natgillin/translations-raw huggingface dataset:
However, no clinically relevant effects on ECG have been observed in clinical studies with SANCUSO, including a through QT study in 240 healthy subjects (section 5.1).
Vendar pa v kliničnih študijah z zdravilom SANCUSO, vključno s temeljito študijo QT pri 240 zdravih prostovoljcih, niso opazili klinično pomembnih učinkov na EKG (poglavje 5.1).
What SANCUSO looks like and contents of the pack
Izgled zdravila SANCUSO in vsebina pakiranja
Although no evidence of an increased incidence of adverse reactions have been observed in patients with renal or hepatic impairment receiving granisetron orally and intravenously, based on granisetron pharmacokinetics, a degree of caution must be exercised in this population.
Čeprav niso opazili znakov zvečane pogostnosti neželenih učinkov pri bolnikih z okvarami ledvic ali jeter, ki so prejemali granisetron peroralno in intravensko, na podlagi farmakokinetike granisetrona, moramo biti pri tej skupini bolnikov nekoliko previdnejši.
How to use SANCUSO
Kako uporabljati zdravilo SANCUSO
The transdermal patch will still contain active substance following use.
Transdermalni obliž po uporabi še vedno vsebuje učinkovino.
No consistent gender effects on pharmacokinetics were observed in clinical studies with SANCUSO, with a large inter-individual variability reported in both sexes.
V kliničnih študijah z zdravilom SANCUSO niso opazili nikakršnih skladnih učinkov spola na farmakokinetiko, so pa pri obeh spolih poročali o veliki variabilnosti med posameznimi osebami.
If the transdermal patch starts to become unstuck, the same transdermal patch may be secured to the same area of skin.
Če se transdermalni obliž odlepi, lahko isti transdermalni obliž ponovno pritrdite na isti predel kože.
The transdermal patch can be worn for up to 7 days depending on the duration of the chemotherapy regimen.
Bolnik lahko nosi transdermalni obliž do 7 dni, odvisno od trajanja kemoterapevtske sheme.
This leaflet was last revised in July 2018
Navodilo je bilo nazadnje revidirano dne
The transdermal patch should not be cut into pieces.
Transdermalnega obliža ni dovoljeno razrezati v več kosov.
No clinical studies have been performed specifically to investigate the pharmacokinetics of SANCUSO in patients with renal or hepatic impairment.
Kliničnih študij posebej za to, da bi se raziskala farmakokinetika zdravila SANCUSO pri bolnikih z okvarami ledvic ali jeter, niso opravili.
Due to a gradual increase in plasma levels of granisetron following application of the transdermal patch, a slower onset of efficacy compared to 2 mg oral granisetron may be observed at the start of chemotherapy; the patch should be applied 24-48 hours before chemotherapy.
Zaradi postopnega naraščanja plazemske koncentracije granisetrona po namestitvi transdermalnega obliža opažamo v začetku kemoterapije počasnejši nastop učinkovitosti kot pri 2-miligramskem peroralnem granisetronu; obliž je treba nalepiti 24-48 ur pred kemoterapijo.
Thin, translucent, matrix-type, rectangular-shaped transdermal patch with rounded corners.
transdermalni obliž Tanek, prosojen, pravokotno oblikovan transdermalni obliž matrične vrste z zaobljenimi vogali.
After removal, the used transdermal patch should be folded firmly in half, adhesive side inwards and then discarded out of the reach of children.
Ko bolnik uporabljeni transdermalni obliž odstrani, naj ga čvrsto prepogne na pol z lepljivo stranjo navznoter in ga nato zavrže zunaj dosega otrok.
Uncommon side effects are: - headache, a feeling of “spinning” even when you are standing still (vertigo) - decreased appetite, weight loss - flushing (or redness) - feeling sick (nausea), retching, dry mouth - pain in your joints - swelling due to water retention (oedema) - changes in liver function tests (if you are having blood tests, tell the doctor or nurse that you have been given SANCUSO).
- siljenje na bruhanje (navzea), spahovanje, suha usta, - bolečine v sklepih, - otekanje zaradi zastajanja vode (edemi), - spremembe testov jetrnih funkcij (če vam vzamejo kri za preiskave, povejte zdravniku ali medicinski sestri, da so vam dali zdravilo SANCUSO).
- Hypersensitivity reactions, e.g. anaphylaxis, urticaria - Insomnia - Headache - Extrapyramidal reactions - Somnolence - Dizziness - QT prolongation - Constipation - Diarrhoea - Elevated hepatic transaminases - Rash - Asthenia
- glavobol, - ekstrapiramidne reakcije, - zaspanost, - omotica, - podaljšanje intervala QT, - zaprtost, - driska, - zvišane jetrne transaminaze,
Consequently, SANCUSO is indicated for use in patients where oral anti-emetic administration is complicated by factors making swallowing difficult.
Zato je transdermalni obliž SANCUSO indiciran za uporabo pri bolnikih, pri katerih peroralno uporabo antiemetikov zapletajo dejavniki, ki otežujejo požiranje.
Put the transdermal patch on a clean, dry, healthy area of skin on the outside part of your upper arm.
Transdermalni obliž si nalepite na čist, suh, zdrav predel kože na zunanji strani nadlakta.
Class effects Class effects for granisetron seen with other formulations (oral and intravenous) include the following:
Učinki skupine Učinki skupine granisetrona, ki jih najdemo pri drugih pripravkih (peroralnih in intravenskih),
Patients must be advised to cover the transdermal patch application site, e.g. with clothing, if there is a risk of exposure to sunlight throughout the period of wear and for 10 days following its removal.
Bolnikom moramo priporočiti, naj mesto aplikacije transdermalnega obliža pokrijejo, na primer z oblačili, za ves čas nošenja obliža in še za 10 dni po njegovi odstranitvi, če obstaja nevarnost izpostavljanja sončni svetlobi.
- SSRIs (selective serotonin reuptake inhibitors) used to treat depression and/or anxiety including fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, escitalopram.
- Zaviralci SSRI (selektivni zaviralci ponovnega privzema serotonina) se uporabljajo za zdravljenje depresije in/ali anksioznosti ter vključujejo fluoksetin, paroksetin, sertralin,
Remove the transdermal patch at least 1 day (24 hours) after completing your chemotherapy.
Odstranite transdermalni obliž vsaj 1 dan (24 ur) po dokončanju kemoterapije.
Metabolism and nutrition disorders Decreased appetite
Presnovne in prehranske motnje zmanjšan tek občasni
Furthermore, no interaction has been observed between granisetron and emetogenic cancer therapies.
Prav tako niso ugotovili medsebojnega delovanja med granisetronom in emetogenimi kemoterapevtiki za zdravljenje raka.
While holding the remaining half of the rigid plastic film, apply the transdermal patch to the skin on the outside part of your upper arm.
Držite preostalo polovico čvrste plastične podloge in prilepite transdermalni obliž na kožo na zunanji strani nadlakta.
Wash your hands after applying the transdermal patch.
Po namestitvi transdermalnega obliža si umijte roke.
You must talk to a doctor if you do not feel better or if you feel worse after the first day of chemotherapy.
Če se po prvem dnevu kemoterapije ne počutite bolje ali če se počutite slabše, se morate pogovoriti z zdravnikom.
No differences in the metabolic profiles of granisetron were observed between the oral and transdermal uses.
Biotransformacija Opazili niso nobenih razlik v presnovnih profilih granisetrona pri peroralni in transdermalni uporabi.
Take the transdermal patch out of the sachet.
Vzemite transdermalni obliž iz vrečice.
Avoid these activities while wearing this transdermal patch.
Ko nosite ta transdermalni obliž, se tem dejavnostim izogibajte.
The transdermal patch should be applied to clean, dry, intact healthy skin on the outer part of the upper arm.
Transdermalni obliž je treba namestiti na čisto, suho, nepoškodovano zdravo kožo na zunanji strani nadlakta.
Talk to your doctor if you want to remove the patch before the end of your chemotherapy treatment course (up to 7 days).
Če želite obliž odstraniti pred koncem zdravljenja s kemoterapijo (do 7 dni), se posvetujte s svojim zdravnikom.
SANCUSO transdermal patches did not show any potential for photoirritation or photosensitivity when tested in vivo in guinea-pigs.
Transdermalni obliži SANCUSO pri testiranju in vivo na budrah niso pokazali potenciala za fotoiritacijo ali fotosenzibilnost.
Preclinical data did not reveal any special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, reproductive toxicity and genotoxicity.
Predklinični podatki na osnovi običajnih študij varnostne farmakologije, toksičnosti pri ponavljajočih se odmerkih, genotoksičnosti, vpliva na sposobnost razmnoževanja in razvoja ne kažejo posebnega tveganja za človeka.
When tested for skin sensitising potential in guinea pigs, SANCUSO showed a low potential for irritancy.
Ko so zdravilo SANCUSO testirali glede potenciala senzitizacije kože na budrah, je zdravilo kazalo majhen potencial draženja.
Adverse reactions are presented in order of decreasing seriousness within each frequency grouping.
V razvrstitvah pogostnosti so neželeni učinki navedeni po padajoči resnosti.
No significant effect on QTc prolongation was observed for SANCUSO.
Pri zdravilu SANCUSO niso opazili pomembnega vpliva na podaljšanje intervala QTc.
The transdermal patch should be removed a minimum of 24 hours after completion of chemotherapy.
Bolnik mora odstraniti transdermalni obliž najmanj 24 ur po dokončanju kemoterapije.
- You should avoid external heat (for example hot water bottles or heat pads) on the area of the transdermal patch.
- Izogibajte se zunanji toploti (na primer termoforju ali ogrevalnim blazinam) v predelu transdermalnega obliža.
Each sachet contains one transdermal patch stuck onto a rigid plastic film.
Vsaka vrečica vsebuje en transdermalni obliž, prilepljen na čvrsto plastično podlogo.
SANCUSO is a thin, clear, rectangular-shaped transdermal patch with rounded corners, stuck onto a rigid plastic film.
Zdravilo SANCUSO je tanek, prosojen, pravokotno oblikovan transdermalen obliž z zaobljenimi vogali, prilepljen na čvrsto plastično podlogo.
Each 52 cm2 transdermal patch contains 34.3 mg of granisetron, releasing 3.1 mg of granisetron per 24 hours.
En transdermalni obliž s površino 52 cm2 vsebuje 34,3 mg granisetrona in sprosti 3,1 mg granisetrona na 24 ur.
Granisetron has been shown to block both sodium and potassium channels, which could affect cardiac depolorisation and repolarisation and therefore PR, QRS, and QT intervals.
Pokazali so, da granisetron blokira tako natrijeve kot kalijeve kanalčke, kar bi lahko vplivalo na depolarizacijo in repolarizacijo srca in s tem na intervale PR, QRS in QT. Ti podatki pomagajo pojasniti mehanizme, s katerimi lahko nastanejo nekatere od elektrokardiografskih sprememb (posebno podaljšanje QT in QRS), povezanih s to skupino substanc.
When to apply and remove the transdermal patch
Kdaj si namestite in odstranite transdermalni obliž
No dose adjustments are necessary for the elderly or patients with renal or hepatic impairment.
Pri starejših bolnikih in pri bolnikih z okvarami ledvic ali jeter prilagajanje odmerka ni potrebno.
Musculoskeletal and connective tissue disorders
Bolezni mišično-skeletnega sistema in vezivnega tkiva bolečine v sklepih občasni
If it is not possible to apply the transdermal patch to the arm, it can be applied to the abdomen.
Če ni možno namestiti transdermalnega obliža na nadlaket, ga lahko nalepimo na trebuh.
Apply a transdermal patch at least 1 day (24 hours) before you are scheduled to have chemotherapy treatment.
Namestite transdermalni obliž vsaj 1 dan (24 ur) pred načrtovano kemoterapijo.
This medicine delivers the active substance slowly and constantly through your skin and into your blood stream for the duration that you are wearing the transdermal patch.
Ves čas uporabe transdermalnega obliža prehaja učinkovina iz zdravila počasi in stalno skozi kožo v krvni obtok.
No clinically relevant effects have been observed in clinical studies with SANCUSO.
V kliničnih študijah z zdravilom SANCUSO niso opazili klinično pomembnih učinkov.
You can continue to shower and wash normally while wearing the transdermal patch.
Ko nosite transdermalni obliž, se lahko normalno tuširate in umivate.
Each carton contains one transdermal patch.
Ena škata vsebuje en transdermalni obliž.
Wear the transdermal patch all the time during your chemotherapy.
Med kemoterapijo nosite transdermalni obliž ves čas.
Immune system disorder
Bolezni imunskega sistema preobčutljivostne reakcije neznana
No clear relationship between renal function (as measured by creatinine clearance) and granisetron clearance was identified in population PK modelling.
Pri modeliranju populacijske farmakokinetike niso ugotovili nikakršne jasne povezave med funkcijo ledvic (merjeno z očistkom kreatinina) in očistkom granisetrona.
Adverse reactions reported for SANCUSO System Organ Class
Preglednica 1: Neželeni učinki zdravila SANCUSO, o katerih poročajo Organski sistem
External heat (for example hot water bottles or heat pads) should be avoided on the area of the transdermal patch.
Bolnik naj se izogiba zunanji toploti (na primer vročemu termoforju ali ogrevalnim blazinam) v predelu transdermalnega obliža.
Each carton contains 1 transdermal patch.
Ena škatla vsebuje 1 transdermalni obliž.
- Allergic reactions including urticaria (itchy, red, raised skin rash) and anaphalaxis (a serious allergic reaction which may include sudden wheeziness, difficulty in breathing, swelling of the eyelids, face or lips, rash or itching) - Difficulty sleeping/disturbed sleep - Excessive sleepiness - Prolonged QT interval in the ECG (changes to the heart rate trace (ECG) indicating a heart rhythm disorder) - Constipation - Diarrhoea - Lack of energy/weakness /Loss of strength
Drugi možni neželeni učinki, povezani z zdravili z granisetronom (pogostnost ni znana): - alergijske reakcije, vključno z urtikarijo (srbeč, rdeč, privzdignjen kožni izpuščaj) in anafilaksijo (resna alergijska reakcija, ki lahko vključuje nenadno sopenje, težave z dihanjem, otekanje vek, obraza ali ustnic, izpuščaj ali srbenje)
Keep the transdermal patch in place for the whole time you are having chemotherapy.
Transdermalni obliž naj bo prilepljen ves čas trajanja kemoterapije.
How to store SANCUSO
Shranjevanje zdravila SANCUSO
SANCUSO 3.1 mg/24 h transdermal patch Granisetron Transdermal use
SANCUSO 3,1 mg/24 h transdermalni obliž granisetron transdermalna uporaba
Contents of the pack and other information
Shranjevanje zdravila SANCUSO Vsebina pakiranja in dodatne informacije
Gently wash the area with soap and water to remove it. Alcohol or other dissolving liquids such as nail polish remover may cause skin irritation and should not be used.
Ne uporabljajte alkohola ali drugih topil, na primer odstranjevalca laka za nohte, ker lahko povzročajo draženje kože.
An initial peak in plasma concentrations of granisetron, attributable to the intravenous dose, was reached at 10 minutes post-administration.
Deset minut po dajanju je bil dosežen začeten vrh plazemske koncentracije granisetrona, ki ga lahko pripišemo intravenskemu odmerku.
Paediatric population No studies have been performed to investigate the pharmacokinetics of SANCUSO in paediatrics.
Študij, s katerimi bi raziskovali farmakokinetiko zdravila SANCUSO pri pediatričnih bolnikih, niso izvedli.
Granisetron was not phototoxic when tested in vitro in a mouse fibroblast cell line.
Pri testiranju in vitro na celični liniji mišjih fibroblastov granisetron ni bil fototoksičen.
How to apply the transdermal patch
Kako si nalepite transdermalni obliž
SANCUSO 3.1 mg/24 hours transdermal patch
SANCUSO 3,1 mg/24 ur transdermalni obliž
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS SACHET
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH
In agreement with these data, no clinically relevant interactions have been reported in clinical studies with SANCUSO.
V kliničnih študijah z zdravilom SANCUSO ne poročajo o klinično pomembnem medsebojnem delovanju, kar se ujema s temi podatki.
Where to apply the transdermal patch
Kje si nalepite transdermalni obliž
In vitro studies have shown that ketoconazole may inhibit the metabolism of granisetron via the cytochrome P450 3A isoenzyme family.
Pri preiskovancih je spodbujanje jetrnih encimov s fenobarbitalom po intravenskem dajanju granisetrona povzročilo zvečanje celotnega plazemskega očistka (približno za 25 %).Študije in vitro so pokazale, da lahko ketokonazol zavre presnovo granisetrona preko izoencimske skupine citokroma P450 3A.
- Keep this leaflet.
- izpuščaj,
SANCUSO 3.1 mg/24 hours transdermal patch Granisetron
SANCUSO 3,1 mg/24 ur transdermalni obliž granisetron
Common Dry mouth, nausea, retching Uncommon
Bolezni prebavil zaprtost pogosti občasni suha usta, navzea, spahovanje
External heat, for example from hot water bottles or heat pads, should be avoided on the area of the transdermal patch.
V predelu obliža se izogibajte zunanji toploti, na primer iz termoforja ali ogrevalne blazine.
You may see mild redness on the skin where the transdermal patch is removed.
Na koži, kjer ste odstranili transdermalni obliž, boste mogoče videli blago rdečino, ki bo sčasoma izginila.
Nervous system disorders
Bolezni živčevja glavobol distonija občasni redki redki diskinezija
The transdermal patch can be worn for up to 7 days depending on the duration of your chemotherapy treatment.
Odvisno od trajanja kemoterapije lahko transdermalni obliž nosite do 7 dni.
General disorders and administration site conditions
Splošne težave in spremembe na mestu aplikacije generaliziran edem občasni
Ear and labyrinth disorders
Ušesne bolezni, vključno z motnjami labirinta vrtoglavica občasni
Hypersensitivity reactions
- alergijske kožne reakcije.
Flushing
OVOJNINAH
Date of first authorisation: 10 September 2013 Date of latest renewal: 21 June 2018
Datum prve odobritve: 10. september 2013 Datum zadnjega podaljšanja: 21. junij 2018
• reduce the signs and symptoms of your disease,
• zmanjšanje znakov in simptomov vaše bolezni,
Children and adolescents The information above also applies to children and adolescents.
Otroci in mladostniki Zgoraj navedene informacije veljajo tudi za otroke in mladostnike.
Adults (≥18 years)
Odrasli bolniki (≥ 18 let)
Some of these reactions may be serious or life-threatening.
Nekateri od teh učinkov so lahko resni ali življenjsko ogrožujoči.
If you are 65 years of age or older, you have a greater risk.
Če ste stari 65 let ali več, je to tveganje večje.
• Orencia (which contains abatacept).
• Orencia (ki vsebuje abatacept).
The reconstituted solution should stand for 5 minutes.
Rekonstituirana raztopina mora stati 5 minut.
• Kineret (which contains anakinra).
• Kineret (ki vsebuje anakinro).
• improve your physical function.
• izboljšanje telesne sposobnosti.
In particular, tell your doctor if you are using any of the following medicines:
Še posebej povejte svojemu zdravniku, če uporabljate katero od naslednjih zdravil:
(furunculosis)
(plevritis)
• Blood test result showing ‘antibodies' against your own body.
• rezultati krvnih preiskav, ki zaznajo ''protitelesa'' proti vašemu lastnemu telesu
23 Academy-ro, Yeonsu-gu, Incheon, 22014 Republic of Korea
23 Academy -ro, Yeonsu-gu, Incheon, 22014 Republika Koreja
Before reconstitution
Pred rekonstitucijo
• The table below shows how often you will usually have this medicine after your first dose.
• Spodnja preglednica prikazuje, kako pogosto boste prejemali to zdravilo po prvem odmerku.
These infections are caused by specific types of fungi that can affect the lungs or other parts of your body.
Te okužbe povzročajo posebne vrste glivic, ki lahko prizadenejo pljuča ali druge dele telesa.
• Severe allergic reaction that may cause loss of consciousness and could be life-threatening
• huda alergijska reakcija, ki lahko povzroči izgubo zavesti in je lahko smrtno nevarna
• you are allergic to infliximab or any of the other ingredients of this medicine (listed in section 6),
• če ste alergični na infliksimab ali katerokoli sestavino tega zdravila (navedeno v poglavju 6),
It is important that you and your doctor record the brand name and batch number of your medicine.
Pomembno je, da vi in zdravnik zabeležita lastniško ime in številko serije vašega zdravila.
The solution should be colourless to light yellow and opalescent.
Raztopina mora biti brezbarvna do svetlo rumena in opalescentna.
This evaluation should include colonoscopy and biopsies per local recommendations.
Med te teste sodijo na primer kolonoskopija in biopsije v skladu z lokalnimi priporočili.
EU/1/13/854/001 1 vial EU/1/13/854/002 2 vials EU/1/13/854/003 3 vials EU/1/13/854/004 4 vials EU/1/13/854/005 5 vials
EU/1/13/854/001 1 viala EU/1/13/854/002 2 viali EU/1/13/854/003 3 viale EU/1/13/854/004 4 viale EU/1/13/854/005 5 vial
For any information about this medicine, please contact the local representative of the Marketing Authorisation holder:
Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na predstavništvo imetnika dovoljenja za promet z zdravilom:
• Abnormal values of a blood protein called ‘complement factor' which is part of the immune system.
• nenormalne vrednosti beljakovine v krvi, imenovane ''faktor komplementa'', ki je del imunskega sistema
Table 9 Effects on ACR and PASI in IMPACT and IMPACT 2 IMPACT
Preglednica 9 Učinki na ACR in PASI v študijah IMPACT in IMPACT 2
• In some patients receiving infliximab, the body may not make enough of the blood cells that help fight infections or help stop bleeding.
• Pri nekaterih bolnikih, ki prejemajo infliksimab, telo morda ne tvori dovolj krvnih celic, ki se borijo proti okužbam ali pripomorejo k zaustavitvi krvavitve.
Pack sizes of 1, 2, 3, 4, 5 vials.
Velikosti pakiranja 1, 2, 3, 4, 5 vial.
In this trial, sixty-six percent of the patients (686 out of 1,040) received at least one shortened infusion of 90 minutes or less and 44% of the patients (454 out of 1,040) received at least one shortened infusion of 60 minutes or less.
V tem preskušanju je 66 % bolnikov (686 od 1.040) prejelo najmanj eno skrajšano infuzijo v trajanju 90 minut ali manj, 44 % bolnikov (454 od 1.040) pa je prejelo najmanj eno skrajšano infuzijo v trajanju 60 minut ali manj.
• Your doctor should test you for hepatitis B virus.
• Vaš zdravnik vas mora testirati za virus hepatitisa B.
This will depend on your disease, weight and how well you respond to Inflectra.
To bo odvisno od vaše bolezni, telesne mase in tega, kako se odzivate na zdravilo Inflectra.
Shortened infusions at doses >6 mg/kg have not been studied (see section 4.8).
Uporabe skrajšanih infuzij v odmerkih > 6 mg/kg niso proučevali (glejte poglavje 4.8).
THE VIAL MUST NOT BE SHAKEN.
VIALE NE SMETE STRESATI!
No dose adjustment is required (see section 5.2).
Prilagoditev odmerka ni potrebna (glejte poglavje 5.2).
• you have tuberculosis (TB) or another serious infection such as pneumonia or sepsis(serious bacterial infection of the blood),
• če imate tuberkulozo (TBC) ali katero drugo hudo okužbo, npr. pljučnico ali sepso (resno bakterijsko okužbo krvi),
5 years at 2 °C - 8 °C.
5 let pri temperaturi 2 °C - 8 °C.
If visibly opaque particles, discolouration or foreign particles are observed it should not be used.
Če opazite vidne neprosojne delce, obarvanje ali tuje delce, ga ne smete uporabiti.
Prior therapy with PUVA, methotrexate, ciclosporin, or acitretin had been received by 71.4% of patients, although they were not necessarily therapy resistant.
Predhodno terapijo s PUVA, metotreksatom, ciklosporinom ali acitretinom je prejelo 71,4 % bolnikov, čeprav ni nujno, da so bili odporni na uvodno terapijo.
Keep this card with you for 4 months after your last dose of Inflectra, or in case of pregnancy, for at least 6 months after the birth of your baby.
To kartico imejte pri sebi še 4 mesece po zadnjem odmerku zdravila Inflectra ali v primeru nosečnosti še vsaj 6 mesecev po rojstvu otroka.
N ≥ 90% improvement ≥ 75% improvement ≥ 50% improvement
≥ 90 % izboljšanje ≥ 75 % izboljšanje ≥ 50 % izboljšanje
EXP EXP, if not refrigerated _________________________
EXP Rok uporabnosti izven hladilnika ___________________
Hypersensitivity to the active substance, to other murine proteins, or to any of the excipients listed in section 6.1.
Preobčutljivost na učinkovino, druge glodalske beljakovine ali katerokoli pomožno snov, navedeno v poglavju 6.1.