natgillin/translations-raw huggingface dataset:
Co-treatment with colistimethate sodium and macrolides such as azithromycin and clarithromycin, or fluoroquinolones such as norfloxacin and ciprofloxacin should be undertaken with caution in patients with myasthenia gravis (see section 4.4).
Pri bolnikih z miastenijo gravis je potrebna previdnost v primeru sočasnega zdravljenja z natrijevim kolistimetatom in makrolidi, kot sta azitromicin in klaritromicin, ali fluorokinoloni, kot sta norfloksacin in ciprofloksacin (glejte poglavje 4.4).
Taking such medicines at the same time as [Product name] can increase the risk of damage to the kidneys.
Jemanje takšnih zdravil hkrati z zdravilom [Ime zdravila] lahko poveča tveganje za neželene učinke na živčevju.
As the development of resistance to intravenous colistin has been reported in particular when it is used as a monotherapy, co- administration with other antibacterial should also be considered in order to prevent the emergence of resistance.
Opisan je pojav odpornosti proti intravenskemu kolistinu, zlasti če je bil uporabljan kot monoterapija, zato pride v poštev tudi sočasna uporaba z drugim protibakterijskim zdravilom, da bi preprečili pojav odpornosti.
Concomitant use of intravenous colistimethate sodium with other medications that are potentially nephrotoxic or neurotoxic should be undertaken with great caution.
Natrijev kolistimetat je treba zelo previdno uporabljati sočasno z drugimi potencialno nefrotoksičnimi ali nevrotoksičnimi zdravili.
Your doctor will monitor your kidney function regularly while you receive [Product name].
Zdravnik vam bo med zdravljenjem z zdravilom [Ime zdravila] redno kontroliral delovanje ledvic.
Data supporting the posology are very limited.
Podatkov v podporo odmerjanju je zelo malo.
Older people Dose adjustment is not considered necessary
Starejše osebe Prilagoditev odmerka ni potrebna.
They may range from mild to lifethreatening in severity.
Segata lahko od blagih do smrtno nevarnih oblik.
Colistimethate sodium should be used with extreme caution in patients with porphyria.
Pri bolnikih s porfirijo je treba natrijev kolistimetat uporabljati skrajno previdno.
It is important to consider this diagnosis in patients who develop diarrhoea during or after the use of colistimethate sodium (see section 4.8).
Na to diagnozo treba pomisliti pri vsakem bolniku, ki se mu med uporabo natrijevega kolistimetata ali po njej pojavi driska (glejte poglavje 4.8).
Due to the effects of colistin on the release of acetylcholine, non-depolarising muscle relaxants should be used with caution in patients receiving colistimethate sodium as their effects could be prolonged (see section 4.4).
Zato je treba pri bolnikih, ki dobivajo natrijev kolistimetat, nedepolarizirajoče mišične relaksante uporabljati previdno, ker se njihovi učinki lahko podaljšajo (glejte poglavje 4.4).
Renal maturity should be taken into consideration when selecting the dose.
Pri izbiri odmerka je treba upoštevati dozorelost ledvic.
Colistin undergoes extensive renal tubular reabsorption and may either be cleared non-renally or undergo renal metabolism with the potential for renal accumulation.
Kolistin se v veliki meri reabsorbira v ledvičnih tubulih in se lahko odstrani neledvično ali se presnovi v ledvicah (s posledičnim možnim kopičenjem v ledvicah).
No specific dosing recommendation can be made in children for intrathecal and intraventricular routes of administration.
Za intratekalno in intraventrikularno pot uporabe pri otrocih ni mogoče dati specifičnih priporočil za odmerjanje.
Changes agreed by the CHMP to the Product Information of CMS-containing products for solution for inhalation or nebulisation
Spremembe, dogovorjene s CHMP za informacije o zdravilih za raztopino za inhaliranje ali za nebulizacijo, ki vsebujejo NKM
Consideration should be given to co-administering intravenous colistimethate sodium with another antibacterial agent whenever this is possible, taking into account the remaining susceptibilities of the pathogen(s) under treatment.
Kadar koli je mogoče, naj bi intravenski natrijev kolistimetat uporabili skupaj z drugim protibakterijskim zdravilom, upoštevaje preostale občutljivosti patogena/patogenov, zaradi katerih je potrebno zdravljenje.
The use of doses >150.000 IU/kg/day has been reported in children with cystic fibrosis.
Pri otrocih s cistično fibrozo je opisana uporaba odmerkov > 150.000 i.e./kg/dan.
Resistance
Odpornost (rezistenca)
No dose recommendations have been established in children with impaired renal function.
Za otroke z okvarjenim delovanjem ledvic ni oblikovanih priporočil za odmerjanje.
Monitoring should be performed for perioral paraesthesia and paraesthesia in the extremities, which are signs of overdose (see section
Bolnika je treba kontrolirati glede perioralnih parestezij in parestezij v okončinah, ki so znak prevelikega odmerjanja (glejte poglavje 4.9).
Note: The wording of this section should be revised for all SmPCs for products for intravenous administration of CMS/colistin to include the following statements:
Opomba: Besedilo tega poglavja je treba revidirati v povzetkih glavnih značilnosti vseh zdravil za intravensko uporabo NKM/kolistina, da bodo obsegala naslednje navedbe:
Note: The wording of this section should be revised for all SmPCs for products for intravenous administration of CMS/colistin to include the following warnings:
Opomba: Besedilo tega poglavja je treba revidirati v povzetkih glavnih značilnosti vseh zdravil za intravensko uporabo NKM/kolistina, da bodo obsegala naslednja opozorila:
EUCAST Breakpoints
Mejne vrednosti po EUCAST
It is estimated that approximately 30% of colistimethate sodium is converted to colistin in healthy subjects, its clearance is dependent on creatinine clearance and as renal function decreases, a greater portion of CMS is converted to colistin.
Očistek je odvisen od očistka kreatinina in z zmanjševanjem delovanja ledvic se večji delež NKM pretvori v kolistin.
Colistimethate sodium undergoes hydrolysis to the active substance colistin in aqueous solution.
Natrijev kolistimetat v vodni raztopini hidrolizira v zdravilno učinkovino kolistin.
There are no data in patients with hepatic impairment.
Okvara jeter Podatkov o bolnikih z okvaro jeter ni.
After infusion of colistimethate sodium the inactive pro-drug is converted to the active colistin.
Po infundiranju natrijevega kolistimetata se neaktivno predzdravilo pretvori v aktivni kolistin.
Confusion and medication errors have occurred because of the different expressions of dose in terms of potency.
Zaradi različnega izražanja odmerka glede na jakost so se pojavile zmeda in napake pri uporabi zdravila.
Having [Product name] as an infusion at the same time as receiving [Product name] as an inhalation can increase your risk of side effects.
Če dobite zdravilo [Ime zdravila] v infuziji in hkrati tudi v inhalaciji, to lahko poveča tveganje za neželene učinke.
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.