natgillin/translations-raw huggingface dataset:
LeukoScan is a sterile, lyophilised formulation, containing 0.31 mg of sulesomab per vial and includes 0.22 mg stannous chloride dihydrate, 3.2 mg potassium sodium tartrate tetrahydrate, 7.4 mg sodium acetate trihydrate, 5.5 mg sodium chloride, glacial acetic acid (trace), hydrochloric acid (trace), 37.8 mg sucrose, nitrogen (vacuum).
LeukoScan je sterilen, liofiliziran pripravek, ki v posamezni viali vsebuje 0,31 mg sulezomaba in vključuje 0,22 mg kositrovega klorida dihidrata, 3,2 mg kalijevega natrijevega tartrata tetrahidrata, 7,4 mg natrijevega acetata trihidrata, 5,5 mg natrijevega klorida, koncentrirano ocetno kislino (v sledovih), klorovodikovo kislino (v sledovih), 37,8 mg saharoze, dušik (vakuum).
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell
Če katerikoli neželeni učinek postane resen ali če opazite katerikoli neželeni učinek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika.
Any unused product or waste material should be disposed of in accordance with local requirements.
Vsa neporabljena količina zdravila ali odpadni material morata biti odstranjena v skladu z lokalnimi predpisi.
* Effective Dose Equivalent and Effective Dose are in units of µSv/MBq.
povprečna doza μGy/MBq ekvivalent efektivne doze efektivna doza * Ekvivalent efektivne doze in efektivna doza sta izražena v enotah µSv/MBq.
Method and/or route(s) of administration
Postopek in/ali pot(i) uporabe zdravila
In clinical trials, single doses of 1.0 mg of LeukoScan radiolabelled with 900 ± 200 MBq of 99mTc were administered to 11 patients with various types of infection and there were no adverse reactions at this
V kliničnih študijah so bile posamezne doze 1,0 mg zdravila LeukoScan, ki je bil radiološko označen z 900 ± 200 MBq 99mTc, aplicirane 11 bolnikom z različnimi tipi infekcij in pri teh odmerkih niso opazili neželenih
LeukoScan has not been employed to diagnose osteomyelitis in patients with sickle cell anaemia.
Zdravilo LeukoScan ni bilo uporabljeno za diagnosticiranje osteomielitisa pri bolnikih s srpasto celično
SPECIAL STORAGE CONDITIONS Store in a refrigerator (2ºC-8ºC).
POSEBNA NAVODILA ZA SHRANJEVANJE Shranjujte v hladilniku (2 °C - 8 °C).
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS (VIAL LABEL)
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH (VIALA)
Radiopharmaceuticals should be prepared by the user in a manner which satisfies both radiation safety and pharmaceutical quality requirements.
Radiofarmake je potrebno pripraviti na način, ki bo zadoščal tako zaščiti pred sevanjem kakor tudi farmacevtskim zahtevam po kakovosti.
Following reconstitution, 1 ml sodium pertechnetate [99mTc] is added.
Po rekonstituciji dodamo 1 ml raztopine natrijevega pertehnetata [99mTc].
Radiopharmaceutical agents should be used only by qualified personnel with appropriate government authorisation for the use and manipulation of radionuclides.
Radiofarmake sme uporabljati samo strokovno usposobljeno osebje z ustreznim uradnim pooblastilom za uporabo in ravnanje z radionuklidi.
In a subgroup of patients in whom LeukoScan was compared directly to the currently available 111Inlabelled (occasionally 99mTc-labelled) autologous white blood cell (WBC) scanning test, LeukoScan showed a statistically significant increase in sensitivity over that achieved by WBC scanning (87.7% vs. 72.6%, p = 0.003 by McNemar's Test), with no discernible decrease in specificity as compared to WBC
V podskupini bolnikov, pri katerih je bilo zdravilo LeukoScan neposredno primerjano s trenutno razpoložljivim z 111In označenim (priložnostno z 99mTc označenim) avtolognim presejalnim testom z belimi krvnimi celicami, je zdravilo LeukoScan v primerjavi s presejalnim testom z belimi krvnimi celicami pokazalo statistično pomemben porast občutljivosti (87,7% vs 72,6%, p = 0,003, ob uporabi McNemarovega testa), brez razločnega zmanjšanja specifičnosti v primerjavi s slikanjem z označenimi belimi krvnimi celicami (67,1% vs 69,4%).
The radiolabelled solution should be administered as an intravenous injection.
Z radioaktivnim izotopom označena raztopina mora biti aplicirana v obliki intravenske injekcije.
Following reconstitution, unused radiopharmaceutical and vial should be handled as radioactive waste and disposed of in accordance with local requirements.
Po rekonstituciji morata biti vsa neporabljena količina radiofarmaka in viala tretirana kot radioaktivni odpadek in morata biti odstranjena v skladu z lokalnimi
• Radiopharmaceutical agents should be used only by qualified personnel with appropriate government authorisation for the use and manipulation of radionuclides.
• Radiofarmake sme uporabljati samo strokovno usposobljeno osebje z ustreznim uradnim pooblastilom za uporabo in ravnanje z radionuklidi.
Patients who have previously received murine monoclonal antibody products are more likely to have HAMA.
Pri bolnikih, ki so predhodno že prejemali zdravila, ki vsebujejo glodalska monoklonalna protitelesa, je verjetnost, da bodo razvili HAMA, večja.
• You should not be given LeukoScan if you are pregnant.
• Če ste noseči, ne smete prejeti zdravila LeukoScan.
The imaging agent, technetium-99m LeukoScan [technetium-99m sulesomab] is formed by reconstitution of the contents of the LeukoScan vial with 0.5 mL sodium chloride for injection followed by the addition of 1100 MBq of sodium pertechnetate [99mTc] in 1 mL of Sodium Chloride for Injection.
Sredstvo za prikazovanje, tehnecij-99m LeukoScan (tehnecij-99m sulezomab), nastane pri rekonstituciji vsebine viale zdravila LeukoScan z 0,5 ml raztopine natrijevega klorida za injiciranje, ki ji sledi dodatek 1100 MBq natrijevega pertehnetata [99mTc] v 1 ml raztopine natrijevega klorida za injiciranje.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
• Če katerikoli neželeni učinek postane resen ali če opazite katerikoli neželeni učinek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika.
Each vial contains stannous chloride, sodium chloride, sodium potassium tartrate, sodium acetate, sucrose,
Vsaka viala vsebuje kositrov klorid, natrijev klorid, natrijev kalijev tartrat, natrijev acetat, saharozo, dušik.
Swirl and shake the vial contents gently for 30 seconds to insure dissolution.
30 sekund nežno vrtite in stresajte vialo, da se bo vsebina raztopila.
When a bone scan is negative, imaging with LeukoScan may rarely show a positive response and this may indicate early osteomyelitis.
Če je rentgenski posnetek kosti pozitiven in slikanje z LeukoScanom daje negativen rezultat, infekcija ni Če je rentgenski posnetek kosti negativen, slikanje z LeukoScanom v redkih primerih lahko daje pozitivni odgovor, kar lahko pomeni zgodnjo stopnjo osteomielitisa.
LeukoScan is not expected to bind to leukocytes in patients with paroxysmal nocturnal hemoglobinuria.
Ni pričakovano, da bi se zdravilo LeukoScan vezalo na levkocite bolnikov s paroksizmalno nočno
Due to the short six-hour, half-life of 99mTc, a dose of less than 1 mSv in mother's milk can be expected 24 hours after the administration of LeukoScan [99mTc].
Zaradi kratke razpolovne dobe 99m-Tc, ki znaša 6 ur, se odmerek, ki je manjši od 1 mSv, v materinem mleku lahko pričakuje 24 ur po vnosu zdravila
If the administration is considered necessary, breast feeding should be interrupted and the expressed feeds discarded.
Če je vnos radiofarmaka nujen, je potrebno dojenje prekiniti in mleko zavreči.
One vial prepared so as to contain 0.31 mg lyophilised LeukoScan monoclonal antibody fragment.
Ena viala je pripravljena tako, da vsebuje 0,31 mg liofiliziranih LeucoScan fragmentov monoklonalnih
Hydrochloric Acid (Trace) Sodium Potassium Tartrate, Tetrahydrate Sodium Acetate, Trihydrate
natrijev klorid klorovodikova kislina (sledovi) natrijev acetat trihidrat
After mixing with Tc, the final product must be disposed of as radioactive waste in accordance with local law.
Po mešanju s tehnecijem mora biti končni produkt odstranjen kakor radioaktivni odpadek v skladu z
Pharmacotherapeutic group: Diagnostic Radiopharmaceuticals.
Farmakoterapevtska skupina: Radiofarmaki za diagnostiko oznaka ATC: VO4D
Each 3 ml vial contains 0.31 mg sulesomab (IMMU-MN3 murine Fab′-SH antigranulocyte monoclonal antibody fragments) for the preparation of 99mTc labelled LeukoScan.
Ena 3 ml viala vsebuje 0,31 mg sulezomaba (IMMU-MN3 fragmenti Fab'-SH antigranulocitnih monoklonalnih protiteles glodalcev) za pripravo 99mTc označenega zdravila LeukoScan.
Readministration should only be considered in patients whose sera are negative for human anti-mouse antibody (HAMA) elevation in the fragment assay.
O ponovnem vnosu je mogoče razmisliti le pri bolnikih, katerih preiskava serumskih fragmentov je dala negativen rezultat na človeška protitelesa proti mišjim antigenom (HAMA).
• After use, the container should be disposed of as radioactive waste.
• Po uporabi je potrebno vsebnik zavreči kot radioaktivni odpadek.
The estimated absorbed radiation doses to an average adult patient (70 kg) from an intravenous administration of LeukoScan labeled with 750 MBq of technetium-99m are provided in Table 1.
Ocenjene absorbirane doze sevanja za povprečnega odraslega bolnika (70 kg) po intravenskem vnosu zdravila LeukoScan, označenega s 750 MBq tehnecija-99m so navedene v tabeli 1.
There was essentially no difference in the detection of the presence or absence of osteomyelitis between the 1-2 hour timepoint and the 5-8 hour timepoint after injection.
Če je bila preiskava opravljena 1-2 uri ali pa 5-8 ur po injiciranju, se rezultati zaznavanja prisotnosti oziroma odsotnosti osteomielitisa niso bistveno razlikovali.
PACKAGE LEAFLET: INFORMATION FOR THE USER LeukoScan (0.31 powder for solution for injection) (sulesomab)
NAVODILO ZA UPORABO INFORMACIJA ZA UPORABNIKA LeukoScan (0,31 prašek za raztopino za injiciranje) sulezomaba
LeukoScan is used in patients with suspected infection of the bone called osteomyelitis.
Zdravilo LeukoScan se uporablja pri bolnikih s sumom na vnetje kosti, imenovano osteomielitis.
NAME OF MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION LeukoScan 0.31 mg, powder for solution for injection 0.31 mg lyophilised sulesomab, stannous chloride and stabilizers.
IME ZDRAVILA IN POT(I) UPORABE ZDRAVILA LeukoScan 0,31 mg prašek za raztopino za injiciranje 0,31 mg liofiliziranega sulezomaba, kositrov klorid in stabilizatorji
Store in a refrigerator (2°C-8°C).
Komplet - Shranjujte v hladilniku (2 °C - 8 °C).
In the unlikely event of a radiation overdose being administered with LeukoScan [99mTc], the absorbed dose to the patient may be reduced by increased oral or intravenous intake of fluids to promote excretion
V primeru prevelike doze sevanja, prejete ob vnosu zdravila LeukoScan [99mTc], kar pa ni verjetno, se absorbirana doza lahko zmanjša s povečanim peroralnim ali intravenskim vnosom tekočin, kar pospeši
For diagnostic nuclear medicine investigations, the current evidence suggests that the adverse effects will occur with low frequency because of the low radiation doses incurred.
Zaradi nizkih doz sevanja, ki so jim bolniki izpostavljeni, dosedanji dokazi nakazujejo, da se bodo pri diagnostičnih nuklearnih medicinskih preiskavah neželeni učinki redko pojavljali.
Summary of Normal Organ Dosimetry to an Average Adult Patient (70 kg) from an Intravenous Dose of LeukoScan Labelled with 750 MBq of Technetium-99m [Dose Estimate from 13 Subjects 26 Administrations]
Povzetek doze, ki jo prejmejo normalni organi pri povprečnem odraslem bolniku (70 kg) po intravenskem vnosu zdravila LeukoScan, označenega s 750 MBq tehnecija-99m[ocenjena doza sevanja pridobljena na osnovi 13 oseb in 26 vnosov]
LeukoScan is reconstituted with 0.5 ml isotonic sodium chloride injection.
LeukoScan rekonstituiramo z 0,5 ml izotonične raztopine natrijevega klorida za injiciranje.
In the unlikely event of the administration of a radiation overdose with LeukoScan, the absorbed dose to the patient may be reduced by increased oral or intravenous intake of fluids to promote excretion of the
V primeru prevelike doze sevanja, prejete ob vnosu zdravila LeukoScan, kar pa ni verjetno, se absorbirana doza lahko zmanjša s povečanim peroralnim ali intravenskim vnosom tekočin, kar pospeši izločanje
After radiolabelling the antibody and diluting a 10 µl sample with 1.5 ml saline, immediately determine the radiochemical purity by Instant Thin Layer Chromatography on silica gel impregnated glass fiber strips, 1 × 9 cm using acetone as the solvent.
Po radioaktivni označitvi protitelesa in spiranju 10µl vzorca z 1,5 ml 0,9% raztopine natriejvega klorida za injiciranje takoj določite radiokemijsko čistoto s tenkoplastno kromatografijo hitre izvedbe (ITLCInstant Thin Layer Chromatography) na s silikagelom impregniranih ploščicah iz steklenih vlaken, 1 x 9 cm, topilo je aceton.
4.7 Effects on ability to drive and use machines
4.7 Vpliv na sposobnost vožnje in upravljanja s stroji Študije o vplivu na sposobnost vožnje in upravljanja s stroji niso bile izvedene.
(77.5% vs. 75.8%, respectively).
Diagostična natančnost pa je pri teh dveh pojavnih oblikah enaka (77,5% vs 75,8%).
A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE AND
A. IZDELOVALEC (IZDELOVALCI) BIOLOŠKE ZDRAVILNE UČINKOVINE IN IMETNIK
Radionuclide procedures carried out on pregnant women also involve radiation doses to the foetus.
Vsi postopki, ki vključujejo uporabo radionuklidov in so izvedeni na nosečih ženskah, hkrati pomenijo določeno obsevalno dozo za zarodek.
Image acquisition in analogue and/or digital word-mode and at least a 128 x 128 matrix is recommended.
Priporočljivo je snemanje slike v analognem in/ali digitalnem modusu in z matriko
The recommended adult dose is 0.25 mg of Fab′ fragment labelled with 900 ± 200 MBq of technetium 99mTc pertechnetate (approximately 1.2 ml).
Priporočeni odmerek za odrasle je 0,25 mg Fab' fragmenta, označenega z 900 ± 200 MBq tehnecijevega
6.6 Special precautions for disposal and other handling Read complete directions thoroughly before starting the preparation procedure.
Preden pričnete s postopkom priprave natančno preberite celotno navodilo.
HAMA titers should be determined before repeated administration of LeukoScan.
Pred ponovnim vnosom zdravila LeukoScan je potrebno določiti HAMA titre.
After use, the container should be disposed of as radioactive waste.
Po uporabi je potrebno vsebnik zavreči kot radioaktivni odpadek.
Anaphylactic and other hypersensitivity reactions are possible whenever mouse protein materials are administered to patients.
Kadar so bolnikom aplicirani mišji proteini, so anafilaktične in druge preobčutljivostne reakcije vedno možne.
These dose estimates assume a urinary bladder voiding interval of two hours.
Te doze so ocenjene na osnovi predpostavke, da se mehur prazni vsaki dve uri.
Rehydrate with sterile, non-pyrogenic 99mTc Na pertechnetate.
Rehidrirajte s sterilno, apirogeno raztopino natrijevega pertehnetata [99mTc].
BEFORE YOU USE LEUKOSCAN You should not use LeukoScan 0.31 mg, sulesomab,powder for solution for injection
KAJ MORATE VEDETI, PREDEN BOSTE UPORABILI ZDRAVILO LEUKOSCAN Zdravila LeukoScan 0,31 mg, prašek za raztopino za injiciranje ne smete uporabiti
For reconstitution of lyophilised powder, with a sterile disposable syringe add 0.50 ml of saline injection into the shielded LeukoScan 3-ml vial.
Za rekonstituiranje liofiliziranega praška s sterilno odstranljivo brizgo dodajte 0,5 ml 0,9% raztopine natrijevega klorida za injiciranje v 3ml vialo zdravila LeukoScan, nameščeno v zaščitnem vsebniku.
Using saline injection, bring the final volume of eluate solution to 1.0 ml.
Dodajte toliko 0,9% raztopine natrijevega klorida za injiciranje, da bo končni volumen eluata znašal 1,0 ml.
NAME OF THE MEDICINAL PRODUCT LeukoScan 0.31 mg, powder for solution for injection
IME ZDRAVILA LeukoScan 0,31 Prašek za raztopino za injiciranje
4.9 Overdose
6.2 Inkompatibilnosti
If either are present, the
Če je prisotno karkoli od naštetega, je potrebno zdravilo
ATC code: VO4D At the concentrations and activities used for diagnostic procedures, LeukoScan does not appear to exert
V koncentracijah in ob aktivnostih, uporabljenih za diagnostične postopke, ni videti, da bi zdravilo LeukoScan izkazovalo kakršnekoli farmakodinamične učinke.
These values were calculated according to Medical Internal Radiation Dosimetry.
Vrednosti so bile izračunane v skladu z MIRD
MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH
(IMETNIKI) DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA
RELEASE
Izračunajte
• If you have ever received LeukoScan or another product made from a mouse antibody, your doctor should take a sample of blood for testing to be sure that you have not developed an allergy to it.
• Če ste kadarkoli že prejeli zdravilo LeukoScan ali drugo zdravilo, pripravljeno iz mišjih protiteles,
Medicinal product subject to medical prescription
Ponovni vnos (readministracija zdravila)
Your doctor will prepare the LeukoScan and the radioactive isotope technetium in a volume of 1.5 ml.
Vaš zdravnik bo pripravil zdravilo LeukoScan in radioaktivni izotop tehnecija, pripravljeni volumen bo znašal 1,5 ml. 0,25 mg zdravila LeukoScan bo označenega s 740 - 1110 MBq tehnecija.
Each 3 ml vial contains 0.31 mg sulesomab (IMMU-MN3 murine Fab′-SH antigranulocyte monoclonal
Komplet za pripravo 99mTc označenega zdravila LeukoScan Vsaka 3 ml viala vsebuje 0,31 mg sulezomaba (IMMU-MN3 fragmenti Fab'-SH antigranulocitnih natrijev klorid klorovodikova kislina (sledovi) natrijev acetat trihidrat
6.2 Incompatibilities This medicinal product must not be mixed with other medicinal products except those mentioned in 6.6 or
To zdravilo se ne sme mešati z drugimi zdravili razen s tistimi, ki so navedena v poglavju 6.6 ali 12. 6.3 Rok uporabnosti: komplet - 48 mesecev rekonstituiran in radioaktivno označen material - 4 ure
Contains 0.31 mg lyophilised sulesomab, stannous chloride and stabilizers.
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT Vsebuje 0,31 mg liofiliziranega sulezomaba, kositrov klorid in stabilizatorje.
No induction of human anti-mouse antibody (HAMA) reactive with fragment was observed in any
Pri nobenem od bolnikov, ki je prejel zdravilo LeukoScan, niso opazili indukcije človeških protiteles proti mišjim antigenom (HAMA), ki bi reagirali s fragmentom.
Immediately prior to use, contents of the vial are reconstituted in the unlabeled form to prepare LeukoScan [99mTc].
Za pripravo zdravila LeukoScan [99mTc] je potrebno z radioizotopom neoznačeno vsebino viale neposredno pred uporabo rekonstituirati.
The kit does not include the
Ne shranjujte v
4.2 Posology and method of administration
4.4 Posebna opozorila in previdnostni ukrepi
There was no doseresponse effect for imaging efficacy (sensitivity or specificity) over antibody doses ranging from 0.1 mg
Pri odmerkih protiteles v razponu od 0,1 mg do 1,0 mg velikost odmerka ni vplivala na učinkovitost slikanja
It was intended for use only when other antibiotics were not suitable.
Uporabljalo naj bi se le, kadar drugi antibiotiki ne bi bili primerni.
‘Complicated' means that the infection is difficult to treat.
„Zapletena okužba“ pomeni, da jo je težko zdraviti.
If you are in a clinical trial and need more information about your treatment, contact the doctor who is giving it to you.
Če ste vključeni v klinično preskušanje in potrebujete več informacij o zdravljenju, se obrnite na zdravnika, ki vam je zdravljenje predpisal.
Because the medicine blocks the production of new proteins, the bacteria cannot multiply and they eventually die.
Ker zdravilo preprečuje tvorbo novih beljakovin, se bakterije ne morejo razmnoževati in končno odmrejo.
Tigecycline Accord was expected to be used to treat adults and children older than 8 years with complicated infections of the skin and soft tissue (the tissue below the skin), except foot infections in people with diabetes.
Zdravilo Tigecycline Accord naj bi se uporabljalo za zdravljenje odraslih in otrok, starejših od 8 let, z zapletenimi okužbami kože in mehkih tkiv (tkiva pod kožo), razen okužb stopala pri osebah s sladkorno boleznijo.
As for every medicine, the company also provided studies on the quality of Tigecycline Accord.
Kot to velja za vsako zdravilo, je družba zagotovila študije o kakovosti zdravila Tigecycline Accord.
It works against the bacteria that cause infections by blocking the bacteria's ribosomes, the parts of the cell where new proteins are made.
Deluje proti bakterijam, ki povzročajo okužbe, tako da preprečuje delovanje bakterijskih ribosomov, delov celice, kjer nastajajo nove beljakovine.
On 12 September 2017, Accord Healthcare Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Tigecycline Accord, for the treatment of certain complicated infections.
Družba Accord Healthcare Limited je dne 12. septembra 2017 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP) , da želi umakniti vlogo za pridobitev dovoljenja za promet z zdravilom Tigecycline Accord, namenjenim zdravljenju nekaterih zapletenih okužb.
Studies on the benefits and risks of the active substance in the approved uses have already been carried out with the reference medicine, Tygacil, and did not need to be repeated for Tigecycline Accord.
Študije o koristih in tveganjih zdravilne učinkovine pri odobrenih načinih uporabe so že bile izvedene z referenčnim zdravilom Tygacil, zato jih ni treba ponoviti za zdravilo Tigecycline Accord.
Tigecycline Accord was developed as a ‘generic medicine'.
Zdravilo Tigecycline Accord je bilo razvito kot „generično zdravilo“.
In its letter notifying the Agency of the withdrawal of the application, the company stated that it was withdrawing the medicine for marketing reasons because of the issues at the manufacturing site.
Družba je v dopisu, s katerim agencijo obvešča o umiku vloge, navedla, da se je za umik vloge odločila zaradi razlogov v zvezi s trženjem zaradi težav na lokaciji proizvodnje.
The company informed the CHMP that there are no consequences for patients currently included in clinical trials using Tigecycline Accord.
Družba je odbor CHMP obvestila, da umik nima nobenih posledic za bolnike, ki trenutno sodelujejo v kliničnih preskušanjih zdravila Tigecycline Accord.
It was also intended to treat complicated infections in the abdomen (belly).
Namenjeno naj bi bilo tudi zdravljenju zapletenih okužb v trebuhu.
This means that Tigecycline Accord contains the same active substance and was intended to work in the same way as a ‘reference medicine' already authorised in the European Union called Tygacil.
To pomeni, da vsebuje enako zdravilno učinkovino in ima enak način delovanja kot „referenčno zdravilo“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilo Tygacil.
There was no need for ‘bioequivalence' studies to investigate whether Tigecycline Accord is absorbed similarly to the reference medicine to produce the same level of the active substance in the blood.
Izvedba študij biološke enakovrednosti, s katerimi se proučuje, ali se zdravilo Tigecycline Accord absorbira podobno kot referenčno zdravilo in tako ustvari enake ravni zdravilne učinkovine v krvi, ni bila potrebna.
Based on the review of the data, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Tigecycline Accord could not have been approved to treat complicated infections.
Odbor CHMP je na podlagi pregleda podatkov ob umiku vloge izrazil določene zadržke in je začasno menil, da zdravila Tigecycline Accord ni mogoče odobriti za zdravljenje zapletenih okužb.
Tigecycline Accord is an antibiotic medicine that contains the active substance tigecycline.
Tigecycline Accord je antibiotično zdravilo, ki vsebuje zdravilno učinkovino tigeciklin.
The CHMP's main concern was lack of compliance with Good Manufacturing Practice (GMP) by the manufacturing site for the medicine's active substance.
Glavni pomislek odbora CHMP je bil, da lokacija proizvodnje zdravilne učinkovine zdravila ni dovolj skladna z dobro proizvodno prakso (GMP).
It was to be available as a powder to make a solution for infusion (drip) into a vein.
Na voljo naj bi bilo v obliki praška za pripravo raztopine za infundiranje (kapalne infuzije) v veno.