natgillin/translations-raw huggingface dataset:
Vepured contains adjuvants (aluminium hydroxide and DEAE-dextran) to enhance the immune response.
Zdravilo Vepured vsebuje tudi „adjuvansa“ (aluminijev hidroksid in DEAE-dekstran) za povečanje imunskega odziva.
Oedema disease is caused by a bacterial toxin (poison) known as verotoxin 2e that is produced by certain strains of Escherichia coli.
Edemsko bolezen povzroči bakterijski toksin (strup), znan kot verotoksin 2e in ga proizvajajo določeni sevi bakterije Escherichia coli.
Vepured is a veterinary vaccine used to protect piglets against oedema disease (caused by verotoxin 2e produced by E. coli) and to reduce the loss of daily weight gain until slaughter.
Zdravilo Vepured je cepivo za uporabo v veterinarski medicini, ki se uporablja za zaščito pujskov pred edemskimi boleznimi (ki jih povzroča verotoksin 2e iz E. coli) in za zmanjšanje izgube dnevnega pridobivanja telesne mase do zakola.
For practical information about using Vepured, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Za praktične informacije o uporabi zdravila Vepured naj lastniki ali skrbniki živali preberejo navodilo za uporabo ali se posvetujejo z veterinarjem ali farmacevtom.
When Vepured is given to pigs, the animal's immune system recognises the toxin contained in the vaccine as ‘foreign' and makes antibodies against it.
Ko pujski prejmejo zdravilo Vepured, njihov imunski sistem prepozna toksin, ki ga vsebuje cepivo, kot tujek in proti njemu tvori protitelesa.
How is Vepured used?
Kako se zdravilo Vepured uporablja?
For more information about treatment with Vepured, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Za več informacij o zdravljenju z zdravilom Vepured naj lastniki ali skrbniki živali preberejo navodilo za uporabo ali se posvetujejo z veterinarjem ali farmacevtom.
The European Commission granted a marketing authorisation valid throughout the EU for Vepured on 17 August 2017.
Evropska komisija je dovoljenje za promet z zdravilom Vepured, veljavno po vsej Evropski uniji, izdala
How does Vepured work?
Kako zdravilo Vepured deluje?
• Aronson JK (editor).
• Aronson JK (urednik).
• contraindications were sometimes relative rather than absolute.
• kontraindikacije so bile včasih relativne in ne absolutne.
ANNEX II
Dodatek II
In several countries there was no information in section 4.2 on this group of patients.
V več državah v poglavju 4.2 ni bilo informacij o tej skupini bolnikov.
• Sweetman SC (editor), Martindale: The Complete Drug Reference 36.
• Sweetman SC (urednik), Martindale: The Complete Drug Reference 36.
Press <http://www.medicinescomplete.com/> (Accessed Sep-Nov 2009)
Press <http://www.medicinescomplete.com/> (dostop: september-november 2009)
Section 4.8 Undesirable Effects
Poglavje 4.8 Neželeni učinki
Specific treatment advice was not included as treatment protocols may vary between countries.
Nasveti glede specifičnega zdravljenja niso bili vključeni, saj se lahko protokoli zdravljenja med posameznimi državami razlikujejo.
• lack of data concerning safety in specific patients groups was the only justification for listing certain contraindications;
• nezadostni podatki o varnosti pri posameznih skupinah bolnikov so bili edina utemeljitev za navajanje določenih kontraindikacij;
A total of 214 patients (age range 64 - 81 years) were included in this trial.
V to preskušanje je bilo vključenih skupaj 214 bolnikov (starih od 64 do 81 let).
The paragraph ‘Clinical/Efficacy Studies' has been slightly rewording for more clarity.
Odstavek „Klinične študije/študije učinkovitosti“ je bil zaradi večje jasnosti nekoliko preoblikovan.
Section 4.5 Interaction with Other Medicinal Products and Other Forms of Interaction
Poglavje 4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij
Furthermore, the addition of an ACE inhibitor may further attenuate this effect.
Poleg tega lahko dodajanje zaviralca ACE ta učinek še zmanjša.
Differences in level of detail existed between Member States for special warnings and precautions for use.
Med državami članicami so bile razlike v podrobnostih glede posebnih opozoril in previdnostnih ukrepov.
Overall summary of the scientific evaluation of Vascace Plus and associated names (see Annex I)
Splošni povzetek znanstvenega vrednotenja zdravila Vascace Plus in povezanih imen (glejte Dodatek I)
It presented in a succinct manner some important facts on these two molecules.
V strnjeni obliki predstavlja nekatera pomembna dejstva o teh dveh molekulah.
Combination therapy with antihypertensive agents is rarely necessary.
Kombinacijska terapija z antihipertenzivnimi zdravili je le redko potrebna.
Information on pharmacokinetics of hydrochlorothiazide in special populations has been added to section 5.2.
Podatki o farmakokinetiki hidroklorotiazida pri posebnih populacijah so bili dodani v poglavje 5.2.
The proposed text included a general statement concerning emergency treatment of angioedema.
Predlagano besedilo je vključevalo splošno izjavo o nujnosti zdravljenja angioedema.
The warning may be based on concerns about crossreactivity with sulfonamide antibiotics, which are know to aggravate porphyria.
Opozorilo morda temelji na pomislekih o navzkrižnih reakcijah s sulfonamidnimi antibiotiki, za katere je znano, da poslabšujejo porfirijo.
Therefore, Vascace Plus is not recommended for patients with severe renal impairment (see section 4.3)”.
Zato se zdravilo Vascace Plus ne priporoča za zdravljenje bolnikov s hudo okvaro ledvic (glejte poglavje 4.3).“
In the SPC of several countries the same or slightly modified wording was used.
V povzetku glavnih značilnosti zdravila je bilo v več državah uporabljeno enako ali nekoliko spremenjeno besedilo.
This wording of the therapeutic indications for Vascace Plus was identical in many EU countries.
To besedilo za terapevtske indikacije za zdravilo Vascace Plus je bilo enako v več državah EU.
It is widely known that thiazides as a class can increase uric acid levels (Meyler; Martindale).
Splošno znano je, da lahko tiazidi kot skupina povečajo koncentracijo sečne kisline (Meyler; Martindale).
Treatment is difficult and rather infrequent, since patients with cirrhosis have a tendency towards low blood pressure.
Zdravljenje je težko in redko, saj so bolniki s cirozo nagnjeni k nizkemu krvnemu tlaku.
Children The CHMP agreed that the use of Vascace Plus is not recommended in children.
Otroci CHMP se je strinjal, da uporaba zdravila Vascace Plus pri otrocih ni priporočljiva.
The proposed summary of the safety profile has been updated by the MAH taking into account the most recent guidelines and the definition of “frequency” used in the studies as supporting evidence.
Predlagani povzetek varnostnega profila je imetnik dovoljenja za promet z zdravilom posodobil ter pri tem upošteval najnovejše smernice in opredelitev izraza „pogostnost“, ki je v študijah uporabljen kot podporni dokaz.
Also the MAH presented the studies published which evaluated the combination of cilazapril and hydrochlorothiazide: Pordy et al (1995; 1994), Martina et al (1994), Yodfat et al. (1994), and Sanchez
Imetnik dovoljenja za promet z zdravilom je predstavil tudi objavljene študije, ki so ocenjevale kombinacijo cilazaprila in hidroklorotiazida: Pordy et al. (1995; 1994), Martina et al. (1994), Yodfat et al. (1994) in Sanchez (1989).
The pathophysiological association between liver impairment, cardiovascular function and arterial hypertension is complex.
Patofiziološka povezava med okvaro jeter, kardiovaskularno funkcijo in arterijsko hipertenzijo je kompleksna.
This was based on results of an epidemiological study which found that exposure to ACE inhibitors restricted to the first trimester of pregnancy was associated with increased risk of major congenital malformations including central nervous system and kidney malformations.
To je temeljijo na rezultatih epidemiološke študije, ki je pokazala, da je izpostavljenost zaviralcem ACE, omejena na prvo trimesečje nosečnosti, povezana s povečanim tveganjem hujših prirojenih nepravilnosti, vključno s centralnim živčnim sistemom in malformacijami ledvic.
The CHMP agreed to change the text “Pregnancy and lactation (see section 4.6)” under this section to “Second and third trimesters of pregnancy (see sections 4.4 and 4.6)”.
CHMP je potrdil spremenjeno besedilo v poglavju „Nosečnost in dojenje (glejte poglavje 4.6)“, ki se zdaj glasi „Drugo in tretje trimesečje nosečnosti (glejte poglavji 4.4 in 4.6)“.
In addition, a long-term, randomized, blinded, parallel group, multicenter study was conducted specifically in elderly patients with mild to moderate hypertension.
Poleg tega je bila izvedena tudi dolgotrajna, randomizirana, slepa, vzporedna in multicentrična študija, v kateri so sodelovali predvsem starejši bolniki z blago do zmerno hipertenzijo.
The CHMP considered a number of areas of disharmony in the Product Information.
CHMP je preučil več neusklajenih področij v informacijah o zdravilu.
Electrolyte disturbances including hypokalaemia, hyponatraemia and dehydration are mainly associated with thiazides, whilst ACE inhibitors can cause hyperkalaemia.
Elektrolitske motnje, vključno s hipokaliemijo, hiponatriemijo in dehidracijo, so povezane predvsem s tiazidi, medtem ko lahko zaviralci ACE povzročijo hiperkaliemijo.
In some SPCs, relative contraindications were discussed in section 4.4 (Special Warnings and Precautions), rather than in section 4.3;
V nekaterih povzetkih glavnih značilnosti zdravila so bile relativne kontraindikacije navedene v poglavju 4.4 (Posebna opozorila in previdnostni ukrepi) in ne v poglavju 4.3;
The CHMP noted that the substitution of the free combination of the active substances given at the same dose is an acceptable indication based on the long experience of concomitant use.
CHMP je menil, da je zamenjava kombinacije zdravilnih učinkovin z istimi odmerki sprejemljiva indikacija, utemeljena na podlagi dolgoročnih izkušenj s sočasno uporabo.
Over 600 of these patients received the cilazapril/hydrochlorothiazide combination for 6 months and more, and approximately 200 of these patients were treated with the combination for one year or longer.
Več kot 600 bolnikov je kombinacijo cilazaprila/hidroklorotiazida prejemalo šest mesecev ali dlje, okoli 200 bolnikov izmed teh pa se je s kombinacijo obeh zdravilnih učinkovin zdravilo eno leto ali dlje.
SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET PRESENTED BY THE EUROPEAN MEDICINES AGENCY
Znanstveni zaključki in podlaga za dopolnilo povzetka glavnih značilnosti zdravila, označevanja in navodila za uporabo, ki jih je predstavila Evropska agencija za zdravila
In other countries a modified statement including also impaired liver function was given, or patients with liver impairment were contraindicated.
V drugih državah je bila vključena spremenjena izjava, ki je vključevala tudi okvarjeno delovanje jeter, ali pa je bilo zdravilo za bolnike z okvarjenim delovanjem jeter kontraindicirano.
Some SPCs recommend that fluid and electrolyte disturbances should be corrected before starting treatment.
Nekateri povzetki glavnih značilnosti zdravila priporočajo, da je treba tekočinske in elektrolitske motnje pred pričetkom zdravljenja odpraviti.
The CHMP endorsed most of the MAH's proposal except for pregnancy.
CHMP je potrdil večino predlogov imetnika dovoljenja za promet z zdravilom, razen glede nosečnosti.
Section 4.4 Special Warnings and Precautions for Use
Poglavje 4.4 Posebna opozorila in previdnostni ukrepi
Section 5.3 Preclinical safety data
5.3 Predklinični podatki o varnosti
The 76 non-responders were treated with combination therapy.
76 bolnikov, ki se na zdravljenje z monoterapijo ni odzvalo, so zdravili s kombinacijsko terapijo.
It reflected the relevant information on nonclinical safety data with cilazapril and hydrochlorothiazide.
Vsebovalo je pomembne informacije o nekliničnih podatkih o varnosti v zvezi s cilazaprilom in hidroklorotiazidom.
Of these patients with mild to moderate hypertension (sitting diastolic blood pressure 95 - 115 mm hg), 1.027 patients were treated with the cilazapril/hydrochlorothiazide combination, 453 patients with cilazapril and 366 with hydrochlorothiazide alone and 238 patients received placebo.
Izmed teh bolnikov z blago do zmerno hipertenzijo (diastolični krvni tlak v sedečem položaju 95-115 mm Hg) je bilo 1 027 bolnikov zdravljenih s kombinacijo cilazaprila/hidroklorotiazida, 453 bolnikov samo s cilazaprilom in 366 bolnikov samo s hidroklorotiazidom, 238 bolnikov pa je prejelo placebo.
Moreover, according to the PhVWP recommendation, angiotensin converting enzyme inhibitors are contraindicated in second and third trimesters of pregnancy but not during the first trimester of pregnancy or lactation.
Poleg tega so ob upoštevanju priporočila delovne skupine za farmakovigilanco zaviralci angiotenzinske konvertaze kontraindicirani v drugem in tretjem trimesečju nosečnosti, ne pa tudi v prvem trimesečju in v času dojenja.
A very cautious treatment is required due to the therapeutic properties of cilazapril and a cross reference to section 4.4 has been added.
Zaradi terapevtskih značilnosti cilazaprila je potrebno zelo pazljivo zdravljenje, zato je bil dodan sklic na poglavje 4.4.
The number of products for Vascace Plus is considerably higher than for cilazapril alone, since numerous molecules had been added where a potential interaction with hydrochlorothiazide was suspected.
Število izdelkov za zdravilo Vascace Plus je bistveno večje kot samo za cilazapril, saj so bile v primeru suma na možno interakcijo s hidroklorotiazidom dodane številne molekule.
A diuretic such as hydrochlorothiazide enhances efficacy of the ACE inhibitor by stimulating the renin-angiotensin system and shifting the hypertensive state to a more renin-dependent condition.
Diuretik, kot je hidroklorotiazid, povečuje učinkovitost zaviralca ACE, tako da spodbuja sistem reninangiotenzin, hipertenzivno stanje pa spreminja v stanje, ki je bolj odvisno od renina.
The CHMP agreed with the MAH proposal to include this adverse effect of thiazides in section 4.8 but not under 4.4.
CHMP se je strinjal s predlogom imetnika dovoljenja za promet z zdravilom ter vključil ta neželeni učinek tiazidov v poglavje 4.8 in ne v poglavje 4.4.
The magnitude of the antihypertensive effect of the combination at peak (i. e. 15 mm Hg) did not render an increased incidence of hypotensive events, which could be of concern in elderly patients.
Največji antihipertenzivni učinek pri kombinacijski terapiji (to je 15 mm Hg) ni povzročil povečane pojavnosti hipotenzivnih dogodkov, kar bi bilo lahko posebej zaskrbljujoče pri starejših bolnikih.
Doubling the initial dose (5.0 mg cilazapril 12.5 mg hydroclorthiazide) resulted in a further increase in efficacy.
Podvojitev prvotnega odmerka (5,0 mg cilazaprila; 12,5 mg hidroklorotiazida) je povzročila še večje povečanje učinkovitosti.
Estimates of frequency were based on the proportion of patients reporting each adverse reaction during Vascace Plus clinical trials.
Ocene pogostnosti so utemeljene na deležu bolnikov, ki so poročali o posameznem neželenem učinku med kliničnim preskušanjem zdravila Vascace Plus.
The CHMP endorsed the following harmonised wording for the posology: “The dosage of Vascace Plus is one tablet (5.0 mg cilazapril and 12.5 mg hydrochlorothiazide) administered once daily”.
CHMP je potrdil naslednje usklajeno besedilo za odmerjanje: „Odmerek zdravila Vascace Plus je ena tableta (5,0 mg cilazaprila in 12,5 mg hidroklorotiazida) enkrat na dan.“
The information which is given about the possible interactions and their outcome are endorsed by the CHMP.
CHMP je potrdil navedene podatke o možnih interakcijah in njihovih rezultatih.
To support the proposed indication the MAH presented 4 placebo controlled clinical trials sponsored by Roche and run in 2.084 hypertensive patients.
Imetnik dovoljenja za promet z zdravilom je v podporo predlagani indikaciji predstavil štiri s placebom nadzorovana klinična preskušanja, ki jih je financirala družba Roche in v katerih je sodelovalo 2 084 bolnikov s hipertenzijo.
As it is not foreseen to start treatment with the fixed combination, the CHMP endorsed the following: “In clinical studies, the efficacy and tolerability of cilazapril and hydrochlorothiazide administered concomitantly was similar in both elderly and younger hypertensive patients, although pharmacokinetic data show that clearance of both components in elderly patients was reduced (see section 5.2)”.
Ker pričetek zdravljenja s fiksno kombinacijo ni predviden, je CHMP potrdil naslednje besedilo: „V kliničnih študijah sta bila učinkovitost in prenašanje cilazaprila in hidroklorotiazida, ki so ju bolniki jemali sočasno, pri starejših in mlajših bolnikih s hipertenzijo podobna, čeprav farmakokinetični podatki kažejo, da je očistek obeh učinkovin pri starejših bolnikih zmanjšan (glejte poglavje 5.2).“
Additional information was included in some Member States in warnings in respect of risk of hypotension, renovascular hypertension/renal artery stenosis, kidney transplantation, use in concomitant heart failure, anaemia, cough, ethnic groups, primary aldosteronism, and doping.
Nekatere države so pri opozorilih dodale dodatne informacije v zvezi s tveganjem hipotenzije, v povezavi z renovaskularno hipertenzijo/stenozo ledvične arterije, presaditvijo ledvic, uporabo pri obstoječem popuščanju srca, anemiji, kašlju, etničnih skupinah, primarnem aldosteronizmu in jemanju prepovedanih poživil.
Based on these data the combination of cilazapril 5 mg with hydrochlorothiazide 12.5 mg, given once daily, is a rational clinical choice for patients whose blood pressure is not normalized on cilazapril monotherapy.
Na podlagi teh podatkov je kombinacija 5 mg cilazaprila in 12,5 mg hidroklorotiazida enkrat na dan racionalna klinična izbira za bolnike, pri katerih se krvni tlak pri monoterapiji s cilazaprilom ne normalizira.
The CHMP concluded that the contraindication during the first trimester of pregnancy must be deleted from the product information of Vascace Plus and the PI should be updated to include the wording recommended by the PhVWP for both pregnancy and lactation.
CHMP je sklenil, da je treba kontraindikacijo za prvo trimesečje nosečnosti izbrisati iz podatkov o zdravilu Vascace Plus, podatke o zdravilu pa posodobiti, da bodo vključevali besedilo, ki ga je za nosečnost in dojenje priporočila delovna skupina za farmakovigilanco.
The CHMP, considering that there is plausible effect based on the pharmacologic action of the drug to affect the ability to drive, endorsed the following: “When driving and operating machines, it should be taken into account that occasionally dizziness and fatigue may occur during treatment with Vascace Plus (see sections 4.4 and 4.8)”.
Ob upoštevanju, da bi zaradi farmakološkega delovanja zdravilo lahko vplivalo na sposobnost vožnje, je CHMP potrdil besedilo: „Pri vožnji in upravljanju s stroji je treba upoštevati, da se med zdravljenjem z zdravilom Vascace Plus lahko občasno pojavita omotica in utrujenost (glejte poglavji 4.4 in 4.8).“
However, the MAH did not propose to include such a warning as considered that this is implied in the warning that patients should have regular monitoring of renal function and electrolytes which is included in the proposed SPC.
Vendar imetnik dovoljenja za promet z zdravilom ni predlagal vključitve takšnega opozorila, saj je menil, da je to implicirano v opozorilu, da je pri bolnikih potrebno redno nadzorovanje delovanja ledvic in elektrolitov, kar pa je vključeno v predlagano besedilo povzetka glavnih značilnosti zdravila.
Considering this, the MAH suggested to include a warning concerning the use of thiazides in patients with a history of gout, but not to include gout as a contraindication.
Ob upoštevanju navedenega je imetnik dovoljenja za promet z zdravilom predlagal vključitev opozorila glede uporabe tiazidov pri bolnikih z anamnezo protina, vendar brez vključitve protina kot kontraindikacije.
The CHMP also considered that add-on to hydrochlorothiazide and to the non-responders to hydrochlorothiazide cannot be accepted as only the highest cilazapril dose is available in the fixed combination and the dose has to be titrated up with single components.
CHMP je prav tako menil, da dodajanje zdravila hidroklorotiazidu in bolnikom, ki se ne odzivajo na samostojno zdravljenje s hidroklorotiazidom, ni sprejemljivo, saj je pri kombinacijski terapiji s fiksnimi odmerki na voljo le največji odmerek cilazaprila, odmerek pa je treba titrirati s posameznimi sestavinami.
The MAH acknowledged the number of contraindications in the SPCs of Members States and explained that:
Imetnik dovoljenja za promet z zdravilom je upošteval število kontraindikacij v povzetkih glavnih značilnosti zdravila držav članic in pojasnil:
Following review and discussion regarding the teratogenic potential of ACE inhibitors, the Pharmacovigilance Working Party (PhVWP) concluded that the contraindication of ACE inhibitors during the first trimester of pregnancy is not justified given the limited evidence related to a teratogenic risk.
Po pregledu in razpravi o teratogenem potencialu zaviralcev ACE je delovna skupina za farmakovigilanco sklenila, da ob upoštevanju omejenih dokazov v zvezi s teratogenim tveganjem kontraindikacija zaviralcev ACE v prvem trimesečju nosečnosti ni upravičena.
The recommendation for once-daily dosage is based on the finding that an apparently subtherapeutic dose of hydrochlorothiazide in combination with cilazapril results in potentiation of the antihypertensive effect.
Priporočilo za odmerjanje enkrat na dan temelji na ugotovitvi, da navidez subterapevtski odmerek hidroklorotiazida v kombinaciji s cilazaprilom povzroči večji antihipertenzivni učinek.
Several Vascace Plus SPCs included a warning concerning the effect of thiazide on lipid profile.
Več povzetkov glavnih značilnosti zdravila Vascace Plus je vključevalo opozorilo glede učinka tiazidov na profil lipidov.
However, hydrochlorothiazide is currently listed as `safe' or `probably safe' by several authorities (e.g. European Porphyria Initiative http://www.porphyria-europe.com/03-drugs/drugs-and-porphyrias.asp; The Drug Data-base for Acute Porphyria http://www.drugs-porphyria.com.
Več organizacij (na primer Evropska pobuda za porfirijo, http://www.porphyria-europe.com/03-drugs/drugs-and-porphyrias.asp; Podatkovna zbirka zdravil za akutno porfirijo http://www.drugs-porphyria.com) je hidroklorotiazid označilo kot „varen“ ali „verjetno varen“.
The antihypertensive effect for the combination group was maintained for the duration of this long-term study and was of a similar magnitude to that observed after the first weeks of cilazapril/hydrochlorothiazide therapy combination with no development of tolerance for the therapy.
Antihipertenzivni učinek v skupini, zdravljeni s kombinirano terapijo, je bil stabilen skozi celotno trajanje te dolgotrajne študije, po obsegu pa je bil podoben učinku, zaznanem po prvih tednih zdravljenja s kombinacijsko terapijo cilazaprila/hidroklorotiazida, pri katerem se ni razvila toleranca na zdravljenje.
The dosing recommendations given for patients with cirrhosis/impaired liver function varied considerably among MSs.
Priporočila za odmerjanje za bolnike s cirozo/okvarjenim delovanjem jeter so se med posameznimi državami članicami močno razlikovala.
Vascace Plus was included in the list of products for Summary of Product Characteristics (SPC) harmonisation, due to the divergent national decisions taken by Member States concerning the authorisation of the product.
Zdravilo Vascace Plus je bilo dodano na seznam zdravil, za katera je potrebna uskladitev povzetka glavnih značilnosti zdravila zaradi različnih nacionalnih odločitev držav članic glede odobritve zdravila.
Some SPCs included under the heading “hypotension” warnings about the use of anaesthetics.
Nekateri povzetki glavnih značilnosti zdravila so pod naslovom „Hipotenzija“ vključevali opozorila glede uporabe anestetikov.
The MAH used the published meta-analyses of mono- and combination therapy as basis for this section.
Imetnik dovoljenja za promet z zdravilom je kot podlago za to poglavje uporabil objavljene meta analize monoterapije in kombinacijske terapije.