FrancophonIA/ELRC3.0 huggingface dataset:
English: Pull the plunger rod slightly downwards to draw the mixed solution into the syringe.
Slovenian: Potegnite nosilec bata rahlo navzdol, da boste zmešano raztopino potegnili v brizgo.
English: • The syringe with adequately reconstituted product is now ready for administration in a CEmarked infusion pump (accepting a 50 ml syringe).
Slovenian: • Brizga z ustrezno pripravljenim zdravilom je zdaj pripravljena za dajanje z infuzijsko črpalko
English: The reconstituted solution is colourless.
Slovenian: Pripravljena raztopina je brezbarvna.
English: NovoSeven 1 mg (50 KIU)
Slovenian: NovoSeven 1 mg (50 k.i.e.)
English: Turn the syringe with the vial upside down and withdraw the contents of the vial into the syringe.
Slovenian: Obrnite brizgo z vialo na glavo in potegnite vsebino viale v brizgo.
English: Do not take the vial adapter out of the protective cap.
Slovenian: Ne vzemite nastavka viale iz zaščitnega pokrovčka.
English: • Attach the syringe with the vial adapter or transfer needle to the powder vial.
Slovenian: • Namestite brizgo z nastavkom za vialo ali iglo na vialo s praškom.
English: The closed vial is equipped with a polypropylene tamper-evident snap-off cap.
Slovenian: Zaprta viala je opremljena s polipropilenskim zaščitnim snemnim pokrovčkom.
English: NovoSeven powder and solvent vials should be at room temperature at reconstitution.
Slovenian: NovoSeven prašek in topilo morata biti za pripravo ogreta na sobno temperaturo.
English: The syringe cap consists of bromobutyl rubber and polypropylene tamper evident seal.
Slovenian: Pokrovček brizge je iz bromobutilne gume in polipropilenskega zaščitnega pečata.
English: Attach the syringe with vial adapter or transfer needle to the powder vial.
Slovenian: Namestite brizgo z nastavkom za vialo ali iglo na vialo s praškom.
English: The efficacy rates were 81% and 82%, respectively, in patients with positive or negative refractoriness to platelet transfusions, and 77% and 85%, respectively, in patients testing positive or negative for antibodies to platelets.
Slovenian: Pri bolnikih s pozitivnim testom na protitelesa proti trombocitom je delež učinkovitosti znašal 77 %, pri bolnikih z negativnim testom na protitelesa proti trombocitom pa je delež učinkovitosti znašal 85 %.
English: If using a transfer needle, remove the protective cap and insert the transfer needle into the rubber stopper of the solvent vial.
Slovenian: Če uporabljate iglo, odstranite zaščitni pokrovček in iglo zabodite v gumijasti zamašek viale s topilom.
English: • Push the plunger rod slowly until all air bubbles are gone.
Slovenian: • Nosilec bata potiskajte, dokler vsi zračni mehurčki ne izginejo.
English: After reconstitution, 1 ml of the solution contains 1 mg eptacog alfa (activated).
Slovenian: Po pripravi vsebuje 1 ml raztopine 1 mg aktiviranega eptakoga alfa.
English: Do not store the reconstituted solution without advice from your doctor or nurse.
Slovenian: Pripravljene raztopine ne shranjujte brez posveta s svojim zdravnikom ali medicinsko sestro.
English: - Headache
Slovenian: - glavobol
English: Turn over the protective cap, and snap the vial adapter onto the vial.
Slovenian: Obrnite zaščitni pokrovček in namestite nastavek za vialo na vialo.
English: • Turn over the protective cap, and snap the vial adapter onto the vial.
Slovenian: • Obrnite zaščitni pokrovček in namestite nastavek za vialo na vialo.
English: Store below 25°C Do not freeze
Slovenian: Shranjujte pri temperaturi do 25 °C.
English: Push the plunger slowly to inject the solvent into the powder vial.
Slovenian: Počasi potiskajte bat in tako vbrizgajte topilo v vialo s praškom.
English: NovoSeven 5 mg (250 KIU)
Slovenian: NovoSeven 5 mg (250 k.i.e.)
English: Reconstitute the powder with the solvent • Hold the pre-filled syringe slightly tilted with the vial pointing downwards.
Slovenian: Prašek zmešajte s topilom • Napolnjeno injekcijsko brizgo držite rahlo nagnjeno, tako da je viala obrnjena navzdol.
English: Once attached, remove the protective cap. Take care not to touch the spike on the vial adapter.
Slovenian: Ko odstranjujete zaščitni pokrovček, pazite, da ne dvignete nastavka za vialo z viale.
English: Do not open the equipment until you are ready to use it. Do not use the equipment if it has been dropped, or if it is damaged.
Slovenian: Ne uporabljajte opreme, če vam je padla ali če je poškodovana.
English: - 1 vial (2 ml) with white powder for solution for injection - 1 pre-filled syringe (3 ml) with solvent for reconstitution - 1 plunger rod - 1 vial adapter, with an integrated particle filter with a pore size of 25 micrometer.
Slovenian: - 1 napolnjeno injekcijsko brizgo (3 ml) s topilom za pripravo raztopine, - 1 nosilec bata, - 1 nastavek za vialo z integriranim filtrom za delce z velikostjo por 25 mikrometrov.
English: • Keep the plunger rod pushed completely in.
Slovenian: • Držite nosilec bata pritisnjen do konca.
English: These reactions are reported as uncommon
Slovenian: Pogostnost ni znana
English: Lightly squeeze the protective cap with the thumb and index finger.
Slovenian: S palcem in kazalcem rahlo stisnite zaščitni pokrovček.
English: In syringe (50 ml polypropylene) in hospital settings only Reconstitution must take place in controlled and validated aseptic conditions by adequately trained staff.
Slovenian: Rekonstitucijo mora opraviti ustrezno usposobljeno osebje v nadzorovanih in preverjenih aseptičnih pogojih.
English: (may affect up to 1 in 100 treatment episodes)
Slovenian: Občasni (pojavijo se lahko pri največ 1 od 100 epizod zdravljenja)
English: • The other ingredients in the powder are sodium chloride, calcium chloride dihydrate, glycylglycine, polysorbate 80, mannitol, sucrose, methionine, hydrochloric acid, sodium hydroxide.
Slovenian: • Pomožne snovi v prašku so natrijev klorid, kalcijev klorid dihidrat, glicilglicin, polisorbat 80,
English: NovoSeven 2 mg (100 KIU)
Slovenian: NovoSeven 2 mg (100 k.i.e)
English: Dosing frequency should initially be every second hour until clinical improvement is observed.
Slovenian: Zdravilo je treba uvodoma, do kliničnega izboljšanja, dajati na dve uri.
English: No cases of overdose have been reported in patients with acquired haemophilia or Glanzmann's thrombasthenia.
Slovenian: Med bolniki s pridobljeno hemofilijo ali Glanzmannovo trombastenijo ni opisanih primerov prevelikega odmerjanja.
English: Do not store reconstituted NovoSeven in plastic syringes, unless as described in section 6.3.
Slovenian: Pripravljene raztopine zdravila NovoSeven ne shranjujte v plastičnih brizgah, razen v primeru,
English: Uncommon (may affect up to 1 in 100 treatment episodes)
Slovenian: Ostali občasni neželeni učinki (pojavijo se lahko pri največ 1 od 100 epizod zdravljenja)
English: The powder vial contains white powder and the solvent vial contains a clear colourless solution.
Slovenian: Viala s praškom vsebuje bel prašek, viala s topilom pa bistro in brezbarvno raztopino.
English: NovoSeven 8 mg (400 KIU)
Slovenian: NovoSeven 8 mg (400 k.i.e)
English: During in vitro studies, the chemical and physical in-use stability has been demonstrated for 24 hours at 25°C in a 50 ml syringe (polypropylene).
Slovenian: Postopek za združevanje vsebine vial (le za bolnišnično uporabo) Med študijami in vitro sta bili kemična in fizikalna stabilnost med uporabo dokazani za 24 ur pri temperaturi 25 °C v 50-mililitrski brizgi (polipropilen).
English: • Push the plunger rod to inject all the solvent into the vial.
Slovenian: • Potiskajte nosilec bata, da boste v vialo vbrizgali celotno količino topila.
English: Powder in vial and solvent in vial:
Slovenian: Prašek in topilo v viali
English: Rare (may affect up to 1 in 1,000 treatment episodes)
Slovenian: Ostali redki neželeni učinki (pojavijo se lahko pri največ 1 od 1.000 epizod zdravljenja)
English: If the plastic cap is loose or missing, do not use the vial.
Slovenian: Če plastični pokrovček ni trdno pričvrščen ali ga sploh ni, viale ne uporabite.
English: If you use a transfer needle, make sure to penetrate the centre of the rubber stopper.
Slovenian: Če uporabljate iglo, pazite, da jo boste zabodli skozi sredino gumijastega zamaška.
English: • NovoSeven powder and solvent vials should be at room temperature at reconstitution.
Slovenian: • Viali s praškom in topilom morata biti za pripravo ogreti na sobno temperaturo.
English: • Remove the empty solvent vial.
Slovenian: • Odstranite prazno vialo s topilom.
English: If you use a transfer needle, remove the transfer needle from the vial, replace the transfer needle cap, and twist the transfer needle off the syringe.
Slovenian: Če uporabljate iglo, izvlecite iglo iz viale, pokrijte jo s pokrovčkom igle in iglo odvijte z brizge.
English: After reconstitution, the product contains 1 mg/ml eptacog alfa (activated) when reconstituted with solvent.
Slovenian: Po rekonstituciji s topilom vsebuje zdravilo 1 mg/ml aktiviranega eptakoga alfa.
English: Screw the syringe tightly onto the vial adapter on the solvent vial.
Slovenian: Brizgo trdno privijte v nastavek za vialo na viali s topilom.
English: If the syringe cap is loose or missing, do not use the pre-filled syringe.
Slovenian: Če pokrovček brizge ne sedi trdno ali ga sploh ni, napolnjene injekcijske brizge ne uporabite.
English: • Screw the plunger rod clockwise into the plunger inside the pre-filled syringe until resistance is felt.
Slovenian: • Privijte nosilec bata v smeri urinega kazalca v bat, ki je v notranjosti napolnjene injekcijske brizge, dokler ne začutite upora.
English: Screw the syringe securely onto the vial adapter until resistance is felt.
Slovenian: Injekcijsko brizgo trdno privijte na nastavek za vialo, dokler ne začutite upora.
English: Dose, dose range and dose interval
Slovenian: Odmerek, odmerno območje in odmerni interval
English: Eptacog alfa (activated) 8 mg/vial (400 KIU/vial), 1 mg/ml after reconstitution
Slovenian: Aktivirani eptakog alfa, 8 mg/vialo (400 k.i.e./vialo), 1 mg/ml po pripravi;
English: - Related laboratory findings, including elevated levels of Ddimmer and decreased levels of AT (see section
Slovenian: - povezani laboratorijski izvidi, vključno s povečano koncentracijo
English: • If using a vial adapter, unscrew the vial adapter with the empty vial.
Slovenian: • Če uporabljate nastavek za vialo, odvijte nastavek za vialo in prazno vialo.
English: Powder and solvent for solution for injection Eptacog alfa (activated)
Slovenian: prašek in topilo za raztopino za injiciranje aktivirani eptakog alfa
English: • 1 pre-filled syringe with solvent for reconstitution
Slovenian: • 1 napolnjeno injekcijsko brizgo s topilom za pripravo raztopine,
English: If you touch the syringe tip, germs from your fingers can be transferred.
Slovenian: Če se dotaknete konice injekcijske brizge, lahko nanjo prenesete klice s prstov.
English: Clean the rubber stoppers on the vials with alcohol swabs and allow them to dry before use.
Slovenian: Gumijasta zamaška na vialah očistite z alkoholnima zložencema.
English: Thread
Slovenian: Odmerek
English: Eptacog alfa (activated) 5 mg/vial (250 KIU/vial), 1 mg/ml after reconstitution
Slovenian: Aktivirani eptakog alfa, 5 mg/vialo (250 k.i.e./vialo), 1 mg/ml po pripravi;
English: NovoSeven is presented as powder and solvent for solution for injection containing 5 mg eptacog alfa (activated) per vial (corresponds to 250 KIU/vial).
Slovenian: Zdravilo NovoSeven je na voljo kot prašek in topilo za raztopino za injiciranje in vsebuje 5 mg aktiviranega eptakoga alfa na vialo (ustreza 250 k.i.e./vialo).
English: Acquired Haemophilia
Slovenian: Pridobljena hemofilija
English: Immediately connect the plunger rod to the syringe by turning it clockwise into the plunger inside the pre-filled syringe until resistance is felt.
Slovenian: • Takoj privijte nosilec bata v injekcijsko brizgo, tako da ga vrtite v smeri urinega kazalca v bat, ki je v notranjosti napolnjene injekcijske brizge,
English: White lyophilised powder.
Slovenian: prašek in topilo za raztopino za injiciranje Bel liofiliziran prašek.
English: NovoSeven is presented as powder and solvent for solution for injection containing 8 mg eptacog alfa (activated) per vial (corresponds to 400 KIU/vial).
Slovenian: Zdravilo NovoSeven je na voljo kot prašek in topilo za raztopino za injiciranje in vsebuje 8 mg aktiviranega eptakoga alfa na vialo (ustreza 400 k.i.e./vialo).
English: Eptacog alfa (activated) 2 mg/vial (100 KIU/vial), 1 mg/ml after reconstitution
Slovenian: Aktivirani eptakog alfa, 2 mg/vialo (100 k.i.e./vialo), 1 mg/ml po pripravi;
English: Gently swirl the vial until all the powder is dissolved.
Slovenian: Previdno vrtite vialo, dokler se prašek ne raztopi.
English: Powder vial
Slovenian: gumijasti zamašek
English: • Screw the syringe tightly onto the vial adapter on the solvent vial.
Slovenian: • Brizgo trdno privijte v nastavek za vialo na viali s topilom.
English: Administration
Slovenian: Aplikacija
English: If you use a transfer needle, make sure that the transfer needle tip is in the solution.
Slovenian: Če uporabljate iglo, poskrbite, da bo konica igle v topilu.
English: NovoSeven is presented as powder and solvent for solution for injection containing 1 mg eptacog alfa (activated) per vial (corresponds to 50 KIU/vial).
Slovenian: Zdravilo NovoSeven je na voljo kot prašek in topilo za raztopino za injiciranje in vsebuje 1 mg aktiviranega eptakoga alfa na vialo (ustreza 50 k.i.e./vialo).
English: In clinical trials of patients with factor VII deficiency, formation of antibodies against NovoSeven and FVII is the only adverse drug reaction reported (frequency: common (≥ 1/100 to < 1/10)).
Slovenian: Pojav protiteles proti zdravilu NovoSeven in FVII je edini neželeni učinek zdravila, opisan v kliničnih preskušanjih bolnikov s pomanjkanjem faktorja VII, izpostavljenih zdravilu NovoSeven (pogostnost:
English: NOVOSEVEN USER INSTRUCTIONS
Slovenian: NAVODILA ZA UPORABO
English: If the caps are loose or missing, do not use the vials.
Slovenian: Če pokrovček ne sedi trdno ali ga sploh ni, viale ne uporabite.
English: - For storage conditions of the reconstituted medicinal product, see section 6.3.
Slovenian: - Za pogoje shranjevanja pripravljenega zdravila glejte poglavje 6.3. 6.5 Vrsta ovojnine in vsebina
English: Hold the syringe slightly tilted with the vial pointing downwards.
Slovenian: Držite brizgo rahlo nagnjeno, tako da je vstavljena viala spodaj.
English: Eptacog alfa (activated) 1 mg/vial (50 KIU/vial), 1 mg/ml after reconstitution
Slovenian: Aktivirani eptakog alfa, 1 mg/vialo (50 k.i.e./vialo), 1 mg/ml po pripravi;
English: If you use a vial adapter, unscrew the vial adapter with the empty vial.
Slovenian: Če uporabljate nastavek za vialo, odvijte nastavek za vialo in prazno vialo.
English: 1 vial of powder
Slovenian: Nalepka za vialo s praškom
English: NovoSeven is presented as powder and solvent for solution for injection containing 2 mg eptacog alfa (activated) per vial (corresponds to 100 KIU/vial).
Slovenian: Zdravilo NovoSeven je na voljo kot prašek in topilo za raztopino za injiciranje in vsebuje 2 mg aktiviranega eptakoga alfa na vialo (ustreza 100 k.i.e./vialo).
English: You should talk to your doctor before using NovoSeven with these medicines.
Slovenian: Preden uporabite zdravilo NovoSeven skupaj s temi zdravili, se morate posvetovati s svojim zdravnikom.
English: • 1 pre-filled syringe with solvent
Slovenian: • 1 napolnjeno injekcijsko brizgo s topilom,
English: Rare (≥1/10,000 to <1/1,000) Frequency Not Known
Slovenian: pogosto (≥ 1/100 do < 1/10)).
English: • Turn the syringe with the vial upside down.
Slovenian: • Obrnite brizgo skupaj z vialo s topilom na glavo.
English: • Gently swirl the vial until all the powder is dissolved.
Slovenian: • Previdno vrtite vialo, dokler se prašek ne raztopi.
English: The NovoSeven 1 mg (50 KIU)/NovoSeven 2 mg (100 KIU) package contains either - 1 vial (2 ml) with white powder for solution for injection - 1 vial (2 ml) with solvent for reconstitution or
Slovenian: vsebuje: - 1 vialo (2 ml) z belim praškom za raztopino za injiciranje, - 1 vialo (2 ml) s topilom za pripravo raztopine ali
English: NovoSeven is now ready to inject into your vein.
Slovenian: Zdravilo NovoSeven je zdaj pripravljeno za injiciranje v veno.
English: EU/1/96/006/010
Slovenian: EU/1/96/006/006 EU/1/96/006/010
English: If you touch the spike on the vial adapter germs from your fingers can be transferred.
Slovenian: Če se dotaknete konice nastavka za vialo, lahko nanj prenesete klice s prstov.
English: 1 pre-filled syringe of solvent with separate plunger rod 1 vial adapter for reconstitution
Slovenian: 1 napolnjeno injekcijsko brizgo s topilom in ločen nosilec bata,
English: How to store NovoSeven
Slovenian: Shranjevanje zdravila NovoSeven
English: - Nausea
Slovenian: Žilne bolezni
English: Hydrochloric acid (for pH-adjustment) Sodium hydroxide (for pH-adjustment)
Slovenian: Prašek natrijev klorid kalcijev klorid dihidrat glicilglicin polisorbat 80 manitol saharoza metionin klorovodikova kislina (za uravnavanje pH) natrijev hidroksid (za uravnavanje pH)
English: EU/1/96/006/008
Slovenian: EU/1/96/006/004 EU/1/96/006/008
English: NovoSeven 1 mg (50 KIU) powder and solvent for solution for injection NovoSeven 2 mg (100 KIU) powder and solvent for solution for injection NovoSeven 5 mg (250 KIU) powder and solvent for solution for injection NovoSeven 8 mg (400 KIU) powder and solvent for solution for injection
Slovenian: prašek in topilo za raztopino za injiciranje NovoSeven 5 mg (250 k.i.e.)
English: NovoSeven 8 mg Powder for injection Eptacog alfa (activated) IV
Slovenian: NovoSeven 8 mg prašek za injekcijo aktivirani eptakog alfa i.v.
English: Other uncommon side effects
Slovenian: Preglednica neželenih učinkov
English: Administer the solution as an intravenous bolus injection over 2 - 5 minutes.
Slovenian: Aplicira se ga v intravenski bolusni injekciji.
English: EU/1/96/006/011
Slovenian: EU/1/96/006/007 EU/1/96/006/011
English: Do not reuse the equipment.
Slovenian: Opremo uporabite samo enkrat.
English: 90 µg/kg (range 28 to 450 µg/kg).
Slovenian: Mediani odmerek na aplikacijo pri zdravljenju 333 epizod krvavitev je znašal 90 µg/kg (razpon od 28 do 450 µg/kg).
English: EU/1/96/006/005
Slovenian: EU/1/96/006/005 EU/1/96/006/009
English: NovoSeven 1 mg Powder for injection Eptacog alfa (activated) IV
Slovenian: NovoSeven 1 mg prašek za injekcijo aktivirani eptakog alfa i.v.
English: NovoSeven 5 mg Powder for injection Eptacog alfa (activated) IV
Slovenian: NovoSeven 5 mg prašek za injekcijo aktivirani eptakog alfa i.v.
English: Hold the syringe slightly tilted with the vial facing downwards.
Slovenian: Držite injekcijsko brizgo rahlo nagnjeno in tako, da je viala obrnjena navzdol.
English: NovoSeven 2 mg Powder for injection Eptacog alfa (activated) IV
Slovenian: NovoSeven 2 mg prašek in topilo za raztopino za injiciranje aktivirani eptakog alfa
English: Vial adapter Protective cap
Slovenian: Namestite nastavek za vialo
English: Syringe cap
Slovenian: - tromb v srcu
English: Do not store the solution without your doctor's advice.
Slovenian: Raztopine za injiciranje ne shranjujte, ne da bi se prej posvetovali z zdravnikom.
English: Thromboembolic events - arterial and venous
Slovenian: cerebrovaskularni incident, tromboza ledvične arterije,
English: Hold the prefilled syringe slightly tilted with the vial pointing downwards.
Slovenian: Napolnjeno injekcijsko brizgo držite rahlo nagnjeno in viala naj bo obrnjena navzdol.
English: If you forget an injection of NovoSeven
Slovenian: Kaj vsebuje zdravilo NovoSeven
English: should be considered.
Slovenian: V tem primeru vas morajo skrbno nadzorovati.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Label for pre-filled syringe with solvent
Slovenian: Nalepka za napolnjeno injekcijsko brizgo s topilom
English: The NovoSeven 5 mg (250 KIU)/NovoSeven 8 mg (400 KIU) package contains either - 1 vial (12 ml) with white powder for solution for injection - 1 vial (12 ml) with solvent for reconstitution or
Slovenian: vsebuje: - 1 vialo (12 ml) z belim praškom za raztopino za injiciranje, - 1 vialo (12 ml) s topilom za pripravo raztopine ali
English: If using a transfer needle, insert the transfer needle into the rubber stopper of the solvent vial.
Slovenian: Če uporabljate iglo, jo zabodite v gumijasti zamašek viale s topilom.
English: If the protective paper is not fully sealed or if it is broken, do not use the vial adapter.
Slovenian: Če zaščitni pokrovček ne sedi trdno ali ga sploh ni, viale ne uporabite.
English: • If you have acquired haemophilia
Slovenian: • pridobljeno hemofilijo,
English: Attach the plunger rod and the syringe
Slovenian: Namestite nosilec bata in injekcijsko brizgo
English: Date of first authorisation: 28 January 2000 Date of latest renewal: 28 January 2015
Slovenian: Datum prve odobritve: 28. januar 2000 Datum zadnjega podaljšanja: 28. januar 2015
English: Renagel must be taken three times per day with meals.
Slovenian: Zdravilo Renagel je treba jemati trikrat na dan z obroki.
English: Contact your doctor who will decide on continuing the treatment or not.
Slovenian: Posvetujte se s svojim zdravnikom, ki bo presodil, ali naj zdravljenje nadaljujete ali ne.
English: As data on the chronic use of sevelamer for over one year are not yet available, potential absorption and accumulation of sevelamer during long-term chronic treatment cannot be totally excluded (see section 5.2).
Slovenian: Ker podatki o kronični uporabi sevelamera več kot eno leto še niso na voljo, možne absorpcije in kopičenja sevelamera v dolgotrajnem kroničnem zdravljenju ni možno povsem izključiti (glejte poglavje 5.2).
English: Your doctor will check for interactions between Renagel and other medicines on a regular basis.
Slovenian: Vaš zdravnik bo redno preverjal medsebojno delovanje zdravila Renagel in ostalih zdravil.
English: Therefore your doctor may monitor the levels of TSH in your blood more closely.
Slovenian: Zato se lahko vaš zdravnik odloči za skrbno nadziranje ravni TSH v vaši krvi.
English: Adverse reactions from these studies (299 patients), from uncontrolled clinical trials (384 patients), and that were spontaneously reported from post-marketing experience are listed by frequency in the table below.
Slovenian: Neželeni učinki iz teh študij (299 bolnikov), iz nekontroliranih kliničnih preskušanj (384 bolnikov), in tisti, o katerih so spontano poročali po začetku trženja, so glede na pogostost našteti v spodnji preglednici.
English: Renagel is not absorbed and may affect the bioavailability of other medicinal products.
Slovenian: Zdravilo Renagel se ne absorbira in lahko vpliva na biološko uporabnost drugih zdravil.
English: There is at present insufficient data to exclude the possibility of folate deficiency during long term Renagel treatment.
Slovenian: Trenutno ni dovolj podatkov, da bi izključili možnost pomanjkanja folatov med dolgotrajnim zdravljenjem z zdravilom Renagel.
English: Do not use this medicine after the expiry date stated on the carton and bottle after “EXP”.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in/ali plastenki poleg oznake: “EXP”.
English: Genzyme Europe B.V., Paasheuvelweg 25, 1105 BP Amsterdam, the Netherlands
Slovenian: Genzyme Europe B.V., Paasheuvelweg 25, 1105 BP Amsterdam, Nizozemska.
English: One gram of Renagel contains approximately 180 mg (5.1 mEq) chloride.
Slovenian: En gram zdravila Renagel vsebuje približno 180 mg (5,1 mEq) klorida.
English: Since Renagel does not contain calcium your doctor might prescribe additional calcium tablets.
Slovenian: Ker zdravilo Renagel ne vsebuje kalcija, vam utegne zdravnik predpisati dodatne kalcijeve tablete.
English: Name and address of the manufacturer responsible for batch release Genzyme Ireland Limited, IDA Industrial Park, Old Kilmeaden Road, Waterford, Ireland
Slovenian: A. PROIZVAJALEC, ODGOVOREN ZA SPROŠČANJE SERIJ Ime in naslov proizvajalca, odgovornega za sproščanje serij Genzyme Ireland Limited, IDA Industrial Park, Old Kilmeaden Road, Waterford, Irska
English: Package sizes are:
Slovenian: Velikosti pakiranj so:
English: The average actual daily dose used in the chronic phase of a one year clinical study was 7 grams of sevelamer.
Slovenian: Povprečni dnevni odmerek sevelamera, ki so ga v enoletni klinični študiji dajali bolnikom v kronični fazi, je bil 7 gramov.