natgillin/translations-raw huggingface dataset:
Manufacturer Responsible for Batch Release:
Izdelovalec zdravila odgovoren za sproščanje serij:
Merck Sharp and Dohme, B. V., Waarderweg 39, 2031 BN Haarlem, The Netherlands
Merck Sharp & Dohme B. V., Waarderweg 39, 2031 BN Haarlem, Nizozemska
Sanofi Pasteur MSD, Sími: +32.2.726.95.84 Italia:
Sanofi Pasteur MSD, Sími: +32. 2. 726. 95. 84 44 Italia:
52 This leaflet was last approved in:
Datum zadnje revizije navodila:
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Reconstitution instructions The solvent is a clear colourless liquid.
Navodilo za pripravo cepiva Vehikel je bistra brezbarvna tekočina.
Before mixing with the solvent, the powder is a light yellow compact crystalline cake.
Pred mešanjem z vehiklom je cepivo v prašku bel do bledo rumen kompakten kristalni skupek.
When completely reconstituted, the vaccine is a clear yellow liquid.
Po končani pripravi je cepivo bistrarumena tekočina.
Gently agitate to dissolve completely.
Z rahlim stresanjem vsebino dobro premešajte.
Do not use the reconstituted vaccine if you notice any particulate matter or if the appearance of the solvent or powder or of the reconstituted vaccine differs from that described above.
Pripravljenega cepiva ne uporabite, če v njem opazite delce snovi ali če se videz vehikla ali praška ali pripravljenega cepiva razlikuje od zgornjega opisa.
See also section 3 HOW TO USE M-M-RVAXPRO.
KAKO UPORABLJATI M- M- RVAXPRO.
M-M-RVAXPRO Powder and solvent for suspension for injection in pre-filled syringe Measles, mumps and rubella vaccine (live)
M- M- RVAXPRO Prašek in vehikel za suspenzijo za injiciranje v vnaprej napolnjeni brizgi cepivo proti ošpicam, mumpsu in rdečkam (živo)
1.
Navodilo vsebuje 7.
What M-M-RVAXPRO is and what it is used for 2.
Kaj je cepivo M- M- RVAXPRO in za kaj ga uporabljamo 8.
Before you use M-M-RVAXPRO 3.
Kaj morate vedeti, preden boste uporabili cepivo M- M- RVAXPRO 9.
How to use M-M-RVAXPRO 4.
Kako uporabljati cepivo M- M- RVAXPRO 10.
How to store M-M-RVAXPRO 6.
Shranjevanje cepiva M- M- RVAXPRO 12.
WHAT M-M-RVAXPRO IS AND WHAT IT IS USED FOR
KAJ JE M- M- RVAXPRO IN ZA KAJ GA UPORABLJAMO
54
- Če imate vi ali vaš otrok aktivno nezdravljeno tuberkulozo.
- If you or your child have a family history of congenital or hereditary immunodeficiency,
46
unless the immune competence of your or your child is demonstrated.
- Če imate vi ali vaš otrok kakršnokoli bolezen z zvišano telesno temperaturo nad 38, 5° C; malo
55 Pregnancy and breast-feeding M-M-RVAXPRO must not be given to pregnant females.
Nosečnost in dojenje Nosečnic se ne sme cepiti s cepivom M- M- RVAXPRO.
M-M-RVAXPRO should be injected into the muscle under the skin either in the area of the outer thigh or of the upper arm.
M- M- RVAXPRO se z injekcijo injicira v mišico ali pod kožo v predel zunanje strani stegna ali nadlakti.
M- M-RVAXPRO is not to be injected directly into any blood vessel.
Cepiva M- M- RVAXPRO se ne sme injicirati neposredno v katerokoli žilo.
Approximately 1 out of 10 patients reported the following side effects with the use of M-M-RVAXPRO: fever (38.5°C or higher), injection site redness, and injection site pain and swelling.
Približno 1 od 10 bolnikov je poročal o naslednjih neželenih učinkih: zvišana telesna temperatura (38, 5 ºC ali več), rdečina na mestu injiciranja, bolečina in oteklina na mestu injiciranja.
56 The doctor has a more complete list of side effects for M-M-RVAXPRO.
Zdravnik ima podrobnejši seznam neželenih učinkov cepiva M- M- RVAXPRO.
Store and transport refrigerated (2°C- 8°C).
Hranite in prevažajte v hladilniku (2 °C - 8ºC).
Measles virus1 Enders’ Edmonston strain (live, attenuated)......... not less than 1x103 CCID50* Mumps virus1 Jeryl Lynn™ [Level B] strain (live, attenuated).... not less than 12.5x103 CCID50* Rubella virus2 Wistar RA 27/ 3 strain (live, attenuated)............... not less than 1x103 CCID50*
Virus ošpic, sev Enders 'Edmonston (živ, oslabljen)......................... najmanj 1 x 103 CCID50 * Virus mumpsa, sev Jeryl Lynn™ (nivo B) (živ, oslabljen)............... najmanj 12, 5 x 103 CCID50 Virus rdečk, sev Wistar RA 27/ 3 (živ, oslabljen).............................. najmanj 1 x 103 CCID50
Powder: sorbitol, sodium phosphate, potassium phosphate, sucrose, hydrolysed gelatin, medium 199 with Hanks’ salts, MEM, monosodium L-glutamate, neomycin, phenol red, sodium bicarbonate, hydrochloric acid (to adjust pH), and sodium hydroxide (to adjust pH)
Prašek Sorbitol, natrijev fosfat, kalijev fosfat, saharoza, hidrolizirana želatina, medij 199 s Hanksovimi solmi, MEM, mononatrijev L- glutamat, neomicin, fenol rdeče, natrijev bikarbonat, klorovodikova kislina (za prilagoditev pH- ja) in natrijev hidroksid (za prilagoditev pH- ja).
57 What M-M-RVAXPRO looks like and contents of the pack
Izgled M- M- RVAXPRO in vsebina pakiranja
M-M-RVAXPRO is available in packs of 1, 10 and 20, with or without needles.
M- M- RVAXPRO je na voljo v pakiranjih po 1, 10 in 20.
Sanofi Pasteur MSD, Tlf: +45.4526.7887 Deutschland:
Deutschland:
Sanofi Pasteur MSD Spa, Tel: +39.06.664.092.11 Kύπρος:
Sanofi Pasteur MSD Spa, Tel: +39. 06. 664. 092. 11 49 Kύπρος:
This leaflet was last approved in:
Datum zadnje revizije navodila:
When completely reconstituted, the vaccine is a clear yellow liquid.
Po končani pripravi, je cepivo bistra rumena tekočina.
ed EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR)
t me EVROPSKO JAVNO POROČILO O OCENI ZDRAVILA (EPAR)
ris EPAR summary for the public
pro Povzetek EPAR za javnost
tho This document is a summary of the European Public Assessment Report (EPAR).
Ta dokument je povzetek Evropskega javnega poročila o oceni zdravila (EPAR).
It explains how the Committee for Medicinal products for Human Use (CHMP) assessed the studies performed, to
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil opravljene raziskave, na
au reach their recommendations on how to use the medicine.
za podlagi česar je oblikoval priporočila glede uporabe zdravila.
If you need more information about your medical condition or your treatment, read the Package Leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Če
If you want more information on the basis of the CHMP recommendations, read the Scientific Discussion (also part
nja želite več informacij o podlagi za priporočila CHMP, preberite znanstveno razpravo (ki je prav tako del EPAR).
r of the EPAR).
lje Kaj je zdravilo Monotard?
What is Monotard? ge lon Monotard is an insulin suspension for injection.
Zdravilo Monotard je suspenzija insulina za injiciranje.
Monotard contains the active ingredient insulin human (rDNA).
Zdravilo Monotard vsebuje zdravilno učinkovino človeški insulin vo (rDNA).
What is Monotard used for? no
Za kaj se zdravilo Monotard uporablja? do
The medicine can only be obtained with a prescription. t uc
Zdravilo se dobi samo na recept. eā
The rod
Če je primerno, se av
patient's blood sugar should be tested regularly to find the lowest effective dose.
lahko daje tudi v abdominalno steno (trebuh), zadnjico ali predel deltoidne mišice (rame).
In type 1 diabetes, the dosage varies between 0.5 and 1.0 IU/ kg (0.7 and 1.0 IU/ kg in children before puberty), in type 2 diabetes the dosage is 0.3 to 0.6 IU/ kg.
Za določitev najnižjega učinkovitega odmerka je potrebno redno spremljati bolnikovo raven sladkorja v krvi.
Monotard is a long-acting insulin, it can be given as a once daily or twice daily injection, with or without a fast-acting insulin (at meal times), according to the lP
Pri sladkorni bolezni tipa 1 se odmerek giblje med 0, 5 in 1, 0 IU/ kg (0, 7 in 1, 0 IU/ kg pri predpubertetnih nim
doctor’ s recommendation.
otrocih), pri sladkorni bolezni tipa 2 pa znaša odmerek med 0, 3 do 0, 6 IU/ kg.
How does Monotard work? na
Kako zdravilo Monotard deluje?
Diabetes is a disease in which the body does not produce enough insulin to control the blood sugar.
Zdravilo Monotard je nadomestni insulin, ki je enak insulinu, ki ga proizvaja trebušna slinavka.
Monotard is a replacement insulin which identical to the insulin made by the pancreas. The active ingredient of Monotard, insulin human (rDNA), is produced by a method known as ‘ recombinant i
Zdravilno učinkovino zdravila Monotard, človeški insulin (rDNA), izdelujejo z metodo, znano pod rav
technology ’.
imenom “ rekombinantna tehnologija ”.
The insulin is made by a yeast that has received a gene (DNA), which makes it able to dic
Insulin izdelajo kvasovke, ki so prejele ustrezni gen (DNA), s pomočjo katerega postanejo sposobne tvoriti insulin.
The replacement insulin acts in same way as naturally produced insulin and helps Me
Nadomestni insulin deluje na enak način kot naravno Zd
glucose enter cells from the blood.
proizveden insulin in omogoča, da lahko glukoza vstopi iz krvi v celico.
(44-20) 74 18 84 00 Fax (44-20) 74 18 86 68 E-mail: mail@emea. eu. int http: / /www. emea. eu. int ©EMEA 2006 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged How has Monotard been studied?
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 86 68 E- mail: mail@ emea. eu. int http: // www. emea. eu. int ©EMEA 2006 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Kako je bilo zdravilo Monotard raziskano?
ed What benefit has Monotard shown during the studies?
t Kakšne koristi je zdravilo Monotard izkazalo med raziskavami?
ris controlled to a similar level to that seen with other human insulin.
me Z uporabo zdravila Monotard se je znižala raven HbA1c, kar kaže na to, da je bila raven sladkorja v krvi vzdrževana na podobnih ravneh kot pri uporabi drugih vrst človeškega insulina.
tho What is the risk associated with Monotard?
pro Kakšna tveganja so povezana z zdravilom Monotard?
Monotard should not be used in people who may be hypersensitive (allergic) to insulin human (rDNA)
za Zdravila Monotard ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) človeški insulin (rDNA) ali katero koli drugo sestavino.
Monotard doses might also need to be adjusted when given with a number of other medicines which may have an effect on blood sugar (the full list is available in the Package Leaflet).
Odmerke zdravila Monotard bo morda potrebno prilagoditi, če se zdravilo jemlje istočasno s številnimi drugimi zdravili, ki vplivajo na koncentracijo sladkorja v krvi (celoten seznam le- teh najdete v Navodilih za uporabo).
r ge Why has Monotard been approved?
nja Zakaj je bilo zdravilo Monotard odobreno?
The Committee for Medicinal products for Human Use (CHMP) decided that Monotard’ s benefits are greater than its risks for the treatment of diabetes.
Odbor za zdravila za uporabo v humani medicini (CHMP) je odločil, da so koristi zdravila Monotard pri zdravljenju sladkorne bolezni večje od z njim povezanih tveganj.
They recommended that Monotard be given lon marketing authorisation.
Zato je priporočil, da se za lje zdravilo Monotard podeli dovoljenje za promet z zdravilom. vo Druge informacije o zdravilu Monotard:
The European Commission granted a marketing authorisation valid throughout the European Union, for Monotard to Novo Nordisk A/ S in on 7 October 2002. no
Evropska komisija je dovoljenje za promet z zdravilom Monotard, veljavno po vsej Evopski uniji, odobrila družbi Novo Nordisk A/ S dne 7. oktobra 2002. do
The full EPAR for Monotard is available here. t uc
Celotno Evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Monotard je na voljo tukaj. eā
This summary was last updated in 1-2006 rod lP Me
Ta povzetek je bil nazadnje posodobljen 1- 2006. av nim ilo rav Zd
d se EU number
t e Eu številka
Packaging
Velikost
ri EU/ 1/ 02/ 235/ 001 Monotard
ro EU/ 1/ 02/ 235/ 001
Suspension for injection Subcutaneous use
suspenzija za injiciranje
ho EU/ 1/ 02/ 235/ 002 Monotard
p EU/ 1/ 02/ 235/ 002
t EU/ 1/ 02/ 235/ 003 Monotard
za EU/ 1/ 02/ 235/ 003 EU/ 1/ 02/ 235/ 004
Vial (glass)
Monotard Monotard
10ml (3.5 mg/ ml)
100 i. e. / ml 100 i. e. / ml
EU/ 1/ 02/ 235/ 004 Monotard
suspenzija za injiciranje suspenzija za injiciranje
Suspension for injection Subcutaneous use
za subkutano uporabo za subkutano uporabo
Vial (glass)
viala (steklena) viala (steklena)
10 ml (3.5 mg/ ml)
10 ml (3, 5 mg/ ml) 10 ml (3, 5 mg/ ml)
5 vials
1viala 5 vial
ger
ja n lje vo o d eā v a m ni ilo v ra d
P
Z
London, 21 September 2006 Doc. Ref.
London, 21. september 2006 Sklic dok.
On 6 September 2006, sanofi-aventis officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for MULTAQ, for the treatment of atrial fibrillation and atrial flutter.
Podjetje sanofi- aventis je 6. septembra 2006 uradno obvestilo Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za dovoljenje za promet za zdravilo MULTAQ za zdravljenje atrijske fibrilacije in atrijskega plapolanja.
The patients’ heart rates were measured when they were resting.
Srčne frekvence so merili, ko so bolniki počivali.
Once the company has supplied responses to the questions, the CHMP reviews them and may, before
Ko podjetje pripravi odgovore na vprašanja, jih CHMP pregleda in pred izdajo mnenja lahko do 180. dne zaprosi
(44-20) 74 18 84 00 Fax (44-20) 75 23 71 29 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2006 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged giving an opinion, ask any remaining questions at day 180.
(44- 20) 74 18 84 00 Fax (44- 20) 75 23 71 29 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2006 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged podjetje še za odgovore na dodatna vprašanja.
Based on the review of the data and the company’ s response to the CHMP’ s list of questions at the time of the withdrawal, the CHMP had concerns and was of the provisional opinion that MULTAQ could not be approved for the treatment of atrial fibrillation or atrial flutter.
Na podlagi pregleda podatkov in odgovorov podjetja na seznam vprašanj s strani CHMP, je imel odbor v času umika vloge zadržke in bil začasnega mnenja, da za zdravilo MULTAQ ni mogoče odobriti dovoljenja za zdravljenje bolnikov z atrijsko fibrilacijo ali atrijskim plapolanjem.
The CHMP was concerned that the studies presented by the company had not sufficiently shown that MULTAQ’ s effects on heart rate and rhythm would be beneficial to patients, since they had not compared MULTAQ to an existing medicine licensed for the same conditions.
CHMP je imel zadržke, da predstavljene raziskave niso zadostno prikazale koristi učinkov zdravila MULTAQ na srčno frekvenco in ritem, saj v teh raziskavah niso primerjali zdravila MULTAQ z obstoječim zdravilom, ki je odobren za isti bolezni.
Therefore, at the time of the withdrawal, the CHMP’ s view was that further studies were needed to adequately assess the medicine ’ s benefits and risks.
Zato je bil v času umika CHMP mnenja, da so za ustrezno ovrednotenje koristi in tveganj, povezanih s tem zdravilom potrebne dodatne raziskave.
1 CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES
1 POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA, KI JIH MORAJO UVESTI DRŽAVE ČLANICE
The Member States should ensure that all conditions or restrictions with regard to the safe and effective use of the medicinal product described below i. e. the details of a prescription checklist are implemented:
Države članice morajo zagotoviti, da so vsi pogoji ali omejitve glede varne in učinkovite uporabe zdravila, tj. podrobnosti seznama za preverjanje ob predpisovanju, uvedene:
• Mycamine is contra-indicated if the patient has a history of hypersensitivity to micafungin or excipients. • Mycamine should not be used during pregnancy unless clearly necessary. • Caution must be demonstrated if the patient:
• Zdravilo Mycamine je kontraindicirano, če ima bolnik anamnezo preobčutljivosti na mikafungin ali pomožne snovi • Zdravila Mycamine se ne sme uporabljati med nosečnostjo, razen če je nujno potrebno. • Zdravnik mora biti pozoren, če:
- has severe liver function impairment
- ima bolnik hude motnje v delovanju jeter
- has chronic liver diseases known to represent preneoplastic conditions (e. g. advanced liver
- ima bolnik kronično bolezen jeter, za katero je znano, da predstavlja preneoplastično
fibrosis, cirrhosis, viral hepatitis, neonatal liver disease or congenital enzyme defects)
stanje (npr. napredovalo jetrno fibrozo, cirozo, virusni hepatitis, neonatalno jetrno bolezen ali prirojeni encimski defekt)
- is receiving a concomitant therapy including hepatotoxic and/ or genotoxic properties
- je bolnik deležen sočasnega zdravljenja s hepatotoksičnimi in/ ali genotoksičnimi
- has history of haemolysis, haemolytic anaemia or renal impairment.
- gre za bolnika s hemolizo, hemolitično anemijo ali motnjo v delovanju ledvic v anamnezi.
• Patients receiving sirolimus, nifedipine or itraconazole in combination with Mycamine should be monitored for sirolimus, nifedipine or itraconazole toxicity and the sirolimus, nifedipine or itraconazole dosage should be reduced if necessary. • Patients should be carefully monitored for liver damage and for worsening of renal function. • To minimise the risk of adaptive regeneration and potentially subsequent liver tumour formation, early discontinuation in the presence of significant and persistent elevation of ALT/ AST is recommended.
• Bolnike, ki prejemajo sirolimus, nifedipin ali itrakonazol v kombinaciji z zdravilom Mycamine, je treba spremljati zaradi možnosti pojava toksičnosti sirolimusa, nifedipina ali itrakonazola ter po potrebi zmanjšati njihove odmerke. • Bolnike je treba pozorno spremljati zaradi možnih poškodb jeter in poslabšanja v delovanju ledvic. • Za zmanjšanje tveganja adaptivne regeneracije in morebiten posledičen razvoj jetrnih tumorjev na najmanjšo možno mero, je v primeru značilnega in trajnega povišanja ALT/ AST priporočljiva predčasna prekinitev zdravljenja.
If you need more information about your medical condition or your treatment, read the Package Leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil opravljene študije, na podlagi katerih je oblikoval priporočila glede uporabe zdravila Če potrebujete več informacij o svojem zdravstvenem stanju ali zdravljenju, preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte s svojim zdravnikom ali farmacevtom.
Mycamine is a powder that is dissolved to make a solution for infusion (drip into a vein).
Zdravilo Mycamine je prašek za pripravo raztopine za infundiranje (kapalna infuzije v veno).
Mycamine is used in babies, children and adults in the following situations: • to treat invasive candidiasis (a type of fungal infection caused by a yeast-like fungus called Candida). ‘ Invasive ’ means that the fungus has spread into tissue and blood vessels; • to prevent infection with Candida in patients who are having a bone marrow transplant (to treat bone marrow or blood problems, or certain types of cancer) or who are expected to have neutropenia (low levels of neutrophils, a type of white blood cell) for 10 days or more.
Zdravilo Mycamine se uporablja pri dojenčkih, otrocih in odraslih v naslednjih primerih: • za zdravljenje invazivne kandidoze (vrste glivične okužbe, ki jo povzroča kvasovkam podobna gliva, imenovana Candida); „ invazivna “ pomeni, da se je gliva razširila v tkivo in krvne žile; • za preprečevanje okužbe s Candido pri bolnikih po presaditvi kostnega mozga (za zdravljenje kostnega mozga ali težav s krvjo oz. pri nekaterih vrstah raka) ali pri bolnikih, za katere predvidevajo, da bodo 10 ali več dni imeli nevtropenijo (nizko raven nevtrofilov, vrste belih krvničk).
Doctors should only use Mycamine when using other antifungal medicines is not appropriate.
Zdravniki naj bi zdravilo Mycamine uporabljali le v primeru, ko druga protiglivična zdravila niso primerna.
This is because micafungin has been shown to increase the risk of liver tumours developing in rats.
Za mikafungin je bilo namreč dokazano povečanje tveganja za razvoj tumorjev na jetrih pri podganah.
Treatment with Mycamine should be initiated by a doctor who has experience in the management of fungal infections, and after considering official or national guidance on the use of antifungal medicines.
Zdravljenje z zdravilom Mycamine mora uvesti zdravnik z izkušnjami pri zdravljenju glivičnih okužb, upoštevajoč uradne oz. nacionalne smernice za uporabo protiglivičnih zdravil.
The dose depends on what it is being used for, the patient’ s weight, and the response to treatment.
Odmerek je odvisen od namena, bolnikove telesne mase in odziva na zdravljenje.
The active substance in Mycamine, micafungin, is an antifungal medicine, which belongs to the group ‘ echinocandins’.
Zdravilna učinkovina zdravila Mycamine, mikafungin, je protiglivično zdravilo, ki spada v skupino ehinokandinov.
It works by interfering with the production of a component of the fungal cell wall called 1,3-β -D-glucan, which is necessary if the fungus is to continue living and growing.
Deluje tako, da posega v tvorbo ene od sestavin celične stene glive, imenovane 1, 3- β- D- glukan, ki je nujna, če želi gliva še naprej živeti in rasti.
The list of fungi against which Mycamine is active can be found in the Summary of Product Characteristics (also part of the EPAR).
Za seznam gliv, proti katerim zdravilo Mycamine učinkuje, glejte povzetek glavnih značilnosti zdravila (ki je prav tako del EPAR).
The effects of Mycamine were first tested in experimental models before being studied in humans.
Učinki zdravila Mycamine so bili najprej preizkušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
For the treatment of invasive candidiasis, Mycamine was compared with amphotericin B in one study involving 531 adults and 106 children, including newborns and premature babies.
Glede zdravljenja invazivne kandidoze so zdravilo Mycamine primerjali z amfotericinom B v študiji, v katero je bilo vključenih 531 odraslih in 106 otrok, vključno z novorojenčki in nedonošenčki.
For the treatment of oesophageal candidiasis, Mycamine was compared with fluconazole in one study involving 518 adults, and with caspofungin in another study involving 452 adults.
Glede zdravljenja kandidoze požiralnika so zdravilo Mycamine primerjali s flukonazolom v študiji, v katero je bilo vključenih 518 odraslih, ter s kaspofunginom v drugi študiji, v katero je bilo vključenih 452 odraslih.
In all three studies, the main measure of effectiveness was the number of patients in whom treatment was successful, based on an improvement in symptoms and eradication of the fungus at the end of treatment.
V vseh treh študijah je bilo glavno merilo učinkovitosti število bolnikov, pri katerih je bilo zdravljenje uspešno, kar je izkazovalo izboljšanje simptomov in izkoreninjenje glive ob koncu zdravljenja.
For the prevention of candidiasis, Mycamine was compared with fluconazole in 889 adults and children undergoing a bone marrow transplant.
Glede preprečevanja kandidoze so zdravilo Mycamine primerjali s flukonazolom pri 889 odraslih in otrocih, ki so prestali presaditev kostnega mozga.
In the study of invasive candidiasis, around 90% of the adults receiving either Mycamine or amphotericin B were successfully treated.
V študiji invazivne kandidoze je bilo uspešno zdravljenih 90% odraslih, ki so prejemali bodisi zdravilo Mycamine bodisi amfotericin B.
Similar results were seen in children.
Podobni rezultati so bili ugotovljeni pri otrocih.
In the two studies of oesophageal candidiasis, around 90% of the patients were successfully treated with Mycamine, fluconazole or caspofungin.
V dveh študijah kandidoze požiralnika je bilo okrog 90% bolnikov uspešno zdravljenih z zdravilom Mycamine, flukonazolom ali kaspofunginom.