natgillin/translations-raw huggingface dataset:
At this level of oxygen saturation, nitric oxide combines predominantly with oxyhaemoglobin to produce methaemoglobin and nitrate.
Pri tej ravni nasičenosti s kisikom se dušikov oksid veže predvsem na oksihemoglobin ter tvori methemoglobin in nitrat.
Elevations in methaemoglobinaemia reduce the oxygen delivery capacity of the circulation.
Povečanje methemoglobina zmanjša sposobnost krvnega obtoka za prenašanje kisika.
The nitric oxide delivery system for intermittent flow ventilation should be adequate to avoid spikes in nitric oxide concentration.
Sistem za dovajanje dušikovega oksida za predihavanje s prekinitvami pretoka bi moral te dvige koncentracije dušikovega oksida ustrezno odpraviti.
Storage in the pharmacy department
Shranjevanje v lekarnah
Marketing Authorisation Holder Linde Healthcare AB SE-181 81 Lidingö Sweden
Imetnik dovoljenja za promet z zdravilom Linde Healthcare AB SE-181 81 Lidingö
Therapy is usually required for about 4 days in newborn infants with lung failure associated with high blood pressure in the lungs.
Pri novorojenčkih z odpovedjo pljuč, povezano z visokim krvnim tlakom v pljučih, je običajno potrebno približno 4-dnevno zdravljenje.
Dizziness c a: Identified from the clinical trial b: Identified from Post Marketing experience c: Identified from Post-Marketing experience, experienced by healthcare personnel following accidental exposure d: Post Marketing Safety Surveillance (PMSS) data, effects associated with acute withdrawal of the medicinal product, and /or delivery system failures.
Bolezni živčevja glavobolc omoticac a. Ugotovljeni v kliničnem preskušanju b. Ugotovljeni v obdobju trženja c. Ugotovljeni v obdobju trženja, poročali zdravstveni delavci po nenamerni izpostavitvi.
A 2 litre gas cylinder filled at 155 bar absolute brings 307 litres of gas under pressure of 1 bar at 15oC.
2-litrska jeklenka, napolnjena pri tlaku 155 bar, vsebuje 307 litrov plina pri tlaku 1 bar in temperaturi 15 oC.
A 10 litre gas cylinder filled at 155 bar absolute brings 1535 litres of gas under pressure of 1 bar at 15oC.
10-litrska jeklenka, napolnjena pri tlaku 155 bar, vsebuje 1535 litrov plina pri tlaku 1 bar in temperaturi 15 oC.
No effect of inhaled nitric oxide has been documented in newborn babies with a malformation where the diaphragm is not fully complete, so called ‘congenital diaphragmatic hernia'.
Pri novorojenčkih s prirojeno diafragmalno hernijo, malformacijo, pri kateri diafragma ni popolnoma razvita, niso dokumentirali nobenega učinka zdravljenja z vdihavanjem dušikovega oksida.
INOmax therapy must be available for manual ventilation such as suctioning, patient transport, and resuscitation.
Zdravljenje z zdravilom INOmax mora biti pri posegih, kot so sukcija, prevoz bolnika in oživljanje, mogoče tudi z ročnim predihavanjem.
155 bar absolute brings 307 litres of gas under pressure of 1 bar at 15 at 155 bar absolute brings 1535 litres of gas under pressure of 1 bar at 15oC.
napolnjena pri tlaku 155 bar, vsebuje 307 litrov plina pri tlaku 1 bar in temperaturi 15 oC. 10-litrska jeklenka, napolnjena pri tlaku 155 bar, vsebuje 1535 litrov plina pri tlaku 1 bar in temperaturi 15 oC.
How to store INOmax
Shranjevanje zdravila INOmax
Nitric oxide may react with oxygen forming nitrogen dioxide that may cause airway irritation.
Dušikov oksid lahko reagira s kisikom, pri čemer nastane dušikov dioksid, ki lahko draži dihalne poti.
Persistent Pulmonary Hypertension in the Newborn (PPHN) Prescription of nitric oxide should be supervised by a physician experienced in neonatal intensive care.
Predpisovanje dušikovega oksida mora nadzirati zdravnik z izkušnjami v intenzivni negi novorojenčkov.
Attempts to wean INOmax should be commenced as soon as the haemodynamics have stabilised in conjunction to weaning from ventilator and inotropic support.
Zdravljenje z zdravilom INOmax ter ventilatorsko in inotropno podporo je treba prekiniti takoj, ko se hemodinamika stabilizira.
Rapid rebound reactions such as intensified pulmonary vasoconstriction and hypoxia after sudden withdrawal of inhaled nitric oxide therapy has been described, precipitating cardiovascular collapse.
reakcije kot sta povečana pljučna vazokonstrikcija in hipoksija, ki so povzročile kardiovaskularni kolaps.
This will be monitored by blood samples and if required the INOmax dose will be decreased and the administration of medicines such as vitamin C, methylene blue, or eventually blood transfusion, in order to improve the oxygen carrying capacity, may be considered.
Poleg tega je sposobnost krvi za prenašanje kisika mogoče izboljšati z dajanjem zdravil, kot sta vitamin C in metilen modro, ter s transfuzijo krvi.
Inhaled nitric oxide should be used with caution in patients with complex heart defect, where high pressure in the pulmonary artery is of importance for maintaining circulation.
Pri bolnikih s kompleksno srčno okvaro, pri kateri je visok tlak v pljučni arteriji pomemben za vzdrževanje cirkulacije, je treba inhalacijski dušikov oksid uporabljati previdno.
Side effects that are very commonly seen (affects more than 1 user in 10) in association with INOmax therapy include:
Med neželenimi učinki, ki se zelo pogosto (pri več kot 1 od 10 bolnikov) pojavijo pri zdravljenju z zdravilom INOmax, so: • majhno število trombocitov.
The INOmax gas cylinder pressure must be displayed to allow timely gas cylinder replacement without inadvertent loss of therapy and backup gas cylinders must be available to provide timely replacement.
Tlak v jeklenki z zdravilom INOmax mora biti prikazan, da jo lahko pravočasno zamenjate brez prekinitve zdravljenja.
- If you have any further questions, ask your doctor - If you get any side effects, talk to your doctor.
- Če imate dodatna vprašanja, se posvetujte z zdravnikom.
NO2 rapidly forms in gas mixtures containing nitric oxide and O2, and nitric oxide may in this way cause airway inflammation and damage.
V zmeseh plinov, ki vsebujejo dušikov oksid in O2, se hitro tvori NO2.
GENERAL CLASSIFICATION FOR SUPPLY Medicinal product subject to medical prescription
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM
The other ingredient is nitrogen.
Pomožna snov je dušik.
MARKETING AUTHORISATION HOLDER Linde Healthcare AB
IMETNIK DOVOLJENJA ZA PROMET Z ZDRAVILOM Linde Healthcare AB
INOmax contains nitric oxide, a gas used for the treatment of newborn babies with lung failure associated with high blood pressure in the lungs, a condition known as hypoxic respiratory failure.
- novorojenčkov s pljučno odpovedjo, povezano z visokim tlakom v pljučih, stanje, ki ga poznamo kot hipoksično respiratorno odpoved.
For patients who are to be referred to another hospital, to prevent worsening of their condition on acute discontinuation of INOmax, the availability of nitric oxide during transport should be assured.
Pri bolnikih, ki bodo premeščeni v drugo bolnišnico, zagotovite možnost dovajanja dušikovega oksida med prevozom, da preprečite poslabšanje zdravstvenega stanja ob nenadni prekinitvi dovajanja zdravila INOmax.
The active substance in INOmax is nitric oxide 400 ppm mol/mol.
Zdravilna učinkovina v zdravilu INOmax je dušikov oksid 400 ppm mol/mol.
Weaning from inhaled nitric oxide should be performed with caution.
Pri prekinitvi vdihovanja dušikovega oksida morate biti previdni.
6.1 List of excipients
6.1 Seznam pomožnih snovi dušik
NAME OF THE MEDICINAL PRODUCT INOmax 400 ppm mol/mol inhalation gas
IME ZDRAVILA INOmax 400 ppm mol/mol plin za inhaliranje
Rescue, such as Extra Corporeal Membrane Oxygenation (ECMO) where available, should be considered based on continued deterioration or failure to improve, defined by criteria based on local circumstances.
V primeru stalnega slabšanja ali izostanka izboljšanja glede na trenutne okoliščine pretehtajte možnost uporabe rešilnega sistema, kot je ECMO (zunajtelesna membranska oksigenacija).
Intermittent flow neonatal ventilation may be associated with spikes in nitric oxide concentration.
Predihavanje s prekinitvami pretoka pri novorojenčku je lahko povezano z znatnimi dvigi koncentracije dušikovega oksida.
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING 2 litres gas cylinder
PODATKI NA PRIMARNI OVOJNINI 2-litrska jeklenka
Do not discard used gas cylinders.
Uporabljenih jeklenk ne zavrzite.
The active substance in INOmax is nitric oxide 800 ppm mol/mol.
Zdravilna učinkovina v zdravilu INOmax je dušikov oksid 800 ppm mol/mol.
In the NINOS trial, 235 neonates with hypoxic respiratory failure were randomised to receive 100 % O2 with (n=114) or without (n=121) nitric oxide most with an initial concentration of 20 ppm with weaning as possible to lower doses with a median duration of exposure of 40 hours.
V preizkusu NINOS so naključno razdelili 235 novorojenčkov s hipoksično respiratorno odpovedjo tako, da so prejemali 100 % O2 z dušikovim oksidom (n = 114) ali brez njega (n = 121).
There may be an additive effect with INOmax on the risk of developing methaemoglobinemia with nitric oxide donor substances, including sodium nitroprusside and nitroglycerin.
Zdravilo INOmax v kombinaciji s snovmi, ki so donorji dušikovega oksida, vključno z natrijevim nitroprusidom in nitroglicerinom, lahko povzroči dodatno tveganje za razvoj methemoglobinemije.
AUTHORISATION
Delovanje
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING 10 litres gas cylinder
PODATKI NA PRIMARNI OVOJNINI 10-litrska jeklenka
Formation of methaemoglobin
Nadzor nastajanja methemoglobina (MetHb)
NAME OF THE MEDICINAL PRODUCT INOmax 800 ppm mol/mol inhalation gas
IME ZDRAVILA INOmax 800 ppm mol/mol plin za inhaliranje
Inhaled nitric oxide may have a mild but influence on the platelets (components that help the blood to clot) of you or your child and any signs of bleeding and or haematoma should be observed.
(komponente, ki pomagajo pri strjevanju krvi), zato morate biti pozorni na kakršnekoli znake krvavitve ali hematoma.
The European Medicines Agency has waived the obligation to submit the results of studies with INOmax in all subsets of the paediatric population in persistent pulmonary hypertension and other pulmonary heart disease.
INOmax pri vseh podskupinah pediatričnih bolnikov s persistentno pljučno hipertenzijo in drugimi pljučnimi srčnimi boleznimi (za podatke o uporabi pri pediatrični populacijiglejte poglavje 4.2).
MARKETING AUTHORISATION NUMBER(S) EU/1/01/194/003, EU/1/01/194/004
ŠTEVILKA(E) DOVOLJENJA ZA PROMET Z ZDRAVILOM EU/1/01/194/003, EU/1/01/194/004
Nervous system disorders
Žilne bolezni hipotenzijaa,
MARKETING AUTHORISATION NUMBER(S) EU/1/01/194/001, EU/1/01/194/002
ŠTEVILKA(E) DOVOLJENJA ZA PROMET Z ZDRAVILOM EU/1/01/194/001, EU/1/01/194/002
The educational pack should contain the following: Summary of Product Characteristics and Patient Information Leaflet for INOmax
Vsebina pakiranjain dodatne informacije Kaj vsebuje zdravilo INOmax
Treatment with inhaled nitric oxide might aggravate cardiac insufficiency in a situation with left-toright shunting.
V primeru obvoda krvnega obtoka z leve na desno lahko zdravljenje z vdihovanjem dušikovega oksida poslabša srčno insuficienco.
Tabulated list of adverse reactions
Razpredelnica z neželenimi učinki
Instructions for use/handling INOmax
B. NAVODILO ZA UPORABO
Do not use INOmax
Bodite posebno pozorni pri uporabi zdravila INOmax
No evidence of a carcinogenic effect was apparent, at inhalation exposures up to the recommended dose (20 ppm), in rats for 20 h/day for up to two years.
Pri podganah, ki so največ dve leti po 20 h/dan dobivale inhalacijske odmerke, manjše ali enake priporočenemu (20 ppm), ni bilo dokazov o karcinogenem učinku.
- Keep this leaflet.
upoštevajte naslednje.
INOmax 800 ppm mol/mol inhalation gas Nitric oxide
INOmax 800 ppm mol/mol plin za inhaliranje dušikov oksid
Within the pulmonary system, nitric oxide can combine with oxygen and water to produce nitrogen dioxide and nitrite, respectively, which interact with oxyhaemoglobin to produce methaemoglobin and nitrate.
V pljučih se dušikov oksid lahko veže s kisikom in vodo ter tvori dušikov dioksid in nitrit.
Keep this medicine out of the sight and reach of children
Zdravilo shranjujte nedosegljivo otrokom!
INOmax 400 ppm mol/mol inhalation gas Nitric oxide
INOmax 400 ppm mol/mol plin za inhaliranje dušikov oksid
Substances known to cause increased methaemoglobin levels should thus be used with caution during therapy with inhaled nitric oxide.
Torej morate med zdravljenjem z vdihavanjem dušikovega oksida previdno uporabljati snovi, za katere je znano, da povečajo koncentracije methemoglobina.
Common Uncommon Rare Very rare
Zelo redki
QUALITATIVE AND QUANTITATIVE COMPOSITION Nitric oxide (NO) 400 ppm mol/mol.
Dušikov oksid (NO) 400 ppm mol/mol.
STATEMENT OF ACTIVE SUBSTANCE(S) Nitric oxide (NO) 800 ppm mol/mol.
Dušikov oksid (NO) 800 ppm mol/mol.
MARKETING AUTHORISATION NUMBER(S) EU/1/01/194/001
ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/01/194/001
The dose of nitric oxide should be reduced if the concentration of nitrogen dioxide exceeds 0.5 ppm.
Če koncentracija dušikovega dioksida preseže
MARKETING AUTHORISATION NUMBER(S) EU/1/01/194/004
ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/01/194/004
A 2 litre aluminium gas cylinder (identification with aquamarine shoulder and white body) filled under a pressure of 155 bar, equipped with a stainless steel positive pressure (residual) valve with a specific outlet connection and a standard valve hand-wheel.
2-litrska aluminijasta jeklenka (prepoznate jo po zelenomodrem vratu in belem telesu), napolnjena pod tlakom 155 bar, opremljena z nadtlačnim ventilom (ki onemogoča nenamerno popolno izpraznitev jeklenke) iz nerjavečega jekla s specifičnim izhodnim priključkom in standardnim ročnim kolesom ventila.
A 10 litre aluminium gas cylinder (identification with aquamarine shoulder and white body) filled under a pressure of 155 bar, equipped with a stainless steel positive pressure (residual) valve with a specific outlet connection and a standard valve hand-wheel.
10-litrska aluminijasta jeklenka (prepoznate jo po zelenomodrem vratu in belem telesu), napolnjena pod tlakom 155 bar, opremljena z nadtlačnim ventilom (ki onemogoča nenamerno popolno izpraznitev jeklenke) iz nerjavečega jekla s specifičnim izhodnim priključkom in standardnim ročnim kolesom ventila.
A 2 litre aluminium gas cylinder (identification with aquamarine shoulder and white body) filled under a pressure of 155 bar, equipped with a stainless steel positive pressure (residual) valve with a specific outlet connection and a INOmeter device equipped valve hand-wheel.
2-litrska aluminijasta jeklenka (prepoznate jo po zelenomodrem vratu in belem telesu), napolnjena pod tlakom 155 bar, opremljena z nadtlačnim ventilom (ki onemogoča nenamerno popolno izpraznitev jeklenke) iz nerjavečega jekla s specifičnim izhodnim priključkom in ročnim kolesom ventila z merilnikom INOmeter.
NAME OF THE MEDICINAL PRODUCT INOmax 400 ppm mol/mol inhalation gas Nitric oxide
Navodilo za uporabo INOmax 400 ppm mol/mol plin za inhaliranje dušikov oksid
Nitric oxide is genotoxic in some test systems.. No evidence of a carcinogenic effect was apparent, at inhalation exposures up to the recommended dose (20 ppm), in rats for 20 h/day for up to two years.
20 h/dan dobivale inhalacijske odmerke, manjše ali enake priporočenemu (20 ppm), ni bilo dokazov o karcinogenem učinku.
NAME OF THE MEDICINAL PRODUCT INOmax 800 ppm mol/mol inhalation gas Nitric oxide
Navodilo za uporabo INOmax 800 ppm mol/mol plin za inhaliranje dušikov oksid
A 10 litre aluminium gas cylinder (identification with aquamarine shoulder and white body) filled under a pressure of 155 bar, equipped with a stainless steel positive pressure (residual) valve with a specific outlet connection and a INOmeter device equipped valve hand-wheel.
10-litrska aluminijasta jeklenka (prepoznate jo po zelenomodrem vratu in belem telesu), napolnjena pod tlakom 155 bar, opremljena z nadtlačnim ventilom (ki onemogoča nenamerno popolno izpraznitev jeklenke) iz nerjavečega jekla s specifičnim izhodnim priključkom in ročnim kolesom ventila z merilnikom INOmeter.
Side effects that may be seen, but uncommonly (affects between 1 user in 100 and 1 user in 1000) are: increase in methaemoglobin, thus reduced oxygen carrying capacity.
Neželeni učinki, ki se pojavijo občasno (med 1 od 100 bolnikov in 1 od 1000 bolnikov), so:
Weaning
Odmerjanje
Vascular disorders
Drugi viri infromacij
Respiratory, thoracic and mediastinal disorders
Bolezni krvi in limfatičnega sistema trombocitopenija a methemoglobinemija a
Two medicines are bioequivalent when they produce the same levels of the active substance in the body and are therefore expected to have the same effect.
Dve zdravili sta biološko enakovredni, kadar dosegata enake ravni učinkovine v telesu in se zato pričakuje, da bosta imeli enak učinek.
The Committee was also concerned that the studies on how the patch sticks to the skin had only been done in young adults.
Zaskrbljen je bil tudi glede dejstva, da so bile študije o tem, kako se obliž drži kože, opravljene samo pri mlajših odraslih.
Since Parkinson's disease usually occurs in people over 60 years, studies in older people would be required because the skin structure changes due to aging.
Ker se Parkinsonova bolezen običajno pojavlja pri ljudeh, starejših od 60 let, bi bile potrebne študije pri starejših ljudeh, saj se struktura kože s staranjem spreminja.
In its letter notifying the Agency of the withdrawal of the application, the company stated that it would be unable to provide the required additional data in the time available.
Družba je v dopisu, s katerim je agencijo obvestila o umiku vloge, navedla, da v zahtevanem časovnem okviru ne bi mogla zagotoviti potrebnih dodatnih podatkov.
Withdrawal of the marketing authorisation application for Rotigotine Mylan (rotigotine) EMA/43037/2018
Umik vloge za pridobitev dovoljenja za promet z zdravilom Rotigotine Mylan (rotigotin) EMA/43037/2018
Dopamine is a messenger substance in the parts of the brain that control movement and coordination.
Dopamin je prenašalec v tistem delu možganov, ki nadzira gibanje in koordinacijo.
The CHMP was concerned that insufficient data had been provided on the quality of the medicine and its manufacturing process.
Imel je pomisleke, da o kakovosti zdravila in njegovem proizvodnem postopku ni bilo predloženih dovolj podatkov.
It was to be available as transdermal patches (patches that deliver a medicine across the skin).
Na voljo naj bi bilo v obliki transdermalnih obližev (obližev, ki dovajajo zdravilo skozi kožo).
The way rotigotine works in restless-legs syndrome is not fully understood.
Način delovanja rotigotina pri sindromu nemirnih nog ni v celoti znan.
Rotigotine Mylan was expected to be used to treat adults with Parkinson's disease and adults with restless-leg syndrome (a disorder where the patient has uncontrollable urges to move the legs to stop uncomfortable, painful or odd sensations in the body, usually at night).
Zdravilo Rotigotine Mylan naj bi se uporabljalo za zdravljenje odraslih s Parkinsonovo boleznijo in odraslih s sindromom nemirnih nog (motnje, pri kateri bolnik čuti nenadzorovano potrebo po premikanju nog, da bi prekinil neprijetne, boleče ali nenavadne občutke v telesu, običajno ponoči).
Studies on the benefits and risks of the active substance in the approved uses have already been carried out with the reference medicine, Neupro, and did not need to be repeated for Rotigotine Mylan.
Študije o koristih in tveganjih učinkovine pri odobrenih načinih uporabe so že bile izvedene z referenčnim zdravilom Neupro, zato jih ni treba ponoviti za zdravilo Rotigotine Mylan.
In patients with Parkinson's disease, the cells that produce dopamine die and the amount of dopamine in the brain decreases.
Pri bolnikih s Parkinsonovo boleznijo celice, ki proizvajajo dopamin, odmirajo, zato se količina dopamina v možganih zmanjša.
As for every medicine, the company provided studies on the quality of Rotigotine Mylan, including studies on how the patch sticks to the skin.
Tako kot za vsako zdravilo je družba predložila študije o kakovosti zdravila Rotigotine Mylan, vključno s študijami o tem, kako se obliž drži kože.
The syndrome is thought to be caused by problems in the way dopamine works in the brain, which may be improved by rotigotine.
Sindrom naj bi povzročile težave pri delovanju dopamina v možganih, kar je mogoče izboljšati z jemanjem rotigotina.
Rotigotine stimulates the brain as dopamine would, so that patients can control their movement and have fewer of the signs and symptoms of Parkinson's disease, such as stiffness and slowness of movement.
Rotigotin stimulira možgane enako kot dopamin, tako da lahko bolniki spet nadzirajo svoje gibe in kažejo manj znakov in simptomov Parkinsonove bolezni, kot sta okorelost in upočasnjeno izvajanje gibov.
Rotigotine Mylan was developed as a ‘generic medicine'.
Zdravilo Rotigotine Mylan je bilo razvito kot „generično zdravilo“.
On 22 December 2017, Mylan SAS officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Rotigotine Mylan, for the treatment of Parkinson's disease and restless-leg syndrome.
je 22. decembra 2017 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za pridobitev dovoljenja za promet z zdravilom Rotigotine Mylan, namenjenim zdravljenju Parkinsonove bolezni in sindroma nemirnih nog.
The company informed the CHMP that there are no ongoing clinical trials with Rotigotine Mylan.
Družba je odbor CHMP obvestila, da trenutno ne potekajo nobena klinična preskušanja z zdravilom Rotigotine Mylan.
The active substance in Rotigotine Mylan, rotigotine, is a dopamine agonist, which means that it imitates the action of dopamine.
Učinkovina v zdravilu Rotigotine Mylan, rotigotin, je dopaminski agonist, kar pomeni, da posnema delovanje dopamina.
The company also carried out studies to investigate whether Rotigotine Mylan is ‘bioequivalent' to the reference medicine.
Družba je opravila tudi študije za proučitev, ali je zdravilo Rotigotine Mylan biološko enakovredno referenčnemu zdravilu.
This means that Rotigotine Mylan contains the same active substance and was intended to work in the same way as a ‘reference medicine' already authorised in the European Union called Neupro.
To pomeni, da vsebuje enako učinkovino in naj bi delovalo enako kot „referenčno zdravilo“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilo Neupro.
Withdrawal of the marketing authorisation application for Rotigotine Mylan (rotigotine)
Umik vloge za pridobitev dovoljenja za promet z zdravilom Rotigotine Mylan (rotigotin)
Rotigotine Mylan is a medicine that contains the active substance rotigotine.
Rotigotine Mylan je zdravilo, ki vsebuje učinkovino rotigotin.
Based on the review of the data, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Rotigotine Mylan could not have been approved for the treatment Parkinson's disease and restless-leg syndrome.
Odbor CHMP je na podlagi pregleda podatkov ob umiku vloge izrazil določene zadržke in je začasno menil, da zdravila Rotigotine Mylan ni mogoče odobriti za zdravljenje Parkinsonove bolezni in sindroma nemirnih nog.
Therefore, at the time of the withdrawal, the CHMP was of the opinion that the benefits of Rotigotine Mylan did not outweigh its risks.
Zato je odbor CHMP ob umiku vloge menil, da koristi zdravila Rotigotine Mylan ne odtehtajo z njim povezanih tveganj.
What is Rotigotine Mylan?
Kaj je zdravilo Rotigotine Mylan?
How does Rotigotine Mylan work?
Kako zdravilo Rotigotine Mylan deluje?
What was Rotigotine Mylan expected to be used for?
Za kaj naj bi se zdravilo Rotigotine Mylan uporabljalo?
26 May 2016
26. maj 2016
This is particularly important for the following medicines:
Navedeno je zlasti pomembno pri uporabi naslednjih zdravil:
It is advisable to take your medicine at the same time each day.
Priporočljivo je, da vzamete zdravilo vsak dan ob istem času.
Both components contributed to the risk reduction.
K zmanjšanju tveganja sta prispevali obe sestavini zdravila.
The clinical relevance of these findings is unknown.
Klinični pomen teh ugotovitev ni znan.
Relative risk reduction p-value ***
relativno zmanjšanje tveganja vrednost p***