natgillin/translations-raw huggingface dataset:
EU/1/13/836/001 10 film-coated tablets EU/1/13/836/002 14 film-coated tablets EU/1/13/836/003 21 film-coated tablets EU/1/13/836/004 28 film-coated tablets EU/1/13/836/005 30 film-coated tablets EU/1/13/836/006 42 film-coated tablets EU/1/13/836/007 50 film-coated tablets EU/1/13/836/008 56 film-coated tablets EU/1/13/836/009 98 film-coated tablets EU/1/13/836/010 100 film-coated tablets EU/1/13/836/011 112 film-coated tablets
EU/1/13/836/001 10 filmsko obloženih tablet EU/1/13/836/002 14 filmsko obloženih tablet EU/1/13/836/003 21 filmsko obloženih tablet EU/1/13/836/004 28 filmsko obloženih tablet EU/1/13/836/005 30 filmsko obloženih tablet EU/1/13/836/006 42 filmsko obloženih tablet EU/1/13/836/007 50 filmsko obloženih tablet EU/1/13/836/008 56 filmsko obloženih tablet EU/1/13/836/009 98 filmsko obloženih tablet EU/1/13/836/010 100 filmsko obloženih tablet EU/1/13/836/011 112 filmsko obloženih tablet
15 mg tablet week 4 and beyond 20 mg tablets once a day
4. teden in naprej 20 mg tablete enkrat dnevno
Venous thrombosis/thromboembolism
Pogosti Občasni hipertenzija venska tromboza/tromboembolija
Cellulose microcrystalline (E 460) Starch pregelatinised (E 1404) Lactose anhydrous Colloidal anhydrous silica (E 551) Magnesium stearate (E 470b)
Jedro tablete mikrokristalna celuloza (E 460) predgelirani škrob (E 1404) brezvodna laktoza brezvoden koloidni silicijev dioksid (E 551) magnezijev stearat (E 470b)
MARKETING AUTHORISATION NUMBER(S) EU/1/13/836/023
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/13/836/023
Week 3 (day 15-21): The patient should take one and a half 10 mg film-coated tablets (15 mg) per day for 7 days.
1. teden (1.-7. dan): Bolnik mora sedem dni jemati polovico 10 mg filmsko obložene tablete (5 mg) na dan. 2. teden (8.-14. dan): Bolnik mora sedem dni jemati eno 10 mg filmsko obloženo tableto (10 mg) na dan. 3. teden (15.-21. dan): Bolnik mora sedem dni jemati eno in pol 10 mg filmsko obloženo tableto (15 mg) na dan.
MARKETING AUTHORISATION NUMBER(S) EU/1/13/836/012
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/13/836/012
The following Adverse Reactions listed in the Table below have been accumulated in clinical studies with memantine and since its introduction in the market.
V spodnji preglednici so navedeni podatki o neželenih učinkih memantina, zbrani v kliničnih študijah in v obdobju trženja.
MARKETING AUTHORISATION NUMBER(S) EU/1/13/836/022
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/13/836/022
Dose titration
Pretisni omot
Cellulose microcrystalline (E 460), starch pregelatinised (E 1404), lactose anhydrous, colloidal anhydrous silica (E 551), magnesium stearate (E 470b).
Jedro tablete mikrokristalna celuloza (E 460), predgelirani škrob (E 1404), brezvodna laktoza, brezvoden koloidni silicijev dioksid (E 551), magnezijev stearat (E 470b).
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blister
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI TRAKU
Continue to take Memantine ratiopharm as long as it is of benefit to you.
Jemljite zdravilo Memantin ratiopharm tako dolgo, kot vam pomaga in se ne pojavijo neželeni učinki, ki jih ne prenašate.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer packaging (HDPE bottle)
PODATKI NA ZUNANJI OVOJNINI Zunanja ovojnina (plastenka HDPE)
What Memantine ratiopharm looks like and contents of the pack The 5 mg film-coated tablets are white to off-white, capsule shaped, biconvex tablets plain on one side and debossed with “5” on the other side.
Izgled zdravila Memantin ratiopharm in vsebina pakiranja 5 mg filmsko obložene tablete so bele do belkaste, kapsulaste, bikonveksne tablete, ravne na eni strani in izbočeno oznako »5« na drugi.
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING Label (HDPE bottle)
PODATKI NA PRIMARNI OVOJNINI Nalepka (plastenka HDPE)
HDPE bottles
Plastenke HDPE
Do not take Memantine ratiopharm:
Ne jemljite zdravila Memantin ratiopharm
Lactose (160 mg/film-coated tablet) and soya lecithin (0.26 mg/film-coated tablet).
Laktoza (160 mg/filmsko obloženo tableto) in sojin lecitin (0,26 mg/filmsko obloženo tableto).
Dosage in patients with impaired kidney function If you have impaired kidney function, your doctor will decide upon a dose that suits your condition.
V primeru, da imate ledvično okvaro, vam bo vaš zdravnik prilagodil odmerek v skladu z vašim stanjem.
Memantine ratiopharm contains the active substance memantine hydrochloride.
Zdravilo Memantin ratiopharm vsebuje učinkovino memantinijev klorid.
Talk to your doctor or pharmacist before taking Memantine ratiopharm:
Pred začetkom jemanja zdravila Memantin ratiopharm se posvetujte z zdravnikom ali farmacevtom:
Memantine ratiopharm should be administered orally once a day and should be taken at the same time every day.
Zdravilo Memantin ratiopharm je treba jemati peroralno enkrat dnevno in ga je treba zaužiti ob istem času vsak dan. Filmsko obložene tablete lahko bolnik zaužije s hrano ali brez nje.
Memantine ratiopharm is available in packs of 10, 14, 21, 28, 30, 42, 56, 98 and 100 film-coated tablets.
Zdravilo Memantin ratiopharm je na voljo v velikostih pakiranja po 10, 14, 21, 28, 30, 42, 56, 98 in 100 filmsko obloženih tablet.
Take only one tablet per day Week 4
Vzemite eno tableto na dan.
How to take Memantine ratiopharm
Kako jemati zdravilo Memantin ratiopharm
100 tablets
10 mg tableta
Lactose (80 mg/film-coated tablet) and soya lecithin (0.13 mg/film-coated tablet).
Laktoza (80 mg/filmsko obloženo tableto) in sojin lecitin (0,13 mg/filmsko obloženo tableto).
PHARMACEUTICAL FORM AND CONTENTS Film-coated tablet
FARMACEVTSKA OBLIKA IN VSEBINA filmsko obložena tableta 7 filmsko obloženih tablet
Blister packs Do not store above 25°C.
Pretisni omoti Shranjujte pri temperaturi do 25 °C.
● If you find you have forgotten to take your dose of Memantine ratiopharm, wait and take your next dose at the usual time.
• Če ste ugotovili, da ste pozabili vzeti predpisani odmerek zdravila Memantin ratiopharm,
Memantine ratiopharm is available in packs of 10, 14, 21, 28, 30, 42, 50, 56, 98, 100 and 112 filmcoated tablets.
Zdravilo Memantin ratiopharm je na voljo v velikostih pakiranja po 10, 14, 21, 28, 30, 42, 50, 56, 98, 100, 112 filmsko obloženih tablet.
What Memantine ratiopharm looks like and contents of the pack White to off-white, capsule shaped, biconvex tablets with a break score on one side and debossed with “20” on the other side.
Izgled zdravila Memantin ratiopharm in vsebina pakiranja Bele do belkaste, kapsulaste, bikonveksne tablete z razdelilno zarezo na eni strani in izbočeno oznako »20« na drugi.
Dizziness Balance disorders Gait abnormal Seizures
Pogosti Pogosti Občasni Zelo redki omotica motnje ravnotežja neobičajna hoja epileptični napadi
INFORMATION IN BRAILLE Memantine ratiopharm 20 mg
PODATKI V BRAILLOVI PISAVI Memantin ratiopharm 20 mg
The 20 mg film-coated tablets are white to off-white, capsule shaped, biconvex tablets with a break score on one side and debossed with “20” on the other side.
20 mg filmsko obložene tablete so bele do belkaste, kapsulaste, bikonveksne tablete z razdelilno zarezo na eni strani in izbočeno oznako »20« na drugi.
In postmarketing experience these reactions have been reported in patients treated with memantine.
Pri bolnikih, zdravljenih z memantinom, so o teh učinkih poročali po začetku trženja zdravila.
Each film-coated tablet contains 5 mg of memantine hydrochloride equivalent to 4.15 mg memantine.
Ena filmsko obložena tableta vsebuje 5 mg memantinijevega klorida, kar ustreza 4,15 mg memantina.
Each film-coated tablet contains 15 mg of memantine hydrochloride equivalent to 12.46 mg memantine.
Ena filmsko obložena tableta vsebuje 15 mg memantinijevega klorida, kar ustreza 12,46 mg memantina.
The 15 mg film-coated tablets are white to off-white, capsule shaped, biconvex tablets plain on one side and debossed with “15” on the other side.
15 mg filmsko obložene tablete so bele do belkaste, kapsulaste, bikonveksne tablete, ravne na eni strani in izbočeno oznako »15« na drugi.
Other medicines and Memantine ratiopharm
Shranjevanje zdravila Memantin ratiopharm
What Memantine ratiopharm looks like and contents of the pack White to off-white, capsule shaped, biconvex tablets with a break score on one side and debossed with “10” on the other side.
Izgled zdravila Memantin ratiopharm in vsebina pakiranja Bele do belkaste, kapsulaste, bikonveksne tablete z razdelilno zarezo na eni strani in izbočeno oznako »10« na drugi.
half a 10 mg tablet week 2
1. teden polovica 10 mg tablete
How does Memantine ratiopharm work
Kako deluje zdravilo Memantin ratiopharm
● other NMDA-antagonists at the same time should be avoided.
• ostali zaviralci receptorjev NMDA.
INFORMATION IN BRAILLE Memantine ratiopharm 5 mg
PODATKI V BRAILLOVI PISAVI Memantin ratiopharm 5 mg
The 10 mg film-coated tablets are white to off-white, capsule shaped, biconvex tablets with a break score on one side and debossed with “10” on the other side.
10 mg filmsko obložene tablete so bele do belkaste, kapsulaste, bikonveksne tablete z razdelilno zarezo na eni strani in izbočeno oznako »10« na drugi.
Each film-coated tablet contains 20 mg of memantine hydrochloride equivalent to 16.62 mg memantine.
Ena filmsko obložena tableta vsebuje 20 mg memantinijevega klorida kar ustreza 16,62 mg memantina.
Memantine ratiopharm 5 mg Memantine ratiopharm 10 mg Memantine ratiopharm 15 mg Memantine ratiopharm 20 mg film-coated tablets memantine hydrochloride
Memantin ratiopharm 5 mg Memantine ratiopharm 10 mg Memantine ratiopharm 15 mg Memantine ratiopharm 20 mg filmsko obložene tablete memantinijev klorid
INFORMATION IN BRAILLE Memantine ratiopharm 15 mg
PODATKI V BRAILLOVI PISAVI Memantin ratiopharm 15 mg
INFORMATION IN BRAILLE Memantine ratiopharm 10 mg
PODATKI V BRAILLOVI PISAVI Memantin ratiopharm 10 mg
White to off-white, capsule shaped, biconvex tablets with a break score on one side and debossed with “20” on the other side.
Bele do belkaste, kapsulaste, bikonveksne tablete z razdelilno zarezo na eni strani in izbočeno oznako »20« na drugi.
NAME OF THE MEDICINAL PRODUCT Memantine ratiopharm 20 mg tablets memantine hydrochloride
IME ZDRAVILA Memantin ratiopharm 20 mg tablete memantinijev klorid
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer packaging for 4 week treatment initiation pack ( 20 mg, 7 tablets, week 4)
PODATKI NA ZUNANJI OVOJNINI Zunanja ovojnina za 4-tedensko pakiranje za začetno zdravljenje (20 mg, 7 tablet, 4. teden)
Take one 20 mg tablet once day (white to off-white, capsule shaped, biconvex, with a break score on one side and debossed with “20” on the other side) for 7 days.
Vzemite po eno 20 mg tableto enkrat dnevno (bela do belkasta, kapsulasta, bikonveksna tableta z razdelilno zarezo na eni strani in izbočeno oznako »20« na drugi strani), jemljite 7 dni.
Elevated liver function test Hepatitis
Bolezni jeter, žolčnika in žolčevodov Pogosti Neznana pogostnost zvišane vrednosti testov jetrne funkcije hepatitis
Memantine ratiopharm 5 mg film-coated tablets Memantine ratiopharm 10 mg film-coated tablets Memantine ratiopharm 15 mg film-coated tablets Memantine ratiopharm 20 mg film-coated tablets
Memantin ratiopharm 5 mg filmsko obložene tablete Memantin ratiopharm 10 mg filmsko obložene tablete Memantin ratiopharm 15 mg filmsko obložene tablete Memantin ratiopharm 20 mg filmsko obložene tablete
The patient should take one 20 mg film-coated tablet per day (white to off-white, capsule shaped, biconvex tablets with a break score on one side and debossed with “20” on the other side.)
Bolnik naj 7 dni jemlje eno 20 mg filmsko obloženo tableto na dan (bele do belkaste, kapsulaste, bikonveksne tablete z razdelilno zarezo na eni strani in izbočeno oznako »20« na drugi).
Memantine ratiopharm 5 mg film-coated tablets Memantine ratiopharm 10 mg film-coated tablets Memantine ratiopharm 15 mg film-coated tablets Memantine ratiopharm 20 mg film-coated tablets memantine hydrochloride
Memantin ratiopharm 5 mg filmsko obložene tablete Memantin ratiopharm 10 mg filmsko obložene tablete Memantin ratiopharm 15 mg filmsko obložene tablete Memantin ratiopharm 20 mg filmsko obložene tablete memantinijev klorid
What Memantine ratiopharm contains - The active substance is memantine hydrochloride.
Kaj vsebuje zdravilo Memantin ratiopharm - Učinkovina je memantinijev klorid.
100 film-coated tablets
10 mg filmsko obložene tablete
Lactose (40 mg/film-coated tablet) and soya lecithin (0.065 mg/film-coated tablet).
Laktoza (40 mg/filmsko obloženo tableto) in sojin lecitin (0,065 mg/filmsko obloženo tableto) Memantine ratiopharm 10 mg
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer packaging for 4 week treatment initiation pack ( 15 mg, 7 tablets, week 3)
PODATKI NA ZUNANJI OVOJNINI Zunanja ovojnina za 4-tedensko pakiranje za začetno zdravljenje (15 mg, 7 tablet, 3. teden)
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 10 mg memantine hydrochloride equivalent to 8.31 mg memantine.
NAVEDBA ENE ALI VEČ UČINKOVIN Ena tableta vsebuje 10 mg memantinijevega klorida, kar ustreza 8,31 mg memantina.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer packaging for 4 week treatment initiation pack ( 10 mg, 7 tablets, week 2)
Zunanja ovojnina za 4-tedensko pakiranje za začetno zdravljenje (10 mg, 7 tablet, 2. teden)
Take one 10 mg tablet once a day (white to off-white, capsule shaped, biconvex, with a break score on one side and debossed with “10” on the other side) for 7 days.
Vzemite po eno 10 mg tableto enkrat dnevno (bela do belkasta, kapsulasta, bikonveksna tableta z razdelilno zarezo na eni strani in izbočeno oznako »10« na drugi strani), jemljite 7 dni.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer packaging for 4 week treatment initiation pack ( 5 mg, 7 tablets, week 1)
PODATKI NA ZUNANJI OVOJNINI Zunanja ovojnina za 4-tedensko pakiranje za začetno zdravljenje (5 mg, 7 tablet, 1. teden)
NAME OF THE MEDICINAL PRODUCT Memantine ratiopharm 10 mg film-coated tablets Memantine ratiopharm 20 mg film-coated tablets
Memantin ratiopharm 10 mg filmsko obložene tablete Memantin ratiopharm 20 mg filmsko obložene tablete
Lactose (120 mg/film-coated tablet) and soya lecithin (0.195 mg/film-coated tablet).
Laktoza (120 mg/filmsko obloženo tableto) in sojin lecitin (0,195 /filmsko obloženo tableto) Memantine ratiopharm 20 mg
White to off-white, capsule shaped, biconvex tablets with a break score on one side and debossed with “10” on the other side.
Bele do belkaste, kapsulaste, bikonveksne tablete z razdelilno zarezo na eni strani in izbočeno oznako »10« na drugi.
STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 5 mg memantine hydrochloride equivalent to 4.15 mg memantine.
NAVEDBA ENE ALI VEČ UČINKOVIN Ena filmsko obložena tableta vsebuje 5 mg memantinijevega klorida, kar ustreza 4,15 mg memantina.
Take one 15 mg tablet once a day (white to off-white, capsule shaped, biconvex, plain on one side and debossed with “15” on the other side) for 7 days.
Vzemite po eno 15 mg tableto enkrat dnevno (bela do belkasta, kapsulasta, bikonveksna tableta, ravna na eni strani in izbočeno oznako »15« na drugi strani), jemljite 7 dni.
The patient should take one 5 mg film-coated tablet per day (white to off-white, capsule shaped, biconvex tablets plain on one side and debossed with “5” on the other side) for 7 days.
Bolnik naj 7 dni jemlje eno 5 mg filmsko obloženo tableto na dan (bele do belkaste, kapsulaste, bikonveksne tablete, ravne na eni strani in z izbočeno oznako »5« na drugi).
Take one 5 mg tablet once a day (white to off-white, capsule shaped, biconvex, plain on one side and debossed with “5” on the other side) for 7 days.
Vzemite po eno 5 mg tableto enkrat dnevno (bela do belkasta, kapsulasta, bikonveksna tableta, ravna na eni strani in izbočeno oznako »5« na drugi strani), jemljite 7 dni.
The patient should take one 10 mg film-coated tablet per day (white to off-white, capsule shaped, biconvex tablets with a break score on one side and debossed with “10” on the other side.)
Bolnik naj 7 dni jemlje eno 10 mg filmsko obloženo tableto na dan (bele do belkaste, kapsulaste, bikonveksne tablete z razdelilno zarezo na eni strani in izbočeno oznako »10« na drugi).
White to off-white, capsule shaped, biconvex tablets plain on one side and debossed with “5” on the other side.
Bele do belkaste, kapsulaste, bikonveksne tablete, ravne na eni strani in z izbočeno oznako »5« na drugi.
NAME OF THE MEDICINAL PRODUCT Memantine ratiopharm 10 mg tablets memantine hydrochloride
Memantine ratiopharm 10 mg tablete memantinijev klorid
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer packaging (Blister)
PODATKI NA ZUNANJI OVOJNINI Zunanja ovojnina (pretisni omot)
NAME OF THE MEDICINAL PRODUCT Memantine ratiopharm 5 mg film-coated tablets memantine hydrochloride
Memantin ratiopharm 5 mg filmsko obložene tablete memantinijev klorid
NAME OF THE MEDICINAL PRODUCT Memantine ratiopharm 15 mg film-coated tablets memantine hydrochloride
Memantin ratiopharm 15 mg filmsko obložene tablete memantinijev klorid
White to off-white, capsule shaped, biconvex tablets plain on one side and debossed with “15” on the other side.
Bele do belkaste, kapsulaste, bikonveksne tablete, ravne na eni strani in z izbočeno oznako »15« na drugi.
The patient should take one 15 mg film-coated tablet per day (white to off-white, capsule shaped, biconvex tablets plain on one side and debossed with “15” on the other side.)
Bolnik naj 7 dni jemlje eno 15 mg filmsko obloženo tableto na dan (bele do belkaste, kapsulaste, bikonveksne tablete, ravne na eni strani in z izbočeno oznako »15« na drugi).
Drug hypersensitivity
Pogosti preobčutljivost za zdravilo
NAME OF THE MEDICINAL PRODUCT Memantine ratiopharm 10 mg film-coated tablets memantine hydrochloride
Memantine ratiopharm 10 mg filmsko obložene tablete memantinijev klorid
NAME OF THE MEDICINAL PRODUCT memantine ratiopharm 20 mg film-coated tablets Memantine hydrochloride
Memantine ratiopharm 20 mg filmsko obložene tablete memantinijev klorid
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 20 mg memantine hydrochloride equivalent to 16.62 mg memantine.
NAVEDBA ENE ALI VEČ UČINKOVIN Ena tableta vsebuje 20 mg memantinijevega klorida, kar ustreza 16,62 mg memantina.
Package leaflet: Information for the patient Memantine ratiopharm 10 mg film-coated tablets memantine hydrochloride
Navodilo za uporabo Memantin ratiopharm 10 mg filmsko obložene tablete memantinijev klorid
No cytochrome P 450 catalysed metabolism has been detected in vitro.
Nobeden od teh presnovkov nima antagonističnega učinka na NMDA. In vitro niso zaznali presnove preko citokroma P 450.
Package leaflet: Information for the patient Memantine ratiopharm 20 mg film-coated tablets memantine hydrochloride
Navodilo za uporabo Memantin ratiopharm 20 mg filmsko obložene tablete memantinijev klorid
6.5 Nature and contents of container 10 mg film-coated tablets
FARMACEVTSKA OBLIKA IN VSEBINA filmsko obložena tableta 100 filmsko obloženih tablet
Responses were received by 16 October 2007.
Odgovore je prejel do 16. oktobra 2007.
It is therefore recommended to delete this indication.
Zaradi tega se priporoča, da se ta indikacija izbriše.
Treated animals should have free access to water.
Zdravljene živali morajo imeti prost dostop do vode.
There is no indication that necessitates a new safety assessment.
Nobenih znakov ni, zaradi katerih bi bilo treba opraviti novo ocenjevanje varnosti.
On 12 July 2007 CVMP sent a list of questions to all marketing authorisation holders.
Dne 12. julija 2007 je odbor CVMP poslal seznam vprašanj vsem imetnikom dovoljenja za promet z zdravilom.
Thus, the risk of transmission of zoonotic pathogens to humans is considered rather low.
Zaradi tega se zdi tveganje za prenos zoonoznih patogenov na človeka precej nizko.
Therapeutic indication:
Terapevtske indikacije:
France stated that these matters are of community interest because animal and human health concerns are at stake.
Francija je navedla, da so predstavljene zadeve v interesu skupnosti, saj gre za zdravje živali in ljudi.
However, horses are treated individually and considered of relatively little importance as food producing species.
Vendar pa se konji zdravijo posamično in se štejejo za sorazmerno nepomembne kot živalska vrsta za proizvodnjo hrane.
2.3 Periodic Safety Update Reports
2.3 Periodična poročila o varnosti
Ireland VPA
Irska VPA
Since the procedure concerns a range of products, the assessment has been limited to specific parts of the authorisations in accordance with Article 35(2) of Directive 2001/82/EC, as amended.
Ker postopek zadeva sklop zdravil, je bilo ocenjevanje omejeno na točno določene dele dovoljenj za promet v skladu s členom 35(2) Direktive 2001/82/ES, kakor je bila spremenjena.
Belgium 282IS20F7
Belgija 282IS20F7
For horses, the following dosages can be applied according to the nature and seriousness of the ailment:
Pri konjih je mogoče v skladu z naravo in resnostjo bolezni uporabiti naslednje odmerke:
Strength / Active substance (INN)
Jakost / zdravilna učinkovina (INN)
CVMP decided not to review the ecotoxicity, as this was considered not applicable in the framework of the procedure.
Odbor CVMP je odločil, da ne bo pregledal ekotoksičnosti, saj se to ni štelo za smiselno v okviru postopka.
2.4 Antimicrobial resistance development and justification of recommended dose
2.4 Razvoj odpornosti na antibiotike in utemeljitev priporočenega odmerka
The treatment must be given during 10 days.
Zdravljenje je treba izvajati deset dni.
(Belgium)
(Belgija)
Member State / Marketing Authorisation Number
Država članica / številka dovoljenja za promet z zdravilom
2.1 Questions put to the Marketing Authorisation Holder
2.1 Vprašanja, zastavljena imetniku dovoljenja za promet z zdravilom
The information provided does not cover the entire sales, but most products are included and the period covered by the PSURs is longer than requested.
Predložene informacije ne zajemajo celotne prodaje, vendar pa je vključena večina zdravil, obdobje, ki ga zajemajo periodična poročila o varnosti, pa je daljše, kot je bilo zahtevano.
Iceland MTnr 880040
Islandija MTnr 880040
For the submission of responses Schering-Plough Limited (UK) represented Schering-Plough NV/SA (Belgium), Schering-Plough A/S (Denmark), AST Beheer BV and AST Farma BV.
Pri predložitvi odgovorov je družba Schering-Plough Limited (UK) zastopala družbe Schering-Plough NV/SA (Belgium), Schering-Plough A/S (Denmark), AST Beheer BV in AST Farma BV.
Some products include the recommendation to base treatment on susceptibility testing.
Nekatera zdravila vključujejo priporočilo, da naj zdravljenje temelji na testiranju dovzetnosti.
Each division on the
Vsak razdelek na batu za
The aim of the assessment was to establish whether marketing authorisations of veterinary medicinal products included in the referral procedure should be maintained, suspended, varied or revoked with view to the grounds for referral.
Cilj ocenjevanja je bil ugotoviti, ali naj se dovoljenja za promet z zdravili za uporabo v veterinarski medicini, ki so vključena v posvetovalni postopek, obdržijo, kakršna so, umaknejo, spremenijo ali razveljavijo glede na razloge za posvetovalni postopek.
Animal species
Žival ska vrsta
Norbrook Laboratories Limited represented Scanvet Animal Health A/S.
Družba Norbrook Laboratories Limited je zastopala družbo Scanvet Animal Health A/S.
− Infections of the genital tracts.
− Okužbe genitalnega trakta.
Boehringer-Ingelheim Limited and Fort Dodge Animal Health responded separately.
BoehringerIngelheim Limited, družba Fort Dodge Animal Health pa je odgovorila ločeno.
Amendments to be included in the relevant sections of the SPC: 4.2.
Dopolnila, ki jih je treba vključiti v zadevne razdelke Povzetka glavnih značilnosti zdravila: 4.2.
Indications for use, specifying the target species Delete, where applicable, salmonellosis from the indications.
Indikacije za uporabo, ki navajajo ciljne živalske vrste Kjer je smiselno, je kot indikacijo treba izbrisati salmonelozo.
This dose needs to be administered in 2 times.
Ta odmerek je treba dati dvakrat.