natgillin/translations-raw huggingface dataset:
• A physician will provide training on the following elements: - Precaution for storage - Dose calculation and indication (i.e. only acute HAE attacks) - Preparation of one dose of Ruconest (50 U/kg, up to 4200 U) by reconstituting one or two vials - Method of reconstitution of each powder vial - Technique of intravenous injection - Method and rate of administration of one dose of Ruconest - Guidance on use of a second dose of Ruconest - Instruction to immediately seek medical attention in case of failure to gain venous access, in case of lack of efficacy, in the event of any adverse reaction including hypersensitivity, or after self administering Ruconest for an acute laryngeal HAE attack. 
- Pripravo enega odmerka zdravila Ruconest (50 e./kg, do 4200 e.) z rekonstitucijo ene viale ali dveh - Način rekonstitucije ene viale s praškom - Tehniko intravenoznega injiciranja - Navodila za uporabo drugega odmerka zdravila Ruconest
Each powder vial contains 2100 units of conestat alfa, 
Ena viala vsebuje 2100 enot (e.) konestata alfa, kar ustreza
Keep the powder vial in the outer carton in order to protect from light. 
Vialo s praškom shranjujte v originalni ovojnini za zagotovitev zaščite pred svetlobo.
Powder vial 
Viala s praškom
Tighten it to compress the vein. 
da stisnete žilo.
The reconstituted solution in each vial contains 2100 U conestat alfa at 150 U/ml and appears as a clear colourless solution. 
Rekonstituirana raztopina v vsaki viali vsebuje 2100 e. konestata alfa, kar ustreza 150 e./ml, in je bistra, brezbarvna raztopina.
Step 2: Disinfection of vial stoppers 
4. korak: Vbrizgavanje vehikla
A solution exhibiting particulates or discoloration should not be used. 
Raztopine, v kateri so trdni delci ali je spremenjene barve, se ne sme uporabiti.
Attach the syringe with solvent to the adapter on the powder vial and turn clockwise until it locks. 
Brizgo z vehiklom namestite na adapter viale s praškom in vrtite v smeri urinega kazalca, dokler se ne zaskoči na mestu.
One vial contains 2100 units of conestat alfa, corresponding to 2100 units per 14 ml after reconstitution, or a concentration of 150 units/ml. 
Ena viala vsebuje 2100 enot konestata alfa, kar ustreza 2100 enotam na 14 ml po rekonstituciji ali koncentraciji 150 enot/ml.
Step 8: Check prepared syringes • Recheck that the volume in the syringe(s) you prepared in step 7 is correct. 
• Znova preverite količino v brizgi ali brizgah, ki ste jo pripravili v 7. koraku.
Patients with HAE have low levels of C4 in the circulation. 
Bolniki s HAE imajo v obtoku prenizke ravni C4. Glede iz plazme pridobljenega C1INH farmakodinamični učinki konestata alfa na
How to store Ruconest 
Shranjevanje zdravila Ruconest
Sodium citrate (E331) Citric acid 
Viala s praškom: saharoza natrijev citrat (E331) citronska kislina
- Keep this leaflet. 
Pri tem stisnite tudi pest.
Each vial of Ruconest contains 19.5 mg of sodium. 
Ena viala zdravila Ruconest vsebuje 19,5 mg natrija.
• Unlock the syringe from the adapter by turning counter-clockwise. 
• Brizgo odstranite z adapterja tako, da jo zavrtite v nasprotni smeri od vrtenja urinega kazalca.
84 kg and above 
Telesna masa 84 kg ali več
As for plasma-derived C1INH, the pharmacodynamic effects of conestat alfa on C4 show dose-dependent restoration of complement homeostasis in HAE patients at a plasma C1INH activity level greater than 0.7 U/ml, which is the lower limit of the normal range. 
pri ravni aktivnosti C1INH v plazmi, večji od 0,7 e/ml, ki je spodnja meja normalne vrednosti.
The following describes how Ruconest solution must be prepared and administered. 
V nadaljevanju so opisana navodila za pripravo in dajanje zdravila Ruconest.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS POWDER VIAL LABEL 
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH
PARTICULARS TO APPEAR ON THE OUTER PACKAGING ADMINISTRATION KIT VIAL CARTON 
PODATKI NA ZUNANJI OVOJNINI ŠKATLA VIALE
Time (minutes) to beginning of relief median (95% CI) 
Povprečni čas (minute) do začetka ublažitve
The information recorded should include: - Date and time of treatment - Batch number and dose - Response to treatment - Any adverse events 
Bolnikov dnevnik mora zajemati naslednje ključne elemente: • Datum in čas zdravljenja
One powder vial contains 2100 U of conestat alfa, corresponding to 2100 U/14 ml after reconstitution, or a concentration of 150 U/ml. 
Ena viala s praškom vsebuje 2100 e. konestata alfa, kar ustreza 2100 e./14 ml po rekonstituciji ali koncentraciji 150 e./ml.
One vial contains 2100 U of conestat alfa, corresponding to 2100 U/14 ml after reconstitution, or a concentration of 150 U/ml. 
Ena viala vsebuje 2100 e. konestata alfa, kar ustreza 2100 e./14 ml po rekonstituciji ali koncentraciji 150 e./ml.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING VIAL CARTON 
PODATKI NA ZUNANJI OVOJNINI ŠKATLA VIALE V KOMPLETU ZA DAJANJE ZDRAVILA
• Remove the plastic flip-off cap from the powder and solvent vials. 
• Z viale s praškom in viale z vehiklom odstranite plastični pokrovček »flip-off«.
Ruconest 2100 U powder for solution for injection. 
Ruconest 2100 e. prašek za raztopino za injiciranje
Attach the syringe to the adapter on the solvent vial and turn clockwise until it locks. 
Brizgo namestite na adapter viale z vehiklom in vrtite v smeri urinega kazalca, dokler se ne zaskoči na mestu.
Vertigo Paraesthesia 
Rekonstituirana raztopina
Sodium Citrate (E331), Citric Acid. 
Pomožne snovi: saharoza, natrijev citrat (E331), citronska kislina.
Ruconest contains conestat alfa as the active substance. 
Zdravilna učinkovina v zdravilu Ruconest je konestat alfa.
Attach the infusion set to the syringe and turn clockwise until it locks. 
Na brizgo namestite komplet za infundiranje in vrtite v smeri urinega kazalca, dokler se ne zaskoči na mestu.
Ruconest 2100 U powder and solvent for solution for injection. 
Ruconest 2100 e. prašek in vehikel za raztopino za injiciranje
• Unlock the syringe(s) by turning it counter-clockwise and discard the vial(s) with adapter. 
• Brizgo ali brizgi odstranite z adapterja tako, da jo zavrtite v smeri, ki je nasprotna smeri vrtenja urinega kazalca, in zavrzite vialo ali viali z adapterjem.
Diarrhoea 
Odmerjanje
Solvent vial: • The ingredient of the solvent is water for injections. 
Viala s topilom: Viala vsebuje vodo za injekcije.
Disposal 
Uporaba
PARTICULARS TO APPEAR ON THE OUTER PACKAGING ADMINISTRATION KIT OUTER CARTON 
PODATKI NA ZUNANJI OVOJNINI ŠKATLA KOMPLETA ZA DAJANJE ZDRAVILA
Powder vial: 
korak: Razkuževanje zaporke vial
STATEMENT OF ACTIVE SUBSTANCE(S) 
Volumen zdravila za dajanje (ml)
Step 7: Drawing up prepared solution 
7. korak: Vbrizgavanje pripravljene raztopine
Gastrointestinal disorders 
- Tehniko intravenoznega injiciranja
• The training to be provided should address the following elements - Precaution for storage - Dose calculation and indication (i.e. only acute HAE attacks) - Preparation of one dose of Ruconest (50 U/kg, up to 4200 U) by reconstituting one or two vials - Method of reconstitution of each powder vial - Technique of intravenous injection - Guidance on use of a second dose of Ruconest - Instruction to immediately seek medical attention in case of failure to gain venous access, in case of lack of efficacy, in the event of any adverse reaction including hypersensitivity, or after selfadministering Ruconest for an acute laryngeal HAE attack. 
- Navodila za takojšnjo nujno medicinsko pomoč v primeru neuspešnega dostopa v veno, v primeru neučinkovanja, kakršnega koli neželenega učinka vključno s preobčutljivostjo, ali po samostojnem dajanju zdravila Ruconest zaradi akutnega laringalnega napada HAE
Ensure that the tourniquet is released. 
Prepričajte se, da je žilna preveza sproščena.
• Sensation of tingling, prickling or numbness in the skin or limb (paraesthesia) 
Občasni (pojavijo se lahko pri največ 1 od 100 bolnikov • Občutek mravljinčenja, zbadanja ali omrtvelosti kože ali okončin (parestezije)
• Risk Management Plan (RMP) 
• Načrt obvladovanje tveganja (RMP)
Date of first authorisation: 15 May 2002 Date of latest renewal: 15 May 2007 
Datum prve pridobitve dovoljenja: 15 maj 2002 Datum zadnjega podaljšanja dovoljenja: 15 maj 2007
Patients with rare hereditary problems of fructose intolerance should not take this medicine. 
Bolniki z redko dedno intoleranco za fruktozo ne smejo jemati tega zdravila
Once daily 
enkrat dnevno
In case of signs and symptoms of general central nervous system (CNS) overstimulation, careful symptomatic clinical treatment should be considered. 
Pri znakih in simptomih splošne prekomerne stimulacije centralnega živčnega sistema (CŽS) je treba razmisliti o previdnem simptomatičnem kliničnem zdravljenju.
- If you find you have forgotten to take your dose of Ebixa, wait and take your next dose at the usual time. 
- Če ste ugotovili, da ste pozabili vzeti predpisani odmerek zdravila Ebixa, počakajte in vzemite naslednji odmerek ob običajnem času.
CARTON AND LABEL FOR BOTTLE 
ŠKATLA IN NALEPKA ZA STEKLENICO
Paediatric population No data are available. 
Pediatrična populacija Podatkov ni na voljo.
Ebixa is not recommended for children and adolescents under the age of 18 years. 
Zdravila Ebixa ne priporočajo otrokom in mladostnikom, mlajšim od 18 let.
• Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone beeing reached. 
• ob vsakršni spremembi sistema za obvladovanje tveganj, zlasti kadar je tovrstna sprememba posledica prejema novih informacij, ki lahko privedejo do znatne spremembe razmerja med koristmi in tveganji, ali kadar je ta sprememba posledica tega, da je bil dosežen pomemben mejnik (farmakovigilančni ali povezan z zmanjševanjem tveganja).
Ebixa with food and drink 
Zdravilo Ebixa skupaj s hrano in pijačo
C-memantine, a mean of 84% of the dose was recovered within 20 days, more than 99% being excreted renally. 
C-memantina se je izločilo 84 % odmerka v 20 dneh, več kot 99 % preko ledvic.
For detailed instructions on the preparation and handling of the product see section 6.6. 
Za podrobna navodila za pripravo in ravnanje z zdravilom glejte poglavje 6.6.
CARTON FOR 28 TABLETS - TREATMENT INITIATION PACK - 4 WEEK TREATMENT SCHEDULE 
ŠKATLA ZA 28 TABLET - PAKIRANJE ZA UVAJALNO ZDRAVLJENJE - ŠTIRI TEDENSKI PROGRAM ZDRAVLJENJA
50 ml (and 10 x 50 ml) in brown glass bottles (Hydrolytic Class II) and 100 ml in brown glass bottles (Hydrolytic Class III). 
50 ml (in 10 × 50 ml) v rjavih stekleničkah (hidrolitski razred II) in 100 ml v rjavih stekleničkah (hidrolitski razred III).
For detailed instructions on the preparation and handling of the product see end of this leaflet. 
Za podrobna navodila za pripravo in ravnanje z zdravilom glejte konec tega navodila za uporabo.
At the beginning of treatment you will start by using Ebixa 5 mg film-coated tablets once a day. 
Na začetku zdravljenja boste uporabljali zdravilo Ebixa 5 mg filmsko obložene tablete enkrat dnevno.
The Ebixa treatment initiation pack is only to be used for the beginning of the treatment with Ebixa. 
Pakiranje za uvajalno zdravljenje se uporablja samo na začetku zdravljenja z zdravilom Ebixa.
Do not take Ebixa if you are allergic to memantine or any of the other ingredients of this medicine (listed in section 6). 
- če ste alergični na memantin ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
What Ebixa is and what it is used for 
Kaj je zdravilo Ebixa in za kaj ga uporabljamo
Take only one tablet per day 
Vzemite le eno tableto na dan.
If you go into hospital, let your doctor know that you are taking Ebixa. 
V primeru, da ste sprejeti v bolnišnico, obvestite zdravnika, da jemljete zdravilo Ebixa.
In the most extreme case of overdose, the patient survived the oral intake of a total of 2000 mg memantine with effects on the central nervous system (coma for 10 days, and later diplopia and agitation). 
V najekstremnejšem primeru prevelikega odmerka je bolnik preživel peroralni vnos 2000 mg memantina z učinki na centralni živčni sistem (desetdnevna koma, kasneje diplopija in vznemirjenost).
If you take more Ebixa than you should 
Če ste vzeli večji odmerek zdravila Ebixa, kot bi smeli
The treatment scheme is also indicated on the treatment initiation pack. 
Urnik zdravljenja je prikazan tudi na ovojnini za uvajalno zdravljenje.
- if you have a history of epileptic seizures - if you have recently experienced a myocardial infarction (heart attack), or if you are suffering from congestive heart failure or from an uncontrolled hypertension (high blood pressure). 
- če ste v preteklosti imeli epileptične napade, - če ste pred kratkim preboleli srčni infarkt (srčna kap), imate kongestivno srčno odpoved ali neurejeno hipertenzijo (visok krvni tlak).
- If you take a large overdose of Ebixa, contact your doctor or get medical advice, as you may need medical attention. 
- V primeru, da ste zaužili prevelik odmerek zdravila Ebixa, obvestite svojega zdravnika ali se obrnite po nasvet na zdravstveno službo, ker boste morda potrebovali zdravniško obravnavo.
20 mg tablets once a day 
20 mg tablete enkrat dnevno
Other medicines and Ebixa 
Druga zdravila in zdravilo Ebixa
Excipients with known effect: Each millilitre of solution contains 100 mg sorbitol (E420) and 0.5 mg potassium, see section 4.4. 
Pomožne snovi z znanim učinkom: En mililiter raztopine vsebuje 100 mg sorbitola (E420) in 0.5 mg kalija, glejte poglavje 4.4.
Ebixa oral solution is available in bottles of 50 ml, 100 ml or 10 x 50 ml. 
Ebixa peroralna raztopina je na voljo v stekleničkah po 50 ml, 100 ml ali 10 x 50 ml.
In clinical trials in mild to severe dementia, involving 1,784 patients treated with Ebixa and 1,595 patients treated with placebo, the overall incidence rate of adverse reactions with Ebixa did not differ from those with placebo; the adverse reactions were usually mild to moderate in severity. 
V kliničnih preskušanjih bolnikov z zmerno do hudo demenco, ki so zajeli 1784 bolnikov, zdravljenih z zdravilom Ebixa in 1595 bolnikov, ki so prejemali placebo, se skupna incidenca neželenih reakcij pri zdravilu Ebixa ni razlikovala od placeba, neželeni učinki pa so bili po resnosti večinoma blagi do zmerni.
If you are suffering from states of renal tubulary acidosis (RTA, an excess of acid-forming substances in the blood due to renal dysfunction (poor kidney function)) or severe infections of the urinary tract (structure that carries urine), your doctor may need to adjust the dose of your medicine. 
Če imate ledvično tubularno acidozo (preveliko količino kislih spojin v krvi zaradi renalne disfunkcije (slabega delovanja ledvic)) ali če ste zboleli zaradi hudega vnetja sečil (strukture, po kateri se prenaša seč), bo vaš zdravnik morda prilagodil odmerek vašega zdravila.
If the pump does not function as described during intended use and according to instruction, the patient should consult the treating physician or a pharmacist. 
Če odmerna črpalka med uporabo, za katero je namenjena ne deluje, kot je opisano in v skladu z navodili, naj se bolnik posvetuje s svojim zdravnikom ali farmacevtom.
Not known (frequency cannot be estimated from the available data): • Inflammation of the pancreas, inflammation of the liver (hepatitis) and psychotic reactions 
Neznana (pogostosti ni mogoče oceniti iz razpoložljivih podatkov): • vnetje trebušne slinavke, vnetje jeter (hepatitis) in psihotične reakcije
What you need to know before you take Ebixa 
Kaj morate vedeti, preden boste vzeli zdravilo Ebixa
What Ebixa is and what it is used for What you need to know before you take Ebixa How to take Ebixa 
Kaj je zdravilo Ebixa in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Ebixa Kako jemati zdravilo Ebixa Možni neželeni učinki
- amantadine, ketamine, dextromethorphan - dantrolene, baclofen - cimetidine, ranitidine, procainamide, quinidine, quinine, nicotine - hydrochlorothiazide (or any combination with hydrochlorothiazide) - anticholinergics (substances generally used to treat movement disorders or intestinal cramps) - anticonvulsants (substances used to prevent and relieve seizures) - barbiturates (substances generally used to induce sleep) - dopaminergic agonists (substances such as L-dopa, bromocriptine) - neuroleptics (substances used in the treatment of mental disorders) - oral anticoagulants 
- amantadin, ketamin, dekstrometorfan - dantrolen, baklofen - cimetidin, ranitidin, prokainamid, kinidin, kinin, nikotin - hidroklorotiazid (ali kombinacije zdravil, ki vsebujejo hidroklorotiazid) - antiholinergiki (zdravila, ki se na splošno uporabljajo za zdravljenje motenj gibanja in trebušnih krčev) - antikonvulzivi (zdravila za preprečevanje ali lajšanje epileptičnih krčev) - barbiturati (zdravila, ki se na splošno uporabljajo kot uspavala) - dopaminergični agonisti (učinkovine kot L-dopa, bromokriptin) - nevroleptiki (zdravila za zdravljenje duševnih motenj) - peroralni antikoagulanti
The recommended treatment dose of 20 mg per day is achieved by a gradual increase of the Ebixa dose during the first 3 weeks of treatment. 
Priporočeni zdravilni odmerek 20 mg na dan, se doseže s postopnim povečevanjem odmerka zdravila Ebixa v prvih treh tednih zdravljenja.
Furthermore, Ebixa has minor or moderate influence on the ability to drive and use machines such that outpatients should be warned to take special care. 
Prav tako lahko zdravilo Ebixa ima blag ali zmeren vpliv na sposobnost vožnje in upravljanja s stroji, zato je potrebno bolnike opozoriti na posebno previdnost.
You should inform your doctor if you have recently changed or intend to change your diet substantially (e.g. from normal diet to strict vegetarian diet), as your doctor may need to adjust the dose of your medicine. 
Obvestite svojega zdravnika, če ste pred kratkim spremenili ali če nameravate bistveno spremeniti prehrano (npr. če preidete iz običajne hrane na strogo vegetarijansko prehrano).
In particular, Ebixa may change the effects of the following medicines and their dose may need to be adjusted by your doctor: 
Posebno v primeru, da skupaj z zdravilom Ebixa jemljete naslednja zdravila, se učinki le teh lahko spremenijo in bo morda vaš zdravnik moral prilagoditi odmerek:
If you forget to take Ebixa 
Če ste pozabili vzeti zdravilo Ebixa
”Possible side effects”. 
»Možni neželeni učinki«.
- In general, taking too much Ebixa should not result in any harm to you. 
- Na splošno zaužitje večjega odmerka zdravila Ebixa ne sme imeti škodljivih posledic.
To do this, the dosing pump head has to be turned in the direction of the arrow about one eighth of a turn, until a resistance is felt (fig. 4) 
Da to storimo, moramo glavo odmerne črpalke obračati v smeri puščice približno za eno osmino obrata, dokler ne začutiomo upora (sl. 4).
Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). 
Predpisovaje in izdaja zdravila je le s posebnim režimom (glejte Prilogo I: Povzetek glavnih značilnosti zdravila, poglavje 4.2)
Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMA) http://www.ema.europa.eu 
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu.
If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicinal product. 
Če vam je zdravnik povedal, da ne prenašate nekaterih sladkorjev, se posvetujte z njim, preden vzamete to zdravilo
When patients were identified with concurrent worsening in all three domains, results showed a statistically significant effect of memantine in preventing worsening, as twice as many placebo-treated patients as memantine-treated patients showed worsening in all three domains (21% vs. 11%, p0.0001). 
Pri bolnikih, kjer so ocenili hkratno poslabšanje vseh treh domen, so rezultati pokazali statistično značilen učinek memantina pri preprečevanju poslabšanja, saj se je pri dvakrat več bolnikih, ki so prejemali placebo, kot pri bolnikih, zdravljenih z memantinom, pokazalo poslabšanje na področju vseh treh domen (21 % proti 11 %, p<0,0001).
The most frequently occurring adverse reactions with a higher incidence in the Ebixa group than in the placebo group were dizziness (6.3% vs 5.6%, respectively), headache (5.2% vs 3.9%), constipation (4.6% vs 2.6%), somnolence (3.4% vs 2.2%) and hypertension (4.1% vs 2.8%). 
Najpogostejši neželeni učinki, ki so se pogosteje pojavili pri skupini bolnikov, ki je jemala zdravilo Ebixa, kot pri skupini, ki je prejemala placebo, so bili omotica (6,3 % proti 5,6 %), glavobol (5,2 % proti 3,9 %), zaprtje (4,6 % proti 2,6 %), zaspanost (3,4 % proti 2,2 %) in hipertenzija (4,1 % proti 2,8 %).
Other Anti-dementia drugs, ATC code: N06DX01. 
Farmakoterapevtska skupina: psihoanaleptiki; druga zdravila za zdravljenje demence, oznaka ATC: N06DX01.
Ebixa is used for the treatment of patients with moderate to severe Alzheimer's disease. 
Zdravilo Ebixa uporabljamo za zdravljenje bolnikov z zmerno do hudo Alzheimerjevo boleznijo.
• In post-marketing experience, isolated cases with international normalized ratio (INR) increases have been reported in patients concomitantly treated with warfarin. 
• V okviru izkušenj v obdobju trženja so poročali o osamljenih primerih zvečanja mednarodno umerjenega razmerja (INR) pri bolnikih, ki so bili sočasno zdravljeni z varfarinom.
Relative large overdoses (200 mg and 105 mg/day for 3 days, respectively) have been associated with either only symptoms of tiredness, weakness and/or diarrhoea or no symptoms. 
Sorazmerno veliki preveliki odmerki (200 mg dnevno oziroma 105 mg dnevno, tri dni) so bili povezani bodisi samo s simptomi utrujenosti, šibkosti in/ali driske bodisi je bilo brez simptomov.
In short term studies in rats, memantine like other NMDA-antagonists have induced neuronal vacuolisation and necrosis (Olney lesions) only after doses leading to very high peak serum concentrations. 
V kratkotrajnih študijah na podganah je memantin, tako kot drugi antagonisti receptorjev NMDA povzročil nastanek vakuol in nekrozo v nevronih (Olneyeve lezije), vendar le pri odmerkih, ki dajo zelo visoko maksimalno plazemsko koncentracijo.
Week 2 (day 8-14) 
1. teden (1.-7. dan)
In patients with mild or moderate hepatic impaired function (Child-Pugh A and Child-Pugh B), no dose adjustment is needed. 
Pri bolnikih z blago ali zmerno jetrno okvaro (Child-Pugh A in Child-pugh B) prilagoditev odmerka ni potrebna.
Each pack of 28 film-coated tablets for a 4 week treatment schedule contains: 7 film-coated tablets of Ebixa 5 mg 
Eno pakiranje z 28 filmsko obloženimi tabletami za štiri tedenski program zdravljenja vsebuje: 7 filmsko obloženih tablet Ebixa 5 mg
In postmarketing experience these reactions have been reported in patients treated with Ebixa. 
V okviru izkušenj v obdobju trženja so te učinke navajali pri bolnikih, zdravljenih z zdravilom Ebixa.
EU/1/02/219/022 7 x 5 mg + 7 x 10 mg + 7 x 15 mg 7 x 20 mg film-coated tablets EU/1/02/219/036 7 x 5 mg + 7 x 10 mg + 7 x 15 mg 7 x 20 mg film-coated tablets 
EU/1/02/219/022 7 x 5 mg + 7 x 10 mg + 7 x 15 mg 7 x 20 mg filmsko obložene tablete EU/1/02/219/036 7 x 5 mg + 7 x 10 mg + 7 x 15 mg 7 x 20 mg filmsko obložene tablete
EU/1/02/219/ 013500 ml (10 bottles of 50 ml) 
EU/1/02/219/013 500 ml (10 stekleničk po 50 ml)
A glass with a little water or a spoon should be held below the nozzle and the dosing pump head has to be pushed down in a firm but calm and steady manner (not too slowly) right down to the stop (fig. 7, fig. 8). 
Pod cevnim izvodilom pridržimo kozarec z malo vode ali žlico; odmerno črpalko pritiskamo navzdol odločno, a mirno in enekomerno (ne prepočasi), vse dokler se ne zaustavi (sl.7, sl. 8).
Place the bottle on a flat, horizontal surface, for example a table top, and only use it in an upright position. 
Postavite stekleničko na ravno vodoravno površino, na primer na mizo, in jo uporabljate samo v navpičnem položaju.
Venous thrombosis/thromboembolism 
Občasni venska tromboza/tromboembolija
The solution also contains potassium sorbate and sorbitol E420. 
Raztopina vsebuje tudi kalijev sorbat in sorbitol E420.