natgillin/translations-raw huggingface dataset:
On 17 June 2008, Euro Nippon Kayaku GmbH officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Spanidin, for the induction of remission in adult patients suffering from clinically refractory Wegener's granulomatosis.
Družba Euro Nippon Kayaku GmbH je dne 17. junija 2008 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za dovoljenje za promet z zdravilom Spanidin, namenjenim indukciji remisije pri odraslih bolnikih s klinično refraktarno Wegenerjevo granulomatozo.
What are the consequences of the withdrawal for patients undergoing clinical trials or compassionate use programmes with Spanidin?
Kakšne so posledice umika za bolnike, ki sodelujejo v kliničnih preskušanjih ali programih sočutne uporabe zdravila Spanidin?
What were the reasons given by the company to withdraw the application?
Kakšni so bili razlogi družbe za umik vloge?
Once the company has supplied responses to the questions, the CHMP reviews them and may, before giving an opinion, ask any remaining questions at day 180.
Ko družba predloži odgovore na vprašanja, jih CHMP pregleda in lahko pred izdajo svojega mnenja na 180. dan postopka zastavi morebitna druga vprašanja.
In this disease, the immune system attacks neutrophils (a type of white blood cell), causing inflammation of small and medium-sized blood vessels and the formation of granulomas (clumps of white blood cells).
Pri tej bolezni imunski sistem napade nevtrofilce (vrsto belih krvnih celic), kar povzroči vnetje majhnih in srednje velikih krvnih žil in nastajanje granulomov (skupkov belih krvnih celic).
What was Spanidin expected to be used for?
Za kaj naj bi se zdravilo Spanidin uporabljalo?
The CHMP was also concerned that the study included some patients for whom induction treatment was not necessary, and others who did not have the symptoms of ‘classic' Wegener's granulomatosis affecting the airways, lungs or kidneys.
CHMP je imel zadržke tudi glede dejstva, da je študija vključevala nekaj bolnikov, pri katerih indukcijsko zdravljenje ni bilo potrebno, in nekatere bolnike brez simptomov „klasične“ Wegenerjeve granulomatoze, ki prizadene dihalne poti, pljuča ali ledvice.
Spanidin is a powder that is made up into a solution for injection.
Zdravilo Spanidin je prašek za pripravo raztopine za injiciranje.
Wegener's granulomatosis is a rare, auto-immune disease (a disease which is caused by the body's own defence system attacking normal tissue).
Wegenerjeva granulomatoza je redka avtoimunska bolezen (bolezen, pri kateri obrambni sistem napade normalno tkivo lastnega telesa).
This study would need to involve patients who are truly refractory to other treatments, or it would need to compare Spanidin directly with cyclophosphamide (the standard treatment for inducing remission in Wegener's granulomatosis).
Taka študija bo morala zajeti bolnike, ki so resnično neodzivni na ostala zdravljenja, ali pa bo morala primerjati zdravilo Spanidin neposredno s ciklofosfamidom (standardnim zdravljenjem za indukcijo remisije pri Wegenerjevi granulomatozi).
Spanidin was expected to be used to control the symptoms of Wegener's granulomatosis in patients who were not responding to other treatments.
Zdravilo Spanidin bi se naj uporabljalo za nadzor nad simptomi Wegenerjeve granulomatoze pri bolnikih, ki se niso odzvali na druga zdravljenja.
How is Spanidin expected to work?
Kako naj bi zdravilo Spanidin delovalo?
Based on the review of the data and the company's response to the CHMP list of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Spanidin could not have been approved for the induction of remission in adult patients suffering from clinically refractory Wegener's granulomatosis.
Na podlagi pregleda podatkov in odgovorov družbe na seznam vprašanj, ki jih je do umika vloge zastavil CHMP, je Odbor izrazil določene zadržke in je začasno menil, da zdravila Spanidin ni mogoče odobriti za indukcijo remisije pri odraslih bolnikih s klinično refraktarno Wegenerjevo granulomatozo.
The active substance in Spanidin, gusperimus, is an immunosuppressive medicine, which means that it reduces the activity of the immune system (the body's natural defences).
Zdravilna učinkovina v zdravilu Spanidin, gusperimus, je imunosupresivno zdravilo, kar pomeni, da zavira delovanje imunskega sistema (naravne obrambe telesa).
The application was at day 194 when the company withdrew.
Družba je vlogo umaknila na 194. dan postopka.
Spanidin has been studied in one main study involving 45 patients with Wegener's granulomatosis who were ‘refractory' (not responding) to standard treatment.
Zdravilo Spanidin so preučevali v eni glavni študiji, ki je vključevala 45 bolnikov z Wegenerjevo granulomatozo, ki so bili „refraktarni“ (neodzivni) na standardno zdravljenje.
They received Spanidin for six ‘cycles', with each cycle consisting of three weeks ‘on' treatment followed by one week ‘off'.
Zdravilo Spanidin so prejemali v šestih ciklusih, pri čemer je vsak ciklus obsegal tri tedne prejemanja zdravila, ki mu je sledil en teden brez dajanja zdravila.
Therefore, at the time of the withdrawal, the CHMP was of the opinion that a benefit of Spanidin had not been sufficiently demonstrated and any benefits did not outweigh the identified risks.
CHMP je zato v času umika menil, da koristi zdravila Spanidin niso bile zadostno dokazane in da ne odtehtajo znanih tveganj.
The company informed the CHMP that there are no consequences for patients currently included in clinical trials or compassionate use programmes with Spanidin.
Družba je obvestila CHMP, da umik nima nobenih posledic za bolnike, ki trenutno sodelujejo v kliničnih preskušanjih ali programih sočutne uporabe zdravila Spanidin.
It is expected to work in Wegener's granulomatosis by disrupting the growth and activity of white blood cells called lymphocytes, which are involved in the inflammation process.
Pri Wegenerjevi granulomatozi bi naj delovala tako, da bi zavirala rast in aktivnost belih krvnih celic, imenovanih limfociti, ki sodelujejo v vnetnem procesu.
Spanidin was not compared with any other treatment in this study, but the patients could take corticosteroids (a group of immunosuppressive medicines) in addition to Spanidin.
V tej študiji zdravila Spanidin niso primerjali z nobenim drugim zdravilom, so pa bolniki lahko kot dodatek k zdravilu Spanidin jemali kortikosteroide (skupina imunosupresivnih zdravil).
By reducing the number of lymphocytes and interfering with the way they work, Spanidin is expected to reduce the inflammation in the blood vessels that causes the symptoms of the disease.
Zdravilo Spanidin bi naj z zmanjšanjem števila limfocitov in oviranjem njihovega delovanja zmanjšalo vnetje v krvnih žilah, ki povzroča simptome te bolezni.
24 June 2016
24. junij 2016
• bad taste in your mouth
• slab okus v ustih
Reconstitution time is less than 2 minutes.
Priprava traja manj kot 2 minuti.
Each vial is for single use only.
Vsaka viala je samo za enkratno uporabo.
This reaction may be life-threatening.
Ta reakcija je lahko smrtno nevarna.
A risk to newborns/infants cannot be excluded.
Tveganja za novorojenčke/dojenčke ni mogoče izključiti.
A course of treatment usually lasts from 5 to up to 14 days, depending on the type of infection you have and how you respond to treatment.
Zdravljenje po navadi traja od 5 do 14 dni, odvisno od vrste okužbe, ki jo imate, in vašega odziva na zdravilo.
It can kill many types of bacteria.
Uniči lahko številne vrste bakterij.
Overall, the safety profile in these 61 children was similar to that observed in the adult population with cIAI.
Na splošno je bil varnostni profil pri teh 61 otrocih podoben kot pri odrasli populaciji s cIAI.
This test looks for antibodies that fight against your red blood cells.
Ta preiskava ugotavlja protitelesa, ki delujejo proti vašim lastnim rdečim krvnim celicam.
Elderly patients (≥65 years)
Starejši (≥ 65 let)
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.
Če ni uporabljeno takoj, so čas shranjevanja med uporabo in pogoji pred uporabo odgovornost uporabnika.
Currently available data are described in section 4.8 but no recommendation on a posology can be made.
Trenutno razpoložljivi podatki so opisani v poglavju 4.8, vendar priporočil o odmerjanju ni mogoče dati.
The reconstituted vial should be used immediately.
Rekonstituirano vialo je treba uporabiti takoj.
This is because it is not known if the medicine is safe to use in these age groups.
Ni namreč znano, ali je uporaba tega zdravila v teh starostnih skupinah varna.
From a microbiological point of view, the medicinal product should be used immediately.
Z mikrobiološkega stališča je treba zdravilo uporabiti takoj.
Paediatric population Safety and efficacy in children and adolescents below 18 years of age have not yet been established.
Pediatrična populacija Varnost in učinkovitost pri otrocih in mladostnikih do 18. leta starosti še nista ugotovljeni.
It allows continued monitoring of the benefit/risk balance of the medicinal product.
Omogoča namreč stalno spremljanje razmerja med koristjo in tveganjem zdravila.
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Upoštevati je treba uradne smernice za ustrezno uporabo antibiotikov.
If this happens do not take medicines that stop or slow bowel movement.
Če se to zgodi, ne jemljite zdravil, ki ustavijo ali upočasnijo gibanje črevesa.
• severe allergic reaction (see Serious side effects, above)
• huda alergijska reakcija (glejte Resni neželeni učinki, zgoraj)
Do not use this medicine after the expiry date which is stated on the container.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na vsebniku.
Zavicefta than you should)
Zavicefta, kot bi smeli).
The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of European Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines webportal.
Zahteve glede predložitve rednega posodobljenega poročila o varnosti zdravila za to zdravilo so določene v seznamu referenčnih datumov EU (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES, in vseh kasnejših posodobitvah, objavljenih na evropskem spletnem portalu o zdravilih.
Zavicefta should not be used in children and adolescents .
Zdravila Zavicefta se ne sme uporabljati pri otrocih in mladostnikih.
• swelling under the skin, particularly lips and around the eyes
• oteklost pod kožo, zlasti na ustnicah in okrog oči.
Duration of treatment
Trajanje zdravljenja
• infections caused by bacteria that other antibiotics may not be able to kill
• okužb z bakterijami, ki jih drugi antibiotiki morda ne morejo uničiti.
The marketing authorisation holder shall submit the first periodic safety update report for this product within 6 months following authorisation.
Imetnik dovoljenja za promet z zdravilom mora prvo redno posodobljeno poročilo o varnosti zdravila za to zdravilo predložiti v 6 mesecih po pridobitvi dovoljenja za promet.
Clinical efficacy against specific pathogens
Klinična učinkovitost proti specifičnim patogenom
Other infections
Druge okužbe
The total time interval between starting reconstitution and completing preparation of the intravenous infusion should not exceed 30 minutes.
Celotni čas med začetkom priprave in koncem priprave intravenske infuzije ne sme preseči 30 minut.
It is possible that this could cause anaemia (which may make you feel tired) and jaundice (yellowing of the skin and eyes)
Obstaja verjetnost, da to povzroči anemijo (zaradi katere lahko občutite utrujenost) in zlatenico (porumenelost kože in oči).
Very rare: (may affect up to 1 in 10,000 people) • swelling in a part of the kidney that causes a reduction in its normal working function
Zelo redki: (pojavijo se lahko pri največ 1 od 10.000 bolnikov) • oteklost v delu ledvice, ki zmanjša njeno normalno delovanje
It is available in packs containing 10 vials.
Na voljo je v pakiranjih, ki vsebujejo 10 vial.
In some patients, the creatinine clearance estimated from serum creatinine can change quickly, especially early in the course of treatment for the infection.
Nekaterim bolnikom se lahko očistek kreatinina, ocenjen iz serumskega kreatinina, hitro spremeni, zlasti zgodaj v poteku zdravljenja okužbe.
Store in the original package in order to protect from light.
Shranjujte v originalni ovojnini za zagotovitev zaščite pred svetlobo.
The safety assessment in children is based on the safety data from 1 trial in which 61 paediatric patients aged from 3 years to less than 18 years with cIAI received Zavicefta.
Ocena varnosti pri otrocih temelji na podatkih o varnosti iz 1 preskušanja, v katerem je 61 pediatričnih bolnikov s cIAI, starih od 3 let do manj kot 18 let, prejemalo zdravilo Zavicefta.
What is in this leaflet:
Kaj vsebuje navodilo:
shown in blood tests
pokaže se na preiskavah krvi
Limitations of the clinical data
Omejitve kliničnih podatkov
The maximum recommended daily dose of this medicinal product contains 444 mg sodium (found in table salt).
Največji priporočeni dnevni odmerek tega zdravila vsebuje 444 mg natrija (ki ga najdemo v kuhinjski soli).
Antibacterial activity in combination with other antibacterial agents
Protibakterijsko delovanje v kombinaciji z drugimi protibakterijskimi zdravili
From a microbiological point of view, the medicinal product should be used immediately unless reconstitution and dilution has taken place in controlled and validated aseptic conditions.
Z mikrobiološkega stališča je treba zdravilo uporabiti takoj, razen če sta bila priprava in redčenje opravljena v nadzorovanih in preverjenih aseptičnih pogojih.
The clinical relevance of this finding is unknown, but due to the possibility of antagonism in vivo this drug combination should be avoided.
Klinični pomen tega ni znan, a zaradi možnega antagonizma in vivo se je treba tej kombinaciji zdravil izogibati.
This may affect you being able to drive, use tools or machines.
To lahko neugodno vpliva na vašo sposobnost upravljanja vozil, orodij in strojev.
In case of hypersensitivity reactions, treatment with Zavicefta must be discontinued immediately and adequate emergency measures must be initiated.
V primeru preobčutljivostnih reakcij je treba zdravljenje z zdravilom Zavicefta nemudoma prekiniti in uvesti ustrezne nujne ukrepe.
• severe allergic reactions - signs include sudden swelling of your lips, face, throat or tongue, a severe rash or other severe skin reactions, difficulty swallowing or breathing.
• Hude alergijske reakcije - med znaki so nenadna oteklost ustnic, obraza, žrela ali jezika, hud izpuščaj ali druge hude kožne reakcije, težko požiranje ali težko dihanje.
The powder must be reconstituted with water for injections and the resulting concentrate must then be immediately diluted prior to use.
Prašek je treba pripraviti z vodo za injekcije, nastali koncentrat pa nato takoj razredčiti pred uporabo.
Not known: (frequency cannot be estimated from the available data)
Neznana pogostnost: (ni mogoče oceniti iz razpoložljivih podatkov)
Patients with CrCL 30 to 50 mL/min received a lower dose of Zavicefta than is currently recommended for patients in this sub-group.
Bolniki z ledvičnim očistkom (CrCL) 30 do 50 ml/min so prejeli nižji odmerek zdravila Zavicefta kot je trenutno priporočeno pri bolnikih v tej podskupini.
Adverse reactions are classified according to frequency and System Organ Class.
Neželeni učinki so razvrščeni po pogostnosti in organskem sistemu.
Unknown (cannot be estimated from the available data)
Neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov)
Transfer the entire contents (approximately 12.0 mL) of the resultant solution to an infusion bag immediately.
Celotno količino (približno 12,0 ml) nastale raztopine takoj prenesite v infuzijsko vrečko.
• you have kidney problems - your doctor may give you a lower dose to make sure you don't get too much medicine.
• če imate težave z ledvicami - vam bo zdravnik lahko predpisal nižji odmerek zdravila, da bo prepričan, da ne prejmete prevelikega odmerka zdravila.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine.
Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom, preden dobite to zdravilo.
The compatibility of Zavicefta with other medicines has not been established.
Kompatibilnost zdravila Zavicefta z drugimi zdravili ni ugotovljena.
Alternatively they are stable for up to 24 hours under refrigerated storage.
Do 24 ur so stabilne tudi, če so shranjene v hladilniku.
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 - 8ºC, unless reconstitution/dilution has taken place in controlled and validated aseptic conditions.
Če ni uporabljeno takoj, so čas in pogoji shranjevanja pred uporabo odgovornost uporabnika; čas običajno ne sme presegati 24 ur na temperaturi od 2 do 8 °C, razen če sta priprava in redčenje opravljena v nadzorovanih in preverjenih aseptičnih pogojih.
This could cause symptoms such as fits (see section If you use more
To bi lahko povzročilo simptome, kot so napadi, podobni epileptičnim (glejte poglavje Če ste uporabili večji odmerek zdravila
Frequency categories are derived from adverse reactions and/or potentially clinically significant laboratory abnormalities, and are defined according to the following conventions:
Kategorije pogostnosti so oblikovane na podlagi neželenih učinkov in/ali potencialno klinično pomembnih laboratorijskih nepravilnosti ter so opredeljene po naslednjem dogovoru:
Zavicefta can also affect the results of some urine tests for sugar.
Zdravilo Zavicefta lahko vpliva tudi na rezultate nekaterih preiskav za sladkor v urinu.
Patients with limited treatment options
Bolniki z omejenimi možnostmi zdravljenja
Studies have shown that Zavicefta solutions for infusion are stable for up to 12 hours at room temperature.
Študije so pokazale, da so raztopine za infundiranje Zavicefta na sobni temperaturi stabilne do 12 ur.
The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing authorisation and any agreed subsequent updates of the RMP.
Imetnik dovoljenja za promet z zdravilom bo izvedel zahtevane farmakovigilančne aktivnosti in ukrepe, podrobno opisane v sprejetem RMP, predloženem v modulu 1.8.2 dovoljenja za promet z zdravilom, in vseh nadaljnjih sprejetih posodobitvah RMP.
These show how well your kidneys are working.
kako dobro vam delujejo ledvice
If you have kidney problems your doctor may lower your dose.
Če imate težave z ledvicami, vam bo zdravnik morda zmanjšal odmerek.
Volume of diluent to be added (mL)
Količina vehikla, ki jo je treba dodati (ml)
Serious and occasionally fatal hypersensitivity reactions are possible (see sections 4.3 and 4.8).
Možne so resne preobčutljivostne reakcije, občasno s smrtnim izidom (glejte poglavji 4.3 in 4.8).
• you are allergic to ceftazidime, avibactam or any of the other ingredients of this medicine (listed in section 6)
• če ste alergični na ceftazidim, avibaktam ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
Once removed from refrigeration to room temperature, the diluted product must be used within 12 hours.
Ko je razredčeno zdravilo enkrat vzeto iz hladilnika in dano na sobno temperaturo, ga je treba uporabiti v 12 urah.
Clinical efficacy and safety studies of Zavicefta have been conducted in cIAI, cUTI and HAP (including VAP).
Klinične študije učinkovitosti in varnosti zdravila Zavicefta so izvedli le pri cIAI, cUTI in HAP (vključno z VAP).
Medicinal products that inhibit peristalsis should not be given.
Zdravil, ki zavirajo peristaltiko, se ne sme uporabljati.
Any unused product or waste material should be disposed of in accordance with local requirements.
Neuporabljeno zdravilo ali odpadni material zavrzite v skladu z lokalnimi predpisi.
Contains sodium carbonate - see package leaflet for further details.
Vsebuje natrijev karbonat - za dodatne podrobnosti glejte navodilo za uporabo.
Ceftazidime/avibactam should only be used during pregnancy if the potential benefit outweighs the possible risk.
Kombinacijo ceftazidima in avibaktama se sme med nosečnostjo uporabiti le, če morebitne koristi pretehtajo možno tveganje.
Uncommon Very rare
Zelo redki Neznana pogostnost
This is equivalent to 22.2% of the adult recommended maximum daily dietary intake for sodium.
To ustreza 22,2 % priporočenega največjega dnevnega vnosa natrija s hrano za odrasle osebe.
Other types of interaction
Druge vrste medsebojnih delovanj
Plasma exposure levels at maternal and foetal NOAEL (100 mg/kg/day) indicate moderate to low margins of safety.
Plazemska koncentracija ob NOAEL za mater in plod (100 mg/kg/dan) kaže zmerno do nizko mejo varnosti.
Mix gently to reconstitute and check to see that the contents have dissolved completely.
Za pripravo previdno premešajte in se prepričajte, ali se je celotna vsebina povsem raztopila.
It is given as a drip into a vein - this will take about 2 hours.
Zdravilo se daje kot infuzija v veno; infundiranje traja približno 2 uri.
In seven Phase 2 and Phase 3 clinical trials, 2024 adult patients were treated with Zavicefta.
V sedmih kliničnih preskušanjih 2. in 3. faze so z zdravilom Zavicefta zdravili 2024 odraslih bolnikov.
In patients with renal impairment, close monitoring of estimated creatinine clearance is advised.
Pri bolnikih z okvaro ledvic je priporočljivo natančno spremljati ocenjeni očistek kreatinina.
5-10 days
5-10 dni
Instructions for the reconstitution of Zavicefta vial are summarized below:
Navodila za pripravo viale zdravila Zavicefta so povzeta spodaj:
The most common adverse reactions occurring in ≥ 5% of patients treated with Zavicefta were Coombs direct test positive, nausea, and diarrhoea.
Najpogostejši neželeni učinki, ki so se pojavili pri ≥ 5 % bolnikov, zdravljenih z zdravilom Zavicefta, so bili pozitiven direktni Coombsov test, navzea in driska.
The chemical and physical in-use stability has been demonstrated for up to 24 hours at 2 - 8°C, followed by up to 12 hours at not more than 25
Kemična in fizikalna stabilnost med uporabo sta dokazani do 24 ur pri temperaturi od 2 do 8 °C in nato do 12 ur pri največ 25°C.
A 100 mL infusion bag can be used to prepare the infusion, based on the patient's volume requirements.
Za pripravo infuzije je mogoče uporabiti 100-ml infuzijsko vrečko glede na količino, ki jo potrebuje bolnik.
7-14 days
7-14 dni
In two studies in patients with cIAI, the most common diagnosis (approximately 42%) was appendiceal perforation or peri-appendiceal abscess.
V dveh študijah pri bolnikih s cIAI je bila najpogostejša diagnoza (približno 42 %) predrtje slepiča ali periapendikalni absces.
Hospital-acquired pneumonia, including VAP
Bolnišnična pljučnica, vključno z VAP
During a 4-hour haemodialysis period, 55% of the avibactam dose was removed.
Štiriurna hemodializa je odstranila 55 % odmerka avibaktama.
Zavicefta will be given to you by a doctor or a nurse.
Zdravilo Zavicefta vam bo dal zdravnik ali medicinska sestra.
Before beginning treatment, it should be established whether the patient has a history of hypersensitivity reactions to ceftazidime, to other cephalosporins or to any other type of β-lactam antibacterial agent.
Pred začetkom zdravljenja je treba ugotoviti, ali ima bolnik anamnezo preobčutljivostne reakcije na ceftazidim, kakšen drug cefalosporin ali katero koli drugo vrsto betalaktamskih antibiotikov.
A decision must be made whether to discontinue breast feeding or to discontinue/abstain from ceftazidime/avibactam therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.
Odločiti se je treba bodisi za prenehanje dojenja bodisi za prekinitev/prenehanje zdravljenja s kombinacijo ceftazidima in avibaktama, upoštevaje korist dojenja za otroka in korist zdravljenja za žensko.