natgillin/translations-raw huggingface dataset:
Tylosin Biovet JSC 200 mg/ml solution for injection for cattle, sheep, goats and pigs
Tylosin Biovet JSC 200 mg/ml solution for govedo, koze, prašiči,
Milk from sheep is considered a minor food commodity, and in line with the CVMP guideline on safety and residue data requirements for pharmaceutical veterinary medicinal products intended for minor use or minor species (MUMS)/limited market (EMA/CVMP/SWP/66781/2005-Rev.1) extrapolation can be done from cow's milk to sheep milk.
Mleko ovac se šteje za manj pomembno živilo, karenca za ovčje mleko pa se lahko v skladu s smernicami odbora CVMP o zahtevah glede varnosti in podatkov o ostankih za zdravila za uporabo v veterinarski medicini, namenjena za manj pomembno uporabo ali uporabo pri manj pomembnih vrstah (MUMS)/na omejenem trgu (EMA/CVMP/SWP/66781/2005-Rev. 1), ekstrapolira s karenc za kravje mleko.
From this study, the injection site was confirmed as the withdrawal period determining tissue.
V tej študiji je bilo potrjeno, da je tkivo, ki določa karenco, mesto injiciranja.
Milk from sheep is, however, considered a minor food commodity, and withdrawal periods for sheep milk can be extrapolated from those for cows' milk, in accordance with the CVMP guideline on safety and residue data requirements for pharmaceutical veterinary medicinal products intended for minor use or minor species (MUMS)/limited market (EMA/CVMP/SWP/66781/2005-Rev.1).
Ovčje mleko pa se šteje za manj pomembno živilo in karenca zanj se lahko v skladu s smernicami odbora CVMP o zahtevah glede varnosti in podatkov o ostankih za zdravila za uporabo v veterinarski medicini, namenjena za manj pomembno uporabo ali uporabo pri manj pomembnih vrstah (MUMS)/na omejenem trgu (EMA/CVMP/SWP/66781/2005-Rev. 1), ekstrapolira s karence za kravje mleko.
10 Avenue De La Ballastiere 33500 Libourne France solution for injection for cattle, pigs, sheep and goat base injection goats, pigs, sheep
33500 Libourne France cattle, pigs, sheep and goat ovce pot
The reference product Tylan 200 has a sheep milk withdrawal period of 108 hours, and this is the same withdrawal period for the milk of cattle in most Member States for the same product.
Karenca za referenčno zdravilo Tylan 200 za ovčje mleko je 108 ur.
PHARMASIN 200 mg/ml oldatos injekció szarvasmarhák, juhok, kecskék és sertések részére
PHARMASIN 200 mg/ml oldatos injekció szarvasmarhák, juhok, kecskék és sertések
For sheep over 50 kg, the CVMP recommends that the dose is divided over two injection sites.
Odbor CVMP priporoča, da se pri ovcah, težjih od 50 kg, odmerek razdeli na dve mesti injiciranja.
Cattle, sheep, pigs, dogs, cats
Tilocen tilozinijev tartrat govedo, ovce, prašiči, psi, mačke
The European Commission issued a decision on 6 October 2009.
Evropska komisija je odločbo izdala dne 6. oktobra 2009.
Dr. Karl Broich (Germany)
Dr. Karl Broich (Nemčija)
Ref. EMA/CHMP/393579/2009 rev1 EMEA/H/A-29/1168
: EMA/CHMP/393579/2009 rev1 EMEA/H/A-29/1168
Co-rapporteur(s):
Soporočevalec(ci):
Dr. Concha Prieto Yerro (Spain)
Dr. Concha Prieto Yerro (Španija)
The grounds for the referral were that:
Razlogi za napotitev so bili:
London, 6 October 2009 Doc.
London, 6. oktobra 2009 Sklic dok.
Questions and answers on the referral for Fentrix and associated names 25, 50, 70 and 100 microgram/hour fentanyl transdermal patch
Vprašanja in odgovori v zvezi z napotitvijo za Fentrix in z njim povezana imena 25, 50, 70 in 100 mikrogramov/uro fentanil transdermalni obliž
It is used to treat severe long-term (chronic) pain which can only be adequately treated with opioid painkillers (medicines that are related to morphine).
Uporablja se za zdravljenje hudih, dolgotrajnih (kroničnih) bolečin, ki se jih da ustrezno zdraviti z zdravili proti bolečinam z opioidi (zdravili, ki so povezana z morfinom).
The review was carried out under an ‘Article 29' referral 1 .
Pregled je bil izveden v skladu z napotitvenim postopkom 1 .
This is a procedure when one Member State (the ‘reference Member State', in this instance Germany) assesses a medicine with a view of granting a marketing authorisation that will be valid in this country as well as in other Member States (the ‘concerned Member States', in this instance Austria, Belgium, Italy, the Netherlands, Portugal, Slovenia and Spain).
To je postopek, pri katerem ena država članica („referenčna država članica“, v tem primeru Nemčija) oceni zdravilo glede tega, ali se zanj lahko odobri dovoljenje za promet, ki bo veljavno v tej državi in drugih državah članicah („zadevnih državah članicah“, v tem primeru v Avstriji, Belgiji, Italiji, na Nizozemskem, Portugalskem, v Sloveniji in Španiji).
However, the Member States were not able to reach an agreement and the Spanish medicines regulatory agency referred the matter to the CHMP for arbitration on 4 May 2009.
Ker pa omenjene države članice niso dosegle soglasja, je španski regulatorni organ dne 4. maja 2009 zadevo napotil na CHMP v arbitražo.
Why was Fentrix reviewed?
Zakaj je bilo zdravilo Fentrix pregledano?
Based on the evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that the benefits of Fentrix outweigh its risks, and therefore the marketing authorisation for Fentrix should be granted in all concerned Member States.
CHMP je glede na oceno trenutno razpoložljivih podatkov in znanstveno razpravo znotraj odbora sklenil, da koristi zdravila Fentrix odtehtajo z njim povezana tveganja in da bi zato dovoljenje za promet moralo biti odobreno v vseh zadevnih državah članicah.
The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of Fentrix outweigh its risks, and the marketing authorisation can be granted in Germany and in the following Member States of the EU, Austria, Belgium, Italy, the Netherlands, Portugal, Slovenia and Spain.
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da koristi zdravila Fentrix odtehtajo z njim povezana tveganja in da se dovoljenje za promet z zdravilom lahko odobri v Nemčiji in naslednjih državah članicah Evropske unije: Avstriji, Belgiji, Italiji, na Nizozemskem, Portugalskem, v Sloveniji in Španiji.
This means that Fentrix is similar to a ‘reference medicine' already authorised in the European Union (EU) called Durogesic.
To pomeni, da je podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Durogesic.
• the non-clinical local irritation and how sensitive the skin was to Fentrix were not investigated in accordance with current CHMP guidelines.
• neklinično lokalno draženje in stopnja občutljivosti kože na Fentrix nista bila raziskana v skladu s trenutnimi smernicami CHMP.
Fentrix is a ‘generic medicine'.
Zdravilo Fentrix je „generično zdravilo“.
The active substance in Fentrix, fentanyl, is an opioid that acts on receptors in the brain and spinal cord to prevent pain.
Zdravilna učinkovina v zdravilu Fentrix, fentanil, je opioid, ki deluje na receptorje v možganih in hrbtenjači in tako preprečuje bolečino.
Helm Pharmaceuticals GmbH submitted Fentrix transdermal patch to Germany for a decentralised procedure.
Družba Helm Pharmaceutical GmbH je Nemčiji predložila zdravilo Fentrix transdermalni obliž v decentralizirani postopek.
What is Fentrix?
Kaj je zdravilo Fentrix?
The European Medicines Agency (EMEA) has completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of Fentrix transdermal patch and associated names.
Evropska agencija za zdravila (EMEA) je po nesoglasju med državami članicami Evropske unije glede odobritve zdravila Fentrix transdermalni obliž zaključila arbitražni postopek.
• that Fentrix did not show a comparable local skin tolerability to the reference medicine, Durogesic;
• za zdravilo Fentrix lokalna primernost za kožo, primerljiva z referenčnim zdravilom Durogesic ni bila dokazana;
Fentrix is a transdermal patch (device that delivers the drug across the skin) that contains the active substance fentanyl.
Zdravilo Fentrix je transdermalni obliž (ki dovaja zdravilo skozi kožo), ki vsebuje zdravilno učinkovino fentanil.
This medicine is the same as CoAprovel, which is already authorised in the European Union (EU).
To zdravilo je enako zdravilu CoAprovel, ki je že odobreno v Evropski uniji (EU).
The full EPAR for Irbesartan Hydrochlorothiazide Zentiva can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Irbesartan Hydrochlorothiazide Zentiva je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Irbesartan on its own has been approved in the EU since 1997 under the names Karvea and Aprovel.
Irbesartan je kot samostojno zdravilo v Evropski uniji (EU) odobren od leta 1997 pod imenoma Karvea in Aprovel.
The European Commission granted a marketing authorisation valid throughout the European Union for Irbesartan Hydrochlorothiazide Winthrop on 19 January 2007.
Evropska komisija je dovoljenje za promet z zdravilom Irbesartan Hydrochlorothiazide Winthrop, veljavno po vsej Evropski uniji, odobrila dne 19. januarja 2007.
The CHMP decided that Irbesartan Hydrochlorothiazide Zentiva's benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Irbesartan Hydrochlorothiazide Zentiva večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
For more information about treatment with Irbesartan Hydrochlorothiazide Zentiva, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Irbesartan Hydrochlorothiazide Zentiva preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
The most common side effects with Irbesartan Hydrochlorothiazide Zentiva (seen in between 1 and 10 patients in 100) are dizziness, nausea (feeling sick) or vomiting, abnormal urination, fatigue (tiredness), and increases in blood urea nitrogen (BUN, a breakdown product of protein), creatinine (a breakdown product of muscle) and creatine kinase (an enzyme found in muscles).
Najpogostejši neželeni učinki zdravila Irbesartan Hydrochlorothiazide Zentiva (opaženi pri 1 do 10 bolnikih od 100) so omotica, navzeja (slabost) ali bruhanje, nenormalno uriniranje, utrujenost in povečane vrednosti dušika sečnine v krvi (BUN, produkta razgradnje beljakovin), kreatinina (produkta metabolizma mišic) in kreatin kinaze (encima, ki ga najdemo v mišicah).
This is a summary of the European public assessment report (EPAR) for Irbesartan Hydrochlorothiazide Zentiva.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Irbesartan Hydrochlorothiazide Zentiva.
The company that makes CoAprovel has agreed that its scientific data can be used for Irbesartan Hydrochlorothiazide Zentiva.
Družba, ki izdeluje zdravilo CoAprovel, je dovolila, da se znanstveni podatki tega zdravila uporabijo tudi za zdravilo Irbesartan Hydrochlorothiazide Zentiva.
The name of the medicine was changed to Irbesartan Hydrochlorothiazide Zentiva on 6 February 2012.
Ime zdravila je bilo 6. februarja 2012 spremenjeno v Irbesartan Hydrochlorothiazide Zentiva.
The full list of these medicines is given in the package leaflet.
Za celoten seznam teh zdravil glejte navodilo za uporabo.
For the full list of all side effects reported with Irbesartan Hydrochlorothiazide Zentiva, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Irbesartan Hydrochlorothiazide Zentiva, glejte navodilo za uporabo.
The dose of Irbesartan Hydrochlorothiazide Zentiva to be used depends on the dose of irbesartan or hydrochlorothiazide that the patient was taking before.
Odmerek zdravila Irbesartan Hydrochlorothiazide Zentiva, ki ga naj bolnik jemlje, je odvisen od odmerka irbesartana ali hidroklorotiazida, ki ga je bolnik jemal prej.
Irbesartan Hydrochlorothiazide Zentiva must not be used in people who are hypersensitive (allergic) to irbesartan, hydrochlorothiazide, sulfonamides, or any of the other ingredients.
Zdravila Irbesartan Hydrochlorothiazide Zentiva ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) irbesartan, hidroklorotiazid, sulfonamide ali katero koli drugo sestavino zdravila.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Irbesartan Hydrochlorothiazide Zentiva.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Irbesartan Hydrochlorothiazide Zentiva, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
EPAR summary for the public irbesartan / hydrochlorothiazide
Povzetek EPAR za javnost irbesartan/hidroklorotiazid
Irbesartan Hydrochlorothiazide Zentiva in combination with aliskiren-containing medicines (used to treat essential hypertension) must not be used in patients with diabetes, or moderate or severe kidney impairment.
Zdravilo Irbesartan Hydrochlorothiazide Zentiva se v kombinaciji z zdravili, ki vsebujejo aliskiren (ki se uporablja za zdravljenje esencialne hipertenzije), ne sme uporabljati pri bolnikih s sladkorno boleznijo ali zmerno do hudo ledvično okvaro.
Irbesartan Hydrochlorothiazide Zentiva is used in adults who have essential hypertension (high blood pressure) that is not adequately controlled by irbesartan or hydrochlorothiazide alone.
Zdravilo Irbesartan Hydrochlorothiazide Zentiva se uporablja pri odraslih bolnikih z esencialno hipertenzijo (visokim krvnim tlakom), ki ni ustrezno uravnana z uporabo zgolj irbesartana ali zgolj hidroklorotiazida.
Care must be taken when using Irbesartan Hydrochlorothiazide Zentiva with other medicines that have an effect on blood potassium levels.
Posebna previdnost je potrebna, če se zdravilo Irbesartan Hydrochlorothiazide Zentiva jemlje sočasno z drugimi zdravili, ki vplivajo na koncentracijo kalija v krvi.
Other information about Irbesartan Hydrochlorothiazide Zentiva
Druge informacije o zdravilu Irbesartan Hydrochlorothiazide Zentiva
Previously known as Irbesartan Hydrochlorothiazide Winthrop.
Prej znano kot zdravilo Irbesartan Hydrochlorothiazide Winthrop.
Irbesartan Hydrochlorothiazide Zentiva must also not be used in patients who have severe liver, kidney or bile problems, blood potassium levels that are too low or blood calcium levels that are too high.
Zdravila Irbesartan Hydrochlorothiazide Zentiva prav tako ne smejo uporabljati bolniki s hudim obolenjem jeter, ledvic ali žolčnika ali bolniki s prenizko koncentracijo kalija v krvi ali s previsoko koncentracijo kalcija v krvi.
Irbesartan Hydrochlorothiazide Zentiva is a medicine that contains two active substances, irbesartan and hydrochlorothiazide.
Irbesartan Hydrochlorothiazide Zentiva je zdravilo, ki vsebuje dve zdravilni učinkovini, irbesartan in hidroklorotiazid.
25 mg hydrochlorothiazide once a day are not recommended.
Odmerki, večji od 300 mg irbesartana in 25 mg hidroklorotiazida enkrat dnevno, niso priporočeni.
What benefit has Irbesartan Hydrochlorothiazide Zentiva shown during the studies?
Kakšne koristi je zdravilo Irbesartan Hydrochlorothiazide Zentiva izkazalo med študijami?
Irbesartan Hydrochlorothiazide Zentiva was more effective than placebo (a dummy treatment) and than hydrochlorothiazide alone in reducing diastolic blood pressure.
Zdravilo Irbesartan Hydrochlorothiazide Zentiva je bilo pri zniževanju diastoličnega krvnega tlaka učinkovitejše od placeba (zdravila brez zdravilne učinkovine) in od hidroklorotiazida kot samostojnega zdravila.
Irbesartan Hydrochlorothiazide Zentiva contains two active substances, irbesartan and hydrochlorothiazide.
Zdravilo Irbesartan Hydrochlorothiazide Zentiva vsebuje dve zdravilni učinkovini, irbesartan in hidroklorotiazid.
What is the risk associated with Irbesartan Hydrochlorothiazide Zentiva?
Kakšna tveganja so povezana z zdravilom Irbesartan Hydrochlorothiazide Zentiva?
The studies of Karvea/Aprovel used with hydrochlorothiazide as separate tablets were used to support the use of Irbesartan Hydrochlorothiazide Zentiva.
V podporo uporabi zdravila Irbesartan Hydrochlorothiazide Zentiva so bile uporabljene študije z zdraviloma Karvea in Aprovel, uporabljenima skupaj s hidroklorotiazidom v ločenih tabletah.
Why has Irbesartan Hydrochlorothiazide Zentiva been approved?
Zakaj je bilo zdravilo Irbesartan Hydrochlorothiazide Zentiva odobreno?
Irbesartan Hydrochlorothiazide Zentiva may be added to some other treatments for hypertension.
Hydrochlorothiazide Zentiva se lahko uvede sočasno z nekaterimi drugimi zdravili za zdravljenje visokega krvnega tlaka.
What is Irbesartan Hydrochlorothiazide Zentiva?
Kaj je zdravilo Irbesartan Hydrochlorothiazide Zentiva?
How is Irbesartan Hydrochlorothiazide Zentiva used?
Kako se zdravilo Irbesartan Hydrochlorothiazide Zentiva uporablja?
How has Irbesartan Hydrochlorothiazide Zentiva been studied?
Kako je bilo zdravilo Irbesartan Hydrochlorothiazide Zentiva raziskano?
What is Irbesartan Hydrochlorothiazide Zentiva used for?
Za kaj se zdravilo Irbesartan Hydrochlorothiazide Zentiva uporablja?
How does Irbesartan Hydrochlorothiazide Zentiva work?
Kako zdravilo Irbesartan Hydrochlorothiazide Zentiva deluje?
7 - 21 days
7 - 21 dni
The following wording was adopted:
Sprejeto je bilo naslednje besedilo:
A precautionary measure would be to more frequently monitor the INR.
Previdnostni ukrep bi bil bolj pogosto spremljanje INR.
The usual dose for adults is one bottle bag once daily.
Običajen odmerek za odrasle je ena steklenica vreča enkrat na dan.
It is important that you complete the course of treatment, even if you begin to feel better after a few days.
Pomembno je, da se zdravljenje v celoti zaključi, tudi če se po nekaj dneh počutite bolje.
The text proposed for 4.4 was shortened in order to make it clearer.
Besedilo, predlagano za 4.4, so skrajšali zaradi jasnosti.
The major concern was the need for further qualification of the conditions of use.
Glavni zadržek je bila potreba po nadaljnjih določitvah pogojev uporabe.
If you are female or elderly, you may be more sensitive to ECG changes.
Če ste ženskega spola ali starejša oseba, ste lahko bolj občutljivi na EKG spremembe.
95, Marathonos Avenue 190-09 Pikermi Greece
95, Marathonos Avenue 190-09 Pikermi Grčija
Studies in rats (p.o. and i.v.)
Študije na podganah (p.o. in i.v.)
The recommended dose and duration of treatment should not be exceeded (see section 2.
Priporočenega odmerka in trajanja zdravljenja se ne sme preseči (glejte poglavje 2.
(Invented) Name Strength Pharmaceutical Form
(Izmišljeno) ime Jakost Farmacevtska oblika
Any prospective surveillance study would need to be very carefully designed such that data collected from year to year could be compared with some degree of confidence and the Applicant proposal would not fulfil this requirement.
Kakršna koli prospektivna študija nadzora bi morala biti skrbno načrtovana, tako da bi lahko podatke, zbrane leto za letom, primerjali z neko stopnjo zaupanja, predlagateljev predlog pa te zahteve ne bi izpolnil.
This medicinal product is authorised in the Member States of the EEA under the following names: Austria:
Zdravilo je v državah članicah EGP pridobilo dovoljenje za promet z naslednjimi imeni: Avstrija:
The infectious and inflammatory conditions, age and general status of the patient appear to be risk factors.
Zdi se, da so okužbe in vnetna stanja, starost in splošno stanje bolnika dejavniki tveganja.
The CHMP maintained its previous position.
CHMP je ohranil svoje predhodno mnenje.
If any such data was necessary, the Applicant should work with already established projects, adequately designed to collect reliable data prospectively.
Če bi bili tovrstni podatki potrebni, bi se moral predlagatelj zateči k že uveljavljenim projektom, ki so primerno oblikovani za prospektivno zbiranje zanesljivih podatkov.
After the Commission Decision the Member State Competent Authorities, in liaison with the Reference Member State, will update the product information as required.
Po odločbi komisij pristojnih organov oblasti v zadevnih državah članicah in v sodelovanju z referenčno državo, bodo podatki o zdravilu ustrezno posodobljeni.
The Applicant attended an oral explanation at the May 2009 CHMP, during which the Applicant argumentation and data previously submitted in the context of the written responses was re-iterated.
Predlagatelj se je maja 2009 udeležil ustnih pojasnil pred CHMP, kjer so znova preučili predlagateljevo argumentacijo in predhodno predložene podatke v obliki pisnih odgovorov.
If necessary, the oral anticoagulant dosage should be adjusted as appropriate.
Če je potrebno, je treba peroralni odmerek antikoagulanta ustrezno prilagoditi.
The CHMP maintained its previous position, as no new data was provided.
CHMP je ohranil svoje predhodno mnenje, saj novi podatki niso bili predloženi.
The CHMP and requested the Applicant to further discuss this issue.
CHMP je prosil predlagatelja za nadaljnjo razpravo o tem vprašanju.
The recommended total duration of intravenous and oral treatment is 7 - 14 days for CAP and 7 - 21 days for cSSSI.
Priporočeno skupno trajanje intravenskega in peroralnega zdravljenja je 7 do 14 dni za CAP in 7 do 21 dni za cSSSI.
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Upoštevati je treba uradne smernice glede primerne uporabe protibakterijskih učinkovin.
The duration of treatment depends upon the type of infection, and how well you respond to treatment but the recommended durations of use are:
Trajanje zdravljenja je odvisno od vrste okužbe in vašega odziva na zdravljenje; sicer se priporoča naslednje trajanje zdravljenja:
OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF OCTEGRA AND ASSOCIATED NAMES (SEE ANNEX I)
SPLOŠNI POVZETEK ZNANSTVENEGA VREDNOTENJA ZDRAVILA OCTEGRA IN Z NJIM POVEZANIH IMEN (GLEJTE DODATEK I)
Microbiological Susceptibility
Mikrobiološka občutljivost
The CHMP considered that the literature reviews were neither valid nor helpful.
CHMP je menil, da pregledi gradiva niso bili niti veljavni niti koristni.
Furthermore, appropriate infection control measures should be undertaken to reduce the risk of transmission.
Hkrati je treba zagotoviti ustrezen nadzor, da bi s tem zmanjšali prenos okužbe.
This medicinal product must not be mixed with other medicinal products except those mentioned in section
Zdravila se ne sme mešati z drugimi zdravili razen s tistimi, ki so omenjena v poglavju 6.6.
Streptococcus agalactiae (Group B)
Streptococcus agalactiae (skupina B)
On the basis of the pharmacokinetic studies carried out so far in patients with liver failure (Child Pugh A, B), it is not possible to determine whether there are any differences compared with healthy volunteers.
Na podlagi do sedaj opravljenih farmakokinetičnih študij pri bolnikih z okvaro jeter (Child-Pugh A, B), ni mogoče dokazati, ali obstajajo kakršnekoli razlike v primerjavi z zdravimi prostovoljci.
- Quinolone antibiotics may make your skin become more sensitive to sunlight or UV light.
Kinolonski antibiotiki lahko povzročijo večjo občutljivost vaše kože na sončno ali UV svetlobo.
- If you have a severe liver disease or liver enzymes (transaminases) that are higher than 5 times the upper normal limit.
če imate hudo jetrno bolezen ali zvečane vrednosti jetrnih encimov (transaminaz), ki za več kot petkrat presegajo zgornje normalne meje.
The corresponding peak concentration in alveolar macrophages amounted to 56.7 mg/kg.
Ustrezno največja koncentracija v alveolarnih makrofagih je 56,7 mg/kg.
The proposed restricted indication does not preclude the use of moxifloxacin for the initial treatment of CAP if in accordance with the local/regional/national guidance.
Predlagana omejena indikacija ne izključuje uporabe moksifloksacina pri začetnem zdravljenju izvenbolnišnično pridobljene pljučnice, če je v skladu z lokalnimi/regionalnimi/nacionalnimi smernicami.