natgillin/translations-raw huggingface dataset:
Check the child's pulse if they seem unwell.
Če se otrok ne počuti dobro, izmerite njegov utrip.
• pneumonia
• pljučnice,
dose was low at approximately 3% (range 1.3-13.3%) in children aged 7-14 years undergoing intraocular surgery (n = 6) due to the medicinal product's low lipid solubility.
Povprečna absolutna peroralna biološka razpoložljivost glikopironija je bila v primerjavi z enim peroralnim odmerkom 50 µg/kg in enim intravenskim odmerkom 5 µg/kg pri otrocih, starih od 7 do 14 let (n = 6), med intraokularno operacijo nizka in je znašala približno 3 % (razpon 1,3-13,3 %) zaradi nizke topnosti zdravila v lipidih.
Sialanar acts on the salivary glands to reduce production of saliva.
Zdravilo Sialanar učinkuje na žleze slinavke, ki zmanjšajo izločanje sline.
• Fungal infection (thrush) of the throat (oesophageal candidiasis)
• glivična okužba (oralna kandidoza) v grlu (kandidoza požiralnika)
Co-administration with food results in a marked decrease in systemic glycopyrronium exposure.
Pri jemanju zdravila s hrano je sistemska izpostavljenost glikopironiju bistveno manjša.
glycopyrronium.
Zeller idr.
How to use Sialanar
Kako jemati zdravilo Sialanar
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING GLASS BOTTLE
PODATKI NA PRIMARNI OVOJNINI STEKLENICA
• Difficulty in passing stools (constipation)
• težave pri odvajanju blata (zaprtost)
Physostigmine salicylate is recommended when tachydysrhythmia with subsequent hemodynamic compromise, intractable seizure, severe agitation or psychosis is present.
Pri tahiaritmiji z dodatnimi hemodinamskimi težavami, trdovratnih napadih, hudi razdraženosti ali psihozi se priporoča uporaba fizostigmin salicilata.
− stomach ache and swelling (paralytic ileus)
− v primeru bolečin v trebuhu ali otekanja (paralitični ileus),
Gastrointestinal motility disorder
Sialanar Peroralna raztopina
Caution should be exercised in children with compromised blood brain barrier eg.
Paziti je treba pri uporabi zdravila pri otrocih s poškodovano krvnomožgansko pregrado, npr. z intraventrikularnim šantom, možganskim tumorjem ali encefalitisom.
• Dry mouth
• zamašen nos
• inability to sweat normally
• težave z normalnim potenjem,
The following medicinal product interaction information is relevant to glycopyrronium.
Za medsebojno delovanje glikopironija z drugimi zdravili so na voljo naslednje informacije.
A reduction in corpora lutea was observed in female rats administered glycopyrronium.
Pri samicah podgan, pri katerih se je uporabil glikopironij, je bilo opaženo zmanjšanje rumenih telesc.
Check that you have drawn up the correct level on the syringe before giving Sialanar.
Pred dajanjem zdravila Sialanar na brizgi preverite, ali ste zajeli pravilno količino zdravila.
potassium chloride solid oral dose;
peroralnim odmerkom kalijevega klorida v trdi farmacevtski obliki,
• urinary retention
• zastajanja urina,
Glycopyrronium treatment should be withdrawn until the constipation resolves.
Zdravljenje z glikopironijem je treba prekiniti, dokler težave z zaprtjem ne izginejo.
administration probably reflects the complex absorption and distribution of glycopyrronium by each route.
Ti razpolovni dobi, zlasti doba za peroralno uporabo, sta daljši kot razpolovna doba za intravensko uporabo, kar verjetno odraža zapleteno absorpcijo in porazdelitev glikopironija po vsaki poti.
Respiratory, thoracic and mediastinal disorders
Bolezni dihal, prsnega koša in mediastinalnega prostora zamašen nos zelo pogosti
Frequency category
Številka serije
Frustration
Plodnost
Hepatic impairment
Bolezni dihal
Temper tantrum
Raven odmerka 1
• antispasmodics used to treat sickness or vomiting e.g.domperidone and metaclopramide
• spazmolitiki, ki se uporabljajo za zdravljenje siljenja na bruhanje in bruhanja, npr.
Upper respiratory tract infection
Infekcijske in parazitske bolezni okužbe zgornjih dihal pogosti pljučnica pogosti okužbe sečil pogosti
The active substance is glycopyrronium.
Učinkovina je glikopironij.
Instructions for use How to use the oral syringe
Kako uporabljati brizgo za peroralno odmerjanje?
− has ulcerative colitis (inflammation of the intestine)
− v primeru ulceroznega kolitisa (vnetje črevesja),
• Being sick (vomiting)
• siljenje na bruhanje (bruhanje)
Common side effects (may affect up to 1 in 10 people)
Pogosti neželeni učinki (pojavijo se lahko pri največ 1 od 10 bolnikov) • okužbe zgornjih dihalnih poti (okužba v prsnem košu)
Feeling sad
Okvara jeter
10 DATE OF REVISION OF THE TEXT
DATUM ZADNJE REVIZIJE BESEDILA MM/LLLL
3 PHARMACEUTICAL FORM
NAČIN IZDAJANJA ZDRAVILA
The majority of these side effects disappear within 1 to 2 days.
Večina teh neželenih učinkov izgine v enem ali dveh dneh.
It contains a flu strain called A/Vietnam/1194/2004 (H5N1).
Vsebuje sev gripe, imenovan A/Vietnam/1194/2004 (H5N1).
Further information can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/foclivia.
Nadaljnje informacije za zdravilo Foclivia so na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/foclivia.
This helps to protect against the disease caused by the virus.
To prispeva k obrambi pred boleznijo, ki jo ta virus povzroča.
The vaccine also contains an ‘adjuvant' to increase the vaccine's effectiveness.
Cepivo vsebuje tudi „adjuvans“ za povečanje učinkovitosti cepiva.
What measures are being taken to ensure the safe and effective use of Foclivia?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Foclivia?
The European Medicines Agency decided that Foclivia's benefits are greater than its risk and it can be authorised for use in the EU.
Evropska agencija za zdravila je zaključila, da so koristi cepiva Foclivia večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
The main measures of effectiveness were the levels of antibodies against the flu virus in the blood before vaccination, on the day of the second injection (day 22), and 21 days later (day 43).
Glavna merila učinkovitosti so bile koncentracije protiteles proti virusu gripe v krvi pred cepljenjem, na dan drugega cepljenja (22. dan) in 21 dni pozneje (43. dan).
As for all medicines, data on the use of Foclivia are continuously monitored.
Tako kot za vsako zdravilo, se tudi podatki o uporabi zdravila Foclivia stalno spremljajo.
Vaccines work by preparing the immune system (the body's natural defences) to defend itself against a disease.
Cepiva delujejo tako, da imunski sistem (naravni obrambni mehanizem telesa) pripravijo na to, da se brani pred boleznijo.
The vaccine can only be obtained with a prescription and should be used according to official recommendations.
Predpisovanje in izdaja zdravila je le na recept, uporabljati pa se mora v skladu z uradnimi priporočili.
Other information about Foclivia
Druge informacije o zdravilu Foclivia
Foclivia received a marketing authorisation valid throughout the EU on 19 October 2009.
Za zdravilo Foclivia je bilo 19. oktobra 2009 izdano dovoljenje za promet, veljavno po vsej EU.
This is a special type of vaccine that can be developed to help with the management of a future pandemic.
To je posebna vrsta cepiva, ki ga je mogoče pripraviti za pomoč pri nadzoru morebitne pandemije.
They test this vaccine to see how people react to it, allowing them to predict how people will react when the flu strain causing a pandemic is included in the vaccine.
To cepivo preizkusijo, da bi preverili, kako se ljudje nanj odzivajo, na podlagi česar lahko predvidevajo, kako se bodo ljudje odzivali, ko bo cepivo vključevalo sev gripe, ki povzroča pandemijo.
When the person comes into contact with this or a similar virus, these antibodies, together with other components of the immune system, will be able to kill the viruses and help protect against the disease.
Ko je oseba izpostavljena temu ali podobnemu virusu, ta protitelesa skupaj z drugimi mehanizmi imunskega sistema uničijo virus in pripomorejo k zaščiti pred boleznijo.
Foclivia would be given according to official recommendations.
Cepivo Foclivia se daje v skladu z uradnimi priporočili.
Recommendations and precautions to be followed by healthcare professionals and their patients for the safe and effective use of Foclivia 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 Foclivia upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
The study showed that Foclivia produced an antibody response that satisfies these criteria.
Raziskava je pokazala, da zdravilo Foclivia izzove odziv protiteles, ki zadovolji to merilo.
Every year, the European Medicines Agency will review any new information that may become available and this summary will be updated as necessary.
Evropska agencija za zdravila bo vsako leto ponovno pregledala vse nove podatke, ki bodo na voljo.
Before a pandemic starts, nobody knows which strain of flu virus will be involved, so companies cannot prepare the correct vaccine in advance.
Pred začetkom pandemije ni znano, kateri sev virusa gripe bo razsajal, zato podjetja ne morejo vnaprej pripraviti ustreznega cepiva.
The most common side effects with Foclivia (which may affect up to 1 people in 10) are headache, sweating, arthralgia (joint pain), myalgia (muscle pain), reactions at the site of the injection (redness, swelling, hardening, bruising, pain), fever, feeling unwell, tiredness and shivering.
Najpogostejši neželeni učinki zdravila Foclivia (ki se lahko pojavijo pri največ 1 od 10 bolnikov) so glavobol, znojenje, artralgija (bolečine v sklepih), mialgija (bolečine v mišicah), reakcije na mestu injiciranja (rdečina, otekanje, otrdelost, podplutbe in bolečine), vročina, slabo počutje, utrujenost in tresenje.
Twenty-one days after the second injection, 86% of the people receiving the vaccine with 7.5 micrograms haemagglutinin had levels of antibodies that would protect them against H5N1.
Enaindvajset dni po drugem injiciranju je imelo 86 % ljudi, ki so prejeli cepivo s 7,5 mikrogrami hemaglutinina, tako koncentracijo protiteles, ki bi jih lahko zaščitila pred H5N1.
The figure was 85% in people who received the 15-microgram dose.
Pri bolnikih, ki so prejeli 15-mikrogramski odmerek, je bil ta delež 85 %.
Instead, they can prepare a vaccine that contains a strain of flu virus specifically chosen because nobody has been exposed to it, and to which nobody is immune.
Lahko pa pripravijo cepivo, ki vsebuje posebej izbrani sev virusa gripe, ki mu ni bil še nihče izpostavljen in proti kateremu nihče ni imun.
Foclivia should not be given to people who have had an anaphylactic reaction (severe allergic reaction) to any of the components of the vaccine, or to any substances found at trace levels in the vaccine, such as egg, chicken protein, kanamycin or neomycin (antibiotics), formaldehyde and cetyltrimethylammonium bromide (CTAB).
Zdravilo Foclivia se ne sme dajati osebam, ki so imele v preteklosti anafilaktično reakcijo (hudo alergijsko reakcijo) na katero koli izmed sestavin cepiva ali na katero koli od snovi, ki se v sledovih nahajajo v cepivu, kot na primer na jajca, piščančje beljakovine, kanamicin ali neomicin (antibiotika), formaldehid in cetiltrimetilamonijev bromid (CTAB).
The authorisation was based on the authorisation granted to Focetria in 2007 (‘informed consent').
Podlaga za izdajo je bilo dovoljenje za promet, izdano za zdravilo Focetria leta 2007 (uporaba dokumentacije s soglasjem).
Why is Foclivia authorised in the EU?
Zakaj je bilo zdravilo Foclivia odobreno v EU?
An overview of Foclivia and why it is authorised in the EU
Pregled zdravila Foclivia in zakaj je odobreno v EU
Foclivia contains some parts of inactivated (killed) influenza (flu) virus.
Vsebuje nekatere dele inaktiviranega (uničenega) virusa gripe.
What benefits of Foclivia have been shown in studies?
Kakšne koristi zdravila Foclivia so se pokazale v študijah?
Foclivia is a vaccine used in adults to protect against flu when a ‘pandemic' has been officially declared by the World Health Organization (WHO) or the European Union (EU).
Zdravilo Foclivia je cepivo, ki se uporablja pri odraslih za zaščito pred gripo, v primeru da Svetovna zdravstvena organizacija (WHO) ali Evropska unija (EU) uradno razglasi pandemijo gripe.
Foclivia is given by injection into the upper arm muscle or the thigh in two doses, at least 3 weeks apart.
Zdravilo Foclivia se injicira v mišico nadlakti ali stegna v dveh odmerkih v razmiku vsaj treh tednov.
According to EMA's criteria, a pandemic preparedness vaccine needs to bring about protective levels of antibodies in at least 70% of people for it to be considered suitable.
V skladu z merili agencije EMA je cepivo za pripravljenost na pandemijo ustrezno učinkovito le, če zagotovi zaščitno raven protiteles pri vsaj 70 % ljudi.
During a pandemic, the virus strain in Foclivia will have to be replaced by the strain causing the pandemic before the vaccine can be used.
Med pandemijo bo sev virusa v cepivu Foclivia nadomeščen s sevom, ki povzroča pandemijo, preden bo cepivo mogoče uporabljati.
Since Foclivia has been authorised under exceptional circumstances, the company that markets Foclivia will collect information on the safety and effectiveness of the final pandemic vaccine when it includes the flu strain responsible for a pandemic in the vaccine.
Ker je zdravilo Foclivia pridobilo dovoljenje za promet v izjemnih okoliščinah, bo podjetje, ki ga trži, zbralo informacije o varnosti in učinkovitosti končnega pandemičnega cepiva, ko bo vključevalo sev gripe, ki povzroča pandemijo.
Foclivia has been authorised under ‘exceptional circumstances'.
Cepivo Foclivia je pridobilo dovoljenje za promet v „izjemnih okoliščinah“.
This means that, because the vaccine is a pandemic preparedness vaccine and does not yet contain the strain of flu virus that is causing a pandemic, it has not been possible to obtain full information about the final pandemic vaccine.
Gre namreč za cepivo za pripravljenost na pandemijo, ki še ne vsebuje seva virusa gripe, ki utegne povzročiti pandemijo, zato ni bilo mogoče pridobiti vseh informacij o končnem pandemičnem cepivu.
However, if a pandemic has started, it may be appropriate to give the vaccine to these people, as long as facilities for resuscitation are available.
Ob pojavu pandemije pa bo cepljenje teh oseb morda vseeno upravičeno, vendar mora biti na voljo oprema za oživljanje.
What is Foclivia and what is it used for?
Kaj je zdravilo Foclivia in za kaj se uporablja?
What are the risks associated with Foclivia?
Kakšna tveganja so povezana z zdravilom Foclivia?
Side effects reported with Foclivia are carefully evaluated and any necessary action taken to protect people who receive Foclivia.
Neželeni učinki, o katerih so poročali pri zdravilu Foclivia, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
The participants received two injections of Foclivia, containing either 7.5 or 15 micrograms of haemagglutinin (a protein found in flu viruses), 21 days apart.
Udeleženci študije so prejeli dve injekciji cepiva Foclivia, ki sta vsebovali bodisi 7,5 ali 15 mikrogramov hemaglutinina (beljakovine, ki se nahaja v virusih gripe), v razmiku 21 dni.
Foclivia is a ‘pandemic preparedness' vaccine.
Zdravilo Foclivia je cepivo „za pripravljenost na pandemijo“.
What information is still awaited for Foclivia?
Katere informacije o zdravilu Foclivia še pričakujemo?
The main study of Foclivia included 486 healthy people (a third of whom were over the age of 60) and compared the ability of two doses of Foclivia to trigger the production of antibodies (immunogenicity).
V glavno študijo cepiva Foclivia je bilo vključenih 486 zdravih oseb (tretjina izmed njih je bila stara več kot 60 let).
The immune system will then be able to produce antibodies more quickly when it comes into contact with the virus again.
Ob ponovni izpostavitvi virusu bo imunski sistem tako lahko hitreje tvoril protitelesa.
For the full list of all side effects of Foclivia, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Foclivia, glejte navodilo za uporabo.
How is Foclivia used?
Kako se zdravilo Foclivia uporablja?
A flu pandemic occurs when a new type (strain) of flu virus can spread easily from person to person because people have no immunity (protection) against it. A pandemic can affect most countries and regions around the world.
Do pandemije gripe pride, ko se novi sev virusa gripe med ljudmi hitro širi, ker nanj niso imuni (zaščiteni).
How does Foclivia work?
Kako zdravilo Foclivia deluje?
Foclivia contains some parts the H5N1 virus.The virus has been first inactivated so that it does not cause disease.
Cepivo Foclivia vsebuje nekaj delov virusa H5N1.
Whole virion influenza vaccine, inactivated containing antigen of pandemic strain*: A/California/7/2009 (H1N1)v 7.5 micrograms** per 0.5 ml dose * propagated in Vero cells (continuous cell line of mammalian origin) ** expressed in micrograms haemagglutinin.
A/California/07/2009 (H1N1)v 7,5 mikrograma** na odmerek 0,5 ml * razmnožen v celicah Vero (neprekinjena celična linija sesalskega izvora) ** izraženo v mikrogramih hemaglutinina o č
Intramuscular use vial (glass) 0.5 ml
Intramuskularna uporaba viala (iz stekla)
Invented name Strength Pharmaceutical Form
Izmišljeno ime
The CHMP also looked at other small studies.
CHMP je obravnaval tudi druge manjše študije.
The 27-year post-marketing period offers a long period of safety profile surveillance.
Varnost 27-letno postmarketinško obdobje predstavlja dolgo obdobje spremljanja varnostnega profila.
It was first authorised in 1979 and is currently authorised in the EU in Belgium, France, Italy, Luxembourg and Portugal under the names Agreal and Agradil.
Prvič je bilo odobreno leta 1979 in je trenutno odobreno v EU v Belgiji, Franciji, Italiji, Luksemburgu in na Portugalskem pod imeni Agreal in Agradil.
Until June 2005, veralipride was authorised in Spain.
Do junija 2005 je bil veraliprid odobren v Španiji.
Few data are available beyond 3 months, mostly in non comparative studies.
Za obdobje, daljše od 3 mesecev, je na voljo malo podatkov, večinoma iz neprimerjalnih študij.
In addition, the Committee considered that the proposed risk minimisation activities were not able to reduce the risks to an acceptable level or predict which women may be at risk;
Nadalje je Odbor menil, da predlagane aktivnosti za minimaliziranje tveganja ne morejo zmanjšati tveganja na sprejemljivo raven ali napovedati, katere ženske utegnejo biti ogrožene;
In this review, the CHMP assessed all of the available information on the safety and efficacy of veralipride.
V tem pregledu je CHMP ovrednotil vse razpoložljive informacije o varnosti in učinkovitosti veraliprida.
This included mainly 11 studies involving around 600 women, in which veralipride was compared with placebo, and two studies in around 100 women where it was compared with conjugated oestrogens.
Te so obsegale predvsem 11 študij, ki so vključevale približno 600 žensk in v katerih so veraliprid primerjali s placebom, ter dve študiji s približno 100 ženskami, v katerih so ga primerjali s konjugiranimi estrogeni.
• The Committee considered the referral made under article 31 of Directive 2001/83/EC, as amended, for medicinal products containing veralipride
• Odbor je obravnaval napotitev v skladu s členom 31 Direktive 2001/83/ES, z vsemi spremembami, za zdravila, ki vsebujejo veraliprid;
OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF MEDICINAL PRODUCTS CONTAINING VERALIPRIDE (see Annex I)
SPLOŠNI POVZETEK ZNANSTVENEGA VREDNOTENJA ZDRAVIL, KI VSEBUJEJO VERALIPRID (glejte Dodatek I)
In addition, some of these side effects can occur not only during treatment, but also after it is stopped and it is also impossible to predict which women may be at risk.
Nadalje lahko nekateri izmed teh učinkov nastopijo ne le med zdravljenjem, temveč tudi ko je le-to prekinjeno, poleg tega pa je nemogoče napovedati, katere ženske so ogrožene.
Most of them occurred beyond 3 months of treatment.
Večina med njimi je nastopila po 3 mesecih zdravljenja.
Spain therefore withdrew veralipride's marketing authorisation on 27 June 2005.
Španija je iz tega razloga dne 27. junija 2005 umaknila dovoljenje za promet za veraliprid.
It should be noted that in the evaluation of the causality assessment of veralipride in the psychiatric events, the role of veralipride is not always clear.
Omeniti je treba, da pri vrednotenju vzročnosti veraliprida v psihiatričnih dogodkih vloga veraliprida ni vedno jasna.
It has to be noted that tardive dyskinesias are not predictable and can develop even after the treatment has been discontinued.
Omeniti je treba, da tardivnih diskinezij ni mogoče napovedovati in se utegnejo razviti celo po prekinitvi zdravljenja.
The absence of cases of suggestive QT-prolongation in the database is not sufficient to conclude that this effect does not occur with veralipride.
Odsotnost primerov sugestivnega podaljšanja QT v bazi podatkov ne zadošča za sklep, da ta učinek pri veralipridu ne nastopa.
In addition, the duration of the trials was too short to allow for proper assessment of maintenance of efficacy.
Poleg tega je bilo trajanje študij prekratko, da bi dopuščalo ustrezno oceno vzdrževanja učinkovitosti.
No studies were performed to evaluate whether veralipride has an effect on QT.
Za ovrednotenje, ali veraliprid vpliva na QT, ni bila izvedena nobena študija.
In addition, hyperprolactinemia and the risk of QT prolongation are also concerns;
Nadalje predstavljata pomislek tudi hiperprolaktinemija in tveganje za podaljšanje QT;
Following reports of serious side effects affecting the nervous system, the Spanish National Competent Authority concluded that its benefits did not outweigh its potential risks.
Zaradi poročil o resnih neželenih učinkih, ki prizadenejo živčni sistem, je pristojni španski nacionalni organ sklenil, da njegove koristi ne odtehtajo potencialnih tveganj.
-Introduction of the contraindications in patients with Parkinson's disease, or in combination with other neuroleptics and dopaminergic agonists.
-Vključitev kontraindikacij za bolnike s Parkinsonovo boleznijo ali v kombinaciji z drugimi nevroleptiki in dopaminergičnimi agonisti.
However, cases of tardive dyskinesia have also been reported within the first 3 months of treatment.
Vendar pa so o primerih tardivne diskinezije poročali tudi v prvih 3 mesecih zdravljenja.
Consequently, the European Commission triggered a referral procedure on 7 September 2006 and requested the CHMP to give its opinion on whether the marketing authorisations for products containing veralipride should be maintained, varied, suspended or withdrawn across the European Union following the assessment of these safety risks their impact on the benefit/risk assessment of veralipride.
Zaradi tega je Evropska komisija 7. septembra 2006 sprožila napotitveni postopek in zaprosila CHMP za mnenje, ali naj se dovoljenje za promet z izdelki, ki vsebujejo veraliprid, ohrani, spremeni, zacasno preklice ali umakne po vsej Evropski uniji v skladu z oceno z njimi povezanih tveganj in oceno razmerja med koristmi in tveganji zdravila veraliprid.
The proposal of close monitoring including neurological examination after each 20 day treatment cycle might reduce these risks, but is a measure of considerable burden to both patient and doctor.
Skrbno spremljanje, vključno z nevrološkim pregledom po vsakem 20-dnevnem ciklu zdravljenja, bi utegnilo zmanjšati ta tveganja, vendar pa predstavlja tak ukrep znatno obremenitev tako za bolnika kot zdravnika.
But the effect of hyperprolactinemia in women with history of breast cancer is not elucidated.
Vendar pa učinek hiperprolaktinemije pri ženskah z rakom dojke v anamnezi ni pojasnjen.