natgillin/translations-raw huggingface dataset:
Of these patients, stabilization or improvement in mean HFMSE (1.4; SD 4.02) and RULM (2.1; SD 2.56) scores were observed from baseline to Study Day 265 in Study CS11.
Pri teh bolnikih so stabilizacijo ali izboljšanje povprečnega rezultata HFMSE (1,4; SD 4,02) in rezultata RULM (2,1; SD 2,56) v študiji CS11 ugotavljali od izhodišča do
Proportion at Day 394
delež na 183. dan delež na 302. dan delež na 394. dan
Post-authorisation efficacy study (PAES): In order to evaluate the long term efficacy and safety of nusinersen in pre-symptomatic patients with spinal muscular atrophy, the MAH should conduct and submit the results of the Phase 2, open-label study (NURTURE (SM201))
(PAES): Da bo imetnik dovoljenja za promet z zdravilom ocenil dolgoročno učinkovitost in varnost nusinersena pri predsimptomatičnih bolnikih s spinalno mišično atrofijo, mora izvesti odprto študijo 2. faze (NURTURE (SM201)) in predložiti rezultate.
Each ml contains 2.4 mg of nusinersen.
En ml vsebuje 2,4 mg nusinersena.
- The other ingredients are sodium dihydrogen phosphate dihydrate, disodium phosphate, sodium chloride, potassium chloride, calcium chloride dihydrate, magnesium chloride hexahydrate,
- Druge sestavine zdravila so natrijev dihidrogenfosfat dihidrat, natrijev hidrogenfosfat, natrijev klorid, kalijev klorid, kalcijev klorid dihidrat, magnezijev klorid heksahidrat, natrijev hidroksid, klorovodikova kislina, voda za injekcije.
Of patients who initiated Spinraza treatment in Study CS4 (n=39), stabilization or additional improvements in mean HFMSE (0.2; SD 3.06) and RULM (0.7; SD 2.69) scores were observed from baseline to Study Day 265 in Study CS11.
Pri bolnikih, pri katerih je bilo zdravljenje z zdravilom Spinraza uvedeno v študiji CS4 (n = 39), so stabilizacijo ali dodatna izboljšanja povprečnega rezultata HFMSE (0,2; SD 3,06) in rezultata RULM (0,7; SD 2,69) v študiji CS11 ugotavljali od izhodišča do 265. dne.
- Each ml contains 2.4 mg of nusinersen.
- En ml vsebuje 2,4 mg nusinersena.
0.5 (95% CI: -0.6, 1.6)
0,5 (95-% IZ: -0,6, 1,6)
HFMSE score
Icepharma hf
Symptomatic patients
Bolniki s
4Assessed at the later of Day 183, Day 302, and Day 394 Study Visit 5According to Hammersmith Infant Neurological Examination (HINE) section 2: ≥2 point increase [or maximal score] in ability to kick, OR ≥1 point increase in the motor milestones of head control, rolling, sitting, crawling, standing or walking, AND improvement in more categories of motor milestones than worsening, defined as a responder for this primary analysis.
5V skladu s preiskavo Hammersmith Infant Neurological Examination (HINE), 2. poglavje: bolnik, ki je pokazal zvečanje za ≥2 točki (ali maksimalni rezultat) pri sposobnosti brcanja, ALI zvečanje za ≥1 točko pri motoričnih mejnikih obvladovanja glave, zvijanja, sedenja, plazenja, stanja ali hoje IN izboljšanje pri več kategorijah motoričnih mejnikov kot poslabšanje, je bil za to primarno analizo opredeljen kot bolnik, ki se odziva na zdravljenje.
Thrombocytopenia and coagulation abnormalities
Trombocitopenija in abnormalnosti koagulacije krvi
- Each 5 ml vial contains nusinersen sodium equivalent to 12 mg nusinersen.
- Ena 5 ml viala vsebuje natrijev nusinersenat, ki ustreza 12 mg nusinersena.
It is recommended that the volume of CSF, equivalent to the volume of Spinraza to be injected, is removed prior to administration of Spinraza.
Priporočljivo je, da pred injiciranjem zdravila Spinraza odstranite volumen CSF, ki je enak volumnu zdravila Spinraza, ki ga boste injicirali.
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Preobčutljivost na učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1. 4.4 Posebna opozorila in previdnostni ukrepi Postopek lumbalne punkcije
The mean total score was13.8 (SD 3.09) at Day 253 and 15.7 (SD 1.92) at Day 1050.
13,8 (SD 3,09) po 253 dneh in 15,7 (SD 1,92) po 1050 dneh.
Spinraza 12 mg solution for injection
Spinraza 12 mg raztopina za injiciranje
Musculoskeletal and connective tissue disorders
Bolezni mišično-skeletnega sistema in vezivnega tkiva bolečina v hrbtu*
Table 3: Primary and secondary endpoints at final analysis - Study CS41 Spinraza treated Patients
Preglednica 3: Primarni in sekundarni končni opazovani dogodki pri končni analizištudija CS41
In the efficacy set, 18 patients (25%) in the Spinraza group and 12 patients (32%) in the sham-control group required permanent ventilation.
V naboru za oceno učinkovitosti je 18 bolnikov (25 %) v skupini z zdravilom Spinraza in
Of the 13 patients with infantile-onset SMA, 7 of out 9 patients (78%; 95%CI: 45, 94) in the Spinraza group and 0 out of 4 patients (0%; 95%CI: 0, 60) in the sham group met the criteria for motor milestone response (according to HINE section 2: ≥2 point increase [or maximal score] in ability to kick OR ≥1 point increase in the motor milestones of head control, rolling, sitting, crawling, standing or walking and improvement in more categories of motor milestones than worsening) .
Od 13 bolnikov, ki so jim postavili diagnozo simptomatične SMA z nastopom pri dojenčku, je 7 od 9 bolnikov (78 %; 95-% IZ: 45, 94) v skupini bolnikov, zdravljenih z zdravilom Spinraza, in 0 od 4 bolnikov (0 %; 95-% IZ: 0, 60) v kontrolni skupini bolnikov na placebu izpolnilo merila za doseganje odzivnosti, opredeljene z motoričnimi mejniki (v skladu s HINE,
How Spinraza is given
Kako se daje zdravilo Spinraza
Pharmacotherapeutic group: Other drugs for disorders of the musculo-skeletal system, ATC code: M09AX07
oznaka ATC: M09AX07 Mehanizem delovanja
Each 5 ml vial contains nusinersen sodium equivalent to 12 mg nusinersen (2.4 mg/ml).
NAVEDBA ENE ALI VEČ UČINKOVIN Ena 5 ml viala vsebuje natrijev nusinersenat, ki ustreza 12 mg nusinersena (2,4 mg/ml).
Figure 1: Change in CHOP INTEND from Baseline to Later of Day 183, Day 302, and Day 394 Study Visit - Endear Study /CS3B (Efficacy Set, ES)
183., 302. ali 394. dan) - študija Endear/CS3B (nabor za oceno učinkovitosti - Efficacy Set, ES)
Reporting of side effects If you or your child get any side effects, talk to your doctor or nurse.
Če pri sebi ali svojem otroku opazite katerega koli izmed neželenih učinkov, se posvetujte zdravnikom ali medicinsko sestro.
56.8% (95% CI:45.6, 68.1) P=0.00065
56,8 % (95-% IZ: 45,6, 68,1)
Number of patients who died Hazard Ratio (95% CI) p-value6
Razmerje ogroženosti (95-% IZ) Vrednost p6
The primary endpoint was the proportion of patients who improved in one or more categories in motor milestones (according to HINE section 2: ≥2 point increase [or maximal score] in ability to kick or voluntary grasp OR ≥1 point increase in the motor milestones of head control, rolling, sitting, crawling, standing or walking).
Primarni končni opazovani dogodek je bil delež bolnikov, ki so se izboljšali v eni ali več kategorijah motoričnih mejnikov (v skladu s poglavjem 2 HINE: zvečanje za ≥ 2 točki (ali maksimalni rezultat)
Hepatic impairment
Bolezni živčevja glavobol*
Spinraza 12 mg solution for injection nusinersen
Spinraza 12 mg raztopina za injiciranje nusinersen
The use of ultrasound or other imaging techniques to assist with intrathecal administration of Spinraza, can be considered at the physician's discretion.
Po presoji zdravnika lahko pride v poštev uporaba ultrazvoka ali drugih tehnik slikanja kot pomoč pri intratekalnem dajanju zdravila
Statistically significant effects on event-free survival, overall survival, the proportion of patients achieving the definition of a motor milestone responder, and the percentage of patients with at least a 4-point improvement from baseline in Children's Hospital of Philadelphia
Statistično značilne učinke na preživetje brez dogodkov, stopnjo preživetja, delež bolnikov, ki so dosegli odzivnost, opredeljeno z motoričnimi mejniki in delež bolnikov z izboljšanjem za najmanj 4 točk od izhodišča v rezultatu testa za dojenčke za živčnomišične bolezni bolnišnice Children's Hospital of Philadelphia (Children's Hospital of Philadelphia Infant Test for Neuromuscular DiseaseCHOP INTEND) so ugotovili pri bolnikih v skupini z zdravilom Spinraza v primerjavi z rezultati kontrolne skupine na placebu (preglednica 2).
Calcium chloride dihydrate Magnesium chloride hexahydrate Sodium hydroxide (for pH adjustment) Hydrochloric acid (for pH adjustment) Water for injections
FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi natrijev dihidrogenfosfat dihidrat natrijev hidrogenfosfat natrijev klorid kalijev klorid kalcijev klorid dihidrat magnezijev klorid heksahidrat natrijev hidroksid (za uravnavanje pH) klorovodikova kislina (za uravnavanje pH) voda za injekcije
If you are not sure, talk to your doctor or nurse before you or your child are given Spinraza.
Če ste negotovi, se posvetujte z zdravnikom ali medicinsko sestro, preden prejmete ali preden vaš otrok prejme zdravilo Spinraza.
Spinraza treated Patients
Bolniki, zdravljeni z zdravilom Spinraza
There have been reports of communicating hydrocephalus not related to meningitis or bleeding in patients treated with nusinersen in the post-marketing setting.
Pri bolnikih, zdravljenih z nusinersenom v obdobju trženja, so poročali o komunikantnem hidrocefalusu, ki ni bil povezan z meningitisom ali krvavitvijo.
The median time to death or permanent ventilation was 50.9 weeks after initiation of Spinraza treatment in Study CS11.
Po uvedbi zdravljenja z zdravilom Spinraza v študiji CS11 je vrednost mediane časa do smrti ali trajne ventilacije znašala 50,9 tedna.
A sustained improvement was seen in patients with Type II SMA who experienced a mean improvement from baseline HFMSE score of 5.1 (SD 4.05, n=11) at Day 253, and 9.1(SD 6.61, n=9) at Day 1050.
Trajno izboljšanje so ugotovili pri bolnikih s SMA tipa II, ki so se povprečno izboljšali z izhodiščnega rezultata 5,1 (SD 4,05, n=11) po 253 dneh,
Thrombocytopenia and coagulation abnormalities, including acute severe thrombocytopenia, have been observed after administration of other subcutaneously or intravenously administered antisense oligonucleotides.
Po dajanju drugih subkutano ali intravensko apliciranih protismiselnih oligonukleotidov so opazili trombocitopenijo in abnormalnosti koagulacije krvi, vključno z akutno hudo trombocitopenijo.
Sham-control Patients
Kontrolni bolniki na placebu
Sedation may be required to administer Spinraza, as indicated by the clinical condition of the patient.
Glede na klinično stanje bolnika bo za dajanje zdravila Spinraza mogoče potrebna sedacija.
Pharma MT limited Tel: +356 213 37008/9
Tel: +356 213 37008/9
Each 5 ml vial contains nusinersen sodium equivalent to 12 mg nusinersen.
KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena 5 ml viala vsebuje natrijev nusinersenat, ki ustreza 12 mg nusinersena.
Icepharma hf Sími: +354 540 8000
Sími: +354 540 8000
Adverse reactions associated with the administration of Spinraza by lumbar puncture have been observed.
Opazili so neželene učinke, povezane z lumbalno punkcijo ob uporabi zdravila Spinraza.
At the interim analysis, all 25 (100%) patients had achieved the WHO motor milestone of sitting without support, 22 (88%) patients were walking with assistance.
sedenja brez opore, 22 (88 %) bolnikov pa je hodilo s podporo.
The median age when patients received their first dose was 164.5 days for treated patients, and 205 days for sham-control.
99 % bolnikov je imelo po 2 kopiji gena SMN2 in je bilo zato zanje najverjetneje, da se bo razvila SMA tipa I. Mediana starost, pri kateri so bolniki prejeli prvi odmerek, je bila pri zdravljenih bolnikih 164,5 dni, pri kontrolnih bolnikih na placebu pa 205 dni.
Change from baseline in total HFMSE score at 15 months1,2,3
Spremembe povprečja najmanjših kvadratov HFMSE od izhodišča meseci
Potassium chloride
Toksičnost za ledvice
April 2023.
265. dne.
Spinraza has not been studied in patients with hepatic impairment.
Pri bolnikih z okvaro jeter zdravila Spinraza niso proučevali.
How to store Spinraza
Shranjevanje zdravila Spinraza
3At the final analysis, CHOP INTEND and motor milestone analyses were conducted using the Efficacy Set (Spinraza n=73; Sham-control n=37).
3V končni analizi so opravili analize CHOP INTEND in motoričnih mejnikov z uporabo nabora za oceno učinkovitosti
It is essentially ‘sodium-free' and can be used by people on a sodium-restricted diet.
To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na odmerek, kar v bistvu pomeni ‘brez natrija' in ga lahko uporabljajo ljudje, ki so na dieti z nadzorovanim vnosom natrija.
19.7% (95% CI: 10.9, p=0.0811
19,7% (95-% IZ: 10,9,
Side effects related to the lumbar puncture may occur while Spinraza is being given or afterwards.
Med dajanjem ali po dajanju zdravila Spinraza se lahko pojavijo neželeni učinki, povezani z lumbalno punkcijo.
Clinical efficacy and safety
Klinična učinkovitost in varnost Simptomatični bolniki Začetek bolezni pri dojenčkih
• Back pain
• bolečina v hrbtu
Talk to your doctor before you or your child are given Spinraza.
Preden vam ali vašemu otroku dajo zdravilo Spinraza, se posvetujte z zdravnikom.
Renal toxicity has been observed after administration of other subcutaneously and intravenously administered antisense oligonucleotides.
Po dajanju drugih subkutano ali intravensko apliciranih protismiselnih oligonukleotidov so opazili toksičnost za ledvice.
The analysis was conducted in the ITT population (Spinraza: n=84; sham-control: n=42), and post-baseline HFMSE data for patients without a Month 15 visit were imputed using the multiple imputation method.
placebo: n=42), poizhodiščne podatke HFMSE pa so bolnikom brez pregleda v 15. mesecu pripisali z metodo večkratne imputacije.
Mean change from baseline to month 15 in total RULM score2,3
Povprečna sprememba celotnega rezultata RULM od izhodišča do
WHO motor milestones
odzivnega z motoričnimi mejniki
Adverse reactions have been identified during post-approval use of Spinraza.
Med uporabo zdravila Spinraza po pridobitvi dovoljenja za promet so ugotovili neželene učinke.
MedDRA System Organ Class
Organski sistemi po MedDRA Priporočeni izraz po MedDRA
Package leaflet: Information for the user Spinraza 12 mg solution for injection nusinersen
Navodilo za uporabo Spinraza 12 mg raztopina za injiciranje nusinersen
Breast-feeding
Hidrocefalus
Study CS4 (CHERISH) was a Phase 3, randomised, double-blind, sham-procedure controlled study conducted in 126 symptomatic patients with later-onset SMA (symptom onset after 6 months of age).
Študija CS4 (CHERISH) je bila randomizirana, dvojno slepa, s placebom kontrolirana študija 3. faze,
Patients with Type III SMA demonstrated a mean improvement from baseline HFMSE score of 1.3 (SD 1.87, n=16) at Day 253 and 1.2 (SD 4.64, n=11) at Day 1050.
(SD 1,87, n=16) po 253 dneh in 1,2 (SD 4,64, n=11) po 1050 dneh zdravljenja.
The median age of onset of clinical signs and symptoms of SMA was 6.5 weeks and 8 weeks for Spinraza treated versus sham-control patients respectively, with 99% of patients having 2 copies of the SMN2 gene and therefore deemed most likely to develop Type I SMA.
Mediana starost ob začetku kliničnih znakov in simptomov SMA je bila pri bolnikih, zdravljenih z zdravilom Spinraza, 6,5 tedna, pri kontrolnih bolnikih na placebu pa 8 tednov.
If removed from the original carton, the total time out of refrigeration should not exceed 30 hours, at a temperature that does not exceed 25°C.
30 ur pri temperaturi, ki ni višja od 25 °C.
4.2(95% CI: 3.4, 5.0) p=0.00000016
4,2 (95-% IZ: 3,4, 5,0)
OTHER
Od
The median age at first dose was 162 days.
Smatrali so, da je najbolj verjetno, da se bo pri bolnikih v tej študiji razvila SMA tipa I. Mediana starost pri prvem odmerku je bila 162 dni.
Interactions
Odmerjanje
Spinraza is given;
Spinraza.
out of 20 patients (55%) met the endpoint of an increase in total CHOP INTEND score of ≥4 points as of the last study visit.
doseglo končni opazovani dogodek zvečanja rezultata CHOP INTEND za ≥ 4 točke do zadnjega pregleda v študiji pred zaključkom zbiranja podatkov.
Further information on Gefitinib Mylan can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Nadaljnje informacije o zdravilu Gefitinib Mylan so na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
What measures are being taken to ensure the safe and effective use of Gefitinib Mylan?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Gefitinib Mylan?
Studies on the benefits and risks of the active substance in the authorised use have already been carried out with the reference medicine, Iressa, and do not need to be repeated for Gefitinib Mylan.
Študije o koristih in tveganjih učinkovine pri odobrenem načinu uporabe so že bile izvedene z referenčnim zdravilom Iressa, zato jih ni treba ponoviti za zdravilo Gefitinib Mylan.
EGFR is involved in the growth and spread of cancer cells.
EGFR je vpleten v rast in širjenje rakavih celic.
It is used in patients whose cancer cells have a mutation in the genes that make a protein called epidermal growth factor receptor (EGFR).
Uporablja se pri bolnikih, katerih rakave celice imajo mutacijo v genih, ki tvorijo beljakovino, imenovano receptor epidermalnega rastnega dejavnika (EGFR).
Because Gefitinib Mylan is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Ker je zdravilo Gefitinib Mylan generično zdravilo in je bioekvivalentno referenčnemu zdravilu, so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
An overview of Gefitinib Mylan and why it is authorised in the EU
Pregled zdravila Gefitinib Mylan in zakaj je odobreno v EU
This means that it blocks specific enzymes known as tyrosine kinases.
To pomeni, da zavira delovanje določenih encimov, imenovanih tirozin-kinaze.
As for every medicine, the company provided studies on the quality of Gefitinib Mylan.
Tako kot za vsako zdravilo je podjetje predložilo študije o kakovosti zdravila Gefitinib Mylan.
The European Medicines Agency concluded that, in accordance with EU requirements, Gefitinib Mylan has been shown to have comparable quality and to be bioequivalent to Iressa.
Evropska agencija za zdravila je zaključila, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Gefitinib Mylan primerljivo raven kakovosti in je bioekvivalentno referenčnemu zdravilu Iressa.
Side effects reported with Gefitinib Mylan are carefully evaluated and any necessary action taken to protect patients.
Neželeni učinki, o katerih so poročali pri zdravilu Gefitinib Mylan, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Gefitinib Mylan have been included in the summary of product characteristics and the package leaflet.
Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Gefitinib Mylan upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
What are the benefits and risks of Gefitinib Mylan?
Kakšne so koristi in tveganja zdravila Gefitinib Mylan?
These enzymes can be found on the surface of cancer cells, such as EGFR on the surface of non-small cell lung cancer cells.
Te encime je mogoče najti na površini rakavih celic, denimo EGFR na površini celic nedrobnoceličnega raka pljuč.
Gefitinib Mylan is used to treat adults who have non-small cell lung cancer that is locally advanced or metastatic (when cancer cells have spread from the original site to other parts of the body).
Gefitinib Mylan je zdravilo proti raku, ki se uporablja za zdravljenje odraslih bolnikov z lokalno napredovalim ali metastatskim (kadar so se rakave celice s prvotnega mesta razsejale v druge dele telesa) nedrobnoceličnim rakom pljuč.
For more information about using Gefitinib Mylan, see the package leaflet or contact your doctor or pharmacist.
Za več informacij glede uporabe zdravila Gefitinib Mylan glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
Gefitinib Mylan can only be obtained with a prescription and treatment should be started and supervised by a doctor who has experience with anticancer treatments.
Predpisovanje in izdaja zdravila Gefitinib Mylan je le na recept, zdravljenje z njim pa mora uvesti in nadzorovati zdravnik, ki ima izkušnje z uporabo zdravil za zdravljenje raka.
As for all medicines, data on the use of Gefitinib Mylan are continuously monitored.
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Gefitinib Mylan stalno spremljajo.
Other information about Gefitinib Mylan
Druge informacije o zdravilu Gefitinib Mylan
Why is Gefitinib Mylan authorised in the EU?
Zakaj je bilo zdravilo Gefitinib Mylan odobreno v EU?
This means that Gefitinib Mylan contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the EU called Iressa.
To pomeni, da vsebuje enako učinkovino in deluje na enak način kot „referenčno zdravilo“, ki je že odobreno v EU in se imenuje Iressa.
What is Gefitinib Mylan and what is it used for?
Kaj je zdravilo Gefitinib Mylan in za kaj se uporablja?
The active substance in Gefitinib Mylan, gefitinib, is a protein tyrosine kinase inhibitor.
Učinkovina v zdravilu Gefitinib Mylan, gefitinib, je „zaviralec protein-tirozin kinaze“.
The tablet can be dispersed in water for patients who have difficulty swallowing.
Pri bolnikih, ki težko požirajo, se tableta lahko raztopi v vodi.
Gefitinib Mylan contains the active substance gefitinib and is a ‘generic medicine'.
Zdravilo Gefitinib Mylan vsebuje učinkovino gefitinib in je „generično zdravilo“.
Gefitinib Mylan is available as 250 mg tablets to be taken by mouth.
Na voljo je v obliki 250-miligramskih tablet, ki se jemljejo peroralno.
By blocking EGFR, Gefitinib Mylan helps to slow down the growth and spread of the cancer.
Zdravilo Gefitinib Mylan z zaviranjem EGFR pripomore k manjši rasti in širjenju raka.
Gefitinib Mylan works only in non-small cell lung cancer cells that have a mutation in their EGFR.
Tako deluje samo v celicah nedrobnoceličnega raka pljuč, ki imajo mutacijo EGFR.
Therefore, the Agency's view was that, as for Iressa, the benefit of Gefitinib Mylan outweighs the identified risk and it can be authorised for use in the EU.
Zato je agencija menila, da koristi zdravila Gefitinib Mylan enako kot pri zdravilu Iressa odtehtajo znana tveganja in da se zdravilo lahko odobri v EU.
How is Gefitinib Mylan used?
Kako se zdravilo Gefitinib Mylan uporablja?
How has Gefitinib Mylan been studied?
Kako je bilo zdravilo Gefitinib Mylan raziskano?
How does Gefitinib Mylan work?
Kako zdravilo Gefitinib Mylan deluje?
* Equivalent to titre prior to inactivation (log10)
(*) Ekvivalent titru pred inaktivacijo (log 10)
Subcutaneous use Type I glass bottle with a chlorobutyl rubber stopper and aluminium cap
Govedo, ovce Subkutano Steklenička tipa I s klorobutilno gumijasto zaporko
EMEA Number Invented name
EU številka Izmišljeno ime
Withdrawal period
Suspenzija za injiciranje
Adopted at the 6-9 June 2016 PRAC
Sprejeto na seji odbora PRAC med 6. in 9. junijem 2016
Page 2/2
Vmesni rezultati so pokazali stran 2/2
The available data do not indicate a clinically significant benefit from riociguat treatment in these patients.
Razpoložljivi podatki ne kažejo klinično pomembne koristi zdravljenja z riociguatom pri teh bolnikih.
Section 2 - What you need to know before you take Adempas Do NOT take Adempas: - If you have increased pressure in your pulmonary circulation associated with scarring of the lungs, of unknown cause (idiopathic pulmonary pneumonia).
Poglavje 2 - Kaj morate vedeti, preden boste vzeli zdravilo Adempas NE jemljite zdravila Adempas: - če imate zvišan tlak v pljučnem krvnem obtoku, povezan z brazgotinjenjem pljuč neznanega vzroka (idiopatsko pljučnico).
Riociguat - Increased mortality and serious adverse events (SAEs) in patients with pulmonary hypertension (PH) associated with idiopathic interstitial pneumonias (IIP) in a single clinical trial (EPITT no 18681)
Riociguat - povečana umrljivost in pojavnost resnih neželenih učinkov pri bolnikih s pljučno hipertenzijo (PH), povezano z idiopatsko intersticijsko pljučnico (IIP), v kliničnem preskušanju (št. EPITT 18681)