FrancophonIA/ELRC3.0 huggingface dataset:
English: 5 CVMP note for guidance on the approach towards harmonisation of withdrawal periods (EMEA/CVMP/036/95) - link the influence of increasing the injection volume/site of injection on the absorption rate is difficult to quantify.
Slovenian: 5 CVMP note for guidance on the approach towards harmonisation of withdrawal periods (EMEA/CVMP/036/95) - link za več kot 250 %.
English: However, as the injection site is the withdrawal period determining tissue, for the product containing polyethylene glycol 400 (Tilocen, marketing authorisation holder: A. Nikolakopoulos S.A), and in view of the effect of this excipient on product viscosity, a different rate of absorption of residues from the injection site cannot be ruled out.
Slovenian: Ker pa je tkivo, ki določa trajanje karence, mesto injiciranja, za zdravilo, ki vsebuje polietilenglikol 400 (zdravilo Tilocen, imetnik dovoljenja za promet z zdravilom: A. Nikolakopoulos, S.A), in glede na učinek te pomožne snovi na viskoznost zdravila ni mogoče izključiti drugačne hitrosti absorpcije ostankov z mesta injiciranja.
English: 1 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)https://www.ema.europa.eu/documents/scientific-guideline/guideline-safety-residue-data-requirements-pharmaceuticalveterinary-medicinal-products-intended/limited-market_en.pdf the CVMP in the interests of protecting consumer safety in the Union, and requested the Committee to review all available residue depletion data and recommend withdrawal periods for sheep (meat and offal, and milk).
Slovenian: 1 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)https://www.ema.europa.eu/documents/scientific-guideline/guideline-safety-residue-data-requirements-pharmaceuticalveterinary-medicinal-products-intended/limited-market_en.pdf uporabo v veterinarski medicini (CVMP), ter zahtevala, da Odbor pregleda vse razpoložljive podatke o izločanju ostankov in priporoči karence pri ovcah (za meso, organe in mleko).
English: At day 21 after the last dose was administered, the residue concentrations in the injection site were all below the established MRL for tylosin in sheep meat, of 100 µg/kg.
Slovenian: 21. dan po dajanju zadnjega odmerka so bile vse koncentracije ostankov na mestu injiciranja pod mejno vrednostjo ostankov za tilozin v mesu ovac, ki znaša 100 µg/kg.
English: A GLP compliant residue depletion study was provided by one of the marketing authorisation holders involved in the procedure, and while a number of shortcoming on the study design were identified, the data allowed the recommendation to have a 42 day withdrawal period for meat and offal for 49 out of the 50 concerned products, i.e., for products containing 50 mg/ml and 200 mg/ml tylosin as a solution for injection for intramuscular use in sheep, containing benzyl alcohol and propylene glycol as excipients.
Slovenian: Čeprav so bile pri pregledu načrta študije ugotovljene številne pomanjkljivosti, so podatki omogočili določitev 42-dnevne karence za meso in organe za 49 od 50 zadevnih zdravil, tj. za zdravila, ki vsebujejo 50 mg/ml in 200 mg/ml tilozina v obliki raztopine za injiciranje za intramuskularno uporabo pri ovcah, ki kot pomožni snovi vsebujejo benzilalkohol in propilenglikol.
English: Cattle,
Slovenian: ovce
English: The remaining product contains polyethylene glycol 400 instead of propylene glycol.
Slovenian: Preostalo zdravilo namesto propilenglikola vsebuje polietilenglikol 400.
English: Given that the viscosities of propylene glycol and polyethylene glycol 400 are different, a significant impact on the absorption and residue depletion from the injections site, and consequently on the withdrawal periods cannot be excluded.
Slovenian: Glede na to, da sta viskoznosti propilenglikola in polietilenglikola 400 različni, ni mogoče izključiti pomembnega vpliva na absorpcijo in izločanje ostankov z mesta injiciranja ter posledično na karence.
English: DOSAGE FOR EACH SPECIES, ROUTE AND METHOD OF ADMINISTRATION For sheep over 50 kg of bodyweight, the injection should be divided over two injection sites (maximum 2.5 ml injection volume per injection site).
Slovenian: ODMERKI ZA POSAMEZNE ŽIVALSKE VRSTE TER POT(I) IN NAČIN UPORABE ZDRAVILA Pri ovcah s telesno maso več kot 50 kg je treba injiciranje razdeliti na dve mesti injiciranja (največ 2,5 ml volumna injiciranja na mesto injiciranja).
English: BOVINS OVINS CAPRINS ET PORCINS
Slovenian: CAPRINS ET PORCINS
English: All references to target species sheep should be deleted from the summary of product characteristics, labelling and package leaflet.
Slovenian: Iz povzetka glavnih značilnosti zdravila, označevanja in navodila za uporabo je treba izbrisati vse navedbe za ciljno vrsto ovce.
English: Nevertheless, it has been reported that the rate of absorption from the injection site depends on a number of factors (e.g. injection volume, excipients, lipophilicity of the active substance), and without specific residue data,
Slovenian: Kljub temu so poročali, da je hitrost absorpcije na mestu injiciranja odvisna od številnih dejavnikov (npr. volumna injiciranja, pomožnih snovi, lipofilnosti učinkovine), zato je brez specifičnih podatkov o ostankih težko izmeriti vpliv povečanja volumna injiciranja/mesta injiciranja na hitrost absorpcije.
English: No proprietary residue depletion studies in ewes were submitted.
Slovenian: Predložena ni bila nobena lastniška študija o izločanju ostankov pri ovčjih samicah.
English: Although a number of shortcoming were identified from this study (more specifically that the number of treated animals (n=3) was below the number required in VICH GL 48, animals were very young (12 kg mean bw), and also the sampling of the injection site did not include an outer ring sample), the results showed that the injection site is the withdrawal period determining tissue and results from this residue study have been used for establishing the withdrawal periods for 49 out of the 50 products concerned.
Slovenian: Zato podatkov iz te študije, iz zgoraj navedenega razloga, ni bilo mogoče ekstrapolirati na edino zdravilo, ki vsebuje pomožno snov polietilenglikol 400 (zdravilo Tilocen, imetnik dovoljenja za promet z zdravilom: A. Nikolakopoulos, S.A) Čeprav so bile v tej študiji ugotovljene številne pomanjkljivosti (natančneje, število zdravljenih živali (n = 3) je bilo manjše od števila, zahtevanega v smernicah VICH GL 48, živali so bile zelo mlade (povprečna telesna masa 12 kg), poleg tega pa vzorčenje na mestu injiciranja ni vključevalo vzorca zunanjega obroča), so rezultati pokazali, da je tkivo, ki določa karenco, mesto injiciranja, rezultati iz te študije ostankov pa so bili uporabljeni za določitev karence za 49 od 50 zadevnih zdravil.
English: 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)1 allows extrapolation of the withdrawal period between animal species, but only from a major species to a minor species.
Slovenian: Smernice odbora CVMP o zahtevah glede podatkov o varnosti in 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)1, omogočajo ekstrapolacijo karence med živalskimi vrstami, vendar le z glavne vrste na manj pomembno vrsto.
English: For the product containing the excipient polyethylene glycol 400 (Tilocen, marketing authorisation holder: A. Nikolakopoulos S.A), no suitable residue depletion data are available for establishing a withdrawal period for sheep meat, offal, and milk.
Slovenian: Za zdravilo, ki vsebuje pomožno snov polietilenglikol 400 (zdravilo Tilocen, imetnik dovoljenja za promet z zdravilom: A. Nikolakopoulos, S.A), ni na voljo ustreznih podatkov o izločanju ostankov za določitev karence za meso, organe in mleko ovac.
English: Residue depletion in sheep meat and offal
Slovenian: Izločanje ostankov iz mesa in organov ovac
English: Therefore the Committee used the ‘alternative' method for determining the withdrawal period, in line with CVMP note for guidance on the approach towards harmonisation of withdrawal periods (EMEA/CVMP/036/95)5.
Slovenian: Zato je Odbor v skladu z usmerjevalno opombo odbora CVMP o pristopu k usklajevanju karenc (EMEA/CVMP/036/95)5 za določanje karence uporabil „alternativno“ metodo.
English: Tylosin tartrate
Slovenian: Tylmasin tilozinijev tartrat
English: For sheep over 50 kg, however, the CVMP recommends that the dose is divided over two injection sites (maximum injection volume per site of 2.5 ml).
Slovenian: Odbor CVMP za ovce, težje od 50 kg, priporoča, da se odmerek razdeli na dve mesti injiciranja (največji volumen injiciranja 2,5 ml na mesto).
English: The differences on concentrations of benzyl alcohol and propylene glycol, and on pH adjustors have been considered not to have an impact on residue absorption from the injection site.
Slovenian: Odbor je presodil, da razlike v koncentracijah benzilalkohola in propilenglikola ter regulatorjev pH ne vplivajo na absorpcijo ostankov z mesta injiciranja.
English: PHARMASIN 50 mg/ml injekcinis tirpalas kiaulėms, galvijams, avims, ožkoms, šunims ir katėms
Slovenian: PHARMASIN 50 mg/ml injekcinis tirpalas kiaulėms, galvijams, avims, ožkoms, šunims ir katėms mačke, govedo, psi, koze, prašiči, ovce
English: A half-life (T1/2) of approximately two days for the absorption from the injection site was determined from the available residue study.
Slovenian: To pomeni, da se na mestu injiciranja odloži približno štirikrat večja količina tilozina, kot je bila uporabljena v razpoložljivi študiji ostankov, z volumnom 0,6 ml. Razpolovna doba (T1/2) približno 2 dni za absorpcijo z mesta injiciranja je bila določena na podlagi razpoložljive študije o ostankih.
English: Huvepharma NV Uitbreidingstraat 80
Slovenian: Huvepharma NV
English: Tylovet B-50, solution for injection for cattle, sheep, goats, swine, dogs and cats
Slovenian: Tylovet B-50, solution for injection for cattle, sheep, goats, swine, dogs and cats mačke, govedo, psi, koze, prašiči, ovce
English: Tylovet B-200 solution for injection for cattle, sheep, goats, swine and dogs
Slovenian: Tylovet B-200 solution for injection for cattle, sheep, goats, swine and dogs govedo, psi, koze, prašiči, ovce
English: While the residue studies mentioned above were made available, milk from sheep is 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).
Slovenian: Čeprav so bile zgoraj navedene študije o ostankih na voljo, se mleko ovac šteje za manj pomembno živilo in se lahko karenca zanj 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.
English: Regarding the establishment of withdrawal periods for sheep milk, no proprietary residue depletion studies in ewes were submitted.
Slovenian: V zvezi z določitvijo karence za ovčje mleko niso bile predložene nobene lastniške študije o izločanju ostankov pri ovčjih samicah, odboru CVMP pa sta bili predloženi dve javno9, 10 dostopni študiji.
English: A GLP-compliant residue study with tylosin solution for injection, conducted in sheep via intramuscular administration was made available to CVMP.
Slovenian: Odbor CVMP je dal na razpolago študijo o ostankih, skladno z dobro laboratorijsko prakso, ki je bila izvedena pri ovcah z raztopino tilozina za injiciranje, in sicer z intramuskularnim dajanjem.
English: 2600 Antwerpen Belgium bovini, ovini, caprini e suini route
Slovenian: Uitbreidingstraat 80 2600 Antwerpen Belgium soluzione iniettabile per bovini, ovini, caprini e suini baza injiciranje koze, prašiči, ovce intramuskularna pot
English: MG/ML SOLUTION INJECTABLE POUR
Slovenian: MG/ML SOLUTION INJECTABLE POUR BOVINS OVINS
English: For only one concerned product (Tilocen, marketing authorisation holder: A. Nikolakopoulos S.A), the solvent polyethylene glycol 400 is used instead of propylene glycol.
Slovenian: Nikolakopoulos, S.A) se namesto propilenglikola uporablja vehikel polietilenglikol 400.
English: Tylosin Biovet JSC 200 mg/ml solution for injection for cattle, sheep, goats and pigs
Slovenian: Tylosin Biovet JSC 200 mg/ml solution for govedo, koze, prašiči,
English: 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.
Slovenian: 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.
English: From this study, the injection site was confirmed as the withdrawal period determining tissue.
Slovenian: V tej študiji je bilo potrjeno, da je tkivo, ki določa karenco, mesto injiciranja.
English: 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).
Slovenian: 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.
English: 10 Avenue De La Ballastiere 33500 Libourne France solution for injection for cattle, pigs, sheep and goat base injection goats, pigs, sheep
Slovenian: 33500 Libourne France cattle, pigs, sheep and goat ovce pot
English: 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.
Slovenian: Karenca za referenčno zdravilo Tylan 200 za ovčje mleko je 108 ur.
English: PHARMASIN 200 mg/ml oldatos injekció szarvasmarhák, juhok, kecskék és sertések részére
Slovenian: PHARMASIN 200 mg/ml oldatos injekció szarvasmarhák, juhok, kecskék és sertések
English: For sheep over 50 kg, the CVMP recommends that the dose is divided over two injection sites.
Slovenian: Odbor CVMP priporoča, da se pri ovcah, težjih od 50 kg, odmerek razdeli na dve mesti injiciranja.
English: Cattle, sheep, pigs, dogs, cats
Slovenian: Tilocen tilozinijev tartrat govedo, ovce, prašiči, psi, mačke
English: The European Commission issued a decision on 6 October 2009.
Slovenian: Evropska komisija je odločbo izdala dne 6. oktobra 2009.
English: Dr. Karl Broich (Germany)
Slovenian: Dr. Karl Broich (Nemčija)
English: Ref. EMA/CHMP/393579/2009 rev1 EMEA/H/A-29/1168
Slovenian: : EMA/CHMP/393579/2009 rev1 EMEA/H/A-29/1168
English: Co-rapporteur(s):
Slovenian: Soporočevalec(ci):
English: Dr. Concha Prieto Yerro (Spain)
Slovenian: Dr. Concha Prieto Yerro (Španija)
English: The grounds for the referral were that:
Slovenian: Razlogi za napotitev so bili:
English: London, 6 October 2009 Doc.
Slovenian: London, 6. oktobra 2009 Sklic dok.
English: Questions and answers on the referral for Fentrix and associated names 25, 50, 70 and 100 microgram/hour fentanyl transdermal patch
Slovenian: Vprašanja in odgovori v zvezi z napotitvijo za Fentrix in z njim povezana imena 25, 50, 70 in 100 mikrogramov/uro fentanil transdermalni obliž
English: 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).
Slovenian: 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).
English: The review was carried out under an ‘Article 29' referral 1 .
Slovenian: Pregled je bil izveden v skladu z napotitvenim postopkom 1 .
English: 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).
Slovenian: 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).
English: 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.
Slovenian: Ker pa omenjene države članice niso dosegle soglasja, je španski regulatorni organ dne 4. maja 2009 zadevo napotil na CHMP v arbitražo.
English: Why was Fentrix reviewed?
Slovenian: Zakaj je bilo zdravilo Fentrix pregledano?
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: This means that Fentrix is similar to a ‘reference medicine' already authorised in the European Union (EU) called Durogesic.
Slovenian: To pomeni, da je podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Durogesic.
English: • the non-clinical local irritation and how sensitive the skin was to Fentrix were not investigated in accordance with current CHMP guidelines.
Slovenian: • neklinično lokalno draženje in stopnja občutljivosti kože na Fentrix nista bila raziskana v skladu s trenutnimi smernicami CHMP.
English: Fentrix is a ‘generic medicine'.
Slovenian: Zdravilo Fentrix je „generično zdravilo“.
English: The active substance in Fentrix, fentanyl, is an opioid that acts on receptors in the brain and spinal cord to prevent pain.
Slovenian: Zdravilna učinkovina v zdravilu Fentrix, fentanil, je opioid, ki deluje na receptorje v možganih in hrbtenjači in tako preprečuje bolečino.
English: Helm Pharmaceuticals GmbH submitted Fentrix transdermal patch to Germany for a decentralised procedure.
Slovenian: Družba Helm Pharmaceutical GmbH je Nemčiji predložila zdravilo Fentrix transdermalni obliž v decentralizirani postopek.
English: What is Fentrix?
Slovenian: Kaj je zdravilo Fentrix?
English: 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.
Slovenian: Evropska agencija za zdravila (EMEA) je po nesoglasju med državami članicami Evropske unije glede odobritve zdravila Fentrix transdermalni obliž zaključila arbitražni postopek.
English: • that Fentrix did not show a comparable local skin tolerability to the reference medicine, Durogesic;
Slovenian: • za zdravilo Fentrix lokalna primernost za kožo, primerljiva z referenčnim zdravilom Durogesic ni bila dokazana;
English: Fentrix is a transdermal patch (device that delivers the drug across the skin) that contains the active substance fentanyl.
Slovenian: Zdravilo Fentrix je transdermalni obliž (ki dovaja zdravilo skozi kožo), ki vsebuje zdravilno učinkovino fentanil.
English: This medicine is the same as CoAprovel, which is already authorised in the European Union (EU).
Slovenian: To zdravilo je enako zdravilu CoAprovel, ki je že odobreno v Evropski uniji (EU).
English: 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.
Slovenian: 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.
English: Irbesartan on its own has been approved in the EU since 1997 under the names Karvea and Aprovel.
Slovenian: Irbesartan je kot samostojno zdravilo v Evropski uniji (EU) odobren od leta 1997 pod imenoma Karvea in Aprovel.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Irbesartan Hydrochlorothiazide Winthrop on 19 January 2007.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Irbesartan Hydrochlorothiazide Winthrop, veljavno po vsej Evropski uniji, odobrila dne 19. januarja 2007.
English: The CHMP decided that Irbesartan Hydrochlorothiazide Zentiva's benefits are greater than its risks and recommended that it be given marketing authorisation.
Slovenian: 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.
English: For more information about treatment with Irbesartan Hydrochlorothiazide Zentiva, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: 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.
English: 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).
Slovenian: 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).