natgillin/translations-raw huggingface dataset:
Type I flint glass vial, with grey butyl rubber stopper and aluminium seal with plastic flip-off cap containing 4 mg of topotecan.
HYCAMTIN 4 mg prašek za koncentrat za raztopino za infundiranje Viala iz kristalnega stekla (tipa I) s sivim zamaškom iz butilne gume in aluminijasto zaporko s plastičnim pokrovom (flip-off) vsebuje 4 mg topotekana.
5 x 4 mg vials
5 x 4 mg viale
There is insufficient experience with the use of topotecan in patients with severely impaired renal function (creatinine clearance <20 ml/min).
Monoterapija (karcinom jajčnika in drobnocelični pljučni karcinom): Z uporabo topotekana pri bolnikih s hudo okvaro ledvične funkcije (z očistkom kreatinina <20 ml/min) ni na voljo dovolj izkušenj.
One Phase II study (Study 065) and one Phase III study (Study 396) were conducted to evaluate the efficacy of oral topotecan versus intravenous topotecan in patients who had relapsed ≥90 days after completion of one prior regimen of chemotherapy (see Table 1).
Za oceno učinkovitosti peroralnega topotekana v primerjavi z intravenskim topotekanom pri bolnikih, pri katerih je prišlo do ponovitve ≥90 dni po koncu ene predhodne sheme kemoterapije, so izvedli eno študijo faze II (Študija 065) in eno študijo faze III (Študija 396) (glejte preglednico 1).
Median time to onset of severe neutropenia was day 12 with a median duration of 7 days.
Mediani čas do pojava hude nevtropenije je bil 12 dni, trajala pa je mediano sedem dni.
9/l) for seven days or more or severe neutropenia associated with fever or infection, or who have had treatment delayed due to neutropenia, the dose should be reduced by 0.25 mg/m 2/day to
9/l), ki traja sedem ali več dni, ali s hudo nevtropenijo z zvišano telesno temperaturo ali okužbo ali pri bolnikih, ki jim je bilo treba zdravljenje odložiti zaradi nevtropenije, je treba odmerek zmanjšati za 0,25 mg/m 2/dan na 1,25 mg/m 2/dan (ali ga kasneje po potrebi še dodatno zmanjšati do
Myelosuppression leading to sepsis and fatalities due to sepsis have been reported in patients treated with topotecan (see section 4.8).
Pri bolnikih, ki so se zdravili s topotekanom, so poročali o mielosupresiji, ki je povzročila sepso, in o primerih smrti zaradi sepse (glejte poglavje 4.8).
Topotecan is partly eliminated via renal excretion and renal impairment might lead to increased exposure to topotecan.
Okvara ledvic zato lahko poveča izpostavljenost topotekanu.
1 x 1 mg vial
1 x 1 mg viala
The prescribing information for cisplatin should be consulted for a full list of adverse events associated with cisplatin use.
Za celoten seznam neželenih učinkov, povezanih s cisplatinom, glejte podatke za predpisovanje cisplatina.
• The other ingredients are: tartaric acid (E334), mannitol (E421), hydrochloric acid (E507) and sodium hydroxide.
• Druge sestavine zdravila so: vinska kislina (E334), manitol (E421), klorovodikova kislina
How to store Hycamtin
Kako dajati zdravilo Hycamtin
Diarrhoea, including severe diarrhoea requiring hospitalisation, has been reported during treatment with oral topotecan.
Med zdravljenjem s peroralnim topotekanom so poročali o driski, vključno s hudo drisko, zaradi katere je bil potreben sprejem v bolnišnico.
• Feeling sick (nausea), being sick (vomiting); diarrhoea; stomach pain; constipation.
• siljenje na bruhanje, bruhanje, driska, bolečine v trebuhu, zaprtje;
Hycamtin 0.25 mg hard capsules Hycamtin 1 mg hard capsules topotecan
Hycamtin 0,25 mg trde kapsule Hycamtin 1 mg trde kapsule topotekan
9/l) for seven days or more or severe neutropenia associated with fever or infection, or who have had treatment delayed due to neutropenia, the dose should be reduced by 0.4 mg/m 2/day to
9/l), ki traja sedem ali več dni, ali s hudo nevtropenijo z zvišano telesno temperaturo ali okužbo, ali pri bolnikih, ki jim je bilo treba zdravljenje odložiti zaradi nevtropenije, je treba odmerek zmanjšati za 0,4 mg/m 2/dan na 1,9 mg/m 2/dan (ali ga kasneje po potrebi še dodatno zmanjšati do
1 x 4 mg vial
1 x 4 mg viala
How Hycamtin is used
Kako uporabljati zdravilo Hycamtin
HYCAMTIN 1 mg powder for concentrate for solution for infusion HYCAMTIN 4 mg powder for concentrate for solution for infusion
HYCAMTIN 1 mg prašek za koncentrat za raztopino za infundiranje HYCAMTIN 4 mg prašek za koncentrat za raztopino za infundiranje
In a comparative study of topotecan and paclitaxel in patients previously treated for ovarian carcinoma with platinum-based chemotherapy (n = 112 and 114, respectively), the response rate (95% CI) was 20.5% (13%, 28%) versus 14% (8%, 20%) and median time to progression 19 weeks versus 15 weeks (hazard ratio 0.7 [0.6, 1.0]), for topotecan and paclitaxel, respectively.
Stopnja odzivnosti na zdravljenje (95-odstotni interval zaupanja) je znašala 20,5 % (13 %, 28 %) oziroma 14 % (8 %, 20 %), mediana časa do napredovanja pa 19 tednov za topotekan in 15 tednov za paklitaksel (razmerje ogroženosti 0,7 [0,6, 1,0]).
9/l) occurred in 32% of patients in 13% of courses.
9/l) se je pojavila pri 32 % bolnikov v
Cisplatin is administered as an intravenous infusion on day 1 at a dose of 50 mg/m2/day and following the topotecan dose.
1. dan po prejemu odmerka topotekana bolnica prejme še intravensko infuzijo cisplatina v odmerku 50 mg/m2/dan.
It is available in packs containing either 1 or 5 glass vials; each vial contains 1 mg or 4 mg of topotecan.
Vsaka viala vsebuje 1 mg ali 4 mg topotekana.
Oral and intravenous topotecan were associated with similar symptom palliation in patients with relapsed sensitive SCLC in patient selfreports on an unblinded symptom scale assessment in each of these two studies.
Na podlagi neslepljene ocene lestvice simptomov po navedbi bolnikov samih sta peroralni in intravenski topotekan v obeh navedenih študijah pri bolnikih s ponovitvijo dovzetnega drobnoceličnega pljučnega raka dosegla podobno ublažitev simptomov.
5 x 1 mg vials
5 x 1 mg viale
Severe bone marrow depression prior to starting first course, as evidenced by baseline neutrophils <1.5 x 10
- huda preobčutljivost na učinkovino ali katero koli pomožno snov, - dojenje (glejte poglavje 4.6), - huda depresija kostnega mozga že pred začetkom prvega ciklusa, kar je razvidno iz izhodiščnega števila nevtrofilcev <1,5 x 10
When topotecan (0.75 mg/m2/day for 5 consecutive days) and cisplatin (60 mg/m2/day on day 1) were administered in 13 patients with ovarian cancer, a slight increase in AUC (12%, n = 9) and Cmax (23%, n = 11) was noted on day 5.
13 bolnicam z rakom jajčnika so 5. dan opazili rahlo povečanje vrednosti AUC (za 12 %, n = 9) in Cmax (za 23 %, n = 11).
Hycamtin 1 mg powder for concentrate for solution for infusion Hycamtin 4 mg powder for concentrate for solution for infusion topotecan
Hycamtin 1 mg prašek za koncentrat za raztopino za infundiranje Hycamtin 4 mg prašek za koncentrat za raztopino za infundiranje topotekan
Special populations
Starejši ljudje
The incidence of severe (Grade 3 or 4) nausea, vomiting, diarrhoea and mucositis was 4, 3, 2 and 1%, respectively.
Hude oblike (3. ali 4. stopnje) motenj so ugotavljali z naslednjimi pogostnostmi: navzea 4 %, bruhanje 3 %, driska 2 %, vnetje ustne sluznice 1 %.
Topotecan has been shown to cause embryo-foetal lethality and malformations in preclinical studies (see section 5.3).
Ženske v rodni dobi/kontracepcija pri moških in ženskah Predklinične raziskave so pokazale, da topotekan povzroča smrt in deformacije zarodka oziroma ploda (glejte poglavje 5.3).
Following intravenous administration of topotecan at doses of 0.5 to 1.5 mg/m as a 30-minute infusion daily for five days, topotecan demonstrated a high plasma clearance of 62 l/h (SD 22), corresponding to approximately 2/3 of liver blood flow.
5 zaporednih dni visok, in sicer 62 l/h (s standardno deviacijo 22), kar pomeni približno 2/3 pretoka krvi skozi jetra.
Malaise
Nevtropenija
Platelet transfusions were given in 4% of courses.
V 4 % ciklusov zdravljenja so bolniki prejeli transfuzije trombocitov.
1.9 mg/m 2/day (or subsequently down to 1.5 mg/m 2/day if necessary).
1,5 mg/m 2/dan).
Thrombocytopenia Severe thrombocytopenia (Grade 4 - platelets <10 x 10
Trombocitopenija Huda trombocitopenija (4. stopnje - število trombocitov manj kot 10 x 10
Very common side effects
Zelo pogosti neželeni učinki
HYCAMTIN 4 mg powder for concentrate for solution for infusion
HYCAMTIN 4 mg prašek za koncentrat za raztopino za infundiranje
These may affect up to 1 in 1,000 people treated with Hycamtin:
Pojavijo se lahko pri največ 1 od 1.000 bolnikov, ki se zdravijo z zdravilom Hycamtin:
• Itchy rash (or hives).
• srbeč izpuščaj (ali koprivnica).
Median survivals for the two groups were 25.0 and 24.7 weeks, respectively.
Mediana časa preživetja bolnikov v skupini, ki je prejemala topotekan, je bila 25,0 tedna, v skupini, ki je prejemala kombinacijo CAV pa 24,7 tedna.
These may affect more than 1 in 10 people treated with Hycamtin:
Pojavijo se lahko pri več kot 1 od 10 bolnikov, ki se zdravijo z zdravilom Hycamtin:
HYCAMTIN 1 mg powder for concentrate for solution for infusion
HYCAMTIN 1 mg prašek za koncentrat za raztopino za infundiranje
HYCAMTIN 4 mg powder for concentrate for solution for infusion topotecan
HYCAMTIN 4 mg prašek za koncentrat za raztopino za infundiranje topotekan
Interstitial lung disease (some cases have been fatal)
Bolezni dihal, prsnega koša in mediastinalnega prostora redki intersticijska bolezen pljuč (nekateri primeri s smrtnim izidom)
However, there are insufficient data available to make a dose recommendation for this patient group (see section 4.2).
Pri tem so opažali zmanjšan očistek topotekana, vendar ni na voljo dovolj podatkov, da bi lahko oblikovali priporočila za odmerjanje za to skupino bolnikov (glejte poglavje 4.2).
HYCAMTIN 1 mg powder for concentrate for solution for infusion topotecan
HYCAMTIN 1 mg prašek za koncentrat za raztopino za infundiranje topotekan
9/l, the platelet count is
9/l, število trombocitov
HYCAMTIN capsules should only be prescribed and therapy supervised by a physician experienced in the use of chemotherapeutic agents.
Le zdravnik, ki ima izkušnje z uporabo kemoterapevtikov, sme predpisati kapsule HYCAMTIN in nadzorovati zdravljenje.
Hycamtin 1 mg powder for concentrate for solution for infusion should be reconstituted with 1.1 ml of water for injections to provide 1 mg per ml of topotecan.
Hycamtin 1 mg prašek za koncentrat za raztopino za infundiranje morate rekonstituirati z 1,1 ml vode za injekcije, da dobite raztopino s koncentracijo 1 mg topotekana na ml. Hycamtin 4 mg prašek za koncentrat za raztopino za infundiranje morate rekonstituirati s 4 ml vode za injekcije, da dobite raztopino s koncentracijo 1 mg topotekana na ml.
• the results of blood tests carried out before treatment The prescribed number of capsules should be swallowed whole, once a day for 5 days.
Predpisano število kapsul morate jemati enkrat na dan 5 dni.
Topotecan was also shown to cause embryo-foetal lethality when given to rats and rabbits.
Raziskave na kuncih in podganah so pokazale, da topotekan povzroča smrt zarodka oziroma ploda.
In another randomised Phase III study which compared intravenous (IV) topotecan to cyclophosphamide, doxorubicin and vincristine (CAV) in patients with relapsed, sensitive SCLC, the overall response rate was 24.3% for topotecan compared to 18.3% for the CAV group.
Pri bolnikih s ponovitvijo dovzetnega drobnoceličnega pljučnega raka je bil celoten odstotek odziva na topotekan 24,3 %, na kombinacijo CAV pa 18,3 %.
These may affect up to 1 in 100 people treated with Hycamtin:
Pojavijo se lahko pri največ 1 od 100 bolnikov, ki se zdravijo z zdravilom Hycamtin:
• Stomach pain, constipation, indigestion.
• siljenje na bruhanje, bruhanje;
IV use
Način uporabe
Check with your doctor or pharmacist if you are not sure.
Če ste negotovi, se posvetujte z zdravnikom ali farmacevtom.
However, there are insufficient data available to make a dose recommendation for this patient group (see section 4.4).
Pri tem so opažali zmanjšan očistek topotekana, vendar ni na voljo dovolj podatkov, da bi lahko oblikovali priporočila za odmerjanje za to skupino bolnikov (glejte poglavje 4.4).
The recommended dose of topotecan is 0.75 mg/m2/day administered as a 30-minute intravenous infusion on days 1, 2 and 3.
Priporočeni odmerek topotekana je 0,75 mg/m2/dan.
There is little or no accumulation of topotecan with repeated daily dosing and there is no evidence of a change in pharmacokinetics after multiple doses.
Prav tako ni znakov, da bi se farmakokinetika spremenila po večkratnem odmerjanju.
• Mouth sores, difficulty swallowing, abdominal pain, nausea, vomiting, diarrhoea, bloody stools
• razjede v ustih, oteženo požiranje, bolečine v trebuhu, občutek slabosti, bruhanje, driska, kri v blatu (to so lahko znaki in simptomi vnetja sluznice v ustih, želodcu in/ali črevesu [vnetje sluznic])
These may affect up to 1 in 10 people treated with Hycamtin:
Pojavijo se lahko pri največ 1 od 10 bolnikov, ki se zdravijo z zdravilom Hycamtin:
Plasma clearance in patients with renal impairment (creatinine clearance 41-60 ml/min.)
Plazemski očistek pri bolnikih z ledvično okvaro (očistek kreatinina 41 60 ml/min) se je v primerjavi s kontrolno skupino zmanjšal na približno 67 %.
ITT population Cisplatin 50 mg/m on day 1, every 21 days
Vključene bolnice (ITT populacija) cisplatin 50 mg/m na
Do not breast-feed if you are being treated with Hycamtin.
Če se zdravite z zdravilom Hycamtin, ne smete dojiti.
Anhydrous ethanol - see leaflet for further information Propylene glycol
Črno barvilo črni železov oksid (E172) šelak brezvodni etanol - za dodatne informacije glejte navodilo propilenglikol izopropilalkohol butanol koncentrirana raztopina amoniaka kalijev hidroksid
Should diarrhoea occur during treatment with oral topotecan, physicians are advised to aggressively manage diarrhoea.
Če se pojavi med zdravljenjem s peroralnim topotekanom,
This summary was last updated in April 2017.
Povzetek je bil nazadnje posodobljen aprila 2017.
When used before an operation it is given at least 3 hours before the operation and treatment may be continued for up to one week.
Kadar se uporablja pred kirurškim posegom, se daje najmanj tri ure pred njim, zdravljenje pa se lahko nadaljuje do največ enega tedna.
The full EPAR for Quadrisol can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Quadrisol je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
The amount of gel given in each dose is adjusted depending on the weight of the animal.
Količina gela v vsakem odmerku se prilagodi glede na telesno maso živali.
The European Commission granted a marketing authorisation valid throughout the EU for Quadrisol on 4 December 1997.
Evropska komisija je dovoljenje za promet z zdravilom Quadrisol, veljavno po vsej Evropski uniji, izdala 4. decembra 1997.
This is a summary of the European public assessment report (EPAR) for Quadrisol.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Quadrisol.
The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Quadrisol's benefits are greater than its risks and recommended that it be approved for use in the EU.
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) pri agenciji je zaključil, da so koristi zdravila Quadrisol večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
For the full list of restrictions, see the package leaflet.
Za celoten seznam omejitev glejte navodilo za uporabo.
In horses, skin rashes (urticaria) have been reported.
Pri konjih so poročali tudi o kožnih izpuščajih (urtikariji).
Quadrisol has been studied in both laboratory and field studies.
Zdravilo Quadrisol je bilo proučevano v laboratorijskih in terenskih študijah.
Quadrisol, available as an oral (mouth) gel, is given twice daily before feeding for a maximum of two weeks.
Zdravilo Quadrisol je na voljo kot peroralni gel in se daje dvakrat na dan pred hranjenjem največ dva tedna.
It is not intended to provide practical advice on how to use Quadrisol.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
The withdrawal period for meat from horses treated with Quadrisol is 12 days.
Karenca za meso konj, zdravljenih z zdravilom Quadrisol, je 12 dni.
It contains the active substance vedaprofen.
Vsebuje zdravilno učinkovino vedaprofen.
Side effects are generally reversible once the medicine is stopped.
Neželeni učinki v splošnem izginejo po prenehanju dajanja zdravila.
As prostaglandins are substances that trigger inflammation, pain, and fever, vedaprofen reduces these signs of injury.
Ker so prostaglandini snovi, ki povzročajo vnetje, bolečino in povišano telesno temperaturo, vedaprofen zmanjšuje te znake poškodbe.
What are the risks associated with Quadrisol?
Kakšna tveganja so povezana z zdravilom Quadrisol?
The medicine is not authorised for use in horses producing milk for human consumption.
Zdravilo ni odobreno za uporabo pri konjih, katerih mleko je namenjeno prehrani ljudi.
It must not be given to foals aged less than six months or to mares producing milk.
Ne sme se dajati žrebetom do šestega meseca starosti ali kobilam, ki dajejo mleko.
Vedaprofen blocks an enzyme called cyclooxygenase which is involved in the production of prostaglandins.
Zavira encim, imenovan ciklooksigenaza, ki sodeluje pri tvorjenju prostaglandinov.
Quadrisol contains vedaprofen, which belongs to a class of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).
Zdravilo Quadrisol vsebuje vedaprofen, ki spada v skupino zdravil, imenovanih nesteroidna protivnetna zdravila (NSAID).
Other information about Quadrisol:
Druge informacije o zdravilu Quadrisol
Quadrisol oral gel improved lameness and soft tissue injuries in horses and the response to treatment with Quadrisol was similar to the response to either flunixine meglumine or phenylbutazone, which are other NSAIDs used to treat these conditions.
Zdravilo Quadrisol peroralni gel je pri konjih izboljšalo šepavost in poškodbe mehkega tkiva, odziv na zdravljenje z zdravilom Quadrisol pa je bil podoben odzivu na fluniksin meglumin ali fenilbutazon, ki sta drugi zdravili iz skupine NSAID za zdravljenje teh stanj.
Quadrisol can also be used to relieve pain and reduce inflammation after an operation.
Lahko se uporablja tudi za lajšanje bolečine in zmanjšanje vnetja po kirurškem posegu.
Why is Quadrisol approved?
Zakaj je bilo zdravilo Quadrisol odobreno?
What is Quadrisol and what is it used for?
Kaj je zdravilo Quadrisol in za kaj se uporablja?
What benefits of Quadrisol have been shown in studies?
Kakšne koristi je zdravilo Quadrisol izkazalo v študijah?
It is also the time required after administration of a medicine before milk may be used for human consumption.
Pomeni tudi čas, ki mora preteči po dajanju zdravila, preden se lahko mleko uporabi za prehrano ljudi.
For practical information about using Quadrisol, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Za praktične informacije o uporabi zdravila Quadrisol naj lastniki ali skrbniki živali preberejo navodilo za uporabo ali se posvetujejo z veterinarjem ali farmacevtom.
For more information about treatment with Quadrisol, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Za več informacij o zdravljenju z zdravilom Quadrisol naj lastniki ali skrbniki živali preberejo navodilo za uporabo ali se posvetujejo z veterinarjem ali farmacevtom.
Quadrisol must not be given to horses with stomach and gut disorders or to horses with reduced heart, liver and kidney function.
Zdravilo Quadrisol se ne sme dajati konjem, ki imajo obolenja želodca ali črevesja ali konjem z oslabljenim delovanjem srca, jeter in ledvic.
The side effects of Quadrisol are typical for those seen with other medicines from this product class (NSAIDs) such as lethargy or damage to (lesions) the mouth, stomach, intestines (including soft stools or diarrhoea) and kidneys.
Neželeni učinki, opaženi pri zdravilu Quadrisol, so značilni za zdravila iz te skupine (NSAID), kot so letargija ali poškodbe (lezije) ust, želodca, črevesja (vključno z mehkim blatom ali drisko) in ledvic.
This included studies in a large number of horses with bone, muscle and other soft tissue and joint problems.
Vanje je bilo vključenih veliko število konjev s kostnimi in mišičnimi težavami ter težavami z mehkim tkivom in sklepi.
Quadrisol is a veterinary medicine used in horses to relieve pain and reduce inflammation due to injury to the muscle, bones and joints as well as to other non-bony areas of the body (so called soft tissue lesions).
Zdravilo Quadrisol je zdravilo za uporabo v veterinarski medicini, ki se uporablja pri konjih za lajšanje bolečine in zmanjšanje vnetja zaradi poškodb mišic, kosti in sklepov, kot tudi nekostnih delov telesa (tj. poškodb mehkega tkiva).
How does Quadrisol work?
Kako zdravilo Quadrisol deluje?
How is Quadrisol used?
Kako se zdravilo Quadrisol uporablja?
The medicine can only be obtained with a prescription For further information, see the package leaflet.
Predpisovanje in izdaja zdravila je le na recept.
Unpublished internal report.
Neobjavljeno interno poročilo.
o Is not favourable in all other currently approved indications.
o ni ugodno za vse druge trenutno odobrene indikacije,
However it is important that this be confirmed in an appropriate pharmacokinetic study.
Vendar pa je pomembno, da se to potrdi v ustrezni farmakokinetični študiji.
However new cases of cardiotoxicity continued to be reported.
Kljub temu so še naprej poročali o novih primerih kardiotoksičnosti.
CMDh position
Stališče skupine CMDh
Domperidone is commonly used across Europe since 1970s when it was first time authorized via national procedures.
Domperidon se pogosto uporablja v Evropi od 70. let prejšnjega stoletja, ko so ga prvič odobrili po nacionalnih postopkih.
Therefore some of the high dose formulations can no longer be recommended.
Nekatere visokoodmerne farmacevtske oblike zato niso več priporočene;
Therefore, in accordance with Article 116 of Directive 2001/83/EC, the PRAC recommends:
Zato odbor PRAC skladno s členom 116 Direktive 2001/83/ES priporoča:
As a consequence, the intravenous formulation was withdrawn worldwide.
Posledično so intravensko obliko zdravila umaknili s trgov po vsem svetu.
• Nausea and vomiting of functional, organic, infectious or dietetic origin
• slabost in bruhanje funkcionalnega, organskega, infekcijskega ali prehranskega izvora;
However, it is not expected that the mechanism of action will differ between adults and children, and there is in some Member States long-lasting clinical experience with this product in children.
Kljub temu ni pričakovati, da bi bil mehanizem delovanja pri otrocih drugačen kot pri odraslih, poleg tega pa v nekaterih državah članicah beležijo dolgoletne klinične izkušnje s tem zdravilom pri otrocih.
these circumstances patients should not be exposed to the additional risk associated to a combination product.
V teh okoliščinah bolniki ne bi smeli biti izpostavljeni dodatnemu tveganju, ki je povezano s kombiniranim zdravilom.
The CMDh agreed to:
Skupina CMDh se je strinjala, da:
Minor amendments were also introduced in the Product Information for clarity.
Manjše spremembe so zaradi jasnosti vključili tudi v informacije o zdravilu.
Overall summary of the scientific evaluation by PRAC
Splošni povzetek znanstvenega vrednotenja odbora PRAC
• radiotherapy or drug therapy
• radioterapija ali zdravljenje z zdravili,
• dopamine agonists (such as L-dopa and bromocriptine) used in the treatment of Parkinson's disease
• dopaminski agonisti (kot sta na primer L-dopa in bromokriptin), ki se uporabljajo za zdravljenje Parkinsonove bolezni.
• The revocation of the marketing authorisations for:
• odvzem dovoljenj za promet z zdravilom za:
1 - PRAC recommendation
1 - Priporočilo odbora PRAC
Having reviewed the PRAC recommendation, the CMDh agreed with the overall scientific conclusions and grounds for recommendation.
Potem ko je skupina CMDh pregledala priporočilo odbora PRAC, se je strinjala s splošnimi znanstvenimi zaključki in podlago za priporočilo.