natgillin/translations-raw huggingface dataset:
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
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Celvapan, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove
What is the risk associated with Celvapan?
Kakšna tveganja so povezana z zdravilom Celvapan?
What benefit has Celvapan shown during the studies?
Kakšne koristi je zdravilo Celvapan izkazalo med študijami?
In both studies, the full dose of the vaccine was shown to bring about protective levels of antibodies to a satisfactory level in line with the criteria laid down by the CHMP.
V obeh študijah je bilo dokazano, da celotni odmerek zdravila povzroči nastanek zadovoljivih zaščitnih ravni protiteles v skladu z merili, ki jih je določil CHMP.
Two main studies have been carried out that looked at the ability of two doses of Celvapan H1N1 given three weeks apart to trigger an immune response.
Izvedeni sta bili dve glavni študiji, v katerih so proučevali, ali dva odmerka cepiva Celvapan H1N1, dana v razmiku treh tednov, lahko sprožita imunski odziv.
For more information about treatment with Celvapan, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Celvapan preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
Celvapan is given by injection into the muscle of the shoulder or thigh, as two doses at least three
Cepivo Celvapan se injicira v ramensko ali stegensko mišico v dveh odmerkih v razmiku najmanj treh
The CHMP decided that Celvapan's benefits of are greater than its risks and recommended that it be
CHMP je zaključil, da so koristi cepiva Celvapan večje od z njim povezanih tveganj, in priporočil, da se
The most common side effects with Celvapan (seen in more than 1 people vaccinated in 10) are headache and fatigue (tiredness).
Najpogostejša neželena učinka cepiva Celvapan (opažena pri več kot 1 cepljeni osebi od 10) sta glavobol in utrujenost.
When a person is given the vaccine, the immune system recognises the inactivated virus as ‘foreign' and makes antibodies against it.
Ko oseba prejme cepivo, imunski sistem prepozna inaktivirani virus kot tujek in proti njemu razvije protitelesa.
Celvapan is a vaccine.
Zdravilo Celvapan je cepivo.
The viruses used in Celvapan are grown in mammal cells (‘vero cells'), as opposed to hen's eggs.
Virusi, uporabljeni pri cepivu Celvapan, so vzgojeni v celicah sesalcev (celicah vero) in ne v kokošjih jajcih.
influenza vaccine (H1N1)v (whole virion, Vero cell derived, inactivated)
cepivo proti gripi (H1N1)v (celoten virion, razmnožen v celicah vero,
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Celvapan, including the appropriate precautions to be followed by healthcare
V skladu s tem načrtom so bile v povzetek glavnih značilnosti cepiva in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni
Celvapan was originally developed as a pandemic vaccine, to be used during the influenza A (H1N1) pandemic declared in June 2009.
Cepivo Celvapan je bilo prvotno pripravljeno kot pandemsko cepivo, ki naj bi se uporabljalo med pandemijo gripe A(H1N1), razglašene junija 2009.
How has Celvapan been studied?
Kako je bilo zdravilo Celvapan raziskano?
Celvapan is a vaccine that is given by injection.
Zdravilo Celvapan je cepivo za injiciranje.
Celvapan contains a flu strain called A/California/07/2009 (H1N1)v.
Cepivo Celvapan vsebuje sev gripe, imenovan A/California/07/2009 (H1N1)v.
Celvapan is a vaccine to protect against flu caused by the A (H1N1)v 2009 virus.
Zdravilo Celvapan je cepivo za zaščito pred gripo, ki jo povzroča virus A (H1N1)v 2009.
Celvapan contains a virus called A(H1N1)v 2009.
Cepivo Celvapan vsebuje virus A(H1N1) v 2009.
Celvapan is given
Cepivo se daje
For the full list of all side effects reported with Celvapan, see the
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila
The medicine can only be obtained with a prescription.
Zakaj je bilo zdravilo Celvapan odobreno?
28830 San Fernando de Henares (Madrid) Spain
28830 San Fernando de Henares (Madrid) Španija
20139 Milano Italy
20139 Milano Italija
19002 Paiania, Greece
19002 Paiania, Grčija
1110 Wien Austria
1110 Wien Avstrija
821 02 Bratislava Slovak Republic
821 02 Bratislava Slovaška Republika
Meda Oy Vaisalantie 4 02130 Espoo Finland
Meda Oy Vaisalantie 4 02130 Espoo Finska
Unit 34/35, Block A Dunboyne Business Park Dunboyne, Co. Meath Ireland
Unit 34/35, Block A Dunboyne Business Park Dunboyne, Co. Meath Irska
BIOPROJET PHARMA 9 Rue Rameau 75002 Paris France
BIOPROJET PHARMA 9 Rue Rameau 75002 Paris Francija
1186 DM Amstelveen The Netherlands
1186 DM Amstelveen Nizozemska
Pipers väg 2A, Box 906 SE-170 09, Solna Sweden
Pipers väg 2A, Box 906 SE-170 09, Solna Švedska
Meda Pharma Hungary Kft. Váci út 91.
Madžarska Meda Pharma Hungary Kft. Váci út 91.
Adrenaline Ph. Eur.
Adrenalin Ph. Eur.
Belgium Meda Pharma sa-nv Chaussée de la Hulpe 166 1170 Brussels
Meda Pharma sa-nv Chaussée de la Hulpe 166 1170 Brussels Belgija
Jankovcova 1569/2c 170 00 Prague Czech Republic
Jankovcova 1569/2c 170 00 Prague Češka Republika
DK-3450 Allerød Denmark
DK-3450 Allerød Danska
Adrenaline (epinephrine) 1 in 1000 solution for injection BP auto-injector
Adrenalinijev tartrat Adrenaline (epinephrine) 1 in 1000 solution for injection BP auto-injector
List of the names, pharmaceutical form(s), strength(s) of the medicinal product(s), route(s) of administration, marketing authorisation holder(s) in the Member States
Priloga I Seznam imen, farmacevtskih oblik, jakosti zdravila, poti uporabe zdravila,
Adrenalin (hydrochloride)
Adrenalin (hidroklorid)
Slovak Republic
Slovaška Republika
Salisbury SP2 0AH United Kingdom
Salisbury SP2 0AH Združeno Kraljestvo
Adrenaline (as adrenaline tartrate)
Adrenalin (kot adrenalinijev tartrat)
1 in 1000 Solution for injection Intramuscular/subcu taneous use
1 in 1000 raztopina za injiciranje intramuskularna/sub kutana uporaba
1, 61352 Bad Homburg v.d. Höhe Germany
1, 61352 Bad Homburg v.d. Höhe Nemčija
Nepipe Junior mikrogram
Nepipe Junior mikrogram parenteralna uporana
Hersholm 2970 Denmark
Hersholm 2970 Danska
Adrenalin (tartrate) Jext
Adrenalin (tartrat) Jext
61352 Bad Homburg Germany
61352 Bad Homburg Nemčija
DK-2970 Hørsholm Denmark
DK-2970 Hørsholm Danska
Meda Pharma SIA Vienibas gatve 109 Riga, LV-1058 Latvia
Meda Pharma SIA Vienibas gatve 109 Riga, LV-1058
Adrenaline tartrate Emerade mikrogram
Adrenalinijev tartrat Emerade mikrogram parenteralna uporana
Epinephrine hydrotartrat
Adrenalinijev hidrotartrat
Jext 150 microgram, oplossing voor injectie microgram/ dosis
Jext 150 microgram, oplossing voor injectie microgram/ dosis ntramuskularna uporaba
ALK ABELLÓ, S/A Bloque Alle, 6-8 DK-2970 Horsholm Denmark
ALK ABELLÓ, S/A Bloque Alle, 6-8 DK-2970 Horsholm Danska
EpiPen jr mikrogram
EpiPen jr mikrogram parenteralna uporana
ALK-Abello A/S Bøge Alle 6-8 B.O.BOX 408 2970 Horsholm Denmark
ALK-Abello A/S Bøge Alle 6-8 B.O.BOX 408 2970 Horsholm Danska
2970 Horsholm Denmark
2970 Horsholm Danska
Adrenaline tartrate Jext mikrogram
Adrenalinijev tartrat Jext mikrogram parenteralna uporana
Alk Abello A-S Boge Alle 6-8 Hersholm 2970 Denmark
Alk Abello A-S Boge Alle 6-8 Hersholm 2970 Danska
EpiPen mikrogram
EpiPen mikrogram parenteralna uporana
DK-2970 Horshlom Denmark
DK-2970 Horshlom Danska
Nepipe mikrogram
Nepipe mikrogram parenteralna uporana
Adrenaline tartrate Jext 300 microgramos solución inyectable en pluma precargada
Adrenalinijev tartrat Jext 300 microgramos solución inyectable en pluma precargada
Adrenaline tartrate Jext
Adrenalinijev tartrat Jext
DK-2970 Horsholm Denmark
DK-2970 Horsholm Danska
165 mcg Solution for injection in a prefilled injector
165 mcg raztopina za injiciranje v napolnjeni injekcijski brizgi
Alk Abello A/S Boge Alle 6-8 2970 Horsholm Denmark
Alk Abello A/S Boge Alle 6-8 2970 Horsholm Danska
Meda Pharma GmbH & Co. KG
MEDA Pharma GmbH & Co.
Adrenaline tartrate Jext 300 micrograms solution for injection in pre-filled pen micrograms
Adrenalinijev tartrat Jext 300 micrograms solution for injection in pre-filled pen micrograms
0,3 mg/dose Solution for injection Intramuscular use
0,3 mg/dose raztopina za injiciranje
Germany MEDA Pharma GmbH & Co. KG
Romunija MEDA Pharma GmbH & Co.
Adrenaline tartrate Jext 150 micrograms solution for injection in pre-filled pen micrograms
Adrenalinijev tartrat Jext 150 micrograms solution for injection in pre-filled pen micrograms
150 mcg Solution for infusion Intramuscular use
150 mcg raztopina za injiciranje
300 mcg Solution for infusion Intramuscular use
300 mcg raztopina za injiciranje
300 microg Solution for injection Intramuscular use
300 microg raztopina za injiciranje
Adrenalinum bítartrat (Epinephrinum bítartrat)
Adrenalinijev bítartrat
0,15 mg/3ml Solution for injection Intramuscular use
0,15 mg/3ml raztopina za injiciranje
Adrenaline tartrate Emerade 500 micrograms solution for injection in pre-filled pen micrograms
Adrenalinijev tartrat Emerade 500 micrograms solution for injection in pre-filled pen micrograms
330 mcg Solution for injection in a prefilled injector
330 mcg raztopina za injiciranje v napolnjeni injekcijski brizgi
Lithuania Lincoln Medical Ltd Unit 8, Wilton Business Centre
Madžarska Lincoln Medical Ltd Unit 8, Wilton Business Centre
150 microg Solution for injection Intramuscular use
150 microg raztopina za injiciranje
0,5 mg/ 1 ml Solution for injection Intramuscular use
0,5 mg/ 1 ml raztopina za injiciranje
Adrenaline tartrate Emerade 300 micrograms solution for injection in pre-filled pen micrograms
Adrenalinijev tartrat Emerade 300 micrograms solution for injection in pre-filled pen micrograms
Adrenaline tartrate Emerade 150 micrograms solution for injection in pre-filled pen micrograms
Adrenalinijev tartrat Emerade 150 micrograms solution for injection in pre-filled pen micrograms
0,15 mg Solution for injection Intramuscular use
0,15 mg raztopina za injiciranje
Jext 150 mikrogramov 150 µg/dose Solution for injection in pre-filled pen
Jext 150 mikrogramov 150 µg/dose raztopina za injiciranje v napolnjenem peresniku
Anapen 300 micrograms in 0.3ml solution for injection in a pre-filled syringe micrograms in 0.3ml solution
Anapen 300 micrograms in 0.3ml solution for injection in a pre-filled syringe micrograms in 0.3ml solution raztopina za injiciranje v napolnjeni injekcijski brizgi
Denmark Lincoln Medical Ltd Unit 8 Wilton Business Centre
Slovenija Lincoln Medical Ltd Unit 8 Wilton Business Centre
Anapen 150 micrograms/0,3 ml solution for injection in pre-filled syringe micrograms/ 0,3 ml
Anapen 150 micrograms/0,3 ml solution for injection in pre-filled syringe micrograms/ 0,3 ml raztopina za injiciranje v napolnjeni injekcijski brizgi
ANAPEN 300 mikrogramm/0,3 ml oldatos injekció előretöltött fecskendőben microgramm /0,3 ml
ANAPEN 300 mikrogramm/0,3 ml oldatos injekció előretöltött fecskendőben microgramm /0,3 ml raztopina za injiciranje v napolnjeni injekcijski brizgi
Jext 300 mikrogramov 300 µg/dose Solution for injection in pre-filled pen
Jext 300 mikrogramov 300 µg/dose raztopina za injiciranje v napolnjenem peresniku
Anapen 300 micrograms/0,3 ml solution for injection in pre-filled syringe micrograms/ 0,3 ml
Anapen 300 micrograms/0,3 ml solution for injection in pre-filled syringe micrograms/ 0,3 ml raztopina za injiciranje v napolnjeni injekcijski brizgi
0.15 mg Solution for injection Intramuscular use
0.15 mg raztopina za injiciranje
ANAPEN JUNIOR 150 mikrogramm/0,3 ml oldatos injekció előretöltött fecskendőben microgramm /0,3 ml
ANAPEN JUNIOR 150 mikrogramm/0,3 ml oldatos injekció előretöltött fecskendőben microgramm /0,3 ml raztopina za injiciranje v napolnjeni injekcijski brizgi
Epinephrine Bitartrate
Adrenalinijev Bitartrat
150 mcg Solution for injection, prefilled pen
150 mcg raztopina za injiciranje, napolnjen peresnik
Adults, including the elderly
Odrasli, vključno s starejšimi
These include:
Med takšnimi so:
Not known (frequency cannot be estimated from the available data).
Ni znano (pogostnosti ni mogoče oceniti na podlagi podatkov, ki so na voljo).
Date of first authorisation: 22 March 2018
Datum prve odobritve: 22. marec 2018
Treatment was discontinued on study exit (Day 365).
Zdravljenje se je prenehalo ob izhodu iz študije (365. dan).
Do not give this medicine to children and adolescents under 18 years of age.
Tega zdravila ne dajajte otrokom in mladostnikom, mlajšim od 18 let.
Hypokalaemia may be observed (see section 4.8).
Lahko se pojavi hipokaliemija (glejte poglavje 4.8).
In addition, clinical studies have shown it not to be systemically absorbed.
Poleg tega so klinične študije pokazale, da se ne absorbira sistemsko.
• Try to take Lokelma at the same time each day.
• Zdravilo Lokelma poskusite vzeti vsak dan ob istem času.
To open, cut across top.
Za odprtje prerežite na vrhu.
The white powder will settle in the glass quickly.
Beli prašek se v kozarcu hitro sesede.
Do not use this medicine during pregnancy because there is no information on its use in pregnancy.
Ne uporabljajte tega zdravila med nosečnostjo, ker o njegovi uporabi med nosečnostjo ni informacij.
• Then take the next dose as usual at your normal time.
• Naslednji običajni odmerek vzemite kot po navadi.
• Do not take this starting dose for more than three days.
• Tega začetnega odmerka ne jemljite več kot tri dni.
• diuretics (medicines that increase urine production)
• diuretiki (zdravila, ki povečajo nastajanje urina)
• This is to make sure you are getting the correct dose.
• Tako se bosta prepričala, da prejemate ustrezen odmerek.
• You can take this medicine with or without meal.
• To zdravilo lahko vzamete s hrano ali brez nje.
It should be ensured that all of the content is taken.
Zagotoviti je treba, da bolnik zaužije celotno vsebino.
NS: not significant
NZ: neznačilno
No dietary restrictions were imposed; patients were instructed to continue their usual diet without any specified alterations.
Prehranskih omejitev ni bilo; bolnikom je bilo naročeno, naj nadaljujejo svojo običajno prehrano brez specifičnih sprememb.
If this happens, stir the liquid again and drink it all up.
Če se to zgodi, tekočino spet premešajte in jo vso popijte.
No consistent effect on systolic and diastolic blood pressure has been observed.
Doslednega učinka na sistolični ali diastolični krvni tlak niso opazili.
• The medicine takes one to two days to work.
• Da zdravilo začne delovati, sta potrebna dan ali dva.
Do not reduce the dose of this medicine or stop taking it without talking to the doctor who prescribed it.
Ne zmanjšajte odmerka tega zdravila in ne prenehajte ga jemati, ne da bi se posvetovali z zdravnikom, ki vam ga je predpisal.
In addition, two open-label maintenance studies tested long-term safety of Lokelma.
Poleg tega sta dve odprti vzdrževalni študiji preverjali dolgoročno varnost zdravila Lokelma.
The safety and efficacy of Lokelma in children and adolescents (< 18 years) have not been established.
Varnost in učinkovitost zdravila Lokelma pri otrocih in mladostnikih (< 18 let) nista bili dokazani.
Due to these factors and its insolubility, no in vivo or in vitro studies have been performed to examine its effect on cytochrome P450 (CYP450) enzymes or transporter activity.
Zaradi teh dejavnikov in njegove netopnosti niso izvedli in vivo ali in vitro študij za proučitev njegovega vpliva na encime citokroma P450 (CYP450) ali aktivnost prenašalcev.
The powder will not dissolve.
Prašek se ne raztopi.
These events were mild to moderate in nature, none were reported as serious and were generally resolved while the patient continued treatment.
Ti učinki so bili blagi do zmerni, noben ni bil prijavljen kot resen in so na splošno minili med nadaljevanjem zdravljenja.
If normokalaemia is not achieved after 72 hours of treatment, other treatment approaches should be considered.
Če normokaliemija ni dosežena niti po 72 urah zdravljenja, je treba razmisliti o drugih načinih zdravljenja.
The adverse reactions identified from controlled trials are shown in Table 1.
Neželeni učinki, ugotovljeni v kontroliranih preskušanjih, so prikazani v Preglednici 1.
• Your doctor may decide that you need more (10 g once a day) or less than this (5 g every other day).
• Zdravnik se lahko odloči, da potrebujete več (10 g enkrat na dan) ali manj (5 g vsaki drugi dan) od tega.
Also, tell your doctor or nurse if you are taking any of the following:
Prav tako obvestite zdravnika ali medicinsko sestro, če jemljete katero od naslednjih zdravil:
• Rinse the glass with more water and drink it all up to take all the medicine.
• Splaknite kozarec z nekaj dodatne vode in to vodo popijte, da boste zaužili vse zdravilo.
The sachets are supplied in a carton containing 3, 28 or 30 sachets.
Vrečice so na voljo v škatlah, ki vsebujejo 3, 28 ali 30 vrečic.
Therefore, the subject was eligible for the Correction Phase ITT Population; however, the time point was excluded from the analysis.
Zato je bil sicer ustrezen za populacijo z namenom zdravljenja v obdobju korekcije, toda časovna točka je bila izključena iz analize.
If the powder settles, the water should be stirred again.
Če se prašek sesede, je treba vodo znova premešati.
Do not use this medicine after the expiry date which is stated on the carton and the sachet after ‘EXP'.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in vrečici poleg oznake "EXP".
Summary of the safety profile The most commonly reported adverse reactions were hypokalaemia (4.1%) and oedema related events
Povzetek varnostnih značilnosti Najpogosteje poročani neželeni učinki so bili hipokaliemija (4,1 %) in z edemi povezani dogodki
• you start to have a build up of fluid in the tissues, leading to swelling anywhere in your body (usually in the feet and ankles).
• če se vam začne kopičiti tekočina v tkivih; to povzroči otekanje kjer koli v telesu (običajno v stopalih ali gležnjih).
Typically, normokalaemia is achieved within 24 to 48 hours.
Praviloma je normokaliemija dosežena v 24 do 48 urah.
The entire contents of the sachet should be emptied in a drinking glass containing approximately 45 ml of water and stirred well.
Celotno vsebino vrečice je treba stresti v kozarec, v katerem je približno 45 ml vode in dobro premešati.
If patients are still hyperkalaemic after 48 hours of treatment, the same regimen can be continued for an additional 24 hours.
Če je bolnik tudi po 48 urah zdravljenja še vedno hiperkaliemičen, je treba enako shemo nadaljevati dodatnih 24 ur.
Long-term exposure Clinical trials with Lokelma have not included exposure longer than one year.
Dolgotrajna izpostavljenost Klinična preskušanja z zdravilom Lokelma niso obsegala izpostavljenosti, daljše od enega leta.
Long term exposure
Dolgotrajna izpostavljenost
The following convention was used for frequency of adverse reactions: Very common (≥ 1/10); Common (≥ 1/100 to < 1/10); Uncommon (≥ 1/1,000 to < 1/100); Rare (≥ 1/10,000 to < 1/1,000); Very rare (< 1/10,000), not known (cannot be estimated from the available data).
Pogostnost neželenih učinkov je razvrščena po naslednji konvenciji: zelo pogosti (≥ 1/10), pogosti (od ≥ 1/100 do < 1/10), občasni (od ≥ 1/1.000 do < 1/100), redki (od ≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000), neznana (ni mogoče oceniti iz razpoložljivih podatkov).
Median time to normokalaemia was 2.2 hours with 66% of patients achieving normokalaemia at 24 hours and 88% at 48 hours.
Mediani čas do normokaliemije je bil 2,2 ure; 66 % bolnikov je doseglo normokaliemijo v 24 urah in 88 % v 48 urah.
Tell your doctor or nurse if you experience any of the following: Common side effects (may affect up to 1 in 10 people).
Zdravniku ali medicinski sestri povejte, če se vam pojavi kaj od naslednjega: Pogosti neželeni učinki (pojavijo se lahko pri največ 1 od 10 bolnikov).
CP at 48 hours
FK po 48 urah
• The powder does not dissolve and the liquid appears cloudy.
• Prašek se ne raztopi in tekočina je motnega videza.
Lokelma is indicated for the treatment of hyperkalaemia in adult patients (see section 4.4 and 5.1).
Zdravilo Lokelma je indicirano za zdravljenje hiperkaliemije pri odraslih bolnikih (glejte poglavji 4.4 in 5.1).
5 or 10 g of powder in sachets made of a PET/alu/LLDPE or PET/LDPE/alu/EAA/LLDPE laminate
5 ali 10 g praška v vrečicah, narejenih iz PET/aluminij/LLDPE ali PET/LDPE/aluminij/EEA/LLDPE laminata.
The suspension can be taken with or without food.
Suspenzijo lahko bolnik popije s hrano ali brez nje.
Pack sizes: 3, 28 or 30 sachets
Velikosti pakiranj: 3, 28 ali 30 vrečic.
Do not take Lokelma • If you are allergic to the active substance.
Ne jemljite zdravila Lokelma: • Če ste alergični na učinkovino.
Maintenance (day)
Vzdrževanje (dan)
Lokelma 10 g three times daily (N=749)
Zdravilo Lokelma 10 g trikrat na dan (N = 749)
All three studies tested the initial effect of Lokelma to correct hyperkalaemia during a 48-hour period and two studies also tested maintenance of normokalaemia effect obtained.
Vse tri študije so preverjale začetni učinek zdravila Lokelma na odpravo hiperkaliemije v 48-urnem obdobju, dve študiji pa sta preverjali tudi vzdrževanje doseženega normokaliemičnega učinka.
What Lokelma is and what it is used for
Kaj je zdravilo Lokelma in za kaj ga uporabljamo
• you have sudden or severe pain in your abdomen as this may be a sign of a problem that is observed with other medications that work in the gastrointestinal tract.
• če imate nenadne ali hude bolečine v trebuhu; to je lahko znak težave, opažene med uporabo drugih zdravil, ki delujejo v prebavilih.
CP at 24 hours
FK po 24 urah
1.25 g three times daily
1,25 g trikrat na dan
Do not take any more until you have spoken to a doctor.
Zdravila ne vzemite več, dokler se ne posvetujete z zdravnikom.
• Stir well and drink the tasteless liquid straight away.
• Dobro premešajte in tekočino, ki je brez okusa, takoj popijte.
When normokalaemia is achieved, the maintenance regimen should be followed (see below).
Ko je dosežena normokaliemija, je treba upoštevati shemo za vzdrževalno zdravljenje (glejte spodaj).
• Do not take a maintenance dose of more than 10 g once a day.
• Ne jemljite vzdrževalnega odmerka, večjega od 10 g enkrat na dan.
Note: One subject had a post-dose value that was more than 1 day after last dose.
Opomba: En preiskovanec je imel evidentirano vrednost po odmerku več kot 1 dan po zadnjem odmerku.
If the patient is having abdominal X-rays, radiographers should keep this in mind.
Če mora bolnik opraviti rentgensko slikanje trebuha, mora radiolog upoštevati to dejstvo.
This is because the effects of Lokelma in children and adolescents are not known.
Učinki zdravila Lokelma pri otrocih in mladostnikih namreč niso znani.
Pharmacotherapeutic group: Drugs for treatment of hyperkalaemia and hyperphosphatemia, ATC code: V03AE10
Farmakoterapevtska skupina: zdravila za zdravljenje hiperkaliemije in hiperfosfatemije, Oznaka ATC: V03AE10
When normokalaemia has been achieved, the minimal effective dose of Lokelma to prevent recurrence of hyperkalaemia should be established.
Ko je normokaliemija dosežena je treba uvesti najmanjši učinkoviti odmerek zdravila Lokelma za preprečevanje ponovne hiperkaliemije.
What you need to know before you take Lokelma
Kaj morate vedeti, preden boste vzeli zdravilo Lokelma
Correction (hour)
Korekcija (ura)
Maintenance phase
Obdobje vzdrževanja
• angiotensin converting enzyme (ACE) inhibitors such as enalapril, and angiotensin receptor blockers which name ends with sartan (medicines for high blood pressure and for heart problems)
• zaviralci angiotenzinske konvertaze (ACE), na primer enalapril in blokatorji receptorjev angiotenzina, katerih ime se končuje na "sartan" (zdravila za visok krvni tlak in za težave s srcem)
There are no other ingredients in this medicine.
To zdravilo ne vsebuje drugih sestavin.