natgillin/translations-raw huggingface dataset:
Baseline patient demographics and disease characteristics were generally balanced between arms: the median age was 61 years; 71% of patients were male; 61% were Caucasian, 35% Asian; the ECOG PS was 0 for 39% of patients, 1 for
Skupini zdravljenja sta bili uravnoteženi glede na izhodiščne demografske podatke bolnikov in lastnosti bolezni: mediana starost je bila 61 let; 71 % bolnikov je bilo moškega spola; 61 % je bilo belcev, 35 % je bilo Azijcev; ocena stanja zmogljivosti po ECOG je bila 0 za 39 % bolnikov in 1 za 61 % bolnikov; 81 % bolnikov je imelo merljivo bolezen; 79 % je imelo rak želodca, 21 % pa adenokarcinom gastro-ezofagealnega prehoda.
Clinically relevant reactions (including Grade ≥3) associated with antiangiogenic therapy observed in ramucirumab-treated patients across clinical studies were: gastrointestinal perforations, infusionrelated reactions and proteinuria (see sections 4.2 and 4.4).
Klinično pomembne reakcije (vključno z razredom ≥ 3), ki so povezane z antiangiogenim zdravljenjem in so jih opazili pri bolnikih, zdravljenih z ramucirumabom v kliničnih študijah, so:
- Severe bleeding: Cyramza may increase the risk of severe bleeding.
Zdravilo Cyramza lahko poveča tveganje za hudo krvavitev.
Concentrate for solution for infusion 100 mg/10 ml
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 100 mg/10 ml
There have been no formal studies with Cyramza in patients with renal impairment.
Okvarjeno delovanje ledvic Formalnih študij z zdravilom Cyramza pri bolnikih z okvarjenim delovanjem ledvic niso izvedli.
There was an increase in median PFS of 1.5 months in favour of the Cyramza plus paclitaxel arm: 4.4 months in the Cyramza plus paclitaxel arm and 2.9 months in the placebo plus paclitaxel arm.
Mediano preživetje brez poslabšanja bolezni se je v skupini z zdravilom Cyramza in paklitakselom povečalo za 1,5 meseca: 4,4 mesece v skupini z zdravilom Cyramza in paklitakselom in 2,9 meseca v skupini s placebom in paklitakselom.
Patients should be monitored for the development or worsening of proteinuria during ramucirumab therapy.
Med zdravljenjem z ramucirumabom je treba bolnike spremljati in biti pozorni na razvoj ali poslabšanje proteinurije.
In severe cases symptoms included bronchospasm, supraventricular tachycardia, and hypotension.
V hujših primerih so simptomi vključevali bronhospazem,
Treatment with Cyramza may need to be stopped temporarily until high blood pressure is controlled with medicines, or stopped permanently if it cannot be adequately controlled.
dokler visok krvni tlak ne bo uravnan z zdravili, ali pa trajno prekiniti, če krvnega tlaka ne bo mogoče zadovoljivo uravnati.
- Each 50 ml vial contains 500 mg of ramucirumab.
- Ena 50-mililitrska viala vsebuje 500 mg ramucirumaba.
Baseline patient demographics and disease characteristics were generally balanced between arms: the median age was 62 years; 67% of patients were male; 82% were Caucasian, 13% Asian; the ECOG PS
Demografski podatki bolnikov in izhodiščne lastnosti bolezni so bili med obema skupinama v splošnem uravnoteženi: mediana starost je bila 62 let; 67 % bolnikov je bilo moškega spola; 82 % bolnikov je bilo belcev, 13 % bolnikov je bilo azijske rase; indeks stanja zmogljivosti ECOG je pri 32 % bolnikov znašal 0, pri 67 % bolnikov 1; 73 % bolnikov je imelo neploščatocelično histologijo in 26
the geometric means of ramucirumab Cmin were 46.3 μg/ml (range of 7.7-119 μg/ml) and 65.1 μg/ml
FOLFIRI je geometrično povprečje vrednosti Cmin za ramucirumab v serumu bolnikov z metastatskim kolorektalnim rakom znašalo 46,3 μg/ml (razpon 7,7-119 μg/ml) in 65,1 μg/ml (razpon 14,5205 μg/ml) pred dajanjem tretjega oziroma petega odmerka.
- The other ingredients are histidine, histidine monohydrochloride, sodium chloride, glycine (E640), polysorbate 80 (E433) and water for injections (see section 2 “Cyramza contains sodium”).
- Druge sestavine zdravila so histidin, histidinijev klorid, natrijev klorid, glicin (E640), polisorbat
- Each 10 ml vial contains 100 mg of ramucirumab.
- Ena 10-mililitrska viala vsebuje 100 mg ramucirumaba.
Each 50 ml vial contains 500 mg of ramucirumab.
Ena 50-mililitrska viala vsebuje 500 mg ramucirumaba.
b Based on study RAINBOW (ramucirumab plus paclitaxel).
b Na podlagi študije RAINBOW (ramucirumab in paklitaksel).
c Based on study RAINBOW (ramucirumab plus paclitaxel).
c Na podlagi študije RAINBOW (ramucirumab in paklitaksel).
e Includes: abdominal pain, abdominal pain lower, abdominal pain upper, and hepatic pain.
e Vključuje: bolečine v trebuhu, bolečine v spodnjem delu trebuha, bolečine v zgornjem delu trebuha in bolečine v jetrih.
Table 11: Summary of efficacy data - ITT population Cyramza plus docetaxel N=628
Tabela 9: Povzetek podatkov o učinkovitosti - ITT populacija zdravilo Cyramza N=238
Each 10 ml vial contains 100 mg of ramucirumab.
Ena 10-mililitrska viala vsebuje 100 mg ramucirumaba.
Ramucirumab therapy should be permanently discontinued in the event of: Severe arterial thromboembolic events (see section 4.4).
Trajno prekinite zdravljenje z ramucirumabom pri bolnikih, pri katerih se pojavijo resni arterijski trombembolični dogodki (glejte poglavje 4.2).
For recurrent Grade 2 stomatitis, reduce by 2 dose levels for 5-FU.
Pri ponavljajočem se stomatitisu razreda 2 5-FU
An increased incidence of proteinuria was reported in patients receiving ramucirumab as compared to placebo.
Pri bolnikih, ki so prejemali ramucirumab, so poročali o povečani incidenci proteinurije v primerjavi s placebom.
Figure 3: Kaplan-Meier curves of overall survival for Cyramza versus placebo in REGARD
Slika 3: Kaplan-Meierjevi krivulji celokupnega preživetja za zdravilo Cyramza v primerjavi s placebom v študiji REGARD
If diarrhoea has recovered to Grade ≤1, reduce by 2 dose levels for 5-FU and irinotecan.
Če se je diareja izboljšala do razreda≤ 1, 5-FU in irinotekan zmanjšajte za 2 odmerni ravni.
A trend towards less efficacy with increasing age has been observed in patients receiving ramucirumab plus docetaxel for the treatment of advanced NSCLC with disease progression after platinum-based chemotherapy (see section 5.1).
Pri bolnikih, ki so prejemali ramucirumab in docetaksel za zdravljenje napredovalega NSCLC z napredovanjem bolezni po kemoterapiji na osnovi platine, so opazili trend manjše učinkovitosti z naraščajočo starostjo (glejte poglavje 5.1).
Talk to your doctor about the best contraception for you.
Zdravnik vam bo svetoval glede uporabe zanesljivih načinov kontracepcije.
Median (95% CI) Hazard ratio (95% CI) Stratified log-rank p-value
Celokupno preživetje, meseci Mediana (95 % IZ) Razmerje tveganja (95 % IZ) p-vrednost za stratificiran test logrank
An increased incidence of severe hypertension was reported in patients receiving ramucirumab as compared to placebo.
Pri bolnikih, ki so prejemali ramucirumab, so poročali o povečani incidenci hude hipertenzije v primerjavi s placebom.
It should not be administered as an intravenous bolus or push.
Zdravila ne dajajte v obliki intravenskega bolusa ali hitre intravenske injekcije.
Overall survival, months
Probability of Overall Survival
If you have a wound that heals poorly during treatment, dosing of Cyramza will be stopped until the wound is fully healed.
Če v vaši črevesni steni nastane luknjica, bo zdravljenje z zdravilom Cyramza trajno prekinjeno.
Cyramza 10 mg/ml sterile concentrate ramucirumab
IME ZDRAVILA IN POT(I) UPORABE Cyramza 10 mg/ml sterilni koncentrat ramucirumab
Figure 1: Kaplan-Meier curves of overall survival for Cyramza plus paclitaxel versus placebo plus paclitaxel in RAINBOW
Slika 1: Kaplan-Meierjevi krivulji celokupnega preživetja za zdravilo Cyramza in paklitaksel v primerjavi s placebom in paklitakselom v študiji RAINBOW
Figure 4: Kaplan-Meier curves of overall survival for Cyramza plus FOLFIRI versus placebo plus FOLFIRI in RAISE
Slika 4: Kaplan-Meierjeve krivulje celokupnega preživetja za zdravilo Cyramza in shemo FOLFIRI v primerjavi s placebom in shemo FOLFIRI v študiji RAISE
If diarrhoea has recovered to Grade ≤1, reduce by 1 dose level for 5-FU and irinotecan.
Če se je diareja izboljšala do razreda ≤ 1, 5-FU in irinotekan zmanjšajte za 1 odmerno raven.
Abbreviations: CI = confidence interval, CR= complete response, PR= partial response, CMH= Cochran-Mantel-Haenszel
p-vrednost stratificiranega testa log-rank Objektivna stopnja odziva (PO + DO) Stopnja-odstotki (95-odstotni interval zaupanja) Razmerje obetov p-vrednost stratificiranega testa CMH Okrajšave: IZ = interval zaupanja, PO = popolni odziv, DO = delni odziv, CMH= Cochran-MantelHaenszel
Cyramza will be permanently stopped if you develop a hole in the wall of your gut.
Zdravilo Cyramza lahko poveča tveganje za pojav luknjic v vaši črevesni steni.
OS was statistically significantly improved in patients receiving Cyramza plus docetaxel compared with those receiving placebo plus docetaxel (HR 0.857; 95% CI: 0.751 to 0.979; p=0.024).
Cyramza in docetaksel, v primerjavi z bolniki, ki so prejemali placebo in docetaksel (RT: 0,857; 95 % IZ: 0,751 do 0,979; p = 0,024).
For recurrent Grade 2 diarrhoea, reduce by 1 dose level for 5-FU and irinotecan.
Pri ponavljajoči se diareji razreda 2 5-FU in irinotekan zmanjšajte za 1 odmerno raven.
4.4), patients pre-treated with taxanes (HR 0.81; 95% CI:0.62 to 1.07; mOS 10.8 vs 10.4 months) and those with time since start of prior therapy ≥9 months (HR 0.95; 95% CI: 0.75 to 1.2; mOS: 13.7 vs
≥ 65 let niso opazili razlik v učinkovitosti med skupinama zdravljenja (RT za SP: 1,10, 95 % IZ: 0,89, 1,36; mediani SP [mOS]: 9,2 v primerjavi z 9,3 meseca, glejte poglavje 4.4); bolniki, predhodno zdravljeni s taksani (RT 0,81; 95 % IZ: 0,62 do 1,07; mOS: 10,8 v primerjavi z 10,4 meseca), in bolniki, pri katerih je bil čas od začetka predhodnega zdravljenja ≥ 9 mesecev (HR 0,95; 95 % IZ: 0,75
FOLFIRI dose adjustments
Prilagajanje odmerka paklitaksela
A separate infusion line with a protein sparing 0.22 micron filter must be used for the infusion and the line must be flushed with sodium chloride 9 mg/ml (0.9%) solution for injection at the end of the infusion.
Linijo morate ob koncu infundiranja sprati z 9 mg/ml (0,9 %) raztopino natrijevega klorida za injiciranje.
Overall survival was statistically significantly improved in patients receiving Cyramza plus FOLFIRI compared with those receiving placebo plus FOLFIRI (HR 0.844; 95% CI: 0.730 to 0.976; p=0.0219).
Cyramza in shemo FOLFIRI, v primerjavi z bolniki, ki so prejemali placebo in shemo FOLFIRI (RT: 0,844; 95 % IZ: 0,730 do 0,976; p = 0,0219).
The recommended dose of docetaxel is 75 mg/m2 administered by intravenous infusion over approximately 60 minutes on day 1 of a 21 day cycle.
Priporočeni odmerek docetaksela je 75 mg/m2, dan z intravensko infuzijo v približno
Figure 6: Kaplan-Meier curves of overall survival for Cyramza plus docetaxel versus placebo plus docetaxel in REVEL
Slika 6: Kaplan-Meierjeve krivulje celokupnega preživetja za zdravilo Cyramza in docetaksel v primerjavi s placebom in docetakselom v študiji REVEL
Patients should be monitored for the development, or worsening of proteinuria during ramucirumab therapy.
Med zdravljenjem z ramucirumabom spremljajte bolnike in bodite pozorni na razvoj ali poslabšanje proteinurije.
Ramucirumab treatment should be discontinued in patients who develop fistula (see section 4.2).
Pri bolnikih, pri katerih se pojavi fistula, je treba zdravljenje z ramucirumabom prekiniti (glejte poglavje 4.2).
The median relative dose intensity of paclitaxel was 87.7% for the Cyramza plus paclitaxel arm and 93.2% for the placebo plus paclitaxel arm. A similar percentage of patients discontinued treatment due to adverse events: 12% of patients treated with Cyramza plus paclitaxel compared with 11% of patients treated with placebo plus paclitaxel.
Mediana intenzivnost relativnega odmerka paklitaksela je znašala 87,7 % za skupino z zdravilom Cyramza in paklitakselom ter 93,2 % za skupino s placebom in paklitakselom.
You should avoid getting pregnant while receiving this medicine and for at least 3 months after the last dose of Cyramza.
Med prejemanjem tega zdravila in še najmanj 3 mesece po prejemu zadnjega odmerka zdravila
Package leaflet: Information for the user Cyramza 10 mg/ml concentrate for solution for infusion ramucirumab
Navodilo za uporabo Cyramza 10 mg/ml koncentrat za raztopino za infundiranje ramucirumab
Very common side effects (may affect more than 1 in 10 people): - low white blood cell counts (may increase the risk of infection) - feeling tired or weak - diarrhoea - nose bleed - inflammation of the lining of the mouth - swelling of hands, feet and legs due to fluid retention - high blood pressure - low platelet count (blood cells that help the blood to clot) - abdominal pain - inflammation of mucous membranes, such as digestive and respiratory tracts - headache - protein in the urine (abnormal urine test)
- driska - krvavitev iz nosu - vnetje ustne sluznice - otekanje dlani, stopal in nog zaradi zastajanja tekočine - visok krvni tlak
Figure 7: Kaplan-Meier curves of progression-free survival for Cyramza plus docetaxel versus placebo plus docetaxel in REVEL
Slika 7: Kaplan-Meierjeve krivulje preživetja brez napredovanja bolezni za zdravilo Cyramza in docetaksel v primerjavi s placebom in docetakselom v študiji REVEL
13.3 months).
vsakih 21 dni.
Figure 5: Kaplan-Meier curves of progression -free survival for Cyramza plus FOLFIRI versus placebo plus FOLFIRI in RAISE
Slika 5: Kaplan-Meierjeve krivulje preživetja brez napredovanja bolezni za zdravilo Cyramza in shemo FOLFIRI v primerjavi s placebom in shemo FOLFIRI v študiji RAISE
Paclitaxel and docetaxel are also given by a drip into a vein (intravenous infusion) over a period of approximately 60 minutes.
Če prejemate zdravilo Cyramza v kombinaciji s paklitakselom ali docetakselom Tudi paklitaksel in docetaksel se dajeta z intravensko infuzijo (kapalna infuzija) v času približno 60
Patients were required to have experienced disease progression during, or within 4 months after the last dose of first-line therapy and with ECOG PS 0-1.
Vključili so bolnike, pri katerih je bolezen napredovala v času zdravljenja prve izbire ali v 4 mesecih po zadnjem odmerku zdravljenja prve izbire, ter ki so imeli status zmogljivosti 0-1 po ECOG. Bolniki so bili randomizirani v razmerju 1:1 za prejemanje zdravila Cyramza in paklitaksela (n=330)
Table 12: Summary of efficacy data in REACH-2 - Intent to treat (ITT) population Cyramza N=197
Tabela 12: Povzetek podatkov o učinkovitosti v študiji REACH-2 - ITT populacija
Figure 2: Kaplan-Meier curves of progression-free survival for Cyramza plus paclitaxel versus placebo plus paclitaxel in RAINBOW
Slika 2: Kaplan-Meierjevi krivulji celokupnega preživetja brez napredovanja bolezni za zdravilo Cyramza in paklitaksel v primerjavi s placebom in paklitakselom v študiji RAINBOW
Women of childbearing potential/Contraception in females Women of childbearing potential should be advised to avoid becoming pregnant while on Cyramza and should be informed of the potential hazard to the pregnancy and foetus.
Cyramza in jih je treba seznaniti z možnim tveganjem za nosečnost in plod.
Neutrophils
Nevtrofilci
Patients with squamous histology are at higher risk of developing serious pulmonary bleeding, however, no excess of Grade 5 pulmonary haemorrhage was observed in ramucirumab treated patients with squamous histology in REVEL.
vendar pa v študiji REVEL pri bolnikih, zdravljenih z ramucirumabom, ki so imeli ploščatocelično histologijo, niso opazili pljučnih krvavitev, ki bi presegale stopnjo 5.
INFORMATION IN BRAILLE
Študija REGARD
None of the patients with ADAs experienced an IRR.
Če se pri bolniku pojavi z infuzijo povezana reakcija (IRR
Reduce by 2 dose levels for 5-FU and irinotecan.
5-FU in irinotekana zmanjšajte za 2 ravni.
Cyramza contains sodium
Zdravilo Cyramza vsebuje natrij.
NCI CTCAE grade
Razred po NCI CTCAE (Merila pogostih toksičnosti
Once the urine protein level returns to <2 g/24 hours, treatment should be resumed at a reduced dose level (see Table 3).
Znova uvedite zdravljenje z zmanjšano ravnjo odmerka (glejte Tabelo 3), ko se raven beljakovin v urinu zniža na vrednost < 2 g/24 ur.
The pharmacokinetics of docetaxel were not affected when co-administered with ramucirumab.
Na farmakokinetiko docetaksela sočasno dajanje ramucirumaba ni vplivalo.
Hazard ratio (95% CI) Stratified log-rank p-value 12-week PFS rate% (95% CI) Abbreviations: CI = confidence interval
Celokupno preživetje, meseci Mediano (95-odstotni IZ) Razmerje tveganja (95-odstotni IZ) p-vrednost stratificiranega testa log-rank Preživetje brez poslabšanja bolezni, meseci Mediano (95-odstotni IZ) Razmerje tveganja (95-odstotni IZ) p-vrednost stratificiranega testa log-rank 12-tedenska stopnja preživetja brez napredovanja bolezni v % (95-odstotni IZ) Okrajšave: IZ = interval zaupanja
The primary endpoint was OS and secondary endpoints included PFS.
Primarni opazovani dogodek je bilo celokupno preživetje, sekundarni opazovani er je tn st el a pr ži et ja
ADRs are listed below by MedDRA body system organ class.
Neželeni učinki zdravila so navedeni spodaj po organskih sistemihglede na podatkovno bazo MedDRA. Pogostnost je navedena v skladu z naslednjim dogovorom:
If there is medically significant hypertension that cannot be controlled safely with antihypertensive therapy, ramucirumab therapy should be permanently discontinued (see section 4.4).
Trajno prekinite zdravljenje z ramucirumabom, če se pojavi zdravstveno pomembna hipertenzija, ki je ni mogoče nadzirati z antihipertenzivnim zdravljenjem (glejte poglavje 4.4).
Once the urine protein level returns to <2 g/24 hours, treatment should be resumed at a reduced dose level.
Znova uvedite zdravljenje z zmanjšano ravnjo odmerka, ko se raven beljakovin v urinu zniža na vrednost < 2 g/24 ur.
Impaired wound healing
Slabo celjenje ran
Reduce by 1 dose level for 5-FU and irinotecan.
5-FU in irinotekana zmanjšajte za 1 raven.
NSCLC
NSCLC Študija REVEL
In HCC patients, hepatic encephalopathy was reported at a higher rate in the ramucirumab-treated patients compared to the placebo-treated patients (see section 4.8).
Pri bolnikih s hepatocelularnim karcinomom so o hepatični encefalopatiji poročali z večjo pogostnostjo pri bolnikih, zdravljenih z ramucirumabom, kot pri bolnikih, zdravljenih s placebom
There was an increase in median PFS of 1.2 months in favour of the Cyramza plus FOLFIRI arm: 5.7 months in the Cyramza plus FOLFIRI arm and 4.5 months in the placebo plus FOLFIRI arm. Efficacy results are shown in Table 10 and Figures 4 and 5.
Opazili so porast medianega preživetja brez napredovanja bolezni za 1,5 meseca v korist skupine z zdravilom Cyramza in docetaksel: 4,5 meseca v skupini z zdravilom Cyramza in docetaksel in 3 mesece v skupini s placebom in docetaksel.
Vascular disorders Hypertensiona,d
Infekcijske in parazitske bolezni sepsaa,b
There was an increase in median PFS of 1.5 months in favour of the Cyramza plus docetaxel arm: 4.5 months in the Cyramza plus docetaxel arm and 3 months in the placebo plus docetaxel arm. ORR was significantly improved in patients receiving Cyramza plus docetaxel compared with those receiving placebo plus docetaxel (22.9% vs. 13.6%, p<0.001).
Objektivna stopnja odziva (popolni odziv [PO] + delni odziv [DO]) se je pomembno izboljšala pri bolnikih, ki so prejemali zdravilo Cyramza in docetaksel, v primerjavi z bolniki, ki so prejemali placebo in docetaksel (22,9 % v primerjavi s 13,6 %, p < 0,001).
A second reduction of 10 mg/m2 is recommended if these toxicities persist or reoccur.
Če te toksičnosti niso odpravljene oz. če se pojavijo znova, je priporočljivo drugo zmanjšanje odmerka za 10 mg/m2.
The recommended dose of ramucirumab is 8 mg/kg on days 1 and 15 of a 28 day cycle, prior to paclitaxel infusion.
Rak želodca in adenokarcinom gastro-ezofagealnega prehoda Zdravilo Cyramza v kombinaciji s paklitakselom Priporočeni odmerek ramucirumaba je 8 mg/kg 1. in 15. dan 28-dnevnega cikla, pred infuzijo paklitaksela.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL - 10 ml vial
OVOJNINAH NALEPKA NA VIALI - 10-mililitrska viala
- The active substance is ramucirumab.
Začetni odmerek ramucirumaba
The volume of distribution is high (approximately 1,000 litres), indicating extensive distribution.
Volumen porazdelitve je velik (približno 1.000 litrov), kar kaže na obširno porazdelitev.
The amount of food you use will depend on how many capsules you need to use every day:
Količina uporabljene hrane bo odvisna od tega, koliko kapsul morate uporabiti vsak dan:
The risk of having seizures is higher if you have had them before;
Tveganje za pojav napadov krčev je večje, če ste jih imeli že kdaj prej,
For patients that can swallow you will need:
Za bolnike, ki lahko požirajo, boste potrebovali:
• Check that you have the correct strength of capsules.
• Preverite, da imate pravo jakost kapsul.
The dose can be increased to achieve a desired target iPTH range.
Odmerek je mogoče povečati, da bi dosegli želeno ciljno območje iPTH.
†see section 4.4 *see section c c) Description of selected adverse reactions
† glejte poglavje 4.4 * glejte del c c) Opis izbranih neželenih učinkov
Not known: frequency cannot be estimated from available data
Neznana: pogostnosti ni mogoče oceniti iz razpoložljivih podatkov
• Wash your hands thoroughly with soap and water.
• Skrbno si umijte roke z milom in vodo.
Take all food or liquid immediately.
Takoj zaužijte vso hrano ali tekočino.
Before you start taking Mimpara, tell your doctor if you have or have ever had:
Pred začetkom jemanja zdravila Mimpara, morate zdravniku povedati, če imate ali ste kdaj imeli:
Seventeen patients received at least one dose of cinacalcet and 11 completed at least 12 weeks of treatment.
Sedemnajst bolnikov je dobilo vsaj en odmerek cinakalceta in 11 bolnikov je dokončalo vsaj 12 tednov zdravljenja.
10 to < 12.5
od 10 do < 12,5
Only the granules should be administered.
Uporabiti je treba le zrnca.
Gender: Clearance of cinacalcet may be lower in women than in men.
Spol: Očistek cinakalceta je pri ženskah morda manjši kot pri moških.
What Mimpara is and what it is used for
Kaj je zdravilo Mimpara in za kaj ga uporabljamo
The dose should be increased sequentially through available dose levels (see table 1) no more frequently than every 4 weeks.
Odmerek je treba povečevati zaporedno po razpoložljivih ravneh odmerka (glejte preglednico 1) in ne pogosteje kot na vsake 4 tedne.
To open the capsule:
Da boste kapsulo odprli:
Common: may affect up to 1 in 10 people
Pogosti: lahko se pojavijo pri največ 1 od 10 bolnikov
Mimpara is used in children aged 3 years to less than 18 years of age:
Zdravilo Mimpara se uporablja pri otrocih, starih od 3 let do manj kot 18 let:
Aclar/PVC/PVAc/Aluminium blister containing 14 tablets.
Pretisni omot (Aclar/PVC/PVAc/aluminij), ki vsebuje 14 tablet.
Available sequential dose levels (mg)
Zaporedne ravni odmerka, ki so na voljo (mg)
The frequencies of the individual preferred terms including angioedema and urticaria cannot be estimated from available data.
Pogostnosti posameznih prednostnih izrazov, vključno z angioedemom in urtikarijo, ni mogoče oceniti iz razpoložljivih podatkov.
Blister: 5 years.
Plastenka: 5 let.
- The tablets are coated with:
- Tablete so obložene s:
Very common: may affect more than 1 in 10 people • nausea and vomiting, these side effects are normally quite mild and do not last for long.
Zelo pogosti: lahko se pojavijo pri več kot 1 od 10 bolnikov • siljenje na bruhanje in bruhanje; ta neželena učinka sta ponavadi blaga in ne trajata dolgo.
Mimpara has not been tested in pregnant women.
Zdravilo Mimpara ni preizkušeno pri nosečnicah.
Date of latest renewal: 23 September 2009
Datum prve odobritve: 22. oktober 2004 Datum zadnjega podaljšanja: 23. september 2009
Reduce or withhold dose of Mimpara.
Zmanjšajte ali zadržite odmerek zdravila Mimpara.
Do not take Mimpara if you have low levels of calcium in your blood.
Ne jemljite zdravila Mimpara, če imate nizke koncentracije kalcija v krvi.
• Do not mix granules of different strengths to avoid incorrect dosing.
• Ne mešajte zrnc različnih jakosti, da boste preprečili uporabo nepravilnega odmerka.
See section 6.1
Glejte poglavje 6.1.
It is important that you take your dose of Mimpara as advised by your doctor.
Pomembno je, da vzamete odmerek zdravila Mimpara, kot vam je naročil zdravnik.