Blisters per Dose
Slovenian: število 1-mg pretisnih omotov na odmerek število 3-mg pretisnih omotov na odmerek
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each unit dose blister contains 1 mg insulin human.
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN En enoodmerni pretisni omot vsebuje 1 mg humanega insulina.
English: • If you feel hypoglycaemia (low blood sugar) coming on. See the information at the end of section 4 “Possible side effects” of this leaflet for further advice.
Slovenian: Za nadaljnje nasvete glejte informacije na koncu poglavja 4 “Možni neželeni učinki” tega navodila.
English: • A pack containing 60 x 1 of 3 mg PVC/Aluminium perforated unit dose blisters (2 pouches) and 2 spare Insulin Release Units (IRU)
Slovenian: • pakiranje, ki vsebuje 60 x 1 3-mg perforiran pretisni omot za enkratni odmerek iz PVC/aluminija (2 vrečki) in 2 rezervna nastavka za sproščanje insulina (Insulin release unitIRU)
English: • A kit containing 90 x 1 of 1 mg PVC/Aluminium perforated unit dose blisters (3 pouches), 1 insulin inhaler, 1 spare chamber and 6 spare Insulin Release Units (IRU)
Slovenian: • Komplet, ki vsebuje 90 x 1 perforiran pretisni omot za enkratni odmerek iz PVC/aluminija (3 vrečke), 1 insulinski inhalator, 1 rezervno komoro in 6 rezervnih nastavkov za sproščanje insulina (Insulin release unit - IRU)
English: Your ability to concentrate or react may be reduced if you have too low blood sugar (hypoglycaemia).
Slovenian: Pri prenizkem krvnem sladkorju (hipoglikemiji) bosta vaša sposobnost koncentracije ali vaša odzivnost morda zmanjšani.
English: There is no experience with EXUBERA in patients with infection of
Slovenian: Z uporabo zdravila EXUBERA ni izkušenj pri bolnikih, ki imajo okužbo globoko v pljučih (pljučnico).
English: • A kit containing 90 x 1 of 3 mg PVC/Aluminium perforated unit dose blisters (3 pouches), 1 insulin inhaler, 1 spare chamber and 6 spare Insulin Release Units (IRU)
Slovenian: • komplet, ki vsebuje 90 x 1 3-mg perforiran pretisni omot za enkratni odmerek iz PVC/aluminija (3 vrečke), 1 insulinski inhalator, 1 rezervno komoro in 6 rezervnih nastavkov za sproščanje
English: Speak to a doctor immediately if you are not able to control the hypoglycaemia or if it recurs.
Slovenian: Če hipoglikemije ne morete obvladati ali če se ponavlja, se nemudoma pogovorite z zdravnikom.
English: In patients with type 2 diabetes sufficiently controlled with oral agents the glycaemic control was not further improved by inhaled insulin.
Slovenian: Insulin za inhaliranje ni dodatno izboljšal urejenosti glikemije pri bolnikih z diabetesom tipa 2, ki so imeli bolezen zadostno urejeno s
English: • A kit containing 90 x 1 PVC/Aluminium perforated unit dose blisters (3 pouches), 1 insulin inhaler, 1 spare chamber and 6 spare Insulin Release Units (IRU) Additional insulin inhaler, insulin release units and chamber packages are available.
Slovenian: 90 x 1 perforiran pretisni omot za enkratni odmerek iz PVC/aluminija (3 vrečke), 1 insulinski inhalator, 1 rezervna komora in 6 rezervnih nastavkov za sproščanje insulina (Insulin release unit
English: If your blood sugar is too low (hypoglycaemia)
Slovenian: - če čutite, da se bliža hipoglikemija (nizek krvni sladkor).
English: oC and use within 3 months of opening.
Slovenian: Po odprtju prekrivne folije: shranjujte pri temperaturi do 25o C in porabite najpozneje v 3 mesecih po odprtju.
English: • Cardboard box containing 270 x 1 PVC/Aluminium perforated unit dose blisters (9 pouches)
Slovenian: • Kartonska škatla, ki vsebuje 270 x 1 perforiran pretisni omot za enkratni odmerek iz
English: • Cardboard box containing 30 x 1 PVC/Aluminium perforated unit dose blisters (1 pouch)
Slovenian: • Kartonska škatla, ki vsebuje 30 x 1 perforiran pretisni omot za enkratni odmerek iz
English: Respiratory,
Slovenian: Varnost za dihala
English: --1 Live non-pathogenic Escherichia coli O8:K87* (F4ac):.......................1.3x108 to 9.0x108 CFU** Live non-pathogenic Escherichia coli O141:K94* (F18ac): ...............2.8x108 to 3.0x109 CFU**
Slovenian: --1 Živa nepatogena Escherichia coli O8:K87* (F4ac):.......................1.3x108 do 9.0x108 CFU** Živa nepatogena Escherichia coli O141:K94* (F18ac): ...............2.8x108 do 3.0x109 CFU**
English: 4 vials Zero days
Slovenian: 4 viale Nič dni
English: * not attenuated ** CFU - colony forming units
Slovenian: * neatenuirana ** CFU - enota, ki tvori kolonijo
English: Packaging Content Package size
Slovenian: Način uporabe Pakiranje Vsebina Velikost pakiranj a
English: EU (MA) Number Invented name
Slovenian: Izmišljen o ime
English: Packaging Content (concentration)
Slovenian: izmišljeno ime jakost farmacevtska oblika pot uporabe ovojnina vsebina (koncentracija)
English: 0.6 ml (20 mg/ml) 1 vial
Slovenian: 0,6 ml (20 mg/ml) 1 viala
English: EU/1/18/1278/001 Carmustine Obvius 100 mg Powder and solvent for solution for infusion
Slovenian: EU/1/18/1278/001 Carmustine Obvius
English: Powder: 100 mg Solvent: 3 ml
Slovenian: Prašek: 100 mg Vehikel: 3 ml
English: Intravenous use Powder: vial (glass) Solvent: ampoule (glass)
Slovenian: Vehikel: ampula (steklo)
English: MA (EU) number (Invented) name Strength Pharmaceutical Form
Slovenian: (Izmišljeno) ime
English: - 3 years.
Slovenian: - 3 leta.
English: Warnings and precautions:
Slovenian: Opozorila in previdnostni ukrepi:
English: Your doctor will not prescribe OSSEOR for you if you are at particular risk.
Slovenian: Zdravnik vam ne bo predpisal zdravila OSSEOR, če pri vas obstaja posebno tveganje.
English: OSSEOR with food and drink:
Slovenian: Zdravilo OSSEOR skupaj s hrano in pijačo:
English: What OSSEOR is and what it is used for
Slovenian: Kaj je zdravilo OSSEOR in za kaj ga uporabljamo
English: However, these effects were mild and short-lived and usually did not cause the patients to stop taking their treatment.
Slovenian: Ti učinki so bili blagi ter prehodni in bolniki zaradi njih običajno niso prekinjali zdravljenja.
English: You can take OSSEOR again when you have finished taking these antibiotics.
Slovenian: Zdravilo OSSEOR lahko ponovno začnete jemati, ko prenehate z jemanjem tovrstnih antibiotikov.
English: Children and adolescents OSSEOR is not intended for use in children and adolescents (below the age of 18).
Slovenian: Otroci in mladostniki Zdravilo OSSEOR ni namenjen otrokom in mladostnikom (mlajšim od 18 let).
English: The safety and efficacy of OSSEOR in children aged below 18 years have not been established.
Slovenian: Varnost in učinkovitost zdravila OSSEOR pri otrocih, mlajših od 18 let, nista bili dokazani.
English: OSSEOR has been studied in clinical trials involving nearly 8,000 participants.
Slovenian: Zdravilo OSSEOR so proučevali v kliničnih študijah, ki so zajele skoraj 8000 bolnikov.
English: Adverse reactions are listed below using the following convention : very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).
Slovenian: Neželeni učinki so našteti po naslednjem pravilu: zelo pogosti (≥ 1/10), pogosti (≥1/100 do <1/10), občasni (≥1/1.000 do <1/100), redki (≥1/10.000 do <1/1.000), zelo redki (< 1/10.000); neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov).
English: Heart attack may occur commonly in patients at high risk for heart disease.
Slovenian: Srčni infarkt se običajno lahko pojavi pri bolnikih z velikim tveganjem za nastanek srčne bolezni.
English: If tests are positive for one or both alleles, OSSEOR should not be started.
Slovenian: Če so testi pozitivni za enega ali oba alela, se zdravila OSSEOR ne sme uvesti.
English: However, absence of these alleles upon genotyping does not exclude that SJS/TEN can still occur.
Slovenian: Vendar pa odsotnost obeh alelov pri genotipizaciji ne izključuje možnosti za pojav SJS/TEN.
English: The PASS final study report submitted by the MAH complies with their obligation to perform a PASS to evaluate risk of serious cardiac disorders as imposed during the Article 20 procedure EMA/112925/2014.
Slovenian: Končno poročilo študije PASS, predloženo s strani imetnika dovoljenja za promet (MAH), zadosti obvezi po izvedbi študije PASS za ovrednotenje tveganja za resne srčne motnje, kot je bilo določeno s postopkom po 20. členu, EMA/112925/2014.
English: • Prescriber guide and checklist • Patient alert card
Slovenian: • Navodila za zdravnika in seznam za preverjanje • Kartica z opozorili za bolnika
English: Paper/polyethylene/aluminium/polyethylene sachets.
Slovenian: Vrečke iz papirja/polietilena/aluminija/polietilena.
English: However, it is recommended to drink the suspension immediately after preparation (see section 3).
Slovenian: Vseeno je suspenzijo priporočljivo popiti takoj po pripravi (glejte 3. poglavje).
English: On the basis of the scientific conclusions for the results of the study for the medicinal product mentioned above, the CHMP is of the opinion that the benefit-risk balance of this medicinal product is unchanged, subject to the proposed changes to the product information.
Slovenian: Na podlagi znanstvenih zaključkov o izsledkih študije z zgoraj navedenim zdravilom odbor CHMP meni, da je razmerje med koristjo in tveganjem tega zdravila nespremenjeno ob upoštevanju predlaganih sprememb v informacijah o zdravilu.
English: If you need to have blood or urine tests to check your level of calcium, you should tell the laboratory that you are taking OSSEOR as it may interfere with some testing methods.
Slovenian: Če morate opraviti preiskave krvi ali urina, ki pokažejo vašo raven kalcija, morate osebju v laboratoriju povedati, da jemljete zdravilo OSSEOR, ker lahko jemanje zdravila vpliva na nekatere laboratorijske preiskave.
English: Following episodes of overdoses during clinical trials (up to 4 g/day for a maximal duration of 147 days), no clinically relevant events were observed.
Slovenian: Po obdobjih prevelikega odmerjanja v kliničnih študijah (do 4 g na dan največ 147 dni) niso opazili klinično pomembnih dogodkov.
English: Talk to your doctor if any effects become troublesome or persist.
Slovenian: Posvetujte se s svojim zdravnikom, če opazite, da katerikoli učinek postane neprijeten ali traja dlje časa.
English: The European Medicines Agency has waived the obligation to submit the results of studies with OSSEOR in all subsets of the paediatric population in osteoporosis (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z zdravilom OSSEOR za vse podskupine pediatrične populacije pri osteoporozi (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: Your doctor should be able to advise if a blood test is necessary before taking OSSEOR.
Slovenian: Vaš zdravnik vam bo svetoval, ali je potrebno izvesti krvni test, preden začnete jemati zdravilo OSSEOR.
English: Your doctor will tell you how long you should continue to take OSSEOR.
Slovenian: Zdravnik vam bo povedal, koliko časa morate jemati zdravilo OSSEOR.
English: What OSSEOR looks like and contents of the pack OSSEOR is available in sachets containing yellow granules for oral suspension.OSSEOR is supplied in boxes of 7, 14, 28, 56, 84 or 100 sachets.
Slovenian: Izgled zdravila OSSEOR in vsebina pakiranja OSSEOR je na voljo v vrečkah, ki vsebujejo rumena zrnca za peroralno suspenzijo Škatle zdravila OSSEOR vsebujejo 7, 14, 28, 56, 84 ali 100 vrečk.
English: Strontium ranelate has no or negligible influence on the ability to drive and use machines.
Slovenian: Stroncijev ranelat nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja s strojev.
English: OSSEOR can treat your severe osteoporosis only if you continue to take it.
Slovenian: Zdravilo OSSEOR lahko zdravi hudo osteoporozo, le če ga jemljete neprekinjeno.
English: Recovery could be slow and recurrences of the syndrome have been reported in some cases after discontinuation of corticosteroid therapy.
Slovenian: Okrevanje je lahko dolgotrajno, v nekaterih primerih pa so poročali tudi o ponovnem pojavu sindroma po prekinitvi zdravljenja s kortikosteroidi.
English: These potentially life-threatening skin rashes are often accompanied by flu-like symptoms.
Slovenian: Omenjene morebitno življenje ogrožajoče kožne izpuščaje pogosto spremljajo gripi podobni simptomi.
English: Pharmacotherapeutic group: Drugs for the treatment of bone diseases - Other drugs affecting bone structure and mineralisation, ATC code: M05BX03.
Slovenian: Farmakoterapevtska skupina: zdravila za zdravljenje bolezni kosti - druga zdravila z učinkom na mineralizacijo kosti, oznaka ATC: M05BX03
English: Musculo-skeletal fraction > 3 times the upper limit of the normal range.
Slovenian: Mišičnoskeletna frakcija > 3-kratna gornja meja razpona normalnih vrednosti.
English: The risk of these skin reactions in patients of Asian origin, particularly Han Chinese, may be predicted.
Slovenian: Pri bolnikih azijskega porekla, predvsem pri kitajskih bolnikih etnične skupine Han, je tveganje za te kožne reakcije mogoče predvideti.
English: What you need to know before you take OSSEOR
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo OSSEOR
English: The following adverse reactions have been reported during clinical studies and/or post marketing use with strontium ranelate.
Slovenian: O naslednjih neželenih učinkih so poročali v kliničnih študijah in/ali postmarketinški uporabi stroncijevega ranelata.