natgillin/translations-raw huggingface dataset:
What are the risks associated with Myalepta?
Kakšna tveganja so povezana z zdravilom Myalepta?
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Myalepta have also been included in the summary of product characteristics and the package leaflet.
Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Myalepta upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
What is Myalepta and what is it used for?
Kaj je zdravilo Myalepta in za kaj se uporablja?
For more information about using Myalepta, see the package leaflet or contact your doctor or pharmacist.
Za več informacij glede uporabe zdravila Myalepta glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
The active substance in Myalepta, metreleptin, is similar to leptin.
Učinkovina v zdravilu Myalepta, metreleptin, je podobna leptinu.
Since Myalepta has been authorised under exceptional circumstances, the company that markets Myalepta will set-up a registry of patients treated the medicine, and conduct studies to further investigate the benefits and risks of treatment including the possibility for Myalepta to trigger the production of antibodies.
Ker je zdravilo Myalepta pridobilo dovoljenje za promet v izjemnih okoliščinah, bo podjetje, ki ga trži, zagotovilo seznam bolnikov, ki prejemajo zdravilo, in izvedlo študije za nadaljnjo raziskavo koristi in tveganj zdravljenja, vključno z možnostjo, da zdravilo Myalepta sproži tvorbo protiteles.
The company that markets Myalepta will provide educational materials to patients and doctors with detailed information on how to use the medicine and what to do in case of side effects, including allergic reactions, hypoglycaemia and serious infections.
Podjetje, ki trži zdravilo Myalepta, bo bolnikom in zdravnikom zagotovilo izobraževalno gradivo s podrobnimi informacijami o uporabi zdravila in ukrepanju v primeru neželenih učinkov, vključno z alergijskimi reakcijami, hipoglikemijo in resnimi okužbami.
Side effects seen with Myalepta are of the kind expected from this type of treatment.
Neželeni učinki zdravila Myalepta so pričakovani za to vrsto zdravljenja.
• adults and children above the age of 12 years with partial (localised) lipodystrophy (including Barraquer-Simons syndrome), when standard treatments have failed.
• odraslih in otrocih, starejših od 12 let, s parcialno (lokalizirano) lipodistrofijo (vključno z Barraquer
Myalepta is a medicine used in addition to diet to treat lipodystrophy, where patients have loss of fatty tissue under the skin and build-up of fat elsewhere in the body such as in the liver and muscles.
Zdravilo Myalepta je zdravilo, ki se uporablja kot dodatek prehrani za zdravljenje lipodistrofije, pri kateri imajo bolniki premalo maščobnega tkiva pod kožo in kopičijo maščobo drugje v telesu, na primer v jetrih in mišicah.
What information is still awaited for Myalepta?
Katere informacije o zdravilu Myalepta še pričakujemo?
Myalepta can only be obtained with a prescription and treatment should be started and monitored by a doctor experienced in the diagnosis and management of patients with metabolic disorders.
Predpisovanje in izdaja zdravila Myalepta je le na recept, zdravljenje z njim pa mora uvesti in spremljati zdravnik, ki ima izkušnje z diagnosticiranjem in zdravljenjem bolnikov s presnovnimi motnjami.
For the full list of side effects and restrictions with Myalepta, see the package leaflet.
Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Myalepta glejte navodilo za uporabo.
Myalepta contains the active substance metreleptin.
Zdravilo Myalepta vsebuje učinkovino metreleptin.
This is because it has not been possible to obtain complete information about Myalepta due to the rarity of the condition.
To pomeni, da zaradi redkosti bolezni ni bilo mogoče pridobiti vseh podatkov o zdravilu.
• adults and children above the age of 2 years with generalised (throughout the body) lipodystrophy (Berardinelli-Seip syndrome and Lawrence syndrome);
• odraslih in otrocih, starejših od dveh let, z generalizirano (po celotnem telesu) lipodistrofijo
How is Myalepta used?
Kako se zdravilo Myalepta uporablja?
How does Myalepta work?
Kako zdravilo Myalepta deluje?
It must also not be used in patients who are suspected to have had in the past an allergic reaction called ‘allergic contact dermatitis' to Exelon patch.
Prav tako ga ne smejo uporabljati bolniki, pri katerih obstaja sum, da so v preteklosti doživeli alergijsko reakcijo, imenovano „alergijski kontaktni dermatitis“, na obliže zdravila Exelon.
The full EPAR for Rivastigmine 1 A Pharma 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) za zdravilo Rivastigmine 1 A Pharma je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Rivastigmine 1 A Pharma should be given twice a day, with morning and evening meals.
Zdravilo Rivastigmine 1 A Pharma se daje dvakrat na dan ob jutranjem in večernem obroku.
The European Commission granted a marketing authorisation valid throughout the European Union for Rivastigmine 1 A Pharma on 11 December 2009.
Evropska komisija je dovoljenje za promet z zdravilom Rivastigmine 1 A Pharma, veljavno po vsej Evropski uniji, odobrila 11. decembra 2009.
This is a summary of the European public assessment report (EPAR) for Rivastigmine 1 A Pharma.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Rivastigmine 1 A Pharma.
Treatment should only be started if a caregiver is available who will regularly monitor the use of Rivastigmine 1 A Pharma by the patient.
Zdravljenje se lahko začne samo, če je na voljo negovalec, ki bo pri bolniku redno spremljal uporabo zdravila Rivastigmine 1 A Pharma.
Overall, the most common side effects include nausea (feeling sick, seen in 38 patients in 100) and vomiting (seen in 23 patients in 100), particularly during the phase when the dose of Rivastigmine 1 A Pharma is being increased.
Na splošno sta med najpogostejšimi neželenimi učinki navzeja (slabost, opažena pri 38 bolnikih od 100) in bruhanje (opaženo pri 23 bolnikih od 100), zlasti v obdobju povečevanja odmerka zdravila Rivastigmine 1 A Pharma.
For more information about treatment with Rivastigmine 1 A Pharma, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Rivastigmine 1 A Pharma preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
The CHMP concluded that Rivastigmine 1 A Pharma has a modest effectiveness in treating the symptoms of Alzheimer's dementia, although this does reflect an important benefit in some patients.
CHMP je zaključil, da ima zdravilo Rivastigmine 1 A Pharma pri zdravljenju simptomov Alzheimerjeve demence skromen učinek, čeprav ta pomeni pomembno korist za nekatere bolnike.
Rivastigmine 1 A Pharma must not be used in people who are hypersensitive (allergic) to rivastigmine, other carbamate derivatives or any of the other ingredients.
Zdravila Rivastigmine 1 A Pharma ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) rivastigmin, druge derivate karbamata ali katero koli drugo sestavino zdravila.
Rivastigmine 1 A Pharma was more effective than placebo at controlling symptoms.
Zdravilo Rivastigmine 1 A Pharma je bilo pri obvladovanju simptomov učinkovitejše od placeba.
Treatment with Rivastigmine 1 A Pharma should be initiated and supervised by a doctor who has experience in the diagnosis and treatment of Alzheimer's disease or dementia in patients with Parkinson's disease.
Zdravljenje z zdravilom Rivastigmine 1 A Pharma mora uvesti in nadzorovati zdravnik, ki ima izkušnje z diagnosticiranjem in zdravljenjem Alzheimerjeve bolezni ali demence pri bolnikih s Parkinsonovo boleznijo.
The Committee initially concluded that for the treatment of dementia due to Parkinson's disease, Rivastigmine 1 A Pharma's benefits did not outweigh its risks.
Odbor je prvotno sklenil, da za zdravljenje demence, ki je posledica Parkinsonove bolezni, koristi zdravila Rivastigmine 1 A Pharma ne odtehtajo njegovih tveganj.
Therefore, the Committee decided that Rivastigmine 1 A Pharma's benefits are greater than its risks and recommended that it be given marketing authorisation.
Odbor je zato menil, da so koristi zdravila Rivastigmine 1 A Pharma večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
All of the studies lasted six months and compared the effects of Rivastigmine 1 A Pharma with those of placebo (a dummy treatment).
Vse študije so trajale šest mesecev, v njih pa so učinke zdravila Rivastigmine 1 A Pharma primerjali z učinki placeba (zdravila brez zdravilne učinkovine).
Rivastigmine 1 A Pharma is used for the treatment of patients with mild to moderately severe Alzheimer's dementia, a progressive brain disorder that gradually affects memory, intellectual ability and behaviour.
Zdravilo Rivastigmine 1 A Pharma se uporablja za zdravljenje bolnikov z blago do zmerno hudo Alzheimerjevo demenco, tj. napredujočo okvaro možganov, ki postopoma prizadene spomin, intelektualne zmožnosti in vedenje.
An additional study in 27 patients was used to show that Rivastigmine 1 A Pharma capsules and oral solution produced similar levels of the active substance in the blood.
Z dodatno študijo s 27 bolniki so dokazali, da kapsule in peroralna raztopina zdravila Rivastigmine 1 A Pharma dosegajo podobne ravni zdravilne učinkovine v krvi.
Rivastigmine 1 A Pharma has been studied in three main studies involving 2,126 patients with mild to moderately severe Alzheimer's disease.
Zdravilo Rivastigmine 1 A Pharma so proučevali v treh glavnih študijah, v katerih je sodelovalo 2 126 bolnikov z blago do zmerno hudo obliko Alzheimerjeve bolezni.
Rivastigmine 1 A Pharma was also studied in 541 patients with dementia due to Parkinson's disease.
Zdravilo Rivastigmine 1 A Pharma so proučevali tudi pri 541 bolnikih z demenco kot posledico Parkinsonove bolezni.
The global symptom score also improved more in the patients taking Rivastigmine 1 A Pharma.
Tudi rezultat celostne ocene simptomov je bil boljši pri bolnikih, ki so jemali zdravilo Rivastigmine 1 A Pharma.
Other information about Rivastigmine 1 A Pharma
Druge informacije o zdravilu Rivastigmine 1 A Pharma
In the three studies of Rivastigmine 1 A Pharma in patients with Alzheimer's dementia, patients taking doses of Rivastigmine 1 A Pharma between 6 and 9 mg per day had an average increase in cognitive symptoms of 0.2 points from a baseline of 22.9 points at the start of the study, where a lower score indicates better performance.
V treh študijah zdravila Rivastigmine 1 A Pharma pri bolnikih z Alzheimerjevo demenco je bilo pri tistih, ki so jemali od 6- do 9-miligramske odmerke zdravila Rivastigmine 1 A Pharma, opaziti povprečno povečanje kognitivnih simptomov za 0,2 točke od izhodiščne vrednosti 22,9 točke na začetku študije, pri čemer nižji rezultat pomeni boljšo učinkovitost.
By blocking these enzymes, Rivastigmine 1 A Pharma allows levels of acetylcholine to be increased in the brain, helping to reduce the symptoms of Alzheimer's dementia and dementia due to Parkinson's disease.
Zdravilo Rivastigmine 1 A Pharma z zaviranjem teh encimov omogoča, da se ravni acetilholina v možganih povečajo, zaradi česar se simptomi Alzheimerjeve demence in demence zaradi Parkinsonove bolezni ublažijo.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Rivastigmine 1 A Pharma.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Rivastigmine 1 A Pharma, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
Rivastigmine 1 A Pharma is a medicine containing the active substance rivastigmine.
Rivastigmine 1 A Pharma je zdravilo, ki vsebuje zdravilno učinkovino rivastigmin.
The patients with dementia due to Parkinson's disease taking Rivastigmine 1 A Pharma capsules showed an improvement in cognitive symptoms of 2.1 points, compared with a worsening of 0.7 points in those taking placebo, from a baseline of around 24 points.
Pri bolnikih z demenco zaradi Parkinsonove bolezni, ki so jemali kapsule zdravila Rivastigmine 1 A Pharma, je bilo opaziti izboljšanje kognitivnih simptomov za 2,1 točke, v primerjavi s poslabšanjem za 0,7 točke pri tistih, ki so jemali placebo, od izhodiščne vrednosti približno 24 točk.
For the global score, patients taking Rivastigmine 1 A Pharma had an increase in symptoms of 4.1 points, compared with 4.4 in those taking placebo.
Kar zadeva rezultat celostne ocene simptomov, je pri bolnikih, ki so jemali zdravilo Rivastigmine 1 A Pharma, prišlo do povečanja simptomov za 4,1 točke v primerjavi s 4,4 točke pri tistih, ki so jemali placebo.
For the full list of all side effects reported with Rivastigmine 1 A Pharma, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Rivastigmine 1 A Pharma, glejte navodilo za uporabo.
What benefit has Rivastigmine 1 A Pharma shown during the studies?
Kakšne koristi je zdravilo Rivastigmine 1 A Pharma izkazalo med študijami?
The types of side effects seen with Rivastigmine 1 A Pharma depend on the type of dementia it is being used to treat.
Vrste neželenih učinkov, opaženih pri zdravilu Rivastigmine 1 A Pharma, so odvisne od vrste demence, ki se zdravi.
Rivastigmine 1 A Pharma is also used to treat mild to moderately severe dementia in patients with Parkinson's disease.
Zdravilo se lahko uporablja tudi za zdravljenje blage do zmerno hude demence pri bolnikih s Parkinsonovo boleznijo.
The active substance in Rivastigmine 1 A Pharma, rivastigmine, is an antidementia medicine.
Zdravilna učinkovina zdravila Rivastigmine 1 A Pharma, rivastigmin, je zdravilo za zdravljenje demence.
What is the risk associated with Rivastigmine 1 A Pharma?
Kakšna tveganja so povezana z zdravilom Rivastigmine 1 A Pharma?
Why has Rivastigmine 1 A Pharma been approved?
Zakaj je bilo zdravilo Rivastigmine 1 A Pharma odobreno?
What is Rivastigmine 1 A Pharma?
Kaj je zdravilo Rivastigmine 1 A Pharma?
How has Rivastigmine 1 A Pharma been studied?
Kako je bilo zdravilo Rivastigmine 1 A Pharma raziskano?
What is Rivastigmine 1 A Pharma used for?
Za kaj se zdravilo Rivastigmine 1 A Pharma uporablja?
How is Rivastigmine 1 A Pharma used?
Kako se zdravilo Rivastigmine 1 A Pharma uporablja?
How does Rivastigmine 1 A Pharma work?
Kako zdravilo Rivastigmine 1 A Pharma deluje?
Some of the areas harmonised include:
Nekatera področja, ki jih je treba uskladiti, so:
It must also not be used in the second and third trimesters (the last six months) of pregnancy.
Prav tako se ne sme uporabljati v drugem in tretjem trimesečju (zadnjih šest mesecev) nosečnosti.
János Borvendég (Hungary)
János Borvendég (Madžarska)
The company that markets these medicines is F. Hoffmann - La Roche Ltd.
Družba, ki trži ta zdravila, je F. Hoffmann - La Roche Ltd.
Vascace should be taken once a day at about the same time each day.
Zdravilo Vascace je treba vzeti enkrat na dan, vsak dan ob približno istem času.
The usual dose is 2.5 to 5 mg per day.
Običajen odmerek je 2,5 do 5 mg na dan.
Treatment with diuretics (medicines that help increase the amount of water removed from the body in the urine) should, where possible, be stopped two to three days before starting treatment with Vascace.
Zdravljenje z diuretiki (zdravila, ki pomagajo povečati količino vode, izločene iz telesa z urinom) je treba, kadar je to mogoče, dva do tri dni pred pričetkom zdravljenja z zdravilom Vascace, prekiniti.
Vascace is authorised in the EU via national procedures.
Zdravilo Vascace je v EU odobreno z nacionalnimi postopki.
Vascace is also available in the EU under other trade names: Dynorm, Inhibace, Inibace, Justor and Vascase.
Zdravilo Vascace je v EU na voljo tudi pod drugimi trgovskimi imeni: Dynorm, Inhibace, Inibace, Justor in Vascase.
Patients with impairment of kidney function may have to take lower doses.
Bolniki z okvarjenim delovanjem ledvic bodo morali morda jemati manjše odmerke.
Why was Vascace reviewed?
Zakaj je bilo zdravilo Vascace pregledano?
The European Medicines Agency has completed a review of Vascace.
Evropska agencija za zdravila je zaključila pregled zdravila Vascace.
Other sections such as those on special warnings, interactions and pregnancy and lactation were also harmonised.
Usklajena so bila tudi druga poglavja, kot na primer poglavje s posebnimi opozorili, interakcijami ter poglavje o nosečnosti in dojenju.
It is used to treat hypertension and long-term heart failure (inability of the heart to pump enough blood around the body).
Uporablja se za zdravljenje hipertenzije in dolgotrajnega srčnega popuščanja (nezmožnost srca, da črpa zadostno količino krvi po telesu).
The reduced blood pressure also helps patients with heart failure, because it is easier for the heart to pump out blood if the pressure in the blood vessels is not too high.
Znižan krvni tlak pomaga tudi bolnikom s srčnim popuščanjem, saj srce lažje črpa kri, kadar tlak v krvnih žilah ni previsok.
It blocks the action of the enzyme ACE, which is responsible for the production of a hormone in the body called angiotensin II.
Zavira delovanje encima ACE, ki je odgovoren za tvorjenje telesnega hormona, imenovanega angiotenzin II.
This has led to divergences across Member States in the way the medicine can be used, as seen in the differences in the summaries of product characteristics (SmPCs), labelling and package leaflets in the countries where the medicine is marketed.
Zaradi tega je med državami članicami prišlo do razhajanj glede uporabe zdravila, kar je razvidno iz razlik v povzetkih glavnih značilnosti zdravila, označevanju in navodilih za uporabo v državah, kjer je zdravilo na trgu.
It must not be used in patients with angioedema (swelling beneath the skin) associated with previous treatment with ACE inhibitor or in patients with hereditary or idiopathic angioedema.
Ne sme se uporabljati pri bolnikih z angioedemom (podkožnim otekanjem), povezanim s predhodnim zdravljenjem z zaviralci ACE ali pri bolnikih z dednim ali idiopatskim angioedemom.
If this dose is well tolerated by the patient, it can be increased to 1 or 2.5 mg once a day.
Če bolnik ta odmerek dobro prenaša, se odmerek lahko poveča na 1 ali 2,5 mg enkrat na dan.
The CHMP agreed that Vascace should be used for the treatment of hypertension and chronic heart failure.
CHMP se je strinjal, da se zdravilo Vascace lahko uporablja za zdravljenje hipertenzije in kroničnega srčnega popuščanja.
What is Vascace?
Kaj je zdravilo Vascace?
A lower starting dose of 0.5 mg is recommended for hypertension in patients with a highly activated ‘renin-angiotensin-aldosterone system' as they may experience an excessive drop in blood pressure.
Manjši začetni odmerek 0,5 mg se priporoča pri zdravljenju hipertenzije pri bolnikih z močno aktiviranim „sistemom renin-angiotenzin-aldosteron“, saj pri njih lahko pride do prekomernega padca krvnega tlaka.
For hypertension, the recommended starting dose is 1 mg per day, which can be adjusted depending on how the patient's blood pressure responds.
Priporočeni začetni odmerek pri zdravljenju hipertenzije je 1 mg na dan, ki pa se lahko prilagodi glede na odziv bolnikovega krvnega tlaka.
The CHMP, in the light of the data submitted and the scientific discussion within the Committee, was of the opinion that the SmPCs, labelling and package leaflets should be harmonised across the EU.
CHMP je ob upoštevanju predloženih podatkov in znanstvene razprave v odboru menil, da je treba povzetke glavnih značilnosti zdravila, označevanje in navodila za uporabo uskladiti po vsej EU.
The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that there is a need to harmonise the prescribing information for Vascace in the European Union (EU).
Odbor za zdravila za uporabo v humani medicini (CHMP) pri Agenciji je zaključil, da je treba v Evropski uniji (EU) uskladiti podatke o predpisovanju zdravila Vascace.
By blocking the production of this hormone, cilazapril allows the blood vessels to widen, reducing the blood pressure.
Cilazapril z zaviranjem tvorjenja tega hormona omogoča širjenje krvnih žil ter s tem nižanje krvnega tlaka.
The Committee recommended that Vascace should not be used in patients who are hypersensitive (allergic) to cilazapril or to any other ingredients of the product, or to other ACE inhibitors.
Odbor je priporočil, da zdravila Vascace ne smejo uporabljati bolniki, ki utegnejo biti preobčutljivi za (alergični na) cilazapril ali katero koli drugo sestavino zdravila ali druge zaviralce ACE.
Vascace is a medicine that contains the active substance cilazapril.
Vascace je zdravilo, ki vsebuje zdravilno učinkovino cilazapril.
On 16 September 2009, European Commission referred the matter to the CHMP in order to harmonise the marketing authorisations for Vascace in the EU.
Da bi Evropska komisija uskladila dovoljenja za promet z zdravilom Vascace v EU, je dne 16. septembra 2009 zadevo napotila na CHMP.
For heart failure, the recommended starting dose is 0.5 mg once a day for one week.
Priporočeni začetni odmerek pri zdravljenju srčnega popuščanja je 0,5 mg enkrat na dan en teden.
The active substance in Vascace, cilazapril, is an ‘angiotensin converting enzyme (ACE) inhibitor'.
Zdravilna učinkovina v zdravilu Vascace, cilazapril, je „zaviralec angiotenzinske konvertaze (ACE)“.
Vascace was identified as needing harmonisation by the Co-ordination Group on the Mutual and Decentralised Procedures - Human (CMD(h)).
Usklajevalna skupina za postopek z medsebojnega priznavanja in decentralizirane postopke za zdravila za uporabo v humani medicini (CMD(h)) je ugotovila, da je za zdravilo Vascase potrebno usklajevanje.
Company responses provided on: 28 December 2009, 22 March 2010 Opinion date:
Odgovori družbe, poslani dne:
• Do not store below 4°C.
• Ne shranjujte pri temperaturi pod 4°C.
Flexible PVC container holding 1.5, 2.0 or 2.5 litres.
Mehke PVC vrečke po 1,5, 2,0 ali 2,5 litra.
12 months (for medicinal products manufactured at Alliston, Canada and North Cove, USA only).
12 mesecev (samo za zdravila proizvedena v Allistonu, Kanada in North Cove, ZDA).
The Lineo connector contains iodine.
Lineo konektor vsebuje jod.
6.5 Nature and Contents of Container
6.5 Vrsta ovojnine in vsebina
The lineo connector that may equip the Y transfer line of the twin bag, contains 10.5% of Povidone iodine ointment
Lineo konektor, ki lahko opremi Y cevje dvojne vrečke, vsebuje 10,5% povidon jodovo mazilo.
How to store EXTRANEAL
Shranjevanje zravila EXTRANEAL
• Store in the original package.
• Shranjujte v originalni ovojnini.
Changes are shown as greyed boxed wording
Spremembe so prikazane v sivo obarvanem delu teksta.
Summary of Product Characteristics
POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA
The shelf life of the product as packaged for sale is 24 months 12 months (for medicinal products manufactured at Alliston, Canada and North Cove, USA only).
Rok uporabnosti zdravila v prodajnem pakiranju je 24 mesecev 12 mesecev (samo za zdravila proizvedena v Allistonu, Kanada in North Cove, ZDA).
The product, once removed from its overpouch, should be used immediately
Ko zdravilo vzamete iz zunanjega ovoja, ga morate takoj uporabiti.
Not all configurations may be marketed.
Na trgu ni prisotnih vseh oblik pakiranja.
• Dispose EXTRANEAL as you have been trained
• Zdravilo EXTRANEAL odstranjujte, kakor so vas poučili.
Amendments to be included in the relevant sections of the summary of product characteristics and package leaflets for Dianeal PD4 and Extraneal, as applicable.
Priloge, ki se bodo v skladu z ustreznostjo, vključile k posameznim poglavjem Povzetka glavnih značilnosti zdravila in Navodila za uporabo za Dianeal in Extraneal.