natgillin/translations-raw huggingface dataset:
In the pooled adolescent schizophrenia population (13 to 17 years) with exposure up to 2 years, incidence of low serum prolactin levels in females (< 3 ng/mL) and males (< 2 ng/mL) was 29.5 % and 48.3 %, respectively. 
V populaciji mladostnikov s shizofrenijo (13 do 17 let), ki so se zdravili do 2 leti, je bila pogostnost nizke ravni prolaktina v serumu pri ženskah (< 3 ng/ml) 29,5 % in pri moških (< 2 ng/ml) 48,3 %.
No cases of overdose associated with adverse reactions were reported in clinical studies with ABILIFY solution for injection. 
V kliničnih študijah z zdravilom ABILIFY raztopina za injiciranje niso poročali o primerih prevelikega odmerjanja, povezanimi z neželenimi učinki.
ABILIFY orodispersible tablets contain lactose. 
Orodisperzibilne tablete ABILIFY vsebujejo laktozo.
Each mL contains 1 mg of aripiprazole. 
En mililiter vsebuje 1 mg aripiprazola.
ABILIFY 15 mg orodispersible tablets Each orodispersible tablet contains 15 mg of aripiprazole. 
ABILIFY 15 mg orodisperzibilne tablete Ena orodisperzibilna tableta vsebuje 15 mg aripiprazola.
The oral solution contains sodium. 
Peroralna raztopina vsebuje natrij.
Excipient with known effect 62.18 mg lactose (as monohydrate) per tablet 
62,18 mg laktoze (v obliki monohidrata) na tableto ABILIFY 15 mg tablete
ABILIFY solution for injection contains sodium. 
Raztopina za injiciranje ABILIFY vsebuje natrij.
Rhabdomyolysis Myalgia 
Peroralna raztopina
Package leaflet: Information for the user ABILIFY 7.5 mg/mL solution for injection aripiprazole 
Navodilo za uporabo ABILIFY 7,5 mg/ml raztopina za injiciranje aripiprazol
Package leaflet: Information for the user ABILIFY 1 mg/mL oral solution aripiprazole 
Navodilo za uporabo ABILIFY 1 mg/ml peroralna raztopina aripiprazol
Aripiprazole is well absorbed when administered orally as the solution. 
Peroralno uporabljeni aripiprazol v obliki raztopine se dobro absorbira.
ABILIFY contains lactose 
Zdravilo ABILIFY vsebuje laktozo
Solution for injection Clear, colourless, aqueous solution. 
Bistra, brezbarvna, vodna raztopina.
Medicines that increase the level of serotonin are typically used in conditions including depression, generalised anxiety disorder, obsessive-compulsive disorder (OCD) and social phobia as well as migraine and pain: 
Zdravila, ki povečajo raven serotonina, navadno uporabljamo za bolezni, vključno z depresijo,
Aspiration pneumonia Laryngospasm Oropharyngeal spasm 
Bolezni dihal, prsnega koša in mediastinalnega prostora kolcanje aspiracijska pljučnica laringospazem orofaringealni spazem
Mouth dry 
Okvara jeter
Each orodispersible tablet contains 30 mg of aripiprazole. 
Ena orodisperzibilna tableta vsebuje 30 mg aripiprazola.
Kaplan-Meier relapse rates at week 16 were 35 % for aripiprazole and 52 % for placebo; the hazard ratio for relapse within 16 weeks (aripiprazole/placebo) was 0.57 (non-statistically significant difference). 
Razmerje ogroženosti za ponovitev v 16 tednih (aripiprazol/placebo) je bilo
Each tablet contains 30 mg of aripiprazole. 
Ena tableta vsebuje 30 mg aripiprazola.
Each tablet contains 5 mg of aripiprazole. 
Ena tableta vsebuje 5 mg aripiprazola.
The recommended dose for adults is 15 mL solution (corresponding to 15 mg aripiprazole) once a day. 
Priporočeni odmerek za odrasle je 15 ml raztopine (kar ustreza 15 mg aripiprazola) enkrat na dan, toda vaš zdravnik vam lahko predpiše odmerek, ki je manjši ali večji, do največ 30 mg (tj. 30 ml)
Hepatic failure Hepatitis Jaundice 
žolčnika in žolčevodov odpoved jeter hepatitis zlatenica
EU/1/04/276/030 (30 mg, 14 × 1 orodispersible tablets) EU/1/04/276/031 (30 mg, 28 × 1 orodispersible tablets) EU/1/04/276/032 (30 mg, 49 × 1 orodispersible tablets) 
EU/1/04/276/030 (30 mg, 14 × 1 orodisperzibilna tableta) EU/1/04/276/031 (30 mg, 28 × 1 orodisperzibilna tableta) EU/1/04/276/032 (30 mg, 49 × 1 orodisperzibilna tableta)
These medicines may increase the risk of side effects or reduce the effect of ABILIFY; if you get any unusual symptom taking any of these medicines together with ABILIFY you should see your doctor. 
Ta zdravila lahko povečajo tveganje za neželene učinke ali zmanjšajo učinek zdravila ABILIFY.
Each orodispersible tablet contains 15 mg of aripiprazole. 
Ena orodisperzibilna tableta vsebuje 15 mg aripiprazola.
Each orodispersible tablet contains 10 mg of aripiprazole. 
Ena orodisperzibilna tableta vsebuje 10 mg aripiprazola.
• diabetes mellitus, 
• epileptični krči,
3 mg aspartame (E 951) and 0.1125 mg lactose per orodispersible tablet 
3 mg aspartama (E 951) in 0,1125 mg laktoze na orodisperzibilno tableto ABILIFY 30 mg orodisperzibilne tablete Ena orodisperzibilna tableta vsebuje 30 mg aripiprazola.
In a 26-week, olanzapine-controlled, double-blind, multi-national study of schizophrenia which included 314 adult patients and where the primary endpoint was weight gain, significantly less patients had at least 7 % weight gain over baseline (i.e. a gain of at least 5.6 kg for a mean baseline weight of ~80.5 kg) on aripiprazole (n = 18, or 13 % of evaluable patients), compared to olanzapine (n = 45, or 33 % of evaluable patients). 
za vsaj 5,6 kg pri povprečni izhodiščni masi ~ 80,5 kg) značilno redkejše pri bolnikih, ki so dobivali peroralni aripiprazol, (n = 18 ali 13 % ocenljivih bolnikov) kot pri tistih, ki so dobivali peroralni olanzapin (n = 45 ali 33 % ocenljivih bolnikov).
In the paediatric bipolar population (10 to 17 years) with exposure up to 30 weeks, incidence of low serum prolactin levels in females (< 3 ng/mL) and males (< 2 ng/mL) was 28.0 % and 53.3 %, 
V pediatrični populaciji z bipolarno motnjo (10 do 17 let), ki so se zdravili do 30 tednov, je bila pogostnost nizke ravni prolaktina v serumu pri deklicah (< 3 ng/ml) 28,0 %, pri dečkih (< 2 ng/ml) pa
It may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine builds up because the body cannot remove it properly. 
Lahko vam škoduje, če imate fenilketonurijo, redko genetsko bolezen,
EU/1/04/276/024 (10 mg, 14 × 1 orodispersible tablets) EU/1/04/276/025 (10 mg, 28 × 1 orodispersible tablets) EU/1/04/276/026 (10 mg, 49 × 1 orodispersible tablets) 
EU/1/04/276/024 (10 mg, 14 × 1 orodisperzibilna tableta) EU/1/04/276/025 (10 mg, 28 × 1 orodisperzibilna tableta) EU/1/04/276/026 (10 mg, 49 × 1 orodisperzibilna tableta)
ABILIFY orodispersible tablets are supplied in perforated unit dose blisters packed in cartons containing 14 × 1, 28 × 1, or 49 × 1 orodispersible tablets. 
ABILIFY na voljo so v perforiranih pretisnih omotih v škatlah, ki vsebujejo po 14 × 1, 28 × 1 ali
The mean elimination half-lives for aripiprazole are approximately 75 hours in extensive metabolisers of CYP2D6 and approximately 146 hours in poor metabolisers of CYP2D6. 
Izločanje Pri osebah, ki dobro presnavljajo s CYP2D6 je srednji razpolovni čas izločanja aripiprazola približno
Disodium edetate 
PRETISNI OMOTI
ABILIFY 10 mg orodispersible tablets aripiprazole 
ABILIFY 10 mg orodisperzibilne tablete aripiprazol
Each tablet contains 15 mg of aripiprazole. 
Ena tableta vsebuje 15 mg aripiprazola.
ABILIFY orodispersible tablets contain sodium. 
Orodisperzibilne tablete ABILIFY vsebujejo natrij.
Each tablet contains 10 mg of aripiprazole. 
Ena tableta vsebuje 10 mg aripiprazola.
Tics associated with Tourette's disorder in paediatric patients (see section 4.2) The efficacy of aripiprazole was studied in paediatric subjects with Tourette's disorder (aripiprazole: n = 99, placebo: n = 44) in a randomised, double-blind, placebo controlled, 8 week study using a fixed dose weight-based treatment group design over the dose range of 5 mg/day to 20 mg/day and a starting dose of 2 mg. 
n = 99, placebo: n = 44) v 8-tedenski randomizirani, dvojno slepi, s placebom nadzorovani študiji, zasnovani z zdravljenimi skupinami, ki so prejemale nespremenjen odmerek glede na telesno maso posameznika v razponu od 5 mg/dan do 20 mg/dan, z začetnim odmerkom 2 mg. Bolniki so bili stari od 7 do 17 let, povprečni izhodiščni rezultat njihovega števila trzajev po skupni oceni resnosti trzajev na lestvici TTS-YYGTSS (angl. Total Tic Severity Score - Yale Global Tic Severity Scale) pa je bil
EU/1/04/276/027 (15 mg, 14 × 1 orodispersible tablets) EU/1/04/276/028 (15 mg, 28 × 1 orodispersible tablets) EU/1/04/276/029 (15 mg, 49 × 1 orodispersible tablets) 
EU/1/04/276/027 (15 mg, 14 × 1 orodisperzibilna tableta) EU/1/04/276/028 (15 mg, 28 × 1 orodisperzibilna tableta) EU/1/04/276/029 (15 mg, 49 × 1 orodisperzibilna tableta)
ABILIFY 15 mg orodispersible tablets aripiprazole 
ABILIFY 15 mg orodisperzibilne tablete aripiprazol
PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING 
PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI BESEDILO NA ŠKATLI IN PLASTENKI
In a pooled analysis on lipid parameters from placebo controlled clinical trials in adults, aripiprazole has not been shown to induce clinically relevant alterations in levels of total cholesterol, triglycerides, High Density Lipoprotein (HDL) and Low Density Lipoprotein (LDL). 
Vrednosti lipidov Združena analiza vrednosti lipidov v s placebom nadzorovanih kliničnih preskušanjih pri odraslih ni pokazala, da bi aripiprazol klinično pomembno spremenil vrednosti skupnega holesterola,
ABILIFY 10 mg orodispersible tablets 10 mg: Round and pink, marked with "A" over "640" on one side and "10" on the other. 
ABILIFY 10 mg orodisperzibilne tablete so okrogle oblike in roza barve, označene z '"A" nad "640"'
ABILIFY 1 mg/mL oral solution 
ABILIFY 1 mg/ml peroralna raztopina
ABILIFY 10 mg tablets Red iron oxide (E 172) 
ABILIFY 10 mg tablete rdeči železov oksid (E 172)
ABILIFY 30 mg orodispersible tablets aripiprazole 
ABILIFY 30 mg orodisperzibilne tablete aripiprazol
ABILIFY contains parahydroxybenzoates 
Zdravilo ABILIFY vsebuje parahidroksibenzoate
ABILIFY 30 mg orodispersible tablets Red iron oxide (E 172) 
ABILIFY 30 mg orodisperzibilne tablete rdeči železov oksid (E 172)
How to store ABILIFY 
Shranjevanje zdravila ABILIFY
6 mg aspartame (E 951) and 0.225 mg lactose per orodispersible tablet 
6 mg aspartama (E 951) in 0,225 mg laktoze na orodisperzibilno tableto Za celoten seznam pomožnih snovi glejte poglavje 6.1.
ABILIFY 10 mg orodispersible tablets Red iron oxide (E 172) 
ABILIFY 10 mg orodisperzibilne tablete rdeči železov oksid (E 172)
In intravenous reproductive toxicity studies, no new safety concerns were observed at maternal exposures up to 15 (rat) and 29 (rabbit) times human exposure at 30 mg. 
Pri izpostavljenosti mater, ki je bila 15krat (podgane) in 29-krat (kunčice) večja od izpostavljenosti človeka pri 30 mg odmerku pri študijah vplivov na sposobnost razmnoževanja po intravenskem dajanju niso ugotovili dodatnih težav glede varnosti.
Musculoskeletal and connective tissue disorders 
Bolezni mišično skeletnega sistema in vezivnega tkiva rabdomioliza mialgija togost
Manic episodes in Bipolar I Disorder in adolescents aged 13 years and older The frequency and type of adverse reactions in adolescents with Bipolar I Disorder were similar to those in adults except for the following reactions: very commonly (≥ 1/10) somnolence (23.0 %), extrapyramidal disorder (18.4 %), akathisia (16.0 %), and fatigue (11.8 %); and commonly (≥ 1/100, < 1/10) abdominal pain upper, heart rate increased, weight increased, increased appetite, muscle twitching, and dyskinesia. 
Pri mladostnikih z bipolarno motnjo I so bili neželeni učinki po pogostnosti in vrsti podobni kot pri odraslih, z izjemo naslednjih: somnolence (23,0 %), ekstrapiramidnih motenj (18,4 %), akatizije
ABILIFY 30 mg tablets Red iron oxide (E 172) 
ABILIFY 30 mg tablete rdeči železov oksid (E 172)
Potential for other medicinal products to affect ABILIFY solution for injection 
Možnost vpliva drugih zdravil na ABILIFY raztopina za injiciranje Sočasna uporaba lorazepama v obliki raztopine za injiciranje ne vpliva na farmakokinetiko ABILIFY
The most commonly reported adverse reactions in placebo-controlled trials were nausea, dizziness and somnolence each occurring in more than 3 % of patients treated with aripiprazole solution for injection. 
Vsak se je pojavil pri več kot 3 % bolnikov, ki so se zdravili z aripiprazolom v obliki raztopine za injiciranje.
ABILIFY 1 mg/mL oral solution is a clear, colourless to light yellow liquid supplied in bottles with polypropylene child-resistant closure containing 50 mL, 150 mL or 480 mL per bottle. 
Na voljo je v plastenkah, ki imajo za otroke varno zaporko iz polipropilena in vsebujejo 50 ml, 150 ml ali 480 ml.
ABILIFY 15 mg orodispersible tablets Yellow iron oxide (E 172) 
ABILIFY 15 mg orodisperzibilne tablete rumeni železov oksid (E 172)
ABILIFY 30 mg orodispersible tablets 30 mg: Round and pink, marked with "A" over "643" on one side and "30" on the other. 
ABILIFY 30 mg orodisperzibilne tablete so okrogle oblike in roza barve, označene z '"A" nad "643"'
• tiredness, 
• driska,
• low levels of blood platelets, 
• nizke ravni trombocitov,
Excipient with known effect 186.54 mg lactose (as monohydrate) per tablet 
186,54 mg laktoze (v obliki monohidrata) na tableto Za celoten seznam pomožnih snovi glejte poglavje 6.1.
ABILIFY contains the active substance aripiprazole and belong to a group of medicines called antipsychotics. 
Raztopina za injiciranje ABILIFY vsebuje učinkovino aripiprazol in spada v skupino zdravil,
Water for injections 
Raztopina za injiciranje.
Peripheral oedema 
peroralna raztopina
In clinical trials aripiprazole has not been shown to induce clinically relevant weight gain. 
Zvečanje telesne mase Klinična preskušanja niso pokazala, da bi aripiprazol povzročil klinično pomembno zvečanje telesne mase.
ABILIFY 10 mg orodispersible tablets 
ABILIFY 10 mg orodisperzibilne tablete
Magnesium stearate 
OVOJNINAH NALEPKA VIALE
• high blood pressure, 
• visok krvni tlak, • izguba zavesti,
Temperature regulation disorder (e.g. hypothermia, pyrexia) Chest pain 
Splošne težave in spremembe na mestu aplikacije izčrpanost motnje uravnavanja telesne temperature (npr. hipotermija, pireksija)
When weak inhibitors of CYP3A4 (e.g. diltiazem) or CYP2D6 (e.g. escitalopram) are used concomitantly with aripiprazole, modest increases in plasma aripiprazole concentrations may be expected. 
Med sočasno uporabo aripiprazola in šibkih zaviralcev CYP3A4 (npr. diltiazema) ali CYP2D6 (npr. escitaloprama)
ABILIFY 30 mg orodispersible tablets 
ABILIFY 30 mg orodisperzibilne tablete
Tablet coat 
• kolcanje.
• inflammation of the liver, 
• vnetje trebušne slinavke,
Aripiprazole was superior to placebo in change from baseline at week 4 and at week 12 on the Y-MRS total score. 
Aripiprazol se je v 4. tednu in v 12. tednu pri spremembi skupne ocene po lestvici YMRS od izhodišča izkazal za boljšega od placeba.
It is important that you carry on receiving ABILIFY solution for injection for as long as your doctor has told you to. 
Odmerek ABILIFY raztopine za injiciranje in trajanje zdravljenja bo določil zdravnik.
Methyl parahydroxybenzoate (E 218) Propylene glycol 
FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi dinatrijev edetat fruktoza glicerol mlečna kislina metilparahidroksibenzoat (E 218) propilenglikol propilparahidroksibenzoat (E 216) natrijev hidroksid saharoza prečiščena voda aroma pomaranče
ABILIFY 15 mg orodispersible tablets 
ABILIFY 15 mg orodisperzibilne tablete
Schizophrenia with oral aripiprazole 
Uporaba peroralnega aripiprazola pri shizofreniji
Tics associated with Tourette's disorder in paediatric patients (see section 4.2) The efficacy of aripiprazole was studied in paediatric subjects with Tourette's disorder (aripiprazole: n = 99, placebo: n = 44) in a randomised, double-blind, placebo-controlled, 8 week study using a fixed dose weight-based treatment group design over the dose range of 5 mg/day to 20 mg/day and a starting dose of 2 mg. 
Trzaji, povezani s Tourettovim sindromom, pri pediatričnih bolnikih (glejte poglavje 4.2) Učinkovitost aripiprazola je bila raziskana pri pediatrični populaciji s Tourettovo motnjo (aripiprazol:
• slower heartbeat, 
• kolcanje, • suha usta.
ABILIFY 15 mg orodispersible tablets are round and yellow, marked with ‘"A" over "641"' on one side and ‘15' on the other. 
Okrogle oblike in rumene barve, označene z "A" nad "641" na eni strani in 15 na drugi.
In clinical trials oral aripiprazole has not been shown to induce clinically relevant weight gain. 
Zvečanje telesne mase Klinična preskušanja niso pokazale, da bi peroralni aripiprazol povzročil klinično pomembno zvečanje telesne mase.
Crospovidone 
Distonija
ABILIFY 30 mg orodispersible tablets are round and pink, marked with ‘"A" over "643"' on one side and ‘30' on the other. 
Okrogle oblike in roza barve, označene z "A" nad "643" na eni strani in 30 na drugi.
ABILIFY 15 mg tablets Yellow iron oxide (E 172) 
ABILIFY 15 mg tablete rumeni železov oksid (E 172)
Talk to your doctor before taking ABILIFY. 
Pred začetkom uporabe zdravila ABILIFY se posvetujte z zdravnikom.
Sulfobutylether β-cyclodextrin (SBECD) Tartaric acid 
FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi sulfobutileter betaciklodekstrin (SBECD) vinska kislina natrijev hidroksid voda za injekcije
ABILIFY contains sodium 
Zdravilo ABILIFY vsebuje natrij
Tell the doctor or nurse if you feel dizzy or faint after the injection. 
Če ste po prejemu injekcije omotični ali omedlite, o tem obvestite zdravnika ali medicinsko sestro.
ABILIFY 30 mg tablets Each tablet contains 30 mg of aripiprazole. 
57 mg laktoze (v obliki monohidrata) na tableto ABILIFY 30 mg tablete Ena tableta vsebuje 30 mg aripiprazola.
The occurrence of suicidal behaviour is inherent in psychotic illnesses and mood disorders and in some cases has been reported early after initiation or switch of antipsychotic treatment, including treatment with aripiprazole (see section 4.8). 
V nekaterih primerih so o njegovem pojavu poročali zgodaj po uvedbi ali zamenjavi antipsihotičnega zdravljenja,
This can lead to symptoms such as: 
To lahko privede do simptomov, kot so:
Overall Response Rate, % 
Celokupni delež odgovora, %
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 12 December 2018 
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM Datum prve odobritve: 12. december 2018
Children and adolescents Ogivri is not recommended for anyone under the age of 18 years. 
Otroci in mladostniki Zdravilo Ogivri ni priporočljivo za mlajše od 18 let.
This medicinal product must not be mixed or diluted with other medicinal products except those mentioned in section 6.6. 
Zdravila ne smemo mešati ali redčiti z drugimi zdravili, razen s tistimi, ki so omenjena v poglavju 6.6.
• Your doctor will advise you of the risks and benefits of taking Ogivri during pregnancy. 
• Zdravnik vam bo svetoval glede tveganja in koristi uporabe zdravila Ogivri v času nosečnosti.
The bioactivity of D7D and the clinical impact of the elevation of this metabolite were unclear. 
Biološka aktivnost D7D in klinični vpliv zaradi dviga ravni tega metabolita nista bila jasna.
Therefore, your doctor may decide to continue to check your heart functions, even after you finish treatment. 
Zato se bo vaš zdravnik morda odločil za nadaljevanje spremljanja delovanja vašega srca tudi po končanem zdravljenju.
In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. 
Za izboljšanje sledljivosti bioloških zdravil je treba ime in številko serije uporabljenega zdravila jasno zabeležiti.
Side effects of not known frequency: frequency cannot be estimated from the available data 
Neželeni učinki z neznano pogostnostjo - pogostnosti ni mogoče oceniti iz podatkov, ki so na voljo:
• increased muscle tone or tension (hypertonia) 
• povečan mišični tonus ali napetost (hipertonija)
Ogivri should only be given by a doctor or nurse. 
Zdravilo Ogivri lahko daje le zdravnik ali medicinska sestra.
In this section, the following categories of frequency have been used: 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). 
V tem poglavju so neželeni učinki navedeni po pogostnosti na naslednji način: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1000 do < 1/100), redki (≥ 1/10.000 do < 1/1000), zelo redki (< 1/10.000), neznano (ni mogoče oceniti iz razpoložljivih podatkov).
• breathlessness (including breathlessness at night), 
• težave z dihanjem (vključno s težavami z dihanjem ponoči),
Ogivri can cause breathing difficulties, especially when it is first given. 
Zdravilo Ogivri lahko povzroči težave z dihanjem, še zlasti, ko ga prejmete prvič.
Patients with HFI cannot break down fructose, which may cause serious side effects. 
Bolniki s HFI ne morejo razgraditi fruktoze, kar lahko privede do resnih neželenih učinkov.
Therefore, these patients should not be treated with trastuzumab (see section 4.3). 
Zato takih bolnikov ne smemo zdraviti s trastuzumabom (glejte poglavje 4.3).
Infusion reactions, allergic-like reactions and hypersensitivity It is estimated that approximately 40 % of patients who are treated with trastuzumab will experience some form of infusion-related reaction. 
Infuzijske reakcije, alergiji podobne reakcije in preobčutljivost Ocenjujejo, da se pri približno 40 % bolnikov, ki prejemajo trastuzumab, pojavi neka oblika reakcij, povezanih z infuzijo.
If you have hereditary fructose intolerance (HFI), a rare genetic disorder, you must not receive this medicine. 
Če imate dedno intoleranco za fruktozo (HFI), kar je redka genetska bolezen, tega zdravila ne smete jemati.
If not used immediately, in-use storage times and conditions are the responsibility of the user. 
Če se zdravilo ne uporabi takoj, je za čas in pogoje shranjevanja pred uporabo odgovoren uporabnik.
* defined as absence of any invasive cancer both in the breast and axillary nodes 
* Definiran kot odsotnost kakršnega koli invazivnega raka v dojkah in aksilarnih bezgavkah
The reconstituted solution should not be frozen. 
Pripravljene raztopine se ne sme zamrzniti.
Approximately 17 % of cardiac dysfunction related events occurred after completion of trastuzumab. 
Približno 17 % dogodkov, povezanih z motnjo delovanja srca, je nastopilo po zaključku zdravljenja s trastuzumabom.
Serious reactions have been treated successfully with supportive therapy such as oxygen, beta agonists, and corticosteroids. 
Resne reakcije so uspešno zdravili s podpornim zdravljenjem, kot so kisik, beta agonisti in kortikosteroidi.
47.3 (32-ne) 
47,3 (32-no)
See section 4.8 for how to report adverse reactions 
Glejte poglavje 4.8 o tem, kako poročati o neželenih učinkih.
Duration of Response, Median months 
Trajanje odgovora, mediana mesecev
Some of these symptoms can be serious and some patients have died (see section 2 under “Warnings and precautions”). 
Nekateri od teh simptomov so lahko resni in opisani so primeri smrti (glejte poglavje 2, “Opozorila in previdnostni ukrepi”).
The dose of Ogivri depends on your body weight. 
Odmerek zdravila Ogivri je odvisen od vaše telesne mase.
These effects mainly occur with the first intravenous infusion (“drip” into your vein) and during the first few hours after the start of the infusion. 
Ti učinki se pojavijo predvsem med prvo intravensko infuzijo (“kapljanjem” zdravila v žilo) in prvih nekaj ur po pričetku infuzije.
The results of these simulations indicate that at least 95 % of patients will reach concentrations that are < 1 mcg/mL (approximately 3 % of the population predicted Cmin,ss, or about 97 % washout) by 7 months. 
Rezultati teh simulacij kažejo, da bo najmanj 95 % bolnikov do 7. meseca doseglo koncentracije < 1 μg/ml (približno 3 % Cmin, ss predvidene za populacijo ali približno 97-% izpiranje).
12 weeks. 
24 mesecih.
As human IgG1 is secreted into human milk, and the potential for harm to the infant is unknown, women should not breast-feed during trastuzumab therapy and for 7 months after the last dose. 
Ker se humani IgG1 izloča v materino mleko, potencialni škodljivi vpliv na otroka pa ni znan, naj ženske ne dojijo med zdravljenjem s trastuzumabom in še 7 mesecev po zadnjem odmerku.