FrancophonIA/ELRC3.0 huggingface dataset:
English: The venipuncture set provided with the product must not be used for drawing blood because it contains an in line filter.
Slovenian: Priloženi pribor za vensko punkcijo se ne sme uporabljati za odvzem krvi, ker vsebuje filter.
English: Hold the vial on end above the vial adapter and syringe (I).
Slovenian: Vialo držite na koncu nad adapterjem za vialo in injekcijsko brizgo (I).
English: Table 3: Consumption and overall success rates (patients treated with prophylaxis only) Younger children years)
Slovenian: Preglednica 3: Poraba in skupna stopnja uspešnosti (samo bolniki s profilaktičnim zdravljenjem)
English: Development of neutralising antibodies (inhibitors) may occur in patients with haemophilia A treated with factor VIII (FVIII), including with Kovaltry.
Slovenian: Nevtralizirajoča protitelesa (inhibitorji) lahko nastanejo pri bolnikih s hemofilijo A, ki so bili zdravljeni s faktorjem VIII (FVIII), vključno z zdravilom Kovaltry.
English: This medicine may be stored at room temperature (up to 25 °C) for up to 12 months when you keep it in its outer carton.
Slovenian: To zdravilo lahko shranjujete pri sobni temperaturi (do 25 °C) največ 12 mesecev, če ga hranite v zunanji ovojnini.
English: Post-authorisation Efficacy Study: In order to investigate the safety and efficacy of Kovaltry in previously untreated patients, the MAH should submit the results of the ongoing study “13400 - Leopold Kids Part B”
Slovenian: Poavtorizacijska študija učinkovitosti: Z namenom raziskati varnost in učinkovitost zdravila Kovaltry pri predhodno nezdravljenih bolnikih, mora imetnik dovoljenja za promet predložiti izsledke študije, ki je v teku »13400
English: 1 vial with powder, 1 pre-filled syringe with water for injections, 1 vial adapter and 1 venipuncture set.
Slovenian: 1 viala s praškom, 1 napolnjena injekcijska brizga z vodo za injekcije, 1 adapter za vialo in 1 pribor za vensko punkcijo.
English: ≥ 18 years N=109
Slovenian: ≥ 18 let n = 109
English: Also factor VIII is an intrinsic protein and not known to cause any reproductive or carcinogenic effects.
Slovenian: je intrinzična beljakovina in ni znano, da ima kakršne koli učinke na sposobnost razmnoževanja ali kancerogene učinke.
English: For patients who have received previous treatment with factor VIII (more than 150 days of treatment) inhibitor antibodies (see section 2) may form uncommonly (less than 1 in 100 patients).
Slovenian: Pri bolnikih, ki so bili predhodno zdravljeni s faktorjem VIII (več kot 150 dni zdravljenja), lahko občasno (pri manj kot 1 od 100 bolnikov) nastanejo inhibitorji (protitelesa proti faktorju VIII) (glejte poglavje 2).
English: Байер България ЕООД Tел.
Slovenian: България Байер България ЕООД
English: Hold the syringe upright and push the plunger until no air is left in the syringe.
Slovenian: Injekcijsko brizgo držite pokončno in pritiskajte na bat brizge toliko časa, da v injekcijski brizgi ni več zraka.
English: Patients should be informed of the early signs of hypersensitivity reactions including hives, nausea, generalised urticaria, tightness of the chest, wheezing, hypotension, and anaphylaxis.
Slovenian: Bolnike je treba poučiti, kako prepoznavati zgodnje znake preobčutljivosti, vključno s koprivnico, navzeo, generalizirano urtikarijo, tiščanjem v prsnem košu, zasoplostjo, hipotenzijo in anafilakso.
English: Do not use the venipuncture set provided for drawing blood because it contains an in-line filter.
Slovenian: Priloženega pribora za vensko punkcijo ne uporabite za odvzem krvi, ker vsebuje filter.
English: • the factor VIII level that is needed.
Slovenian: • potrebna aktivnost faktorja VIII.
English: * Based on population PK estimates **AUC calculated for a dose of 50 IU/kg
Slovenian: Vss (dl/kg) * na podlagi populacijskega farmakokinetičnega modela **AUC izračunana za odmerek 50 i.e./kg
English: Management of such patients should be directed by physicians with experience in the care of haemophilia and factor VIII inhibitors.
Slovenian: Potek zdravljenja mora pri teh bolnikih voditi zdravnik z izkušnjami v zdravljenju hemofilije in inhibitorjev faktorja VIII.
English: If you are using Kovaltry to prevent bleeding, your doctor will calculate the dose for you.
Slovenian: Preprečevanje krvavitve Če zdravilo Kovaltry uporabljate za preprečevanje krvavitev, vam bo odmerek izračunal zdravnik.
English: Rarely, inhibitors may develop after the first 50 exposure days but continues throughout life although the risk is uncommon.
Slovenian: Inhibitorji le redko nastanejo po prvih 50 dneh izpostavitve.
English: • one vial with powder (10 mL clear glass type 1 vial with grey halogenobutyl rubber blend stopper and aluminium seal)
Slovenian: • 1 vialo s praškom (10-mililitrska viala iz prozornega stekla tipa 1 s sivim halogenobutilnim gumijastim zamaškom in aluminijastim tesnilom)
English: Use only the components (vial adapter, pre filled syringe containing solvent and venipuncture set) provided with each package of this medicine.
Slovenian: Uporabite samo pribor adapter za vialo, napolnjena injekcijska brizga z vehiklom in pribor za vensko punkcijo), ki je priložen v vsakem pakiranju tega zdravila.
English: In an international study involving 41 clinical laboratories, the performance of Kovaltry in FVIII:C assays was evaluated and compared to a marketed full length rFVIII product.
Slovenian: V mednarodni študiji, v katero je bilo vključenih 41 kliničnih laboratorijev, so določali aktivnost zdravila Kovaltry z metodami za določitev aktivnosti faktorja VIII in jo primerjali z aktivnostjo zdravila z rekombinantnim faktorjem VIII s polno dolžino, ki je na trgu.
English: The potency (IU) is determined using the European Pharmacopoeia chromogenic assay.
Slovenian: Jakost zdravila (i.e.) se določa s pomočjo kromogene metode po Evropski farmakopeji.
English: Ensure that the full content of the vial is drawn into the syringe.
Slovenian: Preverite ali je v injekcijski brizgi celotna vsebina viale.
English: Minor surgery including tooth extraction
Slovenian: Kirurški posegi manjši kirurški posegi, tudi izdrtje zob
English: Frequency of doses (hours)/ Duration of therapy (days)
Slovenian: Pogostnost odmerjanja (ure)/
English: If you experience dizziness or any other symptoms affecting your ability to concentrate and react, do not drive or use machines until the reaction subsides.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Če občutite omotico ali katere koli druge simptome, ki vplivajo na sposobnost koncentracije in vaše reakcije, ne vozite ali upravljajte strojev, dokler ti učinki ne minejo.
English: Stop administering the product immediately and seek medical advice if this occurs.
Slovenian: tem primeru takoj prenehajte injicirati zdravilo in takoj poiščite medicinsko pomoč.
English: Study 2 3 x/week dosing
Slovenian: 2 x/teden
English: What Kovaltry looks like and contents of the pack
Slovenian: Izgled zdravila Kovaltry in vsebina pakiranja
English: EU/1/15/1076/002 1 x (Kovaltry 250 IU - solvent (2.5 mL); pre-filled syringe (3 mL)) EU/1/15/1076/012 - 1 x (Kovaltry 250 IU - solvent (2.5 mL); pre-filled syringe (5 mL)) EU/1/15/1076/004 - 1 x (Kovaltry 500 IU - solvent (2.5 mL); pre-filled syringe (3 mL)) EU/1/15/1076/014 - 1 x (Kovaltry 500 IU - solvent (2.5 mL); pre-filled syringe (5 mL)) EU/1/15/1076/006 - 1 x (Kovaltry 1000 IU - solvent (2.5 mL); pre-filled syringe (3 mL)) EU/1/15/1076/016 - 1 x (Kovaltry 1000 IU - solvent (2.5 mL); pre-filled syringe (5 mL)) EU/1/15/1076/008 - 1 x (Kovaltry 2000 IU - solvent (5 mL); pre-filled syringe (5 mL)) EU/1/15/1076/010 - 1 x (Kovaltry 3000 IU - solvent (5 mL); pre-filled syringe (5 mL)) EU/1/15/1076/017 30 x (Kovaltry 250 IU - solvent (2.5 mL); pre-filled syringe (3 mL)) EU/1/15/1076/018 - 30 x (Kovaltry 250 IU - solvent (2.5 mL); pre-filled syringe (5 mL)) EU/1/15/1076/019 - 30 x (Kovaltry 500 IU - solvent (2.5 mL); pre-filled syringe (3 mL)) EU/1/15/1076/020 - 30 x (Kovaltry 500 IU - solvent (2.5 mL); pre-filled syringe (5 mL)) EU/1/15/1076/021 - 30 x (Kovaltry 1000 IU - solvent (2.5 mL); pre-filled syringe (3 mL)) EU/1/15/1076/022 - 30 x (Kovaltry 1000 IU - solvent (2.5 mL); pre-filled syringe (5 mL)) EU/1/15/1076/023 - 30 x (Kovaltry 2000 IU - solvent (5 mL); pre-filled syringe (5 mL)) EU/1/15/1076/024 - 30 x (Kovaltry 3000 IU - solvent (5 mL); pre-filled syringe (5 mL))
Slovenian: EU/1/15/1076/002 - 1 x (Kovaltry 250 i.e. - raztopina (2,5 ml); napolnjena injekcijska brizga (3 ml)) EU/1/15/1076/012 - 1 x (Kovaltry 250 i.e. - raztopina (2,5 ml); napolnjena injekcijska brizga (5 ml)) EU/1/15/1076/004 - 1 x (Kovaltry 500 i.e. - raztopina (2,5 ml); napolnjena injekcijska brizga (3 ml)) EU/1/15/1076/014 - 1 x (Kovaltry 500 i.e. - raztopina (2,5 ml); napolnjena injekcijska brizga (5 ml)) EU/1/15/1076/006 - 1 x (Kovaltry 1000 i.e. - raztopina (2,5 ml); napolnjena injekcijska brizga (3 ml)) EU/1/15/1076/016 - 1 x (Kovaltry 1000 i.e. - raztopina (2,5 ml); napolnjena injekcijska brizga (5 ml)) EU/1/15/1076/008 - 1 x (Kovaltry 2000 i.e. - raztopina (5 ml); napolnjena injekcijska brizga (5 ml)) EU/1/15/1076/010 - 1 x (Kovaltry 3000 i.e. - raztopina (5 ml); napolnjena injekcijska brizga (5 ml)) EU/1/15/1076/017 - 30 x (Kovaltry 250 i.e. - raztopina (2,5 ml); napolnjena injekcijska brizga (3 ml)) EU/1/15/1076/018 - 30 x (Kovaltry 250 i.e. - raztopina (2,5 ml); napolnjena injekcijska brizga (5 ml)) EU/1/15/1076/019 - 30 x (Kovaltry 500 i.e. - raztopina (2,5 ml); napolnjena injekcijska brizga (3 ml)) EU/1/15/1076/020 - 30 x (Kovaltry 500 i.e. - raztopina (2,5 ml); napolnjena injekcijska brizga (5 ml)) EU/1/15/1076/021 - 30 x (Kovaltry 1000 i.e. - raztopina (2,5 ml); napolnjena injekcijska brizga (3 ml))
English: 0-<6 years N=24
Slovenian: 0-< 6 let n = 24
English: 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 vial adapter.
Slovenian: Prašek zdravila Kovaltry se lahko rekonstituira le s priloženim vehiklom (2,5 ml ali 5 ml vode za injekcije) v napolnjeni injekcijski brizgi in z adapterjem za vialo.
English: België/Belgique/Belgien Bayer SA-NV
Slovenian: België/Belgique/Belgien
English: The clinical relevance of inhibitor development will depend on the titre of the inhibitor, with low titre posing less of a risk of insufficient clinical response than high titre inhibitors.
Slovenian: Nizek titer inhibitorjev predstavlja manjše tveganje za nezadosten klinični odziv kot visok titer inhibitorjev.
English: If you store it at room temperature it expires after 12 months or at the expiry date if this is earlier.
Slovenian: Če ga shranjujete pri sobni temperaturi, se rok uporabnosti izteče ob koncu 12mesečnega obdobja ali z datumom izteka roka uporabnosti, odvisno kaj nastopi prej.
English: Treatment with rFVIII normalizes the aPTT similar to that achieved with plasma-derived factor VIII.
Slovenian: Zdravljenje z rekombinantnim faktorjem VIII normalizira APTČ podobno kot faktor VIII, pridobljen iz plazme.
English: Table 5: Phase III incremental recovery results Study participants
Slovenian: Preglednica 5: Dejanski dvigi aktivnosti (t.i. incremental recovery) v kliničnih študijah III. faze
English: If you switch factor VIII products, you may be at risk of your inhibitor coming back.
Slovenian: Pri menjavah zdravil s faktorjem VIII obstaja tveganje za ponovni nastanek inhibitorjev.
English: Table 4: PK parameters (geometric mean (%CV)) based on chromogenic assay.
Slovenian: Preglednica 4: Farmakokinetični parametri (geometrična sredina (% CV)) na podlagi kromogene metode* Farmakokinetični parameter
English: The factor VIII/von Willebrand factor (vWF) complex consists of two molecules (factor VIII and vWF) with different physiological functions.
Slovenian: Mehanizem delovanja Kompleks faktorja VIII in von Willebrandovega faktorja (vWF) je sestavljen iz dveh molekul
English: BW: Body weight *Success rate defined as % of bleeds treated successfully with ≤ 2 infusions
Slovenian: *Stopnja uspešnosti je opredeljena kot % uspešno zdravljenih krvavitev z ≤ 2 infuzijama 5.2 Farmakokinetične lastnosti
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS PRE-FILLED SYRINGE WITH WATER FOR INJECTIONS NAME OF THE MEDICINAL PRODUCT AND IF NECESSARY ROUTE(S) OF ADMINISTRATION water for injections METHOD OF ADMINISTRATION EXPIRY DATE
Slovenian: NAPOLNJENA INJEKCIJSKA BRIZGA Z VODO ZA INJEKCIJE IME ZDRAVILA IN, ČE JE POTREBNO, POT(I) UPORABE
English: Do not use Kovaltry if you are allergic to octocog alfa or to any of the other ingredients of this medicine (listed in section 6 and end of section 2).
Slovenian: • alergični na oktokog alfa ali katero koli sestavino tega zdravila (navedeno v poglavju 6 in v zadnjem odstavku poglavja 2),
English: The table presented below is according to the MedDRA system organ classification (SOC and Preferred Term Level).
Slovenian: MedDRA (uporabljen je organski sistem in prednostni izraz po klasifikaciji MedDRA).
English: 6-<12 years N=27
Slovenian: 6-< 12 let n = 27
English: For children not previously treated with factor VIII medicines, inhibitor antibodies (see section 2) may form very commonly (more than 1 in 10 patients).
Slovenian: Pri otrocih, ki predhodno niso bili zdravljeni z zdravili s faktorjem VIII, lahko zelo pogosto (pri več kot 1 od 10 bolnikov) nastanejo inhibitorji (protitelesa proti faktorju VIII) (glejte poglavje 2).
English: FVIII inhibition very common (PUPs)* uncommon (PTPs)*
Slovenian: zelo pogosti (PUP)*
English: Pack sizes 1 single pack.
Slovenian: − 1 posamezno pakiranje.
English: Keep the vial and the pre filled syringe in the outer carton in order to protect from light.
Slovenian: Vialo in napolnjeno injekcijsko brizgo shranjujte v zunanji ovojnini za zagotovitev zaščite pred svetlobo.
English: The FVIII:C of Kovaltry can be measured in plasma with a one-stage coagulation assay as well as with a chromogenic assay using the routine methods of the laboratory.
Slovenian: Aktivnost faktorja VIII zdravila Kovaltry se lahko izmeri v plazmi z uporabo rutinskih metod laboratorija, tako z enostopenjsko koagulacijsko metodo kot tudi s kromogeno metodo.
English: 51368 Leverkusen Germany
Slovenian: 51368 Leverkusen Nemčija
English: Peel off the paper cover on the plastic housing of the vial adapter.
Slovenian: Odstranite papirnati pokrov s plastičnega ohišja adapterja za vialo.
English: Factor VIII level required (%) (IU/dL)
Slovenian: (%) (i.e./dl)
English: 12-<18 years N=23
Slovenian: 12-< 18 let n = 23
English: How to use Kovaltry
Slovenian: Kako uporabljati zdravilo Kovaltry
English: Older children years)
Slovenian: Starejši otroci
English: The active substance is human coagulation factor VIII (octocog alfa).
Slovenian: Učinkovina je humani koagulacijski faktor VIII (oktokog alfa).
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 2.5 mL [for reconstitution of strengths 250/500/1000 IU]
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 2,5 ml [za rekonstitucijo jakosti 250/500/1000 i.e.]
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 5 mL [for reconstitution of strengths 2000/3000 IU]
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 5 ml [za rekonstitucijo jakosti 2000/3000 i.e.]
English: The chemical and physical in-use stability after reconstitution has been demonstrated for 3 hours at room temperature.
Slovenian: 30 mesecev Po rekonstituciji je zdravilo shranjeno pri sobni temperaturi, kemijsko in fizikalno stabilno 3 ure.
English: Kovaltry should be reconstituted and administered with the components (vial adapter, prefilled syringe, venipuncture set) provided with each package.
Slovenian: Zdravilo Kovaltry se lahko rekonstituira in aplicira le s pripomočki (adapter za vialo, napolnjena injekcijska brizga, pribor za vensko punkcijo), priloženimi v vsakem pakiranju.
English: Kovaltry is provided as a powder and solvent for solution for injection.
Slovenian: Zdravilo Kovaltry je na voljo kot prašek in vehikel za raztopino za injiciranje.
English: UAB Bayer Tel. +37 05 23 36 868
Slovenian: Tel. +37 05 23 36 868
English: Hold a pad firmly over the injection site on your outstretched arm for about 2 minutes.
Slovenian: Držite roko iztegnjeno in na mestu injiciranja še približno 2 minuti pritiskajte blazinico.
English: The reconstituted solution must be used within 3 hours.
Slovenian: Zdravilo je treba uporabiti v 3 urah po rekonstituciji.
English: to use a central venous access device for the administration of Kovaltry.
Slovenian: • je za vnos zdravila Kovaltry potreben centralni venski kanal.
English: ABR - all bleeds (median, Q1,Q3)
Slovenian: (mediana, Q1,Q3)
English: Do not use Kovaltry if you notice visible particulate matter or turbidity.
Slovenian: Ne uporabite zdravila Kovaltry, če v raztopini opazite vidne delce ali je raztopina motna.
English: Name and address of the manufacturer of the biological active substance
Slovenian: Ime in naslov proizvajalca biološke zdravilne učinkovine (učinkovin)
English: The new expiry date must be noted on the outer carton.
Slovenian: Novi datum izteka roka uporabnosti zdravila je treba navesti na zunanjo ovojnino.
English: The reconstituted product must be filtered by using the vial adapter before administration to remove any possible particles in the solution.
Slovenian: Rekonstituirano zdravilo morate pred uporabo filtrirati s pomočjo adapterja za vialo, da odstranite morebitne delce v raztopini.
English: Solvent: water for injections, a clear solution.
Slovenian: Vehikel: voda za injekcije, bistra raztopina
English: Check with your doctor or pharmacist if you are not sure.
Slovenian: Posvetujte se z zdravnikom ali farmacevtom, če:
English: You may be at risk of device related complications where the catheter is inserted including:
Slovenian: povezane s pripomočkom, na mestu vstavitve katetra, vključno z
English: When infused into a haemophiliac patient, factor VIII binds to vWF in the patient's circulation.
Slovenian: Po infundiranju bolniku s hemofilijo, se faktor VIII v krvnem obtoku veže na vWF.
English: Haemophilia A is a sex-linked hereditary disorder of blood coagulation due to decreased levels of factor VIII:C and results in profuse bleeding into joints, muscles or internal organs, either spontaneously or as a result of accidental or surgical trauma.
Slovenian: Hemofilija A je na spol vezana dedna motnja strjevanja krvi zaradi znižanja ravni faktorja VIII, ki se kaže kot obsežne krvavitve v sklepe, mišice ali notranje organe.
English: Remove the protective cap from the vial (A).Wipe the rubber stopper on the vial with an alcohol swab and allow the stopper to air dry before use.
Slovenian: Gumijasti zamašek na viali obrišite z alkoholnim zložencem ter ga pustite, da se pred uporabo osuši na zraku.
English: If you use more Kovaltry than you should Tell your doctor if this occurs.
Slovenian: Če ste uporabili večji odmerek, kot bi smeli, o tem obvestite zdravnika.
English: Slovenská republika Bayer spol.
Slovenian: Bayer spol.
English: 30 months
Slovenian: 3 urah.
English: The calculation of the required dose of factor VIII is based on the empirical finding that 1 International Unit (IU) factor VIII per kg body weight raises the plasma factor VIII activity by 1.5% to 2.5% of normal activity.
Slovenian: (i.e.) faktorja VIII na kilogram telesne mase poveča aktivnost faktorja VIII v plazmi za 1,5 - 2,5 % normalne aktivnosti.
English: 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
Slovenian: Kovaltry 250 i.e. prašek in vehikel za raztopino za injiciranje Kovaltry 500 i.e. prašek in vehikel za raztopino za injiciranje Kovaltry 1000 i.e. prašek in vehikel za raztopino za injiciranje Kovaltry 2000 i.e. prašek in vehikel za raztopino za injiciranje Kovaltry 3000 i.e. prašek in vehikel za raztopino za injiciranje
English: • the severity of your haemophilia A
Slovenian: • stopnja hemofilije A
English: Blood and lymphatic system disorders Lymphadenopathy common
Slovenian: Bolezni krvi in limfatičnega sistema limfadenopatija pogosti inhibicija faktorja VIII
English: Inject the solvent by slowly pushing down on the plunger rod (G).
Slovenian: S počasnim potiskanjem bata brizge navzdol vbrizgajte vehikel (G).
English: Name and address of the manufacturer responsible for batch release
Slovenian: Ime in naslov proizvajalca, odgovornega za sproščanje serij Bayer AG
English: Tlf: +47 23 13 05 00
Slovenian: Bayer AS Tlf: +47 23 13 05 00
English: Do not use this medicine if you notice any particles in the solution or if the solution is cloudy.
Slovenian: Ne uporabljajte tega zdravila, če v raztopini opazite vidne delce ali je raztopina motna.
English: The new expiry date must be noted on the outer carton when the medicine is removed from the refrigerator.
Slovenian: Ko zdravilo vzamete iz hladilnika, na zunanji ovojnini navedite novi datum izteka roka uporabnosti zdravila.
English: After reconstitution, the solution is drawn back into the syringe.
Slovenian: Po rekonstituciji se raztopino potegne nazaj v injekcijsko brizgo.
English: bleeding that is not being controlled with your usual dose of Kovaltry.
Slovenian: • se krvavitev po uporabi za vas predpisanega običajnega odmerka zdravila Kovaltry ne ustavi.
English: Uncommon (may affect up to 1 in 100 users): allergic reactions including severe sudden allergic reaction dysgeusia (strange taste) urticaria (itchy rash) flushing (redness of the face)
Slovenian: • alergijske reakcije, tudi huda nenadna alergijska reakcija • disgevzija (nenavaden okus)
English: Place the powder vial on a firm, non slip surface.
Slovenian: Vialo s praškom postavite na trdno nedrsečo površino.
English: Kovaltry is available in pack sizes of: 1 single pack 1 multipack with 30 single packs Not all pack sizes may be marketed.
Slovenian: − 1 skupno pakiranje s 30 posameznimi pakiranji Na trgu morda ni vseh navedenih pakiranj.
English: During the course of treatment, appropriate determination of factor VIII levels is advised to guide the dose to be administered and the frequency of repeated infusions.
Slovenian: Spremljanje zdravljenja Med zdravljenjem je priporočljivo glede na izmerjene aktivnosti faktorja VIII določiti ustrezni odmerek in pogostnost infundiranj.
English: NOVAGEM Limited Tηλ: +357 22 48 38 58
Slovenian: Tηλ: +357 22 48 38 58
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING INNER CARTON OF A MULTIPACK (WITHOUT BLUE BOX)
Slovenian: PODATKI NA ZUNANJI OVOJNINI NOTRANJA ŠKATLA SKUPNEGA PAKIRANJA (BREZ PODATKOV ZA MODRO
English: Study 1 Study 2 2 x/week dosing
Slovenian: Študija 1 Študija 2
English: Haemophilic patients with cardiovascular risk factors or diseases may be at the same risk to develop cardiovascular events as non-haemophilic patients when clotting has been normalised by treatment with factor VIII.
Slovenian: Srčnožilni dogodki Pri hemofilikih z dejavniki tveganja za srčnožilne bolezni ali s srčnožilnimi boleznimi, katerim se je strjevanje krvi normaliziralo z zdravljenjem s faktorjem VIII, obstaja enako tveganje za nastanek srčnožilnih bolezni kot pri bolnikih, ki nimajo hemofilije.
English: 3000 IU) solvent (clear glass cylinder type 1 with grey bromobutyl rubber blend stopper)
Slovenian: in 3000 i.e.) vehikla (valjasti del iz prozornega stekla tipa 1 s sivim bromobutilnim gumijastim zamaškom)
English: The other ingredients are sucrose, histidine, glycine, sodium chloride, calcium chloride dihydrate, polysorbate 80, acetic acid glacial and water for injections.
Slovenian: Druge sestavine zdravila so saharoza, histidin, glicin, natrijev klorid, kalcijev klorid dihidrat, polisorbat 80, koncentrirana ocetna kislina (ledocet) in voda za injekcije.
English: Warnings and precautions Talk to your doctor or pharmacist if you have: tightness in the chest, dizziness (including when you get up from sitting or lying down), itchy nettle-rash, wheezing, feeling sick or faint.
Slovenian: • imate občutek tiščanja v prsnem košu, vrtoglavico (tudi kadar vstanete iz sedečega ali ležečega položaja), srbeč zpuščaj (koprivnica), ste zasopli, imate občutek siljenja na bruhanje ali ste omotični.