natgillin/translations-raw huggingface dataset:
koncentrat za raztopino za infundiranje
Concentrate for solution for infusion
Koncentrat za raztopino za infundiranje (sterilen koncentrat).
Concentrate for solution for infusion (sterile concentrate).
koncentrat za raztopino za infundiranje 130 mg/26 ml
Concentrate for Solution for infusion 130 mg/26 mL
Koncentrata zdravila Zoledronska kislina Actavis ne smete mešati z raztopinami, ki vsebujejo kalcij ali kakšne druge dvovalentne katione, npr. z raztopino Ringerjevega laktata.
Do not mix Zoledronic acid Actavis concentrate with calcium-containing or other divalent cation containing solutions such as lactated Ringer’s solution.
Koncentrationstidsprofilerna är liknande för epitelvätska och plasma.
The concentration time profiles are similar for ELF and plasma.
Konjunktivitis
Conjunctivitis
Konjunktivitis.
Conjunctivitis.
Konjunktivizacija je en izmed najpomembnejših simptomov LSCD.
Conjunctivalisation is one of the most important symptoms of LSCD.
Konstipácia
Constipation
Kontakt Deres dyrlæge vedrørende bortskaffelse af lægemidler, der ikke længere findes anvendelse for.
Ask your veterinary surgeon how to dispose of medicines no longer required.
Kontakta din läkare igen innan du börjar ta Emtriva oral lösning på nytt.
Contact your doctor again before you restart taking Emtriva oral solution.
Kontakta din läkare igen innan du börjar ta kapslar med Emtriva på nytt.
Contact your doctor again before you restart taking Emtriva capsules.
Kontakta ombudet för innehavaren av godkännandet för försäljning om du vill veta mer om detta läkemedel:
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Kontaktujte ihned svého lékaře, pokud se u Vás objeví: horečka, známky infekce nebo extrémní únava.
Contact your doctor immediately if you experience: fever, signs of infection or extreme tiredness.
Kontracepcija pri moških in ženskah
Contraception in males and females
Kontracepcijska zaščita moških in žensk
Contraception in males and females
Kontraindicirana sočasna uporaba: Cepivo proti rumeni mrzlici: tveganje za smrtno generalizirano bolezen po cepljenju (glejte poglavje 4.3).
Concomitant use contraindicated: Yellow fever vaccine: risk of fatal generalised vaccinale disease (see section 4.3).
Kontraindikace
Contraindications
Kontraindikacije
Contraindications
Kontraindikacije
Renal impairment
Kontraindikacije za cisplatin; oglejte si povzetek glavnih značilnosti za cisplatin.
Contraindications for cisplatin; refer to the cisplatin SmPC.
Kontraindikationer
Contraindications
Kontraindikácie
Contraindications
Kontrolní seznam k probíhajícímu sledování a řízení bezpečnosti pacientů, včetně fáze titrace během léčby přípravkem Intuniv
Checklist for ongoing monitoring and safety management of patients including titration phase during treatment with Intuniv
Kontrolní seznam před zahájením léčby přípravkem Intuniv za účelem identifikace pacientů s rizikem závažných nežádoucích účinků
Checklist prior to initiating treatment with Intuniv to identify patients at risk for serious undesirable effects
Kontroly, které bude Váš lékař provádět během léčby přípravkem Intuniv
Checks your doctor will do when you take Intuniv
kontuzija, napaka pri predpisovanju zdravila
Contusion, medication error
Konvulzije, hipestezija in tetanija (zaradi
(secondary to hypocalcaemia)
Končna produkta dušikovega oksida, ki vstopita v krvni obtok, sta večinoma methemoglobin in nitrat.
The end medicinal products of nitric oxide that enter the systemic circulation are predominantly methaemoglobin and nitrate.
Končna produkta dušikovega oksida, ki vstopita v krvni obtok, sta večinoma methemoglobin in nitrat.
Thus, the end products of nitric oxide that enter the systemic circulation are predominantly methaemoglobin and nitrate.
Končna razpolovna doba izločanja iz plazme je približno 3 do 5 ur.
Terminal plasma half- life is approximately 3-5 hours.
Končna razpolovna doba izločanja iz plazme je približno 3 do 5 ur.
Terminal plasma half-life is approximately 3-5 hours.
Končna razpolovna doba izločanja iz plazme je približno 4 do 5 ur.
Terminal plasma half- life is approximately 4-5 hours.
Končna razpolovna doba izločanja iz plazme je približno 4 do 5 ur.
Terminal plasma half-life is approximately 4-5 hours.
Končni volumen v infuzijski vrečki mora biti 250 ml.
The final volume in the infusion bag should be 250 mL.
Koostoimed teiste ravimitega
Interactions with other medicinal products
Koostoimed teiste ravimitega ja muud koostoimed
Interaction with other medicinal products and other forms of interaction
Kopolymer MA/EA 1:1 Monohydrát laktosy Povidon
Methacrylic acid-Ethyl acrylate copolymer Lactose monohydrate
Koprivnica.
Urticaria.
kopřivka (svědivá vyrážka), alopecie (neobvyklá ztráta nebo řídnutí vlasů), pruritus (svědění)
urticaria (itchy rash), alopecia (unusual hair loss or thinning), pruritus (itching)
Korduvannuse uuringutes koertel hemolüütilist aneemiat ei täheldatud.
In repeat dose studies in dogs, haemolytic anaemia was not observed.
Korigirani serumski kalcij se je hitreje normaliziral 4. dan z 8 mg zoledronske kisline in 7. dan s 4 mg in 8 mg zoledronske kisline.
There was faster normalisation of corrected serum calcium at day 4 for 8 mg zoledronic acid and at day 7 for 4 mg and 8 mg zoledronic acid.
Koristnosti zdravljenja s kombinacijo klopidrogela in ASA, ki bi bilo daljše od štirih tednov, v tem okviru niso preučevali (glejte poglavje 5.1).
The benefit of the combination of clopidogrel with ASA beyond four weeks has not been studied in this setting (see section 5.1).
Korsresistens bland medlemmar som tillhör azolklassen av läkemedel har observerats inom Candida-arter, även om resistens mot en medlem av klassen inte nödvändigtvis ger resistens mot andra azoler.
Cross-resistance amongst members of the azole class of drugs has been observed within Candida species although resistance to one member of the class does not necessarily confer resistance to other azoles.
Korsresistens bland medlemmar som tillhör azolklassen av läkemedel har observerats inom Candida-arter, även om resistens mot en medlem av klassen inte nödvändigtvis ger resistens mot andra azoler.
Cross-resistance amongst members of the azole class of drugs has been observed within Candida species, although resistance to one member of the class does not necessarily confer resistance to other azoles.
Kortikosteroidi
Corticosteroids
KORTIKOSTEROIDY
CORTICOSTEROIDS
koruzni škrob
Magnesium stearate
Kot je bilo pričakovati, se bolniki v slabšem telesnem stanju (PS>1) slabše odzivajo na zdravilo in pri njih tudi pogosteje opažamo zaplete, kot so zvišana telesna temperatura, okužbe in sepsa (glejte poglavje 4.8).
As expected, patients with poor performance status (PS>1) have a lower response rate and an increased incidence of complications such as fever, infection and sepsis (see section 4.8).
Kot posledico toksičnosti pemetrekseda v kombinaciji s cisplatinom za prebavila so opažali hudo dehidracijo.
Due to the gastrointestinal toxicity of pemetrexed given in combination with cisplatin, severe dehydration has been observed.
Kot pri drugih antitrombotikih je potrebno klopidogrel uporabljati previdno pri bolnikih s tveganjem za povečano krvavitev zaradi poškodbe, kirurškega posega ali drugih patoloških stanj in pri bolnikih, ki se zdravijo z acetilsalicilno kislino, heparinom ali zaviralci glikoproteina IIb/IIIa ali nesteroidnimi protivnetnimi zdravili (NSAID) vključno z zaviralci COX-2 ali s selektivnimi zaviralci privzema serotonina (SSRI).
As with other antiplatelet agents, clopidogrel should be used with caution in patients who may be at risk of increased bleeding from trauma, surgery or other pathological conditions and in patients receiving treatment with ASA, heparin, glycoprotein IIb/IIIa inhibitors or non-steroidal anti-inflammatory drugs (NSAIDs) including Cox-2 inhibitors, or selective serotonin reuptake inhibitors (SSRIs).
Kot pri drugih potencialno toksičnih učinkovinah za zdravljenje raka je potrebna previdnost pri ravnanju z raztopinami pemetrekseda za infundiranje ter pripravi teh raztopin.
As with other potentially toxic anti-cancer agents, care should be exercised in the handling and preparation of pemetrexed infusion solutions.
Kot varnostni ukrep se je med nosečnostjo bolje izogibati uporabi zdravila STELARA.
As a precautionary measure, it is preferable to avoid the use of STELARA in pregnancy.
Kot velja za vsako citotoksično kemoterapijo, morate svetovati uporabo učinkovite kontracepcijske zaščite, če se kateri od partnerjev zdravi s topotekanom.
As with all cytotoxic chemotherapy, effective contraceptive methods must be advised when either partner is treated with topotecan.
Kot vsa zdravila ima lahko tudi to zdravilo neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi zdravilo Pramipeksol Accord neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi zdravilo Teysuno neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
Like all medicines, Teysuno can cause side effects, although not everybody gets them.
Kot vsa zdravila, ima lahko tudi zdravilo PhotoBarr neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
Like all medicines, PhotoBarr can cause side effects, although not everybody gets them.
Kovaltry 1000 IU съдържа (1 000 IU / 2,5 ml) = 400 IU октоког алфа на ml след разтваряне.
Kovaltry 1000 IU contains (1,000 IU / 2.5 mL) = 400 IU octocog alfa per mL after reconstitution.
Kovaltry 1000 IU съдържа (1 000 IU / 2,5 ml) = 400 IU октоког алфа на ml след разтваряне.
Kovaltry 1000 IU contains (1000 IU / 2.5 mL) = 400 IU octocog alfa per mL after reconstitution.
Kovaltry 2000 IU съдържа (2 000 IU / 5 ml) = 400 IU октоког алфа на ml след разтваряне.
Kovaltry 2000 IU contains (2,000 IU / 5 mL) = 400 IU octocog alfa per mL after reconstitution.
Kovaltry 2000 IU съдържа (2 000 IU / 5 ml) = 400 IU октоког алфа на ml след разтваряне.
Kovaltry 2000 IU contains (2000 IU / 5 mL) = 400 IU octocog alfa per mL after reconstitution.
Kovaltry 250 IU прах и разтворител за инжекционен разтвор Kovaltry 500 IU прах и разтворител за инжекционен разтвор Kovaltry 1000 IU прах и разтворител за инжекционен разтвор Kovaltry 2000 IU прах и разтворител за инжекционен разтвор Kovaltry 3000 IU прах и разтворител за инжекционен разтвор Рекомбинантен човешки коагулационен фактор VІІІ (октоког алфа) (Recombinant human coagulation factor VIII (octocog alfa))
Kovaltry 250 IU powder and solvent for solution for injection Kovaltry 500 IU powder and solvent for solution for injection Kovaltry 1000 IU powder and solvent for solution for injection Kovaltry 2000 IU powder and solvent for solution for injection Kovaltry 3000 IU powder and solvent for solution for injection Recombinant human coagulation factor VIII (octocog alfa)
Kovaltry 250 IU прах и разтворител за инжекционен разтвор Kovaltry 500 IU прах и разтворител за инжекционен разтвор Kovaltry 1000 IU прах и разтворител за инжекционен разтвор Kovaltry 2000 IU прах и разтворител за инжекционен разтвор Kovaltry 3000 IU прах и разтворител за инжекционен разтвор рекомбинантен човешки коагулационен фактор VІІІ (октоког алфа)
Kovaltry 250 IU powder and solvent for solution for injection Kovaltry 500 IU powder and solvent for solution for injection Kovaltry 1000 IU powder and solvent for solution for injection Kovaltry 2000 IU powder and solvent for solution for injection Kovaltry 3000 IU powder and solvent for solution for injection recombinant human coagulation factor VIII (octocog alfa)
Kovaltry 250 IU съдържа (250 IU / 2,5 ml) = 100 IU октоког алфа на ml след разтваряне.
Kovaltry 250 IU contains (250 IU / 2.5 mL) = 100 IU octocog alfa per mL after reconstitution.
Kovaltry 3000 IU съдържа (3 000 IU / 5 ml) = 600 IU октоког алфа на ml след разтваряне.
Kovaltry 3000 IU contains (3,000 IU / 5 mL) = 600 IU octocog alfa per mL after reconstitution.
Kovaltry 3000 IU съдържа (3 000 IU / 5 ml) = 600 IU октоког алфа на ml след разтваряне.
Kovaltry 3000 IU contains (3000 IU / 5 mL) = 600 IU octocog alfa per mL after reconstitution.
Kovaltry 500 IU съдържа (500 IU / 2,5 ml) = 200 IU октоког алфа на ml след разтваряне.
Kovaltry 500 IU contains (500 IU / 2.5 mL) = 200 IU octocog alfa per mL after reconstitution.
Kovaltry е лекарство, което се използва за лечение и профилактика на кръвоизливи при пациенти с хемофилия А (наследствено нарушение на кръвосъсирването, причинено от липсата на протеин, наречен фактор VIII, отговорен за съсирването на кръвта).
Kovaltry is a medicine used for the treatment and prevention of bleeding in patients with haemophilia A (an inherited bleeding disorder caused by lack of a clotting protein called factor VIII).
Kovaltry е лекарство, което съдържа активното вещество човешки рекомбинантен коагулационен фактор VІІІ, наричано още октоког алфа.
Kovaltry is a medicine that contains the active substance human recombinant coagulation factor VIII, also called octocog alfa.
Kovaltry е получен чрез рекомбинантна технология без добавяне на никакви компоненти от човешки или животински произход в процеса на производство.
Kovaltry is prepared by recombinant technology without addition of any human- or animal-derived components in the manufacturing process.
Kovaltry прах трябва да се разтвори с предоставения разтворител (2,5 ml или 5,0 ml вода за инжекции) в предварително напълнена спринцовка и вградено уплътнение и приспособление за прехвърляне на течност.
Kovaltry powder should only be reconstituted with the supplied solvent (2.5 mL or 5 mL water for injections) in the prefilled syringe and the integrated seal and liquid transfer component.
Kovaltry се използва за лечение и предпазване от кръвоизливи при възрастни, юноши и деца от всички възрасти с хемофилия А (вроден дефицит на фактор VІІІ).
Kovaltry is used for treatment and prevention of bleeding in adults, adolescents and children of all ages with haemophilia A (congenital factor VIII deficiency).
Kovaltry се предлага като прах и разтворител за инжекционен разтвор и е сух бял до бледожълт прах или компактна маса.
Kovaltry is provided as a powder and solvent for solution for injection and is a dry, white to slightly yellow powder or cake.
Kovaltry трябва да се разтвори и приложи с помощта на съдържащите се във всяка опаковка принадлежности (предварително напълнена спринцовка, набор за венепункция).
Kovaltry should be reconstituted and administered with the components (prefilled syringe, venipuncture set) provided with each package.
Koža: izguba las, srbenje, izpuščaj (ali dermatitis, kožna reakcija), suha koža, reakcije na rokah in nogah (bolečina, otekanje in pordelost rok in/ali nog), pigmentne lise na koži
Skin: hair loss, itchiness, rash or dermatitis, skin reaction, dry skin, hand-and-foot reaction (pain, swelling and redness of hands and/or feet), pigmented skin patches
Kože ne stiskajte premočno.
Do not squeeze it tightly
Kožne reakcije (pordelost in oteklost) na mestu infundiranja, izpuščaj, srbenje.
Skin reactions (redness and swelling) at the infusion site, rash, itching.
kožni izpuščaj, bolezenska sprememba na lasišču/laseh (vključno z alopecijo)
Skin rash, Scalp/hair abnormality (including alopecia)
Kožni preskus preobčutljivosti na svetlobo
Photosensitivity skin test
KPATKA XAPAKTEPl1CTl1KA HA nPO)],YKTA l1ME HA JIEKAPCTBEHl1.s nPO)],YKT
SUMMARY OF PRODUCT CHARACTERISTICS
KRABIČKA
CARTON
Krakow Полша
Krakow Poland
Krampanfall har förekommit i toxikologiska studier vid Cmax-nivåer av ceftarolin som var 7-25 gånger den till människa (se avsnitt 5.3).
Seizures have occurred in toxicology studies at 7-25 times human ceftaroline Cmax levels (see section 5.3).
Kramper har observerats vid relativt hög exponering i studier med enkla och multipla doser hos både råtta och apa (≥ 7 gånger beräknad Cmax-nivå av ceftarolin för en dos på 600 mg två gånger per dag).
Convulsions have been observed at relatively high exposures during single and multi-dose studies in both the rat and monkey (≥ 7 times to the estimated ceftaroline Cmax level of a 600 mg twice a day).
Kraste navadno izginejo v dveh tednih po tem, ko smo opazili male otekline.
The scabs usually disappear within 2 weeks after the small swellings have been observed.
Kratek opis in razlaga Barretovega požiralnika ter visoke stopnje displazije
Brief background and introduction to Barrett’s oesophagus and high grade dysplasia
Kraven för att lämna in periodiska säkerhetsrapporter för detta läkemedel anges i den förteckning över referensdatum för unionen (EURD-listan) som föreskrivs i artikel 107c.7 i direktiv 2001/83/EG och eventuella uppdateringar och som offentliggjorts på webbportalen för europeiska läkemedel.
The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of European Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Kraven för att lämna in periodiska säkerhetsrapporter för detta läkemedel anges i den förteckning över referensdatum för unionen (EURD-listan) som föreskrivs i artikel 107c.7 i direktiv 2001/83/EG och eventuella uppdateringar och som offentliggjorts på webbportalen för europeiska läkemedel.
The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web- portal.
KRd = Kyprolis, леналидомид и дексаметазон; Rd = леналидомид и дексаметазон;
KRd = Kyprolis, lenalidomide and dexamethasone; Rd = lenalidomide and dexamethasone;
KRd = Kyprolis, леналидомид и дексаметазон; Rd = леналидомид, дексаметазон; PFS = преживяемост без прогресия; HR = коефициент на риск; CI = доверителен интервал; IMWG = Международна работна група по миелом; EBMT = Европейска група по костно-мозъчна трансплантация
KRd = Kyprolis, lenalidomide and dexamethasone; Rd = lenalidomide, dexamethasone; PFS = progression-free survival; HR = hazard ratio; CI = confidence interval; IMWG = International Myeloma Working Group; EBMT = European blood and marrow transplantation
KRd комбинирана терапия
KRd combination therapy
KRd рамоa (N = 396)
KRd arma (N = 396)
Kreatin-fosfokinaza se je klinično pomembno zvišala (KF ≥ 5-kratnika ZMN ≥ 10-kratnika ZMN brez simptomov v mišicah) pri 0,38 % bolnikov, ki so prejemali zdravilo Pravafenix.
Clinically important elevations in creatine phosphokinase (CK ≥ 5 times the ULN, < 10 times the ULN without muscular symptoms) were seen in 0.38% of the patients treated with Pravafenix.
Kreatinin- clearancea (ml/min)
Creatinine clearancea
Kreatininclearance (CLcr) (ml/min)
Creatinine Clearance (CLcr) (ml/min)
Kreatínfosfokináza (CPK)  2,5 x ULN
Creatine phosphokinase (CPK)  2.5 x ULN
Kriteriji ne-manjvrednosti so bili izpolnjeni, če je bila spodnja meja 97,5-odstotnega intervala za razliko med pogostnostjo popolnega odziva pri intravenskem palonosetronu in pri intravenskem ondansetronu večja kot -15 %.
Non- inferiority criteria were met if the lower bound of the 97.5% confidence interval for the difference in Complete Response rates of intravenous palonosetron minus intravenous ondansetron was larger than -15%.
Krivulje preživetja so pokazale, da so imeli do konca celotnega spremljevalnega obdobja bolniki v skupini, ki je dobivala PhotoBarr PDT + OM, 83% možnost, da ne zbolijo za rakom, v primerjavi s 53% možnostjo pri bolnikih, ki so se zdravili samo z OM.
The survival curves indicated that, by the end of the entire follow-up period, patients in the PhotoBarr PDT + OM group had a 83% chance of being cancer-free as compared to a 53% chance for patients in the OM only group.
Krivulje spreminjanja serumske koncentracije ustekinumaba s časom po enkratnem ali večkratnem dajanju subkutane injekcije zdravila so bile na splošno predvidljive.
Serum concentration-time profiles of ustekinumab were generally predictable after single or multiple subcutaneous dose administrations.
KRKA d.d., Novo mesto, Šmarješka cesta 6
KRKA, d.d., Novo mesto Šmarješka cesta 6
KRKA Finland Oy Puh/Tel: + 358 20 754 5330
KRKA Finland Oy Puh/Tel: +358 20 754 5330
KRKA Finland Oy Puh/Tel: +358 20 754 5330
KRKA Finland Oy Puh/Tel: + 358 20 754 5330
KRKA Latvija SIA
KRKA Latvija SIA Tel: + 371 6 733 86 10
KRKA Sverige AB KRKA Slovensko, s.r.o.
KRKA Sverige AB
KRKA България ЕООД Teл.: + 359 (02) 962 34 50
КРКА България ЕООД Teл.: + 359 (02) 962 34 50
KRKA – FARMA d.o.o.
KRKA - FARMA d.o.o.
KRKA, Belgium, SA.
KRKA Belgium, SA.
Krka, d.d, Novo mesto-Locna Šmarješka cesta 6
Krka, d.d., Novo mesto- Locna Šmarješka cesta 6
KRKA, d.d., Novo mesto Eesti filiaal Tel: + 372 (0) 6 671 658
KRKA, d.d., Novo mesto Eesti filiaal
KRKA, d.d., Novo mesto Eesti filiaal Tel: + 372 (0)6 671 658
KRKA, d.d., Novo mesto Eesti filiaal Tel: + 372 (0) 6 671 658
KRKA, d.d., Novo mesto Šmarješka cesta 6 8501 Novo mesto Словения
KRKA, d.d., Novo mesto Šmarješka cesta 6 8501 Novo mesto Slovenia
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto 8501, Словения
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Словения
KRKA, d. d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Словения KRKA-POLSKA Sp. z o.o., ul.
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia KRKA-POLSKA Sp. z o.o., ul.
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Словения TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Германия KRKA - FARMA d.o.o., V. Holjevca 20/E, 10450 Jastrebarsko, Хърватия
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany KRKA - FARMA d.o.o., V. Holjevca 20/E, 10450 Jastrebarsko, Croatia
KRKA, d.d., Novo mesto, Šmarješka cesta 6, Novo mesto, 8501, Словения
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
Kronična pulmonarna hipertenzija novorojenčka (PPHN – »pulmonary hypertension of the newborn«) se pojavlja kot primarna razvojna okvara ali kot posledica drugih bolezni, kot so mekonijski aspiracijski sindrom (MAS), pljučnica, sepsa, sindrom dihalne stiske pri novorojenčkih, prirojena diafragmalna hernija (CDH – »congenital diaphragmatic hernia«) in pljučna hipoplazija.
Persistent pulmonary hypertension of the newborn (PPHN) occurs as a primary developmental defect or as a condition secondary to other diseases such as meconium aspiration syndrome (MAS), pneumonia, sepsis, hyaline membrane disease, congenital diaphragmatic hernia (CDH), and pulmonary hypoplasia.
Kronični ali akutni pankreatitis, razen akutnega pankreatitisa zaradi hude hipertrigliceridemije (glejte poglavje 4.4).
Chronic or acute pancreatitis with the exception of acute pancreatitis due to severe hypertriglyceridaemia (see section 4.4).
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Krospovidon Talk
Crospovidone Talc
krvavenje, izguba krvi, večje nagnjenje k podpludbam.
bleeding, loss of blood, increased tendency to bruise
krvavitev iz nosu
nosebleed
krvavitev tumorja, bolečine pri raku
Tumour haemorrhage, cancer pain
krvavitev v prebavila in retroperitonealna krvavitev s smrtnim izidom, pankreatitis, kolitis (vključno z ulceroznim ali limfocitnim
Gastrointestinal and retroperitoneal haemorrhage with fatal outcome, pancreatitis, colitis (including ulcerative or lymphocytic colitis), stomatitis
krvavitev v prebavila, driska, bolečine v trebuhu, dispepsija
Gastrointestinal haemorrhage, diarrhoea, abdominal pain, dyspepsia
krvavitve na mestu vboda
Bleeding at puncture site
Krvavitve so bile najpogosteje opisan učinek tako v kliničnih študijah kot v obdobju trženja zdravila, kjer so se najpogosteje pojavile prvi mesec zdravljenja.
Bleeding is the most common reaction reported both in clinical studies as well as in post-marketing experience where it was mostly reported during the first month of treatment.