natgillin/translations-raw huggingface dataset:
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Solvent for Luveris
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Otapalo za Luveris voda za injekcije s.c.
How to store Luveris
Kako čuvati Luveris
(EU/1/00/155/001-003) One vial of solvent contains: 1 ml water for injection.
Jedna ampula s otapalom sadrži: 1 ml vode za injekcije. (EU/1/00/155/001-003) Jedna bočica s otapalom sadrži: 1 ml vode za injekcije. (EU/1/00/155/004-006)
• Feeling sick, vomiting, diarrhoea, abdominal discomfort or abdominal pain
• Osjećaj slabosti, povraćanje, proljev, nelagoda ili bol u trbuhu.
How to use Luveris
Kako primjenjivati Luveris
Moderate OHSS may additionally present with nausea, vomiting, ultrasound evidence of ascites or marked ovarian enlargement.
Simptomi umjerenog OHSS mogu biti mučnina, povraćanje, ultrazvučna potvrda dijagnoze ascitesa ili znatnog uvećanja jajnika.
• ovarian, uterine, or mammary carcinoma
• karcinom jajnika, maternice ili dojke.
Gastrointestinal disorders Common: Abdominal pain, abdominal discomfort, nausea, vomiting, diarrhoea.
Poremećaji probavnog sustava Često: Bol u trbuhu, nelagoda u trbuhu, mučnina, povraćanje, proljev.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING LUVERIS 75 IU, VIALS
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU LUVERIS 75 IU, BOČICE
Attach the reconstitution needle to the syringe and draw up some air into the syringe by pulling the plunger to approximately the 1 ml mark. Then, insert the needle into the vial, push the plunger to expel the air, turn the vial upside down and gently draw up all the solvent.
Pričvrstite iglu za rekonstituciju na štrcaljku i uvucite nešto zraka u štrcaljku tako da klip povučete otprilike do oznake 1 ml.
You and your partner's fertility should be evaluated before the treatment is started.
Prije početka liječenja potrebno je provjeriti Vašu plodnost i plodnost Vašeg partnera.
If you are not sure, talk to your doctor or pharmacist before using this medicine.
Prije nego primijenite ovaj lijek provjerite s Vašim liječnikom ili ljekarnikom ako niste sigurni.
10 vials of powder for solution for injection / 10 ampoules of solvent.
10 bočica s praškom za otopinu za injekciju / 10 ampula s otapalom.
3 vials of powder for solution for injection / 3 ampoules of solvent.
3 bočice s praškom za otopinu za injekciju / 3 ampule s otapalom.
1 vial of powder for solution for injection / 1 ampoule of solvent.
1 bočica s praškom za otopinu za injekciju / 1 ampula s otapalom.
Luveris 75 IU Powder for injection Lutropin alfa Subcutaneous use
Prašak za injekciju lutropin alfa Potkožno
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LUVERIS 75 IU, SOLVENT AMPOULES
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE LUVERIS 75 IU, AMPULE S OTAPALOM
Disodium phosphate dihydrate Sodium dihydrogen phosphate monohydrate Polysorbate 20
Prašak: saharoza natrijev hidrogenfosfat dihidrat natrijev dihidrogenfosfat hidrat polisorbat 20 fosfatna kiselina, koncentrirana (za podešavanje pH) natrijev hidroksid (za podešavanje pH)
The prevalence of congenital malformations after ART may be slightly higher than after spontaneous conceptions.
Prevalencija prirođenih malformacija nakon primjene metoda potpomognute oplodnje može biti blago povišena u odnosu na spontana začeća.
10 vials of powder for solution for injection / 10 vials of solvent.
10 bočica s praškom za otopinu za injekciju / 10 bočica s otapalom.
• Lower abdominal pain together with nausea or vomiting.
• Bol u donjem dijelu trbuha, katkada popraćena mučninom ili povraćanjem.
Tel.: +48 22 53 59 700
Merck Sp. z o.o. Tel.: +48 22 53 59 700
3 vials of powder for solution for injection / 3 vials of solvent.
3 bočice s praškom za otopinu za injekciju / 3 bočice s otapalom.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LUVERIS 75 IU, VIALS
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE LUVERIS 75 IU, BOČICE
November 2000.
Datum prvog odobrenja: 29. studenog 2000.
Subcutaneous use
Spontani pobačaj
General disorders and administration site conditions:
Opći poremećaji i reakcije na mjestu primjene
Birth defects
Prirođena oštećenja
Do not use Luveris if you are pregnant or breast-feeding.
Nemojte uzimati Luveris ako ste trudni ili dojite.
EU/1/11/679/001
EU/1/11/679/007 Pravafenix 40 mg/160 mg tvrde kapsule
MA (EU) number (Invented) name Strength
Broj (EU) odobrenja>
Vita Longa P.C.
Češka Republika Vita Longa P.C.
Iceland Janssen-Cilag International Nv
Janssen-Cilag International Nv
Arrow Generics LimitedTransferred To Actavis Group Ptc Ehf
Arrow Generics Limited - Transferred To Actavis Group Ptc Ehf
Metformin-Puren Actavis Deutschland
Kg Metformin-Puren Actavis Deutschland
France Eg Labo - Laboratoires Eurogenerics
Eg Labo - Laboratoires Eurogenerics Metformine Eg
Norway Astrazeneca Ab
Astrazeneca Ab
Austria Ratiopharm Arzneimittel VertriebsGmbh
Ratiopharm Arzneimittel VertriebsGmbh
Belgium Teva Pharma Belgium N.V.-S.A Metformine Teva
Teva Pharma Belgium N.V.-S.A
Dr. Max
Max
Ratiopharm Nederland B.V
Nederland B.V
Cyprus Delorbis Pharmaceuticals Ltd
Delorbis Pharmaceuticals Ltd
Bulgaria Teva Pharmaceuticals Bulgaria Eood
Teva Pharmaceuticals Bulgaria Eood Tevamet
Germany Rosemont Pharmaceuticals Limited Metfoliquid Geriasan
Rosemont Pharmaceuticals Limited Metfoliquid Geriasan
Slovakia Pharmaswiss česká Republika S.R.O.
Češka Republika Pharmaswiss česká Republika S.R.O.
Laboratories
Pharmaceuticals
Metformin Hydrochloride 1g Tablet
Metforminklorid 1 g tableta
Poland Zentiva, A.S.
Češka Republika Zentiva, A.S.
500mg Tablet
500 mg tableta
Sanofi - Produtos Farmaceuticos Lda
Sanofi - Produtos Farmaceuticos Lda Metformina Zentiva
Pinewood Laboratories Limited Metformin Hydrochloride Pinewood Laboratories Ltd
Metformin Hydrochloride Pinewood Laboratories Ltd
Germany Laboratori Guidotti S.P.A.
Češka Republika Laboratori Guidotti S.P.A.
Metformin Hydrochloride Bp 500mg
Metforminklorid Bp 500 mg
Romania Generics [uk] Limited
Češka Republika Generics [uk] Limited
Slovakia Merck Santé S.A.S.
Češka Republika Merck Santé S.A.S.
Metformin Hydrochloride 500ml/5 Ml
Metforminklorid 500 ml/5
Metformin 850mg Tablet
Metformin 850 mg tableta
Metformin Hydrochloride 400mg Capsule, Glibenclamide 2.5mg Capsule
Metforminklorid 400 mg kapsula, glibenklamid 2,5 mg kapsula kapsula
Slovakia Stada Arzneimittel Ag
Češka Republika Stada Arzneimittel Ag
Metformin 1000mg Tablet
Metformin 1000 mg tableta
Metformin Hydrochloride 850mg
Metforminklorid 850 mg
Metformin Medley Pharma
Metformin Crescent Pharma
Lithuania Vitabalans Oy
Češka Republika Vitabalans Oy
Germany Glenmark Arzneimittel Gmbh
Glenmark Arzneimittel Gmbh
Slovakia Medreg S.R.O.
Češka Republika Medreg S.R.O.
Rosemont Pharmaceuticals Limited Metformin Hydrochloride Rosemont Pharmaceuticals
Rosemont Pharmaceuticals Limited Metformin Hydrochloride Rosemont
Pinewood Laboratories Limited Metformin Hydrochloride Pinewood Laboratories
Metformin Hydrochloride Pinewood Laboratories
France Ranbaxy Pharmacie Generiques Metformine Ranbaxy
Ranbaxy Pharmacie Generiques
Slovakia Actavis Group Ptc Ehf.
Češka Republika Actavis Group Ptc Ehf.
Norway Rosemont Pharmaceuticals Limited Metformin Rosemont
Rosemont Pharmaceuticals Limited Metformin Rosemont
Portugal
Grčka
Austria Bluefish Pharmaceuticals Ab
Češka Republika Bluefish Pharmaceuticals Ab
Metformin 500mg Tablet
Metformin 500 mg tableta
Metformin Wockhardt Uk
Metformin Wockhardt Uk Ltd
Metformin Hydrochloride 100mg/ Ml
Metforminklorid 100 mg/
Metformin Hydrochloride 850mg Tablet, Alogliptin 25mg Tablet
Metforminklorid 850 mg tableta, alogliptin 25 mg tableta
Germany Heumann Pharma Gmbh & Co. Generica Kg
Heumann Pharma Gmbh & Co.
Germany Berlin-Chemie Ag
Češka Republika Berlin-Chemie Ag
Metformin Hydrochloride 170mg/Ml
Metforminklorid 170 mg/Ml oralna otopina
Metformin Hydrochloride Glenmark Generics Europe
Glenmark Generics (Europe) Limited Metformin Hydrochloride Glenmark Generics
Metformin Hydrochloride 850mg Tablet, Linagliptin 2.5mg Tablet
Metforminklorid 850 mg tableta, linagliptin 2,5 mg tableta
Metformin Hydrochloride 850mg Tablet, Dapagliflozin 5mg Tablet
Metforminklorid 850 mg tableta, dapagliflozin 5 mg tableta
Metformin Wockhardt Uk Ltd Metformin Hydrochloride 500mg Tablet
Metformin Wockhardt Uk Metforminklorid 500 mg tableta filmom obložena tableta
Metformin Hydrochloride 1000mg Tablet, Sitagliptin 50mg Tablet
Metforminklorid 1000 mg tableta, sitagliptin 50 mg tableta
Metformin Hydrochloride 850mg Tablet, Alogliptin 12.5mg Tablet
Metforminklorid 850 mg tableta, alogliptin 12,5 mg tableta
Metformin Hydrochloride 1000mg Tablet, Empagliflozin 12.5mg Tablet
Metforminklorid 1000 mg tableta, empagliflozin 12,5 mg tableta
Metformin Hydrochloride 1000mg Tablet, Linagliptin 2.5mg Tablet
Metforminklorid 1000 mg tableta, linagliptin 2,5 mg tableta
Metformin Wockhardt Uk Ltd Metformin Hydrochloride 850mg Tablet
Metformin Wockhardt Uk Metforminklorid 850 mg tableta filmom obložena tableta
Metformin Hydrochloride 500mg Film Film-Coated Tablet
Metforminklorid 500 mg film filmom obložena tableta
Metformin Hydrochloride 1000µg Tablet Film-Coated Tablet
Metforminklorid 1000µg tableta filmom obložena tableta
Metformin Hydrochloride 1000mg Sachet Powder For Oral Solution
Metforminklorid 1000 mg vrećica prašak za oralnu otopinu
Metformin Hydrochloride 1000mg Film Film-Coated Tablet
Metforminklorid 1000 mg film filmom obložena tableta
Metformin Embonate 700mg Tablet
Metforminembonat 700 mg tableta tableta
Metformin Hydrochloride 500mg G
Metforminklorid 500 mg
Metformin Crescent Pharma Metformin Hydrochloride 850mg Tablet
Metformin Medley Pharma Metforminklorid 850 mg tableta tableta
Metformin Hydrochloride 850mg Tablet, Sitagliptin 50mg Tablet
Metforminklorid 850 mg tableta, sitagliptin 50 mg tableta
Metformin Crescent Pharma Metformin Hydrochloride 500mg Tablet
Metformin Medley Pharma Metforminklorid 500 mg tableta tableta
Metformin Hydrochloride 850mg Tablet, Empagliflozin 12.5mg Tablet
Metforminklorid 850 mg tableta, empagliflozin 12,5 mg tableta
Metformin Hydrochloride 850mg Tablet, Empagliflozin 5mg Tablet
Metforminklorid 850 mg tableta, empagliflozin 5mg tableta
Metformin Hydrochloride 1000mg Tablet, Saxagliptin 2.5mg Tablet
Metforminklorid 1000 mg tableta, saksagliptin 2,5 mg tableta
Metformin Lindopharm Metformin Hydrochloride 500mg Tablet
Metformin Lindopharm Metforminklorid 500 mg tableta filmom obložena tableta
Wörwag Pharma Gmbh & Co. Kg Metfogamma
Wörwag Pharma Gmbh & Co.
Metformin Lindopharm Metformin Hydrochloride 850mg Tablet
Metformin Lindopharm Metforminklorid 850 mg tableta filmom obložena tableta
Metformin Relonchem Metformin Hydrochloride 850mg Tablet
Metformin Relonchem Metforminklorid 850 mg tableta filmom obložena tableta
Metformin Hydrochloride 1000mg Tablet, Empagliflozin 5mg Tablet
Metforminklorid 1000 mg tableta, empagliflozin 5mg tableta
Metformin Hydrochloride 850mg Sachet Powder For Oral Solution
Metforminklorid 850 mg Vrećica prašak za oralnu otopinu
Metformin Hydrochloride 850mg Tablet, Saxagliptin 2.5mg Tablet
Metforminklorid 850 mg tableta, saksagliptin 2,5 mg tableta
Metformin Hydrochloride 1000mg/1117 Mg
Metforminklorid 1000 mg/1117 Mg filmom obložena tableta
Metformin Hydrochloride 1000mg Tablet, Dapagliflozin 5mg Tablet
Metforminklorid 1000 mg tableta, dapagliflozin 5 mg tableta
Metformin Hydrochloride 850mg Tablet, Pioglitazone 15mg Tablet
Metforminklorid 850 mg tableta, Pioglitazon 15mg tableta
Metformin Hcl Ratiopharm Metformin Hydrochloride 850mg Tablet
Metformin Hcl Ratiopharm Metforminklorid 850 mg tableta filmom obložena tableta
Metformin Relonchem Metformin Hydrochloride 500mg Tablet
Metformin Relonchem Metforminklorid 500 mg tableta filmom obložena tableta
Metformin Hydrochloride 1000mg Sachet Powder For Oral Solution In Sachet
Metforminklorid 1000 mg vrećica prašak za oralnu otopinu u vrećici
United Kingdom
Nizozemska
Metformin Hcl Ratiopharm Metformin Hydrochloride 1000mg Tablet Film-Coated Tablet
Metformin Hcl Ratiopharm Metforminklorid 1000 mg tableta filmom obložena tableta
Metformin Hydrochloride 1000mg Tablet Tablet
Metforminklorid 1000 mg tableta Šumeća tableta
Metformin Hydrochloride 500mg Sachet Powder For Oral Solution
Metforminklorid 500 mg vrećica prašak za oralnu otopinu
Metformin Hydrochloride 400mg Tablet, Glibenclamide 5mg Tablet
Metforminklorid 400 mg tableta, glibenklamid 5 mg tableta
Metformin Hydrochloride 400mg Tablet, Glibenclamide 2.5mg Tablet
Metforminklorid 400 mg tableta, glibenklamid 2,5 mg tableta
Metformin Hydrochloride 500mg Tablet, Glibenclamide 5mg Tablet
Metforminklorid 500 mg tableta, glibenklamid 5 mg tableta
Metformin Hydrochloride 2.5mg Tablet, Glibenclamide 500mg Tablet
Metforminklorid 2,5 mg, glibenklamid 500 mg tableta
Metformin Hydrochloride 500mg Tablet, Glibenclamide 2.5mg Tablet
Metforminklorid 500 mg tableta, glibenklamid 2,5 mg tableta
Metformina Mylan Generics Metformin Hydrochloride 1000mg Tablet Film-Coated Tablet
Metformine Hcl Mylan Metforminklorid 1000 mg tableta filmom obložena tableta
Germany Sandoz Pharmaceuticals Gmbh Metformin Sandoz
Sandoz Pharmaceuticals Gmbh
Focus Pharmaceuticals Limited Metformin Focus Pharmaceuticals
Metformin Focus Pharmaceuticals
Metformin Hcl Ratiopharm Metformin Hydrochloride 500mg Tablet
Metformin Hcl Ratiopharm Metforminklorid 500 mg tableta filmom obložena tableta
Slovenia Wörwag Pharma Gmbh & Co. Kg Metfogamma
Češka Republika Wörwag Pharma Gmbh & Co.
Metformine Arrow Generiques Metformin Hydrochloride 1000mg Tablet Film-Coated Tablet
Metformine Arrow Lab Metforminklorid 1000 mg tableta filmom obložena tableta
Metformin Hydrochloride 500mg Sachet Powder For Oral Solution In Sachet
Metforminklorid 500 mg vrećica prašak za oralnu otopinu u vrećici
Metformin Hydrochloride 1000mg Tablet, Glibenclamide 5mg Tablet
Metforminklorid 1000 mg tableta, glibenklamid 5 mg tableta
Metformin Hydrochloride 850mg Tablet, Canagliflozin 50mg Tablet
Metforminklorid 850 mg tableta, kanagliflozin 50 mg tableta
Metformin Hydrochloride 850mg Sachet Powder For Oral Solution In Sachet
Metforminklorid 850 mg vrećica prašak za oralnu otopinu
Metformina Mylan Generics Metformin Hydrochloride 850mg Tablet
Metformine Hcl Mylan Metforminklorid 850 mg tableta filmom obložena tableta
Metformin-Ratiopharm Metformin Hydrochloride 850mg Tablet
Metformin-Ratiopharm Metforminklorid 850 mg tableta filmom obložena tableta
Metformin Hydrochloride 1000mg Tablet, Canagliflozin 50mg Tablet
Metforminklorid 1000 mg tableta, kanagliflozin 50 mg tableta
Metformin-Ratiopharm Metformin Hydrochloride 500mg Tablet
Metformin-Ratiopharm Metforminklorid 500 mg tableta filmom obložena tableta
Metformin Hydrochloride 1000mg Tablet, Canagliflozin 150mg Tablet
Metforminklorid 1000 mg tableta, kanagliflozin 150 mg tableta
Metformin Hcl Plus Pharmacie Metformin Hydrochloride 1000mg Tablet Film-Coated Tablet
Metformin 1 A Pharma Metforminklorid 1000 mg tableta filmom obložena tableta
Metformina Mylan Generics Metformin Hydrochloride 500mg Tablet
Metformine Hcl Mylan Metforminklorid 500 mg tableta filmom obložena tableta
Metformin Ratiopharm Metformin Hydrochloride 850mg Tablet
Metformin Ratiopharm Metforminklorid 850 mg tableta filmom obložena tableta
Metformin Ratiopharm Metformin Hydrochloride 1000mg Tablet Film-Coated Tablet
Metformin Ratiopharm Metforminklorid 1000 mg tableta filmom obložena tableta
Metformina Ratiopharm Metformin Hydrochloride 1000mg Tablet Film-Coated Tablet
Metformina Ratiopharm Metforminklorid 1000 mg tableta filmom obložena tableta
Metformine Ratiopharm Metformin Hydrochloride 1000mg Tablet Film-Coated Tablet
Metformine Ratiopharm Metforminklorid 1000 mg tableta filmom obložena tableta
Metformin Ratiopharm Metformin Hydrochloride 500mg Tablet
Metformin Ratiopharm Metforminklorid 500 mg tableta filmom obložena tableta
Metformin Hydrochloride 850mg Tablet, Canagliflozin 150mg Tablet
Metforminklorid 850 mg tableta, kanagliflozin 150 mg tableta
Metformina Ratiopharm Metformin Hydrochloride 850mg Tablet
Metformina Ratiopharm Metforminklorid 850 mg tableta filmom obložena tableta
Kingdom
Španjolska
Metformine Ratiopharm Metformin Hydrochloride 850mg Tablet
Metformine Ratiopharm Metforminklorid 850 mg tableta filmom obložena tableta
Metformina Ratiopharm Metformin Hydrochloride 500mg Tablet
Metformina Ratiopharm Metforminklorid 500 mg tableta filmom obložena tableta
(Invented) name Strength
(Zaštićeno) ime Doza
The European Commission issued a decision on 22 August 2016.
Europska komisija objavila je odluku 22. kolovoza 2016.
30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom22 August 2016
30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom22. kolovoza 2016.
The procedure was concluded and on 11 July 2014 the European Commission adopted a Decision1.
Postupak je završen i 11. srpnja 2014.
Outcome of a referral procedure under Article 35 of Directive 2001/82/EC (EMEA/V/A/110)
Ishod postupka upućivanja u skladu s člankom 35. Direktive 2001/82/EZ (EMEA/V/A/110)
What are lincomycin and spectinomycin?
Što su linkomicin i spektinomicin?
Which data has the CVMP reviewed?
Koje je podatke CVMP ocijenio?
The full changes made to the product information for powders for use in the drinking water are detailed in Annex III of the CVMP opinion on the 'All documents' tab.
Cjelovite izmjene informacija o proizvodu za praškove za uporabu u vodi za piće detaljno su navedene u prilogu III. mišljenju CVMP-a u kartici „Svi dokumenti”.
The lincosamides are considered to be bacteriostatic agents.
Linkozamidi se smatraju bakteriostatskim agensima.
Commission Decision concerning, in the framework of Article 34 of Directive 2001/82/EC of the European Parliament and of the Council, the marketing authorisations for “Linco-Spectin 100 and its associated names”, veterinary medicinal products which contain the active substances “Lincomycin and spectinomycin” ((2014)5053 of 11/07/2014) http://ec.europa.eu/health/documents/community-register/html/vo25233.htm
Direktive 2001/82/EZ Europskog parlamenta i Vijeća o odobrenjima za stavljanje u promet proizvoda „Linco-Spectin 100 i povezane nazive”, veterinarsko-medicinskih proizvoda koji sadrže djelatne tvari „linkomicin i spektinomicin” ((2014)5053 od 11. srpnja 2014.) http://ec.europa.eu/health/documents/community-register/html/vo25233.htm
Subsequent to the outcome of the aforementioned Article 34 referral procedure for Linco-Spectin 100, Belgium considered that it is in the interest of the EU to promote effective and rational use of the lincomycin-spectinomycin combination in orally administered veterinary medicinal products, and thereby limit the risk of the development of resistance.
Nakon ishoda prethodno navedenog postupka upućivanja u skladu s člankom 34. za Linco-Spectin 100, Belgija je smatrala da je u interesu EU-a promicati učinkovitu i racionalnu uporabu kombinacije linkomicina i spektinomicina u veterinarsko-medicinskim proizvodima koji se oralno primjenjuju te da na taj način ograničiti rizik od razvoja otpornosti.
Questions and answers on veterinary medicinal products containing a combination of lincomycin and spectinomycin to be administered orally to pigs and/or poultry EMA/462762/2016
Pitanja i odgovori o veterinarsko-medicinskim proizvodima koji sadrže kombinaciju linkomicina i spektinomicina za oralnu primjenu u svinja i/ili peradi EMA/462762/2016
Why were veterinary medicinal products containing a combination of lincomycin and spectinomycin reviewed?
Zašto su veterinarsko-medicinski proizvodi koji sadrže kombinaciju linkomicina i spektinomicina ponovno ocjenjivani?
In September 2012 Belgium initiated a referral procedure under Article 34 of Directive 2001/82/EC for Linco-Spectin 100, powder for use in the drinking water for pigs and chickens (EMEA/V/A/088).
Belgija je pokrenula postupak upućivanja u skladu s člankom 34. Direktive 2001/82/EZ za Linco-Spectin 100, prašak za uporabu u vodi za piće za svinje i perad (EMEA/V/A/088).
Therefore, on 5 May 2015, Belgium initiated a procedure under Article 35 of Directive 2001/82/EC for veterinary medicinal products containing a combination of lincomycin and spectinomycin to be administered orally to pigs and/or poultry.
Belgija je stoga 5. svibnja 2015. pokrenula postupak u skladu s člankom 35. Direktive 2001/82/EZ za veterinarsko-medicinske proizvode koji sadrže kombinaciju linkomicina i spektinomicina za oralnu primjenu u svinja i/ili peradi.
Proprietary data and scientific references on efficacy and residue depletion were provided by the marketing authorisation holders in this Article 35 referral procedure.
Nositelji odobrenja za stavljanje u promet pružili su podatke proizvođača i znanstvena upućivanja o učinkovitosti i smanjenju rezidua u okviru postupka upućivanja iz članka 35.
No amendments to the currently approved withdrawal periods for pigs and chicken for the aforementioned powders for use in the drinking water were considered necessary.
Zaključeno je da postojeća razdoblja karencije za svinje i piliće za prethodno navedene praškove za uporabu u vodi za piće nije potrebno mijenjati.
Lincomycin is a lincosamide antibiotic derived from Streptomyces lincolnensis which inhibits protein synthesis.
Linkomicin je linkozamidni antibiotik koji se dobiva iz bakterije Streptomyces lincolensis, koji onemogućuje sintezu bjelančevina.
Lincomycin is active against gram-positive bacteria, some anaerobic gram-negative bacteria and Mycoplasma spp.
Linkomicin je djelotvoran protiv gram-pozitivnih bakterija, nekih anaerobnih gram-negativnih bakterija i bakterije Mycoplasma spp.
The CVMP was requested to assess the available data and to review the indications, dosage regimens and withdrawal periods for pigs and poultry in order to ensure consumer safety, efficacious treatment in pigs, chickens and other poultry species, as well as a lower risk of the development of antimicrobial resistance to lincomycin and spectinomycin.
Od CVMP-a je zatraženo da procijeni dostupne podatke i ponovno ocijeni indikacije, režime doziranja i razdoblja karencije za svinje i perad radi osiguravanja sigurnosti potrošača, djelotvorne terapijske primjene u svinja, pilića i drugih vrsta peradi te manjeg rizika od razvoja antimikrobne otpornosti na linkomicin i spektinomicin.
On 19 May 2016, the European Medicines Agency (the Agency) completed a review of the safety and effectiveness of, and antimicrobial resistance to, veterinary medicinal products containing a combination of lincomycin and spectinomycin to be administered orally to pigs and/or poultry.
Europska agencija za lijekove (Agencija) dovršila je 19. svibnja 2016. ocjenjivanje sigurnosti i učinkovitosti veterinarsko-medicinskih proizvoda koji sadrže kombinaciju linkomicina i spektinomicina za oralnu primjenu u svinja i/ili peradi te antimikrobnu otpornost na te proizvode.
Questions and answers on veterinary medicinal products containing a combination of lincomycin and spectinomycin to be administered orally to pigs and/or poultry
Pitanja i odgovori o veterinarsko-medicinskim proizvodima koji sadrže kombinaciju linkomicina i spektinomicina za oralnu primjenu u svinja i/ili peradi
For pigs and poultry three pharmaceutical forms for oral administration exist with a combination of lincomycin and spectinomycin - premixes for medicated feeding stuff, powders to be administered with the feed and powders for use in the drinking water.
Postoje tri farmaceutska oblika oralne primjene kombinacije linkomicina i spektinomicina u svinja i peradi, a to su premiksi za hranu za životinje s dodatkom lijeka, prašci za primjenu s hranom za životinje i prašci za uporabu u vodi za piće.
The CVMP recommended that all marketing authorisations for premixes for medicated feeding stuff and powders to be administered with the feed containing a combination of lincomycin and spectinomycin be withdrawn throughout the European Union (EU).
CVMP je preporučio povlačenje svih odobrenja za stavljanje u promet premiksa za hranu za životinje s dodatkom lijekova i praškova za primjenu s hranom koji sadrže kombinaciju linkomicina i spektinomicina na prostoru Europske unije (EU-a).