natgillin/translations-raw huggingface dataset:
Multi-dose container composed of two extruded parts, one external white polypropylene rigid tube and one internal (ethylene-methacrylic acid)-zinc copolymer (Surlyn) flexible pouch containing a steel ball, closed with a 1 ml dosing airless pump equipped with a flexible atraumatic cannula and covered by a plastic cap.
Fleksibilna vrećica sadržava čeličnu kuglicu i zatvorena je s 1mL-skom dozacijskom bezzračnom pumpicom, koja je opremljena atraumatskom kanilon na čijem vrhu je plastična kapica.
Miconazole as nitrate
Mikonazol (u obliku nitrata)
Use of the veterinary medicinal product should be based on identification of infecting organisms and susceptibility testing and take into account official and local antimicrobial policies.
U obzir treba uzeti i službenu i lokalnu antimikrobnu strategiju.
A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturer responsible for batch release VIRBAC
ZA PROIZVODNJU ODGOVORAN(I) ZA PUŠTANJE SERIJE U PROMET Naziv i adresa proizvođača odgovornog za otpuštanje serije u promet: VIRBAC
France VIRBAC 13ème rue - L.I.D - BP 27 06517 Carros Hrvatska VIRBAC
France VIRBAC 13ème rue - L.I.D - BP 27 06517 Carros Hrvatska VIRBAC S.A. 1ère avenue 2065 m - L.I.D 06516 Carros
23843 Bad Oldesloe Tel: 49 (4531) 805 111
Tel: 49 (4531) 805 111
Bacterial and fungal otitis is often secondary in nature and appropriate diagnosis should be used to determine the primary factors involved.
Bakterijska i gljivična upala uha je, vrlo često, sekundarna upala.
At 3 and 5 times the recommended dose, no local or general adverse reactions were observed with the exception of some dogs showing erythema and papulae in the ear canal.
Nakon primjene 3-5 puta veće doze od preporučene nisu primijećene ni lokalne ni sustavne nuspojave.
Easotic ear drops, suspension for dogs
Kapi za uho, suspenzija Bijela otopina
Shake the bottle thoroughly before first administration and prime the pump by pressing it. Introduce the atraumatic canula in the ear canal.
Dobro protresti bočicu prije prve primjene i pritiskanjem napuniti pumpu za aplikaciju.
NAME OF THE VETERINARY MEDICINAL PRODUCT
NAZIV VETERINARSKO-MEDICINSKOG PROIZVODA Easotic
Introduce the atraumatic canula in the ear canal.
4 - Uvedite atraumatsku kanilu u vanjski slušni kanal.
In very rare cases, Type-I Hypersensitivity reactions (facial swelling, allergic pruritus) have been observed.
Također, u vrlo malo slučajeva (< 0.01%) primijećena je i reakcija preosjetljivosti tipa
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
PROIZVOĐAČ(I) BIOLOŠKI DJELATNE(IH) TVARI I NOSITELJ(I) ODOBRENJA
Use of the veterinary medicinal product deviating from the instructions given in the summary of product characteristics may increase the prevalence of bacteria and fungi resistant to gentamicin and miconazole respectively and may decrease the effectiveness of treatment with aminoglycosides and azole antifungal agents, due to the potential for cross-resistance.
Ako ovaj VMP koristimo suprotno od uputa danih u ovom sažetku opisa svojstava može doći do učestalije pojave bakterija i gljivica otpornih na gentamicin i mikonazol.
The product as presented allows treating a dog suffering from bilateral otitis.
Ovaj VMP omogućava primjenu kod pasa s obostranom upalom vanjskog slušnog kanala.
6000 Kolding
6.3 Rok valjanosti
Administer one dose (1 ml) of the product in each affected ear.
Uvesti atraumatsku kanilu u vanjski slušni kanal i aplicirati jednu dozu (1 mL) u inficirano uho.
Auricular use.
Za uho.
Pre-filled syringe (glass) with needle guard
Napunjena štrcaljka (staklo) sa štitnikom za iglu
2 pre-filled pens + 2 alcohol wipes
2 napunjene olovke + 2 alkoholne maramice
2 dose-dispenser cartridges + 2 alcohol wipes
2 uloška za dozator + 2 alkoholne maramice
The study was then extended to four years.
Ispitivanje je zatim produljeno na četiri godine.
Further information on Rebif can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/rebif.
Više informacija o lijeku Rebif dostupno je na internetskim stranicama Agencije: ema.europa.eu/medicines/human/EPAR/rebif
All patients should be assessed at least once every two years.
Stanje svih bolesnika trebalo bi ocijeniti barem jednom svake dvije godine.
Other information about Rebif
Ostale informacije o lijeku Rebif
The patients had experienced at least two relapses in the previous two years.
Bolesnici su iskusili barem dva relapsa u prethodne dvije godine.
What is Rebif and what is it used for?
Što je Rebif i za što se koristi?
What measures are being taken to ensure the safe and effective use of Rebif?
Koje se mjere poduzimaju da bi se osigurala sigurna i učinkovita primjena lijeka Rebif?
A 22-microgram dose is recommended for patients who cannot tolerate the higher dose.
Doza od 22 mikrograma preporuča se bolesnicima koji ne podnose višu dozu lijeka.
Rebif (44 micrograms given once or three times a week) has also been compared with placebo in 515 patients who had experienced a single attack of demyelination.
Rebif (od 44 mikrograma primjenjivanog jednom do tri puta tjedno) također je uspoređen s placebom u 515 bolesnika koji su iskusili samo jedan napad demijelinizacije.
When first starting treatment with Rebif, the dose should be slowly increased from a starting dose of 8.8 micrograms three times a week to avoid side effects.
Na početku terapije lijekom Rebif dozu je potrebno polako povećavati s početne doze od 8,8 mikrograma tri puta tjedno kako bi se izbjegle nuspojave.
The probability of developing MS over 24 months was 62.5% for patients given Rebif three times a week and 75.5% for patients given Rebif once a week compared with 85.8% for patients given placebo.
Vjerojatnost da će se razviti MS tijekom 24 mjeseca iznosila je 62,5 % u bolesnika koji su primali Rebif tri puta tjedno i 75,5 % u bolesnika koji su primali Rebif jednom tjedno u usporedbi s 85,8 % u bolesnika koji su primali placebo.
Some effect on progression of disability could be seen, but only in the patients who had relapses in the two years before the start of the study.
Zabilježen je određeni učinak na progresiju invaliditeta, ali samo u bolesnika koji su iskusili relapse u dvije godine prije početka ispitivanja.
Rebif received a marketing authorisation valid throughout the EU on 4 May 1998.
Lijek Rebif dobio je odobrenje za stavljanje u promet koje je na snazi u EU-u od 4. svibnja 1998.
Side effects reported with Rebif are carefully evaluated and any necessary action taken to protect patients.
Nuspojave prijavljene za lijek Rebif pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
What are the risks associated with Rebif?
Koji su rizici povezani s lijekom Rebif?
The patients can inject Rebif themselves once they have been trained.
Bolesnici si mogu sami ubrizgavati Rebif nakon što prođu odgovarajuću obuku.
Rebif must not be used in patients who have severe depression or have thoughts of suicide.
Lijek Rebif ne smiju uzimati bolesnici s teškom depresijom ili osobe koje razmišljaju o samoubojstvu.
As for all medicines, data on the use of Rebif are continuously monitored.
Kao i za sve lijekove, podatci o primjeni lijeka Rebif kontinuirano se prate.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Rebif 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 Rebif nalaze se u sažetku opisa svojstava i u uputi o lijeku.
The European Medicines Agency decided that Rebif's benefits are greater than its risks and it can be authorised for use in the EU.
Europska agencija za lijekove zaključila je da koristi od lijeka Rebif nadmašuju s njim povezane rizike te da lijek može biti odobren za primjenu u EU-u.
Patients received either Rebif (22 or 44 micrograms) or placebo (a dummy treatment) for two years.
Bolesnici su primili ili Rebif (22 ili 44 mikrograma) ili placebo (prividno liječenje) tijekom dvije godine.
The most common side effects with Rebif (which may affect more than 1 in 10 people) are flu-like symptoms, neutropenia, lymphopenia and leucopenia (low white blood cell counts), thrombocytopenia (low blood platelet counts), anaemia (low red blood cell counts), headache, inflammation and other reactions at the injection site, and increases in transaminases (liver enzymes).
Najčešće nuspojave lijeka Rebif (koje se mogu javiti u više od 1 na 10 osoba) jesu simptomi slični gripi, neutropenija, limfopenija i leukopenija (nizak broj bijelih krvnih stanica), trombocitopenija (niska razina trombocita), anemija (nizak broj crvenih krvnih stanica), glavobolja, upala i druge reakcije na mjestu injiciranja te povišene transaminaze (jetreni enzimi).
MS is a disease in which inflammation damages the protective insulation around nerves (demyelination) as well as the nerves themselves.
MS je bolest u koje upala oštećuje zaštitnu ovojnicu živaca (demijelinizacija) kao i same živce.
An overview of Rebif and why it is authorised in the EU
Pregled informacija o lijeku Rebif i zašto je odobren u EU-u
Why is Rebif authorised in the EU?
Zašto je lijek Rebif odobren u EU-u?
Rebif is a medicine used to treat patients with relapsing multiple sclerosis (MS).
Rebif je lijek koji se koristi za liječenje bolesnika s relapsnom multiplom sklerozom (MS).
The recommended dose of Rebif is 44 micrograms given three times a week by injection under the skin.
Preporučena doza lijeka Rebif iznosi 44 mikrograma tri puta tjedno primjenom potkožne injekcije.
Relapsing MS is the type of MS where the patient has attacks (relapses) between periods with no symptoms.
Relapsni MS vrsta je MS-a u kojoj bolesnik ima napade (relapse) između razdoblja bez simptoma.
The doctor may advise the patient to take a fever-reducing painkiller before each injection and for 24 hours after injection to reduce the influenza (flu)-like symptoms that may occur as a side effect of treatment.
Liječnik bolesniku može savjetovati da uzima lijek protiv bolova i vrućice prije svake injekcije te tijekom 24 sata nakon injekcije za sprečavanje simptoma nalik gripi koji se mogu javiti kao nuspojava terapije.
In MS, the immune system (the body's natural defences) malfunctions and attacks parts of the central nervous system (the brain, spinal cord and optic nerve [nerve that sends signals from the eye to the brain]), causing inflammation that damages the nerves and the insulation around them.
Kod MS-a imunosni sustav (prirodna obrana tijela) ne radi ispravno i napada dijelove središnjeg živčanog sustava (mozak, kralježničnu moždinu i optički živac [živac koji šalje signale iz oka u mozak]) što uzrokuje upalu koja oštećuje živce i njihove ovojnice.
Rebif is available as a solution for injection in prefilled syringes, prefilled pens and cartridges for use in an electronic injection device.
Rebif je dostupan u obliku otopine za injekciju u napunjenim štrcaljkama, napunjenim brizgalicama i ampulama za uporabu u uređaju za elektroničko ubrizgavanje.
For more information about using Rebif, see the package leaflet or contact your doctor or pharmacist.
Više informacija o primjeni lijeka Rebif pročitajte u uputi o lijeku, odnosno obratite se liječniku ili ljekarniku.
Rebif's effectiveness has not been shown in patients with secondary progressive MS (the type of MS that comes after relapsing MS) that is not relapsing.
Učinkovitost lijeka Rebif nije utvrđena u bolesnika sa sekundarnim progresivnim MS-om (vrstom MS-a koja se razvija nakon relapsnog MS-a) koji nije relapsni.
The exact way that Rebif works in MS is not yet known but the active substance, interferon beta-1a, seems to calm down the immune system, and prevents relapses of MS.
Još uvijek nije potpuno poznato na koji način lijek Rebif djeluje kod MSa, ali čini se da djelatna tvar interferon beta-1a smiruje imunosni sustav i sprječava relapse MS-a.
How does Rebif work?
Kako djeluje Rebif?
Rebif can only be obtained with a prescription and treatment should be started by a doctor who has experience in the management of MS.
Rebif se izdaje samo na recept, a liječenje mora započeti liječnik s iskustvom u liječenju MS-a.
Rebif was more effective than placebo in reducing the number of relapses in relapsing MS. Relapses were reduced by about 30% over two years for both Rebif 22 and 44 micrograms compared with placebo, and by 22% (Rebif 22 micrograms) and 29% (Rebif 44 micrograms) over four years.
Broj relapsa smanjen je za oko 30 % tijekom dvije godine i za Rebif od 22 mikrograma i za onaj od 44 mikrograma u usporedbi s placebom, te za 22 % (Rebif od 22 mikrograma) i 29 % (Rebif od 44 mikrograma) tijekom četiri godine.
What benefits of Rebif have been shown in studies?
Koje su koristi od lijeka Rebif utvrđene u ispitivanjima?
Rebif can also be used in patients who have had a single attack of demyelination accompanied by inflammation.
Rebif se može primjenjivati i u bolesnika koji su iskusili samo jedan napad demijelinizacije popraćene upalom.
Rebif contains the active substance interferon beta-1a.
Rebif sadrži djelatnu tvar interferon beta-1a.
Rebif has been studied in 560 patients with relapsing MS.
Rebif je ispitivan na 560 bolesnika s relapsnim MS-om.
The active substance in Rebif is the protein interferon beta-1a, one of a group of interferons that can be naturally produced by the body to help it fight against viruses and other attacks.
Djelatna tvar lijeka Rebif bjelančevina je naziva interferon beta-1a iz skupine interferona koje tijelo prirodno proizvodi kako bi se lakše borilo protiv virusa i drugih napada.
Rebif has also been studied in patients with secondary progressive MS. Rebif had no significant effect on the progression of disability, but the relapse rate was reduced by about 30%.
Rebif nije imao značajnog učinka na progresiju invalidnosti, ali se stopa relapsa smanjila za oko 30 %.
It is used when the patient is considered to be at high risk of developing MS. Before using Rebif, doctors need to exclude other causes for the symptoms.
Prije uporabe lijeka Rebif liječnik mora isključiti druge uzroke simptoma.
How is Rebif used?
Kako se Rebif primjenjuje?
For the full list of side effects and restrictions with Rebif, see the package leaflet.
Potpuni popis nuspojava i ograničenja zabilježenih pri primjeni lijeka Rebif potražite u uputi o lijeku.
3 x 30 tablets (multipack)
3 x 30 tableta (višestuko pakiranje)
Route of Administration
Farmaceutski oblik Put primjene Unutarnje pakiranje
Progressive means that symptoms get steadily worse over time.
Progresivno znači da se simptomi s vremenom stalno pogoršavaju.
In addition, the Committee was of the opinion that more information was needed about how the medicine is absorbed, modified and removed from the body.
Osim toga, mišljenje Odbora bilo je da je potrebno više informacija o tome kako se lijek apsorbira, modificira i uklanja iz tijela.
Symptoms include weakness, difficulty walking and problems with vision.
Simptomi uključuju slabost, otežano hodanje i probleme s vidom.
The main measure of effectiveness was improvement in vision.
Glavna mjera učinkovitosti bila je poboljšanje vida.
15 December 2017 EMA/821654/2017 EMEA/H/C/004153
EMA/821654/2017 EMEA/H/C/004153
measure of effectiveness was the number of patients whose overall disability decreased and whose ability to walk improved.
Glavna mjera djelotvornosti bio je broj bolesnika čija se ukupna nesposobnost smanjila i čija se sposobnost hodanja poboljšala.
What is Qizenday?
Što je Qizenday?
Qizenday is a medicine that contains the active substance biotin.
Qizenday je lijek koji sadrži djelatnu tvar biotin.
Three of these enzymes are involved in energy production, while a fourth is believed to be involved in the production of sheaths around the nerve cells.
Tri od tih enzima uključena su u proizvodnju energije, a za četvrtog se smatra da je uključen u proizvodnju ovojnica oko živčanih stanica.
The second study involved 93 patients with multiple sclerosis who had visual loss due to inflammation of the optic nerve.
Drugim ispitivanjem obuhvaćeno je 93 bolesnika s multiplom sklerozom koji su imali gubitak vida zbog upale optičkog živca.
The mechanism of action of Qizenday in multiple sclerosis is not well understood; however, it is thought that the medicine acts on enzymes (known as carboxylases) to increase energy production in the damaged nerves and to help repair the protective sheath around the nerve cells.
Mehanizam djelovanja lijeka Qizenday kod multiple skleroze nije dobro poznat; međutim, smatra se da taj lijek djeluje na enzime (naziva karboksilaze) tako da povećava proizvodnju energije u oštećenim živcima i pomaže popraviti zaštitnu ovojnicu oko živčanih stanica.
The CHMP considered that the data on the medicine's effectiveness were not robust enough, and that there were uncertainties regarding the medicine's safety given the small number of patients treated with Qizenday.
CHMP je smatrao da podatci o učinkovitosti lijeka nisu dovoljno pouzdani i da je bilo nedoumica u vezi sa sigurnošću lijeka s obzirom na mali broj bolesnika liječenih lijekom Qizenday.
The company presented data from two main studies comparing Qizenday with placebo (a dummy treatment).
Tvrtka je predstavila rezultate dvaju glavnih ispitivanja u kojima je lijek Qizenday uspoređen s placebom (prividno liječenje).
On 13 November 2017, Medday Pharmaceuticals officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Qizenday, for the treatment of progressive multiple sclerosis.
Dana 13. studenoga 2017. tvrtka Medday Pharmaceuticals službeno je obavijestila Odbor za lijekove za humanu uporabu (CHMP) kako želi povući svoj zahtjev za odobrenje za stavljanje u promet lijeka Qizenday za liječenje progresivne multiple skleroze.
Qizenday was to be used to treat adults with the progressive form of multiple sclerosis, a disease in which the protective sheath around the nerve cells in the brain and spinal cord is damaged, and the nerves progressively degenerate.
Qizenday je lijek koji se trebao koristiti za liječenje odraslih osoba s progresivnim oblikom multiple skleroze, bolesti u kojoj je zaštitna ovojnica oko živčanih stanica u mozgu i leđnoj moždini oštećena, a živci progresivno degeneriraju.
How does Qizenday work?
Kako djeluje Qizenday?
The first study involved 154 patients with spinal progressive multiple sclerosis.
Prvim ispitivanjem obuhvaćeno je 154 bolesnika sa spinalnom
Withdrawal of the marketing authorisation application for Qizenday (biotin)
Povlačenje zahtjeva za izdavanje odobrenja za stavljanje u promet lijeka Qizenday (biotin)
The company informed the CHMP that there are no consequences for patients currently included in clinical trials or compassionate use programmes using Qizenday.
Tvrtka je obavijestila CHMP da nema posljedica za bolesnike koji su u ovom trenutku uključeni u klinička ispitivanja ili programe milosrdnog davanja lijekova u kojima se koristi lijek Qizenday.
What was Qizenday expected to be used for?
Za što se Qizenday trebao koristiti?
Based on the review of the data and the company's response to the CHMP lists of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Qizenday could not have been approved for the treatment of progressive multiple sclerosis.
Na temelju pregleda podataka i odgovora tvrtke na popise pitanja CHMP-a, u trenutku povlačenja CHMP je smatrao da postoje razlozi za zabrinutost te je njegovo privremeno mišljenje bilo da nije moguće dati odobrenje za lijek Qizenday za liječenje progresivne multiple skleroze.
In its letter notifying the Agency of the withdrawal of the application, the company stated that the withdrawal is based on the CHMP's opinion that the clinical data presented do not allow the Committee to conclude on a positive benefit-risk balance for Qizenday.
U svojem dopisu kojim obavještava Agenciju o povlačenju zahtjeva tvrtka je navela da povlači zahtjev zbog mišljenja CHMP-a da izneseni klinički podatci ne omogućuju Odboru da zaključi da je omjer koristi i rizika za Qizenday pozitivan.
Withdrawal of the marketing authorisation application for Qizenday (biotin) EMA/821654/2017
(biotin) EMA/821654/2017
Therefore, at the time of the withdrawal, the CHMP was of the opinion that the benefits of Qizenday did not outweigh its risks.
Sukladno navedenome CHMP je u vrijeme povlačenja smatrao kako koristi od lijeka Qizenday ne nadmašuju s njim povezane rizike.
• concentrate.
• koncentrirati se.
Adults and elderly
Odrasli i stariji
Adolescent subjects must weigh at least 34 kg.
Adolescentni ispitanici moraju imati težinu od najmanje 34 kg.
Take the medicine pack with you and tell them how much you have taken.
Ponesite sa sobom pakiranje lijeka i recite im koliko ste ga uzeli.
They can find it hard to behave well at home, at school or in other places.
Teško im je pristojno se ponašati kod kuće, u školi i na drugim mjestima.
Children under 6 years
Djeca mlađa od 6 godina
• you have fainted recently
• ako ste se nedavno onesvijestili
Date of first authorisation: 17/09/2015
Datum prvog odobrenja: 17. rujna 2015.
• seeing or hearing things that are not there (hallucination).
• vide se ili čuju stvari koje ne postoje (halucinacija)
These checks may include:
Te pretrage mogu uključivati:
It is recommended clinical judgement be exercised during this period.
Preporučuje se klinička prosudba tijekom tog razdoblja.
Lactose is a type of sugar.
Laktoza je vrsta šećera.
If you forget a dose, wait until the next day and take your usual dose.
Ako zaboravite uzeti dozu, pričekajte do sljedećeg dana i uzmite svoju uobičajenu dozu.
This will show if you still need to take the medicine.
Tako će se pokazati trebate li i dalje uzimati ovaj lijek.
These small changes are not expected to be clinically meaningful.
Ne očekuje se da će ove male promjene biti klinički značajne.
ADHD does not affect the intelligence of a child or young person.
ADHD ne utječe na inteligenciju djeteta ili mlade osobe.
This is because this medicine can make these problems worse.
Razlog je taj što ovaj lijek može pogoršati te tegobe.
Week 5 Week 6 Week 7
5. tjedan 6. tjedan 7. tjedan
ADHD can cause problems with everyday life.
ADHD može uzrokovati tegobe u svakodnevnom životu.
Patients should be advised to drink plenty of fluid.
Bolesnicima treba savjetovati da piju puno tekućine.
Tel + 44 (0) 1256 894 959 e-mail medinfoEMEA@shire.com
+ 44 (0) 1256 894 959 e-mail: medinfoEMEA@shire.com
Activated charcoal may be useful in limiting the absorption.
Aktivni ugljen može biti koristan u ograničavanju apsorpcije.
Intuniv with food, drinks and alcohol
Intuniv s hranom, pićem i alkoholom
• sit still
• mirno sjediti
This medicine belongs to a group of medicines which affects brain activity.
Ovaj lijek pripada skupini lijekova koji utječu na moždanu aktivnost.
The medicine is given as part of a treatment programme, which usually includes the following:
Lijek se daje u sklopu programa liječenja, koje obično uključuje sljedeće:
Always take this medicine exactly as your doctor or pharmacist has told you.
Uvijek uzimite ovaj lijek točno onako kako Vam je rekao Vaš liječnik ili ljekarnik.
Intuniv is taken once daily either morning or evening.
Intuniv se uzima jedanput na dan, bilo ujutro ili navečer.
• This leaflet has been written as though the person taking the medicine is reading it.
• Ova je uputa pisana kao da je čita osoba koja uzima lijek.
However, individuals may have larger increases than reflected by the mean changes.
No kod pojedinih osoba može doći do većeg porasta od onog koji odražavaju srednje vrijednosti promjene.
Your doctor will routinely monitor you to see how this medicine affects you.
Liječnik će Vas rutinski pratiti da vidi kako ovaj lijek djeluje na Vas.
Syncope has also been observed.
Opažena je i sinkopa.
The elimination half-life of guanfacine is approximately 18 hours.
Poluvijek eliminacije gvanfacina iznosi približno 18 sati.
• You may not notice an immediate effect upon starting treatment, some patients may notice an improvement after the first week but it could take longer.
• Možda nećete primijetiti učinak odmah na početku liječenja; neki bolesnici mogu primijetiti poboljšanje nakon prvog tjedna, ali možda bude potrebno i dulje.