FrancophonIA/ELRC3.0 huggingface dataset:
English: Oseltamivir significantly reduced the incidence of clinical influenza illness occurring in the contacts of confirmed influenza cases from 24/200 (12 %) in the placebo group to 2/205 (1 %) in the oseltamivir group (92 % reduction [95 % CI 6 - 16; p ≤ 0.0001]).
Slovenian: V skupini, ki je jemala oseltamivir, je bila pogostnost pojava klinične gripe, ki se je pojavila po stiku z bolniki, okuženimi z virusom influence, pomembno zmanjšana (2/205 (1 %) v primerjavi s placebo skupino (24/200 (12 %)) (92-% zmanjšanje [95-% interval zaupanja 6-16; p ≤ 0,0001]).
English: 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”.
Slovenian: Trda kapsula ima svetlo rumeno neprozorno telo z napisom “ROCHE” in svetlo rumen neprozoren pokrov z napisom “30 mg”.
English: Teratology studies have been conducted in rats and rabbits at doses of up to 1,500 mg/kg/day and 500 mg/kg/day, respectively.
Slovenian: Študije teratogenosti pri podganah, ki so prejemale odmerke do 1500 mg/kg/dan, in pri kuncih, ki so prejemali odmerke do 500 mg/kg/dan, niso pokazale vplivov na razvoj zarodka.
English: • If you have the right capsule strength for the dose needed (a 75 mg dose), you will open the capsule and stir its contents into one teaspoon (or less) of a suitable sweetened food product.
Slovenian: Priprava tekočega zdravila Tamiflu doma · Če imate na voljo ustrezne kapsule za odmerek, ki ga potrebujete (75-mg odmerek), boste kapsulo odprli in vsebino vmešali v eno čajno žličko (ali manj) primerne sladke hrane.
English: Tamiflu 75 mg hard capsules
Slovenian: Tamiflu 75 mg trde kapsule
English: A 3 ml oral dispenser (graduated in 0.1 ml steps) should be used for dosing infants less than 1 year old requiring 1 to 3 ml of Tamiflu oral suspension.
Slovenian: Za odmerjanje dojenčkom, mlajšim od 1 leta, ki potrebujejo 1 do 3 ml peroralne suspenzije Tamiflu, je potrebno uporabiti 3-ml peroralni odmernik (z oznakami po 0,1 ml).
English: • Sore throat
Slovenian: boleče grlo,
English: The hard capsule consists of a grey opaque body bearing the imprint “ROCHE” and a light yellow opaque cap bearing the imprint “75 mg”.
Slovenian: Trda kapsula ima sivo neprozorno telo z napisom “ROCHE” in svetlo rumen neprozoren pokrov z napisom “75 mg”.
English: Use the larger dispenser to draw up 12.5 ml water.
Slovenian: s katerim boste odmerili 12,5 ml vode.
English: The indication in infants below the age of 1 is based upon extrapolation of efficacy data from older children and the recommended posology is based upon pharmacokinetic modelling data (see Section
Slovenian: Indikacija pri dojenčkih, mlajših od 1 leta, temelji na ekstrapolaciji podatkov o učinkovitosti pri starejših otrocih.
English: Treatment of influenza: Dose adjustment is recommended for adults and adolescents (13 to 17 years of age) with moderate or severe renal impairment.
Slovenian: Zdravljenje gripe: prilagajanje odmerkov je priporočljivo za odrasle in mladostnike (stare od 13 do 17
English: NAME OF THE MEDICINAL PRODUCT Tamiflu 6 mg/ml powder for oral suspension Oseltamivir
Slovenian: IME ZDRAVILA Tamiflu 6 mg/ml prašek za peroralno suspenzijo oseltamivir
English: Patients with Resistance Mutations (%) Phenotyping* Geno- and Phenotyping* Adults and adolescents 0.88% (21/2377)
Slovenian: Bolniki z virusnimi sevi, odpornimi na oseltamivir (%) Fenotipizacija* Genotipizacija in fenotipizacija*
English: • Anaphylactic and anaphylactoid reactions: severe allergic reactions, with face and skin swelling, itchy rashes, low blood pressure and breathing difficulties
Slovenian: · anafilaktične in anafilaktoidne reakcije: hude alergijske reakcije z otekanjem obraza in kože,
English: There is insufficient clinical data available in infants and children (1 year of age or older) with renal impairment to be able to make any dosing recommendation (see sections 4.2 and 5.2).
Slovenian: Zadostnih kliničnih podatkov za pripravo priporočil o odmerjanju pri dojenčkih in otrocih (starih 1 leto ali več) z ledvično okvaro ni na voljo (glejte poglavji
English: Respiratory, thoracic and mediastinal disorders
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora kašelj,
English: In households of influenza-infected index cases, there was a reduction in the incidence of influenza from 26 % (23/89) in the group not receiving prevention to 11 % (9/84) in the group receiving prevention (58.5 % reduction [95 % CI 15.6 - 79.6; p = 0.0114]).
Slovenian: V gospodinjstvu s kliničnimi simptomi gripe je bilo znižanje pojavnosti influence iz 26 % (23/89) v skupini, ki ni prejemala zdravila za preprečevanje, na 11 % (9/84) v skupini, ki je prejemala zdravilo za preprečevanje (58,5-% znižanje [95-% interval zaupanja
English: 10.0 ml twice daily 10.0 ml once daily
Slovenian: 10 ml dvakrat na dan 10 ml enkrat na dan
English: • Vomiting.
Slovenian: • siljenje na bruhanje,
English: 7.5 ml once daily
Slovenian: 7,5 ml enkrat na dan
English: Tamiflu 45 mg hard capsules
Slovenian: Tamiflu 45 mg trde kapsule
English: The hard capsule consists of a grey opaque body bearing the imprint “ROCHE” and a grey opaque cap bearing the imprint “45 mg”.
Slovenian: Trda kapsula ima sivo neprozorno telo z napisom “ROCHE” in siv neprozoren pokrov z napisom “45 mg”.
English: • Prepare the oral dispenser
Slovenian: · Pripravite peroralni odmernik
English: 12.5 ml once daily
Slovenian: 12,5 ml enkrat na dan
English: • The other ingredients are: capsule contents: pregelatinised starch, talc, povidone, croscarmellose sodium and sodium stearyl fumarate capsule shell: gelatin, yellow iron oxide (E172), red iron oxide (E172), black iron oxide (E172) and titanium dioxide (E171) printing ink: shellac (E904), titanium dioxide (E171) FD and C Blue 2 (indigo carmine E132).
Slovenian: • Pomožne snovi so: vsebina kapsule: predgelirani škrob, smukec, povidon, natrijev premrežen karmelozat in natrijev stearilfumarat; ovojnica kapsule: želatina, rumeni železov oksid (E172), rdeči železov oksid (E172), črni železov oksid (E172) in titanov dioksid (E171); barvilo za tisk: šelak (E904), titanov dioksid (E171) in FD in C modro 2 (indigotin E132).
English: Prevention during an influenza epidemic in the community Prevention during an influenza epidemic has not been studied in children below 12 years of age.
Slovenian: Preprečevanje gripe med epidemijo v okolici Preprečevanje gripe med epidemijo v okolici ni bilo preučevano pri otrocih, mlajših od 12 let.
English: Treatment: The recommended oral dose is 75 mg oseltamivir twice daily for 5 days for adolescents (13 to 17 years of age) and adults.
Slovenian: Zdravljenje: priporočeni peroralni odmerek za mladostnike (stare od 13 do 17 let) in odrasle je 75 mg oseltamivirja dvakrat na dan 5 dni.
English: Stevens-Johnson syndrome, Toxic epidermal necrolysis
Slovenian: toksična epidermalna nekroliza
English: You must tell your doctor if you are breast-feeding so that your doctor can decide if Tamiflu is right for you.
Slovenian: Če dojite, obvestite zdravnika, ki bo odločil o tem, ali boste prejeli zdravilo Tamiflu ali ne.
English: According to subgroup analysis in children at 1 to 12 years of age, the incidence of laboratoryconfirmed clinical influenza among children was significantly reduced from 19 % (21/111) in the group not receiving prevention to 7 % (7/104) in the group receiving prevention (64.4 % reduction [95 % CI 15.8 - 85.0; p = 0.0188]).
Slovenian: Glede na analizo podskupin pri otrocih, starih od 1 do 12 let, je bila pojavnost klinične laboratorijsko potrjene influence med otroci značilno zmanjšana iz 19 % (21/111) v skupini, ki ni prejemala zdravila za preprečevanje, na 7 % (7/104) v skupini, ki je prejemala zdravilo za preprečevanje gripe (64,4-%
English: Black iron oxide (E172) Titanium dioxide (E171)
Slovenian: Tiskarsko črnilo šelak titanov dioksid (E171)
English: • The other ingredients are: capsule contents: pregelatinised starch, talc, povidone, croscarmellose sodium and sodium stearyl fumarate capsule shell: gelatin, yellow iron oxide (E172), red iron oxide (E172) and titanium dioxide (E171) printing ink: shellac (E904), titanium dioxide (E171) and FD and C Blue 2 (indigo carmine E132).
Slovenian: · Pomožne snovi so: vsebina kapsule: predgelirani škrob, smukec, povidon, natrijev premrežen karmelozat in natrijev stearilfumarat; ovojnica kapsule: želatina, rumeni železov oksid (E172), rdeči železov oksid (E172) in titanov dioksid (E171); barvilo za tisk: šelak (E904), titanov dioksid (E171) in FD in C modro 2 (indigotin E132).
English: 1.8 ml twice daily 1.8 ml once daily 3 ml
Slovenian: 1,8 ml enkrat na dan 1,2 ml enkrat na dan 3 ml
English: upper abdominal pain), Dyspepsia, Nausea
Slovenian: Bolezni prebavil bruhanje bolečina v trebuhu (vključno z bolečino v zgornjem delu trebuha), dispepsija, navzea
English: 60 mg dose
Slovenian: 60-mg odmerek
English: The recommended dose is based on the patient's body weight.You must use the amount of oral capsules or suspension prescribed by the doctor.
Slovenian: Jemati morate toliko peroralnih kapsul ali suspenzije, kot vam je predpisal zdravnik.
English: Hold a 30 mg capsule upright over a bowl and carefully snip off the rounded tip with scissors.
Slovenian: 30-mg kapsulo držite navpično nad posodo in s škarjami odrežite zaobljeno konico.
English: Before you take Tamiflu, make sure the prescribing doctor knows
Slovenian: Opozorila in previdnostni ukrepi Preden boste vzeli zdravilo Tamiflu, obvestite zdravnika, ki vam je predpisal zdravilo:
English: 1.8 ml once daily
Slovenian: 1,8 ml enkrat na dan
English: 5 ml once daily
Slovenian: 5 ml enkrat na dan
English: Storage of the pharmacy compounded suspension Shelf life of 10 days when stored below 25 °C.
Slovenian: Rok uporabnosti je 10 dni, če se zdravilo shranjuje pri temperaturi do 25 °C.
English: • The other ingredients are: capsule contents: pregelatinised starch, talc, povidone, croscarmellose sodium and sodium stearyl fumarate capsule shell: gelatin, black iron oxide (E172) and titanium dioxide (E171) printing ink: shellac (E904), titanium dioxide (E171) and FD and C Blue 2 (indigo carmine E132).
Slovenian: · Pomožne snovi so: vsebina kapsule: predgelirani škrob, smukec, povidon, natrijev premrežen karmelozat in natrijev stearilfumarat; ovojnica kapsule: želatina, črni železov oksid (E172) in titanov dioksid (E171); barvilo za tisk: šelak (E904), titanov dioksid (E171) in FD in C modro 2 (indigotin E132).
English: NAME OF THE MEDICINAL PRODUCT Tamiflu 30 mg capsules Oseltamivir
Slovenian: IME ZDRAVILA Tamiflu 30 mg kapsule oseltamivir
English: 75 mg dose
Slovenian: 75-mg odmerek
English: Hold a 45 mg capsule upright over a bowl and carefully snip off the rounded tip with scissors.
Slovenian: 45-mg kapsulo držite navpično nad posodo in s škarjami odrežite zaobljeno konico.
English: Each hard capsule contains oseltamivir phosphate equivalent to 75 mg of oseltamivir.
Slovenian: Ena trda kapsula vsebuje 75 mg oseltamivirja v obliki oseltamivirjevega fosfata.
English: • Pain in limb
Slovenian: · bolečina v okončinah,
English: Treatment of influenza in children: In a study of otherwise healthy children (65 % influenza-positive) aged 1 to 12 years (mean age 5.3 years) who had fever (≥ 37.8 °C) plus either cough or coryza, 67 % of influenza-positive patients were infected with influenza A and 33 % with influenza B. Oseltamivir treatment, started within 48 hours of onset of symptoms, significantly reduced the time to freedom from illness (defined as the simultaneous return to normal health and activity and alleviation of fever, cough and coryza) by 1.5 days (95 % CI 0.6 - 2.2 days; p < 0.0001) compared to placebo.
Slovenian: Zdravljenje z oseltamivirjem, ki so ga začeli v 48 urah po nastopu simptomov, je pomembno skrajšalo čas do obdobja brez bolezni (definirano kot sočasna vrnitev normalnega zdravja in aktivnosti ter znižanje zvišane telesne temperature, ublažitev kašlja in nahoda) za 1,5 dni (95-% interval zaupanja 0,6-2,2 dni; p < 0,0001) v primerjavi s placebom.
English: 2.8 ml once daily
Slovenian: 2,8 ml enkrat na dan
English: 3.0 ml once daily
Slovenian: 3,0 ml enkrat na dan
English: 12.5 ml twice daily
Slovenian: 12,5 ml dvakrat na dan
English: • Each hard capsule contains oseltamivir equivalent to 75 mg of oseltamivir
Slovenian: • Ena trda kapsula vsebuje 75 mg oseltamivirja.
English: See section 4.2 for information on paediatric use.
Slovenian: Tamiflu za eno ali več skupin pediatrične populacije pri gripi (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: If you forget to take Tamiflu Do not take a double dose to make up for a forgotten dose.
Slovenian: Če ste prenehali jemati zdravilo Tamiflu Če prenehate z jemanjem zdravila Tamiflu, ne pride do pojava neželenih učinkov.
English: 1.5 ml twice daily 1.5 ml once daily 3 ml
Slovenian: 2,3 ml enkrat na dan 1,5 ml enkrat na dan 3 ml
English: Hold a 75 mg capsule upright over a bowl and carefully snip off the rounded tip with scissors.
Slovenian: 75-mg kapsulo držite navpično nad posodo in s škarjami odrežite zaobljeno konico.
English: Each hard capsule contains oseltamivir phosphate equivalent to 45 mg of oseltamivir.
Slovenian: Ena trda kapsula vsebuje 45 mg oseltamivirja v obliki oseltamivirjevega fosfata.
English: NAME OF THE MEDICINAL PRODUCT Tamiflu 75 mg capsules Oseltamivir
Slovenian: IME ZDRAVILA Tamiflu 75 mg kapsule oseltamivir
English: Adults, adolescents and infants and children 1 year of age or older who are unable to swallow intact capsules
Slovenian: Odrasli in mladostniki, stari 13 let in več Zelo pogosti neželeni učinki
English: Each ml of reconstituted suspension contains oseltamivir phosphate equivalent to 6 mg of oseltamivir.
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA En ml pripravljene suspenzije vsebuje količino oseltamivirjevega fosfata, ki ustreza 6 mg oseltamivirja.
English: Each hard capsule contains oseltamivir phosphate equivalent to 30 mg of oseltamivir.
Slovenian: Ena trda kapsula vsebuje 30 mg oseltamivirja v obliki oseltamivirjevega fosfata.
English: Tamiflu 30 mg hard capsules 10 years
Slovenian: 6.3 Rok uporabnosti Tamiflu 30 mg trde kapsule 10 let
English: NAME OF THE MEDICINAL PRODUCT Tamiflu 45 mg capsules Oseltamivir
Slovenian: IME ZDRAVILA Tamiflu 45 mg kapsule oseltamivir
English: Povidone
Slovenian: samopoškodba
English: To make a 30 mg or a 60 mg dose, you need:
Slovenian: Za pripravo 30-mg ali 60-mg odmerka potrebujete: · eno ali dve 30-mg kapsuli zdravila Tamiflu, · ostre škarje, · eno majhno posodo,
English: Hepatobiliary disorders
Slovenian: hemoragični kolitis
English: 3.5 ml once daily
Slovenian: 3,5 ml enkrat na dan
English: NAME OF THE MEDICINAL PRODUCT Tamiflu 30 mg hard capsules Oseltamivir
Slovenian: IME ZDRAVILA Tamiflu 30 mg trde kapsule oseltamivir
English: 5.0 ml once daily
Slovenian: 5,0 ml enkrat na dan
English: 2.0 ml once daily
Slovenian: 2,0 ml enkrat na dan
English: Step 4: Draw up the liquid mixture
Slovenian: Korak 4: odvzemite tekočo mešanico Prepričajte se, da imate pravilno velikost odmernika.
English: NAME OF THE MEDICINAL PRODUCT Tamiflu 45 mg hard capsules Oseltamivir
Slovenian: IME ZDRAVILA Tamiflu 45 mg trde kapsule oseltamivir
English: Third, follow the procedure below for compounding the 6 mg/ml suspension from Tamiflu capsules: In a glass beaker of suitable size place the stated amount of water containing 0.05 % w/v sodium benzoate added as a preservative.
Slovenian: V stekleno čašo ustrezne velikosti dajte navedeno količino vode, ki vsebuje 0,05 % m/v natrijevega benzoata kot konzervans.
English: 4.0 ml once daily
Slovenian: 4,0 ml enkrat na dan
English: 45 mg dose
Slovenian: 45-mg odmerek
English: NAME OF THE MEDICINAL PRODUCT Tamiflu 75 mg hard capsules Oseltamivir
Slovenian: IME ZDRAVILA Tamiflu 75 mg trde kapsule oseltamivir
English: For infants and children 1 year of age or older: Tamiflu 30 mg and 45 mg capsules are available as an alternative to the recommended dose of Tamiflu 6 mg/ml suspension.
Slovenian: Namesto priporočenega odmerka suspenzije zdravila Tamiflu 6 mg/ml so na voljo tudi 30-mg in 45-mg kapsule zdravila Tamiflu.
English: 3.0 ml twice daily 3.0 ml once daily 3 ml
Slovenian: 2,0 ml enkrat na dan 1,3 ml enkrat na dan 3 ml
English: 1.5 ml once daily
Slovenian: 1,5 ml enkrat na dan
English: • Upper abdominal fullness
Slovenian: vrh bat bat vrh
English: 2.5 ml once daily
Slovenian: 2,5 ml enkrat na dan
English: Tamiflu 75 mg hard capsules oseltamivir
Slovenian: Navodilo za uporabo Tamiflu 75 mg trde kapsule oseltamivir
English: Tamiflu 45 mg hard capsules oseltamivir
Slovenian: Navodilo za uporabo Tamiflu 45 mg trde kapsule oseltamivir
English: MARKETING AUTHORISATION NUMBER(S) EU/1/02/222/005
Slovenian: ŠTEVILKA(E) DOVOLJENJA ZA PROMET EU/1/02/222/005
English: Tamiflu 30 mg hard capsules oseltamivir
Slovenian: Navodilo za uporabo Tamiflu 30 mg trde kapsule oseltamivir
English: • The bottle, containing Tamiflu powder (in the medicine pack)
Slovenian: Faza 1 Pripravite novo steklenico zdravila Potrebovali boste: · steklenico, ki vsebuje Tamiflu prašek (v pakiranju), · zaporko za steklenico (v pakiranju),
English: Yellow iron oxide (E172) Red iron oxide (E172) Titanium dioxide (E171)
Slovenian: rdeči železov oksid (E172)
English: • if you have a severe medical condition, which may require immediate hospitalisation
Slovenian: V tem primeru bo morda potrebno prilagoditi odmerek; · če imate resno zdravstveno stanje, ki morda zahteva takojšnjo hospitalizacijo; · če vaš imunski sistem ne deluje; · če imate kronično bolezen srca ali bolezen dihal.
English: • Convulsions and delirium, including altered level of consciousness
Slovenian: Med zdravljenjem z zdravilom Tamiflu so poročali o redkih dogodkih, ki vključujejo: · konvulzije in delirij, vključno s spremenjeno ravnijo zavesti,
English: 3.0 ml twice daily
Slovenian: 3,0 ml dvakrat na dan
English: How to store Tamiflu
Slovenian: Shranjevanje zdravila Tamiflu
English: 2.3 ml once daily
Slovenian: 2,3 ml enkrat na dan
English: For infants and children1 year of age or older: The recommended dose of Tamiflu 6 mg/ml oral suspension is indicated in the table below.
Slovenian: Za dojenčke in otroke, stare 1 leto ali več: priporočeno odmerjanje peroralne suspenzije zdravila
English: A funnel may be used to eliminate any spillage.
Slovenian: Da se izognete razlivanju, lahko uporabite lijak.
English: Dose adjustment is recommended for both treatment and prevention in adolescents (13 to 17 years of age) and adults with severe renal impairment.
Slovenian: Pri hudi ledvični okvari pri mladostnikih (starih od 13 do 17 let) in odraslih je priporočljivo prilagoditi odmerek za zdravljenje in preprečevanje gripe.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/02/222/004
Slovenian: ŠTEVILKA(E) DOVOLJENJA ZA PROMET EU/1/02/222/004
English: MARKETING AUTHORISATION NUMBER(S) EU/1/02/222/001
Slovenian: ŠTEVILKA(E) DOVOLJENJA ZA PROMET EU/1/02/222/001
English: 3.5ml twice daily 3.5 ml once daily
Slovenian: 5 ml dvakrat na dan 5 ml enkrat na dan
English: Take this medicine exactly as your doctor has told you.
Slovenian: Pri jemanju tega zdravila natančno upoštevajte navodila zdravnika.
English: Dose of Tamiflu Number of capsules
Slovenian: Telesna masa Odmerek zdravila Tamiflu
English: Dispenser size to use
Slovenian: Velikost uporabljenega odmernika
English: Keep it out of sight and reach of children.
Slovenian: Shranjujte nedosegljivo otrokom.
English: To make a 75 mg dose, you need:
Slovenian: Za pripravo 75-mg odmerka potrebujete: · eno 75-mg kapsulo zdravila Tamiflu, · ostre škarje, · eno majhno posodo,
English: MARKETING AUTHORISATION NUMBER(S) EU/1/02/222/003
Slovenian: ŠTEVILKA(E) DOVOLJENJA ZA PROMET EU/1/02/222/003
English: 3.8 ml twice daily 3.8 ml once daily
Slovenian: 3,8 ml dvakrat na dan
English: 2.8 ml twice daily 2.8 ml once daily
Slovenian: 2,8 ml dvakrat na dan
English: 2.0 ml twice daily
Slovenian: 2,0 ml dvakrat na dan
English: Tutti frutti flavour (including maltodextrins [maize], propylene glycol, arabic gum E414 and natural identical flavouring substances [mainly consisting of banana, pineapple and peach flavour]).
Slovenian: 6.1 Seznam pomožnih snovi sorbitol (E420) natrijev dihidrogencitrat (E331[a]) ksantanski gumi (E415) natrijev benzoat (E211) natrijev saharinat (E954) titanov dioksid (E171) sadna aroma (vključuje maltodekstrine [koruzne], propilenglikol, arabski gumi E414 in naravna identična sredstva za izboljšanje okusa [aroma banane, ananasa in breskve])
English: • if you have chronic heart disease or respiratory disease.
Slovenian: · epileptični krči, · nenormalen srčni ritem,
English: 4.5 ml once daily
Slovenian: 4,5 ml enkrat na dan
English: 4.0 ml twice daily
Slovenian: 4,0 ml dvakrat na dan
English: 30 mg dose
Slovenian: 30-mg odmerek
English: 4.8 ml twice daily 4.8 ml once daily
Slovenian: 4,8 ml dvakrat na dan
English: Sodium stearyl fumarate
Slovenian: Roche Pharma AG
English: 18 mg once daily
Slovenian: 6 kg 18 mg enkrat na dan
English: Rare side effects (may affect up to 1 in 1,000 people)
Slovenian: (ti se lahko pojavijo pri največ 1 od 1000 bolnikov)
English: 10 ml once daily
Slovenian: 10,0 ml enkrat na dan
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom week during treatment.
Slovenian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom20.
English: 20 October 2015 EMA/487922/2015
Slovenian: oktober 2015 EMA/487922/2015
English: The flowers for medicinal use are obtained either from plants that have been cultivated or found in the wild.
Slovenian: Cvetovi za medicinsko uporabo se pridobivajo iz rastlin, ki so bile gojene ali divje rastoče.
English: Patients with open wounds, extensive skin damage or acute (short-term) skin disease, high fever and severe infections should not have full or partial baths with matricaria oil.
Slovenian: Bolniki z odprtimi ranami, obsežnimi poškodbami kože ali akutnimi (kratkotrajnimi) kožnimi boleznimi, močno povišano telesno temperaturo ali resnimi okužbami ne smejo uporabljati delnih kopeli ali kopeli celega telesa z eteričnim oljem prave kamilice.
English: This summary is not intended to provide practical advice on how to use medicines containing matricaria oil.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o uporabi zdravil, ki vsebujejo eterično olje prave kamilice.
English: Further information on the risks associated with matricaria oil medicines, including the appropriate precautions for their safe use, can be found in the monograph under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Slovenian: Dodatne informacije o tveganjih, povezanih z zdravili, ki vsebujejo eterično olje prave kamilice, vključno z ustreznimi previdnostnimi ukrepi za njihovo varno uporabo, so na voljo v monografiji na spletni strani agencije pod zavihkom „Vsi dokumenti“: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: Matricaria oil EMA/487922/2015
Slovenian: EMA/487922/2015
English: This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of matricaria oil.
Slovenian: To je povzetek znanstvenih zaključkov Odbora za zdravila rastlinskega izvora (HMPC) v zvezi z medicinsko uporabo eteričnega olja prave kamilice.
English: How are matricaria oil medicines approved in the EU?
Slovenian: Kako so zdravila, ki vsebujejo eterično olje prave kamilice, odobrena v EU?
English: The HMPC conclusions on the use of matricaria oil medicines for irritation of the skin and areas around anus and genitals are based on their ‘traditional use' in this condition.
Slovenian: Zaključki odbora HMPC o uporabi zdravil, ki vsebujejo eterično olje prave kamilice, pri razdraženosti kože in predelov okoli anusa (zadnjika) in spolovil, temeljijo na njihovi „tradicionalni uporabi“ pri teh stanjih.
English: Matricaria oil is obtained by a current of steam through the fresh or dried flowers or flowering tops of the plant.
Slovenian: Eterično olje prave kamilice se pridobiva s pomočjo toka pare skozi sveže ali posušene cvetove ali cvetoče vrhove rastline.