natgillin/translations-raw huggingface dataset:
• Do not use the prepared solution if it is cloudy, contains particles or has changed colour.
• Če je pripravljena raztopina motna, vsebuje delce ali je spremenila barvo, je ne uporabite.
Saline n = 16
Fiziološka raztopina n =16
In case of an insufficient clinical response, an additional dose (50 U/kg body weight up to 4200 U) can be administered.
V primeru nezadostnega kliničnega odziva se lahko da dodatni odmerek (50 e./kg telesne mase do
Ruconest should be initiated under the guidance and supervision of a physician experienced in the diagnosis and treatment of hereditary angioedema.
Zdravilo Ruconest je treba uvesti po navodilih in pod nadzorom zdravnika z izkušnjami pri diagnosticiranju in zdravljenju dednega angioedema.
Biotransformation and elimination
Biotransformacija
• Take a packaged adapter in one hand and remove the lid.
• Z eno roko primite adapter v ovojnini in odstranite pokrov.
• Repeat steps 4 and 5 if you need to prepare a second solution.
• Če je treba pripraviti še eno raztopino, ponovite 4. in 5. korak.
- Instruction in handling possible adverse drug reactions including an acute hypersensitivity reaction - Information on the need to keep a diary to document each treatment administered at home and to bring it at each visit.
- 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 - Informacije o potrebi pisanja dnevnika za dokumentiranje vsakega odmerka, danega doma, in predložitev tega dnevnika pri vsakem zdravniškem pregledu.
- Body weight up to 84 kg One intravenous injection of 50 U/kg body weight.
Ena intravenska injekcija 50 e./kg telesne mase.
Respiratory, thoracic and mediastinal disorders
Bolezni dihal, prsnega koša in mediastinalnega prostora draženje v grlu
Each vial of Ruconest (2100 U) should be reconstitued with 14 ml of solvent.
Vsako vialo zdravila Ruconest (2100 e.) je treba rekonstituirati s 14 ml vehikla.
The reconstituted solution contains 150 U/ml conestat alfa and appears as a clear colourless solution.
Rekonstituirana raztopina vsebuje 150 e./ml konestata alfa in je bistra, brezbarvna raztopina.
Unlock the syringe from the adapter by turning counter clockwise and discard the vial with adapter.
Brizgo odstranite z adapterja tako, da jo zavrtite v nasprotno smer, in zavrzite vialo z adapterjem.
Patients should be advised not to drive and use machines if they experience headache or vertigo.
naj ne vozijo ali upravljajo strojev, če se pri njih pojavi glavobol ali vrtoglavica.
The solvent should be added slowly to avoid forceful impact on the powder and mixed gently to minimise foaming of the solution.
Vehikel dodajajte počasi, da se izognete močnemu curku na prašek, in rahlo mešajte, da v največji možni meri omejite penjenje raztopine.
2100 U of conestat alfa powder in a 25 ml vial (type 1 glass) with a stopper (siliconized chlorobutyl rubber) and a flip-off seal (aluminium and coloured plastic).
2100 e. praška konestata alfa v 25 ml viali (steklo vrste 1) z zaporko (silikonizirana klorobutilna guma) in tesnilom „flip-off“ (aluminij in barvna plastika).
Contents of the pack and other information
Shranjevanje zdravila Ruconest Vsebina pakiranja in dodatne informacije
There is no experience with the use of Ruconest in pregnant and breast-feeding women.
Z uporabo zdravila Ruconest pri nosečnicah in doječih materah ni izkušenj.
• That Ruconest should be initiated under the guidance and supervision of a physician experienced in the diagnosis and treatment of hereditary angioedema.
• Da je treba zdravilo Ruconest uvesti po navodilih in pod nadzorom zdravnika z izkušnjami pri diagnosticiranju in zdravljenju dednega angioedema.
corresponding to 2100 units per 14 ml after reconstitution, or a concentration of 150 units/ml.
2100 enotam na 14 ml po rekonstituciji ali koncentraciji 150 enot/ml.
- 1 syringe if 1 powder and 1 solvent vial is required - 2 syringes if 2 powder and 2 solvent vials are required
- 1 brizgo potrebujete v primeru 1 viale s praškom in 1 viale z vehiklom - 2 brizgi potrebujete v primeru 2 vial s praškom in 2 vial z vehiklom2.
Before Ruconest can be administered, it needs to be dissolved in water for injections, by a healthcare professional.
Pred dajanjem mora zdravstveni delavec zdravilo Ruconest raztopiti v vodi za injekcije.
These patients have a shortage of the C1 inhibitor protein in their blood.
Tem bolnikom v krvi primanjkuje beljakovine, imenovane zaviralec
Solvent vial: Do no store above 25°C.
Viala z vehiklom: Shranjujte pri temperaturi do 25 °C.
• 1 self-adhesive plaster
• 1 samolepilni obliž
Each powder vial contains approximately 19.5 mg sodium.
Ena viala s praškom vsebuje približno 19,5 mg natrija.
Disinfect the rubber stoppers of the powder and solvent vials and put a vial adapter onto each solvent and powder vial until it snaps onto the vial neck.
Razkužite gumijasto zaporko viale s praškom in viale z vehiklom, nato pa adapterja za vialo nastavite na vialo z vehiklom in na vialo s praškom, da zaskočita na vrat viale.
Do not use this medicine if you notice particles in the solution or if the solution is discolored.
Ne uporabljajte tega zdravila, če raztopina spremeni barvo, ali če vsebuje delce.
- Body weight of 84 kg or greater One intravenous injection of 4200 U (two vials).
• Ena intravenska injekcija 4200 e. (dve viali).
Powder vial: 2100 U of conestat alfa powder in a vial (type 1 glass) with a stopper (siliconized chlorobutyl rubber) and a flip-off seal (aluminium and coloured plastic).
Viala s praškom: 2100 e. praška konestata alfa v viali (steklo vrste 1) z zaporko (silikonizirana klorobutilna guma) in tesnilom „flip-off“ (aluminij in barvna plastika).
• 1 sterile non-woven pad
• 1 sterilni netkani tampon
Gently press the syringe plunger to carefully fill the infusion set with the prepared solution.
Nežno pritisnite bat brizge tako, da se komplet za infundiranje napolni s pripravljeno raztopino.
The doses evaluated in the clinical studies ranged from a single vial of 2100 U (corresponding to 18-40 U/kg), to 50 and 100 U/kg.
2100 e. (kar ustreza 18-40 e./kg) do 50 in 100 e./kg.
Step 6: Check prepared solutions
6. korak: Preverjanje pripravljene raztopine
• Put the syringe(s) on the work surface.
• Brizgo ali brizgi položite na delovno površino.
The other ingredients are sucrose, sodium citrate (E331) and citric acid.
Pomožne snovi so saharoza, natrijev citrat (E331) in citronska kislina.
Ruconest 2100 Units powder for solution for injection conestat alfa
Ruconest 2100 Enot prašek za raztopino za injiciranje konestat alfa
For patients up to 84 kg calculate the volume required to be administered according to the formula below:
Telesna masa do 84 kg • Za bolnike s telesno maso do 84 kg izračunajte potrebno količino v skladu s spodnjo preglednico:
• 1 powder vial
• 1 viala z vehiklom
• Hold the syringe with the tip pointing upwards.
• Brizgo držite tako, da je konica obrnjena navzgor.
MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
IZDELOVALEC (IZDELOVALCI), ODGOVOREN (ODGOVORNI) ZA
• If you have prepared two syringes: - fold over the tubing near the connector of the infusion set to prevent backflow - unscrew the empty syringe from the infusion set and immediately replace it with the second syringe
• Če ste pripravili dve brizgi: - preganite cevko v bližini konektorja kompleta za injiciranje, s tem boste preprečili povratni tok
General disorders and administration site conditions
Splošne težave in spremembe na mestu aplikacije oteklina
After reconstitution with 14 ml water for injections, the solution contains 150 U conestat alfa per ml.
2100 e. konestata alfa Po rekonstituciji s 14 ml vode za injekcije vsebuje raztopina 150 e. konestata alfa na ml.
Step 12: Administration of the prepared solution
12. korak: Aplikacija pripravljene raztopine
• Known or suspected allergy to rabbits (see section 4.4) • Hypersensitivity to the active substance or to any of the excipients listed in section 6.1
• Znana alergija na kunce ali sum nanjo (glejte poglavje 4.4).
Ruconest 2100 Units powder and solvent for solution for injection conestat alfa
Ruconest 2100 Enot prašek in vehikel za raztopino za injiciranje konestat alfa
Each vial of Ruconest contains approximately 19.5 mg sodium.
Ena viala zdravila Ruconest vsebuje približno 19,5 mg natrija.
Check with your doctor or nurse if you are not sure.
Če ste negotovi, se posvetujte z zdravnikom ali medicinsko sestro.
The reconstituted solution in each vial contains 2100 U conestat alfa at 150 U/ml.
Rekonstituirana raztopina v vsaki viali vsebuje 2100 e. konestata alfa kar ustreza 150 e./ml.
• 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