natgillin/translations-raw huggingface dataset:
Patients were randomised in a 1:1 ratio to treatment with Epclusa for 12 weeks or SOF+RBV for 12 weeks.
Bolesnici su randomizirani u omjeru 1:1 za liječenje lijekom Epclusa tijekom 12 tjedana ili SOF+RBV tijekom 12 tjedana.
Breast-feeding Do not breast-feed during treatment with Epclusa.
Nemojte dojiti tijekom liječenja lijekom Epclusa.
ANTIFUNGALS Ketoconazole
Ketokonazol
Gilead Sciences Ltd. Tel: + 44 (0) 8000 113 700
Tel: + 44 (0) 8000 113700
Of the 552 treated patients, the median age was 52 years (range: 19 to 76); 62% of the patients were male; 89% were White, 9% were Asian; 1% were Black; 20% had a baseline body mass index of at least 30 kg/m2; 61% had non-CC IL28B alleles (CT or TT); 70% had baseline HCV RNA levels of at least 800,000 IU/mL, 30% had compensated cirrhosis and 26% were treatment-experienced.
Od 552 liječena bolesnika, medijan dobi iznosio je 52 godina (raspon: 19 do 76); 62 % bolesnika bili su muškarci; 89 % bijelci, 9 % azijati; 1 % crnci; 20 % bolesnika imali su početni indeks tjelesne mase od najmanje 30 kg/m2; 61 % su imali ne-CC IL28B alele (CT ili TT); 70 % bolesnika su imali početne razine HCV RNK od najmanje 800.000 IU/ml; 30 % je imalo kompenziranu cirozu; i 26 % je prethodno liječeno.
Table 14: SVR12 in study ASTRAL-4 by HCV genotype
Tablica 14: SVR12 u ispitivanju ASTRAL-4 prema genotipu HCV-a Epclusa
Tenofovir alafenamide Sofosbuvir
Tenofovirdisoproksilfumarat
No dose adjustment of Epclusa or atorvastatin is required.
Nije potrebna prilagodba doze lijeka Epclusa ili atorvastatina.
Observed: Pravastatin ↑
Digoksin ↑
Severe RI (eGFR <30 mL/min/1.7 3m2)
Teško oštećenje bubrega (eGFR < 30 ml/ min/ 1,73 m2)
Epclusa is contraindicated with rifampicin (see section 4.3).
Lijek Epclusa je kontraindiciran s rifampicinom (vidjeti dio 4.3).
Patients were randomised in a 1:1:1 ratio to treatment with Epclusa for 12 weeks, Epclusa + RBV for 12 weeks or Epclusa for 24 weeks.
Bolesnici su randomizirani u omjeru 1:1:1 za liječenje lijekom Epclusa tijekom 12 tjedana ili Epclusa + RBV tijekom 12 tjedana ili lijekom Epclusa tijekom 24 tjedna.
Of the 266 treated patients, the median age was 58 years (range: 23 to 81); 59% of the patients were male; 88% were White, 7% were Black; 33% had a baseline body mass index of at least 30 kg/m2; 62% had non-CC IL28B alleles (CT or TT); 80% had baseline HCV RNA levels of at least 800,000 IU/mL; 14% had compensated cirrhosis and 15% were treatment-experienced.
Od 266 liječenih bolesnika, medijan dobi iznosio je 58 godina (raspon: 23 do 81); 59 % bolesnika bili su muškarci; 88 % bijelci, 7 % crnci; 33 % bolesnika imali su početni indeks tjelesne mase od najmanje 30 kg/m2; 62 % su imali ne-CC IL28B alele (CT ili TT); 80 % bolesnika imalo je početne razine HCV RNK od najmanje 800.000 IU/ml; 14 % je imalo kompenziranu cirozu; i 15 % je prethodno liječeno.
↔ ↔ ↔ No dose adjustment of Epclusa or methadone is required.
R-metadon ↔ ↔ ↔ Nije potrebna prilagodba doze lijeka Epclusa ili metadona.
Epclusa [Outer packaging only]
16. PODACI NA BRAILLEOVOM PISMU Epclusa [samo vanjsko pakiranje]
No dose adjustment of Epclusa, atazanavir (ritonavir boosted) or emtricitabine/ tenofovir disoproxil fumarate is required.
Nije potrebna prilagodba doze lijeka Epclusa, atazanavira (pojačanog ritonavirom) ili emtricitabina/ tenofovirdizoproksilfumarata.
Table 10 presents the SVR12 for the ASTRAL-1 study by HCV genotypes.
U tablici 10 predstavljen je SVR12 za ispitivanje ASTRAL-1 prema genotipu HCV-a.
↔ ↔ ↔ No dose adjustment of Epclusa, darunavir (ritonavir boosted) or emtricitabine/ tenofovir disoproxil fumarate is required.
↔ ↔ ↔ Nije potrebna prilagodba doze lijeka Epclusa, darunavira (pojačanog ritonavirom) ili emtricitabina/ tenofovirdizoproksilfumarata.
Table 17 presents the SVR12 for the ASTRAL-5 study by HCV genotype.
U tablici 17 prikazan je SVR12 za ispitivanje ASTRAL-5 prema genotipu HCV-a.
Norelgestromin Norgestrel
Norelges tromin
No NS5B nucleoside inhibitor (NI) RAVs were observed at failure in the 2 patients.
U ova dva bolesnika nisu opažene varijante NS5B povezane s rezistencijom na nukleozidne inhibitore pri neuspjehu.
Rilpivirine ↔ ↔ ↔ No dose adjustment of Epclusa or emtricitabine/ rilpivirine/ tenofovir disoproxil fumarate is required.
Rilpivirin ↔ ↔ ↔ Nije potrebna prilagodba doze lijeka Epclusa ili emtricitabina/rilpivirina/ tenofovirdizoproksilfumarata.
Without cirrhosis 98% (160/163) With cirrhosis a Five patients with missing cirrhosis status in the SOF+RBV 24 week group were excluded from this subgroup analysis.
Pet bolesnika u kojih je nedostajao status ciroze u skupini sa SOF+RBV tijekom 24 tjedna bili su isključeni iz analize ove podskupine.
You may need closer monitoring of your blood glucose levels and/or adjustment of your diabetes medication after starting Epclusa.
Nakon što počnete uzimati lijek Epclusa, možda ćete trebati pažljivije pratiti razinu glukoze u krvi i/ili prilagoditi lijek protiv šećerne bolesti.
Dolutegravir (50 mg once daily)/ sofosbuvir/ velpatasvir (400/ 100 mg once daily)
Dolutegravir (50 mg/jedanput na dan)/sofosbuvir/velpatasvir (400/100 mg jedanput na dan)c, d
No dose adjustment of Epclusa, raltegravir or emtricitabine/ tenofovir disoproxil fumarate is required.
Nije potrebna prilagodba doze lijeka Epclusa, raltegravira ili emtricitabina/ tenofovirdizoproksilfumarata.
Elvitegravir ↔ ↔ ↔ No dose adjustment of Epclusa or elvitegravir/ cobicistat/ emtricitabine/ tenofovir alafenamide fumarate is required.
Elvitegravir ↔ ↔ ↔ Nije potrebna prilagodba doze lijeka Epclusa ili elvitegravira/kobicistata/ emtricitabina/ tenofoviralafenamidfumarata.
Close monitoring of INR is recommended with all vitamin K antagonists.
Preporučuje se pomno praćenje međunarodnog normaliziranog omjera (INR) uz sve antagoniste vitamina K zbog promjena u funkciji jetre tijekom liječenja Epclusa.
Treatment-naïve (n = 201)
Bolesnici koji prethodno nisu bili liječeni (n = 201)
Table 14 presents the SVR12 for the ASTRAL-4 study by HCV genotype.
U tablici 14 predstavljen je SVR12 za ispitivanje ASTRAL-4 prema genotipu HCV-a.
Interaction only studied with velpatasvir Expected:
Interakcija ispitana samo s velpatasvirom
ANTIARRHYTHMICS Amiodarone
Antagonisti vitamina
Elvitegravir ↔ ↔ ↔ No dose adjustment of Epclusa or elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil fumarate is required.
Elvitegravir ↔ ↔ ↔ Nije potrebna prilagodba doze lijeka Epclusa ili elvitegravira/kobicistata/ emtricitabina/ tenofovirdizoproksilfumarata.
Darunavir boosted with ritonavir (800/ 100 mg once daily) + emtricitabine/ tenofovir disoproxil fumarate (200/ 300 mg once daily)/ sofosbuvir/ velpatasvir (400/ 100 mg once daily)c, d
Darunavir pojačan ritonavirom (800/100 mg jedanput na dan) + emtricitabin/ tenofovirdizoproksilfumarat (200/300 mg jedanput na dan)/sofosbuvir/velpatasvir (400/100 mg jedanput na dan)c, d
Addition of ribavirin may be considered for genotype 3 infected patients with compensated cirrhosis (see section 5.1.)
Za bolesnike zaražene genotipom 3 s kompenziranom cirozom možda će se razmotriti dodavanje ribavirina (vidjeti dio 5.1) Bolesnici s dekompenziranom cirozom Epclusa + ribavirin tijekom 12 tjedana a.
Lopinavir boosted with ritonavir (4x200 mg/ 50 mg once daily) + emtricitabine/ tenofovir disoproxil fumarate (200/ 300 mg once daily)/ sofosbuvir/ velpatasvir (400/ 100 mg once daily)c, d
Lopinavir pojačan ritonavirom (4x200 mg/50 mg jedanput na dan) + emtricitabin/ tenofovirdizoproksilfumarat (200/300 mg jedanput na dan)/sofosbuvir/velpatasvir (400/100 mg jedanput na dan)c, d
CPT Class C cirrhosis
Ciroza jetre CPT stadija C
Famotidine (40 mg single dose)/ sofosbuvir/ velpatasvir (400/ 100 mg single dose)c
40 mg)/sofosbuvir/velpatasvir (jedna doza od 400/100 mg)c
Dosed 1
PRILOG I.
HMG-CoA REDUCTASE INHIBITORS Atorvastatin (40 mg single dose) + sofosbuvir / velpatasvir (400/ 100 mg once daily)d
Atorvastatin (jedna doza od 40 mg) + sofosbuvir /velpatasvir (400/ 100 mg jedanput na dan)d
The pharmacokinetic properties of sofosbuvir, GS-331007 and velpatasvir have been evaluated in healthy adult subjects and in patients with chronic hepatitis C. Following oral administration of Epclusa, sofosbuvir was absorbed quickly and the peak median plasma concentration was observed 1 hour post-dose.
Farmakokinetička svojstva sofosbuvira, GS-331007 i velpatasvira ocijenjena su u zdravih odraslih ispitanika i u bolesnika s kroničnim hepatitisom C.
Elvitegravir/ cobicistat/ emtricitabine/ tenofovir alafenamide fumarate (150/ 150/ 200/ 10 mg once daily)/ sofosbuvir/ velpatasvir (400/ 100 mg once daily)c, d
Elvitegravir/kobicistat/emtricitabi n/tenofoviralafenamidfumarat (150/150/200/10 mg jedanput na dan)/sofosbuvir/velpatasvir (400/100 mg jedanput na dan)c, d
Efavirenz/ emtricitabine/ tenofovir disoproxil fumarate (600/ 200/ 300 mg once daily)/ sofosbuvir/ velpatasvir (400/ 100 mg once daily)c, d
Efavirenz/emtricitabin/ tenofovirdizoproksilfumarat (600/200/300 mgjedanput na dan)/sofosbuvir/velpatasvir (400/100 mg jedanput na dan)c, d
Ciclosporin (600 mg single dose)f/ velpatasvir (100 mg single dose)d
600 mg)f/velpatasvir (jedna doza od 100 mg)d
Co-administration with such medicinal products is not recommended with Epclusa (see section 4.4).
Ne preporučuje se istodobna primjena takvih lijekova s lijekom Epclusa (vidjeti dio 4.4).
Emtricitabine/ rilpivirine/ tenofovir disoproxil fumarate (200/ 25/ 300 mg once daily)/ sofosbuvir/ velpatasvir (400/ 100 mg once daily)c, d
Emtricitabin/rilpivirin/ tenofovirdizoproksilfumarat (200/25/300 mg/jedanput na dan)/sofosbuvir/velpatasvir (400/100 mg jedanput na dan)c, d
Epclusa 12 weeks (n = 90)
12 tjedana (n = 90)
↔ ↔ ↔ No dose adjustment of Epclusa, lopinavir (ritonavir boosted) or emtricitabine/ tenofovir disoproxil fumarate is required.
↔ ↔ ↔ Nije potrebna prilagodba doze lijeka Epclusa, darunavira (pojačanog lopinavirom) ili emtricitabina/ tenofovirdizoproksilfumarata.
Cobicistat
Kobicistat
Table 11: SVR12 in study ASTRAL-2 (HCV genotype 2)
Tablica 11: SVR12 u ispitivanju ASTRAL-2 (genotip 2 HCV-a) Epclusa 12 tjedana (n = 134)
Epclusa is contraindicated with St. John's wort (see section 4.3).
Lijek Epclusa je kontraindiciran s gospinom travom (vidjeti dio 4.3).
Proton pump inhibitors Omeprazole (20 mg once daily)/ sofosbuvir/ velpatasvir (400/ 100 mg single dose fasted)c
Omeprazol (20 mg jedanput na dan)/sofosbuvir/ velpatasvir (jedna doza od 400/ 100 mg natašte)c
Elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil fumarate (150/ 150/ 200/ 300 mg once daily)/ sofosbuvir/ velpatasvir (400/ 100 mg once daily)c, d
Elvitegravir/kobicistat/emtricitabi n/tenofovirdizoproksilfumarat (150/150/200/300 mg jedanput na dan)/sofosbuvir/velpatasvir (400/100 mg jedanput na dan)c, d
heartburn or acid reflux as they can decrease the amount of velpatasvir in your blood.
• Potražite savjet liječnika ili ljekarnika ako uzimate lijekove koji se primjenjuju za liječenje želučanog vrijeda, žgaravice ili povrata želučane kiseline jer oni mogu smanjiti količinu velpatasvira u Vašoj krvi.
EXP
ESRD
Observed: Atorvastatin
Atorvastatin
IMMUNOSUPPRESSANTS Ciclosporin (600 mg single dose)/ sofosbuvir (400 mg single dose)f
600 mg)/sofosbuvir (jedna doza od 400 mg)f
Rosuvastatin (10 mg single dose)/ velpatasvir (100 mg once daily)d (Inhibition of OATP1B and BCRP)
Rosuvastatin (jedna doza od 10 mg)/velpatasvir (100 mg jedanput na dan)d
Genotype 3 infected patients with the NS5A RAV Y93H at baseline had a lower SVR12 rate than patients without Y93H after treatment with Epclusa for 12 weeks, as summarised in Table 7.
Početni RAV-ovi nisu utjecali na stope SVR12 u bolesnika zaraženih HCV-om genotipa 1, 2, 4, 5 i 6 što je sažeto prikazano u tablici 6. Bolesnici zaraženi HCV-om genotipa 3 s početnim NS5A RAV-om Y93H imali su nižu stopu SVR12 od bolesnika bez Y93H poslije liječenja lijekom Epclusa tijekom 12 tjedana, što je sažeto prikazano u tablici 7.
GT-5 (n = 35)
(n = 35)
Gilead Sciences Netherlands B.V. Tel: + 31 (0) 20 718 36 98
Gilead Sciences Poland Sp. z o.o. Tel: +48 (0) 22 262 8702
and <50 mL/min/1.73 m2)
Blago oštećenje bubrega (eGFR ≥ 50 i < 80 ml/min/ 1,73 m2)
GT-2 (n = 104)
(n = 104)
No dose adjustment of Epclusa or ciclosporin is required at initiation of co-administration.
Ciklosporin ↔ ↔ Nije potrebna prilagodba doze lijeka Epclusa ili ciklosporina na početku istodobne primjene.
HIV ANTIVIRAL AGENTS: HIV PROTEASE INHIBITORS Atazanavir boosted with ritonavir (300/ 100 mg once daily) + emtricitabine/ tenofovir disoproxil fumarate (200/ 300 mg once daily)/ sofosbuvir/ velpatasvir (400/ 100 mg once daily)c, d
Atazanavir pojačan ritonavirom (300/100 mg jedanput na dan) + emtricitabin/ tenofovirdizoproksilfumarat (200/300 mg jedanput na dan)/sofosbuvir/velpatasvir (400/100 mg jedanput na dan)c, d
Observed: Sofosbuvir
Očekuje se: ↔ Sofosbuvir
• fainting.
• ošamućenost
Lot
K
Elderly
Ranitidine
Tel: + 39 02 439201
Gilead Sciences S.r.l. Tel: + 39 02 439201
• Drink alcohol, see Mixtard with alcohol in section 2.
• pijete alkohol, pogledajte Mixtard s alkoholom u dijelu 2.
Mixtard which has been frozen must not be used.
Mixtard koji je bio zamrznut ne smije se primijeniti.
Mixtard will start to lower your blood sugar about 30 minutes after you inject it, and the effect will last for approximately 24 hours.
Mixtard će početi snižavati razinu šećera u krvi oko 30 minuta nakon što ga injicirate, a učinak će trajati približno 24 sata.
What Mixtard is and what it is used for
Što je Mixtard i za što se koristi
Mixtard dosing is individual and determined in accordance with the needs of the patient.
Doziranje lijeka Mixtard individualno je i određuje se u skladu s potrebama bolesnika.
Mixtard with alcohol
Mixtard s alkoholom
This should be kept in mind if treatment with the combination of pioglitazone and Mixtard is considered.
Ovo treba imati na umu ako se razmatra liječenje kombinacijom pioglitazona i lijeka Mixtard.
However, the Mixtard dose may need to be adjusted.
Međutim, možda će biti potrebno prilagoditi dozu lijeka Mixtard.
What Mixtard looks like and contents of the pack
Kako Mixtard izgleda i sadržaj pakiranja
Serious allergic reaction to Mixtard or one of its ingredients (called a systemic allergic reaction) is a very rare side effect, but it can potentially be life threatening.
Ozbiljna alergijska reakcija na Mixtard ili neki od njegovih sastojaka (takozvana sistemska alergijska reakcija) je vrlo rijetka nuspojava, ali može biti opasna po život.
Mixtard is used to reduce the high blood sugar level in patients with diabetes mellitus (diabetes).
Mixtard se koristi za snižavanje visoke razine šećera u krvi u bolesnika s dijabetesom (šećernom bolešću).
Other medicines and Mixtard
Drugi lijekovi i Mixtard
If any of these apply, do not use Mixtard.
Ako se nešto od toga odnosi na Vas, nemojte primjenjivati Mixtard.
► If you are treated with Mixtard Penfill and another insulin Penfill cartridge, you should use two insulin delivery systems, one for each type of insulin.
► Ako se liječite lijekom Mixtard Penfill i još jednim inzulinom u Penfill ulošku, morate koristiti dva pomagala za primjenu inzulina, po jedan za svaku vrstu inzulina.
Mixtard can be used during pregnancy.
Mixtard se može koristiti u trudnoći.
► Every time you use a new Mixtard Penfill (before you put the cartridge into the insulin delivery system).
► Svaki puta kada koristite novi Mixtard Penfill (prije nego što uložak stavite u pomagalo za primjenu inzulina)
Mixtard can be used in elderly patients.
Mixtard se može koristiti u starijih bolesnika.
► Inject the insulin under your skin.
Injicirajte inzulin pod kožu.
Treatment with Mixtard helps to prevent complications from your diabetes.
Liječenje lijekom Mixtard pomaže spriječiti komplikacije šećerne bolesti.
In case of hypoglycaemia or if hypoglycaemia is suspected, Mixtard must not be injected.
U slučaju hipoglikemije ili sumnje na hipoglikemiju Mixtard se ne smije injicirati.
Mixtard Penfill is accompanied by a package leaflet with detailed instructions for use to be followed.
Uz Mixtard Penfill priložena je Uputa o lijeku s detaljnim naputcima za primjenu koje treba slijediti.
There is no restriction on treatment with Mixtard during breast-feeding.
Nema ograničenja za liječenje lijekom Mixtard tijekom dojenja.
Combination of Mixtard with pioglitazone
Kombinacija lijeka Mixtard s pioglitazonom
Patients must be instructed to always check the insulin label before each injection to avoid accidental mix-ups between Mixtard and other insulin products.
Bolesnicima se mora objasniti da prije svakog injiciranja uvijek provjere naljepnicu na inzulinu kako bi izbjegli slučajne zamjene lijeka Mixtard i drugih inzulinskih pripravaka.
After removing Mixtard Penfill from the refrigerator, it is recommended to allow the Mixtard Penfill to reach room temperature before resuspending the insulin as instructed for first time use.
Nakon što se Mixtard Penfill izvadi iz hladnjaka preporučuje se pustiti ga da dosegne sobnu temperaturu prije resuspendiranja inzulina prema uputama za prvu uporabu.
Mixtard is administered subcutaneously by injection in the thigh, the abdominal wall, the gluteal region or the deltoid region.
Mixtard se primjenjuje supkutanom injekcijom u bedro, trbušnu stijenku, glutealno ili deltoidno područje.
Patients transferred to Mixtard from another type of insulin may require an increased number of daily injections or a change in dose from that used with their usual insulin medicinal products.
Bolesnicima koji su prešli na Mixtard s druge vrste inzulina možda će biti potreban veći broj injekcija dnevno ili različita doza nego kod primjene njihovih uobičajenih inzulinskih pripravaka.
Mixtard can be used in children and adolescents.
Mixtard se može koristiti u djece i adolescenata.
When transferring from other intermediate or long-acting insulin medicinal products, adjustment of the Mixtard dose and timing of administration may be necessary.
Pri prijelazu s drugih srednjedugodjelujućih ili dugodjelujućih inzulinskih pripravaka možda će biti potrebno prilagoditi dozu i vrijeme primjene lijeka Mixtard.
Mixtard is human insulin with both a fast-acting and a long-acting effect.
Mixtard je humani inzulin s brzim i dugotrajnim djelovanjem.
Mixtard is presented as a suspension for injection.
Mixtard je suspenzija za injekciju.
What you need to know before you use Mixtard Do not use Mixtard
Što morate znati prije nego počnete primjenjivati Mixtard
Mixtard is a dual-acting insulin.
Mixtard je inzulin dvostrukog djelovanja.
Mixtard is indicated for treatment of diabetes mellitus.
Mixtard je indiciran za liječenje šećerne bolesti.
Mixtard is a dual-acting human insulin.
Mixtard je humani inzulin dvostrukog djelovanja.
On rare occasions, injection site reactions may require discontinuation of Mixtard.
Zbog reakcija na mjestu injiciranja rijetko će biti potrebno prekinuti liječenje lijekom Mixtard.
Mixtard Penfill is designed to be used with Novo Nordisk insulin delivery systems and NovoFine or NovoTwist needles.
Mixtard Penfill je namijenjen uporabi s pomagalima za primjenu inzulina proizvođača Novo Nordisk i iglama NovoFine ili NovoTwist.
Instructions on how to use Mixtard 30 suspension for injection in InnoLet Read the instructions carefully before using your InnoLet.
Upute za uporabu Mixtard 30 suspenzije za injekciju u brizgalici InnoLet Prije uporabe brizgalice InnoLet pozorno pročitajte ove upute.
How to use Mixtard Dose and when to take your insulin
Doza i kada trebate primijeniti inzulin
Instructions on how to use Mixtard 30 suspension for injection in FlexPen Read the following instructions carefully before using your FlexPen.
Upute za uporabu Mixtard 30 suspenzije za injekciju u brizgalici FlexPen Prije uporabe brizgalice FlexPen pozorno pročitajte ove upute.
How to handle Mixtard 30 InnoLet
Kako rukovati brizgalicom Mixtard 30 InnoLet
Mixtard 30 FlexPen is a pre-filled disposable pen containing a mixture of fast-acting and long-acting human insulin in the ratio 30/70.
Mixtard 30 FlexPen je jednokratna napunjena brizgalica koja sadrži mješavinu brzodjelujućeg i dugodjelujućeg humanog inzulina u omjeru 30/70.
You must use the pen as described in the Instructions on how to use Mixtard 30 InnoLet.
Brizgalicom morate rukovati na način opisan u uputama za uporabu Mixtard 30 InnoLet brizgalice.
Mixtard is administered by injection under the skin (subcutaneously).
Mixtard je namijenjen injiciranju pod kožu (supkutano).
Mixtard 30 InnoLet is a pre-filled disposable pen containing a mixture of fast-acting and long-acting human insulin in the ratio 30/70.
Mixtard 30 InnoLet je jednokratna napunjena brizgalica koja sadrži mješavinu brzodjelujućeg i dugodjelujućeg humanog inzulina u omjeru 30/70.
► Check the label to make sure it is the right type of insulin.
Provjerite naljepnicu kako biste bili sigurni da je vrsta inzulina odgovarajuća.
You must use the pen as described in the Instructions on how to use Mixtard 30 FlexPen.
Brizgalicom morate rukovati na način opisan u uputama za uporabu Mixtard 30 FlexPen brizgalice.
After removing Mixtard vial, cartridge or pre-filled pen from the refrigerator, it is recommended to allow the Mixtard vial, cartridge or pre-filled pen to reach room temperature before resuspending the insulin as instructed for first time use.
6.6 Posebne mjere za zbrinjavanje i druga rukovanja lijekom Nakon što se izvadi iz hladnjaka, preporučuje se pustiti Mixtard bočicu, uložak ili napunjenu brizgalicu da dosegne sobnu temperaturu prije resuspendiranja inzulina prema uputama za prvu uporabu.
Mixtard vials are for use with insulin syringes with a corresponding unit scale.
Mixtard bočice koriste se s inzulinskim štrcaljkama s odgovarajućom jediničnom skalom.
► After each injection, be sure to remove and discard the needle and store Mixtard without the needle attached.
► Nakon svakog injiciranja iglu obavezno skinite i bacite u otpad te spremite Mixtard bez pričvršćene igle.
Mixtard 30 vial (40 international units/ml)/Mixtard 30 vial (100 international units/ml)
Mixtard 30 bočica (40 internacionalnih jedinica/ml)/Mixtard 30 bočica (100 internacionalnih jedinica/ml)
Mixtard is a mixture consisting of 40% soluble human insulin and 60% isophane human insulin.
Mixtard je mješavina koja se sastoji od 40% otopine humanog inzulina i 60% humanog izofan inzulina.
What Mixtard is and what it is used for What you need to know before you use Mixtard How to use Mixtard
Što morate znati prije nego počnete primjenjivati Mixtard Kako primjenjivati Mixtard
Read carefully the Instructions on how to use Mixtard 30 InnoLet included in this package leaflet.
Pažljivo pročitajte upute za uporabu Mixtard 30 InnoLet brizgalice u ovoj Uputi o lijeku.
Mixtard is a mixture consisting of 50% soluble human insulin and 50% isophane human insulin.
Mixtard je mješavina koja se sastoji od 50% otopine humanog inzulina i 50% humanog izofan inzulina.
Mixtard 30 vial (40 international units/ml)
Mixtard 30 bočica (40 internacionalnih jedinica/ml)
How to inject Mixtard
Kako injicirati Mixtard
Mixtard is a mixture consisting of 30% soluble human insulin and 70% isophane human insulin.
Mixtard je mješavina koja se sastoji od 30% otopine humanog inzulina i 70% humanog izofan inzulina.
Mixtard 30 vial (100 international units/ml)
Mixtard 30 bočica (100 internacionalnih jedinica/ml)
► Needles and Mixtard InnoLet must not be shared.
► Igle i Mixtard InnoLet ne smiju se dijeliti s drugim osobama.
Paediatric population Mixtard can be used in children and adolescents.
Primjena u djece i adolescenata Mixtard se može primjenjivati u djece i adolescenata.
Read carefully the Instructions on how to use Mixtard 30 FlexPen included in this package leaflet.
Pažljivo pročitajte upute za uporabu Mixtard 30 FlexPen brizgalice u ovoj Uputi o lijeku.
Mixtard InnoLet is only suitable for subcutaneous injections.
Mixtard InnoLet je prikladan samo za potkožne injekcije.
► Needles and Mixtard FlexPen must not be shared.
► Igle i Mixtard FlexPen ne smiju se dijeliti s drugim osobama.
Mixtard FlexPen is only suitable for subcutaneous injections.
Mixtard FlexPen je prikladan samo za potkožne injekcije.
How to handle Mixtard 30 FlexPen
Kako rukovati brizgalicom Mixtard 30 FlexPen
Mixtard Penfill is only suitable for subcutaneous injections from a reusable pen.
Mixtard Penfill je prikladan samo za potkožne injekcije iz brizgalice za višekratnu uporabu.