natgillin/translations-raw huggingface dataset:
It is recommended that colistimethate sodium (CMS) should be administered under the supervision of physicians with appropriate experience in its use. 
Opomba: Besedilo v tem poglavju je treba nadomestiti z naslednjim besedilom: Priporočljivo je, da uporaba natrijevega kolistimetata (NKM) poteka pod nadzorom zdravnikov, ki imajo ustrezne izkušnje z njegovo uporabo.
Burkholderia cepacia and related species Proteus spp 
Achromobacter xylosoxidans (prej Alcaligenes xylosoxidans) Inherentno odporni organizmi Burkholderia cepacia in sorodne vrste Proteus spp
Hepatic impairment Dose adjustment is not considered necessary 
Prilagoditev odmerka ni potrebna.
Caution is advised when administering colistimethate sodium to infants < 1 year of age as renal function is not fully mature in this age group. 
Pri dojenčkih, mlajših od 1 let, je treba natrijev kolistimetat uporabljati previdno, ker delovanje ledvic v tej starostni skupini še ni povsem dozorelo.
For dose preparation, particularly where combination of multiple vials is needed, reconstitution of the required dose must be performed using strict aseptic technique (see section 6.6). 
Za pripravo odmerka je treba uporabiti strogo aseptičen postopek, še zlasti kadar je potrebno uporabiti več vial (glejte poglavje
Maintenance dose 9MIU/day in 2-3 divided doses 
Odrasli in mladostniki Vzdrževalni odmerek 9 milijonov i.e./dan v 2 do 3 deljenih odmerkih
Species for which acquired resistance may be a problem 
Vrste, pri katerih je lahko problem pridobljena odpornost Stenotrophomonas maltophilia
Do not <take><use> [Product name] If you are allergic (hypersensitive) to colistimethate sodium, colistin or to other polymyxins. 
- Če ste alergični (preobčutljivi) na natrijev kolistimetat, kolistin ali druge polimiksine.
If you also take other inhaled medicines, your doctor will tell you which order to taken them in. 
vam bo zdravnik povedal, v kakšnem zaporedju jih uporabite.
The mechanism of conversion of colistimethate sodium to the active substance, colistin, is not characterised. 
Mehanizem pretvorbe natrijevega kolistimetata v zdravilno učinkovino kolistin ni razjasnjen.
CMS conversion table 
Preglednica za pretvorbo NKM Jakost
5.5-7.5 MIU 
Dnevni odmerek 5,5-7,5 Mi.e.
- If you suffer from myasthenia gravis - If you suffer from porphyria 
- če imate porfirijo.
Adults and adolescents 
Otroci, mlajši od 2 let
Both CMS and colistin display linear PK in the clinically relevant dose range. 
V klinično pomembnem razponu odmerkov imata tako NKM kot kolistin linearno farmakokinetiko.
Taking such medicines at the same time as [Product name] can increase the risk of side effects in your nervous system - medicines called muscle relaxants, often used during general anaesthesia. 
- zdravila, imenovana mišični relaksanti, ki se pogosto uporabljajo med splošno anestezijo.
[Product name] is used when these infections are cause by specific bacteria called Pseudomonas aeruginosa. 
Zdravilo [Ime zdravila] se uporablja, če te okužbe povzročajo posebne bakterije, imenovane
If you suffer from myasthenia gravis and are also taking other antibiotics called macrolides (such as azithromycin, clarithromycin or erythromycin) or antibiotics called fluoroquinolones (such as ofloxacin, norfloxacin and ciprofloxacin), taking [Product name] further increases the risk of muscle weakness and breathing difficulties. 
Če imate miastenijo gravis in jemljete tudi druge antibiotike, imenovane makrolidi (na primer azitromicin,
Respiratory arrest has been reported following intramuscular administration of colistimethate sodium. 
Po intramuskularni uporabi natrijevega kolistimetata je bil opisan zastoj dihanja.
MIU = million IU 
1-2 Mi.e.
IU 
≈ masa
Children < 2 years 0.5-1 MIU twice daily (max 2 MIU/ day) 
dvakrat na dan (največ 2 Mi.e./dan)
Caution is advised when administering colistimethate sodium in these patients. 
Pri teh bolnikih je treba natrijev kolistimetat uporabljati previdno.
• Balance of water and salts in your body. 
• Ravnovesje vode in soli v telesu.
The following measures will be taken where necessary: 
Če bo treba, bo uporabil naslednje ukrepe:
These parameters should be carefully monitored during treatment. 
Te parametre je treba med zdravljenjem skrbno kontrolirati.
If this happens to you, tell your doctor or nurse straight away. 
Če se vam to zgodi, morate takoj povedati zdravniku ali medicinski sestri.
The product information may be subsequently updated by the Member State competent authorities, in liaison with the Reference Member State, as appropriate, in accordance with the procedures laid down in Chapter 4 of Title III of Directive 2001/83/EC. 
Informacije o zdravilu lahko pozneje posodobijo pristojni organi države članice v sodelovanju z referenčno državo članico, kot je primerno, v skladu s postopki določenimi v Poglavju 4 Naslova III Direktive 2001/83/EC.
Your doctor will monitor your heart and your unborn baby. 
Zdravnik vam bo kontroliral srce in bo nadzoroval vašega nerojenega otroka.
You will receive <invented name> for a maximum of 48 hours. 
Zdravilo <izmišljeno ime> boste prejemali največ 48 ur.
This short term delay may be used to implement other measures known to improve perinatal health. 
Ta kratkotrajni odlog je mogoče izkoristiti za uporabo drugih ukrepov, ki izboljšajo perinatalno zdravje.
<invented name> is contra-indicated in the following conditions: 
Zdravilo <izmišljeno ime> je kontraindicirano v naslednjih primerih:
Your doctor may also take blood tests to monitor for changes in your blood (see section 3). 
Zdravnik lahko opravi tudi preiskave krvi za spremljanje sprememb v krvi (glejte poglavje 3).
*Hypotension (see section 4.4) *Peripheral vasodilatation. 
*hipotenzija (glejte poglavje 4.4) *periferna vazodilatacija
This includes herbal medicines. 
To velja tudi za zeliščna zdravila.
If you have ever experienced miscarriage in the first two trimesters of your pregnancy. 
če ste kdaj imeli spontan splav v prvih dveh trimesečjih nosečnosti.
<invented name> can have an effect on the way some medicines work, and some medicines can effect how <invented name> works. 
Zdravilo <izmišljeno ime> lahko vpliva na delovanje nekaterih zdravil in nekatera zdravila lahko vplivajo na delovanje zdravila <izmišljeno ime>.
This Summary of Product Characteristics, labelling and package leaflet is the outcome of the referral procedure. 
Ta Povzetek glavnih značilnosti zdravila, Označevanje in Navodilo za uporabo so rezultat napotitvenega postopka.
In the short term management of uncomplicated premature labour. 
Za kratkotrajno vodenje nezapletenega prezgodnjega poroda
This will give your doctor or midwife time to take extra measures that will improve the health of your baby. 
To bo zdravniku ali babici omogočilo, da uporabita dodatne ukrepe, ki bodo izboljšali otrokovo zdravje.
How to use <invented name> 
Kako uporabljati zdravilo <izmišljeno ime>
To temporarily delay premature labour 
Za začasno odložitev prezgodnjega poroda
Treatment should be discontinued, whenever possible, at least 6 hours before any scheduled anaesthesia with halogenated anaesthetics. 
Če je le mogoče, je treba zdravljenje prekiniti vsaj 6 ur pred predvideno anestezijo s halogeniranimi anestetiki.
Tell your doctor, nurse or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription. 
Jemanje drugih zdravil Obvestite zdravnika, medicinsko sestro ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo, vključno z zdravili, dobljenimi brez recepta.
The volume of fluid in which the drug is administered should thus be kept to a minimum. 
Količino tekočine, v kateri je aplicirano zdravilo, je zato treba omejiti na najmanjšo možno mero.
[The existing product information shall be amended (insertion, replacement or deletion of the text as appropriate) to reflect the agreed wording as provided below] 
[Obstoječe informacije o zdravilu bodo posodobljene (vstavitev, zamenjava ali izbris besedila, kot je primerno), tako da bodo odražale dogovorjeno besedilo, kot je predvideno spodaj]
• <invented name> is <also> used in women who have unexpectedly gone into early labour (premature labour) between the 22nd and 37th week of gestation, to provide a short delay in the early delivery of the baby. 
• Zdravilo <izmišljeno ime> se uporablja <tudi> pri ženskah, ki se jim je nepričakovano začel porod (prezgodnji porod) med 22. in 37. tednom nosečnosti, za zagotovitev kratkega odloga zgodnjega rojstva otroka.
B. Parenteral medicinal products for obstetric indications 
B. Parenteralna zdravila za porodniške indikacije
Systemic corticosteroids are frequently given during premature labour to enhance foetal lung development. 
Sistemski kortikosteroidi se med prezgodnjim porodom pogosto uporabljajo za pospešitev razvoja plodovih pljuč.
Falls in diastolic pressure are usually within the range of 10 to 20mmHg. 
Diastolični krvni tlak se po navadi zniža za 10 do 20 mmHg.
Do not have <invented name> if: you are less than 22 weeks pregnant 
Preden boste dobili zdravilo <izmišljeno ime> Zdravila <izmišljeno ime> ne smete prejeti: če ste noseči manj kot 22 tednov.
It will always be given to you by a person who is qualified to do so after careful consideration of the balance of benefits of <invented name> to your baby and the potential untoward effects the treatment may have on you. 
Tega zdravila si nikoli ne boste dali sami, Vedno vam ga bo dala usposobljena oseba, potem ko bo skrbno pretehtala razmerje med koristmi zdravila <izmišljeno ime> za vašega otroka in možnimi neželenimi učinki, ki bi jih zdravilo lahko imelo pri vas.
What <invented name> is and what it is used for. 
Kaj je zdravilo <izmišljeno ime> in za kaj ga uporabljamo
[Details on dose and infusion rate will need to be adapted to specifics for individual drug substances i.e. retained as is per product any reference to continuing treatment with oral maintenance therapy should be removed.] 
[Podrobnosti o odmerku in hitrosti infundiranja bo treba prilagoditi specifičnostim posamezne zdravilne učinkovine, tj. ohraniti kot je glede na zdravilo; morebitno referenco na nadaljevanje zdravljenja s peroralnim vzdrževalnim zdravljenjem je treba odstraniti.]
If there are changes in ECG recording and you have chest pain your doctor will stop the administration of <invented name>. 
Če so na EKG-posnetku prisotne spremembe in imate bolečino v prsih, bo zdravnik prekinil uporabo zdravila <izmišljeno ime>.
The most common undesirable effects of <invented name> are correlated with the betamimetic pharmacological activity and may be limited or avoided by a close monitoring of hemodynamic parameters, such as blood pressure and heart rate, and an appropriate adjustment of the dose. 
Najpogostejši neželeni učinki zdravila <izmišljeno ime> so povezani z betamimetičnim farmakološkim delovanjem in jih je mogoče zmanjšati ali se jim izogniti s skrbnim spremljanjem hemodinamskih parametrov, na primer krvnega tlaka in srčne frekvence, in z ustrezno prilagoditvijo odmerka.
The effect of infusion on foetal heart rate is less marked, but increases of up to 20 beats per minute may occur. 
Vpliv infundiranja na plodovo srčno frekvenco je manj izrazit, a pojavijo se lahko povečanja do 20 utripov na minuto.
If so, you may need some additional blood sugar tests when you are given <invented name>. 
V tem primeru boste med prejemanjem zdravila <izmišljeno ime> morda potrebovali dodatne meritve krvnega sladkorja.
In addition, any reference to the obstetric indications in all other sections of the Product information, for example in section 4.2 “Posology and methods of administration” of the Summary of Product characteristics, as well as any reference to the obstetric indications in the Package Leaflet should be removed] 
Poleg tega naj se odstrani vse reference, ki se nanašajo na porodničarske indikacije v vseh drugih poglavjih informacij o zdravilu, na primer v poglavju 4.2 “Odmerjanje in način uporabe” Povzetka glavnih značilnosti zdravila, kot tudi reference, ki se nanašajo na porodničarske indikacije v Navodilu za uporabo.]
In premature labour in a patient with known or suspected cardiac disease, a physician experienced in cardiology should assess the suitability of treatment before intravenous infusion with <invented name>. 
Če ima bolnica s prezgodnjim porodom znano srčno bolezen ali sum na takšno bolezen, mora zdravnik, izkušen na področju kardiologije, oceniti primernost zdravljenja pred začetkom intravenskega infundiranja zdravila <izmišljeno ime>.
Special cautions for infusion: The dose must be individually titrated with reference to suppression of contractions, increase in pulse rate and changes in blood pressure, which are limiting factors. 
Posebni previdnostni ukrepi za infundiranje: Odmerek je treba individualno titrirati glede na supresijo kontrakcij, povečanje srčne frekvence in spremembe krvnega tlaka, ki so omejujoči dejavniki.
[This section should replace any existing one which reflects the obstetric indications and should read as follows:] 
[To poglavje mora nadomestiti morebitno obstoječe poglavje, ki omenja porodničarske indikacije, in mora biti formulirano takole:]
Maternal blood pressure may fall slightly during the infusion; the effect being greater on diastolic than on systolic pressure. 
Materin krvni tlak se lahko med infundiranjem rahlo zniža; ta vpliv je izrazitejši na diastolični kot na sistolični krvni tlak.
If you are scheduled for surgery with general anaesthetics your doctor will stop the administration of <invented name> 6 hours before surgery whenever possible to protect you from adverse effects (e.g. irregular heart beat or bleeding of your womb). 
Če imate predvideno operacijo v splošni anesteziji, vam bo zdravnik nehal dajati zdravilo <izmišljeno ime> 6 ur pred operacijo, kadar koli je to mogoče, da bi vas obvaroval pred neželenimi učinki (npr. nerednim bitjem srca ali krvavitvijo v maternico).
Metabolism and nutrition disorders Common - *Hypokalaemia Rare - *Hyperglycaemia 
Presnovne in prehranske motnje Pogosti - *hipokaliemija Redki - *hiperglikemija
The following side effects have also been observed with all beta-agonists like <invented name> when used to delay premature labour. 
Naslednje neželene učinke so opažali tudi pri vseh agonistih adrenergičnih receptorjev beta, kakršno je zdravilo <izmišljeno ime>, če so bili uporabljeni za odložitev prezgodnjega poroda.
Important side effects to look out for when treated for premature labour: 
Pomembni neželeni učinki, na katere morate biti pozorni, če prejemate to zdravilo za prezgodnji porod:
<invented name> should be administered as early as possible after the diagnosis of premature labour, and after evaluation of the patient to eliminate any contra-indications to the use of <INN SABA> (see section 4.3). 
Zdravilo <izmišljeno ime> je treba uporabiti čim prej po diagnosticiranju prezgodnjega poroda in po preverjanju, da bolnica nima nobenih kontraindikacij za uporabo <INN SABA> (glejte poglavje 4.3).
This should include an adequate assessment of the patient's cardiovascular status with supervision of cardiorespiratory function and ECG monitoring throughout treatment (see section 4.4). 
To mora vključevati ustrezno ocenitev bolničinega kardiovaskularnega stanja z nadziranjem kardiorespiratorne funkcije in spremljanjem EKG med celotnim zdravljenjem (glejte poglavje 4.4).
Treatment should be discontinued if signs of myocardial ischaemia (such as chest pain or ECG changes) develop. 
Zdravljenje je treba prekiniti, če se pojavijo znaki ishemije miokarda (na primer bolečina v prsnem košu ali spremembe na EKG).
A controlled infusion device should be used, preferably a syringe pump. 
Uporabljati je treba pripomoček za kontrolirano infundiranje, po možnosti injekcijsko črpalko.
• Blood sugar level and the occurrence of low body pH with a build-up of lactate in your blood (also known as lactic acidosis) 
• Koncentracija krvnega sladkorja in pojav nizkega telesnega pH s kopičenjem laktat v krvi (to imenujemo tudi laktacidoza).
Annex III Amendments to relevant sections of the summary of product characteristics and package leaflets 
Spremembe ustreznih poglavij v povzetku glavnih značilnosti zdravila in navodilu za uporabo
[The wording below should be inserted in the relevant sections] 
[Spodnje besedilo je treba vnesti v ustrezna poglavja]
Anti-diabetics 
Antidiabetiki
A. Oral formulation medicinal products and suppositories 
A. Peroralne formulacije zdravil in svečke
Uncommon (affects less than 1 in 100 people) Fluid accumulation in the lungs (pulmonary oedema) which may cause difficulty breathing 
Občasni (pojavijo se pri manj kot 1 od 100 oseb) Kopičenje tekočine v pljučih (pljučni edem), ki lahko povzroči težave z dihanjem
It should be carried out in facilities adequately equipped to perform continuous monitoring of maternal and foetus health status. 
Izvajati ga je treba v ustanovah, ki so ustrezno opremljene za stalen nadzor zdravstvenega stanja matere in ploda.
Duration of treatment should not exceed 48 hours as data show that the main effect of tocolytic therapy is a delay in delivery of up to 48 hours; no statistically significant effect on perinatal mortality or morbidity has been observed in randomised, controlled trials. 
Podatki namreč kažejo, da je glavni učinek tokolitičnega zdravljenja odlog poroda do 48 ur; v randomiziranih, kontroliranih preskušanjih niso opazili statistično značilnega učinka na perinatalno umrljivost ali obolevnost.
<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