FrancophonIA/ELRC3.0 huggingface dataset:
English: Chemical and physical in-use stability has been demonstrated for 48 hours at 2°C-8°C and at 25°C after dilution in 100 ml sodium chloride 9 mg/ml (0.9%) solution for injection or 5% w/v glucose solution (minimal concentration: 3 mg/100 ml; maximal concentration: 4 mg/100 ml).
Slovenian: Med uporabo je bila dokazana kemična in fizikalna stabilnost 48 ur, pri temperaturi od 2 °C - 8 °C in pri temperaturi 25°C po redčenju v 100 ml raztopine natrijevega klorida 9 mg/ml (0,9 %) za injiciranje ali 5 % m/V raztopini glukoze (minimalna koncentracija: 3 mg/100 ml; maksimalna koncentracija: 4 mg/100 ml).
English: Caution is indicated when zoledronic acid is used with other potentially nephrotoxic medicinal products.
Slovenian: Ob sočasnem dajanju zoledronske kisline z drugimi potencialno nefrotoksičnimi zdravili, je potrebna previdnost.
English: After dilution: Chemical and physical in-use stability has been demonstrated for 48 hours at 2°C-8°C and at 25°C after dilution in 100 ml sodium chloride 9 mg/ml (0.9%) solution for injection or 5% w/v glucose solution (minimal concentration: 3 mg/100 ml; maximal concentration: 4 mg/100 ml).
Slovenian: Po redčenju: Med uporabo je bila dokazana kemična in fizikalna stabilnost 48 ur, pri temperaturi od 2°C - 8°C in pri temperaturi 25°C po redčenju v 100 ml raztopine natrijevega klorida 9 mg/ml (0.9 %) za injiciranje ali 5 % m/V raztopini glukoze (minimalna koncentracija: 3 mg/100 ml; maksimalna koncentracija: 4 mg/100 ml).
English: Uncommon: Rare:
Slovenian: ledvična okvara občasni: redki:
English: Caution is advised when zoledronic acid is administered with anti-angiogenic medicinal products as an increase in the incidence of ONJ has been observed in patients treated concomitantly with these medicinal products.
Slovenian: Pri uporabi zoledronske kisline skupaj z antiangiogenimi zdravili je potrebna previdnost, saj so pri bolnikih, ki so sočasno prejemali navedena zdravila, opažali povečano pogostnost osteonekroze čeljustnic.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/12/786/001
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/12/786/001
English: Zoledronic acid Mylan contains sodium.
Slovenian: Zdravilo Zoledronska kislina Mylan vsebuje natrij.
English: It is used: - To prevent bone complications, e.g. fractures, in adult patients with bone metastases (spread of cancer from primary site to the bone).
Slovenian: Uporabljamo jo za: - preprečevanje zapletov na kosteh, na primer zlomov, pri odraslih bolnikih z metastazami v kosteh (z razširitvijo raka s prvotnega mesta na kosti), - zniževanje količine kalcija v krvi pri odraslih, kadar je ta prevelika zaradi prisotnosti tumorja.
English: Statistically significant differences are marked (*p< 0.05) for between treatment comparisons (4 mg zoledronic acid vs.
Slovenian: Povprečne spremembe od izhodišča na BPI lestvici, označene so statistično značilne vrednosti p (*p< 0,05) za primerjavo med obema vrstama zdravljenja (4 mg zoledronska kislina v primerjavi s placebom)
English: Rare (may affect up to 1 in 1,000 people): - As a consequence of low calcium values: irregular heart beat (cardiac arrhythmia; secondary to hypocalcaemia).
Slovenian: Redki (lahko se pojavijo pri največ 1 od 1.000 bolnikov): - zaradi nizke vrednosti kalcija: motnje srčnega ritma (aritmija, razvije se zaradi hipokalciemije).
English: This medicinal product contains less than 1 mmol sodium (23 mg) per vial, i.e. essentially ‘sodium-free'.
Slovenian: Ena viala zdravila vsebuje manj kot 1 mmol natrija (23 mg) kar praktično pomeni, da “ne vsebuje natrija”.
English: You must not be given Zoledronic acid Mylan: - if you are breast-feeding.
Slovenian: Zdravila Zoledronska kislina Mylan ne smete dobiti: - če dojite.
English: Special precautions for disposal and other handling Prior to administration, 5 ml concentrate from one vial or the volume of the concentrate withdrawn as required must be further diluted with 100 ml of calcium-free infusion solution (sodium chloride 9 mg/ml (0.9%) solution for injection or 5% w/v glucose solution).
Slovenian: Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom Pred uporabo je treba 5 ml koncentrata iz ene viale oziroma ustrezni volumen odvzetega koncentrata dodatno razredčiti s 100 ml infuzijske raztopine v kateri ni kalcija (9 mg/ml (0,9 %) raztopine natrijevega klorida za injiciranje ali s 5-odstotno m/V raztopino glukoze).
English: • Hypersensitivity to the active substance, to other bisphosphonates or to any of the excipients listed in section 6.1
Slovenian: • preobčutljivost na zdravilno učinkovino, na druge difosfonate ali katero koli pomožno snov,
English: - Zoledronic acid Mylan must only be given by healthcare professionals trained in administering bisphosphonates intravenously, i.e. through a vein.
Slovenian: - Zdravilo Zoledronska kislina Mylan vam sme dati samo zdravstveni delavec, ki je usposobljen za intravensko (kar pomeni v veno) dajanje difosfonatov.
English: Administration of 0.001 mg/kg/day subcutaneously in rats and 0.005 mg/kg intravenously once every 2-3 days in dogs for up to 52 weeks was also well tolerated.
Slovenian: Podgane so dobro prenašale tudi do 52-tedensko subkutano dajanje po 0,001 mg/kg/dan, psi pa enako dolgo intravensko dajanje po 0,005 mg/kg enkrat na 2 - 3 dni.
English: Do not mix Zoledronic acid Mylan concentrate with calcium-containing or other divalent cation-containing solutions such as lactated Ringer's solution.
Slovenian: Ne mešajte rekonstituirane raztopine zdravila Zoledronska kislina Mylan z raztopinami, ki vsebujejo kalcij ali druge dvovalentne katione, na primer z raztopino Ringerjevega laktata.
English: - The other ingredients are: sodium citrate, sodium hydroxide, hydrochloric acid and water for injections.
Slovenian: - Pomožne snovi so natrijev citrat, natrijev hidroksid, klorovodikova kislina in prečiščena voda za injekcije.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/12/786/001-004
Slovenian: ŠTEVILKE DOVOLJENJ ZA PROMET Z ZDRAVILOM EU/1/12/786/001-004
English: Blood creatinine and blood urea increased, hypocalcaemia
Slovenian: zvišanje vrednosti kreatinina in sečnine v krvi, hipokalciemija občasni:
English: Rare (may affect up to 1 in 1,000 people): - Slow heart beat.
Slovenian: Redki (lahko se pojavijo pri največ 1 od 1.000 bolnikov): - počasno bitje srca, - zmedenost,
English: In the clinical studies, patients with serum creatinine > 400 μmol/l or > 4.5 mg/dl were excluded.
Slovenian: Bolniki z vrednostmi serumskega kreatinina > 400 µmol/l ali > 4,5 mg/dl so bili izključeni iz kliničnih študij.
English: How to prepare and administer Zoledronic acid Mylan
Slovenian: Kako pripraviti in dajati zdravilo Zoledronska kislina Mylan
English: 1 vial of 5 ml 4 vials of 5 ml 10 vials of 5 ml
Slovenian: Štiri viale s 5 ml
English: Zoledronic acid Mylan concentrate must not be mixed with calcium or other divalent cation-containing infusion solutions such as lactated Ringer's solution, and should be administered as a single intravenous solution in a separate infusion line.
Slovenian: Koncentrata zdravila Zoledronska kislina Mylan se ne sme mešati z infuzijskimi raztopinami, ki vsebujejo kalcij ali druge dvovalentne katione, na primer z raztopino Ringerjevega laktata in jo je treba dajati kot samostojno intravensko raztopino z ločenim infuzijskim sistemom.
English: Zoledronic acid is contraindicated in breast-feeding women (see section 4.3).
Slovenian: Pri doječih ženskah je uporaba zdravila Zoledronska kislina Mylan kontraindicirana (glejte poglavje 4.3).
English: The withdrawn amount of concentrate must be further diluted in 100 ml of sterile sodium chloride 9 mg/ml (0.9%) solution for injection or 5% w/v glucose solution.
Slovenian: Odvzeto količino koncentrata je potrebno dodatno redčiti v 100 ml 9 mg/ml (0,9 %) sterilne raztopine natrijevega klorida za injiciranje ali 5-odstotne (m/v) raztopine glukoze.
English: - Studies with polyolefin bags (prefilled with sodium chloride 9 mg/ml (0.9%) solution for injection or 5% w/v glucose solution), showed no incompatibility with Zoledronic acid Mylan.
Slovenian: - Študije s poliolefinskimi vrečkami (vnaprej napolnjenimi z 9 mg/ml (0,9 %) raztopino natrijevega klorida za injiciranje ali 5-odstotno m/V raztopino glukoze niso pokazale inkompatibilnosti z zdravilom Zoledronska kislina Mylan.
English: Warnings and precautions Talk to your doctor before you are given Zoledronic acid Mylan: - if you have or have had a kidney problem.
Slovenian: Preden vam dajo zdravilo Zoledronska kislina Mylan se posvetujte z zdravnikom: - če imate ali ste imeli težave z ledvicami.
English: Zoledronic acid 8 mg (N=90) 55.6% (p=0.021)* 83.3% (p=0.010)* 86.7% (p=0.015)* Pamidronate 90 mg (N=99) *p-values compared to pamidronate.
Slovenian: 55,6 % (p=0,021)* 83,3 % (p=0,010)* 86,7 % (p=0,015)*
English: Studies with polyolefin bags (prefilled with sodium chloride 9 mg/ml (0.9%) solution for injection or 5% w/v glucose solution), showed no incompatibility with Zoledronic acid Mylan.
Slovenian: Študije s poliolefinskimi vrečkami (vnaprej napolnjenimi z 9 mg/ml (0,9 %) raztopino natrijevega klorida za injiciranje ali 5-odstotno m/V raztopino glukoze niso pokazale inkompatibilnosti z zdravilom Zoledronska kislina Mylan.
English: Patients must be assessed prior to administration of zoledronic acid to ensure that they are adequately hydrated.
Slovenian: Splošno Pred uporabo zoledronske kisline je potrebno bolnike oceniti, za zagotovitev ustrezne hidratacije.
English: Prevention of skeletal related events in patients with advanced malignancies involving bone: When initiating treatment with zoledronic acid in patients with multiple myeloma or metastatic bone lesions from solid tumours, serum creatinine and creatinine clearance (CLcr) should be determined.
Slovenian: Pri uvajanju zdravljenja z zoledronsko kislino pri bolnikih z multiplim mielomom ali metastatičnimi kostnimi lezijami zaradi čvrstih tumorjev je treba določiti vrednosti serumskega kreatinina in očistka kreatinina (CLcr).
English: Zoledronic acid Mylan is not recommended for use in adolescents and children below the age of 18 years.
Slovenian: Pri otrocih in mladostnikih, ki so stari manj kot 18 let, uporaba zdravila Zoledronska kislina Mylan ni priporočljiva.
English: Zoledronic acid Mylan 4 mg/5 ml concentrate for solution for infusion Zoledronic acid
Slovenian: Zoledronska kislina Mylan 4 mg/5 ml koncentrat za raztopino za infundiranje zoledronska kislina
English: What Zoledronic acid Mylan contains - The active substance is zoledronic acid.
Slovenian: Kaj vsebuje zdravilo Zoledronska kislina Mylan - Zdravilna učinkovina zdravila Zoledronska kislina Mylan je zoledronska kislina.
English: No dose adjustment is necessary in TIH patients with serum creatinine < 400 μmol/l or < 4.5 mg/dl (see section 4.4).
Slovenian: Pri bolnikih s tumorsko povzročeno hiperkalciemijo (TIH), z vrednostmi serumskega kreatinina < 400 µmol/l ali < 4,5 mg/dl, prilagajanje odmerjanja ni potrebno (glejte poglavje 4.4).
English: Table 4: Efficacy results (breast cancer and multiple myeloma patients)
Slovenian: Preglednica 4: Rezultati učinkovitosti (bolnice/bolniki z rakom dojke in multiplim mielomom) katerikoli SRE (+TIH)
English: - Keep Zoledronic acid Mylan out of the sight and reach of children.
Slovenian: - Zdravilo Zoledronska kislina Mylan shranjujte nedosegljivo otrokom!
English: The adverse reactions ranked under headings of frequency, are presented in Table 6.
Slovenian: V preglednici 6 so prikazani po padajoči pogostnosti razvrščeni neželeni učinki.
English: - Do not use Zoledronic acid Mylan after the expiry date stated on the vial and carton after EXP. - The unopened vial does not require any specific storage conditions.
Slovenian: - Zdravilo Zoledronska kislina Mylan ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na viali in škatli za oznako EXP:.
English: Prevention of skeletal related events in patients with advanced malignancies involving bone Adults and elderly people
Slovenian: Preprečevanje z okostjem povezanih dogodkov pri bolnikih z napredovalimi malignimi boleznimi, ki zajamejo kosti
English: To avoid potential incompatibilities, the infusion solution used for dilution must be either sodium chloride 9 mg/ml (0.9%) solution for injection or 5% w/v glucose solution.
Slovenian: Da ne bi prišlo do možnih inkompatibilnosti, mora biti infuzijska raztopina, ki se uporablja za redčenje, bodisi raztopina natrijevega klorida za injiciranje 9 mg/ ml (0,9-odstotna ut/vol raztopina) bodisi 5-odstotna ut/vol raztopina glukoze.
English: To avoid potential incompatibilities, Zoledronic acid Mylan concentrate is to be diluted with sodium chloride 9 mg/ml (0.9%) solution for injection or 5% w/v glucose solution.
Slovenian: Da se izognete možnim nezdružljivostim, redčite koncentrat zdravila Zoledronska kislina Mylan s sterilno raztopino 9 mg/ml (0,9 %) natrijevega klorida za injiciranje ali 5-odstotno m/V raztopino glukoze.
English: Standard hypercalcaemia-related metabolic parameters, such as serum levels of calcium, phosphate and magnesium, should be carefully monitored after initiating zoledronic acid therapy.
Slovenian: Po začetku zdravljenja z zoledronsko kislino je treba skrbno spremljati standardne presnovne parametre, povezane s hiperkalciemijo, kot so: serumske koncentracije kalcija, fosfata in magnezija.
English: The first randomised, double-blind, placebo-controlled study compared zoledronic acid 4 mg to placebo for the prevention of skeletal related events (SREs) in prostate cancer patients.
Slovenian: Rezultati kliničnih preskušanj v preprečevanju z okostjem povezanih dogodkov pri bolnikih z napredovalimi malignimi boleznimi, ki zajemajo kosti V prvi randomizirani, dvojno slepi, s placebom nadzorovani študiji, so primerjali zoledronsko kislino 4 mg s placebom glede preprečevanja z okostjem povezanih dogodkov (SREs - skeletal related events) pri bolnikih z rakom prostate.
English: - For single use only.
Slovenian: - Zdravilo je namenjeno samo za enkratno uporabo.
English: Zoledronic acid 4 mg (N=86) 45.3% (p=0.104)
Slovenian: 45,3 % (p=0,104)
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Zoledronic acid Mylan 4 mg/5 ml concentrate for solution for infusion Zoledronic acid
Slovenian: IME ZDRAVILA IN POT(I) UPORABE Zoledronska kislina Mylan 4 mg/5 ml koncentrat za raztopino za infundiranje zoledronska kislina
English: NAME OF THE MEDICINAL PRODUCT Zoledronic acid Mylan 4 mg/5 ml concentrate for solution for infusion
Slovenian: IME ZDRAVILA Zoledronska kislina Mylan 4 mg/5 ml koncentrat za raztopino za infundiranje
English: In clinical trials with zoledronic acid, patients with serum creatinine > 265 μmol/l or > 3.0 mg/dl were excluded.
Slovenian: Bolniki z vrednostmi serumskega kreatinina > 265 µmol/l ali > 3,0 mg/dl so bili iz kliničnih študij z zoledronsko kislino izključeni.
English: Hypocalcaemia has been reported in patients treated with zoledronic acid.
Slovenian: O teh primerih so poročali predvsem pri odraslih bolnikih z rakom, ki so se zdravili z zoledronsko kislino.
English: How Zoledronic acid Mylan is used
Slovenian: Kako uporabljati zdravilo Zoledronska kislina Mylan
English: Osteonecrosis of the jaw (ONJ) has been reported uncommonly in clinical trials and in the post marketing setting in patients receiving zoledronic acid.
Slovenian: O osteonekrozi čeljustnic (ONJ) so občasno poročali pri bolnikih, ki so prejemali zoledronsko kislino v kliničnih preskušanjih ali so se z njim zdravili po začetku trženja zdravila.
English: Clinical trial results in the prevention of skeletal related events in patients with advanced malignancies involving bone
Slovenian: Preprečevanje z okostjem povezanih dogodkov pri bolnikih z napredovalimi malignimi boleznimi, ki zajamejo kosti:
English: There have been very rare cases of drowsiness and sleepiness with the use of zoledronic acid.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Ob uporabi zoledronske kisline je v zelo redkih primerih prišlo do dremavosti in zaspanosti.
English: In post-marketing experience, severe and occasionally incapacitating bone, joint, and/or muscle pain have been reported in patients taking zoledronic acid.
Slovenian: Iz izkušenj v obdobju trženja pri bolnikih, ki so prejemali zoledronsko kislino, so poročali o hudih bolečinah v kosteh, sklepih in/ali mišicah.
English: How to store Zoledronic acid Mylan
Slovenian: Shranjevanje zdravila Zoledronska kislina Mylan
English: Can't be sold separately.
Slovenian: Sestavni del skupnega pakiranja.Ni za posamezno prodajo.
English: STATEMENT OF ACTIVE SUBSTANCE(S) One vial contains 4 mg zoledronic acid (as monohydrate).
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena viala vsebuje 4 mg zoledronske kisline (v obliki monohidrata).
English: The concentrate is supplied in a clear and colourless glass vial with a rubber stopper and a plastic flip-off cap. One vial contains 5 ml of concentrate.
Slovenian: Koncentrat je pakiran v vialo iz prozornega brezbarvnega stekla z gumijastim zamaškom in plastičnim zaščitnim pokrovčkom.
English: - Irregular heart rhythm (atrial fibrillation) has been seen in patients receiving zoledronic acid for postmenopausal osteoporosis.
Slovenian: - pri bolnicah, ki so prejemale zoledronsko kislino zaradi pomenopavzalne osteoporoze, so opažali nepravilno bitje srca (atrijsko fibrilacijo).
English: Contact your doctor if you experience pain, weakness or discomfort in your thigh, hip or groin as this may be an early indication of a possible fracture of the thigh bone.
Slovenian: Posvetujte se z zdravnikom, če občutite bolečine, šibkost ali nelagodje v stegnu, kolku ali dimljah, saj so to lahko zgodnji znaki možnega zloma stegnenice, - intersticijska bolezen pljuč (vnetje tkiva okoli zračnih mešičkov v pljučih), - simptomi, ki spominjajo na gripo, vključno z artritisom in oteklinami sklepov, - boleča rdečina in/ali oteklina očesa.
English: Within three days after zoledronic acid administration, an acute phase reaction has commonly been reported, with symptoms including bone pain, fever, fatigue, arthralgia, myalgia, rigors and arthritis with subsequent joint swelling; these symptoms usually resolve within a few days (see description of selected adverse reactions).
Slovenian: Pogosto so poročali o reakciji akutne faze, do katere pride v prvih treh dneh po vnosu zoledronske kisline simptomi pa vključujejo bolečine v kosteh, zvišano telesno temperaturo, utrujenost, artralgijo, mialgijo, okorelost in artritis, ki povzroči otekline sklepov.
English: - Urticaria.
Slovenian: Navodilo shranite.
English: How Zoledronic acid Mylan is given - Zoledronic acid Mylan is given as a drip (infusion) into a vein which should take at least 15 minutes and should be administered as a single intravenous solution in a separate infusion line.
Slovenian: Kako boste prejeli zdravilo Zoledronska kislina Mylan - Zdravilo Zoledronska kislina Mylan dobijo bolniki v obliki infuzije v veno, ki naj traja vsaj
English: PHARMACEUTICAL FORM Concentrate for solution for infusion.
Slovenian: FARMACEVTSKA OBLIKA koncentrat za raztopino za infundiranje bistra in brezbarvna raztopina
English: Placebo zoledronic acid 4 mg
Slovenian: zdravljenje kosti z obsevanjem zoledronska kislina 4 mg placebo zoledronska kislina 4mg placebo zoledronska kislina 4 mg placebo
English: This is because you may develop serum electrolyte abnormalities (e.g. abnormal levels of calcium, phosphorus and magnesium) and/or changes in kidney function, including severe kidney impairment.
Slovenian: Če ste prejeli večji odmerek zdravila Zoledronska kislina Mylan, kot bi smeli Če ste prejeli odmerek, ki je večji od priporočenega, vas mora zdravnik natančno nadzorovati, zato ker lahko pride do nepravilnosti elektrolitov v serumu (do nepravilnih koncentracij kalcija, fosforja in magnezija) in/ali do spremenjenega delovanja ledvic, vključno z ledvično odpovedjo.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING BOX OF 1 VIAL
Slovenian: PODATKI NA ZUNANJI OVOJNINI ŠKATLA Z 1 VIALO ŠKATLA S 4 VIALAMI ŠKATLA Z 10 VIALAMI
English: You should not be given Zoledronic acid Mylan if you are pregnant.
Slovenian: Če ste noseči, vam ne bi smeli dati zdravila Zoledronska kislina Mylan.
English: - High blood pressure, shortness of breath, dizziness, anxiety, sleep disturbances, taste disturbances, trembling, tingling or numbness of the hands or feet, diarrhoea, constipation,
Slovenian: Občasni (lahko se pojavijo pri največ 1 od 100 bolnikov): - preobčutljivostne reakcije, - nizek krvni tlak, - bolečina v prsih, - kožne reakcije (rdečina in otekanje) na mestu infuzije, izpuščaj, srbenje, - visok krvni tlak, zadihanost, omotičnost, tesnoba, motnje spanja, motnje okušanja, tresenje,
English: You must not be given Zoledronic acid Mylan if you are breast-feeding.
Slovenian: Če dojite, vam ne smejo dati zdravila Zoledronska kislina Mylan.
English: Tell your doctor immediately if you experience symptoms such as new onset or worsening of aches, pain or stiffness while being treated with Zoledronic acid Mylan or after stopping treatment.
Slovenian: Če se med zdravljenjem ali po zaključku zdravljenja z zdravilom Zoledronska kislina Mylan pojavijo simptomi kot so pojav bolečine, ki je prej ni bilo, poslabšanje obstoječe bolečine ali okornost, takoj obvestite zdravnika.
English: Concentrate for solution for infusion
Slovenian: Način uporabe intravenska uporaba
English: Clinical trial results in the treatment of TIH
Slovenian: DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA
English: Blister (OPA/Alu /PVC-Alu) 10 x 1 tablets (unit dose)
Slovenian: 40 mg tableta peroralna uporaba pretisni omot (OPA/aluminij/PVCaluminij)
English: Tablet
Slovenian: Jakost
English: Date of first authorisation: 06 October 2008 Date of latest renewal: 06 October 2013
Slovenian: Datum prve odobritve: 6. oktober 2008 Datum zadnjega podaljšanja: 6. oktober 2013
English: The frequency of the type of event is not known (cannot be estimated from available data).
Slovenian: Pogostnost tovrstnega dogodka ni znana (ni mogoče oceniti iz razpoložljivih podatkov).
English: No data are currently available for ages younger than 2 years.
Slovenian: Trenutno ni razpoložljivih podatkov o uporabi pri otrocih, mlajših od 2 let.
English: The temperature must not exceed 37°C.
Slovenian: Temperatura ne sme preseči 37 °C.
English: Jerusalem 9777605, Israel
Slovenian: Jeruzalem 9777605, Izrael
English: Such substances should be removed to the greatest possible extent before applying the product.
Slovenian: Takšne snovi je treba pred uporabo zdravila čimbolj odstraniti.
English: The exact content and format of the educational material and educational programme including communication media, distribution modalities, and any other aspects of the programme, shall be agreed with the National Competent Authority.
Slovenian: Natančno vsebino in obliko izobraževalnega materiala in programa, vključno s komunikacijskimi mediji, načini razširjanja in vsemi drugimi vidiki programa je treba uskladiti s pristojnimi nacionalnimi organi.
English: The vials should be thawed in one of the following ways:
Slovenian: Viale morate odtaliti na enega od naslednjih načinov:
English: For laparoscopy, see recommendations below.
Slovenian: Glede laparoskopije glejte priporočila, ki so navedena spodaj.
English: Both syringes should be filled with equal volumes, and should not contain air bubbles.
Slovenian: Obe brizgi morata biti napolnjeni z enakim volumnom in ne smeta vsebovati zračnih mehurčkov.
English: Frequencies have been evaluated according to the following convention: 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).
Slovenian: Pogostnost je bila ocenjena v skladu z naslednjim dogovorom: 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).
English: Human Fibrinogen:
Slovenian: Humani fibrinogen:
English: At the Cmax, the plasma concentration represented only 1-2% of the applied dose.
Slovenian: Plazemska koncentracija Cmax je predstavljala le 1-2 % nanesenega odmerka.
English: The application can be repeated, if necessary.
Slovenian: Če je treba, se lahko nanašanje ponovi.