natgillin/translations-raw huggingface dataset:
In RMS, a decrease in lymphocyte < LLN was observed in 20.7% of Ocrevus patients compared with 32.6% of patients treated with interferon beta-1a.
Limfociti Pri RMS so zmanjšanje števila limfocitov pod spodnjo normalno mejo opažali pri 20,7 % bolnikov, ki so prejemali zdravilo Ocrevus, in pri 32,6 % bolnikov, ki so prejemali interferon beta-1a.
Data are available on the effects of tetanus toxoid, 23-valent pneumococcal polysaccharide, keyhole limpet hemocyanin neoantigen, and seasonal influenza vaccines in patients receiving Ocrevus.
valentnega pnevmokoknega polisaharida, neoantigena hemocianina iz školjke (keyhole limpet hemocyanin) in sezonskih cepiv proti gripi.
Common: may affect up to 1 in 10 people · cough · a build-up of thick mucus in the nose, throat or chest.
• nastajanje goste sluzi v nosu, žrelu ali prsnem košu
7.6% Ocrevus vs 12.0% IFN 40% (p=0.0025)7 43 % (p=0.0278)7
7,6 % zdravilo Ocrevus v primerjavi z 12,0 % IFN 40 % (p = 0,0025)
Solutions of Ocrevus for intravenous administration are prepared by dilution of the drug product into an infusion bag containing isotonic 0.9% sodium chloride (300 mg / 250 mL or 600 mg / 500 mL), to a final drug concentration of approximately 1.2 mg/mL.
Raztopino zdravila Ocrevus za intravensko infundiranje je treba pripraviti z razredčenjem zdravila v infuzijski vreči, ki vsebuje izotonični 0,9-% natrijev klorid (300 mg/250 ml ali 600 mg/500 ml), tako da je končna koncentracija zdravila približno 1,2 mg/ml.
Disease history at screening
Anamneza bolezni ob presejanju
Initial Dose (600 mg) divided into 2 infusions
(600 mg) razdeljen na
· The other ingredients are sodium acetate trihydrate, glacial acetic acid, trehalose dihydrate, polysorbate 20 and water for injection.
• Druge sestavine zdravila so natrijev acetat trihidrat, koncentrirana ocetna kislina,
Subsequent doses of Ocrevus thereafter are administered as a single 600 mg intravenous infusion every 6 months (Table 1).
Nadaljnji odmerki Nadaljnje odmerke zdravila Ocrevus je treba dajati v odmerku 600 mg v enkratni intravenski infuziji na 6 mesecev (preglednica 1).
After you stop Ocrevus treatment, you may still experience side effects until your B-cells return to normal.
• Nekateri neželeni učinki so lahko povezani z majhnim številom celic B. Po koncu zdravljenja z zdravilom Ocrevus boste morda še vedno imeli neželene učinke, dokler število celic B ne postane spet normalno.
Patients should be monitored during the infusion and for at least one hour after the completion of the infusion.
Obvladovanje z infuzijo povezanih reakcij med infundiranjem in po njem Bolnike je treba nadzirati med infundiranjem in vsaj še eno uro po koncu infundiranja.
Pharmacotherapeutic group: selective immunosuppressants group, ATC code: L04AA36.
Oznaka ATC: L04AA36.
If a patient experiences a severe IRR (such as dyspnea) or a complex of flushing, fever, and throat pain symptoms, the infusion should be interrupted immediately and the patient should receive symptomatic treatment.
Če se bolniku pojavi huda z infuzijo povezana reakcija (npr. dispneja) ali skupek simptomov, ki obsega zardevanje, zvišano telesno temperaturo in bolečine v žrelu, je treba infundiranje nemudoma prekiniti in bolnika simptomatsko zdraviti.
The treatment interval of 6 months (with a minimum of 5 months) for Ocrevus should be maintained between doses (see Table 1).
6 mesecev (oz. vsaj 5 mesecev) (glejte preglednico 1).
Infusion Adjustments in case of IRRs
Prilagoditve infundiranja v primeru z infuzijo povezanih reakcij
If a patient experiences a mild to moderate IRR (e.g. headache), the infusion rate should be reduced to half the rate at the onset of the event.
Če se bolniku pojavi blaga do zmerna z infuzijo povezana reakcija (npr. glavobol), je treba hitrost infundiranja zmanjšati na polovico tiste hitrosti, pri kateri je prišlo do reakcije.
Ocrevus is a monoclonal antibody and cleared via catabolism (rather than hepatic metabolism), and a change in dose is not expected to be required for patients with hepatic impairment (see section 5.2).
Zdravilo Ocrevus je monoklonsko protitelo, ki se odstrani s katabolizmom (ne s presnovo v jetrih), zato ni pričakovati, da bi bilo bolnikom z okvaro jeter odmerek treba prilagoditi
The overall proportion of patients experiencing a serious infection was similar to comparators (see section 4.8).
Celotni delež bolnikov, ki se jim je pojavila resna okužba, je bil podoben kot s primerjalnimi zdravili
Patients with known IgE mediated hypersensitivity to ocrelizumab must not be treated (see section 4.3).
S tem zdravilom se ne sme zdraviti bolnikov, ki imajo znano z IgE posredovano preobčutljivost na okrelizumab (glejte poglavje 4.3).
In the placebo-controlled (PPMS) clinical trial, IRR was the most common adverse event in patients treated with Ocrevus with an overall incidence of 40.1% compared with an incidence of 25.5% in the placebo group.
V kliničnih preskušanjih (PPMS), kontroliranih s placebom, so bile z infuzijo povezane reakcije najpogostejši neželeni učinek pri bolnikih, zdravljenih z zdravilom Ocrevus; njihova skupna pojavnost je bila pri teh bolnikih 40,1 %, pri prejemnikih placeba pa 25,5 %.
An increased number of malignancies (including breast cancers) have been observed in clinical trials in patients treated with ocrelizumab, compared to control groups.
V kliničnih preskušanjih so med prejemniki okrelizumaba opažali več malignih bolezni (vključno z rakom dojke) kot v kontrolnih skupinah, vendar je bila njihova pojavnost v okviru deleža, pričakovanega za populacijo z multiplo sklerozo.
Infusion 1 300 mg in 250 mL · Initiate the infusion at a rate of 30 mL/hour for 30 minutes
300 mg v 250 ml • Infundiranje začnite s hitrostjo 30 ml/uro za
Moreover, post-hoc analyses suggested that younger patients with T1 Gd-enhancing lesions at baseline have the better treatment effect (≤ 45 years: HR 0.52 [0.27-1.00]; ≤ 46 years [median age of the
Poleg tega so analize post-hoc pokazale, da je pri mlajših bolnikih, ki imajo v izhodišču z gadolinijem obarvane lezije T1, učinek zdravljenja boljši: ≤ 45 let: RO 0,52 [0,27-1,00); ≤ 46 let [mediana starost v študiji WA25046]; RO 0,48 [0,25-0,92]; < 51 let: RO 0,53 [0,31-0,89].
If there are signs of a life threatening or disabling IRR during an infusion, such as acute hypersensitivity or acute respiratory distress syndrome the infusion must be stopped immediately and the patient should receive appropriate treatment.
Če se med infundiranjem pojavijo znaki z infuzijo povezane reakcije, ki ogrozi bolnikovo življenje ali bolnika onesposobi, na primer akutna preobčutljivost ali sindrom akutne dihalne stiske, je treba infundiranje nemudoma prekiniti in bolnika ustrezno zdraviti.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Ocrevus 300 mg concentrate for solution for infusion ocrelizumab
IME ZDRAVILA IN POT(I) UPORABE Ocrevus 300 mg koncentrat za raztopino za infundiranje okrelizumab i.v.
Defined as an increase of ≥ 1.0 point from the baseline Expanded Disability Status Scale (EDSS) score for patients with baseline score of 5.5 or less, or ≥ 0.5 when the baseline score is > 5.5, Kaplan-Meier estimates at Week 96
Opredeljeno kot povečanje za ≥ 1,0 točko od izhodiščne ocene EDSS pri bolnikih z izhodiščno oceno 5,5 ali manj oziroma za ≥ 0,5 točke v primeru izhodiščne ocene > 5,5; Kaplan-Meierjeve ocene po 96 tednih.
IFN 44 mcg (n=411)
IFN 44 µg (n = 411)
Ocrevus 300 mg concentrate for solution for infusion Ocrelizumab
Ocrevus 300 mg koncentrat za raztopino za infundiranje okrelizumab
· Ocrevus should be prepared by a healthcare professional using aseptic technique.
Navodila za razredčenje • Zdravilo Ocrevus mora pripraviti zdravstveni delavec; postopek mora biti opravljen aseptično.
Primary Progressive MS
Primarno progresivna multipla skleroza
· You might get infections more easily with Ocrevus.
• Med zdravljenjem z zdravilom Ocrevus se vam lahko poveča dovzetnost za okužbe.
NAME OF THE MEDICINAL PRODUCT Ocrevus 300 mg concentrate for solution for infusion
IME ZDRAVILA Ocrevus 300 mg koncentrat za raztopino za infundiranje
Ocrevus medicinal product must be diluted before administration.
Zdravilo Ocrevus je treba pred uporabo razredčiti.
Roche Pharma AG Emil-Barell-Strasse 1 79639 Grenzach-Whylen Germany
79639 Grenzach-Whylen Nemčija
None of the patients was reported with Grade 4 lymphopenia (< 200 cells/mm3).
3) in en bolnik z nevtropenijo 4. stopnje (< 500 celic/mm
How to store Ocrevus
Kako se daje zdravilo Ocrevus
1 Defined as an increase of ≥ 1.0 point from the baseline EDSS score for patients with baseline score of 5.5 or less, or ≥ 0.5 when the baseline score is > 5.5, Kaplan-Meier estimates at Week 120.
(p = 0,0206) Opredeljeno kot povečanje za ≥ 1,0 točko od izhodiščne ocene EDSS pri bolnikih z izhodiščno oceno 5,5 ali manj oziroma za ≥ 0,5 točke v primeru izhodiščne ocene > 5,5; Kaplan-Meierjeve ocene po 120 tednih.
Please refer to section 4.8 for information about the Systemic Inflammatory Response Syndrome (SIRS) that occurred in a patient treated with Ocrevus 2000 mg.
Za informacije o sindromu sistemskega vnetnega odziva, ki se je pojavil pri bolniku, zdravljenem z 2000 mg zdravila Ocrevus, glejte poglavje 4.8.
Postponing vaccination with live or live-attenuated vaccines should be considered for neonates and infants born to mothers who have been exposed to Ocrevus in utero.
Pri novorojenčkih in dojenčkih, ki so bili izpostavljeni zdravilu Ocrevus in utero, je treba razmisliti o odlogu cepljenja z živimi ali živimi oslabljenimi cepivi.
The respiratory tract infections reported in patients treated with Ocrevus were predominately mild to moderate (80 - 90 %).
Okužbe dihal, zabeležene pri prejemnikih zdravila Ocrevus, so bile pretežno blage do zmerne
21,7% and 10.1% of Ocrevus treated patients experienced mild and moderate IRRs respectively, 2.4% experienced severe IRRs and 0.1% experienced lifethreatening IRRs.
Med bolniki, ki so prejemali zdravilo Ocrevus, so se blage z infuzijo povezane reakcije pojavile pri 21,7 % in zmerne pri 10,1 % bolnikov; hude z infuzijo povezane reakcije so se pojavile pri 2,4 % bolnikov, življenjsko ogrožajoče pa pri 0,1 % bolnikov.
· Hypersensitivity may be difficult to distinguish from an IRR in terms of symptoms.
• Kar zadeva simptome, je preobčutljivost včasih težko razločiti od z infuzijo povezane reakcije.
There is no experience in patients with moderate and severe renal impairment.
Izkušenj pri bolnikih z zmerno in hudo okvaro ledvic ni.
Percentage change in Timed 25-Foot Walk from baseline to Week 120 Relative reduction in progression rate of walking time
Odstotek spremembe pri testu hoje na 25 čevljev (7,62 m) od izhodišča do 120. tedna
· Hypotension, as a symptom of IRR, may occur during Ocrevus infusions.
• Med infundiranjem zdravila Ocrevus se lahko kot simptom z infuzijo povezanih reakcij pojavi hipotenzija.
· Current active infection (see section 4.4) · Patients in a severely immunocompromised state (see section 4.4 ).
• Trenutno aktivna okužba (glejte poglavje 4.4)
2 weeks apart.
26 dni.
· Talk to your doctor before vaccinating your baby.
• Preden daste otroka cepiti, se pogovorite z zdravnikom.
Respiratory, thoracic and mediastinal disorders
Bolezni dihal, prsnega koša in mediastinalnega prostora kašelj, katar
What Ocrevus contains
Kaj vsebuje zdravilo Ocrevus
Transient peripheral B-cell depletion and lymphocytopenia have been reported in infants born to mothers exposed to other anti-CD20 antibodies during pregnancy.
Pri dojenčkih mater, ki so bile med nosečnostjo izpostavljene drugim protitelesom proti CD20, so poročali o prehodnem zmanjšanju števila perifernih celic B in o limfocitopeniji.
Patients with mild renal impairment were included in clinical trials.
V klinična preskušanja so bili vključeni bolniki z blago okvaro ledvic.
The following information is intended for healthcare professionals only:
Naslednje informacije so namenjene samo zdravstvenemu osebju: Za dodatne informacije preberite povzetek glavnih značilnosti zdravila.
Common: may affect up to 1 in 10 people sinus infection bronchitis (bronchial tube inflammation) herpes infection (cold sore or shingles).
- gripa pogoste: pojavijo se lahko pri do 1 od 10 bolnikov - okužba obnosnih votlin (sinusov)
There is no experience in patients with moderate and severe hepatic impairment.
Izkušenj pri bolnikih z zmerno in hudo okvaro jeter ni.
Annualised Relapse Rate (ARR) (primary endpoint)
Klinični opazovani dogodki Na leto preračunani delež recidivov (primarni opazovani dogodek)
Patients enrolled in the ongoing clinical trials continue to be dosed with 600 mg ocrelizumab every six months after they become 55 and older.
tudi po 55. letu še naprej prejemajo odmerek 600 mg okrelizumaba na šest mesecev.
Roche Registration GmbH Emil-Barell-Strasse 1 79639 Grenzach-Wyhlen Germany
D-79639 Grenzach-Wyhlen Nemčija
IV after dilution
po razredčenju
26.7% and 11.9% of Ocrevus treated patients experienced mild and moderate IRRs respectively, 1.4% experienced severe IRRs.
Med bolniki, ki so prejemali zdravilo Ocrevus, so se blage z infuzijo povezane reakcije pojavile pri 26,7 % in zmerne pri 11,9 % bolnikov; hude z infuzijo povezane reakcije so se pojavile pri 1,4 % bolnikov.
6.2 Incompatibilities
2 infundiranji
They will watch you closely while you are being given this medicine.
Med dajanjem zdravila vas bodo skrbno opazovali za primer, da bi se vam pojavili kakšni neželeni učinki.
Solutions of Ocrevus for intravenous infusion are prepared by dilution of the medicinal product into an infusion bag containing 0.9% sodium chloride, to a final concentration of approximately 1.2 mg/mL.For instructions on dilution of the medicinal product before administration see section 6.6.
Raztopino zdravila Ocrevus za intravensko infundiranje je treba pripraviti tako, da se zdravilo razredči v infuzijski vreči, ki vsebuje 0,9-% natrijev klorid, do končne koncentracije približno 1,2 mg/ml.
There is no PK information available in patients with moderate or severe renal impairment.
Informacij o farmakokinetiki pri bolnikih z zmerno ali hudo okvaro ledvic ni.
Posology:
Po infundiranju:
Clinical efficacy and safety
Klinična učinkovitost in varnost Recidivne oblike multiple skleroze
A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturer of the biological active substance
Ime in naslov izdelovalca biološke učinkovine
in common with 23-PPV.
Pozitivni odziv na ≥ 5 serotipov iz cepiva 23-PPV
What Ocrevus is and what it is used for What you need to know before you are given Ocrevus How Ocrevus is given
Kaj morate vedeti, preden boste dobili zdravilo Ocrevus Kako se daje zdravilo Ocrevus
Patients with mild hepatic impairment were included in clinical trials.
V klinična preskušanja so bili vključeni bolniki z blago okvaro jeter.
There is no PK information available in patients with moderate or severe hepatic impairment.
Informacij o farmakokinetiki pri bolnikih z zmerno ali hudo okvaro jeter ni.
Infusion instruction
2. infuzija
MRI evidence should be used to confirm inflammatory activity in all patients.
Vnetno aktivnost je treba pri vseh bolnikih potrditi z dokazi, vidnimi na magnetnoresonančnem posnetku.
If you are able to become pregnant (conceive), you must use contraception: · during treatment with Ocrevus and · for 12 months after your last infusion of Ocrevus.
Če bi lahko zanosili, morate uporabljati kontracepcijo:
Mean number of T1 Gd-enhancing lesions per MRI scan
Opazovani dogodki z magnetnoresonančnimi posnetki Povprečno število z gadolinijem obarvanih lezij T1 na magnetnoresonančni posnetek
30 minutes to a maximum of
30 minut.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Roche Registration GmbH
Ocrevus 600 mg (n=488)
Zdravilo Ocrevus 600 mg (n = 488) Placebo (n = 244)
Measurable levels of ocrelizumab were detected in milk (approximated 0.2% of steady state trough serum levels) during the lactation period.
Na potek obeh okužb pri novoskotenih mladičih je potencialno lahko vplivalo zmanjšanje števila celic B. Pri novoskotenih mladičih samic, izpostavljenih okrelizumabu, so med fazo po skotitvi opažali zmanjšano številčnost populacij celic B. Med obdobjem dojenja so v mleku ugotovili merljivo koncentracijo okrelizumaba (približno 0,2 % najnižje koncentracije v serumu v fazi dinamičnega ravnovesja).
Hrvatska
VIALA
The majority of these decreases reported in Ocrevus treated patients were Grade 1 (<LLN800 cells/mm3) and 2 (between 500 and 800 cells/mm3) in severity.
3) in 2. stopnje (med 500 in 800 celic/mm
Malignancies
MedDRA
· You will be closely monitored while you are being given Ocrevus and for at least 1 hour after the infusion has been given.
• Medtem ko boste dobivali infuzijo zdravila Ocrevus in vsaj še 1 uro po koncu infuzije vas bodo natančno nadzirali, da bi odkrili kakršne koli neželene učinke (na primer z infuzijo povezane reakcije), če bi se ti pojavili.
Ocrevus must be diluted before it is given to you.
Preden dobite zdravilo Ocrevus, ga morajo razredčiti.
MedDRA System Organ Class (SOC)
Povprečna ocena po EDSS*
Renal Impairment
Okvara jeter
Package leaflet: Information for the patient
Shranjevanje zdravila Ocrevus Vsebina pakiranja in dodatne informacije
The Reference Member State were Estonia, Latvia, Lithuania, Netherlands, Spain, United Kingdom.
Zadevne države članice so bile Estonija, Latvija, Litva, Nizozemska, Španija in Združeno kraljestvo.
The Sweden referred the reasons for disagreement to the EMEA on 3 March 2006.
Švedska je agenciji EMEA posredovala razloge za nesoglasje dne 3. marca 2006.
During the June 2006 meeting, the CHMP, in the light of the overall data submitted and the scientific discussion within the Committee, was of the opinion that the benefit/risk ratio is favourable for Doxastad 4 mg prolonged release tablets and associated names, that the objections raised should not prevent the granting of a Marketing Authorisation and that the Summary of Product Characteristics, labelling and package leaflet of the Reference Member State should be amended.
Med svojim zasedanjem junija 2006 je CHMP na podlagi vseh posredovanih podatkov in znanstvene razprave v okviru Odbora, sprejel mnenje, da je razmerje med tveganji in koristmi za zdravilo Doxastad 4 mg tablete s podaljšanim sproščanjem in povezana imena ugodno, ter da podani ugovori ne bi smeli preprečiti podelitve dovoljenja za promet z zdravilom, ter da je treba Povzetek glavnih značilnosti zdravila, označevanje in Navodila za uporabo referenčne države članice dopolniti.
The scope of the referral was to agree whether Doxastad 4mg prolonged release tablets differ significantly with regards to the release profile from the originator product with potential for increased incidence of adverse events such as dizziness and hypotension, whether there were significant differences in performance of test batches in the single dose phase of studies 5208 and 1995 and whether the applicant has deviated from CHMP guidelines on the design of the bioequivalence studies, particularly in relation to the effect of food.
Namen napotitve je bil doseči soglasje o tem, ali se zdravilo Doxastad 4 mg tablete s podaljšanim sproščanjem, kar se tiče profila sproščanja, pomembno razlikuje od originatorjevega zdravila, in ali je možnost pojavov neželenih učinkov, kot so omotica in hipotenzija, morebiti povečana; nadalje ali so bile razlike v rezultatih iz študij 5208 in 1995 testnih serij pri enkratnem odmerjanju pomembne, ter končno ali se je vlagatelj oddaljil od smernic CHMP o načrtovanju bioekvivalenčnih raziskav, zlasti kar se tiče učinka, ki bi ga lahko imela hrana.
Doxastad 4 mg prolonged release tablets and associated names (Doxazosin) is 1 is a receptor alfa blocking agent used in the treatment of patients with essential hypertension and in the symptomatic treatment of patients with benign prostatic hyperplasia.
Doxastad 4 mg tablete s podaljšanim sproščanjem in povezana imena (Doxazosin) vsebujejo snov, ki blokira receptor alfa 1 in se uporablja za zdravljenje bolnikov z esencialno hipertenzijo in simptomatično zdravljenje bolnikov z benigno hiperplazijo prostate.
Stada Artzneimittel submitted applications for mutual recognition of Doxastad 4 mg prolonged release tablets and associated names on the basis of the marketing authorisation granted by the Sweden on 4 July 2004.
Družba Stada Arzneimittel je podala vloge za medsebojno priznavanje zdravila Doxastad 4 mg tablete s podaljšanim sproščanjem in povezana imena na podlagi dovoljenja za promet z zdravilom, ki ga je izdala Švedska dne 4 julija 2004.
The Marketing Authorisation Holder provided written explanations on 06 April 2006.
Imetnik dovoljenja za promet z zdravilom je predložil pisna pojasnila dne 6. aprila 2006, ustna pojasnila pa je podal dne 27. junija 2006.
COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) OPINION FOLLOWING AN ARTICLE 29(2)1 REFERRAL FOR Doxastad 4 mg prolonged release tablets and associated names International Non-Proprietary Name (INN): Doxazosin
Doxastad 4 mg tablete s podaljšanim sproščanjem in povezana imena Mednarodno nelastniško ime (INN): Doxazosin
*Relative Potency by a mice potency test compared to a reference vaccine efficacious in sheep and cattle **Relative potency by a mice potency test compared to a reference vaccine efficacious in sheep.
* Relativna potenca pri testu potence pri miših v primerjavi z učinkovitim referenčnim cepivom pri ovcah.
--1 Each dose of 2 ml of vaccine contains one of the following inactivated bluetongue virus strains: Inactivated bluetongue virus, serotype 1, strain BTV-1/ALG2006/01 E1 RP* ≥ 1
--1 Odmerek (2 ml) vsebuje naslednje inaktivirane seve virusa modrega jezika: inaktiviran virus modrega jezika, serotip 1, sev BTV-1/ALG2006/01 E1 RP* ≥ 1 inaktiviran virus modrega jezika, serotip 8, sev BTV-8/BEL2006/02 RP* ≥ 1 inaktiviran virus modrega jezika, serotip 4, sev SPA-1/2004 RP** ≥ 0,8 * Relativna potenca pri testu potence pri miših v primerjavi z učinkovitim referenčnim cepivom pri ovcah in govedu.
1 dose (1 ml) contains: Hepatitis A virus (inactivated)1,2
1 odmerek (1 ml) vsebuje: Virus hepatitisa A (inaktivirani)1,2
3Produced in yeast cells (Saccharomyces cerevisiae) by recombinant DNA technology 4Adsorbed on aluminium phosphate
3Pridobljen s tehnologijo rekombinantne DNA na celični kulturi kvasovk (Saccharomyces cerevisiae) 4Adsorbiran na aluminijev fosfat
(glass)
(Izmišljeno) ime
More information
Več informacij
Recommendations for patients and carers
Priporočila za bolnike in negovalce
• If you have any questions speak to your healthcare professional.
• Če imate kakršna koli vprašanja, se posvetujte z zdravstvenim delavcem.
Always follow the instructions of your healthcare professional.
Vedno upoštevajte navodila zdravstvenega delavca.
Recommendations for healthcare professionals
Priporočila za zdravstvene delavce
Focus on colour differentiation, warning statements on carton/label and other safety design features (such as tactile elements on the pre-filled pen).
Osredotočite se na razlike v barvi, opozorilne izjave na škatli/nalepki in druge varnostne značilnosti zasnove (kot so otipni elementi na napolnjenem peresniku).
• Always carefully check the product selected in electronic prescribing or dispensing systems.
• Izbrano zdravilo vedno skrbno preverite v elektronskih sistemih predpisovanja ali izdajanja.
• Pharmacists should be aware that insulins are now available in different strengths.
• Farmacevti se morajo zavedati, da so insulini zdaj na voljo v različnih jakostih.
More detailed information on such dose adjustment is provided in the product information.
Več informacij o prilagajanju odmerka je na voljo v informacijah o zdravilu.
Pharmacists should also check that patients have been trained on how to use the new pen.
Farmacevti naj preverijo tudi, da so bolniki usposobljeni za uporabo novega peresnika.
• Ensure that your patients are adequately informed on how to use their high-strength insulin.
• Poskrbite, da so vaši bolniki ustrezno seznanjeni s tem, kako morajo uporabljati insulin velike jakosti.