natgillin/translations-raw huggingface dataset:
as monotherapy - in adult patients (particularly overweight patients) inadequately controlled by diet and exercise for whom metformin is in appropriate because of contraindications or intolerance as dual oral therapy in combination with - metformin, in adult patients (particularly overweight patients) with insufficient glycaemic control despite maximal tolerated dose of monotherapy with metformin 
kot dvojno peroralno zdravljenje v kombinaciji: - z metforminom pri odraslih bolnikih (predvsem bolnikih s prekomerno telesno maso) z nezadostnim nadzorom glikemije kljub najvišjemu toleriranemu odmerku metformina v monoterapiji - s sulfonilsečnino, le pri odraslih bolnikih, ki ne prenašajo metformina ali je metformin pri njih kontraindiciran, z nezadostnim nadzorom glikemije kljub najvišjemu toleriranemu odmerku sulfonilsečnine v monoterapiji.
Pioglitazone Accord may be used on its own in patients who are unable to take metformin, and where treatment with diet and exercise has failed to control blood sugar or may be added to other therapies (such as metformin, sulfonylurea or insulin) which have failed to provide sufficient control of blood sugar. 
Zdravilo Pioglitazone Accord se lahko uporablja kot samostojno zdravilo pri bolnikih, ki ne morejo jemati metformina, in ko zdravljenje z dieto in s telesno vadbo ni uspešno pri nadzoru krvnega sladkorja.
Respiratory, thoracic and mediastinal disorders dyspnoea common 
Bolezni dihal, prsnega koša in media-stinal nega prostora dispneja pogosti
Pioglitazone Accord should be used every day to work properly. 
Če ste prenehali jemati zdravilo Pioglitazone Accord Za pravilno delovanje morate zdravilo Pioglitazone Accord jemati vsak dan.
An increased incidence in bone fractures in women was seen in a pooled analysis of adverse reactions of bone fracture from randomised, controlled, double blind clinical trials in over 8100 pioglitazone and 7400 comparator treated patients, on treatment for up to 3.5 years. 
V skupni analizi neželenih učinkov zlomov kosti iz randomiziranih, nadzorovanih, dvojno slepih kliničnih preskušanj pri več kot 8.100 s pioglitazonom in 7.400 s primerjalnim zdravilom zdravljenimi bolniki, ki so se zdravili do 3,5 let, so opazili povečano incidenco zlomov kosti pri ženskah.
Other medicines and Pioglitazone Accord 
Shranjevanje zdravila Pioglitazone Accord
• Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached 
Poleg tega je treba posodobljen RMP predložiti: po prejemu novih informacij, ki lahko vplivajo na trenutne specifikacije varnosti zdravila, načrt farmakovigilance ali na dejavnosti za zmanjševanje tveganja, v 60 dneh po doseženem pomembnem mejniku (farmakovigilančnem ali povezanem z zmanjševanjem tveganja),
Allergic reactions have been reported (frequency cannot be estimated from the available data) in patients taking Pioglitazone Accord. 
Pri bolnikih, ki so jemali zdravilo Pioglitazone Accord, so poročali o alergijskih reakcijah (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti).
If you get any side effects, talk to your doctor, pharmacist. 
Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom ali s farmacevtom.
Pioglitazone Accord tablets contain lactose monohydrate and therefore should not be administered to patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucosegalactose malabsorption. 
Bolniki z redko dedno intoleranco za galaktozo, laponsko obliko zmanjšane aktivnosti laktaze ali malabsorpcijo glukoze/galaktoze ne smejo jemati tega zdravila.
Bladder cancer has been experienced uncommonly (may affect up to 1 in 100 people) in patients taking Pioglitazone Accord. 
Pri bolnikih, ki so jemali zdravilo Pioglitazone Accord, so občasno (pri največ 1 od 100 bolnikov) poročali o pojavu raka sečnega mehurja.
EU/1/11/722/001-010 (14/28/30/50/56/84/90/98/112/196 tablets in alu/alu blister) EU/1/11/722/011-020 (14/28/30/50/56/84/90/98/112/196 tablets in alu/alu blister) EU/1/11/722/021-030 (14/28/30/50/56/84/90/98/112/196 tablets in alu/alu blister) 
EU/1/11/722/001-010 (14/28/30/50/56/84/90/98/112/196 Tableta alu/alu Pretisni omot) EU/1/11/722/011-020 (14/28/30/50/56/84/90/98/112/196 Tableta alu/alu Pretisni omot) EU/1/11/722/021-030 (14/28/30/50/56/84/90/98/112/196 Tableta alu/alu Pretisni omot)
• Pioglitazone Accord 45 mg tablets are white to off white, flat, round uncoated tablets with beveled edges debossed with ‘PIO' on one side and ‘45' on the other side. 
- Pioglitazone Accord 45 mg tablete so bele ali skoraj bele barve, ploščate, okrogle, neobložene tablete s poševnim robom, z oznako ‘PIO' na eni in ‘45' na drugi strani.
Take Pioglitazone Accord daily as prescribed. 
Če ste pozabili vzeti zdravilo Pioglitazone Accord Zdravilo Pioglitazone Accord jemljite vsak dan, kakor vam je predpisano.
Blurred vision due to swelling (or fluid) at the back of the eye (frequency cannot be estimated from the available data) has also been reported in patients taking Pioglitazone Accord. 
Pri bolnikih, ki so jemali zdravilo Pioglitazone Accord, so poročali tudi o zamegljenem vidu zaradi otekanja (ali tekočine) očesnega ozadja (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti).
Pioglitazone Accord 15 mg tablets Each tablet contains 15 mg of pioglitazone (as hydrochloride). 
Pioglitazone Accord 15 mg tablete Ena tableta vsebuje 15 mg pioglitazona (v obliki pioglitazonijevega klorida).
The tablets are white to off white, round, biconvex, uncoated tablets debossed with ‘P' on one side and ‘15' on other side. 
Tablete so bele ali skoraj bele barve, okrogle, bikonveksne, neobložene tablete, z oznako 'P' na eni in '15' na drugi strani.
Localised swelling (oedema) has also been experienced very commonly (may affect more than 1 in 10 people) in patients taking Pioglitazone Accord in combination with insulin. 
Pri bolnikih, ki so jemali zdravilo Pioglitazone Accord v kombinaciji z insulinom, so zelo pogosto (pri več kot 1 od 10 bolnikov) poročali o lokalnem otekanju (edemih).
• Each Pioglitazone Accord 30 mg tablet contains 30 mg of pioglitazone (as hydrochloride). 
- Ena tableta zdravila Pioglitazon Accord 30 mg tablete vsebuje 30 mg pioglitazona (v obliki pioglitazonijevega klorida).
• Pioglitazone Accord 30 mg tablets are white to off white, flat, round uncoated tablets with beveled edges debossed with ‘PIO' on one side and ‘30' on the other side. 
- Pioglitazone Accord 30 mg tablete so bele ali skoraj bele barve, ploščate, okrogle, neobložene tablete s poševnim robom, z oznako ‘PIO' na eni in ‘30' na drugi strani.
If you stop using Pioglitazone Accord, your blood sugar may go up. 
Če zdravilo Pioglitazone Accord prenehate jemati, se lahko raven krvnega sladkorja zviša, zato se pred prekinitvijo zdravljenja najprej posvetujte z zdravnikom.
The tablets are white to off white, flat, round uncoated tablets with beveled edges debossed with ‘PIO' on one side and ‘45' on the other side. 
Tablete so bele ali skoraj bele barve, ploščate, okrogle, neobložene tablete s poševnim robom, z oznako ‘PIO' na eni in ‘45' na drugi strani
If you stop taking Pioglitazone Accord 
Ne jemljite zdravila Pioglitazone Accord
EU/1/11/722/021 14 tablets EU/1/11/722/022 28 tablets EU/1/11/722/023 30 tablets EU/1/11/722/024 50 tablets EU/1/11/722/025 56 tablets EU/1/11/722/026 84 tablets EU/1/11/722/027 90 tablets EU/1/11/722/028 98 tablets EU/1/11/722/029 112 tablets EU/1/11/722/030 196 tablets 
EU/1/11/722/021 14 tablet EU/1/11/722/022 28 tablet EU/1/11/722/023 30 tablet EU/1/11/722/024 50 tablet EU/1/11/722/025 56 tablet EU/1/11/722/026 84 tablet EU/1/11/722/027 90 tablet EU/1/11/722/028 98 tablet EU/1/11/722/029 112 tablet EU/1/11/722/030 196 tablet
The tablets are white to off white, flat, round uncoated tablets with beveled edges debossed with ‘PIO' on one side and ‘30' on the other side. 
Tablete so bele ali skoraj bele barve, ploščate, okrogle, neobložene tablete s poševnim robom, z oznako ‘PIO' na eni in ‘30' na drugi strani
EU/1/11/722/001 14 tablets EU/1/11/722/002 28 tablets EU/1/11/722/003 30 tablets EU/1/11/722/004 50 tablets EU/1/11/722/005 56 tablets EU/1/11/722/006 84 tablets EU/1/11/722/007 90 tablets EU/1/11/722/008 98 tablets EU/1/11/722/009 112 tablets EU/1/11/722/010 196 tablets 
EU/1/11/722/001 14 tablet EU/1/11/722/002 28 tablet EU/1/11/722/003 30 tablet EU/1/11/722/004 50 tablet EU/1/11/722/005 56 tablet EU/1/11/722/006 84 tablet EU/1/11/722/007 90 tablet EU/1/11/722/008 98 tablet EU/1/11/722/009 112 tablet EU/1/11/722/010 196 tablet
EU/1/11/722/011 14 tablets EU/1/11/722/012 28 tablets EU/1/11/722/013 30 tablets EU/1/11/722/014 50 tablets EU/1/11/722/015 56 tablets EU/1/11/722/016 84 tablets EU/1/11/722/017 90 tablets EU/1/11/722/018 98 tablets EU/1/11/722/019 112 tablets EU/1/11/722/020 196 tablets 
EU/1/11/722/011 14 tablet EU/1/11/722/012 28 tablet EU/1/11/722/013 30 tablet EU/1/11/722/014 50 tablet EU/1/11/722/015 56 tablet EU/1/11/722/016 84 tablet EU/1/11/722/017 90 tablet EU/1/11/722/018 98 tablet EU/1/11/722/019 112 tablet EU/1/11/722/020 196 tablet
• Each Pioglitazone Accord 45 mg tablet contains 45 mg of pioglitazone (as hydrochloride). 
- Ena tableta zdravila Pioglitazon Accord 30 mg tablete vsebuje 45 mg pioglitazona (v obliki pioglitazonijevega klorida).
• Each Pioglitazone Accord 15 mg tablet contains 15 mg of pioglitazone (as hydrochloride). 
- Ena tableta zdravila Pioglitazon Accord 15 mg tablete vsebuje 15 mg pioglitazona (v obliki pioglitazonijevega klorida).
• Pioglitazone Accord 15 mg tablets are white to off white, round, biconvex, uncoated tablets debossed with ‘P' on one side and ‘15' on other side. 
Izgled zdravila Pioglitazone Accord in vsebina pakiranja - Pioglitazon Accord 15 mg tablete so bele do sivo bele barve, okrogle, bikonveksne, neobložene tablete, z oznako ‘P' na eni in ‘15' na drugi strani.
Heart failure has been experienced commonly (may affect up to 1 in 10 people) in patients taking Pioglitazone Accord in combination with insulin. 
Pri bolnikih, ki so jemali zdravilo Pioglitazone Accord v kombinaciji z insulinom, so pogosto (pri največ 1 do 10 bolnikov) poročali o pojavu srčnega popuščanja.
Nervous system disorders hypo-aesthesia common common common common common headache common uncommon dizziness common insomnia uncommon uncommon uncommon uncommon uncommon 
Kombinacija z metfor-min om s sulfonil-seč nino z metfor-min om in sulfonil-seč nino z insulinom omotica pogosti nespečnost občasni občasni občasni občasni občasni
General disorders and administration site conditions 
Splošne težave in spremembe na mestu aplikacije Edem5
NAME OF THE MARKETING AUTHORISATION HOLDER Accord (Logo) 
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET Z ZDRAVILOM
*ITT = intention to treat. 
* ITT = namera zdravljenja (angl. intention to treat).
> 24 hours 
> 24 ur
Its antitumour activity is believed to be due to 3 mechanisms: 
Njegovo protitumorsko delovanje je zasnovano na treh mehanizmih:
Patients who met each of the following criteria: 
Bolniki, ki izpolnjujejo vsa naslednja merila:
The table below summarises the key efficacy results for this study. 
V tabeli spodaj je povzetek ključnih rezultatov učinkovitosti, pridobljenih v tej študiji.
Your doctor will give you Ivozall once every day for 5 days. 
Zdravnik vam bo dajal zdravilo Ivozall enkrat na dan 5 dni zaporedoma.
The infusion will be given over 2 hours. 
Infundiranje bo trajalo 2 uri.
Talk to your doctor about contraception. 
Posvetujte se z zdravnikom o kontracepciji.
However, there are no known clinically significant interactions with other medicinal products or laboratory tests. 
Vendar ni znanih klinično pomembnih interakcij z drugimi zdravili ali laboratorijskimi preiskavami.
It is important to drink plenty of water to avoid dehydration. 
Piti morate veliko vode, da bi preprečili dehidracijo.
After 24 hours, about 60% of the dose is excreted unchanged in the urine. 
Po 24 urah se približno 60 % odmerka izloči z urinom v nespremenjeni obliki.
(There are no exposure data in rabbits.) 
(Za kunce ni podatkov o izpostavljenosti.)
ITT* patients (n = 61) 
Bolniki ITT* (n = 61)
Estimated creatinine clearance (ml/min) 
Ocenjen kreatininski očistek (ml/min)
Children weighing < 20 kg 
Otroci, ki tehtajo < 20 kg
This means that because of the rarity of this disease it has been impossible to get complete information on the reference medicine. 
To pomeni, da zaradi redkosti bolezni ni bilo mogoče pridobiti vseh podatkov o referenčnem zdravilu.
MARKETING AUTHORISATION NUMBER EU/1/19/1396/001 
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/19/1396/001
Adverse reactions reported during the post-marketing period are also included in the table under the frequency category “not known” (cannot be estimated from the available data). 
Neželeni učinki, o katerih so poročali v obdobju trženja, so prav tako vključeni v spodnjo tabelo, pod kategorijo pogostnosti »neznana« (ni mogoče oceniti iz razpoložljivih podatkov).
See the section ‘Pregnancy and breast-feeding' below. 
Glejte poglavje »Nosečnost in dojenje« spodaj.
Estimates based on noncompartmental analysis (n = 14 / n = 14) 
Ocena, ki temelji na nekompartmentalni analizi (n = 14/n = 14)
If you (or your child) weigh less than 20 kg, the infusion time may be longer. 
Če tehtate manj kot 20 kg (ali če vaš otrok tehta manj kot 20 kg), lahko infundiranje traja dlje.
Your doctor will monitor your health and may change your dose depending on your response to the treatment. 
Zdravnik bo spremljal vaše zdravstveno stanje in lahko spremeni odmerek glede na vaš odziv na zdravljenje.
Body surface area must be calculated using the actual height and weight of the patient before the start of each cycle. 
Telesno površino je treba izračunati na podlagi dejanske višine in mase bolnika pred začetkom vsakega cikla.
Prophylactic anti-emetic medicinal products should be considered. 
Razmisliti je treba o profilaktičnih antiemetičnih zdravilih.
There are no data on the use of clofarabine in pregnant women. 
Ni podatkov o uporabi klofarabina pri nosečnicah.
At this time, treatment may be reinitiated at the full dose. 
Takrat lahko zdravljenje nadaljujemo s polnim odmerkom.
Do not use this medicine after the expiry date which is stated on the vial label and box after EXP. 
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki na viali in škatli poleg oznake »EXP«.
The excretion of clofarabine in milk has not been studied in animals. 
Izločanja klofarabina v mleko pri živalih niso raziskovali.
During treatment with Ivozall, your doctor will carry out regular blood tests and other tests to monitor your health. 
Med zdravljenjem z zdravilom Ivozall bo zdravnik opravljal redne krvne in druge preiskave, s katerimi bo spremljal vaše zdravstveno stanje.
Each box contains 1 vial. 
Vsaka škatla vsebuje 1 vialo.
Estimates based on other analysis 
Ocena, ki temelji na drugi analizi
Ivozall contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the EU. 
Zdravilo Ivozall vsebuje enako učinkovino in deluje na enak način kot “referenčno zdravilo“, ki je že pridobilo dovoljenje za promet v EU.
It is a clear colourless solution that is prepared and diluted before it is used. 
Je bistra, brezbarvna raztopina, ki jo je treba pred uporabo pripraviti in razredčiti.
(≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100; rare (≥ 1/10,000 to < 1/1,000) and very rare (< 1/10,000)) in the table below. 
(≥1/10), pogosti (≥1/100 do <1/10), občasni (≥1/1.000 do <1/100), redki (≥1/10.000 do <1/1.000) in zelo redki (<1/10.000).
It works by hindering the growth of abnormal white blood cells, and eventually kills them. 
Deluje tako, da ovira rast nenormalnih belih krvnih celic in jih sčasoma ubije.
This is usually reversible and appears to be dose-dependent. 
Ta je navadno reverzibilna in kaže, da je odvisna od odmerka.
The European Medicines Agency will review any new information on the reference medicine every year and any updates for the reference medicine will also be included as appropriate in the information for Ivozall, such as this leaflet. 
Evropska agencija za zdravila bo vsako leto pregledala vse nove podatke o referenčnem zdravilu, ki bodo na voljo, in kakršne koli posodobitve informacij o referenčnem zdravilu bodo vključene tudi v informacije za zdravilo Ivozall, npr. v to navodilo za uporabo.
Therefore, Ivozall should not be used during pregnancy, especially not during the first trimester, unless clearly necessary (i.e. only if the potential benefit to the mother outweighs the risk to the foetus). 
Zato se zdravilo Ivozall ne sme uporabljati med nosečnostjo, zlasti ne v prvem trimesečju, razen če je nujno potrebno (tj. samo, če koristi zdravljenja matere odtehtajo tveganje za plod).
This has occurred more frequently within 30 days of treatment, and in the setting of combination chemotherapy. 
Ta se je pogosteje pojavil v 30 dneh zdravljenja in v kombinaciji s kemoterapijo.
Acute lymphoblastic leukaemia is caused by abnormal growth of some types of white blood cells. 
Akutno limfoblastno levkemijo povzroča nenormalna rast nekaterih vrst belih krvnih celic.
Children < 1 year old 
Otroci, stari < 1 leto
Response category 
Kategorija odziva
**Patients alive and in remission at the time of last follow up were censored at that time point for the analysis. 
** Podatke o bolnikih, ki so bili ob času zadnjega sledenja živi in v remisiji, so ob času analize cenzurirali.
Before Ivozall is given to you, it will be diluted in a sodium chloride solution (salt and water). 
Preden vam bodo dali zdravilo Ivozall, ga bodo razredčili v raztopini natrijevega klorida (sol in voda).
Ivozall may harm both male and female reproductive organs. 
Zdravilo Ivozall lahko škodljivo vpliva na moške in ženske spolne organe.
Most of the cardiac adverse reactions were reported in the first 2 cycles. 
Večino neželenih učinkov, povezanih s srčnimi boleznimi, so poročali med prvima dvema cikloma.
• DNA polymerase α inhibition resulting in termination of DNA chain elongation and/or DNA synthesis / repair. 
• inhibicija DNA polimeraze α, zaradi katere pride do terminacije elongacije verige DNA in/ali sinteze/popravljanja DNA;
This is equivalent to 3.53% of the recommended maximum daily intake of sodium for an adult. 
To ustreza 3,53 % priporočenega največjega dnevnega vnosa natrija za odraslega.
CR + CRp + PR 18 
PR + PRt + DR 18
In this regard, patients should be closely monitored when clofarabine is used in combined regimens. 
Zato je treba bolnike skrbno spremljati, kadar je klofarabin uporabljen v kombiniranih režimih.
Tell your doctor if you are on a controlled sodium diet as it could affect how you will be given your medicine. 
Povejte zdravniku, če ste na dieti z nadzorovanim vnosom natrija, ker to lahko vpliva na način dajanja zdravila.
However, the majority of these hypotensive events were reported in patients who had confounding severe infections. 
O večini teh dogodkov hipotenzije so poročali pri bolnikih, ki so imeli mešane hude okužbe.
No carcinogenicity studies have been performed. 
Študij kancerogenosti niso opravili.
If you are pregnant or you become pregnant during treatment with clofarabine, get medical advice immediately. 
Če ste noseči ali med zdravljenjem s klofarabinom zanosite, se takoj posvetujte z zdravnikom.
The incidence of these toxicities was dependent on both the dose of clofarabine administered and the duration of treatment. 
Pogostost teh toksičnih učinkov je bila odvisna od odmerka klofarabina in trajanja zdravljenja.
As a result, it is not expected to affect the metabolism of active substances which are known substrates for these enzymes. 
Zato ni pričakovati, da bi vplival na presnovo učinkovin, za katere je znano, da so substrati teh encimov.
If you use more Ivozall than you should If you think you may have been given too much medicine, tell your doctor straight away. 
Če ste uporabili večji odmerek zdravila Ivozall, kot bi smeli Če menite, da so vam dali preveč zdravila, takoj povejte zdravniku.
• The use of prophylactic steroids (e.g., 100 mg/m2 hydrocortisone on Days 1 through 3) may be of benefit in preventing signs or symptoms of SIRS or capillary leak. 
• Uporaba profilaktičnih steroidov (npr. 100 mg/m2 hidrokortizona od 1. do 3. dne) lahko koristi pri preprečevanju znakov ali simptomov SIRS ali kapilarne krvavitve.
See section 2 “Ivozall contains sodium”. 
Glejte poglavje 2 »Zdravilo Ivozall vsebuje natrij«.
However, the final dilution volume may vary depending on the patient's clinical status and physician discretion. 
Končni volumen raztopine je lahko različen, glede na bolnikovo zdravstveno stanje in zdravnikovo odločitev.
Overall Survival (weeks) 
celokupno preživetje (tedni)
Ivozall must not be mixed with or concomitantly administered using the same intravenous line as other medicinal products (see section 6.2). 
Zdravilo Ivozall ne smete mešati ali ga sočasno dajati po isti intravenski liniji z drugimi zdravili (glejte poglavje 6.2).
Men must also use effective contraception while they or their partner are treated with clofarabine. 
Tudi moški morajo uporabljati učinkovito kontracepcijsko zaščito, kadar se s klofarabinom zdravijo oni ali njihova partnerka.
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C to 8°C unless dilution has taken place under controlled and validated aseptic conditions. 
Če se ne uporabi takoj, je uporabnik odgovoren za čas in pogoje shranjevanja pred uporabo, ti pa ne bi smeli trajati dlje kot 24 ur pri 2 °C do 8 °C, razen če se je redčenje izvedlo v nadzorovanih in preverjeno aseptičnih okoliščinah.
• Respiratory status, blood pressure, fluid balance and weight throughout and immediately after the 5 day clofarabine administration period. 
• respiratorni status, krvni tlak, ravnotežje tekočin in telesno maso ves čas 5-dnevnega obdobja dajanja klofarabina in takoj po njem.
It was also active against quiescent lymphocytes and macrophages. 
Učinkovit je bil tudi proti mirujočim limfocitom in makrofagom.
Dose excreted in urine 
Odmerek, izločen z urinom
Procedures for proper handling of antineoplastic agents should be observed. 
Upoštevati morate postopke za ustrezno ravnanje z antineoplastiki.
• Recovery of peripheral counts (platelets ≥ 100 x 109/l and ANC ≥ 1.0 x 109/l) 
• periferna obnovitev števila krvnih celic (trombociti ≥ 100 x 109/l in ANC ≥ 1,0 x 109/l)
It will be given to you as an infusion through a long thin tube which goes into a vein (a drip), or into a small medical appliance that is inserted under the skin (port-a-cath) if you (or your child) have one implanted. 
Dali vam ga bodo v obliki infuzije skozi dolgo, tanko cevko, ki vstopa v veno ali v majhno medicinsko napravo, ki je vstavljena pod kožo (»port-a-cath«), če jo imate vstavljeno vi ali vaš otrok.
Safety and efficacy have been assessed in studies of patients ≤ 21 years old at initial diagnosis (see section 5.1). 
Varnost in učinkovitost so ocenili v študijah na bolnikih, starih ≤ 21 let pri prvi diagnozi (glejte poglavje 5.1).
• Renal and hepatic function prior to, during active treatment and following therapy. 
• delovanje ledvic in jeter pred zdravljenjem, med aktivnim zdravljenjem in po njem.
Storage at low temperatures, i.e. below 15°C, might lead to formation of particles, which can be redissolved by letting the vial warm to room temperature and gentle swirling until all visible particles have dissolved. 
Med shranjevanjem pri nizki temperaturi, tj. pod 15 °C, lahko nastanejo delci, ki se lahko ponovno raztopijo, če pustite, da se viala segreje na sobno temperaturo, in jo nežno sukate, dokler se vsi vidni delci ne raztopijo.
• Patients who met all of the criteria for a CR except for recovery of platelet counts to > 100 x 109/l 
• Bolniki, ki izpolnjujejo vsa merila za PR, razen obnovitve števila trombocitov na > 100 x 109/l
Responses were seen in different immunophenotypes of ALL, including pre-B cell and T-cell. 
Odzive so videli pri vseh imunofenotipih ALL, vključno s pre-B- in T-celično.
The reference medicine for Ivozall has been authorised under ‘exceptional circumstances'. 
Referenčno zdravilo za zdravilo Ivozall je pridobilo dovoljenje za promet v »izjemnih okoliščinah«.