natgillin/translations-raw huggingface dataset:
LABEL ON MULTIPACKS WITH 4 BOTTLES WRAPPED IN TRANSPARENT FOIL (INCLUDING BLUE BOX)
NALEPKA NA SKUPNEM PAKIRANJU S 4 STEKLENICAMI, ZAVITIMI V PROZORNO FOLIJO (VKLJUČNO Z BLUE BOX)
- are having dental treatment or are due to undergo dental surgery; tell your dentist that you are being treated with Zoledronic acid medac and inform your doctor about your dental treatment.
da se zdravite z zdravilom Zoledronska kislina medac, in obvestite svojega zdravnika o svojem zobozdravstvenem zdravljenju.
There have been very rare cases of drowsiness and sleepiness with the use of zoledronic acid.
Vpliv na sposobnost upravljanja vozil in strojev Ob uporabi zoledronske kisline v zelo redkih primerih prišlo do dremavosti in zaspanosti.
LABEL ON MULTIPACKS WITH 10 BOTTLES WRAPPED IN TRANSPARENT FOIL (INCLUDING BLUE BOX)
NALEPKA NA SKUPNEM PAKIRANJU Z 10 STEKLENICAMI, ZAVITIMI V PROZORNO FOLIJO (VKLJUČNO Z BLUE BOX)
BATCH NUMBER Lot
placebo Δ
Table 4: Efficacy results (breast cancer and multiple myeloma patients) Any SRE (+TIH)
Preglednica 4: Rezultati učinkovitosti (bolnice/bolniki z rakom dojke in multiplim mielomom) kateri koli SRE (+TIH) zlomi*
Zoledronic acid medac is supplied as unit packs containing 1 vial or 4 vials and as multipacks of 4 or 10 cartons each containing 1 vial.
Zdravilo Zoledronska kislina medac je na voljo v posamičnih pakiranjih po 1 vialo ali 4 viale in v večodmernih pakiranjih s 4 ali 10 škatlami, od katerih vsaka vsebuje 1 vialo.
What Zoledronic acid medac contains - The active substance is zoledronic acid.
Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Zoledronska kislina medac - Učinkovina je zoledronska kislina.
To avoid potential incompatibilities, the infusion solution used for dilution must be either sodium chloride 9 mg/ml (0.9%) solution for injection or 5% w/v glucose solution.
Da ne bi prišlo do možnih inkompatibilnosti, mora biti infuzijska raztopina bodisi 9 mg/ml (0,9
Following initiation of therapy, serum creatinine should be measured prior to each dose of zoledronic acid and treatment should be withheld if renal function has deteriorated.
Po uvedbi terapije je treba izmeriti serumski kreatinin pred vsakim odmerkom zoledronske kisline,
Multiple event analysis showed a 36% risk reduction in developing SREs in the zoledronic acid 4 mg group compared with placebo.
Analiza večkratnih dogodkov je pokazala za 36 % zmanjšano tveganje za razvoj z okostjem povezanih dogodkov (SRE) v skupini, ki je prejemala zoledronsko kislino 4 mg, v primerjavi s placebom.
Multiple event analysis showed 30.7% risk reduction in developing SREs in the zoledronic acid 4 mg group compared with placebo.
Analiza večkratnih dogodkov je pokazala za 30,7 % zmanjšano tveganje za razvoj z okostjem povezanih dogodkov (SRE) v skupini, ki je prejemala zoledronsko kislino 4 mg, v primerjavi s placebom.
The proportion of patients with at least one SRE (excluding hypercalcaemia) was 29.8 % in the zoledronic acid-treated group versus 49.6 % in the placebo group (p=0.003).
29,8 % v primerjavi s skupino s placebom, kjer je bil 49,6 % (p=0,003).
EXP: Read the leaflet for the shelf life of the medicinal product after first opening.
Za datum izteka roka uporabnosti zdravila po prvem odprtju preberite navodila.
It is especially important that you tell your doctor if you are also taking: - • Aminoglycosides (medicines used to treat severe infections), calcitonin (a type of medicine used to treat post-menopausal osteoporosis and hypercalcaemia), loop diuretics (a type of medicine to treat high blood pressure or oedema) or other calcium-lowering medicines, since the combination of these with bisphosphonates may cause the calcium level in the blood to become too low.
Posebno pomembno je, da zdravniku poveste, če jemljete tudi naslednja zdravila: - aminoglikozide (zdravila, ki jih uporabljamo za zdravljenje težkih okužb), kalcitonin (vrsta zdravila, ki ga uporabljamo za zdravljenje pri postmenopavzalni osteoporozi in hiperkalciemiji),
Zoledronic acid medac is supplied as packs containing 1 bottle or multipacks of 4 or 10 packs each containing 1 bottle.
Zdravilo Zoledronska kislina medac je na voljo v pakiranjih po eno steklenico ali skupno pakiranje po 4 ali 10 škatel s po 1 steklenico.
MARKETING AUTHORISATION NUMBER EU/1/12/779/004
ŠTEVILKE DOVOLJENJ ZA PROMET Z ZDRAVILOM EU/1/12/779/004
Diarrhoea, constipation, abdominal pain, dyspepsia, stomatitis, dry mouth
driska, zapeka, bolečine v trebuhu, dispepsija,
If not used immediately, in use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2-8°C unless dilution has taken place in controlled and validated aseptic conditions.
Če se zdravilo ne uporabi takoj, je uporabnik odgovoren za trajanje in pogoje shranjevanja pred uporabo, kar ponavadi ne traja dalj kot 24 ur pri temperaturi 2 ºC do 8 ºC, razen če je redčenje potekalo v kontroliranih in validiranih aseptičnih pogojih.
How to store Zoledronic acid medac
Shranjevanje zdravila Zoledronska kislina medac
Figure 1: Mean changes from baseline in BPI scores.
BPI: povprečne spremembe od izhodišča
Within three days after zoledronic acid administration, an acute phase reaction has been reported, with symptoms including bone pain, fever, fatigue, arthralgia, myalgia, rigors and arthritis with subsequent joint swelling; these symptoms usually resolve within a few days (see description of selected adverse reactions).
So poročali o reakciji akutne faze, do katere pride v prvih treh dneh po vnosu zoledronske kisline, simptomi pa vključujejo bolečine v kosteh, zvišano telesno temperaturo, utrujenost, artralgijo, mialgijo, okorelost in artritis, ki povzroči otekline sklepov.
Fracture adverse events of long bones in the lower extremities were reported in approximately 24% (femur) and 14% (tibia) of zoledronic acid-treated patients versus 12% and 5% of pamidronate-treated patients with severe osteogenesis imperfecta, regardless of disease type and causality but overall incidence of fractures was comparable for the zoledronic acid and pamidronate-treated patients: 43% (32/74) versus 41% (31/76).
O zlomih dolgih kosti spodnjih okončin so pri bolnikih s hudo obliko osteogenesis imperfecta, ki so prejemali zoledronsko kislino, poročali v približno 24 % (zlom stegnenice) in v 14 % (zlom golenice) v primerjavi z enakovrednimi bolniki, ki so prejemali pamidronat, pri katerih so o zlomu stegnenice poročali v 12 %, o zlomu golenice pa v 5 %.
Placebo Zoledronic acid 4 mg
4 mg placebo zoledronska kislina
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 °C - 8 °C, unless dilution has taken place in controlled and validated aseptic conditions.
se zdravilo ne uporabi takoj, je uporabnik odgovoren za trajanje in pogoje shranjevanja pred uporabo, kar ponavadi ne traja dalj kot 24 ur pri temperaturi 2 ºC do 8 ºC, razen če je redčenje potekalo v kontroliranih in validiranih aseptičnih pogojih.
- if you are allergic to zoledronic acid, another bisphosphonate (the group of substances to which
Zdravila Zoledronska kislina medac ne smete dobiti: - če dojite, - če ste alergični na zoledronsko kislino, kak drug difosfonat (skupina snovi, ki ji pripada zdravilo
Table 3: Efficacy results (prostate cancer patients receiving hormonal therapy) Any SRE (+TIH)
Preglednica 3: Rezultati učinkovitosti (bolniki z rakom prostate, ki so prejemali hormonsko zdravljenje)
- High blood pressure, shortness of breath, dizziness, sleep disturbances, taste disturbances,
- bolečina v prsih, - kožne reakcije (rdečina in otekanje) na mestu infuzije, izpuščaj, srbenje, - visok krvni tlak, zadihanost, omotičnost, motnje spanja, motnje okušanja, tresenje,
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 °C - 8 °C.
Če zdravstveni delavec raztopine ne uporabi takoj, je sam odgovoren za trajanje in pogoje shranjevanja pred uporabo, kar ponavadi ne traja dalj kot 24 ur pri temperaturi 2ºC
QUALITATIVE AND QUANTITATIVE COMPOSITION One bottle with 100 ml solution contains 4 mg zoledronic acid (as monohydrate).
Ena plastenka s 100 ml raztopine vsebuje 4 mg zoledronske kisline (v obliki monohidrata).
How Zoledronic acid medac is used
Kako se zdravilo Zoledronska kislina medac daje
- Weight increase.
- Navodilo shranite.
NAME OF THE MEDICINAL PRODUCT Zoledronic acid medac 4 mg/100 ml solution for infusion Zoledronic acid
Zoledronska kislina medac 4 mg/100 ml raztopina za infundiranje zoledronska kislina
You must not be given Zoledronic acid medac if you are breast-feeding.
Če dojite, vam ne smejo dati zdravila Zoledronska kislina medac.
NAME OF THE MEDICINAL PRODUCT Zoledronic acid medac 4 mg/100 ml solution for infusion
Zoledronska kislina medac 4 mg/100 ml raztopina za infundiranje
It is especially important that you tell your doctor if you are also taking: - Aminoglycosides (medicines used to treat severe infections), calcitonin (a type of medicine used to treat post-menopausal osteoporosis and hypercalcaemia), loop diuretics (a type of medicine to treat high blood pressure or oedema) or other calcium-lowering medicines, since the combination of these with bisphosphonates may cause the calcium level in the blood to become too low.
diuretike Henlejeve zanke (vrsta zdravila za zdravljenje visokega krvnega tlaka ali otekanja) ali druga zdravila, ki znižujejo koncentracijo kalcija, ker kombinacija le-teh z difosfonati lahko preveč zniža koncentracijo kalcija v krvi, - talidomid (zdravilo, ki ga uporabljamo pri zdravljenju določenih vrst krvnega raka, ki zajemajo kosti) ali druga zdravila, ki lahko škodujejo ledvicam,
• Zoledronic acid medac 4 mg/100 ml solution for infusion can be used immediately without further preparation for patients with normal renal function.
• Za bolnike z normalnim delovanjem ledvic je zdravilo Zoledronska kislina medac 4 mg/100 ml raztopina za infundiranje mogoče uporabiti takoj brez dodatne priprave.
You should not be given Zoledronic acid medac if you are pregnant.
Če ste noseči, vam ne bi smeli dati zdravila Zoledronska kislina medac.
Zoledronic acid medac must only be prescribed and administered to patients by healthcare professionals experienced in the administration of intravenous bisphosphonates.
Zdravilo Zoledronska kislina medac smejo predpisovati in dajati bolnikom samo zdravstveni delavci,
NAME OF THE MEDICINAL PRODUCT Zoledronic acid medac 4 mg/5 ml concentrate for solution for infusion
Zoledronska kislina medac 4 mg/5 ml koncentrat za raztopino za infundiranje
PHARMACEUTICAL FORM Solution for infusion Clear, colourless solution.
raztopina za infundiranje bistra in brezbarvna raztopina
3.5 mg*
4,0 mg 3,5 mg* 3,3 mg* 3,0 mg*
MARKETING AUTHORISATION NUMBER(S) EU/1/12/779/005
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/12/779/005
Cases of osteonecrosis of the jaw have been reported, predominantly in cancer patients treated with medicinal products that inhibit bone resorption, such as Zoledronic acid medac (see section 4.4).
Predvsem pri bolnikih z rakom, zdravljenih z zdravili, ki zavirajo resorpcijo kosti, kot je zdravilo
1 bottle of 100 ml.
1 steklenica s 100 ml. Del skupnega pakiranja.
Very common (may affect more than 1 in 10 people): - Low level of phosphate in the blood.
Zelo pogosti (pojavijo se lahko pri več kot 1 od 10 bolnikov):
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Zoledronic acid medac 4 mg/5 ml sterile concentrate Intravenous use.
Zoledronska kislina medac 4 mg/5 ml sterilni koncentrat intravenska uporaba
Episcleritis
uveitis episkleritis
Table 3: Efficacy results (solid tumours other than breast or prostate cancer)
Preglednica 3: Rezultati učinkovitosti (čvrsti tumorji, razen raka dojke in prostate) kateri koli SRE (+TIH) zlomi*
NAME OF THE MEDICINAL PRODUCT Zoledronic acid medac 4 mg/5 ml concentrate for solution for infusion Zoledronic acid
Zoledronska kislina medac 4 mg/5 ml koncentrat za raztopino za infundiranje zoledronska kislina
Each vial contains 100 ml of solution
Ena viala vsebuje 100 ml koncentrata.
Uncommon: Very rare:
preobčutljivostna reakcija redki:
- Increased sweating.
- zvečanje telesne mase, - zvečano znojenje,
Additionally, there have been sporadic reports of osteonecrosis of other sites, including the hip and femur, reported predominantly in adult cancer patients treated with Zoledronic acid medac.
O teh primerih so poročali predvsem pri odraslih bolnikih z rakom, ki so se zdravili z zdravilom Zoledronska kislina medac.
Common: Uncommon:
konjunktivitis občasni:
MARKETING AUTHORISATION NUMBER(S) EU/1/12/779/002
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/12/779/002
Tell your doctor and dentist immediately if you experience such symptoms while being treated with Zoledronic acid medac or after stopping treatment.
Če pride do takih simptomov med zdravljenjem ali po prenehanju zdravljenja z zdravilom Zoledronska kislina medac, takoj obvestite svojega zdravnika in zobozdravnika.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING LABEL ON MULTIPACKS WITH 4 VIALS WRAPPED IN TRANSPARENT FOIL (INCLUDING BLUE BOX)
NALEPKA NA SKUPNEM PAKIRANJU S 4 VIALAMI, OVITIMI V PROZORNO FOLIJO (Z BLUE BOX)
LABEL ON MULTIPACKS WITH 10 VIALS WRAPPED IN TRANSPARENT FOIL (INCLUDING BLUE BOX)
NALEPKA NA SKUPNEM PAKIRANJU Z 10 VIALAMI, OVITIMI V PROZORNO FOLIJO (Z BLUE BOX)
This is because you may develop serum electrolyte abnormalities (e.g. abnormal levels of calcium, phosphorus and magnesium) and/or changes in kidney function, including severe kidney impairment.
Če ste prejeli večji odmerek zdravila Zoledronska kislina medac, kot bi smeli Če ste prejeli odmerek, ki je večji od priporočenega, vas mora zdravnik natančno nadzorovati, zato ker lahko pride do nepravilnosti elektrolitov v serumu (do nepravilnih koncentracij kalcija, fosforja in magnezija) in/ali do spremenjenega delovanja ledvic, vključno z ledvično odpovedjo.
MARKETING AUTHORISATION NUMBER(S) EU/1/12/779/004
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/12/779/004
Uveitis
zmedenost
- Blurred vision, tearing of the eye, eye sensitivity to light.
- zamegljen vid, solzenje oči, občutljivost oči na svetlobo, - nenaden občutek hladu z izgubo zavesti, mlahavost ali kolaps (padec zaradi nenadnega znižanja krvnega tlaka),
Package leaflet: Information for the user Zoledronic acid medac 4 mg/100 ml solution for infusion Zoledronic acid
Navodilo za uporabo Zoledronska kislina medac 4 mg/100 ml raztopina za infundiranje zoledronska kislina
Grounds for the variation to the terms of the marketing authorisation(s)
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET Z ZDRAVILOM
Package leaflet: Information for the user Zoledronic acid medac 4 mg/5 ml concentrate for solution for infusion Zoledronic acid
Navodilo za uporabo Zoledronska kislina medac 4 mg/5 ml koncentrat za raztopino za infundiranje zoledronska kislina
Zoledronic acid medac 4mg/100ml solution for infusion medac Gesellschaft für klinische Spezialpräparate mbH Theaterstr.
IZDELOVALCI, ODGOVORNI ZA SPROŠČANJE SERIJ Ime in naslov izdelovalcev, odgovornih za sproščanje serij Zoledronska kislina medac 4 mg/100 ml raztopina za infundiranje medac Gesellschaft für klinische Spezialpräparate mbH
SPECIAL STORAGE CONDITIONS Do not freeze.
POSEBNA NAVODILA ZA SHRANJEVANJE
In patients with bone metastases presenting with mild to moderate renal impairment prior to initiation of therapy, which is defined for this population as CLcr 30-60 ml/min, the following zoledronic acid dose is recommended (see also section 4.4):
(opredeljeno za to skupino bolnikov kot CLcr 30-60 ml/min), priporočajo naslednji odmerek zoledronske kisline (glejte tudi poglavje 4.4):
STATEMENT OF ACTIVE SUBSTANCE(S) One bottle contains 4 mg of zoledronic acid (as monohydrate).
Ena steklenica vsebuje 4 mg zoledronske kisline (v obliki monohidrata).
STATEMENT OF ACTIVE SUBSTANCE(S) One vial contains 4 mg of zoledronic acid (as monohydrate).
Ena viala vsebuje 4 mg zoledronske kisline (v obliki monohidrata).
How to prepare and administer Zoledronic acid medac
Kako zdravilo Zoledronska kislina medac pripravljate in dajete
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BOTTLE LABEL
PODATKI NA STIČNI OZ. PRIMARNI OVOJNINI NALEPKA STEKLENICE
If you are given more Zoledronic acid medac than you should be If you have received doses higher than those recommended, you must be carefully monitored by your doctor.
Kaj morate vedeti, preden vam bodo dali zdravilo Zoledronska kislina medac Skrbno se ravnajte po vseh navodilih, ki vam jih je dal vaš zdravnik.
It is available as chewable tablets (2.5 mg/20 mg, 5 mg/40 mg and 10 mg/80 mg).
Na voljo je v obliki žvečljivih tablet (2,5 mg/20 mg, 5 mg/40 mg in 10 mg/80 mg).
The European Commission granted a marketing authorisation valid throughout the European Union, for Cardalis on 23 July 2012.
Evropska komisija je dovoljenje za promet z zdravilom Cardalis, veljavno po vsej Evropski uniji, odobrila dne 23. julija 2012.
Other information about Cardalis:
Druge informacije o zdravilu Cardalis:
The tablets may either be mixed with a small amount of food offered to the dog just before the main meal, or with the meal itself.
Tablete se lahko primešajo majhni količini hrane, ki se psu ponudi tik pred glavnim obrokom, ali v sam obrok.
This is a type of heart disease where the heart cannot pump enough blood around the body.
To je vrsta srčnega obolenja, ko srce ne more načrpati dovolj krvi po vsem telesu.
It must not be used in dogs intended or used for breeding.
Ni ga dovoljeno uporabljati pri psih, ki so namenjeni ali se uporabljajo za vzrejo.
The main measure of effectiveness was good treatment compliance, which was defined as dogs consuming at least 90% of their tablets.
Glavno merilo učinkovitosti je bilo dobro sodelovanje pri zdravljenju, ki je bilo opredeljeno kot psi, ki so zaužili vsaj 90 % tablet.
People should wash their hands after handling the tablets.
Po dajanju tablet si je treba umiti roke.
The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Cardalis exceed the risks and recommended that be given a marketing authorisation.
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je zaključil, da so koristi zdravila Cardalis večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
The field study showed Cardalis to be voluntarily and fully consumed 92% of the time when offered with or without food and around 86% of dogs showed good compliance with treatment.
Terenska študija je pokazala, da je bilo zdravilo Cardalis prostovoljno in v celoti zaužito v 92 % primerov, ko je bilo ponujeno s hrano ali brez nje, 86 % psov pa je dobro sodelovalo pri zdravljenju.
The safety study showed Cardalis to have a good safety profile.
Študija varnosti je pokazala, da ima zdravilo Cardalis dober varnostni profil.
Spironolactone also works on the heart and blood vessels in other ways, although these mechanisms have not yet been fully demonstrated in dogs.
Spironolakton na srce in krvne žile deluje tudi na druge načine, čeprav teh mehanizmov delovanja pri psih še niso popolnoma dokazali.
What benefit has Cardalis shown during the studies?
Kakšne koristi je zdravilo Cardalis izkazalo med študijami?
A field study was conducted in dogs to demonstrate how well Cardalis tablets were taken and how easy they were to give.
Terenska študija pri psih je bila izvedena, da bi prikazali, kako dobro so bile tablete zdravila Cardalis zaužite in kako enostavno je bilo njihovo dajanje.
The tablets are given to the dog once a day with food at a dose of 0.25 mg benazepril hydrochloride and 2 mg spironolactone per kilogram bodyweight.
Tablete se dajejo psu enkrat na dan skupaj s hrano v odmerku 0,25 mg benazeprilhidroklorida in 2 mg spironolaktona na kilogram telesne mase.
Benazepril hydrochloride / spironolactone
Cardalis benazeprilhidroklorid/spironolakton
The company also presented the results of field studies with the individual active substances given as separate tablets, where the main measure of effectiveness was the number of dogs that died due to heart disease.
Družba je predstavila tudi rezultate terenskih študij s posamičnima zdravilnima učinkovinama, danima v ločenih tabletah, pri čemer je bilo glavno merilo učinkovitosti število psov, ki so zaradi obolenja srca poginili.
What is the risk associated with Cardalis?
Kakšna tveganja so povezana z zdravilom Cardalis?
Pregnant women should take special care to avoid accidental oral exposure because ACE inhibitors have been found to affect the unborn child.
Nosečnice morajo biti posebno previdne in preprečiti nenamerno peroralno izpostavljenost, saj je bilo ugotovljeno, da zaviralci ACE vplivajo na nerojenega otroka.
Information on the prescription status of this product can be found on the label/outer package.
Podatki o predpisovanju zdravila so navedeni na nalepki/zunanji ovojnini.
This allows the blood pressure to drop, reducing the load on the heart.
S tem se krvni tlak zniža in obremenitev srca zmanjša.
This decreases the overall blood volume, reducing the effort needed for the heart to pump blood and thereby improving its function.
S tem se zmanjša splošni krvni volumen, zaradi česar srce potrebuje manj moči za črpanje krvi, kar izboljša njegovo delovanje.
Benazepril is a prodrug, a substance that is converted to benazeprilat in the body.
Benazepril je predzdravilo, snov, ki se v telesu pretvori v benazeprilat.
Cardalis should not be given to growing dogs due to its effect on male sex hormones.
Odraščajoči psi zdravila Cardalis ne smejo prejemati zaradi vpliva na moške spolne hormone.
In the laboratory study, Cardalis was shown to be bioequivalent to combined treatment with products containing the single active substances (medicines are bioequivalent when they produce the same levels of active substance in the body).
V laboratorijski študiji se je pokazalo, da je zdravilo Cardalis biološko enakovredno kombiniranemu zdravljenju z zdravili, ki vsebujejo samo eno zdravilno učinkovino (zdravila so biološko enakovredna, kadar v telesu dosegajo enake ravni zdravilne učinkovine).
People with known hypersensitivity (allergy) to spironolactone or benazepril should avoid contact with Cardalis.
Osebe z znano preobčutljivostjo za (alergijo na) spironolakton ali benazepril naj se stiku z zdravilom Cardalis izogibajo.
Cardalis is a veterinary medicine that contains two active substances, benazepril hydrochloride and spironolactone.
Cardalis je zdravilo za uporabo v veterinarski medicini, ki vsebuje dve zdravilni učinkovini, benazeprilhidroklorid in spironolakton.
Why has Cardalis been approved?
Zakaj je bilo zdravilo Cardalis odobreno?
This allowed the existing field data on the single active substances to be applied to Cardalis.
Zato je bilo mogoče obstoječe podatke s terena o posamezni zdravilni učinkovini uporabiti za zdravilo Cardalis.
A six month safety study was also conducted in Beagle dogs at up to five times the recommended dose.
Pri psih pasme beagle so izvedli tudi šestmesečno študijo o varnosti s petkratnikom priporočenega odmerka.
ACE inhibitors lower the production of angiotensin II, a powerful vasoconstrictor (a substance that narrows blood vessels).
Zaviralci ACE zmanjšujejo nastajanje angiotenzina II, ki je močan vazokonstriktor (snov, ki oži krvne žile).
It must not be used in dogs which are hypersensitive (allergic) to ACE inhibitors or to any of the ingredients.
Ne sme se uporabljati pri psih, ki so preobčutljivi za (alergični na) zaviralce ACE ali katero koli drugo sestavino zdravila.
Spironolactone blocks the actions of aldosterone, a hormone that causes the kidneys to retain salt and water within the body with harmful effects on the cardiovascular system.
Spironolakton zavira delovanje aldosterona, hormona, zaradi katerega ledvice zadržujejo sol in vodo v telesu, kar škodljivo vpliva tudi na srčno-žilni sistem.
By blocking aldosterone, spironolactone increases the elimination of salt and water in the urine.
Spironolakton blokira aldosteron in s tem poveča izločanje soli in vode v seču.
Benazeprilat is an ‘angiotensin converting enzyme (ACE) inhibitor'.
Benazeprilat je „zaviralec encima angiotenzinske konvertaze (ACE)“.