natgillin/translations-raw huggingface dataset:
The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
· Načrt za obvladovanje tveganja (RMP) Imetnik dovoljenja za promet z zdravilom bo izvedel zahtevane farmakovigilančne aktivnosti in ukrepe, podrobno opisane v sprejetem RMP, predloženem v modulu 1.8.2 dovoljenja za promet z zdravilom, in vseh nadaljnjih sprejetih posodobitvah RMP.
Look at the right column to check the number of capsules you will need to give the patient for a single dose.
V stolpcu na desni strani preverite, koliko kapsul boste potrebovali za bolnika za en odmerek.
Give the whole contents of the second bowl (Tamiflu liquid mixture with sweet food added) to the child straight away.
Takoj dajte celotno vsebino druge posode (zdravilo Tamiflu v obliki tekočine z dodano sladko hrano) otroku.
You now have a bottle of Tamiflu oral suspension ready to measure out a dose.
Sedaj imate steklenico s peroralno suspenzijo zdravila Tamiflu pripravljeno in lahko odmerite odmerek.
Step 3: Choose the correct amount for your child's weight Look up the child's weight on the left side of the table.
Korak 3: izberite ustrezno količino glede na otrokovo maso Poiščite otrokovo telesno maso na levi strani preglednice.
• If you need smaller doses, making liquid Tamiflu from capsules involves extra steps.
· Kadar potrebujete manjše odmerke, priprava zdravila Tamiflu v obliki tekočine iz kapsul vključuje dodatne korake.
Stage 2 Measure and give the correct dose
Faza 2 Odmerite in dajte pravi odmerek
Exposure does not exceed that for treatment of infants < 1 year (3 mg/kg twice daily) and is anticipated to result in a comparable safety profile (see Section 4.8).
Izpostavljenost ne presega izpostavljenosti, dosežene pri zdravljenju dojenčkov, mlajših od 1 leta (3 mg/kg dvakrat dnevno), in pričakujemo lahko primerljiv varnostni profil (glejte poglavje 4.8).
On the basis of drug exposure and tolerability, dosage adjustments are not required for older people unless there is evidence of moderate or severe renal impairment (creatinine clearance below 60 ml /min) (see section 4.2).
Na podlagi izpostavljenosti zdravilu in prenosljivosti prilagajanje odmerkov pri starejših ljudeh ni potrebno, razen v primerih zmerne ali hude ledvične okvare (kreatininski očistek pod 60 ml/min) (glejte poglavje 4.2).
Or you can make sugar water: mix a teaspoon of water with three-quarters (3/4) of a teaspoon of sugar.
Lahko pa pripravite sladkano vodo: zmešajte čajno žličko vode s tričetrtine (3/4) čajne žličke sladkorja.
Tamiflu should be used for the treatment and prevention of influenza only when reliable epidemiological data indicate that influenza virus is circulating in the community.
Zdravilo Tamiflu uporabimo za zdravljenje ali preprečevanje gripe le, kadar zanesljivi epidemiološki podatki kažejo na prisotnost virusa influence v okolici.
Incidence of Oseltamivir Resistance in Clinical Studies
Incidenca odpornosti na oseltamivir v kliničnih študijah
Add all 55 ml of water into the bottle, recap the bottle and shake the closed bottle well for 15 seconds.
Dodajte vseh 55 ml vode v steklenico, jo ponovno zaprite in 15 sekund močno pretresajte.
What Tamiflu is and what it is used for
Kaj je zdravilo Tamiflu in za kaj ga uporabljamo
Patients who are unable to swallow capsules:
Bolniki, ki kapsul ne morejo pogoltniti:
Preventing flu: dose for 10 days
Preprečevanje gripe: odmerjanje za 10 dni
137.5 ml (or 150 ml)*
137,5 ml (ali 150 ml)*
Whereas very high oral single doses of oseltamivir phosphate salt, up to the highest dose tested (1,310 mg/kg), had no adverse reactions in adult rats, such doses resulted in toxicity in juvenile 7-dayold rat pups, including death.
Medtem ko zelo veliki peroralni enkratni odmerki soli oseltamivirjevega fosfata, do najvišjega preizkušenega odmerka (1310 mg/kg), nimajo neželenih učinkov pri odraslih podganah, so taki odmerki povzročili zastrupitve pri mladih, 7 dni starih podganah, vključno s smrtjo.
Table 1 Adverse reactions in studies investigating Tamiflu for treatment and prevention of influenza in adults and adolescents or through post-marketing surveillance
Preglednica 1 Neželeni učinki v študijah, ki so proučevale zdravilo Tamiflu za zdravljenje in preprečevanje gripe pri odraslih in mladostnikih ali pri spremljanju zdravila po prihodu na trg
The safety profile of Tamiflu observed in this study was consistent with that observed in previous clinical trials where Tamiflu was administered for treatment of influenza in non-immunocompromised patients (otherwise healthy patients or “at risk” patients [i.e., those with respiratory and/or cardiac comorbidities]).
Varnostni profil zdravila Tamiflu v tej študiji se je skladal z ugotovljenim v predhodnih kliničnih preskušanjih, pri katerih so zdravilo Tamiflu uporabljali za zdravljenje gripe pri imunsko neogroženih bolnikih (sicer zdravi bolniki ali “ogroženi” bolniki [npr. tisti z respiratornimi in/ali srčnimi soobolenji)].
Remove the dispenser from the bottle.
Odstranite odmernik iz steklenice.
Pharmacotherapeutic group: Antivirals for systemic use, neuraminidase inhibitors ATC code: J05AH02
Farmakoterapevtska skupina: Zdravila za sistemsko zdravljenje virusnih infekcij, zaviralci nevraminidaze, oznaka ATC: J05AH02.
To allow for accurate volume withdrawal of up to 10 doses (2 withdrawals per daily treatment dose for 5 days), the column indicating measurement loss is to be considered for compounding.
Da bi omogočili natančen odvzem volumna za 10 odmerkov (2 odvzema za dnevni odmerek zdravljenja za 5 dni), je treba pri pripravi upoštevati podatke v stolpcu, kjer je izguba pri odmerjanju upoštevana.
Stop taking Tamiflu and contact a doctor or pharmacist immediately.
Prenehajte jemati zdravilo Tamiflu in takoj obvestite zdravnika ali farmacevta.
Reports of overdoses with Tamiflu have been received from clinical trials and during post-marketing experience.
Poročila o prevelikem odmerjanju z zdravilom Tamiflu so bila prejeta iz kliničnih preskušanj in po prihodu zdravila na trg.
Patient Population
Populacija bolnikov
Before you take Tamiflu, make sure your prescribing doctor knows if you have hereditary fructose intolerance.
Preden boste vzeli zdravilo Tamiflu, obvestite zdravnika, če imate dedno intoleranco za fruktozo.
Treatment Dose (for 5 days)
Odmerek za zdravljenje (za 5 dni)
• Conditions or Restrictions with Regard to the Safe and Effective Use of the Medicinal Product
· Pogoji ali omejitve v zvezi z varno in učinkovito uporabo zdravila
If there is some mixture left in the bowl, rinse the bowl with a small amount of water and get the patient to drink it all.
Če je v posodi ostalo še nekaj mešanice, posodo sperite z majhno količino vode, bolnik pa naj jo v celoti popije.
If there is anything left in the second bowl, rinse the bowl with a small amount of water and get the child to drink it all.
Če je v drugi posodi še kaj ostalo, posodo sperite z majhno količino vode, otrok pa naj jo v celoti popije.
• Mild to severe liver function disorders
· blaga do huda motnja jetrnih funkcij,
• Ear inflammation and other ear disorders
· vnetje ušes in ostale ušesne bolezni,
A total of 1473 children (including otherwise healthy children aged 1-12 years old and asthmatic children aged 6-12 years old) participated in clinical studies of oseltamivir given for the treatment of influenza.
Skupno 1473 otrok (vključujoč drugače zdrave otroke, stare 1-12 let, in otroke z astmo stare 6-12 let) je sodelovalo v kliničnih študijah, kjer je bil oseltamivir dan za zdravljenje gripe.
Amount of Tamiflu suspension
Količina suspenzije Tamiflu
The appropriate dispenser sizes for taking the correct volume of Tamiflu suspension (6 mg/ml) are shown below.
Ustrezne velikosti odmernikov za odvzem pravilnega volumna suspenzije zdravila Tamiflu (6 mg/ml) so navedene spodaj.
You must use the amount of Tamiflu prescribed by the doctor.
Jemati morate toliko zdravila Tamiflu, kot vam je predpisal zdravnik.
Oseltamivir-resistant viruses isolated from oseltamivir-treated patients and oseltamivir-resistant laboratory strains of influenza viruses have been found to contain mutations in N1 and N2 neuraminidases.
Virusi, odporni na oseltamivir, ki so jih izolirali iz bolnikov, zdravljenih z oseltamivirjem, in laboratorijski sevi virusa gripe, odporni na oseltamivir, so imeli mutacije v N1 in N2 nevraminidazah.
The safety profile reported in subjects who received the recommended dose of Tamiflu for prophylaxis (75 mg once daily for up to 6 weeks) was qualitatively similar to that seen in the treatment studies, despite a longer duration of dosing in the prophylaxis studies.
Varnostni profil, katerega so poročali pri osebah, ki so prejele priporočeni odmerek zdravila Tamiflu za preprečevanje (75 mg enkrat na dan do 6 tednov), je kakovostno podoben tistemu, ki so ga opazili v študijah zdravljenja, kljub dolgotrajnemu odmerjanju v študijah preprečevanja.
Patients who are unable to swallow capsules
Bolniki, ki kapsul ne morejo pogoltniti
Tamiflu has no influence on the ability to drive and use machines.
Zdravilo Tamiflu nima vpliva na sposobnost vožnje in upravljanja strojev.
Driving and using machines Tamiflu has no effect on your ability to drive or use machines.
Vpliv na sposobnost upravljanja vozil in strojev Zdravilo Tamiflu nima vpliva na vašo sposobnost vožnje in upravljanja strojev.
Adverse events reported following overdose were similar in nature and distribution to those observed with therapeutic doses of Tamiflu, described in section 4.8 Undesirable effects.
Neželeni dogodki, o katerih so poročali po prevelikem odmerjanju, so bili po naravi in pogostnosti podobni tistim, ki so jih opazili pri terapevtskih odmerkih zdravila Tamiflu, opisanih v poglavju 4.8
• The active substance is oseltamivir (6 mg/ml oseltamivir after reconstitution).
· Učinkovina je oseltamivir (6 mg/ml oseltamivirja po rekonstituciji).
• Water
· vodo,
• phenylbutazone (used to treat pain and inflammation)
· fenilbutazon (uporablja se za zdravljenje bolečine in vnetij),
The NNT in this study was 28 (95 % CI 24 - 50).
NNT v tej študiji je bil 28 (95-% interval zaupanja 24-50).
Such neuropsychiatric events have also been reported in patients with influenza who were not taking Tamiflu.
O takih nevropsihiatričnih dogodkih so poročali tudi pri bolnikih z gripo, ki niso jemali zdravila Tamiflu.
The suspension is caused by some of the excipients of Tamiflu capsules, which are insoluble.)
Suspenzijo tvorijo nekatere pomožne snovi zdravila Tamiflu kapsule, ki so netopne.)
• Shake the bottle
· Pretresite steklenico
The MAH shall agree the communication plan for the DHPC letter with the National Competent Authority in the Member States where the letter will be distributed.
Imetnik dovoljenja za promet se mora dogovoriti z nacionalnim pristojnim organom za zdravila glede komunikacijskega načrta v zvezi z DHPC obvestilom v vseh državah, kjer bo obvestilo razposlano.
• If you have further questions, ask your doctor or pharmacist.
· Če imate dodatna vprašanja, se posvetujte z zdravnikom ali farmacevtom.
The signs of flu often include a sudden fever (more than 37.8 °C), cough, runny or stuffy nose, headaches, muscle aches and extreme tiredness.
Pogosti znaki gripe so nenadno zvišanje telesne temperature (več kot 37,8 oC), kašelj, zamašen nos ali izcedek iz nosu, glavoboli, bolečine v mišicah in huda utrujenost.
In general, the adverse reaction profile in children with pre-existing bronchial asthma was qualitatively similar to that of otherwise healthy children.
Otroci s predhodno bronhialno astmo V splošnem je bil profil neželenih učinkov pri otrocih s predhodno bronhialno astmo kakovostno podoben tistemu pri drugače zdravih otrocih.
For children unable to drink from a bowl, spoon-feed or use a bottle to feed the child the remaining liquid.
Otrokom, ki ne morejo piti iz posode, dajte preostalo tekočino po žlici ali uporabite stekleničko.
Infants less than 1 year (0 to 12 months)
Dojenčki, mlajši od 1 leta (0-12 mesecev)
Pharmacokinetic properties of oseltamivir, such as low protein binding and metabolism independent of the CYP450 and glucuronidase systems (see section 5.2), suggest that clinically significant drug interactions via these mechanisms are unlikely.
Farmakokinetične lastnosti oseltamivirja, kot sta majhna vezava na beljakovine in presnova, ki je neodvisna od sistema CYP450 in glukoronidaznih sistemov (glejte poglavje 5.2), nakazujejo, da klinično pomembna medsebojna delovanja z drugimi zdravili na osnovi omenjenih mehanizmov niso verjetna.
If you take more Tamiflu than you should
Če ste vzeli večji odmerek zdravila Tamiflu, kot bi smeli
Tamiflu is not a vaccine: it treats infection, or prevents the flu virus spreading.
Zdravilo Tamiflu ni cepivo: zdravi okužbo, ali prepreči širjenje virusa gripe.
Tamiflu will not change the effectiveness of a flu vaccine, and you might be prescribed both by your doctor.
Zdravilo Tamiflu ne vpliva na učinkovitost cepiva proti gripi, torej vam zdravnik lahko predpiše oboje.
Psychiatric disorders and nervous system disorders Influenza can be associated with a variety of neurologic and behavioural symptoms which can include events such as hallucinations, delirium, and abnormal behaviour, in some cases resulting in fatal outcomes.
Psihiatrične motnje in bolezni živčevja Gripa je lahko povezana s številnimi nevrološkimi in vedenjskimi simptomi, ki lahko vključujejo dogodke, kot so halucinacije, delirij, nenavadno vedenje, in so v nekaterih primerih lahko tudi smrtni.
This is based upon clinical data in infants and children 1 year of age or older and adults showing that a prophylaxis dose equivalent to half the daily treatment dose is clinically efficacious for the prevention of influenza.
To temelji na kliničnih podatkih pri dojenčkih in otrocih, starih 1 leto ali več, in odraslih, ki kažejo, da je odmerek, ki je ekvivalenten polovici dnevnega odmerka za zdravljenje pri preprečevanju gripe,
See the second set of instructions.
Glejte drugi del navodil.
Patients who are unable to swallow capsules may receive appropriate doses of Tamiflu suspension.
Bolniki, ki ne morejo pogoltniti kapsul, lahko dobijo ustrezne odmerke suspenzije zdravila Tamiflu.
Always use the oral dispenser provided with your medicine to measure a correct dose.
Vedno uporabite peroralni odmernik, ki je priložen zdravilu, da odmerite pravilni odmerek.
• Tamiflu is used for adults, adolescents, children and infants (including full-term newborn babies) for treating flu (influenza).
· Zdravilo Tamiflu se uporablja pri odraslih, mladostnikih, otrocih in dojenčkih (vključno z donošenimi novorojenčki) za zdravljenje gripe (influence).
What Tamiflu is and what it is used for What you need to know before you take Tamiflu How to take Tamiflu
Kaj je zdravilo Tamiflu in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Tamiflu Kako jemati zdravilo Tamiflu
Take Tamiflu as soon as possible, ideally within two days of the flu symptoms starting.
Zdravilo Tamiflu začnite jemati čim prej, najbolje v dveh dneh po pojavu simptomov gripe.
One bottle of reconstituted suspension (65 ml) contains 390 mg of oseltamivir.
Ena steklenica pripravljene suspenzije (65 ml) vsebuje 390 mg oseltamivirja.
Amount of oral suspension to withdraw
Količina peroralne suspenzije za odvzem
Open a second capsule for a 60 mg dose.
Za pripravo 60-mg odmerka odprite tudi drugo kapsulo.
Therefore, prescribers should take into account the most recent information available on oseltamivir susceptibility patterns of the currently circulating viruses when deciding whether to use Tamiflu.
Zato morajo zdravniki pri predpisovanju zdravila Tamiflu upoštevati najnovejše razpoložljive informacije o občutljivosti vzorcev trenutno krožečega virusa na oseltamivir.
• Two small bowls (use separate pairs of bowls for each child)
(za vsakega otroka uporabljajte ločen par posod),
Transfer the suspension to an amber glass or amber polyethyleneterephthalate (PET) bottle.
Suspenzijo prenesite v steklenico iz jantarjevega stekla ali plastenko iz jantarjevega polietilentereftalata (PET).
Close the bottle tightly with the cap (on the top of the bottle adapter).
S pokrovčkom tesno zaprite steklenico (na vrh nastavka za steklenico).
Infants less than 1 year of age: The pharmacokinetics, pharmacodynamics and safety of Tamiflu have been evaluated in two uncontrolled open-label studies including influenza infected children less than one year of age (n=135).
Dojenčki, mlajši od 1 leta: farmakokinetika, farmakodinamika in varnost zdravila Tamiflu je bila ovrednotena v dveh odprtih kliničnih študijah brez kontrolne skupine, ki sta vključevali z gripo okužene otroke, mlajše od 1 leta (n = 135).
In patients with influenza who were receiving Tamiflu, there have been postmarketing reports of convulsions and delirium (including symptoms such as altered level of consciousness, confusion, abnormal behaviour, delusions, hallucinations, agitation, anxiety, nightmares), in a very few cases resulting in self-injury or fatal outcomes.
Pri bolnikih z gripo, ki so prejemali zdravilo Tamiflu, so po prihodu zdravila na trg poročali o konvulzijah in deliriju (vključno s simptomi, kot so spremenjena raven zavesti, zmedenost, nenavadno vedenje, prividi, halucinacije, agitacija, aksioznost, more), ki je v zelo redkih primerih vodil do samopoškodbe ali smrti.
• Tamiflu can also be prescribed for adults, adolescents, children and infants above 1 year of age for preventing flu, on a case-by-case basis - for instance, if you have been in contact with someone who has flu.
· Zdravilo Tamiflu se lahko predpiše odraslim, mladostnikom, otrokom in dojenčkom, starejšim od 1 leta, tudi za preprečevanje gripe, odvisno od primera do primera - na primer, če ste bili v stiku z osebo, ki ima gripo.
Slowly pull out the plunger to draw medicine into the dispenser.
Počasi izvlecite bat, da odvzamete zdravilo v odmernik.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 20 June 2002
Datum prve odobritve: 20. junij 2002 Datum zadnjega podaljšanja: 22. maj 2012
Tamiflu is indicated in adults and children including full term neonates who present with symptoms typical of influenza, when influenza virus is circulating in the community.
Zdravilo Tamiflu je indicirano pri odraslih in otrocih, vključno z donošenimi novorojenčki, ki imajo simptome, značilne za gripo, ko je virus influence prisoten v okolici.
Titanium dioxide (E171) FD and C Blue 2 (indigo carmine, E132)
Tiskarsko črnilo šelak titanov dioksid (E171) FD in C modro 2 (indigo karmin, E132)
In a double blind study for the treatment of influenza, a total of 199 adult immunocompromised patients (evaluable for safety) were randomized to receive Tamiflu for 10 days: 98 patients received the standard dose (75 mg twice daily) and 101 patients received the double dose (150 mg twice daily).
V dvojno slepi študiji zdravljenja gripe so skupno randomizirali 199 odraslih imunsko ogroženih bolnikov (ocenljivih glede varnosti), ki so prejemali zdravilo Tamiflu 10 dni: 98 bolnikov je prejemalo običajni odmerek (75 mg dvakrat na dan), 101 bolnik pa je prejemal dvojni odmerek (150 mg dvakrat na dan).
Tamiflu hard capsules and Tamiflu suspension are bioequivalent formulations.
Trde kapsule zdravila Tamiflu in suspenzija zdravila Tamiflu sta bioekvivalentni obliki.
Doses of 2 mg/kg give oseltamivir carboxylate exposures comparable to those achieved in adults receiving a single 75 mg dose (approximately 1 mg/kg).
Pri odmerku 2 mg/kg je izpostavljenost oseltamivir karboksilatu primerljiva z izpostavljenostjo, ki jo dosežemo pri odraslih, ki prejmejo enkratni odmerek 75 mg (približno 1 mg/kg).
In addition, 199 immunocompromised adult patients received Tamiflu for the treatment of influenza and 475 immunocompromised patients (including 18 children, of these 10 Tamiflu and 8 placebo) received Tamiflu or placebo for the prophylaxis of influenza.
Poleg tega je 199 odraslih imunsko ogroženih bolnikov prejemalo zdravilo Tamiflu za zdravljenje gripe in 475 imunsko ogroženih bolnikov (vključno z 18 otroki, od tega jih je 10 prejemalo zdravilo Tamiflu in 8 placebo) prejemalo zdravilo Tamiflu ali placebo za preprečevanje gripe.
The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
· Redno posodobljena poročila o varnosti zdravila (PSUR) Zahteve glede predložitve rednega posodobljenega poročila o varnosti zdravila za to zdravilo so določene v seznamu referenčnih datumov EU (seznamu EURD), opredeljenem v členu 107c(7)
Titanium dioxide (E171)
titanov dioksid (E171)
• Skin reactions (inflammation of the skin, red and itchy rash, scaling skin).
· kožne reakcije (vnetje kože, rdeč in srbeč izpuščaj, luščenje kože).
See the first set of instructions.
Glejte prvi del navodil.
After reconstitution with 55 ml of water, the usable volume of oral suspension allows for the retrieval of a total of 10 doses of 30 mg oseltamivir.
Po rekonstituciji s 55 ml vode je uporaben volumen peroralne suspenzije za 10 odmerkov po 30 mg oseltamivirja.
• Close the bottle, keep it safe Put the cap back on the bottle.
· Zaprite steklenico in jo shranite na varno Zaporko pritrdite nazaj na steklenico.
It is recommended that Tamiflu powder for oral suspension be constituted by a pharmacist prior to dispensing to the patient (see section 6.6).
Priporočljivo je, da peroralno suspenzijo zdravila Tamiflu pripravi farmacevt, preden zdravilo izda bolniku (glejte poglavje 6.6).
Measure 55 ml of water by filling the measuring cup to the indicated level (measuring cup included in the box).
Odmerite 55 ml vode, tako da jo napolnite v merilno čašo do označenega nivoja (merilna čaša je priložena v škatli).
Infants (<1year) * Full genotyping was not performed in all studies.
odrasli in mladostniki otroci (1-12 let) dojenčki (< 1 leto) * Popolne genotipizacije v vseh študijah niso izvedli.
Based on preclinical data, there is no evidence that Tamiflu has an effect on male or female fertility (see section 5.3).
Glede na predklinične podatke, ni dokazov, da bi zdravilo Tamiflu vplivalo na plodnost moških ali žensk (glejte poglavje 5.3).
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT The volume of the reconstituted suspension is 65 ml 1 ml contains 6 mg oseltamivir
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT Volumen rekonstituirane suspenzije je 65 ml 1 ml vsebuje 6 mg oseltamivirja
Then turn the whole unit upside down (bottle and dispenser together).
Vse skupaj (steklenico in odmernik) obrnite od zgoraj navzdol.
Check the cap is secure, and then shake the bottle of Tamiflu oral suspension.
Preverite, da je zaporka pritrjena in nato pretresite steklenico peroralne suspenzije zdravila Tamiflu.
Shake the bottle well for 15 seconds.
Steklenico ponovno zaprite z zaporko in dobro stresajte 15 sekund.
In pre- and post-natal rat studies, prolonged parturition was noted at 1,500 mg/kg/day: the safety margin between human exposure and the highest no-effect dose (500 mg/kg/day) in rats is 480-fold for oseltamivir and 44-fold for the active metabolite, respectively.
V pre- in postnatalnih študijah pri podganah so pri odmerku 1500 mg/kg/dan opazili podaljšan porod: varnostno razmerje med izpostavljenostjo pri ljudeh in največjim odmerkom, ki ni povzročil omenjenega neželenega učinka (500 mg/kg/dan) pri podganah, je 480-krat večje za oseltamivir in 44krat večje za aktivni presnovek.
This procedure describes the preparation of a 6 mg/ml suspension that will provide one patient with enough medication for a 5-day course of treatment or a 10-day course of prophylaxis.
Postopek opisuje pripravo 6 mg/ml suspenzije, ki enemu bolniku zadošča za 5-dnevni potek zdravljenja ali 10-dnevni potek preprečevanja bolezni.
Tamiflu is not a substitute for influenza vaccination.
Zdravilo Tamiflu ni nadomestilo cepljenja proti gripi.