natgillin/translations-raw huggingface dataset:
It is possible for the fungus to spread to other tissues and organs.
Gliva se lahko razširi na druga tkiva in organe.
In most healthy individuals, the natural ability to fight disease destroys the spores and removes them from the body.
Pri večini zdravih posameznikov naravna sposobnost obrambe pred boleznimi spore uniči in jih odstrani iz telesa.
Some medical conditions lower the body’ s resistance to diseases.
Nekatere bolezni zmanjšajo telesno odpornost.
Also, certain medicines prescribed for patients who are organ or bone marrow recipients lower the body’ s resistance to diseases.
Prav tako jo zmanjšajo nekatera zdravila, ki jih dobivajo prejemniki presajenih organov ali kostnega mozga.
These are the patients who are most likely to develop an Aspergillus infection.
To so bolniki, pri katerih je verjetnost okužbe z glivami vrste Aspergillus največja.
Persistent fever due to infection may occur following chemotherapy or medical conditions that lower the body’ s resistance to disease by lowering counts of certain white blood cells.
Dolgotrajna povišana telesna temperatura zaradi okužbe se lahko pojavi po kemoterapiji ali bolezenskem stanju, ki zmanjša odpornost organizma zaradi zmanjšega števila določenih belih krvnih celic.
If the fever is not reduced by treatment with an antibiotic, your doctor may suspect that you have a fungal infection and prescribe CANCIDAS to treat it.
Če se povišana telesna temperatura po terapiji z antibiotikom ne zniža, bo vaš zdravnik posumil na glivično okužbo in za zdravljenje predpisal CANCIDAS.
BEFORE YOU TAKE CANCIDAS
KAJ MORATE VEDETI, PREDEN BOSTE VZELI ZDRAVILO CANCIDAS
Do not take CANCIDAS
Zdravila CANCIDAS ne smete dobivati:
- if you are hypersensitive (allergic) to caspofungin or any of the other ingredients of
- če ste preobčutljivi za (alergični na) kaspofungin ali katerokoli sestavino zdravila
Take special care with CANCIDAS
Pri zdravljenju z zdravilom CANCIDAS bodite posebej pozorni:
- if you have had or now have liver problems.
- če ste kdaj imeli ali imate težave z jetri.
Some patients with liver problems may require a
Pri nekaterih bolnikih s težavami z jetri je treba
dosage adjustment.
prilagoditi odmerek.
- if you are taking cyclosporin, a medicine to help prevent organ transplant rejection or to treat
- če jemljete ciklosporin, zdravilo, ki pomaga preprečiti reakcijo zavrnitve presajenega organa ali
certain problems with your immune system.
se uporablja za zdravljenje določenih težav z imunskim sistemom.
Your physician may order additional blood tests during your treatment.
Vaš zdravnik se bo med zdravljenjem morda odločil za dodatne preiskave krvi.
- if you have any allergies.
- če imate kakršnokoli alergijo.
Tell your doctor about any medical conditions you have or have had.
Svojega zdravnika seznanite z vsemi zdravstvenimi težavami, ki jih imate ali ste jih imeli.
CANCIDAS has been approved for use in children and adolescents for all the infection types described above.
Zdravilo CANCIDAS je bilo odobreno za uporabo pri otrocih in mladostnikih za vse vrste okužb, ki so opisane zgoraj.
The dose used in paediatric patients may differ from the dose used in adult patients.
Odmerek za pediatrične bolnike se lahko razlikuje od odmerka za odrasle bolnike.
Your physician will determine if any adjustments should be made to other medicines you may be taking.
Vaš zdravnik bo odločil, ali so potrebne kakršnekoli prilagoditve pri drugih zdravilih, ki jih morda jemljete.
If you are receiving cyclosporine, your physician may order additional blood tests during your treatment.
Če jemljete ciklosporin, se bo vaš zdravnik med zdravljenjem morda odločil za dodatne preiskave krvi.
It is particularly important for your doctor to know if you are taking certain anti-HIV medicines (including efavirenz or nevirapine), the antiseizure (epilepsy) medicines phenytoin and carbamazepine, the steroid dexamethasone, the antibiotic rifampicin, and the immunosuppressant tacrolimus.
Še posebej pomembno je, da vaš zdravnik ve, če jemljete določena zdravila proti HIV (vključno z efavirenzom ali nevirapinom), zdravili proti epilepsiji fenitoin in karbamazepin, steroid deksametazon, antibiotik rifampicin ali imunosupresiv takrolimus.
CANCIDAS has not been studied in pregnant women, and should be used in pregnancy only if the potential benefit justifies the potential risk to the foetus.
V nosečnosti se sme uporabljati samo, če pričakovana korist opravičuje morebitno tveganje za plod.
Women receiving CANCIDAS should not breast-feed.
Ženske, ki dobivajo CANCIDAS, ne smejo dojiti.
Ask you doctor for advice before taking any medicine.
Posvetujte se z zdravnikom ali farmacevtom, preden vzamete katerokoli zdravilo.
There is no information to suggest that CANCIDAS affects your ability to drive or operate machinery.
Ni podatkov, ki bi kazali, da CANCIDAS vpliva na sposobnost vožnje ali upravljanja s stroji.
Important information about some of the ingredients of CANCIDAS
Pomembne informacije o nekaterih sestavinah zdravila CANCIDAS
CANCIDAS contains sucrose.
CANCIDAS vsebuje saharozo.
HOW TO TAKE CANCIDAS
KAKO JEMATI ZDRAVILO CANCIDAS
CANCIDAS will always be prepared and given to you by a doctor or another healthcare professional.
CANCIDAS bo vedno pripravil in vam ga dal zdravnik ali drug zdravstveni delavec.
42 CANCIDAS should be administered once daily by slow intravenous infusion over approximately 1 hour.
CANCIDAS se daje enkrat dnevno v počasni, približno enourni intravenski infuziji.
Your physician will determine the duration of your treatment and how much CANCIDAS you will receive each day.
42 Vaš zdravnik bo določil trajanje zdravljenja in dnevni odmerek zdravila CANCIDAS.
He will monitor your response and condition.
Spremljal in nadziral bo vaš odziv in vaše zdravstveno stanje.
The dose will not need to be adjusted according to your age or if you are suffering from renal impairment.
Glede na vašo starost ali če imate morda okvaro ledvic, odmerka ne bo potrebno prilagajati.
If you weigh more than 80 kg, a dose adjustment may be required.
Morda pa bo to potrebno, če tehtate več kot 80 kg.
If you take more CANCIDAS than you should
Če ste vzeli večji odmerek zdravila CANCIDAS, kot bi smeli
Your doctor will monitor your response and condition to determine what CANCIDAS treatment is needed.
Vaš zdravnik bo spremljal vaš odziv in vaše stanje, da bi ugotovil, kakšno zdravljenje z zdravilom CANCIDASpotrebujete.
However, if you are concerned that you may have been given too much CANCIDAS, contact your doctor or another healthcare professional immediately.
Če pa vas skrbi, da ste morda dobili prevelik odmerek zdravila CANCIDAS, se takoj pogovorite z vašim zdravnikom ali drugim zdravstvenim delavcem.
If you miss/ forget to take a dose of CANCIDAS
Če ste pozabili vzeti zdravilo CANCIDAS
Your doctor will monitor your response and condition to determine what CANCIDAS treatment is needed.
Vaš zdravnik bo spremljal vaš odziv in vaše stanje, da bi ugotovil, kakšno zdravljenje z zdravilom CANCIDAS potrebujete.
However, if you are concerned that you may have missed a dose, contact your doctor or another healthcare professional immediately.
Če pa vas skrbi, da je bil odmerek zdravila CANCIDAS izpuščen, se takoj pogovorite z vašim zdravnikom ali drugim zdravstvenim delavcem.
If you stop taking CANCIDAS
Če ste prenehali jemati zdravilo CANCIDAS
There are no known withdrawal symptoms.
Ni nobenih znanih odtegnitvenih simptomov.
Like all medicines, CANCIDAS can cause side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi zdravilo CANCIDAS neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
The following terms are used to describe how often side effects have been reported.
Za navedbo pogostosti neželenih učinkov se uporabljajo naslednji izrazi:
Very Common (occurring in at least 1 in 10 patients treated) Common (occurring in at least 1 of 100 and less than 1 of 10 patients treated) Uncommon (occurring in at least 1of 1000 and less than 1 of 100 patients treated) Rare (occurring in at least 1 of 10,000 and less than 1 of 1000 patients treated) Not known (cannot be estimated from the available data)
Zelo pogosti (pojavljajo se pri več kot 1 od 10 zdravljenih bolnikov) Pogosti (pojavljajo se pri vsaj 1 od 100 in pri manj kot 1 od 10 zdravljenih bolnikov) Občasni (pojavljajo se pri vsaj 1 od 1. 000 in pri manj kot 1 od 100 zdravljenih bolnikov) Redki (pojavljajo se pri vsaj 1 od 10. 000 in pri manj kot 1 od 1. 000 zdravljenih bolnikov) Neznani (iz razpoložjivih podatkov jih ni moč oceniti)
Adults 18 years of age or older:
Odrasli, stari 18 let ali več:
Common: rapid heart beat Not known: swelling of the hands, ankles or feet
Pogosti: hiter utrip srca Neznani: otekanje rok, gležnjev in stopal
Common: flushing
Pogosti: rdečica
Common: shortness of breath
Pogosti: kratka sapa
Common: stomach pain, nausea, vomiting, diarrhoea
Pogosti: bolečine v trebuhu, občutek siljenja na bruhanje, bruhanje, driska
Common: rash, itching, sweating
Pogosti: izpuščaj, srbenje, potenje
43 General disorders and administration site conditions:
43 Splošne težave in spremembe na mestu aplikacije:
Very common: fever Common: pain, chills, vein irritations at the infusion site (including itching, redness, discharge, swelling, burning sensation, or clotting)
Zelo pogosti: zvišana telesna temperatura Pogosti: bolečina, mrzlica, vnetje žile na vbodnem mestu infuzije (vključno s srbenjem, rdečino, izcedkom, oteklino, pekočim občutkom ali strdki)
Rare: impaired liver function
Redki: motnje v delovanju jeter
Common: alterations in some laboratory blood tests (including decreased red blood cell count and increased values of some liver and kidney tests Uncommon: high calcium
Pogosti: spremembe nekaterih laboratorijskih izvidov krvi (vključno z zmanjšanjem števila rdečih krvnih celic in povečanjem vrednosti nekaterih jetrnih in ledvičnih testov) Občasni: visoka koncentracija kalcija
Children and adolescents (12 months to 17 years of age):
Otroci in mladostniki (stari od 12 mesecev do 17 let):
Common: rapid heart beat
Pogosti: hiter utrip srca
Common: flushing, low blood pressure
Pogosti: rdečica, nizek krvni tlak
Common: rash, itching
Pogosti: izpuščaj, srbenje
Very common: fever Common: chills, pain at the catheter site
Zelo pogosti: zvišana telesna temperatura Pogosti: mrzlica, bolečina na mestu katetra
Common: alterations in some laboratory blood tests (including increased values of some liver tests)
Pogosti: spremembe nekaterih laboratorijskih izvidov krvi (vključno s povečanjem vrednosti nekaterih jetrnih testov)
Possible histamine-mediated symptoms have been reported including reports of rash, swelling of the face and/ or lips, itching, sensation of warmth, or trouble breathing.
Poročali so o simptomih, pri katerih bi posrednik lahko bil histamin, vključno s primeri izpuščaja, otekanja obraza, srbenja, občutka toplote ali težav z dihanjem.
Life-threatening allergic reactions that might include difficulty breathing with wheezing or worsening of an existing rash have also been reported rarely during administration of CANCIDAS.
Med prejemanjem zdravila CANCIDAS so redko poročali tudi o življenjsko ogrožujočih alergijskih reakcijah, ki lahko vključujejo težave pri dihanju s piskanjem ali poslabšanje obstoječega izpuščaja.
Other side effects may also occur rarely, and as with any prescription medicine, some side effects may be serious.
Redko lahko pride tudi do drugih neželenih učinkov, in tako kot pri kateremukoli zdravilu na recept, so nekateri lahko resni.
Ask your doctor for more information.
Za podrobnejše informacije vprašajte svojega zdravnika.
HOW TO STORE CANCIDAS
SHRANJEVANJE ZDRAVILA CANCIDAS
Do not use CANCIDAS after the expiry date which is stated on the carton and the vial.
Zdravila CANCIDAS ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in na viali.
The first 2 numbers indicate the month; the next 4 numbers indicate the year.
Prvi dve številki pomenita mesec, naslednje 4 pa leto.
Store in a refrigerator (2°C to 8°C).
Shranjujte v hladilniku (2 ˚C do 8 ˚C).
44 Reconstituted CANCIDAS should be used immediately because it does not contain any preservatives to prevent bacterial contamination.
44 Pripravljeni CANCIDAS je treba uporabiti takoj, ker ne vsebuje konzervansov, ki bi preprečili, da bi se raztopina okužila z bakterijami.
Only a trained health care professional who has read the complete directions (please see below “ Instructions of how to reconstitute and dilute CANCIDAS”) can properly prepare this medicine for use.
Zdravilo lahko za uporabo pripravi le usposobljen zdravstveni delavec, ki je prebral celotno navodilo (v nadaljevanju glejte » Navodilo za pripravo in razredčevanje zdravila CANCIDAS «).
What CANCIDAS contains The active substance of CANCIDAS is caspofungin (as acetate).
Kaj vsebuje zdravilo CANCIDAS Zdravilna učinkovina je kaspofungin (v obliki acetata).
The other ingredients are: sucrose, mannitol, glacial acetic acid, and sodium hydroxide.
Pomožne snovi so saharoza, manitol, koncentrirana ocetna kislina (ledocet) in natrijev hidroksid.
What CANCIDAS looks like and contents of the pack CANCIDAS is a sterile, white to off-white, freeze-dried compact powder.
Izgled zdravila CANCIDAS in vsebina pakiranja CANCIDAS je sterilen, bel do sivobel, liofiliziran, kompakten prašek.
Each pack contains one vial containing 50 mg Caspofungin (as acetate).
Vsako pakiranje vsebuje eno vialo, ki vsebuje 50 mg kaspofungina (v obliki acetata).
Marketing Authorisation Holder Merck Sharp & Dohme Limited Hertford Road, Hoddesdon Hertfordshire EN11 9BU United Kingdom
Merck Sharp & Dohme Limited Hertford Road, Hoddeson Hertfordshire EN11 9BU Velika Britanija
Product Manufacturer Merck Sharp & Dohme B.
Merck Sharp & Dohme B. V.
V.
Waarderweg 39, P. O.
Waarderweg 39, Postbus 581 2003 PC Haarlem The Netherlands
Box 581 2003 PC Haarlem Nizozemska
46 The following information is intended for medical or healthcare professionals only:
46 Naslednje informacije so namenjene samo zdravstvenemu osebju:
Reconstitution of CANCIDAS DO NOT USE ANY DILUENTS CONTAINING GLUCOSE as CANCIDAS is not stable in diluents containing glucose.
Priprava zdravila CANCIDAS NE UPORABLJAJTE TOPIL, KI VSEBUJEJO GLUKOZO, ker CANCIDAS v njih ni stabilen.
DO NOT MIX OR CO-INFUSE CANCIDAS WITH ANY OTHER MEDICINES, as there are no data available on the compatibility of CANCIDAS with other intravenous substances, additives, or medicinal products.
Zdravila CANCIDAS NE MEŠAJTE IN GA NE INFUNDIRAJTE SKUPAJ Z DRUGIMI ZDRAVILI, ker ni podatkov o kompatibilnosti zdravila CANCIDAS z drugimi učinkovinami, aditivi ali zdravili za intravensko uporabo.
The white to off-white compact lyophilised powder will dissolve completely.
Beli do sivobeli kompaktni liofilizirani prah se bo popolnoma raztopil.
Mix gently until a clear solution is obtained.
Previdno pretresite, da dobite čisto raztopino.
This reconstituted solution may be stored for up to 24 hours at or below 25°C.
Tako pripravljeno raztopino lahko hranite do 24 ur pri temperaturi 25 °C ali manj.
The solution for infusion is prepared by aseptically adding the appropriate amount of reconstituted concentrate (as shown in the table below) to a 250 ml infusion bag or bottle.
Raztopino za infundiranje pripravite tako, da ustrezno količino pripravljenega koncentrata (kot je prikazano v spodnji tabeli) aseptično dodate v 250 ml infuzijsko vrečko ali steklenico.
Reduced volume infusions in 100 ml may be used, when medically necessary, for 50 mg or 35 mg daily doses.
Če je to potrebno, lahko za 50 ali 35 mg dnevne odmerke uporabimo zmanjšane prostornine infuzij – 100 ml.
This infusion solution must be used within 24 hours if stored at or below 25°C, or within 48 hours if stored refrigerated at 2 to 8°C.
Raztopino za infundiranje je treba porabiti v 24 urah, če jo shranjujete pri temperaturi 25 °C ali manj, oziroma v 48 urah, če jo shranjujete v hladilniku pri temperaturi med 2 in 8 °C.
Chemical and physical in-use stability of the diluted solution in sterile lactated Ringer’ s solution and sodium chloride solution 9 mg/ ml (0.9%), 4.5 mg/ ml (0.45%), and 2.25 mg/ ml (0.225%) for infusion has been demonstrated for 24 hours at 25°C and for 48 hours at 2 to 8°C.
Kemijsko in fizikalno stabilnost pripravljene raztopine v sterilni raztopini Ringerjevega laktata ali raztopini natrijevega klorida za infuzijo 9 mg/ ml (0, 9%), 4, 5 mg/ ml (0, 45%) ali 2, 25 mg/ ml (0, 225%) pri temperaturi 25 °C so dokazali za obdobje 24 ur po pripravi, pri temperaturi med 2 in 8 °C pa za obdobje 48 ur.
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless reconstitution and dilution has taken place in controlled and validated aseptic conditions.
Normalno naj ta čas ne bi bil daljši od 24 ur, če raztopino shranjujemo med 2 in 8 °C, razen če sta priprava in razredčenje potekala v kontroliranih, validiranih aseptičnih pogojih.
PREPARATION OF THE SOLUTION FOR INFUSION IN ADULTS
47 PRIPRAVA RAZTOPINE ZA INFUNDIRANJE ZA ODRASLE
DOSE*
ODMEREK *
Volume of recon- stituted CANCIDAS for transfer to intravenous bag or bottle
koncentrata zdravila CANCIDAS, ki ga je treba vbrizgati v infuzijsko vrečko ali steklenico
Standard preparation (reconstituted CANCIDAS added to 250 ml) final concentration
CANCIDAS, dodan v 250 ml) končna koncentracija
Reduced volume infusion (reconstituted CANCIDAS added to 100 ml) final concentration
prostornino (pripravljeni CANCIDAS, dodan v 100 ml) končna koncentracija
volume 35 mg for moderate
prostornina infuzije 35 mg pri zmerni okvari
hepatic insufficiency (from one 50 mg vial) 35 mg for moderate hepatic insufficiency
jeter (iz ene viale po 50 mg) 35 mg pri zmerni okvari jeter (iz ene viale po
(from one 50 mg vial) at reduced volume
50 mg) / zmanjšana prostornina infuzije
* 10.5 ml should be used for reconstitution of all vials
* Za pripravo koncentrata je treba vedno uporabiti 10, 5 ml.
47 INSTRUCTIONS FOR USE IN PAEDIATRIC PATIENTS
NAVODILA ZA UPORABO PRI PEDIATRIČNIH BOLNIKIH
(Mosteller 3 Formula)
Višina( cm) xTeža( kg) Telesna površina (m2) = 3600
Preparation of the 50 mg/ m2 infusion for paediatric patients > 3 months of age (using a 50-mg vial) 1.
Priprava infuzije 50 mg/ m2 za pediatrične bolnike, stare > 3 mesece (z uporabo 50- mg viale) 1.
BSA (m2) X 50 mg/ m2 = Daily Maintenance Dose The daily maintenance dose should not exceed 70 mg regardless of the patient's calculated dose.
48 Telesna površina (m2) X 50 mg/ m2 = dnevni vzdrževalni odmerek Dnevni vzdrževalni odmerek ne sme preseči 70 mg, ne glede na izračunani odmerek za bolnika.
48 Preparation notes:
Opombe v zvezi s pripravo:
a The white to off-white cake will dissolve completely.
Bela ali skoraj bela pogača se bo povsem raztopila.
c CANCIDAS is formulated to provide the full labeled vial dose (50 mg) when 10 ml is withdrawn from the vial.
Zdravilo CANCIDAS je pripravljeno tako, da zagotavlja polni na viali označeni odmerek (50 mg), če iz viale potegnete 10 ml.
Persons at high risk for invasive candidiasis include surgical patients and those whose immune systems are deficient.
Med tistimi, ki jih invazivna kandidiaza zelo ogroža, so bolniki po kirurškem posegu in bolniki z oslabelim imunskim sistemom.
- if you are taking cyclosporin, a medicine to help prevent organ transplant rejection or to treat
- če jemljete ciklosporin, zdravilo, ki pomaga preprečiti reakcijo zavrnitve presajenega organa
certain problems with your immune system.
ali se uporablja za zdravljenje določenih težav z imunskim sistemom.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Obvestite svojega zdravnika ali farmacevta, če jemljete ali ste pred kratkim jemalikaterokoli drugo zdravilo, tudi če ste ga dobili brez recepta.
CANCIDAS has not been studied in pregnant women, and should be used in pregnancy only if the potential benefit justifies the potential risk to the foetus
V nosečnosti se sme uporabljati samo, če pričakovana korist opravičuje morebitno tveganje za plod.
51 CANCIDAS should be administered once daily by slow intravenous infusion over approximately 1 hour.
CANCIDAS se daje enkrat dnevno v počasni, približno enourni intravenski infuziji.
Your physician will determine the duration of your treatment and how much CANCIDAS you will receive each day.
51 Vaš zdravnik bo določil trajanje zdravljenja in dnevni odmerek zdravila CANCIDAS.
Your doctor will monitor your response and condition to determine what CANCIDAS treatment is needed.
Vaš zdravnik bo spremljal vaš odziv in vaše stanje, da bi ugotovil, kakšno zdravljenje z zdravilomCANCIDAS potrebujete.
If you stop taking CANCIDAS There are no known withdrawal symptoms.
Ni nobenih znanih odtegnitvenih simptomov.
Very common: fever Common: pain, chills, vein irritations at the infusion site (including itching, redness, discharge, swelling, burning sensation, or clotting)
52 Pogosti: bolečina, mrzlica, vnetje žile na vbodnem mestu infuzije (vključno s srbenjem, rdečino, izcedkom, oteklino, pekočim občutkom ali strdki)
Other side effects may also occur rarely, and as with any prescription medicine, some side effects may be serious.
Redko lahko pride tudi do drugih neželenih učinkov, in tako kot pri kateremkoli zdravilu na recept, so nekateri lahko resni.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Če katerikoli neželeni učinek postane resen ali če opazite katerikoli neželeni učinek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika ali farmacevta..
Do not use CANCIDAS after the expiry date which is stated on the carton and the vial.
Zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in na viali.
The first 2 numbers indicate the month; the next 4 numbers indicate the year.
Prvi dve številki pomenita mesec, naslednje štiri pa leto.
53 Reconstituted CANCIDAS should be used immediately because it does not contain any preservatives to prevent bacterial contamination.
53 delavec, ki je prebral celotno navodilo (v nadaljevanju glejte "Navodilo za pripravo in razredčevanje zdravila CANCIDAS").
Each pack contains one vial containing 70 mg Caspofungin (as acetate).
Vsako pakiranje vsebuje eno vialo, ki vsebuje 70 mg kaspofugina (v obliki acetata).
Marketing Authorisation Holder and Manufacturer
Imetnik dovoljenja za promet z zdravilom in izdelovalec zdravila
Marketing Authorisation Holder Merck Sharp & Dohme Limited Hertford Road, Hoddesdon Hertfordshire EN11 9BU United Kingdom
Merck Sharp & Dohme Limited Hetford Road, Hoddeson Hertfortshire EN11 9BU Velika Britanija
Eλλάδα BIANEΞ Α .Ε Τηλ: +3 0210 80091 11 Mailbox@vianex. gr
54 Eλλάδα BIANEΞ Α. Ε Τηλ: +3 0210 80091 11 Mailbox@ vianex. gr
55 The following information is intended for medical or healthcare professionals only:
55 Naslednje informacije so namenjene samo zdravstvenemu osebju:
Reconstitution of CANCIDAS DO NOT USE ANY DILUENTS CONTAINING GLUCOSE, as CANCIDAS is not stable in diluents containing glucose.
Priprava zdravila CANCIDAS NE UPORABLJAJTE TOPIL, KI VSEBUJEJO GLUKOZO, ker CANCIDAS v njih ni stabilen.
PREPARATION OF THE SOLUTION FOR INFUSION IN ADULTS
56 PRIPRAVA RAZTOPINE ZA INFUNDIRANJE ZA ODRASLE
Volume of reconstituted CANCIDAS for transfer to intravenous bag or bottle
koncentrata zdravila CANCIDAS, ki ga je treba vbrizgati v infuzijsko vrečko ali steklenico
70 mg 70 mg
70 mg 70 mg (iz dveh vial
Not Recommended
Ni priporočljivo
(from two 50-mg vials)** 35 mg for moderate
po 50 mg) ** 35 mg za zmerno
hepatic insufficiency (from one 70 mg vial)
jetrno ene 70
5 ml
odpoved (iz 5 ml mg viale)
* 10.5 ml should be used for reconstitution of all vials ** If 70 mg vial is not available, the 70 mg dose can be prepared from two 50-mg vials
* Za pripravo koncentrata je treba vedno uporabiti 10, 5 ml.
56 INSTRUCTIONS FOR USE IN PAEDIATRIC PATIENTS
NAVODILA ZA UPORABO PRI PEDIATRIČNIH BOLNIKIH
(Mosteller 4 Formula)
Višina( cm) xTeža( kg) Telesna površina (m2) = 3600
Preparation of the 50 mg/ m2 infusion for paediatric patients > 3 months of age (using a 70-mg vial) 1.
Priprava infuzije 50 mg/ m2 za pediatrične bolnike, stare > 3 mesece (z uporabo 70- mg viale) 1.