natgillin/translations-raw huggingface dataset:
• The usual starting dose is 1.25 mg once daily to 2.5 mg twice daily.
• Običajen začetni odmerek je od 1,25 mg enkrat na dan do 2,5 mg dvakrat na dan.
Patients with renal impairment (see section 4.2)
Bolniki z okvaro jeter (glejte poglavje 5.2)
Latvia: Cardace 2.5 mg tabletes, Cardace 5 mg tabletes, Cardace 10 mg tabletes
Latvija: Cardace 2.5 mg tabletes, Cardace 5 mg tabletes, Cardace 10 mg tabletes
• The usual dose is 10 mg once daily.
• Običajen odmerek je 10 mg enkrat na dan.
Gastrointestinal inflammation, digestive disturbances, abdominal discomfort, dyspepsia, diarrhoea, nausea, vomiting
Bolezni živčevja glavobol, omotica vrtoglavica, parestezije, agevzija, dizgevzija,
HOW TO STORE TRITACE [To be completed nationally]
SHRANJEVANJE ZDRAVILA TRITACE [Izpolni država članica]
• The usual starting dose is 1.25 mg once daily.
• Običajen začetni odmerek je 1,25 mg enkrat na dan.
Diuretic-Treated patients
Bolniki, ki dobivajo diuretike
• The usual starting dose is 2.5 mg once daily.
• Običajen začetni odmerek je 2,5 mg enkrat na dan.
Significant activation of renin-angiotensin-aldosterone system is to be anticipated and medical supervision including blood pressure monitoring is necessary, for example in: - patients with severe hypertension - patients with decompensated congestive heart failure - patients with haemodynamically relevant left ventricular inflow or outflow impediment (e.g. stenosis of the aortic or mitral valve) - patients with unilateral renal artery stenosis with a second functional kidney - patients in whom fluid or salt depletion exists or may develop (including patients with diuretics) - patients with liver cirrhosis and/or ascites - patients undergoing major surgery or during anaesthesia with agents that produce hypotension.
- z enostransko stenozo ledvične arterije in drugo funkcionalno ledvico - s pomanjkanjem soli, tekočine ali možnostjo pojava pomanjkanja (vključno z bolniki, ki dobivajo diuretike) - cirozo jeter in/ali ascitesom - velikimi operacijami ali med anestezijo z anestetiki, ki povzročijo hipotenzijo.
Myocardial ischaemia including angina pectoris or myocardial infarction,
Srčne bolezni ishemija miokarda, vključno z angino pektoris ali miokardnim infarktom, tahikardija, aritmija, palpitacije, periferni edemi
Check your blood sugar amounts closely while taking TRITACE
Med jemanjem zdravila TRITACE morate natančno kontrolirati krvni sladkor.
• Fever
• zardevanje
PHARMACOKINETIC PROPERTIES
5.2 Farmakokinetične lastnosti
Angioedema; very exceptionally, the airway obstruction resulting from angioedema may have a fatal outcome; pruritus, hyperhidrosis
Bolezni kože in podkožja izpuščaj, zlasti makulopapulozen angioedem; zelo izjemoma se lahko zožitev dihal zaradi angioedema konča s smrtjo, srbenje, hiperhidroza eksfoliativni dermatitis, urtikarija, oniholiza,
Slovak Republic: Tritace 1.25 mg tablety, Tritace 2.5 mg tablety, Tritace 5 mg tablety, Tritace 10 mg tablety
Slovaška: Tritace 1.25 mg tablety, Tritace 2.5 mg tablety, Tritace 5 mg tablety, Tritace 10 mg tablety
-Hypotension and renal dysfunction after acute myocardial infarction occurred more frequently with ramipril than placebo in the target population in the AIRE study.
- Agranulocitoza: besedilo je treba razširiti tako, da vključuje mielosupresijo in druge vplive na kri - Pri ciljni populaciji v študiji AIRE je pri jemanju ramiprila pogosteje kot pri jemanju placeba prišlo do hipotenzije in motenega delovanja ledvic po akutnem miokardnem infarktu.
NATURE AND CONTENTS OF CONTAINER [To be completed nationally]
6.5 Vrsta ovojnine in vsebina [Izpolni država članica]
PHARMACEUTICAL PARTICULARS LIST OF EXCIPIENTS [To be completed nationally] INCOMPATIBILITIES [To be completed nationally]
6 FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi [Izpolni država članica] 6.2 Inkompatibilnosti [Izpolni država članica] 6.3 Rok uporabnosti [Izpolni država članica] 6.4 Posebna navodila za shranjevanje [Izpolni država članica]
• Severe flaking or peeling of the skin, itchy, lumpy rash
• hudo luščenje ali lupljenje kože, srbeč in bulast izpuščaj
Lithuania: Cardace 2.5 mg tabletės, Cardace 5 mg tabletės, Cardace 10 mg tabletės
Litva: Cardace 2.5 mg tabletës, Cardace 5 mg tabletës, Cardace 10 mg tabletës
Always take TRITACE exactly as your doctor has told you.
Pri jemanju zdravila TRITACE natančno upoštevajte zdravnikova navodila.
Stop taking TRITACE and see a doctor straight away, if you notice any of the following serious side effects - you may need urgent medical treatment:
Če opazite katerega od naslednjih resnih neželenih učinkov, nehajte jemati zdravilo TRITACE in nemudoma pojdite k zdravniku.
Tritace 2.5 mg tabletki, Tritace 5 mg tabletki, Tritace 10 mg tabletki
Poljska: Tritace 2.5 mg tabletki, Tritace 5 mg tabletki, Tritace 10 mg tabletki
They can make TRITACE work less well:
Naslednja zdravila lahko poslabšajo delovanje zdravila TRITACE:
TRITACE and associated names (see Annex I) 1.25 mg capsules TRITACE and associated names (see Annex I) 2.5 mg capsules TRITACE and associated names (see Annex I) 5 mg capsules TRITACE and associated names (see Annex I) 10 mg capsules
TRITACE in povezana imena (glejte Dodatek I) 1.25 mg kapsule TRITACE in povezana imena (glejte Dodatek I) 2.5 mg kapsule TRITACE in povezana imena (glejte Dodatek I) 5 mg kapsule TRITACE in povezana imena (glejte Dodatek I) 10 mg kapsule
TRITACE and associated names (see Annex I) 1.25 mg tablets TRITACE and associated names (see Annex I) 2.5 mg tablets TRITACE and associated names (see Annex I) 5 mg tablets TRTACE and associated names (see Annex I) 10 mg tablets
TRITACE in povezana imena (glejte Dodatek I) 1.25 mg tablets TRITACE in povezana imena (glejte Dodatek I) 2.5 mg tablets TRITACE in povezana imena (glejte Dodatek I) 5 mg tablete TRITACE in povezana imena (glejte Dodatek I) 10 mg tablete
TRITACE and associated names (see Annex I) 1.25 mg hard capsules TRITACE and associated names (see Annex I) 2.5 mg hard capsules TRITACE and associated names (see Annex I) 5 mg hard capsules TRITACE and associated names (see Annex I) 10 mg hard capsules [See Annex I - To be completed nationally]
TRITACE in povezana imena (glejte Dodatek I) 1.25 mg trde kapsule TRITACE in povezana imena (glejte Dodatek I) 2.5 mg trde kapsule TRITACE in povezana imena (glejte Dodatek I) 5 mg trde kapsule TRITACE in povezana imena (glejte Dodatek I) 10 mg trde kapsule [Glejte Dodatek I - Izpolni država članica]
B-1180 Brussels
Egide Van Ophemstraat 110 B-1180 Bruselj Belgija
TRITACE and associated names (see Annex I) 1.25 mg tablets TRITACE and associated names (see Annex I) 2.5 mg tablets TRITACE and associated names (see Annex I) 5 mg tablets TRITACE and associated names (see Annex I) 10 mg tablets
TRITACE in povezana imena (glejte Dodatek I) 1.25 mg tablete TRITACE in povezana imena (glejte Dodatek I) 2.5 mg tablete TRITACE in povezana imena (glejte Dodatek I) 5 mg tablete TRITACE in povezana imena (glejte Dodatek I) 10 mg tablete
1,25 mg 2,5 mg 2,5 mg 5 mg 5 mg 10 mg
1,25 mg 2,5 mg 2,5 mg 5 mg 5 mg 10 mg tablete
TRITACE and associated names (see Annex I) 1.25 mg hard capsules TRITACE and associated names (see Annex I) 2.5 mg hard capsules TRITACE and associated names (see Annex I) 5 mg hard capsules TRITACE and associated names (see Annex I) 10 mg hard capsules
TRITACE in povezana imena (glejte Dodatek I) 1.25 mg trde kapsule TRITACE in povezana imena (glejte Dodatek I) 2.5 mg trde kapsule TRITACE in povezana imena (glejte Dodatek I) 5 mg trde kapsule TRITACE in povezana imena (glejte Dodatek I) 10 mg trde kapsule
Treatment of heart failure
Hospitalizacija zaradi srčnega popuščanja
DEUTSCHLAND GmbH 65926 Frankfurt am Main Germany
D-65926 Frankfurt am Main Nemčija
Tablet Hard Capsule
FARMACEVTSKA OBLIKA IN VSEBINA tableta trda kapsula
• Skin rash or bruising
• izpuščaj na koži ali podplutbe
2.5 mg 5.0 mg 10 mg
2.5 mg 5.0 mg 10 mg kapsula
1,25mg 2,5mg 5mg
1,25mg 2,5mg 5mg kapsula
Because insufficient information is available regarding the use of ramipril during breastfeeding (see section 5.2), ramipril is not recommended and alternative treatments with better established safety profiles during breast-feeding are preferable, especially while nursing a newborn or preterm infant.
Ker informacij o uporabi ramiprila med obdobjem dojenja ni dovolj, njegova uporaba med tem obdobjem ni priporočljiva (glejte poglavje 5.2).
Tritace contains ramipril, a second-generation nonsulfhydryl angiotensin converting enzyme inhibitor (ACE-I).
SPLOŠNI POVZETEK ZNANSTVENEGA VREDNOTENJA ZDRAVILA TRITACE IN Z NJIM POVEZANIH IMEN (GLEJTE DODATEK I) Zdravilo Tritace vsebuje ramipril, nesulfhidrilni zaviralec angiotenzinske konvertaze (ACE-I) druge generacije.
Hospitalisation for heart failure 3.2 Complications related to diabetes 6.4
Zapleti, povezani s sladkorno boleznijo
CONTRAINDICATIONS
DRUGI PODATKI
• Chest pain
• bolečine v prsih
This overview was last updated in February 2019.
Pregled je bil nazadnje posodobljen februarja 2019.
The medicine can be used:
Zdravilo se lahko uporablja za:
This small volume of liquid is absorbed through the skin and has an effect throughout the animal's body.
Ta majhna količina tekočine se absorbira skozi kožo in učinkuje na celotno telo živali.
Further information on Felisecto Plus can be found on the Agency's website: ema.europa.eu/medicines/veterinary/EPAR/felisecto-plus.
Nadaljnje informacije o zdravilu Felisecto Plus so na voljo na spletni strani agencije: ema.europa.eu/medicines/veterinary/EPAR/felisecto-plus.
This medicine is the same as Stronghold Plus, which is already authorised in the European Union (EU).
To zdravilo je enako zdravilu Stronghold Plus, ki je že odobreno v Evropski uniji (EU).
In case of skin or eye contact, the affected area should be rinsed immediately with water.
V primeru stika s kožo ali očmi je treba prizadeto področje nemudoma izprati z vodo.
Because ticks must start feeding on the cat in order to be killed by the medicine, the risk of transmission of diseases that they may carry cannot be excluded.
Ker se morajo klopi začeti hraniti s krvjo mačke, da bi jih zdravilo lahko uničilo, ni mogoče izključiti tveganja za prenos bolezni, s katerimi so ti lahko okuženi.
Felisecto Plus (selamectin / sarolaner)
Felisecto Plus (selamektin/sarolaner)
This results in uncontrolled activity of the nervous system and the paralysis and death of the parasites.
S tem povzroči nenadzorovano delovanje živčnega sistema ter paralizo in smrt zajedavcev.
Used pipettes of the medicine must be disposed of immediately.
Uporabljene merilne kapalke zdravila je treba takoj odvreči.
On the day of treatment, treated cats must not be allowed to sleep in the same bed as their owner, especially children.
Na dan nanosa zdravila zdravljene mačke ne smejo spati v isti postelji z lastniki, zlasti ne z otroki.
The European Medicines Agency decided that Felisecto Plus's benefits are greater than its risks and it can be authorised for use in the EU.
Evropska agencija za zdravila je odločila, da so koristi zdravila Felisecto Plus večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
It can also be used as part of a treatment for flea allergy dermatitis (an allergic reaction to flea bites)
Uporablja se lahko tudi kot del zdravljenja alergijskega dermatitisa, ki ga povzročajo bolhe (alergijske reakcije na ugrize bolh),
Sarolaner is effective against ticks and fleas.
Sarolaner je učinkovit proti klopom in bolham.
This authorisation was based on the authorisation granted to Stronghold Plus in 2017 (‘informed consent').
Izdaja tega dovoljenja je temeljila na dovoljenju za promet z zdravilom Stronghold Plus, ki je bilo izdano leta 2017 („uporaba dokumentacije s soglasjem“).
The strength and number of pipettes used depends on the weight of the cat being treated.
Jakost in število merilnih kapalk, ki jih uporabljamo, sta odvisna od teže mačke, ki jo zdravimo.
Felisecto Plus received a marketing authorisation valid throughout the EU on 26 April 2019.
Zdravilo Felisecto Plus je pridobilo dovoljenje za promet, veljavno po vsej Evropski uniji, 26/04/2019.
In order to be exposed to selamectin and sarolaner, fleas and ticks must commence feeding on the cat's blood.
Da bi bili bolhe in klopi izpostavljeni selamektinu in sarolanerju, se morajo začeti hraniti s krvjo mačke.
If the product is accidentally swallowed by a person, the advice of a doctor should be sought immediately.
Če človek zdravilo nenamerno zaužije, se mora nemudoma posvetovati z zdravnikom.
Felisecto Plus must only be used when there is a need to treat ticks and one or more of the above parasites.
Zdravilo Felisecto Plus se lahko uporablja le, ko obstaja potreba po zdravljenju klopov in ene ali več vrst zgoraj navedenih zajedavcev.
People with sensitive skin or who are hypersensitive (allergic) to selamectin or sarolaner should handle Felisecto Plus with caution.
Osebe z občutljivo kožo ali preobčutljivostjo za (alergičnostjo na) selamektin ali sarolaner, morajo z zdravilom Felisecto Plus ravnati previdno.
The effectiveness of Felisecto Plus was investigated in a field study in cats naturally infested with fleas.
Učinkovitost zdravila Felisecto Plus so raziskovali v terenski študiji pri mačkah, ki so bile naravno okužene z bolhami.
Felisecto Plus is a medicine used to treat mixed infestations with both ticks and other parasites that may be found on the skin or fur of cats, such as fleas, ear mites and lice and/or worms that can enter and infect the body.
Felisecto Plus je zdravilo, ki se uporablja za zdravljenje mešanih infestacij s klopi in drugimi paraziti, ki jih je mogoče najti na koži ali dlaki mačk, kot so bolhe, ušesne garje in uši ter/ali črvi, ki lahko vstopijo v telo in ga okužijo.
Children must not be allowed to play with treated cats for 4 hours after treatment.
Otroci se z zdravljenimi mačkami ne smejo igrati še štiri ure po nanosu zdravila.
Other information about Felisecto Plus
Druge informacije o zdravilu Felisecto Plus
This causes the paralysis or death of the parasites.
To povzroči paralizo in pogin zajedavcev.
Felisecto Plus must not be used in cats suffering from other diseases or in cats that are weak and underweight (for their age).
Zdravilo Felisecto Plus se ne sme uporabljati pri mačkah, obolelih zaradi drugih bolezni, ali mačkah, ki so oslabljene ali podhranjene (glede na starost).
The company that makes Stronghold Plus has agreed that its scientific data can be used for Felisecto Plus (‘informed consent').
Podjetje, ki proizvaja zdravilo Stronghold Plus, se strinja, da se lahko znanstveni podatki o tem zdravilu uporabijo tudi za zdravilo Felisecto Plus („uporaba dokumentacije s soglasjem“).
A second field study was conducted in cats naturally infested with ticks.
Druga terenska študija je bila izvedena z mačkami, ki so bile naravno okužene s klopi.
For more information about using Felisecto Plus, see the package leaflet or contact your veterinarian or pharmacist.
Za več informacij glede uporabe zdravila Felisecto Plus glejte navodilo za uporabo ali se posvetujte z veterinarjem ali farmacevtom.
Felisecto Plus kills fleas and some ticks within 24 hours and it continues to work for 5 weeks against fleas and 4 to 5 weeks against ticks (depending on the type).
Zdravilo Felisecto Plus povzroča pogin bolh in nekaterih vrst klopov v 24 urah ter nadaljnjih pet tednov učinkuje proti bolham in od štiri do pet tednov proti klopom (odvisno od vrste).
Sarolaner blocks the normal movement of charged chloride particles in and out of nerve cells, especially those associated with gamma-aminobutyric acid (GABA) and glutamate, two substances that convey messages between nerves (neurotransmitters).
Zavira normalno prehajanje nabitih kloridnih delcev v živčne celice in iz njih, in sicer zlasti tistih, ki so povezani z gamaaminomasleno kislino (GABA) in glutamatom, tj. dvema snovema, ki prenašata sporočila med živci (živčnima prenašalcem).
It is recommended to treat cats in the evening.
Priporoča se, da se zdravilo nanese zvečer.
The most common side effects with Felisecto Plus (which may affect up to 1 in 100 cats) are mild to moderate alopecia (hair loss) at the application site, erythema (reddening of the skin) and drooling.
Najpogostejši neželeni učinki zdravila Felisecto Plus (ki lahko prizadenejo največ 1 mačko od 100) so blaga do zmerna alopecija (izpadanje dlake) na mestu nanosa, eritem (pordelost kože) in slinjenje.
An overview of Felisecto Plus and why it is authorised in the EU
Pregled zdravila Felisecto Plus in zakaj je odobreno v EU
Why is Felisecto Plus authorised in the EU?
Zakaj je zdravilo Felisecto Plus odobreno v EU?
The content of the pipette is squeezed onto the skin after parting the fur at the base of the cat's neck in front of the shoulder blades.
Vsebino merilne kapalke iztisnemo na kožo, potem ko razmaknemo dlako v predelu zatilja mačke v sprednjem delu lopatic.
Hands should be washed after use and any product in contact with the skin should be washed off immediately with soap and water.
Po uporabi zdravila si je treba umiti roke ter nemudoma z milom in vodo sprati izdelke, ki pridejo v stik s kožo.
Safety information has been included in the summary of product characteristics and the package leaflet for Felisecto Plus, including the appropriate precautions to be followed by healthcare professionals and animal owners or keepers.
V povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo so bile vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in lastniki ali skrbniki živali.
What are the risks associated with Felisecto Plus?
Kakšna tveganja so povezana z zdravilom Felisecto Plus?
• to treat and prevent flea infestations.
• zdravljenje in preprečevanje infestacij z bolhami.
Treated animals must not be touched until the application area is dry.
Izogibati se je treba dotikanja živali, na katere je bilo naneseno zdravilo, dokler se mesto nanosa ne posuši.
Use of the medicine may result in mild and short-lived itching at the application site.
Uporaba zdravila lahko povzroči blago in kratkotrajno srbenje na mestu nanosa.
What is Felisecto Plus and what is it used for?
Kaj je zdravilo Felisecto Plus in za kaj se uporablja?
Selamectin is effective against fleas, ear mites, biting lice, heartworm larvae, roundworms and hookworms.
Selamektin učinkuje proti bolham, ušesnim garjam, ušem, ličinkam srčne gliste, valjastim in kavljastim črvom.
What benefits of Felisecto Plus have been shown in studies?
Kakšne koristi je zdravilo Felisecto Plus izkazalo v študijah?
Felisecto Plus contains selamectin and sarolaner, which are antiparasitic medicines.
Zdravilo Felisecto Plus vsebuje učinkovini selamektin in sarolaner, ki sta antiparazitski zdravili.
Two laboratory studies were conducted in cats with intestinal worms which showed Felisecto Plus to have more than 94% effectiveness.
Izvedeni sta bili dve laboratorijski študiji z mačkami z intestinalnimi črvi, ki sta pokazali, da ima zdravilo Felisecto Plus več kot 94-odstotno učinkovitost.
Felisecto Plus was as effective as the other medicine and reduced tick counts by more than 90%.
Zdravilo Felisecto Plus je bilo enako učinkovito kot drugo zdravilo in je zmanjšalo število klopov za več kot 90 %.
Felisecto Plus is highly flammable and should be kept away from heat, sparks, any open flame or other sources of ignition.
Zdravilo Felisecto Plus je lahko vnetljivo, zato ga je treba hraniti zaščitenega pred vročino, iskrami, odprtim plamenom ali drugimi vnetljivimi viri.
Cats were treated with Felisecto Plus monthly for 3 months or another medicine, containing fipronil.
Mačke so tri mesece zapored enkrat na mesec zdravili z zdravilom Felisecto Plus ali drugim zdravilom, ki je vsebovalo fipronil.
A laboratory study with cats infested with biting lice showed selamectin to eliminate biting lice for 42 days after treatment compared to placebo treated cats.
Laboratorijska študija z mačkami, okuženimi z ušmi, je pokazala, da selamektin uši odpravi v 42 dneh po zdravljenju v primerjavi z mačkami, zdravljenimi s placebom.
Two laboratory studies with cats artificially infested with ear mites showed Felisecto Plus to reduce ear mites by more than 90% 30 days after a single treatment.
Dve laboratorijski študiji z mačkami, umetno okuženimi z ušesnimi garjami, sta pokazali, da zdravilo Felisecto Plus zmanjšuje ušesne garje za več kot 90 % v 30 dneh po enem samem zdravljenju.
Cats were treated with Felisecto Plus monthly for 3 months or another similar antiparasitic medicine, containing imidacloprid and moxidectin.
Mačke so bile tri mesece zapored enkrat na mesec zdravili z zdravilom Felisecto Plus ali drugim podobnim antiparazitskim zdravilom, ki je vsebovalo imidakloprid in moksidektin.
• to treat adult roundworms and adult hookworms in the gut
• zdravljenje infestacij z odraslimi valjastimi črvi in odraslimi intestinalnimi kavljastimi črvi,
A laboratory study with cats artificially infected with heartworm showed Felisecto Plus to be effective for the prevention of heartworm disease.
Laboratorijska študija z mačkami, ki so bile umetno okužene s srčno glisto, je pokazala, da zdravilo Felisecto Plus učinkovito preprečuje obolenje srčne glistavosti.
Felisecto Plus was as effective as the other medicine and reduced flea counts by more than 95%.
Zdravilo Felisecto Plus je bilo enako učinkovito kot drugo zdravilo in je zmanjšalo število bolh za več kot 95 %.
• to prevent heartworm disease
• preprečevanje obolenja srčne glistavosti.
Felisecto Plus contains two active substances, selamectin and sarolaner.
Zdravilo Felisecto Plus vsebuje dve učinkovini, selamektin in sarolaner.
Felisecto Plus is harmful after swallowing.
Zdravilo Felisecto Plus je nevarno ob zaužitju.
How is Felisecto Plus used?
Kako se zdravilo Felisecto Plus uporablja?
The medicine must be kept in its packaging until use, in order to prevent access by children.
Da bi preprečili dostop otrokom, je treba zdravilo do uporabe hraniti v originalni ovojnini.
Felisecto Plus is available as a spot-on solution in three different strengths and can only be obtained with a prescription.
Zdravilo Felisecto Plus je na voljo v obliki raztopine za kožni nanos v treh jakostih.
• to treat tick infestations
• zdravljenje infestacij s klopi,
How does Felisecto Plus work?
Kako zdravilo Felisecto Plus deluje?
• to treat biting lice infestations
• zdravljenje infestacij z ušmi,
The defect has been corrected in the new system.
Napaka je bila v novem sistemu odpravljena.
All the studies described above were carried out with a different delivery device, which was recalled from the market in 2008 because of a defect in the design of the system.
Vse študije, navedene zgoraj, so bile izvedene z drugačno napravo za dovajanje, ki je bila leta 2008 zaradi napake v zasnovi sistema odpoklicana s trga.
Ionsys can be used up to six times in one hour, but for no more than 80 doses within a 24-hour period.
Ionsys je mogoče uporabiti do šestkrat na uro, vendar največ 80 odmerkov v 24-urnem obdobju.
The system will stop working 24 hours after the first dose or after 80 doses have been delivered, whichever comes first.
Sistem bo prenehal delovati 24 ur po prvem odmerku ali po prejemu 80 odmerkov, odvisno od tega, kar od navedenega nastopi prej.
What measures are being taken to ensure the safe and effective use of Ionsys?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Ionsys?
The full EPAR and risk management plan summary for Ionsys can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) in povzetek načrta obvladovanja tveganj za zdravilo Ionsys sta na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The safety profile is acceptable and is similar to morphine given by injection into a vein.
Varnostni profil je sprejemljiv in je podoben varnostnemu profilu morfija, ki se injicira v žilo.