natgillin/translations-raw huggingface dataset:
Animals should not be stroked, groomed or allow to groom each other, until the application site is dry, and they should not be allowed to swim or treated with shampoo within 48 hours after treatment.
Paziti je treba, da se živali ne božajo, čistijo ali čistijo druga drugi dlake, dokler mesto nanosa ni suho, prav tako pa živalim ne smete dovoliti plavanja ali jih šamponirati 48 ur po zdravljenju.
Furthermore, the CVMP concluded that the product is effective as part of a treatment strategy for flea allergy dermatitis and recommended that Activyl be given a marketing authorisation.
Poleg tega je Odbor ugotovil, da je zdravilo učinkovito kot del strategije zdravljenje dermatitisa zaradi alergije na bolhe, ter priporočil, da se za zdravilo Activyl odobri dovoljenje za promet.
Why has Activyl been approved?
Zakaj je bilo zdravilo Activyl odobreno?
The effectiveness against the specified parasites was investigated in both laboratory studies and in five field studies (four for the spot-on for cats or dogs only and one for both cats and dogs).
Učinkovitost zoper določene zajedavce so proučevali v laboratorijskih in petih terenskih študijah (štirih za kožni nanos pri samo mačkah ali samo psih ter eni pri mačkah in psih).
Activyl is a medicine that contains the active substance indoxacarb.
Activyl je zdravilo, ki vsebuje zdravilno učinkovino indoksakarb.
Pet owners should avoid skin contact with the pipette contents.
Lastniki živali naj se izogibajo stika kože z vsebino kapalke.
After application, indoxacarb is eaten by the insects and activated in their gut into an active compound.
Po nanosu indoksakarb pojedo insekti, ta pa se v njihovem črevesju aktivira v aktivno spojino.
The contents of one full Activyl pipette (appropriate to the animal and its weight) is applied directly to the skin, after parting the animals fur, onto the back of the cat's neck at the base of its head, or between the shoulder blades and along the back of dogs.
Vsebina ene cele kapalke zdravila Activyl (primerne glede na žival in njeno težo) se nanese neposredno na kožo, potem ko ste razmaknili dlako živali, in sicer na zatilje pri mačkah ali med lopatice in vzdolž hrbta pri psih.
Activyl is used to treat and prevent flea infestations in dogs and cats and to treat flea allergy dermatitis (an allergic reaction to flea bites).
Zdravilo Activyl se uporablja za zdravljenje in preprečevanje infestacije z bolhami pri psih in mačkah ter za zdravljenje dermatitisa zaradi alergije na bolhe (alergijske reakcije na ugrize bolh).
The results from the laboratory studies and from the field studies, in both cats and dogs, showed that Activyl is as effective as the comparator medicine.
Rezultati laboratorijskih in terenskih študij so pokazali, da je zdravilo Activyl pri mačkah in psih enako učinkovito kot primerjalno zdravilo.
The studies also showed that Activyl helps with the management of allergic flea dermatitis.
Študije so tudi pokazale, da zdravilo Activyl pomaga pri obvladovanju dermatitisa zaradi alergije na bolhe.
It is available as a clear, colourless to yellow solution presented as a ‘spot-on' in pipettes already filled with the correct amount of Activyl needed to treat one cat or dog depending on its weight (5 sizes of pipettes for different dog weights and 2 sizes of pipettes for different cat weights).
Na voljo je kot bistra brezbarvna do rumena raztopina za kožni nanos v kapalkah, ki so že napolnjene z ustreznim odmerkom zdravila Activyl za zdravljenje ene mačke ali psa, odvisno od teže živali (pet velikosti kapalk za različne teže psov in dve velikosti kapalk za različne teže mačk).
The active substance in Activyl, indoxacarb, is an ectoparasiticide.
Zdravilna učinkovina v zdravilu Activyl, indoksakarb, je ektoparaziticid.
For a full list of all side-effects reported with Activyl, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Activyl, glejte navodilo za uporabo.
The effectiveness was measured by counting of fleas, flea allergy dermatitis assessment, observations on local reactions at the application site after treatment.
Učinkovitost so merili na podlagi števila bolh, ocene dermatitisa zaradi alergije na bolhe, opažanj glede lokalnih reakcij na mestu nanosa po zdravljenju.
They should not smoke, eat or drink, and should wash their hands thoroughly after use.
Med nanašanjem zdravila ne smejo kaditi, jesti ali piti, po uporabi pa si morajo temeljito umiti roke.
The CVMP concluded that the benefits of Activyl exceed the risks for the treatment and prevention of flea infestations in dogs and cats.
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je zaključil, da so koristi zdravila Activyl za zdravljenje in preprečevanje infestacij z bolhami pri psih in mačkah večje od z njim povezanih tveganj.
A reduction in symptoms of flea allergy dermatitis was recorded in both target species.
Pri obeh ciljnih vrstah je bilo zabeleženo zmanjšanje simptomov dermatitisa zaradi alergije na bolhe.
What is Activyl used for?
Za kaj se zdravilo Activyl uporablja?
Activyl is given as a single treatment.
Zdravilo Activyl se aplicira samo enkrat.
How has Activyl been studied?
Kako je bilo zdravilo Activyl raziskano?
What is Activyl?
Kaj je zdravilo Activyl?
How does Activyl work?
Kako zdravilo Activyl deluje?
There might also be some temporary itchiness, inflammation or hair loss at the place where the product has been applied to the skin.
Na mestu nanosa zdravila se lahko pojavi prehodno srbenje, vnetje ali izpadanje dlak.
This means that, although there is insufficient evidence from clinical trials, the effectiveness of these herbal medicines is plausible and there is evidence that they have been used safely in this way for at least 30 years (including at least 15 years within the EU).
To pomeni, da je kljub nezadostnim podatkom iz kliničnih preskušanj učinkovitost teh zdravil rastlinskega izvora verjetna, saj obstajajo dokazi, da so se na navedeni način varno uporabljala vsaj 30 let (najmanj 15 let tudi v EU).
The HMPC recommended that these medicines should not be used in patients with stomach and gut ulcers, hyperthyroidism (overactive thyroid gland) or cardiovascular problems, such as hypertension (high blood pressure) and arrhythmias (heart rhythm problems).
Odbor HMPC je priporočil, da se teh zdravil ne sme uporabljati pri bolnikih z razjedami na želodcu ter črevesu, hipertiroidizmom (čezmerno dejavno ščitnico) ali srčno-žilnimi težavami, kot so hipertenzija (visok krvni tlak) in aritmije (motnje srčnega ritma).
Guarana seed should only be used in adults.
Seme gvarane se lahko uporablja samo pri odraslih.
Guarana seed EMA/HMPC/284498/2013
Seme gvarane EMA/HMPC/284498/2013
What is guarana seed?
Kaj je seme gvarane?
Guarana seed is the common name for the seed of the plant Paulinia cupana Kunth ex H.B.K.
Seme gvarane je splošno ime za seme rastline Paulinia cupana Kunth ex H.B.K.
In its assessment, the HMPC considered studies on the effects of guarana seed on behaviour, which showed that it had a stimulant effect and led to improvements in symptoms of fatigue.
Pri svoji oceni je odbor HMPC upošteval študije učinkov semena gvarane na vedenje, ki so pokazale, da ima stimulativen učinek in izboljša simptome utrujenosti.
This summary is not intended to provide practical advice on how to use medicines containing guarana seed.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o uporabi zdravil, ki vsebujejo seme gvarane.
This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of guarana seed.
To je povzetek znanstvenih zaključkov Odbora za zdravila rastlinskega izvora (HMPC) v zvezi z medicinsko uporabo semena gvarane.
The HMPC conclusions on the use of guarana seed medicines for fatigue and weakness are based on their ‘traditional use'.
Zaključki odbora HMPC o uporabi zdravil proti utrujenosti in šibkosti, ki vsebujejo seme gvarane, temeljijo na njihovi „tradicionalni uporabi“.
Further information on the risks associated with guarana seed medicines, including the appropriate precautions for their safe use, can be found in the monograph under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Dodatne informacije o tveganjih, povezanih z zdravili, ki vsebujejo seme gvarane, vključno z ustreznimi previdnostnimi ukrepi za njihovo varno uporabo, so na voljo v monografiji na spletni strani agencije pod zavihkom „Vsi dokumenti“: ema.europa.eu/Find medicine/Herbal medicines for human use.
If symptoms persist for longer than one week during the use of Guarana seed, a qualified healthcare practitioner should be consulted.
Če simptomi med njegovo uporabo vztrajajo več kot en teden, se je treba posvetovati z zdravnikom.
Detailed instructions on how to take guarana seed medicines and who can use them can be found in the package leaflet that comes with the medicine.
Podrobna navodila o tem, kako jemati zdravila s semenom gvarane in o tem, kdo jih lahko jemlje, so na voljo v navodilu za uporabo, ki je priloženo posameznemu zdravilu.
Guarana seed can also be found in combination with other herbal substances in some herbal medicines.
Seme gvarane je v nekaterih zdravilih rastlinskega izvora lahko na voljo tudi v kombinaciji z drugimi rastlinskimi snovmi.
Information on the use and licensing of guarana seed medicines in EU Member States should be obtained from the relevant national authorities.
Za informacije o uporabi in dovoljenjih za promet z zdravili, ki vsebujejo seme gvarane, v državah članicah EU se obrnite na pristojni nacionalni organ.
The HMPC conclusions are taken into account by EU Member States when evaluating applications for the licensing of herbal medicines containing guarana seed.
Ugotovitve odbora HMPC države članice EU upoštevajo pri ocenjevanju vlog za izdajo dovoljenja za promet z zdravili rastlinskega izvora, ki vsebujejo seme gvarane.
Guarana seed
Seme gvarane
Herbal medicines containing guarana seed are usually available in solid forms to be taken by mouth.
Zdravila rastlinskega izvora, ki vsebujejo seme gvarane, so navadno na voljo v trdnih oblikah, ki se jemljejo peroralno (zaužijejo skozi usta).
Any applications for the licensing of medicines containing guarana seed have to be submitted to the national authorities responsible for medicinal products, which will assess the application for the herbal medicine and take into account the scientific conclusions of the HMPC.
Vlogo za izdajo dovoljenja za promet z zdravili, ki vsebujejo seme gvarane, je treba predložiti pristojnemu nacionalnemu organu za zdravila, ki bo to vlogo za izdajo dovoljenja za promet z zdravilom rastlinskega izvora ocenil in upošteval znanstvene zaključke odbora HMPC.
Further information on the HMPC assessment of guarana seed medicines, including details of the Committee's conclusions, can be found under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Dodatne informacije o oceni zdravil, ki vsebujejo seme gvarane, ki jo je opravil odbor HMPC, vključno z njegovimi znanstvenimi zaključki, so na voljo na spletni strani agencije pod zavihkom „Vsi dokumenti“: ema.europa.eu/Find medicine/Herbal medicines for human use.
The HMPC concluded that, on the basis of its long-standing use, guarana seed can be used for the relief of symptoms of fatigue (tiredness) and weakness.
Odbor HMPC je sklenil, da se lahko na podlagi izkušenj dolgoletne uporabe seme gvarane uporablja za lajšanje simptomov utrujenosti in šibkosti.
How are guarana seed medicines approved in the EU?
Kako so zdravila, ki vsebujejo seme gvarane, odobrena v EU?
Other information about guarana seed medicines
Druge informacije o zdravilih, ki vsebujejo seme gvarane
What are the risks associated with guarana seed medicines?
Kakšna tveganja so povezana z zdravili, ki vsebujejo seme gvarane?
What evidence supports the use of guarana seed medicines?
Kateri dokazi podpirajo uporabo zdravil, ki vsebujejo seme gvarane?
For more information about treatment with guarana seed medicines, read the package leaflet that comes with the medicine or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravili, ki vsebujejo seme gvarane, preberite navodilo za uporabo, ki je priloženo posameznemu zdravilu, ali se posvetujte z zdravnikom ali farmacevtom.
EMA/HMPC/284498/2013
EMA/HMPC/284498/2013 Odbor za zdravila rastlinskega izvora (HMPC)
For practical information about using guarana seed medicines, patients should read the package leaflet that comes with the medicine or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravil s semenom gvarane naj bolniki preberejo navodilo za uporabo, ki je priloženo posameznemu zdravilu, ali se posvetujejo z zdravnikom ali farmacevtom.
Guarana seed preparations are obtained by drying and powdering the seeds.
Pripravki s semenom gvarane se pridobivajo s sušenjem semen in njihovo predelavo v prašek.
Intravenous use vial (plastic)
viala (plastična)
Pharmaceutical Form Route of Administration
Farmacevtsk a oblika
Intravenous use vial (glass)
Velikost pakiranja viala (steklena)
--1 Cell-associated live recombinant turkey herpesvirus expressing the fusion protein of Newcastle disease virus and the VP2 protein of infectious bursal disease virus: 103.3 - 104.6 PFU* * PFU: plaque forming units.
--1 Na celico vezan živ rekombinantni puranji herpesvirus (sev HVP360) z izraženim fuzijskim proteinom virusa atipične kokošje kuge in proteinom VP2 Gumborske bolezni: 103.3 - 104.6 PFU1.
Invented name Strength Pharmaceutical form
EU številka Izmišljeno ime Jakost Farmacevtska oblika
This depends on the patient's response and requirements (e.g. diet, physical activity and life-style).
Ta je odvisen od bolnikovega odziva in potreb (kot so prehrana, telesna dejavnost in življenjski stil).
The marketing authorisation holder is Pfizer Limited.
Imetnik dovoljenja za promet z zdravilom je Pfizer Limited.
The European Commission granted a marketing authorisation valid throughout the European Union for Exubera on 24 January 2006.
Evropska komisija je dovoljenje za promet z zdravilom Exubera, veljavno po vsej Evropski uniji, odobrila dne 24. januarja 2006.
If you want more information on the basis of the CHMP recommendations, read the Scientific Discussion (also part
Če želite več informacij o podlagi za priporočila CHMP, preberite znanstveno razpravo (ki je prav
Exubera is given within 10 minutes before the start of a meal.
Zdravilo Exubera dajemo v roku 10 minut pred obrokom.
Smokers must have stopped smoking for at least 6 month before they can take Exubera.
Kadilci morajo prenehati s kajenjem vsaj 6 mesecev preden lahko uporabijo zdravilo Exubera.
The company will also monitor side effects, provide educational material, and improve the design of the blister packs so that it is easier to tell the
Podjetje bo tudi spremljalo neželene učinke, priskrbelo izobraževalno gradivo in izboljšalo zasnovo pretisnih omotov, da bo lažje
So Exubera is not suitable when small (less than 3 IU) adjustments of insulin are necessary (for example in patient with low body weight).
Zato zdravilo Exubera ni primerno, kadar so potrebna majhna (manj kot 3 ME) prilagajanja insulina (na primer pri bolniku z nizko telesno maso).
They will also look at the development of insulin antibodies (proteins that are produced in response to treatment with Exubera).
Raziskali bodo tudi razvoj protiteles proti insulinu (beljakovine, ki nastajajo kot odziv na zdravljenje z zdravilom Exubera).
By controlling the level of blood sugar, the symptoms and complications of diabetes are reduced.
Z nadzorom ravni krvnega sladkorja se zmanjšajo simptomi in zapleti sladkorne bolezni.
A doctor decides for each patient the starting doses and the timing of the doses, and the dose adjustment schedule.
Zdravnik za vsakega bolnika določi začetni odmerek, časovni razpored odmerkov ter načrt prilagajanja le-teh.
The company that makes Exubera will carry out studies to further test its safety, particularly in patients who might have an increased risk of side effects, such as patients with asthma or chronic obstructive pulmonary disease.
Podjetje, ki izdeluje zdravilo Exubera, bo opravilo raziskave za nadaljnje preskušanje njene varnosti, zlasti pri bolnikih, ki bi lahko imeli povečano tveganje za neželene učinke, kot so bolniki z astmo ali kronično obstruktivno pljučno boleznijo.
Before starting Exubera, a doctor or a nurse must explain to the patient how to use the inhaler properly to minimise risk and ensure that the patient gets the best benefit from their treatment.
Pred začetkom uporabe zdravila Exubera mora bolniku zdravnik ali medicinska sestra razložiti, kako pravilno uporabljati inhalator, da se zmanjša tveganje in zagotovi, da je zdravljenje čimbolj koristno.
When inhaled, some of the insulin is absorbed into the blood (the rest is broken down in the lungs).
Ob vdihovanju se nekaj insulina absorbira v kri (preostanek se razgradi v pljučih).
Patients with poor or unstable lung function, such as asthma, emphysema or chronic bronchitis, should not use Exubera.
Bolniki s slabo ali nestabilno pljučno funkcijo, denimo, z astmo, emfizemom ali kroničnim bronhitisom, zdravila Exubera ne smejo uporabljati.
The insulin in Exubera is produced by a method known as ‘recombinant DNA technology' which means that the insulin is made by a bacterium which has received a gene (DNA) that makes it able to produce the insulin.
Insulin v zdravilu Exubera je izdelan z metodo, imenovano ‘tehnologija rekombinantne DNA', kar pomeni, da insulin izdeluje bakterija, ki je prejela gen (DNA), ki ji omogoča izdelovanje insulina.
If a patient already has lung disease, it is not clear how the use of Exubera affects their lungs or how the lung disease affects the intake of insulin from the lungs.
Če bolnik že ima pljučno obolenje, ni jasno, kako uporaba zdravila Exubera vpliva na pljuča ali kako pljučna bolezen vpliva na vnos insulina iz pljuč.
If a patient smokes, the amount of insulin that is absorbed from the lungs greatly increases and this may increase the risk of hypoglycaemia.
Če bolnik kadi, se količina insulina, ki se absorbira iz pljuč, močno poveča, kar lahko poveča nevarnost za hipoglikemijo.
Once in the blood, the insulin facilitates the transport of glucose into cells and helps to control the level of blood sugar.
Ko je enkrat v krvi, insulin pospešuje transport glukoze v celice in pomaga nadzorovati raven krvnega sladkorja.
Three 1 mg doses should not be used instead of one 3 mg dose because this gives a higher insulin dose and may increase the risk of hypoglycaemia.
Namesto enega 3 mg odmerka ne smemo uporabiti treh odmerkov po 1 mg, ker to pomeni višji odmerek insulina in lahko poveča nevarnost za hipoglikemijo.
The Committee for Medicinal products for Human Use (CHMP) decided that Exubera's benefits are greater than its risks in certain adult patients with diabetes when used as described in the Product information, and recommended that Exubera be given marketing authorisation.
Odbor za zdravila za uporabo v humani medicini (CHMP) meni, da koristi zdravila Exubera presegajo njena tveganja pri določenih odraslih bolnikih s sladkorno boleznijo ob uporabi, kot je opisano v Navodilu za uporabo, zato priporoča odobritev dovoljenja za promet z zdravilom Exubera.
Diabetes is a disease in which the body does not produce enough insulin to control the level of blood sugar.
Sladkorna bolezen je bolezen, pri kateri telo ne izdeluje dovolj insulina, da bi obvladovalo raven krvnega sladkorja.
To take a dose, the patient places the blister in the inhaler, and inhales it through the mouth into the lungs.
Da dobi odmerek, bolnik položi pretisni omot v inhalator in ga prek ust vdihne v pljuča.
The most common side effects of Exubera are hypoglycaemia (low blood glucose) and cough.
Najpogostejša neželena učinka zdravila Exubera sta hipoglikemija (nizka raven glukoze v krvi) in kašelj.
During the studies, Exubera showed a small negative effect on lung function that may disappear when Exubera is stopped.
V raziskavah je Exubera pokazala majhen negativni učinek na pljučno funkcijo, ki lahko po prenehanju uporabe zdravila Exubera izzveni.
If a patient starts or resumes smoking when treated with Exubera, they must use another anti-diabetic treatment immediately.
Če bolnik začne kaditi ali ponovno začne kaditi med zdravljenjem z zdravilom Exubera, mora takoj zamenjati zdravilo Exubera za drugo antidiabetično zdravljenje.
The studies measured the level in the blood of glycosylated haemoglobin (HbA1c), which gives an indication of how well the blood glucose is controlled.
V raziskavah so merili raven glikoziliranega hemoglobina (HbA1c) v krvi, kar nam pove, kako dobro je raven glukoze v krvi nadzorovana.
What benefit has Exubera shown during the studies?
Kakšne koristi je zdravilo Exubera izkazalo med raziskavami?
Exubera is an insulin used for the treatment of adults with type 2 diabetes, when it is not properly controlled with anti-diabetes tablets.
Exubera je insulin, ki ga uporabljamo za zdravljenje odraslih bolnikov s sladkorno boleznijo tipa 2, kadar ta ni ustrezno nadzorovana z uporabo antidiabetičnih tablet.
How has Exubera been studied?
Kako je bilo zdravilo Exubera raziskano?
Exubera contains 1 mg or 3 mg of
Exubera vsebuje 1 mg ali 3 mg zdravilne učinkovine humanega insulina.
What is the risk associated with Exubera?
Kakšna tveganja so povezana z zdravilom Exubera?
A 1 mg unit dose blister gives about the same dose as an injection of 3 IU of fast-acting subcutaneous insulin and a 3 mg unit dose blister about the same as 8 IU of fast-acting subcutaneous insulin.
Pretisni omot z odmerkom 1 mg zagotovi enak odmerek kot podkožno injiciranje 3 ME hitrodelujočega insulina, pretisni omot z odmerkom 3 mg zagotovi približno tak odmerek kot podkožno injiciranje 8 ME hitrodelujočega insulina.
Exubera is a fast-acting insulin powder for inhalation (breathing in).
Exubera je hitrodelujoči insulin v obliki praška za inhaliranje (vdihovanje).
Patients must not smoke while taking Exubera.
Bolniki med jemanjem zdravila Exubera ne smejo kaditi.
Exubera is used only with its insulin inhaler.
Zdravilo Exubera uporabljamo samo skupaj z njegovim insulinskim inhalatorjem.
Overall, in studies in type 1 and type 2 diabetes, Exubera gave similar blood glucose control to that given by fast-acting subcutaneous human insulin.
V splošnem je v raziskavah sladkorne bolezni tipa 1 in 2 zdravilo Exubera omogočalo podoben nadzor ravni krvnega sladkorja, kot ga daje hitrodelujoči podkožni humani insulin.
Exubera can also be used for certain adults with type 1 diabetes, who can benefit from replacing fast-acting subcutaneous insulin by this inhaled insulin, taking into
Zdravilo Exubera lahko uporabljamo tudi za določene odrasle bolnike s sladkorno boleznijo tipa 1, za katere je lahko ob upoštevanju možnih tveganj, koristna zamenjava hitrodelujočega insulina, ki se injicira pod kožo, s
Exubera has been studied in patients with type 2 or type 1 diabetes.
Zdravilo Exubera so preučevali pri bolnikih s sladkorno boleznijo tipa 1 ali 2.
Exubera should not be used in people who may be hypersensitive (allergic) to human insulin or any of
Zdravila Exubera ne smejo uporabljati ljudje, ki utegnejo biti preobčutljivi za (alergični na) humani
Exubera is a replacement insulin which is identical to the insulin made by the pancreas.
Exubera je nadomestni insulin, ki je enak insulinu, ki ga izdeluje trebušna slinavka.
EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) EXUBERA EPAR summary for the public
EVROPSKO JAVNO POROČILO O OCENI ZDRAVILA (EPAR) EXUBERA
The insulin is contained as a powder in a blister.
Insulin je v obliki praška in je pakiran v pretisnem omotu.
Exubera works in type 1 diabetes, when the pancreas cannot produce enough insulin, and in type 2 diabetes when the body is unable to use insulin effectively.
pri sladkorni bolezni tipa 1, ko trebušna slinavka ne more izdelati dovolj insulina, in pri sladkorni bolezni tipa 2, ko telo ni zmožno učinkovito uporabljati insulina.
In type 1 diabetes, Exubera was compared to subcutaneous (injected) insulin.
Pri sladkorni bolezni tipa 1 so zdravilo Exubera primerjali s podkožnim (injiciranim) insulinom.