natgillin/translations-raw huggingface dataset:
The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 3 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
Imetnik dovoljenja za promet z zdravilom se zavezuje, da bo opravil dodatne farmakovigilančne aktivnosti, podrobno opisane v načrtu farmakovigilance, sprejetem v različici 3 načrta z obvadovanje tveganja (RMP), predstavljenega v modulu 1. 8. 2 vloge za pridobitev dovoljenja za promet z zdravilom in vseh nadaljnih posodobitvah RMP, s katerimi soglaša CHMP.
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
Po smernicah CHMP za sisteme za obvladovanje tveganja za zdravila za uporabo v humani medicini mora biti posodobljen RMP predložen hkrati z naslednjim periodičnim poročilom o varnosti zdravila (PSUR).
In addition, an updated RMP should be submitted • When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached • At the request of the EMEA
Poleg tega je treba posodobljen RMP predložiti: • kadar imetnik dovoljenja za uporabo z zdravilom prejme nove informacije, ki lahko vplivajo na trenutne varnostne specifikacije, načrt farmakovigilance ali na dejavnosti za zmanjševanje tveganja;. • v 60 dneh po dosegu pomembnega mejnika (pri farmakovigilanci ali zmanjševanju tveganja). • na zahtevo Evropske agencije za zdravila (EMEA)
The PSUR of Tadalafil Lilly is aligned with the cross-referred product, Cialis, until otherwise specified.
PSUR zdravila Tadalafil Lilly je usklajen z referenčnim zdravilom Cialis, razen če ne bo drugače navedeno.
Tadalafil Lilly 20 mg film-coated tablets tadalafil
Tadalafil Lilly 20 mg filmsko obložene tablete tadalafil
18 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER
18 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
Tadalafil Lilly 20 mg tablets tadalafil
Tadalafil Lilly 20 mg tablete tadalafil
What Tadalafil Lilly is and what it is used for 2.
Kaj je zdravilo Tadalafil Lilly in za kaj ga uporabljamo 2.
Before you take Tadalafil Lilly 3.
Kaj morate vedeti, preden boste vzeli zdravilo Tadalafil Lilly 3.
How to take Tadalafil Lilly 4.
Kako jemati zdravilo Tadalafil Lilly 4.
Possible side effects 5 How to store Tadalafil Lilly 6.
Shranjevanje zdravila Tadalafil Lilly 6.
WHAT Tadalafil Lilly IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO Tadalafil Lilly IN ZA KAJ GA UPORABLJAMO
Tadalafil Lilly is a treatment for men with erectile dysfunction.
Zdravilo Tadalafil Lilly je namenjeno zdravljenju moških z erektilno disfunkcijo.
Tadalafil Lilly belongs to a group of medicines called phosphodiesterase type 5 inhibitors.
Zdravilo Tadalafil Lilly spada v skupino zdravil, imenovanih inhibitorji fosfodiesteraze tipa 5.
BEFORE YOU TAKE Tadalafil Lilly
KAJ MORATE VEDETI, PREDEN BOSTE VZELI ZDRAVILO Tadalafil Lilly
Do not take Tadalafil Lilly
Ne jemljite zdravila Tadalafil Lilly
- if you are allergic (hypersensitive) to tadalafil or any of the other ingredients of Tadalafil Lilly.
- če ste alergični na (preobčutljivi za) tadalafil ali katerokoli sestavino zdravila Tadalafil Lilly.
- if you have serious heart disease or have had a recent heart attack.
-
- if you have had a recent stroke.
- če imate resno srčno obolenje ali ste nedavno preboleli srčni infarkt.
- if you have low blood pressure or uncontrolled high blood pressure.
- če ste nedavno preboleli možgansko kap.
- if you have ever had loss of vision because of non-arteritic anterior ischemic optic neuropathy
- če imate nizek krvni tlak ali nekontroliran visok krvni tlak.
The following are reasons why Tadalafil Lilly may also not be suitable for you.
V nadaljevanju so našteti razlogi, zakaj zdravilo Tadalafil Lilly morda tudi ni primerno za vas.
It is not known if Tadalafil Lilly is effective in patients who have undergone pelvic surgery or radical non-nerve-sparing prostatectomy.
Ni znano, če je zdravilo Tadalafil Lilly učinkovito pri bolnikih po operacijah v medenici ali po radikalni prostatektomiji brez ohranjanja živcev.
Tadalafil Lilly is not intended for use by women or by adolescents under the age of 18.
Zdravilo Tadalafil Lilly ni namenjeno za uporabo pri ženskah ali pri mladostnikih, mlajših od 18 let.
This is particularly important if you are treated with nitrates as you should not take Tadalafil Lilly if you are taking these medicines.
To je še posebej pomembno, če se zdravite z nitrati, saj zdravila Tadalafil Lilly ne smete jemati, če že jemljete ta zdravila.
Do not take Tadalafil Lilly with other medicines if your doctor tells you that you may not.
Ne jemljite zdravila Tadalafil Lilly z drugimi zdravili, če vam je vaš zdravnik povedal, da tega ne smete.
You should not use Tadalafil Lilly together with any other treatments for erectile dysfunction.
Zdravila Tadalafil Lilly ne uporabljajte, če se za erektilno disfunkcijo zdravite še na kakšen drug način.
Taking Tadalafil Lilly with food and drink You may take Tadalafil Lilly with or without food.
Jemanje zdravila Tadalafil Lilly skupaj s hrano in pijačo Zdravilo Tadalafil Lilly lahko vzamete s hrano ali brez nje.
Check carefully how you react to the medicines before driving or using any machinery.
Vpliv na sposobnost upravljanja vozil in strojev Nekateri moški, ki so zdravilo Tadalafil Lilly jemali v kliničnih študijah, so poročali o omotici Pred vožnjo ali upravljanjem s stroji skrbno preverite kako reagirate na zdravila.
Tadalafil Lilly contains lactose.
Pomembne informacije o nekaterih sestavinah zdravila Tadalafil Lilly Zdravilo Tadalafil Lilly vsebuje laktozo.
HOW TO TAKE Tadalafil Lilly
KAKO JEMATI ZDRAVILO Tadalafil Lilly
Always take Tadalafil Lilly exactly as your doctor has told you.
22 Pri jemanju zdravila Tadalafil Lilly natančno upoštevajte zdravnikova navodila.
22 The recommended starting dose of tadalafil is one 10 mg tablet before sexual activity.
Priporočeni začetni odmerek tadalafila je ena 10 mg tableta pred spolno aktivnostjo.
Tadalafil Lilly tablets are for oral use.
Tablete zdravila Tadalafil Lilly so namenjene peroralni uporabi.
You may take Tadalafil Lilly with or without food.
Zdravilo Tadalafil Lilly lahko vzamete s hrano ali brez nje.
If you have taken or are planning to take Tadalafil Lilly, avoid excessive drinking (blood alcohol level of 0.08% or greater), since this may increase the risk of dizziness when standing up.
Če ste vzeli ali nameravate vzeti zdravilo Tadalafil Lilly, se izogibajte čezmernemu pitju (raven alkohola v krvi 0, 08% ali več), ker lahko to poveča tveganje za omotico ob vstajanju.
You should NOT take Tadalafil Lilly more than once a day.
Zdravila Tadalafil Lilly NE SMETE vzeti več kot enkrat na dan.
Tadalafil at doses of 10 mg and 20 mg is intended for use prior to anticipated sexual activity and is not recommended for continuous daily use.
Tadalafil v odmerkih 10 mg in 20 mg je namenjen za uporabo pred pričakovano spolno aktivnostjo in ga ne priporočamo za dolgotrajno vsakodnevno uporabo.
If you take more Tadalafil Lilly than you should Tell your doctor.
Če ste vzeli večji odmerek zdravila Tadalafil Lilly, kot bi smeli Povejte svojemu zdravniku.
Like all medicines, Tadalafil Lilly can cause side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi zdravilo Tadalafil Lilly neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
Very commonly reported side effect in patients taking tadalafil were headache and indigestion.
Zelo pogosto poročani neželeni učinki pri bolnikih, ki so jemali tadalafil, so bili glavoboli in prebavne motnje.
Commonly reported side effects in patients taking tadalafil include back pain, muscle aches, facial flushing, nasal congestion, dizziness, pounding heartbeat sensation, abdominal pain and reflux.
Pogosto poročani neželeni učinki pri bolnikih, ki so jemali tadalafil, vključujejo bolečine v hrbtu, bolečine v mišicah, zardevanje v obraz, zamašen nos, omotico, občutek razbijanja srca, bolečino v trebuhu in refluks.
Rare side effects in patients taking tadalafil include fainting, migraine and swelling of the face.
Redki neželeni učinki pri bolnikih, ki so jemali tadalafil vključujejo omedlevico, migreno in otekanje obraza.
In rare instances it is possible that a prolonged and possibly painful erection may occur after taking tadalafil.
23 V redkih primerih je možno, da se po zaužitju tadalafila pojavi podaljšana in morda boleča erekcija.
Heart attack and stroke have also been reported rarely in men taking tadalafil.
Pri moških, ki so jemali tadalafil, so redko poročali tudi o srčnem infarktu in možganski kapi.
It is not possible to determine whether these events were directly related to tadalafil.
Ni možno ugotoviti, ali so bili ti dogodki neposredno povezani s tadalafilom.
23 Partial, sudden, temporary, or permanent decrease or loss of vision in one or both eyes has been rarely reported.
Redko so poročali o delnem, nenadnem, začasnem ali trajnem poslabšanju ali izgubi vida na enem ali obeh očesih.
Some additional side effects have been reported in men taking tadalafil that were not seen in clinical trials and their incidence is unknown.
Pri moških, ki so jemali tadalafil so poročali o nekaterih dodatnih neželenih učinkih, ki jih niso opažali v kliničnih preskušanjih in njihova incidenca je neznana.
HOW TO STORE Tadalafil Lilly
SHRANJEVANJE ZDRAVILA Tadalafil Lilly
Do not use Tadalafil Lilly after the expiry date stated on the carton and blister.
Zdravila Tadalafil Lilly ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in pretisnem omotu.
What Tadalafil Lilly contains The active substance is tadalafil.
Kaj vsebuje zdravilo Tadalafil Lilly Zdravilna učinkovina je tadalafil.
What Tadalafil Lilly looks like and contents of the pack Tadalafil Lilly 20 mg comes as yellow film-coated tablets.
Izgled zdravila Tadalafil Lilly in vsebina pakiranja Zdravilo Tadalafil Lilly 20 mg so rumene filmsko obložene tablete.
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
25 Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na predstavništvo imetnika dovoljenja za promet z zdravilom:
Tel: + 420 234 664 111 Danmark Eli Lilly Danmark A/ S Tlf: +45 45 26 61 00 Deutschland Lilly Deutschland GmbH Tel. + 49-(0) 6172 273 2222 Eesti Eli Lilly Holdings Limited.
Tel: + 420 234 664 111 Danmark Eli Lilly Danmark A/ S Tlf: +45 45 26 61 00 Deutschland Lilly Deutschland GmbH Tel. + 49 - (0) 6172 273 2222 Eesti Eli Lilly Holdings Limited.
Eesti filiaal Tel: +372 6441100 Ελλάδα ΦΑΡΜΑΣΕΡΒ -ΛΙΛΛΥ Α .Ε .Β .Ε Τηλ: +30 210 629 4600 España Lilly, S. A.
Eesti filiaal Tel: +372 6441100 Ελλάδα ΦΑΡΜΑΣΕΡΒ- ΛΙΛΛΥ Α. Ε. Β. Ε Τηλ: +30 210 629 4600 España Lilly, S. A.
Tel: +43-(0) 1 711 780 Polska Eli Lilly Polska Sp. z o. o.
Tel: +43 - (0) 1 711 780 Polska Eli Lilly Polska Sp. z o. o.
France Lilly France S. A. S Tél.: +33-(0)1 55 49 34 34 Ireland Eli Lilly and Company (Ireland) Limited.
France Lilly France S. A. S Tél.: +33 - (0) 1 55 49 34 34 Ireland Eli Lilly and Company (Ireland) Limited.
Tel: + 421 220 663 111 Suomi/ Finland Oy Eli Lilly Finland Ab.
Tel: +421 220 663 111 Suomi/ Finland Oy Eli Lilly Finland Ab.
Tamiflu is a medicine that contains the active substance oseltamivir.
Tamiflu je zdravilo, ki vsebuje zdravilno učinkovino oseltamivir.
It is available as capsules (yellow:
Na voljo je v obliki kapsul (rumene:
30 mg; grey:
30 mg; sive:
45 mg; yellow and grey:
45 mg; rumene in sive:
75 mg) and as a powder to be made up into an oral suspension (12 mg/ ml).
75 mg) in praška za pripravo peroralne suspenzije (12 mg/ ml).
Tamiflu is used to treat or prevent influenza (‘ flu’) in adults and children over the age of one year: • in the treatment of flu, it can be used in patients who have the symptoms of flu, when the influenza virus is known to be circulating in the community. • in the prevention of flu, it can be used in patients who have been in contact with someone who has flu.
Zdravilo Tamiflu se uporablja za zdravljenje ali preprečevanje influence (gripe) pri odraslih in otrocih, starejših od enega leta: • pri zdravljenju gripe se lahko uporablja pri bolnikih, ki imajo simptome gripe, kadar je virus gripe prisoten v okolici; • pri preprečevanju gripe se lahko uporablja pri bolnikih, ki so bili v stiku z osebo, okuženo z gripo.
This is generally done on a case-by-case basis, but can be done in exceptional cases as a seasonal programme, for example when the flu vaccine may not be sufficient and there is a pandemic (a global epidemic of flu).
Načeloma se obravnava vsak posamezni primer posebej, v izjemnih primerih pa lahko tudi kot sezonsko preprečevanje, denimo, ko cepivo proti gripi morda ne bo zadostovalo in gre za pandemijo (vsesplošno epidemijo gripe).
In the treatment of flu, Tamiflu must be started within two days of the onset of symptoms.
Pri zdravljenju gripe je treba z jemanjem zdravila Tamiflu začeti v dveh dneh po pojavu simptomov.
It is given as one dose twice a day for five days.
Daje se v enem odmerku dvakrat na dan pet dni.
It is given as one dose once a day for at least 10 days after contact with an infected person.
Daje se v enem odmerku enkrat na dan vsaj 10 dni po stiku z okuženo osebo.
The dose of Tamiflu is 75 mg in adults and in children who weigh more than 40 kg.
Odmerek zdravila Tamiflu je 75 mg za odrasle in otroke, ki tehtajo več kot 40 kg.
For children who weigh less than 40 kg, the dose is adjusted according to their weight using the lower dose capsules (30 or 45 mg) or, for children who cannot swallow capsules, the oral suspension.
Pri otrocih, ki tehtajo manj kot 40 kg, je treba odmerek prilagoditi glede na njihovo telesno maso z uporabo kapsul z nižjim odmerkom (30 ali 45 mg), pri otrocih, ki kapsul ne morejo pogoltniti, pa uporabiti peroralno suspenzijo.
Tamiflu is not to be used in children under the age of one year.
Zdravilo Tamiflu se ne sme uporabljati pri otrocih, mlajših od enega leta.
The doses need to be lower in patients who have kidney problems.
Odmerke je treba ustrezno znižati pri bolnikih, ki imajo težave z ledvicami.
Reproduction is authorised provided the source is acknowledged. cannot spread.
Kako zdravilo Tamiflu deluje?
The effects of Tamiflu were first tested in experimental models before being studied in humans.
Učinki zdravila Tamiflu so bili najprej preskušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
In humans, Tamiflu has been compared with placebo (a dummy treatment) in studies in the treatment of flu (2,413 adults and adolescents, 741 elderly patients and 1,033 children).
V študijah zdravljenja gripe pri ljudeh (2 413 odraslih in mladostnikov, 741 starejših bolnikov in 1 033 otrok) so zdravilo Tamiflu primerjali s placebom (zdravilom brez zdravilne učinkovine).
The effectiveness was measured using a score card where patients recorded their symptoms (feeling feverish, muscle pain, headache, sore throat, cough, overall discomfort and runny nose).
Učinkovitost so merili z uporabo točkovalne kartice, kamor so bolniki beležili svoje simptome (vročina, bolečine v mišicah, glavobol, boleče žrelo, kašelj, splošno slabo počutje in izcedek iz nosu).
In the prevention of flu, Tamiflu was studied in patients who had been exposed to the disease when one of their family members contracted flu (962 cases) or during an epidemic (1,562 subjects aged between 16 and 65 years, and 548 elderly subjects in nursing homes).
Pri preprečevanju gripe so zdravilo Tamiflu proučevali pri bolnikih, ki so bili izpostavljeni bolezni, ko se je eden od družinskih članov okužil z gripo (962 primerov) ali med epidemijo (1 562 sodelujočih, starih od 16 do 65 let, ter 548 starejših ljudi v domovih starejših občanov).
The studies measured the number of cases of flu, proven by laboratory tests.
V študijah so merili število primerov gripe, dokazanih z laboratorijskimi preiskavami.
A study also looked at using Tamiflu in a family setting (277 families) for both the treatment of the person with flu, and the treatment or prevention of flu in those in contact with him or her.
V eni študiji so proučevali tudi uporabo zdravila Tamiflu v družinskem okolju (277 družin) tako za zdravljenje okuženih z gripo kot tudi za zdravljenje ali preprečevanje gripe pri tistih, ki so bili v stiku z okuženim članom družine.
In the treatment studies in adults, Tamiflu reduced the duration of the illness from 5.2 days for a patient taking placebo, to 4.2 days for a patient taking Tamiflu.
V študijah zdravljenja pri odraslih je zdravilo Tamiflu skrajšalo trajanje bolezni s 5, 2 dneva pri bolniku, ki je jemal placebo, na 4, 2 dneva pri bolniku, ki je jemal zdravilo Tamiflu.
The reduction in the length of the disease in children aged one to six years was 1.5 days.
Pri otrocih, starih od enega do šest let, se je trajanje bolezni skrajšalo za 1, 5 dneva.
In the prevention studies, Tamiflu reduced the incidence of flu among the people in contact with a flu sufferer.
V študijah preprečevanja je zdravilo Tamiflu zmanjšalo pogostost gripe pri ljudeh, ki so bili v stiku z osebo, obolelo za gripo.
In the study carried out during an epidemic, 1% of the people taking Tamiflu developed flu after contact, compared with 5% of those taking placebo.
V študiji, izvedeni med epidemijo, je 1% ljudi, ki so jemali Tamiflu, po stiku z okuženim zbolelo za gripo, v primerjavi s 5% tistih, ki so prejemali placebo.
In families with one person with flu, 7% of the family members in the household developed flu when receiving prevention with Tamiflu, compared with 20% with no prevention treatment.
V družinah z enim članom, obolelim za gripo, je 7% družinskih članov v gospodinjstvu zbolelo za gripo ob prejemanju preventivnega zdravljenja z zdravilom Tamiflu v primerjavi z 20% obolelih, ki niso prejemali preventivnega zdravljenja.
The most common side effects with Tamiflu in adults and adolescents (seen in more than 1 patient in 10) are headache and nausea (feeling sick).
Najpogostejša neželena učinka zdravila Tamiflu pri odraslih in mladostnikih (opažena pri več kot 1 bolniku od 10) sta glavobol in navzeja (slabost).
In children, the side effects seen in more than 1 patient in 10 are vomiting and diarrhoea.
Pri otrocih sta najpogostejša neželena učinka (opažena pri več kot 1 bolniku od 10) bruhanje in driska.
For the full list of all side effects reported with Tamiflu, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Tamiflu, glejte navodilo za uporabo.
Tamiflu should not be used in patients who may be hypersensitive (allergic) to oseltamivir or to any of the other ingredients.
Zdravila Tamiflu ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) oseltamivir ali katero koli drugo sestavino zdravila.
Why has Tamiflu been approved?
Zakaj je bil Tamiflu odobren?
Seasonal flu is normally handled using vaccination.
Sezonska gripa se običajno obvladuje s cepivom.
The Committee for Medicinal Products for Human Use (CHMP) decided that Tamiflu’ s benefits are greater than its risks for the treatment and prevention of influenza, as an additional method in case of a pandemic or when flu vaccines are not effective against the influenza virus causing the seasonal epidemic.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Tamiflu pri zdravljenju in preprečevanju gripe kot dodatna metoda v primeru pandemije ali kadar cepiva proti gripi niso učinkovita proti virusu influence, ki povzroča sezonsko epidemijo, večje od z njim povezanih tveganj.
The Committee recommended that Tamiflu be given marketing authorisation.
Odbor je priporočil, da se za zdravilo Tamiflu odobri dovoljenje za promet.
Other information about Tamiflu:
Druge informacije o zdravilu Tamiflu:
The European Commission granted a marketing authorisation valid throughout the European Union for Tamiflu to Roche Registration Limited on 20 June 2002.
Evropska komisija je dovoljenje za promet z zdravilom Tamiflu, veljavno po vsej Evropski uniji, odobrila družbi Roche Registration Limited dne 20. junija 2002.
The marketing authorisation was renewed on 20 June 2007.
Dovoljenje za promet z zdravilom je bilo obnovljeno dne 20. junija 2007.
The full EPAR for Tamiflu can be found here.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Tamiflu je na voljo tukaj.
EU/ 1/ 02/ 222/ 001
(koncentracija) EU/ 1/ 02/ 222/ 001
blister (PVC/ PE/ PVDC/ alu)
pretisni omot (PVC/ PE/ PVDC/ Alu)
Powder for oral suspension Capsule, hard Capsule, hard
prašek za peroralno suspenzijo
bottle (glass) blister (PVC/ PE/ PVDC/ alu) blister (PVC/ PE/ PVDC/ alu)
steklenica (steklo)
1 bottle 10 capsules 10 capsules
1 steklenica
Tamiflu 30 mg hard capsule.
Tamiflu 30 mg trde kapsule
Each hard capsule contains oseltamivir phosphate equivalent to 30 mg of oseltamivir.
Ena trda kapsula vsebuje 30 mg oseltamivirja v obliki oseltamivir fosfata.
Hard capsule The hard capsule consists of a light yellow opaque body bearing the imprint “ ROCHE” and a light yellow opaque cap bearing the imprint “ 30 mg”.
Trda kapsula ima svetlo rumeno neprozorno telo z napisom “ ROCHE ” in svetlo rumen neprozoren pokrov z napisom “ 30 mg ”.
Treatment of influenza In patients one year of age and older who present with symptoms typical of influenza, when influenza virus is circulating in the community.
Zdravljenje gripe Pri bolnikih, starih eno leto in več, ki imajo simptome, značilne za gripo, ko je virus influence prisoten v okolici.
This indication is based on clinical studies of naturally occurring influenza in which the predominant infection was influenza A (see section 5.1).
Ta indikacija temelji na kliničnih študijah gripe, ki se pojavlja naravno in pri kateri je bila glavna okužba gripa tipa A (glejte poglavje 5. 1).
- Post-exposure prevention in individuals one year of age or older following contact with a
- Preventiva po predhodni izpostavljenosti virusu pri posameznikih, starih eno leto ali več, ki so
clinically diagnosed influenza case when influenza virus is circulating in the community.
bili v stiku s klinično diagnosticirano gripo, ko je virus influence razširjen v okolici.
- The appropriate use of Tamiflu for prevention of influenza should be determined on a case by
- Primernost uporabe zdravila Tamiflu za preprečevanje gripe moramo določiti za vsak
case basis by the circumstances and the population requiring protection.
posamezen primer posebej, odvisno od okoliščin in skupine ljudi, ki potrebuje zaščito.
In exceptional situations (e. g., in case of a mismatch between the circulating and vaccine virus strains, and a pandemic situation) seasonal prevention could be considered in individuals one year of age or older.
V izjemnih primerih (npr. pojav virusa, proti kateremu cepivo ne učinkuje, ali pri pandemiji) ga lahko pri posameznikih, starih eno leto ali več, uporabimo kot sezonsko preventivo.
Decisions regarding the use of antivirals for treatment and prophylaxis should take into consideration what is known about the characteristics of the circulating influenza viruses and the impact of the disease in different geographical areas and patient populations.
Pri odločitvi glede uporabe protivirusnih zdravil za zdravljenje in preprečevanje gripe je treba upoštevati vse, kar je znanega o značilnostih krožečih virusov gripe in vplivu bolezni na različnih geografskih območjih in na različne skupine bolnikov.
Tamiflu capsules and Tamiflu suspension are bioequivalent formulations.
Kapsule zdravila Tamiflu in suspenzija zdravila Tamiflu sta bioekvivalentni obliki.
75 mg doses can be administered as either
75- mg odmerek lahko damo kot
- one 75 mg capsule or
- eno 75- mg kapsulo ali
- one 30 mg capsule plus one 45 mg capsule or
- eno 30- mg kapsulo in eno 45- mg kapsulo ali
- by administering one 30 mg dose plus one 45 mg dose of suspension.
- z dajanjem enega 30- mg odmerka in enega 45- mg odmerka suspenzije.