natgillin/translations-raw huggingface dataset:
The vaccine is shaken before use and an intramuscular (into a muscle) injection of one dose (2 ml) is given in the neck behind the ear.
Intramuskularna injekcija (injekcija v mišico) enega odmerka (2 ml) se daje v vrat v predel za ušesom.
Porcilis Pesti has been studied in two safety field trials, one in finishing pigs and one in sows using different vaccination doses.
Zdravilo Porcilis Pesti so preučevali v okviru dveh terenskih študij varnosti, eni na pitancih in eni na svinjah, pri čemer sta bila uporabljena različna odmerka cepiva.
Viraemia was only prevented by two injections (as recommended in the vaccination schedule for Porcilis Pesti).
Viremijo je bilo mogoče preprečiti z dvema injekcijama (kot je priporočeno v shemi cepljenja z zdravilom Porcilis Pesti).
Temporary hyperthermia (increased temperature) may occur after the second injection.
Po drugi injekciji lahko pride do začasne hipertermije (povišane temperature).
The main measure of effectiveness in a field trial with piglets was the survival of the piglets when exposed to the CSF virus later in life.
Glavno merilo učinkovitosti pri terenskih študijah s pujski je bilo preživetje pujskov, če so bili izpostavljeni virusu KPK pozneje v življenju.
Porcilis Pesti can cause a swelling at the injection site for up to 4 weeks after each injection of the vaccine.
Zdravilo Porcilis Pesti lahko povzroči oteklino na mestu injiciranja, ki lahko traja do 4 tedne po vsakem posameznem injiciranju cepiva.
All the vaccinations prevented death when the piglets were exposed to CSF virus at a later date.
Vsa cepljenja so preprečila smrt pujskov, ko so bili ti kasneje izpostavljeni virusu KPK.
What benefit has Porcilis Pesti shown during the studies?
Kakšne koristi je zdravilo Porcilis Pesti izkazalo med raziskavami?
The European Commission granted a marketing authorisation valid throughout the European Union for Porcilis Pesti to Intervet International B.V. on 9 February 2000, which was renewed in February
Evropska komisija je dovoljenje za promet z zdravilom Porcilis Pesti, veljavno po vsej Evropski uniji, odobrila družbi Intervet International B.V.
Antibodies to the CSF antigen showed that the piglets developed immunity after 2 weeks, which was maintained for 6 months.
Protitelesa proti antigenu virusa KPK so pokazala, da se je imunost pri pujskih razvila po 2 tednih in je trajala 6 mesecev.
Porcilis Pesti contains an antigen - E2 (a substance that stimulates an immune response) to CSF.
Zdravilo Porcilis Pesti vsebuje antigen - E2 (snov, ki spodbuja imunski odziv) proti KPK.
The package leaflet should be taken to the doctor.
V tem primeru je treba k zdravniku odnesti tudi Navodila za uporabo.
The Committee for Medicinal Products for Veterinary Use (CVMP) agreed that the benefits of Porcilis Pesti are greater than any risks to immunise pigs from the age of 5 weeks onwards to prevent death and to reduce clinical signs of Classical Swine Fever.
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je sklenil, da so koristi zdravila Porcilis Pesti pri imunizaciji prašičev, starih 5 tednov in več, pri preprečevanju smrtnosti in zmanjšanju kliničnih znakov klasične prašičje kuge večje od morebitnih tveganj.
They recommended that Porcilis Pesti should be given a marketing authorisation.
Zato je priporočil, da se za zdravilo Porcilis Pesti odobri dovoljenje za promet.
What is the risk associated with Porcilis Pesti?
Kakšna tveganja so povezana z zdravilom Porcilis Pesti?
Porcilis Pesti contains Classical Swine Fever Virus -E2 subunit antigen.
Zdravilo Porcilis Pesti vsebuje virus klasične prašičje kuge - antigenska podenota E2.
The start and length of immunity was measured by antibodies produced by the piglets to the CSF antigen (E2).
Začetek in trajanje imunosti so merili na podlagi protiteles proti antigenu (E2) virusa KPK, ki so jih tvorili pujski.
Why has Porcilis Pesti been approved?
Zakaj je bilo zdravilo Porcilis Pesti odobreno?
Abscesses may be seen at the injection site.
Na mestu injiciranja so možni abscesi.
What is Porcilis Pesti used for?
Za kaj se zdravilo Porcilis Pesti uporablja?
What is Porcilis Pesti?
Kaj je zdravilo Porcilis Pesti?
How does Porcilis Pesti work?
Kako zdravilo Porcilis Pesti deluje?
How has Porcilis Pesti been studied?
Kako je bilo zdravilo Porcilis Pesti raziskano?
Porcilis Pesti contains mineral oil.
Zdravilo Porcilis Pesti vsebuje tekoči parafin.
Porcilis Pesti is used to immunise healthy pigs from the age of 5 weeks onwards to prevent death and to reduce clinical signs of Classical Swine Fever (CSF).
S tem se preprečuje smrtnost in zmanjšujejo klinični znaki klasične prašičje kuge (KPK).
This summary was last updated on 05/09/2006.
Ta povzetek je bil nazadnje posodobljen 05/09/2006.
The vaccine was assessed in the context of an emergency situation which means that further studies with Nobilis H5N2 are still ongoing and will be assessed.
Cepivo je bilo ocenjeno v izrednih razmerah, kar pomeni, da nadaljnje raziskave z zdravilom Nobilis Influenza H5N2 še vedno potekajo in bodo ovrednotene v prihodnosti.
The European Commission granted a marketing authorisation valid throughout the European Union, for Nobilis Influenza H5N2 to Intervet International BV on 01/09/2006.
Evropska komisija je dovoljenje za promet z zdravilom Nobilis Influenza H5N2, veljavno po vsej Evropski uniji, odobrila družbi Intervet International BV dne 01/09/2006.
The virus used for the vaccine carries the H5 (haemagglutinin 5) and N2 (neuramidase 2) antigens.
Virus, uporabljen za cepivo, vsebuje antigena H5 (hemaglutinin 5) in N2 (nevraminidaza 2).
The company carried out laboratory safety studies using a vaccine very similar to Nobilis Influenza H5N2.
Podjetje je izvedlo laboratorijske raziskave o varnosti v katerih je uporabilo cepivo, ki je zelo podobno zdravilu Nobilis Influenza H5N2.
Vaccinated birds can be differentiated from infected birds by a diagnostic test for antibodies against the N2 component.
Cepljene ptice je mogoče razlikovati od okuženih ptic z diagnostičnim testom za protitelesa proti sestavini N2.
Nobilis Influenza H5N2 is a vaccine containing an inactivated avian influenza virus H5N2 (inactivated means that the virus has been killed so that it cannot cause the disease any more).
Zdravilo Nobilis Influenza H5N2 je cepivo, ki vsebuje inaktivirani virus aviarne influence H5N2 (inaktiviran pomeni, da je bil virus ubit, zaradi česar ne more več povzročiti bolezni).
Nobilis Influenza H5N2 has been authorised under “Exceptional Circumstances”.
Zdravilo Nobilis Influenza H5N2 je bilo odobreno v »izjemnih okoliščinah«.
Nobilis Influenza H5N2 is a vaccine used in chickens to protect against avian influenza.
Zdravilo Nobilis Influenza H5N2 je cepivo, ki se uporablja pri piščancih za zaščito pred aviarno influenco.
• If the circulating avian influenza field virus has a different N component to the N2 included in the vaccine, it may be possible to differentiate between vaccinated from infected birds by using a diagnostic test to detect Neuraminidase antibodies.
• Če ima krožeči divji virus aviarne influence sestavino N, ki se razlikuje od sestavine N2 v cepivu, lahko cepljene ptice razlikujemo od okuženih z diagnostičnim testom za odkrivanje protiteles proti nevraminidazi.
They also tested the safety of three standard production batches of Nobilis Influenza H5N2.
Preizkušena je bila tudi varnost treh standardnih proizvodnih serij zdravila Nobilis Influenza H5N2.
Nobilis Influenza H5N2 is a vaccine.
Zdravilo Nobilis Influenza H5N2 je cepivo.
Other information about Nobilis Influenza H5N2:
Druge informacije o zdravilu Nobilis Influenza H5N2:
EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) NOBILIS INFLUENZA H5N2
EMEA/V/C/118 EVROPSKO JAVNO POROČILO O OCENI ZDRAVILA (EPAR) NOBILIS INFLUENZA H5N2 Povzetek EPAR za javnost
What benefit has Nobilis Influenza H5N2 shown during the studies?
Kakšne koristi je zdravilo Nobilis Influenza H5N2 izkazalo med raziskavami?
What is the risk associated with Nobilis Influenza H5N2?
Kakšna tveganja so povezana z zdravilom Nobilis Influenza H5N2?
Why has Nobilis Influenza H5N2 been approved?
Zakaj je bilo zdravilo Nobilis Influenza H5N2 odobreno?
How has Nobilis Influenza H5N2 been studied?
Kako je bilo zdravilo Nobilis Influenza H5N2 raziskano?
What is Nobilis Influenza H5N2?
Kaj je zdravilo Nobilis Influenza H5N2?
What is Nobilis Influenza H5N2 used for?
Za kaj se zdravilo Nobilis Influenza H5N2 uporablja?
How does Nobilis Influenza H5N2 work?
Kako zdravilo Nobilis Influenza H5N2 deluje?
Annual reports: as part of the annual re-assessment dossier
Letna poročila: kot del letnega poročila o ponovni oceni
The more points = worse symptoms.
Več točk = slabši simptomi.
The clinical relevance of these results is unknown.
Klinični pomen teh rezultatov ni znan.
• Cold hands and feet
• hladne dlani in stopala
Your doctor will also monitor your heart at the start of your treatment and also every year thereafter.
Zdravnik bo spremljal tudi vaše srce na začetku zdravljenja in nato vsako leto.
(1=terrible to 7=delighted).
(1 = izjemno slabo do 7 = odlično).
The following side effects have also been reported (frequencies cannot be estimated from the available data):
Ugotovili so tudi naslednje neželene učinke (njihove pogostnosti ni mogoče oceniti iz razpoložljivih podatkov):
Baseline assessments were obtained on day 0.
Izhodiščne ocene so bile pridobljene na dan 0.
Monitoring is advised when possible.
Če je možno, je priporočljivo spremljanje.
They can present in many locations, therefore the clinical presentation can be varied.
Nastanejo lahko na številnih mestih, zato so klinične slike lahko različne.
Frequencies are defined as: Very common (≥ 1/10), Common (≥ 1/100 to < 1/10), Uncommon (≥ 1/1000 to < 1/100), Rare (≥ 1/10,000 to < 1/1,000), Very rare (< 1/10,000) and Unknown (cannot be estimated from available data).
Pogostnosti so opredeljene kot: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000) in neznana (ni mogoče oceniti iz razpoložljivih podatkov).
It is especially important to talk to your doctor if you are taking one of the following medicines or plan to start taking the following medicines:
Zlasti je pomembno, da se pogovorite z zdravnikom, če jemljete katero izmed naslednjih zdravil ali nameravate začeti jemati katero izmed naslednjih zdravil:
• Increase sweating, cold sweat
• povečano znojenje, hladen znoj
Tablets are to be taken with food.
Tablete je treba vzeti s hrano.
The dose you should take is established by your doctor based on the intensity of your symptoms and certain genetic factors.
Odmerek, ki ga boste jemali, določi zdravnik na podlagi jakosti vaših simptomov in nekaterih genskih dejavnikov.
Date of latest renewal: 1 December 2014
Datum prve odobritve: 23. december 2009 Datum zadnjega podaljšanja: 1. december 2014
Patients had a median age of 55.5 years (range: 31 to 75 years) and 62% were female and 38% were male.
Mediana starost bolnikov je bila 55,5 let (razpon: 31 do 75 let), 62 % je bilo žensk in 38 % je bilo moških.
MARKETING AUTHORISATION NUMBER(S) EU/1/09/601/001
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/09/601/001
The safety and efficacy of FIRDAPSE in children aged 0 to 17 years has not been established.
Varnost in učinkovitost zdravila FIRDAPSE pri otrocih, starih od 0 do 17 let, še nista bili dokazani.
Combinations to be taken into consideration
Kombinacije, ki jih je treba upoštevati
No safety margins to human exposure were achieved in the animal studies due to the sensitivity of the animal models used.
Varnostne meje za izpostavljenost pri človeku v študijah na živalih niso bile določene zaradi občutljivosti živalskih modelov.
The following medicines must not be combined with FIRDAPSE:
Naslednjih zdravil ne smete kombinirati z zdravilom FIRDAPSE:
The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Zahteve za predložitev občasno posodobljenih poročil o varnosti zdravila za to zdravilo so navedene na seznamu referenčnih datumov Unije (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES, in morebitnih nadaljnjih posodobitev, objavljenih na evropskem spletnem portalu o zdravilih.
Treatment should be initiated under supervision of a physician experienced in the treatment of the disease.
Zdravljenje je treba začeti pod nadzorom zdravnika z izkušnjami pri zdravljenju te bolezni.
The tablets can be divided into equal halves.
Tableta se lahko deli na enaki polovici.
PHARMACEUTICAL FORM AND CONTENTS 100 tablets
FARMACEVTSKA OBLIKA IN VSEBINA 100 tablet
Tell your doctor if you have
Obvestite svojega zdravnika, če imate:
e p-value based on the Wilcoxon Rank Sum Test for treatment differences.
e p-vrednost na podlagi Wilcoxonovega testa vsote rangov za razlike v zdravljenju.
• Together with medicines with a therapeutic dose close to the maximum safe dose
• sočasno z zdravili, katerih terapevtski odmerek je blizu največjemu varnemu odmerku,
If you discover that you are pregnant during the treatment, inform your doctor immediately.
Če med zdravljenjem ugotovite, da ste noseči, nemudoma obvestite svojega zdravnika.
Clinical and electrocardiogram (ECG) monitoring are indicated at the initiation of the treatment and yearly thereafter.
Klinično in elektrokardiogramsko (EKG) spremljanje je indicirano ob uvedbi zdravljenja in nato vsako leto.
b SGI is a 7-point scale which rates the global impression of the effects of study treatment
b SGI je 7-točkovna lestvica, ki ocenjuje globalno oceno učinkov študijskega zdravljenja
See section 4.8 for how to report adverse reactions.
Glejte poglavje 4.8, kako poročati o neželenih učinkih.>
The dose of the concomitantly given medicinal product should be adjusted if necessary.
Odmerek sočasno uporabljenega zdravila je treba po potrebi prilagoditi.
Total QMG score range 0 - 39, 13 items, 0-3 points on each test.
Razpon ocen QMG 0-39, 13 elementov, pri vsakem testu 0-3 točke.
Schwannomas are generally slow-growing and can exist for months to years without producing symptoms.
Švanomi po navadi rastejo počasi, prisotni pa so lahko mesece ali leta, ne da bi prišlo do nastajanja simptomov.
ANNEX II A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT E. SPECIFIC OBLIGATION TO COMPLETE POST-AUTHORISATION MEASURES FOR THE MARKETING AUTHORISATION UNDER EXCEPTIONAL CIRCUMSTANCES
PRILOGA II A. IZDELOVALCI, ODGOVORNI ZA SPROŠČANJE SERIJ B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET Z ZDRAVILOM D. POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA E. SPECIFIČNE ZAHTEVE ZA IZPOLNITEV UKREPOV PO PRIDOBITVI DOVOLJENJA ZA PROMET Z ZDRAVILOM V IZJEMNIH OKOLIŠČINAH
What FIRDAPSE is and what is it used for
Kaj je zdravilo FIRDAPSE in za kaj ga uporabljamo
• If you were born with heart problems (congenital QT syndromes)
• če imate prirojene težave s srcem (kongenitalne sindrome QT)
c CGI-I is a 7-point scale based on changes in symptoms, behaviour, and functional abilities (1=very much improved to 7=very much worse).
CGI-I je 7-točkovna lestvica, ki temelji na spremembah simptomov, vedenja in funkcionalnih sposobnosti (1 = izredno izboljšanje o do 7 = izredno poslabšanje).
• If you are allergic to amifampridine, or any of the other ingredients of this medicine (listed in section 6)
• če ste alergični na amifampridin ali katero koli sestavino tega zdravila (navedeno v poglavju 6),
It can be associated with certain tumour types (paraneoplastic form of LEMS) or in the absence of these tumours (non-paraneoplastic form of LEMS).
Lahko je povezana z določenimi vrstami tumorjev (paraneoplastična oblika LEMS) ali je brez teh tumorjev (neparaneoplastična oblika LEMS).
Exposure to amifampridine is associated with an increased risk for epileptic seizures.
Izpostavljenost amifampridinu je povezana s povečanim tveganjem epileptičnih napadov.
In case of signs and symptoms indicative of cardiac arrhythmias, ECG should be performed immediately.
V primeru znakov in simptomov srčnih aritmij je treba nemudoma opraviti EKG.
Most Schwannomas are benign and asymptomatic.
Večina švanomov je benignih in asimptomatičnih.
One box contains 100 tablets comprising 10 strips with 10 tablets each.
Ena škatla vsebuje 100 tablet v 10 dvojnih trakovih po 10 tablet.
Concomitant diseases
Sočasne bolezni
Pharmacotherapeutic group: other nervous system drugs, ATC code: N07XX05.
Farmakoterapevtska skupina: druga zdravila z delovanjem na živčevje, oznaka ATC: N07XX05.
To establish a Lambert Eaton Patient Registry as defined in the RMP and also incorporating measures of efficacy.
Vzpostavitev registra bolnikov z Lambert-Eatonovim sindromom, kakor je opredeljeno v RMP, z vključitvijo ukrepov učinkovitosti.
If you have LEMS but do not have cancer, your doctor will make a thorough assessment of the potential risk of cancer with FIRDAPSE before commencing treatment.
Če imate LEMS brez raka, bo zdravnik pred začetkom zdravljenja temeljito preučil možno tveganje raka v povezavi z zdravilom FIRDAPSE.
• If you have uncontrolled asthma
• če imate neobvladovano astmo,
• Tingling and numbness around the mouth and extremities (such as feet and hands)
• ščemenje ali odrevenelost okoli ust in po okončinah (kot so stopala in dlani),
• Increase in certain liver enzymes (transaminases) seen on blood tests
• zvišanje ravni določenih jetrnih encimov (transaminaz), razvidno iz analiz krvi
Supportive care should be given as clinically indicated, including close monitoring of vital signs.
Zagotavljati je treba podporno oskrbo glede na klinične indikacije, vključno z natančnim spremljanjem življenjskih znakov.
Summary of Changes in Primary and Secondary Efficacy Endpoints from Baseline
Povzetek sprememb pri primarnem in sekundarnem opazovanem dogodku učinkovitosti glede na izhodišče
• Concomitant use with medicinal products with a known potential to cause QTc prolongation
• sočasna uporaba zdravil, ki lahko podaljšajo QTc,
Total daily doses above 20 mg should be divided into two to four separate doses.
Skupne dnevne odmerke, večje od 20 mg, je treba razdeliti v dva do štiri ločene odmerke.
Therefore, in exceptional circumstances higher doses up to a maximum of 80 mg/day may be of benefit when given with the appropriate safety monitoring.
Zato so morda v izjemnih primerih ob ustreznem spremljanju varnosti koristni višji odmerki do največ 80 mg/dan.
If you forget to take FIRDAPSE, do not take a double dose to make up for the dose you have forgotten but continue to take your treatment as prescribed by your doctor.
Ne vzemite dvojnega odmerka, če ste pozabili vzeti prejšnji odmerek zdravila FIRDAPSE, ampak nadaljujte zdravljenje, kakor vam je predpisal zdravnik.
• Raynaud's syndrome (circulation disorder affecting the fingers and toes)
• Raynaudov sindrom (bolezen krvnega obtoka, ki vpliva na prste na rokah in nogah)
Perforated unit dose thermoformed blisters (Thermoformed aluminium-PVC/PVDC laminate sheets) containing 10 tablets.
Perforirani enoodmerni termoformirani pretisni omoti (termoformirane pole iz laminata aluminij-PVC/PVDC), ki vsebujejo 10 tablet.
What you need to know before you take FIRDAPSE
Kaj morate vedeti, preden boste vzeli zdravilo FIRDAPSE
A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from FIRDAPSE therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.
Odločiti se je treba med prenehanjem dojenja in prenehanjem/prekinitvijo zdravljenja z zdravilom FIRDAPSE, pri čemer je treba pretehtati prednosti dojenja za otroka in prednosti zdravljenja za mater.
Stop the treatment and immediately consult your doctor in the event of:
Prekinite zdravljenje in se nemudoma posvetujte s svojim zdravnikom v primeru:
Although the metabolite is inactive at potassium channels, potential off target effects due to accumulation are unknown.
Čeprav je presnovek neaktiven za kalcijeve kanalčke, možni neciljni učinki zaradi kopičenja niso znani.
The NAT genes are highly polymorphic and result in phenotypes with variable acetylation activity rates ranging from slow to fast.
Geni NAT so močno polimorfni, kar povzroči fenotipe z različnimi stopnjami acetilacije, ki segajo od počasne do hitre.
NAME OF THE MARKETING AUTHORISATION HOLDER BioMarin International Limited
IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM BioMarin International Limited
Two further studies in a total of 57 patients with LEMS have reported data from higher doses of amifampridine.
V dveh drugih študijah so pri 57 bolnikih z LEMS zbirali podatke o višjih odmerkih amifampridina.
Very common side effects which may affect more than 1 in 10 people are:
Pogosti stranski učinki, ki se lahko pojavijo pri več kot 1 od 10 bolnikov, so:
Combinations requiring precautions for use
Kombinacije, ki zahtevajo previdnostne ukrepe
The maximum recommended dose is 60 mg per day (i.e. a total of six tablets to be taken at intervals during the day).
Največji priporočeni odmerek je 60 mg na dan (tj. skupno šest tablet, ki se vzamejo v časovnih presledkih v enem dnevu).
• Reduced sense of touch or sensation
• zmanjšana občutljivost za dotik ali zmanjšano čutenje
Patients must be told to inform any physician they consult that they are taking this medicinal product, since close monitoring of a concomitant disease, particularly asthma, may be necessary.
Bolnikom morate povedati, da morajo vse zdravnike, ki jih obravnavajo, obvestiti, da jemljejo zdravilo FIRDAPSE, ker bo morda treba natančno spremljanje sočasnih bolezni, zlasti astme.
This disease is a disorder affecting the transmission of nerve impulses to muscles, resulting in muscle weakness.
Ta bolezen je motnja prenosa živčnih impulzov na mišice, ki povzroči mišično šibkost.
In safety pharmacology studies in rats, no respiratory system related effects were seen up to 10 mg/kg or on the central nervous system up to 40 mg/kg.
V študijah farmakološke varnosti na podganah niso opazili učinkov, povezanih z dihalnim sistemom, do odmerka 10 mg/kg ali na osrednji živčni sistem do odmerka 40 mg/kg.
This dose suits you only.
Ta odmerek je prilagojen samo vam.
MedDRA Preferred term
MedDRA Priporočeni izraz
Sanders et al 1998 presented data on efficacy and safety of amifampridine treatment at doses up to 100 mg/day in 45 patients with LEMS who were treated for an average of 31 months.
V prispevku Sanders et al 1998 so predstavili podatke o učinkovitosti in varnosti zdravljenja z odmerki amifampridina do 100 mg/dan pri 45 bolnikih z LEMS, ki so bili zdravljeni v povprečju 31 mesecev.
Amifampridine was not genotoxic in a standard battery of in vitro and in vivo tests.
Amifampridin ni bil genotoksičen pri standardni skupini preskusov in vitro ter in vivo.
• In patients with congenital QT syndromes (see section 4.4)
• pri bolnikih s kongenitalnimi sindromi QT (glejte poglavje 4.4).
Patients were allowed to use stable doses of peripherally acting cholinesterase inhibitors or corticosteroids.
Bolniki so lahko prejemali stabilne odmerke periferno delujočih zaviralcev holinesteraze ali kortikosteroidov.
The manifestations of acute overdose include vomiting and abdominal pain.
Manifestacije akutnega prevelikega odmerjanja vključujejo bruhanje in bolečine v trebuhu.
This medicine may cause drowsiness, dizziness, fits (convulsions) and blurred vision, which may affect your ability to drive or use machines.
To zdravilo lahko povzroči zaspanost, vrtoglavico, epileptične napade (konvulzije) ter zamegljen vid, ki utegnejo vplivati na vašo sposobnost vožnje ali upravljanja s stroji.
Renal Status
Ledvični status
Some medicines may interact with FIRDAPSE when taken together.
Nekatera zdravila lahko medsebojno delujejo z zdravilom FIRDAPSE, če jih jemljete sočasno.