natgillin/translations-raw huggingface dataset:
The Committee therefore decided that Menveo's benefits are greater than its risks in people who are at risk of exposure to N. meningitidis bacterium, and recommended that it be given marketing authorisation.
Zato je zaključil, da so koristi zdravila Menveo pri ljudeh, pri katerih obstaja nevarnost izpostavljenosti bakteriji N. meningitidis, večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet
For the full list of all side effects reported with Menveo, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Menveo, glejte navodilo za uporabo.
Menveo is used to protect adults and children from the age of two against invasive disease caused by four groups of the bacterium N. meningitidis (A, C, W135, and Y).
Zdravilo Menveo se uporablja za zaščito odraslih in otrok, starejših od dveh let, pred invazivno boleznijo, ki jo povzročajo štiri skupine bakterije N. meningitidis (A, C, W135 in Y).
Menveo contains small amounts of oligosaccharides (a type of sugar) extracted from four groups of the N. meningitidis bacterium: A, C, W135 and Y. These have been purified, then ‘conjugated' (attached) to a protein from the bacterium Corynebacterium diphtheriae.
Zdravilo Menveo vsebuje majhne količine oligosaharidov (vrste sladkorja), pridobljenih iz štirih skupin bakterije N. meningitidis: A, C, W135 in Y. Ti so bili prečiščeni in nato konjugirani (pripojeni) na beljakovino iz bakterije Corynebacterium diphtheriae.
It is available as a powder and solution that are mixed together to make a solution for injection.
Sestavljata ga prašek in vehikel, ki se zmešata v raztopino za injiciranje.
Menveo was compared with a similar conjugated vaccine against N. meningitidis.
Cepivo Menveo so primerjali s podobnim konjugiranim cepivom proti bakteriji N. meningitidis.
The CHMP noted that five N. meningitidis bacterial groups (A, B, C, W135 and Y) are responsible for invasive disease, and that Menveo provides broader protection than other available vaccines.
CHMP je zaključil, da je za invazivno bolezen odgovornih pet skupin bakterije N. meningitidis (A, B, C, W135 in Y) in da cepivo Menveo zagotavlja boljšo zaščito kot druga cepiva, ki so na voljo.
The results of the main studies showed that Menveo was as effective as the comparator vaccine in stimulating an immune response against all four types of N. meningitidis oligosaccharides in adults and children from the age of two.
Rezultati glavnih študij so pokazali, da je cepivo Menveo enako učinkovito pri spodbujanju imunskega odziva proti štirim vrstam oligosaharidov bakterije N. meningitidis pri odraslih in otrocih, starejših od dveh let, kot primerjalno cepivo.
Menveo meningococcal group A, C, W135 and Y conjugate vaccine
Menveo konjugirano cepivo proti meningokokom skupin A, C, W135 in Y
The main measure of effectiveness was whether Menveo was as good as the comparator vaccine at stimulating immune response against the four types of N. meningitidis oligosaccharides.
Glavno merilo učinkovitosti je bilo vprašanje, ali cepivo Menveo enako dobro spodbuja imunski odziv proti štirim vrstam oligosaharidov bakterije N. meningitidis kot primerjalno cepivo.
What is Menveo used for?
Za kaj se zdravilo Menveo uporablja?
Vaccination should be postponed in people who have a high fever.
Pri osebah, ki imajo povišano telesno temperaturo, je treba cepljenje preložiti.
How has Menveo been studied?
Kako je bilo zdravilo Menveo raziskano?
What is Menveo?
Kaj je zdravilo Menveo?
How is Menveo used?
Kako se zdravilo Menveo uporablja?
How does Menveo work?
Kako zdravilo Menveo deluje?
The usual starting dose is 50 mg twice a day which may be increased weekly to a maximum dose of 300 mg twice a day if used alone, or 200 mg twice a day if given with other epilepsy medicines.
Običajni začetni odmerek je 50 mg dvakrat na dan, ki se lahko tedensko povečuje do največjega odmerka, ki znaša 300 mg dvakrat na dan, če se zdravilo uporablja samostojno, oziroma 200 mg dvakrat na dan, če se daje z drugimi zdravili za zdravljenje epilepsije.
The medicine can only be obtained with a prescription and is available as tablets (50 mg; 100 mg; 150 mg; 200 mg).
Predpisovanje in izdaja zdravila je le na recept, na voljo pa je v obliki tablet (50 mg, 100 mg, 150 mg, 200 mg).
The exact way in which lacosamide works is still unclear but it seems to reduce the activity of sodium channels (pores on the surface of nerve cells) that allow electrical impulses to be transmitted between nerve cells.
Natančen način delovanja lakozamida doslej še ni bil pojasnjen, vendar se zdi, da zmanjšuje dejavnost natrijevih kanalčkov (por na površini živčnih celic), ki omogočajo, da se električni impulzi prenašajo med živčnimi celicami.
It can be used to treat partial-onset seizures with or without secondary generalisation (where the seizure subsequently spreads to other parts of the brain).
Uporablja se lahko za zdravljenje parcialnih napadov s sekundarno generalizacijo ali brez nje (ko se napad posledično razširi na druge dele možganov).
The full EPAR for Lacosamide Accord can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Lacosamide Accord je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Because Lacosamide Accord is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.
Ker je zdravilo Lacosamide Accord generično zdravilo, so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
The European Medicines Agency concluded that, in accordance with EU requirements, Lacosamide Accord has been shown to be comparable to Vimpat.
Evropska agencija za zdravila je zaključila, da je bilo v skladu z zahtevami EU dokazano, da je zdravilo Lacosamide Accord primerljivo z zdravilom Vimpat.
If treatment with Lacosamide Accord has to be stopped, the dose should be gradually reduced.
Če je treba zdravljenje z zdravilom Lacosamide Accord prekiniti, je treba odmerek zmanjševati postopoma.
This is a summary of the European public assessment report (EPAR) for Lacosamide Accord.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Lacosamide Accord.
Lacosamide Accord is an epilepsy medicine used to treat partial-onset seizures (epileptic fits starting in one specific part of the brain) in patients with epilepsy aged 16 years or older.
Lacosamide Accord je zdravilo za epilepsijo, ki se uporablja za zdravljenje parcialnih napadov (epileptičnih napadov, ki se začnejo v določenem delu možganov) pri bolnikih z epilepsijo, starih 16 let ali več.
Together, these actions may prevent abnormal electrical activity spreading through the brain, reducing the chance of an epileptic fit.
Skupaj naj bi to preprečevalo širjenje nenormalne električne dejavnosti po možganih, s čimer se zmanjša možnost pojava epileptičnega napada.
It is also thought that lacosamide might help protect nerve cells from damage.
Pomagal naj bi tudi zaščititi živčne celice pred poškodbo.
What measures are being taken to ensure the safe and effective use of Lacosamide Accord?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Lacosamide Accord?
As for every medicine, the company provided studies on the quality of Lacosamide Accord.
Kot to velja za vsako zdravilo, je družba zagotovila študije o kakovosti zdravila Lacosamide Accord.
Studies on the benefits and risks of the active substance in the approved uses have already been carried out with the reference medicine, Vimpat, and do not need to be repeated for Lacosamide Accord.
Študije o koristih in tveganjih zdravilne učinkovine pri odobrenih načinih uporabe so že bile izvedene z referenčnim zdravilom Vimpat, zato jih ni treba ponoviti za zdravilo Lacosamide Accord.
This is because the active substance, lacosamide, has been shown to be highly soluble and completely absorbed, meaning that almost 100% of the substance reaches the blood when taken by mouth.
Dokazali so namreč, da je zdravilna učinkovina, lakozamid, zelo lahko topna in se popolnoma absorbira, kar pomeni, da skoraj 100 % snovi po peroralnem zaužitju preide v kri.
The Agency recommended that Lacosamide Accord be approved for use in the EU.
Priporočila je, da se zdravilo Lacosamide Accord odobri za uporabo v EU.
This means that Lacosamide Accord contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the European Union (EU) called Vimpat.
To pomeni, da vsebuje enako zdravilno učinkovino in ima enak način delovanja kot „referenčno zdravilo“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilo Vimpat.
Lacosamide Accord is given on its own or combined with other medicines for epilepsy.
Zdravilo Lacosamide Accord se daje samostojno ali v kombinaciji z drugimi zdravili za zdravljenje epilepsije.
What are the benefits and risks of Lacosamide Accord?
Kakšne so koristi in tveganja, povezani z zdravilom Lacosamide Accord?
There was no need for ‘bioequivalence' studies to investigate whether Lacosamide Accord is absorbed similarly to the reference medicine to produce the same level of the active substance in the blood.
Izvedba študij biološke enakovrednosti, s katerimi se proučuje, ali se zdravilo Lacosamide Accord absorbira podobno kot referenčno zdravilo in tako ustvari enake ravni zdravilne učinkovine v krvi, ni bila potrebna.
If the doctor decides that a faster effect is needed, treatment with Lacosamide Accord may be started with a higher first dose (called a loading dose).
potreben hitrejši učinek, se lahko zdravljenje z zdravilom Lacosamide Accord začne z večjim začetnim odmerkom (imenovanim polnilni odmerek).
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Lacosamide Accord have been included in the summary of product characteristics and the package leaflet.
Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Lacosamide Accord upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
For more information about treatment with Lacosamide Accord, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Lacosamide Accord preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
For practical information about using Lacosamide Accord, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Lacosamide Accord naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
What is Lacosamide Accord and what is it used for?
Kaj je zdravilo Lacosamide Accord in za kaj se uporablja?
It is not intended to provide practical advice on how to use Lacosamide Accord.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
Therefore, the Agency's view was that, as for Vimpat, the benefit outweighs the identified risk.
Zato je menila, da njegove koristi enako kot pri zdravilu Vimpat odtehtajo znana tveganja.
Other information about Lacosamide Accord
Druge informacije o zdravilu Lacosamide Accord
The active substance in Lacosamide Accord, lacosamide, is an epilepsy medicine.
Zdravilna učinkovina zdravila Lacosamide Accord, lakozamid, je zdravilo za zdravljenje epilepsije.
Why is Lacosamide Accord approved?
Zakaj je bilo zdravilo Lacosamide Accord odobreno?
How has Lacosamide Accord been studied?
Kako je bilo zdravilo Lacosamide Accord raziskano?
How does Lacosamide Accord work?
Kako zdravilo Lacosamide Accord deluje?
Lacosamide Accord contains the active substance lacosamide.
Zdravilo Lacosamide Accord vsebuje zdravilno učinkovino lakozamid.
How is Lacosamide Accord used?
Kako se zdravilo Lacosamide Accord uporablja?
These reactions may be severe.
Te reakcije so lahko hude.
In children this may affect growth and development.
Pri otrocih to lahko vpliva na rast in razvoj.
if you are using the medicine for several months or longer.
• če zdravilo uporabljate več mesecev ali dlje.
if you have cystic fibrosis.
• če imate cistično fibrozo.
The median (50%) onset time of relief was 35.9 hours.
Mediana vrednost (50 %) časa nastopa izboljšanja je znašala 35,9 ur.
if you have any other infection.
• če imate katero koli drugo okužbo.
4.5 Interactions with other medicaments and other forms of interaction
4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij
Use in children aged 3 to 11 years
Uporaba pri otrocih, starih od 3 do 11 let
Therefore, the patient should continue regular use to achieve full therapeutic benefit.
Zato mora bolnik zdravilo redno uporabljati, da se doseže polna terapevtska korist.
In addition, consideration should be given to referring the patient to a paediatric specialist.
Poleg tega je treba razmisliti tudi o napotitvi bolnika k ustreznemu pediatričnemu specialistu.
Breathe out through your mouth.
Izdihnite skozi usta.
Effect on Growth in Paediatric Population
Vpliv na rast pri pediatrični populaciji
It is important to clean your nasal spray regularly, otherwise it may not work properly.
• Pomembno je, da pršilo za nos redno čistite, sicer morda ne bo delovalo pravilno.
Do not stop your treatment even if you feel better unless told to do so by your doctor.
Zdravljenja ne prekinjajte, tudi če se počutite bolje, razen če vam tako svetuje zdravnik.
Repeat steps 3 to 6 for the other nostril (Figure 3).
Ponovite korake od 3 do 6 na drugi nosnici (slika 3).
Please read this leaflet carefully before you start using this medicine because it contains important information for you.
Pred začetkom uporabe zdravila natančno preberite navodilo, ker vsebuje za vas pomembne podatke!
Do not use a larger dose or use the spray more often or for longer than your doctor tells you to.
Ne uporabljajte večjega odmerka in pršila ne uporabljajte pogosteje ali dlje, kot vam je predpisal zdravnik.
No interactions were observed.
Medsebojnega delovanja niso ugotovili.
Frequencies were defined as follows: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100).
Pogostnost je opredeljena z naslednjimi izrazi: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000
It is very important that you use your nasal spray regularly.
Zelo pomembno je, da pršilo za nos redno uporabljate.
Systemic Effects of Corticosteroids
Sistemski učinki kortikosteroidov
There was no effect on fertility.
Vpliva na plodnost ni bilo.
This Summary of Product Characteristics, labelling and package leaflet is the outcome of the referral procedure to which this Commission decision relates.
Ta povzetek glavnih značilnosti zdravila, ovojnina in navodilo za uporabo so rezultat napotitvenega postopka, s katerim je povezana odločitev Komisije.
A clinical interaction study was conducted with loratadine.
Izvedli so klinično študijo medsebojnega delovanja z loratadinom.
You should avoid coming into contact with anyone who has these infections.
Stiku z bolniki s temi okužbami se morate izogibati.
If you use steroids for a long time or in large amounts they may, rarely, affect some of your hormones.
Če steroide uporabljate daljši čas ali v velikih odmerkih, lahko to v redkih primerih vpliva na nekatere hormone.
All observed effects are typical of this class of compounds and are related to exaggerated pharmacologic effects of glucocorticoids.
Vsi učinki, ki so se pojavili, so značilni za ta razred učinkovin in so povezani s pretiranimi farmakološkimi učinki glukokortikoidov.
You should stop taking Nasonex and get immediate medical help if you experience symptoms such as:
Zdravilo Nasonex takoj prenehajte uporabljati in nemudoma poiščite zdravniško pomoč, če se pojavijo simptomi, kot so:
Disturbances of taste and smell
motnje okušanja in vonjanja
140 actuations
140 vpihov
You should not use the nasal spray until your nose has healed.
Pršila za nos ne smete uporabljati, dokler se nos ne zaceli.
Within each system organ class, adverse reactions are ranked by frequency.
Znotraj vsakega organskega sistema so neželeni učinki razvrščeni po pogostnosti.
There are no clinical data concerning the effect of mometasone furoate on fertility.
Kliničnih podatkov o vplivu mometazonfuroata na plodnost ni.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se, preden uporabite to zdravilo, posvetujte z zdravnikom ali farmacevtom.
if you have recently had an operation on your nose or you have injured your nose.
• če ste pred kratkim imeli kirurški poseg na nosu ali imate poškodbo nosu.
The carcinogenicity potential of inhaled mometasone furoate (aerosol with CFC propellant and surfactant) at concentrations of 0.25 to 2.0 micrograms/l was investigated in 24-month studies in mice and rats.
Karcinogeni potencial inhaliranega mometazonfuroata (pršilo s CFC potisnim plinom in površinsko aktivno snovjo) v koncentracijah od 0,25 do 2,0 mikrogramov/l so preučevali v 24-mesečnih študijah pri miših in podganah.
The incidence of all other adverse events was comparable with that of placebo.
Pojavnost vseh ostalih neželenih učinkov je bila primerljiva s pojavnostjo pri placebu.
The dose should be titrated to the lowest dose at which effective control of symptoms is maintained.
Odmerek je treba titrirati do najnižjega odmerka, pri katerem so simptomi še učinkovito nadzorovani.
Pharmacotherapeutic group: Decongestants and Other Nasal Preparations for Topical Use-Corticosteroids, ATC code: R01A D09
Farmakoterapevtska skupina: dekongestivi in druga zdravila za lokalno zdravljenje nosne sluznice, kortikosteroidi, oznaka ATC: R01AD09
Such transfer may also unmask pre-existing allergic conditions, such as allergic conjunctivitis and eczema, previously suppressed by systemic corticosteroid therapy.
Tak prehod lahko odkrije tudi že prisotne prikrite alergije, kot sta alergijski konjunktivitis in ekcem, ki ju je predhodna uporaba sistemskega kortikosteroida prikrila.
Preclinical studies demonstrate that mometasone furoate is devoid of androgenic, antiandrogenic, estrogenic or antiestrogenic activity but, like other glucocorticoids, it exhibits some antiuterotrophic activity and delays vaginal opening in animal models at high oral doses of 56 mg/kg/day and 280 mg/kg/day.
Predklinične študije so pokazale, da mometazonfuroat ne deluje androgeno, antiandrogeno, estrogeno ali antiestrogeno, vendar pa tako kot drugi glukokortikoidi deluje nekoliko antiuterotropno in se pri živalskih modelih po prejemu velikih peroralnih odmerkov 56 mg/kg/dan in 280 mg/kg/dan nožnica začne pozneje odpirati.
Mometasone furoate is a topical glucocorticosteroid with local anti-inflammatory properties at doses that are not systemically active.
Mometazonfuroat je lokalni glukokortikosteroid z lokalnim protivnetnim delovanjem pri odmerkih, ki ne delujejo sistemsko.
The bottle should be discarded after the labelled number of actuations or within 2 months of first use.
Plastenko je treba zavreči po številu vpihov, ki je navedeno na ovojnini, ali v 2 mesecih po prvi uporabi.
Use of Nasonex during an untreated infection in your nose, such as herpes, can worsen the infection.
Uporaba zdravila Nasonex med nezdravljeno okužbo nosu, kot je herpes, lahko poslabša okužbo.
(See 4.4 Special warnings and special precautions for use with systemic corticosteroids)
(Za uporabo skupaj s sistemskimi kortikosteroidi glejte poglavje 4.4 Posebna opozorila in previdnostni ukrepi.)
If you forget to use your nasal spray at the right time, use it as soon as you remember, then carry on as before.
Če ste pršilo za nos ob predvidenem času pozabili uporabiti, ga uporabite takoj, ko se spomnite, nato pa nadaljujte z uporabo zdravila kot običajno.
Shake gently before use.
Pred uporabo nežno pretresite!
If these patients exhibit signs and symptoms of adrenal insufficiency or symptoms of withdrawal (e.g., joint and/or muscular pain, lassitude, and depression initially) despite relief from nasal symptoms, systemic corticosteroid administration should be resumed and other modes of therapy and appropriate measures instituted.
Če se pri takšnih bolnikih pojavijo znaki in simptomi nezadostnega delovanja nadledvične žleze ali odtegnitveni simptomi (npr. bolečina v sklepih in/ali mišicah, utrujenost in začetna depresija), je kljub ublažitvi nazalnih simptomov treba ponovno uvesti zdravljenje s sistemskim kortikosteroidom in druge načine zdravljenja ter ustrezne ukrepe.
Start to breathe in gently or slowly through your nose and whilst you are breathing in squirt a spray of fine mist into your nose by pressing down ONCE with your fingers.
Počasi in nežno začnite vdihovati skozi nos in med vdihom vpihnite fino razpršeno meglico v nos z ENIM pritiskom prstov navzdol.
Put your forefinger and middle finger either side of the nozzle and your thumb underneath the bottle.
Kazalec in sredinec namestite na vsako stran nosnika, palec pa pod plastenko.
As with other nasal corticosteroid preparations, NASONEX Nasal Spray should not be used in pregnancy unless the potential benefit to the mother justifies any potential risk to the mother, foetus or infant.
Tako kot drugih nazalnih kortikosteroidov se tudi zdravila Nasonex pršilo za nos med nosečnostjo ne sme uporabljati, razen če možna korist za mater upravičuje kakršno koli možno tveganje za mater, plod ali otroka.
Remove the nozzle from this nostril and breathe out through the mouth.
Nosnik vzemite iz nosnice in izdihnite skozi usta.
• The active substance is mometasone furoate.
• Zdravilna učinkovina je mometazonfuroat.
• Do not use this medicine after the expiry date which is stated on the bottle and carton after EXP.
• Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na plastenki in škatli poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
These effects are much less likely to occur than with oral corticosteroids and may vary in individual patients and between different corticosteroid preparations.
Verjetnost za pojav teh učinkov je veliko manjša kot pri peroralnih kortikosteroidih in se lahko razlikuje glede na posameznega bolnika in vrsto uporabljenega kortikosteroida.
If growth is slowed, therapy should be reviewed with the aim of reducing the dose of nasal corticosteroid if possible, to the lowest dose at which effective control of symptoms is maintained.
Če se rast upočasni, je treba zdravljenje ponovno ovrednotiti, odmerek nazalnega kortikosteroida pa po možnosti zmanjšati na najmanjši možni odmerek, ki še vzdržuje učinkovit nadzor simptomov.
What Nasonex is and what it is used for What you need to know before you use Nasonex How to use Nasonex
Kaj je zdravilo Nasonex in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Nasonex Kako uporabljati zdravilo Nasonex
Infants born of mothers who received corticosteroids during pregnancy should be observed carefully for hypoadrenalism.
Novorojence mater, ki so med nosečnostjo prejemale kortikosteroide, je treba zaradi možnosti hipoadrenalizma skrbno nadzirati.
Nasal polyps are small growths on the lining of the nose and usually affect both nostrils.
Nosni polipi so majhni izrastki na nosni sluznici, običajno pa sta prizadeti obe nosnici.
Wash the nozzle and dust cap in warm water and then rinse under a running tap.
• Nosnik in pokrovček umijte v topli vodi in ju potem sperite pod tekočo vodo.
If you or your child suffer badly from hayfever, your doctor may tell you to start using Nasonex before the start of the pollen season, as this will help to prevent your hayfever symptoms from occurring.
Če imate vi ali vaš otrok zaradi senenega nahoda hude težave, vam zdravnik lahko predpiše uporabo zdravila Nasonex pred začetkom sezone cvetnega prahu, kar bo pomagalo preprečiti pojav simptomov senenega nahoda.
No statistically significant dose-response relationship was detected for any of the tumour types.
Statistično značilne povezave med odmerkom in odzivom niso ugotovili za noben tip tumorja.