natgillin/translations-raw huggingface dataset:
In the second part, 23 cats received Lodipressin for 16 weeks with no placebo group.
V drugem delu je 23 mačk zdravilo Lodipressin prejemalo 16 tednov, skupine s placebom pa ni bilo.
This means that it blocks channels on the surface of cells through which calcium normally enters the cell.
Učinkovina zavira posebne kanalčke na površini celic, skozi katere v celico običajno vstopa kalcij.
Refusal of the marketing authorisation for Lodipressin (amlodipine besilate)
Zavrnitev vloge za dovoljenje za promet z zdravilom Lodipressin (amlodipin besilat)
The company that applied for authorisation is Le Vet Beheer B.V.
Vlogo za pridobitev dovoljenja za promet z zdravilom je predložila družba Le Vet Beheer B.V.
Lodipressin is a veterinary medicine that contains the active substance amlodipine besilate.
Zdravilo Lodipressin je zdravilo za uporabo v veterinarski medicini, ki vsebuje zdravilno učinkovino amlodipin besilat.
This meant that whilst there is some evidence that Lodipressin is effective in lowering blood pressure, no firm conclusions could be drawn on its effectiveness for treatment of high blood pressure in cats.
To pomeni, da kljub nekaterim dokazom o učinkovitosti zdravila Lodipressin pri zniževanju krvnega tlaka ni bilo mogoče oblikovati trdnih zaključkov o njegovi učinkovitosti pri zdravljenju visokega krvnega tlaka pri mačkah.
The CVMP therefore maintained its recommendation that the marketing authorisation be refused.
Odbor CVMP je zato obdržal priporočilo, da se dovoljenje za promet z zdravilom zavrne.
What is Lodipressin?
Kaj je zdravilo Lodipressin?
By reducing the entry of calcium into these cells, amlodipine prevents the blood vessel from contracting, thus lowering the blood pressure.
Amlodipin z zmanjševanjem pretoka kalcija v celice preprečuje krčenje žil in tako znižuje krvni tlak.
During the re-examination, the CVMP considered advice from an expert group in feline medicine.
Pri ponovnem pregledu je odbor CVMP upošteval nasvet strokovne skupine za medicino mačk.
What were the CVMP's main concerns that led to the refusal?
Kateri so bili glavni zadržki, zaradi katerih je CVMP predlagal zavrnitev dovoljenja za promet?
The expert group advised that although the field study showed some evidence of a reduction in blood pressure, the many shortcomings in the study did not allow to conclude that the benefits of Lodipressin in the treatment of high blood pressure in cats outweigh the risks.
Strokovna skupina je sporočila, da kljub nekaterim dokazom študije o zmanjšanju krvnega tlaka zaradi njenih številnih pomanjkljivosti ni bilo mogoče sklepati, da pri zdravljenju visokega krvnega tlaka pri mačkah koristi zdravila Lodipressin odtehtajo njegova tveganja.
What was Lodipressin expected to be used for?
Za kaj naj bi se zdravilo Lodipressin uporabljalo?
How is Lodipressin expected to work?
Kako naj bi zdravilo Lodipressin delovalo?
When calcium enters the cells in the blood vessel walls this causes contraction.
Ko kalcij vstopi v celice v stenah žil, se te začnejo krčiti.
The study had two parts, an initial part with 19 cats, 11 of which were treated with Lodipressin and 8 of which received placebo (a dummy treatment) for two weeks.
Od teh jih je bilo 11 zdravljenih z zdravilom Lodipressin, 8 pa jih je prejelo placebo (zdravilo brez zdravilne učinkovine).
Pharmaceutical Form
Jakost Farmacevtska oblika
These include (but are not limited to):
Ta zdravila vključujejo (a nanje niso omejena):
All patients were clinically cured.
Vsi bolniki so bili klinično ozdravljeni.
Date of first authorisation: 27 October 2011 Date of latest renewal: 09 September 2016
Datum prve odobritve: 27. oktober 2011 Datum zadnjega podaljšanja: 9. september 2016
− At the request of the European Medicines Agency.
• na zahtevo Evropske agencije za zdravila;
It is not known whether these toxic effects are reversible.
Ni znano, ali so ti toksični učinki reverzibilni.
You or your child can drink water at any time.
Vi ali vaš otrok lahko kadar koli pijete vodo.
If this happens within:
Če se to zgodi:
Most of the side effects are not severe and normally disappear within a few days or weeks after treatment.
Večina neželenih učinkov ni resnih in običajno izginejo po nekaj dneh ali tednih zdravljenja.
Then take the third (last) dose approximately 24 hours after the second dose.
Nato vzemite tretji (zadnji) odmerek približno 24 ur po drugem odmerku.
Never take more than one dose on the same day to make up for a missed dose.
Nikoli ne vzemite več kot enega odmerka na isti dan, da bi nadomestili izpuščeni odmerek.
* see section 5.1
* Glejte poglavje 5.1.
The majority of paediatric experience is derived from African children aged 6 months to 5 years.
Večina pediatričnih izkušenj je izpeljanih iz afriških otrok, starih 6 mesecev do 5 let.
NN: {number} [national reimbursement number or other national number identifying the medicinal product]
NN: {številka} [nacionalna številka povračila stroškov za zdravilo ali druga nacionalna številka za identifikacijo zdravila]>
Concomitant treatment with such medicinal products is not recommended.
Sočasno zdravljenje s temi zdravili se ne priporoča.
Tell your doctor immediately, or go immediately to the emergency department of your nearest hospital, taking this leaflet with you.
To takoj povejte svojemu zdravniku ali se odpravite na urgentni oddelek najbližje bolnišnice in vzemite to navodilo s seboj.
Do not use this medicine if you notice the blister is open.
Ne uporabljajte tega zdravila, če opazite, da je pretisni omot odprt.
The table in this section is for adult patients only.
Tabela v tem poglavju velja samo za odrasle bolnike.
• 31-60 minutes, half the dose must be taken again.
• 31-60 minut po uporabi, je treba ponovno vzeti polovico odmerka.
Via Ragazzi del '99, n. 5 40133 Bologna Italy
Via Ragazzi del '99, n. 5 40133 Bologna Italija
You or your child should take this medicine on an empty stomach.
Vi ali vaš otrok vzemite to zdravilo na prazen želodec.
The extent of interactions in the paediatric population is not known.
Obseg medsebojnega delovanja v pediatrični populaciji ni znan.
Your doctor may suggest special monitoring for you or your child because doses higher than those recommended may have an unwanted, severe effect on the heart (see also section 4).
Vaš zdravnik lahko predlaga poseben nadzor za vas ali vašega otroka, saj imajo lahko odmerki, višji od priporočenih, hud neželen učinek na srce (glejte tudi poglavje 4).
The main consequence of this interaction could be a reduction of efficacy of the co-administered medicinal products.
Glavna posledica tega medsebojnega delovanja bi lahko bila zmanjšanje učinkovitosti sočasno uporabljenih zdravil.
The concentration of artenimol may also be reduced.
Zmanjšajo se lahko tudi koncentracije artenimola.
No data are available for these paediatric subsets.
Podatki za ti pediatrični podskupini niso na voljo.
• is female, elderly (over 65 years) or vomiting;
• ste ženska, starejša oseba (nad 65 let) oziroma če bruhate;
• is in the 1st trimester of pregnancy or breastfeeding (see below);
• ste v 1. trimesečju nosečnosti ali dojite (glejte spodaj);
This can cause a life-threatening abnormality of the heart rhythm.
To lahko povzroči življenjsko nevarno nenormalnost srčnega ritma.
The elimination half-life of piperaquine is around 22 days for adult patients and around 20 days for paediatric patients.
Razpolovna doba izločanja piperakina je približno 22 dni za odrasle bolnike in približno 20 dni za pediatrične bolnike.
Consideration should be given to official guidance on the appropriate use of antimalarial medicinal products.
Upoštevati je treba uradna navodila glede ustrezne uporabe antimalarikov.
Examples are listed in the section “Other medicines and Eurartesim”.
Primeri so navedeni v poglavju „Druga zdravila in zdravilo Eurartesim“.
Artenimol is able to reach high concentrations within the parasitized erythrocytes.
Artenimol lahko dosega visoke koncentracije znotraj parazitiranih eritrocitov.
The results for the primary endpoint in the modified intent to treat (m-ITT) populations (defined as all randomised patients who received at least one dose of the study treatment, with the exclusion of those patients lost to follow up for unknown reasons) were as follows:
Rezultati primarnega končnega opazovanega dogodka za modificirane populacije z namenom zdravljenja (m-ITT - modified Intent to Treat) (opredeljene kot vsi randomizirani bolniki, ki so prejeli vsaj en odmerek študijskega zdravila, brez bolnikov, ki so bili izgubljeni za spremljanje zaradi neznanega razloga), so bili naslednji:
Compared to adult males, female patients and elderly patients have longer QTc intervals.
V primerjavi z odraslimi moškimi imajo ženske bolnice in starejši bolniki daljše intervale QTc.
• Certain antimicrobialmedicinal products, including medicinal products of the following classes:
• nekatera antimikrobna zdravila, vključno z zdravili naslednjih skupin:
The safety profile of these patients did not differ from that of patients receiving the recommended dose, with no patient reporting SAEs.
Varnostni profil teh bolnikov se ni razlikoval od tistega pri bolnikih, ki so prejeli priporočeni odmerek, pri čemer ni noben bolnik poročal o neželenih učinkih.
In both studies, the true treatment failure rate was below the 5% efficacy threshold set by WHO.
V obeh študijah je bila stopnja neuspešnosti zdravljenja pod 5-odstotnim pragom učinkovitosti, kot ga določa SZO.
Risk factors may include young age (children under 5 years old) and previous treatment with IV artesunate.
Dejavniki tveganja lahko vključujejo nizko starost (otroci, mlajši od 5 let) in predhodno zdravljenje z i.v.
Daily dose (mg)
Dnevni odmerek (mg)
Twenty-two of these patients were shown to be parasitic free at the last microscopic analysis of the blood sample; three patients did not complete parasitological blood analysis.
V tej študiji 22 bolnikov pri zadnji mikroskopski analizi krvnega vzorca ni imelo parazitov; 3 bolniki niso opravili parazitološke analize krvi.
The Marketing Authorisation Holder shall ensure that all physicians who are expected to prescribe or use Eurartesim are provided with a healthcare profession educational pack containing the following:
Imetnik dovoljenja za promet mora zagotoviti, da bodo vsi zdravniki, za katere se pričakuje, da bodo predpisovali ali uporabljali zdravilo Eurartesim, prejeli izobraževalno gradivo za zdravstvene delavce, ki vsebuje:
Vomiting when taking this medicine
Bruhanje po jemanju tega zdravila
The mixture should be used immediately after preparation.
Pripravljeno mešanico je treba takoj porabiti.
• is taking or has taken any other medicines for the treatment of malaria (other than those mentioned above);
• jemljete vi ali vaš otrok druga zdravila za zdravljenje malarije (razen zgoraj omenjenih);
Any effects are unlikely to persist beyond 24 hours after the last intake of artenimol.
Ni verjetno, da bi kateri od učinkov trajal dalj kot 24 ur po zadnji uporabi artenimola.
The daily dose depends on the patient's body weight.
Dnevni odmerek je odvisen od telesne mase bolnika.
Do not take this medicine after the expiry date which is stated on the package after ‘EXP'.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli poleg oznake "EXP".
These adverse reactions were seen in animals at exposure levels similar to clinical exposure levels, and with possible relevance to clinical use.
Te neželene učinke so opazili v študijah na živalih pri stopnjah izpostavljenosti, ki so bile podobne stopnjam klinične izpostavljenosti in z možnim pomenom za klinično uporabo.
− and also pentamidine and saquinavir.
− ter tudi pentamidin in sakvinavir.
− Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
• ob vsakršni spremembi sistema za obvladovanje tveganj, zlasti kadar je tovrstna sprememba posledica prejema novih informacij, ki lahko privedejo do znatne spremembe razmerja med koristmi in tveganji, ali kadar je ta sprememba posledica tega, da je bil dosežen pomemben mejnik (farmakovigilančni ali povezan z zmanjševanjem tveganja).
Therefore, Eurartesim should be taken with water only as described in section 4.2.
Zato je treba zdravilo Eurartesim jemati z vodo, kot je opisano v poglavju 4.2.
A corresponding table for paediatric patients is presented in the specific section below.
Ustrezna tabela za pediatrične bolnike je predstavljena v specifičnem poglavju spodaj.
The elimination half-life of artenimol is approximately 1 hour.
Razpolovna doba izločanja artenimola je približno 1 ura.
If the tablets are difficult to swallow, you can crush and mix them with water; drink the mixture immediately.
Pri težavah s požiranjem tablet jih lahko zdrobite in zmešate z vodo; mešanico je treba spiti takoj.
The systemic exposure to artenimol was slightly lower following the last dose of Eurartesim (lower than after the first dose by up to 15%).
Sistemska izpostavljenost artenimolu je bila nekoliko nižja po zadnjem odmerku zdravila Eurartesim (nižja kot po prvem odmerku za do 15 %).
• has recently (for example within about one month) been treated for malaria with certain medicines or has taken certain medicines to prevent malaria.
- če ste se vi ali vaš otrok pred kratkim (na primer približno v roku enega meseca) zdravili zaradi malarije z določenimi zdravili ali jemali zdravila za preprečevanje malarije.
Both piperaquine and artenimol are highly bound to human plasma proteins: the protein binding observed in in vitro studies was 44-93% for artenimol and >99% for piperaquine.
Tako piperakin kot artenimol se močno vežeta na beljakovine v človeški plazmi: vezava na beljakovine, ki so jo opazili v študijah in vitro, je bila 44-93 % za artenimol in > 99 % za piperakin.
Contact your doctor urgently to obtain an alternative treatment for malaria.
Urgentno se posvetujte z zdravnikom, da dobite drugo zdravilo za malarijo.
Your doctor will advise you when these readings will be taken.
Zdravnik vam bo povedal, kdaj bo napravil posnetek.
The exposure of pregnant women during the 2nd and 3rd trimester was not associated with any harm of the unborn child.
Izpostavljenost nosečnic zdravilu v 2. in 3. trimesečju nosečnosti ni bila povezana s škodljivi vplivi na otroka.
Piperaquine, a highly lipophilic compound, is slowly absorbed.
Piperakin, visoko lipofilna spojina, se absorbira počasi.
The mean oral clearance was slightly higher for paediatric patients, however the differences were minor in magnitude (<20%).
Povprečni peroralni očistek je bil nekoliko višji za pediatrične bolnike, vendar so bile razlike po velikosti majhne (< 20 %).
PQP Artenimol
PKP Artenimol
For patients unable to swallow the tablets, such as infants and young children, Eurartesim may be crushed and mixed with water.
Za bolnike, ki tablet ne morejo pogoltniti, zlasti za dojenčke in majhne otroke, se lahko zdravilo Eurartesim zdrobi in zmeša z vodo.
A total of 15 (1.5%) subjects had serious ADRs in the study.
Skupaj 15 (1,5 %) oseb je imelo v študiji hude neželene učinke.
Drug-drug interaction studies have only been performed in adults.
Študije medsebojnega delovanja med zdravili so izvedli le pri odraslih.
The same comparison showed that piperaquine absorption rate constant and terminal half-life in children were predominantly similar to those seen in adults.
Enaka primerjava je pokazala, da je konstanta hitrosti absorpcije piperakina in končna razpolovna doba pri otrocih v glavnem podobna kot pri odraslih.
Dosing should be based on body weight as shown in the table below.
Odmerjanje naj temelji na telesni masi, kot je prikazano v spodnji tabeli:
• 30 minutes of taking Eurartesim, the whole dose must be taken again.
• 30 minut po uporabi zdravila Eurartesim, je treba ponovno vzeti ves odmerek;
• The ECG monitoring recommendations.
• Priporočila za spremljanje bolnikov z EKG.
The efficacy and safety of Eurartesim have been assessed in two large randomised, open-label clinical trials:
Učinkovitost in varnost zdravila Eurartesim so preskušali v dveh velikih odprtih randomiziranih kliničnih preskušanjih.
In clinical trials, nine patients received double the cumulative intended dose of Eurartesim.
V kliničnih preskušanjih je devet bolnikov prejelo dvojni kumulativni predvideni odmerek zdravila Eurartesim.
The most important potential cardiac effect was related to cardiac conduction.
Najpomembnejši možni srčni učinek je bil povezan s srčno prevodnostjo.
- Severe malaria according to WHO definition.
- Huda malarija po definiciji SZO.
You should not breast-feed your baby while taking this medicine because the medicine may pass through breast milk to your baby.
Med jemanjem tega zdravila ne smete dojiti, ker zdravilo lahko prehaja z mlekom v vašega otroka.
If a patient vomits within 30 minutes of taking Eurartesim, the whole dose should be re-administered; if a patient vomits within 30-60 minutes, half the dose should be re-administered.
Če bolnik v 30 minutah po uporabi zdravila Eurartesim bruha, je treba odmerek dati ponovno; če bolnik bruha v 30-60 minutah, je treba ponovno dati polovico odmerka.
The Physician Leaflet should contain the following key messages:
Vodnik za zdravnika mora vsebovati naslednje ključne informacije:
If you or your child gets a rash, swelling of the face, lips, tongue or throat with difficulty in swallowing or breathing, these may be signs of an allergic reaction.
Če se pri vas ali pri vašem otroku pojavijo izpuščaj, oteklina obraza, ustnic, jezika ali žrela s težavami požiranja ali dihanja, so lahko to znaki alergijske reakcije.
Based on animal data Eurartesim is suspected to harm the unborn child when used during the first three months of pregnancy.
Na podlagi podatkov pri živalih se sumi, da zdravilo Eurartesim škoduje nerojenemu otroku, če se uporablja v prvih treh mesecih nosečnosti.
Total number of tablets for treatment
Skupno število tablet na zdravljenje
Some medicines can affect the way Eurartesim works and your doctor may decide that Eurartesim is not suitable or that extra checks are needed while you or your child is taking the medicines which could cause possible interactions.
Nekatera zdravila lahko vplivajo na način delovanja zdravila Eurartesim in vaš zdravnik se bo morda odločil, da jemanje zdravila Eurartesim ni ustrezno ali da je treba vas ali vašega otroka dodatno pregledovati med jemanjem zdravil, ki bi lahko povzročila medsebojno delovanje.
Re-dosing with Eurartesim should not be attempted more than once.
Zdravila Eurartesim ne poskušajte dajati ponovno več kot enkrat.
Special precaution is advised in young children when vomiting, as they are likely to develop electrolyte disturbances.
Posebna pozornost se priporoča pri majhnih otrocih, ki bruhajo, saj obstaja večja možnost, da se razvijejo motnje elektrolitov.
The safety of Eurartesim has been evaluated in two phase III open-label studies involving 1,239 paediatric patients up to 18 years and 566 adult patients >18 years treated with Eurartesim.
Varnost zdravila Eurartesim so ocenili v dveh odprtih študijah faze III, ki sta vključevali 1.239 pediatričnih bolnikov, starih do 18 let, in 566 odraslih bolnikov, starih več kot 18 let, zdravljenih z zdravilom Eurartesim.
Effects on blood pressure and on PR and QRS duration were observed at high piperaquine doses.
Učinke na krvni tlak in trajanje PR in QRS so opazili samo pri visokih odmerkih piperakina.
Pharmacokinetic profiles of artenimol and piperaquine have been investigated in animal models and in different human populations (healthy volunteers, adult patients and paediatric patients).
Farmakokinetična profila artenimola in piperakina so preučili na živalskih modelih in pri različnih populacijah ljudi (zdravi prostovoljci, odrasli bolniki in pediatrični bolniki).
However, there was no delay in neonatal development following exposure in utero or via milk (see section 5.3).
Vendar pa ni bilo zakasnitve v neonatalnem razvoju po izpostavitvi in utero ali z mlekom (glejte poglavje 5.3).
Its clearance was found to be slightly lower in female than in male healthy volunteers.
Ugotovili so, da je očistek nekoliko manjši pri ženskih zdravih prostovoljkah kot pri moških zdravih prostovoljcih.
Adverse event data collected in clinical trials suggest that Eurartesim has no influence on the ability to drive and operate machines once the patient has recovered from the acute infection.
Podatki o neželenih učinkih, zbrani v kliničnih preskušanjih, kažejo, da zdravilo Eurartesim nima vpliva na sposobnost vožnje in upravljanja strojev, ko enkrat bolnik okreva od akutne okužbe.
If a dose is missed, it should be taken as soon as realised and then the recommended regimen continued until the full course of treatment has been completed.
Če bolnik izpusti odmerek, ga mora vzeti takoj, ko se to opazi, nato pa naj s priporočenim režimom jemanja nadaljuje do zaključka celotnega poteka zdravljenja.
This pharmacokinetic effect is accompanied by an increased effect on prolongation of the QT interval.
Ta farmakokinetični učinek spremlja večji učinek na podaljšanje intervala QT.
Very common (may affect more than 1 in 10 people) Influenza, cough, fever.
Zelo pogosti (pojavijo se lahko pri več kot 1 od 10 bolnikov): gripa, kašelj, zvišana telesna temperatura.
However, it is reported in the literature that the excretion of unchanged active substance in human urine and faeces is negligible for artemisinin derivatives.
Vendar pa viri navajajo, da je izločanje nespremenjene učinkovine v človeškem urinu in blatu zanemarljivo za derivative artemizinina.
What Eurartesim is and what it is used for
Kaj je zdravilo Eurartesim in za kaj ga uporabljamo
Data regarding artenimol excretion in humans are scarce.
Podatki o izločanju artenimola pri ljudeh so redki.
The exact mechanism of action of piperaquine is unknown, but it likely mirrors that of chloroquine, a close structural analogue.
Natančen mehanizem delovanja piperakina ni znan, vendar verjetno posnema delovanje klorokina, bližnjega analoga po zgradbi.
In a perinatal and postnatal development study (segment III) in female rats treated with 80 mg/kg, some animals had a delay of delivery inducing mortality of the neonates.
V študijah perinatalnega in ponatalnega razvoja (segment III) pri podganjih samicah, ki so jim dajali 80 mg/kg, se je pri nekaterih živalih pojavila zakasnitev kotenja, kar je induciralo smrtnost rojenih goličev.
Before the third dose of Eurartesim, in one of the two Phase III studies 3/767 patients (0.4%) were reported to have a QTcF value of >500 ms versus none in the comparator group.
Pred tretjim odmerkom zdravila Eurartesim so v eni od dveh študij 3. faze pri 3/767 bolnikov (0,4 %) poročali o vrednosti QTcF > 500 ms v primerjavi z nobenim v primerjalni skupini.
Examples are listed below (but there are several others): - some medicines used to treat high cholesterol in the blood (such as atorvastatin, lovastatin,
Primeri so našteti spodaj (vendar obstaja še veliko drugih): - nekatera zdravila za zdravljenje visokega holesterola v krvi (kot so atorvastatin, cerivastatin,
A total of 6 (0.8%) subjects had serious ADRs in the study.
Skupaj 6 (0,8 %) oseb je imelo v študiji hude neželene učinke.
A heart problem, called QT prolongation, can occur while taking Eurartesim and for some days after taking the last dose.
Težave s srcem, imenovane podaljšanje intervala QT, se lahko pojavijo pri jemanju zdravila Eurartesim in še nekaj dni po zadnjem odmerku.
Eurartesim kills the Plasmodium falciparum parasite.
Zdravilo Eurartesim ubije parazita Plasmodium falciparum.
The potential for Eurartesim to prolong the QTc interval was investigated in parallel groups of healthy volunteers who took each dose with high (~1000 Kcal) or low (~400 Kcal) fat/calorie meals or in fasting conditions.
Potencial zdravila Eurartesim, da podaljša interval QTc, so preučili v vzporednih skupinah zdravih prostovoljcev, ki so vzeli vsak odmerek z visoko (~1000 Kcal) ali nizko (~400 Kcal) vsebnostjo maščob/kalorij ali na tešče.
- Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.
- Preobčutljivost na zdravilni učinkovini ali katero koli pomožno snov, navedeno v poglavju 6.1.