natgillin/translations-raw huggingface dataset:
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 5 mL [for reconstitution of strengths 2000/3000 IU]
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 5 ml [za rekonstitucijo jakosti 2000/3000 i.e.]
The chemical and physical in-use stability after reconstitution has been demonstrated for 3 hours at room temperature.
30 mesecev Po rekonstituciji je zdravilo shranjeno pri sobni temperaturi, kemijsko in fizikalno stabilno 3 ure.
Kovaltry should be reconstituted and administered with the components (vial adapter, prefilled syringe, venipuncture set) provided with each package.
Zdravilo Kovaltry se lahko rekonstituira in aplicira le s pripomočki (adapter za vialo, napolnjena injekcijska brizga, pribor za vensko punkcijo), priloženimi v vsakem pakiranju.
Kovaltry is provided as a powder and solvent for solution for injection.
Zdravilo Kovaltry je na voljo kot prašek in vehikel za raztopino za injiciranje.
UAB Bayer Tel. +37 05 23 36 868
Tel. +37 05 23 36 868
Hold a pad firmly over the injection site on your outstretched arm for about 2 minutes.
Držite roko iztegnjeno in na mestu injiciranja še približno 2 minuti pritiskajte blazinico.
The reconstituted solution must be used within 3 hours.
Zdravilo je treba uporabiti v 3 urah po rekonstituciji.
to use a central venous access device for the administration of Kovaltry.
• je za vnos zdravila Kovaltry potreben centralni venski kanal.
ABR - all bleeds (median, Q1,Q3)
(mediana, Q1,Q3)
Do not use Kovaltry if you notice visible particulate matter or turbidity.
Ne uporabite zdravila Kovaltry, če v raztopini opazite vidne delce ali je raztopina motna.
Name and address of the manufacturer of the biological active substance
Ime in naslov proizvajalca biološke zdravilne učinkovine (učinkovin)
The new expiry date must be noted on the outer carton.
Novi datum izteka roka uporabnosti zdravila je treba navesti na zunanjo ovojnino.
The reconstituted product must be filtered by using the vial adapter before administration to remove any possible particles in the solution.
Rekonstituirano zdravilo morate pred uporabo filtrirati s pomočjo adapterja za vialo, da odstranite morebitne delce v raztopini.
Solvent: water for injections, a clear solution.
Vehikel: voda za injekcije, bistra raztopina
Check with your doctor or pharmacist if you are not sure.
Posvetujte se z zdravnikom ali farmacevtom, če:
You may be at risk of device related complications where the catheter is inserted including:
povezane s pripomočkom, na mestu vstavitve katetra, vključno z
When infused into a haemophiliac patient, factor VIII binds to vWF in the patient's circulation.
Po infundiranju bolniku s hemofilijo, se faktor VIII v krvnem obtoku veže na vWF.
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.
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.
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.
Gumijasti zamašek na viali obrišite z alkoholnim zložencem ter ga pustite, da se pred uporabo osuši na zraku.
If you use more Kovaltry than you should Tell your doctor if this occurs.
Če ste uporabili večji odmerek, kot bi smeli, o tem obvestite zdravnika.
30 months
3 urah.
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.
(i.e.) faktorja VIII na kilogram telesne mase poveča aktivnost faktorja VIII v plazmi za 1,5 - 2,5 % normalne aktivnosti.
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
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
• the severity of your haemophilia A
• stopnja hemofilije A
Blood and lymphatic system disorders Lymphadenopathy common
Bolezni krvi in limfatičnega sistema limfadenopatija pogosti inhibicija faktorja VIII
Inject the solvent by slowly pushing down on the plunger rod (G).
S počasnim potiskanjem bata brizge navzdol vbrizgajte vehikel (G).
Name and address of the manufacturer responsible for batch release
Ime in naslov proizvajalca, odgovornega za sproščanje serij Bayer AG
Do not use this medicine if you notice any particles in the solution or if the solution is cloudy.
Ne uporabljajte tega zdravila, če v raztopini opazite vidne delce ali je raztopina motna.
The new expiry date must be noted on the outer carton when the medicine is removed from the refrigerator.
Ko zdravilo vzamete iz hladilnika, na zunanji ovojnini navedite novi datum izteka roka uporabnosti zdravila.
After reconstitution, the solution is drawn back into the syringe.
Po rekonstituciji se raztopino potegne nazaj v injekcijsko brizgo.
bleeding that is not being controlled with your usual dose of Kovaltry.
• se krvavitev po uporabi za vas predpisanega običajnega odmerka zdravila Kovaltry ne ustavi.
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)
• alergijske reakcije, tudi huda nenadna alergijska reakcija • disgevzija (nenavaden okus)
Place the powder vial on a firm, non slip surface.
Vialo s praškom postavite na trdno nedrsečo površino.
Kovaltry is available in pack sizes of: 1 single pack 1 multipack with 30 single packs Not all pack sizes may be marketed.
− 1 skupno pakiranje s 30 posameznimi pakiranji Na trgu morda ni vseh navedenih pakiranj.
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.
Spremljanje zdravljenja Med zdravljenjem je priporočljivo glede na izmerjene aktivnosti faktorja VIII določiti ustrezni odmerek in pogostnost infundiranj.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING INNER CARTON OF A MULTIPACK (WITHOUT BLUE BOX)
PODATKI NA ZUNANJI OVOJNINI NOTRANJA ŠKATLA SKUPNEGA PAKIRANJA (BREZ PODATKOV ZA MODRO
Study 1 Study 2 2 x/week dosing
Študija 1 Študija 2
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.
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.
3000 IU) solvent (clear glass cylinder type 1 with grey bromobutyl rubber blend stopper)
in 3000 i.e.) vehikla (valjasti del iz prozornega stekla tipa 1 s sivim bromobutilnim gumijastim zamaškom)
The other ingredients are sucrose, histidine, glycine, sodium chloride, calcium chloride dihydrate, polysorbate 80, acetic acid glacial and water for injections.
Druge sestavine zdravila so saharoza, histidin, glicin, natrijev klorid, kalcijev klorid dihidrat, polisorbat 80, koncentrirana ocetna kislina (ledocet) in voda za injekcije.
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.
• 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.
If a further dose is needed, use a new syringe with product reconstituted as described above.
Če je potreben dodaten odmerek zdravila, uporabite novo injekcijsko brizgo z zdravilom,
Contents of the pack and other information
Shranjevanje zdravila Kovaltry Vsebina pakiranja in dodatne informacije
Within its overall shelf life of 30 months the product when kept in its outer carton, may be stored up to 25 °C for a limited period of 12 months.
V 30-mesečnem roku uporabnosti lahko zdravilo (kadar je v zunanji ovojnini) shranjujete pri sobni temperaturi (do 25 °C) največ 12 mesecev.
If you stop using Kovaltry Do not stop using Kovaltry without checking with your doctor.
Ne prenehajte uporabljati zdravila Kovaltry, ne da bi se prej posvetovali z zdravnikom.
* Frequency is based on studies with all FVIII products which included patients with severe haemophilia A. PTPs = previously-treated patients, PUPs = previously-untreated patients ** includes injection site extravasation, hematoma, infusion site pain, pruritus, swelling *** rash, rash erythematous, rash pruritic
Žilne bolezni pordelost občasni * Pogostnost temelji na študijah z vsemi zdravili s faktorjem VIII, v katere so bili vključeni bolniki s težko stopnjo hemofilije A. PTP = Previously Treated Patients (predhodno zdravljeni bolniki), PUP = Previously Untreated Patients (predhodno nezdravljeni bolniki)
For reconstitution read package leaflet before use.
Glede rekonstitucije zdravila pred uporabo preberite priloženo navodilo.
How Kovaltry is given
Kako se daje zdravilo Kovaltry
Kovaltry is injected into a vein over 2 to 5 minutes depending on the total volume and your comfort level and should be used within 3 hours after reconstitution.
Zdravilo Kovaltry se injicira v veno 2 do 5 minut, odvisno od skupne količine in vašega počutja.
Hypersensitivity or allergic reactions (which may include angioedema, burning and stinging at the infusion site, chills, flushing, generalised urticaria, headache, hives, hypotension, lethargy, nausea, restlessness, tachycardia, tightness of the chest, tingling, vomiting, wheezing) have been observed and may in some cases progress to severe anaphylaxis (including shock).
Opažene so bile preobčutljivost ali alergijske reakcije (le-te lahko vključujejo angioedem, pekoč občutek in občutek zbadanja na mestu infundiranja, mrzlico, pordelost, generalizirano urtikarijo,
CL (dL/h/kg) Vss (dL/kg)
očistek (dl/h/kg)
Haemorrhage
oteklino
Allergic type hypersensitivity reactions are possible with Kovaltry.
Po uporabi zdravila Kovaltry se lahko pojavijo preobčutljivostne reakcije alergijskega tipa.
Kovaltry contains sodium
Zdravilo Kovaltry vsebuje natrij
Sucrose, histidine, glycine, sodium chloride, calcium chloride dihydrate, polysorbate 80, acetic acid glacial and water for injections.
Pomožne snovi: saharoza, histidin, glicin, natrijev klorid, kalcijev klorid dihidrat, polisorbat 80, koncentrirana ocetna kislina (ledocet) in voda za injekcije.
The risk of developing inhibitors is correlated to the severity of the disease as well as the exposure to factor VIII , this risk being highest within the first 20 exposure days.
Tveganje za nastanek inhibitorjev je odvisno od stopnje bolezni in izpostavljenosti faktorju VIII.
• whether you have inhibitors and how high their level is
• prisotnost inhibitorjev faktorja VIII in njihova raven
At least 1 day, until the bleeding episode as indicated by pain is resolved or healing is achieved.
Zdravljenje naj traja vsaj 1 dan, dokler se krvavitev
This result is similar to the reported values for factor VIII derived from human plasma.
Ti izsledki so bili v okviru vrednosti, o katerih so poročali za faktor VIII,
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 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 rekombinantni humani koagulacijski faktor VIII (oktokog alfa)
Bayer AG 51368 Leverkusen Germany
IMETNIK DOVOLJENJA ZA PROMET Z ZDRAVILOM Bayer AG 51368 Leverkusen Nemčija
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER LABEL OF MULTIPACK WITH 30 SINGLE PACKS (INCLUDING BLUE BOX)
ZUNANJA ŠKATLA SKUPNEGA PAKIRANJA S 30 POSAMEZNIMI PAKIRANJI (S PODATKI ZA MODRO OKENCE)
Laboratory tests at suitable intervals help to ensure you always have adequate factor VIII levels.
Za zagotavljanje ustreznih ravni faktorja VIII je zelo priporočljivo, da se v rednih presledkih naredijo ustrezne laboratorijske preiskave.
previously developed factor VIII inhibitors to a different product.
• so pri vas že kdaj nastali inhibitorji faktorja VIII pri uporabi drugih zdravil s faktorjem VIII.
More extensive haemarthrosis, muscle bleeding or haematoma
mišice ali hematomi
Grasp the plunger rod as per the diagram and attach the rod by turning it firmly clockwise into the threaded stopper (C).
Napolnjeno injekcijsko brizgo z vehiklom držite navpično, primite bat brizge kot je narisano in ga z močnim privijanjem v smeri urinega kazalca pritrdite v navojni zamašek (C).
Attach the pre filled syringe to the threaded vial adapter by turning clockwise (F).
Z obračanjem v smeri urinega kazalca pritrdite napolnjeno injekcijsko brizgo v navoj adapterja za vialo (F).
How Kovaltry is prepared for administration
Kako se pripravi zdravilo Kovaltry za uporabo
Repeated PK measurements after 6 to 12 months of prophylaxis treatment with Kovaltry did not indicate any relevant changes in PK characteristics after long-term treatment.
Kovaltry niso pokazale pomembnih sprememb farmakokinetičnih parametrov po dolgotrajnem zdravljenju.
Bayer HealthCare LLC 800 Dwight Way Berkeley
Bayer HealthCare LLC
STATEMENT OF ACTIVE SUBSTANCE(S) Kovaltry 2000 IU contains (2000 IU / 5 mL) = 400 IU octocog alfa per mL after reconstitution.
Zdravilo Kovaltry 2000 i.e. vsebuje (2000 i.e. / 5 ml) = 400 i.e. oktokoga alfa na ml po rekonstituciji.
6.6 Special precautions for disposal and other handling
6.6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom Podrobnejša navodila za pripravo in uporabo so v navodilu za uporabo, ki je priložen zdravilu
Detailed instructions for preparation and administration are contained in the package leaflet provided with Kovaltry.
Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Kovaltry
6.5 Nature and contents of container and special equipment for use, administration or implantation
6.5 Vrsta ovojnine in vsebina ter posebna oprema za uporabo, dajanje ali implantacijo Vsako posamezno pakiranje zdravila Kovaltry vsebuje:
Calcium chloride dihydrate Polysorbate 80
Prašek saharoza histidin glicin natrijev klorid kalcijev klorid dihidrat polisorbat 80 koncentrirana ocetna kislina (ledocet) (za uravnavanje pH)
Treatment monitoring
Trajanje zdravljenja
STATEMENT OF ACTIVE SUBSTANCE(S) Kovaltry 250 IU contains (250 IU / 2.5 mL) = 100 IU octocog alfa per mL after reconstitution.
Zdravilo Kovaltry 250 i.e. vsebuje (250 i.e. / 2,5 ml) = 100 i.e. oktokoga alfa na ml po rekonstituciji.
• syringe plunger rod
Bayer Hungária KFT
STATEMENT OF ACTIVE SUBSTANCE(S) Kovaltry 3000 IU contains (3000 IU / 5 mL) = 600 IU octocog alfa per mL after reconstitution.
Zdravilo Kovaltry 3000 i.e. vsebuje (3000 i.e. / 5 ml) = 600 i.e. oktokoga alfa na ml po rekonstituciji.
STATEMENT OF ACTIVE SUBSTANCE(S) Kovaltry 500 IU contains (500 IU / 2.5 mL) = 200 IU octocog alfa per mL after reconstitution.
Zdravilo Kovaltry 500 i.e. vsebuje (500 i.e. / 2,5 ml) = 200 i.e. oktokoga alfa na ml po rekonstituciji.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 3000 IU (octocog alfa) (600 IU/mL after reconstitution).
3000 i.e. (oktokog alfa) (600 i.e./ml po rekonstituciji)
How to store Kovaltry
Shranjevanje zdravila Kovaltry
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 250 IU (octocog alfa) (100 IU/mL after reconstitution).
250 i.e. (oktokog alfa) (100 i.e./ml po rekonstituciji)
STATEMENT OF ACTIVE SUBSTANCE(S) Kovaltry 1000 IU contains (1000 IU / 2.5 mL) = 400 IU octocog alfa per mL after reconstitution.
Zdravilo Kovaltry 1000 i.e. vsebuje (1000 i.e. / 2,5 ml) = 400 i.e. oktokoga alfa na ml po rekonstituciji.
Kovaltry 250 IU powder and solvent for solution for injection One mL Kovaltry 250 IU contains approximately 100 IU (250 IU / 2.5 mL) of recombinant human coagulation factor VIII (INN: octocog alfa) after reconstitution with water for injections.
Po rekonstituciji z vodo za injekcije vsebuje 1 ml zdravila Kovaltry 250 i.e. približno 100 i.e. (250 i.e./2,5 ml) rekombinantnega humanega koagulacijskega faktorja VIII (INN: oktokog alfa).
OTHER Bayer-Logo
Logotip Bayer
Kovaltry 500 IU powder and solvent for solution for injection One mL Kovaltry 500 IU contains approximately 200 IU (500 IU / 2.5 mL) of recombinant human coagulation factor VIII (INN: octocog alfa) after reconstitution with water for injections.
Po rekonstituciji z vodo za injekcije vsebuje 1 ml zdravila Kovaltry 500 i.e. približno 200 i.e. (500 i.e./2,5 ml) rekombinantnega humanega koagulacijskega faktorja VIII (INN: oktokog alfa).
Parenteral medicinal products should be inspected visually for particulate matter and discoloration prior to administration.
Zdravilo za paranteralno uporabo je treba pred uporabo vizualno pregledati, če so v njem delci ali se je spremenila barva.
- a blood clot in the blood vessel.
- lokalnimi okužbami, - prisotnostjo bakterij v krvi, - nastankom krvnih strdkov v krvnih žilah.
The most serious side effects are allergic reactions or severe allergic reaction.Stop injecting Kovaltry immediately and speak to your doctor at once if such reactions occur.
Najbolj resni neželeni učinki so alergijske reakcije ali huda alergijska reakcija.
Kovaltry 2000 IU powder and solvent for solution for injection One mL Kovaltry 2000 IU contains approximately 400 IU (2000 IU / 5 mL) of recombinant human coagulation factor VIII (INN: octocog alfa) after reconstitution with water for injections.
Po rekonstituciji z vodo za injekcije vsebuje 1 ml zdravila Kovaltry 2000 i.e. približno 400 i.e. (2000 i.e./5 ml) rekombinantnega humanega koagulacijskega faktorja VIII (INN: oktokog alfa).
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON OF A SINGLE PACK (INCLUDING BLUE BOX)
PODATKI NA ZUNANJI OVOJNINI ŠKATLA POSAMEZNEGA PAKIRANJA (S PODATKI ZA MODRO OKENCE)
Kovaltry 1000 IU powder and solvent for solution for injection One mL Kovaltry 1000 IU contains approximately 400 IU (1000 IU / 2.5 mL) of recombinant human coagulation factor VIII (INN: octocog alfa) after reconstitution with water for injections.
Po rekonstituciji z vodo za injekcije vsebuje 1 ml zdravila Kovaltry 1000 i.e. približno 400 i.e. (1000 i.e./2,5 ml) rekombinantnega humanega koagulacijskega faktorja VIII (INN: oktokog alfa).
SN
V
Histidine
OVOJNINAH
The adapter will snap over the vial cap. Do not remove the adapter housing at this point.
Ohišja adapterja zaenkrat še ne odstranite.
Powder: solid, white to slightly yellow.
Prašek: trden, bel do rahlo rumen
United Kingdom Bayer plc
Deutschland Bayer Vital GmbH
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 500 IU (octocog alfa) (200 IU/mL after reconstitution).
500 i.e. (oktokog alfa) (200 i.e./ml po rekonstituciji)
Type of surgical procedure
veliki kirurški posegi
- bacteria in the blood
• mesto in obseg krvavitve
The following symptoms could be an early warning of these reactions: chest tightness/general feeling of being unwell dizziness a reduction in blood pressure, which may make you feel faint upon standing) feeling sick (nausea)
• omotica, • znižanje krvnega tlaka, zaradi česar se vam lahko vrti, kadar vstanete,
EU/1/15/1076/024 - 30 x (Kovaltry 3000 IU - solvent (5 mL); pre-filled syringe (5 mL))
EU/1/15/1076/024 - 30 x (Kovaltry 3000 i.e. - raztopina (5 ml); napolnjena injekcijska brizga (5 ml))
EU/1/15/1076/023 - 30 x (Kovaltry 2000 IU - solvent (5 mL); pre-filled syringe (5 mL))
EU/1/15/1076/023 - 30 x (Kovaltry 2000 i.e. - raztopina (5 ml); napolnjena injekcijska brizga (5 ml))
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 2000 IU (octocog alfa) (400 IU/mL after reconstitution).
2000 i.e. (oktokog alfa) (400 i.e./ml po rekonstituciji)
NAME OF THE MEDICINAL PRODUCT Kovaltry 500 IU powder and solvent for solution for injection recombinant human coagulation factor VIII (octocog alfa)
Kovaltry 500 i.e. prašek in vehikel za raztopino za injiciranje rekombinantni humani koagulacijski faktor VIII (oktokog alfa)
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 1000 IU (octocog alfa) (400 IU/mL after reconstitution).
1000 i.e. (oktokog alfa) (400 i.e./ml po rekonstituciji)
NAME OF THE MEDICINAL PRODUCT Kovaltry 250 IU powder and solvent for solution for injection recombinant human coagulation factor VIII (octocog alfa)
Kovaltry 250 i.e. prašek in vehikel za raztopino za injiciranje rekombinantni humani koagulacijski faktor VIII (oktokog alfa)
NAME OF THE MEDICINAL PRODUCT Kovaltry 2000 IU powder and solvent for solution for injection recombinant human coagulation factor VIII (octocog alfa)
Kovaltry 2000 i.e. prašek in vehikel za raztopino za injiciranje rekombinantni humani koagulacijski faktor VIII (oktokog alfa)
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/1/15/1076/017 - 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))
The rate of administration should be determined by the patient's comfort level (maximal rate of infusion: 2 mL/min).
Hitrost injiciranja naj bo prilagojena bolnikovemu počutju (največja dovoljena hitrost injiciranja:
NAME OF THE MEDICINAL PRODUCT Kovaltry 3000 IU powder and solvent for solution for injection recombinant human coagulation factor VIII (octocog alfa)
Kovaltry 3000 i.e. prašek in vehikel za raztopino za injiciranje rekombinantni humani koagulacijski faktor VIII (oktokog alfa)
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Kovaltry 250 IU powder for solution for injection recombinant human coagulation factor VIII (octocog alfa) Intravenous use.
Kovaltry 250 i.e. prašek za raztopino za injiciranje rekombinantni humani koagulacijski faktor VIII (oktokog alfa) Intravenska uporaba.
Bayer AB
UAB Bayer
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/1/15/1076/006 - 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))
- local infections
voda za injekcije
NAME OF THE MEDICINAL PRODUCT Kovaltry 1000 IU powder and solvent for solution for injection recombinant human coagulation factor VIII (octocog alfa)
Kovaltry 1000 i.e. prašek in vehikel za raztopino za injiciranje rekombinantni humani koagulacijski faktor VIII (oktokog alfa)
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/1/15/1076/019 - 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))
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Kovaltry 500 IU powder for solution for injection recombinant human coagulation factor VIII (octocog alfa) Intravenous use.
Kovaltry 500 i.e. prašek za raztopino za injiciranje rekombinantni humani koagulacijski faktor VIII (oktokog alfa) Intravenska uporaba.
Kaiser-Wilhelm-Allee 51368 Leverkusen Germany
Keiser-Wilhelm Allee