natgillin/translations-raw huggingface dataset:
In patients (n = 39) with recurrence within 180 days after chemoradiotherapy with cisplatin, the median survival in the topotecan plus cisplatin arm was 4.6 months (95 % C.I.
Pri bolnicah (n = 39) s ponovitvijo v 180 dneh po kemoradioterapiji s cisplatinom je bila mediana vrednost preživetja v skupini, ki je prejemala topotekan in cisplatin, 4,6 meseca (95 % interval zaupanja: 2,6; 6,1), v skupini, ki je prejemala cisplatin, pa 4,5 meseca (95 % intervala zaupanja: 2,9; 9,6), razmerje tveganja 1,15 (0,59; 2,23).
Topotecan is contraindicated in patients who
Topotekan je kontraindiciran pri: - bolnikih, ki imajo v anamnezi hudo preobčutljivostno reakcijo na zdravilno učinkovino ali
Common - mild allergic reactions (including rash) - yellow skin (jaundice) caused by liver problems - itching (pruritus)
• rumeno obarvanje kože (zlatenica) zaradi težav z jetri;
It is a type of chemotherapy.
• ponovitve drobnoceličnega pljučnega raka po kemoterapiji.
Concentrate for solution for infusion (3 mg/ml)
klorovodikova kislina (E507) voda za injekcije koncentrat za raztopino za infundiranje (3 mg/ml)
The recommended dose of topotecan is 0.75 mg/m2/day administered as 30 minute intravenous infusion daily on days 1, 2 and 3.
Priporočeni odmerek topotekana je 0,75 mg/m2/dan.
Median (95 % C.I.)
Mediana vrednost (95 % interval zaupanja)
: 4.9, 9.5) for the cisplatin arm with an hazard ratio of 0.75 (0.49, 1.16).
Pri bolnicah (n = 102) s ponovitvijo po 180 dneh je bila mediana vrednost preživetja v skupini, ki je prejemala topotekan in cisplatin, 9,9 meseca (95 % interval zaupanja: 7; 12,6) v skupini, ki je prejemala cisplatin, pa 6,3 meseca (95 % interval zaupanja: 4,9; 9,5), razmerje tveganja 0,75 (0,49; 1,16).
Read the leaflet for the shelf life of the diluted product.
Za rok uporabnosti razredčenega zdravila glejte priloženo navodilo.
Topotecan Eagle 3 mg/1 ml concentrate for solution for infusion topotecan
NAVODILO ZA UPORABO Topotekan Eagle 3 mg/1 ml koncentrat za raztopino za infundiranje topotekan
Topotecan Eagle 15 mg/5 ml concentrate for solution for infusion Topotecan
NAVODILO ZA UPORABO Topotekan Eagle 15 mg/5 ml koncentrat za raztopino za infundiranje topotekan
This medicine is not recommended if you have severe kidney problems; - if you have liver problems.
Zdravila Topotekan Eagle se ne priporoča v primeru hudih težav z ledvicami;
NAME OF THE MEDICINAL PRODUCT Topotecan Eagle 3 mg/1 ml concentrate for solution for infusion topotecan
IME ZDRAVILA IN POT(I) UPORABE Topotekan Eagle 3 mg/1 ml koncentrat za raztopino za infundiranje topotekan i.v.
You should stop breast-feeding before starting treatment with
Pred začetkom zdravljenja z zdravilom Topotekan Eagle morate prekiniti z
NAME OF THE MEDICINAL PRODUCT Topotecan Eagle 15 mg/5 ml concentrate for solution for infusion topotecan
IME ZDRAVILA IN POT(I) UPORABE Topotekan Eagle 15 mg/5 ml koncentrat za raztopino za infundiranje topotekan i.v.
The information provided in the Physician Leaflet should provide information on dose reduction, discontinuation and wash out procedures in the event of raised ALT.
Informacije v navodilu za zdravnika morajo vsebovati podatke o prilagajanju odmerka, prenehanju zdravljenja in postopkih za odstranitev v primeru povišanih vrednosti ALT.
• The identified risk of synergistic hepato- or haematotoxicity associated with combination therapy with another Disease-Modifying Antirheumatic Drug (e.g. methotrexate)
• O ugotovljenem tveganju za sinergistično hepato ali hematotoksičnost v povezavi s kombinirano terapijo z drugimi imunomodulirajočimi protirevmatičnimi zdravili (diseasemodifying antirheumatic drug (DMARD) (na primer metotreksat).
The Member States shall ensure that the Marketing Authorisation Holder (MAH) provides physicians who are expected to prescribe/use Repso with a physician educational pack containing the following:
Imetnik dovoljenja za promet bo poskrbel, da bodo vsi zdravniki, ki nameravajo predpisovati zdravilo Repso dobili izobraževalno gradivo, ki vsebuje:
• That there is a risk of severe liver injury and so regular measurement of ALT (SGPT) levels to monitor liver function is important.
• Da obstaja tveganje za hudo jetrno poškodbo in je zato pomembno redno spremljanje jetrne funkcije z meritvami vrednosti ALT (SGPT).
• inactivated polioviruses;
• inaktivirane polioviruse;
The choice of booster vaccine depends on official recommendations.
Izbira poživitvenega cepiva je odvisna od uradnih priporočil.
The main measure of effectiveness was the production of protective antibodies.
Glavno merilo učinkovitosti je bila tvorba zaščitnih protiteles.
• parts of the hepatitis B virus;
• dele virusa hepatitisa B;
The full EPAR for Infanrix hexa can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Infanrix hexa je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Vaccines work by ‘teaching' the immune system (the body's natural defences) to defend the body against the infections.
Cepiva delujejo tako, da imunski sistem (naravni obrambni mehanizem telesa) „naučijo“, kako naj brani telo pred okužbami.
This is a summary of the European public assessment report (EPAR) for Infanrix hexa.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Infanrix hexa.
The European Medicines Agency therefore decided that Infanrix hexa's benefits are greater than its risks and recommended that it be given marketing authorisation.
Evropska agencija za zdravila je zato zaključila, da so koristi zdravila Infanrix hexa večje od z njim povezanih tveganj, in priporočila, da se zanj izda dovoljenje za promet.
Infanrix hexa has been studied in nine studies, involving a total of almost 5,000 children aged between 6 weeks and 2 years.
Zdravilo Infanrix hexa so raziskali v devetih študijah, v katere je bilo skupaj vključenih skoraj 5 000 otrok, starih od šest tednov do dveh let.
• toxoids (chemically weakened toxins) from diphtheria and tetanus;
• toksoide (kemično oslabljene toksine) davice in tetanusa;
The European Commission granted a marketing authorisation valid throughout the EU for Infanrix hexa on 23 October 2000.
Evropska komisija je dovoljenje za promet z zdravilom Infanrix hexa, veljavno po vsej Evropski uniji, izdala 23. oktobra 2000.
What measures are being taken to ensure the safe and effective use of Infanrix hexa?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Infanrix hexa?
The vaccination schedule for Infanrix hexa is a course of 2 or 3 doses, given at least 1 month apart, according to official recommendations, usually in the first 6 months of life.
Program cepljenja za zdravilo Infanrix hexa sta 2 ali 3 odmerki, ki se dajo v razmaku vsaj enega meseca, v skladu z uradnimi priporočili, običajno v prvih šestih mesecih življenja.
When a child is given the vaccine, the immune system recognises the parts of the bacteria and viruses in the vaccine as ‘foreign' and makes antibodies against them.
Ko otrok prejme cepivo, imunski sistem prepozna dele bakterij in virusov v cepivu kot „tujke“ in proti njim razvije protitelesa.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Infanrix hexa have been included in the summary of product characteristics and the package leaflet.
Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Infanrix hexa upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
Other information about Infanrix hexa:
Druge informacije o zdravilu Infanrix hexa:
Infanrix hexa must not be used in infants who have had encephalopathy (brain disease) of unknown cause within 7 days of receiving a pertussis vaccine.
Cepivo Infanrix hexa se ne sme uporabljati pri dojenčkih, ki so v preteklosti preboleli encefalopatijo (obolenje možganov) neznanega vzroka v sedmih dneh po prejemu cepiva proti oslovskemu kašlju.
• parts of Bordetella pertussis (B. pertussis, a bacterium that causes whooping cough);
• dele bakterije Bordetella pertussis (B. pertussis, bakterije, ki povzroča oslovski kašelj);
An additional five studies looked at the effects of a booster vaccination with Infanrix hexa.
V dodatnih petih študijah so proučevali učinke poživitvenega cepljenja z zdravilom Infanrix hexa.
The most common side effects with Infanrix hexa (seen in more than 1 in 10 doses of the vaccine) are swelling, pain and redness at the injection site, loss of appetite, fever of 38ºC or more, tiredness, abnormal crying, irritability and restlessness.
Najpogostejši neželeni učinki zdravila Infanrix hexa (ki se lahko pojavijo pri več kot 1 odmerku od 10 odmerkov cepiva) so zatekanje, bolečina in pordelost na mestu injiciranja, izguba teka, povišana telesna temperatura, ki znaša 38 ºC ali več, utrujenost, neobičajen jok, razdražljivost in nemir.
For more information about treatment with Infanrix hexa, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Infanrix hexa preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
A booster dose of Infanrix hexa or a similar vaccine must be given at least 6 months after the last dose of the initial course.
Poživitveni odmerek cepiva Infanrix hexa ali podobnega cepiva je treba dati najmanj šest mesecev po zadnjem odmerku začetnega cepljenja.
• polysaccharides (sugars) from Haemophilus influenzae type b.
• polisaharide (sladkorje) bakterije Haemophilus influenzae tipa b.
For practical information about using Infanrix hexa, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Infanrix hexa naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
The safety of Infanrix hexa is similar to other vaccines used to prevent these conditions.
Varnost zdravila Infanrix hexa je podobna varnosti drugih cepiv, ki se uporabljajo za preprečevanje teh bolezni.
Infanrix hexa is a vaccine that protects against a range of infections.
Zdravilo Infanrix hexa je cepivo, ki ščiti proti različnim okužbam.
Why is Infanrix hexa approved?
Zakaj je bilo zdravilo Infanrix hexa odobreno?
Subsequent injections should be given in different areas.
Mesto injiciranja je treba pri naslednjih injekcijah zamenjati.
Infanrix hexa is given by deep injection into a muscle.
Zdravilo Infanrix hexa se daje z injiciranjem globoko v mišico.
For the full list of side effects reported with Infanrix hexa, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Infanrix hexa, glejte navodilo za uporabo.
Infanrix hexa must not be used in infants who are hypersensitive (allergic) to any of the active substances, to any of the other ingredients of the vaccine, or to neomycin and polymyxin (antibiotics) and formaldehyde.
Zdravilo Infanrix hexa se ne sme uporabljati pri dojenčkih, ki so preobčutljivi za (alergični na) katero koli zdravilno učinkovino, na katero koli drugo sestavino cepiva ali na neomicin in polimiksin (antibiotika) ter formaldehid.
Infanrix hexa contains the following active substances:
Zdravilo Infanrix hexa vsebuje naslednje zdravilne učinkovine:
It is not intended to provide practical advice on how to use Infanrix hexa.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
What benefits of Infanrix hexa have been shown in studies?
Kakšne koristi je zdravilo Infanrix hexa izkazalo v študijah?
What is Infanrix hexa and what is it used for?
Kaj je zdravilo Infanrix hexa in za kaj se uporablja?
Results of the studies taken together showed that a course of injections with Infanrix hexa was as effective at producing protective levels of antibodies as giving separate vaccines containing the same active substances.
Skupna analiza rezultatov študij je pokazala, da je bilo cepljenje z zdravilom Infanrix hexa enako učinkovito pri tvorjenju zaščitnih ravni protiteles kot dajanje ločenih cepiv, ki so vsebovala enake zdravilne učinkovine.
What is the risk associated with Infanrix hexa?
Kakšna tveganja so povezana z zdravilom Infanrix hexa?
Infanrix hexa diphtheria (D), tetanus (T), pertussis (acellular, component) (PA), hepatitis B (rDNA) (HBV), poliomyelitis (inactivated) (IPV) and Haemophilus influenzae type b (Hib) conjugate vaccine (adsorbed)
Infanrix hexa konjugirano (adsorbirano) cepivo proti davici (D), tetanusu (T), oslovskemu kašlju (acelularno, komponentno) (PA), hepatitisu B (rDNA) (HBV), otroški paralizi (inaktivirano) (IPV) in bakteriji Haemophilus influenzae tipa b (Hib)
It must not be used in infants who have had an allergic reaction to a vaccine containing diphtheria, tetanus, pertussis, hepatitis B, polio or Hib.
Ne sme se uporabljati pri dojenčkih, ki so v preteklosti imeli alergijsko reakcijo na cepivo, ki je vsebovalo komponente davice, tetanusa, oslovskega kašlja, hepatitisa B, otroške paralize ali Hib.
The effects of Infanrix hexa were compared with those of separate vaccines containing the same active substances.
Učinke zdravila Infanrix hexa so primerjali z učinki ločenih cepiv, ki so vsebovala enake zdravilne učinkovine.
Over 3,000 of the children received a course of vaccination with Infanrix hexa.
Z zdravilom Infanrix hexa je bilo cepljenih več kot 3 000 otrok.
Infanrix hexa is a vaccine used to protect babies and toddlers against diphtheria, tetanus, pertussis (whooping cough), hepatitis B, poliomyelitis (polio) and diseases such as bacterial meningitis caused by the bacterium Haemophilus influenzae type b (Hib).
Zdravilo Infanrix hexa je cepivo za zaščito dojenčkov in malčkov proti davici, tetanusu, oslovskemu kašlju, hepatitisu B, poliomielitisu (otroški paralizi) in boleznim, kot je bakterijski meningitis, ki ga povzroča bakterija Haemophilus influenzae tipa b (Hib).
Infanrix hexa is available as a powder and suspension that are made up into a suspension for injection.
Zdravilo Infanrix hexa je na voljo kot prašek in raztopina za pripravo raztopine za injiciranje.
These studies showed that booster vaccinations with Infanrix hexa were as effective as giving separate vaccines containing the same active substances 1 month after the booster vaccination.
V teh študijah so dokazali, da je bilo poživitveno cepljenje z zdravilom Infanrix hexa en mesec po poživitvenem cepljenju enako učinkovito kot dajanje ločenih cepiv, ki so vsebovala enake zdravilne učinkovine.
Infanrix hexa has been shown to be effective at producing protective levels of antibodies against diphtheria, tetanus, pertussis, hepatitis B virus, polioviruses, and Hib.
Dokazali so, da je zdravilo Infanrix hexa učinkovito pri tvorjenju zaščitnih ravni protiteles proti davici, tetanusu, oslovskemu kašlju, virusu hepatitisa B, poliovirusom in Hib.
The immune system will then be able to produce antibodies more quickly when the person comes into contact with the bacteria or viruses.
Ko bo oseba prišla v stik z bakterijami ali virusi, bo imunski sistem zato sposoben hitreje tvoriti protitelesa.
How is Infanrix hexa used?
Kako se zdravilo Infanrix hexa uporablja?
Overall, between 95 and 100% of the children had antibodies to diphtheria, tetanus, pertussis, hepatitis B virus, polioviruses, and Hib, 1 month after the vaccination course.
Po enem mesecu od cepljenja je na splošno med 95 in 100 % otrok razvilo protitelesa proti davici, tetanusu, oslovskemu kašlju, hepatitisu B, poliovirusom in Hib.
How does Infanrix hexa work?
Kako zdravilo Infanrix hexa deluje?
5 x (1 x 10 ml) vials
5 x (1 x 10 ml) vial
EU number Invented name Strength Pharmaceutical form Route of administration Packaging Content (concentration)
Lastniško ime Jakost Farmacevtska obllika
You can do this by holding them in your hands until they feel as warm as your hands.
To lahko naredite tako, da ju držite v dlaneh, dokler nista enako topli kot vaše dlani.
Your doctor might change the dose.
Zdravnik vam lahko spremeni odmerek.
When to treat yourself
Kdaj se morate zdraviti
Positive status indicates at least one positive test at any admission.
Pozitivni status pomeni vsaj en pozitivni test pri katerem koli sprejemu v bolnišnico.
Always wash your hands and ensure that the area around you is clean.
Vedno si umijte roke in poskrbite, da je vaša okolica čista.
It must be colourless.
Biti mora brezbarvna.
Monitoring of treatment - laboratory tests
Nadziranje zdravljenja - laboratorijske preiskave
Two dosing regimens can be recommended:
Priporočiti je mogoče dve shemi odmerjanja:
This reduces the need for hospitalisation and days absent from work and school.
To zmanjša potrebo po sprejemu v bolnišnico in število dni odsotnosti z dela ali iz šole.
Handling procedures for both presentations are described below.
Postopki za ravnanje z obema oblikama so opisani spodaj.
Talk to your doctor about when to use the injections and how long to keep using them.
Posvetujte se z zdravnikom o tem, kako uporabljati injekcije in kako dolgo nadaljevati z njihovo uporabo.
Date of first authorisation: 23 February 1996 Date of latest renewal: 23 February 2006
Datum zadnjega podaljšanja: 23. februar 2006
To achieve the best results, follow the prescribed dose carefully.
Da boste dosegli najboljše uspehe, natančno upoštevajte predpisani odmerek.
• If you are allergic to mouse, hamster or cow proteins (such as cows' milk).
• če ste alergični na mišje, hrčkove ali kravje beljakovine (npr. kravje mleko).
Clearance appears related with age, therefore in younger patients clearance may be increased by more than 50%.
Kot kaže, je očistek povezan s starostjo, zato je lahko očistek pri mlajših bolnikih za več kakor 50 % večji.
The equipment is for single use only.
Oprema je namenjena samo za enkratno uporabo.
You will usually need hospital care.
Verjetno boste potrebovali zdravljenje v bolnišnici.
Distribution, elimination and linearity
Porazdelitev, izločanje in linearnost
The pharmacokinetic profiles indicated dose proportionality.
Farmakokinetični profili so pokazali sorazmernost odmerku.
1 KIU equals 1,000 IU (International Units).
je enako 1.000 i.e. (mednarodnih enot).
• Inject slowly over 2 to 5 minutes.
• Injicirajte počasi, v času od 2 do 5 minut.
• Check the name, strength and colour of the package, to make sure it contains the correct product.
• Preverite ime, jakost in barvo pakiranja; tako se boste prepričali, da vsebuje pravo zdravilo.
The pharmacokinetics were similar across sex and ethnic groups.
Farmakokinetika je bila med spoloma in etničnima skupinama podobna.
The mean in vivo plasma recovery was approximately 20%.
Povprečna in vivo obnova v plazmi je bila približno 20 %.
• Lack of effect or decreased response to treatment.
• Pomanjkljiv učinek ali zmanjšan odziv na zdravljenje.
• Wash your hands and dry them properly using a clean towel or air dry.
• Umijte si roke in jih povsem osušite s čisto brisačo ali na zraku.
Current clinical experience does not warrant a general differentiation in dosing between children and adults, although children have faster clearance than adults.
Trenutne klinične izkušnje ne zahtevajo splošno drugačnega odmerjanja pri otrocih in pri odraslih, čeprav je očistek pri otrocih hitrejši kot pri odraslih.
- Increased fibrin degradation products
- zvišanje razgradnih produktov fibrina
Remind your doctor if you have a history of allergic reactions as you may need to be monitored more carefully.
Zdravnika opozorite, če ste kdaj imeli alergijsko reakcijo, kajti morda vas bo moral natančneje spremljati.
All findings in the preclinical safety programme were related to the pharmacological effect of rFVIIa.
Vsi izsledki v programu predklinične varnosti so bili povezani s farmakološkim učinkom rFVIIa.
The dose schedule should not be intentionally increased above the recommended doses due to the absence of information on the additional risk that may be incurred.
Razporeda odmerkov se ne sme namenoma povečati nad priporočene odmerke, ker ni informacij o dodatnih tveganjih, ki jih to lahko povzroči.
• Each time you use NovoSeven, tell your doctor or hospital as soon as possible.
• Vsakokrat, ko uporabite zdravilo NovoSeven, o tem čim prej obvestite zdravnika ali bolnišnico.
- Angina pectoris
- angina pektoris
• In cases of a mild or moderate bleed, you should treat yourself as early as possible, ideally at home.
• V primerih blage ali zmerne krvavitve morate samozdravljenje začeti čim prej, najbolje doma.
The duration of home therapy should not exceed 24 hours.
Zdravljenje na domu ne sme trajati več kot 24 ur.
Pharmacotherapeutic group: Blood coagulation factors, ATC code: B02BD08
Farmakoterapevtska skupina: krvni koagulacijski faktorji, oznaka ATC: B02BD08.
The mean terminal half-life ranged from 3.9 to 6.0 hours.
Povprečni terminalni razpolovni čas sega od 3,9 do 6,0 ur.
Invasive procedure/surgery
Invazivni postopki/operacija
Start treatment of a bleed as early as possible, ideally within 2 hours.
Zdravljenje krvavitve začnite čim prej, najbolje v 2 urah.
• If bleeding is not controlled within 24 hours, contact your doctor immediately.
• Če krvavitev ni obvladana v 24 urah, se nemudoma posvetujte s svojim zdravnikom.
IX > 5 Bethesda Units (BU)
5 Bethesda-enot (BU),
Do not treat yourself for longer than 24 hours without consulting your doctor.
Sami se ne smete zdraviti več kot 24 ur, ne da bi se posvetovali z zdravnikom.
• Do not use this medicine after the expiry date that is stated on the carton.
• Zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli.
This incompatibility may prevent administration of the drug and/or result in damage to the needleless connector.
Ta nezdružljivost lahko prepreči aplikacijo zdravila in/ali povzroči okvaro brezigelnega konektorja.
Follow the instructions for use for the needleless connector.
Upoštevajte navodila za uporabo brezigelnega konektorja.
The dose should be repeated after 2 hours and then at 2 - 3 hour intervals for the first 24 - 48 hours depending on the intervention performed and the clinical status of the patient.
Odmerek je treba ponoviti čez 2 uri in potem v 2- do 3-urnih presledkih v prvih 24 do 48 urah, odvisno od opravljenega posega in bolnikovega kliničnega stanja.
If not used immediately, the conditions prior to use are the responsibility of the user and the in-use storage time must not be longer than as stated above.
Če zdravilo ni uporabljeno takoj, so pogoji pred uporabo odgovornost uporabnika in čas shranjevanja med uporabo ne sme biti daljši, kot je navedeno zgoraj.
• If you have a serious blood infection
• če imate resno okužbo krvi,
- Therapeutic response decreased*
- zmanjšan terapevtski odziv*
Treatment with NovoSeven, alone or in combination with antifibrinolytics and/or platelets, was defined as effective when bleeding was stopped for at least 6 hours.
Zdravljenje z zdravilom NovoSeven, samim ali v kombinaciji z antifibrinolitiki in/ali s trombociti, je bilo opredeljeno kot učinkovito, če se je krvavitev ustavila za vsaj 6 ur.
* Lack of efficacy (therapeutic response decreased) has been reported.
* Opisano je bilo pomanjkanje učinkovitosti (zmanjšan terapevtski odziv).
In most cases of blood clots, the patients were predisposed to blood clotting disorders.
V večini primerov krvnih strdkov so bolniki imeli nagnjenost k motnjam strjevanja krvi.
• If not reconstituted, pooled or used as recommended the in-use times and conditions prior to use are the responsibility of the user.
• Če zdravilo ni pripravljeno, združeno ali uporabljeno, kot je priporočeno, so čas in pogoji med uporabo odgovornost uporabnika.
- Hypersensitivity (see sections 4.3 and 4.4)
- preobčutljivost (glejte poglavji 4.3 in 4.4)
The excretion of rFVIIa in milk has not been studied in animals.
Izločanje rFVIIa v mleko pri živalih ni raziskano.
As a precautionary measure, it is preferable to avoid use of NovoSeven during pregnancy.
Iz previdnosti se je uporabi zdravila NovoSeven med nosečnostjo bolje izogniti.