natgillin/translations-raw huggingface dataset:
Hypocalcaemia has been reported in patients treated with zoledronic acid.
O teh primerih so poročali predvsem pri odraslih bolnikih z rakom, ki so se zdravili z zoledronsko kislino.
How Zoledronic acid Mylan is used
Kako uporabljati zdravilo Zoledronska kislina Mylan
Osteonecrosis of the jaw (ONJ) has been reported uncommonly in clinical trials and in the post marketing setting in patients receiving zoledronic acid.
O osteonekrozi čeljustnic (ONJ) so občasno poročali pri bolnikih, ki so prejemali zoledronsko kislino v kliničnih preskušanjih ali so se z njim zdravili po začetku trženja zdravila.
Clinical trial results in the prevention of skeletal related events in patients with advanced malignancies involving bone
Preprečevanje z okostjem povezanih dogodkov pri bolnikih z napredovalimi malignimi boleznimi, ki zajamejo kosti:
There have been very rare cases of drowsiness and sleepiness with the use of zoledronic acid.
Vpliv na sposobnost upravljanja vozil in strojev Ob uporabi zoledronske kisline je v zelo redkih primerih prišlo do dremavosti in zaspanosti.
In post-marketing experience, severe and occasionally incapacitating bone, joint, and/or muscle pain have been reported in patients taking zoledronic acid.
Iz izkušenj v obdobju trženja pri bolnikih, ki so prejemali zoledronsko kislino, so poročali o hudih bolečinah v kosteh, sklepih in/ali mišicah.
How to store Zoledronic acid Mylan
Shranjevanje zdravila Zoledronska kislina Mylan
Can't be sold separately.
Sestavni del skupnega pakiranja.Ni za posamezno prodajo.
STATEMENT OF ACTIVE SUBSTANCE(S) One vial contains 4 mg zoledronic acid (as monohydrate).
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena viala vsebuje 4 mg zoledronske kisline (v obliki monohidrata).
The concentrate is supplied in a clear and colourless glass vial with a rubber stopper and a plastic flip-off cap. One vial contains 5 ml of concentrate.
Koncentrat je pakiran v vialo iz prozornega brezbarvnega stekla z gumijastim zamaškom in plastičnim zaščitnim pokrovčkom.
- Irregular heart rhythm (atrial fibrillation) has been seen in patients receiving zoledronic acid for postmenopausal osteoporosis.
- pri bolnicah, ki so prejemale zoledronsko kislino zaradi pomenopavzalne osteoporoze, so opažali nepravilno bitje srca (atrijsko fibrilacijo).
Contact your doctor if you experience pain, weakness or discomfort in your thigh, hip or groin as this may be an early indication of a possible fracture of the thigh bone.
Posvetujte se z zdravnikom, če občutite bolečine, šibkost ali nelagodje v stegnu, kolku ali dimljah, saj so to lahko zgodnji znaki možnega zloma stegnenice, - intersticijska bolezen pljuč (vnetje tkiva okoli zračnih mešičkov v pljučih), - simptomi, ki spominjajo na gripo, vključno z artritisom in oteklinami sklepov, - boleča rdečina in/ali oteklina očesa.
Within three days after zoledronic acid administration, an acute phase reaction has commonly been reported, with symptoms including bone pain, fever, fatigue, arthralgia, myalgia, rigors and arthritis with subsequent joint swelling; these symptoms usually resolve within a few days (see description of selected adverse reactions).
Pogosto so poročali o reakciji akutne faze, do katere pride v prvih treh dneh po vnosu zoledronske kisline simptomi pa vključujejo bolečine v kosteh, zvišano telesno temperaturo, utrujenost, artralgijo, mialgijo, okorelost in artritis, ki povzroči otekline sklepov.
- Urticaria.
Navodilo shranite.
How Zoledronic acid Mylan is given - Zoledronic acid Mylan is given as a drip (infusion) into a vein which should take at least 15 minutes and should be administered as a single intravenous solution in a separate infusion line.
Kako boste prejeli zdravilo Zoledronska kislina Mylan - Zdravilo Zoledronska kislina Mylan dobijo bolniki v obliki infuzije v veno, ki naj traja vsaj
PHARMACEUTICAL FORM Concentrate for solution for infusion.
FARMACEVTSKA OBLIKA koncentrat za raztopino za infundiranje bistra in brezbarvna raztopina
Placebo zoledronic acid 4 mg
zdravljenje kosti z obsevanjem zoledronska kislina 4 mg placebo zoledronska kislina 4mg placebo zoledronska kislina 4 mg placebo
This is because you may develop serum electrolyte abnormalities (e.g. abnormal levels of calcium, phosphorus and magnesium) and/or changes in kidney function, including severe kidney impairment.
Če ste prejeli večji odmerek zdravila Zoledronska kislina Mylan, kot bi smeli Če ste prejeli odmerek, ki je večji od priporočenega, vas mora zdravnik natančno nadzorovati, zato ker lahko pride do nepravilnosti elektrolitov v serumu (do nepravilnih koncentracij kalcija, fosforja in magnezija) in/ali do spremenjenega delovanja ledvic, vključno z ledvično odpovedjo.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING BOX OF 1 VIAL
PODATKI NA ZUNANJI OVOJNINI ŠKATLA Z 1 VIALO ŠKATLA S 4 VIALAMI ŠKATLA Z 10 VIALAMI
You should not be given Zoledronic acid Mylan if you are pregnant.
Če ste noseči, vam ne bi smeli dati zdravila Zoledronska kislina Mylan.
- High blood pressure, shortness of breath, dizziness, anxiety, sleep disturbances, taste disturbances, trembling, tingling or numbness of the hands or feet, diarrhoea, constipation,
Občasni (lahko se pojavijo pri največ 1 od 100 bolnikov): - preobčutljivostne reakcije, - nizek krvni tlak, - bolečina v prsih, - kožne reakcije (rdečina in otekanje) na mestu infuzije, izpuščaj, srbenje, - visok krvni tlak, zadihanost, omotičnost, tesnoba, motnje spanja, motnje okušanja, tresenje,
You must not be given Zoledronic acid Mylan if you are breast-feeding.
Če dojite, vam ne smejo dati zdravila Zoledronska kislina Mylan.
Tell your doctor immediately if you experience symptoms such as new onset or worsening of aches, pain or stiffness while being treated with Zoledronic acid Mylan or after stopping treatment.
Če se med zdravljenjem ali po zaključku zdravljenja z zdravilom Zoledronska kislina Mylan pojavijo simptomi kot so pojav bolečine, ki je prej ni bilo, poslabšanje obstoječe bolečine ali okornost, takoj obvestite zdravnika.
Concentrate for solution for infusion
Način uporabe intravenska uporaba
Clinical trial results in the treatment of TIH
DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA
Blister (OPA/Alu /PVC-Alu) 10 x 1 tablets (unit dose)
40 mg tableta peroralna uporaba pretisni omot (OPA/aluminij/PVCaluminij)
Tablet
Jakost
Date of first authorisation: 06 October 2008 Date of latest renewal: 06 October 2013
Datum prve odobritve: 6. oktober 2008 Datum zadnjega podaljšanja: 6. oktober 2013
The frequency of the type of event is not known (cannot be estimated from available data).
Pogostnost tovrstnega dogodka ni znana (ni mogoče oceniti iz razpoložljivih podatkov).
No data are currently available for ages younger than 2 years.
Trenutno ni razpoložljivih podatkov o uporabi pri otrocih, mlajših od 2 let.
The temperature must not exceed 37°C.
Temperatura ne sme preseči 37 °C.
Jerusalem 9777605, Israel
Jeruzalem 9777605, Izrael
Such substances should be removed to the greatest possible extent before applying the product.
Takšne snovi je treba pred uporabo zdravila čimbolj odstraniti.
The exact content and format of the educational material and educational programme including communication media, distribution modalities, and any other aspects of the programme, shall be agreed with the National Competent Authority.
Natančno vsebino in obliko izobraževalnega materiala in programa, vključno s komunikacijskimi mediji, načini razširjanja in vsemi drugimi vidiki programa je treba uskladiti s pristojnimi nacionalnimi organi.
The vials should be thawed in one of the following ways:
Viale morate odtaliti na enega od naslednjih načinov:
For laparoscopy, see recommendations below.
Glede laparoskopije glejte priporočila, ki so navedena spodaj.
Both syringes should be filled with equal volumes, and should not contain air bubbles.
Obe brizgi morata biti napolnjeni z enakim volumnom in ne smeta vsebovati zračnih mehurčkov.
Frequencies have been evaluated according to the following convention: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data).
Pogostnost je bila ocenjena v skladu z naslednjim dogovorom: zelo pogosti (≥1/10); pogosti (≥1/100 do <1/10); občasni (≥1/1.000 do <1/100); redki (≥1/10.000 do <1/1.000); zelo redki (<1/10.000); neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov).
At the Cmax, the plasma concentration represented only 1-2% of the applied dose.
Plazemska koncentracija Cmax je predstavljala le 1-2 % nanesenega odmerka.
The application can be repeated, if necessary.
Če je treba, se lahko nanašanje ponovi.
If you feel unwell tell your doctor immediately, even if your symptoms are different from those just described.
Če se ne počutite dobro, nemudoma obvestite zdravnika, čeprav so vaši simptomi drugačni od zgoraj naštetih.
Read this before you open the package
Preberite, preden odprete ovojnino
In case of shock, standard medical treatment for shock should be implemented.
V primeru šoka morate uvesti standardno zdravljenje.
EVICEL comes in sterile packages and therefore it is important to use only undamaged packages which have not been opened (post-sterilisation is not possible).
Zdravilo EVICEL je v sterilnem pakiranju, zato je pomembno, da uporabljate samo nepoškodovano pakiranje, ki še ni bilo odprto (naknadna sterilizacija ni možna).
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, even those not prescribed.
Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo, tudi če ste ga dobili brez recepta.
Analysis of cerebrospinal fluid did not reveal major signs of inflammation.
Analiza cerebrospinalnega likvorja ni pokazala poglavitnih znakov vnetja.
To be used as two-component product with supplied device.
Za uporabo kot dvokomponentni izdelek s priloženim pripomočkom.
If you experience any of the above mentioned symptoms, or any other symptoms related to your surgery, please contact your doctor or surgeon immediately.
Če občutite katerega od zgoraj navedenih simptomov ali kateri koli drug simptom, povezan s kirurškim posegom, se nemudoma obrnite na zdravnika ali kirurga.
If the tag is provided as part of the medicinal product, it should be incorporated in the product information via a variation procedure
Če je oznaka na voljo kot del zdravila, mora biti vključena v informacije o zdravilu preko postopka za spremembo dovoljenja za promet z zdravilom.
For laparoscopy, see section 4.4.
Za laparoskopijo glejte poglavje 4.4.
• The use of EVICEL has not been studied in the following procedures, and there is therefore no information to show that it would be effective in these procedures:
• Pri v nadaljevanju naštetih postopkih uporabe zdravila EVICEL niso preučevali, zato ni podatkov, ki bi dokazovali njegovo učinkovitost pri naslednjih postopkih:
In isolated cases, these reactions have progressed to severe anaphylaxis.
V posamičnih primerih so se te reakcije stopnjevale do resne oblike anafilaksije.
The date on which refrigerator storage was started should be marked on the carton in the space provided.
Datum začetka shranjevanja v hladilniku označite na škatli v označenem prostoru.
Of these, 2 were children aged 2 and 5 years and 2 were adolescents of 16 years.
Od teh sta bila dva preiskovanca otroka, stara med 2 in 5 let, dva preiskovanca pa mladostnika, stara 16 let.
• Pressure regulators do not exceed the maximum pressure of 1.7 bars for spraying EVICEL, and contain labels stating the recommended pressure and distance.
- regulatorji tlaka ne presežejo najvišjega tlaka 1,7 bara za napršitev zdravila EVICEL in vsebujejo oznake, ki navajajo priporočeni tlak in razdaljo.
As a consequence, intravascular pharmacokinetic studies were not performed in man.
Zaradi tega intravaskularne farmakokinetične študije pri ljudeh niso bile opravljene.
The Marketing Authorisation Holder (MAH) shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Imetnik dovoljenja za promet z zdravilom bo izvedel zahtevane farmakovigilančne aktivnosti in ukrepe, podrobno opisane v sprejetem RMP, predloženem v modulu 1.8.2 dovoljenja za promet z zdravilom, in vseh nadaljnjih sprejetih posodobitvah RMP.
Fax: +972-3-5316590
Faks: +972-3-5316590
The healthcare professionals will record the name and batch number of the medicinal product in order to trace any possible infection source.
Zdravstveno osebje si zabeleži ime in serijsko številko zdravila zaradi sledljivosti do morebitnega vira okužbe.
Distance from target tissue
Razdalja od ciljnega tkiva
What EVICEL is and what it is used for
Kaj je zdravilo EVICEL in za kaj ga uporabljamo
The accessory tips should only be used by persons adequately trained in laparoscopic, laparoscopic-assisted, or open surgical procedures.
Nastavke smejo uporabljati samo osebe, ki so ustrezno usposobljene za laparoskopske, laparoskopsko asistirane ali odprte kirurške postopke.
Fibrin sealants in general may, in rare cases (up to 1 patient in 1,000 people), cause an allergic reaction.
Fibrinska lepila lahko na splošno v redkih primerih (pri največ 1 od 1000 bolnikov) povzročijo alergijsko reakcijo.
• If you are hypersensitive (allergic) to products made from human blood or to any of the other ingredients of EVICEL (listed in section 6).
• Če ste alergični (preobčutljivi) na zdravila, izdelana iz človeške krvi ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
However, for some procedures (e.g., liver traumata) larger volumes may be required.
Vendar bo morda treba pri določenih posegih (npr. poškodbe jeter) uporabiti večje volumne.
The initial volume of the product to be applied at a chosen anatomic site or target surface area should be sufficient to entirely cover the intended application area.
Začetni uporabljeni volumen zdravila na izbranem anatomskem mestu ali površini mora biti dovolj velik, da pokrije celotno ciljno področje nanosa.
No major macroscopic signs of local intolerance and no treatment-related macroscopic findings were observed.
Niso opazili poglavitnih makroskopskih znakov lokalne intolerance ali z zdravljenjem povezanih makroskopskih odkritij.
A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
A. IZDELOVALEC BIOLOŠKIH ZDRAVILNIH UČINKOVIN IN IZDELOVALEC, ODGOVOREN ZA SPROŠČANJE SERIJ
Pharmacotherapeutic group: local haemostatics, combinations, ATC code: B02BC30
Farmakoterapevtska skupina: hemostatiki za lokalno zdravljenje, kombinacije, oznaka ATC: B02BC30
No adverse reactions were reported during the study.
Med študijo niso poročali o nobenih neželenih učinkih.
No toxicological effects due to the solvent detergent reagents (TnBP and Triton X-100) used in the virus inactivation procedure are expected since the residual levels are less than 5 µg/ml.
Ni pričakovati toksikoloških učinkov zaradi topnih detergentov (TnBP in Triton X-100), ki se uporabljata v postopku inaktivacije virusov, ker rezidualne ravni ne presegajo 5 µg/ml.
- EVICEL is not sprayed via an endoscope when the recommended minimum safe distance from the tissue cannot be observed.
- se zdravilo EVICEL ne prši prek endoskopa, kadar priporočene najmanjše varne razdalje od tkiva ni mogoče spremljati.
• When medicines are made from human blood or plasma, certain measures are put into place to prevent infections being passed on to patients.
• Pri zdravilih, ki se izdelajo iz človeške krvi ali plazme, se izvajajo določeni ukrepi za preprečevanje prenosa okužb na bolnike.
Adequate data are not available to support the use of this product in tissue gluing, application through a flexible endoscope for treatment of bleeding, or in gastrointestinal anastomoses.
Na voljo ni dovolj podatkov, ki bi podpirali uporabo tega zdravila za lepljenje tkiv, uporabo prek fleksibilnega endoskopa za zdravljenje krvavitve ali pri gastrointestinalnih anastomozah.
Experimental animal studies are insufficient to assess the safety with respect to reproduction, development of the embryo or foetus, the course of gestation, and peri- and post-natal development.
Podatki iz študij na živalih ne zadoščajo za oceno varnosti glede reprodukcije, razvoja zarodka ali plodu, poteka gestacije ter peri- in postnatalnega razvoja.
CARTON BOX
KARTONSKA ŠKATLA
I-thrombin it was shown that a slow absorption of biologically inactive peptides resulting from the breakdown of thrombin occurred, reaching a Cmax in the plasma after 6-8 hours.
I-trombinom so dokazali, da je absorpcija biološko inaktivnih peptidov, ki nastanejo pri razkroju trombina, počasna, in v plazmi doseže Cmax po 6-8 urah.
The volume of EVICEL to be applied and the frequency of application should always be oriented towards the underlying clinical needs of the patient.
Količina zdravila EVICEL, ki se uporabi, ter pogostnost uporabe se vedno določata glede na obstoječe klinične potrebe bolnika.
The vials must be stored in an upright position.
Viale morajo biti shranjene v pokončnem položaju.
At 30 days post-operatively the incidence of SSIs was similar between the two treatment groups.
Trideset dni po posegu je bila pojavnost okužb kirurškega mesta v obeh zdravljenih skupinah podobna.
The pressure regulator should be used in accordance with the manufacturer's instructions.
Regulator tlaka morate uporabljati v skladu z navodili izdelovalca.
This device allows equal amounts of the two components of EVICEL to be administered at the same time, and ensures that they mix evenly, which is important for the sealant to have its optimal effect.
Aplikator je pripomoček, ki omogoča sočasno nanašanje enakih količin dveh raztopin zdravila EVICEL, hkrati pa zagotovi njuno enakomerno mešanje, kar je pomembno, da lepilo doseže optimalni učinek.
Before administration of EVICEL, care is to be taken that parts of the body outside the desired application area are sufficiently protected (covered) to prevent tissue adhesion at undesired sites.
Pred nanašanjem zdravila EVICEL morate dele telesa, ki so zunaj želenega območja nanašanja zdravila, ustrezno zaščititi (prekriti), da preprečite lepljenje tkiv na neželenih mestih.
After local application, absorption of thrombin into the plasma is slow and consists principally of thrombin degradation products which are eliminated.
Po lokalnem nanosu je absorpcija trombina v plazmo počasna, in sicer gre predvsem za absorpcijo razgradnih produktov trombina, ki se eliminirajo.
At the end of this period the product has to be used or discarded.
Ob koncu tega obdobja je treba zdravilo porabiti ali zavreči.
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 lahko nastopijo zlasti pri ponavljajoči uporabi zdravila ali pri bolnikih, za katere je znano, da so preobčutljivi za sestavine zdravila..
The approved shelf life of EVICEL is 2 years storage at ≤ -18
Odobreni rok uporabnost zdravila EVICEL je 2 leti ob shranjevanju pri ≤ -18 °C.
For epilesional use.
Za epilezijsko uporabo.
What you need to know before you use EVICEL
Kaj morate vedeti, preden boste uporabili zdravilo EVICEL
If the applicator tip becomes blocked, the catheter tip can be cut back in 0.5 cm increments.
Če se nastavek aplikatorja zamaši, lahko katetrski nastavek odrežete po 0,5-centimetrskih korakih.
It is dripped or sprayed onto cut tissue where it forms a thin layer that seals the tissue and/or stops bleeding.
Zdravilo nakapamo ali razpršimo na tkivo, kjer tvori tanek sloj, ki zalepi tkivo in/ali zaustavi krvavitev.
The product should only be reconstituted and administered according to the instructions and with the devices recommended for this product.
Zdravilo se sme rekonstituirati in nanašati samo po navodilih in s pripomočki, priporočenimi za to zdravilo.
• In accordance with the European Commission decision on the procedure EMEA/H/C/000898/A20/0018 to mitigate the risk of potentially life threatening air/gas embolism when the product is sprayed at higher than recommended pressures and/or in close proximity to the tissue surface, the MAH shall ensure that: - When EVICEL is sprayed using pressurized gas, the gas should be carbon dioxide because the greater solubility of carbon dioxide in blood reduces the risk of embolism.
V skladu s sklepom - Evropske komisije o postopku EMEA/H/C/000898/A20/0018 za zmanjšanje tveganja potencialno življenjsko nevarne zračne/plinske embolije, kadar je zdravilo napršeno z višjim tlakom od priporočenega in/ali preblizu površine tkiva, mora imetnik dovoljenja za promet zagotoviti, da: - kadar je zdravilo EVICEL napršeno s pomočjo plina pod tlakom, mora biti ta plin ogljikov dioksid, saj večja topnost ogljikovega dioksida v krvi zmanjša tveganje za pojav embolije.
The vials can be stored at room temperature for up to 24 hours.
Viale lahko hranimo pri sobni temperaturi do 24 ur.
There is not enough information available to know whether any particular risks are associated with the use of EVICEL during pregnancy or whilst breast-feeding.
Na voljo ni dovolj podatkov, da bi lahko ugotovili, ali obstajajo tveganja, ki so povezana z uporabo zdravila EVICEL med nosečnostjo ali v obdobju dojenja.
Manufacturers of these products also include steps in the processing of the blood and plasma that can inactivate or remove viruses.
Izdelovalci teh zdravil vključijo tudi stopnje priprave krvi in plazme, kjer se virusi inaktivirajo ali odstranijo.
If application of a single layer of EVICEL does not completely stop the bleeding, a second layer may be applied.
Če nanos enega sloja zdravila EVICEL krvavitve ne ustavi popolnoma, je mogoče nanesti drugi sloj.
For storage conditions after thawing of the medicinal product, see section 6.3.
Za pogoje shranjevanja po odtalitvi zdravila glejte poglavje 6.3.
Data are too limited to support the safety and effectiveness of EVICEL in children and adolescents.
Podatki so preveč omejeni, da bi lahko podpirali varnost in učinkovitost zdravila EVICEL pri otrocih in mladostnikih.
• Nearby areas should be protected to make sure that EVICEL is only applied onto the surface which is to be treated.
• Bližnje površine je treba zaščititi, da bi zagotovili, da je zdravilo EVICEL naneseno le na zdravljene površine.
Headache Hydrocephalus Subdural hygroma
Hidrocefalus Subduralni higrom
2°C-8°C (refrigerator): vials thaw within 1 day,
2 °C-8 °C (hladilnik): viale se odtalijo v 1 dnevu,
The amount of EVICEL that will be applied depends on the surface area of tissue to be treated during the operation.
Količina uporabljenega zdravila je odvisna od površine tkiva, zdravljenega med operacijskim posegom.
A non-interventional post-authorisation safety study was conducted which involved 300 patients undergoing vascular surgery during which EVICEL was used.
Po pridobitvi dovoljenja za promet je bila opravljena neintervencijska študija varnosti, ki je zajela 300 bolnikov po žilnem kirurškem posegu, med katerim je bilo uporabljeno zdravilo EVICEL.
• The educational package should contain: o The Summary of Product Characteristics o The section titled “The following information is intended for medical or healthcare professionals only” of the latest package leaflet.
• Izobraževalni paket bo vseboval: o Povzetek glavnih značilnosti zdravila, o poglavje z naslovom »Naslednje informacije so na voljo samo zdravstvenemu osebju« v najnovejših Navodilih za uporabo, o gradivo za izobraževanje, namenjeno zdravstvenemu osebju
Do not refrigerate EVICEL once it has reached room temperature.
Zdravila EVICEL ne smete shraniti v hladilniku potem, ko je doseglo sobno temperaturo.
The application device should be stored at room temperature, separately from the fibrinogen and thrombin.
Aplikator shranjujte pri sobni temperaturi ločeno od raztopin fibrinogena in trombina.
• As with any product containing proteins, allergic-type hypersensitivity reactions are possible.
• Kot pri vseh zdravilih, ki vsebujejo beljakovine, so možne preobčutljivostne reakcije alergijskega tipa.
Name and address of the manufacturer of the biological active substance
Ime in naslov izdelovalca bioloških zdravilnih učinkovin