natgillin/translations-raw huggingface dataset:
In the trial with previously untreated patients, between 0 and 6 years of age, a total of 46 adverse reactions were reported in 33 of 60 patients exposed to NovoEight.
V preskušanju s predhodno nezdravljenimi bolniki, starimi od 0 do 6 let, je bilo skupno opisanih
NovoEight 250 IU powder and solvent for solution for injection
NovoEight 250 i.e. prašek in vehikel za raztopino za injiciranje
Pull the plunger rod slightly downwards to draw the reconstituted solution into the syringe.
Potegnite nosilec bata rahlo navzdol, da boste potegnili pripravljeno raztopino v brizgo.
Repeat every 12 to 24 hours, at least 1 day, until the bleeding episode as indicated by pain is resolved or healing achieved
1 dan, dokler se krvavitev (kot jo kaže bolečina) ne ustavi oziroma je doseženo celjenje.
Do not stop using NovoEight without talking to your doctor.
Raztopine ne shranjujte, brez da bi se prej posvetovali z zdravnikom.
b Frequency is based on studies with all FVIII products which included patients with severe haemophilia A. c Injection site reactions include injection site erythema, injection site extravasation and injection site pruritus.
c Reakcije na mestu injiciranja vključujejo eritem na mestu injiciranja, ekstravazacijo na mestu injiciranja in srbenje na mestu injiciranja.
If you notice visible particles or discolouration, do not use it. Use a new package instead.
Če v njej opazite vidne delce ali če je spremenjene barve, je ne uporabite.
NovoEight 1000 IU
NovoEight 1000 i.e.
Do not use the equipment without proper training from your doctor or nurse.
Opreme ne uporabite, če vas zdravnik ali medicinska sestra nista posebej usposobila za to. Vedno si umijte roke in poskrbite, da je prostor okrog vas čist.
Sucrose
pireksija
Turn over the protective cap, and snap the vial adapter onto the vial.
• Obrnite zaščitni pokrovček in nataknite nastavek za vialo na vialo.
• 4 hours stored up to 40°C, for product which has been kept for a single period no longer than 3 months at above room temperature (30°C up to 40°C).
• 4 urah, če je raztopina hranjena pri temperaturi, ki ne presega 40 °C, v primeru, da je bilo zdravilo shranjeno pri temperaturah, višjih od sobne temperature (30 °C - 40 °C), za enkratno obdobje, ki ni daljše od 3 mesecev.
Heart rate increased
občasni zvišanje frekvence srčnega utripa
NovoEight is a powder and solvent for solution for injection.
Zdravilo NovoEight vsebuje prašek in vehikel za raztopino za injiciranje.
Vomiting
• zardevanje
administration of 50 IU/kg
debelost razreda II/III: ITM ≥ 35 kg/m2
Pyrexia, catheter site erythema
• rdečica na mestu vstavljenega katetra
Development of neutralising antibodies (inhibitors) may occur in patients with haemophilia A treated with factor VIII, including with NovoEight.
Pri bolnikih s hemofilijo A, zdravljenih s faktorjem VIII, vključno z zdravilom NovoEight, lahko pride do nastanka nevtralizirajočih protiteles (zaviralcev).
After reconstitution:
Neodprta viala:
The medicinal product contains 30.5 mg sodium per reconstituted vial, equivalent to 1.5% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
Opomba o pomožnih snovehZdravilo po pripravi vsebuje 30,5 mg natrija na vialo, kar je enako 1,5 %
NovoEight in previously treated patients with severe haemophilia A (FVIII ≤1%).
NovoEight v odmerku 50 i.e./kg pri predhodno že zdravljenih bolnikih s hudo hemofilijo A
• 4 hours stored at ≤ 30°C, for product which has been kept for a single period no longer than 9 months at room temperature (≤30°C)
• 4 ure v primeru shranjevanja pri temperaturi 30 °C, v primeru, da je bilo zdravilo shranjeno pri sobni temperaturi (≤ 30 °C) za enkratno obdobje, ki ni daljše od 9 mesecev,
Management of such patients should be directed by physicians with experience in the care of haemophilia and factor VIII inhibitors.
ki imajo izkušnje z zdravljenjem hemofilije in zaviralci faktorja VIII.
Screw the pre-filled syringe securely onto the vial adapter until resistance is felt.
Napolnjeno injekcijsko brizgo trdno privijte na nastavek za vialo, dokler ne začutite upora.
After reconstitution NovoEight contains approximately 62.5 IU/ml of human coagulation factor VIII (rDNA), turoctocog alfa.
Po pripravi vsebuje zdravilo NovoEight približno 62,5 i.e./ml humanega koagulacijskega faktorja VIII (rDNA) (turoktokog alfa).
Table 5 Single-dose pharmacokinetic parameters of NovoEight (50 IU/kg) by age - chromogenic assay - Mean (SD)
Farmakokinetični parametri enkratnega odmerka zdravila NovoEight (50 i.e./kg) glede na starost - kromogeni preizkus - povprečje (SD)
• above room temperature (30°C up to 40°C) for a single period no longer than 3 months
• temperaturah, višjih od sobne temperature (30 °C - 40 °C), za enkratno obdobje, ki ni daljše od
Overview Vial with NovoEight powder
Pregled viala s praškom zdravila NovoEight plastičen pokrovček gumijasti zamašek
Remove the protective cap from the vial adapter.
Odstranite zaščitni pokrovček z nastavka za vialo.
NovoEight 250 IU powder for solution for injection turoctocog alfa
NovoEight 250 i.e. prašek za raztopino za injiciranje turoktokog alfa za intravensko uporabo
Plunger
OVOJNINAH
White or slightly yellow powder or friable mass. Clear and colourless solution for injection.
prašek in vehikel za raztopino za injiciranje Bel ali rumenkast prašek ali krhka masa.
After reconstitution NovoEight contains approximately 750 IU/ml of human coagulation factor VIII (rDNA), turoctocog alfa.
Po pripravi vsebuje zdravilo NovoEight približno 750 i.e./ml humanega koagulacijskega faktorja VIII (rDNA) (turoktokog alfa).
Incorrect dose administered
Napolnjena injekcijska brizga
NovoEight 2000 IU powder for solution for injection turoctocog alfa
NovoEight 2000 i.e. prašek za raztopino za injiciranje turoktokog alfa za intravensko uporabo
NovoEight 3000 IU powder for solution for injection turoctocog alfa
NovoEight 3000 i.e. prašek za raztopino za injiciranje turoktokog alfa za intravensko uporabo
NovoEight 1500 IU powder for solution for injection turoctocog alfa
NovoEight 1500 i.e. prašek za raztopino za injiciranje turoktokog alfa za intravensko uporabo
Uncommonb
• omotica
Unscrew the vial adapter with the vial.
• Odvijte nastavek za vialo skupaj z vialo.
NovoEight 500 IU powder for solution for injection turoctocog alfa
NovoEight 500 i.e. prašek za raztopino za injiciranje turoktokog alfa za intravensko uporabo
1 vial with NovoEight powder 1 vial adapter
• 1 vialo s praškom zdravila NovoEight,
One ml of NovoEight contains approximately 62.5 IU of human coagulation factor VIII (rDNA), turoctocog alfa after reconstitution
En mililiter zdravila NovoEight vsebuje po pripravi približno 62,5 i.e. humanega koagulacijskega faktorja VIII (rDNA) (turoktokog alfa).
Store the reconstituted product in the vial.
Pripravljeno zdravilo shranite v viali.
(slightly unclear).
(pod pokrovčkom brizge)
One ml of NovoEight contains approximately 375 IU of human coagulation factor VIII (rDNA), turoctocog alfa after reconstitution
En mililiter zdravila NovoEight vsebuje po pripravi približno 375 i.e. humanega koagulacijskega faktorja VIII (rDNA) (turoktokog alfa).
Table 4 Single-dose pharmacokinetic parameters of NovoEight (50 IU/kg) by age - one stage clotting assay - Mean (SD)
Farmakokinetični parametri enkratnega odmerka zdravila NovoEight (50 i.e./kg) glede na starost - enostopenjski preizkus strjevanja - povprečje (SD)
NovoEight 2000 IU powder and solvent for solution for injection turoctocog alfa (human coagulation factor VIII (rDNA))
NovoEight 2000 i.e. prašek in vehikel za raztopino za injiciranje turoktokog alfa (humani koagulacijski faktor VIII (rDNA))
- The active substance is turoctocog alfa (human coagulation factor VIII (rDNA)).
Kaj vsebuje zdravilo NovoEight - Učinkovina je turoktokog alfa (humani koagulacijski faktor VIII (rDNA)).
NovoEight 250 IU powder and solvent for solution for injection turoctocog alfa (human coagulation factor VIII (rDNA))
NovoEight 250 i.e. prašek in vehikel za raztopino za injiciranje turoktokog alfa (humani koagulacijski faktor VIII (rDNA))
NovoEight 1000 IU powder for solution for injection turoctocog alfa
NovoEight 1000 i.e. prašek za raztopino za injiciranje turoktokog alfa za intravensko uporabo
NovoEight contains turoctocog alfa, a human coagulation factor VIII (rDNA), with a truncated Bdomain.
Turoktokog alfa (humani koagulacijski faktor VIII (rDNA)) je prečiščen protein s
NovoEight 500 IU powder and solvent for solution for injection turoctocog alfa (human coagulation factor VIII (rDNA))
NovoEight 500 i.e. prašek in vehikel za raztopino za injiciranje turoktokog alfa (humani koagulacijski faktor VIII (rDNA))
One ml of NovoEight contains approximately 125 IU of human coagulation factor VIII (rDNA), turoctocog alfa after reconstitution
En mililiter zdravila NovoEight vsebuje po pripravi približno 125 i.e. humanega koagulacijskega faktorja VIII (rDNA) (turoktokog alfa).
NovoEight 2000 IU EU/1/13/888/005
ŠTEVILKE DOVOLJENJ ZA PROMET EU/1/13/888/005
United Kingdom
Danska
NovoEight 3000 IU powder and solvent for solution for injection turoctocog alfa (human coagulation factor VIII (rDNA))
NovoEight 3000 i.e. prašek in vehikel za raztopino za injiciranje turoktokog alfa (humani koagulacijski faktor VIII (rDNA))
One ml of NovoEight contains approximately 750 IU of human coagulation factor VIII (rDNA), turoctocog alfa after reconstitution
En mililiter zdravila NovoEight vsebuje po pripravi približno 750 i.e. humanega koagulacijskega faktorja VIII (rDNA) (turoktokog alfa).
On-demand treatment
aplikaciji zdravila
Life threatening haemorrhages
smrtno nevarne krvavitve
NovoEight 1500 IU powder and solvent for solution for injection turoctocog alfa (human coagulation factor VIII (rDNA))
NovoEight 1500 i.e. prašek in vehikel za raztopino za injiciranje turoktokog alfa (humani koagulacijski faktor VIII (rDNA))
NovoEight 1000 IU powder and solvent for solution for injection turoctocog alfa (human coagulation factor VIII (rDNA))
NovoEight 1000 i.e. prašek in vehikel za raztopino za injiciranje turoktokog alfa (humani koagulacijski faktor VIII (rDNA))
(bromobutyl) and a syringe cap with a stopper (bromobutyl) - 1 plunger rod (polypropylene).
- 1 nosilec bata (polipropilen).
Wide top end
Minimum; maksimum
One ml of NovoEight contains approximately 500 IU of human coagulation factor VIII (rDNA), turoctocog alfa after reconstitution
En mililiter zdravila NovoEight vsebuje po pripravi približno 500 i.e. humanega koagulacijskega faktorja VIII (rDNA) (turoktokog alfa).
One ml of NovoEight contains approximately 250 IU of human coagulation factor VIII (rDNA), turoctocog alfa after reconstitution
En mililiter zdravila NovoEight vsebuje po pripravi približno 250 i.e. humanega koagulacijskega faktorja VIII (rDNA) (turoktokog alfa).
Rash, lichenoid keratosis, skin burning sensation
Bolezni kože in podkožja pogosti izpuščaj, eritematozni izpuščaj občasni izpuščaj, lihenoidna keratoza, pekoč občutek na koži
Haemarthrosis, Muscle haemorrhage
zaščitni papir pokrovček brizge konica brizge
• fever
• bruhanje
Table 7 Single-dose pharmacokinetic parameters of NovoEight (50 IU/kg) by BMI classesaChromogenic assay - Mean (SD)
Farmakokinetični parametri enkratnega odmerka zdravila NovoEight (50 i.e./kg) glede na skupine ITMa - kromogeni preizkus - povprečje (SD)
STATEMENT OF ACTIVE SUBSTANCE
NAVEDBA UČINKOVINE
Table 6 Single-dose pharmacokinetic parameters of NovoEight (50 IU/kg) by BMI classesaOne-stage clotting assay - Mean (SD)
Farmakokinetični parametri enkratnega odmerka zdravila NovoEight (50 i.e./kg) glede na skupine ITMa - enostopenjski preizkus strjevanja - povprečje (SD)
NovoEight 3000 IU EU/1/13/888/006
ŠTEVILKE DOVOLJENJ ZA PROMET EU/1/13/888/006
What NovoEight is and what it is used for What you need to know before you use NovoEight How to use NovoEight
Kaj morate vedeti, preden boste uporabili zdravilo NovoEight
FVIII inhibition
hipotenzijo in anafilaksijo.
Plunger rod
OVOJNINAH Viala
Do not wait until the next planned cycle.
Ne čaka se do naslednjega načrtovanega cikla.
Your doctor will discuss this with you.
Vaš zdravnik se bo o tem pogovoril z vami.
Appropriate aseptic technique should be used.
Uporabiti je treba ustrezno aseptično tehniko.
Allow the vial to stand undisturbed for approximately 5 minutes.
Pustite stati vialo pri miru približno 5 minut.
If not used immediately, in-use storage times and conditions are the responsibility of the user.
Če zdravila ne uporabite takoj, so čas in pogoji shranjevanja odgovornost uporabnika.
Not known: frequency cannot be estimated from the available data
Neznana pogostnost: pogostnosti iz razpoložljivih podatkov ni mogoče oceniti
Children and adolescents Trazimera is not recommended for anyone under the age of 18 years.
Otroci in mladostniki Zdravilo Trazimera ni priporočljivo za mlajše od 18 let.
88397 Biberach an der Riss Germany
88397 Biberach an der Riss Nemčija
For intravenous/I.V.
za intravensko/i.v.
One vial contains either:
Ena viala vsebuje:
• Your doctor will advise you of the risks and benefits of taking Trazimera during pregnancy.
• Zdravnik vam bo svetoval glede tveganja in koristi uporabe zdravila Trazimera v času nosečnosti.
Clinical experience is limited in patients above 65 years of age.
Klinične izkušnje pri bolnikih, starejših od 65 let, so omejene.
This helps your medicine work as well as it can.
To vašemu zdravilu omogoči, da deluje kar najbolj učinkovito.
This could be more serious if you are already breathless.
Težave so lahko resnejše, če že težko dihate.
The bioactivity of D7D and the clinical impact of the elevation of this metabolite was unclear.
Biološka aktivnost D7D in klinični vpliv zaradi povišanja ravni tega presnovka nista bila jasna.
Your doctor will prescribe a dose and treatment regimen that is right for you.
Vaš zdravnik vam bo predpisal odmerek in režim zdravljenja, ki bo primeren za vas.
In other situations, the decision on the need for additional cytotoxic chemotherapy is determined based on individual factors.
V drugih primerih odločitev glede potrebe po dodatni citotoksični kemoterapiji temelji na dejavnikih posameznika.
4.7 Effects on ability to drive and use machines
4.7 Vpliv na sposobnost vožnje in upravljanja strojevi
The product is not intended to be stored after reconstitution and dilution unless this has taken place under controlled and validated aseptic conditions.
Zdravilo ni namenjeno shranjevanju po rekonstituciji in redčenju, razen če je to potekalo v kontroliranih in validiranih aseptičnih pogojih.
Total pathological complete response
Skupni popolni patološki odgovor
All doses should be taken at the right time every week or every three weeks (depending on your dosing schedule).
Vse odmerke morate prejeti v ustreznem času vsak teden ali vsake 3 tedne (glede na vašo shemo odmerjanja).
The presence of trastuzumab in the serum of infant monkeys was not associated with any adverse effects on their growth or development from birth to 1 month of age.
Prisotnost trastuzumaba v serumu opičjih mladičev ni bila povezana z nobenimi neželenimi učinki na njihovo rast ali razvoj od rojstva do 1 meseca starosti.
Trazimera can cause breathing difficulties, especially when it is first given.
Zdravilo Trazimera lahko povzroči težave z dihanjem, še zlasti, ko ga prejmete prvič.
The primary endpoint was overall survival which was defined as the time from the date of randomization to the date of death from any cause.
Primarni opazovani dogodek v preskušanju je bilo celokupno preživetje, ki so ga definirali kot čas od dneva randomizacije do dneva smrti iz kateregakoli vzroka.
• Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
• ob vsakršni spremembi sistema za obvladovanje tveganj, zlasti kadar je tovrstna sprememba posledica prejema novih informacij, ki lahko privedejo do znatne spremembe razmerja med koristmi in tveganji, ali kadar je ta sprememba posledica tega, da je bil dosežen pomemben mejnik (farmakovigilančni ali povezan z zmanjševanjem tveganja)
For monotherapy, the rate was 6% - 9%.
Za monoterapijo je bil ta odstotek 6-9 %.
Patients should be warned of the possibility of such a late onset and should be instructed to contact their physician if these symptoms occur.
Bolnike je treba opozoriti na možnost tako poznega pojava simptomov in jim svetovati, naj takoj obvestijo svojega zdravnika, če se ti simptomi pojavijo.
Your doctor will closely supervise your therapy.
Vaš zdravnik bo pozorno spremljal vaše zdravljenje.
In this section, the following categories of frequency have been used: 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).
V tem poglavju so neželeni učinki navedeni po pogostnosti na naslednji način: 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 (ni mogoče oceniti iz razpoložljivih podatkov).
TTP = time to progression; "ne" indicates that it could not be estimated or it was not yet reached.
TTP = čas do napredovanja bolezni (time to progression); ''no'' = ni bilo mogoče oceniti ali pa še ni bilo doseženo; IZ = interval zaupanja
Your doctor will monitor your heart regularly during and after treatment but you should tell your doctor immediately if you notice any of the above symptoms.
Vaš zdravnik bo med zdravljenjem in po njem redno nadzoroval vaše srce, vendar kljub temu nemudoma obvestite svojega zdravnika, če opazite kateregakoli od zgoraj naštetih simptomov.
• low counts of red blood cells and white blood cells (which help fight infection) sometimes with fever
• majhno število rdečih in belih krvnih celic (ki pomagajo v boju proti okužbi), včasih s povišano telesno temperaturo
What you need to know before you are given Trazimera
Kaj morate vedeti, preden boste prejeli zdravilo Trazimera
Infusion reactions, allergic-like reactions and hypersensitivity It is estimated that approximately 40% of patients who are treated with trastuzumab will experience some form of infusion-related reaction.
Infuzijske reakcije, alergiji podobne reakcije in preobčutljivost Ocenjujejo, da se pri približno 40 % bolnikov, ki prejemajo trastuzumab, pojavi neka oblika z infuzijo povezane reakcije.
Interruption or slowing the rate of the infusion may help control such symptoms.
Prekinitev ali upočasnitev hitrosti infundiranja lahko pomaga pri nadzoru teh simptomov.
Such methods must clearly be precise and accurate enough to demonstrate overexpression of HER2 and must be able to distinguish between moderate (congruent with 2+) and strong (congruent with 3+) overexpression of HER2.
Te metode morajo biti dovolj natančne in točne, da pokažejo čezmerno izražanje HER2 ter ločijo med zmernim (skladno z 2+) in močnim (skladno s 3+) čezmernim izražanjem HER2.
Trazimera should only be given by a doctor or nurse.
Zdravilo Trazimera lahko daje le zdravnik ali medicinska sestra.
HER2 testing must be performed in a specialised laboratory which can ensure adequate validation of the testing procedures (see section 5.1).
Testiranje na HER2 je treba opraviti v specializiranem laboratoriju, ki lahko zagotovi ustrezno validacijo postopkov testiranja (glejte poglavje 5.1).
These effects mainly occur with the first intravenous infusion (“drip” into your vein) and during the first few hours after the start of the infusion.
Ti učinki se pojavijo predvsem med prvo intravensko infuzijo (''kapljanjem'' zdravila v žilo) in v prvih nekaj urah po pričetku infuzije.
The dose of Trazimera depends on your body weight.
Odmerek zdravila Trazimera je odvisen od vaše telesne mase.
Slight foaming of the product upon reconstitution is not unusual.
Rahlo penjenje zdravila po rekonstituciji ni neobičajno.
Serious reactions have been treated successfully with supportive therapy such as oxygen, beta- agonists, and corticosteroids.
Resne reakcije so uspešno zdravili s podpornim zdravljenjem, kot so kisik, beta agonisti in kortikosteroidi.
Trazimera is for intravenous use.
Zdravilo Trazimera je za intravensko uporabo.
The results of these simulations indicate that at least 95% of patients will reach concentrations that are <1 μg/mL (approximately 3% of the population predicted Cmin,ss, or about 97% washout) by 7 months.
Rezultati teh simulacij kažejo, da bo najmanj 95 % bolnikov do 7. meseca doseglo koncentracije < 1 μg/ml (približno 3 % Cmin, ss, predvidene za populacijo, ali približno 97 % izpiranje).
All the terms included are based on the highest percentage seen in pivotal clinical trials.
Vsi navedeni neželeni učinki temeljijo na najvišjem odstotku, ki so ga opazili v ključnih kliničnih preskušanjih.
To ensure accurate and reproducible results, the testing must be performed in a specialised laboratory, which can ensure validation of the testing procedures.
Za zagotovitev točnih in ponovljivih rezultatov je treba testiranje opraviti v specializiranem laboratoriju, ki lahko zagotovi validacijo postopkov testiranja.
There is no relevant use of Trazimera in the paediatric population.
Uporaba zdravila Trazimera pri pediatrični populaciji ni smiselna.
• you have ever had or are currently using a medicine called doxorubicin or epirubicin (medicines used to treat cancer).
• prejemate ali ste kadarkoli prejeli zdravilo, ki se imenuje doksorubicin ali epirubicin (zdravili, ki ju uporabljamo za zdravljenje raka).
FP + H: Fluoropyrimidine/cisplatin + trastuzumab FP: Fluoropyrimidine/cisplatin Odds ratio
FP+H: fluoropirimidin/cisplatin + trastuzumab FP: fluoropirimidin/cisplatin razmerje obetov
Once the infusion is prepared it should be administered immediately.
Ko je infuzija pripravljena, jo je treba takoj infundirati.
If you develop any signs of heart failure (inadequate pumping of blood by the heart), your heart function may be checked more frequently (every six to eight weeks), you may receive treatment for heart failure or you may have to stop Trazimera treatment.
Če se bodo pri vas pojavili kakršnikoli znaki srčnega popuščanja (to je, da vaše srce ne črpa krvi v zadostni meri), bo zdravnik delovanje vašega srca preveril pogosteje (vsakih 6 do 8 tednov); morda boste prejeli zdravila proti srčnemu popuščanju ali pa boste morali prekiniti zdravljenje z zdravilom Trazimera.
Patients classified as staining 2+ or 3+ were included, while those staining 0 or 1+ were excluded.
Bolnike z vrednostjo 2+ ali 3+ so vključili v preskušanje, tiste z 0 ali 1+ pa izključili.
For storage conditions of the reconstituted medicinal product, see sections 6.3 and 6.6.
Za pogoje shranjevanja po rekonstituciji zdravila glejte poglavji 6.3 in 6.6.
Some of these symptoms can be serious and some patients have died (see section 2 under “Warnings and precautions”).
Nekateri od teh simptomov so lahko resni, poročali so o smrtnih primerih (glejte poglavje 2, ''Opozorila in previdnostni ukrepi'').
In order to improve the traceability of biological medicinal products, the trade name and the batch number of the administered product should be clearly recorded.
Za izboljšanje sledljivosti bioloških zdravil je treba jasno zabeležiti zaščiteno ime in številko serije uporabljenega zdravila.
These tissues were fixed in formalin or Bouin's fixative.
Tkiva so fiksirali s formalinom ali v Bouinsovem fiksativu.
Do not use this medicine after the expiry date which is stated on the outer carton and on the vial label after EXP.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in na nalepki na viali poleg oznake ''EXP''.
However, trastuzumab may elevate the overall exposure of one doxorubicin metabolite, (7-deoxy-13 dihydro-doxorubicinone, D7D).
Trastuzumab lahko poveča celokupno izpostavljenost enemu metabolitu doksorubicina (7-deoksi-13- dihidro-doksorubicinonu, D7D).
Initial improvement followed by clinical deterioration and delayed reactions with rapid clinical deterioration have also been reported.
Poročali so tudi o primerih začetnega izboljšanja, ki mu je sledilo klinično poslabšanje, in primerih zapoznelih reakcij s hitrim kliničnim poslabšanjem.
What Trazimera is and what it is used for
Kaj je zdravilo Trazimera in za kaj ga uporabljamo