natgillin/translations-raw huggingface dataset:
Lacosamide Accord 200 mg film coated tablets: EU/1/17/1230/013-016
Lakozamid Accord 200 mg filmom obložene tablete EU/1/17/1230/013-016
Blue, oval, approximately 16.4 x 7.6 mm, coated tablets, debossed “L” on one side and “200” on other side.
Plave, ovalne filmom obložene tablete približne veličine 16,4 x 7,6 mm s utisnutom oznakom„L“ na jednoj strani i „200“ na drugoj strani.
Blister label - week 4
LIJEČENJA Blister - 3. tjedan
08039 Barcelona, Spain
Ind. Zona Franca 08040 Barcelona ŠPANJOLSKA
Lacosamide Accord 150 mg film coated tablets: EU/1/17/1230/009-012
Lakozamid Accord 150 mg filmom obložene tablete EU/1/17/1230/009-012
OTHER Week 3
DRUGO 3. tjedan
Lacosamide Accord 50 mg film coated tablets: EU/1/17/1230/001-004
Lakozamid Accord 50 mg filmom obložene tablete EU/1/17/1230/001-004
Titanium dioxide (E171) Lecithin (soya) Iron oxide red (E172) Iron oxide black (E172) Iron oxide yellow (E172)
Ovojnica tablete polivinilni alkohol polietilenglikol talk titanijev dioksid (E171) lecitin (soja) željezov oksid, crveni (E172) željezov oksid, crni (E172) željezov oksid, žuti (E172)
Lacosamide Accord 200 mg 1 film-coated tablet contains 200 mg lacosamide.
Lakozamid Accord 200 mg 1 filmom obložena tableta sadrži 200 mg lakozamida.
Lacosamide Accord 150 mg are salmon, oval, approximately 15.0 x 6.9 mm, coated tablets, debossed “L” on one side and “150” on other side.
Lakozamid Accord 150 mg su boje lososa, ovalne filmom obložene tablete približne veličine od 15,0 x 6,9 mm s utisnutom oznakom „L“ na jednoj strani i „150“ na drugoj strani.
Lacosamide Accord 150 mg 1 film-coated tablet contains 150 mg lacosamide.
Lakozamid Accord 150 mg 1 filmom obložena tableta sadrži 150 mg lakozamida.
Lacosamide Accord 100 mg 1 film-coated tablet contains 100 mg lacosamide.
Lakozamid Accord 100 mg 1 filmom obložena tableta sadrži 100 mg lakozamida.
Lacosamide Accord 200 mg film-coated tablets One film-coated tablet contains 200 mg lacosamide.
Lakozamid Accord 200 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 200 mg lakozamida.
50 mg tablet: Iron oxide red (E172), iron oxide black (E172), indigo carmine aluminum lake (E132) 100 mg tablet: Iron oxide yellow (E172)
50 mg tableta: crveni željezov oksid (E172), crni željezov oksid (E172), indigo karmin aluminium lake (E132)
Titanium dioxide (E171) Lecithin (soya) Iron oxide yellow (E172)
Ovojnica tablete polivinilni alkohol polietilenglikol talk titanijev dioksid (E171) lecitin (soja) željezov oksid, žuti (E172)
Lacosamide Accord 150 mg film-coated tablets One film-coated tablet contains 150 mg lacosamide.
Lakozamid Accord 150 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 150 mg lakozamida.
Titanium dioxide (E171) Iron oxide red (E172) Iron oxide black (E172) Indigo carmine aluminum lake (E132) Lecithin (soya)
Ovojnica tablete polivinilni alkohol polietilenglikol talk titanijev dioksid (E171) željezov oksid, crveni (E172) željezov oksid, crni (E172) indigo karmin aluminium lake (E132) lecitin (soja)
1 film-coated tablet contains 200 mg lacosamide.
Jedna filmom obložena tableta sadrži 200 mg lakozamida.
How to store Lacosamide Accord
Kako čuvati Lakozamid Accord
Excipients
Pruritis
Lacosamide Accord 200 mg film-coated tablets
Lakozamid Accord 200 mg filmom obložene tablete
• fits (seizures), heart beat problems such as a slow, fast or irregular heart beat , coma or a fall in blood pressure with rapid heartbeat and sweating.
• napadaje, poremećaje srčanog ritma kao što su usporeni, ubrzani ili nepravilni otkucaji srca,
Lacosamide Accord 100 mg film-coated tablets One film-coated tablet contains 100 mg lacosamide.
Lakozamid Accord 100 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 100 mg lakozamida.
What Lacosamide Accord is
Što je Lakozamid Accord
Lacosamide Accord 150 mg film-coated tablets
Lakozamid Accord 150 mg filmom obložene tablete
Lacosamide Accord 100 mg are dark yellow, oval, approximately 13.0 x 6.0 mm, coated tablets, debossed “L” on one side and “100” on other side.
Lakozamid Accord 100 mg su tamnožute, ovalne filmom obložene tablete približne veličine od 13,0 x 6,0 mm s utisnutom oznakom „L“ na jednoj strani i „100“ na drugoj strani.
Lacosamide Accord 100 mg film-coated tablets
Lakozamid Accord 100 mg filmom obložene tablete
Lacosamide Accord 50 mg film-coated tablets
Lakozamid Accord 50 mg filmom obložene tablete
1 film-coated tablet contains 150 mg lacosamide.
Jedna filmom obložena tableta sadrži 150 mg lakozamida.
1 film-coated tablet contains 100 mg lacosamide.
Jedna filmom obložena tableta sadrži 100 mg lakozamida.
Lacosamide Accord 100 mg film-coated tablets Lacosamide Accord 150 mg film-coated tablets Lacosamide Accord 200 mg film-coated tablets
Lakozamid Accord 100 mg filmom obložene tablete Lakozamid Accord 150 mg filmom obložene tablete Lakozamid Accord 200 mg filmom obložene tablete
NAME OF THE MEDICINAL PRODUCT Lacosamide Accord 50 mg film-coated tablets Lacosamide Accord 100 mg film-coated tablets Lacosamide Accord 150 mg film-coated tablets Lacosamide Accord 200 mg film-coated tablets
Lakozamid Accord 50 mg filmom obložene tablete Lakozamid Accord 100 mg filmom obložene tablete Lakozamid Accord 150 mg filmom obložene tablete Lakozamid Accord 200 mg filmom obložene tablete
The treatment initiation pack contains 56 film-coated tablets in 4 packages: the package marked ‘Week 1'contains 14 tablets of 50 mg, the package marked ‘Week 2' contains 14 tablets of 100 mg,
• Pakiranje označeno '1.tjedan ' sadrži 14 tableta od 50 mg,
This will be until you reach a maintenance dose between 100 mg and 300 mg twice a day.
Liječnik može povećati Vašu dozu koju uzimate dvaput na dan svakih tjedan dana za 50 mg dok ne dosegnete dozu održavanja između 100 mg i 300 mg dvaput na dan.
• feeling sick (nausea) or being sick (vomiting);
• mučninu ili povraćanje;
Lacosamide Accord 50 mg Lacosamide Accord 100 mg Lacosamide Accord 150 mg Lacosamide Accord 200 mg film-coated tablets lacosamide
Lakozamid Accord 50 mg Lakozamid Accord 100 mg Lakozamid Accord 150 mg Lakozamid Accord 200 mg filmom obložene tablete lakozamid
Each film-coated tablet contains 50 mg lacosamide.
Jedna filmom obložena tableta sadrži 50 mg lakozamida.
NAME OF THE MEDICINAL PRODUCT Lacosamide Accord 150 mg film-coated tablets lacosamide
Lakozamid Accord 150 mg filmom obložene tablete lakozamid
Dose-related prolongations in PR interval with lacosamide have been observed in clinical studies.
U kliničkim ispitivanjima pri liječenju lakozamidom uočeno je produljenje PR-intervala, ovisno o dozi.
NAME OF THE MEDICINAL PRODUCT Lacosamide Accord 50 mg film-coated tablets lacosamide
Lakozamid Accord 50 mg filmom obložene tablete lakozamid
--P1 Live gEP-P tkP-P double-gene deleted Bovine Herpes Virus type 1 (BoHV-1), strain CEDDEL: 10P6.3P - 10P7.3P CCIDR50 Rper 2 ml (gEP-P: deleted glycoprotein E; tkP-P: deleted thymidine kinase; CCID: cell culture infectious dose)
--P1 PŽivi gEP-P tkP-P goveđi herpes virus tip 1 (GHV-1), s dvostrukom delecijom gena, soj CEDDEL: 10P6.3P - 10P7.3P CCIDR50
Invented Name
EU broj odobrenja Izmišljeno ime
Lyophilisate: bottle (type I glass); solvent: bottle (type I glass or PET)
Szarvasmarha Intramuszkulárisan Liofilizat: bocu (stakla tipa I); otapalo: bocu (stakla tipa
EU (MA) Number
R (2 ml)
EMA/263379/2014 EMEA/V/C/002759
EMA/263379/2014 EMEA/H/C/002759
This summary was last updated in March 2015.
Sažetak je posljednji put ažuriran u ožujku 2015.
In the future, if the animals are exposed to these infections the immune system will be able to respond more quickly.
Ako životinje u budućnosti budu izložene tim infekcijama, imunosni sustav moći će brže reagirati.
It is typically transmitted through bites of infected animals.
Obično se prenosi putem ugriza zaraženih životinja.
Responses in puppies were lower than adult dogs in some cases, because of antibodies inherited from their mothers.
Odgovori u štenaca bili su niži nego u odraslih pasa u nekim slučajevima jer su oni naslijedili protutijela od svojih majki.
Vaccines work by ‘teaching' the immune system (the body's natural defences) how to defend itself against a disease.
Cjepiva djeluju „učeći” imunosni sustav (prirodui obranu tijela) kako da se obrani protiv bolesti.
The percentage of dogs with protective levels of antibodies for parvovirus ranged from 73 to 100%, for parainfluenza virus 73 to 97%, for leptospira 59 to 96% and for rabies virus 86 to 100%.
Postotak pasa sa zaštitnim razinama protutijela za parvovirus bio je u rasponu od 73 do 100 %, za virus parainfluence 73 do 97 %, za leptospirozu 59 do 96 %, te za virus bjesnoće 86 do 100 %.
In situations where puppies are expected to inherit very high antibody levels from the bitch the vaccination protocol should be planned accordingly.
U situacijama u kojima se očekuje da će štenci naslijediti vrlo visoke razine protutijela od kuje, plan cijepljenja treba planirati shodno tome.
The measures of effectiveness were clinical signs, body temperature and level of antibodies.
Mjerila djelotovornosti bila su klinički znakovi, tjelesna temperatura i razina protutijela.
The dogs were either vaccinated twice with a three or four week interval or they received a single annual booster vaccination.
Psi su ili bili cijepljeni dvaput u razmaku od tri ili četiri tjedna ili su primili jednu godišnju dozu docjepljivanja.
The vaccine is given to puppies from eight to nine weeks of age as an injection, under the skin, and repeated once the puppies reach twelve weeks of age.
Cjepivo se daje štencima u dobi od osam do devet tjedana u obliku potkožne injekcije i ponavlja se nakon što štenci dosegnu dob od 12 tjedana.
The European Commission granted a marketing authorisation valid throughout the European Union, for Versican Plus DHPPi/L4R on 7 May 2014.
Europska komisija izdala je odobrenje za stavljanje u promet koje je na snazi u Europskoj uniji za cjepivo Versican Plus DHPPi/L4R dana 7. svibnja 2014.
The most common side effect (seen in more than 1 in 100 dogs) with Versican Plus DHPPi/L4R is a short lived swelling of up to 5 cm which may occur at the injection site after vaccination.
Najčešća nuspojava (uočena kod više od 1 na 100 pasa) kod primjene cjepiva Versican Plus DHPPi/L4R je kratkotrajna oteklina do 5 cm koja se može javiti na mjestu injekcije nakon cijepljenja.
The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Versican Plus DHPPi/L4R exceed the risks for the approved indications and recommended that Versican Plus DHPPi/L4R be given a marketing authorisation.
Odbor za veterinarsko-medicinske proizvode (CVMP) zaključio je da koristi cjepiva DHPPi/L4R nadmašuju rizike za odobrene indikacije i preporučio izdavanje odobrenja za stavljanje cjepiva Versican Plus DHPPi/L4R u promet.
The effectiveness of Versican Plus DHPPi/L4R was initially investigated in a field study involving 129 dogs.
Djelotvornost cjepiva Versican Plus DHPPi/L4R prvo je ispitana u terenskom ispitivanju koje je obuhvatilo 129 pasa.
When Versican Plus DHPPi/L4R is given to dogs the animals' immune system recognises the viruses and bacteria as ‘foreign' and makes antibodies against them.
Kada se Versican Plus DHPPi/L4R daje psima, imunosni sustav životinje prepoznaje viruse i bakterije kao „strana tijela” i proizvodi protutijela protiv njih.
Versican Plus DHPPI/L4R is used to protect dogs against:
Versican Plus DHPPi/L4R koristi se za zaštitu pasa od:
• canine adenovirus, which causes an acute liver infection that may produce signs of jaundice (yellowing of the skin and eyes);
• psećeg adenovirusa koji uzrokuje akutnu infekciju jetre koja može uzrokovati znakove žutice (žućenje kože i očiju)
In these studies dogs were vaccinated twice with a three week interval and were challenged with canine distemper virus, canine adenovirus and canine parvovirus three years after the second vaccination.
Tijekom tih ispitivanja psi su bili cijepljeni dvaput u razmaku od tri tjedna te su bili podvrgnuti provokaciji virusom štenećaka, psećim adenovirusom i psećim parvovirusom tri godine nakon drugog cijepljena.
• canine distemper, an infectious disease which is sometimes called hard pad since dogs can develop thickening of the skin on the foot pads, as well as runny nose, cough, fever, vomiting and diarrhoea, excessive salivation and in some cases fits;
• štenećaka, infektivne bolesti koja se ponekad naziva i bolest tvrdih mekuši jer psi mogu razviti zadebljanje kože na jastučićima šapa kao i curenje iz nosa, kašalj, vrućicu, povraćanje i proljev, prekomjerno slinjenje i u nekim slučajevima napadaje
• rabies, a viral zoonotic (communicable to man) disease that affects the central nervous system (brain and spinal cord), leading to death.
• bjesnoće, bolesti virusne zoonoze (koja se može prenijeti na ljude) koja zahvaća središnji živčani sustav (mozak i kralješničnu moždinu) koja uzrokuje smrt.
The field study showed that vaccination with Versican Plus DHPPi/L4R resulted in levels of antibodies that were sufficient to protect against canine distemper virus and canine adenovirus in all dogs.
Terensko ispitivanje pokazalo je da cijepljenje cjepivom Versican Plus DHPPi/L4R stvara razine protutijela koje su dostatne za zaštitu od virusa štenećaka i psećeg adenovirusa u svih pasa.
Versican Plus DHPPi/L4R contains an adjuvant (aluminium hydroxide) to enhance the immune response.
Versican Plus DHPPi/L4R sadrži adjuvans (aluminijev hidroksid) za povećavanje imunosnog odgovora.
• leptospirosis, a bacterial disease that may be transmitted via infected urine and result in bleeding, hepatitis (inflammation of the liver) and jaundice or nephritis (kidney inflammation);
• leptospiroze, bakterijske bolesti koja se može prenijeti preko zaraženog urina i uzrokovati krvarenje, hepatitis (upalu jetre) i žuticu ili nefritis (upalu bubrega)
Laboratory studies were conducted subsequently to determine the period of protection against distemper, canine adenovirus (type 1 and 2) and parvovirus.
Nakon toga provedena su laboratorijska ispitivanja kako bi se utvrdilo razdoblje zaštite od štenećaka, infekcije psećim adenovirusom (tipa 1 i 2) i infekcije parvovirusom.
Versican Plus DHPPi/L4R is a veterinary vaccine that contains live attenuated (weakened) canine distemper virus, canine adenovirus type 2, canine parvovirus type 2b and canine parainfluenza virus type 2 as well as inactivated (killed) strains of Leptospira bacteria and rabies virus.
Versican Plus DHPPi/L4R je veterinarsko cjepivo koje sadrži živi, atenuirani (oslabljeni) virus štenećaka, pseći adenovirus tipa 2, pseći parvovirus tipa 2b i virus pseće parainfluence tipa 2 kao i inaktivirane (ubijene) sojeve bakterija Leptospira i virus bjesnoće.
The canine distemper virus, canine adenovirus, canine parvovirus and canine parainfluenza virus in Versican Plus DHPPi/L4R are alive but they have been attenuated (weakened) so that they do not cause disease; they are combined with killed (inactivated) strains of Leptospira bacteria and rabies virus.
Virus štenećaka, pseći adenovirus, pseći parvovirus i virus pseće parainfluence u cjepivu Versican Plus DHPPi/L4R su živi, ali su atenuirani (oslabljeni) tako da ne uzrokuju bolest; kombinirani su s ubijenim (inaktiviranim) sojevima bakterije Leptospira i virusom bjesnoće.
• canine parvovirus disease, an infection that may severely affect puppies, resulting in lethargy, fever, vomiting and bloody diarrhoea;
• infekcije psećim parvovirusom koja može teško utjecati na štence, što uzrokuje letargiju, vrućicu, povraćanje i krvavi proljev
This will help protect them against distemper, adenovirus, parvovirosis, kennel cough, leptospirosis and rabies.
To će pomoći u njihovoj zaštiti od štenećaka, infekcije adenovirusom, infekcije parvovirusom, „kašlja čopora” (zaraznog traheobronhitisa), leptospiroze i bjesnoće.
The laboratory studies showed the period of protection to be three years for canine distemper, canine adenovirus and canine parvovirus.
Laboratorijska ispitivanja pokazala su da je razdoblje zaštite tri godine za štenećak, pseći adenovirus i pseći parvovirus.
Versican Plus DHPPi/L4R is a vaccine.
Versican Plus DHPPi/L4R je cjepivo.
Versican Plus DHPPi/L4R is available as a lyophilisate (freeze-dried pellet) with solvent for injection.
Versican Plus DHPPi/L4R dostupan je u obliku liofilizata (peleta zamrznutih sušenjem) s otapalom za injekciju.
Canine distemper, adenovirus, parvovirus, parainfluenza virus (live attenuated), canine leptospirosis, rabies (inactivated) vaccine
Cjepivo protiv virusa štenećaka, psećeg adenovirusa, parvovirusa, virusa parainfluence (živog atenuiranog), pseće leptospiroze, bjesnoće (inaktivirano)
For revaccination, a single dose of Versican Plus DHPPi/L4R is required every three years for distemper, canine adenovirus (type 1 and 2) and parvovirus.
Za docjepljivanje protiv štenećaka, psećeg adenovirusa (tipa 1 i 2) i parvovirusa potrebna je jedna doza cjepiva Versican Plus DHPPi/L4R svake tri godine.
Why has Versican Plus DHPPi/L4R been approved?
Zašto je Versican Plus DHPPi/L4R odobren?
Other information about Versican Plus DHPPi/L4R:
Ostale informacije o cjepivu Versican Plus DHPPi/L4R:
What is the risk associated with Versican Plus DHPPi/L4R?
Koji su rizici povezani s cjepivom Versican Plus DHPPi/L4R?
What is Versican Plus DHPPi/L4R?
Što je Versican Plus DHPPi/L4R?
Annual revaccination is required for protection against parainfluenza virus, leptospirosis and rabies.
Kao zaštita od virusa parainfluence, leptospiroze i bjesnoće potrebno je docjepljivanje jednom godišnje.
• canine parainfluenza virus, the cause of kennel cough;
• virusa pseće parainfluence koji uzrokoje zarazni traheobronhitis (kašalj čopora)
What benefit has Versican Plus DHPPi/L4R shown during the studies?
Koje su koristi cjepiva Versican Plus DHPPi/L4R utvrđene u ispitivanjima?
What is Versican Plus DHPPi/L4R used for?
Za što se Versican Plus DHPPi/L4R koristi?
How does Versican Plus DHPPi/L4R work?
Kako djeluje Versican Plus DHPPi/L4R?
How has Versican Plus DHPPi/L4R been studied?
Kako je Versican Plus DHPPi/L4R ispitivan?
The recommended dose is one tablet per day, taken with food.
Preporučena doza je jedna tableta po danu, uzeta s hranom.
Tybost is available as tablets (150 mg).
Tybost je dostupan u obliku tableta (150 mg).
The full EPAR for Tybost can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Cjelovito Europsko javno izvješće o ocjeni dokumentacije o lijeku (EPAR) može se naći na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
A risk management plan has been developed to ensure that Tybost is used as safely as possible.
Razvijen je plan upravljanja rizikom kako bi se osiguralo da se Tybost koristi što je sigurnije moguće.
The European Commission granted a marketing authorisation valid throughout the European Union for Tybost on 19 September 2013.
Europska komisija izdaje odobrenje za stavljanje u promet koje za Tybost vrijedi na prostoru Europske unije od 19. rujna 2013.
Tybost is given together with 300 mg atazanavir once per day or with 800 mg darunavir once per day.
Tybost se koristi skupa s 300 mg atazanavira jednom na dan ili s 800 mg darunavira jednom na dan.
Other information about Tybost
Druge informacije o lijeku Tybost
Tybost was shown to be as effective as ritonavir: around 85% of patients (293 out of 344 patients) given Tybost responded to treatment, compared with around 87% of patients (304 out of 348 patients) given ritonavir.
Dokazano je da je Tybost jednako djelotvoran kao ritonavir: približno 85% bolesnika (293 od 344 bolesnika) koji su primali Tybost reagirali su na liječenje, u usporedbi s približno 87% bolesnika (304 od 348 bolesnika) koji su primali ritonavir.
When the enzyme is blocked, the virus cannot reproduce normally, which slows down the spread of infection.
Kad je enzim blokiran, virus se ne može razmnožavati na normalan način što smanjuje brzinu širenja infekcije.
It is not intended to provide practical advice on how to use Tybost.
Svrha sažetka nije davati praktične savjete o načinu korištenja lijeka Tybost.
What measures are being taken to ensure the safe and effective use of Tybost?
Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Tybost?
This is a summary of the European public assessment report (EPAR) for Tybost.
Ovo je sažetak Europskoga javnog izvješća o ocjeni dokumentacije o lijeku (EPAR) za Tybost.
Why is Tybost approved?
Zašto je Tybost odobren?
The main measure of effectiveness was based on the reduction in viral load (the amount of virus found in the blood): patients who attained a viral load of less than 50 HIV-1 RNA copies/ml after 48 weeks of treatment were considered to have responded to treatment.
Glavna mjera djelotvornosti temeljila se na redukciji virusnog opterećenja (količine virusa nađene u krvi): smatrano je da bolesnici koji su postigli virusno opterećenje manje od 50 kopija HIV-1 RNK/ml nakon 48 tjedana liječenja odgovaraju na liječenje.
Tybost must not be taken together with a number of other medicines that affect the way Tybost is broken down or whose action is affected by Tybost: alfuzosin (used to treat an enlarged prostate gland); amiodarone or quinidine (used to correct irregular heartbeat); carbamazepine, phenobarbital, or phenytoin (used to prevent seizures); rifampicin (used to prevent and treat tuberculosis and other infections); dihydroergotamine, ergometrine or ergotamine (used to treat migraine headache); cisapride (used to relieve certain stomach problems); St. John's wort (a herbal remedy used for depression and anxiety); lovastatin or simvastatin (used to lower blood cholesterol); pimozide (used to treat abnormal thoughts or feelings); sildenafil (used to treat pulmonary arterial hypertension); and oral midazolam or triazolam (used to aid sleep or relieve anxiety).
Tybost se ne smije uzimati skupa s brojnim drugim lijekovima koji utječu na način razgradnje lijeka Tybost ili na čije akcije djeluje lijek Tybost. alfuzosin (koristi se za liječenje uvećane prostate); amiodaron ili kinidin (koristi se za korekciju nepravilnih srčanih otkucaja); karbamazepin, fenobarbital ili fenitoin (koristi se za sprječavanje napadaja); rifampicin (koristi se za sprječavanje i liječenje tuberkuloze i drugih infekcija); dihidroergotamin, ergometrin ili ergotamin (koristi se za liječenje migrenskih glavobolja); cisaprid (koristi se za olakšavanje problema sa želucem); gospina trava (biljni lijek koji se koristi za depresiju i anksioznost); lovastatin ili simvastatin (koristi se za snižavanje kolesterola u krvi); pimozid (koristi se za liječenje nenormalnih misli ili osjećaja); sildenafil (koristi se za liječenje plućne arterijske hipertenzije); te peroralni midazolam ili triazolam (koristi kao pomoćno sredstvo u uspavljivanju ili za olakšavanje anksioznosti).
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Tybost's benefits are greater than its risks and recommended that it be approved for use in the EU.
Povjerenstvo za lijekove za primjenu kod ljudi (CHMP) pri Agenciji odlučilo je da koristi od lijeka Tybost nadmašuju s njim povezane rizike te je preporučila njegovo odobrenje za korištenje u Europskoj uniji.
Tybost was compared with another medicine called ritonavir in one main study involving 698 patients infected with HIV-1.
Tybost je uspoređen s drugim lijekom zvanim ritonavir u jednom glavnom ispitivanju koje je uključivalo 698 bolesnika zaraženih virusom HIV-1.
What are the risks associated with Tybost?
Koji su rizici povezani s lijekom Tybost?
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Tybost, including the appropriate precautions to be followed by healthcare professionals and patients.
Na temelju tog plana u sažetak opisa svojstava lijeka kao i u uputu o lijeku za Tybost uključene su sigurnosne informacije uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
It is used in the treatment of adults infected with HIV-1, a virus that causes acquired immune deficiency syndrome (AIDS).
Koristi se u liječenju odraslih osoba zaraženih virusom HIV-1 koji uzrokuje sindrom stečene imunodeficijencije (AIDS).