natgillin/translations-raw huggingface dataset:
Immune system disorders Rare:
Bolezni imunskega sistema Neznana pogostnost:
ACE inhibitors, potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium, cyclosporin or other medicinal products such as heparin sodium).
Zdravila, ki lahko povečajo raven kalija ali povzročijo hiperkaliemijo (npr. zaviralci ACE; diuretiki, ki varčujejo s kalijem; dodatki kalija; nadomestki soli, ki vsebujejo kalij; ciklosporin ali druga zdravila, kot je natrijev heparinat).
Most cases of hepatic function abnormal/liver disorder from post-marketing experience with telmisartan occurred in Japanese patients.
Nenormalno jetrno delovanje ali jetrna bolezen O večini primerov nenormalnega jetrnega delovanja ali jetrne bolezni so v obdobju po začetku trženja telmisartana poročali pri japonskih bolnikih, pri katerih tudi sicer obstaja večja verjetnost teh neželenih reakcij.
Decreased blood potassium levels, anxiety, fainting (syncope), sensation of tingling, pins and needles (paraesthesia), feeling of spinning (vertigo), fast heart beat (tachycardia), heart rhythm disorders, low blood pressure, a sudden fall in blood pressure when you stand up, shortness of breath (dyspnoea), diarrhoea, dry mouth, flatulence, back pain, muscle spasm, muscle pain, erectile dysfunction (inability to get or keep an erection), chest pain, increased blood uric acid levels.
Občasni (pojavijo se lahko pri največ 1 od 100 bolnikov): Znižana raven kalija v krvi, tesnoba, omedlevanje (sinkopa), ščemenje, mravljinci (parestezija), vrtoglavica, hiter srčni utrip (tahikardija), motnje srčnega ritma, nizek krvni tlak, nenadno znižanje krvnega tlaka med vstajanjem, zasoplost (dispneja), driska, suha usta, napenjanje, bolečina v hrbtu, mišični krč, bolečina v mišicah, erektilna disfunkcija (nezmožnost erekcije ali vzdrževanja erekcije), bolečina v prsnem košu, povečana raven sečne kisline v krvi.
- Liver disease.
Žilne bolezni
Actelsar HCT 80 mg/25 mg tablets are white or almost white, 9.0 x 17.0 mm oval-shaped and biconvex tablets marked with “TH” on one side and “25” on the other side.
Izgled zdravila Actelsar HCT in vsebina pakiranja Actelsar HCT 80 mg/25 mg tablete so bele ali skoraj bele, ovalne in bikonveksne tablete, velikosti 9,0 x 17,0 mm, z oznako “TH” na eni strani in “25” na drugi strani.
Hypotension, orthostatic hypotension Respiratory, thoracic and mediastinal disorders Uncommon:
hipotenzija, ortostatska hipotenzija Bolezni dihal, prsnega koša in mediastinalnega prostora
- class Ia antiarrythmics (e.g. quinidine, hydroquinidine, disopyramide) - class III antiarrythmics (e.g. amiodarone, sotalol, dofetilide, ibutilide) - some antipsychotics (e.g. thioridazine, chlorpromazine, levomepromazine, trifluoperazine,
Enako velja za jemanje z naslednjimi zdravili, ki lahko povzročijo torsades de pointes (med njimi tudi z nekaterimi antiaritmiki), ker je hipokaliemija predisponirajoči dejavnik za pojav torsades de pointes: - antiaritmiki skupine Ia (npr. kinidin, hidrokinidin, dizopiramid) - antiaritmiki skupine III (npr. amiodaron, sotalol, dofetilid, ibutilid) - nekateri antipsihotiki: (npr. tioridazin, klorpromazin, levomepromazin,
There was evidence for a benefit of telmisartan compared to placebo in the pre-specified secondary composite endpoint of cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke [0.87 (95% CI 0.76-1.00, p=0.048)].
Podatki dokazujejo korist zdravljenja s telmisartanom v primerjavi s placebom na podlagi njegovega učinka na vnaprej opredeljen sekundarni, sestavljeni opazovani dogodek, ki je zajemal srčnožilno smrt, neusodni miokardni infarkt in neusodno možgansko kap [0,87 (95-odstotni IZ 0,76 do 1,00, p =
Actelsar HCT is not recommended for mothers who are breast-feeding and your doctor may choose another treatment for you if you wish to breast-feed.
Zdravila Actelsar HCT ne priporočajo materam, ki dojijo.
Telmisartan was found to be similarly effective to ramipril in the pre-specified secondary endpoint of cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke [0.99 (97.5% CI 0.90-1.08), p (non-inferiority) =0.0004], the primary endpoint in the reference study HOPE (The Heart Outcomes Prevention Evaluation Study), which had investigated the effect of ramipril vs. placebo.
[0,99 (97,5-odstotni IZ 0,90 do 1,08), p (enakovrednost) = 0,0004], in je bil primarni opazovani dogodek v referenčni raziskavi HOPE (The Heart Outcome Prevention Evaluation Study), v kateri so ramipril primerjali s placebom.
Musculoskeletal, connective tissue and bone disorders Uncommon:
Bolezni mišično-skeletega sistema, vezivnega tkiva in kosti Neznana pogostnost:
Summary of the safety profile The most commonly reported adverse reaction is dizziness.
Najpogostnejši neželeni učinek je bila omotica.
Endocrine disorders Not known:
Bolezni endokrinega sistema Neznana pogostnost:
Investigations Uncommon:
Preiskave Neznana pogostnost:
For Al/Al blisters and HDPE tablet container: 2 years.
Al/Al pretisni omot in HDPE vsebnik za tablete:
Side effects of unknown frequency (frequency cannot be estimated from the available data) Inflammation of the salivary gland, skin and lip cancer (Non-melanoma skin cancer), decreases in the number (or even lack) of cells in the blood, including low red and white blood cell count, serious allergic reactions (e.g. hypersensitivity, anaphylactic reaction), decreased or loss of appetite, restlessness, light-headedness, blurred or yellowing of vision, decrease in vision and eye pain (possible signs of acute myopia or acute-angle closure glaucoma), inflammation of blood vessels (vasculitis necrotising), inflamed pancreas, upset stomach, yellowing of the skin or eyes (jaundice), lupus-like syndrome (a condition mimicking a disease called systemic lupus erythematosus where the body's immune system attacks the body); skin disorders such as inflamed blood vessels in the skin, increased sensitivity to sunlight, rash, redness of the skin, blistering of the lips, eyes or mouth, skin peeling, fever (possible signs of erythema multiforme),weakness, kidney inflammation or impaired kidney function, glucose in the urine (glycosuria), fever, impaired electrolyte balance, high blood cholesterol levels, decreased blood volume, increased blood levels of glucose, difficulties in controlling blood/ urine levels of glucose in patients with a diagnosis of diabetes mellitus, or fat in the blood.
Neželeni učinki neznane pogostnosti (ni mogoče oceniti iz razpoložljivih podatkov): vnetje žleze slinavke, kožni rak in rak ustnice (nemelanomski kožni rak), zmanjšanje števila (ali celo popolno pomanjkanje) krvnih celic, tudi majhno število rdečih in belih krvničk, resne alergijske reakcije (npr. preobčutljivost, anafilaktična reakcija), zmanjšan tek ali izguba teka, nemir, vrtoglavica, zamegljen vid ali rumenkasta obarvanost stvari, ki jih vidite, poslabšan vid in očesna bolečina (možna znaka akutne miopije ali akutnega glavkoma zaprtega zakotja), vnetje žil (nekrotizirajoči vaskulitis), vnetje trebušne slinavke, želodčne težave, porumenelost kože ali oči (zlatenica), lupusu podoben sindrom (bolezensko stanje, ki je podobno sistemskemu eritematoznemu lupusu, pri kateri telo napade človekov lastni imunski sistem), kožne motnje, kot so vnetje žil v koži; povečana občutljivost za sončno svetlobo, izpuščaj,
- Other medicines used to treat high blood pressure, corticosteroids, painkillers (such as nonsteroidal anti-inflammatory drugs [NSAIDs]), medicines to treat cancer, gout, or arthritis.
- druga zdravila za zdravljenje visokega krvnega tlaka, kortikosteroidi, protibolečinska zdravila (kot so nesteroidni antirevmatiki [NSAR]), zdravila za zdravljenje raka, protina ali artritisa; - zaviralec ACE ali aliskiren (glejte tudi informacije pod naslovoma "Ne jemljite zdravila Actelsar HCT" in "Opozorila in previdnostni ukrepi");
Telmisartan Adverse reactions occurred with similar frequency in placebo and telmisartan treated patients.
Telmisartan Pojavnost neželenih učinkov je bila enako pogosta kot pri placebu.
Very rare (may affect up to 1 in 10,000 people): Increased pH (disturbed acid-base balance) due to low blood chloride level.
povišan pH (porušeno ravnovesje med kislino in bazo) zaradi nizke ravni klorida v krvi.
Actelsar HCT 80 mg/25 mg
PODATKI V BRAILLOVI PISAVI Actelsar HCT 80 mg/25 mg
Exposure to angiotensin II receptor antagonist therapy during the second and third trimesters is known to induce human fetotoxicity (decreased renal function, oligohydramnios, skull ossification retardation) and neonatal toxicity (renal failure, hypotension, hyperkalaemia) (see section 5.3).
oligohidramnij, zapoznela zakostenitev lobanje) in toksične učinke pri novorojenčku (ledvična odpoved, hipotenzija, hiperkaliemija) (glejte poglavje 5.3).
Tablet 30 tablets 90 tablets 250 tablets
250 tablet
Respiratory, thoracic and mediastinal disorders Uncommon:
Bolezni jeter, žolčnika in žolčevodov Neznana pogostnost:
- Medicines that are affected by changes of the blood potassium level such as heart medicines (e.g. digoxin) or medicines to control the rhythm of your heart (e.g. quinidine, disopyramide, amiodarone, sotalol), medicines used for mental disorders (e.g. thioridazine, chlorpromazine, levomepromazine) and other medicines such as certain antibiotics (e.g. sparfloxacine, pentamidine) or certain medicines to treat allergic reactions (e.g. terfenadine).
sotalol), zdravila za zdravljenje duševnih motenj (npr. tioridazin, klorpromazin, levomepromazin) in nekatera druga zdravila, na primer nekateri antibiotiki (npr. sparfloksacin, pentamidin) ali zdravila za zdravljenje alergijskih reakcij (npr. terfenadin); - zdravila za zdravljenje sladkorne bolezni (insulini ali peroralna zdravila, kot je metformin);
Thiazide diuretic associated azotaemia may occur in patients with impaired renal function.
Pri bolnikih z zmanjšanim delovanjem ledvic se lahko pojavi azotemija, ki je povezana z jemanjem tiazidnih diuretikov.
Actelsar HCT 80 mg/12.5 mg
Actelsar HCT 80 mg/12,5 mg tablete
Actelsar HCT 80 mg/12.5 mg tablets White or almost white, 9.0 x 17.0 mm capsule-shaped tablets marked with “TH 12.5” on both sides.
Bele ali skoraj bele tablete v obliki kapsule velikosti 9,0 x 17,0 mm, z oznako “TH 12.5” na obeh straneh.
Adverse reactions known to occur with each component given singly but which have not been seen in clinical trials may occur during treatment with Actelsar HCT.
Neželeni učinki, o katerih so poročali za posamezni sestavini zdravila, se lahko pojavijo tudi pri zdravilu Actelsar HCT, čeprav jih v kliničnih preskušanjih kombinacije niso zasledili.
- Cholestasis and biliary obstructive disorders.
- Holestaza in obolenja z zaporo žolčevoda.
High blood pressure, if not treated, can damage blood vessels in several organs, which could lead sometimes to heart attack, heart or kidney failure, stroke, or blindness.
Posledice takšnih poškodb so lahko srčni infarkt, odpoved srca ali ledvic, možganska kap ali slepota.
Nervous system disorders Rare:
Bolezni imunskega sistema Redki:
EU/1/13/817/045 EU/1/13/817/029 EU/1/13/817/046 EU/1/13/817/030 EU/1/13/817/031 EU/1/13/817/032 EU/1/13/817/033 EU/1/13/817/034 EU/1/13/817/035 EU/1/13/817/036 EU/1/13/817/037 EU/1/13/817/038 EU/1/13/817/039 EU/1/13/817/040 EU/1/13/817/041
EU/1/13/817/045 EU/1/13/817/029 EU/1/13/817/046 EU/1/13/817/030 EU/1/13/817/031 EU/1/13/817/032 EU/1/13/817/033 EU/1/13/817/034 EU/1/13/817/035
Therefore, the use of Actelsar HCT is not recommended.
Ker o uporabi telmisartana med dojenjem ni podatkov, uporaba zdravila Actelsar HCT ni priporočljiva.
Actelsar HCT 40 mg/12.5 mg
PODATKI V BRAILLOVI PISAVI Actelsar HCT 40 mg/12,5 mg
The overall incidence and pattern of adverse reactions reported with telmisartan/hydrochlorothiazide 80 mg/25 mg was comparable with telmisartan/hydrochlorothiazide 80 mg/12.5 mg. A doserelationship of adverse reaction was not established and they showed no correlation with gender, age or race of the patients.
Celokupno pogostnost in vzorec (pojavljanja) neželenih učinkov zdravila Actelsar HCT 80 mg/25 mg so primerjali z zdravilom Actelsar HCT 80 mg/12,5 mg.
EU/1/13/817/006 EU/1/13/817/007 EU/1/13/817/008 EU/1/13/817/009 EU/1/13/817/010 EU/1/13/817/011 EU/1/13/817/012 EU/1/13/817/013
EU/1/13/817/001 EU/1/13/817/042 EU/1/13/817/002 EU/1/13/817/003 EU/1/13/817/004 EU/1/13/817/005 EU/1/13/817/006 EU/1/13/817/007 EU/1/13/817/008 EU/1/13/817/009 EU/1/13/817/010 EU/1/13/817/011 EU/1/13/817/012 EU/1/13/817/013
EU/1/13/817/039 EU/1/13/817/040 EU/1/13/817/041
EU/1/13/817/036 EU/1/13/817/037 EU/1/13/817/038 EU/1/13/817/039 EU/1/13/817/040 EU/1/13/817/041
Al/Al blister: 14, 28, 30, 56, 84, 90 and 98 tablets Al/PVC/PVDC blister: 28, 56, 84, 90 and 98 tablets Tablet container: 30, 90 and 250 tablets
Al/Al pretisni omoti:14, 28, 30, 56, 84, 90 in 98 tablet Al/PVC/PVDC pretisni omoti: 28, 56, 84, 90 in 98 tablet Vsebniki za tablete: 30, 90 in 250 tablet
Package leaflet: Information for the user Actelsar HCT 80 mg/25 mg tablets telmisartan/hydrochlorothiazide
IME ZDRAVILA Actelsar HCT 80 mg/25 mg tablete telmisartan/hidroklorotiazid
Package leaflet: Information for the user Actelsar HCT 80 mg/12.5 mg tablets telmisartan/hydrochlorothiazide
IME ZDRAVILA Actelsar HCT 80 mg/12,5 mg tablete telmisartan/hidroklorotiazid
Erectile dysfunction General disorders and administration site conditions Uncommon:
Splošne težave in spremembe na mestu aplikacije Neznana pogostnost:
Talk to your doctor before taking Actelsar HCT, if you are taking: - any of the following medicines used to treat high blood pressure: an ACE-inhibitor (for example enalapril, lisinopril, ramipril), in particular if you have diabetes-related kidney problems.
Pred začetkom jemanja zdravila Actelsar HCT se posvetujte z zdravnikom, če jemljete: - katero od naslednjih zdravil, ki se uporabljajo za zdravljenje visokega krvnega tlaka:
Infections and infestations Not known:
Infekcijske in parazitske bolezni Neznana pogostnost:
Al/Al blister packs: 14, 30, 28, 56, 84, 90 and 98 tablets Al/PVC/PVDC blister packs: 14, 28, 56, 84, 90 and 98 tablets Tablet containers: 30, 90 and 250 tablets
Al/Alpretisni omoti: 14, 30, 28, 56, 84, 90 in 98 tablet Al/PVC/PVDC pretisni omoti: 14, 28, 56, 84, 90 in 98 tablet Vsebniki za tablete: 30, 90 in 250 tablet
Package leaflet: Information for the user Actelsar HCT 40 mg/12.5 mg tablets telmisartan/hydrochlorothiazide
IME ZDRAVILA Actelsar HCT 40 mg/12,5 mg tablete telmisartan/hidroklorotiazid
Sepsis including fatal outcome3 Blood and lymphatic system disorders Uncommon:
sepsa, vključno s smrtnim izidom3
ACE-inhibitors and angiotensin II receptor blockers should not be used concomitantly in patients with diabetic nephropathy.
Pri bolnikih z diabetično nefropatijo se zaviralcev ACE in antagonistov receptorjev angiotenzina II
- If you are taking an ACE-inhibitor or aliskiren (see also information under the headings “Do not take Actelsar HCT” and “Warnings and precautions”).
Actelsar HCT" in "Opozorila in previdnostni ukrepi"); - digoksin.
Other antihypertensive agents
Nesteroidna protivnetna zdravila
Beta-blockers and diazoxide
Bolezni krvi in limfatičnega sistema
1.35) for BCC and 3.98 (95% CI: 3.68-4.31) for SCC.
1,03, 95-odstotni IZ 0,85 do 1,24).
Although clinically significant hyperkalaemia has not been documented with Actelsar HCT, risk factors for the development of hyperkalaemia include renal insufficiency and/or heart failure, and diabetes mellitus.
Dejavniki tveganja za njen razvoj so zmanjšano ledvično delovanje ali srčno popuščanje ali obe obolenji in diabetes mellitus.
Strength Pharmaceutical Form Route of Administration
Številka EU ime jakost farmacevtska oblika pot uporabe ovojnina vsebina velikost pakiranja
However, it may be appropriate to give the vaccine to these patients during a pandemic, as long as facilities for resuscitation are available.
Vendar je morda primerno, da se cepivo da tem osebam med pandemijo, če je na voljo oprema za oživljanje.
Further information on Aflunov can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/aflunov.
Nadaljnje informacije za cepivo Aflunov so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/aflunov.
What measures are being taken to ensure the safe and effective use of Aflunov?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Aflunov?
Aflunov received a marketing authorisation valid throughout the EU on 29 November 2010.
Za cepivo Aflunov je bilo 29. novembra 2010 izdano dovoljenje za promet, veljavno po vsej EU.
The European Medicines Agency therefore decided that Aflunov's benefits are greater than its risks and it can be authorised for use in the EU.
Evropska agencija za zdravila je zato zaključila, da so koristi cepiva Aflunov večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
This vaccine contains some parts of the H5N1 virus.
Cepivo vsebuje nekatere delce virusa H5N1.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Aflunov 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 cepiva Aflunov upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
Aflunov should not be given to patients who have had an anaphylactic reaction (severe allergic reaction) to any of the components of the vaccine, including those found at trace (very low) levels (egg or chicken protein, ovalbumin [a protein in egg white], kanamycin or neomycin sulphate [antibiotics], barium sulphate, formaldehyde and cetyltrimethylammonium bromide).
Cepivo Aflunov se ne sme dajati osebam, ki so imele anafilaktično reakcijo (hudo alergijsko reakcijo) na katero koli sestavino cepiva, vključno s tistimi, ki so ugotovljene v sledeh (v zelo majhnih količinah] (jajčne ali piščančje beljakovine, ovalbumin [beljakovina v jajčnem beljaku], kanamicin ali neomicin sulfat [antibiotiki], barijev sulfat, formaldehid in cetiltrimetilamonijev bromid).
An overview of Aflunov and why it is authorised in the EU
Pregled zdravila Aflunov in zakaj je odobreno v EU
Other information about Aflunov
Druge informacije o zdravilu Aflunov
Side effects reported with Aflunov are carefully evaluated and any necessary action taken to protect patients.
Neželeni učinki, o katerih so poročali pri cepivu Aflunov, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
When the person comes into contact with the virus, these antibodies, together with other components of the immune system, will be able to kill the virus and help protect against the disease.
Ob izpostaviti virusu bodo lahko ta protitelesa skupaj z drugimi mehanizmi imunskega sistema uničila virus in pripomogla k zaščiti pred boleznijo.
Why is Aflunov authorised in the EU?
Zakaj je bilo zdravilo Aflunov odobreno v EU?
As for all medicines, data on the use of Aflunov are continuously monitored.
Tako kot za vsako zdravilo se tudi podatki o uporabi cepiva Aflunov stalno spremljajo.
The most common side effects with Aflunov (which may affect more than 1 patient in 10) are headache, myalgia (muscle pain), reactions at the site of injection (swelling, pain, induration and redness) and fatigue (tiredness).
Najpogostejši neželeni učinki cepiva Aflunov (ki lahko prizadenejo več kot 1 od 10 oseb) so glavobol, mialgija (bolečine v mišicah), reakcije na mestu injiciranja (oteklina, bolečina, otrdina in pordelost) ter utrujenost.
What is Aflunov and what is it used for?
Kaj je zdravilo Aflunov in za kaj se uporablja?
The study showed that 21 days after the second injection, around 70% of adults below 60 years and around 64% of adults above 60 years produced an acceptable antibody response.
Študija je pokazala, da je 21 dni po drugi injekciji približno 70 % odraslih, mlajših od 60 let, in približno 64 % odraslih, starejših od 60 let, imelo sprejemljive ravni protiteles.
The studies looked at the ability of the vaccine to trigger the production of antibodies (‘immunogenicity') against the flu virus.
V študijah so proučevali zmožnost cepiva, da sproži tvorbo protiteles („imunogenost“) proti virusu gripe.
In the first study, 21 days after the second injection, around 90% of people aged below 60 years and around 80% of those aged above 60 years had levels of antibodies that would protect them against H5N1.
V prvi študiji je 21 dni po drugi injekciji približno 90 % ljudi, mlajših od 60 let, in približno 80 % oseb, starejših od 60 let, imelo raven protiteles, ki bi jih zaščitila pred H5N1.
In one study involving 3,372 people, subjects were given either a seasonal flu vaccine followed by two doses of Aflunov three weeks apart, or placebo (a dummy vaccine) followed by two doses of an adjuvanted seasonal vaccine three weeks apart.
V eni študiji, v katero je bilo vključenih 3 372 oseb, so preiskovanci prejeli bodisi sezonsko cepivo proti gripi, ki sta mu sledila dva odmerka cepiva Aflunov v razmiku treh tednov, ali placebo (cepivo brez učinkovine), ki sta mu sledila dva odmerka sezonskega cepiva z adjuvansom v razmiku treh tednov.
In the second study involving 240 people, subjects were given Aflunov using different vaccination schedules.
V drugi študiji, v katero je bilo vključenih 240 oseb, so preiskovanci prejemali cepivo Aflunov po različnih razporedih cepljenja.
Aflunov can only be obtained with a prescription and should be used according to official recommendations
Predpisovanje in izdaja cepiva Aflunov je le na recept, uporabljati pa se mora v skladu z uradnimi priporočili.
What are the risks associated with Aflunov?
Kakšna tveganja so povezana z zdravilom Aflunov?
This study established that Aflunov should be given as two doses at least three weeks apart.
V tej študiji je bilo ugotovljeno, da je treba zdravilo Aflunov dajati v dveh odmerkih v razmiku najmanj treh tednov.
Aflunov is a type of vaccine to be given before or during a flu pandemic to protect against a new strain of flu.
Aflunov je vrsta cepiva, ki se daje pred pandemijo gripe ali med njo, da se ustvari zaščita pred novim sevom gripe.
In the event of an officially declared pandemic caused by the H5N1 strain of the influenza A, people who have already been vaccinated with Aflunov (with one or two doses) may be given only one more dose, instead of the two doses recommended for unvaccinated people.
V primeru uradno razglašene pandemije zaradi seva H5N1 gripe A lahko posamezniki, ki so že bili cepljeni s cepivom Aflunov (z enim ali dvema odmerkoma), prejmejo samo še en odmerek in ne dveh, kot se priporoča za ljudi, ki predhodno še niso bili cepljeni
When a person is given the vaccine, the immune system recognises the virus parts in the vaccine as ‘foreign' and makes antibodies against them.
Po cepljenju s cepivom imunski sistem prepozna delce virusa v cepivu kot „tujke“ in začne proti njim tvoriti protitelesa.
What benefits of Aflunov have been shown in studies?
Kakšne koristi je zdravilo Alfunov izkazalo v študijah?
Aflunov is a vaccine used in adults to protect against flu caused by the H5N1 (‘bird flu') strain of the influenza A virus.
Aflunov je cepivo, ki se uporablja pri odraslih za zaščito pred gripo, ki jo povzroča sev virusa influence A H5N1 („ptičja gripa“).
At the time of the initial marketing authorisation, two main studies using a strain called A/Vietnam/1194/2004 (H5N1)-like strain (NIBRG-14) provided data on vaccination with Aflunov in healthy adults aged below and above 60 years.
V času prvotnega dovoljenja za promet z zdravilom so bili iz dveh glavnih študij, v katerih je bil uporabljen sevu A/Vietnam/1194/2004 (H5N1) podoben sev (NIBRG-14), pridobljeni podatki o cepljenju s cepivom Aflunov pri zdravih odraslih, starejših in mlajših od 60 let.
It was noted that it is likely that a H5N1 strain of influenza will cause a pandemic in the future and Aflunov was shown to produce sufficient antibodies to stimulate an immune response and protect against H5N1.
Ugotovljeno je bilo, da je verjetno, da bo sev gripe H5N1 v prihodnosti povzročil pandemijo, pri čemer se je izkazalo, da cepivo Aflunov proizvede dovolj protiteles za pospeševanje imunskega odziva in zaščito pred H5N1.