FrancophonIA/ELRC3.0 huggingface dataset:
English: Servier Pharma, d. o. o. Tel.: +385 (0)1 3016 222
Croatian: Tel.: +385 (0)1 3016 222
English: Lonsurf 15 mg/6.14 mg film-coated tablets Hypromellose
Croatian: Lonsurf 15 mg/ 6,14 mg filmom obložene tablete Hipromeloza
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 15 mg trifluridine and 6.14 mg of tipiracil (as hydrochloride).
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Jedna filmom obložena tableta sadrži 15 mg trifluridina i 6,14 mg tipiracila (u obliku tipiracilklorida).
English: • mouth pain or problems
Croatian: • bol ili poteškoće u ustima
English: Pyrexia
Croatian: Kseroza
English: NAME OF THE MEDICINAL PRODUCT Lonsurf 20 mg/8.19 mg film-coated tablets trifluridine/tipiracil
Croatian: NAZIV LIJEKA Lonsurf 20 mg/8,10 mg filmom obložene tablete trifluridin/tipiracil
English: 15 mg/6.14 mg 20 mg/8.19 mg
Croatian: 20 mg/8,19
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 20 mg trifluridine and 8.19 mg of tipiracil (as hydrochloride).
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Jedna filmom obložena tableta sadrži 20 mg trifluridina i 8,19 mg tipiracila (u obliku tipiracilklorida).
English: Pancytopenia Granulocytopenia Monocytopenia Erythropenia Leukocytosis Monocytosis
Croatian: Monocitopenija Eritropenija
English: Abdominal pain Constipation Stomatitis Oral disorder
Croatian: Bolovi u abdomenu Konstipacija Stomatitis
English: After oral administration of Lonsurf with [14C]-tipiracil hydrochloride, at least 27% of the administered tipiracil hydrochloride was absorbed and 50% of the total radioactivity dose measured into faeces, suggestive of moderate gastrointestinal absorption of tipiracil hydrochloride.
Croatian: Nakon peroralne primjene Lonsurfa s [14C]tipiracilkloridom, najmanje je 27% primjenjenog tipiracilklorida apsorbirano i 50% ukupne
English: Gastric cancer
Croatian: Karcinom želuca
English: • bloating, passing gas, indigestion
Croatian: • nadutost, vjetrovi, probavne smetnje
English: • swelling or pain in your joints or big toes
Croatian: • oticanje ili bol u zglobovima ili palcima
English: Lonsurf 20 mg/8.19 mg film-coated tablets
Croatian: Lonsurf 20 mg/8,19 filmom obložene tablete
English: • Severe renal impairment (CrCl below 30 mL/min) or end stage renal disease Administration is not recommended in patients with severe renal impairment or end stage renal disease as there are no data available for these patients (see section 4.4).
Croatian: Primjena lijeka se ne preporučuje u bolesnika s teškim oštećenjem bubrega ili s terminalnom fazom bubrežne bolesti jer nema dostupnih podataka za ove bolesnike (vidjeti dio 4.4).
English: Marketing Authorisation Holder Les Laboratoires Servier 50 rue Carnot
Croatian: 50 rue Carnot
English: Hypokalaemia
Croatian: Anemija
English: Bone pain
Croatian: Eλλάδα
English: System Organ Class (MedDRA)a
Croatian: Servier Danmark A/S
English: NAME OF THE MEDICINAL PRODUCT Lonsurf 15 mg/6.14 mg film-coated tablets trifluridine/tipiracil
Croatian: Lonsurf 15 mg/6,14 mg filmom obložene tablete trifluridin/tipiracil
English: Servier Laboratories (Ireland) Ltd. Tel: +353 (0)1 663 8110
Croatian: Tel: +353 (0)1 663 8110
English: Activated partial thromboplastin time prolonged
Croatian: Produljeno aktivirano parcijalno tromboplastinsko vrijeme Povišena ureja u krvi Povišena laktat dehidrogenaza u krvi
English: Servier Pharma d. o. o. Tel.: +386 (0)1 563 48 11
Croatian: Tel.: +386 (0)1 563 48 11
English: 15 mg/6.14 mg 20 mg/8.19 mg Level 1 dose reduction: From 35 mg/m2 to 30 mg/m2 30 mg/m2
Croatian: Stupanj 1 smanjenja doze: Sa 35 mg/m2 na 30 mg/m2 30 mg/m2
English: Pain
Croatian: Bolovi
English: Hyperhidrosis Blister
Croatian: Dehidracija Hiperglikemija
English: Diarrhoea Nausea Vomiting
Croatian: Mučnina Povraćanje
English: Luxembourg/Luxemburg S.A. Servier Benelux N.V. Tel: +32 (0)2 529 43 11
Croatian: Slovenská republika Servier Slovensko spol. s r.o. Tel.:+421 (0) 2 5920 41 11
English: Periodontal disease Tooth disorder
Croatian: Poremećaji zubi
English: An OS analysis of the study, carried out as planned at 76% (N = 384) of events, demonstrated that Lonsurf plus BSC resulted in a statistically significant improvement in OS compared to placebo plus BSC with an hazard ratio (HR) of 0.69 (95% CI: 0.56, 0.85; 1- and 2-sided p-values were 0.0003 and 0.0006, respectively) corresponding to a 31% reduction in the risk of death in the Lonsurf group.
Croatian: Analiza ukupnog preživljenja (OS), provedena kako je planirana za 76% (N=384) događaja, pokazala je klinički i statistički značajnu korist u smislu ukupnog preživljenja kod primjene Lonsurfa uz BSC u usporedbi sa primjenom placeba uz BSC uz omjer hazarda 0,69 (95% interval pouzdanosti [CI]: 0,56;
English: Discomfort
Croatian: Neutropenija
English: Enterocolitis haemorrhagic Gastrointestinal haemorrhage Pancreatitis acute Ascites
Croatian: Enterokolitis, hemoragijski Gastrointestinalno krvarenje
English: Rash Alopecia Pruritus Dry skin
Croatian: Orofaringealna bol Epistaksa Kašalj
English: Hyponatraemia
Croatian: Hipoalbuminemija
English: Myalgia
Croatian: Leukopenija
English: Flatulence
Croatian: Proljev
English: In particular tell your doctor or pharmacist if you are taking medicines used for treatment of HIV, such as zidovudine.
Croatian: • lijekove koji se koriste za liječenje HIV-a, kao što je zidovudin.
English: Hypernatraemia
Croatian: Hiperhidroza
English: Adverse drug reactions are grouped according to their frequencies.
Croatian: Nuspojave su grupirane prema učestalosti.
English: If you experience any side effects, talk to your doctor or pharmacist.
Croatian: Ako primijetite bilo koju nuspojavu potrebno je obavijestiti liječnika ili ljekarnika.
English: Decreased appetite Hypoalbuminaemia Dehydration Hyperglycaemia
Croatian: Hipernatrijemija Hiponatrijemija Hipokalcemija
English: • ear pain
Croatian: • bol u uhu
English: Retching
Croatian: Rinoreja
English: • Lonsurf 15 mg/6.14 mg is a white, biconvex, round, film-coated tablet, printed with “15” on one side and “102” and “15 mg” on the other side in grey ink.
Croatian: • Lonsurf 15 mg/6,14 mg je bijela, bikonveksna, okrugla filmom obložena tableta, s oznakom “15”
English: Gingival bleeding Glossitis
Croatian: Leukocitoza Monocitoza
English: Servier Nederland Farma B.V. Tel: +31 (0)71 5246700
Croatian: Tel: +31 (0)71 5246700
English: Mucosal inflammation Malaise
Croatian: Upala sluznice Malaksalost
English: Electrocardiogram QT prolonged
Croatian: Povišeni kreatinin u krvi Produljeni QT na elektrokardiogramu Povišen INR
English: Thrombocytopenia
Croatian: Granulocitopenija
English: Cough
Croatian: mg
English: Posology
Croatian: Plikovi
English: Patients were followed up for 3 years and could be given repeat treatment if appropriate.
Croatian: Bolesnike se pratilo 3 godine i po potrebi su mogli primiti ponovljeno liječenje.
English: In addition, injections do not need to be given frequently because the implant stays in the eye for several months.
Croatian: Osim toga, injekcije se ne moraju davati često jer implantat ostaje u oku nekoliko mjeseci.
English: • blockage of the veins carrying blood from the back of the eye;
Croatian: • začepljenjem vena koje prenose krv iz stražnjeg dijela oka;
English: Further information on Ozurdex can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/ozurdex.
Croatian: Više informacija o lijeku Ozurdex dostupno je na internetskim stranicama Agencije: ema.europa.eu/medicines/human/EPAR/ozurdex.
English: The bleeding is thought to be caused by the injection procedure and not by the medicine itself.
Croatian: Smatra se da je krvarenje uzrokovano postupkom ubrizgavanja, a ne lijekom.
English: Further treatments can be given if the patient's condition improves but then gets worse and if the doctor believes that the patient will benefit from further treatment.
Croatian: Lijek se može primijeniti ponovno ako se stanje bolesnika poboljša i nakon toga opet pogorša te ako liječnik vjeruje da će bolesnik od toga imati koristi.
English: Ozurdex received a marketing authorisation valid throughout the European Union on 27 July 2010.
Croatian: Lijek Ozurdex dobio je odobrenje za stavljanje u promet koje je na snazi u EU-u od 27. srpnja 2010.
English: The implant is made of a material that dissolves over several months while gradually releasing the dexamethasone.
Croatian: Implantat je izrađen od materijala koji se razgrađuje tijekom nekoliko mjeseci i pri tome postupno otpušta deksametazon.
English: • damage to blood vessels caused by diabetes in patients who have an artificial lens in their eye or in whom other treatment did not work or was unsuitable.
Croatian: • oštećenjem krvnih žila uzrokovanim dijabetesom u bolesnika koji imaju umjetnu leću u oku ili kod kojih druga terapija nije djelovala ili nije bila prikladna.
English: What measures are being taken to ensure the safe and effective use of Ozurdex?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Ozurdex?
English: Ozurdex (dexamethasone)
Croatian: Ozurdex (deksametazon)
English: Side effects reported with Ozurdex are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Ozurdex pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: Each implant is in an applicator and contains 700 micrograms of the active substance, dexamethasone.
Croatian: Svaki se implantat isporučuje s aplikatorom i sadrži 700 mikrograma djelatne tvari, deksametazona.
English: It is used to treat adults with impaired vision due to macular oedema associated with:
Croatian: Koristi se za liječenje odraslih osoba s oštećenjem vida zbog makularnog edema povezanog sa:
English: This ensures that adequate amounts of dexamethasone reach the area inside the eye where the inflammation in macular oedema and uveitis occurs.
Croatian: Time se osigurava da će dostatne količine deksametazona doprijeti do područja unutar oka gdje se odvijaju upala u makularnom edemu i uveitis.
English: What is Ozurdex and what is it used for?
Croatian: Što je Ozurdex i za što se koristi?
English: The active substance in Ozurdex, dexamethasone, belongs to a group of anti-inflammatory medicines known as corticosteroids.
Croatian: Djelatna tvar u lijeku Ozurdex, deksametazon, pripada skupini protuupalnih lijekova poznatih kao kortikosteroidi.
English: Eyesight was measured using the ‘best corrected visual acuity' (BCVA) indicating how well a person can see (after they have been given corrective lenses).
Croatian: Vid se mjerio uz pomoć najbolje korigirane oštrine vida (BCVA) kojom se utvrđuje koliko dobro osoba vidi (nakon što je dobila korektivne leće).
English: In addition, the company that makes Ozurdex will ensure that patients are provided an information pack, including a booklet and an audio CD.
Croatian: Nadalje, tvrtka koja proizvodi lijek Ozurdex osigurat će informativni paket za bolesnike koji će sadržavati brošuru i CD sa zvučnim zapisom.
English: Other information about Ozurdex
Croatian: Ostale informacije o lijeku Ozurdex
English: Ozurdex injection causes only minor trauma to the eyeball and the increase in intraocular pressure is considered to be manageable.
Croatian: Injekcija lijeka Ozurdex uzrokuje samo manju traumu očne jabučice i smatra se da je povišenje intraokularnog tlaka moguće kontrolirati.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Ozurdex have been included in the summary of product characteristics and the package leaflet.
Croatian: Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Ozurdex nalaze se u sažetku opisa svojstava i u uputi o lijeku.
English: An overview of Ozurdex and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Ozurdex i zašto je odobren u EU-u
English: Ozurdex is an implant that is injected into the eye.
Croatian: Ozurdex je implantat koji se ubrizgava u oko.
English: As for all medicines, data on the use of Ozurdex are continuously monitored.
Croatian: Kao i za sve lijekove, podatci o primjeni lijeka Ozurdex kontinuirano se prate.
English: Macular oedema is swelling in the macula, the central part of the retina (the light-sensing layer at the back of the eye), which can reduce the central part of a person's vision and affect tasks such as reading and driving.
Croatian: Makularni edem je oticanje makule, središnjeg dijela mrežnice (sloja stražnjeg dijela oka osjetljivog na svjetlost), koje može pogoršati središnji vid osobe i utjecati na radnje poput čitanja i upravljanja vozilom.
English: However, in those with an artificial lens in the affected eye or who previously have not responded to or are unsuitable for other non-corticosteroid treatments, the benefits of Ozurdex were considered to outweigh the risks.
Croatian: Međutim, smatra se da u bolesnika s umjetnom lećom u oboljelom oku ili u onih koji prethodno nisu reagirali na druge nekortikosteroidne lijekove ili ti lijekovi za njih nisu prikladni, koristi od lijeka Ozurdex nadmašuju s njima povezane rizike.
English: Patients whose vision gets better and stays better should not receive any more implants.
Croatian: Bolesnicima kod kojih se poboljšanje vida pojavi i zadrži ne bi trebalo ubrizgavati nove implantate.
English: Because dexamethasone is a well-known anti-inflammatory medicine, the company presented studies from the published literature where Ozurdex was compared with a ‘sham' treatment (where an applicator was pressed against their eye but nothing was actually injected).
Croatian: Budući da je deksametazon dobro poznat protuupalni lijek, tvrtka je predočila ispitivanja iz objavljene literature u kojima je lijek Ozurdex uspoređivan s fiktivnim liječenjem (kod kojeg se aplikator pritisne na oko, ali se ništa ne ubrizgava).
English: For more information about using Ozurdex, see the package leaflet or contact your doctor or pharmacist.
Croatian: Za više informacija o primjeni lijeka Ozurdex pročitajte uputu o lijeku odnosno obratite se liječniku ili ljekarniku.
English: Ozurdex must not be used in patients who have or are thought to have ocular or periocular infections (infections in or around the eyes) and in patients with advanced glaucoma (damage to the nerve of the eye usually caused by high pressure inside the eye) that is not adequately controlled with medicines alone.
Croatian: Lijek Ozurdex ne smije se primjenjivati u bolesnika koji imaju ili postoji sumnja da imaju okularne ili periokularne upale (upale u očima ili oko njih) i bolesnika s uznapredovalim glaukomom (oštećenjem živca oka obično uzrokovano visokim tlakom unutar oka) koji se na odgovarajući način ne može kontrolirati samo lijekovima.
English: The most common side effects with Ozurdex (which may affect more than 1 in 10 people) are increased intraocular pressure (the pressure inside the eye), conjunctival haemorrhage (bleeding from the membrane over the white of the eye) and cataract (clouding of the lens - in patients with uveitis and with diabetes).
Croatian: Najčešće nuspojave lijeka Ozurdex (koje se mogu javiti u više od 1 na 10 osoba) jesu povišen intraokularni tlak (tlak unutar oka), konjunktivno krvarenje (krvarenje iz opne koja obavija bjeloočnicu) i katarakta (zamućenje leće - u bolesnika s uveitisom i dijabetesom).
English: Why is Ozurdex authorised in the EU?
Croatian: Zašto je lijek Ozurdex odobren u EU-u?
English: It must also not be used in certain cases where the back of the membrane that surrounds the lens (the lens capsule) is torn.
Croatian: Ne smije se primjenjivati ni u određenim slučajevima kada je stražnji dio opne koja okružuje leću oštećen.
English: In two main studies involving a total of 1,267 adults Ozurdex was more effective than the sham treatment at improving patients' eyesight.
Croatian: U dvama glavnim ispitivanjima koja su obuhvatila 1 267 odraslih osoba lijek Ozurdex bio je djelotvorniji od fiktivnog liječenja kada je riječ o poboljšanju vida u bolesnika.
English: What are the risks associated with Ozurdex?
Croatian: Koji su rizici povezani s lijekom Ozurdex?
English: Therefore the use of Ozurdex in patients with macular oedema related to diabetes was restricted to these two groups.
Croatian: Stoga je primjena lijeka Ozurdex u bolesnika s makularnim edemom povezanim s dijabetesom ograničena na te dvije skupine.
English: In the second study, the figures were around 22% for Ozurdex after 90 days and 12% for the sham treatment.
Croatian: U drugom ispitivanju rezultati su bili oko 22 % za Ozurdex i 12 % za fiktivno liječenje nakon 90 dana.
English: It works by entering cells and blocking the production of vascular endothelial growth factor (VEGF) and prostaglandins, substances that are involved in inflammation.
Croatian: Djeluje tako što ulazi u stanice i inhibira ekspresiju vaskularnog endotelnog čimbenika rasta (VEGF) i lučenje prostaglandina, tvari koje sudjeluju u upali.
English: The European Medicines Agency decided that Ozurdex's benefits are greater than its risks in patients with uveitis or macular oedema related to blocked veins, and it can be authorised for use in the EU.
Croatian: Europska agencija za lijekove zaključila je da koristi od lijeka Ozurdex nadmašuju s njim povezane rizike u bolesnika s uveitisom ili makularnim edemom povezanim sa začepljenim venama, te da lijek može biti odobren za primjenu u EU-u.
English: Patients whose vision is getting worse and is not improved by Ozurdex should also not receive any more implants.
Croatian: Ni bolesnici čiji se vid pogoršava i nema poboljšanja nakon terapije lijekom Ozurdex ne smiju primati nove implantate.
English: Ozurdex was more effective than sham treatment at reducing inflammation in patients with uveitis measured by an improvement in patients' vitreous haze score which gives an indication of inflammation, with zero indicating no inflammation.
Croatian: Lijek Ozurdex bio je djelotvorniji od fiktivnog liječenja kada je riječ o smanjenju upale u bolesnika s uveitisom, izmjereno poboljšanjem rezultata u pogledu zamućenosti staklastog tijela što je naznaka upale, pri čemu nula naznačuje izostanak upale.
English: Macular oedema related to diabetes
Croatian: Makularni edem povezan s dijabetesom
English: Two main studies involving 1,048 patients compared the effects of a 700 microgram or a 350 microgram implant of Ozurdex.
Croatian: U dvama glavnim ispitivanjima koja su obuhvaćala 1 048 bolesnika uspoređivali su se učinci implantata lijeka Ozurdex od 700 mikrograma i 350 mikrograma.
English: How does Ozurdex work?
Croatian: Kako djeluje Ozurdex?
English: In the first study, around 23% of the patients receiving Ozurdex had increased BCVA of at least 15 letters after 180 days compared with 17% of the patients receiving the sham treatment.
Croatian: U prvom ispitivanju oko 23 % bolesnika koji su primali lijek Ozurdex imalo je povećanje vrijednosti BCVA-a od najmanje 15 slova nakon 180 dana u usporedbi sa 17 % bolesnika koji su primili fiktivno liječenje.
English: In the overall group of patients with macular oedema related to diabetes the Agency noted that the benefit was modest and was outweighed by the risks, including the development of cataracts.
Croatian: Agencija je utvrdila da su koristi u cjelokupnoj skupini bolesnika s makularnim edemom povezanim s dijabetesom skromne te da ih nadmašuju rizici, uključujući razvoj katarakti.
English: Macular oedema related to blocked veins of the retina
Croatian: Makularni edem povezan sa začepljenim venama mrežnice
English: In one main study involving 229 adults with uveitis, 8 weeks after injection, around 47% of patients treated with 700 micrograms of Ozurdex achieved a vitreous haze score of zero, compared with 36% of patients treated with 350 micrograms of Ozurdex and 12% of patients who received the sham treatment.
Croatian: U jednom glavnom ispitivanju koje je obuhvaćalo 229 odraslih osoba s uveitisom oko 47 % bolesnika koji su primili 700 mikrograma lijeka Ouzurdex imalo je osmog tjedna nakon primjene injekcije nulti stupanj zamućenja staklastog tijela u usporedbi s 36 % bolesnika koji su primili 350 mikrograma lijeka Ozurdex i 12 % bolesnika koji su primili fiktivno liječenje.
English: Ozurdex can only be obtained with a prescription and must be given by an ophthalmologist (eye specialist) who has experience in giving intravitreal injections (injections into the vitreous humour, the jelly-like fluid in the eye).
Croatian: Lijek Ozurdex izdaje se samo na recept i smije ga primjenjivati samo oftalmolog (specijalist za oči) s iskustvom u intravitrealnom injiciranju lijekova (injekcija u staklasto tijelo, želatinastu tekućinu u oku).
English: Ozurdex implants are injected directly into the vitreous humour of the eye.
Croatian: Implantati lijeka Ozurdex ubrizgavaju se izravno u staklasto tijelo oka.
English: In patients in whom other types of treatment had not worked or were unsuitable, there was an average improvement in BCVA over both studies of 3.2 letters after Ozurdex 700 micrograms, compared with 1.5 letters after sham treatment.
Croatian: U bolesnika kod kojih druge vrste liječenja nisu djelovale ili nisu bile prikladne dogodilo se prosječno poboljšanje u pogledu vrijednosti BCVA-a u obama ispitivanjima, i to 3,2 slova nakon primanja lijeka Ozurdex od 700 mikrograma u usporedbi s 1,5 slova nakon fiktivnog liječenja.
English: Ozurdex is also used to treat adults with non-infectious uveitis at the back of the eye. Uveitis is inflammation of the uvea, the middle layer of the eye.
Croatian: Ozurdex se koristi i za liječenje odraslih osoba s neinfekcijskim uveitisom u stražnjem dijelu oka.
English: What benefits of Ozurdex have been shown in studies?
Croatian: Koje su koristi lijeka Ozurdex utvrđene u ispitivanjima?
English: In patients whose lens had already been surgically replaced, there was an average improvement in BCVA over both studies of 6.5 letters after Ozurdex 700 micrograms, compared with 1.7 letters after sham treatment.
Croatian: U bolesnika čije su leće prethodno kirurški zamijenjene dogodilo se prosječno poboljšanje u pogledu BCVA-a u obama ispitivanjima, i to 6,5 slova nakon primanja lijeka Ozurdex od 700 mikrograma u usporedbi s 1,7 slova nakon fiktivnog liječenja.
English: Patients receive one Ozurdex implant at a time, injected directly into the vitreous humour.
Croatian: Bolesnicima se daje jedan po jedan implantat lijeka Ozurdex ubrizgavanjem izravno u staklasto tijelo.
English: For the full list of restrictions with Ozurdex, see the package leaflet.
Croatian: Potpuni popis ograničenja povezanih s primjenom lijeka Ozurdex potražite u uputi o lijeku.
English: For the full list of side effects of Ozurdex, see the package leaflet.
Croatian: Potpuni popis nuspojava povezanih s lijekom Ozurdex potražite u uputi o lijeku.
English: HR=High Risk.
Croatian: HR=visoki rizik.
English: Some of these reactions have been severe.
Croatian: Neke od tih reakcija bile su teške.
English: CI=Confidence Interval.
Croatian: CI=interval pouzdanosti.
English: Allergic reactions have been reported.
Croatian: Prijavljene su alergijske reakcije.
English: Please speak to your doctor for more information.
Croatian: Obratite se liječniku za dodatne informacije.
English: First injection: at chosen date
Croatian: Prva injekcija: na odabrani datum
English: Paediatric population (children <9 years of age)
Croatian: Pedijatrijska populacija (djeca <9 godina)
English: Number of cases*
Croatian: n Broj slučajeva*
English: Evidence of anamnestic (Immune Memory) response
Croatian: Dokazi anamnestičkog odgovora (imunološkog pamćenja)
English: Tell your doctor or pharmacist if you or your child is taking, has recently taken or might take any other medicines, including medicines obtained without a prescription.
Croatian: Obavijestite svog liječnika ili ljekarnika ako Vi ili Vaše dijete uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove, uključujući i one koje ste nabavili bez recepta.
English: In this study, a durable protection was statistically demonstrated to approximately 10 years.
Croatian: U ovom je ispitivanju statistički dokazana zaštita u trajanju od približno 10 godina.
English: Long-term effectiveness studies
Croatian: Ispitivanja dugotrajne učinkovitosti