natgillin/translations-raw huggingface dataset:
Medicinal products affected by serum potassium disturbances: periodic monitoring of serum potassium is recommended when Karvezide is administered with medicinal products affected by serum potassium disturbances (e.g. digitalis glycosides, antiarrhythmics).
Zdravila, na katera vpliva serumska koncentracija kalija: med hkratnim zdravljenjem z zdravilom Karvezide in drugimi zdravili, na katerih delovanje vpliva serumska koncentracija kalija (npr. z digitalisovimi glikozidi, antiaritmiki), je priporočeno redno preverjanje kalija v serumu.
Angiotensin II Receptor Antagonists (AIIRAs):
Antagonisti angiotenzina II
Protect your skin from sun exposure and UV rays while taking Karvezide.
Med jemanjem zdravila Karvezide zaščitite kožo pred izpostavljenostjo soncu in UV-žarkom.
 The other ingredients are lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, hypromellose, silicon dioxide, magnesium stearate, titanium dioxide, macrogol 3000, red and yellow ferric oxides, carnauba wax.
Druge sestavine zdravila so laktoza monohidrat, mikrokristalna celuloza, premreženi natrijev karmelozat, hipromeloza, silicijev dioksid, magnezijev stearat, titanov dioksid, makrogol 3000, rdeči in rumeni železov oksid, karnauba vosek.
 The other ingredients are microcrystalline cellulose, croscarmellose sodium, lactose monohydrate, magnesium stearate, colloidal hydrated silica, pregelatinised maize starch, red and yellow ferric oxides (E172).
Druge sestavine zdravila so mikrokristalna celuloza, premreženi natrijev karmelozat, laktoza monohidrat, magnezijev stearat, hidratirani koloidni silicijev dioksid, predgelirani koruzni škrob, rdeči in rumeni železov oksid (E172).
When measured by ambulatory blood pressure monitoring, the trough to peak effects of Karvezide 150 mg/12.5 mg were 100%.
Med 24-urnim merjenjem krvnega tlaka pri bolnikih, ki so prejemali zdravilo Karvezide 150 mg/12,5 mg, je bilo razmerje med najmanjšim in največjim učinkom 100%.
No dosage adjustment is necessary in patients with renal impairment whose creatinine clearance is ≥ 30 ml/min.
Pri bolnikih z ledvično okvaro, pri katerih je ledvični očistek kreatinina ≥ 30 ml/min,
The two active ingredients in Karvezide work together to lower blood pressure further than if either was given alone.
Zdravilni učinkovini v zdravilu Karvezide znižujeta krvni tlak, in to še bolj kot če bi jemali vsako učinkovino posebej.
(It is also better to avoid Karvezide in early pregnancy - see pregnancy section) if you have severe liver or kidney problems if you have difficulty in producing urine if your doctor determines that you have persistently high calcium or low potassium levels in your blood if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren.
če imate hudo okvaro jeter ali ledvic če imate težave z odvajanjem seča če je zdravnik ugotovil, da imate stalno zvečano koncentracijo kalcija ali zmanjšano koncentracijo kalija v krvi če imate sladkorno bolezen ali okvarjeno delovanje ledvic in se zdravite z zdravilom za znižanje krvnega tlaka, ki vsebuje aliskiren.
Uncommon side effects -may affect up to 1 in 100 people): diarrhoea low blood pressure fainting heart rate increased flushing swelling sexual dysfunction (problems with sexual performance) blood tests may show lowered levels of potassium and sodium in your blood.
driska nizek krvni tlak omedlevica hiter srčni utrip zardevanje otekline spolne motnje (težave pri spolnih odnosih) krvne preiskave lahko pokažejo znižane vrednosti kalija in natrija v krvi.
Karvezide 300 mg/25 mg film-coated tablets.
Karvezide 300 mg/25 mg filmsko obložene tablete
Undesirable effects where the frequency is not known are: headache, ringing in the ears, cough, taste disturbance, indigestion, pain in joints and muscles, liver function abnormal and impaired kidney function, increased level of potassium in your blood and allergic reactions such as rash, hives, swelling of the face, lips, mouth, tongue or throat.
prebavne motnje, bolečine v sklepih in mišicah, nenormalno delovanje jeter, okvara delovanja ledvic, zvišanje vrednosti kalija v krvi in alergijske reakcije, kot so izpuščaj, koprivnica in lokalizirana oteklina obraza, ustnic, ust, jezika ali žrela.
 If you get any side effects, talk to your doctor or pharmacist.
Če opazite kateri koli neželeni učinek, se posvetujte s svojim zdravnikom ali s farmacevtom.
Increases in cholesterol and triglyceride levels have been associated with thiazide diuretic therapy; however at the 12.5 mg dose contained in Karvezide, minimal or no effects were reported.
Pri bolnikih, ki so jemali po 12,5 mg hidroklorotiazida, kolikor ga vsebuje zdravilo Karvezide, je bil ta učinek zelo majhen ali pa ga sploh ni bilo.
No dosage adjustment of Karvezide is necessary in older people.
Pri starostnikih odmerka zdravila Karvezide ni treba prilagajati.
When clinically appropriate direct change from monotherapy to the fixed combinations may be considered:  Karvezide 150 mg/12.5 mg may be administered in patients whose blood pressure is not adequately controlled with hydrochlorothiazide or irbesartan 150 mg alone;  Karvezide 300 mg/12.5 mg may be administered in patients insufficiently controlled by irbesartan 300 mg or by Karvezide 150 mg/12.5 mg.  Karvezide 300 mg/25 mg may be administered in patients insufficiently controlled by Karvezide 300 mg/12.5 mg.
Kadar je klinično primerno, se lahko razmisli o prehodu iz monoterapije na kombinirano zdravljenje: Zdravilo Karvezide 150 mg/12,5 mg je namenjeno bolnikom, pri katerih se zvišan krvni tlak med zdravljenjem samo s hidroklorotiazidom ali samo s 150 mg irbesartana ni dovolj znižal.
How to store Karvezide
Shranjevanje zdravila Karvezide
Although not specifically studied with the Karvezide, rebound hypertension has not been seen with either irbesartan or hydrochlorothiazide.
Posebnih študij z zdravilom Karvezide ni, kljub temu pa povratnega zvišanja krvnega tlaka pri bolnikih, ki so jemali bodisi irbesartan bodisi hidroklorotiazid, po prenehanju jemanja zdravila niso opazili.
Excipient with known effect: Each film-coated tablet contains 89.5 mg of lactose (as lactose monohydrate).
Ena filmsko obložena tableta vsebuje 89,5 mg laktoze (v obliki laktoze monohidrata).
 if you suffer from heart problems  if you suffer from liver problems  if you suffer from diabetes if you suffer from lupus erythematosus (also known as lupus or SLE) if you suffer from primary aldosteronism (a condition related to high production of the hormone aldosterone, which causes sodium retention and, in turn, an increase in blood pressure).
če imate primarni aldosteronizem (stanje, povezano s čezmernim izločanjem hormona aldosterona, kar povzroči zastajanje natrija in posledično zvišanje krvnega tlaka)
Karvezide 150 mg/12.5 mg tablets are supplied in blister packs of 14, 28, 56 or 98 tablets.
Karvezide 150 mg/12,5 mg tablete so na voljo v pretisnih omotih s 14, 28, 56 ali 98 tabletami.
headache
Glavobol
Excipient with known effect: Each film-coated tablet contains 53.3 mg of lactose (as lactose monohydrate).
Ena filmsko obložena tableta vsebuje 53,3 mg laktoze (v obliki laktoze monohidrata).
Karvezide 300 mg/12.5 mg tablets are supplied in blister packs of 14, 28, 56 or 98 tablets.
Karvezide 300 mg/12,5 mg tablete so na voljo v pretisnih omotih s 14, 28, 56 ali 98 tabletami.
Common side effects (may affect up to 1 in 10 people): nausea/vomiting abnormal urination fatigue dizziness (including when getting up from a lying or sitting position) blood tests may show raised levels of an enzyme that measures the muscle and heart function (creatine kinase) or raised levels of substances that measure kidney function (blood urea nitrogen, creatinine).
krvne preiskave lahko pokažejo zvišanje vrednosti encima, ki kaže na delovanje mišic in srca (encim kreatin-kinaza), ali zvišanje vrednosti snovi, ki so merilo delovanja ledvic (dušik sečnine v krvi, kreatinin).
Excipient with known effect: Each tablet contains 26.65 mg of lactose (as lactose monohydrate).
Ena tableta vsebuje 26,65 mg laktoze (v obliki laktoze monohidrata).
Each film-coated tablet of Karvezide 300 mg/25 mg contains 300 mg irbesartan and 25 mg hydrochlorothiazide.
Ena Karvezide 300 mg/25 mg filmsko obložena tableta vsebuje 300 mg irbesartana in 25 mg hidroklorotiazida.
Vistor hf.
UV-žarkom.
A total of 697 patients were randomized in a 2:1 ratio to either irbesartan/hydrochlorothiazide 150 mg/12.5 mg or to irbesartan 150 mg and systematically force titrated (before assessing the response to the lower dose) after one week toirbesartan/hydrochlorothiazide 300 mg/25 mg or irbesartan 300 mg, respectively.
Skupaj je bilo randomiziranih 697 bolnikov v razmerju 2:1, bodisi na irbesartan/hidroklorotiazid 150 mg/12,5 mg bodisi na irbesartan 150 mg.
What Karvezide contains  The active substances are irbesartan and hydrochlorothiazide.
Zdravilni učinkovini sta irbesartan in hidroklorotiazid.
Because no information is available regarding the use of Karvezide during breast-feeding, Karvezide is not recommended and alternative treatments with better established safety profiles during breastfeeding are preferable, especially while nursing a newborn or preterm infant.
Podatkov o uporabi zdravila Karvezide med dojenjem ni na voljo, zato uporaba zdravila Karvezide med dojenjem ni priporočljiva.
Warnings and precautions Talk to your doctor before taking Karvezide and if any of the following apply to you:  if you get excessive vomiting or diarrhoea  if you suffer from kidney problems or have a kidney transplant  if you suffer from heart problems if you suffer from liver problems  if you suffer from diabetes if you suffer from lupus erythematosus (also known as lupus or SLE) if you suffer from primary aldosteronism (a condition related to high production of the hormone aldosterone, which causes sodium retention and, in turn, an increase in blood pressure).
če začnete prekomerno bruhati ali dobite hudo drisko če imate težave z ledvicami ali presajeno ledvico če imate težave s srcem če imate težave z jetri če imate sladkorno bolezen če imate eritematozni lupus (znan tudi kot lupus ali sistemski eritematozni lupus)
Karvezide is unlikely to affect your ability to drive or use machines.
Možnost, da bi zdravilo Karvezide vplivalo na sposobnost za upravljanje vozil in strojev je majhna.
Karvezide 300 mg/25 mg film-coated tablets are supplied in blister packs of 14, 28, 30, 56, 84, 90 or 98 film-coated tablets.
Karvezide 300 mg/25 mg filmsko obložene tablete so na voljo v pretisnih omotih s 14, 28, 30, 56, 84, 90 ali 98 filmsko obloženimi tabletami.
Each film-coated tablet contains 300 mg of irbesartan and 25 mg of hydrochlorothiazide.
Ena filmsko obložena tableta vsebuje 300 mg irbesartana in 25 mg hidroklorotiazida.
cough
Kašelj
These lesions were not observed in macaques;  decreases in serum potassium due to hydrochlorothiazide and partly prevented when hydrochlorothiazide was given in combination with irbesartan.
znižanje kalija v serumu med uporabo hidroklorotiazida, ki je bilo med kombiniranim dajanjem z irbesartanom manj izrazito.
Karvezide 300 mg/12.5 mg film-coated tablets.
Karvezide 300 mg/12,5 mg filmsko obložene tablete
Karvezide 150 mg/12.5 mg film-coated tablets.
Karvezide 150 mg/12,5 mg filmsko obložene tablete
Each tablet of Karvezide 150 mg/12.5 mg contains 150 mg irbesartan and 12.5 mg hydrochlorothiazide.
Ena Karvezide 150 mg/12,5 mg tableta vsebuje 150 mg irbesartana in 12,5 mg hidroklorotiazida.
Karvezide 150 mg/12.5 mg film-coated tablets are supplied in blister packs of 14, 28, 30, 56, 84, 90 or 98 film-coated tablets.
Karvezide 150 mg/12,5 mg filmsko obložene tablete so na voljo v pretisnih omotih s 14, 28, 30, 56, 84, 90 ali 98 filmsko obloženimi tabletami.
Each tablet of Karvezide 300 mg/12.5 mg contains 300 mg irbesartan and 12.5 mg hydrochlorothiazide.
Ena Karvezide 300 mg/12,5 mg tableta vsebuje 300 mg irbesartana in 12,5 mg hidroklorotiazida.
The following changes, observed in rats and macaques receiving the irbesartan/hydrochlorothiazide combination at 10/10 and 90/90 mg/kg/day, were also seen with one of the two medicinal products alone and/or were secondary to decreases in blood pressure (no significant toxicologic interactions were observed):  kidney changes, characterized by slight increases in serum urea and creatinine, and hyperplasia/hypertrophy of the juxtaglomerular apparatus, which are a direct consequence of the interaction of irbesartan with the renin-angiotensin system;  slight decreases in erythrocyte parameters (erythrocytes, haemoglobin, haematocrit);  stomach discoloration, ulcers and focal necrosis of gastric mucosa were observed in few rats in a 6 months toxicity study at irbesartan 90 mg/kg/day, hydrochlorothiazide 90 mg/kg/day, and irbesartan/hydrochlorothiazide 10/10 mg/kg/day.
ledvične spremembe so se kazale kot blago zvečanje sečnine in kreatinina v serumu ter hiperplazija/hipertrofija jukstaglomerulnega aparata, kar je neposredna posledica interakcije med irbesartanom in sistemom renin-angiotenzin; blago zmanjšanje eritrocitnih parametrov (eritrocitov, hemoglobina in hematokrita);
Karvezide 300 mg/25 mg film-coated tablets irbesartan/hydrochlorothiazide
Karvezide 300 mg/25 mg filmsko obložene tablete irbesartan/hidroklorotiazid
Karvezide 300 mg/12.5 mg film-coated tablets are supplied in blister packs of 14, 28, 30, 56, 84, 90 or 98 film-coated tablets.
Karvezide 300 mg/12,5 mg filmsko obložene tablete so na voljo v pretisnih omotih s 14, 28, 30, 56, 84, 90 ali 98 filmsko obloženimi tabletami.
Each film-coated tablet of Karvezide 150 mg/12.5 mg contains 150 mg irbesartan and 12.5 mg hydrochlorothiazide.
Ena Karvezide 150 mg/12,5 mg filmsko obložena tableta vsebuje 150 mg irbesartana in 12,5 mg hidroklorotiazida.
Each film-coated tablet contains 150 mg of irbesartan and 12.5 mg of hydrochlorothiazide.
Ena filmsko obložena tableta vsebuje 150 mg irbesartana in 12,5 mg hidroklorotiazida.
Excipient with known effect: Each tablet contains 65.8 mg of lactose (as lactose monohydrate).
Ena tableta vsebuje 65,8 mg laktoze (v obliki laktoze monohidrata).
Each tablet contains 150 mg of irbesartan and 12.5 mg of hydrochlorothiazide.
Ena tableta vsebuje 150 mg irbesartana in 12,5 mg hidroklorotiazida.
Each tablet contains 300 mg of irbesartan and 12.5 mg of hydrochlorothiazide.
Ena tableta vsebuje 300 mg irbesartana in 12,5 mg hidroklorotiazida.
Each film-coated tablet contains 300 mg of irbesartan and 12.5 mg of hydrochlorothiazide.
Ena filmsko obložena tableta vsebuje 300 mg irbesartana in 12,5 mg hidroklorotiazida.
Each film-coated tablet of Karvezide 300 mg/12.5 mg contains 300 mg irbesartan and 12.5 mg hydrochlorothiazide.
Ena Karvezide 300 mg/12,5 mg filmsko obložena tableta vsebuje 300 mg irbesartana in 12,5 mg hidroklorotiazida.
Karvezide 150 mg/12.5 mg film-coated tablets irbesartan/hydrochlorothiazide
Karvezide 150 mg/12,5 mg filmsko obložene tablete irbesartan/hidroklorotiazid
While this is not documented with Karvezide, a similar effect should be anticipated.
Podoben učinek bi lahko pričakovali pri zdravljenju z zdravilom Karvezide, čeprav to pri zdravljenju z njim ni bilo dokazano.
Karvezide 300 mg/12.5 mg film-coated tablets irbesartan/hydrochlorothiazide
Karvezide 300 mg/12,5 mg filmsko obložene tablete irbesartan/hidroklorotiazid
The trough to peak effects measured by cuff during office visits were 68% and 76% for Karvezide 150 mg/12.5 mg and Karvezide 300 mg/12.5 mg, respectively.
Pri merjenju z manšeto v ambulanti je bilo pri bolnikih, ki so jemali zdravilo Karvezide 150 mg/12,5 mg, to razmerje 68%, pri tistih, ki so dobivali zdravilo
You may need to have blood checks if you take: potassium supplements salt substitutes containing potassium potassium sparing medicines or other diuretics (water tablets) some laxatives medicines for the treatment of gout therapeutic vitamin D supplements medicines to control heart rhythm medicines for diabetes (oral agents or insulins) carbamazepine (a medicine for the treatment of epilepsy).
zdravila za uravnavanje srčnega ritma zdravila za zdravljenje sladkorne bolezni (peroralni pripravki ali insulin) karbamazepin (zdravilo za zdravljenje epilepsije)
EU/1/98/085/008 - 14 tablets EU/1/98/085/004 - 28 tablets EU/1/98/085/005 - 56 tablets EU/1/98/085/010 - 56 x 1 tablets EU/1/98/085/006 - 98 tablets
EU/1/98/085/028 - 56 x 1 tableta EU/1/98/085/026 - 84 tablet
Package leaflet: Information for the patient Karvezide 300 mg/25 mg film-coated tablets irbesartan/hydrochlorothiazide
Navodilo za uporabo Karvezide 300 mg/25 mg filmsko obložene tablete irbesartan/hidroklorotiazid
EU/1/98/085/007 - 14 tablets EU/1/98/085/001 - 28 tablets EU/1/98/085/002 - 56 tablets EU/1/98/085/009 - 56 x 1 tablets EU/1/98/085/003 - 98 tablets
EU/1/98/085/009 - 56 x 1 tableta EU/1/98/085/003 - 98 tablet
Package leaflet: Information for the patient Karvezide 150 mg/12.5 mg tablets irbesartan/hydrochlorothiazide
Navodilo za uporabo Karvezide 150 mg/12,5 mg tablete irbesartan/hidroklorotiazid
Package leaflet: Information for the patient Karvezide 150 mg/12.5 mg film-coated tablets irbesartan/hydrochlorothiazide
Navodilo za uporabo Karvezide 150 mg/12,5 mg filmsko obložene tablete irbesartan/hidroklorotiazid
Package leaflet: Information for the patient Karvezide 300 mg/12.5 mg tablets irbesartan/hydrochlorothiazide
Navodilo za uporabo Karvezide 300 mg/12,5 mg tablete irbesartan/hidroklorotiazid
Package leaflet: Information for the patient Karvezide 300 mg/12.5 mg film-coated tablets irbesartan/hydrochlorothiazide
Navodilo za uporabo Karvezide 300 mg/12,5 mg filmsko obložene tablete irbesartan/hidroklorotiazid
What Karvezide looks like and contents of the pack Karvezide 300 mg/25 mg film-coated tablets are pink, biconvex, oval-shaped, with a heart debossed on one side and the number 2788 engraved on the other side.
Karvezide 300 mg/25 mg filmsko obložene tablete so rožnate barve, bikonveksne in ovalne oblike.
Karvezide with food and drink Karvezide can be taken with or without food.
Zdravilo Karvezide skupaj s hrano in pijačo
EU/1/98/085/011 - 14 tablets EU/1/98/085/012 - 28 tablets EU/1/98/085/029 - 30 tablets EU/1/98/085/013 - 56 tablets EU/1/98/085/014 - 56 x 1 tablets EU/1/98/085/021 - 84 tablets EU/1/98/085/032 - 90 tablets EU/1/98/085/015 - 98 tablets
EU/1/98/085/014 - 56 x 1 tableta EU/1/98/085/021 - 84 tablet
The European Commission issued a decision on 20 December 2012.
Evropska komisija je sklep izdala 20. decembra 2012.
The company wanted the authorisation to be recognised in the Czech Republic , Denmark, Estonia, Hungary, Lithuania, Latvia, Norway, Poland, Sweden, Slovenia and Slovakia (the ‘concerned Member States').
Družba je želela, da se dovoljenje za promet z zdravilom prizna v Češki republiki, na Danskem, v Estoniji, na Madžarskem, v Litvi, Latviji, na Norveškem, Poljskem, Švedskem, v Sloveniji in na Slovaškem (v „zadevnih državah članicah”).
This means that the use of the active substance has been well-established in the European Union for over ten years.
To pomeni, da je bila uporaba zdravilne učinkovine v Evropski uniji dobro uveljavljena že več kot deset let.
‘Idiopathic' means that the cause of the urticaria is not known.
„Idiopatska” pomeni, da vzrok urtikarije ni znan.
The initial authorisation was based on a wellestablished use application.
Prvotno dovoljenje je temeljilo na vlogi na podlagi dobro uveljavljene uporabe.
Why was Loraxin reviewed?
Zakaj je bilo zdravilo Loraxin pregledano?
However, the Member States were not able to reach an agreement and the Finnish medicines regulatory agency referred the matter to the CHMP for arbitration on 23 December 2011.
Vendar države članice niso mogle doseči soglasja, zato je finska regulativna agencija za zdravila 23. decembra 2011 zadevo napotila na CHMP v arbitražo.
On 21 June 2012, the European Medicines Agency completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicine Loraxin.
Evropska agencija za zdravila je 21. junija 2012 zaključila arbitražni postopek po nesoglasju med državami članicami Evropske unije (EU) glede izdaje dovoljenja za promet z zdravilom Loraxin.
The grounds for the referral were the concerns of the Swedish and Polish medicines agencies that its safety and benefits could not be ascertained on the basis of the data that were submitted.
Razlogi za napotitev so bili pomisleki švedske in poljske agencije za zdravila, da na podlagi predloženih podatkov ni mogoče dokazati varnosti in koristi zdravila.
The active substance in Loraxin, loratadine, is an antihistamine.
Zdravilna učinkovina v zdravilu Loraxin, loratadin, je antihistaminik.
For well-established use applications, data from the published literature on medicines with the same active substance are used to show the benefits and safety of a medicine.
Vloge na podlagi dobro uveljavljene uporabe temeljijo na podatkih iz objavljene literature o zdravilih z isto zdravilno učinkovino, ki naj bi dokazali koristi in varnost zdravila.
Loraxin is a medicine used to relieve the symptoms of allergic rhinitis (inflammation of the nasal passages caused by an allergy such as hay fever or allergy to dust mites) and long-term idiopathic urticaria (itchy rash).
Loraxin je zdravilo, ki se uporablja za lajšanje simptomov alergijskega rinitisa (vnetja nosne votline, ki ga povzroči alergija, na primer seneni nahod ali alergija na pršice) in kronične idiopatske urtikarije (srbečega izpuščaja).
The Committee therefore recommended that the marketing authorisation granted in Finland should not be recognised in other Member States of the EU.
Zato je priporočil, da se dovoljenje za promet z zdravilom, ki je bilo izdano na Finskem, ne prizna v drugih državah članicah EU.
It works by blocking receptors for histamine, a substance in the body that causes allergic symptoms.
Deluje tako, da zavira receptorje, na katere se veže histamin, tj. snov v telesu, ki povzroča alergijske simptome.
What is Loraxin?
Kaj je zdravilo Loraxin?
Therefore, the Committee concluded that the benefits of the medicine could not be shown to outweigh its risks and recommended that the marketing authorisation should not be granted in the concerned Member States.
Zato je zaključil, da ni mogoče dokazati, da koristi zdravila odtehtajo z njim povezana tveganja, in priporočil, da se dovoljenje za promet z zdravilom v zadevnih državah članicah ne izda.
Vitabalans Oy submitted an application for Loraxin for mutual recognition, on the basis of an initial authorisation granted by Finland on 31 August 2010.
Družba Vitabalans Oy je predložila vlogo za pridobitev dovoljenja za promet z zdravilom Loraxin po postopku z medsebojnim priznavanjem na podlagi prvotnega dovoljenja za promet z zdravilom, izdanega 31. avgusta 2010 na Finskem.
The marketing authorisation in Finland should also be suspended.
Prav tako je treba začasno umakniti dovoljenje za promet z zdravilom na Finskem.
The CHMP noted that the published data that was submitted with this application were limited, and not sufficient to support this well-established use application for Loraxin.
CHMP je ugotovil, da so bili objavljeni podatki, ki so bili predloženi v podporo vlogi, omejeni in niso zadostovali za utemeljitev te vloge za pridobitev dovoljenja za promet z zdravilom Loraxin na podlagi dobro uveljavljene uporabe.
In addition, the Committee recommended that the marketing authorisation for Loraxin in Finland should be suspended.
Prav tako je priporočil začasen umik dovoljenja za promet z zdravilom Loraxin na Finskem.
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that it was not possible to show that the benefits of Loraxin outweigh its risks based on the data submitted by the company.
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da na podlagi podatkov, ki jih je predložila družba, ni mogoče dokazati, da koristi zdravila Loraxin odtehtajo z njim povezana tveganja.
Tell your doctor straight away if:
Zdravniku takoj povejte, če:
• Treatment is continued until you get the desired response.
• Zdravljenje se nadaljuje, dokler ne dobite želenega odziva.
In your body:
V vašem telesu:
If this happens, your doctor will need to examine you as soon as possible.
Če se to zgodi, vas mora čim prej pregledati zdravnik.