natgillin/translations-raw huggingface dataset:
Naxcel must only be administered at the base of ear location in non-edible tissue in order to comply with the withdrawal period.
Naxcel se sme dati samo na mestu na bazi ušesa v neužitno tkivo, da se zagotovi karenca za meso.
A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
A. PROIZVAJALEC (PROIZVAJALCI) ZDRAVILA, ODGOVOREN (NI) ZA SPROŠČANJE SERIJ
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary Owing to the low toxicity of ceftiofur in pigs overdoses do not typically lead to any clinical signs, other than transient local swellings as described in section 4.6 (Adverse reactions).
Zaradi nizke toksičnosti ceftiofurja pri prašičih prekomerno odmerjanje praviloma ne povzroči drugih simptomov, razen prehodne lokalne otekline, kot je že opisano v poglavju 4.6 Neželeni učinki.
Injection location for the subcutaneous administration of Naxcel at the posterior aspect of the ear where it attaches to the head (base of ear)
Slika 1. lokacija subkutane injekcije aplikacije zdravila Naxcel v posteriornem pogledu ušesa, kjer je pritrjeno na glavo
MARKETING AUTHORISATION NUMBER (S) EU/2/05/053/001-002
ŠTEVILKE DOVOLJENJ ZA PROMET EU/2/05/053/001-002
Treatment of septicaemia, polyarthritis or polyserositis associated with Streptococcus suis infection.
Zdravljenje septikemije, poliartritisa ali poliserozitisa, ki je povezan s okužbo z Streptococcus suis.
MARKETING AUTHORISATION NUMBER(S) EU/2/05/053/001 (100 ml)
ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/05/053/001 (100ml)
At the recommended therapeutic dose, concentrations in plasma were higher than the MIC90 values
V priporočenem terapevtskem odmerku so bile koncentracije v plazmi za ciljne bakterije izolirane med kliničnimi študijami, tudi še 158 ur po začetku poskusa višje od MIC90 vrednosti (<0,2 mg/ml).
Dose of 5 mg ceftiofur/kg bodyweight (equivalent to 1 ml of Naxcel per 20 kg bodyweight) administered once in the neck by intramuscular injection.
5 mg ceftiofurja/kg telesne mase (ekvivalentno 1 ml zdravila Naxcel na 20 kg telesne mase), z enkratnim intramuskularnim dajanjem v področje vratu.
No studies have been conducted in pregnant or lactating sows, or in breeding pigs.
Pri brejih svinjah, ali svinjah v laktaciji ter pri plemenskih živalih študije niso bile izvedene.
Figure 1.
ŠTEVILKA SERIJE
THE WORDS “KEEP OUT OF THE SIGHT AND REACH OF CHILDREN”
BESEDILO “ ZDRAVILO SHRANJUJTE NEDOSEGLJIVO OTROKOM ”
Do not store above 25 ˚C.
Shranjujte pri temperaturi pod 25 °C.
NAME OF THE VETERINARY MEDICINAL PRODUCT Naxcel 100 mg/ml suspension for injection for pigs
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Naxcel 100 mg/ml suspenzija za injiciranje za prašiče
NAME OF THE VETERINARY MEDICINAL PRODUCT Naxcel 100 mg/ml suspension for injection for pigs ceftiofur
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Naxcel 100 mg/ml suspenzija za injiciranje za prašiče ceftiofur
Do not use as prophylaxis in case of retained placenta.
Zdravilo se ne sme uporabljati za rutinsko profilakso retencije placente.
Name and address of the manufacturer responsible for batch release
Ime in naslov proizvajalca (proizvajalcev) zdravila, odgovornega (odgovornih) za sproščanje serij Zoetis Belgium SA
Single subcutaneous injection of 6.6 mg ceftiofur/kg bodyweight (equivalent to 1 ml of Naxcel per 30 kg bodyweight) administered at the base of the ear.
Enkratna subkutana injekcija 6,6 mg ceftiofurja/kg telesne teže (kar ustreza 1 ml zdravila Naxcel na 30 kg telesne teže) aplicirana na bazi ušesa.
- common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
- zelo pogosti (pri več kot 1,toda manj kot 10 zdravljenih živali) - pogosti (pri več kot 1, toda manj kot 10 živali od 100 zdravljenih živali) - občasni (pri več kot 1, toda manj kot 10 živali od 1.000 zdravljenih živali) - redki (pri več kot 1, toda manj kot 10 živali od 10.000 zdravljenih živali) - zelo redki (pri manj kot 1 živali od 10.000 zdravljenih živali, vključno posameznimi primeri).
WITHDRAWAL PERIOD(S) Meat and offal: 71 days.
Karenca: Meso in organi: 71 dni.
Excipient: Oily vehicle (vegetable origin).
Pomožna snov: Oljni vehikel (rastlinski izvor).
MARKETING AUTHORISATION NUMBER(S) EU/2/05/053/003
ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/05/053/003
PACKAGE LEAFLET: Naxcel 100 mg/ml suspension for injection for pigs
NAVODILO ZA UPORABO Naxcel 100 mg/ml suspenzija za injiciranje za prašiče
Do not use in cases of hypersensitivity to ceftiofur or other ß-lactam antibiotics, or to any of the excipients.
Ne uporabljajte zdravila pri živalih, ki so preobčutljive na ceftiofur ali druge ß-laktamske antibiotike ali katero koli pomožno snov.
The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Pogostost neželenih učinkov je določena po naslednjem dogovoru: - zelo pogosti (neželeni učinki se pokažejo pri več kot 1 od 10 zdravljenih živali) - pogosti (pri več kot 1, toda manj kot 10 živali od 100 zdravljenih živali) - občasni (pri več kot 1, toda manj kot 10 živali od 1.000 zdravljenih živali) - redki (pri več kot 1, toda manj kot 10 živali od 10.000 zdravljenih živali) - zelo redki (pri manj kot 1 živali od 10.000 zdravljenih živali, vključno z posameznimi primeri).
PACKAGE LEAFLET: Naxcel 200 mg/ml suspension for injection for cattle
Naxcel 200 mg/ml suspenzija za injiciranje za govedo
1,000 µg/kg Muscle For porcine species the fat MRL relates to ‘skin and fat in natural proportions'
»kožo in maščobo v naravnih proporcijah«.
Incompatibilities:
Učinkovina:
Ceftiofur is particularly active against the following target pathogens causing respiratory and other diseases in pigs: Actinobacillus pleuropneumoniae, Pasteurella multocida, Haemophilus parasuis and Streptococcus suis.
Ceftiofur je aktiven predvsem proti naslednjim povzročiteljem respiratornih in drugih obolenj pri prašičih:
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE Vial of 100ml
PODATKI NA PRIMARNI OVOJNINI 100 ml viala
NAME OF THE VETERINARY MEDICINAL PRODUCT Naxcel 200 mg/ml suspension for injection for cattle ceftiofur
Naxcel 200 mg/ml suspenzija za injiciranje za govedo ceftiofur
Excipie nt(s): Oily vehicle (vegetable origin).
Pomožne snovi: Oljni vehikel (rastlinski izvor).
PACKAGE SIZE 100 ml
100 ml 50 ml
NAME OF THE VETERINARY MEDICINAL PRODUCT Naxcel 200 mg/ml suspension for injection for cattle
NAVODILO ZA UPORABO Naxcel 200 mg/ml suspenzija za injiciranje za govedo
Pigs
Za prašiče je
DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION Single subcutaneous injection of 6.6 mg ceftiofur/kg bodyweight (equivalent to 1 ml of Naxcel per 30 kg bodyweight) administered at the base of the ear.
Enkratna subkutana injekcija 6.6 mg ceftiofurja/kg telesne teže (kar ustreza 1 ml zdravila Naxcel na 30 kg telesne teže) aplicirana na bazi ušesa.
MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
PROIZVAJALEC (PROIZVAJALCI) ZDRAVILA, ODGOVOREN(NI) ZA SPROŠČANJE SERIJ
OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF YASMINELLE AND ASSOCIATED NAMES (see Annex I)
ZAKLJUČNI POVZETEK ZNANSTVENEGA VREDNOTENJA ZDRAVILA YASMINELLE IN POVEZANIH IMEN (glejte Dodatek I)
Invented Name Strength
Izmišljeno ime
Finally taking into account that the medicinal product is intended for long term use, the possible mistakes and misuse are further minimised.
Če na koncu upoštevamo dejstvo, da je zdravilo namenjeno za dolgotrajno uporabo, je možnost napak in zlorabe še manjša.
The product is marketed in pack size of 3 x 21 film-coated tablets.
Zdravilo se trži v velikostih pakiranj po 3 x 21 filmsko obloženih tablet.
In addition it is not possible to separate blisters from cardboard wallets and therefore the users always have access to the required information.
Poleg tega pretisnega omota ni mogoče ločiti od zloženke iz lepenke, zaradi česar imajo uporabniki vedno dostop do zahtevanih podatkov.
The valid Summary of Product Characteristics, labelling and package leaflet are the final versions achieved during the Coordination group procedure.
Veljavni povzetek glavnih značilnosti zdravila, ovojnina in navodilo za uporabo so končne verzije besedil, sprejete med postopkom Koordinacijske skupine.
It has also been confirmed by blind persons that the Braille text on the cardboard is palpable and readable.
Slepe osebe so potrdile tudi, da je Braillova pisava na lepenki tipljiva in čitljiva.
Therefore blind users will be able to double check the information written on the cardboard wallets (Braille text) with the information obtained from a physician (during the visit).
Zato bodo slepi uporabniki lahko dodatno primerjali podatke, ki so zapisani na zloženkah iz lepenke (Braillova pisava), s podatki, ki so jih dobili od zdravnika (med obiskom).
The required basic information (how to use the product, what to do in case of missed dose, etc.), which ensures the safe use of the product is present on the cardboard wallets and visible through the cellophane wrapping.
Zahtevani osnovni podatki (kako uporabljati zdravilo, kaj narediti v primeru, če pozabite vzeti odmerek zdravila itd.), ki zagotavljajo varno uporabo zdravila, so navedeni na zloženkah iz lepenke in so vidni skozi celofanski ovoj.
ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
DODATEK I SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVILA, POTI UPORABE ZDRAVILA, IMETNIKOV DOVOLJENJA ZA PROMET Z ZDRAVILOM V DRŽAVAH ČLANICAH
Since it is a prescription medicine, the name of the product always will be known to the blind user as during the visit the physicians inform patients about medicinal product they are prescribing, including the name of the product.
Ker gre za zdravilo, ki se izdaja samo na recept, bodo slepe osebe vedno poznale ime zdravila, saj zdravniki med obiski pri njih predstavijo zdravilo, ki ga predpisujejo, vključno z imenom zdravila.
The risk resulting from the separation of a package leaflet from cardboard wallets is comparable with the risk resulting from separation of blisters from conventional external packaging (cardboard box).
Tveganje, ki bi nastalo, če bi se navodilo za uporabo ločilo od zloženke iz lepenke, je primerljivo s tveganjem, do katerega pride, če ločite pretisne omote od pripadajočih običajnih zunanjih ovojnin (škatle iz lepenke).
The wallet with the inserted blister is assembled with a package leaflet (PL) and all components are wrapped together with clear, transparent cellophane wrapping to form the unit pack which prevents the loss of individual components.
Zloženka z vstavljenim pretisnim omotom vsebuje navodilo za uporabo, vsi sestavni deli pa so povezani s čistim in prozornim celofanskim ovojem, ki oblikuje enoto ovojnine, ki preprečuje, da bi se posamezni sestavni deli izgubili.
Moreover cardboard wallets protect blisters against damage.
Poleg tega zloženka iz lepenke ščiti pretisne omote pred poškodbami.
Although different observations in respect to readability of the Braille text through the cellophane wrapping have been made by blind users, it is assumed that before use of the product the cellophane wrapping will be removed and therefore blind person will be in a position to identify the product.
Čeprav so imeli slepi uporabniki glede čitljivosti Braillove pisave preko celofanskega ovoja različne pripombe, se predvideva, da bodo celofanski ovoj pred uporabo odstranili, tako da bodo slepe osebe lahko prepoznale zdravilo.
Once the cellophane wrapping is removed the safe use of the product is still ensured as the cardboard wallets contain the required information.
Ko celofanski ovoj odstranite, je varna uporaba zdravila še vedno zagotovljena, ker so zahtevani podatki navedeni na stenah zloženke iz lepenke.
The Yasminelle blister is glued in a carton which is subsequently folded to a wallet configuration.
Pretisni omot zdravila Yasminelle je prilepljen na lepenko, ki je zložena v obliko, podobno denarnici.
Av. Baix Llobregat, 3-5 08970 Sant Joan Despí, Barcelona Spain
08970 Sant Joan Despí, Barcelona Spain
Marketing autorisation Holder
Država članica Imetnik dovoljenja za promet
143, Avenue Louise 1050 Brussel, Belgium
143, Avenue Louise 1050 Brussel, Belgium filmsko obložene tablete peroralna upora
ANNEX II SCIENTIFIC CONCLUSIONS
DODATEK II
Date of first authorisation: 25 July 2016
Datum prve odobritve: 25. julij 2016
Injection into a vein is rapid, taking 3 to 5 seconds.
Injiciranje v veno je hitro, traja 3 do 5 sekund.
Do not give by other routes.
Ne sme se dajati po nobeni drugi poti.
CI=Confidence Interval
IZ = interval zaupanja
Currently available data are described in section 5.1 but no recommendation on a posology can be made.
Trenutno dostopni podatki so opisani v poglavju 5.1, vendar priporočil za odmerjanje ni mogoče podati.
Median a response duration
Mediano a trajanje odziva
Response rate n: response-evaluable patients
Stopnja odziva n: odziv ocenljivih bolnikov
Peri- and postnatal development studies were not conducted.
Raziskav peri- in postnatalnega razvoja niso opravili.
Horizon, Honey Lane Hurley, SL66RJ United Kingdom
Horizon, Honey Lane Hurley, SL66RJ Velika Britanija
Eighteen percent of patients achieved, or had an improved response [MR (11%) or PR (7%)] with combination treatment.
Pri 18 % bolnikov so dosegli odziv ali izboljšan odziv [MR (11 %) ali PR (7 %)] pri kombiniranem zdravljenju.
All Grade PN
vse stopnje PN
Fertility studies were not performed but evaluation of reproductive tissues has been performed in the general toxicity studies.
Raziskav plodnosti niso opravili, opravili pa so ovrednotenje reproduktivnih tkiv v raziskavah splošne toksičnosti.
In particular, tell your doctor if you are using medicines containing any of the following active substances:
Še posebno morate zdravnika obvestiti, če jemljete zdravila, ki vsebujejo katero izmed naslednjih učinkovin:
Complete response (CR) was evaluated at the end of Block 1.
Popoln odziv (CR) so ocenili na koncu 1. sklopa zdravljenja.
Median follow-up was 16.3 months.
Mediano spremljanje je bilo 16,3 mesecev.
One hundred and twenty seven matched pairs of patients were identified.
Določenih je bilo stosedemindvajset izenačenih parov bolnikov.
Treatment was administered for a maximum of 9 cycles (approximately 54 weeks) and was discontinued early for disease progression or unacceptable toxicity.
Zdravljenje je trajalo največ 9 ciklov (približno 54 tednov) in je bilo v primeru napredovanja bolezni ali nesprejemljive toksičnosti prekinjeno prej.
This survival was greater than the six-to-nine month median survival anticipated by consultant clinical investigators for a similar patient population.
Ta stopnja preživetja je bila večja od 6 do 9-mesečnega medianega preživetja, ki ga pričakujejo konziliarni klinični raziskovalci za podobno skupino bolnikov.
Frequencies are defined as: Very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from the available data).
Pogostnost neželenih učinkov je opredeljena, kot sledi: zelo pogosti (≥ 1/10); pogosti (≥ 1/100 do < 1/10); občasni (≥ 1/1.000 do < 1/100); redki (≥ 1/10.000 do < 1/1.000); zelo redki (< 1/10.000), neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov).
The safety and efficacy of bortezomib in children below 18 years of age have not been established (see sections 5.1 and 5.2).
Varnost in učinkovitost bortezomiba pri otrocih, mlajših od 18 let, nista bili dokazani (glejte poglavji 5.1 in 5.2).
This medicinal product does not require any special temperature storage conditions.
Za shranjevanje tega zdravila ni posebnih temperaturnih omejitev.
Table 14: Summary of disease outcomes from the Phase III (APEX) and Phase II studies Phase III
Preglednica 14:Povzetek izidov bolezni v preskušanjih faze III (APEX) in II faza III
Due to this early crossover, the median duration of follow-up for surviving patients is 8.3 months.
Zaradi te zgodnje zamenjave zdravila, znaša mediano trajanje spremljanja preživelih bolnikov 8,3 mesece.
Based on Independent Review Committee (IRC) assessment (radiological data only).
a Na osnovi ocene neodvisnega odbora (IRC - Independent Review Committee) (samo podatki slikovnih diagnostičnih metod).
The AUClast- geometric mean ratio was 0.99 and 90% confidence intervals were
Razmerje geometričnih sredin vrednosti AUCzadnji je bilo 0,99 in 90 % intervali zaupanja
Consider reduction of the melphalan dose by 25% in the next cycle.
V naslednjem ciklu zdravljenja razmislite o zmanjšanju odmerka melfalana za 25 %.
Two (1%) of the patients had severe reactions; 1 case of pruritus and 1 case of redness.
Pri dveh bolnikih (1 %) so se pojavile hude reakcije; 1 primer pruritusa in 1 primer rdečice.
The median duration of treatment was 13 weeks for the VDDx group and 11 weeks for the BDx group.
Mediani čas trajanja zdravljenja je bil 13 tednov v skupini VDDx in 11 tednov v skupini BDx.
The median survival of all patients enrolled was 17 months (range < 1 to 36+ months).
Mediano preživetja vseh bolnikov, vključenih v preskušanje, je bilo 17 mesecev (območje < 1 do 36+ mesecev).
The final survival update was performed with a median duration of follow-up of 60.1 months.
Končno posodobitev podatkov o preživetju so izvedli po medianem trajanju spremljanja 60,1 meseca.
• Hypersensitivity (allergic reaction)
• preobčutljivost (alergijska reakcija)
Grade 1 (asymptomatic; loss of deep tendon reflexes or paraesthesia) with no pain or loss of function
Stopnja 1 (asimptomatska; izguba refleksa globoke tetive ali parestezija) brez bolečine ali izguba funkcije ni potrebna
Do not use this medicine after the expiry date stated on the vial and the carton after EXP.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na viali in škatli poleg oznake »EXP«.
A protocol-defined interim analysis (based on 249 TTP events) triggered early study termination for efficacy.
S protokolom določena vmesna analiza (na osnovi 249 TTP dogodkov) je vodila do predčasne prekinitve preskušanja, kar zadeva ugotavljanje učinkovitosti.
Do not drive or operate tools or machines if you experience such side effects; even if you do not, you should still be cautious.
Če imate navedene neželene učinke, ne vozite in ne upravljajte orodij ali strojev; tudi če teh učinkov nimate, vseeno bodite previdni.
Exposure of bortezomib (dose-normalised AUC and Cmax) was comparable among all the groups (see section 4.2).
Izpostavljenost bortezomibu (AUC in Cmax normalizirana na odmerek) je bila primerljiva med vsemi skupinami (glejte poglavje 4.2).
NF-kB is a transcription factor whose activation is required for many aspects of tumourigenesis, including cell growth and survival, angiogenesis, cell-cell interactions, and metastasis.
NF-kB je transkripcijski faktor, katerega aktivacija je potrebna za mnoge stopnje nastanka tumorja, vključno z rastjo in preživetjem celic, angiogenezo, interakcije med celicami in metastaziranje.
The Cmax after subcutaneous administration (20.4 ng/ml) was lower than intravenous (223 ng/ml).
Cmax je bila po subkutanem dajanju (20,4 ng/ml) manjša kot pri intravenskem (223 ng/ml).
• St. John's Wort (Hypericum perforatum), used for depression or other conditions
• šentjanževko (Hypericum perforatum), ki se uporablja pri depresiji ali drugih stanjih
In addition, secondary response-related and time to event related efficacy endpoints showed consistent results for subcutaneous and intravenous administration (Table 15).
Poleg tega so sekundarni, s stopnjo odziva in časom do dogodka povezani opazovani dogodki učinkovitosti pokazali trdne rezultate za subkutano in intravensko uporabo (preglednica 15).
Similar proportions of patients had creatinine clearance ≤ 30 ml/min (3% in each arm).
Podobno razmerje bolnikov je imelo očistek kreatinina ≤ 30 ml/min (3 % v vsakem kraku preskušanja).
Most adverse reactions are mild to moderate in nature and are observed throughout treatment.
Večina neželenih učinkov je po jakosti blagih do zmernih in jih opažamo ves čas zdravljenja.
Patients achieving a complete response can continue treatment for at least 2 cycles after the first evidence of complete response, even if this requires treatment for more than 8 cycles.
Bolniki s popolnim odzivom lahko z zdravljenjem nadaljujejo še najmanj dva cikla po prvi ugotovitvi popolnega odziva, tudi če to zahteva zdravljenje, daljše od 8 ciklov.
Each pack contains 1 single-use vial.
Ena škatla vsebuje eno vialo za enkratno uporabo.
The reported efficacy data are considered inconclusive (see section 4.2).
Podatki, o katerih so poročali, niso podali dokončnih zaključkov o učinkovitosti (glejte poglavje 4.2).
In each Member State, the Marketing Authorisation Holder (MAH) shall agree the content and format of the educational material with the national competent authority.
Imetnik dovoljenja za promet z zdravilom se bo v vsaki državi članici s pristojnim nacionalnim organom dogovoril za obliko in vsebino izobraževalnega gradiva.
Median duration of follow up is 11.8 months
e Mediano trajanje spremljanja je 11,8 mesecev.
≥ Grade 2 PN
≥ stopnja 2 PN
#, Different degrees of visual impairment (up to blindness)*
#, različne stopnje okvare vida (vse do slepote)*
In dogs, the decreased cardiac contractility and hypotension responded to acute intervention with positive inotropic or pressor agents.
Psi z zmanjšano kontraktilnostjo srca in hipotenzijo so se odzvali na učinkovine s pozitivnim inotropnim ali presorskim delovanjem.
Treatment with bortezomib can very commonly cause a decrease in the numbers of red and white blood cells and platelets in your blood.
Zdravljenje z bortezomibom lahko zelo pogosto povzroči zmanjšanje števila rdečih in belih krvnih celic ter krvnih ploščic v krvi.
Table 7 has been generated using Version 14.1 of the MedDRA.
Preglednica 7 je pripravljena skladno z MedDRA, različica 14.1.
Both men and women receiving bortezomib must use effective contraception during and for up to 3 months after treatment.
Moški in ženske, ki prejemajo bortezomib, morajo uporabljati učinkovito kontracepcijo med in do 3 mesece po zdravljenju.
• Loss of consciousness
• izguba zavesti
Other medicines and Bortezomib Hospira Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Druga zdravila in zdravilo Bortezomib Hospira Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste začeli jemati katerokoli drugo zdravilo.
Patients with renal impairment should be monitored closely (see sections 4.2 and 5.2).
Bolnike z okvaro ledvic je treba skrbno spremljati (glejte poglavji 4.2 in 5.2).
After correcting for the BSA effect, other demographics such as age, body weight and sex did not have clinically significant effects on bortezomib clearance.
Po prilagoditvi glede na telesno površino, drugi demografski dejavniki, kot so starost, telesna masa in spol, niso imeli klinično pomembnega vpliva na očistek bortezomiba.
• Blood clot in small blood vessels (thrombotic microangiopathy)
• krvni strdek v majhnih krvnih žilah (trombotična mikroangiopatija)
The other ingredient is mannitol (E421).
Druga sestavina zdravila je manitol (E421).
Potential benefit of the treatment should be carefully weighed against the risks, particularly in case of moderate to severe thrombocytopenia and risk factors for bleeding.
Skrbno pretehtajte možne koristi zdravljenja glede na tveganja, še posebno v primeru srednje do hude trombocitopenije in ob obstoječih dejavnikih tveganja za krvavitev.
in BDx group and 52/242 [21%] in VDDx group).
(42/240 [18 %] v skupini BDx in 52/242 [21 %] v skupini VDDx).
The total storage time for the reconstituted medicinal product should not exceed 8 hours prior to administration.
Skupni čas shranjevanja rekonstituiranega zdravila pred injiciranjem ne sme biti daljši od 8 ur.