natgillin/translations-raw huggingface dataset:
EXP Use immediately after dilution. 
Nakon razrjeđenja odmah upotrijebiti.
To avoid potential incompatibilities, Zoledronic Acid Accord concentrate is to be diluted with 0.9% w/v sodium chloride solution for Injection or 5% w/v glucose solution. 
Da bi se izbjegle moguće inkompatibilnosti, koncentrat Zoledronatne kiseline Accord treba razrijediti sa 0,9%-tnom m/V otopinom natrijevog klorida za injekciju ili sa 5%-tnom m/V otopinom glukoze.
Table 4: Efficacy results (breast cancer and multiple myeloma patients) Any SRE (+TIH) 
Tablica 4: Rezultati djelotvornosti (u bolesnika s karcinomom dojke i multiplim mijelomom)
How to prepare and administer Zoledronic Acid Accord 
Kako pripremiti i primijeniti Zoledronatnu kiselinu Accord
QUALITATIVE AND QUANTITATIVE COMPOSITION One vial with 5 ml concentrate contains 4 mg zoledronic acid (as monohydrate) One ml concentrate contains 0.8 mg zoledronic acid (as monohydrate). 
2. KVALITATIVNI I KVANTITATIVNI SASTAV Jedna bočica s 5 ml koncentrata sadrži 4 mg zoledronatne kiseline (u obliku hidrata).
6 PHARMACEUTICAL PARTICULARS 
6. FARMACEUTSKI PODACI
Zoledronic Acid Accord treatment in TIH patients who also have severe renal impairment should be considered only after evaluating the risks and benefits of treatment. 
Liječenje bolesnika s hiperkalcemijom izazvanom tumorom koji imaju i teško oštećenje funkcije bubrega Zoledronatnom kiselinom Accord dolazi u obzir tek nakon procjene rizika i koristi od liječenja.
Prevention of skeletal related events in patients with advanced malignancies involving bone: 
Sprječavanje koštanih događaja u bolesnika s uznapredovalom zloćudnom bolešću koja je zahvatila kosti:
What Zoledronic Acid Accord contains 
Što Zoledronatna kiselina Accord sadrži
Very common Vomiting, nausea Common 
Vrlo često: povraćanje, mučnina Često:
• Pain in the mouth, teeth and/or jaw, swelling or non-healing sores inside the mouth or jaw, discharge, numbness or a feeling of heaviness in the jaw, or loosening of a tooth. 
• bol u ustima, zubima i/ili čeljusti, oteklina ili ranice u ustima ili čeljusti koje ne cijele, iscjedak,
There have been very rare cases of drowsiness and sleepiness with the use of Zoledronic Acid Accord. 
U vrlo su rijetkim slučajevima uz primjenu Zoledronatne kiseline Accord nastupile omamljenost i pospanost.
Tell your doctor immediately if you experience symptoms such as new onset or worsening of aches, pain or stiffness while being treated with Zoledronic Acid Accord or after stopping treatment. 
Odmah obavijestite svog liječnika ako za vrijeme liječenja Zoledronatnu kiselinu Accord kiselina ili nakon prestanka liječenja dobijete simptome kao što su novonastali ili pogoršani bolovi ili ukočenost.
Bone pain, myalgia, arthralgia, generalised pain 
bolovi u kostima, mialgija, artralgija, generalizirani bolovi
Zoledronic Acid Accord contains sodium 
Zoledronatna kiselina Accord sadrži natrij
How to store Zoledronic Acid Accord 6. 
Kako čuvati Zoledronatnu kiselinu Accord 6.
You must not be given Zoledronic Acid Accord if you are breast-feeding. 
Ne smijete dobivati Zoledronatnu kiselinu Accord ako dojite.
Osteonecrosis of the jaw (ONJ) has been reported uncommonly in clinical trials and in the postmarketing setting in patients receiving Zoledronic Acid Accord 
Osteonekroza čeljusti zabilježena je manje često u kliničkim ispitivanjima i nakon stavljanja lijeka u promet, u bolesnika koji su se liječili Zoledronatnom kiselinom Accord.
Prior to administration, 5ml concentrate from one vial or the volume of the concentrate withdrawn as required must be further diluted with 100 ml of calcium-free infusion solution (0.9% w/v sodium chloride solution for Injection or 5% w/v glucose solution). 
6.6 Posebne mjere za zbrinjavanje i druga rukovanja lijekom Prije primjene, 5 ml koncentrata iz jedne bočice ili izvučen potreban volumen koncentrata mora se dodatno razrijediti sa 100 ml otopine za infuziju koja ne sadrži kalcij (0,9%-tna m/V otopina natrijevog klorida za injekciju ili 5%-tna m/V otopina glukoze).
How often Zoledronic Acid Accord is given 
Koliko se često daje Zoledronatna kiselina Accord
Mean changes from baseline in BPI scores. 
Prosječna promjena u BPI u odnosu na početnu
Pharmacotherapeutic group: Drugs for treatment of bone diseases, bisphosphonates, ATC code: M05BA08 
ATK oznaka: M05BA08
Zoledronic Acid Accord 4 mg/5 ml concentrate for solution for infusion zoledronic acid 
Zoledronatna kiselina Accord 4 mg/5 ml koncentrat za otopinu za infuziju zoledronatna kiselina
• Headache and a flu-like syndrome consisting of fever, fatigue, weakness, drowsiness, chills and bone, joint and/or muscle ache. 
• glavobolja i sindrom sličan gripi koji se sastoji od vrućice, umora, slabosti, omamljenosti,
SPECIAL STORAGE CONDITIONS 
9. POSEBNE MJERE ČUVANJA
Only clear solution free from particles and discolouration should be used. 
Smije se primijeniti samo bistra otopina koja ne sadrži čestice i nije promijenila boju.
NAME OF THE MEDICINAL PRODUCT Zoledronic Acid Accord 4 mg/5 ml concentrate for solution for infusion 
NAZIV LIJEKA Zoledronatna kiselina Accord 4 mg/5 ml koncentrat za otopinu za infuziju
You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine. 
.Nuspojave možete prijaviti izravno putem nacionalnog sustava za prijavu nuspojava navedenog u Dodatku V.
Baseline creatinine clearance (ml/min) Zoledronic acid recommended dose* 4.0 mg zoledronic acid 3.5 mg* zoledronic acid 3.3 mg* zoledronic acid 3.0 mg* zoledronic acid * Doses have been calculated assuming target AUC of 0.66 (mg-hr/l) (CLcr = 75 ml/min). 
3,0 mg* zoledronatne kiseline *Doze su izračunate uz pretpostavku da je ciljni AUC 0,66 (mg-hr/l) (klirens kreatinina = 75 ml/min).
• Confusion. 
• smetenost.
The hydration status of patients must be assessed prior to and following administration of Zoledronic Acid Accord to ensure that they are adequately hydrated. 
Prije i poslije primjene Zoledronatne kiseline Accord mora se provjeriti status hidracije bolesnika kako bi se osiguralo da su primjereno hidrirani.
Very common Pyrexia, fatigue Common 
Vrlo često: pireksija, umor Često:
Cardiac arrhythmias and neurologic adverse events (including convulsions, hypoasthesia and tetany) have been reported secondary to cases of severe hypocalcaemia. 
Kao posljedica slučajeva teške hipokalcemije zabilježene su srčane aritimije i neurološki štetni događaji (uključujući konvulzije, hipoesteziju i tetaniju).
The following properties have been demonstrated in preclinical studies: In-vivo: Inhibition of osteoclastic bone resorption, which alters the bone marrow microenvironment, making it less conducive to tumour cell growth, anti-angiogenic activity and anti-pain activity. 
U nekliničkim ispitivanjima pokazala je sljedeća svojstva: in vivo: inhibicija osteoklastične resorpcije kosti, koja mijenja mikrookoliš koštane srži i čini je manje pogodnom za rast tumorskih stanica, antiangiogeno djelovanje i analgetsko djelovanje in vitro: inhibicija proliferacije osteoblasta, izravno citostatsko i proapoptotsko djelovanje na tumorske stanice, sinergistički citostatski učinak s drugim antitumorskim lijekovima, antiadhezivno/antiinvazivno djelovanje.
Acute renal failure, haematuria, proteinuria 
akutno zatajenje bubrega, hematurija, proteinurija
Zoledronic acid was teratogenic in the rat at subcutaneous doses  0.2 mg/kg. 
Zoledronatna kiselina primijenjena supkutano u dozama  0,2 mg/kg u štakora pokazala je teratogeno djelovanje.
In clinical trials with zoledronic acid, patients with serum creatinine > 265 µmol/l or > 3.0 mg/dl were excluded. 
Bolesnici s vrijednošću kreatinina u serumu > 265 μmol/l ili > 3,0 mg/dl bili su isključeni iz kliničkih ispitivanja sa zoledronatnom kiselinom.
Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V. 
Nakon dobivanja odobrenja lijeka, važno je prijavljivanje sumnji na njegove nuspojave.Time se omogućuje kontinuirano praćenje omjera koristi i rizika lijeka.Od zdravstvenih djelatnika se traži da prijave svaku sumnju na nuspojavu lijeka putem nacionalnog sustava prijave nuspojava navedenog u Dodatku V.
In post-marketing experience, severe and occasionally incapacitating bone, joint, and/or muscle pain have been reported in patients taking zoledronic acid. 
U razdoblju nakon stavljanja lijeka u promet, u bolesnika koji su uzimali zoledronatnu kiselinu zabilježeni su jaki i ponekad onesposobljavajući bolovi u kostima, zglobovima i/ili mišićima.
you will be given one infusion of Zoledronic Acid Accord every three to four weeks. 
• Ako se liječite radi sprječavanja koštanih komplikacija izazvanih metastazama, dobivat ćete jednu infuziju Zoledronatne kiseline Accord svaka tri do četiri tjedna.
• Severe bone, joint and/or muscle pain, occasionally incapacitating. 
• jaki, ponekad onesposobljavajući bolovi u kostima, zglobovima i/ili mišićima.
Common: 
Serija:
Muscle spasms, osteonecrosis of the jaw 
mišićni spazmi, osteonekroza čeljusti
In clinical trials 69 patients who relapsed or were refractory to initial treatment (zoledronic acid 4 mg, 8 mg or pamidronate 90 mg) were retreated with 8 mg zoledronic acid. 
(zoledronatna kiselina u dozi od 4 mg, 8 mg ili pamidronat u dozi od 90 mg) bilo liječeno zoledronatnom kiselinom u dozi od 8 mg.
How much Zoledronic Acid Accord is given 
Koliko se Zoledronatne kiseline Accord daje
Contact your doctor if you experience pain, weakness or discomfort in your thigh, hip or groin as this may be an early indication of a possible fracture of the thigh bone. 
odmah se javite liječniku, jer to mogu biti rani znakovi mogućeg prijeloma bedrene kosti.
dysgeusia, 
bradikardija,
Placebo zoledronic acid 4 mg 
Placebo Zoledronatna kiselina
How Zoledronic Acid Accord is given 
Kako se daje Zoledronatna kiselina Accord
How to store Zoledronic Acid Accord 
Kako primjenjivati Zoledronatnu kiselinu Accord
Zoledronic acid does not inhibit human P450 enzymes in vitro, shows no biotransformation and in animal studies < 3% of the administered dose was recovered in the faeces, suggesting no relevant role of liver function in the pharmacokinetics of zoledronic acid. 
< 3% primijenjene doze otkrilo se u izmetu, što pokazuje da funkcija jetre nema važnu ulogu u farmakokinetici zoledronatne kiseline.
Hypocalcaemia has been reported in patients treated with zoledronic acid. 
U bolesnika koji su liječeni zoledronatnom kiselinom zabilježena je hipokalcemija.
Dizziness, 
I DOHVATA
NA-Not Applicable 
NP Nije primjenjivo.
Tachycardia 
tahikardija
One vial contains 4 mg of zoledronic acid (as monohydrate). 
Jedan ml koncentrata sadrži 0,8 mg zoledronatne kiseline (u obliku hidrata).
Renal impairment TIH: 
ROK VALJANOSTI Rok valjanosti:
How Zoledronic Acid Accord is used 4. 
Kako primjenjivati Zoledronatnu kiselinu Accord 4. Moguće nuspojave
Zoledronic Acid Accord 4 mg/5 ml concentrate for solution for infusion Zoledronic acid 
Zoledronatna kiselina Accord 4 mg/5 ml sterilni koncentrat zoledronatna kiselina i.v. primjena nakon razrjeđenja
Serum calcium should be measured and hypocalcaemia must be corrected before initiating Zoledronic Acid Accord therapy. 
Prije uvođenja terapije Zoledronatnom kiselinom Accord potrebno je odrediti razinu kalcija u serumu i korigirati hipokalcemiju.
Read the package leaflet before use. 
5. NAČIN I PUT(EVI) PRIMJENE LIJEKA Prije uporabe pročitajte Uputu o lijeku.
If you are pregnant, think you may be pregnant or are planning to have a baby, tell your doctor straight away. 
Ako ste trudni, mislite da biste mogli biti trudni ili planirate imati dijete, odmah se obratite svom liječniku.
Possible side effects Rare (may affect up to 1 in 1,000 people): 
Rijetke (mogu se pojaviti u do 1 na 1000 osoba):
What you need to know before you take [Product name] Pregnancy 
Što morate znati prije nego počnete uzimati [naziv lijeka] Trudnoća
Adopted at the 11-14 June 2019 PRAC 
Usvojeno na sjednici PRAC-a 11.-14. lipnja 2019.
Please see Section 4.4 “Interference with laboratory testing”. 
Vidjeti dio 4.4. „Interferencija s laboratorijskim ispitivanjima”.
Interference with laboratory testing 
Interferencija s laboratorijskim ispitivanjima
Results should be interpreted in conjunction with clinical findings 
Rezultate je potrebno tumačiti zajedno s kliničkim nalazima
You may need treatment with [Product name] during pregnancy if the potential benefit outweighs the potential risk to you and your unborn baby. 
Možda ćete trebati liječenje s [naziv lijeka] tijekom trudnoće ako je potencijalna korist veća od potencijalnog rizika za vas i vaše nerođeno dijete.
Animal studies are insufficient with respect to reproductive toxicity. 
Ispitivanja na životinjama su nedostatna u pogledu reproduktivne toksičnosti.
Rare: Exfoliative dermatitis 2) 2) Cases were reported in patients with psoriasis diagnosis 
Eksfolijativni dermatitis 2) 2) Prijavljeni su slučajevi u bolesnika s dijagnosticiranom psorijazom
Caution should be exercised in the interpretation of these laboratory results in patients who are receiving sulfasalazine. 
Potrebno je pažljivo tumačiti te laboratorijske rezultate u bolesnika koji primaju sulfasalazin.
Tell your doctor, or seek medical attention immediately if you have the following side effects: Frequency not known (cannot be estimated from the available data): - Inflammation of the eye (uveitis) with symptoms such as eye redness, pain, sensitivity to light, runny eyes, seeing small dots or getting blurred vision 
Obavijestite svojeg liječnika ili odmah potražite medicinsku pomoć ako se pojave sljedeće nuspojave: Učestalost nepoznata (ne može se procijeniti iz dostupnih podataka): - Upala oka (uveitis) sa simptomima kao što su crvenilo oka, bol, osjetljivost na svjetlost, suzne oči, točkice u vidnom polju ili zamagljen vid
Examples of such assays may include urea, ammonia, LDH, α-HBDH and glucose. 
Primjeri takvih testova mogu uključivati ureu, amonijak, LDH, α-HBDH i glukozu.
• redness and shedding of skin over a larger area of the body, which may be itchy or painful (exfoliative dermatitis) 
• crvenilo i ljuštenje kože na većem dijelu tijela, koje može biti popraćeno svrbežom ili bolom (eksfolijativni dermatitis)
What you need to know before you take sulfasalazine Tell your doctor if you are taking or have recently taken [Product name], or any other sulfasalazine containing products, because they may affect results of blood and urine tests. 
Što morate znati prije nego počnete uzimati sulfasalazin Obavijestite svojeg liječnika ako uzimate ili ste nedavno uzeli [naziv lijeka] ili bilo koji drugi lijek koji sadrži sulfasalazin jer oni mogu utjecati na rezultate krvnih pretraga i testova mokraće.
Women of childbearing potential should be informed about the potential risks of propylthiouracil use during pregnancy. 
Žene reproduktivne dobi potrebno je obavijestiti o potencijalnim rizicima uporabe propiltiouracila tijekom trudnoće.
Epidemiological studies provide conflicting results regarding the risk of congenital malformations. 
Epidemiološka ispitivanja ne pružaju nedvojbene rezultate u pogledu rizika od kongenitalnih malformacija.
It is possible that alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatine kinase-muscle/brain (CK-MB), glutamate dehydrogenase (GLDH), or thyroxine may also show interference when sulfasalazine treatment is given at high doses. 
Moguće je da alanin aminotransferaza (ALT), aspartat aminotransferaza (AST), kreatin-kinaza mišića/mozga (CK-MB), glutamat dehidrogenaza (GLDH) ili tiroksin također pokažu interferenciju ako se liječenje sulfasalazinom primijeni u velikim dozama.
Special warnings and precautions for use […] Overdose can unmask existing Brugada syndrome. 
Posebna upozorenja i mjere opreza pri uporabi […] Predoziranjem se može otkriti postojeći Brugada sindrom.
Sulfasalazine or its metabolites may interfere with ultraviolet absorbance, particularly at 340 nm, and may cause interference with some laboratory assays that use NAD(H) or NADP(H) to measure ultraviolet absorbance around that wavelength. 
Sulfasalazin ili njegovi metaboliti mogu interferirati s ultraljubičastom apsorbancijom, posebice pri 340 nm, te mogu uzrokovati interferenciju s nekim laboratorijskim testovima koji za mjerenje ultraljubičaste apsorbancije oko te valne duljine primjenjuju NAD(H) ili NADP(H).
Frequency not known: uveitis 
Učestalost nepoznata: uveitis
The potential of [Product name] to cause harm to an unborn baby is uncertain. 
Nije utvrđena mogućnost da [naziv lijeka] može naštetiti nerođenom djetetu.
Consult with the testing laboratory regarding the methodology used. 
Obratite se laboratoriju koji je proveo ispitivanje radi primijenjene metodologije.
If propylthiouracil is used during pregnancy, close maternal, foetal and neonatal monitoring is recommended. 
Ako se propiltiouracil primjenjuje tijekom trudnoće, preporučuje se pomno praćenje majke, fetusa i novorođenčeta.
Frequency ‘not known': Drug reaction with eosinophilia and systemic symptoms (DRESS) 
Učestalost „nepoznata”: reakcija na lijek s eozinofilijom i sistemskim simptomima (DRESS)
Loperamide - Brugada syndrome in the context of abuse with loperamide (EPITT no 19379) 
Loperamid - Brugada sindrom u kontekstu zlouporabe loperamida (EPITT br. 19379)
Propylthiouracil should be administered during pregnancy at the lowest effective dose without additional administration of thyroid hormones. 
Propiltiouracil je tijekom trudnoće potrebno primijeniti u najmanjoj učinkovitoj dozi bez dodatne primjene hormona štitnjače.
[…] Overdose can unmask existing Brugada syndrome. 
Predoziranje […] Predoziranjem se može otkriti postojeći Brugada sindrom.
Individual benefit/risk assessment is necessary before treatment with propylthiouracil during pregnancy. 
Pojedinačna procjena omjera koristi i rizika nužna je prije liječenja propiltiouracilom tijekom trudnoće.
Sulfasalazine - Interference with dihydronicotinamideadenine dinucleotide / dihydronicotinamide-adenine dinucleotide phosphate (NADH/NADP) reaction assays (EPITT no 19351) 
Sulfasalazin - interferencija s testom reakcije dihidronikotinamid-adenin dinukleotida / dihidronikotinamidadenin dinukleotid fosfata (NADH/NADP) (EPITT br. 19351)
Topiramate - Uveitis (EPITT no 19345) 
Topiramat - uveitis (EPITT br. 19345)
Fertility, pregnancy and lactation Women of childbearing potential 
4.6. Plodnost, trudnoća i dojenje
Temozolomide - Drug reaction with eosinophilia and systemic symptoms (DRESS) (EPITT no 19332) 
Temozolomid - reakcija na lijek s eozinofilijom i sistemskim simptomima (DRESS) (EPITT br. 19332)
Rivaroxaban - Premature ending of the GALILEO study in patients who have received an artificial heart valve through a transcatheter aortic valve replacement (TAVR) (EPITT no 
Rivaroksaban - prerani završetak ispitivanja GALILEO u bolesnika koji su primili umjetni srčani zalistak transkateterskom zamjenom aortnog zaliska (TAVR) (EPITT br. 19294)
Secukinumab - Dermatitis exfoliative generalised (EPITT no 19354) 
Sekukinumab - generalizirani eksfolijativni dermatitis (EPITT br. 19354)
Undesirable effects Eye disorders 
Poremećaji oka
Overdose 
Nuspojave
Propylthiouracil - Risk of congenital anomalies (EPITT no 
Propiltiouracil - rizik od kongenitalnih anomalija (EPITT br. 19358)
Propylthiouracil is able to cross the human placenta. 
Propiltiouracil može proći kroz posteljicu u ljudi.
EU/1/08/453/002 
EU/1/08/453/002 Prepandrix 3,75 µg HA
2.5 ml (suspension) 2.5 ml (emulsion) 
2,5 ml (suspenzija) 2,5 ml (emulzija)
After mixing, 1 dose (0.5 ml) contains: Split influenza virus inactivated, containing antigen equivalent to: A/Indonesia/05/2005 (H5N1) like strain used (PR8-IBCDC-RG2) 
Virus influence (fragmentiran, inaktiviran), sadrži antigene* koji odgovaraju soju: A/Indonesia/05/2005 (H5N1) poput kojeg je korišten soj (PR8-IBCDC-RG2)
50 vials (suspension) 2 x 25 vials (emulsion) 
50 bočica (suspenzija) 2 x 25 bočica (emulzija)
3.75 micrograms propagated in eggs ** haemagglutinin 
* umnoženi na jajima ** hemaglutinin
Prepandrix 3.75 µg HA1 Suspension and Emulsion for emulsion for injection 
Suspenzija i emulzija za emulziju za injekciju
Invented name 
ime
Packaging 
Primarno pakiranje
Intramuscular use suspension (H5N1): vial (glass) emulsion (adjuvant): vial (glass) 
U mišić suspenzija (H5N1):
Annex I List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, marketing authorisation holders in the Member States 
Dodatak I Popis naziva, farmaceutskih oblika, jačina lijekova, putova primjene,
Hungary 
Madžarska
0.005 % w/w estradiol / 0.4 % w/w prednisolone containing medicinal products for topical use Member 
Lijekovi koji sadrže 0,005 % w/w estradiola/0,4 % w/w prednizolona za topikalnu primjenu Država članica (u EGP)
0.01 % w/w estradiol containing medicinal products for topical use Member 
Lijekovi koji sadrže 0,01 % w/w estradiola za topikalnu primjenu Država članica (u EGP)
Vaginal cream Vaginal use, topical use 
Krema za rodnicu U rodnicu, Topikalna primjena
Vaginal emulsion Cutaneous use, vaginal use 
Emulzija za rodnicu
Tafinlar is available as capsules (50 and 75 mg). 
Tafinlar je dostupan kao kapsula (50 i 75 mg).
It is used for the treatment of: 
Upotrebljava se i za liječenje:
Further information on Tafinlar can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. 
Više informacija o lijeku Tafinlar nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The main measure of effectiveness was the percentage of patients who responded completely or partially to treatment. 
Glavno mjerilo djelotvornosti bio je postotak bolesnika koji su potpuno ili djelomično reagirali na liječenje.
Treatment may need to be interrupted or stopped, or the dose reduced, if certain side effects occur. 
Možda će biti potrebno prekinuti ili obustaviti liječenje te smanjiti dozu ako se razviju određene nuspojave.
Other information about Tafinlar 
Ostale informacije o lijeku Tafinlar
It is used in combination with trametinib. 
Primjenjuje se samo u kombinaciji s trametinibom.
What measures are being taken to ensure the safe and effective use of Tafinlar? 
Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Tafinlar?
Tafinlar received a marketing authorisation valid throughout the EU on 26 August 2013. 
Lijek Tafinlar dobio je odobrenje za stavljanje u promet koje je na snazi u Europskoj uniji od 26. kolovoza 2013.
Some 40% of patients treated with the combination either died or had their disease come back after an average of about 3.5 years compared with 59% of patients receiving placebo. 
Približno 40 % bolesnika koji su primali kombinaciju lijekova umrlo je ili im se bolest vratila u prosjeku nakon 3,5 godina u usporedbi s 59 % bolesnika koji su primali placebo.
The dose of Tafinlar either used alone or in combination with trametinib is 150 mg twice a day taken on an empty stomach (at least 1 hour before or 2 hours after a meal). 
Doza lijeka Tafinlar koja se primjenjuje samostalno ili u kombinaciji s trametinibom je 150 mg dvaput dnevno na prazan želudac (barem 1 sat prije ili 2 sata nakon obroka).
By blocking the action of the abnormal BRAF, Tafinlar helps to slow down the growth and spread of the cancer. 
Blokiranjem djelovanja abnormalnog BRAF-a, Tafinlar pomaže usporiti rast i širenje raka.
What is Tafinlar and what is it used for? 
Što je Tafinlar i za što se primjenjuje?
An overview of Tafinlar and why it is authorised in the EU 
Pregled informacija o lijeku Tafinlar i zašto je odobren u EU-u
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Tafinlar have been included in the summary of product characteristics and the package leaflet. 
Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Tafinlar nalaze se u sažetku opisa svojstava i u uputi o lijeku.
Treatment with Tafinlar must be started and supervised by a doctor experienced in the use of cancer medicines. 
Liječenje lijekom Tafinlar mora započeti i nadzirati liječnik s iskustvom u primjeni lijekova protiv raka.