natgillin/translations-raw huggingface dataset:
Non-selective Monoamine Oxidase (MAO) inhibitors The use of non-selective MAO inhibitors with levodopa is contraindicated (see section 4.3).
Uporaba neselektivnih zaviralcev monoaminooksidaze z levodopo je kontraindicirana (glejte poglavje 4.3).
Gastrointestinal haemorrhage has been reported with levodopa medicinal products and was observed once in Inbrija clinical studies.
Pri zdravilih z levodopo so poročali o krvavitvi v prebavilih, ki so jo v kliničnih študijah z zdravilom Inbrija opazili enkrat.
Breathe out completely.
Povsem izdihnite zrak iz pljuč.
Henoch-Schonlein purpura, Urticaria,
Henoch-Schönleinova purpura, urtikarija, alopecija, sprememba barve znoja
It is recommended to administer this medicinal product cautiously to patients with severe hepatic impairment (see section 4.2).
Priporoča se previdnost pri dajanju tega zdravila bolnikom s hudo okvaro jeter (glejte poglavje 4.2).
• Do not load 2 capsules at the same time.
• V inhalator ne smete vstaviti 2 kapsul naenkrat.
Musculoskeletal and connective tissue disorders
Bolezni mišično skeletnega sistema in vezivnega tkiva mišični krči,
Hypromellose Titanium dioxide (E 171) Carrageenan
natrijev klorid Ovojnica kapsule hipromeloza titanov dioksid (E 171)
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.
V prisotnosti karbidope je bil navidezni končni razpolovni čas izločanja (t1/2) levodope po aplikaciji enkratnega odmerka 66 mg (2 × 33 mg kapsula) zdravila Inbrija 2,3 ure in je bil primerljiv s tistim po peroralnem odmerku karbidope/levodope 25 mg/100 mg tableta s takojšnjim sproščanjem (1,9 ure).
The hard capsules are supplied in Aluminium / PVC / Aluminium peel-off blisters.
6.5 Vrsta ovojnine in vsebina Trde kapsule so pakirane v pretisne omote iz aluminija/PVC/aluminija.
92 hard capsules + 1 inhaler
60 trdih kapsul + 1 inhalator 92 trdih kapsul + 1 inhalator
Step 4: Remove 1 capsule from package
4. korak: Vzemite 1 kapsulo iz ovojnine.
Twist and pull off the mouthpiece.
Zavrtite in odstranite beli ustnik.
Levodopa should be administered cautiously to patients with a history of peptic ulcer disease (because of the possibility of upper gastro-intestinal haemorrhage).
Potrebna je previdnost pri dajanju levodope bolnikom z anamnezo peptične razjede (zaradi možnosti krvavitve v zgornjih prebavilih).
Carton containing 92 hard capsules (23 blister strips) and one inhaler.
Škatla, ki vsebuje 92 trdih kapsul (23 pretisnih trakov) in en inhalator.
Make sure there are no capsules in the inhaler before you store it.
Prepričajte se, da nobena kapsula ni ostala v inhalatorju.
- if you are taking certain antidepressant medicines called non-selective MAO inhibitors (e.g.
- če jemljete določena zdravila proti depresiji, imenovana neselektivni zaviralci MAO (npr. izokarboksazid in fenelzin).
- Co-administration with non-selective monoamine oxidase (MAO) inhibitors.
- Sočasno dajanje z neselektivnimi zaviralci monoaminooksidaze (MAO).
- The medicine must be used only with the Inbrija inhaler device.
- To zdravilo morate zmeraj uporabljati samo z inhalatorjem za zdravilo Inbrija.
Make sure the mouthpiece is securely attached and will not fall off before moving to Step 7.
Preden nadaljujete s 7. korakom, se prepričajte, da je ustnik varno pritrjen in da ne bo odpadel.
This is because other medicines can affect the way Inbrija works.
To je zato, ker lahko druga zdravila vplivajo na delovanje zdravila
Breast-feeding
blerospazem
Carton containing 60 hard capsules (15 blister strips) and one inhaler.
Škatla, ki vsebuje 60 trdih kapsul (15 pretisnih trakov) in en inhalator.
Baseline Levodopa dose
Izhodiščni odmerek levodope
Inbrija inhalation powder, hard capsules consist of a white powder for inhalation filled into white opaque hard capsules with “A42” printed in black on the cap of the caspule and two black bands printed on the body of the capsule.
polnjenega v bele neprosojne trde kapsule s črnim napisom »A42« na pokrovčku kapsule in dvema črnima progama na telesu kapsule.
COMT inhibitors
Zaviralci COMT
Step 5: Load capsule
5. korak: Vstavite kapsulo.
If you use more Inbrija than you should (or someone accidentally swallows Inbrija) get medical help immediately.
Takoj poiščite zdravniško pomoč, če ste uporabili večji odmerek zdravila Inbrija, kot bi smeli (ali pa je kdo drug nehote pogoltnil zdravilo Inbrija).
Tests
Pregled
Do not load 2 capsules at the same time.
V inhalator ne smete vstaviti 2 kapsul naenkrat.
It is recommended to administer this medicinal product cautiously to patients with severe hepatic impairment.
Priporoča se previdnost pri dajanju tega zdravila bolnikom s hudo okvaro jeter.
Tear off package of 2 capsules.
Odtrgajte ovojnino z 2 kapsulama.
Neoplasm benign, malignant and unspecified (incl.
Benigne, maligne in neopredeljene novotvorbe
A dose adjustment of levodopa may be required with concomitant use of COMT inhibitors.
Pri sočasni uporabi zaviralcev COMT je lahko potrebna prilagoditev odmerka levodope.
Symptomatic postural hypotension has occurred when combinations of levodopa and a dopadecarboxylase inhibitor are added to the treatment of patients already receiving certain antihypertensives.
Pri dodajanju kombinacij levodope in zaviralca dopa-dekarboksilaze k zdravljenju bolnikov, ki so se že zdravili z določenimi antihipertenzivi, se je pojavila simptomatska ortostatska hipotenzija.
The pharmacokinetics of the major levodopa metabolites 3-O-methyldopa (3-OMD), 3,4dihydroxyphenylacetic acid (DOPAC) and homovanillic acid (HVA) were studied following administration of a single inhaled dose of Inbrija and a single oral carbidopa/levodopa 25 mg/100 mg immediate release tablet.
3,4-dihidroksifenilocetne kisline (DOPAC) in homovanilinske kisline (HVA), so proučili po aplikaciji enkratnega inhaliranega odmerka zdravila Inbrija in enkratnega peroralnega odmerka karbidope/levodope 25 mg/100 mg tableta s takojšnjim sproščanjem.
Dose adjustment of the antihypertensive medicinal products may be required during concomitant use of Inbrija.
Pri sočasni uporabi zdravila Inbrija je lahko potrebna prilagoditev odmerka antihipertenzivov.
The change from baseline for DLCO was compared between the Inbrija treatment group and the observational cohort; at the end of 12 months, there was no significant difference in the change from baseline between Inbrija group and the observational cohort in DLCO.
Na koncu 12 mesecev ni bilo značilnih razlik v spremembi DLCO v primerjavi z izhodiščem med skupino z zdravilom Inbrija in opazovalno kohorto.
Intercurrent respiratory infection
Sočasna okužba dihal
- A complete dose is 2 capsules taken one right after the other.
- 2 kapsuli, ki predstavljata celoten odmerek, je treba vzeti takoj eno za drugo.
Cases of falsely diagnosed pheochromocytoma in patients on levodopa/dopa-decarboxylase inhibitor therapy have been reported very rarely.
Zelo redko so poročali o primerih napačno diagnosticiranega feokromocitoma pri bolnikih, ki so se zdravili z levodopo/zaviralcem dopa-dekarboksilaze.
Parkinson's disease affects your movement and it is treated with a medicine that you take regularly.
Parkinsonova bolezen vpliva na vaše gibanje.
The capsules must only be removed from the blister immediately before use.
Kapsule se smejo vzeti iz pretisnega omota šele tik pred uporabo.
Dispose and store Step 12: Dispose of used capsules
12. korak: Odstranite uporabljene kapsule.
A total of 114 patients were randomised and treated with Inbrija 66 mg (two 33 mg capsules) and 112 patients received placebo.
33 mg kapsuli) in 112 bolnikov je prejelo placebo.
Dyspepsia,
disfonija,
Subject features
Lastnosti udeležencev
You can use a dry cotton swab or tissue to wipe the outside of the inhaler.
Zunanjost inhalatorja lahko obrišete s suho vatno blazinico ali robčkom.
Inbrija 33 mg inhalation powder, hard capsules levodopa
Inbrija 33 mg prašek za inhaliranje, trde kapsule levodopa
Baseline mean (SD) LS mean change Mean diff. (95% CI) p-value
Povprečje ob izhodišču (SD) LS povprečne spremembe Povprečna sprememba (95-% IZ)
Colfosceril palmitate (DPPC) Sodium chloride
Vsebina kapsule kolfoscerilpalmitat (DPPC)
Somnolence and episodes of sudden sleep onset
Opis izbranih neželenih učinkov Nenaden nastop spanca
Agranulocytosis, Thrombocytopenia, Leukopenia
Bolezni krvi in limfatičnega sistema anemija, agranulocitoza, trombocitopenija, levkopenija
Hepatic impairment
Peptična razjeda
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.
Duševne motnje Med zdravljenjem z levodopo ali po uvedbi/povečanju odmerka levodope lahko pri bolnikih pride do spremembe ali poslabšanja duševnega stanja in vedenjskih sprememb, tudi resnih, vključno s psihotičnemu podobnim in samomorilnim vedenjem.
Dizziness,
izpuščaj,
Each carton includes blisters of 4 capsules.
V vsaki škatli so pretisni omoti, od katerih vsak vsebuje po 4 kapsule.
You may need to have tests on your heart, liver, kidney, and blood cell tests during long-term treatment with your medicines.
Morda boste med dolgotrajnim zdravljenjem s svojimi zdravili morali opravljati preiskave srca, jeter,
A clinical study was performed with Inbrija 66 mg (2 x 33 mg capsules) administered to 56 healthy subjects (31 non-smokers and 25 smokers).
Izvedli so klinično študijo, v kateri so 56 zdravim prostovoljcem (31 nekadilcem in 25 kadilcem) dali 66 mg (2 × 33 mg kapsula) zdravila Inbrija.
Acorda Therapeutics Ireland Limited 10 Earlsfort Terrace Dublin 2, D02 T380
Dublin 2, D02 T380
Step 10: Remove capsule from inhaler Twist and pull off the mouthpiece
10. korak: Odstranite kapsulo iz inhalatorja.
For use only with the inhaler provided in the pack.
Za uporabo samo s priloženim inhalatorjem.
Read these instructions before you start using Inbrija.
Preden začnete uporabljati zdravilo Inbrija, preberite ta navodila.
Inbrija 33 mg inhalation powder, hard capsules
Inbrija 33 mg prašek za inhaliranje, trde kapsule
When experiencing an OFF period, subjects could use inhaled levodopa on demand up to five times a day.
Pri pojavu obdobja izklopa so udeleženci smeli po potrebi uporabiti levodopo za inhaliranje do petkrat na dan. Apomorfin kot osnovno zdravilo ni bil dovoljen.
Step 7: Hold inhaler away and breathe out Stand or sit with your head and chest upright.
7. korak: Držite inhalator stran od sebe in izdihnite.
How to store Inbrija
Shranjevanje zdravila Inbrija
In a subpopulation of the 12-week study, serial spirometry measurements were performed at 15, 30 and 60 minutes following the first dose of Inbrija 66 mg or placebo.
60 minut po prvem odmerku 66 mg zdravila Inbrija ali placeba.
• Only remove the capsules from the blister immediately before use.
• Kapsuli vzemite iz pretisnega omota šele tik pred uporabo.
Adverse reactions reported with oral levodopa
Neželeni učinki, o katerih so poročali pri peroralni levodopi
- Keep this leaflet.
Pritrdite pokrovček.
Abdominal pain, Constipation, Diarrhoea,
Očesne bolezni zamegljen vid, diplopija, midriaza,
Do not swallow capsules.
Kapsul ne smete pogoltniti.
Responders ONb n = 97a n = 97a
Odzivni bolniki z vklopomb n = 97a n = 97a
Sudden onset of sleep (see section 4.4),
Neznana (glejte poglavje 4.4),
Weight increased
povečana telesna masa
Contents of the pack and other information What Inbrija contains
Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Inbrija - Učinkovina je levodopa.
Because of the risk of bronchospasm, use of levodopa inhalation powder in patients with asthma, chronic obstructive pulmonary disease (COPD), or other chronic underlying lung disease is not recommended.
kronično obstruktivno pljučno boleznijo (KOPB) ali drugo kronično osnovno pljučno boleznijo ne priporoča.
Abnormal thinking including anxiety, depression, being agitated, being paranoid, delusional, or disorientated, aggressive behaviour and delirious;
halucinacijami, zmedenostjo, psihotičnemu podobnemu vedenju, dezorientacijo, agresivnim vedenjem, agitacijo in delirijem.
A symptom complex that resembles neuroleptic malignant syndrome (characterised by elevated temperature, muscular rigidity, altered consciousness, and autonomic instability), with no other obvious aetiology, has been reported in association with rapid dose reduction, withdrawal of, or changes in the background dopaminergic therapy.
V povezavi s hitrim zmanjšanjem odmerka, odtegnitvijo ali spremembami osnovnega dopaminergičnega zdravljenja so poročali o kompleksu simptomov, podobnem nevroleptičnemu malignemu sindromu (za katerega so značilne zvišana telesna temperatura, mišična rigidnost, spremenjena zavest in avtonomna nestabilnost).
Agitation,
motnje hoje,
Allergic oedema
Bolezni imunskega sistema alergijski edem
Black iron oxide (E 172) Propylene glycol Potassium hydroxide
Črnilo šelak črni železov oksid (E 172)
See section 4.4 regarding withdrawal emergent hyperpyrexia and confusion.
Za informacije o hiperpireksiji in zmedenosti, ki nastopita ob odtegnitvi, glejte poglavje 4.4.
- The capsules must only be removed from the blister pack immediately before use.
- Kapsule smete vzeti iz pretisnega omota šele tik pred uporabo.
Package leaflet: Information for the patient Inbrija 33 mg inhalation powder, hard capsules levodopa
Navodilo za uporabo Inbrija 33 mg prašek za inhaliranje, trde kapsule levodopa
risperidone, chlorpromazine, fluphenazine decanoate, phenotiazine, butyrophenone, or trifluoperazine; - metoclopramide to treat nausea; - isoniazid, an antibiotic to treat tuberculosis; - medicines for high blood pressure, as the dose may need to be adjusted; - medicines for depression called tricyclic antidepressants such as clomipramin, desipramin, or doxepin; - amantadine to treat flu or your Parkinson's disease.
- zdravila za zdravljenje visokega krvnega tlaka, saj bo morda treba prilagoditi odmerek; - zdravila proti depresiji, ki jim pravimo triciklični antidepresivi, kot so klomipramin, desipramin ali doksepin;
Smoking
kolcanje
Respiration abnormal, Dysphonia, Hiccups
Bolezni kože in podkožja angioedem, hiperhidroza,
Cognitive disorder, Horner's syndrome, Dementia
Hornerjev sindrom,
- melanoma (a type of skin cancer) or suspicious skin growths or marks.
- novi ali povečani nenormalni telesni gibi (diskinezija); - občutek omotičnosti ob vstajanju (nizek krvni tlak); - melanom (vrsta kožnega raka) ali sumljive spremembe ali izrastki na koži.
Restless legs syndrome, Neuroleptic malignant syndrome (see section 4.4), Ataxia,
nevroleptični maligni sindrom (glejte poglavje 4.4),
Orthostatic hypotension (see section 4.4),
Žilne bolezni ortostatska hipotenzija (glejte poglavje 4.4), hipertenzija, sinkopa,
Caution should be exercised when interpreting the plasma and urine levels of catecholamines and their metabolites in patients on levodopa or levodopa/dopadecarboxylase inhibitor therapy.
Pri bolnikih, zdravljenih z levodopo/zaviralcem dopa-dekarboksilaze je potrebna previdnost pri interpretaciji koncentracij kateholaminov in njihovih presnovkov v plazmi in urinu.
Carefully peel back the foil and take out 1 capsule.
Previdno povlecite in odstranite folijo ter vzemite
Due to cough, 2% of subjects withdrew from the clinical studies with Inbrija.
Inbrija izstopilo 2 % udeležencev.
• Dispose of the inhaler after you are finished all of the capsules in the carton.
• Ko porabite vse kapsule iz škatle, zavrzite inhalator.
Bronchospasm in patients with lung disease
4.4 Posebna opozorila in previdnostni ukrepi Bronhospazem pri bolnikih s pljučno boleznijo
Step 13: Store inhaler Make sure there are no capsules in the inhaler
13. korak: Shranite inhalator.
Delusion
demenca
Upper respiratory tract infection,
Bolezni dihal, prsnega koša in mediastinalnega prostora kašelj okužba zgornjih dihal,
Step 8: Breathe in deeply to inhale powder While keeping the inhaler level, close your lips firmly around the mouthpiece.
8. korak: Globoko vdihnite, da inhalirate prašek.
Worsening of Parkinson's disease,
- amantadin za zdravljenje gripe ali Parkinsonove bolezni.
Oedema peripheral, Asthenia,
nespečnost, psihiatrična motnja,
Inbrija has not specifically been studied in patients with renal impairment.
Zdravila Inbrija niso posebej proučevali pri bolnikih z okvaro ledvic.
Pathological gambling, increased libido, hypersexuality, compulsive spending or buying, binge eating and compulsive eating can occur in patients treated with dopamine agonists and/or other dopaminergic treatments containing levodopa (see section 4.4).
Pri bolnikih, zdravljenih z dopaminskimi agonisti in/ali drugimi dopaminergičnimi zdravili, ki vsebujejo levodopo, se lahko pojavijo patološko igranje iger na srečo, povečan libido,
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.
(2 × 33 mg kapsula) zdravila Inbrija in 45 minut po odmerku karbidope/levodope 25 mg/100 mg tableta s takojšnjim sproščanjem.
Headache,
- kašelj.
Inbrija has not specifically been studied in patients with hepatic impairment.
Zdravila Inbrija niso posebej proučevali pri bolnikih z okvaro jeter.
Nausea, Vomiting
bruksizem, paranoja, blodnje
Daily OFF-time (h)
Dnevni čas izklopa (ure)
Hold the inhaler upright using the handle.
Pokrovček povlecite naravnost z inhalatorja.
Inbrija has not been studied in patients with renal impairment.
Zdravila Inbrija niso proučevali pri bolnikih z okvaro ledvic.
- The other ingredients comprising the powder and capsule are colfosceril palmitate (DPPC), sodium chloride, hypromellose, titanium dioxide (E 171), carrageenan, potassium chloride, carnauba wax, maize starch, shellac, black iron oxide (E 172), propylene glycol and potassium hydroxide.
- Druge sestavine praška in kapsule so kolfoscerilpalmitat (DPPC), natrijev klorid, hipromeloza,
Capsule shell
1 kapsulo iz ovojnine.
Psychotic disorder, Impulse-control disorder (see section 4.4),
Srčne bolezni motnje srčnega ritmaa (glejte poglavje 4.4), palpitacije
Confusional state, Hallucination,
ataksija, disgevzija, kognitivna motnja,
You must be sure that you do not get sudden sleep attacks, dizziness and drowsiness before you drive again or use machines.
Preden ponovno začnete voziti ali uporabljati stroje, morate biti prepričani, da se pri vas ne pojavljajo več nenadni napadi spanca,
Do not swallow Inbrija capsules.
Kapsul zdravila Inbrija ne smete pogoltniti.
How to use Inbrija
Zdravilo Inbrija
Attach the cap over the mouthpiece.
Nataknite pokrovček na ustnik.
General disorders and administration site conditions
Splošne težave in spremembe na mestu aplikacije periferni edem,
- a carton containing 60 hard capsules (15 blister strips) and one inhaler - a carton containing 92 hard capsules (23 blister strips) and one inhaler
- škatla, ki vsebuje 92 trdih kapsul (23 pretisnih trakov) in en inhalator.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Acorda Therapeutics Ireland Limited
Inbrija has not been studied in patients with hepatic impairment.
Zdravila Inbrija niso proučevali pri bolnikih z okvaro jeter.
Ready for storage
- Navodilo shranite.
OTHER
trizem
Inbrija may cause dyskinesia.
Diskinezija Zdravilo Inbrija lahko povzroči diskinezijo.
What you need to know before you use Inbrija Do not use Inbrija:
Kaj je zdravilo Inbrija in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Inbrija Kako uporabljati zdravilo Inbrija
The Inbrija inhaler is to be thrown away after all the capsules have been used.
Ko se porabijo vse kapsule, je treba inhalator za zdravilo Inbrija zavreči.
Date of latest renewal: 9 July 2011
Datum zadnjega podaljšanja: 09. julij 2011
Adequate hydration should be maintained.
Vzdrževati je treba ustrezno hidracijo.
The combination should be used with caution.
Kombinacijo je treba uporabljati previdno.
It is best to take tablets at the same time each day.
Najbolje je, da jih jemljete vsak dan ob istem času.
If you forget to take a dose, take it as soon as possible.
Če ste pozabili vzeti odmerek, ga vzemite čim prej.
This should be taken into account when treating infections caused by H. influenzae.
To je treba upoštevati pri zdravljenju okužb, ki jih povzroča H. influenzae.
Your doctor will tell you how many Ketek tablets to take, at what time and for how long.
Vaš zdravnik vam bo povedal, koliko tablet zdravila Ketek jemljite, kdaj in kako dolgo.
The mechanisms are incompletely known.
Mehanizem ni v popolnosti znan.
Not known (cannot be estimated from the available data)*
Neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov)*
In the event of acute overdose the stomach should be emptied.
V primeru akutnega prevelikega odmerjanja je treba izprazniti želodec.
The significance of these findings for humans is unknown.
Pomen teh izsledkov za človeka ni znan.
The patients should be carefully observed and given symptomatic and supportive treatment.
Bolnike je treba natančno opazovati in jim zagotoviti simptomatsko in podporno zdravljenje.
The in vitro protein binding is approximately 60% to 70%.
In vitro je vezava na beljakovine približno 60 do 70 %.
Ketek is indicated for the treatment of the following infections:
Ketek je indiciran za zdravljenje naslednjih okužb:
If you are pregnant do not take Ketek as the safety of this medicine in pregnancy is insufficiently established.
Če ste noseči, ne jemljite zdravila Ketek, ker varnost tega zdravila med nosečnostjo ni zadostno dokazana.
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
Imetnik dovoljenja za promet z zdravilom mora redno posodobljena poročila o varnosti zdravila za to zdravilo predložiti v skladu z zahtevami, določenimi v seznamu referenčnih datumov Unije (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES in objavljenem na evropskem spletnem
These visual disturbances may happen suddenly and last several hours.
Takšne motnje vida lahko nastopijo nenadoma in trajajo več ur.
The volume of distribution is 2.9±1.0 l/kg.
Volumen porazdelitve je 2,9 ± 1,0 l/kg.
The tablets should be swallowed whole with a sufficient amount of water.
Tablete je treba pogoltniti cele, z zadostno količino vode.
There were no significant changes in ECG parameters and no signs of digoxin toxicity were observed.
Pomembnih sprememb v parametrih EKG ni bilo in znakov toksičnosti digoksina niso opažali.
However, if it is nearly time for your next dose skip the missed dose and take the next tablet at the usual time.
Če pa je že blizu čas za naslednji odmerek, preskočite izpuščeni odmerek in vzemite naslednjo tableto ob običajnem času.
The non-renal clearance is decreased as the dose is increased.
Neledvični očistek se zmanjšuje, ko se odmerek povečuje.
Telithromycin is widely distributed throughout the body.
Telitromicin se široko porazdeljuje po vsem telesu.
Swallow the tablets whole with a glass of water.
Tablete pogoltnite cele s kozarcem vode.
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.
Pri pljučnicah, dobljenih v domačem okolju, je bila učinkovitost dokazana pri omejenem številu bolnikov z dejavniki tveganja, kakršna sta pnevmokokna bakteriemija ali starost nad 65 let.
Ketek is not recommended for use in children less than 12 years old.
Uporaba zdravila Ketek ni priporočljiva pri otrocih pod 12 let.
Take the complete course of tablets prescribed by your doctor, even if you begin to feel better before you have finished them all.
Dokončajte celotno zdravljenje, ki vam ga je predpisal zdravnik, tudi če se začnete počutiti bolje, še preden ste porabili vse.
Most events were mild to moderate; however, severe cases have been reported.
Večina dogodkov je bila blagih do zmernih, vendar pa so poročali tudi o hudih primerih.