natgillin/translations-raw huggingface dataset:
The most common side effects with Fabrazyme (seen in more than 1 patient in 10) are caused by the infusion rather than the medicine.
Najpogostejši neželeni učinki zdravila Fabrazyme (opaženi pri več kot 1 bolniku od 10) so bolj posledica infundiranja kot pa zdravila.
For more information about treatment with Fabrazyme, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Fabrazyme preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
Fabrazyme is given once every two weeks as an infusion of 1 mg per kilogram body weight.
Zdravilo Fabrazyme se daje z infuzijo v odmerku 1 mg na kilogram telesne mase enkrat vsaka dva tedna.
Children treated with Fabrazyme also had decreases in levels of GL-3 in the blood, with all children having normal levels after 20 weeks of treatment.
Tudi pri otrocih, zdravljenih z zdravilom Fabrazyme, je prišlo do znižanja ravni GL-3 v krvi, pri čemer je bila pri vseh otrocih normalna raven dosežena po 20 tednih zdravljenja.
Patients with Fabry disease do not have enough of an enzyme called alpha-galactosidase A. This enzyme normally breaks down a fatty substance called globotriaosylceramide (GL-3 or Gb3).
Bolniki s Fabryjevo boleznijo nimajo dovolj encima, imenovanega alfa-galaktozidaza A. Ta encim običajno razgrajuje maščobno snov, imenovano globotriaozilceramid (GL-3 ali Gb3).
Fabrazyme has been investigated in three studies involving a total of 73 adults.
Zdravilo Fabrazyme je bilo raziskano v treh študijah, v katerih je sodelovalo 73 odraslih.
What benefit has Fabrazyme shown during the studies?
Kakšne koristi je zdravilo Fabrazyme izkazalo med študijami?
In the main study, Fabrazyme produced a highly significant and almost complete clearance of GL-3 in the kidney cells after 20 weeks of treatment: 69% of the patients treated with Fabrazyme had the best score for clearance, compared with none of the patients in the placebo group.
V glavni študiji je zdravilo Fabrazyme po 20 tednih zdravljenja prispevalo k zelo pomembnemu in skoraj popolnemu očistku GL-3 v celicah ledvic: 69 % bolnikov, zdravljenih z zdravilom Fabrazyme, je doseglo najboljši rezultat očistka, medtem ko v skupini bolnikov, zdravljenih s placebom, bolnikov s takšnim rezultatom ni bilo nobenih.
Enzyme replacement therapies provide patients with the enzyme they are lacking.
Encimske nadomestne terapije zagotavljajo bolnikom encim, ki jim ga primanjkuje.
Fabrazyme is intended for long-term use.
Zdravilo Fabrazyme je namenjeno dolgotrajni uporabi.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Fabrazyme.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Fabrazyme, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
The replacement enzyme helps to break down GL-3 and stops it building up in the patient's cells.
Nadomestni encim pomaga razgraditi GL-3 in preprečiti njegovo kopičenje v celicah bolnika.
In the main study, Fabrazyme was compared with placebo (a dummy treatment) in 58 patients.
V glavni študiji so zdravilo Fabrazyme primerjali s placebom (zdravilom brez zdravilne učinkovine) pri 58 bolnikih.
If the enzyme is not present, GL-3 cannot be broken down and it builds up in the body's cells, such as kidney cells.
Če encima primanjkuje, se GL-3 ne more razgraditi in se začne kopičiti v telesnih celicah, kot so na primer celice ledvic.
The study looked at the effects of the medicine on clearing GL-3 from the kidney.
V njej so proučevali učinke zdravila na odstranjevanje GL-3 iz ledvic.
Fabrazyme is designed to replace the human enzyme alpha galactosidase A, which is lacking in patients with Fabry disease.
Zdravilo Fabrazyme je zasnovano tako, da nadomesti človeški encim alfa galaktozidaza A, ki ga primanjkuje pri ljudeh s Fabryjevo boleznijo.
The active substance in Fabrazyme, agalsidase beta, is a copy of the human enzyme, produced by a method known as ‘recombinant DNA technology': it is made by cells that have received a gene (DNA), which makes them able to produce the enzyme.
Zdravilno učinkovino zdravila Fabrazyme, agalzidazo beta, ki je kopija človeškega encima, izdelujejo s „tehnologijo rekombinantne DNK“, pri kateri celica prejme gen (DNK), s katerim lahko tvori encim.
The CHMP decided that Fabrazyme's benefits are greater than its risks and recommended that it be given marketing authorisation.
Zaključil je, da so koristi zdravila Fabrazyme večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
It is available as a powder to be made into a solution for infusion (drip) into a vein.
Na voljo je v obliki praška za pripravo raztopine za infundiranje (kapalne infuzije) v veno.
Fabrazyme must not be used in people who are hypersensitive (allergic) to agalsidase beta or any of the other ingredients.
Zdravila Fabrazyme ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) agalzidazo beta ali katerokoli drugo sestavino zdravila.
What is the risk associated with Fabrazyme?
Kakšna tveganja so povezana z zdravilom Fabrazyme?
Fabrazyme is a medicine that contains the active substance agalsidase beta.
Fabrazyme je zdravilo, ki vsebuje zdravilno učinkovino agalzidaza beta.
Fabrazyme is an enzyme replacement therapy.
Zdravilo Fabrazyme je encimska nadomestna terapija.
The starting infusion rate should be no more than 0.25 mg per minute (15 mg per hour) to reduce the risk of infusion-related side effects.
Da se izognemo neželenim učinkom, povezanih z infuzijo, začetna hitrost infundiranja ne sme presegati 0,25 mg na minuto (15 mg na uro).
The CHMP decided that, for patients with Fabry disease, treatment with Fabrazyme might provide longterm clinical benefits.
CHMP je menil, da lahko zdravljenje z zdravilom Fabrazyme bolnikom s Fabryjevo boleznijo zagotovi dolgotrajne klinične koristi.
Why has Fabrazyme been approved?
Zakaj je bilo zdravilo Fabrazyme odobreno?
Fabrazyme is used to treat patients who have Fabry disease, a rare inherited disorder.
Zdravilo Fabrazyme se uporablja za zdravljenje bolnikov s Fabryjevo boleznijo, ki je redka dedna bolezen.
These include fever, chills, headache, paraesthesia (abnormal sensations like pins and needles), nausea (feeling sick), vomiting and feeling cold. For the full list of all side effects reported with Fabrazyme, see the package leaflet.
Neželeni učinki vključujejo povišano telesno temperaturo, glavobol, parestezijo (neobičajne telesne občutke, kot je mravljinčenje), navzejo (občutek slabosti), bruhanje in mrazenje.
Only a doctor who has experience in treating patients with Fabry disease or other inherited metabolic diseases should give Fabrazyme.
Zdravilo Fabrazyme lahko predpiše samo zdravnik, ki ima izkušnje z zdravljenjem bolnikov s Fabryjevo boleznijo ali drugimi dednimi presnovnimi boleznimi.
What is Fabrazyme used for?
Za kaj se zdravilo Fabrazyme uporablja?
How does Fabrazyme work?
Kako zdravilo Fabrazyme deluje?
How has Fabrazyme been studied?
Kako je bilo zdravilo Fabrazyme raziskano?
What is Fabrazyme?
Kaj je zdravilo Fabrazyme?
How is Fabrazyme used?
Kako se zdravilo Fabrazyme uporablja?
240 mg Film-coated tablet
240 mg filmsko obložene tablete peroralno pretisni omot (alu/alu)
Strength Pharmaceutical Form Route of Administration
Izmišljeno ime Jakost Farmacevtska oblika Pot uporabe Ovojnina
This approach is considered acceptable.
Ta pristop se smatra kot sprejemljiv.
The treatment can be repeated if required.
Zdravljenje se po potrebi lahko ponovi.
No evidence of local intolerability was noted.
Dokazov o lokalni intoleranci niso opazili.
No quality aspects were the subject of disagreement during the Mutual Recognition procedure.
Vidiki kakovosti niso bili predmet nesoglasij med postopkom medsebojnega priznavanja.
The possible reasons for an increase or decrease are:
Možni vzroki za povečanje ali zmanjšanje učinka so:
An allergic reaction can cause any of the following symptoms:
Alergijske reakcije lahko povzročijo katere koli od naslednjih simptomov:
o Evaluation of the spread reactions, specifically as part of future studies.
o ovrednotenjem reakcij, povezanih s širjenjem, specifično kot del prihodnjih študij;
o Commitment to alert the National Competent Authorities if there is a significant change in reporting rate.
o zavezo k opozorilu pristojnih nacionalnih organov v primeru pomembne spremembe v pogostosti poročil.
During a Scientific Advice procedure in 2000, the EMEA did not require or recommend that further Phase II studies be conducted before the Phase III studies were performed.
Med postopkom znanstvenega svetovanja v letu 2000 EMEA ni zahtevala ali priporočila, da se pred izvedbo študij III. faze izvedejo nadaljnje študije II.
No statistical differences were found between both treatment groups.
Med obema zdravljenima skupinama niso opazili statističnih razlik.
Frequency by different indications
Pogostnost po različnih indikacijah
1.3 RECOMMENDATION
1.3 PRIPOROČILA
Your doctor will then take additional precautions.
Zdravnik bo poskrbel za dodatne previdnostne ukrepe;
Electromyographic guidance is not necessary.
Elektromiografsko vodenje ni nujno.
Normally, no additional benefit is conferred by treating more frequently than every three months.
Navadno ni pričakovati dodatnih koristi od zdravljenja pogosteje kot vsake tri mesece.
Nevertheless the product should be used immediately.
Kljub temu je treba zdravilo porabiti takoj.
The initial dose should not exceed 25 U per eye.
Začetni odmerek ne sme preseči 25 e. na oko.
If signs of intoxication appear, hospitalisation with general supportive measures is necessary.
Če se pojavijo znaki zastrupitve, je nujna hospitalizacija in splošni podporni ukrepi.
In addition to the list of follow-up measures discussed and requested by the CMDh, the CHMP requested the following follow-up measures to be submitted to the National Competent Authorities and to be assessed under the co-ordination of the RMS:
Poleg seznama nadaljnjih ukrepov, o katerih je razpravljal in jih zahteval CMDh, je CHMP zahteval naslednje nadaljnje ukrepe, ki jih je treba predložiti pristojnim nacionalnim organom in oceniti v koordinaciji referenčne države članice:
Safety profile
Varnostni profil
In case of an overdose the patient must be monitored medically for several days.
Pri prevelikem odmerjanju je treba bolnika nadzorovati več dni.
Against this background a further extensive dose-ranging program would not have been justifiable from an ethical point of view.
Glede na to nadaljnji razširjeni program za določitev razpona odmerjanja z etičnega vidika ni upravičen.
If no treatment effect occurs within a month after the initial injection, the following measures should be taken:
Če v enem mesecu od prvega injiciranja ni učinkov zdravljenja, je treba uporabiti naslednje ukrepe:
This list is not exhaustive as any of the muscles responsible for controlling head position may be involved and therefore require treatment.
Seznam ni dokončen, saj je lahko vpletena katera koli mišica, odgovorna za nadzor položaja glave, in torej potrebuje zdravljenje.
The incidence of Serious Adverse Events was low in all studies, with a similar frequency in both treatment groups.
Pogostost resnih neželenih dogodkov je bila majhna pri vseh študijah, s podobno pogostostjo v obeh zdravljenih skupinah.
Lack of data on repeated administration and the need for data on immunogenicity
Pomanjkanje podatkov o ponovljeni uporabi in potreba po podatkih o imunogenosti
OTHER SPECIAL WARNING(S); IF NECESSARY
DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA
However, there appears to be no additional benefit obtainable from injecting more than 5.0 U per site.
Vendar je videti, da ni dodatne koristi od injiciranja več kot 5,0 e. na mesto.
Very common: pain, local weakness
Zelo pogosti: bolečina, lokalna šibkost
In addition, at present there are three ongoing clinical studies with Xeomin:
Poleg tega trenutno potekajo tri klinične študije z zdravilom Xeomin:
• if you have or have had swallowing difficulties
• če imate ali ste imeli težave pri požiranju.
The clinical development program was composed by 5 studies provided in the following table:
Klinični razvojni program je sestavljalo 5 študij, navedenih v naslednji tabeli:
At repeat treatment sessions, the dose may be increased up to two-fold if the response to the initial treatment is considered insufficient - usually defined as an effect that does not last longer than two months.
Ob ponovnem zdravljenju se lahko odmerek poveča do dvakrat, če je ocenjeno, da odziv na prvo zdravljenje ni zadosten - to je po navadi opredeljeno kot učinek, ki ne traja več kot dva meseca.
Consequently affected persons should avoid these tasks until their faculties are fully recovered.
Posledično se morajo osebe izogibati tem opravilom, dokler se te sposobnosti ne povrnejo v celoti.
• have had an eye surgery.
• imeli kirurški poseg na očesu.
• Two Phase III studies (one study in each of the intended indication, spasmodic torticollis
• dve študiji III. faze (po ena študija za vsako predvideno indikacijo, spastični tortikolis
• non-response/therapy failure during the course of treatment.
• neodzivnost na zdravljenje/neuspešnost zdravljenja med njegovim izvajanjem.
These findings must be interpreted cautiously because all patients were not systematically tested for Botulinum toxin antibodies.
Te rezultate je treba interpretirati previdno, saj vsi bolniki niso bili sistematično testirani na protitelesa proti botulinskemu toksinu.
The frequency categories are defined as follows: very common (≥1/10); common (≥1/100, <1/10); uncommon (≥1/1,000, <1/100), rare (≥1/10,000, <1/1,000); very rare (<1/10,000).
Pogostnost neželenih učinkov je opredeljena na naslednji način: zelo pogosti (≥ 1/10); pogosti (≥ 1/100, < 1/10); občasni (≥ 1/1,000, < 1/100), redki (≥ 1/10.000, < 1/1.000); zelo redki (< 1/10.000).
Xeomin contains albumin, a derivative of human blood.
Zdravilo Xeomin vsebuje albumin, derivat človeške krvi.
• injections into another muscle
• injiciranje v drugo mišico;
Unopened vial: 3 years
Neodprte viale: 3 leta.
The recommended dilutions are indicated in the following table:
Priporočene razredčitve so navedene v naslednji tabeli:
The effect of each treatment generally lasts approximately 3-4 months, however, it may last significantly longer or shorter.
Učinek vsakega zdravljenja na splošno traja 3-4 mesece, lahko pa tudi bistveno manj ali dlje.
4-Aminochinolines may reduce the effect of Xeomin.
4-aminokinolini lahko zmanjšajo učinek zdravila Xeomin.
(peripheral neuromuscular dysfunction)
(periferno nevromuskulatorno disfunkcijo);
A clinical pack is also available with 6 vials.
Na voljo je tudi klinično pakiranje s 6 vialami.
Three patients discontinued the studies prematurely due to adverse events considered as unrelated to study drug.
Trije bolniki so predčasno prekinili udeležbo v študijah zaradi neželenih dogodkov, ocenjenih kot nepovezanih z obravnavanim zdravilom.
In the management of blepharospasm, total dosing should not exceed 100 U every 12 weeks.
Pri obravnavanju blefarospazma skupni odmerek ne sme preseči 100 e. vsakih 12 tednov.
This is also relevant for medicinal products that weaken the muscle.
To velja tudi za zdravila, ki oslabijo mišice.
Reconstitution and dilution should be performed with good practice, particularly with respect to asepsis.
Rekonstitucijo in redčenje je treba opraviti v skladu z dobro prakso, zlasti glede aseptičnosti.
The HDA tests of the available samples were still in analysis, when the applicant's response was circulated.
Analiza testov HDA razpoložljivih vzorcev je ob razpošiljanju odgovora vlagatelja še potekala.
0.5 ml 1.0 ml 2.0 ml 4.0 ml
0,5 ml 1,0 ml 2,0 ml 4,0 ml 8,0 ml e. e. e. e. e.
• To submit a Risk Management Plan, according to the current guideline, including: o Detailed strategies for educating physicians including appropriate injection techniques, dosing and lack of interchangeability between products as well as programmes for continued and improved monitoring of spread reactions in clinical use and in clinical trials.
• Predložitev načrta za obvladovanje tveganj v skladu z veljavno smernico, vključno s: o podrobno strategijo za izobraževanje zdravnikov, ki vključuje ustrezno tehniko injiciranja, odmerjanje in neobstoj medsebojne zamenljivosti med izdelki, kakor tudi programe za kontinuiran in izboljšan nadzor širjenja pri klinični uporabi in kliničnih preizkušanjih;
In each of the ongoing studies, data are still blinded, but no secondary therapy failures due to antibody development have been reported up to now.
Pri vsaki od potekajočih študij so podatki še vedno slepi (nerazkriti), vendar pa doslej še niso poročali o nobenem sekundarnem neuspehu zdravljenja zaradi razvoja protiteles.
Medical intervention may be necessary (e.g. in the form of a gastric feeding tube) (see also section 4.8).
Morda bo potreben zdravniški poseg (npr. v obliki gastrične sonde za hranjenje) (glejte tudi poglavje 4.8).
• the scope of the referral was the potential risk to public health concerning the need for data in repeated administration and data on immunogenicity for Xeomin
• predmet napotitve je bilo potencialno tveganje za javno zdravje v zvezi s potrebo po podatkih o ponovljeni uporabi in podatkih o imunogenosti zdravila Xeomin,
stiffness, hypertonia
otrplost, hipertonija
Clinical pack.
Klinično pakiranje.
Patients with smaller neck muscle mass, or patients who require bilateral injections into the sternocleidomastoid muscles are at greater risk.
Bolniki z manjšo maso vratnih mišic ali bolniki, pri katerih je potrebno bilateralno injiciranje v sternokleidomastoidne mišice, so izpostavljeni večjemu tveganju.
Any solution for injection that has been stored for more than 24 hours as well as any unused solution for injection should be discarded.
Vso raztopino za injiciranje, ki je bila shranjena več kot 24 ur, in neuporabljeno raztopino za injiciranje je treba zavreči.
• swelling of the hands, feet, ankles, face, lips, mouth or throat.
• otekanje rok, stopal, gležnjev, obraza, ustnic, ust ali grla.
The solvent must be injected gently into the vial.
Vehikel morate nežno vbrizgati v vialo.
Your doctor will know if you are at risk.
Zdravnik bo vedel, ali pri vas obstaja nevarnost za pojav te bolezni.
If you have the impression that the effect of Xeomin is too strong or too weak, let your doctor know.
Če menite, da je učinek zdravila Xeomin premočan ali prešibak, se posvetujte z zdravnikom.
• if you suffer from a disease called amyotrophic lateral sclerosis.
• če imate bolezen, imenovano amiotrofična lateralna skleroza.
• different techniques of preparation of the product by your doctor
• različne tehnike priprave zdravila;
• if you are allergic (hypersensitive) to Botulinum neurotoxin type A or any of the other ingredients of Xeomin (see section 6 “Further information”)
• če ste alergični na (preobčutljivi za) botulinski nevrotoksin tipa A ali katero koli sestavino zdravila Xeomin (glejte poglavje 6 “Dodatne informacije”),
In contrast, one animal treated with Xeomin was tested positively in the ELISA test, but no neutralising activity was detected in the HDA.
V nasprotju s tem je bila ena žival, ki je prejemala zdravilo Xeomin, pozitivna na testu ELISA, vendar pa na testu HDA nevtralizirajoča aktivnost ni bila ugotovljena.
Theoretically, the effect of Xeomin may be reduced by: • certain anti-malaria / anti-rheumatic medicines (4-Aminochinolines).
Teoretično lahko učinek zdravila Xeomin zmanjšajo: • nekatera zdravila proti malariji in antirevmatiki (4-aminokinolini).
Most of the adverse events were of mild or moderate severity in both groups.
Večina neželenih dogodkov v obeh skupinah je bila blage ali zmerne resnosti.
The submitted clinical trial programme consisted of:
Predloženi program kliničnih preizkušanj so tvorile:
No genotoxicity, carcinogenicity and pre- and postnatal development studies have been conducted with Xeomin.
Študij genotoksičnosti, kancerogenosti in pre- in postnatalnega razvoja z zdravilom Xeomin niso opravili.
There are no reports of viral transmissions with albumin manufactured to European Pharmacopoeia specifications by established processes.
Poročil o prenosu virusov z albuminom, izdelanim z uveljavljenimi postopki po specifikacijah Evropske farmakopeje, ni.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF
IME ZDRAVILA IN POT(I) UPORABE
very common more than 1 per 10 treated people common less than 1 per 10, but more than 1 per 100 treated people uncommon less than 1 per 100, but more than 1 per 1,000 treated people rare less than 1 per 1,000, but more than 1 per 10,000 treated people very rare less than 1 per 10,000 treated people, incl.
manj kot pri 1 od 10 zdravljenih oseb, vendar več kot pri 1 od 100 zdravljenih oseb občasni manj kot pri 1 od 100 zdravljenih oseb, vendar več kot pri 1 od 1.000 zdravljenih oseb redki manj kot pri 1 od 1.000 zdravljenih oseb, vendar več kot pri 1 od 10.000 zdravljenih oseb zelo redki manj kot pri 1 od 10.000 zdravljenih oseb, vključno s posameznimi primeri
The applicant has submitted the total number of adverse events with no distinction between adverse events related or not related.
Vlagatelj je predložil skupno število neželenih dogodkov brez delitve na povezane ali nepovezane neželene dogodke.
The period between each treatment session should be at least 10 weeks.
Med dvema cikloma zdravljenja mora biti vsaj 10 tednov.
Recovery of impulse transmission is re-established by the formation of new nerve terminals and motor endplates.
Prenos impulza se na novo vzpostavi s tvorbo novih živčnih končičev in motoričnih ploščic.
- Efficacy issues
- Vidiki učinkovitosti
Based on the results, it could be concluded that pharmacological effect of Xeomin and Botox are almost comparable in animals.
Na podlagi teh podatkov je mogoče skleniti, da sta farmakološka učinka zdravil Xeomin in Botox pri živalih skoraj primerljiva.
The results of initial treatment with Xeomin should be evaluated and may lead to dose adjustment until the desired therapeutic effect is achieved.
Rezultate začetnega zdravljenja z zdravilom Xeomin je treba oceniti in po potrebi prilagoditi odmerek, dokler ni dosežen želeni terapevtski učinek.
This may lead to problems with breathing and you may have a higher risk of inhaling foreign substances or fluids.
To lahko povzroči težave pri dihanju in morda bo tveganje za vdihovanje tujkov ali tekočin večje.
Your doctor can limit these by immediately applying gentle pressure at the injection site.
Zdravnik jih lahko omeji s takojšnjim nežnim pritiskom na mesto injiciranja.
A continuous systemic exposure of the dams during the (unknown) sensitive phase of the organogenesis as a pre-requisite for the induction of teratogenic effects cannot necessarily be assumed.
Ni možno z gotovostjo domnevati, da je neprekinjena sistemska izpostavljenost mladičev med (neznano) občutljivo fazo organogeneze predpogoj za pojav teratogenih učinkov.
This can occur more often if you suffer from disorders of your facial nerves.
Poškodbe so lahko pogostejše, če imate motnje obraznih živcev.
Extra caution is required when injecting at sites close to sensitive structures such as the carotid artery and lung apices.
Posebna previdnost je potrebna pri injiciranju zdravila v mesta, ki so blizu občutljivih struktur, kot so karotidna arterija ali pljučni vršički.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 100 LD50 units
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 100 enot LD50
Prior to administering Xeomin the physician must make himself familiar with the patient's anatomy and any alterations to the anatomy due to prior surgical procedures.
Pred injiciranjem zdravila Xeomin se mora zdravnik seznaniti z bolnikovo anatomijo in vsemi spremembami anatomije zaradi predhodnih kirurških posegov.
For hospital use only
Samo za uporabo v bolnišnicah.
• If you have further questions, please ask your doctor or pharmacist.
• Če imate dodatna vprašanja, se posvetujte z zdravnikom ali s farmacevtom.
• if you receive substances that prevent the blood from clotting (anticoagulant therapy)
• če jemljete zdravila za preprečevanje strjevanja krvi (antikoagulante);