natgillin/translations-raw huggingface dataset:
In turkeys: Dicural oral solution is also indicated for the treatment of infections caused by Pasteurella multocida.
Pri puranih tudi za zdravljenje infekcij, ki jih povzroča Pasteurella multocida.
• Treatment of Bovine respiratory disease (shipping fever, calf pneumonia) caused by single or mixed infections with Pasteurella haemolytica, Pasteurella multocida, and/or Mycoplasma spp.
• Zdravljenje respiratornih obolenj (transportna mrzlica, pljučnice pri teletih), ki jih povzročajosamostojno ali v kombinaciji naslednji mikroorganizmi: Pasteurella haemolytica, Pasteurella multocida in/ali Mycoplasma spp.
Difloxacin is well distributed throughout the animal body, as was demonstrated by the tissue to plasma ratios.
Difloksacin se dobro distribuira po organizmu v različne organe.
NAME OF THE VETERINARY MEDICINAL PRODUCT Dicural 100 mg/ml oral solution for chickens and turkeys
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Dicural 100 mg/ml peroralna raztopina za piščance in purane
Muscle Fat Liver Kidney
Mišičnina Maščoba Jetra
Official and local antimicrobial policies should be taken into account when the product is used.
Zdravilo je treba uporabiti v skladu z lokalnimi predpisi s področja protimikrobnega zdravljenja.
MARKETING AUTHORISATION NUMBER(S) EU/2/97/003/016
ŠTEVILKA(E) V REGISTRU SKUPNOSTI ZDRAVIL EU/2/97/003/016
To be supplied only on veterinary prescription.
Oskrba le na podlagi veterinarskega recepta.
Antagonism may be observed with nitrofurantoin.
Fluorokinoloni in nitrofurani učinkujejo medsebojno antagonistično.
In cattle: Dicural 50 mg/ml solution for injection is indicated for the treatment of bovine respiratory disease (shipping fever, calf pneumonia) caused by single or mixed infections with Pasteurella haemolytica, Pasteurella multocida, and/or Mycoplasma spp.
Dicural 50mg/ml raztopino za injiciranje uporabljamo za zdravljenje respiratornih obolenj (transportna mrzlica, pljučnice pri teletih), ki jih povzročajo-samostojno ali v kombinaciji naslednji mikroorganizmi: Pasteurella haemolytica, Pasteurella multocida in/ali Mycoplasma spp.
Tissue to plasma ratios range from 2.5 (abdominal fat), 3.7 (muscle), 4.8 (lung) to 36.5 (liver).
Pri pet dnevnem dajanju Dicurala v odmerku 10 mg/kg/dan znašajo plezemske koncentracije približno 60 μg/ml.Koncentracija difloksacina v organih pa so različne in znašajo od 2,5 v abdominalni maščobi, do 3,7 v mišicah in 36,5 v jetrih.
A fraction of difloxacin is eliminated by the urine.
Največ difloksacina se izloči z blatom, manj pa z urinom.
In chickens and turkeys: Dicural oral solution is indicated for treatment of chronic respiratory infections caused by sensitive strains of Escherichia coli and Mycoplasma gallisepticum.
Dicural - peroralna raztopina se uporablja za zdravljenje kroničnih repsiratornih infekcij, ki jih povzročajo na difloksacin občutljivi mikroorganizmi: Escherichia coli in Mycoplasma gallisepticum.
8 OJ No. L 143 of 26.06.95
8 OJ št. L 143 z dne 27.06.95
Treatment of Bovine respiratory disease (shipping fever, calf pneumonia) caused by single or mixed infections with Pasteurella haemolytica, Pasteurella multocida, and/or Mycoplasma spp.
Zdravljenje respiratornih obolenj (transportna mrzlica, pljučnice pri teletih), ki jih povzročajosamostojno ali v kombinaciji naslednji mikroorganizmi: Pasteurella haemolytica, Pasteurella multocida in/ali Mycoplasma spp.
For animal treatment only - to be supplied only on veterinary prescription..
Samo za živali - oskrba le na podlagi veterinarskega recepta.
In another study dogs treated orally with difloxacin at 10 times the recommended dose for 10 days showed occasionally mild adverse reactions such as orange/yellowing discoloration of the faeces, emesis and hypersalivation.
Pri desetkrat večjih odmerkih, danih peroralno v obdobju 10 dni, pa so se pokazali blagi neželeni učinki, kot je rumeno-oranžno obarvano blato, emezija in povečano slinjenje
MARKETING AUTHORISATION NUMBER(S) EU/2/97/003/001 - 1 x 250 ml EU/2/97/003/002 - 1 x 1000 ml EU/2/97/003/003 - 6 x 1000 ml
ŠTEVILKA(E) V REGISTRU SKUPNOSTI ZDRAVIL EU/2/97/003/001 - 1 x 250 ml
PARTICULARS TO APPEAR ON THE OUTER PACKAGE Dicural 50 mg/ml, solution for injection for cattle and dogs CARTON for 50 ml vial
PODATKI NA ZUNANJI OVOJNINI Dicural 50mg/ml raztopina za injiciranje za goveda in pse Kartonska škatla za 50 ml steklenico
NAME OF THE VETERINARY MEDICINAL PRODUCT Dicural 50 mg/ml solution for injection for cattle
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Dicural 50 mg/ml raztopina za injiciranje za goveda
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Active substance
NAVEDBA ZDRAVILNE IČINKOVIN(E) IN DRUGE(IH) SESTAVINE(E) Zdravilne učinkovine
No other source of drinking water should be available during the medication period.
V času zdravljenja naj bo to edina voda za pitje.
STATEMENT OF ACTIVE AND OTHER SUBSTANCES Difloxacin (as hydrochloride) 100 mg
NAVEDBA ZDRAVILNE UČINKOVINE IN DRUGIH SNOVI Difloksacin (v obliki klorida) 100 mg
In order to avoid irritation of skin and/or eyes, use gloves and a face-protecting device when handling this product.
Pri ravnanju z zdravilom nosite osebno zaščitno opremo, ki sestoji iz gumijastih rokavic in zaščitne obrazne maske in očal.
METHOD AND ROUTE(S) OF ADMINISTRATION Subcutaneous use
NAČIN(I) UPORABE ZDRAVILA Subkutano dajanje.
B. PACKAGE LEAFLET
DODATEK II
Cattle: Meat and offal: 46 days
Meso in organi: 46 dni Psi:
STATEMENT OF ACTIVE AND OTHER SUBSTANCES Difloxacin (as hydrochloride) 150 mg
NAVEDBA ZDRAVILNE UČINKOVINE IN DRUGIH SNOVI Difloksacin (v obliki klorida) 150 mg
NAME OF THE VETERINARY MEDICINAL PRODUCT Dicural 100 mg coated tablets for dogs Difloxacin
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Dicural 100 mg filmsko obložene tablete za pse Difloksacin
DOSAGE FOR EACH SPECIES, METHOD AND ROUTE(S) OF ADMINISTRATION
ODMEREK ZA POSAMEZNE ŽIVALSKE VRSTE TER NAČIN UPORABE IN DAJANJA ZDRAVILA
STATEMENT OF ACTIVE AND OTHER SUBSTANCES Difloxacin (as hydrochloride) 15 mg
NAVEDBA ZDRAVILNE UČINKOVINE IN DRUGIH SNOVI Difloksacin (v obliki klorida) 15 mg
The medicated drinking water should be prepared freshly each day.
Dnevno naj se pripravi sveža voda za pitje, kateri je primešano zdravilo.
Antacids may interfere with gastro-intestinal absorption.
Istočasna uporaba antacidov lahko zmanjša enteralno resorbcijo difloksacina.
NAME OF THE VETERINARY MEDICINAL PRODUCT Dicural 150 mg coated tablets for dogs
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Dicural 150 mg filmsko obložene tablete za pse
NAME OF THE VETERINARY MEDICINAL PRODUCT Dicural 50 mg/ml solution for injection for cattle and dogs
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Dicural 50 mg/ml raztopina za injiciranje za goveda in pse
Dicural 100 mg difloxacin (as hydrochloride)
Dicural 100 mg difloksacin (v obliki klorida)
NAME OF THE VETERINARY MEDICINAL PRODUCT Dicural 15 mg coated tablets for dogs Difloxacin
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Dicural 15 mg filmsko obložene tablete za pse Difloksacin
STATEMENT OF ACTIVE AND OTHER SUBSTANCES Difloxacin (as hydrochloride) 50 mg
NAVEDBA ZDRAVILNE UČINKOVINE IN DRUGIH SNOVI Difloksacin (v obliki klorida) 50 mg
NAME OF THE VETERINARY MEDICINAL PRODUCT Dicural 50 mg coated tablets for dogs Difloxacin
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Dicural 50 mg filmsko obložene tablete za pse Difloksacin
NAME OF THE VETERINARY MEDICINAL PRODUCT Dicural 100 mg coated tablets for dogs
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Dicural 100 mg filmsko obložene tablete za pse
Dicural 150 mg difloxacin (as hydrochloride)
Dicural 150 mg difloksacin (v obliki klorida)
For animal treatment only -to be supplied only on veterinary prescription.
Samo za živali-oskrba le na podlagi veterinarskega recepta.
In order to avoid irritation of skin and/or eyes, use gloves and a face-protecting device, when handling this product.
Pri ravnanju z zdravilom nosite osebno zaščitno opremo, ki sestoji iz gumijastih rokavic, zaščitne maske in očal.
Dicural 15 mg difloxacin (as hydrochloride)
Dicural 15 mg difloksacin (v obliki klorida)
MARKETING AUTHORISATION NUMBER(S) EU/2/97/003/013 - 10 tablets EU/2/97/003/014 - 20 tablets EU/2/97/003/015 - 100 tablets
ŠTEVILKA(E) V REGISTRU SKUPNOSTI ZDRAVIL EU/2/97/003/013 - 10 tablet
NAME OF THE VETERINARY MEDICINAL PRODUCT Dicural 50 mg coated tablets for dogs
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Dicural 50 mg filmsko obložene tablete za pse
NAME OF THE VETERINARY MEDICINAL PRODUCT Dicural 15 mg coated tablets for dogs
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Dicural 15 mg filmsko obložene tablete za pse
Dicural 50 mg difloxacin (as hydrochloride)
Dicural 50 mg difloksacin (v obliki klorida)
PACKAGE LEAFLET FOR: Dicural 50 mg/ml solution for injection for cattle and dogs
Dicural 50 mg/ml, raztopina za injiciranje za goveda in pse
Coated tablets
100 tablet
Dogs: Not applicable
NEŽELENI UČINKI
MARKETING AUTHORISATION NUMBER(S) EU/2/97/003/004 - 10 tablets EU/2/97/003/005 - 20 tablets EU/2/97/003/006 - 100 tablets
ŠTEVILKA(E) V REGISTRU SKUPNOSTI ZDRAVIL EU/2/97/003/004 - 10 tablet
Strains of Escherichia coli, Pasteurella multocida, Mycoplasma gallisepticum isolated from broilers and turkeys have been shown to be sensitive to difloxacin.
Na učinkovanje difloksacina so občutljivi naslednji mikroorganizmi, izolirani iz piščancev in puranov: Escherichia coli, Pasteurella multocida, Mycoplasma gallisepticum.
The fluoroquinolones exert their antibacterial effect against both replicating and dormant microorganisms.
Fluorokinoloni imajo protimikrobno učinkovanje tako proti mikroorganizmom, ki so v fazi replikacije, kot tistim, ki so v fazi transkripcije pri delitvi celic.
WITHDRAWAL PERIOD Withdrawal period: Cattle - meat and offal 46 days
KARENCA Karenca: Govedo-meso in organi 46 dni
MARKETING AUTHORISATION NUMBER(S) EU/2/97/003/010 - 10 tablets EU/2/97/003/011 - 20 tablets EU/2/97/003/012 - 100 tablets
ŠTEVILKA(E) V REGISTRU SKUPNOSTI ZDRAVIL EU/2/97/003/010 - 10 tablet
Turkeys:
Purani
Cattle (calves and young cattle) Dogs.
Govedo (teleta in mlado govedo) Psi
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE Dicural 50 mg/ml, solution for injection for cattle and dogs 50 ml vial label
PODATKI NA STIČNI, OZ.PRIMARNI OVOJNINI Dicural 50mg/ml raztopina za injiciranje za goveda in pse 50 ml steklenica
Active substance
Zdravilne učinkovine
Dicural coated tablets consist of a core tablet containing difloxacin hydrochloride and a highly palatable coating.
Dicural filmsko obložene tablete vsbujejo difloksacinijev klorid.
Measuring lines indicate the volume supplied.
Na njej so oznake za določanje volumna.
Skilarence is available as tablets (30 and 120 mg).
Zdravilo Skilarence je na voljo v obliki tablet (30 mg in 120 mg).
The main measure of effectiveness was the proportion of patients who achieved a 75% reduction in their score for disease severity.
Glavno merilo učinkovitosti je bil delež bolnikov, ki so dosegli 75-odstotno zmanjšanje rezultata resnosti bolezni.
What measures are being taken to ensure the safe and effective use of Skilarence?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Skilarence?
The full EPAR for Skilarence 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 Skilarence je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Psoriasis results from over-activity of the body's immune (defence) system.
Psoriaza je posledica čezmerne aktivnosti telesnega imunskega (obrambnega) sistema.
Tablets should be swallowed whole during or immediately after a meal.
Tablete je treba pogoltniti cele med obrokom ali takoj po njem.
This is a summary of the European public assessment report (EPAR) for Skilarence.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Skilarence.
Most side effects are mild or moderate.
Večina neželenih učinkov je bila blaga ali zmerna.
Other information about Skilarence
Druge informacije o zdravilu Skilarence
The starting dose is 30 mg once a day and the dose is increased every week according to the schedule shown in the package leaflet until the psoriasis starts improving or until the patient is taking the maximum dose of 240 mg three times a day.
Začetni odmerek je 30 mg enkrat dnevno, odmerek pa se povečuje vsak teden po urniku, prikazanem v navodilu za uporabo, dokler se stanje psoriaze ne začne izboljševati oziroma dokler bolnik ne prejema največjega odmerka 240 mg trikrat dnevno.
It must also not be used by women during pregnancy or if breast-feeding.
Prav tako ga ne smejo uporabljati nosečnice ali doječe matere.
It is not intended to provide practical advice on how to use Skilarence.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
After 16 weeks of treatment, 37% of patients taking Skilarence achieved this reduction, compared with 15% taking placebo and 40% taking Fumaderm .
Po 16 tednih zdravljenja je takšno zmanjšanje doseglo 37 % bolnikov, ki so jemali zdravilo Skilarence, v primerjavi s 15 % bolnikov, ki so jemali placebo, in 40 % bolnikov, ki so jemali zdravilo Fumaderm.
The CHMP considered that the main study has shown Skilarence's short-term effectiveness, and published studies with similar medicines show that the effectiveness is maintained with continued use.
Odbor CHMP je presodil, da je glavna študija dokazala kratkotrajno učinkovitost zdravila Skilarence, objavljene študije s podobnimi zdravili pa kažejo, da se učinkovitost z nadaljnjo uporabo ohranja.
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Skilarence's benefits are greater than its risks and recommended that it be approved for use in the EU.
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da so koristi zdravila Skilarence večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
The company that markets Skilarence will supply educational materials to healthcare professionals about the risk of serious infections, including PML, and how to minimise this risk.
Družba, ki trži zdravilo Skilarence, bo zdravstvenim delavcem priskrbela izobraževalno gradivo o tveganju za resne okužbe, vključno s PML, in o zmanjševanju tega tveganja.
Because Skilarence reduces the activity of the immune system, there is a risk of serious infections, including progressive multifocal leukoencephalopathy (PML, a brain infection), but the risk can be minimised by regular tests for white blood cell counts and stopping treatment if necessary.
Ker zdravilo Skilarence zavira delovanje imunskega sistema, obstaja tveganje za resne okužbe, vključno s progresivno multifokalno levkoencefalopatijo (PML; okužbo možganov), vendar se tveganje lahko zmanjša z rednimi preiskavami števila belih krvnih celic in prekinitvijo zdravljenja, če je potrebno.
What benefits of Skilarence have been shown in studies?
Kakšne koristi je zdravilo Skilarence izkazalo v študijah?
What is Skilarence and what is it used for?
Kaj je zdravilo Skilarence in za kaj se uporablja?
It is used in patients with moderate or severe disease for whom treatments applied direct to the skin do not work well enough.
Uporablja se pri bolnikih z zmerno ali resno obliko bolezni, pri katerih zdravila za neposredni nanos na kožo niso dovolj učinkovita.
It is thought to act on T cells (a type of white blood cell that forms part of the immune system) to prevent the cells from producing substances that cause inflammation and lead to psoriasis.
Delovala naj bi na celice T (vrsto belih krvnih celic, ki so del imunskega sistema) in preprečila nastajanje snovi, ki povzročajo vnetje in privedejo do psoriaze.
What are the risks associated with Skilarence?
Kakšna tveganja so povezana z zdravilom Skilarence?
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Skilarence have also been included in the summary of product characteristics and the package leaflet.
Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Skilarence upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
Why is Skilarence approved?
Zakaj je bilo zdravilo Skilarence odobreno?
A main study involving 704 patients with moderate to severe plaque psoriasis found that Skilarence was more effective than placebo (dummy treatment) at treating the disease and as effective as Fumaderm (a psoriasis medicine that contains dimethyl fumarate and monoethyl fumarate).
V glavni študiji, ki je vključevala 704 bolnike z zmerno do hudo psoriazo v plakih, so ugotovili, da je zdravilo Skilarence pri zdravljenju bolezni učinkovitejše od placeba (zdravila brez zdravilne učinkovine) in enako učinkovito kot zdravilo Fumaderm (zdravilo za psoriazo, ki vsebuje dimetilfumarat in monoetilfumarat).
Skilarence is a medicine used to treat plaque psoriasis, a disease that causes thickened, red and inflamed areas of skin with scaly patches.
Skilarence je zdravilo, ki se uporablja za zdravljenje psoriaze v plakih, bolezni, ki povzroča odebeljena, rdeča in vneta področja na koži z luskastimi zaplatami.
The most common side effects with Skilarence (which may affect more than 1 in 10 people) are effects on the digestive system (diarrhoea, bloating, belly ache and nausea), flushing (reddening of the skin) and low levels of lymphocytes (type of white blood cells) or of white blood cells in general.
Najpogostejši neželeni učinki zdravila Skilarence (ki se lahko pojavijo pri več kot 1 bolniku od 10) so učinki na prebavila (driska, napihnjenost, bolečina v trebuhu in navzea), rdečica (pordelost kože) in nizke vrednosti limfocitov (vrste belih krvnih celic) ali belih krvnih celic na splošno.
For more information about treatment with Skilarence, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Skilarence preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
For practical information about using Skilarence, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Skilarence naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
Skilarence must not be used in patients who have severe problems of the digestive system, liver or kidneys.
Zdravila Skilarence ne smejo uporabljati bolniki s hudimi težavami s prebavili, jetri ali ledvicami.
The active substance in Skilarence, dimethyl fumarate, reduces the activity of the immune system.
Zdravilna učinkovina zdravila Skilarence, dimetilfumarat, zavira delovanje imunskega sistema.
For the full list of all side effects reported with Skilarence, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Skilarence, glejte navodilo za uporabo.
Skilarence can only be obtained with a prescription and it should be used under the supervision of a doctor who has experience in diagnosing and treating psoriasis.
Predpisovanje in izdaja zdravila Skilarence je le na recept, zdravljenje z njim pa se sme uvesti in izvajati samo pod nadzorom zdravnika z izkušnjami z zdravljenjem psoriaze.
How does Skilarence work?
Kako zdravilo Skilarence deluje?
The doctor may reduce the dose when the psoriasis has been brought under control.
Ko je psoriaza pod nadzorom, zdravnik lahko odmerek zmanjša.
Skilarence contains the active substance dimethyl fumarate.
Zdravilo Skilarence vsebuje zdravilno učinkovino dimetilfumarat.
How is Skilarence used?
Kako se zdravilo Skilarence uporablja?
Teva Hungary PLC Pallagi street 13., Debrecen
Madžarska Teva Hungary PLC Pallagi street 13., Debrecen
Member State in EEA
Država članica (v EGP)
Bayer Hungaria ltd Alkotás street 50.
Madžarska Bayer Hungaria ltd Alkotás street 50.
Merck Sharp & Dohme, Lda.
Portugalska Merck Sharp & Dohme, Lda.
List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, marketing authorisation holders in the member states for Combined hormonal contraceptives
Priloga I Seznam poimenovanj, farmacevtskih oblik, jakosti, poti uporabe, imetnikov dovoljenj za promet v državah članicah
Sandoz Hungary LTD Bartók Béla street 4347.
Madžarska Sandoz Hungary LTD Bartók Béla street 43-47.
Bayer Portugal, S.A. Rua Quinta do Pinheiro
Portugalska Bayer Portugal, S.A. Rua Quinta do Pinheiro 5
Vaginal use
Vaginalna uporaba
Laboratórios EFFIK, Sociedade Unipessoal, Lda.
Portugalska Laboratórios EFFIK, Sociedade Unipessoal, Lda.
Laboratórios Pfizer, Lda.
Portugalska Laboratórios Pfizer, Lda.
Italfarmaco - Produtos Farmacêuticos, Lda.
Portugalska Italfarmaco - Produtos Farmacêuticos, Lda.
Vaginal delivery system
Vaginalni dostavni sistem
Medimpex France, S.A 1-3, Rue Caumartin F-75009 Paris France
Portugalska Medimpex France, S.A 1-3, Rue Caumartin F-75009 Paris
Slovak Republic Actavis Group PTC ehf Reykjavikurvegi 76-78
Portugalska Actavis Group PTC ehf Reykjavikurvegi 76-78
Germany betapharm Arzneimittel GmbH Kobelweg 95
Nemčija betapharm Arzneimittel GmbH Kobelweg 95
Sandoz Farmaceutica, Lda.
Portugalska Sandoz Farmaceutica, Lda.
Czech Republic LadeePharma Kft Lajos utca 48-66.
Madžarska LadeePharma Kft Lajos utca 48-66
Slovak Republic Ratiopharm GmbH Graf-Arco-Strasse 3
Madžarska Ratiopharm GmbH Graf-Arco-Strasse 3
Lusal - Producao Quimico-Farmaceutica Luso-Alema, Lda.
Portugalska Lusal, Produção Químico Farmacêutica Luso Alemã, Lda.
Slovak Republic Zentiva, k.s.
Madžarska Zentiva, k.s.
Aramis Pharma Kft. Mester u. 28B III/5 1095 Budapest Hungary gestodene ethinylestradiol
Madžarska Aramis Pharma Kft. Mester u. 28B III/5
540306 Târgu Mureş România
Str. Cuza-Vodă, nr. 99-105 540306 Târgu Mureş România
0.12 mg/0.015 mg Vaginal delivery system
0.12 mg/0.015 mg Vaginalni dostavni sistem
Teva PharmaProdutos
Farmacevtska oblika
BerlifarmaEspecialidades Farmacêuticas, Lda.
Portugalska Berlifarma, Especialidades Farmacêuticas, Lda.
Berlex - Especialidades Farmaceuticas, Lda.
Portugalska Berlex Especialidades Farmacêuticas Lda.
FAES FARMA, S.A. Maximo Aguirre, 14.
FAES FARMA, S.A. Maximo Aguirre, 14. 48940 Lamiaco-Lejona (Vizcaya)
SANOFI AVENTIS FRANCE
Slovenija sanofi-aventis d.o.o.
Czech Republic Medico Uno Pharma Kft.
Madžarska Medico Uno Pharma Kft. Viadukt u. 12
Slovak Republic mibe GmbH Arzneimittel
Slovaška mibe GmbH Arzneimittel Münchener Str. 15
Slovak Republic Bayer Pharma AG Müllerstraße 178
Madžarska Bayer Pharma AG Müllerstrasse 170-178.
Czech Republic mibe GmbH Arzneimittel
Češka mibe GmbH Arzneimittel Münchener Str. 15
89150 Laichingen Germany
85737 Ismaning Germany
Germany mibe GmbH Arzneimittel Münchener Str. 15 06796 Brehna Germany
Nemčija mibe GmbH Arzneimittel Münchener Str. 15
Gedeon Richter Plc.
Madžarska Gedeon Richter Plc.
Czech Republic Laboratorios Leon Farma SA
Madžarska Laboratorios Leon Farma SA Calle La Vallina S/N
Belgium Gedeon Richter Plc.
Nizozemska Gedeon Richter Plc.
This was also supported by the SAG AI.
To je podprla tudi skupina SAG AI.
No new safety risk was identified and the safety profile remains overall unchanged for these products.
Prepoznali niso nobenega novega tveganja za varnost, varnostni profil teh zdravil pa na splošno ostaja nespremenjen.
It remains unknown whether these differences translate into different clinical effects of the medicinal products; this conclusion was also supported by the scientific advisory group expert group meeting on antiinfectives (SAG AI).
Še vedno ni znano, ali te razlike pomenijo tudi drugačne klinične učinke zdravil; ta zaključek so podprli tudi na srečanju znanstvene posvetovalne skupine strokovnjakov za antiinfektive (SAG AI).
The Italian National Competent Authority (AIFA) considered that results of recent studies cast doubt on the efficacy of these products in respiratory infections.
Italijanski pristojni nacionalni organ (AIFA) je presodil, da rezultati nedavnih študij vzbujajo dvom o učinkovitosti teh zdravil pri okužbah dihal.
It is noted that serious hypersensitivity reactions may occur.
Opozoriti je treba, da lahko pride do resnih preobčutljivostnih reakcij.