natgillin/translations-raw huggingface dataset:
For patients transported to other facilities for additional treatment, who need to continue with inhaled nitric oxide, arrangements should be made to ensure the continuous supply of inhaled nitric oxide during transportation.
U slučaju bolesnika koji se moraju prevesti u druge ustanove radi dodatnog liječenja, a moraju nastaviti s inhalacijom dušikovog (II)
Nitrate has been identified as the predominant nitric oxide metabolite excreted in the urine, accounting for > 70 % of the nitric oxide dose inhaled.
Utvrđeno je da je nitrat predominantni metabolit dušikovog (II) oksida koji se izlučuje urinom i čini
At this level of oxygen saturation, nitric oxide combines predominantly with oxyhaemoglobin to produce methaemoglobin and nitrate.
Pri toj zasićenosti kisikom dušikov (II) oksid se prvenstveno veže s oksihemoglobinom te stvara methemoglobin i nitrat.
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.
Glavoboljac Omaglicac a: Podaci iz kliničkih ispitivanja b: Podaci iz iskustva nakon stavljanja lijeka u promet.
Weaning
Odvikavanje
6.1 List of excipients
6.1 Popis pomoćnih tvari dušik
Τηλ.
oksida.
Driving and using machines Not relevant.
Upravljanje vozilima i strojevima
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.
oksida tijekom transporta kako bi se spriječilo pogoršanje stanja nakon akutnog prekida primjene INOmax-a, U slučaju progresivnog pogoršanja ili izostanka poboljšanja, definiranog lokalnim kriterijima, potrebno je razmotriti sustav za spašavanje kao što je izvantjelesna membranska oksigenacija (ECMO, engl.
Please tell your doctor if you (as the patient) or your child (as the patient) are taking or have recently taken or used any other medicines, including medicines obtained without a prescription.
- ako ste Vi (kao bolesnik) ili Vaše dijete (kao bolesnik) alergični (preosjetljivi) na dušikov (II)
Although it is unusual for the methaemoglobin level to increase significantly if the first level is low, it is prudent to repeat methaemoglobin measurements every one to two days.
Mjerenja methemoglobina treba ponavljati svakih dan ili dva, iako porast koncentracije methemoglobina u nastavku liječenja, ako je prva koncentracija niska, nije uobičajen.
A 2 litre gas cylinder filled at 155 bar absolute brings 307 litres of gas under pressure of 1 bar at 15oC.
Spremnik za plin od 2 litre napunjen pod apsolutnim tlakom od 155 bara daje 307 litara plina pod tlakom od 1 bara pri temperaturi od 15 oC.
A 10 litre gas cylinder filled at 155 bar absolute brings 1535 litres of gas under pressure of 1 bar at 15oC.
Spremnik za plin od 10 litara napunjen pod apsolutnim tlakom od 155 bara daje 1535 litara plina pod tlakom od 1 bara pri temperaturi od 15 oC.
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.
U ispitivanju NINOS, 235 novorođenčadi s hipoksičnom respiratornom insuficijencijom bilo je randomizirano u skupine koje su primale 100% O2 (n=114) s dušikovim (II) oksidom ili bez (n=121)
NAME OF THE MEDICINAL PRODUCT INOmax 400 ppm mol/mol inhalation gas
NAZIV LIJEKA INOmax 400 ppm mol/mol plin inhalata
ul.
Tel.
MARKETING AUTHORISATION NUMBER(S) EU/1/01/194/003, EU/1/01/194/004
BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/01/194/003, EU/1/01/194/004
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.
napunjen pod tlakom od 155 bara, opremljen ventilom od nehrđajućeg čelika za pozitivni tlak (rezidualni) s posebnim izlaznim priključkom i ručicom ventila opremljenom uređajem INOmeter.
Inhaled nitric oxide combination with other vasodilators acting by the cGMP or cAMP systems should be done with caution.
Potreban je poseban oprez u kombinacijama inhalacije dušikovog (II) oksida s drugim vazodilatatorima koji djeluju putem sustava cikličkog gvanozinmonofosfata (cGMP) ili cikličkog adenozinmonofosfata (cAMP).
MARKETING AUTHORISATION NUMBER(S) EU/1/01/194/001, EU/1/01/194/002
BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/01/194/001, EU/1/01/194/002
Therapy is usually required for about 4 days in newborn infants with lung failure associated with high blood pressure in the lungs.
U novorođenčadi sa zatajenjem pluća povezanim s visokim krvnim tlakom u plućima liječenje obično traje 4 dana.
Your doctor will decide how long you or your child should be treated with INOmax.
Liječnik će odrediti trajanje liječenja INOmax-om za Vas ili Vaše dijete.
NAME OF THE MEDICINAL PRODUCT INOmax 800 ppm mol/mol inhalation gas
NAZIV LIJEKA INOmax 800 ppm mol/mol plin inhalata
NO2 rapidly forms in gas mixtures containing nitric oxide and O2, and nitric oxide may in this way cause airway inflammation and damage.
Stvaranje dušikovog dioksida (NO2) NO2 brzo se stvara u plinskim mješavinama koje sadržavaju dušikov (II) oksid i O2, a dušikov (II)
The active substance in INOmax is nitric oxide 400 ppm mol/mol.
Djelatna tvar u INOmax-u jest dušikov (II) oksid 400 ppm mol/mol.
The active substance in INOmax is nitric oxide 800 ppm mol/mol.
Djelatna tvar u INOmax-u jest dušikov (II) oksid 800 ppm mol/mol.
Training in administration The key elements that need to be covered in training hospital personnel are as follows.
Edukacija bolničkog medicinskog osoblja mora uključivati sljedeće ključne elemente: Ispravno postavljanje i priključivanje
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.
napunjen pod tlakom od 155 bara, opremljen ventilom od nehrđajućeg čelika za pozitivni tlak (rezidualni) s posebnim izlaznim priključkom i standardnom ručicom ventila.
6.6 Special precautions for disposal and other handling
6.6 Posebne mjere za zbrinjavanje i druga rukovanja lijekom Upute za upotrebu/rukovanje INOmax-om
How to store INOmax
Moguće nuspojave Kako čuvati INOmax
The monitoring of Methaemoglobin level
Praćenje koncentracije methemoglobina (MetHb)
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.
Bolesnicima koji će nastaviti liječenje u drugoj ustanovi treba osigurati dostupnost dušikovog (II)
Posology
Atelektazaa
In clinical studies, NO2 levels > 3 ppm or methaemoglobin levels > 7 % were treated by reducing the dose of, or discontinuing, INOmax.
U kliničkim ispitivanjima razine NO2 > 3 ppm ili methemoglobina
INOmax 400 ppm mol/mol inhalation gas Nitric oxide
INOmax 400 ppm mol/mol plin inhalata dušikov (II) oksid
: +32 70 233 826 info.healthcare.be@linde.com
B-1850 Grimbergen Tél/Tel.: +32 70 233 826 info.healthcare.be@linde.com
Thrombocytopeniaa
Razine methemoglobina
INOmax 800 ppm mol/mol inhalation gas Nitric oxide
INOmax 800 ppm mol/mol plin inhalata dušikov (II) oksid
STATEMENT OF ACTIVE SUBSTANCE(S) Nitric oxide (NO) 400 ppm mol/mol.
NAVOĐENJE DJELATNE(IH) TVARI Dušikov (II) oksid (NO) 400 ppm mol/mol.
STATEMENT OF ACTIVE SUBSTANCE(S) Nitric oxide (NO) 800 ppm mol/mol.
NAVOĐENJE DJELATNE(IH) TVARI Dušikov (II) oksid (NO) 800 ppm mol/mol.
The educational pack should contain the following: Summary of Product Characteristics and Patient Information Leaflet for INOmax
• Sažetak opisa svojstava i Uputu o lijeku za INOmax • Edukacijski materijal za zdravstvene radnike
PHARMACEUTICAL FORM AND CONTENTS Inhalation gas
Plin inhalata
There may be an additive effect with INOmax on the risk of developing methaemoglobinemia with nitric oxide donor substances, including sodium nitroprusside and nitroglycerin.
Zajednička primjena donora dušikovog oksida, uključujući natrijev nitroprusid i nitroglicerin s INOmax-om može imati aditivni učinak na razvoj methemoglobinemije.
NUMBER(S) IN THE COMMUNITY REGISTER OF MEDICINAL PRODUCTS EU/1/01/194/002
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/01/194/002
NUMBER(S) IN THE COMMUNITY REGISTER OF MEDICINAL PRODUCTS EU/1/01/194/003
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/01/194/003
QUALITATIVE AND QUANTITATIVE COMPOSITION Nitric oxide (NO) 400 ppm mol/mol.
Dušikov (II) oksid (NO) 400 ppm mol/mol.
QUALITATIVE AND QUANTITATIVE COMPOSITION Nitric oxide (NO) 800 ppm mol/mol.
Dušikov (II) oksid (NO) 800 ppm mol/mol.
Data in adult humans are conflicting, and there has been no increase in bleeding complications in randomised controlled trials in term and near-term neonates with hypoxic respiratory failure.
U randomiziranim kontroliranim ispitivanjima na donošenoj novorođenčadi i kasnoj nedonoščadi s hipoksičnom respiratornom insuficijencijom nije zabilježeno povećanje broja komplikacija s krvarenjem.
ANNEX I
PRILOG III.
NAME OF THE MEDICINAL PRODUCT INOmax 800 ppm mol/mol inhalation gas Nitric oxide
Uputa o lijeku: Informacije za korisnika INOmax 800 ppm mol/mol plin inhalata dušikov (II) oksid
NAME OF THE MEDICINAL PRODUCT INOmax 400 ppm mol/mol inhalation gas Nitric oxide
Uputa o lijeku: Informacije za korisnika INOmax 400 ppm mol/mol plin inhalata dušikov (II) oksid
Inadequate response
Način primjene
30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom26 January 2018
30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom26. siječnja 2018.
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.
Dva su lijeka bioekvivalentna ako proizvode iste razine djelatne tvari u tijelu i stoga se očekuje da imaju isti učinak.
The application was withdrawn after the CHMP had evaluated the initial documentation provided by the company and formulated a list of questions.
Zahtjev je povučen nakon što je CHMP procijenio inicijalnu dokumentaciju koju je tvrtka dostavila i sastavio popis pitanja.
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.
Budući da Parkinsonova bolest uglavnom nastupa u osoba koje su starije od 60 godina, trebalo bi provesti ispitivanja na starijim osobama jer se struktura kože mijenja zbog starenja.
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.
U svojem dopisu kojim obavještava Agenciju o povlačenju zahtjeva, tvrtka je navela da ne može na vrijeme dostaviti tražene dodatne podatke.
EMEA/H/C/004286
EMA/43037/2018 EMEA/H/C/004286
The CHMP was concerned that insufficient data had been provided on the quality of the medicine and its manufacturing process.
CHMP je izrazio zabrinutost da nisu dostavljeni dostatni podatci o kvaliteti lijeka i njegovom postupku proizvodnje.
The Committee was also concerned that the studies on how the patch sticks to the skin had only been done in young adults.
Odbor je također izrazio zabrinutost u pogledu provedbe ispitivanja prianjanja flastera na kožu samo na mladim punoljetnicima.
Dopamine is a messenger substance in the parts of the brain that control movement and coordination.
Dopamin djeluje kao glasnik u dijelovima mozga koji kontroliraju kretanje i koordinaciju.
The company had not yet responded to the questions at the time of the withdrawal.
U trenutku povlačenja tvrtka još nije bila dostavila svoje odgovore na pitanja.
The way rotigotine works in restless-legs syndrome is not fully understood.
Način djelovanja rotigotina kod sindroma nemirnih nogu nije u potpunosti poznat.
Rotigotine Mylan was developed as a ‘generic medicine'.
Rotigotine Mylan razvijen je kao „generički lijek”.
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 znači da Rotigotine Mylan sadržava istu djelatnu tvar i da je trebao djelovati na isti način kao i „referentni lijek” koji je već odobren u Europskoj uniji (EU) pod nazivom Neupro.
The syndrome is thought to be caused by problems in the way dopamine works in the brain, which may be improved by rotigotine.
Smatra se da je sindrom prouzročen problemima u načinu djelovanja dopamina u mozgu, što se može poboljšati primjenom rotigotina.
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).
Rotigotine Mylan se trebao primjenjivati za liječenje odraslih osoba s Parkinsonovom bolešću i sindromom nemirnih nogu (poremećaj kod kojeg bolesnik ima nesavladiv poriv za pokretanjem ekstremiteta kako bi prekinuo neugodne, bolne ili neobične osjete u tijelu, uglavnom noću).
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 mozak na isti način kao i dopamin tako da bolesnici mogu kontrolirati svoje pokrete te imaju manje znakova i simptoma Parkinsonove bolesti poput ukočenosti i usporavanja pokreta.
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.
Ispitivanja o koristima i rizicima djelatne tvari u odobrenim primjenama već su provedena s referentnim lijekom Neupro i ne treba ih ponavljati za lijek Rotigotine Mylan.
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.
Dana 22. prosinca 2017. tvrtka Mylan SAS službeno je obavijestila Odbor za lijekove za humanu uporabu (CHMP) kako želi povući svoj zahtjev za odobrenje za stavljanje u promet lijeka Rotigotine Mylan za liječenje Parkinsonove bolesti i sindroma nemirnih nogu.
In patients with Parkinson's disease, the cells that produce dopamine die and the amount of dopamine in the brain decreases.
U bolesnika s Parkinsonovom bolešću stanice koje proizvode dopamin odumiru te se smanjuje količina dopamina u mozgu.
What is Rotigotine Mylan?
Što je Rotigotine Mylan?
The company also carried out studies to investigate whether Rotigotine Mylan is ‘bioequivalent' to the reference medicine.
Tvrtka je također provela ispitivanja kako bi istražila je li Rotigotine Mylan „bioekvivalentan” referentnom lijeku.
As for every medicine, the company provided studies on the quality of Rotigotine Mylan, including studies on how the patch sticks to the skin.
Kao i za svaki lijek, tvrtka je dostavila ispitivanja o kvaliteti lijeka Rotigotine Mylan, uključujući ispitivanja prianjanja flastera za kožu.
The active substance in Rotigotine Mylan, rotigotine, is a dopamine agonist, which means that it imitates the action of dopamine.
Djelatna je tvar u lijeku Rotigotine Mylan rotigotin, agonist dopamina, što znači da imitira djelovanje dopamina.
Withdrawal of the marketing authorisation application for Rotigotine Mylan (rotigotine)
Povlačenje zahtjeva za izdavanje odobrenja za stavljanje u promet lijeka Rotigotine Mylan (rotigotin)
The company informed the CHMP that there are no ongoing clinical trials with Rotigotine Mylan.
Tvrtka je obavijestila CHMP da nema kliničkih ispitivanja lijeka Rotigotine Mylan koja su u tijeku.
EMA/43037/2018
Mylan (rotigotin) EMA/43037/2018
It was to be available as transdermal patches (patches that deliver a medicine across the skin).
Trebao je biti dostupan u obliku transdermalnih flastera (flasteri koji otpuštaju lijek preko kože).
Rotigotine Mylan is a medicine that contains the active substance rotigotine.
Rotigotine Mylan je lijek koji sadržava djelatnu tvar 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.
Na temelju pregleda podataka, u trenutku povlačenja CHMP je smatrao da postoje razlozi za zabrinutost te je njegovo privremeno mišljenje bilo da nije moguće dati odobrenje za Rotigotine Mylan za liječenje Parkinsonove bolesti i sindroma nemirnih nogu.
What was Rotigotine Mylan expected to be used for?
Za što se Rotigotine Mylan trebao koristiti?
How does Rotigotine Mylan work?
Kako djeluje Rotigotine Mylan?
Therefore, at the time of the withdrawal, the CHMP was of the opinion that the benefits of Rotigotine Mylan did not outweigh its risks.
Sukladno navedenome, CHMP je u vrijeme povlačenja smatrao kako koristi od lijeka Rotigotine Mylan ne nadmašuju s njim povezane rizike.
This is particularly important for the following medicines:
To je osobito važno za sljedeće lijekove:
26 May 2016
26. svibnja 2016.
It is advisable to take your medicine at the same time each day.
Preporučljivo je da uzimate svoj lijek u isto vrijeme svakog dana.
Do not take Neparvis:
Nemojte uzimati Neparvis:
No significant interaction
Bez značajne interakcije
Therefore, this combination is not recommended.
Stoga se ova kombinacija ne preporučuje.
Both components contributed to the risk reduction.
Obje su komponente doprinijele smanjenju rizika.
Some side effects may be serious.
Neke nuspojave mogu biti ozbiljne.
What Neparvis is and what it is used for
Što je Neparvis i za što se koristi
What Neparvis contains
Što Neparvis sadrži
KM estimate of cumulative failure rate (%)
KM procjena kumulativne stope neuspjeha (%)
This period coincides with 36 weeks of gestation in humans, which could occasionally extend up to 44 weeks after conception in humans.
Ovo se razdoblje podudara s 36 tjedana gestacije u ljudi, koje bi se povremeno moglo produžiti do 44 tjedna nakon začeća u ljudi.
Within 2 years after Commission Decision.
U roku od dvije godine od Odluke Komisije
PVC/PVDC/Aluminium blisters.
PVC/PVDC/aluminij blisteri.
In these patients, exposure may be increased and safety is not established.
U tih bolesnika, izloženost može biti povećana i sigurnost nije utvrđena.
The safety and efficacy of Neparvis in children and adolescents aged below 18 years have not been established.
Sigurnost i djelotvornost Neparvisa u djece i adolescenata u dobi ispod 18 godina nisu ustanovljene.
It may be necessary to change the dose, to take other precautions, or even to stop taking one of the medicines.
Možda će trebati promijeniti dozu, poduzeti druge mjere opreza, ili čak prestati uzimati jedan od lijekova.
Effect of gender
Učinak spola
This is because it has not been studied in this age group.
To je zato što nije bio ispitivan u ovoj dobnoj skupini.
PDE5 inhibitors including sildenafil
PDE5 inhibitori uključujući sildenafil
Before you drive a vehicle, use tools or operate machines, or carry out other activities that require concentration, make sure you know how Neparvis affects you.
Prije nego što upravljate vozilom, upotrebljavate alate ili upravljate strojevima, ili provodite druge aktivnosti koje zahtijevaju koncentraciju, provjerite kako Neparvis utječe na Vas.
The clinical relevance of these findings is unknown.
Klinička relevantnost tih nalaza nije poznata.
This medicine is not for use in children (aged below 18 years).
Ovaj lijek nije za primjenu u djece (mlađe od 18 godina).
Amyloid content was not, however, measured quantitatively in this study.
Amiloidni sadržaj nije, međutim, bio kvantitativno mjeren u ovom ispitivanju.
However, if you forget to take a dose, you should simply take the next one at the scheduled time.
Međutim, ako zaboravite uzeti dozu, jednostavno uzmite sljedeću u planirano vrijeme.
If you feel dizzy or very tired while taking this medicine, do not drive a vehicle, cycle or use any tools or machines.
Ako osjećate omaglicu ili ste vrlo umorni dok uzimate ovaj lijek, nemojte upravljati vozilom, voziti bicikl ili upotrebljavati bilo koje alate ili strojeve.
This type of heart failure occurs when the heart is weak and cannot pump enough blood to the lungs and the rest of the body.
Ova vrsta zatajenja srca nastaje kada je srce slabo i ne može pumpati dovoljno krvi u pluća i ostatak tijela.
Symptomatic treatment should be provided.
Potrebno je osigurati simptomatsko liječenje.
Relative risk reduction p-value ***
Relativno smanjenje rizika p-vrijednost ***
***One-sided p-value
***Jednostrana p-vrijednost
The tablets must be swallowed with a glass of water.
Tablete se moraju progutati uz čašu vode.
This effect was observed early and was sustained throughout the duration of the study (see Figure 1).
Ovaj je učinak bio uočen rano i održao se za vrijeme trajanja ispitivanja (vidjeti Sliku 1).
Do not stop taking your medicine unless your doctor tells you to.
Nemojte prestati uzimati lijek ako Vam to ne kaže liječnik.
NT-proBNP is not a neprilysin substrate and is therefore a more suitable biomarker.
NT-proBNP nije supstrat neprilizina i stoga je prikladniji biomarker.
Whilst there is no controlled epidemiological data on the risk with ARBs, similar risks may exist for this class of medicinal product.
Dok nema kontroliranih epidemioloških podataka o riziku s ARB-ovima, slični rizici mogu postojati i za ovu skupinu lijekova.
• medicines that increase the amount of potassium in the blood.
• lijekovi koji povećavaju količinu kalija u krvi.
This medicine is not recommended in early pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if it is used after the third month of pregnancy.
Ovaj lijek se ne preporučuje u ranoj trudnoći te se ne smije uzimati kada ste trudni više od 3 mjeseca, jer može ozbiljno naštetiti Vašem djetetu ako se uzima nakon trećeg mjeseca trudnoće.
Your doctor will then adjust the dose depending on how you respond to the treatment until the best dose for you is found.
Liječnik će Vam zatim prilagoditi dozu ovisno o tome kako odgovarate na liječenje dok se ne pronađe najbolja doza za Vas.
• At the request of the European Medicines Agency; • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
• na zahtjev Europske agencije za lijekove; • prilikom svake izmjene sustava za upravljanje rizikom, a naročito kada je ta izmjena rezultat primitka novih informacija koje mogu voditi ka značajnim izmjenama omjera korist/rizik, odnosno kada je izmjena rezultat ostvarenja nekog važnog cilja (u smislu farmakovigilancije ili minimizacije rizika).
Fertility, reproduction and development
Plodnost, razmnožavanje i razvoj
Hazard ratio (95% CI)
Omjer rizika (95% CI)
It must not be re-administered.
Ne smije se ponovno primijeniti.
What Neparvis is and what it is used for What you need to know before you take Neparvis How to take Neparvis
Što je Neparvis i za što se koristi Što morate znati prije nego počnete uzimati Neparvis Kako uzimati Neparvis
Appropriate care should be exercised when initiating or ending concomitant treatment with such medicinal products.
Potrebno je primijeniti odgovarajući oprez kod započinjanja ili završavanja istodobnog liječenja s takvim lijekovima.