natgillin/translations-raw huggingface dataset:
CoAprovel 300 mg/12.5 mg may be administered in patients insufficiently controlled by irbesartan 300 mg or by CoAprovel 150 mg/12.5 mg.
 Zdravilo CoAprovel 300 mg/12,5 mg je namenjeno bolnikom, pri katerih se krvni tlak med zdravljenjem s 300 mg irbesartana ali z zdravilom CoAprovel 150 mg/12,5 mg ni dovolj znižal.
Hypersensitivity to the active substances or to any of the excipients listed in section 6.1, or to other sulfonamide-derived substances (hydrochlorothiazide is a sulfonamide-derived substance) Second and third trimesters of pregnancy (see sections 4.4 and 4.6) Severe renal impairment (creatinine clearance < 30 ml/min) Refractory hypokalaemia, hypercalcaemia
Preobčutljivost na zdravilni učinkovini ali katero koli pomožno snov, navedeno v poglavju 6.1 ali na druge derivate sulfonamidov (hidroklorotiazid je derivat sulfonamidov).
NAME OF THE MEDICINAL PRODUCT CoAprovel 300 mg/12.5 mg tablets.
IME ZDRAVILA CoAprovel 300 mg/12,5 mg tablete
Loop diuretics are preferred to thiazides in this population.
Za te bolnike so bolj kot tiazidi primerni diuretiki
The addition of 12.5 mg hydrochlorothiazide to 300 mg irbesartan once daily in patients not adequately controlled on 300 mg irbesartan alone resulted in further placebo-corrected diastolic blood pressure reductions at trough (24 hours post-dosing) of 6.1 mm Hg.
Diastolični krvni tlak se je pri bolnikih, pri katerih zdravljenje s 300 mg irbesartana ni bilo dovolj učinkovito in so začeli jemati tudi po 12,5 mg hidroklorotiazida enkrat na dan, 24 ur po zaužitju odmerka znižal za povprečno 6,1 mmHg bolj kot po uporabi placeba.
The combination of 300 mg irbesartan and 12.5 mg hydrochlorothiazide resulted in an overall placebo-subtracted systolic/diastolic reductions of up to 13.6/11.5 mm Hg.
Med kombiniranim zdravljenjem s 300 mg irbesartana in 12,5 mg hidroklorotiazida se je sistolični krvni tlak znižal do 13,6 mmHg, diastolični pa do 11,5 mmHg bolj kot po uporabi placeba.
CoAprovel 300 mg/25 mg may be administered in patients insufficiently controlled by CoAprovel 300 mg/12.5 mg.
 Zdravilo CoAprovel 300 mg/25 mg je namenjeno bolnikom, pri katerih se krvni tlak med zdravljenjem z zdravilom CoAprovel 300 mg/12,5 mg ni dovolj znižal.
CoAprovel 300 mg/25 mg film-coated tablets are supplied in blister packs of 14, 28, 30, 56, 84, 90 or 98 film-coated tablets.
CoAprovel 300 mg/25 mg filmsko obložene tablete so na voljo v pretisnih omotih s 14, 28, 30, 56, 84, 90 ali 98 filmsko obloženimi tabletami.
Although not specifically studied with the CoAprovel, rebound hypertension has not been seen with either irbesartan or hydrochlorothiazide.
Posebnih študij z zdravilom CoAprovel ni, kljub temu pa povratnega zvišanja krvnega tlaka pri bolnikih, ki so jemali bodisi irbesartan bodisi hidroklorotiazid, po prenehanju jemanja zdravila niso opazili.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 300 mg of irbesartan and 25 mg of hydrochlorothiazide.
KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena filmsko obložena tableta vsebuje 300 mg irbesartana in 25 mg hidroklorotiazida.
EU/1/98/086/008 - 14 tablets EU/1/98/086/004 - 28 tablets EU/1/98/086/005 - 56 tablets EU/1/98/086/010 - 56 x 1 tablets EU/1/98/086/006 - 98 tablets
EU/1/98/086/008 - 14 tablet EU/1/98/086/004 - 28 tablet EU/1/98/086/005 - 56 tablet EU/1/98/086/010 - 56 x 1 tableta EU/1/98/086/006 - 98 tablet
Antigout medicinal products: dosage adjustments of antigout medicinal products may be necessary as hydrochlorothiazide may raise the level of serum uric acid.
Zdravila za zdravljenje protina: hidroklorotiazid lahko zveča serumsko koncentracijo sečne kisline, zato je treba v takem primeru odmerek zdravil za zdravljenje protina prilagoditi.
Each tablet of CoAprovel 150 mg/12.5 mg contains 150 mg irbesartan and 12.5 mg hydrochlorothiazide.
Ena CoAprovel 150 mg/12,5 mg tableta vsebuje 150 mg irbesartana in 12,5 mg hidroklorotiazida.
CoAprovel 150 mg/12.5 mg film-coated tablets are supplied in blister packs of 14, 28, 30, 56, 84, 90 or 98 film-coated tablets.
CoAprovel 150 mg/12,5 mg filmsko obložene tablete so na voljo v pretisnih omotih s 14, 28, 30, 56, 84, 90 ali 98 filmsko obloženimi tabletami.
Peach, biconvex, oval-shaped, with a heart debossed on one side and the number 2776 engraved on the other side.
Na eni strani imajo vtisnjeno obliko srca, na drugi pa vrezano številko 2776.
Peach, biconvex, oval-shaped, with a heart debossed on one side and the number 2775 engraved on the other side.
Na eni strani imajo vtisnjeno obliko srca, na drugi pa vrezano številko 2775.
Peach, biconvex, oval-shaped, with a heart debossed on one side and the number 2875 engraved on the other side.
Na eni strani imajo vtisnjeno obliko srca, na drugi pa vrezano številko 2875.
Peach, biconvex, oval-shaped, with a heart debossed on one side and the number 2876 engraved on the other side.
Na eni strani imajo vtisnjeno obliko srca, na drugi pa vrezano številko 2876.
EU/1/98/086/007 - 14 tablets EU/1/98/086/001 - 28 tablets EU/1/98/086/002 - 56 tablets EU/1/98/086/009 - 56 x 1 tablets EU/1/98/086/003 - 98 tablets
EU/1/98/086/007 - 14 tablet EU/1/98/086/001 - 28 tablet EU/1/98/086/002 - 56 tablet EU/1/98/086/009 - 56 x 1 tableta EU/1/98/086/003 - 98 tablet
Pink, biconvex, oval-shaped, with a heart debossed on one side and the number 2788 engraved on the other side.
Na eni strani imajo vtisnjeno obliko srca, na drugi pa vrezano številko 2788.
Each tablet of CoAprovel 300 mg/12.5 mg contains 300 mg irbesartan and 12.5 mg hydrochlorothiazide.
Ena CoAprovel 300 mg/12,5 mg tableta vsebuje 300 mg irbesartana in 12,5 mg hidroklorotiazida.
Each film-coated tablet of CoAprovel 150 mg/12.5 mg contains 150 mg irbesartan and 12.5 mg hydrochlorothiazide.
Ena CoAprovel 150 mg/12,5 mg filmsko obložena tableta vsebuje 150 mg irbesartana in 12,5 mg hidroklorotiazida.
CoAprovel 300 mg/12.5 mg film-coated tablets are supplied in blister packs of 14, 28, 30, 56, 84, 90 or 98 film-coated tablets.
CoAprovel 300 mg/12,5 mg filmsko obložene tablete so na voljo v pretisnih omotih s 14, 28, 30, 56, 84, 90 ali 98 filmsko obloženimi tabletami.
Cartons of 56 tablets in PVC/PVDC/Aluminium blisters.
Škatle s 56 tabletami v pretisnih omotih iz PVC/PVDC/aluminija.
CoAprovel 300 mg/25 mg film-coated tablets irbesartan/hydrochlorothiazide
CoAprovel 300 mg/25 mg filmsko obložene tablete irbesartan/hidroklorotiazid
Cartons of 14 tablets in PVC/PVDC/Aluminium blisters.
Škatle s 14 tabletami v pretisnem omotu iz PVC/PVDC/aluminija.
While this is not documented with CoAprovel, a similar effect should be anticipated.
Podoben učinek bi lahko pričakovali pri zdravljenju z zdravilom CoAprovel, čeprav to pri zdravljenju z njim ni bilo dokazano.
Cartons of 90 film-coated tablets in PVC/PVDC/Aluminium blisters.
Škatle z 90 filmsko obloženimi tabletami v pretisnih omotihv iz PVC/PVDC/aluminijai.
EU/1/98/086/023 - 14 tablets EU/1/98/086/024 - 28 tablets EU/1/98/086/031 - 30 tablets EU/1/98/086/025 - 56 tablets EU/1/98/086/028 - 56 x 1 tablets EU/1/98/086/026 - 84 tablets EU/1/98/086/034 - 90 tablets EU/1/98/086/027 - 98 tablets
EU/1/98/086/023 - 14 tablet EU/1/98/086/024 - 28 tablet EU/1/98/086/031 - 30 tablet EU/1/98/086/025 - 56 tablet EU/1/98/086/028 - 56 x 1 tableta EU/1/98/086/026 - 84 tablet EU/1/98/086/034 - 90 tablet EU/1/98/086/027 - 98 tablet
EU/1/98/086/011 - 14 tablets EU/1/98/086/012 - 28 tablets EU/1/98/086/029 - 30 tablets EU/1/98/086/013 - 56 tablets EU/1/98/086/014 - 56 x 1 tablets EU/1/98/086/021 - 84 tablets EU/1/98/086/032 - 90 tablets EU/1/98/086/015 - 98 tablets
EU/1/98/086/011 - 14 tablet EU/1/98/086/012 - 28 tablet EU/1/98/086/029 - 30 tablet EU/1/98/086/013 - 56 tablet EU/1/98/086/014 - 56 x 1 tableta EU/1/98/086/021 - 84 tablet EU/1/98/086/032 - 90 tablet EU/1/98/086/015 - 98 tablet
Cartons of 84 film-coated tablets in PVC/PVDC/Aluminium blisters.
Škatle s 84 filmsko obloženimi tabletami v pretisnih omotih iz PVC/PVDC/aluminija.
Cartons of 98 tablets in PVC/PVDC/Aluminium blisters.
Škatle z 98 tabletami v pretisnih omotih iz PVC/PVDC/aluminija.
Cartons of 56 x 1 film-coated tablets in PVC/PVDC/Aluminium perforated unit dose blisters.
Škatle s 56 x 1 filmsko obloženo tableto v perforiranih enoodmernih pretisnih omotih iz PVC/PVDC/aluminija.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 150 mg of irbesartan and 12.5 mg of hydrochlorothiazide.
KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena tableta vsebuje 150 mg irbesartana in 12,5 mg hidroklorotiazida.
CoAprovel 150 mg/12.5 mg film-coated tablets irbesartan/hydrochlorothiazide
CoAprovel 150 mg/12,5 mg filmsko obložene tablete irbesartan/hidroklorotiazid
Each film-coated tablet of CoAprovel 300 mg/12.5 mg contains 300 mg irbesartan and 12.5 mg hydrochlorothiazide.
Ena CoAprovel 300 mg/12,5 mg filmsko obložena tableta vsebuje 300 mg irbesartana in 12,5 mg hidroklorotiazida.
Cartons of 14 film-coated tablets in PVC/PVDC/Aluminium blisters.
Škatle s 14 filmsko obloženimi tabletami v pretisnem omotu iz PVC/PVDC/aluminija.
EU/1/98/086/016 - 14 tablets EU/1/98/086/017 - 28 tablets EU/1/98/086/030 - 30 tablets EU/1/98/086/018 - 56 tablets EU/1/98/086/019 - 56 x 1 tablets EU/1/98/086/022 - 84 tablets EU/1/98/086/033 - 90 tablets EU/1/98/086/020 - 98 tablets
EU/1/98/086/016 - 14 tablet EU/1/98/086/017 - 28 tablet EU/1/98/086/030 - 30 tablet EU/1/98/086/018 - 56 tablet EU/1/98/086/019 - 56 x 1 tableta EU/1/98/086/022 - 84 tablet EU/1/98/086/033 - 90 tablet EU/1/98/086/020 - 98 tablet
QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 300 mg of irbesartan and 12.5 mg of hydrochlorothiazide.
KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena filmsko obložena tableta vsebuje 300 mg irbesartana in 12,5 mg hidroklorotiazida.
Cartons of 28 tablets in PVC/PVDC/Aluminium blisters.
Škatle z 28 tabletami v pretisnih omotih iz PVC/PVDC/aluminija.
CoAprovel 150 mg/12.5 mg may be administered in patients whose blood pressure is not adequately controlled with hydrochlorothiazide or irbesartan 150 mg alone; CoAprovel 300 mg/12.5 mg may be administered in patients insufficiently controlled by irbesartan 300 mg or by CoAprovel 150 mg/12.5 mg.
Kadar je klinično primerno, se lahko razmisli o prehodu iz monoterapije na kombinirano zdravljenje:  Zdravilo CoAprovel 150 mg/12,5 mg je namenjeno bolnikom, pri katerih se zvišan krvni tlak med zdravljenjem samo s hidroklorotiazidom ali samo s 150 mg irbesartana ni dovolj znižal.
Cartons of 28 film-coated tablets in PVC/PVDC/Aluminium blisters.
Škatle z 28 filmsko obloženimi tabletami v pretisnih omotih iz PVC/PVDC/aluminija.
CoAprovel 300 mg/12.5 mg film-coated tablets irbesartan/hydrochlorothiazide
CoAprovel 300 mg/12,5 mg filmsko obložene tablete irbesartan/hidroklorotiazid
QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 300 mg of irbesartan and 12.5 mg of hydrochlorothiazide.
KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena tableta vsebuje 300 mg irbesartana in 12,5 mg hidroklorotiazida.
Each tablet contains: irbesartan 300 mg and hydrochlorothiazide 25 mg
Ena tableta vsebuje 300 mg irbesartana in 25 mg hidroklorotiazida.
Cartons of 56 x 1 tablets in PVC/PVDC/Aluminium perforated unit dose blisters.
Škatle s 56 x 1 tableto v perforiranih enoodmernih pretisnih omotih iz PVC/PVDC/aluminija.
Cartons of 98 film-coated tablets in PVC/PVDC/Aluminium blisters.
Škatle z 98 filmsko obloženimi tabletami v pretisnih omotih iz PVC/PVDC/aluminija.
CoAprovel is for oral use.
Uporablja se peroralno.
Ear and labyrinth disorders:
Ušesne bolezni, vključno z motnjami labirinta:
CoAprovel 150 mg/12.5 mg film-coated tablets.
IME ZDRAVILA CoAprovel 150 mg/12,5 mg filmsko obložene tablete
Nervous system disorders:
Bolezni živčevja:
Package leaflet: Information for the patient CoAprovel 300 mg/25 mg film-coated tablets irbesartan/hydrochlorothiazide
Navodilo za uporabo CoAprovel 300 mg/25 mg filmsko obložene tablete irbesartan/hidroklorotiazid
What CoAprovel looks like and contents of the pack CoAprovel 300 mg/25 mg film-coated tablets are pink, biconvex, oval-shaped, with a heart debossed on one side and the number 2788 engraved on the other side.
Izgled zdravila CoAprovel in vsebina pakiranja CoAprovel 300 mg/25 mg filmsko obložene tablete so rožnate barve, bikonveksne in ovalne oblike.
EU/1/98/086/011-015 EU/1/98/086/021 EU/1/98/086/029 EU/1/98/086/032
EU/1/98/086/011-015 EU/1/98/086/021
Each film-coated tablet contains 150 mg of irbesartan and 12.5 mg of hydrochlorothiazide.
Ena tableta vsebuje 150 mg irbesartana in 12,5 mg hidroklorotiazida.
Package leaflet: Information for the patient CoAprovel 150 mg/12.5 mg film-coated tablets irbesartan/hydrochlorothiazide
Navodilo za uporabo CoAprovel 150 mg/12,5 mg filmsko obložene tablete irbesartan/hidroklorotiazid
What CoAprovel looks like and contents of the pack CoAprovel 150 mg/12.5 mg film-coated tablets are peach, biconvex, oval-shaped, with a heart debossed on one side and the number 2875 engraved on the other side.
Izgled zdravila CoAprovel in vsebina pakiranja CoAprovel 150 mg/12,5 mg filmsko obložene tablete so breskove barve, bikonveksne in ovalne oblike.
Package leaflet: Information for the patient CoAprovel 300 mg/12.5 mg film-coated tablets irbesartan/hydrochlorothiazide
Navodilo za uporabo CoAprovel 300 mg/12,5 mg filmsko obložene tablete irbesartan/hidroklorotiazid
Film-coating:
Bolezni prebavil:
What CoAprovel looks like and contents of the pack CoAprovel 150 mg/12.5 mg tablets are peach, biconvex, oval-shaped, with a heart debossed on one side and the number 2775 engraved on the other side.
Izgled zdravila CoAprovel in vsebina pakiranja CoAprovel 150 mg/12,5 mg tablete so breskove barve, bikonveksne in ovalne oblike.
Package leaflet: Information for the patient CoAprovel 150 mg/12.5 mg tablets irbesartan/hydrochlorothiazide
Navodilo za uporabo CoAprovel 150 mg/12,5 mg tablete irbesartan/hidroklorotiazid
Package leaflet: Information for the patient CoAprovel 300 mg/12.5 mg tablets irbesartan/hydrochlorothiazide
Navodilo za uporabo CoAprovel 300 mg/12,5 mg tablete irbesartan/hidroklorotiazid
Lot
Čet
dizziness
zardevanje
Tablet core:
Žilne bolezni:
Hypromellose Titanium dioxide Macrogol 3350
Filmska obloga: laktoza monohidrat hipromeloza titanov dioksid makrogol 3350 rdeči in črni železov oksid karnauba vosek
(It is also better to avoid CoAprovel in early pregnancy - see pregnancy section) if you have severe liver or kidney problems if you have difficulty in producing urine if your doctor determines that you have persistently high calcium or low potassium levels in your blood if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren.
Ne jemljite zdravila CoAprovel če ste alergični na irbesartan ali katero koli sestavino tega zdravila (navedeno v poglavju 6) če ste alergični na hidroklorotiazid ali druga zdravila, ki vsebujejo derivate sulfonamida če ste noseči dlje kot tri mesece (Jemanju zdravila CoAprovel se je bolje izogniti tudi med zgodnjo nosečnostjo - glejte poglavje o nosečnosti) če imate hudo okvaro jeter ali ledvic če imate težave z odvajanjem seča če je zdravnik ugotovil, da imate stalno zvečano koncentracijo kalcija ali zmanjšano koncentracijo kalija v krvi če imate sladkorno bolezen ali okvarjeno delovanje ledvic in se zdravite z zdravilom za znižanje krvnega tlaka, ki vsebuje aliskiren.
What CoAprovel looks like and contents of the pack CoAprovel 300 mg/12.5 mg film-coated tablets are peach, biconvex, oval-shaped, with a heart debossed on one side and the number 2876 engraved on the other side.
Izgled zdravila CoAprovel in vsebina pakiranja CoAprovel 300 mg/12,5 mg filmsko obložene tablete so breskove barve, bikonveksne in ovalne oblike.
Excipient with known effect: Each film-coated tablet contains 38.5 mg of lactose (as lactose monohydrate).
Ena filmsko obložena tableta vsebuje 38,5 mg laktoze (v obliki laktoze monohidrata).
37100 Tours - France
F-75008 Paris - Francija
flushing
omotica
Do not take CoAprovel if you are allergic to irbesartan or any of the other ingredients of this medicine (listed in section 6) if you are allergic to hydrochlorothiazide or any other sulfonamide-derived medicines if you are more than 3 months pregnant.
Ne jemljite zdravila CoAprovel če ste alergični na irbesartan ali katero koli sestavino tega zdravila (navedeno v poglavju 6) če ste alergični na hidroklorotiazid ali druga zdravila, ki vsebujejo derivate sulfonamida če ste noseči dlje kot tri mesece (Jemanju zdravila CoAprovel se je bolje izogniti tudi med zgodnjo nosečnostjo - glejte poglavje o nosečnosti) če imate hudo okvaro jeter ali ledvic če imate težave z odvajanjem seča če je zdravnik ugotovil, da imate stalno zvečano koncentracijo kalcija ali zmanjšano koncentracijo kalija v krvi če imate sladkorno bolezen ali okvarjeno delovanje ledvic in se zdravite z zdravilom za znižanje krvnega tlaka, ki vsebuje aliskiren.
What CoAprovel looks like and contents of the pack CoAprovel 300 mg/12.5 mg tablets are peach, biconvex, oval-shaped, with a heart debossed on one side and the number 2776 engraved on the other side.
Izgled zdravila CoAprovel in vsebina pakiranja CoAprovel 300 mg/12,5 mg tablete so breskove barve, bikonveksne in ovalne oblike.
if you are taking any of the following medicines used to treat high blood pressure: o an ACE-inhibitor (for example enalapril, lisinopril, ramipril), in particular if you have diabetes-related kidney problems.
 če imate težave s srcem  če imate težave z jetri  če imate sladkorno bolezen  če imate eritematozni lupus (znan tudi kot lupus ali sistemski eritematozni lupus) če imate primarni aldosteronizem (stanje, povezano s čezmernim izločanjem hormona aldosterona, kar povzroči zastajanje natrija in posledično zvišanje krvnega tlaka) če jemljete katero od naslednjih zdravil, ki se uporabljajo za zdravljenje visokega krvnega tlaka: o zaviralec ACE (na primer enalapril, lizinopril ali ramipril), zlasti če imate kakšne težave z ledvicami, ki so povezane s sladkorno boleznijo.
fever
Plodnost
Treatment is given for 5 to 14 days.
Zdravljenje traja pet do 14 dni.
The main measure of effectiveness in both studies was whether the infection was cured.
Glavno merilo učinkovitosti v obeh študijah je bilo, ali je bila okužba ozdravljena.
Further information on Quofenix can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/quofenix.
Nadaljnje informacije za zdravilo Quofenix so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/quofenix.
As a result, the bacteria cannot multiply and die.
Posledično se bakterije ne morejo razmnoževati in odmrejo.
Quofenix must not be used in children or adolescents under 18 years of age.
Zdravilo Quofenix se ne sme uporabljati pri otrocih ali mladostnikih, mlajših od 18 let.
It must not be used in women who are pregnant or breast feeding, or women who are able to have children who are not using contraception.
Ne sme se uporabljati pri ženskah, ki so noseče ali dojijo, ali pri ženskah, ki lahko zanosijo, a ne uporabljajo kontracepcije.
The European Medicines Agency decided that Quofenix's benefits are greater than its risks and it can be authorised for use in the EU.
Evropska agencija za zdravila je zaključila, da so koristi zdravila Quofenix večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
What measures are being taken to ensure the safe and effective use of Quofenix?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Quofenix?
As for all medicines, data on the use of Quofenix are continuously monitored.
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Quofenix stalno spremljajo.
After starting with a drip, the doctor may decide to switch to a tablet by mouth once every 12 hours.
Zdravljenje se začne s kapalno infuzijo, nato pa se zdravnik lahko odloči za prehod na jemanje tablet, in sicer ena tableta peroralno vsakih 12 ur.
Side effects reported with Quofenix are carefully evaluated and any necessary action taken to protect patients.
Neželeni učinki, o katerih so poročali pri zdravilu Quofenix, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
Quofenix is available as a powder to be made into a solution for infusion (300 mg) and as tablets (450 mg).
Zdravilo Quofenix je na voljo v obliki praška za pripravo raztopine za infundiranje (300 mg) in v obliki tablet (450 mg).
Since Quofenix's safety profile was similar to that of other fluoroquinolones, it was considered that, as for other fluoroquinolones, it should be authorised for use only when other antibiotics are not suitable.
Ker je varnostni profil zdravila Quofenix podoben varnostnemu profilu drugih fluorokinolonov, se šteje, da bi bilo treba, tako kot pri drugih fluorokinolonih, uporabo dovoliti samo, če drugi antibiotiki niso primerni.
Fluoroquinolones work by preventing bacteria involved in skin infections from making copies of their DNA (genetic material).
Fluorokinoloni delujejo tako, da bakterijam, ki sodelujejo pri okužbah kože, preprečujejo kopiranje njihove DNK (genetskega materiala).
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Quofenix have been included in the summary of product characteristics and the package leaflet.
Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Quofenix upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
Other information about Quofenix
Druge informacije o zdravilu Quofenix
For more information about using Quofenix, see the package leaflet or contact your doctor or pharmacist.
Za več informacij glede uporabe zdravila Quofenix glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
It contains the active substance delafloxacin.
Vsebuje učinkovino delafloksacin.
Quofenix has a different chemical structure to other fluoroquinolones, which means that it can enter bacterial cells more easily.
Zdravilo Quofenix ima drugačno kemijsko strukturo kot drugi fluorokinoloni, kar pomeni, da lažje vstopa v bakterijske celice.
Why is Quofenix authorised in the EU?
Zakaj je bilo zdravilo Quofenix odobreno v EU?
The active substance in Quofenix, delafloxacin, belongs to a group of antibiotics called fluoroquinolones.
Učinkovina v zdravilu Quofenix, delafloksacin, spada v skupino antibiotikov, imenovanih fluorokinoloni.
An overview of Quofenix and why it is authorised in the EU
Pregled zdravila Quofenix in zakaj je odobreno v EU
Quofenix was shown to be as effective as alternative antibiotics in two main studies of adults with acute bacterial skin and skin structure infections.
Zdravilo Quofenix se je izkazalo za enako učinkovito kot alternativni antibiotiki v dveh glavnih študijah pri odraslih z akutno bakterijsko okužbo kože in kožnih struktur.
Quofenix must not be used in patients who are hypersensitive (allergic) to quinolone or fluoroquinolone antibiotics or in patients who have had tendon disorders related to treatment with a fluoroquinolone antibiotic.
Zdravilo Quofenix se ne sme uporabljati pri bolnikih, ki so preobčutljivi za (alergični na) kinolonske ali fluorokinolonske antibiotike, ali pri bolnikih, ki so imeli težave s kitami, povezane z zdravljenjem s fluorokinolonskimi antibiotiki.
Quofenix is an antibiotic used in adults to treat bacterial infections of the skin and underlying tissues (acute bacterial skin and skin structure infections) when other medicines are not suitable.
Zdravilo Quofenix je antibiotik, ki se uporablja pri odraslih za zdravljenje bakterijskih okužb kože in podkožnih tkiv (akutnih bakterijskih okužbe kože in kožnih struktur), kadar druga zdravila niso primerna.
What benefits of Quofenix have been shown in studies?
Kakšne koristi zdravila Quofenix so se pokazale v študijah?
The most common side effects with Quofenix (which may affect up to 1 in 10 people) are diarrhoea and nausea (feeling sick), which are mild to moderate.
Najpogostejša neželena učinka zdravila Quofenix (ki se lahko pojavita pri največ 1 od 10 bolnikov) sta driska in navzeja (siljenje na bruhanje), ki pa sta blaga do zmerna.
What is Quofenix and what is it used for?
Kaj je zdravilo Quofenix in za kaj se uporablja?