natgillin/translations-raw huggingface dataset:
- inflammation of the bowel (colitis) linked to antibiotic use (can be fatal in rare cases) (see Section 2: Take special care with Ciprofloxacin Bayer) - changes to the blood count (leukopenia, leukocytosis, neutropenia, anaemia), a drop in the number of red and white blood cells and platelets (pancytopenia), which may be fatal, bonemarrow depression which may also be fatal (see Section 2: Take special care with Ciprofloxacin Bayer) - allergic reaction, allergic swelling (oedema), rapid swelling of the skin and mucous membranes (angiooedema), severe allergic reaction (anaphylactic shock) which can be life-threatening (see Section 2: Take special care with Ciprofloxacin Bayer) - increased blood sugar (hyperglycemia) - anxiety reaction, strange dreams, depression, mental disturbances (psychotic reactions) (see Section 2: Take special care with Ciprofloxacin Bayer) - decreased skin sensitivity, tremor, migraine, disorder of sense of smell (olfactory disorders) - tinnitus, impaired hearing - fainting, inflammation of the blood vessel (vasculitis) - shortness of breath including asthmatic symptoms - pancreatitis
pogosti bruhanje, prehodno zvišanje vrednosti transaminaz, izpuščaj občasni trombocitopenija, trombocitemija, zmedenost in dezorientiranost, halucinacije, parestezija in disestezija, krči, vrtoglavica, motnje vida, oglušitev, tahikardija, vazodilatacija, hipotenzija, prehodna jetrna okvara, holestatska zlatenica, ledvična odpoved, edem redki pancitopenija, depresija kostnega mozga, anafilaktični šok, psihotične reakcije, migrena, motnje vonja, okvara sluha, vaskulitis, pankreatitis, jetrna nekroza, petehije, pretrganje kite
NAME OF THE MEDICINAL PRODUCT Ciprofloxacin Bayer and associated names (see Annex I) 250 mg film-coated tablets [See Annex I - To be completed nationally] Ciprofloxacin
Ciprofloksacin Bayer in povezana imena (Glejte Dodatek I) 250 mg filmsko obložene tablete [Glejte Dodatek I - Izpolni država članica] ciprofloksacin
CIPROXIN 500 mg modified release tablets oral use
CIPROXIN 500 mg tablete s prirejenim sproščanjem peroralna uporaba
200 mg/100 ml solution for infusion intravenous use
200 mg/100 ml raztopina za infundiranje intravenska uporaba 2 mg / ml
200 mg /100 ml solution for infusion intravenous use
200 mg/100 ml raztopina za infundiranje intravenska uporaba 2 mg/ml
Anaerobic micro-organisms Mobiluncus
Mobinculus drugi mikroorganizmi
20 mg/kg body weight twice daily with a maximum of 750 mg per dose, corresponding to a 0.2 mL/kg body weight twice daily with a maximum of 7.5 mL per dose
cistična fibroza 20 mg/kg telesne mase dvakrat na dan; največ 750 mg na odmerek kar odgovarja 0,2 ml/kg telesne mase dvakrat na dan; največ 7,5 ml na odmerek
NAME OF THE MEDICINAL PRODUCT Ciprofloxacin Bayer and associated names (see Annex I) 100 mg film-coated tablets [See Annex I - To be completed nationally] Ciprofloxacin
Ciprofloksacin Bayer in povezana imena (Glejte Dodatek I) 100 mg filmsko obložene tablete [Glejte Dodatek I - Izpolni država članica] ciprofloksacin
Ciprofloxacin Bayer and associated names (see Annex I) 100 mg film-coated tablets [See Annex I - To be completed nationally]
Ciprofloksacin Bayer in povezana imena (Glejte Dodatek I) 100 mg filmsko obložene tablete [Glejte Dodatek I - Izpolni država članica]
• Infections of the gastro-intestinal tract (e.g. travellers` diarrhoea)
• okužbe prebavil (npr. potovalna driska)
NAME OF THE MEDICINAL PRODUCT Ciprofloxacin Bayer and associated names (see Annex I) 500 mg film-coated tablets [See Annex I - To be completed nationally] Ciprofloxacin
Ciprofloksacin Bayer in povezana imena (Glejte Dodatek I) 500 mg filmsko obložene tablete [Glejte Dodatek I - Izpolni država članica] ciprofloksacin
Serratia marcescens*
Serratia marcescens * anaerobni mikroorganizmi
(angio-oedema) - increased blood sugar (hyperglycaemia) - confusion, disorientation, anxiety reactions, strange dreams, depression, or hallucinations
− hiperaktivnost, vznemirjenost, zmedenost, dezorientiranost, halucinacije
- a special type of reduced red blood cell count (haemolytic anaemia); a dangerous drop in a type of white blood cells (agranulocytosis ) - severe allergic reaction (anaphylactic reaction, anaphylactic shock, serum sickness) which can be fatal (see Section 2: Take special care with Ciprofloxacin Bayer) - disturbed coordination, unsteady walk (gait disturbance), pressure on the brain (intracranial pressure) - visual colour distortions - various skin eruptions or rashes (e.g. the potentially fatal Stevens-Johnson syndrome or toxic epidermal necrolysis) - muscle weakness, tendon inflammation, worsening of the symptoms of myasthenia gravis (see Section 2: Take special care with Ciprofloxacin Bayer)
− zmanjšanje števila rdečih krvnih celic (hemolitična anemija), nevarno zmanjšanje števila vrste belih krvnih celic (agranulocitoza), zmanjšanje števila rdečih in belih krvnih celic in krvnih ploščic (pancitopenija), ki je lahko smrtno nevarna; depresija kostnega mozga, ki je tudi lahko smrtno nevarna (glejte poglavje 2: Bodite posebno pozorni pri jemanju zdravila Ciprofloksacin Bayer)
Ciproxina OD 1000 mg modified release tablets oral use
Ciproxina OD 1000 mg tablete s prirejenim sproščanjem peroralna uporaba
250 mg/5 ml oral suspension oral use use
250 mg/5 ml peroralna suspenzija peroralna uporaba use 50 mg/ml
20 mg/kg body weight twice daily with a maximum of 750 mg per dose, corresponding to a 0.4 mL/kg body weight twice daily with a maximum of 15-mL per dose
cistična fibroza 20 mg/kg telesne mase dvakrat na dan; največ 750 mg na odmerek kar odgovarja 0,4 ml/kg telesne mase dvakrat na dan; največ 15 ml na odmerek
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER WRAP (containing 1 infusion bag of 200 mg / 100 mL solution for infusion)
PODATKI NA ZUNANJI OVOJNINI ZUNANJI OMOT (vsebuje 1 vrečo s 100 ml raztopine za infundiranje)
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS SINGLE DOSE SACHETS 500 MG
VREČICA ZA ENKRATNO UPORABO 500 MG
Ciprofloxacin Bayer
Ciprofloksacin Bayer
Rare
nevarna)
100 mg film-coated tablets oral use use
100 mg filmsko obložene tablete peroralna uporaba use 100 mg
Muscular weakness Tendinitis Tendon rupture (predominan tly Achilles tendon) (see section 4.4) Exacerbation of symptoms of myasthenia gravis (see section 4.4)
Bolezni živčevja glavobol omotica motnje spanja motnje okusa parestezija in disestezija hipoestezija tremor krči (glejte poglavje 4.4) vrtoglavica migrena motnje koordinacije motnje ravnotežja motnje vohanja zvišan intrakranialni tlak periferna nevropatija (glejte poglavje 4.4)
• taking tizanidine (see Section 2: Taking other medicines)
− občutljivost za svetlobo (glejte poglavje 2: Bodite posebno pozorni pri uporabi zdravila
Section 2: Take special care with Ciprofloxacin Bayer) - decreased skin sensitivity, tremor, migraine, disorder of sense of smell (olfactory disorders) - tinnitus, impaired hearing - fainting, inflammation of the blood vessel (vasculitis) - shortness of breath including asthmatic symptoms - pancreatitis - hepatitis, death of liver cells (liver necrosis) very rarely leading to life-threatening liver failure
Bolezni jeter, žolčnika in žolčevodov prehodno zvišanje vrednosti transaminaz zvišanje vrednosti bilirubina jetrna okvara holestatski ikterus hepatitis jetrna nekroza (zelo redko napreduje v smrtno nevarno jetrno odpoved)
Haemolytic anaemia Agranulocyt osis
Bolezni sečil ledvična ledvična odpoved
Excretion of ciprofloxacin (% of dose) Oral Administration Urine
izločanje ciprofloksacina (% odmerka) peroralna uporaba seč blato ciprofloksacin presnovki (M1 - M4)
What Ciprofloxacin Bayer contains
Kaj vsebuje zdravilo Ciprofloksacin Bayer
Pharmacokinetics of ciprofloxacin were linear over the dose range up to 400 mg administered intravenously.
Farmakokinetika ciprofloksacina je linearna pri i.v.
500 mg twice daily to 750 mg twice daily max. of 3 months
750 mg dvakrat na dan 28 dni do 3 mesecev 250 mg do 500 mg dvakrat na dan
400 mg twice daily to 400 mg three times a day max. of 3 months
400 mg dvakrat na dan do 400 mg trikrat na dan največ 3 mesece zdravljenje okužb ali preprečevanje
Ask your doctor or pharmacist if you are not sure how many tablets to take and how to take Ciprofloxacin Bayer.
Če ste negotovi koliko tablet morate vzeti in kako dolgo jih morate jemati, se posvetujte z zdravnikom ali farmacevtom.
What Ciprofloxacin Bayer looks like and contents of the pack Granules and solvent for oral suspension [To be completed nationally]
Izgled zdravila Ciprofloksacin Bayer in vsebina pakiranja zrnca in vehikel za peroralno suspenzijo [Izpolni država članica]
- nausea, diarrhoea, vomiting - joint pains in children - local reaction at the injection site, rash - temporary increased amounts of substances in the blood (transaminases)
− motnje v delovanju jeter, zvečane vrednosti določenih snovi v krvi (bilirubina), zlatenica
400 mg three times a day
400 mg dvakrat na dan 3 dni tifusna vročica
- sensitivity to light (see Section 2: Take special care with Ciprofloxacin Bayer), small, pin-point bleeding under the skin (petechiae) - muscle pain, inflammation of the joints, increased muscle tone, cramping, tendon ruptureespecially of the large tendon at the back of the ankle (Achilles tendon) (see Section 2: Take special care with Ciprofloxacin Bayer) - blood or crystals in the urine (see Section 2: Take special care with Ciprofloxacin Bayer), urinary tract inflammation - excessive sweating - abnormal levels of a clotting factor (prothromibin) increased levels of the enzyme amylase
− zbadanje, neobičajno zaznavanje dražljajev, zmanjšana občutljivost kože, tremor, krči (glejte poglavje 2: Bodite posebno pozorni pri jemanju zdravila Ciprofloksacin Bayer) ali omotica
Dyspepsia Flatulence
flatulenca
The Ciprofloxacin Bayer 250 mg oral suspension in single-dose sachets are indicated for the treatment of the following infections (see sections 4.4 and 5.1).
Zdravilo Ciprofloksacin Bayer 250 mg peroralna suspenzija, vrečice za enkratno uporabo se uporablja za zdravljenje naslednjih okužb (glejte poglavji 4.4 in 5.1).. Pred začetkom zdravljenja je potrebno posebno pozornost nameniti podatkom o odpornosti na ciprofloksacin.
500 mg oral suspension (in single dose sachets)
500 mg peroralna suspenzija, vrečice za enkratno uporabo peroralna uporaba
Diarrhoea caused by Shigella dysenteriae type 1
400 mg dvakrat na dan 1 dan driska, ki jo povzroča Shigella dysenteriae tipa 1
Ciproxina OD 500 mg modified release tablets oral use
Ciproxina OD 500 mg tablete s prirejenim sproščanjem peroralna uporaba
This means that it reduces the activity of the immune system (the body's natural defences).
To pomeni, da zmanjšuje aktivnost imunskega sistema (naravne obrambe telesa).
Tacrolimus has been used since the mid-1990's.
Takrolimus se uporablja od sredine devetdesetih let preteklega stoletja.
Other information about Advagraf:
Druge informacije o zdravilu Advagraf:
Advagraf is given once a day, in the morning, at least one hour before or two to three hours after food.
Zdravilo Advagraf se daje enkrat dnevno zjutraj, najmanj eno uro pred obrokom ali dve do tri ure po obroku.
The marketing authorisation holder is Astellas Pharma Europe B.V.
Imetnik dovoljenja za promet z zdravilom je družba Astellas Pharma Europe B.V.
The European Commission granted a marketing authorisation valid throughout the EU for Advagraf on 23 April 2007.
Evropska komisija je dovoljenje za promet z zdravilom Advagraf, veljavno po vsej Evropski uniji, odobrila 23. aprila 2007.
Advagraf was as effective as both comparator medicines.
Zdravilo Advagraf je bilo enako učinkovito kot obe primerjalni zdravili.
This can help the patients stick to their treatment.
To lahko bolnikom olajša zdravljenje.
Doctors should monitor the levels of tacrolimus in the blood to check that they stay within predefined ranges.
Zdravnik mora spremljati koncentracije takrolimusa v krvi, da bi se tako prepričal, da te ostajajo znotraj predhodno določenih razponov.
EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) ADVAGRAF EPAR summary for the public
EVROPSKO JAVNO POROČILO O OCENI ZDRAVILA (EPAR) ADVAGRAF Povzetek EPAR za javnost
Patients and doctors must be careful when other medicines (including some herbal remedies) are taken at the same time as Advagraf, as there may be a need to adjust the dose of Advagraf or the dose of the medicine it is taken with.
Bolniki in zdravniki morajo biti pazljivi pri jemanju drugih zdravil (vključno z nekaterimi zeliščnimi zdravili) sočasno z zdravilom Advagraf, saj utegne biti potrebno prilagoditi odmerek zdravila Advagraf ali zdravila, s katerim se zdravilo Advagraf jemlje.
Advagraf is for long-term use.
Zdravilo Advagraf je predvideno za dolgotrajno uporabo.
In the European Union (EU), it has been available as capsules under the name Prograf or Prograft (depending on the country).
V Evropski uniji (EU) je na voljo v obliki kapsul z imenom Prograf ali Prograft (odvisno od države).
Because tacrolimus and Prograf/Prograft have already been used in the EU, the company presented the results of studies that had been carried out with Prograf/Prograft previously, as well as data from the published literature.
Ker se takrolimus in zdravilo Prograf/Prograft v EU že uporabljata, je podjetje predložilo rezultate študij, ki so bile predhodno izvedene z zdravilom Prograf/Prograft, ter podatke iz objavljene literature.
The Committee recommended that Advagraf be given marketing authorisation.
Odbor je zato priporočil, da se za zdravilo Advagraf odobri dovoljenje za promet.
Tacrolimus acts on some special cells in the immune system called T-cells that are primarily responsible for attacking the transplanted organ (organ rejection).
Takrolimus učinkuje na nekatere posebne celice v imunskem sistemu, imenovane celice T, ki so v prvi vrsti odgovorne za napadanje presajenega organa (zavrnitev organa).
Doses are calculated based on the patient's weight.
Odmerki se izračunajo na osnovi bolnikove telesne mase.
It is available as prolongedreleased capsules containing tacrolimus (0.5 mg: yellow and orange; 1 mg: white and orange; 5 mg: greyish-red and orange).
Na voljo je v obliki kapsul s podaljšanim sproščanjem, ki vsebujejo takrolimus (0,5 mg rumene in oranžne barve, 1 mg bele in oranžne barve, 5 mg sivkasto-rdeče in oranžne barve).
Patients also received mycophenolate mofetil (another medicine used in the prevention of rejection).
Bolniki so prejemali tudi mikofenolat mofetil (drugo zdravilo, ki se uporablja za preprečevanje zavrnitve).
‘Prolonged-release' means that tacrolimus is released slowly from the capsule over a few hours.
Podaljšano sproščanje pomeni, da se takrolimus iz kapsule sprošča počasi več ur.
The most common side effects with Advagraf (seen in more than 1 patient in 10) are tremor (shaking), headache, nausea (feeling sick), diarrhoea, kidney problems, hyperglycaemia (raised blood glucose levels), diabetes, hyperkalaemia (raised blood potassium levels), hypertension (high blood pressure) and insomnia (difficulty sleeping).
Najpogostejši neželeni učinki zdravila Advagraf (opaženi pri več kot 1 bolniku izmed 10) so tremor (tresenje), glavobol, navzea (občutek slabosti), driska, težave z ledvicami, hiperglikemija (povečane ravni glukoze v krvi), sladkorna bolezen, hiperkaliemija (povečane ravni kalija v krvi), hipertenzija (visok krvni tlak) in nespečnost.
What benefit has Advagraf shown during the studies?
Kakšne koristi je zdravilo Advagraf izkazalo med raziskavami?
Advagraf can also be used to treat organ rejection in adult patients when other immunosuppressive medicines are not effective.
Zdravilo Advagraf se lahko uporablja tudi za zdravljenje zavrnitev organov pri odraslih bolnikih, kadar druga imunosupresivna zdravila niso učinkovita.
What is the risk associated with Advagraf?
Kakšna tveganja so povezana z zdravilom Advagraf?
The main measure of effectiveness was the number of patients in whom the transplant failed (as measured by looking at, for example, the need for a repeat transplant or a return to dialysis) after one year's treatment.
Glavno merilo učinkovitosti je bilo število bolnikov, pri katerih se je presaditev po enoletnem zdravljenju izkazala za neuspešno (merilo je bila na primer potreba po ponovni presaditvi ali vrnitvi na dializo).
The percentages were 15% in the patients treated with Prograf/Prograft, and 17% in those treated with ciclosporin.
Pri bolnikih, ki so prejemali zdravilo Prograf/Prograft, je bil ta delež 15 %, pri bolnikih, ki so prejemali ciklosporin, pa 17 %.
Advagraf should not be used in people who may be hypersensitive (allergic) to tacrolimus, to macrolide antibiotics (such as erythromycin) or to any of the other ingredients.
Zdravila Advagraf ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) takrolimus, makrolidne antibiotike (kot je na primer eritromicin) ali na katerokoli drugo sestavino zdravila.
Treatment with Advagraf should only be prescribed by doctors who have experience in the management of transplant patients.
Zdravljenje z zdravilom Advagraf sme predpisati samo zdravnik z izkušnjami z zdravljenjem bolnikov s presadki.
Further shorter studies were also carried out in 119 kidney transplant patients and 129 liver transplant patients, looking at how Advagraf is absorbed by the body in comparison to Prograf/Prograft.
Izvedene so bile tudi nadaljnje krajše študije s 119 bolniki s presajenimi ledvicami in 129 bolniki s presajenimi jetri, v katerih so preučevali, kako telo absorbira zdravilo Advagraf v primerjavi z zdravilom Prograf/Prograft.
Advagraf is a medicine containing the active substance tacrolimus.
Advagraf je zdravilo, ki vsebuje zdravilno učinkovino takrolimus.
This allows Advagraf to be given once a day, whereas Prograf/Prograft is given twice a day.
Pri zdravilu Advagraf zato zadošča en odmerek dnevno, medtem ko se zdravilo Prograf/Prograft daje dvakrat dnevno.
Advagraf is very similar to Prograf/Prograft, but the way the medicine is made has been changed so that the active substance is released more slowly from the capsule than it is in Prograf/Prograft.
Zdravilo Advagraf je zelo podobno zdravilu Prograf/Prograft, vendar je izdelano na drugačen način, in sicer tako da se zdravilna učinkovina iz kapsule sprošča počasneje kot pri zdravilu Prograf/Prograft.
It also presented the results of a clinical study in 668 kidney transplant patients comparing the use of Advagraf with that of Prograf/Prograft or ciclosporin (another immunosuppressive medicine used in the prevention of rejection).
Predložilo je tudi rezultate klinične študije s 668 bolniki s presajenimi ledvicami, v kateri so primerjali uporabo zdravila Advagraf z uporabo zdravila Prograf/Prograft ali ciklosporina (drugega imunosupresivnega zdravila, ki se uporablja za preprečevanje zavrnitve).
See the Package Leaflet for details.
Za več podrobnosti glejte Navodilo za uporabo.
In liver transplant, the starting dose is 0.10 to 0.20 mg/kg.
Pri presaditvi jeter je začetni odmerek 0,10 do 0,20 mg/kg.
The shorter studies in kidney and liver transplant patients showed that Advagraf and Prograf/Prograft have comparable absorption in the body.
Krajše študije z bolniki s presaditvijo ledvic in jeter so pokazale, da se zdravili Advagraf in Prograf/Prograft primerljivo absorbirata v telesu.
After one year, 14% of the patients receiving Advagraf had experienced organ failure.
Po enem letu je prišlo do odpovedi organa pri 14 % bolnikov, ki so prejemali zdravilo Advagraf.
In the prevention of rejection, the dose of Advagraf to use depends on the type of transplant the patient has received.
Odmerek zdravila Advagraf, uporabljen za preprečevanje zavrnitve, je odvisen od vrste presadka, ki ga je bolnik prejel.
Why has Advagraf been approved?
Zakaj je bilo zdravilo Advagraf odobreno?
For the full list of all side effects reported with Advagraf, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Advagraf, glejte Navodilo za uporabo.
In kidney transplant, the starting dose is 0.20 to 0.30 mg per kilogram body weight.
Pri presaditvi ledvic je začetni odmerek 0,20 do 0,30 mg na kilogram telesne mase.
The Committee for Medicinal Products for Human Use (CHMP) decided that Advagraf's benefits are greater than its risks for the prophylaxis of transplant rejection in adult kidney and liver allograft recipients, and in the treatment of allograft rejection resistant to treatment with other immunosuppressive medicinal products in adult patients.
Odbor za zdravila za uporabo v humani medicini (CHMP) je sklenil, da so koristi zdravila Advagraf pri preprečevanju zavrnitve presadka pri odraslih prejemnikih alogenskega presadka ledvic ali jeter ter pri zdravljenju zavrnitve alogenskega presadka, odporne na zdravljenje z drugimi imunosupresivnimi zdravili, pri odraslih bolnikih večje od z njim povezanih tveganj.
When treating rejection, these same doses may be used in kidney and liver transplants.
Isti odmerki se lahko pri presaditvah ledvic in jeter uporabljajo za zdravljenje zavrnitve.
The full EPAR for Advagraf can be found here.
Celotno Evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Advagraf je na voljo tukaj.
What is Advagraf used for?
Za kaj se zdravilo Advagraf uporablja?
How has Advagraf been studied?
Kako je bilo zdravilo Advagraf raziskano?
Tacrolimus, the active substance in Advagraf, is an immunosuppressive agent.
Zdravilna učinkovina zdravila Advagraf, takrolimus, je imunosupresivna učinkovina.
What is Advagraf?
Kaj je zdravilo Advagraf?
Advagraf is used in adult patients who have had a kidney or liver transplant, to prevent rejection (when the immune system attacks the transplanted organ).
Zdravilo Advagraf se uporablja za preprečevanje zavrnitve presadka (ko imunski sistem napade presajen organ) pri odraslih bolnikih, pri katerih je bila opravljena presaditev ledvic ali jeter.
How is Advagraf used?
Kako se zdravilo Advagraf uporablja?
How does Advagraf work?
Kako zdravilo Advagraf deluje?
Starting doses are 0.10 to 0.30 mg/kg in other types of transplant (heart, lung, pancreas or intestine).
Pri drugih vrstah presadkov (srce, pljuča, trebušna slinavka ali črevesje) pa znašajo začetni odmerki 0,10 do 0,30 mg/kg.
Consequently, newborn infants should be monitored carefully.
Posledično je treba takšne novorojenčke skrbno nadzirati.
Date of first authorisation: 01 September 2010 Date of latest renewal: 05 May 2015
Datum prve odobritve: 01. september 2010 Datum zadnjega podaljšanja: 05. maj 2015
* See subsection “Falls” below
*Glejte spodaj podpoglavje "Padci"
Reported estimated doses were between 15 and 400 mg.
Prijavljeni ocenjeni odmerki so bili med 15 in 400 mg.
Patients with rapid cycling were excluded from these studies.
Bolniki s hitrejšimi cikli so bili iz teh študij izključeni.
Paediatric population (children and adolescents)
Pediatrična populacija (otroci in mladostniki)
If you are unable to take this medicine as is described below, the treatment may not be effective for you.
Če tega zdravila ne morete jemati tako, kot je opisano v nadaljevanju, zdravljenje pri vas morda ne bo učinkovito.
This medicine belongs to a group of medicines called antipsychotics.
To zdravilo sodi v skupino zdravil, ki jim pravimo antipsihotiki.
Available pharmacokinetic data are described in section 5.2.
Farmakokinetični podatki, ki so na voljo, so opisani v poglavju 5.2.
Keep the tablet under your tongue until it dissolves.
Tableto držite pod jezikom, dokler se ne raztopi.
Patients from the two pivotal 3 week trials were studied for a further 9 weeks an extension trial.
Bolnike iz dveh ključnih 3-tedenskih preskušanj so dodatno preiskovali še v 9-tedenskem podaljšanem preskušanju.
One dose should be taken in the morning and one dose should be taken in the evening.
En odmerek vzemite zjutraj in enega zvečer.
Drynam Road, Swords, Co. Dublin Ireland
Drynam Road, Swords, Co. Dublin Irska
Close medical supervision and monitoring should continue until the patient recovers.
Skrben zdravniški nadzor in spremljanje bolnika naj trajata, dokler bolnik ne okreva.
Following an initial more rapid distribution phase, the terminal half-life of asenapine is approximately 24 h.
Po začetni hitrejši fazi porazdelitve znaša končna razpolovna doba asenapina približno 24 ur.