natgillin/translations-raw huggingface dataset:
- rash, redness of the skin in the face, joint pain, fever, weakness and others caused by the medicine (drug-induced lupus erythematosus), frequency unknown.
- izpuščaj, rdečina kože na obrazu, bolečine v sklepih, zvišana telesna temperatura, slabotnost in drugi znaki, ki jih povzroča zdravilo (z zdravili povzročen eritematozni lupus), pogostnost neznana.
Caution should be exercised when Extavia is administered in combination with medicinal products that have a narrow therapeutic index and are largely dependent on the hepatic cytochrome P450 system for clearance, e.g. anti-epileptics.
Previdnost je potrebna pri sočasni uporabi zdravila Extavia in zdravil, ki imajo ozek terapevtski indeks in katerih očistek je v največji meri odvisen od jetrnega citokromalnega sistema P450 npr.: antiepileptiki.
To reduce the risk of getting injection site reaction you must: use a sterile (aseptic) injection technique, rotate the injection sites with each injection (see Annex Self-Injection procedure).
Za zmanjšanje tveganj reakcij na mestu injiciranja: uporabljajte sterilno (aseptično) tehniko injiciranja, pri vsakem odmerku menjavajte mesto injiciranja (glejte Prilogo Postopek samoinjiciranja).
Secondary Progressive Multiple Sclerosis (North American Study)
sekundarno progresivna multipla skleroza (severnoameriška raziskava)
Dysmenorrhoea Menstrual disorder * Metrorrhagia Impotence
Motnje reprodukcije in dojk dismenoreja menstruacijske motnje * metroragija impotenca
Limited information available on the transfer of interferon beta-1b into breast milk, together with the chemical / physiological characteristics of interferon beta, suggests that levels of interferon beta-1b excreted in human milk are negligible.
Na osnovi omejenega obsega razpoložljivih podatkov o prehajanju interferona beta-1b v materino mleko in kemijskih oziroma fizioloških lastnosti interferona beta je mogoče domnevati, da je količina interferona beta-1b, ki se izloči v materino mleko, zanemarljivo majhna.
Interferon beta-1b has been shown to possess both antiviral and immunoregulatory activity.
Dokazano je, da interferon beta-1b deluje protivirusno in imunoregulacijsko.
Within the study period of three years, CDMS occurred in 51% of the delayed treatment group compared to 37% of the immediate treatment group (Kaplan-Meier estimates).
V triletnem trajanju študije je do CDMS prišlo pri 51 % bolnikov v skupini z odloženim zdravljenjem v primerjavi s 37 % v skupini s takojšnjim zdravljenjem (po metodi Kaplan-Meier).
Note: Do not shake the vial.
Pozor: Ne stresajte viale.
Interferon alpha, interferon beta, and interferon gamma have overlapping yet distinct biological activities.
Interferoni alfa, beta in gama imajo prekrivajoče se, vendar med seboj različno biološko delovanje.
Do not use any area where you can feel lumps, bumps, firm knots, pain or an area that is discoloured, indented, scabbed, or where the skin is broken.
Ne uporabljajte predelov, na katerih čutite zatrdline, bulice, čvrste vozliče, ki so boleči, ali predelov, na katerih je koža razbarvana, vdrta, pokrita s krastami ali ranjena.
This medicinal product contains less than 1 mmol sodium (23 mg) per ml, i.e. essentially ‘sodiumfree'.
To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na ml, kar v bistvu pomeni “brez natrija”.
The effect of alternate-day administration of 250 microgram (8.0 million IU) Extavia on drug metabolism in multiple sclerosis patients is unknown.
Učinek uporabe 250 mikrogramov (8,0 milijonov i.e.) zdravila Extavia vsak drugi dan na presnovo zdravil pri bolnikih z multiplo sklerozo ni znan.
Solvent for Extavia For subcutaneous use after reconstitution.
Vehikel za zdravilo Extavia Za subkutano uporabo po rekonstituciji.
The most serious events often occurred in patients exposed to other medicinal products or substances known to be associated with hepatotoxicity or in the presence of co-morbid medical conditions (e.g. metastasising malignant disease, severe infection and sepsis, alcohol abuse).
Najresnejši učinki so se pogosto pojavili pri bolnikih, ki so dobivali še druga zdravila ali snovi z znanimi hepatotoksičnimi učinki in pri bolnikih s sočasnimi boleznimi (npr. metastatsko maligno boleznijo, hudo okužbo in sepso, zlorabo alkohola).
► Tell your doctor immediately and stop using Extavia: if you experience symptoms such as itching all over your body, swelling of your face and/or your tongue or sudden shortness of breath.
► Zdravnika nemudoma obvestite in prenehajte uporabljati zdravilo Extavia: - če se pojavijo simptomi, kot so srbenje po vsem telesu, otekanje obraza in/ali jezika ali nenadna kratka sapa;
• Choosing an injection site
• Izbira mesta injiciranja
12 - Ensure the plunger stays fully pushed in before proceeding to the next step, as it may have moved.
12 - Preden nadaljujete z naslednjim korakom, se prepričajte, da je bat ostal potisnjen do konca in da se ni premaknil.
Extavia may cause serious side effects.
Zdravilo Extavia lahko povzroči resne neželene učinke.
Transfer all the solvent to the vial.
V vialo prenesite ves vehikel.
The 30-gauge needles provided with the application kit for the administration of this medicine can be used either for manual injection OR with an ExtaviPro 30G auto-injector.
Igle velikosti 30, ki so priložene kompletu za pripravo in uporabo tega zdravila, je mogoče uporabljati za klasično injiciranje ALI z avtoinjektorjem ExtaviPro 30G.
In MS, inflammation destroys the protective sheath (called myelin) around the nerves of the CNS and stops the nerves from working properly.
Pri MS vnetje uniči zaščitno ovojnico (imenovano mielinska ovojnica), ki obdaja živce v OŽ in prepreči njihovo pravilno delovanje.
Sodium chloride Water for injection
Vehikel natrijev klorid voda za injekcije
If, for some reason, you are not able to inject Extavia immediately, you can refrigerate the reconstituted solution for up to 3 hours before using it. Do not freeze the solution, and do not wait longer than 3 hours to inject it.
Če si iz kakršnegakoli razloga zdravila Extavia ne morete vbrizgati takoj, lahko rekonstituirano raztopino pred uporabo do 3 ure hranite v hladilniku.
Adverse events related to the central nervous system associated with the use of Extavia might influence the ability to drive and use machines in susceptible patients.
Z zdravilom Extavia povezani neželeni učinki na osrednje živčevje bi pri dovzetnih bolnikih lahko vplivali na sposobnost vožnje in upravljanja s stroji.
In two years, the risk was 85% in the placebo group and 69% in the Extavia group (Hazard Ratio = 0.57, 95% confidence interval (0.46, 0.71), p<0.00001).
V dveh letih je bilo tveganje 85-odstotno v skupini s placebom in 69-odstotno v skupini z zdravilom Extavia (razmerje tveganja = 0,57, interval zaupanja = 95 % (0,46, 0,71), p<0,00001).
Patients should be started at 62.5 microgram (0.25 ml) subcutaneously every other day, and increased slowly to a dose of 250 microgram (1.0 ml) every other day (see Table A).
Zdravljenje je treba začeti z odmerkom 62,5 mikrogramov (0,25 ml) subkutano vsak drugi dan, nato pa ga večati do 250 mikrogramov (1,0 ml) vsak drugi dan (glejte Preglednico A).
• Patients with relapsing remitting multiple sclerosis and two or more relapses within the last two years.
• bolnikov z recidivno remitentno multiplo sklerozo, ki so v zadnjih dveh letih doživeli dva recidiva ali več.
While Extavia does not have any known direct-acting cardiac toxicity, symptoms of the flu-like syndrome associated with beta interferons may prove stressful to patients with pre-existing significant cardiac disease.
Zdravilo Extavia nima znane neposredne toksičnosti za srce, vendar je lahko kompleks gripi podobnih simptomov, povezan z uporabo interferonov, za bolnike z obstoječo pomembno boleznijo srca stresen.
Relapsing-remitting multiple sclerosis (RR-MS)
Recidivno-remitentna multipla skleroza (RRMS)
If the patient fails to respond, for example a steady progression in Expanded Disability Status Scale (EDSS) for 6 months occurs or treatment with at least 3 courses of adrenocorticotropic hormone (ACTH) or corticosteroids during a one-year period is required despite Extavia therapy, treatment with Extavia should be stopped.
Zdravljenje z zdravilom Extavia je treba končati, če se bolnik ne odzove, npr. če kljub terapiji z zdravilom Extavia stanje po dopolnjeni lestvici statusa invalidnosti (EDSS - Expanded Disability Status Scale) 6 mesecev nenehno napreduje ali so v enoletnem obdobju kljub terapiji z zdravilom Extavia potrebni vsaj 3 ciklusi zdravljenja s kortikotropinom (ACTH) ali kortikosteroidi.
This might happen several weeks to several years after starting Extavia.
To se lahko pojavi nekaj tednov do nekaj let po začetku zdravljenja z zdravilom Extavia.
Table 2 Adverse drug reactions (ADRs) identified during post-marketing surveillance (frequencies - where known - calculated based on pooled clinical trial data N = 1,093)
Preglednica 2 Neželeni učinki zdravila, ki so jih odkrili v času postmarketinškega nadzora (znane pogostnosti so izračunane iz združenih podatkov več kliničnih študij n=1.093)
No investigations on fertility have been conducted.
Raziskav o plodnosti ni bilo.
This treatment effect was still evident after the additional year of follow-up at which stage the risk reduction was 41% (Hazard Ratio = 0.59, 95% confidence interval (0.42, 0.83), p=0.0011).
Ta učinek zdravljenja je bilo še vedno mogoče opaziti po dodatnem letu spremljanja, ko je je bilo zmanjšanje tveganja 41-odstotno (razmerje tveganja=0,59, 95 % interval zaupanja (0,42, 0,83), p=0,0011).
Before injection, the Extavia solution has to be prepared from a vial of Extavia powder and 1.2 ml of liquid from the pre-filled solvent syringe.
Pred injiciranjem je treba raztopino zdravila Extavia pripraviti iz viale s praškom zdravila Extavia in 1,2 ml tekočine iz napolnjene injekcijske brizge z vehiklom.
Maximum serum levels of about 40 IU/ml were found 1-8 hours after subcutaneous injection of 500 microgram (16.0 million IU) interferon beta-1b.
Največjo koncentracijo v serumu okrog 40 i.e./ml so izmerili od 1 do 8 ur po subkutani injekciji 500 mikrogramov (16,0 milijonov i.e.) interferona beta-1b.
Flu-like symptoms may also be reduced by administration of non-steroidal anti-inflammatory medicinal products.
Bolezenski znaki podobni gripi se lahko zmanjšajo z uporabo nesteroidnih protivnetnih zdravil.
These instructions also tell you how to prepare the Extavia solution for injection.
To navodilo opisuje tudi pripravo raztopine zdravila Extavia za injiciranje.
C) Reconstituting and drawing up the solution for injection, step by step D) Making the injection manually (to make an injection with the ExtaviPro 30G auto injector, refer to the instructions for use provided with the auto-injector)
C) Rekonstitucija in izvlek raztopine za injiciranje po korakih D) Klasično injiciranje z brizgo (za injiciranje z avtoinjektorjem ExtaviPro 30G glejte navodila za uporabo, ki so priložena avtoinjektorju)
For subcutaneous use after reconstitution with 1.2 ml of solvent.
Za subkutano uporabo po rekonstituciji z 1,2 ml vehikla Za enkratno uporabo.
One controlled clinical trial was performed with Extavia in patients with relapsing-remitting multiple sclerosis and able to walk unaided (baseline EDSS 0 to 5.5).
Opravljena je bila ena kontrolirana klinična raziskava zdravila Extavia pri bolnikih z recidivnoremitentno multiplo sklerozo, ki so lahko hodili brez pomoči (izhodiščni EDSS 0 do 5,5).
If you suffer from severe depression and/or suicidal thoughts, you will not be treated with Extavia (see also “Do not use Extavia”).
Če imate hudo depresijo in/ali samomorilne misli, vam ne bodo predpisali zdravila Extavia (glejte tudi Ne uporabljajte zdravila Extavia).
The most frequently observed adverse reactions are a flu-like symptom complex (fever, chills, arthralgia, malaise, sweating, headache, or myalgia), which is mainly due to the pharmacological effects of the medicinal product, and injection site reactions.
Najpogostejši neželeni učinki so kompleks gripi podobnih simptomov (zvišana telesna temperatura, mrzlica, artralgija, splošno slabo počutje, znojenje, glavobol ali mialgija), do katerih pride predvsem zaradi farmakoloških učinkov zdravila in reakcij na mestu aplikacije.
Note: Do not shake the vial as this may cause excessive foaming.
Pozor: Ne stresajte viale, da ne pride do čezmernega penjenja.
Injection site reactions may occur less frequently if you use an auto-injector device.
Reakcije na mestu injiciranja so lahko redkejše, če uporabljate samoinjektor.
One way to do that is to note the injection site on the enclosed medication record card.
Ena možnost za vodenje takšne evidence je beleženje na priloženo kartico o uporabi zdravila.
Leave the swab on top of the vial.
Na koncu blazinico pustite na vrhu viale.
Furthermore, for the time being there is no well established definition of a high risk patient, although a more conservative approach is to accept at least nine T2 hyperintense lesions on the initial scan and at least one new T2 or one new Gd-enhancing lesion on a follow-up scan taken at least 1 month after the initial scan.
Vendar je sprejemljivejši konzervativen pristop, to pomeni vsaj 9 hiperintenzivnih lezij T2 v prvi preiskavi in vsaj ena nova T2 ali ena nova lezija po ojačanjem z Gd v naslednji preiskavi, ki je izvedena vsaj 1 mesec po prvi preiskavi.
RR-MS, SP-MS and single clinical event suggestive of MS In all multiple sclerosis studies Extavia was effective in reducing disease activity (acute inflammation in the central nervous system and permanent tissue alterations) as measured by magnetic resonance imaging (MRI).
RRMS, SPMS in enkratni demielinizacijski dogodek, ki nakazuje multiplo sklerozo V vseh študijah multiple skleroze je zdravilo Extavia učinkovito zmanjšalo aktivnost bolezni (akutno vnetje v osrednjem živčevju in trajne spremembe tkiva), merjeno z magnetnoresonančnim slikanjem (MRS).
In the following tables, the most appropriate MedDRA term is used to describe a certain reaction and its synonyms and related conditions.
V naslednjih preglednicah je za opis določenega učinka, njegovih sinonimov in podobnih stanj uporabljen najbolj ustrezen izraz po klasifikaciji MedDRA.
Patients who develop neutropenia should be monitored closely for the development of fever or infection.
Pri bolnikih, pri katerih pride do nevtropenije, je treba pozorno spremljati povišano telesno temperaturo ali pojav okužb.
- Pack containing 5 vials with powder and 5 pre-filled syringes with solvent - Pack containing 14 vials with powder and 14 pre-filled syringes with solvent - Pack containing 15 vials with powder and 15 pre-filled syringes with solvent - Pack containing 14 vials with powder and 15 pre-filled syringes with solvent
- pakiranje, ki vsebuje 5 vial s praškom in 5 napolnjenih injekcijskih brizg z vehiklom - pakiranje, ki vsebuje 14 vial s praškom in 14 napolnjenih injekcijskih brizg z vehiklom - pakiranje, ki vsebuje 15 vial s praškom in 15 napolnjenih injekcijskih brizg z vehiklom - pakiranje, ki vsebuje 14 vial s praškom in 15 napolnjenih injekcijskih brizg z vehiklom
OUTER CARTON OF MULTIPACK (INCLUDING BLUE BOX)
ZUNANJA ŠKATLA SKUPNEGA PAKIRANJA (Z "BLUE BOX" PODATKI)
Injection site skin and tissue breakdown can result in scars forming.
Zaradi razkroja kože in tkiva na mestu injiciranja lahko pride do brazgotinjenja.
- Keep your syringes and syringe disposal unit out of the sight and reach of children; lock the supplies away if possible.
- Brizge in posode za odstranjevanje brizg hranite otrokom skrito in nedosegljivo; če je mogoče,
Patients with current severe depression and/or suicidal ideation (see sections 4.4 and 4.8).
Bolniki s hudimi depresivnimi motnjami in/ali samomorilnimi mislimi (glejte poglavji 4.4 in
New adverse events have not been associated with the development of neutralising activity.
Pojav nevtralizacijske aktivnosti ni bil povezan z novimi neželenimi učinki.
How to use Extavia
Kako uporabljati zdravilo Extavia
- You will need blood tests to determine your blood cell count, blood chemistry and your liver enzymes.
- Opraviti morate krvne preiskave, za pregled celotne krvne slike, biokemijske krvne preiskave in ravni jetrnih encimov.
Interferon beta-1b both decreases the binding affinity and enhances the internalisation and degradation of the interferon-gamma receptor.
Interferon beta-1b zmanjšuje vezavno afiniteto receptorja interferona gama in povečuje njegovo internalizacijo in degradacijo.
There is no evidence of Extavia having an effect on the duration of relapses.
Dokazov, da zdravilo Extavia vpliva na trajanje recidivov, ni.
2 - Use an alcohol swab to clean the skin at the injection site.
2 - Z alkoholno blazinico očistite mesto injiciranja.
In controlled clinical trials serum samples were collected every 3 months for monitoring of development of antibodies to Extavia.
Za spremljanje nastanka protiteles proti zdravilu Extavia so v nadzorovanih kliničnih preskušanjih vsake 3 mesece odvzeli vzorce seruma.
- the liver does not work properly (hepatic injury [including hepatitis], hepatic failure), (rare).
- nezadostno delovanje jeter (okvara jeter [vključno s hepatitisom], odpoved jeter) (redki).
After 3 years, a pre-planned interim analysis showed EDSS progression (confirmed increase in EDSS of greater than or equal to 1.0 compared to baseline) occurred in 24% of the patients in the delayed treatment group compared to 16% in the immediate treatment group [Hazard Ratio = 0.6, 95% confidence interval (0.39, 0.92), p=0.022].
Po treh letih je vnaprej načrtovana vmesna analiza pokazala napredovanje na lestvici EDSS (potrjeno večja ocena na lestvici EDSS za 1,0 ali več, v primerjavi z izhodiščno) pri 24 % bolnikov v skupini z odloženim zdravljenjem v primerjavi s 16 % bolnikov v skupini s takojšnjim zdravljenjem [razmerje tveganja 0,6, 95 % interval zaupanja (0,39, 0,92), p = 0,022].
- The functioning of your thyroid gland will be checked regularly or whenever thought necessary by your doctor for other reasons.
- Delovanje ščitnice je treba preverjati redno ali tudi dodatno zaradi drugih razlogov, če tako oceni zdravnik.
Therapy with Extavia was well accepted in the study of patients with a single clinical event as indicated by a high rate of trial completion (92.8% in the Extavia group).
Pri bolnikih z enim samim kliničnim dogodkom je bilo zdravljenje z zdravilom Extavia dobro sprejeto, na kar kaže veliko število bolnikov, ki so zaključili preskušanje (92,8 % v skupini, ki je prejemala zdravilo Extavia).
- If you notice pain in your belly which is radiating to your back, and/or you feel sick or have a fever.
- če imate bolečine v trebuhu, ki se širijo v hrbet, in/ali vam je slabo ali imate zvišano telesno temperaturo.
At the beginning of treatment side effects are common but in general they decrease with further treatment.
Na začetku zdravljenja so neželeni učinki pogosti, a z nadaljevanjem zdravljenja jih je praviloma manj.
There are sparse and inconclusive data on patients who have developed neutralising activity and have completed Extavia therapy.
Podatkov o bolnikih, pri katerih se je razvila nevtralizacijska aktivnost in so dokončali zdravljenje z zdravilom Extavia, je malo in so nedokončni.
Interferons have been reported to reduce the activity of hepatic cytochrome P450-dependent enzymes in humans and animals.
Poročali so, da interferoni pri ljudeh in živalih zmanjšajo aktivnost jetrnih encimov, odvisnih od citokromalnega sistema P450.
3 ml vial (clear type I glass) with a butyl rubber stopper (type I) and aluminium overseal containing 300 microgram (9.6 million IU) of (recombinant interferon beta-1b) powder.
3 ml viala (prozorno steklo tipa I) z zamaškom iz butilne gume (tip I) in zaporko iz aluminija vsebuje 300 mikrogramov (9,6 milijona i.e.) rekombinantnega interferona beta-1b v prašku.
Retrospective analyses in subgroups showed that a treatment effect on disability progression is most likely in patients with active disease before treatment commences (Hazard Ratio 0.72, 95% confidence interval (0.59, 0.88), p=0.0011, corresponding to a 28% risk reduction due to Extavia in patients with relapses or pronounced EDSS progression, 8.0 million IU Extavia versus all placebo patients).
Retrospektivne analize v podskupinah so pokazale, da je učinek zdravljenja na napredovanje invalidnosti najverjetnejši pri bolnikih, ki imajo aktivno bolezen, preden se začne zdravljenje (razmerje tveganja = 0,72, 95 % interval zaupanja (0,59, 0,88), p=0,0011, kar ustreza 28 % zmanjšanju tveganja zaradi zdravila Extavia pri bolnikih z recidivi ali izrazitim napredovanjem EDSS;
- Set up a permanent storage area in a convenient location out of the sight and reach of children so that your Extavia and other supplies are always easy to find.
- Izberite trajno, primerno, otrokom skrito in nedostopno mesto, kjer boste imeli zdravilo Extavia in druge pripomočke vedno pri roki.
• 30-gauge needles for injecting your medicine
• igle velikosti 30 za injiciranje zdravila
The placebo-controlled phase lasted for 2 years or until the patient developed clinically definite multiple scleroiss (CDMS), whichever came first.
S placebom kontroliran del je trajal 2 leti oziroma do razvoja klinično dokončne multiple skleroze (CDMS - clinically definite multiple sclerosis) pri posameznem bolniku, če je ta nastopil prej kot v dveh letih.
To reconstitute the powder, the pre-filled syringe with solvent should be used with a needle or a vial adapter to inject the 1.2 ml of the solvent (sodium chloride 5.4 mg/ml (0.54%) solution for injection) into the Extavia vial.
Za rekonstitucijo praška je treba uporabiti napolnjeno injekcijsko brizgo z vehiklom in iglo ali adapter z iglo za vialo ter vbrizgati 1,2 ml vehikla (raztopina natrijevega klorida, 5,4 mg/ml (0,54 %) raztopina za injekcije) v vialo z zdravilom Extavia.
If this occurs and a relationship to Extavia is suspected, treatment should be discontinued.
Če sumite na povezavo z uporabo zdravila Extavia, je treba zdravljenje prekiniti.
2.25 ml graduated (with dose marks of: 0.25 ml, 0.5 ml, 0.75 ml, 1.0 ml) pre-filled syringe (type I glass) with 1.2 ml solvent.
2,25 ml odmerna napolnjena injekcijska brizga (z odmernimi oznakami za 0,25 ml, 0,5 ml, 0,75 ml in 1,0 ml) (steklo tipa I) z 1,2 ml vehikla.
2 - Remove the flip off cap from the Extavia vial.
2 - Snemite zaporko z viale z zdravilom Extavia.
The solvent for Extavia is provided in a 2.25 ml pre-filled syringe and contains 1.2 ml sodium chloride 5.4 mg/ml (0.54% w/v) solution for injection.
Vehikel za zdravilo Extavia je na voljo v 2,25-mililitrski napolnjeni brizgi in vsebuje 1,2 ml natrijevega klorida 5,4 mg/ml (0,54 % w/v) raztopine za injekcije.
Extavia is injected under the skin so any food or drink you consume is not thought to have any effect on Extavia.
Zdravilo Extavia skupaj s hrano in pijačo Zdravilo Extavia se injicira pod kožo, zato vpliva hrane ali pijače ni mogoče pričakovati.
The incidence of injection site reactions may be reduced by the use of an auto-injector.
Pogostnost reakcij na mestu injiciranja se lahko zmanjša z uporabo avtoinjektorja.
Skin breakdown and tissue damage (necrosis) around the injection site are reported less frequently.
Manj pogosto poročajo o primerih razpadanja kože in odmiranju tkiva (nekroze) okoli mesta injiciranja.
No separate investigations were performed regarding the influence of Extavia on the cardiovascular system, respiratory system and the function of endocrine organs.
O vplivu zdravila Extavia na srce in ožilje, dihala in delovanje endokrinih organov ni bilo posebnih raziskav.
• 1 pre-filled syringe of solvent for Extavia (sodium chloride solution)
• 1 napolnjeno injekcijsko brizgo z vehiklom za zdravilo Extavia (raztopina natrijevega klorida)
- If you experience symptoms such as itching all over your body, swelling of your face and/or your tongue or sudden shortness of breath.
- če se pojavijo simptomi, kot je srbenje po vsem telesu, oteklost obraza in/ali jezika ali nenadna kratka sapa.
15 - Unscrew the syringe, leaving the vial adapter on the vial.
15 - Odvijte brizgo, adapter pa pustite na viali.
Select an injection site.
- Izberite mesta injiciranja.
If you experience any break in the skin, associated with swelling or fluid leaking out from the injection site:
Če vam poči koža zaradi otekanja ali iztekanja tekočine iz mesta injiciranja: