natgillin/translations-raw huggingface dataset:
<invented name> is also contraindicated in any pre-existing medical conditions with which a betamimetic would have an untoward effect e.g., pulmonary hypertension and cardiac disorders such as hypertrophic obstructive cardiomyopathy or any type of obstruction of the left ventricular outflow tract, e.g. aortic stenosis.
Zdravilo <izmišljeno ime> je kontraindicirano tudi pri vseh obstoječih zdravstvenih stanjih, pri katerih bi lahko imel betamimetik neugodne učinke, npr. pri pljučni hipertenziji in srčnih boleznih, kakršne so hipertrofična obstruktivna kardiomiopatija ali kakršna koli obstrukcija iztočnega dela levega prekata, npr. aortna stenoza.
In order to minimise the risk of hypotension associated with tocolytic therapy, special care should be taken to avoid caval compression by keeping the patient in the left or right lateral positions throughout the infusion.
Da bi čim bolj zmanjšali tveganje za hipotenzijo, povezano s tokolitičnim zdravljenjem, je treba posebno pozornost nameniti temu, da ne pride do kompresije vene cave; zaradi tega mora biti bolnica ves čas infundiranja v levem ali desnem lateralnem položaju.
Tell your doctor immediately if you experience coughing or shortness of breath during treatment.
Zdravniku morate nemudoma povedati, če se vam med zdravljenjem pojavi kašelj ali kratka sapa.
* These reactions have been reported in association with the use of short acting beta-agonists in obstetric indications and are considered class effects (see section 4.4)
*pljučni edem * Te reakcije so bile opisane v povezavi z uporabo kratkodelujočih agonistov adrenergičnih receptorjev beta za porodničarske indikacije in veljajo za učinke skupine (glejte poglavje 4.4)
Treatment should only be carried out in facilities adequately equipped to perform continuous monitoring of maternal and foetal health status.
Zdravljenje se sme izvajati le v ustanovah, ki so ustrezno opremljene za stalen nadzor zdravstvenega stanja matere in ploda.
Generally maternal pulse rate should not be allowed to exceed a steady rate of 120 beats per minute.
Na splošno se ne sme dopustiti, da bi materina srčna frekvenca presegla stalno frekvenco 120 utripov na minuto.
Tocolysis with beta-agonists is not recommended when membranes have ruptured or the cervix dilation is beyond 4cm.
Tokoliza z agonisti adrenergičnih receptorjev beta ni priporočljiva, če so ovojnice pretrgane ali če je maternični vrat razširjen več kot 4 cm.
Treatment with <invented name> should only be initiated by obstetricians/physicians experienced in the use of tocolytic agents.
Zdravljenje z zdravilom <izmišljeno ime> smejo uvesti le porodničarji oziroma zdravniki, ki imajo izkušnje z uporabo tokolitikov.
If signs of pulmonary oedema or myocardial ischaemia develop, discontinuation of treatment should be considered (see section 4.2 and 4.8).
Če se pojavijo znaki pljučnega edema ali ishemije miokarda, je treba razmisliti o prekinitvi zdravljenja (glejte poglavji 4.2 in
You will be given <invented name> by a doctor where facilities are available to continually monitor your health and that of your baby throughout administration.
Zdravilo <izmišljeno ime> vam bo dal zdravnik v ustanovi, kjer je na voljo oprema za stalno spremljanje vašega in otrokovega zdravstvenega stanja ves čas uporabe zdravila.
• Blood pressure and heart rate.
• Krvni tlak in srčni utrip.
4.5 Interaction with other medicinal products and other forms of interaction [The wording below should be inserted in this section]
4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij [Spodnje besedilo je treba vnesti v to poglavje]
If you are pregnant and you or your baby have certain conditions when prolongation of your pregnancy would be dangerous (such as severe high blood pressure, infection of the womb, bleeding, placenta is covering the birth canal or is detaching, or your baby has died inside the womb)
če ste noseči in imate vi ali vaš otrok kakšno bolezen, pri kateri bi bilo podaljšanje nosečnosti nevarno (na primer visok krvni tlak, okužbo maternice, krvavitev, posteljica prekriva porodni kanal ali je odstopila, ali je otrok umrl v maternici).
The maternal pulse rate should be monitored and the need to control such increases by dose reduction or drug withdrawal should be evaluated on a case by case basis.
Materino srčno frekvenco je treba kontrolirati; od primera do primera je treba oceniti, ali je za obvladanje takšnega povečanja treba zmanjšati odmerek ali prekiniti uporabo zdravila.
Patients with predisposing factors including multiple pregnancies, fluid overload, maternal infection and pre-eclampsia may have an increased risk of developing pulmonary oedema.
Bolnice s predispozicijskimi dejavniki (vključno z večplodno nosečnostjo, preobremenitvijo s tekočino, okužbo pri materi ali preeklampsijo) imajo lahko večje tveganje za pljučni edem.
<invented name> should only be administered cautiously to patients suffering from thyrotoxicosis after careful evaluation of the benefits and risks of treatment.
Zdravilo <izmišljeno ime> se sme pri bolnicah s tirotoksikozo uporabljati le previdno, po skrbni oceni koristi in tveganj zdravljenja.
They normally recede upon therapy discontinuation.
Po prenehanju zdravljenja po navadi minejo.
Low blood pressure which may cause light-headedness or dizziness Low levels of potassium in your blood which may cause muscle weakness, thirst, or “pins and needles”
Nizek krvni tlak, ki lahko povzroči vrtoglavico ali omotico Nizka koncentracija kalija v krvi, ki lahko povzroči šibkost mišic, žejo ali mravljinčenje
<invented name> should not be used as a tocolytic agent in patients with significant risk factors for, or a suspicion of any kind of pre-existing heart disease (e.g. tachyarrhythmias, heart failure, or valvular heart disease; see section 4.3).
Zdravila <izmišljeno ime> se kot tokolitika ne sme uporabljati pri bolnicah s pomembnimi dejavniki tveganja ali s sumom na kakršno koli obstoječo srčno bolezen (npr. tahikardne motnje srčnega ritma, srčno popuščanje ali bolezen srčnih zaklopk; glejte poglavje 4.3).
If you suffer from heart disease with palpitations (for example heart valve disorder) or longstanding lung disease (for example chronic bronchitis, emphysema) causing an increase of blood pressure to your lungs (pulmonary hypertension)
če imate srčno bolezen s palpitacijami (razbijanjem srca; na primer bolezen srčnih zaklopk) ali dolgotrajno bolezen pljuč (na primer kronični bronhitis, emfizem), ki povzroča zvišan krvni tlak v pljučih (pljučno hipertenzijo).
Any decision to initiate therapy with <invented name> should be undertaken after careful consideration of the risks and benefits of treatment.
Za uvedbo zdravljenja z zdravilom <izmišljeno ime> se je treba odločiti šele po natančnem pretehtanju tveganj in koristi takšnega zdravljenja.
Halogenated anaesthetics
Halogenirani anestetiki
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!