natgillin/translations-raw huggingface dataset:
Duloxetine Zentiva 60 mg gastro-resistant hard capsules 28, 56, 84 and 98 capsules
Duloksetin Zentiva 60 mg trde gastrorezistentne kapsule 28, 56, 84 in 98 kapsul
There have been reports of bleeding abnormalities, such as ecchymoses, purpura and gastrointestinal haemorrhage with selective serotonin reuptake inhibitors (SSRIs) and serotonin/noradrenaline reuptake inhibitors (SNRIs), including duloxetine.
Pri selektivnih zaviralcih prevzema serotonina (SSRI - selective serotonin reuptake inhibitors) in selektivnih zaviralcih prevzema noradrenalina (SNRI - selective noradrenaline reuptake inhibitors), vključno z duloksetinom, so poročali o nenormalnih krvavitvah, kot so ekhimoze, purpure in krvavitve iz prebavil.
Uncommon side effects (may affect up to 1 in 100 people):
Občasni neželeni učinki (se lahko pojavijo pri največ 1 od 100 bolnikov):
• Duloxetine Zentiva may cause effects that you may not be aware of, such as increases in liver enzymes or blood levels of potassium, creatine phosphokinase, sugar, or cholesterol.
kot povišanje jetrnih encimov ali krvnega nivoja kalija, kreatinske fosfokinaze, sladkorja ali holesterola
Hypromellose acetate succinate Triethyl citrate
Vsebina kapsule saharoza koruzni škrob hipromeloza smukec hipromeloza acetat sukcinat trietilcitrat
Duloxetine Zentiva 30 mg gastro-resistant hard capsules Hard opaque gelatin capsules of length approx. 15.9 mm with white opaque body and light-blue opaque cap which contain off-white to light-brown-yellow spherical pellets.
Duloksetin Zentiva 30 mg trde gastrorezistentne kapsule Trde, neprozorne kapsule iz želatine dolžine približno 15,9 mm z belim neprozornim telesom in svetlo modrim neprozornim pokrovčkom, ki vsebuje umazano bele do svetlo rjavo rumene okrogle pelete.
Caution should be exercised when duloxetine is combined with oral anticoagulants or antiplatelet agents due to a potential increased risk of bleeding attributable to a pharmacodynamic interaction.
Zaradi možnega povečanega tveganja za krvavitev, ki ga lahko pripišemo farmakodinamični interakciji, je potrebna previdnost pri kombinaciji duloksetina s peroralnimi antikoagulanti ali antitrombotičnimi zdravili.
Duloxetine Zentiva 60 mg gastro-resistant hard capsules Hard opaque gelatin capsules of length approx. 19.4 mm with ivory opaque body and light-blue opaque cap which contain off-white to light-brown-yellow spherical pellets.
Duloksetin Zentiva 60 mg trde gastrorezistentne kapsule Trde, neprozorne kapsule iz želatine dolžine približno 19,4 mm z neprozornim telesom v barvi slonovine in svetlo modrim neprozornim pokrovčkom, ki vsebuje umazano bele do svetlo rjavo rumene okrogle pelete.
Duloxetine Zentiva 30 mg gastro-resistant hard capsules Duloxetine Zentiva 60 mg gastro-resistant hard capsules
Duloksetin Zentiva 30 mg trde gastrorezistentne kapsule Duloksetin Zentiva 60 mg trde gastrorezistentne kapsule
What Duloxetine Zentiva contains
Kaj vsebuje zdravilo Duloksetin Zentiva
How to store Duloxetine Zentiva
Shranjevanje zdravila Duloksetin Zentiva
The 30 mg capsules are hard opaque gelatin capsules of length approx. 15.9 mm with white opaque body and light-blue opaque cap which contain off-white to light-brown-yellow spherical pellets.
30 mg so trde, neprozorne kapsule iz želatine dolžine približno 15,9 mm z belim neprozornim telesom in svetlo modrim neprozornim pokrovčkom, ki vsebujejo umazano bele do svetlo rjavo rumene okrogle pelete.
Gynaecological haemorrhage Menstrual disorder Sexual dysfunction Testicular pain
Motnje reprodukcije in dojk erektilna disfunkcija motnje ejakulacije zapoznela ejakulacija ginekološka krvavitev motnje menstruacije spolna disfunkcija bolečina v testisih menopavzalni simptomi galaktoreja hiperprolaktinemija poporodna krvavitev6
Angio-neurotic oedema6
psihomotorični nemir6
General disorders and administration site conditions Falls8
Splošne težave in spremembe na mestu aplikacije
Duloxetine Zentiva 60 mg gastro-resistant hard capsules Capsule cap
Duloksetin Zentiva 60 mg trde gastrorezistentne kapsule Pokrovček kapsule
Adverse reactions may be more common during concomitant use of Duloxetine Zentiva and herbal preparations containing St. John's wort (Hypericum perforatum).
Ob sočasni uporabi zdravila Duloksetin Zentiva in pripravkov rastlinskega izvora, ki vsebujejo šentjanževko (Hypericum perforatum), so lahko neželeni učinki pogostejši.
The 60 mg capsules are hard opaque gelatin capsules of length approx. 19.4 mm with ivory opaque body and light-blue opaque cap which contain off-white to light-brown-yellow spherical pellets.
60 mg so trde, neprozorne kapsule iz želatine dolžine približno 19,4 mm z neprozornim telesom v barvi slonovine in svetlo modrim neprozornim pokrovčkom, ki vsebuje umazano bele do svetlo rjavo rumene okrogle pelete.
Duloxetine Zentiva 30 mg gastro-resistant hard capsules Capsule cap
Duloksetin Zentiva 30 mg trde gastrorezistentne kapsule Pokrovček kapsule
• increased yawning;
• več zehanja
Duloxetine Zentiva is for oral use.
Zdravilo Duloksetin Zentiva jemljemo peroralno.
STATEMENT OF ACTIVE SUBSTANCE(S) Each capsule contains duloxetine hydrochloride equivalent to 60 mg duloxetine.
NAVEDBA ENE ALI VEČ UČINKOVIN Ena kapsula vsebuje duloksetinijev klorid, kar ustreza 60 mg duloksetina.
• muscle pain, muscle spasm;
• mišična bolečina, mišični krč
STATEMENT OF ACTIVE SUBSTANCE(S) Each capsule contains duloxetine hydrochloride equivalent to 30 mg duloxetine.
NAVEDBA ENE ALI VEČ UČINKOVIN Ena kapsula vsebuje duloksetinijev klorid, kar ustreza 30 mg duloksetina.
• throat tightness, nose bleeds;
• napeto grlo, krvavitve iz nosu
• contraction of the jaw muscle;
• krčenje čeljustne mišice
Elevated liver enzymes (ALT, AST, alkaline phosphatase) Acute liver injury
zvišani jetrni encimi (ALT, AST, alkalna fosfataza) akutna okvara jeter odpoved jeter6 zlatenica6
Muscle tightness Muscle twitching
• mišična napetost, mišično trzanje
Duloxetine Zentiva contains sucrose
Zdravilo Duloksetin Zentiva vsebuje saharozo
NAME OF THE MEDICINAL PRODUCT Duloxetine Zentiva 30 mg gastro-resistant hard capsules Duloxetine
Duloksetin Zentiva 30 mg trde gastrorezistentne kapsule duloksetin
NAME OF THE MEDICINAL PRODUCT Duloxetine Zentiva 60 mg gastro-resistant hard capsules Duloxetine
Duloksetin Zentiva 60 mg trde gastrorezistentne kapsule duloksetin
Common side effects (may affect up to 1 in 10 people):
Pogosti neželeni učinki (se lahko pojavijo pri največ 1 od 10 bolnikov):
drowsiness, clumsiness, restlessness, feeling of being drunk, fever, sweating or rigid muscles),
• “serotoninski sindrom” (redka reakcija, ki lahko povzroči občutke velike sreče, zaspanost, okornost, nemir, občutek pijanosti, vročino, znojenje ali toge mišice), epileptični napadi
Skin and subcutaneous tissue disorders Sweating increased
Bolezni kože in podkožja povečano znojenje izpuščaj nočno znojenje urtikarija kontaktni dermatitis hladen znoj fotosenzitivnostne reakcije povečano nagnjenje k modricam
Breakable tablet
Lomljiva tableta
List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, marketing authorisation holders in the member states
Dodatek I Seznam imen, farmacevtskih oblik, jakosti zdravila, poti uporabe zdravila,
The overall treatment period should not be longer than 20 days.
Skupno obdobje zdravljenja naj ne traja več kot 20 dni.
It is used when standard treatment is not available or is no longer feasible.
Uporablja se, kadar standardno zdravljenje ni na voljo ali ni več izvedljivo.
The European Commission granted a marketing authorisation valid throughout the European Union for Removab to Fresenius Biotech GmbH on 20 April 2009.
Evropska komisija je dovoljenje za promet z zdravilom Removab, veljavno po vsej Evropski uniji, odobrila družbi Fresenius Biotech GmbH 20 aprila 2009.
It is usually given as four infusions in increasing doses from 10 to 150 micrograms over 11 days.
Zdravilo se običajno se daje v obliki štirih infuzij v naraščajočih odmerkih od 10 do 150 mg v obdobju 11 dni.
Other information about Removab:
Druge informacije o zdravilu Removab:
On average, patients who received Removab lived for 46 days without the need for further drainage.
V povprečju so bolniki, ki so prejeli zdravilo Removab, živeli 46 dni brez potrebe po nadaljnji drenaži.
There must be an interval of at least two days between infusions, but the interval can be increased if the patient has side effects.
Med infuzijami mora biti vsaj dvodnevni interval, ki se lahko podaljša, če ima bolnik neželene učinke.
Around 90% of patients treated with Removab have side effects.
Okoli 90 % bolnikov, ki so jih zdravili z zdravilom Removab, ima neželene učinke.
Removab is not recommended for use in patients below the age of 18 years because of a lack of information on safety and effectiveness in this age group.
Uporaba zdravila Removab pri bolnikih, mlajših od 18 let, zaradi pomanjkanja podatkov o varnosti in učinkovitosti v tej starostni skupini ni priporočljiva.
Removab must not be given all at once or by any other route.
Zdravilo Removab se ne sme dati v celoti naenkrat ali na kak drugačen način.
The Committee recommended that Removab be given marketing authorisation.
Odbor je priporočil, da se za zdravilo Removab odobri dovoljenje za promet.
Patients should be monitored after each infusion.
Po vsaki infuziji je treba bolnike nadzirati.
Before treatment, it is recommended that patients are given medicines to reduce pain, fever and inflammation.
Priporoča se, da bolniki pred zdravljenjem prejmejo zdravila za zmanjšanje bolečine, vročine in vnetja.
The main measure of effectiveness was how long patients lived without the need for further drainage.
Glavno merilo učinkovitosti je bilo, kako dolgo bolniki niso potrebovali nadaljnje drenaže.
The effects of Removab were first tested in experimental models before being studied in humans.
Učinki zdravila Removab so bili najprej preizkušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
Removab treatment should only be given under the supervision of a doctor who has experience in the use of anticancer medicines.
Zdravljenje z zdravilom Removab mora potekati pod nadzorom zdravnika, ki ima izkušnje z uporabo zdravil proti raku.
Patients who have severe problems with their liver, or moderate or severe kidney problems should only be given Removab treatment after careful consideration of the medicine's benefits and risks.
Bolniki, ki imajo resne težave z jetri ali zmerne oziroma hude težave z ledvicami, naj začnejo zdravljenje z zdravilom Removab le po skrbni obravnavi koristi in tveganj zdravila.
What benefit has Removab shown during the studies?
Kakšne koristi je zdravilo Removab izkazalo med študijami?
This brings the cells close together so that the T-cells can kill the cancer cells.
S tem se te celice tesno približajo, tako da lahko T-celice ubijejo rakave celice.
The most common side effects with Removab (seen in more than 1 patient in 10) are lymphopenia (low level of lymphocytes, a type of white blood cell), abdominal (tummy) pain, nausea (feeling sick), vomiting, diarrhoea, pyrexia (fever), fatigue (tiredness), chills and pain.
Najpogostejši neželeni učinki zdravila Removab (opaženi pri več kot 1 bolniku izmed 10) so limfopenija (nizka raven limfocitov, vrste belih krvničk), bolečine v trebuhu, navzea (občutek slabosti), bruhanje, driska, pireksija (povišana telesna temperatura), utrujenost, mrzlica in bolečine.
T-cells are part of the immune system (the body's natural defences), and are involved in coordinating the death of infected and abnormal cells.
T-celice so del imunskega sistema (naravnega obrambnega mehanizma telesa) in so udeležene pri koordinaciji odmiranja okuženih in nenormalnih celic.
Removab was studied in one main study involving 258 patients with malignant ascites caused by an EpCAM-positive cancer and for which standard therapy was not available or was no longer feasible.
Zdravilo Removab so raziskali v eni glavni študiji, ki je vključevala 258 bolnikov z malignim ascitesom, ki ga je povzročil rak, pozitiven na EpCAM in za katerega standardna terapija ni bila na voljo ali ni bila več izvedljiva.
What is the risk associated with Removab?
Kakšna tveganja so povezana z zdravilom Removab?
Catumaxomab also attaches to a third substance called the Fc-gamma receptor, which also helps the body's immune system to target the cancer cells.
Katumaksomab se prav tako veže na tretjo snov, imenovano receptor Fc-gama, ki prav tako pomaga imunskemu sistemu telesa pri napadanju rakavih celic.
These are cancers where the tumour cells have large quantities of a molecule called EpCAM on their surface.
pri katerih imajo tumorske celice na površini velike količine molekul, imenovanih EpCAM.
By attaching to these two antigens, catumaxomab forms a bridge between the cancer cells and the T-cells.
Z vezavo na ta dva antigena katumaksomab ustvari most med rakavimi celicami in T-celicami.
Removab can only be used in patients with EpCAM-positive carcinomas.
Zdravilo Removab se uporablja le pri bolnikih s karcinomi, pozitivnimi na EpCAM.
EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) REMOVAB EPAR summary for the public
REMOVAB Povzetek EPAR za javnost
In patients with cancer, ascites forms because cancer cells develop on the peritoneum, the membrane around the peritoneal cavity, where they block the natural drainage of fluid from the abdomen.
Pri bolnikih z rakom ascites nastane, ker se rakave celice razvijejo na peritoneju, membrani, ki obdaja peritonealno votlino, in zavirajo naravno odtekanje tekočine iz trebuha.
For the full list of all side effects reported with Removab, see the Package Leaflet.
Za celoten opis neželenih učinkov, o katerih so poročali pri uporabi zdravila Removab, glejte navodilo za uporabo.
This compared with 11 days for patients who were treated with drainage alone.
V primerjavi z bolniki, ki so jih zdravili le z drenažo, je bil ta čas 11 dni.
It contains the active substance catumaxomab.
Vsebuje zdravilno učinkovino katumaksomab.
The active substance in Removab, catumaxomab, is a monoclonal antibody.
Zdravilna učinkovina zdravila Removab, katumaksomab, je monoklonsko protitelo.
Removab must be given as an intraperitoneal (into the peritoneal cavity) infusion using a pump system.
Zdravilo Removab se mora dajati le kot intraperitonealna infuzija (infuzija v trebušno votlino) z uporabo sistema črpalke.
Why has Removab been approved?
Zakaj je bilo zdravilo Removab odobreno?
A monoclonal antibody is an antibody (a type of protein) that has been designed to recognise and attach to a specific structure
Monoklonsko protitelo je protitelo (vrsta beljakovine), zasnovano tako, da prepozna in se veže na specifično strukturo (imenovano antigen), ki se nahaja na določenih celicah v telesu.
Removab with drainage was more effective at treating malignant acsites than drainage alone.
Zdravilo Removab v kombinaciji z drenažo je bilo pri zdravljenju malignega ascitesa učinkovitejše kot drenaža sama.
In this study, Removab used in combination with drainage of fluid from the abdomen was compared with drainage alone.
V tej študiji so primerjali uporabo zdravila Removab v kombinaciji z drenažo tekočine iz trebuha in drenažo samo.
Removab is used to treat malignant ascites, fluid accumulation in the peritoneal cavity (abdominal space) that is caused by a cancer.
Zdravilo Removab se uporablja za zdravljenje malignega ascitesa, nabiranja tekočine v peritonealni votlini (trebušni votlini) zaradi raka.
Catumaxomab has been designed to attach to two antigens: EpCAM, which is found in high levels on some types of cancer cells and CD3, which is found on T-cells.
Katumaksomab je zasnovan za vezavo na dva antigena: EpCAM, ki se nahaja v velikih količinah na nekaterih vrstah rakavih celic,
Removab is a concentrate that is made up into a solution for infusion (a drip).
Zdravilo Removab je koncentrat, ki se pripravi v raztopino za infundiranje (kapalna infuzija).
The Committee for Medicinal Products for Human Use (CHMP) decided that Removab's benefits are greater than its risks for the intraperitoneal treatment of malignant ascites in patients with EpCAM-positive carcinoma where standard therapy is not available or no longer feasible.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Removab pri intraperitonealnem zdravljenju malignega ascitesa pri bolnikih s karcinomom, pozitivnim na
How has Removab been studied?
Kako je bilo zdravilo Removab raziskano?
The full EPAR for Removab can be found here.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Removab je na voljo tukaj.
What is Removab?
Kaj je zdravilo Removab?
What is Removab used for?
Za kaj se zdravilo Removab uporablja?
How is Removab used?
Kako se zdravilo Removab uporablja?
Removab should not be used in people who may be hypersensitive (allergic) to catumaxomab, to any of the other ingredients, or to murine (rat or mouse) proteins.
katumaksomab, katerokoli drugo sestavino zdravila ali beljakovine glodavcev (podgan ali miši).
Eye drops, solution Ocular use bottle (LDPE)
200 µg/ml kapljice za oko, raztopina okularna uporaba plastenka (LDPE) 2,5 ml
MA(EU) number
Številka (EU) dovoljenja za promet
The European Commission issued a decision on 2 June 2010.
Evropska komisija je odločitev izdala dne 2. junija 2010.
Prof. Pieter de Graeff (the Netherlands)
Prof. Pieter de Graeff (Nizozemska)
As the Member States were not able to reach an agreement, the German medicines regulatory agency referred the matter to the CHMP for arbitration on 29 October 2009.
Ker države članice niso dosegle soglasja, je nemški regulatorni organ za zdravila dne 29. oktobra 2009 zadevo napotil na CHMP v arbitražo.
Based on evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that the benefits of Clopidogrel Orion outweigh its risks and recommended that the marketing authorisation be granted in all the concerned Member States.
Na podlagi ocenjevanja trenutno razpoložljivih podatkov in znanstvene razprave v okviru odbora je CHMP zaključil, da koristi zdravila Clopidogrel Orion odtehtajo njegova tveganja, zato je priporočil odobritev dovoljenja za promet z zdravilom v vseh zadevnih državah članicah.
The European Medicines Agency has completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicine Clopidogrel Orion and associated names.
Evropska agencija za zdravila je zaključila arbitražni postopek, do katerega je prišlo po nesoglasju med državami članicami Evropske unije (EU) glede odobritve zdravila Clopidogrel Orion in povezanih imen.
It is used in adults to prevent atherothrombotic events (problems caused by blood clots and hardening of the arteries) such as a heart attack or stroke.
Uporablja se pri odraslih za preprečevanje aterotrombotičnih dogodkov (težav, ki jih povzročajo krvni strdki in otrdelost arterij), kot je srčni napad ali kap.
The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of Clopidogrel Orion outweigh its risks, and the marketing authorisation can be granted in Germany and in the following Member States of the EU: the Czech Republic, Denmark, Finland, Lithuania, Latvia, Norway, Slovakia and Sweden.
Odbor za zdravila za uporabo v humani medicini (CHMP) pri Agenciji je zaključil, da koristi zdravila Clopidogrel Orion odtehtajo njegova tveganja in da se lahko dovoljenje za promet z zdravilom odobri v Nemčiji in tudi v naslednjih državah članicah EU: na Češkem, Danskem, Finskem, v Litvi, Latviji, na Norveškem, Slovaškem in Švedskem.
Clopidogrel Orion is a generic medicine based on a ‘reference medicine', Plavix, which is authorised in the EU.
Clopidogrel Orion je generično zdravilo na osnovi „referenčnega zdravila“ Plavix, ki je odobreno v EU.
Why was Clopidogrel Orion reviewed?
Zakaj je bilo zdravilo Clopidogrel Orion pregledano?
Clopidogrel base is less stable than the salt form, and BHA is included in the medicine to stabilise it..
Klopidogrelna baza je manj stabilna kot sol, zato je za njeno stabilizacijo v zdravilo vključen BHA.
Teva Pharma B.V. submitted Clopidogrel Orion to Germany for a decentralised procedure.
je predložila zdravilo Clopidogrel Orion Nemčiji v decentraliziran postopek.
2 June 2010
2. junij 2010
What is Clopidogrel Orion?
Kaj je zdravilo Clopidogrel Orion?
Clopidogrel Orion is a medicine that contains the active substance clopidogrel.
Clopidogrel Orion je zdravilo, ki vsebuje zdravilno učinkovino klopidogrel.
This is a procedure where one Member State (the ‘reference Member State', in this instance Germany) assesses a medicine with a view to granting a marketing authorisation that will be valid in this country as well as in other Member States (the ‘concerned Member States', in this instance the Czech Republic, Denmark, Finland, Lithuania, Latvia, Norway, Slovakia and Sweden).
državah članicah („zadevnih državah članicah“, v tem primeru na Češkem, Danskem, Finskem, v Litvi, Latviji, na Norveškem, Slovaškem in Švedskem).
Date of first authorisation: 18 May 2018
Datum prve odobritve: 18. maj 2018
Not known (frequency cannot be estimated from the available data)
Neznana (pogostnostni ni mogoče oceniti iz razpoložljivih podatkov)
The information above also applies to children and adolescents.
Zgoraj navedene informacije veljajo tudi za otroke in mladostnike.
Radiographic changes were assessed in study 11.
Spremembe na rentgenskih slikah so ocenjevali v študiji 11.
As this medicine is being given by your doctor or nurse, it is unlikely that you will be given too much.
Ker boste zdravilo prejeli od zdravnika ali medicinske sestre, je zelo malo verjetno, da ga boste prejeli preveč.
For more information see section on Pregnancy and breastfeeding.
Za več informacij glejte poglavje o Nosečnosti in dojenju.
In addition, bone fracture (6.8%) was reported, however, a causal association has not been established.
Dodatno so poročali o zlomih kosti (6,8 %), vendar vzročna povezava ni bila dokazana.
EXP EXP, if not refrigerated
EXP EXP izven hladilnika
In study 2, more than 90% of patients had at least two evaluable X-rays.
V študiji 2 je imelo več kot 90 % bolnikov najmanj dve uporabni rentgenski sliki.
• Improve your physical function.
• izboljšanje funkcije sklepov.
If you feel tired, dizzy or unwell after having Zessly, do not drive or use any tools or machines.
Če se po prejemu zdravila Zessly počutite utrujeni, omotični ali se ne počutite dobro, ne smete voziti ali upravljati kakršnih koli orodij ali strojev.
• You are allergic to infliximab or to any of the other ingredients of this medicine (listed in section 6).
• če ste alergični na infliksimab ali katero koli sestavino tega zdravila (navedeno v poglavju 6),
Check that the solution is colourless to light brown and opalescent.
Preverite, ali je raztopina brezbarvna do svetlo rjava in opalescentna.
For more information about the safety of infliximab in elderly patients see sections 4.4 and 4.8.
Za več informacij o varnosti infliksimaba pri starejših glejte poglavji 4.4 in 4.8.
• It is recommended that when Zessly is prepared for infusion, it is used as soon as possible (within 3 hours).
• Priporočljivo je, da se pripravljeno raztopino za infuzijo zdravila Zessly, uporabi čim prej (v 3 urah).
Zessly should only be used during pregnancy if your doctor feels it is necessary for you.
Zdravilo Zessly se lahko uporablja med nosečnostjo le, če zdravnik meni, da je to pri vas potrebno.
≥ 75% improvement
≥ 75-% izboljšanje
This should be taken into consideration for patients on a controlled sodium diet (see section 6.6).
To je treba upoštevati pri bolnikih, ki so na dieti z nadzorovanim vnosom natrija (glejte poglavje 6.6).
Study 11*
Študija 11*
In this situation, do not return to the refrigerated storage again.
V tem primeru ga ne vračajte ponovno v hladilnik.
Keep this card with you for 4 months after your dose of Zessly, or in case of pregnancy for at least 6 months after the birth of your baby.
To kartico nosite s seboj še 4 mesece po odmerku zdravila Zessly ali v primeru nosečnosti še vsaj 6 mesecev po rojstvu otroka.
This will depend on your disease, weight and how well you respond to Zessly.
To bo odvisno od vaše bolezni, telesne mase in tega, kako se odzivate na zdravilo Zessly.
Key results are presented in Table 10.
Ključni izsledki so predstavljeni v preglednici 10.