natgillin/translations-raw huggingface dataset:
Excipient with known effect: Each film-coated tablet contains 126.34 mg lactose.
Pomožna snov z znanim učinkom: Vsaka filmsko obložena tableta vsebuje 126,34 mg laktoze Za celoten seznam pomožnih snovi glejte poglavje 6.1.
Yellow round flat faced radial edge tablets engraved ‘APO' on one side and ‘OL' over ‘10' on the other side.
Rumene, okrogle, ravne tablete s krožnim krožnim robom in vtisnjenim napisom "APO" na eni strani in "OL" nad "10" na drugi strani.
Yellow round flat faced radial edge tablets engraved ‘APO' on one side and ‘OL' over ‘15' on the other side.
Rumene, okrogle, ravne tablete s krožnim krožnim robom in vtisnjenim napisom "APO" na eni strani in "OL" nad "15" na drugi strani.
White, round biconvex film-coated tablets engraved ‘APO' on one side and ‘OLA' over ‘5' on the other side.
Bele, okrogle, bikonveksne filmsko obložene tablete z vtisnjenim napisom "APO" na eni strani in "OLA" nad "5" na drugi strani..
Patients should be advised not to breast-feed an infant if they are taking olanzapine.
Če jemljejo olanzapin, naj se bolnicam dojenje dojenčka odsvetuje.
Yellow round flat faced radial edge tablets engraved ‘APO' on one side and ‘OL' over ‘5' on the other side.
Rumene, okrogle, ravne tablete s krožnim krožnim robom in vtisnjenim napisom "APO" na eni strani in "OL" nad "5" na drugi strani.
Discontinuation symptoms
Bolezni živčevja
NAME OF THE MEDICINAL PRODUCT Olanzapine Apotex 20 mg orodispersible tablets olanzapine
Olanzapin Apotex 20 mg orodisperzibilne tablete olanzapin
NAME OF THE MEDICINAL PRODUCT Olanzapine Apotex 10 mg orodispersible tablets olanzapine
Olanzapin Apotex 10 mg orodisperzibilne tablete olanzapin
General disorders and administration site conditions Asthenia
Splošne težave in spremembe na mestu aplikacije astenija utrujenost oteklina
NAME OF THE MEDICINAL PRODUCT Olanzapine Apotex 5 mg orodispersible tablets olanzapine
Olanzapin Apotex 5 mg orodisperzibilne tablete olanzapin
NAME OF THE MEDICINAL PRODUCT Olanzapine Apotex 15 mg orodispersible tablets olanzapine
Olanzapin Apotex 15 mg orodisperzibilne tablete olanzapin
4 Observed for fasting normal levels at baseline (< 5.56 mmol/l) which increased to high (≥ 7 mmol/l).
4 Opazovano pri osnovnih normalnih ravneh na tešče (< 5,56 mmol/l), ki so se povišale na visoke
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 20 mg olanzapine.
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena tableta vsebuje 20 mg olanzapina.
Metabolism and nutrition disorders Weight gain
Presnovne in prehranske motnje
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 15 mg olanzapine.
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena tableta vsebuje 15 mg olanzapina.
Transient, asymptomatic elevations of hepatic aminotransferases, alanine transferase (ALT), aspartate transferase (AST) have been seen commonly,especially in early treatment.
(ALT), aspartat transferaze (AST), posebno na začetku zdravljenja.
Drug withdrawal syndrome neonatal (see section 4.6)
Odtegnitve ni sindrom pri novorojenč ku (glejte poglavje 4.
Photosensitivity reaction
Vpliv na sposobnost razmnoževanja
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 5 mg olanzapine.
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena tableta vsebuje 5 mg olanzapina.
Both antibiotics were given for up to two weeks.
Oba antibiotika so dajali do dva tedna.
International non-proprietary name (INN): tigecycline
Mednarodno nelastniško ime (INN): tigecycline
Ref. EMEA/245771/2008
EMEA/402817/2008 Error!
The letter from the company notifying the EMEA of the withdrawal of the application is available here.
Dopis podjetja, s katerim agencijo EMEA obvešča o umiku vloge, je na voljo tukaj.
The CHMP also had concerns over the measures that the company intended to put in place to minimise the risks associated with the medicine.
CHMP je prav tako imel zadržke glede ukrepov, ki jih podjetje namerava sprejeti za zmanjšanje tveganja, povezanega z zdravilom.
By blocking the production of new proteins, the bacteria cannot multiply and they eventually die.
Z blokiranjem tvore novih beljakovin se bakterije ne morejo več razmnoževati in sčasoma odmrejo.
What were the major concerns that led the CHMP to recommend the refusal of the change to the marketing authorisation?
Kateri so bili glavni zadržki, zaradi katerih je CHMP predlagal zavrnitev spremembe dovoljenja za promet?
The effects of Tygacil were first tested in experimental models before being studied in humans.
Učinki zdravila Tygacil so bili najprej preizkušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
On 22 April 2008, Wyeth Europa Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a new indication for Tygacil, in the treatment of community-acquired pneumonia.
Družba Wyeth Europa Limited je dne 22. aprila 2008 obvestilo Odbor za zdravila za uporabo v humani medicini (CHMP), da se je odločilo umakniti vlogo za novo indikacijo za zdravilo Tygacil, namenjeno zdravljenju pljučnice, pridobljene izven bolnišnice.
Community-acquired pneumonia is usually caused by infection with bacteria.
Izvenbolnišnično pridobljena pljučnica je običajno posledica okužbe z bakterijo.
There are no consequences on the use of Tygacil in the authorised indications, for which the balance of benefits and risks remains unchanged.
Umik nima nobenih posledic za uporabo zdravila Tygacil za odobreno indikacijo, pri kateri ostaja razmerje med koristmi in tveganji nespremenjeno.
Following the CHMP's opinion, it usually takes around six weeks for the European Commission to update the licence.
Ko CHMP poda mnenje, Evropska komisija v približno šestih tednih posodobi dovoljenje.
The main measure of effectiveness was the number of patients who were cured of their pneumonia within the three weeks after their last dose of antibiotic.
Glavno merilo učinkovitosti je bilo število bolnikov, pri katerih je bila pljučnica pozdravljena v treh tednih po zadnjem prejetem odmerku antibiotika.
Both studies compared Tygacil with levofloxacin (another antibiotic).
V obeh študijah so zdravilo Tygacil primerjali z levofloksacinom (drugim antibiotikom).
QUESTIONS AND ANSWERS ON THE WITHDRAWAL OF THE APPLICATION FOR A CHANGE TO THE MARKETING AUTHORISATION for TYGACIL
VPRAŠANJA IN ODGOVORI V ZVEZI Z UMIKOM VLOGE ZA SPREMEMBO DOVOLJENJA ZA PROMET z zdravilom TYGACIL
The CHMP was concerned that the patients included in the main studies may not have needed hospital treatment using medicines given intravenously (into a vein), so they did not match the types of patients for whom the medicine was intended.
CHMP je imel zadržke glede tega, da bolniki, ki so bili vključeni v glavni študiji, niso nujno potrebovali bolnišničnega zdravljenja z zdravili, dajanimi intravensko (v žilo), tako da niso ustrezali vrsti bolnikov, katerim je zdravilo namenjeno.
Tigecycline works by blocking the bacteria's ribosomes, the parts of the bacterial cells where new proteins are made.
Tigeciklin deluje tako, da blokira ribosome bakterij oziroma tiste dele bakterijskih celic, ki proizvajajo nove beljakovine.
This is a serious type of lung infection that is caught outside of hospital.
To je huda oblika okužbe pljuč, pridobljena izven bolnišnice.
The effectiveness of Tygacil was tested in two main studies involving a total of 846 adults who needed treatment in hospital for community-acquired pneumonia.
Učinkovitost zdravila Tygacil je bila preučena v dveh glavnih študijah, ki sta vključevali skupaj 846 odraslih, ki so potrebovali bolnišnično zdravljenje zaradi pljučnice, pridobljene izven bolnišnice.
The company informed the CHMP that there are no consequences for patients currently included in clinical trials with Tygacil.
Družba je obvestila CHMP, da umik nima nobenih posledic za bolnike, ki trenutno sodelujejo v kliničnih preskušanjih zdravila Tygacil.
The application was at day 150 when the company withdrew.
Družba je vlogo umaknila na 150. dan postopka.
Based on the review of the data and the company's response to the CHMP list of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Tygacil could not have been approved for the treatment of community-acquired pneumonia.
Na podlagi pregleda podatkov in odgovorov družbe na seznam vprašanj, ki jih je do umika vloge zastavil CHMP, je Odbor izrazil določene zadržke in je začasno menil, da zdravila Tygacil ni mogoče odobriti za zdravljenje pljučnice, pridobljene izven bolnišnice.
The Committee was also concerned over the number of deaths in patients receiving Tygacil with more serious infections, especially in the study of patients who had caught pneumonia in hospital.
Odbor je imel zadržke tudi glede števila smrti pri bolnikih z resnejšimi okužbami, ki so prejemali zdravilo Tygacil, zlasti pri preučevanju bolnikov, ki so pljučnico dobili v bolnišnici.
The active substance in Tygacil, tigecycline, belongs to the group of antibiotics called ‘glycylcyclines', which are similar to tetracycline.
Zdravilna učinkovina zdravila Tygacil, tigeciklin, spada v skupino antibiotikov, imenovanih „glicilciklini“, ki so podobni tetraciklinu.
Therefore, at the time of the withdrawal, the CHMP's view was that a benefit of Tygacil had not been sufficiently demonstrated and any benefits did not outweigh the identified risks.
CHMP je bil zato v času umika mnenja, da koristi zdravila Tygacil niso zadostno dokazane in da niso večje od znanih tveganj.
It contains the active substance tigecycline.
Vsebuje zdravilno učinkovino tigeciliklin.
What are the consequences of the refusal for patients in clinical trials using Tygacil?
Kakšne so posledice umika za bolnike, ki sodelujejo v kliničnih preskušanjih zdravila Tygacil?
Tygacil is an antibiotic that is already used to treat adults with complicated infections of the skin or soft tissue (the tissue below the skin) and complicated infections in the abdomen.
Zdravilo Tygacil je antibiotik, ki se uporablja za zdravljenje odraslih s kompliciranimi okužbami kože ali mehkih tkiv (podkožnega tkiva) in kompliciranimi trebušnimi okužbami.
What is Tygacil?
Kaj je zdravilo Tygacil?
The CHMP normally takes up to 90 days to adopt an opinion after it has received an application for a change to a marketing authorisation.
CHMP po prejemu vloge za spremembo dovoljenja za promet navadno potrebuje do 90 dni, da poda svoje mnenje.
What is happening for Tygacil for treatment of complicated skin and soft tissue infections and complicated infections in the abdomen?
Kakšne so posledice umika za zdravilo Tygacil pri zdravljenju kompliciranih okužb kože in mehkih tkiv ter kompliciranih trebušnih okužb?
What was Tygacil expected to be used for?
Za kaj naj bi se zdravilo Tygacil uporabljalo?
An additional study looked at the effectiveness of Tygacil in patients who had caught pneumonia in hospital.
Z dodatno študijo so preučevali učinkovitost zdravila Tygacil pri bolnikih, ki so se s pljučnico okužili v bolnišnici.
Tygacil was also expected to be used to treat adults with community-acquired pneumonia.
Zdravilo Tygacil naj bi se uporabljalo tudi za zdravljenje odraslih z izvenbolnišnično pridobljeno pljučnico.
This raised doubts over whether Tygacil would be sufficiently effective in the treatment of patients with severe community-acquired pneumonia.
To je povečalo dvome o tem ali je zdravilo Tygacil dovolj učinkovito za zdravljenje bolnikov s hudo pljučnico, pridobljeno izven bolnišnice.
Tygacil is a powder that is made up into a solution for infusion (drip into a vein).
Zdravilo Tygacil je prašek za pripravo raztopine za infundiranje (dajanje v veno).
How is Tygacil expected to work?
Kako naj bi zdravilo Tygacil delovalo?
This is expected to help in the treatment of community-acquired pneumonia.
To naj bi pomagalo pri zdravljenju pljučnice, pridobljene izven bolnišnice.
Further information on Procoralan can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Procoralan.
Več informacij o zdravilu Procoralan je na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/Procoralan.
Procoralan must not be taken with a number of other medicines.
Zdravilo Procoralan se ne sme jemati skupaj s številnimi drugimi zdravili.
The main measure of effectiveness was a reduction in the risk of death due to heart problems and non-fatal heart attack.
Glavno merilo učinkovitosti je bilo zmanjšanje tveganja smrti zaradi težav s srcem in srčnih napadov brez smrtnega izida.
Procoralan received a marketing authorisation valid throughout the EU on 25 October 2005.
Za zdravilo Procoralan je bilo 25. oktobra 2005 izdano dovoljenje za promet, veljavno po vsej EU.
What measures are being taken to ensure the safe and effective use of Procoralan?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Procoralan?
However, a fifth study in 728 patients showed that adding Procoralan to amlodipine did not provide an additional benefit.
V peti študiji s 728 bolniki pa so dokazali, da dodajanje zdravila Procoralan amlodipinu ne prinaša dodatnih koristi.
Procoralan therefore reduces or prevents the symptoms of angina.
Zdravilo Procoralan tako zmanjša ali prepreči simptome angine pektoris.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Procoralan have been included in the summary of product characteristics and the package leaflet.
Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Procoralan upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
As for all medicines, data on the use of Procoralan are continuously monitored.
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Procoralan stalno spremljajo.
The recommended starting dose is 5 mg twice a day with meals, which the doctor may increase to 7.5 mg twice a day or decrease to 2.5 mg (half a 5-mg tablet) twice a day depending on the patient's heart rate and symptoms.
Priporočeni začetni odmerek je 5 mg dvakrat na dan ob obrokih, ki ga lahko zdravnik poveča na 7,5 mg dvakrat na dan ali zmanjša na 2,5 mg (pol 5-miligramske tablete) dvakrat na dan, odvisno od bolnikovega srčnega utripa in simptomov.
An overview of Procoralan and why it is authorised in the EU
Pregled zdravila Procoralan in zakaj je odobreno v EU
The Agency decided that Procoralan's benefits are greater than its risks and it can be authorised for use in the EU.
Zato je zaključila, da so koristi zdravila Procoralan večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
Procoralan is available as tablets (5 and 7.5 mg) and it can only be obtained with a prescription.
Zdravilo Procoralan je na voljo v obliki tablet (5 in 7,5 mg), njegovo predpisovanje in izdaja pa je le na recept.
In a fourth study in 889 patients, Procoralan was more effective than placebo, when both were added to atenolol.
V četrti študiji z 889 bolniki je bilo zdravilo Procoralan učinkovitejše od placeba, pri čemer so oba dodajali atenololu.
What is Procoralan and what is it used for?
Kaj je zdravilo Procoralan in za kaj se uporablja?
Other information about Procoralan
Druge informacije o zdravilu Procoralan
Why is Procoralan authorised in the EU?
Zakaj je bilo zdravilo Procoralan odobreno v EU?
Side effects reported with Procoralan are carefully evaluated and any necessary action taken to protect patients.
Neželeni učinki, o katerih so poročali pri zdravilu Procoralan, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
What benefits of Procoralan have been shown in studies?
Kakšne koristi zdravila Procoralan so se pokazale v študijah?
Results showed that Procoralan was more effective than placebo at preventing death due to disease of the heart or blood vessels or hospitalisation due to worsening heart failure: 24.5% (793 out of 3,241) of patients treated with Procoralan died or were hospitalised due to worsening heart failure, compared with 28.7% (937 out of 3,264) of patients receiving placebo.
Rezultati so pokazali, da je zdravilo Procoralan učinkovitejše od placeba pri preprečevanju smrti zaradi bolezni srca ali ožilja oziroma hospitalizacije zaradi poslabšanja srčnega popuščanja: 24,5 % (793 od 3 241) bolnikov, ki so bili zdravljeni z zdravilom Procoralan, je umrlo ali je bilo prvič hospitaliziranih zaradi poslabšanja srčnega popuščanja v primerjavi z 28,7 % (937 od 3 264) bolnikov, ki so bili zdravljeni s placebom.
The most common side effect with Procoralan (which may affect more than 1 in 10 people) is luminous phenomena or ‘phosphenes' (a temporary brightness in the field of vision).
Najpogostejši neželeni učinek zdravila Procoralan (ki se lahko pojavi pri več kot 1 bolniku od 10) so pojavi svetlikanja ali „fosfeni“ (prehodno povečanje svetlosti v vidnem polju).
For more information about using Procoralan, see the package leaflet or contact your doctor or pharmacist.
Za več informacij glede uporabe zdravila Procoralan glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
The European Medicines Agency concluded that Procoralan was shown to be effective in long-term angina with an acceptable safety profile for it to provide an alternative treatment for patients who cannot take beta blockers or whose disease is not controlled with them.
Evropska agencija za zdravila je zaključila, da je bilo za zdravilo Procoralan dokazano, da je dovolj učinkovito pri zdravljenju kronične angine pektoris in ima sprejemljiv varnostni profil za nadomestno zdravljenje bolnikov, ki ne morejo jemati zaviralcev receptorjev beta oziroma katerih bolezen ni urejena z njimi.
Procoralan must not be used in patients who have a resting heart rate below 70 beats per minute, very low blood pressure, various types of heart disorder (including cardiogenic shock, rhythm disorders, heart attack, unstable or acute (sudden) heart failure and unstable angina) or severe liver problems.
Zdravila Procoralan ne smejo jemati bolniki, ki imajo srčni utrip med mirovanjem nižji od 70 udarcev na minuto, zelo nizek krvni tlak, razne vrste obolenj srca (npr. kardiogeni šok, motnje ritma, srčni napad, nestabilno ali akutno (nenadno) srčno popuščanje in nestabilno angino pektoris) ali hude težave z jetri.
In this study, a specific subgroup of patients who had symptomatic angina had a small but significant increase in the combined risk of cardiovascular death or non-fatal heart attack with Procoralan compared with placebo (3.4% vs 2.9% yearly incidence rates).
V tej študiji je pri posebni podskupini bolnikov s simptomatsko angino pektoris, zdravljenih z zdravilom Procoralan, prišlo do majhnega, vendar pomembnega povečanja združenega tveganja smrti zaradi srčno-žilne bolezni ali srčnega napada brez smrtnega izida v primerjavi s placebom (letni delež pogostnosti 3,4 % v primerjavi z 2,9 %).
A sixth study compared Procoralan with placebo in 19,102 patients with coronary artery disease and without clinical heart failure.
V šesti študiji so primerjali zdravilo Procoralan in placebo pri 19 102 bolnikih z boleznijo koronarnih arterij brez kliničnega srčnega popuščanja.
Procoralan contains the active substance ivabradine.
Zdravilo Procoralan vsebuje zdravilno učinkovino ivabradin.
What are the risks associated with Procoralan?
Kakšna tveganja so povezana z zdravilom Procoralan?
Procoralan was compared with placebo (a dummy treatment) and other treatments in five main studies involving over 4,000 adults with long-term stable angina.
Zdravilo Procoralan so primerjali s placebom (zdravilom brez zdravilne učinkovine) in drugimi zdravili v petih glavnih študijah, v katere je bilo vključenih več kot 4 000 odraslih s kronično stabilno angino pektoris.
Procoralan is also used in patients with long-term heart failure (when the heart cannot pump enough blood to the rest of the body) who have a normal heart rhythm and whose heart rate is at least 75 beats per minute.
Zdravilo Procoralan se uporablja tudi pri bolnikih s kroničnim srčnim popuščanjem (kadar srce ne more načrpati dovolj krvi po telesu), ki imajo sicer normalen srčni ritem, a je njihov srčni utrip najmanj 75 udarcev na minuto.
By lowering the heart rate, Procoralan reduces the stress on the heart, thereby slowing the progression of heart failure and improving symptoms.
Zdravilo Procoralan z zniževanjem srčnega utripa zmanjša obremenitev srca ter upočasni napredovanje srčnega popuščanja in ublaži simptome.
Procoralan was compared with placebo in one main study involving over 6,500 patients with long-term moderate to severe heart failure.
Zdravilo Procoralan so primerjali s placebom v eni glavni študiji, v katero je bilo vključenih več kot 6 500 bolnikov s kroničnim zmernim do hudim srčnim popuščanjem.
Procoralan is a heart medicine used to treat the symptoms of long-term stable angina (pains to the chest, jaw and back, brought on by physical effort) in adults with coronary artery disease (disease of the heart caused by the obstruction of the blood vessels that supply blood to the heart muscle).The medicine is used in patients who have a normal heart rhythm, and whose heart rate is at least 70 beats per minute.
Procoralan je zdravilo za srce, ki se uporablja za zdravljenje simptomov kronične stabilne angine pektoris (bolečin v prsih, čeljusti in hrbtu zaradi telesnega napora) pri odraslih z boleznijo koronarnih arterij (boleznijo srca, ki jo povzroča zapora v krvnih žilah, ki oskrbujejo srčno mišico).Zdravilo se uporablja pri bolnikih z normalnim srčnim ritmom, katerih srčni utrip je vsaj 70 udarcev na minuto.
The active substance in Procoralan, ivabradine, works by blocking the ‘If currents' in the sinus node, the ‘pacemaker' for the heart that controls the heart's contractions and regulates the heart rate.
Zdravilna učinkovina v zdravilu Procoralan, ivabradin, deluje tako, da zavira „tokove If“ v sinusnem vozlu, tj. spodbujevalniku srca, ki nadzoruje krčenje srca in uravnava srčni utrip.
How is Procoralan used?
Kako se zdravilo Procoralan uporablja?
It also concluded that Procoralan was effective in long-term heart failure with an acceptable safety profile.
Prav tako je zaključila, da je zdravilo Procoralan učinkovito pri zdravljenju kroničnega srčnega popuščanja in ima sprejemljiv varnostni profil.
How does Procoralan work?
Kako zdravilo Procoralan deluje?
For the full list of all side effects reported with Procoralan, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Procoralan, glejte navodilo za uporabo.
For the full list of restrictions with Procoralan, see the package leaflet.
Za celoten seznam omejitev pri uporabi zdravila Procoralan glejte navodilo za uporabo.
For the treatment of angina, Procoralan was originally authorised for patients whose heart rate is at least 60 beats per minute.
Zdravilo Procoralan je bilo za zdravljenje angine pektoris prvotno odobreno za uporabo pri bolnikih s srčnim utripom vsaj 60 udarcev na minuto, vendar je bila pozneje njegova uporaba omejena zgolj na bolnike s srčnim utripom vsaj 70 udarcev na minuto1.
Treatment must be stopped if the heart rate is persistently below 50 beats per minute or if symptoms of bradycardia (slow heart rate) continue despite dose reduction.
Pri bolnikih, starejših od 75 let, se lahko uporabi manjši začetni odmerek 2,5 mg dvakrat na dan. Zdravljenje je treba prekiniti, če srčni utrip stalno pada pod 50 udarcev na minuto ali če se nadaljujejo simptomi bradikardije (počasnega srčnega utripa).
What measures are being taken to ensure the safe and effective use of Zubsolv?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Zubsolv?
The tablets are taken once a day by placing them under the tongue and allowing them to dissolve for up to 10 minutes.
Bolniki tablete jemljejo enkrat na dan tako, da jih položijo pod jezik in pustijo do 10 minut, da se raztopijo.
The full EPAR for Zubsolv can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Zubsolv je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.