natgillin/translations-raw huggingface dataset:
Further information on Nityr can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Nadaljnje informacije za zdravilo Nityr so na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
What measures are being taken to ensure the safe and effective use of Nityr?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Nityr?
What are the benefits and risks of Nityr?
Kakšne so koristi in tveganja zdravila Nityr?
As for every medicine, the company provided studies on the quality of Nityr.
Tako kot za vsako zdravilo je podjetje predložilo študije o kakovosti zdravila Nityr.
Nityr is intended for long-term use.
Zdravilo Nityr je namenjeno dolgotrajni uporabi.
Because Nityr is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Ker je zdravilo Nityr generično zdravilo in je bioekvivalentno referenčnemu zdravilu, so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
This is a rare disease in which the body is unable to completely break down the amino acid tyrosine and, as a result, harmful substances are formed, causing serious liver problems and liver cancer.
To je redka bolezen, pri kateri telo ni sposobno popolnoma razgraditi aminokisline tirozin, zaradi česar nastajajo škodljive snovi, ki povzročajo hude težave z jetri in raka jeter.
An overview of Nityr and why it is authorised in the EU
Pregled zdravila Nityr in zakaj je odobreno v EU
Studies on the benefits and risks of the active substance in the authorised use have already been carried out with the reference medicine, Orfadin, and do not need to be repeated for Nityr.
Študije o koristih in tveganjih učinkovine pri odobrenem načinu uporabe so že bile izvedene z referenčnim zdravilom Orfadin, zato jih ni treba ponoviti za zdravilo Nityr.
Why is Nityr authorised in the EU?
Zakaj je bilo zdravilo Nityr odobreno v EU?
Other information about Nityr
Druge informacije o zdravilu Nityr
Side effects reported with Nityr are carefully evaluated and any necessary action taken to protect patients.
Neželeni učinki, o katerih so poročali pri zdravilu Nityr, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
The European Medicines Agency concluded that, in accordance with EU requirements, Nityr has been shown to have comparable quality and to be bioequivalent to Orfadin.
Evropska agencija za zdravila je zaključila, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Nityr primerljivo raven kakovosti in je bioekvivalentno z zdravilom Orfadin.
Treatment should be started as early as possible and the dose of Nityr adjusted according to the patient's response and body weight.
Zdravljenje je treba začeti čim prej, odmerek zdravila Nityr pa je treba prilagoditi bolnikovemu odzivu in telesni masi.
As for all medicines, data on the use of Nityr are continuously monitored.
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Nityr stalno spremljajo.
Patients with HT-1 lack one of these enzymes, so tyrosine is not properly eliminated but is converted into harmful substances.
Bolniki z dedno tirozinemijo tipa 1 nimajo enega od teh encimov, zato se tirozin v njihovem telesu ne razgradi ustrezno, ampak se pretvori v škodljive snovi.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Nityr have been included in the summary of product characteristics and the package leaflet.
Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Nityr upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
What is Nityr and what is it used for?
Kaj je zdravilo Nityr in za kaj se uporablja?
Nityr is a medicine used to treat hereditary tyrosinaemia type 1 (HT-1).
Nityr je zdravilo za zdravljenje dedne tirozinemije tipa 1 (HT-1).
For more information about using Nityr, see the package leaflet or contact your doctor or pharmacist.
Za več informacij glede uporabe zdravila Nityr glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
This means that Nityr contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the EU called Orfadin.
To pomeni, da vsebuje enako učinkovino in deluje na enak način kot „referenčno zdravilo“, ki je že odobreno v EU in se imenuje Orfadin.
Nityr contains the active substance nitisinone and is a ‘generic medicine'.
Zdravilo Nityr vsebuje učinkovino nitizinon in je „generično zdravilo“.
Nityr can only be obtained with a prescription and treatment should be started and monitored by doctors who have experience in the treatment of patients with HT-1.
Predpisovanje in izdaja zdravila Nityr je le na recept, zdravljenje z njim pa lahko uvede in nadzoruje le zdravnik z izkušnjami z zdravljenjem bolnikov z dedno tirozinemijo tipa 1.
The active substance in Nityr, nitisinone, blocks an enzyme that converts tyrosine into harmful substances.
Učinkovina v zdravilu Nityr, nitizinon, zavira encim, ki pretvarja tirozin v škodljive snovi.
Nityr is used together with a diet that restricts the intake of the amino acids tyrosine and phenylalanine.
Zdravilo Nityr se uporablja skupaj z dieto, ki omejuje vnos aminokislin tirozin in fenilalanin.
The diet also needs to be low in phenylalanine, as this is converted to tyrosine in the body.
Dieta mora vsebovati tudi čim manj fenilalanina, saj se ta v telesu pretvarja v tirozin.
However, as the unconverted tyrosine remains in the body during Nityr treatment, patients need to eat
Ker pa tirozin med zdravljenjem z zdravilom Nityr ostane v telesu, potrebujejo bolniki posebno dieto z nizko
Therefore, the Agency's view was that, as for Orfadin, the benefit of Nityr outweighs the identified risk and it can be authorised for use in the EU.
Zato je agencija menila, da koristi zdravila Nityr, enako kot pri zdravilu Orfadin, odtehtajo znana tveganja in se zdravilo lahko odobri v EU.
How does Nityr work?
Kako zdravilo Nityr deluje?
Nityr is available as 10 mg tablets to be taken by mouth.
Na voljo je v obliki 10-miligramskih tablet, ki se jemljejo peroralno.
How has Nityr been studied?
Kako je bilo zdravilo Nityr raziskano?
How is Nityr used?
Kako se zdravilo Nityr uporablja?
a special diet low in tyrosine.
vsebnostjo tirozinov.
The MAH(s) should provide new randomised controlled data that will be able to robustly demonstrate that the benefits of calcitonin-containing medicines outweigh risks in patients with osteoporosis taking into account the increased risk of cancer and cancer mortality associated with long term use of calcitonin.
Analize podatkov randomiziranih kontroliranih preskušanjih pri bolnikih z osteoartritisom in osteoporozo kažejo, da je uporaba kalcitonina povezana s statistično značilnim povečanjem tveganja za raka v primerjavi s tveganjem pri bolnikih, ki so prejemali placebo.
Annex IV Conditions for the lifting of the suspension of the Marketing Authorisations (intranasal formulations)
4.2 Odmerjanje in način aplikacije [vključite spodaj navedeno besedilo]
In order to lift the suspension of the MA, National Competent Authorities shall ensure that the following conditions are fulfilled by the MAH(s) of intranasal formulations of calcitonin-containing medicines:
Kako jemati zdravilo <izmišljeno ime> [vključite spodaj navedeno besedilo] Vaš zdravnik bo določil, kateri odmerek zdravila je primeren za vas in kako dolgo morate prejemati kalcitonin glede na vašo bolezen.
Conditions for the lifting of the suspension of the Marketing Authorisations (intranasal formulations)
Možni neželeni učinki [vključite spodaj navedeno besedilo]
• Try to take it at about the same time each day.
• Poskušajte ga vzeti vsak dan ob približno enakem času.
Date of first authorisation: 18 September 2017
Datum prve odobritve: 18. septembra 2017
• you are often dizzy or fall over.
• ste pogosto omotični ali padate.
• You have been given this medicine to lower the number of fits (seizures) you have.
• To zdravilo ste prejeli, da bi zmanjšalo število napadov (krčev), ki jih imate.
This presentation is not suitable for this category of patients.
Ta oblika ni primerna za bolnike te kategorije.
• medicines to treat heart problems;
• zdravila za zdravljenje težav s srcem;
• In this type of epilepsy, fits first affect only one side of your brain.
• Pri tej vrsti epilepsije napadi v začetku prizadanejo le eno stran možganov.
You may experience:
Lahko se pojavijo:
• you have thoughts of harming or killing yourself.
• imate misli o samopoškodovanju ali samomoru.
Risk related to epilepsy and antiepileptic medicinal products in general
Tveganje, povezano z epilepsijo, in antiepileptiki na splošno
Eating less than usual;
• uživanje manjše količine hrane kot običajno.
Do not take Lacosamide Accord if you are allergic to lacosamide, or any of the other ingredients of this medicine (listed in section 6).
Ne jemljite zdravila Lacosamide Accord če ste alergični na lakozamid ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
This pack (treatment initiation pack) is used when you start your treatment with Lacosamide Accord.
To pakiranje (paket za začetek zdravljenja) se uporablja, ko začnete zdravljenje z zdravilom Lacosamide Accord.
You should continue to take Lacosamide Accord until your doctor tells you to stop.
Zdravilo Lacosamide Accord morate jemati, dokler vam zdravnik ne naroči, da prenehate.
Do not take Lacosamide Accord if any of the above applies to you.
Zdravila Lacosamide Accord ne jemljite, če za vas velja kar koli od zgoraj navedenega.
If you are allergic to peanut or soya, do not use this medicinal product.
Če ste alergični na arašide ali sojo, tega zdravila ne smete jemati.
The dose is determined based on body weight.
Odmerek se določi na podlagi telesne mase.
Maintenance treatment (after the first 4 weeks)
Vzdrževalno zdravljenje (po prvih 4 tednih)
This dose is called a maintenance dose and will depend on how you respond to Lacosamide Accord.
Odmerek se imenuje vzdrževalni odmerek in bo odvisen od vašega odziva na zdravilo Lacosamide Accord.
• Take Lacosamide Accord twice each day- once in the morning and once in the evening.
• Zdravilo Lacosamide Accord vzemite vsak dan dvakrat, enkrat zjutraj in enkrat zvečer.
They will help you decide if you should take Lacosamide Accord or not.
Pomagal vam bo pri odločitvi, ali smete jemati zdravilo Lacosamide Accord ali ne.
• Lacosamide Accord may be used on its own or with other antiepileptic medicines.
• Zdravilo Lacosamide Accord se lahko uporablja samostojno ali z drugimi antiepileptiki.
• you have severe heart disease such as heart failure or have had a heart attack.
• imate hudo srčno obolenje, kot sta srčno popuščanje ali če ste imeli srčni infarkt;
Hypersensitivity to the active substance, soya lecithin or to any of the excipients listed in section 6.1.
Preobčutljivost na učinkovino, sojin lecitin ali katero koli pomožno snov, navedeno v poglavju 6.1.
• Do not stop taking Lacosamide Accord without talking to your doctor, as your epilepsy may come back again or become worse.
• Ne prekinite jemanja zdravila Lacosamide Accord brez posvetovanja z zdravnikom, saj se lahko vaša epilepsija spet pojavi ali poslabša.
In particular, tell your doctor or pharmacist if you are taking any of the following medicines that affect your heart - this is because Lacosamide Accord can also affect your heart:
Zdravniku ali farmacevtu povejte še zlasti, če jemljete katero koli od naslednjih zdravil, ki vplivajo na vaše srce; razlog za to je, da zdravilo Lacosamide Accord prav tako vpliva na vaše srce:
Lacosamide Accord is used as a long term treatment.
Zdravilo Lacosamide Accord se uporablja za dolgotrajno zdravljenje.
Packs of 14, 56, 60 or 168 tablets
Pakiranja po 14, 56, 60 ali 168 tablet
If you take more Lacosamide Accord than you should If you have taken more Lacosamide Accord than you should, contact your doctor immediately.
Če ste vzeli večji odmerek zdravila Lacosamide Accord, kot bi smeli Če ste vzeli večji odmerek zdravila Lacosamide Accord, kot bi smeli, se takoj posvetujte z zdravnikom.
Listed below are the normal recommended doses of Lacosamide Accord for different age groups and weights.
Spodaj so navedeni običajni priporočeni odmerki zdravila Lacosamide Accord za različne starostne skupine in telesne mase.
Also tell your doctor or pharmacist if you are taking any of the following medicines - this is because they may increase or decrease the effect of Lacosamide Accord on your body:
Zdravniku ali farmacevtu povejte tudi, če jemljete katero koli od naslednjih zdravil; razlog za to je, da lahko ta zdravila povečajo ali zmanjšajo učinek zdravila Lacosamide Accord na vaše telo:
Instead take Lacosamide Accord at the next time that you would normally take it.
Namesto tega zdravilo Lacosamide Accord vzemite ob času naslednjega odmerka, kot bi ga običajno vzeli.
What Lacosamide Accord is and what it is used for What you need to know before you take Lacosamide Accord How to take Lacosamide Accord Possible side effects
Kaj je zdravilo Lacosamide Accord in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Lacosamide Accord Kako jemati zdravilo Lacosamide Accord Možni neželeni učinki
For all antiepileptic medicinal products, it has been shown that in the offspring of treated women with epilepsy, the prevalence of malformations is two to three times greater than the rate of approximately 3 % in the general population.
Pri vseh antiepileptikih se je pokazalo, da je pri potomcih zdravljenih žensk z epilepsijo prevalenca malformacij dva- do trikrat večja kot pri normalni populaciji, kjer je ta približno 3 %.
• Swallow the Lacosamide Accord tablet with a glass of water.
• Tableto zdravila Lacosamide Accord pogoltnite s kozarcem vode.
This medicinal product contains lecithin (soya).
To zdravilo vsebuje lecitin (soja).
• medicines used to treat certain types of irregular heart beat or heart failure.
• zdravila, ki se uporabljajo za zdravljenje določenih vrst nepravilnega bitja srca ali srčnega popuščanja.
• medicines which can increase the “PR interval” on a scan of the heart (ECG or electrocardiogram) such as medicines for epilepsy or pain called carbamazepine, lamotrigine or pregabalin;
• zdravila, ki lahko podaljšajo interval P-R med slikanjem srca (EKG ali elektrokardiogram), kot so zdravila za zdravljenje epilepsije ali bolečine, ki se imenujejo karbamazepin, lamotrigin ali pregabalin;
Lacosamide Accord is not recommended for children aged under 4 years.
Zdravilo Lacosamide Accord pri otrocih, mlajših od 4 let, ni priporočeno.
if you have a certain type of heart beat problem called second- or third-degree AV block.
• če imate določeno vrsto težav s srčnim ritmom, ki se imenuje atrioventrikularni blok druge ali tretje stopnje.
• a medicine for HIV called ritonavir;
• zdravilo za HIV, ki se imenuje ritonavir;
In post-marketing experience, AV block (including second degree or higher AV block) has been reported.
V obdobju postmarketinških izkušenj so poročali o atrioventrikularnem bloku (vključno z atrioventrikularnim blokom druge ali višje stopnje).
Do not stop treatment without talking to your doctor first as this could increase your fits (seizures).
Zdavljenja ne prekinite, preden se ne posvetujete z zdravnikom, saj bi se število vaših napadov (krčev) zaradi tega lahko povečalo.
Lacosamide Accord with alcohol As a safety precaution do not take Lacosamide Accord with alcohol.
Zdravilo Lacosamide Accord skupaj z alkoholom Iz varnostnih razlogov ne jemljite zdravila Lacosamide Accord skupaj z alkoholom.
• you have a heart problem that affects the beat of your heart and you often have a particulary slow, fast or irregular heart beat (such as AV block, atrial fibrillation and atrial flutter).
• imate težave s srcem, ki vplivajo na bitje vašega srca in imate pogosto posebej počasno, hitro ali neredno bitje (npr. atrioventrikularni blok, atrijska fibrilacija in atrijska undulacija);
• You may take Lacosamide Accord with or without food.
• Zdravilo Lacosamide Accord lahko jemljete s hrano ali brez nje.
14 film-coated tablets 56 film-coated tablets 60 film-coated tablets 168 film-coated tablets 14 x 1 film-coated tablet 56 x 1 film-coated tablet
14 filmsko obloženih tablet 56 filmsko obloženih tablet 60 filmsko obloženih tablet 168 filmsko obloženih tablet 14 x 1 filmsko obložena tableta 56 x 1 filmsko obložena tableta
• if you are allergic to peanut or soya.
če ste alergični na arašide ali sojo,
In treated patients who completed titration and started withdrawing antiepileptic medicinal products ( 284 and 99 respectively), monotherapy was maintained in 71.5 % and 70.7 % of patients respectively for 57-105 days (median 71 days), over the targeted observation period of 70 days.
Pri zdravljenih bolnikih, ki so končali titracijo in začeli s prenehanjem jemanja antiepileptikov (284 oziroma 99), je bilo v ciljnem opazovanem obdobju 70 dni samostojno zdravljenje vzdrževano pri 71,5 % oziroma 70,7 % bolnikov od 57-105 dni (mediana 71 dni).
Lacosamide Accord treatment initiation pack contains 4 different packages (one for each tablet strength) with 14 tablets each, for the first 2 to 4 weeks of therapy depending on the patient´s response and tolerability.
Paket zdravila Lacosamide Accord za začetek zdravljenja vsebuje 4 različna pakiranja (eno za vsako jakost tablet), vsako s po 14 tabletami, ki glede na bolnikov odziv in prenašanje zdravila zadostuje za prva 2 do 4 tedne zdravljenja.
• If you have missed a dose within the first 6 hours of the scheduled dose, take it as soon as you remember.
• Če ste z odmerkom zamudili do 6 ur od predvidenega časa za odmerek, ga vzemite takoj, ko se spomnite.
Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF United Kingdom or
Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF Združeno kraljestvo ali
Dosage in adolescents and children weighing 50 kg or more is the same as in adults (see above).
Odmerek pri mladostnikih in otrocih, ki tehtajo 50 kg ali več, je enak kot pri odraslih (glejte zgoraj).
• Lacosamide Accord is used in adults, adolescents and children aged 4 years and older.
• Zdravilo Lacosamide Accord se uporablja pri odraslih, mladostnikih in otrocih, starih 4 leta in več.
What you need to know before you take Lacosamide Accord
Kaj morate vedeti, preden boste vzeli zdravilo Lacosamide Accord
In children weighing from 20 to under 30 kg, a maximum dose of 10 mg/kg/day is recommended and in children weighing from 30 to under 50 kg, a maximum dose of 8 mg/kg/day is recommended, although in open-label studies (see sections 4.8 and 5.2), a dose up to 12 mg/kg/day has been used by a small number of these children.
Pri otrocih, ki tehtajo od 20 do manj kot 30 kg, je priporočeni največji odmerek 10 mg/kg/dan in pri otrocih, ki tehtajo od 30 do manj kot 50 kg, je priporočeni največji odmerek 8 mg/kg/dan, čeprav je bil v odprtih študijah (glejte poglavji 4.8 in 5.2) pri majhnem številu takšnih otrok uporabljen odmerek do 12 mg/kg/dan.
• medicines for fungal infections called fluconazole, itraconazole or ketoconazole;
• zdravila za glivične okužbe, ki se imenujejo flukonazol, itrakonazol ali ketokonazol;
Lacosamide Accord film-coated tablets are packed in PVC-PVDC/Aluminium blisters.
Zdravilo Lacosamide Accord filmsko obložene tablete je pakirano v PVC-PVDC/aluminijastih pretisnih omotih.
• If you have missed a dose beyond the first 6 hours of the scheduled dose, do not take the missed tablet anymore.
• Če ste z odmerkom zamudili več kot 6 ur od predvidenega časa za odmerek, ne vzemite izpuščene tablete.
You will start your treatment with a low dose of Lacosamide Accord, usually 50 mg twice a day, and increase it week by week.
Zdravljenje boste začeli z nizkim odmerkom zdravila Lacosamide Accord, običajno 50 mg dvakrat na dan, in ga iz tedna v teden povečevali.
Laboratori Fundacio Dau C/ C, 12-14 Pol. Ind. Zona Franca 08040 Barcelona SPAIN
Laboratori Fundacio Dau C/ C, 12-14 Pol. Ind. Zona Franca 08040 Barcelona Španija
How to store Lacosamide Accord Contents of the pack and other information
Shranjevanje zdravila Lacosamide Accord Vsebina pakiranja in dodatne informacije
It is not recommended to take Lacosamide Accord if you are pregnant or breast-feeding, as the effects of lacosamide on pregnancy and the unborn baby or the new-born child are not known.
V času nosečnosti ali dojenja jemanje zdravila Lacosamide Accord ni priporočljivo, ker učinki lakozamida na nosečnost, nerojenega otroka ali novorojenega otroka niso znani.
Lacosamide Accord is available in packs of 14, 56, 60 or 168 film-coated tablets.
Zdravilo Lacosamide Accord filmsko obložene tablete je na voljo v pakiranjih po 14, 56, 60 ali 168 filmsko obloženih tablet.
• If your doctor decides to stop your treatment with Lacosamide Accord , they will tell you how to decrease the dose step by step.
• Če se bo zdravnik odločil za prekinitev zdravljenja z zdravilom Lacosamide Accord, vam bodo povedali, kako po korakih zmanjševati odmerek.
50 mg: Each film-coated tablet contains 0.105 mg of lecithin (soya) 100 mg: Each film-coated tablet contains 0.210 mg of lecithin (soya) 150 mg: Each film-coated tablet contains 0.315 mg of lecithin (soya) 200 mg: Each film-coated tablet contains 0.420 mg of lecithin (soya) For the full list of excipients, see section 6.1.
50 mg: ena filmsko obložena tableta vsebuje 0,105 mg lecitina (soja) 100 mg: ena filmsko obložena tableta vsebuje 0,210 mg lecitina (soja) 150 mg: ena filmsko obložena tableta vsebuje 0,315 mg lecitina (soja) 200 mg: ena filmsko obložena tableta vsebuje 0,420 mg lecitina (soja) Za celoten seznam pomožnih snovi glejte poglavje 6.1.
Your doctor may also prescribe a starting dose of 100 mg of Lacosamide Accord twice a day.
Zdravnik vam lahko predpiše tudi začetni odmerek 100 mg zdravila Lacosamide Accord dvakrat na dan.
The efficacy of lacosamide as adjunctive therapy at recommended doses (200 mg/day, 400 mg/day) was established in 3 multicenter, randomized, placebo-controlled clinical trials with a 12-week maintenance period.
Učinkovitost dopolnilnega zdravljenja z lakozamidom v priporočenih odmerkih (200 mg/dan, 400 mg/dan) so preučevali v 3 multicentričnih, randomiziranih, s placebom nadzorovanih kliničnih preskušanjih z 12-tedenskim obdobjem vzdrževalnega zdravljenja.
These trials, involving 1,308 patients with a history of an average of 23 years of partial-onset seizures, were designed to evaluate the efficacy and safety of lacosamide when administered concomitantly with 1-3 antiepileptic medicinal products in patients with uncontrolled partial-onset seizures with or without secondary generalisation.
Preskušanja, v katera je bilo vključenih 1308 bolnikov, ki so imeli v anamnezi parcialne napade v povprečju 23 let, so bila načrtovana za oceno učinkovitosti in varnosti lakozamida pri sočasnem jemanju z 1 do 3 antiepileptiki pri bolnikih z nenadzorovanimi parcialnimi napadi s sekundarno generalizacijo ali brez nje.
Table: Start of the treatment (the first 4 weeks)
Preglednica: Začetek zdravljenja (prvi 4 tedni)
In anesthetized dogs and Cynomolgus monkeys, at intravenous doses of 15-60 mg/kg, slowing of atrial and ventricular conductivity, atrioventricular block and atrioventricular dissociation were seen.
Pri anesteziranih psih in opicah vrste Cynomolgus so pri intravenskih odmerkih 15-60 mg/kg opazili zmanjšanje atrijske in ventrikularne prevodnosti, atrioventrikularni blok in atrioventrikularno disociacijo.
WESSLING Hungary Kft, Anonymus u. 6., Budapest, 1045, Hungary
WESSLING Hungary Kft, Anonymus u. 6., Budapest, 1045, Madžarska
A safety pharmacology study with intravenous administration of lacosamide in anesthetized dogs showed transient increases in PR interval and QRS complex duration and decreases in blood pressure most likely due to a cardiodepressant action.
Študije farmakološke varnosti pri intravenski uporabi lakozamida anesteziranim psom so pokazale prehodno podaljšanje intervala P-R in trajanje kompleksa Q-R-S ter znižanje krvnega tlaka, najverjetneje zaradi zaviralnega delovanja na srce.