natgillin/translations-raw huggingface dataset:
If any signs indicate that there is a build-up of fluid in your lungs (also known as pulmonary oedema) (e.g. coughing or shortness of breath), your doctor may stop the administration of <invented name>. 
Če se pojavi kakršen koli znak kopičenja tekočine v pljučih (to imenujemo tudi pljučni edem) (npr. kašelj ali kratka sapa), bo zdravnik prekinil uporabo zdravila <izmišljeno ime>.
*Cardiac arrhythmias, e.g. atrial fibrillation, Myocardial ischaemia (see section 4.4) 
*motnje srčnega ritma, npr. atrijska fibrilacija, ishemija miokarda (glejte poglavje
• Blood potassium levels (low potassium levels may be associated with a risk of irregular heart beat) 
• Koncentracija kalija v krvi (nizko koncentracijo kalija lahko spremlja tveganje za neredno bitje srca).
If you suffer from or have a known risk of developing ischaemic heart disease (disease characterized by reduced blood supply to your heart muscle, causing symptoms such as chest pain (angina)) 
če imate (ali če imate kakšen znan dejavnik tveganja za) ishemično bolezen srca: pri tej bolezni je dotok krvi v srčno mišico zmanjšan in to povzroča simptome, na primer bolečino v prsih (angino pektoris).
Section 4. 
Poglavje 4.
Therefore blood glucose and lactate levels should be monitored in mothers with diabetes and diabetic treatment adjusted accordingly to meet the needs of the diabetic mother during tocolysis (see section 4.5). 
Zato je treba materam s sladkorno boleznijo kontrolirati koncentracijo glukoze in laktata v krvi ter zdravljenje sladkorne bolezni ustrezno prilagoditi, da med tokolizo zadošča potrebam matere s sladkorno boleznijo (glejte poglavje 4.5).
Common: *Palpitations, *decrease in diastolic pressure Rare: 
*palpitacije, *znižanje diastoličnega tlaka
• Electrocardiography (ECG, electric activity of your heart) Tell your doctor immediately if you experience chest pain during treatment. 
• Elektrokardiogram (EKG, električno delovanje vašega srca).
Section 2. 
Poglavje 2.
[The following obstetric indications to be retained only where currently authorised] 
[Naslednje porodničarske indikacije je treba ohraniti le tam, kjer so trenutno odobrene] Zunanji cefalični obrat [ohranite le tam, kjer je trenutno odobreno] Uporaba v nujnih primerih pri specificiranih stanjih [ohranite le tam, kjer je trenutno odobreno]
<invented name> should be used with caution in tocolysis and supervision of cardiorespiratory function and ECG monitoring, should be performed throughout treatment. 
Zdravilo <izmišljeno ime> je treba pri tokolizi uporabljati previdno in ves čas zdravljenja je treba nadzorovati delovanje srca in dihal ter spremljati EKG.
Administration of beta agonists is associated with a rise of blood glucose. 
Uporabo agonistov adrenergičnih receptorjev beta spremlja zvišanje glukoze v krvi.
Owing to the additional antihypertensive effect, there is increased uterine inertia with risk of haemorrhage; in addition, serious ventricular rhythm disorders due to increased cardiac reactivity, have been reported on interaction with halogenated anaesthetics. 
Poleg tega so bile ob medsebojnem delovanju s halogeniranimi anestetiki opisane resne motnje srčnega ritma zaradi povečane reaktivnosti srca.
In particular tell your doctor, nurse or pharmacist if you are taking: medicines for an irregular or fast heartbeat (such as digoxin) Other beta-blocker medicines (such as atenolol or propranolol), including eye drops (such as timolol) 
Še zlasti morate zdravniku, medicinski sestri ali farmacevtu povedati, če jemljete: zdravila za neredno ali hitro bitje srca (na primer digoksin), druge blokatorje adrenergičnih receptorjev beta (na primer atenolol ali propranolol), vključno s kapljicami za oči (na primer timolol), ksantinska zdravila (na primer teofilin ali aminofilin), steroidna zdravila (na primer prednizolon), tablete za odvajanje vode; imenujemo jih tudi diuretiki (na primer furosemid), zdravila za sladkorno bolezen za znižanje krvnega sladkorja (na primer insulin, metformin ali glibenklamid).
4.3 Contraindications [The wording below should be inserted in this section] 
4.3 Kontraindikacije [Spodnje besedilo je treba vnesti v to poglavje]
Common (affects less than 1 in 10 people) Pounding heart beat (palpitations), 
Pogosti (pojavijo se pri manj kot 1 od 10 oseb) Razbijanje srca (palpitacije)
[All oral formulations and suppositories (see Annex I) should delete the obstetric indications from their product information. 
[Iz informacij o zdravilu vseh peroralnih formulacij in svečk (glejte Prilogo I), naj se izbrišejo vse porodničarske indikacije.
you have an overactive thyroid gland you have a history of heart disease characterised by breathlessness, palpitations or angina (see Do not use <invented name> if). 
če ste kdaj imeli srčno bolezen, ki so jo spremljali težko dihanje, razbijanje srca (palpitacije) ali angina pektoris (glejte Ne uporabljajte zdravila <izmišljeno ime>).
Rare (affects less than 1 in 1,000 people) 
Zelo pogosti (pojavijo se pri več kot 1 od 10 oseb)
It is important to check with your doctor or nurse before having your injection if: you have had problems with your pregnancy, if during pregnancy, your waters have broken. 
Bodite posebno pozorni pri uporabi zdravila <izmišljeno ime>: Pomembno je, da se z zdravnikom ali medicinsko sestro posvetujete, preden dobite injekcijo tega zdravila: če ste imeli težave z nosečnostjo.
Owing to the hypokalaemic effect of beta-agonists, concurrent administration of serum potassium depleting agents known to exacerbate the risk of hypokalaemia, such as diuretics, digoxin, methyl xanthines and corticosteroids, should be administered cautiously after careful evaluation of the benefits and risks with special regard to the increased risk of cardiac arrhythmias arising as a result of hypokalaemia (see section 4.4). 
Zato je v primeru sočasne uporabe zdravil, ki znižujejo kalij v serumu in za katere je znano, da povečajo tveganje za hipokaliemijo (na primer diuretikov, digoksina, metilksantinov in kortikosteroidov) potreba previdnost: uporabiti jih je treba šele po skrbni oceni koristi in tveganj in posebej upoštevaje večje tveganje za motnje srčnega ritma zaradi hipokaliemije (glejte poglavje 4.4).
Pulmonary oedema 
Pljučni edem
Increases in maternal heart rate of the order of 20 to 50 beats per minute usually accompany infusion of beta-agonists. 
Infundiranje agonistov adrenergičnih receptorjev beta po navadi spremlja povečanje materine srčne frekvence za okrog 20 do 50 utripov na minuto.
Careful control of the level of hydration is essential to avoid the risk of maternal pulmonary oedema 
Bistveno je natančno nadzorovanje ravni hidracije, da bi se izognili tveganju za pljučni edem pri materi (glejte poglavje 4.4).
infusion will limit risk of fluid overload. 
Uporaba z injekcijsko črpalko in ne z intravenskim infundiranjem zmanjša tveganje za preobremenitev s tekočino.
Your doctor will consider the lowering of your dose or discontinuing <invented name> if your heart rate exceeds 120 beats per minute. 
Če vaš srčni utrip preseže 120 utripov na minuto, bo zdravnik razmislil o znižanju odmerka ali prekinitvi uporabe zdravila <izmišljeno ime>.
Cardiac disorders Very common: 
Žilne bolezni Pogosti:
Go to top of the page 4.8 Undesirable effects [The wording below should be inserted in this section] 
4.8 Neželeni učinki [Spodnje besedilo je treba vnesti v to poglavje]
you have too much fluid in the lungs causing breathlessness (pulmonary oedema) you have high blood pressure you are diabetic. 
če imate v pljučih preveč tekočine, ki povzroča težko dihanje (pljučni edem).
A maximum maternal heart rate of 120 beats per min should not be exceeded. 
Materina največja srčna frekvenca ne sme preseči 120 utripov na minuto.
For the short term management of uncomplicated premature labour To arrest labour between 22 and 37 weeks of gestation in patients with no medical or obstetric contraindication to tocolytic therapy. 
4.1 Terapevtske indikacije [Trenutno odobrene porodničarske indikacije je treba izbrisati in nadomestiti z naslednjim:] Za kratkotrajno vodenje nezapletenega prezgodnjega poroda Za ustavitev poroda med 22. in 37. tednom nosečnosti pri bolnicah, ki nimajo internističnih ali porodničarskih kontraindikacij za tokolitično zdravljenje.
There have been reports of pulmonary oedema in women concomitantly administered with beta-agonists and corticosteroids. 
Pri ženskah, ki so hkrati prejemale agoniste adrenergičnih receptorjev beta in kortikosteroide, je bil opisan pljučni edem.
The administration of beta-agonists is associated with a rise of blood glucose, which can be interpreted as an attenuation of anti-diabetic therapy; therefore individual anti-diabetic therapy may need to be adjusted (see section 4.4). 
Uporaba agonistov adrenergičnih receptorjev beta je povezana z zvišanjem glukoze v krvi; to je mogoče tolmačiti kot zmanjšanje učinka antidiabetičnih zdravil.
As maternal pulmonary oedema and myocardial ischaemia have been reported during or following treatment of premature labour with beta-agonists, careful attention should be given to fluid balance and cardio-respiratory function. 
Med zdravljenjem prezgodnjega poroda z agonisti adrenergičnih receptorjev beta sta bila opisana pljučni edem in ishemija miokarda pri materi.
Chest pain (due to heart problems such as angina). 
Redki (pojavijo se pri manj kot 1 od 1.000 oseb) Bolečina v prsih (zaradi težav s srcem, na primer angine pektoris).
- any condition of the mother or foetus in which prolongation of the pregnancy is hazardous, e.g. severe toxaemia, intrauterine infection, vaginal bleeding resulting from placenta praevia, eclampsia or severe preeclampsia, placental abruption, or cord compression. 
- za katero koli stanje pri gestacijski starosti < 22 tednov, - kot tokolitik pri bolnicah z obstoječo ishemično srčno boleznijo ali bolnicah s pomembnimi dejavniki tveganja za ishemično srčno bolezen, - pri grozečem splavu v 1. in 2. trimesečju nosečnosti, - pri katerem koli stanju matere ali ploda, pri katerem bi bilo podaljšanje nosečnosti nevarno, npr. huda toksemija, intrauterina okužba, nožnična krvavitev zaradi placente previe, eklampsija ali huda preeklampsija, abrupcija placente ali kompresija popkovnice, - v primeru intrauterine smrti ploda, znane smrtne prirojene ali smrtne kromosomske nepravilnosti.
Corticosteroids are known to increase blood glucose and can deplete serum potassium, therefore concomitant administration should be undertaken with caution with continuous patient monitoring owing to the increased risk of hyperglycaemia and hypokalaemia (see section 4.4). 
Zato je sočasno uporabo treba začeti previdno in s stalnim nadzorom bolnice, ker obstaja večje tveganje za hiperglikemijo in hipokaliemijo (glejte poglavje 4.4).
Rare (affects less than 1 in 1,000 people) Unusual or irregular heartbeats High levels of sugar (glucose) and/or lactic acid in your blood Flushing (reddening) of the face 
Redki (pojavijo se pri manj kot 1 od 1.000 oseb) Neobičajni ali neredni utripi srca
Respiratory, thoracic and mediastinal disorders Uncommon: *Pulmonary oedema. 
Bolezni dihal, prsnega koša in mediastinalnega prostora Občasni:
It is important that you are given all the infusions that have been recommended. 
Pomembno je, da prejmete vse infuzije, ki so vam jih priporočili.
Date of first authorisation: 4th March 2013 Date of latest renewal: 8th December 2017 
Datum prve odobritve: 4. marec 2013 Datum zadnjega podaljšanja: 8. december 2017
Thereafter, revert to the original planned schedule. 
Nato se vrnite na prvotno načrtovano razporeditev.
** For the overall treatment period across the 4 studies. 
** Za celotno obdobje zdravljenja v štirih študijah.
Do not wait until the next planned dose. 
Ne čakajte na naslednji načrtovani odmerek.
No specific dose recommendations can be made. 
Specifičnih priporočil o odmerjanju ni mogoče dati.
Data from first interim analysis. 
Podatki prve vmesne analize.
The BERENICE study included two parallel groups of patients. 
Študija BERENICE je vključevala dve vzporedni skupini bolnikov.
The majority of patients were less than 65 years old. 
Večina bolnic je bila starih manj kot 65 let.
Medicinal products to treat such reactions, as well as emergency equipment, should be available for immediate use. 
Zdravila za zdravljenje take reakcije kot tudi oprema za nujne primere morajo biti na voljo za takojšnjo uporabo.
The vial must not be shaken. 
Vial ne smemo tresti.
At the time of the estimate the median follow-up was 45.4 months. 
V času ocene je spremljanje trajalo mediano 45,4 meseca.
Each pack contains one vial. 
Vsako pakiranje vsebuje 1 vialo.
To ensure accurate and reproducible results, the testing must be performed in a specialised laboratory, which can ensure validation of the testing procedures. 
Za zagotovitev točnih in ponovljivih rezultatov mora biti testiranje opravljeno v specializiranem laboratoriju, kjer se lahko zagotovi ustrezna validacija postopka testiranja.
< 6 weeks 
< 6 tednov
Chemical and physical in-use stability has been demonstrated for 24 hours at 30°C. 
Kemijska in fizikalna stabilnost med uporabo sta dokazani za 24 ur pri temperaturi 30 °C.
The safety and efficacy of Perjeta in children and adolescents below 18 years of age have not been established. 
Varnost in učinkovitost zdravila Perjeta pri otrocih in mladostnikih, mlajših od 18 let, nista raziskani.
In order to improve the traceability of biological medicinal products, the name and batch number of the administered product should be clearly recorded. 
Za izboljšanje sledljivosti bioloških zdravil je treba ime in številko serije danega zdravila jasno zabeležiti.
The median age was 51 years, and over 99% of patients were female. 
Mediana starost je bila 51 let in več kot 99 % obolelih je bilo žensk.
Results of Subgroup Analysis 
Rezultati analize podskupin
Perjeta should not be given to patients under the age of 18 years because there is no information on how it works in this age group. 
Zdravila Perjeta ne smemo dajati bolnikom, mlajšim od 18 let, ker ni podatkov o tem, kako zdravilo deluje pri tej starostni skupini.
SPECIAL STORAGE CONDITIONS Store in a refrigerator 
POSEBNA NAVODILA ZA SHRANJEVANJE Shranjujte v hladilniku
HER2 is found in large amounts on the surface of some cancer cells where it stimulates their growth. 
HER2 se v velikih količinah nahaja na površini nekaterih rakavih celic, kjer spodbuja njihovo rast.
The storage details are as follows: 
Podrobnosti o shranjevanju:
Store in a refrigerator (2°C-8°C). 
• Shranjujte v hladilniku (2 °C do 8 °C).
Elderly patients (> 65 years) may have a higher risk of diarrhoea compared with younger patients (< 65 years). 
Starejši bolniki (> 65 let) imajo lahko večje tveganje za drisko v primerjavi z mlajšimi bolniki (< 65 let).
This leaflet was last revised in. 
Navodilo je bilo nazadnje revidirano
For the first infusion: 
Prva infuzija:
If you have ever had heart problems during previous treatment with trastuzumab. 
• če ste kdaj imeli težave s srcem med predhodnim zdravljenjem s trastuzumabom;
They will advise you about the benefits and risks for you and your baby of taking Perjeta while you are pregnant. 
Seznanila vas bosta s koristmi in tveganji, ki jih za vas in otroka pomeni prejemanje zdravila Perjeta med nosečnostjo.
Once the infusion is prepared it should be administered immediately (see section 6.3). 
Ko je infuzija pripravljena, jo je treba uporabiti nemudoma (glejte poglavje 6.3).
Treat diarrhoea according to standard practice and guidelines. 
Zdravljenje driske poteka po standardni praksi in smernicah.
Talk to your doctor about the best contraception for you. 
Z zdravnikom se posvetujte o tem, katera kontracepcija je za vas najprimernejša.
Antibodies are cleared principally by catabolism. 
Protitelesa se v glavnem izločajo s katabolizmom.
Do not stop having this medicine without talking to your doctor first. 
Ne prenehajte zdravljenja s tem zdravilom, ne da bi se pred tem posvetovali z zdravnikom.
Additional supportive clinical trial information 
Dodatne podporne informacije kliničnih preskušanj
Perjeta and trastuzumab can be given in any order. 
Zdravilo Perjeta in trastuzumab je mogoče dati v katerem koli vrstem redu.
3-year event-free rate derived from Kaplan-Meier estimates. 
3-letni delež brez dogodkov je dobljen iz Kaplan-Meierjevih ocen.
≥ 6 weeks 
≥ 6 tednov
• Obligation to conduct post-authorisation measures The MAH shall complete, within the stated timeframe, the following measures: Description 
• Obveznost izvedbe ukrepov po pridobitvi dovoljenja za promet Imetnik dovoljenja za promet z zdravilom mora v določenem časovnem okviru izvesti naslednje ukrepe: Opis
Diarrhoea is a condition where your body produces more watery stools than normal. 
Driska je stanje, ko telo proizvede več tekočega blata kot ponavadi.
°° Infusion reaction includes a range of different terms within a time window, see “Description of selected adverse reactions” below. 
°° Infuzijska reakcija zajema skupino različnih izrazov v časovnem razponu, glejte “Opis izbranih neželenih učinkovˮ spodaj.
What Perjeta is and what it is used for 
Kaj je zdravilo Perjeta in za kaj ga uporabljamo
In clinical trials, single doses higher than 25 mg/kg (1727 mg) have not been tested. 
V kliničnih preskušanjih niso testirali enkratnih odmerkov, večjih od 25 mg/kg (1727 mg).
Read all of this leaflet carefully before you start being given this medicine because it contains important information for you. 
Preden začnete dobivati to zdravilo, natančno preberite navodilo, ker vsebuje za vas pomembne podatke!
Based on modifications made to the study treatment, most reactions were assessed as secondary to docetaxel infusions. 
Na podlagi prilagoditev raziskovanega zdravljenja so večino reakcij ocenili kot posledico infuzij docetaksela.
Feeling sick or being tired 
• slabost ali utrujenost
Those studies included the pivotal trials CLEOPATRA (n=808), NEOSPHERE (n=417), TRYPHAENA (n=225), and APHINITY (n=4804) [pooled in Table 2]. 
Te študije vključujejo ključna preskušanja CLEOPATRA (n = 808), NEOSPHERE (n = 417), TRYPHAENA (n = 225) in APHINITY (n = 4804)
For the initial dose, the recommended infusion period is 60 minutes. 
Priporočeni čas infundiranja začetnega odmerka je 60 minut.
Before starting treatment, you must tell your doctor or nurse if you are pregnant or breast-feeding, or if you think you may be pregnant or are planning to have a baby. 
Pred začetkom zdravljenja morate zdravniku ali medicinski sestri povedati, če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev.
Interruption of treatment with pertuzumab should be considered if no improvement in the patient's condition is achieved. 
Razmisliti je treba o prekinitvi zdravljenja s pertuzumabom, če ne dosežemo izboljšanja bolnikovega stanja.
In both treatment groups, the proportion of patients experiencing febrile neutropenia was highest in the first cycle of therapy and declined steadily thereafter. 
V obeh zdravljenih skupinah je bil delež bolnikov, pri katerih se je pojavila febrilna nevtropenija, največji med prvim ciklom zdravljenja, nato pa se je postopoma znižal.
Most of these patients had received prior anthracycline therapy and 11% of all patients had received prior trastuzumab. 
Večina teh bolnikov je predhodno prejela zdravljenje z antraciklini, 11 % vseh bolnikov pa je predhodno prejemalo trastuzumab.
The median clearance (CL) of pertuzumab was 0.235 litres/day and the median half-life was 18 days. 
Mediani očistek (Cl) pertuzumaba je bil 0,235 litra/dan, mediani razpolovni čas je bil 18 dni.
Number of IDFS events/Total N (%) 
Število dogodkov IDFS / Skupaj n (%)
In a subset of monkeys, chronic dosing (7 to 26 weekly doses) resulted in episodes of severe secretory diarrhoea. 
V podskupini opic je kronična uporaba (od 7 do 26 tedenskih odmerkov) povzročila pojavljanje hude sekretorne driske.
Compared with published data for similar regimens without pertuzumab, high pCR rates were observed in all 3 treatment arms (see Table 4). 
V primerjavi z objavljenimi podatki za podobne sheme brez pertuzumaba so bili visoki deleži pCR opaženi v vseh treh zdravljenih skupinah (glejte Preglednico 4).
This clinical assessment should be based on the severity of the preceding reaction and response to administered treatment for the adverse reaction (see section 4.2). 
Ta klinična ocena mora temeljiti na tem, kako huda je bila prejšnja reakcija in odzivu na zdravljenje neželenega učinka (glejte poglavje 4.2).
Clinical response represents patients with a best overall response of CR or PR during the neoadjuvant period (in the primary breast lesion). 
Klinični odgovor predstavlja bolnike z najboljšim celokupnim odgovorom CR ali PR med neoadjuvantnim obdobjem (v primarni prsni leziji).
No statistically significant differences were found between the two treatment groups in Health Related Quality of Life as assessed by FACT-B TOI-PFB scores. 
Med terapevtskima skupinama niso ugotovili statistično značilnih razlik v z zdravjem povezani kakovosti življenja, ocenjeni s FACT-B TOI-PFB.
Patients should have a pre-treatment LVEF of ≥ 55% (≥ 50% after completion of the anthracycline component of chemotherapy, if given). 
Bolniki morajo imeti LVEF pred zdravljenjem ≥ 55 % (≥ 50 % po koncu antraciklinske komponente kemoterapije, če je uporabljena).
Some of the side effects which you get may be due to your breast cancer. 
Nekateri neželeni učinki, ki se vam lahko pojavijo, so lahko posledica raka dojk.
Simes corr. for CMH test) 
(Simesova korekcija za test CMH)
Approximate 95% CI for difference of two response rates using Hauck-Anderson method. 
Približno 95-% interval zaupanja za razliko med deležema odgovora z uporabo Hauck-Andersonove metode.
There is limited amount of data from the use of pertuzumab in pregnant women. 
Podatkov o uporabi pertuzumaba pri nosečnicah je malo.
° Hypersensitivity/anaphylactic reaction is based on a group of terms. 
° Preobčutljivost/anafilaktična reakcija je osnovana na skupini izrazov.
The breast cancer has been identified to be of the “HER2-positive” form - your doctor will test you for this. 
• če so rak dojke označili kot “HER2-pozitivna oblika” - zdravnik vas bo napotil na te preiskave;
For all following infusions, if the first infusion was well tolerated: 
Nadaljnje infuzije, če ste prvo infuzijo dobro prenesli:
Treatment should include standard anthracycline- and/or taxane-based chemotherapy. 
Zdravljenje mora vključevati standardno kemoterapijo na osnovi antraciklina in/ali taksana.
Infusion reactions, allergic or anaphylactic (more severe allergic) reactions can happen. 
Pojavijo se lahko infuzijske reakcije, alergijske ali anafilaktične (hujše alergijske) reakcije.
After completion of chemotherapy, patients received radiotherapy and/or hormone therapy as per local clinical standard. 
Po dokončanju kemoterapije so bolniki prejemali obsevanje in/ali hormonsko zdravljenje v skladu z lokalnim kliničnim standardom.
The number of infusions you will be given depends on how you respond to treatment and whether you are receiving treatment before or after surgery (neoadjuvant or adjuvant therapy) or for disease which has spread. 
• Število infuzij, ki jih boste dobili, je odvisno od tega, kako se boste odzvali na zdravljenje in tega, ali se boste zdravili pred ali po operaciji (neoadjuvantno ali adjuvantno) ali za razsejano bolezen.
Perjeta will be stored by the health professionals at the hospital or clinic. 
Zdravilo Perjeta bodo shranjevali zdravstveni delavci v bolnišnici ali ambulanti.
Table 3 Summary of efficacy from CLEOPATRA study Parameter 
Povzetek učinkovitosti iz študije CLEOPATRA
The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreeed subsequent updates of the RMP. 
Imetnik dovoljenja za promet z zdravilom bo izvedel zahtevane farmakovigilančne aktivnosti in ukrepe, podrobno opisane v sprejetem RMP, predloženem v modulu 1.8.2 dovoljenja za promet z zdravilom, in vseh nadaljnjih sprejetih posodobitvah RMP.