natgillin/translations-raw huggingface dataset:
The reconstituted solution is colourless.
Pripravljena raztopina je brezbarvna.
NovoSeven 1 mg (50 KIU)
NovoSeven 1 mg (50 k.i.e.)
Turn the syringe with the vial upside down and withdraw the contents of the vial into the syringe.
Obrnite brizgo z vialo na glavo in potegnite vsebino viale v brizgo.
Do not take the vial adapter out of the protective cap.
Ne vzemite nastavka viale iz zaščitnega pokrovčka.
• Attach the syringe with the vial adapter or transfer needle to the powder vial.
• Namestite brizgo z nastavkom za vialo ali iglo na vialo s praškom.
The closed vial is equipped with a polypropylene tamper-evident snap-off cap.
Zaprta viala je opremljena s polipropilenskim zaščitnim snemnim pokrovčkom.
NovoSeven powder and solvent vials should be at room temperature at reconstitution.
NovoSeven prašek in topilo morata biti za pripravo ogreta na sobno temperaturo.
The syringe cap consists of bromobutyl rubber and polypropylene tamper evident seal.
Pokrovček brizge je iz bromobutilne gume in polipropilenskega zaščitnega pečata.
Attach the syringe with vial adapter or transfer needle to the powder vial.
Namestite brizgo z nastavkom za vialo ali iglo na vialo s praškom.
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.
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 %.
If using a transfer needle, remove the protective cap and insert the transfer needle into the rubber stopper of the solvent vial.
Če uporabljate iglo, odstranite zaščitni pokrovček in iglo zabodite v gumijasti zamašek viale s topilom.
• Push the plunger rod slowly until all air bubbles are gone.
• Nosilec bata potiskajte, dokler vsi zračni mehurčki ne izginejo.
After reconstitution, 1 ml of the solution contains 1 mg eptacog alfa (activated).
Po pripravi vsebuje 1 ml raztopine 1 mg aktiviranega eptakoga alfa.
Do not store the reconstituted solution without advice from your doctor or nurse.
Pripravljene raztopine ne shranjujte brez posveta s svojim zdravnikom ali medicinsko sestro.
- Headache
- glavobol
Turn over the protective cap, and snap the vial adapter onto the vial.
Obrnite zaščitni pokrovček in namestite nastavek za vialo na vialo.
• Turn over the protective cap, and snap the vial adapter onto the vial.
• Obrnite zaščitni pokrovček in namestite nastavek za vialo na vialo.
Store below 25°C Do not freeze
Shranjujte pri temperaturi do 25 °C.
Push the plunger slowly to inject the solvent into the powder vial.
Počasi potiskajte bat in tako vbrizgajte topilo v vialo s praškom.
NovoSeven 5 mg (250 KIU)
NovoSeven 5 mg (250 k.i.e.)
Reconstitute the powder with the solvent • Hold the pre-filled syringe slightly tilted with the vial pointing downwards.
Prašek zmešajte s topilom • Napolnjeno injekcijsko brizgo držite rahlo nagnjeno, tako da je viala obrnjena navzdol.
Once attached, remove the protective cap. Take care not to touch the spike on the vial adapter.
Ko odstranjujete zaščitni pokrovček, pazite, da ne dvignete nastavka za vialo z viale.
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.
Ne uporabljajte opreme, če vam je padla ali če je poškodovana.
- 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.
- 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.
• Keep the plunger rod pushed completely in.
• Držite nosilec bata pritisnjen do konca.
These reactions are reported as uncommon
Pogostnost ni znana
Lightly squeeze the protective cap with the thumb and index finger.
S palcem in kazalcem rahlo stisnite zaščitni pokrovček.
In syringe (50 ml polypropylene) in hospital settings only Reconstitution must take place in controlled and validated aseptic conditions by adequately trained staff.
Rekonstitucijo mora opraviti ustrezno usposobljeno osebje v nadzorovanih in preverjenih aseptičnih pogojih.
(may affect up to 1 in 100 treatment episodes)
Občasni (pojavijo se lahko pri največ 1 od 100 epizod zdravljenja)
• The other ingredients in the powder are sodium chloride, calcium chloride dihydrate, glycylglycine, polysorbate 80, mannitol, sucrose, methionine, hydrochloric acid, sodium hydroxide.
• Pomožne snovi v prašku so natrijev klorid, kalcijev klorid dihidrat, glicilglicin, polisorbat 80,
NovoSeven 2 mg (100 KIU)
NovoSeven 2 mg (100 k.i.e)
Dosing frequency should initially be every second hour until clinical improvement is observed.
Zdravilo je treba uvodoma, do kliničnega izboljšanja, dajati na dve uri.
No cases of overdose have been reported in patients with acquired haemophilia or Glanzmann's thrombasthenia.
Med bolniki s pridobljeno hemofilijo ali Glanzmannovo trombastenijo ni opisanih primerov prevelikega odmerjanja.
Do not store reconstituted NovoSeven in plastic syringes, unless as described in section 6.3.
Pripravljene raztopine zdravila NovoSeven ne shranjujte v plastičnih brizgah, razen v primeru,
Uncommon (may affect up to 1 in 100 treatment episodes)
Ostali občasni neželeni učinki (pojavijo se lahko pri največ 1 od 100 epizod zdravljenja)
The powder vial contains white powder and the solvent vial contains a clear colourless solution.
Viala s praškom vsebuje bel prašek, viala s topilom pa bistro in brezbarvno raztopino.
NovoSeven 8 mg (400 KIU)
NovoSeven 8 mg (400 k.i.e)
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).
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).
• Push the plunger rod to inject all the solvent into the vial.
• Potiskajte nosilec bata, da boste v vialo vbrizgali celotno količino topila.
Powder in vial and solvent in vial:
Prašek in topilo v viali
Rare (may affect up to 1 in 1,000 treatment episodes)
Ostali redki neželeni učinki (pojavijo se lahko pri največ 1 od 1.000 epizod zdravljenja)
If the plastic cap is loose or missing, do not use the vial.
Če plastični pokrovček ni trdno pričvrščen ali ga sploh ni, viale ne uporabite.
If you use a transfer needle, make sure to penetrate the centre of the rubber stopper.
Če uporabljate iglo, pazite, da jo boste zabodli skozi sredino gumijastega zamaška.
• NovoSeven powder and solvent vials should be at room temperature at reconstitution.
• Viali s praškom in topilom morata biti za pripravo ogreti na sobno temperaturo.
• Remove the empty solvent vial.
• Odstranite prazno vialo s topilom.
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.
Če uporabljate iglo, izvlecite iglo iz viale, pokrijte jo s pokrovčkom igle in iglo odvijte z brizge.
After reconstitution, the product contains 1 mg/ml eptacog alfa (activated) when reconstituted with solvent.
Po rekonstituciji s topilom vsebuje zdravilo 1 mg/ml aktiviranega eptakoga alfa.
Screw the syringe tightly onto the vial adapter on the solvent vial.
Brizgo trdno privijte v nastavek za vialo na viali s topilom.
If the syringe cap is loose or missing, do not use the pre-filled syringe.
Če pokrovček brizge ne sedi trdno ali ga sploh ni, napolnjene injekcijske brizge ne uporabite.
• Screw the plunger rod clockwise into the plunger inside the pre-filled syringe until resistance is felt.
• Privijte nosilec bata v smeri urinega kazalca v bat, ki je v notranjosti napolnjene injekcijske brizge, dokler ne začutite upora.
Screw the syringe securely onto the vial adapter until resistance is felt.
Injekcijsko brizgo trdno privijte na nastavek za vialo, dokler ne začutite upora.
Dose, dose range and dose interval
Odmerek, odmerno območje in odmerni interval
Eptacog alfa (activated) 8 mg/vial (400 KIU/vial), 1 mg/ml after reconstitution
Aktivirani eptakog alfa, 8 mg/vialo (400 k.i.e./vialo), 1 mg/ml po pripravi;
- Related laboratory findings, including elevated levels of Ddimmer and decreased levels of AT (see section
- povezani laboratorijski izvidi, vključno s povečano koncentracijo
• If using a vial adapter, unscrew the vial adapter with the empty vial.
• Če uporabljate nastavek za vialo, odvijte nastavek za vialo in prazno vialo.
Powder and solvent for solution for injection Eptacog alfa (activated)
prašek in topilo za raztopino za injiciranje aktivirani eptakog alfa
• 1 pre-filled syringe with solvent for reconstitution
• 1 napolnjeno injekcijsko brizgo s topilom za pripravo raztopine,
If you touch the syringe tip, germs from your fingers can be transferred.
Če se dotaknete konice injekcijske brizge, lahko nanjo prenesete klice s prstov.
Clean the rubber stoppers on the vials with alcohol swabs and allow them to dry before use.
Gumijasta zamaška na vialah očistite z alkoholnima zložencema.
Thread
Odmerek
Eptacog alfa (activated) 5 mg/vial (250 KIU/vial), 1 mg/ml after reconstitution
Aktivirani eptakog alfa, 5 mg/vialo (250 k.i.e./vialo), 1 mg/ml po pripravi;
NovoSeven is presented as powder and solvent for solution for injection containing 5 mg eptacog alfa (activated) per vial (corresponds to 250 KIU/vial).
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).
Acquired Haemophilia
Pridobljena hemofilija
Immediately connect the plunger rod to the syringe by turning it clockwise into the plunger inside the pre-filled syringe until resistance is felt.
• Takoj privijte nosilec bata v injekcijsko brizgo, tako da ga vrtite v smeri urinega kazalca v bat, ki je v notranjosti napolnjene injekcijske brizge,
White lyophilised powder.
prašek in topilo za raztopino za injiciranje Bel liofiliziran prašek.
NovoSeven is presented as powder and solvent for solution for injection containing 8 mg eptacog alfa (activated) per vial (corresponds to 400 KIU/vial).
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).
Eptacog alfa (activated) 2 mg/vial (100 KIU/vial), 1 mg/ml after reconstitution
Aktivirani eptakog alfa, 2 mg/vialo (100 k.i.e./vialo), 1 mg/ml po pripravi;
Gently swirl the vial until all the powder is dissolved.
Previdno vrtite vialo, dokler se prašek ne raztopi.
Powder vial
gumijasti zamašek
• Screw the syringe tightly onto the vial adapter on the solvent vial.
• Brizgo trdno privijte v nastavek za vialo na viali s topilom.
Administration
Aplikacija
If you use a transfer needle, make sure that the transfer needle tip is in the solution.
Če uporabljate iglo, poskrbite, da bo konica igle v topilu.
NovoSeven is presented as powder and solvent for solution for injection containing 1 mg eptacog alfa (activated) per vial (corresponds to 50 KIU/vial).
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).
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)).
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:
NOVOSEVEN USER INSTRUCTIONS
NAVODILA ZA UPORABO
If the caps are loose or missing, do not use the vials.
Če pokrovček ne sedi trdno ali ga sploh ni, viale ne uporabite.
- For storage conditions of the reconstituted medicinal product, see section 6.3.
- Za pogoje shranjevanja pripravljenega zdravila glejte poglavje 6.3. 6.5 Vrsta ovojnine in vsebina
Hold the syringe slightly tilted with the vial pointing downwards.
Držite brizgo rahlo nagnjeno, tako da je vstavljena viala spodaj.
Eptacog alfa (activated) 1 mg/vial (50 KIU/vial), 1 mg/ml after reconstitution
Aktivirani eptakog alfa, 1 mg/vialo (50 k.i.e./vialo), 1 mg/ml po pripravi;
If you use a vial adapter, unscrew the vial adapter with the empty vial.
Če uporabljate nastavek za vialo, odvijte nastavek za vialo in prazno vialo.
1 vial of powder
Nalepka za vialo s praškom
NovoSeven is presented as powder and solvent for solution for injection containing 2 mg eptacog alfa (activated) per vial (corresponds to 100 KIU/vial).
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).
You should talk to your doctor before using NovoSeven with these medicines.
Preden uporabite zdravilo NovoSeven skupaj s temi zdravili, se morate posvetovati s svojim zdravnikom.
• 1 pre-filled syringe with solvent
• 1 napolnjeno injekcijsko brizgo s topilom,
Rare (≥1/10,000 to <1/1,000) Frequency Not Known
pogosto (≥ 1/100 do < 1/10)).
• Turn the syringe with the vial upside down.
• Obrnite brizgo skupaj z vialo s topilom na glavo.
• Gently swirl the vial until all the powder is dissolved.
• Previdno vrtite vialo, dokler se prašek ne raztopi.
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
vsebuje: - 1 vialo (2 ml) z belim praškom za raztopino za injiciranje, - 1 vialo (2 ml) s topilom za pripravo raztopine ali
NovoSeven is now ready to inject into your vein.
Zdravilo NovoSeven je zdaj pripravljeno za injiciranje v veno.
If you touch the spike on the vial adapter germs from your fingers can be transferred.
Če se dotaknete konice nastavka za vialo, lahko nanj prenesete klice s prstov.
1 pre-filled syringe of solvent with separate plunger rod 1 vial adapter for reconstitution
1 napolnjeno injekcijsko brizgo s topilom in ločen nosilec bata,
How to store NovoSeven
Shranjevanje zdravila NovoSeven
- Nausea
Žilne bolezni
Hydrochloric acid (for pH-adjustment) Sodium hydroxide (for pH-adjustment)
Prašek natrijev klorid kalcijev klorid dihidrat glicilglicin polisorbat 80 manitol saharoza metionin klorovodikova kislina (za uravnavanje pH) natrijev hidroksid (za uravnavanje pH)
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
prašek in topilo za raztopino za injiciranje NovoSeven 5 mg (250 k.i.e.)
NovoSeven 8 mg Powder for injection Eptacog alfa (activated) IV
NovoSeven 8 mg prašek za injekcijo aktivirani eptakog alfa i.v.
Other uncommon side effects
Preglednica neželenih učinkov
Administer the solution as an intravenous bolus injection over 2 - 5 minutes.
Aplicira se ga v intravenski bolusni injekciji.
Do not reuse the equipment.
Opremo uporabite samo enkrat.
90 µg/kg (range 28 to 450 µg/kg).
Mediani odmerek na aplikacijo pri zdravljenju 333 epizod krvavitev je znašal 90 µg/kg (razpon od 28 do 450 µg/kg).
NovoSeven 1 mg Powder for injection Eptacog alfa (activated) IV
NovoSeven 1 mg prašek za injekcijo aktivirani eptakog alfa i.v.
NovoSeven 5 mg Powder for injection Eptacog alfa (activated) IV
NovoSeven 5 mg prašek za injekcijo aktivirani eptakog alfa i.v.
Hold the syringe slightly tilted with the vial facing downwards.
Držite injekcijsko brizgo rahlo nagnjeno in tako, da je viala obrnjena navzdol.
NovoSeven 2 mg Powder for injection Eptacog alfa (activated) IV
NovoSeven 2 mg prašek in topilo za raztopino za injiciranje aktivirani eptakog alfa
Vial adapter Protective cap
Namestite nastavek za vialo
Syringe cap
- tromb v srcu
Do not store the solution without your doctor's advice.
Raztopine za injiciranje ne shranjujte, ne da bi se prej posvetovali z zdravnikom.
Thromboembolic events - arterial and venous
cerebrovaskularni incident, tromboza ledvične arterije,
Hold the prefilled syringe slightly tilted with the vial pointing downwards.
Napolnjeno injekcijsko brizgo držite rahlo nagnjeno in viala naj bo obrnjena navzdol.
If you forget an injection of NovoSeven
Kaj vsebuje zdravilo NovoSeven
should be considered.
V tem primeru vas morajo skrbno nadzorovati.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Label for pre-filled syringe with solvent
Nalepka za napolnjeno injekcijsko brizgo s topilom
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
vsebuje: - 1 vialo (12 ml) z belim praškom za raztopino za injiciranje, - 1 vialo (12 ml) s topilom za pripravo raztopine ali
If using a transfer needle, insert the transfer needle into the rubber stopper of the solvent vial.
Če uporabljate iglo, jo zabodite v gumijasti zamašek viale s topilom.
If the protective paper is not fully sealed or if it is broken, do not use the vial adapter.
Če zaščitni pokrovček ne sedi trdno ali ga sploh ni, viale ne uporabite.
• If you have acquired haemophilia
• pridobljeno hemofilijo,
Attach the plunger rod and the syringe
Namestite nosilec bata in injekcijsko brizgo
Date of first authorisation: 28 January 2000 Date of latest renewal: 28 January 2015
Datum prve odobritve: 28. januar 2000 Datum zadnjega podaljšanja: 28. januar 2015
Renagel must be taken three times per day with meals.
Zdravilo Renagel je treba jemati trikrat na dan z obroki.
Contact your doctor who will decide on continuing the treatment or not.
Posvetujte se s svojim zdravnikom, ki bo presodil, ali naj zdravljenje nadaljujete ali ne.
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).
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).
Your doctor will check for interactions between Renagel and other medicines on a regular basis.
Vaš zdravnik bo redno preverjal medsebojno delovanje zdravila Renagel in ostalih zdravil.
Therefore your doctor may monitor the levels of TSH in your blood more closely.
Zato se lahko vaš zdravnik odloči za skrbno nadziranje ravni TSH v vaši krvi.
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.
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.
Renagel is not absorbed and may affect the bioavailability of other medicinal products.
Zdravilo Renagel se ne absorbira in lahko vpliva na biološko uporabnost drugih zdravil.
There is at present insufficient data to exclude the possibility of folate deficiency during long term Renagel treatment.
Trenutno ni dovolj podatkov, da bi izključili možnost pomanjkanja folatov med dolgotrajnim zdravljenjem z zdravilom Renagel.
Do not use this medicine after the expiry date stated on the carton and bottle after “EXP”.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in/ali plastenki poleg oznake: “EXP”.
Genzyme Europe B.V., Paasheuvelweg 25, 1105 BP Amsterdam, the Netherlands
Genzyme Europe B.V., Paasheuvelweg 25, 1105 BP Amsterdam, Nizozemska.
One gram of Renagel contains approximately 180 mg (5.1 mEq) chloride.
En gram zdravila Renagel vsebuje približno 180 mg (5,1 mEq) klorida.
Since Renagel does not contain calcium your doctor might prescribe additional calcium tablets.
Ker zdravilo Renagel ne vsebuje kalcija, vam utegne zdravnik predpisati dodatne kalcijeve tablete.
Name and address of the manufacturer responsible for batch release Genzyme Ireland Limited, IDA Industrial Park, Old Kilmeaden Road, Waterford, Ireland
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
Package sizes are:
Velikosti pakiranj so:
The average actual daily dose used in the chronic phase of a one year clinical study was 7 grams of sevelamer.
Povprečni dnevni odmerek sevelamera, ki so ga v enoletni klinični študiji dajali bolnikom v kronični fazi, je bil 7 gramov.
The most frequently occurring (≥5% of patients) adverse reactions were all in the gastrointestinal disorders system organ class.
Najpogostejši neželeni učinki (≥ 5 % bolnikov) so bili vsi v organskem sistemu bolezni prebavil.
Efficacy and safety of Renagel has not been studied in patients with:
Učinkovitost in varnost zdravila Renagel nista bili preučevani pri bolnikih s/z:
Studies in animals have shown that sevelamer did not impair fertility in male or female rats at exposures at a human equivalent dose 2 times the maximum clinical trial dose of 13 g/day, based on a comparison of relative body surface area.
Študije na živalih so pokazale, da sevelamer ne vpliva na plodnost pri samcih in samičkah podgan pri izpostavljenosti primerjalnemu odmerku pri človeku, dvakrat večjemu od največjega odmerka v kliničnem preskušanju 13 g/dan, na osnovi relativne površine telesa.
Intestinal obstruction and ileus/subileus
Obstrukcija črevesj in ileus/subileus
Renagel does not contain calcium.
Zdravilo Renagel ne vsebuje kalcija.
If you forget to take Renagel
Če ste pozabili vzeti zdravilo Renagel
What Renagel is and what it is used for
Kaj je zdravilo Renagel in za kaj ga uporabljamo
Peritonitis is a known complication in patients receiving peritoneal dialysis (PD) and in a clinical study with Renagel, a number of peritonitis cases were reported.
Peritonitis je znan zaplet pri bolnikih, ki prejemajo peritonealno dializo (PD), in v kliničnih študijah z zdravilom Renagel so poročali o številnih primerih peritonitisa.
• Renagel should not be taken at the same time as ciprofloxacin (an antibiotic).
• Zdravila Renagel ne smete jemati sočasno s ciprofloksacinom (antibiotik).
Other medicines and Renagel
Druga zdravila in zdravilo Renagel
In parallel design studies involving 244 haemodialysis patients with treatment duration of up to 54 weeks and 97 peritoneal dialysis patients with treatment duration of 12 weeks were conducted.
Narejene so bile vzporedne študije, ki so vključevale 244 bolnikov na hemodializi, pri katerih je trajalo zdravljenje do 54 tednov, ter 97 bolnikov s peritonelano dializo, pri katerih je zdravljenje trajalo 12 tednov.
In interaction studies in healthy volunteers, Renagel had no effect on the bioavailability of digoxin, warfarin, enalapril or metoprolol.
Ko so preučevali medsebojno delovanje pri zdravih prostovoljcih, zdravilo Renagel ni imelo učinka na biološko uporabnost digoksina, varfarina, enalaprila ali metoprolola.
Renagel alone is not indicated for the control of hyperparathyroidism.
Zdravilo Renagel samo ni namenjeno za nadzorovanje hiperparatiroidizma.
• If you are taking medicines for heart rhythm problems or for epilepsy, you should consult your doctor when taking Renagel.
• Če jemljete zdravila zaradi težav s srčnim ritmom ali zaradi epilepsije, se o jemanju zdravila Renagel posvetujte z zdravnikom.
In interaction studies in healthy volunteers, sevelamer hydrochloride decreased the bioavailability of ciprofloxacin by approximately 50% when co-administered with Renagel in a single dose study.
V študijah medsebojnega delovanja pri zdravih prostovoljcih je sevelamerijev klorid zmanjšal biološko uporabnost ciprofloksacina za približno 50 % pri sočasni uporabi z zdravilom Renagel v študiji z enim odmerkom.