natgillin/translations-raw huggingface dataset:
Take the inhaler out of your mouth and hold your breath for 5 seconds.
Odmaknite inhalator od usta i zadržite dah
The active substance in Inbrija is levodopa.
Djelatna tvar Inbrije je levodopa.
• A complete dose is 2 capsules used one after the other.
• Puna doza iznosi 2 kapsule primijenjene jedna iza druge.
92 hard capsules + 1 inhaler
60 tvrdih kapsula + 1 inhalator 92 tvrde kapsule + 1 inhalator
In the presence of carbidopa, the apparent terminal elimination half-life (t1/2) of levodopa following a single administration of Inbrija 66 mg (2 x 33 mg capsules) was 2.3 hours and comparable to that following an oral dose of carbidopa/levodopa 25 mg/100 mg immediate release tablets of 1.9 hours.
U prisutnosti karbidope prividno terminalno poluvrijeme eliminacije (t1/2) levodope nakon jedne primjene Inbrije u dozi do 66 mg (2 kapsule od 33 mg) iznosilo je 2,3 sata i može se usporediti s onime nakon peroralne primjene karbidope/levodope u dozi od 25 mg/100 mg u obliku tablete s trenutnim oslobađanjem koje je iznosilo 1,9 sati.
If you have any of these symptoms, you may have a eye condition called narrow angle glaucoma, which occurs suddenly: do not take
Ako su prisutni neki od tih simptoma, možda imate očnu bolest koja se naziva glaukom uskog kuta i nastupa iznenada, nemojte uzeti Inbriju i hitno potražite medicinsku pomoć.
Inbrija 33 mg inhalation powder, hard capsules
Inbrija 33 mg prašak inhalata, tvrde kapsule
Concurrent administration of levodopa and amantadine may increase confusion, hallucinations, nightmares, gastro-intestinal disturbances, or other atropine-like side effects.
Istodobna primjena levodope i amantadina može pojačati konfuziju, halucinacije, noćne more,
Glaucoma
Glaukom
Do not swallow Inbrija capsules.
Ne gutati kapsule Inbrija.
Syncope,
sinkopa,
Black iron oxide (E 172) Propylene glycol Potassium hydroxide
Tinta šelak crni željezov oksid (E 172)
Breathe out completely.
Izdahnite do kraja.
Pulmonary safety
Sigurnost primjene za pluća
Paraesthesia,
parestezija,
Fall a Cardiac rhythm disorder here is a combined term representing atrial fibrillation, atrial flutter, atrioventricular block, bundle branch block, sick sinus syndrome, bradycardia, and tachycardia.
atrioventrikularni blok, blok grane snopa, sindrom bolesnog sinusa, bradikardiju i tahikardiju.
Subjects had to be able to recognise OFF periods and to handle the device.
Ispitanici su morali biti sposobni prepoznati OFF-razdoblja i rukovati inhalatorom.
Tear off package of 2 capsules.
Odvojite dio blistera s 2 kapsule.
Nervous system disorders
Poremećaji živčanog sustava diskinezija distonija,
• Only remove the capsules from the blister immediately before use.
• Kapsule izvadite iz blistera samo neposredno prije primjene.
Gastrointestinal haemorrhage, Peptic ulcer (see section 4.4), Dysphagia,
peptički ulkus (vidjeti dio 4.4), disfagija,
Inbrija 33 mg inhalation powder, hard capsules levodopa
Inbrija 33 mg prašak inhalata, tvrde kapsule levodopa
Twist and pull off the mouthpiece.
Zakrenite, povucite i odvojite usnik.
Step 6: Attach white mouthpiece Align arrows on mouthpiece and handle
6. korak: Pričvrstite natrag bijeli usnik Poravnajte strelice na usniku i dršku
Levodopa may have a major influence on the ability to drive and use machines.
4.7 Utjecaj na sposobnost upravljanja vozilima i rada sa strojevima Levodopa može značajno utjecati na sposobnost upravljanja vozilima i rada sa strojevima.
This punctures the capsule.
Tako je kapsula probušena.
It is recommended to administer this medicinal product cautiously to patients with severe hepatic impairment.
Preporučuje se lijek primjenjivati s oprezom u bolesnika s teškom bolešću bubrega.
Patients may experience new or worsening mental status and behavioural changes, which may be severe, including psychotic-like and suicidal behaviour during levodopa treatment or after starting or increasing the dose of levodopa.
Mentalni poremećaji Tijekom liječenja levodopom, nakon započinjanja liječenja ili nakon povećanja doze levodope, u bolesnika mogu nastupiti promjene ili pogoršanje mentalnog stanja i promjene ponašanja, koje mogu biti teškog oblika, uključujući poremećaje nalik psihozi ili suicidalno ponašanje.
The capsules must only be removed from the blister immediately before use.
Kapsule se iz blistera smiju izvaditi samo neposredno prije primjene.
Periodic skin examinations are recommended to monitor for melanoma in patients receiving Inbrija.
U bolesnika koji primjenjuju Inbriju preporučuju se periodični pregledi kože zbog moguće pojave melanoma.
Parts of your Inbrija inhaler
Dijelovi Inbrija inhalatora Strelice za poravnavanje
These may be symptoms of “withdrawal-emergent hyperpyrexia”.
To mogu biti simptomi nastupa hiperpireksije zbog ustezanja primjene lijeka.
• Dispose of all used capsules immediately after use.
• Nakon primjene iskorištene kapsule odmah bacite.
Symptomatic postural hypotension has occurred when combinations of levodopa and a dopadecarboxylase inhibitor are added to the treatment of patients already receiving certain antihypertensives.
Simptomatska posturalna hipotenzija nastupila je kada su bolesnicima koji su primali određene antihipertenzive u terapiju dodane kombinacije levodope i inhibitora dopa-dekarboksilaze.
Dyspnoea,
diplopija,
Skin and subcutaneous tissue disorders
Poremećaji kože i potkožnog tkiva angioedem,
How to store Inbrija
Kako primjenjivati Inbriju
Subject features
Karakteristike ispitanika
Baseline Levodopa dose
Početna doza levodope
Step 4: Remove 1 capsule from package
4. korak: Izvadite 1 kapsulu iz pakiranja Pažljivo odvojite foliju i izvadite 1 kapsulu
Musculoskeletal and connective tissue disorders
Poremećaji mišićno-koštanog sustava i vezivnog tkiva mišićni spazmi, trizmus
The effect of Inbrija on pulmonary function was also evaluated in patients with Parkinson's disease treated with an oral levodopa/dopa-decarboxylase inhibitor in a 12-month, randomised, controlled, open-labeled study.
Učinak Inbrije na plućnu funkciju procijenjen je i u bolesnika s Parkinsonovom bolesti liječenih primjenom peroralne levodope / inhibitora dopa-dekarboksilaze tijekom randomiziranog,
- The capsules must only be removed from the blister pack immediately before use.
- Kapsule se iz blistera smiju izvaditi samo neposredno prije primjene.
- inability to resist the impulse to perform an action that could be harmful, which may include: - strong impulse to gamble excessively despite serious personal or family consequences; - altersed or increased sexual interest and behaviour of significant concern to you or to others, for example, an increased sexual drive; - uncontrollable excessive shopping or spending; - binge eating (eating large amounts of food in a short time period) or compulsive eating (eating more food than normal and more than is needed to satisfy your hunger).
- prejedanje (uzimanje velikih količina hrane u kratkom vremenskom razdoblju) ili kompulzivno uzimanje hrane (uzimanje hrane u količini većoj nego što je uobičajeno i više od količine koja zadovoljava glad).
Hold the inhaler upright using the handle.
Držite inhalator uspravno držeći ga za držak.
Anticholinergics
Antikolinergici
Release the mouthpiece.
Otpustite usnik.
Neoplasm benign, malignant and unspecified (incl.
Dobroćudne, zloćudne i nespecificirane novotvorine
Adverse reactions are presented by system organ class and frequency in Table 1 below.
U tablici 1 u nastavku prikazane su nuspojave prema klasifikaciji organskih sustava i prema učestalosti.
The primary efficacy endpoint was the mean change from baseline in Unified Parkinson's Disease Rating Scale (UPDRS) part III score 30 minutes post dose at week 12.
Primarna mjera ishoda za djelotvornost bila je srednja vrijednost promjene od početnih vrijednosti, prema dijelu III Jedinstvene ocjenske ljestvice za Parkinsonovu bolest (engl.
You can use a dry cotton swab or tissue to wipe the outside of the inhaler.
Možete ga obrisati izvana suhom pamučnom vaticom ili maramicom.
Restless legs syndrome, Neuroleptic malignant syndrome (see section 4.4), Ataxia,
maligni neuroleptički sindrom (vidjeti dio 4.4),
Compress mouthpiece only once
Pritisnite usnik samo jedanput
Responders ONb n = 97a n = 97a
Ispitanici s ON odgovoromb n = 97a n = 97a
Coombs test positive, White blood cells urine positive,
povišena vrijednost ureje u krvi, povišena vrijednost alkalne fosfataze u krvi, pozitivni Coombsov test, pozitivni nalaz leukocita u urinu,
Step 2: Remove blue cap from inhaler
2. korak: Skinite plavu kapicu s inhalatora Ravno povucite kapicu.
The Inbrija inhaler is to be thrown away after all the capsules have been used.
Nakon što se sve kapsule iskoriste Inbrija inhalator mora se baciti.
Step 7: Hold inhaler away and breathe out Stand or sit with your head and chest upright.
Stojte ili sjednite s uspravnom glavom i prsnim košem.
- if you are taking certain antidepressant medicines called non-selective MAO inhibitors (e.g.
- ako imate rijetki oblik tumora nadbubrežne žlijezde koji se naziva feokromocitom. - ako uzimate određene lijekove protiv depresije koji se nazivaju neselektivni MAO inhibitori (npr. izokarboksazid i fenelzin).
Suicide attempt (see section 4.4), Disorientation, Dopamine dysregulation syndrome,
agitacija, pokušaj samoubojstva (vidjeti dio 4.4), dezorijentacija,
- Co-administration with non-selective monoamine oxidase (MAO) inhibitors.
Neselektivni inhibitori monoaminooksidaze (MAO)
- melanoma (a type of skin cancer) or suspicious skin growths or marks.
- novi ili pojačani neprirodni pokreti tijela (diskinezija) - osjećaj omaglice pri ustajanju (niski krvni tlak) - melanom (vrsta raka kože) ili sumnjive izrasline ili promjene na koži.
Depression,
halucinacije, depresija,
Capsule content
4 kapsule.
Orthostatic hypotension (see section 4.4),
Krvožilni poremećaji ortostatska hipotenzija (vidjeti dio 4.4), hipertenzija,
See section 4.4 regarding withdrawal emergent hyperpyrexia and confusion.
O nastupu hiperpireksije i konfuzije nakon prekida uzimanja levodope vidjeti u dijelu 4.4.
Make sure there are no capsules in the inhaler before you store it.
Provjerite da u inhalatoru nema kapsula
• Dispose of the inhaler after you are finished all of the capsules in the carton.
• Nakon što ste potrošili sve kapsule iz kutije, inhalator bacite.
Respiration abnormal, Dysphonia, Hiccups
iritacija ždrijela dispneja, abnormalno disanje,
Capsule shell
Plava kapica
PHARMACEUTICAL PARTICULARS 6.1 List of excipients
FARMACEUTSKI PODACI 6.1 Popis pomoćnih tvari Sadržaj kapsule kolfoscerilpalmitat (DPPC)
Inbrija may cause dyskinesia.
Inbrija može uzorkovati diskineziju.
Baseline mean (SD) LS mean change Mean diff. (95% CI) p-value
Srednja vrijednost razlike (95% CI)
Each carton includes blisters of 4 capsules.
Kapsule Svaka kutija sadrži blistere s po
Confusional state, Hallucination,
Psihijatrijski poremećaji stanje konfuzije,
Inbrija and get urgent medical attention.
Inbriju i opservacijske skupine.
Step 8: Breathe in deeply to inhale powder While keeping the inhaler level, close your lips firmly around the mouthpiece.
Držeći inhalator u razini usta, čvrsto stisnite usne oko usnika.
Step 13: Store inhaler Make sure there are no capsules in the inhaler
13. korak: Čuvanje inhalatora
The median time to maximal plasma concentration of levodopa was 30 minutes after a dose of Inbrija 66 mg (2 x 33 mg capsules) compared to 45 minutes after a dose of carbidopa/levodopa 25 mg/100 mg immediate release tablets.
Inbrije od 66 mg (2 kapsule od 33 mg) u usporedbi s 45 minuta nakon primjene karbidope/levodope u dozi 25 mg/100 mg u obliku tablete s trenutnim oslobađanjem.
On and off phenomenon, Somnolence,
ON- i OFF-fenomen,
Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC
• Periodička izvješća o neškodljivosti lijeka (PSUR-evi) Zahtjevi za podnošenje PSUR-eva za ovaj lijek definirani su u referentnom popisu datuma EU (EURD popis) predviđenom člankom 107.c stavkom 7.
- if you get blurred vision, red eyes, severe eye and head pain, halos around lights, pupils of your eyes that are larger than normal size and feel sick.
Nemojte primjenjivati Inbriju - ako ste alergični na levodopu ili neki drugi sastojak ovog lijeka (naveden u dijelu 6). - ako Vam vid postane zamućen, pojavi Vam se crvenilo očiju, jaki bol u očima i glavi, kolobare (haloi) oko izvora svjetla, zjenice su Vam šire nego inače ili osjećate mučninu.
Dysgeusia,
disfonija,
Blood bilirubin increased, Blood glucose increased, Blood creatinine increased, Blood uric acid increased, Haemoglobin decreased, Haematocrit decreased, Blood urine present, Blood urea increased, Blood alkaline phosphatase increased,
Poremećaji dišnog sustava, prsišta i sredoprsja kašalj infekcija gornjih dišnih putova, promijenjena boja iskašljaja, promijenjena boja nosnog iscjetka,
Inbrija has not specifically been studied in patients with hepatic impairment.
Inbrija nije posebno ispitana u bolesnika s oštećenjem jetrene funkcije.
Ink
SN
- skin cancer; - lack of red blood cells so you are pale and feel tired; being more prone to infections because of a lack of white blood cells; lack of blood platelets which can lead to bruising and a tendency to bleed; - decreased appetite; - confusion; hallucinations; depression; anxiety; bad dreams; unable to sleep; abnormal thinking and perceptions, losing touch with reality; feeling agitated; suicidal; being disorientated; exaggerated feeling of happiness; increased sex drive; grinding of teeth; feeling paranoid and delusional; - movement disorder in which a person's muscles contract uncontrollably; sudden, sometimes unpredictable changes in symptoms, due to the return of Parkinson's disease symptoms; sleepiness; dizziness; worsening of Parkinson's disease; pins and needles; headache; tremors; seizure; sudden onset of sleep; restless legs syndrome; ataxia (disorder affecting co-ordination, balance and speech); distorted sense of taste; mental health disorders that affecting learning, memory, perception, and problem solving; Horner's syndrome (an eye disorder); dementia;
- smetenost; halucinacije; depresija; tjeskoba; ružni snovi; nemogućnost spavanja; abnormalno razmišljanje i doživljavanje, gubitak dodira sa stvarnošću; osjećaj uznemirenosti; želja za samoubojstvom; dezorijentiranost; prekomjerni osjećaj sreće; pojačani spolni nagon; škrgutanje zubima; osjećaj paranoje i sumanutost;
Inbrija has not been studied in patients with hepatic impairment.
Inbrija nije ispitana u bolesnika s oštećenjem jetrene funkcije.
Step 3: Twist and pull off white mouthpiece Twist and pull off the mouthpiece to separate it from the handle.
3. korak: Zakrenite, povucite i odvojite usnik
Abdominal pain, Constipation, Diarrhoea,
Poremećaji probavnog sustava mučnina, povraćanje bol u abdomenu, konstipacija, proljev, suha usta, gastrointestinalno krvarenje,
Immune system disorder
Poremećaji imunološkog sustava alergijski edem
Seizure,
ataksija,
Pruritus,
osip,
Dose adjustment of the antihypertensive medicinal products may be required during concomitant use of Inbrija.
Kada se istodobno primjenjuje Inbrija može biti potrebno prilagoditi dozu antihipertenzivnih lijekova.
- Narrow-angle glaucoma.
RMP-a.
It may harm them,
Poremećaji oka zamagljen vid,
Gastrointestinal disorders
propilenglikol kalijev hidroksid
Nausea, Vomiting
glavobolja, tremor, napadaj,
Glossodynia,
agranulocitoza,
MARKETING AUTHORISATION NUMBER(S)
Srednja vrijednost na početku (SD)
Cardiac rhythm disordersa (see section 4.4),
Srčani poremećaji poremećaji srčanog ritmaa (vidjeti dio 4.4),
It is best to take tablets at the same time each day.
Najbolje je da tablete uzimate svakoga dana u isto vrijeme.
Not known (cannot be estimated from the available data)*
Nepoznato (ne može se procijeniti iz dostupnih podataka)*
If you take more Ketek than you should
Ako uzmete više Keteka nego što ste trebali
Adequate hydration should be maintained.
Treba održavati odgovarajuću hidrataciju.
Date of latest renewal: 9 July 2011
Datum posljednje obnove: 9. srpnja 2011.
If you forget to take a dose, take it as soon as possible.
Ako zaboravite uzeti dozu lijeka, uzmite je što prije.
The onset of the visual reaction may be sudden.
Nastup vizualne reakcije može biti iznenadan.
Your doctor will tell you how many Ketek tablets to take, at what time and for how long.
Liječnik će Vam reći koliko Ketek tableta trebate uzeti te kada i koliko dugo ih trebate uzimati.
The combination should be used with caution.
Ovu kombinaciju treba primjenjivati uz oprez.
What Ketek contains
Što Ketek sadrži
Ketek may be taken with or without food.
Ketek se može uzimati s hranom ili bez hrane.
If you accidentally take one tablet too many, nothing is likely to happen.
Ako ste slučajno uzeti jednu tabletu previše, vjerojatno se ništa neće dogoditi.
Ketek is not recommended for use in children less than 12 years old.
Ketek se ne preporučuje za primjenu u djece mlađe od 12 godina.
Corresponding data for humans is not available.
Odgovarajući podaci za ljude nisu dostupni.
It may happen again when you take the next dose of Ketek.
Može se ponoviti kada uzmete sljedeću dozu lijeka Ketek.
Ketek should not be used during pregnancy unless clearly necessary.
Ketek se ne smije primjenjivati u trudnoći, osim ako to nije neophodno.
Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Detaljnije informacije o ovom lijeku dostupne su na web stranici Europske agencije za lijekove: http://www.ema.europa.eu
These visual disturbances may happen suddenly and last several hours.
Ove smetnje vida mogu se dogoditi iznenada i trajati nekoliko sati.
In the event of acute overdose the stomach should be emptied.
U slučaju akutnog predoziranja treba isprati želudac.
The safety and efficacy of Ketek in children below 12 years of age have not been established (see section 5.2).
Sigurnost i djelotvornost lijeka Ketek u djece mlađe od 12 godina nisu ustanovljeni (vidjeti dio 5.2).
Limit driving or other hazardous activities while taking Ketek.
Ograničite vožnju i druge rizične aktivnosti dok uzimate Ketek.
What Ketek is and what it is used for
Što je Ketek i za što se koristi
Ketek is not recommended in this population.
Ketek se ne preporučuje za primjenu u ovoj populaciji.
However, if it is nearly time for your next dose skip the missed dose and take the next tablet at the usual time.
Međutim, ako je uskoro vrijeme za sljedeću dozu, preskočite propuštenu dozu i uzmite sljedeću dozu u uobičajeno vrijeme.
The tablets should be swallowed whole with a sufficient amount of water.
Tablete treba progutati cijele s dovoljno vode.
The volume of distribution is 2.9±1.0 l/kg.
Volumen distribucije iznosi 2,9 ± 1,01 l/kg.
Take the complete course of tablets prescribed by your doctor, even if you begin to feel better before you have finished them all.
Dovršite cijeli ciklus liječenja koji Vam je propisao liječnik, čak i ako se počnete osjećati bolje prije nego što ste potrošili sve tablete.
Ketek is indicated for the treatment of the following infections:
Ketek je indiciran za liječenje sljedećih infekcija:
Swallow the tablets whole with a glass of water.
Tablete progutajte cijele, s čašom vode.
What you need to know before you take Ketek
Što morate znati prije nego počnete uzimati Ketek
The mechanisms are incompletely known.
Mehanizmi djelovanja nisu u potpunosti poznati.
What Ketek looks like and contents of the pack
Kako Ketek izgleda i sadržaj pakiranja
The midazolam halflife was increased about 2.5-fold.
Poluvijek midazolama povećao se približno 2,5 puta.
What Ketek is and what it is used for What you need to know before you take Ketek
Što je Ketek i za što se koristi Što morate znati prije nego počnete uzimati Ketek
More than 80% of MRSA express cMLSB.
Više od 80% MRSA izražavaju cMLSB.
The above serious side effects may require urgent medical attention.
Prethodno navedene ozbiljne nuspojave mogu zahtijevati hitno liječenje.
This should be taken into account when treating infections caused by H. influenzae.
To treba uzeti u obzir u liječenju infekcija uzrokovanih bakterijom H. influenzae.
Refer also to sections “Do not take Ketek”, “Other medicines and Ketek” and “Driving and using
Pročitajte i dijelove "Nemojte uzimati Ketek", "Drugi lijekovi i Ketek" i "Upravljanje vozilima i
Based on observed data, a 600 mg daily dose is approximately equivalent with the target exposure observed in healthy subjects.
Na temelju zabilježenih podataka, dnevna doza od 600 mg je približno jednaka ciljnoj izloženosti opaženoj u zdravih osoba.
• dronedarone (for atrial fibrillation)
• dronedaron (za fibrilaciju atrija)
Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system
Od zdravstvenih djelatnika se traži da prijave svaku sumnju na nuspojavu lijeka putem nacionalnog sustava prijave nuspojava navedenog u
If you stop taking the tablets too soon, the infection may return, or your
Ako prerano prestanete uzimati tablete, infekcija se može vratiti ili se
(See sections 4.3 and 4.5).
(Vidjeti dio 4.3 i 4.5).
Antibiotics stop the growth of bacteria which cause
Antibiotici zaustavljaju rast bakterija koje uzrokuju infekcije.
The in vitro protein binding is approximately 60% to 70%.
Vezivanje telitromicina za proteine in vitro iznosi oko 60% do 70%.
Limited data, obtained in paediatric patients 13 to 17 years of age, showed that telithromycin concentrations in this age group were similar to the concentrations in patients 18 to 40 years of age.
Ograničeni podaci dobiveni u pedijatrijskih bolesnika u dobi od 13 do 17 godina pokazali su da su koncentracije telitromicina u ovoj dobnoj skupini podjednake koncentracijama u bolesnika u dobi od 18 do 40 godina.
If you stop taking the tablets too soon you may also create a bacterial resistance to the medicine.
Ako prerano prestanete uzimati tablete, također se može razviti rezistencija bakterija na lijek.
No patient in either group developed a ΔQTc >60 msec.
Ni u jednog bolesnika ni iz jedne skupine nije došlo do ΔQTc od > 60 ms.
This may be a sign of bowel inflammation which can occur following treatment with antibiotics.
To može biti znak upale crijeva koja se može pojaviti nakon liječenja antibioticima.
They are available in packs of 10, 14, 20 and 100 tablets.
Dostupno u pakiranjima od 10, 14, 20 i 100 tableta.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription, as some of them could affect or be
Obavijestite liječnika ili ljekarnika ako uzimate ili ste nedavno uzimali ili biste mogli uzeti bilo koje druge lijekove, uključujući i one koje ste nabavili bez recepta jer neki od njih mogu djelovati na Ketek ili Ketek može utjecati na njih.
Elderly population
Populacija starijih osoba
To reduce the potential impact of visual disturbances take the tablets before going to bed (see also
Kako biste smanjili potencijalni učinak smetnji vida, tablete uzmite prije odlaska u krevet (također
These symptoms may appear as early as after the first dose of Ketek.
Ovi se simptomi mogu pojaviti već nakon prve doze lijeka Ketek.
If possible, take your tablets or the box with you to show the doctor or pharmacist.
Ako je moguće, uzmite sa sobom tablete ili kutiju i pokažite ih liječniku ili ljekarniku.
In community acquired pneumonia, efficacy has been demonstrated in a limited number of patients with risk factors such as pneumococcal bacteraemia or age higher than 65 years.
Djelotvornost u izvanbolnički stečenoj pneumoniji dokazana je u malog broja bolesnika s faktorima rizika poput pneumokokne bakterijemije ili dobi iznad 65 godina.
The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European
Nositelj odobrenja će periodička izvješća o neškodljivosti za ovaj lijek podnositi u skladu s referentnim popisom datuma EU (EURD popis) predviđenim člankom 107(c) stavkom 7 Direktive 2001/83/EZ i objavljenim na europskom internetskom portalu za lijekove.
These effects usually disappear during treatment or after completion of treatment with Ketek.
Ovi učinci obično nestaju tijekom liječenja ili nakon završetka liječenja lijekom Ketek.