natgillin/translations-raw huggingface dataset:
Antibodies against components of fibrin sealant/haemostatic products may occur rarely.
V redkih primerih se lahko pojavijo protitelesa proti komponentam fibrinskega lepila/hemostatskega zdravila.
Use VeraSeal immediately and discard any unused contents.
Zdravilo VeraSeal uporabite takoj, morebitno neporabljeno vsebino pa zavrzite.
Atrial fibrillation, ventricular tachycardia
Srčne bolezni atrijska fibrilacija, ventrikularna tahikardija občasni
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology and acute toxicity.
Predklinični podatki na osnovi običajnih študij farmakološke varnosti in akutne toksičnosti ne kažejo posebnega tveganja za človeka.
Parvovirus B19 test positive, activated partial thromboplastin time prolonged, alanine aminotransferase increased, aspartate aminotransferase increased, blood bilirubin increase, blood glucose increase, international normalised ratio increased, prothrombin time prolonged, transaminases increased, urine output decreased
podaljšan aktivirani parcialni tromboplastinski čas, zvišana alanin aminotransferaza, zvišana aspartat aminotransferaza, zvišan bilirubin v krvi, zvišana glukoza v krvi, zvišano internacionalno normalizirano razmerje,
Allergic reactions may especially be seen if the preparation is applied repeatedly, or administered to patients known to be allergic to constituents of the product.
Take reakcije se še posebej lahko pojavijo ob ponovljenih nanosih zdravila ali njegovi uporabi pri bolnikih, za katere je znano, da so alergični na sestavine zdravila.
If you get any side effects, talk to your doctor or surgeon.
Če opazite katerega koli izmed neželenih učinkov, se posvetujte z zdravnikom ali kirurgom.
The rate of hemostasis at the target bleeding site by 4 minutes was 92.8% in the VeraSeal treatment group and was 80.5% in the control group.
Stopnja hemostaze na tarčnem mestu krvavitve po 4 minutah je bila 92,8 % v skupini, zdravljeni z zdravilom VeraSeal, in 80,5 % v kontrolni skupini.
The rate of hemostasis at the target bleeding site by 4 minutes was 76.1% in the VeraSeal treatment group and was 22.8% in the control group.
Stopnja hemostaze na tarčnem mestu krvavitve po 4 minutah je bila 76,1 % v skupini, zdravljeni z zdravilom VeraSeal, in 22,8 % v kontrolni skupini.
If these symptoms occur, the administration must be discontinued immediately.
Če nastopijo ti simptomi, moramo uporabo zdravila takoj prekiniti.
During soft tissue surgery study 327 subjects were enrolled and underwent pelvic and retroperitoneal surgical procedures, and abdominoplasties and mastopexies.
V študijo operacij mehkih tkiv so vključili 327 preiskovancev z medeničnimi in retroperitonealnimi operativnimi posegi, abdominoplastikami in mastopeksijami.
To remove air bubbles from syringes, strike gently the side of the syringe holder one or two times while keeping the syringe holder in an upright position and lightly depress the plunger to eject air. See Figure 4.
Zračne mehurčke iz brizg odstranite tako, da držalo z brizgama nežno enkrat ali dvakrat stresete levo-desno, medtem ko je držalo za injekcijski brizgi obrnjeno navzgor, in nalahko pritisnete bat, da iztisnete zrak.
The rate of hemostasis at the target bleeding site by 4 minutes was 82.8% in the VeraSeal treatment group and was 77.8% in the control group.
Stopnja hemostaze na tarčnem mestu krvavitve po 4 minutah je bila 82,8 % v skupini, zdravljeni z zdravilom VeraSeal, in 77,8 % v kontrolni skupini.
What you need to know before you are treated with VeraSeal
Kaj morate vedeti, preden boste zdravljeni z zdravilom VeraSeal Kako se uporablja zdravilo VeraSeal
Despite this, when medicinal products prepared from human blood or plasma are administered, the possibility of transmitting infective agents cannot be totally excluded.
Kljub temu pri uporabi zdravil, izdelanih iz človeške krvi ali plazme, ni mogoče povsem izključiti možnosti prenosa povzročiteljev okužb.
Apply VeraSeal using the Dual Applicator provided with the product.
Nanašajte zdravilo VeraSeal z dvojnim aplikatorjem, ki je priložen zdravilu.
NOTE: Do not continue pushing the plunger in an attempt to clear the fibrin clot within the Airless Spray Tip; otherwise the applicator may become unusable.
OPOZORILO: Ne nadaljujte s pritiskanjem na bat, da bi poskusili iztisniti fibrinski strdek iz brezzračne razpršilne konice; zaradi tega lahko postane aplikator neuporaben.
NOTE: Red indicator will not be visible if Airless Spray Tip is properly connected.
OPOZORILO: Če je brezzračna razpršilna konica pravilno povezana, rdeči indikator ne bo viden.
After thawing, the kit containing the VeraSeal syringe holder with pre-filled syringes and Dual Applicator can be stored before use for not more than 48 hours in the refrigerator at 2 - 8 ºC or 24 hours at room temperature (20 - 25 °C) if it remains sealed in the original packaging.
Po odtajanju lahko komplet, ki vsebuje držalo za brizgi VeraSeal z napolnjenima brizgama in dvojni aplikator, pred uporabo shranite za največ 48 ur v hladilniku pri 2 - 8 ºC ali za 24 ur pri sobni temperaturi (20 - 25 °C), če ostane zaprt v originalni ovojnini.
Once the blisters are opened, use VeraSeal immediately and discard any unused contents.
Ko pretisne omote odprete, zdravilo VeraSeal uporabite takoj, morebitno neporabljeno vsebino pa zavrzite.
Grasp and bend the drip tip to the desired position.
Primite in upognite kapljalno konico v želeni položaj.
VeraSeal was shown to be non-inferior to the control group (oxidized regenerated cellulose) in achieving hemostasis by 4 minutes.
VeraSeal ni inferiorno v primerjavi s kontrolno skupino (oksidirana regenerirana celuloza) pri doseganju hemostaze po 4 minutah.
Keep the sterilized blister in the outer carton in order to protect from light.
Sterilizirani pretisni omot shranjujte v zunanji škatli za zagotovitev zaščite pred svetlobo.
During parenchymous tissue surgery study 325 subjects were enrolled and underwent liver resections.
V študijo operacij parenhimskih tkiv so vključili 325 preiskovancev z resekcijo jeter.
Open the blister and make the VeraSeal Dual Applicator and two additional Airless Spray Tips available to a second person for transfer to the sterile field.
Odprite pretisni omot in omogočite drugi osebi, da prime dvojni aplikator zdravila VeraSeal in dve dodatni brezzračni razpršilni konici in jih prenese v sterilno polje.
- VeraSeal 2 ml (containing 1 ml of human fibrinogen and 1 ml of human thrombin) - VeraSeal 4 ml (containing 2 ml of human fibrinogen and 2 ml of human thrombin) - VeraSeal 6 ml (containing 3 ml of human fibrinogen and 3 ml of human thrombin) - VeraSeal 10 ml (containing 5 ml of human fibrinogen and 5 ml of human thrombin)
- VeraSeal 2 ml (vsebuje 1 ml humanega fibrinogena in 1 ml humanega trombina), - VeraSeal 4 ml (vsebuje 2 ml humanega fibrinogena in 2 ml humanega trombina), - VeraSeal 6 ml (vsebuje 3 ml humanega fibrinogena in 3 ml humanega trombina), - VeraSeal 10 ml (vsebuje 5 ml humanega fibrinogena in 5 ml humanega trombina).
SPECIAL STORAGE CONDITIONS Store in a freezer (-18 ºC or colder).
POSEBNA NAVODILA ZA SHRANJEVANJE Shranjujte v zamrzovalniku (pri temperaturi -18 °C ali nižji).
Tighten luer locks and ensure the Dual Applicator is firmly attached.
Privijte konektorja luer in se prepričajte, da je dvojni aplikator čvrsto pritrjen.
Discard if the package is damaged.
Če je pakiranje poškodovano, zdravilo zavrzite.
Such reactions may especially be seen, if the preparation is applied repeatedly, or administered to patients known to be hypersensitive to constituents of the product.
Take reakcije se še posebej lahko pojavijo ob ponovljenih nanosih zdravila ali njegovi uporabi pri bolnikih z znano preobčutljivostjo na sestavine zdravila.
Component 1: Fibrinogen 80 mg/ml
Komponenta 1: humani fibrinogen 80 mg/ml
When using accessory tips, the instructions for use of the tips should be followed.
Pri uporabi nanašalnih nastavkov se je treba ravnati po navodilih za njihovo uporabo.
NOTE: Once the VeraSeal blisters are opened, use the product immediately.
OPOZORILO: Ko so pretisni omoti zdravila VeraSeal odprti, uporabite zdravilo takoj.
In use shelf life: Once the blister is opened, VeraSeal should be used immediately.
Rok uporabnosti po odprtju: Po odprtju pretisnega omota je treba zdravilo VeraSeal takoj uporabiti.
Randomized, single-blind clinical studies with VeraSeal were conducted in subjects undergoing vascular, parenchymous tissue and soft tissue surgery demonstrating haemostasis, and suture support in vascular surgery.
Pri bolnikih, ki so prestali vaskularne operacije, operacije parenhimskih in mehkih tkiv, so opravili randomizirane enojno slepe klinične študije z zdravilom VeraSeal, ki so dokazale hemostazo in podporo kirurškim šivom pri vaskularnih operacijah.
It is supplied as a single-use kit containing two pre-filled syringes assembled in a syringe holder.
Na voljo je v obliki kompleta za enkratno uporabo, ki vsebuje dve napolnjeni injekcijski brizgi, nameščeni na držalo za injekcijski brizgi.
The Airless Spray Tips are radiopaque.
Brezzračni razpršilni konici sta rentgensko kontrastni.
Two pre-filled syringes assembled in a syringe holder.
Dve napolnjeni injekcijski brizgi, nameščeni na držalo za injekcijske brizge.
The surgeon will apply VeraSeal to the surface of blood vessels or to the tissue surface of internal organs using an application device during the course of the operation.
Zdravilo VeraSeal bo kirurg s pripomočkom za nanos med posegom nanesel na površino krvnih žil ali na tkivno površino notranjih organov.
See Figure 5.
Glejte sliko 5.
Life threatening thromboembolic complications may occur if the preparation is unintentionally applied intravascularly (see section 4.8).
Ob nehotenem intravaskularnem vnosu zdravila lahko nastopijo smrtno nevarni trombembolični zapleti (glejte poglavje 4.8).
Unscrew and discard the syringe luer cap of both fibrinogen and thrombin syringes.
Odvijte in odložite pokrovčka luer za brizgi tako fibrinogenske kot trombinske brizge.
- Component 2: Calcium chloride, human albumin, sodium chloride, glycine, water for injections.
- Komponenta 2: kalcijev klorid, humani albumin, natrijev klorid, glicin, voda za injekcije.
Hyperglycaemia, hyperkalaemia, hypocalcaemia, hypoglycaemia, hypokalaemia, hypomagnesemia, hyponatraemia, hypoproteinaemia
Presnovne in prehranske motnje hiperglikemija, hiperkaliemija, hipokalciemija, hipoglikemija, hipokaliemija, hipomagneziemija, hiponatriemija, hipoproteinemija občasni
To change the Airless Spray Tip, remove the device from the patient and unscrew the used Airless Spray Tip.
Brezzračno razpršilno konico zamenjate tako, da odmaknete pripravo od bolnika in odvijete rabljeno brezzračno razpršilno konico.
Open the blister and make the VeraSeal syringe holder with pre-filled syringes available to a second person for transfer to the sterile field.
Odprite pretisni omot in omogočite drugi osebi, da prime držalo za brizgi z napolnjenima brizgama zdravila VeraSeal in ga prenese v sterilno polje.
VeraSeal was shown to be superior to the control group (oxidized regenerated cellulose) in achieving hemostasis by 4 minutes.
Dokazali so, da je zdravilo VeraSeal superiorno v primerjavi s kontrolno skupino (oksidirana regenerirana celuloza) pri doseganju hemostaze po 4 minutah.
human thrombin - Calcium chloride, human albumin, sodium chloride, glycine, water for injections.
humani trombin - kalcijev klorid, humani albumin, natrijev klorid, glicin, voda za injekcije.
VeraSeal spray application should only be used if it is possible to accurately judge the spray distance.
Nanašanje pršila VeraSeal je dovoljeno samo, če lahko kirurg natančno presodi razdaljo, v kateri prši.
Signs of hypersensitivity reactions include hives, generalised urticaria, tightness of the chest, wheezing, hypotension, and anaphylaxis.
Znaki preobčutljivostnih reakcij vključujejo koprivnico, generalizirano urtikarijo, stiskanje v prsih, piskanje v pljučih, hipotenzijo in anafilaksijo.
Post-Thawing Storage
Shranjevanje po odtajanju
After thawing the solutions are clear or slightly opalescent and colourless or pale yellow.
Po odtajanju so raztopine bistre ali rahlo opalescentne ter brezbarvne ali bledo rumene.
Once the blister is opened, VeraSeal should be used immediately.
Ko odprete pretisni omot, morate zdravilo VeraSeal uporabiti takoj.
Apply firm even pressure to the plunger to spray the fibrin sealant.
Čvrsto enakomerno pritisnite bat, da boste razpršili fibrinsko lepilo.
Deep vein thrombosis, hypertension, hypotension
Žilne bolezni tromboza globokih ven, hipertenzija, hipotenzija občasni
Can Guasc, 2 - Parets del Vallès E-08150 Barcelona Spain
Can Guasc, 2 - Parets del Vallès
It must not be used if the solutions are cloudy or have deposits.
Zdravila ne smemo uporabiti, če sta raztopini motni ali vsebujeta delce.
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
08150 Barcelona - Španija Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na predstavništvo imetnika dovoljenja za promet z zdravilom:
After thawing, it can be maintained not more than 48 hours at 2ºC - 8ºC or 24 hours at room temperature (20ºC - 25ºC) before use if it remains sealed in the original packaging.
Po odtajanju lahko zdravilo do uporabe shranite za največ 48 ur pri temperaturi 2 ºC - 8 ºC ali 24 ur na sobni temperaturi (20 ºC- 25 ºC), če ostane zatesnjeno v originalni ovojnini.
After thawing, the solutions must be clear to slightly opalescent and colorless to pale yellow.
Po odtajanju morajo biti raztopine bistre do rahlo opalescentne ter brezbarvne do bledo rumene.
• Connection instructions
• Navodila za povezovanje komponent
Abdominal abscess, cellulitis, liver abscess, peritonitis, postoperative wound infection, wound infection incision site infection, post procedural infection.
Infekcijske in parazitske bolezni abdominalni absces, celulitis, absces v jetrih, peritonitis, pooperativna okužba rane, okužba rane, infekcija na mestu vreza, infekcija po posegu občasni
For epilesional use only.
Samo za epilezijsko uporabo.
Unknown
neznana pogostnost
Thaw blister with VeraSeal pre-filled syringes at room temperature using the following steps:
Odtajajte pretisni omot z napolnjenima brizgama zdravila VeraSeal na sobni temperaturi z naslednjimi koraki:
Barcelona
Španija
Store and transport in a freezer (at - 18 ºC or colder).
Zdravilo shranjujte in prevažajte v zamrzovalniku (pri temperaturi -18 °C ali nižji).
Hold the syringe holder with the luers pointed upward.
Držite držalo z brizgama tako, da bosta pokrovčka luer za brizgi obrnjena navzgor.
VeraSeal must not be applied inside blood vessels.
Zdravila VeraSeal ne sme dati v krvno žilo.
Hypersensitivity*
Bolezni imunskega sistema preobčutljivost*
This medicine must not be used after the expiry date which is stated on the label and carton after EXP.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki in škatli poleg oznake EXP. Treba ga je shraniti v zamrzovalniku pri temperaturi -18 °C ali nižji.
After thawing, it can be maintained not more than 48 hours at 2 ºC - 8 ºC or 24 hours at room temperature (20 ºC - 25 ºC) before use.
Po odtajanju lahko zdravilo pred uporabo shranite za največ 48 ur pri temperaturi 2 ºC - 8 ºC ali za največ 24 ur na sobni temperaturi (20 °C-25 °C).
Anxiety, insomnia
Psihiatrične motnje anksioznost, nespečnost občasni
After thawing the solutions must be clear to slightly opalescent and colourless to pale yellow.
Po odtajanju morajo biti raztopine bistre do rahlo opalescenčne in brezbarvne do bledo rumene.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION VeraSeal solutions for sealant
IME ZDRAVILA IN POT(I) UPORABE
Common (may affect up to 1 in 10 people):
Pogosti (lahko se pojavijo pri največ 1 od 10 bolnikov): - navzea,
Solutions for sealant 2 ml
raztopine za lepilo za tkiva 2 ml
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON [2 ml, 4 ml, 6 ml and 10 ml]
NALEPKA PRETISNEGA OMOTA [2 ml, 4 ml, 6 ml in 10 ml]
Eleven paediatric subjects aged 16 years or younger were treated with VeraSeal in the described clinical studies.
Pediatrična populacija V opisanih kliničnih študijah so zdravili z zdravilom VeraSeal enajst pediatričnih bolnikov, starih
VeraSeal was shown to be superior to the control group (manual compression) in achieving hemostasis by 4 minutes.
Dokazali so, da je zdravilo VeraSeal superiorno v primerjavi s kontrolno skupino (ročna kompresija) pri doseganju hemostaze po 4 minutah.
Excipients: human fibrinogen - Sodium citrate dihydrated, sodium chloride, arginine, isoleucine, glutamic acid monosodium, water for injections.
humani fibrinogen - natrijev citrat dihidrat, natrijev klorid, arginin, izolevcin, natrijev glutaminat, voda za injekcije.
Bladder spasm, dysuria, urinary retention
Bolezni sečil spazem sečnega mehurja, dizurija, zastajanje urina pogosti
Apply VeraSeal using the syringe holder and plunger supplied.
Zdravilo VeraSeal nanašajte s priloženim držalom za brizgi in batom.
See scheme below.
Glejte shemo v nadaljevanju.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS SYRINGE LABEL - HUMAN THROMBIN (1 ml, 2 ml, 3 ml and 5 ml)
NALEPKA INJEKCIJSKE BRIZGE - HUMANI TROMBIN (1 ml, 2 ml, 3 ml in 5 ml)
Place the used Airless Spray Tip away from the spare Airless Spray Tips.
Položite rabljeno brezzračno razpršilno konico proč od rezervnih brezzračnih razpršilnih konic.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS SYRINGE LABEL - HUMAN FIBRINOGEN (1 ml, 2 ml, 3 ml and 5 ml)
NALEPKA INJEKCIJSKE BRIZGE - HUMANI FIBRINOGEN (1 ml, 2 ml, 3 ml in 5 ml)
Calcium ions are required for both, the conversion of fibrinogen and the crosslinkage of fibrin.
Za pretvorbo fibrinogena in križno vezavo fibrina so potrebni kalcijevi ioni.
Blood and lymphatic system disorders
Bolezni krvi in limfatičnega sistema anemija, hemoragična anemija,
Headache, somnolence
- zaspanost,
Remove the Airless Spray Tip portion of the spray and drip tip by unscrewing the Airless Spray Tip.
Odstranite brezzračno razpršilno konico z razpršilne in kapljalne konice, tako da odvijete brezzračno razpršilno konico.
Life threatening thromboembolic complications may occur if the preparation is unintentionally applied intravascularly.
Ob nehotenem intravaskularnem vnosu zdravila lahko nastopijo smrtno nevarni trombembolični zapleti.
Skin and subcutaneous tissue disorders
raztopine za lepilo za tkiva
How VeraSeal is stored
Shranjevanje zdravila VeraSeal
Name and address of the manufacturer(s) of the biological active substance(s)
A. PROIZVAJALEC (PROIZVAJALCI) BIOLOŠKE UČINKOVINE (UČINKOVIN) IN
Ecchymosis, erythema
Nanos s pršenjem
Hypersensitivity or allergic reactions (which may include angioedema, burning and stinging at the application site, bronchospasm, chills, flushing, generalised urticaria, headache, hives, hypotension, lethargy, nausea, restlessness, tachycardia, tightness of the chest, tingling, vomiting, wheezing) may occur in rare cases in patients treated with fibrin sealant/haemostatic products.
Povzetek varnostnega profila V redkih primerih se lahko pri bolnikih, zdravljenih s fibrinskimi lepili/hemostatskimi zdravili pojavijo preobčutljivostne ali alergijske reakcije (ki lahko vključujejo angioedem, pekoč in zbadajoč občutek na mestu uporabe, bronhospazem, mrzlico, vročinske oblive, generalizirano urtikarijo,
Hold the VeraSeal syringe holder with syringe luer caps pointed upward.
Držite držalo z brizgama zdravila VeraSeal tako, da bosta pokrovčka luer za brizgi obrnjena navzgor.
Nausea
VeraSeal.
Epilesional use.
epilezijska uporaba
VeraSeal should be applied as a thin layer.
Zdravilo VeraSeal je treba nanesti v tanki plasti.
Dry the syringe holder with pre-filled syringes after thawing, using a sterile surgical gauze.
Po odtajanju s sterilno kirurško gazo osušite držalo za brizgi z napolnjenima brizgama.
Chills, hyperthermia, oedema peripheral, pain, pyrexia, vessel puncture site haematoma
Splošne težave in spremembe na mestu aplikacije mrzlica, zvišana telesna temperatura, periferni edemi, bolečina, pireksija, hematom na mestu punkcije žile pogosti
The other ingredients are: - Component 1: Sodium citrate dihydrated, sodium chloride, arginine, isoleucine, glutamic acid monosodium, water for injections.
- Komponenta 1: natrijev citrat dihidrat, natrijev klorid, arginin, izolevcin, natrijev glutaminat,
Infections and infestations
Prenosljivi povzročitelji okužb
Application by dripping
Nanašanje s kapljanjem
Musculoskeletal and connective tissue disorders
VeraSeal raztopine za lepilo za tkiva
Pulmonary embolism, dyspnoea, hypoxia, pleural effusion, pleurisy, pulmonary oedema, rhonchi, wheezing
Bolezni dihal, prsnega koša in mediastinalnega prostora pljučna embolija, dispnea, hipoksija, plevralni izliv, plevritis, pljučni edem,
Plasma cell myeloma
plazmacitom občasni
Human fibrinogen syringe
- Komponenta 1: humani fibrinogen.
The active substances are: - Component 1: Human fibrinogen - Component 2: Human thrombin
- Komponenta 2: humani trombin.
Human thrombin syringe
Komponenta 2: humani trombin
Human thrombin 500 IU/ml Produced from the plasma of human donors.
Izdelano iz plazme človeških darovalcev.
Transferring instructions
Navodila za prenos zdravila
Signs of such reactions include hives, rash, tightness of the chest, wheezing, drop in blood pressure (e.g. light-headedness, fainting, blurred vision), and anaphylaxis (a severe reaction with a rapid onset).
piskanje v pljučih, padec krvnega tlaka (npr. omotica, omedlevica, zamegljen vid) in anafilaksijo
Name and address of the manufacturer(s) responsible for batch release
PROIZVAJALEC (PROIZVAJALCI), ODGOVOREN (ODGOVORNI) ZA
For epilesional use.
Način uporabe Za epilezijsko uporabo.
Apply individual drops to the surface area to be treated.
Na površino predela, ki ga zdravite, nanašajte posamezne kapljice.
Handling of VeraSeal
Ravnanje z zdravilom VeraSeal
VeraSeal is presented as solutions for sealant.
Zdravilo VeraSeal je na voljo v obliki raztopin za lepilo za tkiva.
VeraSeal must be kept out of the sight and reach of children.
Zdravilo VeraSeal je treba shranjevati nedosegljivo otrokom!
- Anaemia (insufficiency of red blood cells) - Anxiety - Atrial fibrillation (irregular heartbeat) - Back pain - Bladder spasm - Chills
- plevralni izliv (nenormalna količina tekočine okrog pljuč), - plevritis (vnetje popljučnice), - krvavitev po posegu, - okužba po posegu, - pljučni edem (preveč vodene tekočine v pljučih),
Solutions for sealant.
- Navodilo shranite.
What VeraSeal contains
Kaj vsebuje zdravilo VeraSeal Učinkovini sta:
Once thawed, do not refreeze.
Po odtajanju ne zamrzujte ponovno.
Component 2: Thrombin 500 IU/ml
VeraSeal raztopine za lepilo za tkiva Komponenta 2: trombin 500 i.e./ml epilezijska uporaba
Abdominal wound dehiscence, post procedural bile leak, contusion, incision site erythema, incision site pain, post procedural haemorrhage, procedural hypotension, vascular graft complication, vascular graft thrombosis, wound secretion
hipotenzija med posegom, zaplet pri presaditvi žile, tromboza pri presaditvi žile, sekrecija rane občasni
Component 1: 5 ml of human fibrinogen (80 mg/ml) Component 2: 5 ml of human thrombin (500 IU/ml)
Komponenta 1: 5 ml humanega fibrinogena (80 mg/ml) Komponenta 2: 5 ml humanega trombina (500 i.e./ml)
Component 1: 3 ml of human fibrinogen (80 mg/ml) Component 2: 3 ml of human thrombin (500 IU/ml)
Komponenta 1: 3 ml humanega fibrinogena (80 mg/ml) Komponenta 2: 3 ml humanega trombina (500 i.e./ml)
Component 1: 1 ml of human fibrinogen (80 mg/ml) Component 2: 1 ml of human thrombin (500 IU/ml)
Komponenta 1: 1 ml humanega fibrinogena (80 mg/ml) Komponenta 2: 1 ml humanega trombina (500 i.e./ml)
NAME OF THE MEDICINAL PRODUCT VeraSeal solutions for sealant human fibrinogen / human thrombin
Navodilo za uporabo VeraSeal raztopine za lepilo za tkiva humani fibrinogen/humani trombin Za to zdravilo se izvaja dodatno spremljanje varnosti.
Component 1: 2 ml of human fibrinogen (80 mg/ml) Component 2: 2 ml of human thrombin (500 IU/ml)
Komponenta 1: 2 ml humanega fibrinogena (80 mg/ml) Komponenta 2: 2 ml humanega trombina (500 i.e./ml)