FrancophonIA/ELRC3.0 huggingface dataset:
English: Thus, the concomitant use of medicinal products that have been associated with renal toxicity and those eliminated by tubular secretion such as NSAIDs, amphotericin B, methotrexate, aminosides, organoplatines, foscarnet, pentamidine, cyclosporin, tacrolimus, acyclovir and valganciclovir, should be avoided particularly during the 5 day clofarabine administration period (see sections 4.4, 4.8 and 5.2).
Slovenian: Klofarabin se izloča pretežno skozi ledvice, zato se je treba izogibati sočasni uporabi zdravil, ki so povezana s toksičnim učinkom na ledvice, in zdravil, ki se izločajo s tubularno sekrecijo, kot so nesteroidna protivnetna zdravila (NSAIDs), amfotericin B, metotreksat, aminoglikozidi, organske spojine s platino, foskarnet, pentamidin, ciklosporin, takrolimus, aciklovir in valganciklovir, zlasti med 5-dnevnim obdobjem odmerjanja klofarabina (glejte poglavja 4.4, 4.8 in 5.2).
English: Common: Weight decreased
Slovenian: Pogosti: znižanje telesne mase
English: A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturer responsible for batch release
Slovenian: A. IZDELOVALEC, ODGOVOREN ZA SPROŠČANJE SERIJE
English: Suggested dilution schedule based on the recommended dosage of 52 mg/m2/day clofarabine
Slovenian: Predlagane razredčitve za priporočeni odmerek 52 mg klofarabina/m2/dan
English: One patient discontinued treatment due to grade 4 hyperbilirubinaemia considered as related to clofarabine after receiving 52 mg/m2/day clofarabine.
Slovenian: Zdravljenje je bilo prekinjeno pri enem bolniku, potem ko se je po prejemanju odmerka klofarabina 52 mg/m2/dan razvila hiperbilirubinemija 4. stopnje, ki naj bi bila povezana s klofarabinom.
English: Warnings and precautions Tell your doctor if any of these apply to you.
Slovenian: Obvestite zdravnika, če kar koli od tega velja za vas.
English: Very common: Flushing* Common: Hypotension*, capillary leak syndrome, haematoma
Slovenian: Pogosti: hipotenzija*, sindrom kapilarnih razpok, hematom
English: (6.1 to -)
Slovenian: (6,1 do -)
English: What Ivozall contains
Slovenian: Kaj vsebuje zdravilo Ivozall
English: 200 ml *Each ml of concentrate contains 1 mg of clofarabine.
Slovenian: 200 ml * Vsak ml koncentrata vsebuje 1 mg klofarabina.
English: These effects included bilateral degeneration of the seminiferous epithelium with retained spermatids and atrophy of interstitial cells in rats at exaggerated exposure levels (150 mg/m2/day), and cell degeneration of the epididymis and degeneration of the seminiferous epithelium in dogs at clinically relevant exposure levels (≥ 7.5 mg/m2/day clofarabine).
Slovenian: Med njimi je bila bilatelarna degeneracija seminifernega epitela z zadržanjem spermatid in atrofija intersticialnih celic pri podganah pri pretirani izpostavljenosti (150 mg/m2/dan)
English: The patients were enrolled into a single phase I (n = 12) or two phase II (n = 14 / n = 14) safety and efficacy studies, and received multiple doses of clofarabine by intravenous infusion (see section 5.1).
Slovenian: Bolniki so sodelovali v eni študiji varnosti in učinkovitosti I. faze (n = 12) ali dveh študijah varnosti in učinkovitosti II.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Ivozall 1 mg/ml sterile concentrate clofarabine
Slovenian: IME ZDRAVILA IN POT(I) UPORABE Ivozall 1 mg/ml sterilni koncentrat klofarabin intravenska uporaba po redčenju
English: Ivozall 1 mg/ml concentrate for solution for infusion must be diluted prior to administration.
Slovenian: Zdravilo Ivozall 1 mg/ml koncentrat za raztopino za infundiranje je treba pred uporabo razredčiti.
English: Bleeding events have been observed in the setting of thrombocytopaenia.
Slovenian: Ob pojavu trombocitopenije so opažali krvavitve.
English: amphotericin B); - any other medicines including those obtained without a prescription.
Slovenian: - katero koli zdravilo, tudi če ste ga dobili brez recepta.
English: Therefore, clofarabine should be used with caution in patients with mild to moderate hepatic impairment (see sections 4.2 and 4.3).
Slovenian: Zato je treba klofarabin pri bolnikih z blago do zmerno okvaro jeter uporabljati previdno (glejte poglavji 4.2 in 4.3).
English: Driving and using machines Do not drive or use any tools or machines if you feel dizzy, light-headed or faint.
Slovenian: Če imate omotico, vrtoglavico ali omedlevico, ne vozite avtomobila in ne upravljajte orodij ali strojev.
English: You need to allow for this if you are on a controlled sodium diet.
Slovenian: Če ste na dieti z nadzorovanim vnosom natrija,
English: Clofarabine must be discontinued for exfoliative or bullous rash, or if SJS or TEN is suspected.
Slovenian: Ob nastanku eksfolativnih ali buloznih izpuščajev ali če se sumi na SJS ali TEN, je treba z zdravljenem s klofarabinom prenehati.
English: Common: Pain in extremity, myalgia, bone pain, chest wall pain, arthralgia, neck and back pain
Slovenian: Pogosti: bolečina v okončinah, mialgija, bolečina v kosteh, bolečina v prsni steni, artralgija, bolečina v vratu in hrbtu
English: Therefore, a safe and effective dosage recommendation for patients < 1 year old has yet to be established.
Slovenian: Podatkov o farmakokinetiki, varnosti in učinkovitosti klofarabina pri dojenčkih ni. Varna in učinkovita priporočila za odmerjanje pri bolnikih, starih < 1 leto, je treba še ugotoviti.
English: Infectious events
Slovenian: Dogodki, povezani z okužbami
English: NAME OF THE MEDICINAL PRODUCT Ivozall 1 mg/ml concentrate for solution for infusion
Slovenian: IME ZDRAVILA Ivozall 1 mg/ml koncentrat za raztopino za infundiranje
English: A multi-centre, phase II, open-label, non-comparative study of clofarabine was conducted to determine the overall remission (OR) rate in heavily pretreated patients (≤ 21 years old at initial diagnosis) with relapsed or refractory ALL defined using the French-American-British classification.
Slovenian: Za določanje stopnje skupne remisije (SR) pri bolnikih, ki so prejemali intenzivno predhodno zdravljenje (starih ≤ 21 let ob prvi diagnozi) s ponovljeno ali neodzivno ALL, opredeljeno po francosko-ameriško-britanski klasifikaciji, so opravili večcentrično, odprto, neprimerjalno študijo klofarabina 2. faze.
English: Therefore, clofarabine should be used with caution in patients with mild to moderate renal insufficiency (see section 4.2 for dose adjustments).
Slovenian: Zato je treba klofarabin pri bolnikih z blago do zmerno okvarjenimi ledvicami uporabljati previdno (glejte poglavje 4.2 za prilagoditev odmerka).
English: - feeling numb or weak in the arms and legs, numbness of the skin, sleepiness, dizziness, tremor; - hearing problems; - water collecting around the heart, fast heartbeat; - low blood pressure, lump due to bad bruising; - leaking from tiny blood vessels, rapid breathing, nosebleeds, breathing difficulties,
Slovenian: - občutek žeje in temnejši urin kot navadno, manj urina kot navadno, zmanjšan apetit ali izguba apetita, izguba telesne mase; - agitacija, razdražljivost ali nemir; - občutek otrplosti ali šibkosti v rokah in nogah, otrplost kože, zaspanost, omotica, drhtenje; - težave s sluhom; - nabiranje vode okoli srca, hitro bitje srca; - nizek krvni tlak, otekline zaradi hudih modric; - krvavitve iz majhnih žil, hitro dihanje, krvavitve iz nosu, težave pri dihanju, zasoplost, kašelj;
English: Ivozall 1 mg/ml concentrate for solution for infusion clofarabine
Slovenian: Ivozall 1 mg/ml koncentrat za raztopino za infindiranje klofarabin
English: Therefore, clofarabine is contraindicated in patients with severe hepatic impairment (see section 4.3) and should be used with caution in patients with mild to moderate hepatic impairment (see section 4.4).
Slovenian: Zato je uporaba klofarabina pri bolnikih s hudo okvaro jeter kontraindicirana (glejte poglavje 4.3), pri bolnikih z blago do zmerno okvaro jeter pa ga je treba uporabljati previdno (glejte poglavje 4.4).
English: If a patient experiences one or more severe toxicities (US National Cancer Institute (NCI) Common Toxicity Criteria (CTC) Grade 3 toxicities excluding nausea and vomiting), treatment should be delayed until the toxicities resolve to baseline parameters or to the point where they are no longer severe and the potential benefit of continued treatment with clofarabine outweighs the risk of such continuation.
Slovenian: Institute) v ZDA, z izjemo navzee in bruhanja), je treba zdravljenje prestaviti, dokler se toksični učinki ne vrnejo na izhodiščne parametre ali do točke, ko niso več hudi in ko je morebitna korist nadaljevanja zdravljenja s klofarabinom večja od tveganja.
English: Any patient who experiences a severe toxicity on a third occasion, a severe toxicity that does not recover within 14 days (see above for exclusions), or a life-threatening or disabling toxicity (US NCI CTC Grade 4 toxicity) should be withdrawn from treatment with clofarabine (see section 4.4).
Slovenian: Pri bolnikih, pri katerih se tudi tretjič pojavijo hudi toksični učinki, ki se ne izboljšajo v 14 dneh (glejte izjeme zgoraj), ali življenje ogrožujoči ali onesposabljajoči toksični učinki (4. stopnje po CTC
English: Adverse reactions are listed by system organ class and frequency (very common (≥ 1/10); common
Slovenian: V spodnji tabeli so neželeni učinki navedeni po organskih sistemih in pogostnosti (zelo pogosti
English: Twenty-three patients out of 115 experienced a vascular disorder considered to be related to clofarabine, the most frequently reported being flushing (13 events; not serious) and hypotension (5 events; all of which were considered to be serious; see section 4.4).
Slovenian: Najpogosteje so poročali o oblivanju (13 dogodkov; niso bili resni) in hipotenziji (5 dogodkov; vsi so bili ocenjeni kot resni; glejte poglavje 4.4).
English: CRp
Slovenian: PRt
English: Renal clearance
Slovenian: Ledvični očistek
English: Stevens - Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), including fatal cases, have been reported in patients who were receiving or had recently been treated with clofarabine.
Slovenian: Pri bolnikih, ki so prejemali ali so bili pred kratkim zdravljeni s klofarabinom, so poročali o StevensJohnsonovem sindromu (SJS) in toksični epidermalni nekrolizi (TEN) vključno s smrtnimi primeri.
English: Increases in postimplantation loss, reduced foetal body weights and decreased litter sizes together with increases in the number of malformations (gross external, soft tissue) and skeletal alterations (including retarded ossification) were reported in rats receiving doses which produced approximately 2 to 3 fold the clinical exposure (54 mg/m2/day) and in rabbits receiving 12 mg/m2/day clofarabine.
Slovenian: 12 mg klofarabina/m2/dan, so poročali o povečanju postimplantacijske izgube, zmanjšanju telesne mase ploda in zmanjšanju velikosti mladičev, skupaj s povečanjem števila malformacij (zunanje, mehka tkiva) ter spremembami na skeletu (vključno z zaostalo osifikacijo).
English: Very common (may affect more than 1 in 10 people): - anxiety, headache, fever, tiredness; - feeling and being sick, diarrhoea (loose bowels); - flushing, itching and inflamed skin, inflammation of mucus (moist) linings such as the mouth and other areas; - you may have more infections than normal because Ivozall can lower the number of certain types of blood cells in your body; - skin rashes which may be itchy, red, painful or peeling skin including palms of the hands and soles of the feet, or small reddish or purple spots underneath the skin.
Slovenian: morda boste imeli več okužb kot navadno, ker zdravilo Ivozall lahko zmanjša število določenih vrst krvnih celic v telesu; kožni izpuščaji, ki so lahko srbeči, rdeči, boleči, ali luščenje kože na dlaneh in podplatih ali majhne rdečkaste ali vijolične pike pod kožo.
English: Capillary leak syndrome cases reported during the post-marketing period have been associated with a fatal outcome (See section 4.4).
Slovenian: Primeri sindroma kapilarne krvavitve med spremljanjem zdravila po dajanju le tega v promet so bili povezani s smrtnim izidom (glejte poglavje 4.4).
English: Cases of hepatitis and hepatic failure, including fatal outcomes, have been reported with clofarabine treatment (see section 4.8).
Slovenian: Med zdravljenjem s klofarabinom so bili opisani primeri hepatitisa in odpovedi jeter, vključno s smrtnimi izidi (glejte poglavje 4.8).
English: Common: Hyperbilirubinaemia, jaundice, veno-occlusive disease, increases in alanine (ALT)* and aspartate (AST)* aminotransferases, hepatic failure Uncommon: Hepatitis
Slovenian: tiflitis Bolezni jeter, žolčnika in žolčevodov Pogosti: hiperbilirubinemija, zlatenica, venookluzivna bolezen, povečanje vrednosti alanin- (ALT)* in aspartat
English: Hepatic effects were observed in rats following chronic administration of clofarabine.
Slovenian: Pri podganah so po kroničnem odmerjanju klofarabina opazili učinke na jetra.
English: How to store Ivozall
Slovenian: Shranjevanje zdravila Ivozall
English: Overall remission (OR) Rate
Slovenian: Stopnja skupne remisije (SR)
English: Do not use Ivozall - - if you are allergic to clofarabine or any of the other ingredients of this medicine (listed in section 6); - if you are breast-feeding (please read the section “Pregnancy and breast-feeding” below); - if you have severe kidney or liver problems.
Slovenian: - če dojite (prosimo, preberite poglavje Nosečnost in dojenje spodaj); - če imate hude težave z ledvicami ali jetri.
English: Adverse reactions considered to be related to clofarabine reported at frequencies ≥ 1/1,000 (i.e. in > 1/115 patients) in clinical trials and post-marketing
Slovenian: Neželeni učinki, za katere so v kliničnih preskušanjih in v obdobju trženja ocenili, da so povezani z uporabo klofarabina in so o njih poročali s pogostnostjo ≥ 1/1.000
English: There is no experience in patients with hepatic impairment (serum bilirubin > 1.5 x ULN plus AST and ALT > 5 x ULN) and the liver is a potential target organ for toxicity.
Slovenian: Ni izkušenj z uporabo pri bolnikih z okvaro jeter (serumski bilirubin > 1,5 x ULN plus AST in ALT
English: Clofarabine is contraindicated in patients with severe renal insufficiency (see section 4.3) and should be used with caution in patients with mild to moderate renal insufficiency (see section 4.4).
Slovenian: Uporaba klofarabina pri bolnikih s hudo okvarjenim ledvičnim delovanjem je kontraindicirana (glejte poglavje 4.3), pri bolnikih z blago do zmerno okvarjenim ledvičnim delovanjem pa ga je treba uporabljati previdno (glejte poglavje 4.4).
English: Pharmacokinetics in patients aged between 2 to 19 years old with relapsed or refractory ALL or AML following administration of multiple doses of clofarabine by intravenous infusion
Slovenian: Farmakokinetika pri bolnikih, starih od 2 do 19 let s ponovljeno ali neodzivno ALL ali AML
English: Plasma protein binding Serum albumin Elimination: β half-life of clofarabine
Slovenian: Vezava na beljakovine v plazmi Serumski albumin
English: Intravenous use after dilution.
Slovenian: Pred uporabo razredčite.
English: Common: Septic shock*, sepsis, bacteraemia, pneumonia, herpes zoster, herpes simplex, oral candidiasis
Slovenian: Pogosti: septični šok*, sepsa, bakteremija, pljučnica,
English: The liver is a potential target organ for clofarabine toxicity and 25.2% of patients experienced at least one hepato-biliary disorders adverse reaction (see sections 4.3 and 4.4).
Slovenian: Pri 25,2 % bolnikov je prišlo do vsaj enega neželenega učinka bolezni jeter, žolčnika in žolčevodov (glejte poglavji 4.3 in 4.4).
English: Common (may affect up to 1 in 10 people): - infections of the blood, pneumonia, shingles, implant infections, infections of the mouth such as thrush and cold sores; - changes in blood chemistry, changes in white blood cells; - allergic reactions; - feeling thirsty and producing darker or less urine than normal, decreased or loss of appetite,
Slovenian: - okužbe krvi, pljučnica, pasovec, okužbe vsadkov, okužbe v ustih, kot sta kandidoza in mehurčki na ustnicah; - spremembe v krvni sliki, spremembe v belih krvnih celicah; - alergijske reakcije;
English: Common: Maculo-papular rash, petechiae, erythema, pruritic rash, skin exfoliation, generalised rash, alopecia, skin hyperpigmentation, generalised erythema, erythematous rash, dry skin, hyperhidrosis Frequency not known: Stevens Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN)
Slovenian: Pogosti: makulo-papularni izpuščaj, petehije, eritem, srbeči izpuščaji, luščenje kože, generalizirani osip,
English: Occurrences of enterocolitis, including neutropaenic colitis, caecitis, and C. difficile colitis have been reported during treatment with clofarabine.
Slovenian: Med zdravljenjem s klofarabinom so poročali o pojavih enterokolitisa, vključno z nevtropeničnim kolitisom, tiflitisom in kolitisom zaradi C. difficile.
English: Clofarabine should be discontinued immediately if substantial increases in creatinine, liver enzymes and/or bilirubin are observed.
Slovenian: Če opazite znatno povečanje kreatinina, jetrnih encimov in/ali bilirubina, morate zdravljenje s klofarabinom takoj prekiniti;
English: Sodium chloride Water for injections
Slovenian: 6.1 Seznam pomožnih snovi natrijev klorid voda za injekcije
English: Tell your doctor or carer immediately if you experience any of the following as you may need to stop treatment: - if you get a fever or high temperature - because clofarabine reduces the number of blood cells made in the bone marrow, you may be more likely to catch infections; - if you have breathing difficulties, rapid breathing, or breathlessness; - if you feel a change in your heart rate; - if you suffer from dizziness (light-headedness) or fainting - it may be a symptom of low blood pressure; - if you feel sick or have diarrhoea (loose bowels); - if your urine is darker than usual - it is important to drink plenty of water to avoid dehydration; - if you get a rash with blisters or mouth ulcers; - if you lose your appetite, have nausea (feeling sick), vomiting, diarrhea, dark-colored urine and light-coloured stools, stomach pain, jaundice (yellowing of the skin and eyes), or if you feel generally unwell, these could be symptoms of an inflammation of the liver (hepatitis), or liver damage (hepatic failure); - if you pass little or no urine, or experience drowsiness, nausea, vomiting, breathlessness, loss of appetite and / or weakness (these may be signs of acute kidney failure / kidney failure).
Slovenian: - če se pojavi izpuščaj z mehurji ali razjede ustne sluznice; - če izgubite apetit, občutite slabost v želodcu (siljenje na bruhanje), bruhate, imate drisko, temen urin in svetlo blato, bolečine v trebuhu, zlatenico (porumenelost kože in očesnih beločnic), ali če se na splošno slabo počutite, so to lahko simptomi vnetja jeter (hepatitisa) ali okvare jeter
English: 6.4 Special precautions for storage
Slovenian: 6.4 Posebna navodila za shranjevanje Ne zamrzujte.
English: There is no experience in patients with hepatic impairment (serum bilirubin > 1.5 x ULN plus AST and ALT > 5 x ULN) and the liver is a potential target organ for toxicity (see sections 4.3 and 4.4).
Slovenian: plus AST in ALT > 5 x ULN) in jetra so potencialna tarča za toksične učinke (glejte poglavji 4.3 in 4.4).
English: Each ml contains 1 mg of clofarabine.
Slovenian: En ml koncentrata vsebuje 1 mg klofarabina.
English: Delayed ovarian atrophy or degeneration and uterine mucosal apoptosis were observed in female mice at the only dose used of 225 mg/m2/day clofarabine.
Slovenian: Pri mišjih samicah so pri edinem uporabljenem odmerku, 225 mg klofarabina/m2/dan, opazili zapoznelo atrofijo jajčnikov ali degeneracijo in apoptozo maternične sluznice.
English: Further treatment with clofarabine, generally at a lower dose, can be considered when patients are stabilised and organ function has returned to baseline.
Slovenian: Ko so bolniki stabilizirani in se delovanje organov vrne na izhodiščno vrednost, se lahko razmisli o nadaljevanju zdravljenja s klofarabinom, ponavadi z manjšimi odmerki.
English: Severe bone marrow suppression, including neutropaenia, anaemia and thrombocytopaenia have been observed in patients treated with clofarabine.
Slovenian: vključno z nevtropenijo, anemijo in trombocitopenijo.
English: Thus, the concomitant use of medicinal products that have been associated with hepatic toxicity should be avoided wherever possible (see sections 4.4 and
Slovenian: Jetra so potencialni tarčni organ za toksičnost, zato se je treba izogibati sočasni uporabi zdravil, ki so povezana s toksičnimi učinki na jetra, kadar koli je to mogoče (glejte poglavji 4.4 in 4.8).
English: If a patient experiences a hematologic toxicity of Grade 4 neutropaenia (ANC < 0.5 x 10
Slovenian: Če se pri bolniku pojavi hematološka toksičnost v obliki 4. stopnje nevtropenije (ANC <0,5 x 109/l), ki traja ≥ 4 tedne, potem zmanjšajte odmerek za 25 % pri naslednjem ciklu.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of concentrate contains 1 mg of clofarabine.
Slovenian: 200 ml * En ml koncentrata vsebuje 1 mg klofarabina.
English: Dose related toxicities on male reproductive organs were observed in mice, rats and dogs.
Slovenian: Pri miših, podganah in psih so opazili toksične učinke na moške reproduktivne organe, ki so bili odvisni od odmerka.
English: The active substance is clofarabine.
Slovenian: Učinkovina je klofarabin.
English: Sixty-eight patients (59%) experienced at least one serious clofarabine-related adverse event.
Slovenian: Vsaj en resen, s klofarabinom povezan neželeni dogodek, se je pojavil pri oseminšestdesetih bolnikih (59 %).
English: Very common: Vomiting, nausea, diarrhoea Common: Mouth haemorrhage, gingival bleeding, haematemesis, abdominal pain, stomatitis, upper abdominal pain, proctalgia, mouth ulceration Frequency not known: Pancreatitis elevations in serum amylase and lipase, enterocolitis, neutropenic colitis, caecitis
Slovenian: Pogostnost neznana: pankreatitis, povečanje amilaze in lipaze v serumu, enterokolitis, nevtropenični kolitis,
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each 20 ml vial contains 20 mg of clofarabine
Slovenian: Ena 20 ml viala vsebuje 20 mg klofarabina
English: Treatment failure
Slovenian: Neuspešno zdravljenje ni na voljo
English: weight loss; - agitation, irritability, or restlessness;
Slovenian: občutek slabosti in slabost, driska;
English: Your doctor will carry out regular blood tests to check whether your body is working properly; - liver damage (liver failure).
Slovenian: Zdravnik bo opravljal redne krvne preiskave, da bo preveril, ali telo deluje normalno; - okvara jeter (odpoved jeter); - malo ali nič urina, zaspanost, slabost, bruhanje, zasoplost, izguba apetita in/ali oslabelost (možni znaki akutne odpovedi ledvic ali odpovedi ledvic).
English: The recommended dose in monotherapy is 52 mg/m2 of body surface area administered by intravenous infusion over 2 hours daily for 5 consecutive days.
Slovenian: Otroci in mladostniki (≥ 1 leto) Priporočeni odmerek za monoterapijo je 52 mg/m2 telesne površine, dane v obliki intravenske infuzije;
English: - Keep this leaflet.
Slovenian: * = glejte spodaj
English: Ivozall contains the active substance clofarabine.
Slovenian: Kaj je zdravilo Ivozall in za kaj ga uporabljamo Zdravilo Ivozall vsebuje učinkovino klofarabin.
English: It should be visually inspected for particulate matter and discolouration prior to administration.
Slovenian: Raztopino pred uporabo vizualno preglejte in preverite, ali so v njej delci in ali je barva spremenjena.
English: Renal impairment
Slovenian: Žilne bolezni
English: What information is still awaited?
Slovenian: Kakšne informacije še lahko pričakujemo?
English: It should only be used once a flu pandemic has been officially declared by the World Health Organization (WHO) or European Union (EU).
Slovenian: Uporablja se samo, če je pandemijo gripe uradno razglasila Svetovna zdravstvena organizacija ali Evropska unija (EU).
English: There are some data supporting the use of half-doses (0.25 ml) in children three to nine years of age.
Slovenian: Nekateri podatki podpirajo uporabo polovičnih odmerkov (0,25 ml) pri otrocih, starih od tri do devet let.