FrancophonIA/ELRC3.0 huggingface dataset:
English: 9/L) was observed in 41 % of donors and transient 9/L) following filgrastim and leukapheresis was observed in thrombocytopenia (platelets < 100 x 10
Slovenian: Pri 35 % oseb, ki so sodelovale v preskušanju, so po odmerjanju filgrastima in po levkaferezi opazili prehodno trombocitopenijo (št. trombocitov < 100 x 109/l).
English: Capillary leak syndrome*
Slovenian: Občasni sindrom kapilarne prepustnosti*
English: The usual dose is 0.5 million international units (MIU) per kilogram of bodyweight each day.
Slovenian: Običajni odmerek na kilogram telesne mase je 0,5 milijonov mednarodnih enot (i.e.) dnevno.
English: Decreased glucose, elevated alkaline phosphatase, elevated LDH, hyperuricaemia
Slovenian: Presnovne in prehranske motnje Zelo pogosti znižanje glukoze, zvišanje alkalne fosfataze in LDH, hiperurikemija
English: Special precautions in recipients of allogeneic PBPC mobilised with filgrastim
Slovenian: Posebni previdnostni ukrepi pri prejemnikih alogenskih matičnih celic iz periferne krvi, zbranih s pomočjo filgrastima
English: Vascular disorder Capillary leak syndrome*
Slovenian: Bolezni živčevja sindrom kapilarne prepustnosti*
English: Rare pulmonary undesirable effects including interstitial pneumonia, pulmonary oedema and pulmonary infiltrates have been reported in some cases with an outcome of respiratory failure or adult respiratory distress syndrome (ARDS) which may be fatal (see section 4.4).
Slovenian: V nekaterih opisanih primerih je prišlo do respiracijske insuficience ali sindroma dihalne stiske pri odraslih (ARDS), ki sta lahko usodna (glejte poglavje 4.4).
English: Neutrophils produced in response to filgrastim show normal or enhanced function as demonstrated by tests of chemotactic and phagocytic function.
Slovenian: Glede na teste kemotaktične in fagocitne funkcije, nevtrofilci, ki nastanejo kot odgovor na filgrastim, kažejo normalno ali zvečano delovanje.
English: (230 μg)/m
Slovenian: (24 μg)/kg/dan.
English: 9/L prior to leukapheresis; in general apheresis should not be performed if platelets < 100 x 10
Slovenian: Če je potrebna več kot ena levkafereza, je potrebno pred samim postopkom levkafereze posebno pozornost nameniti bolnikom, katerih število trombocitov je < 100 x 109/l; v splošnem levkafereze ne smemo izvesti, če je število trombocitov < 75 x 109/l.
English: Treatment with filgrastim alone does not preclude thrombocytopenia and anaemia due to myelosuppressive medicinal products.
Slovenian: Zaradi mielosupresivne kemoterapije zdravljenje samo s filgrastimom ne zadostuje za preprečevanje trombocitopenije in anemije.
English: Chest pain, musculoskeletal pain
Slovenian: Sweetov sindrom, kožni vaskulitis bolečine v prsih, mišičnoskeletne bolečine
English: Package leaflet: Information for the user
Slovenian: Vsebina pakiranja in dodatne informacije
English: The recommended starting dose is 1.2 MIU (12 μg)/kg/day subcutaneously as a single dose or in divided doses.
Slovenian: (12 μg)/kg/dan subkutano v enkratnem odmerku ali v večkratnih odmerkih.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Pre-filled syringe
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
English: Biograstim 30 MIU/0.5 mL solution for injection or infusion Filgrastim
Slovenian: Biograstim 30 000 k.i.e./0,5 ml raztopina za injiciranje ali infundiranje Filgrastim
English: For patients treated with filgrastim diluted to concentrations below 1.5 MIU (15 μg) per mL, human serum albumin (HSA) should be added to a final concentration of 2 mg/mL.
Slovenian: Pri bolnikih, ki prejemajo zdravilo filgrastim v koncentraciji, ki je nižja od 1,5 x 106 i.e. (15 μg) na ml,
English: The usual starting dose is 1 million international units (MIU) per kilogram of bodyweight each day.
Slovenian: Običajni odmerek na kilogram telesne mase je 1 milijon mednarodnih enot (i.e.) dnevno.
English: Packs containing 1, 5 or 10 pre-filled syringes with 0.5 mL solution or multipacks containing 10 (2 packs of 5) pre-filled syringes with 0.5 mL solution.
Slovenian: Pakiranja po 1, 5 ali 10 napolnjenih injekcijskih brizg z 0,5 ml raztopine ali skupna pakiranja z 10 (2 pakiranji po 5) napolnjenimi injekcijskimi brizgami z 0,5 ml raztopine.
English: The first dose of filgrastim should not be administered less than 24 hours following cytotoxic chemotherapy and within 24 hours of bone marrow infusion.
Slovenian: Bolnik lahko prvi odmerek filgrastima prejme šele 24 ur po citotoksični kemoterapiji, v primeru presaditve kostnega mozga pa mora odmerek prejeti v roku 24-ih ur.
English: Each pre-filled syringe contains 30 million international units [MIU] (300 microgram) of filgrastim in 0.5 mL (60 MIU/mL, 600 microgram/mL).
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena napolnjena injekcijska brizga vsebuje 30 milijonov mednarodnih enot [i.e.] (300 mikrogramov) filgrastima v 0,5 ml (60 000 k.i.e./ml, 600 mikrogramov/ml).
English: Contents of the pack and other information What Biograstim contains
Slovenian: Shranjevanje zdravila Biograstim Vsebina pakiranja in dodatne informacije Navodila za samoinjiciranje
English: What Biograstim is used for
Slovenian: Za kaj uporabljamo zdravilo Biograstim
English: In clinical trials, the most frequent undesirable effects attributable to filgrastim at the recommended dose were mild or moderate musculoskeletal pain, occurring in 10 %, and severe musculoskeletal pain in 3 % of patients.
Slovenian: Blaga do zmerna mišičnoskeletna bolečina, ki se je pojavila pri 10 % bolnikov, ter huda mišičnoskeletna bolečina, ki se je pojavila pri 3 % bolnikov, sta bila najbolj pogosta neželena učinka, ki so ju v kliničnih preskušanjih pripisali filgrastimu v priporočenem odmerku.
English: Biograstim 48 MIU/0.8 mL solution for injection or infusion Filgrastim
Slovenian: Biograstim 48 000 k.i.e./0,8 ml raztopina za injiciranje ali infundiranje Filgrastim
English: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before using this medicine.
Slovenian: Zdravilo Biograstim vsebuje sorbitol in natrij Če vam je zdravnik povedal, da ne prenašate nekaterih sladkorjev, se pred uporabo tega zdravila posvetujte z zdravnikom.
English: In severe chronic neutropenia patients
Slovenian: Bolniki s hudo kronično nevtropenijo
English: Musculoskeletal pain Osteoporosis
Slovenian: Pogosti osteoporoza
English: Special care should be taken in the diagnosis of severe chronic neutropenias to distinguish them from other haematopoietic disorders such as aplastic anaemia, myelodysplasia and myeloid leukaemia.
Slovenian: Preobrazba v levkemijo ali mielodisplatični sindrom Še posebej previdni moramo biti pri diagnosticiranju hude kronične nevtropenije, ki je ne smemo zamenjati z drugimi boleznimi krvotvornih celic, kot so aplastična anemija, mielodisplazija in mieloična levkemija.
English: The recommended starting dose of filgrastim is 1.0 MIU (10 μg)/kg/day given as a 30 minute or 24 hour intravenous infusion or 1.0 MIU (10 μg)/kg/day given by continuous 24 hour subcutaneous infusion.
Slovenian: (10 μg)/kg/dan v obliki 30-minutne ali 24-urne intravenske infuzije ali 1,0 x 106i.e.
English: Filgrastim
Slovenian: Metaanaliza
English: The recommended starting dose is 0.5 MIU (5 μg)/kg/day subcutaneously as a single dose or in divided doses.
Slovenian: (5 μg)/kg/dan subkutano v enkratnem odmerku ali v večkratnih odmerkih.
English: The recommended starting dose of filgrastim is 0.1 MIU (1 μg)/kg/day given daily by subcutaneous injection with titration up to a maximum of 0.4 MIU (4 μg)/kg/day until a normal neutrophil count is
Slovenian: (1 μg)/kg/dan dnevno v obliki subkutane injekcije s povečanjem koncentracije na največ 0,4 x 106i.e.
English: In normal donors, pulmonary adverse events (haemoptysis, pulmonary haemorrhage, lung infiltrates, dyspnoea and hypoxia) have been reported very rarely in postmarketing experience.
Slovenian: Pri normalnih darovalcih so iz izkušenj po začetku trženja zelo redko poročali o pljučnih neželenih učinkih (hemoptiza, pljučna krvavitev, pljučni infiltrati, dispneja in hipoksija).
English: Biograstim 30 MIU/0.5 mL solution for injection or infusion
Slovenian: IME ZDRAVILA Biograstim 30 000 k.i.e./0,5 ml raztopina za injiciranje ali infundiranje
English: Solution for injection or infusion Multipack: 10 (2 packs of 5) pre-filled syringes containing 0.8 mL.
Slovenian: Skupno pakiranje: 10 (2 pakiranji po 5) napolnjenih injekcijskih, ki vsebujejo 0,8 ml.
English: Monitoring of bone density may be indicated in patients with underlying osteoporotic bone diseases who undergo continuous therapy with filgrastim for more than 6 months.
Slovenian: Bolnikom z osteoporozo, ki neprekinjeno prejemajo filgrastim dlje kot 6 mesecev, je potrebno meriti kostno gostoto.
English: Common but generally asymptomatic cases of splenomegaly and very rare cases of splenic rupture have been reported in healthy donors and patients following administration of G-CSFs.
Slovenian: Pri zdravih darovalcih in bolnikih, ki so prejemali faktor, ki spodbuja rast granulocitnih kolonij, so poročali o pogostih, a v splošnem asimptomatskih primerih splenomegalije, zelo redko pa o primerih rupture vranice.
English: Each pre-filled syringe contains 48 million international units [MIU] (480 microgram) of filgrastim in 0.8 mL (60 MIU/mL, 600 microgram/mL).
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Vsaka napolnjena injekcijska brizga vsebuje 48 milijonov mednarodnih enot [i.e.] (480 mikrogramov) zdravila filgrastim v 0,8 ml (60 000 k.i.e./ml, 600 mikrogramov /ml).
English: The syringe has a scale on the syringe barrel.
Slovenian: Na telesu brizge je zarisano merilo.
English: Biograstim 48 MIU/0.8 mL solution for injection or infusion
Slovenian: IME ZDRAVILA Biograstim 48 000 k.i.e./0,8 ml raztopina za injiciranje ali infundiranje
English: The use of filgrastim-mobilised PBPCs has been shown to reduce the depth and duration of thrombocytopenia following myelosuppressive or myeloablative chemotherapy.
Slovenian: Izkazalo se je, da s filgrastimom zbrane matične celice v periferni krvi zmanjšujejo resnost in trajanje trombocitopenije po mielosupresivni ali mieloablativni kemoterapiji.
English: Hepatobiliary disorders
Slovenian: Pogosti hepatomegalija
English: Very rare events of cutaneous vasculitis have been reported in patients treated with filgrastim.
Slovenian: Pri bolnikih, ki so prejemali filgrastim, so poročali o zelo redkih primerih kožnega vaskulitisa.
English: Biograstim 30 MIU/0.5 mL
Slovenian: PODATKI V BRAILLOVI PISAVI Biograstim 30 000 k.i.e./0.5 ml
English: The recommended dose of filgrastim for PBPC mobilisation when used alone is 1.0 MIU (10 μg)/kg/day as a 24 hour subcutaneous continuous infusion or a single daily subcutaneous injection for 5 to 7 consecutive days.
Slovenian: (10 μg)/kg/dan v obliki 24urne subkutane infuzije ali enkraten dnevni odmerek v obliki subkutane injekcije v obdobju od 5-ih do 7-ih dni zapored.
English: The usual starting dose is between 0.5 million and 1.2 million international units (MIU) per kilogram bodyweight each day in a single or divided dose.
Slovenian: Zdravilo Biograstim in huda kronična nevtropenija Običajni odmerek na kilogram telesne mase je od 0,5 do 1,2 milijona mednarodnih enot (i.e.) dnevno, bodisi v enkratnem ali večkratnih odmerkih.
English: Solution for injection or infusion Multipack: 10 (2 packs of 5) pre-filled syringes containing 0.5 mL.
Slovenian: Skupno pakiranje: 10 (2 pakiranji po 5) napolnjenih injekcijskih brizg, ki vsebujejo 0,5 ml.
English: Packs containing 1, 5 or 10 pre-filled syringes with 0.8 mL solution or multipacks containing 10 (2 packs of 5) pre-filled syringes with 0.8 mL solution.
Slovenian: Pakiranja po 1, 5 ali 10 napolnjenih injekcijskih brizg z 0,8 ml raztopine ali skupno pakiranje z 10 (2 pakiranji po 5) napolnjenimi injekcijskimi brizgami z 0,5 ml raztopine.
English: 9/L were reported and attributed to the leukapheresis procedure.
Slovenian: Med njimi so poročali o dveh primerih, pri katerih je bilo število trombocitov < 50 x 109/l, kar so pripisali postopku levkafereze.
English: Dilution to a final concentration less than 0.2 MIU (2 μg) per mL is not recommended at any time.
Slovenian: Zdravila nikoli ne smete razredčiti v tolikšni meri, da bi končna koncentracija padla pod 0,2 x 106 i.e. (2 μg).
English: 9/L, with the median dose frequency being 3 days per week.
Slovenian: (300 μg)/dan od 1 do 7 dni na teden, pri čemer so bolniki v povprečju prejemali 3 odmerke na teden.
English: Biograstim 30 MIU/0.5 mL: Each pre-filled syringe contains 30 million international units [MIU] (300 microgram) of filgrastim in 0.5 mL solution.
Slovenian: 1 ml raztopine za injiciranje ali infundiranje vsebuje 60 milijonov mednarodnih enot [i.e.] (600 mikrogramov) zdravila filigrastim Biograstim 30 000 k.i.e./0,5 ml: ena napolnjena injekcijska brizga vsebuje 30 milijonov mednarodnih enot [i.e.] (300 mikrogramov) zdravila filgrastim v 0,5 ml raztopine.
English: Transient increases with no clinical symptoms were observed in serum uric acid, lactic dehydrogenase and alkaline phosphatase.
Slovenian: Opazili so tudi prehodna povečanja sečne kisline, laktatne dehidrogenaze in alkalne fosfataze, ki pa jih niso spremljali klinični simptomi.
English: Long-term treatment with Biograstim may be required to maintain a normal number of white cells in your blood.
Slovenian: Zato da bi število belih krvničk v vaši krvi ostalo na običajni ravni, bo morda potrebno dolgotrajno zdravljenje z zdravilom Biograstim.
English: In clinical as determined by the patient's ANC, to maintain the neutrophil count at > 2.0 x 10 studies, dosing with 30 MIU (300 μg)/day on 1 to 7 days per week was required to maintain the ANC
Slovenian: V kliničnih preskušanjih je bilo za to, da bi bilo absolutno število nevtrofilcev večje od 2,0 x 109/l, potrebno odmerjati 30 x 1 6i.e.
English: Solution for injection or infusion 5 pre-filled syringes containing 0.8 mL.
Slovenian: 5 napolnjenih injekcijskih brizg, ki vsebujejo 0,8 ml.
English: For infusions, filgrastim should be diluted in 20 mL of glucose 50 mg/mL (5 %) solution for infusion (see section 6.6 for instructions on dilution).
Slovenian: Za infundiranje je potrebno filgrastim razredčiti v 20 ml glukoze 50 mg/ml (5%) raztopini za infundiranje (postopek redčenja je opisan v poglavju 6.6).
English: Do not use any Biograstim that is left in the syringe.
Slovenian: Zdravila Biograstim, ki morebiti ostane v injekcijski brizgi, ne smete več uporabiti.
English: Diluted filgrastim may be adsorbed to glass and plastic materials except diluted, as mentioned in section 6.6.
Slovenian: Če ni razredčeno v skladu z navodili v poglavju 6.6, se razredčen filgrastim lahko adsorbira na steklene in plastične materiale.
English: Filgrastim should be diluted in 20 mL of glucose 50 mg/mL (5 %) solution for infusion (see section 6.6 for instructions on dilution).
Slovenian: Filgrastim je potrebno razredčiti v 20 ml glukoze 50 mg/ml (5%) raztopini za infundiranje (postopek redčenja je opisan v poglavju 6.6).
English: The recommended dose of filgrastim is 0.5 MIU (5 μg)/kg/day.
Slovenian: Priporočen odmerek filgrastima je 0,5 x 106i.e.
English: The long-term safety of filgrastim administration above 2.4 MIU (24 μg)/kg/day in patients with SCN has not been established.
Slovenian: Dolgoročna varnost odmerjanja filgrastima v odmerkih, večjih od 2,4 x 106i.e.
English: Each pre-filled syringe contains 48 MIU (480 µg) of filgrastim in 0.8 mL solution for injection or infusion.
Slovenian: (480 µg) filgrastima v 0,8 ml raztopine za injiciranje ali infundiranje.
English: During long term use, cutaneous vasculitis has been reported in 2 % of SCN patients.
Slovenian: Pri 2 % bolnikov s hudo kronično nevtropenijo, ki so filgrastim prejemali dalj časa, so poročali o kožnem vaskulitisu.
English: Abdominal palpation should be sufficient to detect abnormal increases in splenic volume.
Slovenian: Za to, da ugotovimo povečanje vranice, zadostuje tipanje trebuha.
English: There was a low frequency (approximately 3 %) of myelodysplastic syndromes (MDS) or leukaemia in clinical trial patients with SCN treated with filgrastim.
Slovenian: Pri bolnikih s hudo kronično nevtropenijo, ki so med kliničnim preskušanjem prejemali filgrastim, je bilo malo primerov (približno 3 %) mielodisplastičnih sindromov ali levkemije.
English: EU/1/08/450/007 2 x 5 pre-filled syringes
Slovenian: ŠTEVILKA (E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/08/450/007 2 x 5 napolnjenih injekcijskih brizg
English: Common
Slovenian: Zbiranje
English: When the response has been obtained, the reached and can be maintained at more than 1.5 x 10 minimal effective dose to maintain this level should be established.
Slovenian: Ko je ta meja dosežena, je treba določi minimalen učinkovit odmerek, ki vzdržuje število nevtrofilcev na tej ravni.
English: For PBPC mobilisation in normal donors, filgrastim should be administered at 1.0 MIU (10 μg)/kg/day subcutaneously for 4 to 5 consecutive days.
Slovenian: Za postopek zbiranja matičnih celic iz periferne krvi običajni darovalci 4 do 5 dni zapored prejmejo filgrastim v odmerku 1,0 x 106i.e.
English: Leukocytosis, thrombocytopenia Spleen disorder
Slovenian: Neželeni učinek levkocitoza, trombocitopenija
English: Each pre-filled syringe contains 30 MIU (300 µg) of filgrastim in 0.5 mL solution for injection or infusion.
Slovenian: (300 µg) filgrastima v 0,5 ml raztopine za injiciranje ali infundiranje.
English: Vascular disorders, including veno-occlusive disease and fluid volume disturbances, have been reported occasionally in patients undergoing high dose chemotherapy followed by autologous bone marrow transplantation.
Slovenian: Občasno so pri bolnikih, ki so prejemali močno kemoterapijo po avtologni presaditvi kostnega mozga, poročali o boleznih srca in ožilja, vključno z okluzivno boleznijo ven in nepravilnostmi v pretoku krvi.
English: EU/1/08/450/003 2 x 5 pre-filled syringes
Slovenian: ŠTEVILKA (E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/08/450/003 2 x 5 napolnjenih injekcijskih brizg
English: During intermittent dosing with 30 MIU (300 μg)/day of filgrastim, there can be wide fluctuations in the patient's ANC over time.
Slovenian: (300 μg)/dan, so čez čas lahko opazna velika nihanja v absolutnem številu nevtrofilcev.
English: Diluted filgrastim may be adsorbed to glass and plastic materials except diluted, as mentioned below.
Slovenian: Če ni razredčen v skladu s spodnjimi navodili, se razredčen filgrastim lahko adsorbira na steklene in plastične materiale.
English: Special precautions in sickle cell disease
Slovenian: Posebni previdnostni ukrepi pri bolnikih s srpasto anemijo
English: EXP After dilution use within 24 hours.
Slovenian: Po redčenju je zdravilo uporabno še 24 ur.
English: Hold the syringe and gently take the cover from the needle without twisting.
Slovenian: Pred injiciranjem zdravila Biograstim morate narediti naslednje: Primite injekcijsko brizgo ter nežno in brez sukanja potegnite pokrovček z igle.
English: Special precautions in cancer patients Leukocytosis
Slovenian: Posebni previdnostni ukrepi pri bolnikih z rakom
English: EXPIRY DATE
Slovenian: Pogosti diareja
English: Initial dose adjustment to alternate day dosing with 30 MIU (300 μg)/day by subcutaneous injection is recommended.
Slovenian: Priporoča se prilagoditev dnevnega odmerka v vrednosti 30 x 106i.e.
English: Your doctor will test your blood daily to see how well the treatment is working and to find the dose that is best for you.
Slovenian: Zato da bi ugotovil, kako dobro deluje zdravljenje in kakšen odmerek je najbolj primeren za vas, bo vaš zdravnik vsak dan analiziral vašo kri.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION
Slovenian: ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET Z ZDRAVILOM
English: In patients with severe chronic neutropenia (SCN) Congenital neutropenia
Slovenian: Posebni previdnostni ukrepi pri bolnikih s hudo kronično nevtropenijo
English: Neutrophil count
Slovenian: Število nevtrofilcev
English: Do not attempt to self-administer without this training.
Slovenian: Brez napotkov zdravnika ali sestre si ne poskušajte zdravila odmeriti sami.
English: Consideration should be given to intermittent cessation or decreasing the dose of filgrastim in patients who develop thrombocytopenia, i.e. platelets consistently < 100,000/mm
Slovenian: Pri bolnikih, pri katerih pride do trombocitopenije, kar pomeni, da je število trombocitov stalno < 100.000/mm3, je potrebno razmisliti o začasni prekinitvi zdravljenja ali o zmanjšanju odmerka filgrastima.
English: The recommendation of a minimum yield of 2.0 x 10
Slovenian: Priporočen začetni odmerek je 1,2 x 106i.e.
English: Water for injections
Slovenian: Napolnjena injekcijska brizga
English: Urinary abnormalities
Slovenian: Kongenitalna nevtropenija
English: 9/L during the treatment period the dose of filgrastim should be reescalated according to the above steps
Slovenian: Če se med zdravljenjem absolutno število nevtrofilcev zmanjša, tako da je vrednost < 1,0 x 109/l, je treba odmerek filgrastima povečati, kot je opisano zgoraj.
English: Filgrastim should be administered daily by subcutaneous injection until the neutrophil count has
Slovenian: Filgrastim je potrebno odmerjati dnevno v obliki subkutanih injekcij, dokler število nevtrofilcev ne doseže in ostane večje od 1,5 x 109/l.
English: Meta-analysis a
Slovenian: 1986-2001a
English: Transient thrombocytopenia (platelets < 100 x 10 leukapheresis was observed in 35 % of subjects studied.
Slovenian: Levkocitozo (število belih krvničk > 50 x 109/l) so opazili pri 41 % darovalcev, prehodno trombocitopenijo (število trombocitov < 100 x 109/l) pa pri 35 % darovalcev po odmerjanju filgrastima in po levkaferezi.
English: Vascular disorders
Slovenian: Navodila za samoinjiciranje
English: Transformation to leukaemia or myelodysplastic syndrome
Slovenian: Neželeni učinek anemija, splenomegalija trombocitopenija
English: 9/L to > 5.0 x 10
Slovenian: Zmanjšajte na 0,5 x 106i.e.
English: Your doctor will decide how many days treatment is needed.
Slovenian: Zdravnik bo odločil koliko dni zdravljenja potrebujete.
English: An updated RMP should be submitted:
Slovenian: Posodobljen RMP je treba predloţ iti:
English: Resistant (R >)
Slovenian: Odporen (R >)
English: • If you are a child or growing adolescent below 18 years of age.
Slovenian: • Če ste otrok ali mladostnik, mlajši od 18 let.
English: There is limited experience in patients aged > 75 years.
Slovenian: Izkušnje pri bolnikih, starih> 75 let, so omejene.
English: • Feeling tired
Slovenian: • občutek utrujenosti
English: This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Slovenian: Zdravila se ne sme mešati z drugimi zdravili, razen s tistimi, ki so omenjena v poglavju 6.6.
English: • Change in taste
Slovenian: • spremembe v okusu
English: The total duration of treatment is 5 to 14 days.
Slovenian: Celotno trajanje zdravljenja je od 5 do 14 dni.
English: Clinical efficacy against specific pathogens
Slovenian: Klinična učinkovitost proti specifičnim patogenim organizmom
English: Frequencies are defined as: 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).
Slovenian: Pogostnosti so opredeljene kot: 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).
English: (Any unused portion of the reconstituted solution should be discarded).
Slovenian: (Neuporabljen del rekonstituirane razopine je potrebno zavreči).
English: Each infusion will last about an hour.
Slovenian: Vsaka aplikacija infuzije bo trajala pribliţ no eno uro.
English: • Blood in urine
Slovenian: • kri v urinu
English: If less than 8 hours remain before the next dose, wait until the next scheduled dose.
Slovenian: Če je manj kot 8 ur do naslednjega odmerka, počakajte do naslednjega odmerka.
English: • Ringing or buzzing in the ears (tinnitus)
Slovenian: • zvenenje ali piskanje v ušesih (tinitus)
English: • You have diabetes.
Slovenian: • imate sladkorno bolezen.