natgillin/translations-raw huggingface dataset:
The Committee also noted that the metabolites of metamizole pass into breastmilk in considerable amounts, and therefore recommended that repeated use of metamizole during breastfeeding should be avoided.
Odbor je upošteval tudi, da presnovki metamizola znatno prehajajo v materino mleko, zato je priporočil izogibanje večkratni uporabi metamizola ob dojenju.
• The Committee concluded that the posology recommendations for metamizole-containing medicinal products should be harmonised.
• Odbor je presodil, da je treba priporočila za odmerjanje zdravil, ki vsebujejo metamizol, uskladiti.
The active substance metamizole (also referred to as dipyrone) is a non-addictive pyrazole-type analgesic, spasmolytic and antipyretic drug with weak anti-inflammatory effects.
Učinkovina metamizol (imenovana tudi dipiron) je analgetik pirazolske vrste, ki ne povzroča zasvojenosti, spazmolitik in antipiretik s šibkim protivnetnim učinkom.
The Committee, as a consequence, recommends the variation to the terms of the marketing authorisations for metamizole-containing medicinal products.
Odbor posledično priporoča spremembo pogojev dovoljenj za promet z zdravili, ki vsebujejo metamizol.
The Committee also considered that metamizole containing medicinal products should be contraindicated in the third trimester of pregnancy due to the risks of fetal renal impairment and ductus arteriosus constriction.
Poleg tega je presodil tudi, da so zdravila, ki vsebujejo metamizol, v tretjem trimesečju nosečnosti kontraindicirana zaradi tveganja za okvaro ledvic pri plodu in konstrikcije arterioznega duktusa.
• The Committee reviewed the totality of the data submitted in relation to the maximum daily dose and the use of metamizole in pregnancy and breastfeeding.
• Odbor je pregledal vse predložene podatke v zvezi z največjim dnevnim odmerkom ter uporabo metamizola med nosečnostjo in dojenjem.
On 26 April 2018, Poland therefore triggered a referral under Article 31 of Directive 2001/83/EC, and requested the CHMP to assess all data available concerning the maximum daily dose and its contraindications on pregnancy and breastfeeding, and issue an opinion as to whether the relevant marketing authorisations should be varied.
Direktive 2001/83/ES in odbor CHMP zaprosila za oceno vseh razpoložljivih podatkov o največjem dnevnem odmerku ter kontraindikacijah med nosečnostjo in dojenjem ter izdajo mnenja o tem, ali je treba zadevna dovoljenja za promet z zdravilom spremeniti.
• The Committee considered the identified divergences in the product information of metamizole containing medicinal products, relating to the maximum daily dose and the use of metamizole in pregnancy and breastfeeding.
• Odbor je obravnaval prepoznana razhajanja v informacijah o zdravilih za zdravila, ki vsebujejo metamizol, v zvezi z največjim dnevnim odmerkom in uporabo metamizola med nosečnostjo in dojenjem.
Article 31 of Directive 2001/83/EC for metamizole-containing medicinal products
• Odbor za zdravila za uporabo v humani medicini (CHMP) je obravnaval napotitev v skladu s členom 31 Direktive 2001/83/ES za zdravila, ki vsebujejo metamizol.
Metamizole is available as tablets (film tablet or dispersible), oral drops, solution for injection, and suppositories.
Na voljo je v obliki tablet (filmske ali disperzibilne tablete), peroralnih kapljic, raztopine za injiciranje in svečk.
Poland considered that it is in the interests of the Union to harmonise the information regarding maximum daily dose and contraindications in pregnancy and breastfeeding in the product information of all metamizole-containing medicinal products in the EU.
Poljska je presodila, da je v interesu Evropske unije, da se za vsa zdravila v EU, ki vsebujejo metamizol, v informacijah o zdravilu uskladijo informacije o največjem dnevnem odmerku ter kontraindikacijah med nosečnostjo in dojenjem.
In the frame of a Non Urgent Information (NUI) request, the maximum daily dose and contraindications in pregnancy and breastfeeding were investigated for all metamizole-containing products authorised in European Union (EU).
V okviru zahtevka za nenujne informacije (NUI) so bili za vsa zdravila, ki vsebujejo metamizol in so odobrena v Evropski uniji (EU), proučeni največji dnevni odmerki ter kontraindikacije med nosečnostjo in dojenjem.
Based on the data assessed, the Committee recommended a parenteral single dose in adults and adolescents aged 15 years or over of 500 - 1,000 mg. A single dose can be taken up to 4 times daily at intervals of 6-8 hours leading to a maximum daily dose of 4,000 mg.
Na podlagi ocenjenih podatkov je odbor priporočil posamezen parenteralni odmerek pri odraslih in otrocih, starih 15 let ali več, ki je večji od 500-1 000 mg.
The recommended oral single dose in adults and adolescents aged 15 years or over is also 500 to 1,000 mg. A single dose can be taken up to 4 times daily at intervals of 6-8 hours leading to a maximum daily dose of 4,000 mg.
Tudi priporočeni posamezni peroralni odmerek pri odraslih in mladostnikih, starih 15 let ali več, je od 500 do 1 000 mg.
Your doctor will explain more.
Vaš zdravnik vam bo razložil več.
(See sections 4.2 and 5.3.)
(Glejte poglavji 4.2 in 5.3).
c Tested using alpha of 0.05.
c Testirano z alfa 0,05.
Elderly patients (≥ 65 years old)
Starejši bolniki (≥ 65 let)
Their frequency cannot be estimated from available data.
Njihove pogostnosti ni mogoče oceniti iz razpoložljivih podatkov.
These findings were more marked in young animals.
Ta učinek je bil izrazitejši pri mladih živalih.
Symptoms are listed in section 4.
Simptomi so našteti v poglavju 4.
Currently available data are described in sections 4.8, 5.1, 5.2 and 5.3 but no recommendation on a posology can be made.
Podatki, ki so trenutno na voljo, so opisani v poglavjih 4.8, 5.1, 5.2 in 5.3, vendar priporočil o odmerjanju ni mogoče dati.
- Depression or mental health problems.
- Depresija ali duševne zdravstvene težave
Repeat cycle
Ponovitev cikla
The ampoule is labelled in English only.
Ampula ima le nalepko v angleščini.
Other side effects can include:
Drugi neželeni učinki lahko vključujejo:
Important information to know before you start - Each ampoule is for single use only.
Pomembne informacije, ki jih morate vedeti pred začetkom - Vsaka ampula je samo za enkratno uporabo.
Avoid any unnecessary exercise as this might increase the risk of a tendon rupture.
Izogibajte se morebitni nepotrebni vadbi, saj lahko poveča tveganje za pretrganje tetive.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 26/03/2015
Datum prve odobritve: 26/03/2015
Your doctor may need to give you regular blood tests to check how well your blood can clot.
Vaš zdravnik bo morda redno opravljal krvne preiskave, s katerimi bo ugotovil, kako dobro se vaša kri strjuje.
- Resistance to antibiotics
- Odpornost na antibiotike
The patient should be observed and appropriate hydration maintained.
Bolnika je treba opazovati in ga ohranjati primerno hidriranega.
Via Martin Luther King, 13 20060 Pessano con Bornago (MI) Italy
Via Martin Luther King, 13 20060 Pessano con Bornago (MI) Italija
Patients who experience such symptoms should be advised not to drive or use machines.
Bolnikom, pri katerih se ti simptomi pojavijo, je treba svetovati, naj ne vozijo in ne uporabljajo strojev.
6) When all of the medicine has been delivered, you will hear two ‘beeps', which means the treatment is complete.
6) Ko je dostavljeno vse zdravilo, boste slišali dva piska, kar pomeni, da je zdravljenje končano.
Supportive studies
Podporne študije
Approximately 30 to 40% of levofloxacin is bound to serum protein.
Približno 30% do 40% levofloksacina je vezanega na beljakovine v serumu.
e P-value determined using a log-rank test.
e Vrednost P je bila določena s testom log-rank.
If the infection is not properly treated it will continue to damage the lungs, causing further problems with breathing.
Če se okužba ne zdravi ustrezno, še naprej kvari pljuča in tako povzroča nadaljnje težave z dihanjem.
Basic instructions for use are given below.
Spodaj so navedena osnovna navodila za uporabo.
Treatment will restart.
Zdravljenje se bo nadaljevalo.
Results obtained for the primary and key secondary endpoints are provided in Table 2.
Pridobljeni rezultati za primarne in ključne sekundarne opazovane dogodke so predstavljeni v preglednici 2.
- A severe allergic reaction.
- Huda alergijska reakcija.
If this happens to you, do not drive or use any tools or machines.
Če opazite te učinke, ne vozite in ne uporabljajte orodja ali strojev.
MARKETING AUTHORISATION NUMBER(S) EU/1/14/973/001
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/14/973/001
How and when do I replace the Zirela Nebuliser Handset?
Kako in kdaj naj zamenjam nebulator Zirela?
What if I am using several different inhalers and other therapies for cystic fibrosis?
Kaj, če uporabljam več različnih inhalatorjev in druga zdravila za cistično fibrozo?
Tell your doctor or a pharmacist if you are taking, have recently taken or might take any other medicines.
Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
Each ampoule is for single use only.
Vsaka ampula je samo za enkratno uporabo.
Study 207 (ITT)
Študija 207 (ITT)
How much do I use?
Koliko zdravila naj uporabim?
FEV1 percent predicted
Napovedani odstotek FEV1
Sometimes lengthy treatment with antibiotics can mean that you get another infection caused by other bacteria which are not affected by the antibiotic (superinfection).
Dolgotrajno zdravljenje z antibiotiki lahko včasih pomeni, da boste dobili še drugo okužbo, ki jo povzroča druga bakterija, na katero antibiotik ne vpliva (superinfekcija).
Pivotal Study - Study 209 (Core Phase; ITT)
Osrednja študija - študija 209 (osrednja faza; ITT)
Cyclical therapy may be continued for as long as the physician considers that the patient is obtaining clinical benefit.
S cikličnim zdravljenjem se lahko nadaljuje tako dolgo, dokler zdravnik ocenjuje, da ima bolnik klinične koristi.
* See paragraph below for further details.
* Za več podrobnosti glejte spodnji odstavek.
** See paragraph below for further details.
** Za več podrobnosti glejte spodnji odstavek.
- False test results
- Napačni rezultati preiskav
The frequency categories are defined using the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); and not known (cannot be estimated from the available data).
Kategorije pogostnosti so opredeljene v skladu z naslednjim dogovorom: zelo pogosti (≥ 1/10); pogosti (≥ 1/100 do < 1/10); občasni (≥ 1/1.000 do < 1/100); redki (≥ 1/10.000 do < 1/1.000); zelo redki (< 1/10.000); neznana (ni mogoče oceniti iz razpoložljivih podatkov).
Elderly patients and women may be more sensitive to QTc-prolonging medicinal products.
Starejši bolniki in ženske so morda bolj občutljivi na zdravila, ki podaljšajo interval QTc.
1) Make sure that the Zirela Nebuliser Handset is on a flat and stable surface.
1) Prepričajte se, da je nebulator Zirela postavljen na ravno in stabilno površino.
What if I need to stop my treatment before I've finished?
Kaj naredim, če moram predčasno ustaviti zdravljenje?
Prevention of photosensitisation
Preprečitev fotosensibilizacije
You then start another treatment course.
Nato začnite naslednji cikel zdravljenja.
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Pri zdravljenju je treba upoštevati uradne smernice o ustrezni uporabi protibakterijskih zdravil.
Quinsair should not be given to children and adolescents less than 18 years old as there is not enough information about its use in this age group.
Otroci in mladostniki, stari manj kot 18 let, zdravila Quinsair ne smejo uporabljati, saj ni dovolj podatkov o uporabi v tej starostni skupini.
1) When you start your treatment, sit in a relaxed, upright position.
1) Ob začetku zdravljenja sedite v sproščenem, vzravnanem položaju.
Interference with laboratory tests
Vpliv na laboratorijske preiskave
In the event of overdose, symptomatic treatment should be implemented.
V primeru prevelikega odmerjanja je treba uvesti simptomatsko zdravljenje.
Study 204 (ITT) a
Študija 204 (ITT) a
Women who take these types of medicines may be more likely to be affected.
Bolj pogosto so prizadete ženske, ki jemljejo te vrste zdravil.
Inhale this medicine at least 15 minutes or up to 4 hours before your next dose of Quinsair.
To zdravilo inhalirajte vsaj 15 minut ali do 4 ure pred naslednjim odmerkom zdravila Quinsair.
Interactions with CYP inhibitors or inducers are thus not expected.
Medsebojnega delovanja z zaviralci ali induktorji CYP zato ni pričakovati.
In addition to study drug, patients remained on standard of care treatment for chronic pulmonary infection.
Poleg študijskega zdravila so bolniki še naprej prejemali standardno oskrbo za kronično okužbo pljuč.
If you are diabetic, you should monitor your blood glucose levels carefully.
Če ste sladkorni bolnik, morate natančno spremljati svoje ravni glukoze v krvi.
Pain (including pain in back, chest and extremities)
bolečine (vključno z bolečinami v hrbtu, prsnem košu in udih)
If vision becomes impaired or any effects on the eyes are experienced, an eye specialist should be consulted immediately (see sections 4.7 and 4.8).
Če se pojavijo motnje vida ali se pojavijo kakršni koli učinki na očeh, se je treba nemudoma posvetovati s specialistom za oči (glejte poglavji 4.7 in 4.8).
4) Keeping the handset level, place the mouthpiece in your mouth and close your lips around it (Figure 3).
4) Nebulator držite ravno, dajte ustnik v usta in okoli njega zaprite ustnice (slika 3).
However, at the tested doses in the study, the statistically significant kinetic differences are unlikely to be of clinical relevance.
Toda pri odmerkih, testiranih v študiji, je malo verjetno, da bi bile statistično značilne razlike v kinetiki tudi klinično pomembne.
You will hear one ‘beep' and the status light will turn green.
Zaslišali boste pisk in statusna lučka se bo spremenila na zeleno.
Treatment Difference a
Razlika v zdravljenju na
These effects can be attributed to inhibition of topoisomerase II.
Te učinke je mogoče pripisati zaviranju topoizomeraze II.
Your risk is increased if you are elderly (above 60 years of age), have received an organ transplant, have kidney problems or if you are being treated with corticosteroids.
Tveganje se poveča, če ste starejši (nad 60 let), so vam presadili organ, imate težave z delovanjem ledvic ali se zdravite s kortikosteroidi.
Following systemic administration, the effect of race on levofloxacin pharmacokinetics was examined through a covariate analysis performed on data from 72 subjects: 48 white and 24 non-white.
Po sistemski uporabi so učinek rase na farmakokinetiko levofloksacina preučili s pomočjo analize sospremenljivk s podatki za 72 oseb: 48 belcev in 24 ne-belcev.
Levofloxacin may inhibit the growth of Mycobacterium tuberculosis and, therefore, may give false-negative results in the bacteriological diagnosis of tuberculosis.
Levofloksacin lahko zavira rast Mycobacterium tuberculosis in s tem povzroči lažno negativne rezultate pri bakteriološki diagnozi tuberkuloze.
Prolonged, disabling and potentially irreversible serious adverse drug reactions
Dolgotrajni, onesposabljajoči in potencialno ireverzibilni neželeni učinki
Based on these limited data, there does not appear to be any clinically relevant difference in the safety profile of Quinsair in these subsets of the paediatric population compared to adults.
Na podlagi teh omejenih podatkov ne kaže, da bi obstajale kliničino pomembne razlike v profilu varnosti zdravila Quinsair v teh podskupinah pediatrične populacije v primerjavi z odraslimi.
The parameters associated with the antibacterial effects of levofloxacin are the Cmax/MIC and AUC/MIC ratios (Cmax = maximum concentration at the site of infection, AUC = area under the curve and MIC = minimal inhibitory concentration).
Parametra, povezana s protibakterijskimi učinki levofloksacina, sta razmerji Cmax/MIC in AUC/MIC (Cmax = največja koncentracija na mestu okužbe, AUC = površina pod krivuljo (area under the curve) in MIC = minimalna inhibitorna koncentracija (minimal inhibitory concentration)).
The use of inhaled medicinal products may induce a cough reflex.
Uporaba inhalacijskih zdravil lahko izzove refleks kašlja.
The renal clearance of levofloxacin was reduced by cimetidine (24%) and probenecid (34%).
Ledvični očistek levofloksacina zmanjšata tako cimetidin (24%) kot tudi probenecid (34%).
Sit the patient in a relaxed, upright position.
Bolnik naj sedi v sproščenem, pokončnem položaju.
In patients treated with levofloxacin, determination of opiates in urine may give false-positive results.
Pri bolnikih, zdravljenih s levofloksacinom, so lahko rezultati določanja opiatov v urinu lažno pozitivni.
To conduct a non-interventional post-authorisation safety study in a registry of patients with cystic fibrosis to investigate the long term safety profile of Quinsair in normal clinical practice in the European Union.
Izvedba neintervencijske študije varnosti po pridobitvi dovoljenja za promet z zdravilom v registru bolnikov s cistično fibrozo za preučitev dolgoročnega profila varnosti za zdravilo Quinsair v običajni klinični praksi v Evropski uniji.
These metabolites account for ˂ 5% of the dose following systemic administration and are excreted in urine.
Ta dva presnovka predstavljata ˂ 5% odmerka po sistemski uporabi in se izločita z urinom.
Dornase alfa;
2. dornaza alfa,
This medicine does not require any special temperature storage conditions.
Za shranjevanje zdravila niso potrebni posebni temperaturni pogoji.
It may be necessary to confirm positive opiate screens by more specific methods.
Za potrditev pozitivnih izsledkov opiatov je morda treba uporabiti bolj specifično metodo.
Bacteria can become resistant to treatment with an antibiotic over time.
Sčasoma lahko bakterije postanejo odporne na zdravljenje z antibiotikom.
7) Once complete, open the medicine cap to ensure all of the medicine has been used.
7) Po koncu odprite pokrovček za zdravilo in preverite, ali ste porabili vse zdravilo.
Following oral and intravenous administration, levofloxacin is eliminated relatively slowly from the plasma (t1/2: 6 to 8 hours).
Po peroralni in intravenski uporabi se levofloksacin relativno počasi izloča iz plazme (t1/2 : 6 do 8 ur).
Once an ampoule is opened, the contents should be used immediately (see section 6.6).
Vsebino odprte ampule je treba uporabiti takoj (glejte poglavje 6.6).
Elimination is primarily by the renal route (> 85% of the dose following oral or intravenous administration).
Primarna pot izločanja je skozi ledvice (> 85% odmerka po peroralnem ali intravenskem dajanju).
How do I use the Zirela Nebuliser System?
Kako naj uporabljam sistem nebulatorja Zirela?
if you have experienced a previous episode of aortic dissection (a tear in the aorta wall).
če ste že kdaj doživeli epizodo aortne disekcije (raztrganina aortne stene);
- Do not swallow the liquid in the ampoule.
- Tekočine v ampuli ne smete zaužiti.
However, two cases of arthralgia have been observed in children in clinical studies with Quinsair and long-term safety data are missing especially considering the effects on cartilage observed in animals.
Vendar pa so pri otrocih v kliničnih študijah z zdravilom Quinsair opazili dva primera artralgije, dolgoročni podatki o varnosti pa manjkajo, zlasti ob upoštevanju učinkov na hrustanec, ki so jih ugotovili pri živalih.
* Adverse events with uncertain relatedness to Quinsair but which are known to be associated with systemic administration of levofloxacin and/or are plausibly associated with Quinsair and were reported more frequently than with placebo in clinical studies.
* Neželeni učinki, ki niso zagotovo povezani z zdravilom Quinsair, vendar je znano, da so povezani s sistemsko uporabo levofloksacina in/ali so verjetno povezani z zdravilom Quinsair ter so bili v kliničnih študijah poročani pogosteje kot pri placebu.
- A disease causing muscle weakness and fatigue called myasthenia gravis.
- Bolezen, ki povzroča mišično šibkost in utrujenost, imenovana miastenija gravis.
Median time to pulmonary exacerbation
Mediani čas do pljučnega poslabšanja
b LS Mean difference for Quinsair minus placebo.
b Povprečna razlika LS za zdravilo Quinsair minus placebo.
Tell your doctor if you are taking any of the following medicines: - Vitamin K antagonists such as warfarin (used to prevent blood clots).
Obvestite zdravnika, če uporabljate katero od naslednjih zdravil: - Antagoniste vitamina K, kot je varfarin (uporablja se za preprečevanje krvnih strdkov).
Stop using Quinsair and tell your doctor immediately: - if you experience pain, stiffness and/or swelling in your joints - if you develop problems with your liver.
Prenehajte uporabljati zdravilo Quinsair in takoj povejte zdravniku: - če se pojavi bolečina, togost in/ali oteklost sklepov - če se razvijejo težave z jetri.
Following systemic administration, there were no significant differences in levofloxacin pharmacokinetics between young and elderly subjects except those associated with age-related decreases in creatinine clearance.
Po sistemski uporabi ni bilo značilnih razlik v farmakokinetiki levofloksacina med mlajšimi in starejšimi osebami, razen tistih, ki so povezane z zmanjšanjem očistka kreatinina zaradi starosti.
- Superinfections
- Superinfekcije
- Nerve damage
- Poškodba živcev
A few drops of medicine may remain at the bottom of the reservoir at the end of treatment.
Na dnu vsebnika ob koncu zdravljenja lahko ostane nekaj kapljic zdravila.
The medicine comes in small 3 ml plastic ampoules.
Zdravilo je na voljo v majhnih 3 ml plastičnih ampulah.
You must inhale and exhale through the mouthpiece as before.
Kot prej morate vdihavati in izdihavati skozi ustnik.
Before taking this medicine
Pred uporabo tega zdravila
What Quinsair is and what it is used for
Kaj je zdravilo Quinsair in za kaj ga uporabljamo
Ask the patient to inhale and exhale through the mouthpiece until the treatment is finished.
Bolnika prosite, naj vdihava in izdihava skozi ustnik, dokler ni zdravljenje končano.
Quinsair may make your skin become more sensitive to sunlight.
Zdravilo Quinsair lahko povzroči večjo občutljivost kože na sončno svetlobo.
The mean post-dose sputum concentrations were approximately 500-1900 µg/ml and were approximately 400-1700 times higher than those observed in serum.
Povprečne koncentracije v sputumu po odmerku so bile približno 500-1.900 µg/ml in približno 400-1.700-krat višje kot v serumu.
The doses should be inhaled as close as possible to 12 hours apart.
Odmerke je treba inhalirati s presledkom, čim bližjim 12-urnemu.
System organ class Very common
Organski sistem Zelo pogosti
Pharmacokinetic parameter
Farmakokinetični parametri
Levofloxacin should be discontinued immediately at the first signs or symptoms of any serious adverse reaction and patients should be advised to contact their prescriber for advice.
Levofloksacin je treba prekiniti takoj ob prvih znakih ali simptomih kakršnih koli resnih neželenih učinkov, bolniku pa je treba svetovati, naj se posvetuje z zdravnikom, ki mu je zdravilo predpisal.
5th Inhaled steroids
5. inhalirani steroidi.
Pharmacotherapeutic group: antibacterials for systemic use, fluoroquinolones ATC code: J01MA12
Farmakoterapevtska skupina: zdravila za sistemsko zdravljenje bakterijskih infekcij, fluorokinoloni Oznaka ATC: J01MA12
The most frequently reported adverse reactions were cough/productive cough (54%), dysgeusia (30%) and fatigue/asthenia (25%).
Neželeni učinki, o katerih so najpogosteje poročali, so bili kašelj/produktivni kašelj (54%), disgevzija (30%) in utrujenost/astenija (25%).
It belongs to the group of antibiotics called fluoroquinolones.
Sodi v skupino antibiotikov, imenovanih fluorokinoloni.
When do I use it?
Kdaj naj zdravilo uporabim?
If the contents of the ampoule are swallowed, don't worry but tell your doctor as soon as possible.
Če vsebino ampule zaužijete, ne skrbite, a to čim prej povejte zdravniku.
Do not take any medicines to treat your diarrhoea without first checking with your doctor.
Ne uporabljajte nobenih zdravil za zdravljenje driske, ne da bi se prej posvetovali z zdravnikom.