natgillin/translations-raw huggingface dataset:
O1 Manisa ................................................................................................................................. ≥ 6 PD50* O1 BFS ....................................................................................................................................... ≥ 6 PD50* O Taiwan 3/97 ........................................................................................................................... ≥ 6 PD50* A22 Iraq ..................................................................................................................................... ≥ 6 PD50* A24 Cruzeiro ............................................................................................................................. ≥ 6 PD50* A Turkey 14/98 ......................................................................................................................... ≥ 6 PD50* Asia 1 Shamir ............................................................................................................................. ≥ 6 PD50* SAT2 Saudi Arabia ................................................................................................................... ≥ 6 PD50*
O1 Manisa .................................................................................................................................. ≥ 6 ZO50* O1 BFS ....................................................................................................................................... ≥ 6 ZO50* O Taiwan 3/97 ............................................................................................................................ ≥ 6 ZO50* A22 Iraq ...................................................................................................................................... ≥ 6 ZO50* A24 Cruzeiro .............................................................................................................................. ≥ 6 ZO50* A Turkey 14/98 .......................................................................................................................... ≥ 6 ZO50* Asia 1 Shamir ............................................................................................................................. ≥ 6 ZO50* SAT2 Saudi Arabia……………………………………………………………………………≥ 6 ZO50*
If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.
Če opazite kakršne koli stranske učinke, tudi tiste ki niso navedeni v tem navodilu za uporabo, ali mislite, da zdravilo ni delovalo, obvestite svojega veterinarja.
Avoid accidental contamination of the vaccine after first broaching and during use.
Preprečite nenamerno kontaminacijo cepiva po prvem prebadanju in med uporabo.
Each dose of 2 ml of emulsion contains:
Vsak odmerek (2 ml) emulzije vsebuje:
Schedule should be adjusted accordingly (see section 4.9).
Razpored cepljenja je zato potrebno ustrezno prilagoditi (glejte poglavje 4.9).
Date of first authorisation: 15/07/2013 Date of last renewal: 14/06/2018
Datum zadnjega podaljšanja dovoljenja za promet: 14/06/2018
Do not mix the vaccine by vigorous shaking because it leads to entrapment of air bubbles.
Cepiva ne mešajte z močnim tresenjem, ker to lahko povzroči nastanek zračnih mehurčkov.
The use of this veterinary medicinal product is only allowed under the particular conditions established by European Community legislation on the control of foot-and-mouth disease.
Uporaba tega zdravila za uporabo v veterinarski medicini je dovoljena z zakonodajo Evropske skupnosti le pod posebnimi pogoji v skladu z ukrepi za nadzor nad slinavko in parkljevko.
Pigs: 4 weeks after vaccination.
Prašiči: 4 tedne po cepljenju.
Schedule should be adjusted accordingly (see section “dosage”).
Razpored cepljenja je zato potrebno ustrezno prilagoditi (glejte poglavje »Odmerjanje«).
Merial Laboratoire Porte des Alpes Rue de l'Aviation 69800 Saint Priest FRANCE
Laboratoire Porte des Alpes Rue de l'Aviation 69800 Saint Priest Francija
Cattle and sheep: 7 days after vaccination.
Govedo in ovce: 7 dni po cepljenju.
Polypropylene bottle with a nitrile elastomer closure and sealed with an aluminium cap.
Polipropilenska steklenička z nitrilelastomerno zaporko in zapečatena z aluminijastim pokrovčkom.
Do not use this veterinary medicinal product after the expiry date which is stated on the label after EXP.
Zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na ovojnini poleg oznake EXP.
In cattle, the antibody levels measured were above those shown to be protective.
Pri govedu je nivo izmerjenih protiteles nad tistim, ki je dokazano zaščitni.
Following repeated administration at short intervals, the intensity of these reactions may be increased.
Po večkratnem dajanju v kratkih časovnih intervalih se lahko intenziteta teh reakcij poveča.
10 doses 25 doses 50 doses 100 doses 150 doses 10 x 10 doses 10 x 25 doses 10 x 50 doses 10 x 100 doses 10 x 150 doses
1 x 10 odmerki 1 x 25 odmerki 1 x 50 odmerki 1 x 100 odmerki 1 x 150 odmerki 10 x 10 odmerki 10 x 25 odmerki 10 x 50 odmerki 10 x 100 odmerki 10 x 150 odmerki
Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.
Podrobne informacije o tem zdravilu za uporabo v veterinarski medicini so na voljo na spletni strani Evropske agencije za zdravila: http://www.ema.europa.eu/.
The safety of the veterinary medicinal product has not been established during lactation.
Varnost zdravila v obdobju laktacije ni bila ugotovljena.
White emulsion after shaking.
Bela emulzija po pretresanju.
When animals have to be vaccinated in presence of maternal antibodies, revaccination at 8-10 weeks is recommended.
V primeru da je potrebno živali cepiti ob prisotnosti maternalnih protiteles, je priporočljiva revakcinacija pri 8-10 tednih.
Maternal antibodies may interfere with vaccination.
Maternalna protitelesa lahko motijo nastanek imunosti.
Major incompatibilities: Do not mix with any other veterinary medicinal product.
Glavne inkompatibilnosti: Ne mešajte z nobenim drugim zdravilom za uporabo v veterinarski medicini.
For the full list of excipients, see section 6.1.
Pomožne snovi: Za celoten seznam pomožnih snovi, glejte poglavje 6.1.
* PD50 - 50% protective dose in cattle as described in Ph. Eur.
*ZO50 - 50% zaščitnega odmerka pri govedu, kot določa Ph. Eur monografija 0063.
Pigs: IM.
Prašiči: IM
A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be made on a case by case basis.
Zato se za uporabo tega imunološkega zdravila pred ali po uporabi katerega koli drugega zdravila za uporabo v veterinarski medicini odločamo od primera od primera.
one dose of 2 ml, by subcutaneous route.
en odmerek po 2 ml, subkutano
Pharmaceutical group: inactivated viral vaccine, foot-and-mouth disease virus.
Farmakoterapevtska skupina: Inaktivirana virusna cepiva, virus slinavke in parkljevke.
- in cattle following administration of a double dose followed by a single dose 7 weeks later and a third vaccination with a single dose 13 weeks after the second dose, - in sheep following administration of a double dose followed by a single dose 5 weeks later and a third vaccination with a single dose 7 weeks after the second dose, - in pigs following administration of a double dose followed by a single dose 3 weeks later and a third vaccination with a single dose 7 weeks after the second dose.
- pri govedu po dajanju dvakratnega odmerka in enega odmerka 7 tednov kasneje in tretjim cepljenjem z enim odmerkom 13 tednov po drugem cepljenju, - pri ovcah po dajanju dvakratnega odmerka in enega odmerka 5 tednov kasneje in tretjim cepljenjem z enim odmerkom 7 tednov po drugem cepljenju, - pri prašičih po dajanju dvakratnega odmerka in enega odmerka 3 tedne kasneje in tretjim cepljenjem z enim odmerkom 7 tednov po drugem cepljenju.
When very young pigs (at 2 weeks old) have to be vaccinated, revaccination at 8-10 weeks is recommended.
Če je potrebno cepiti zelo mlade pujske (pri 2 tednih starosti), je priporočljiva revakcinacija pri 8-10 tednih.
Primary vaccination: Cattle from 2 weeks of age:
Osnovno cepljenje: Govedo od 2 tednov starosti dalje:
50 doses 100 doses 150 doses
100 odmerkov 150 odmerkov
Swellings (diameter of up to 12 cm in ruminants and 4 cm in pigs) occurred very commonly in most animals after administration of a dose of vaccine.
Oteklina (premera do 12 cm pri prežvekovalcih in 4 cm pri prašičih) se je po cepljenju z enim odmerkom cepiva zelo pogosto pojavila pri večini živali.
Inactivated foot-and-mouth disease antigens are purified and do not contain sufficient amounts of non-structural proteins (NSP) to induce an antibody response following administration of a trivalent vaccine containing an amount of antigen corresponding with at least 15 PD50 per strain per dose of 2 ml.
Inaktivirani antigeni v cepivu so prečiščeni in ne vsebujejo dovolj ne-strukturnih proteinov (NSP), da bi izzval odziv protiteles po dajanju trivalentnega cepiva, ki vsebuje količino antigena ki ustreza vsaj 15 ZO50 na posamezni sev na 2 ml odmerek.
A slight increase of rectal temperature of up to 1.2 °C for 4 days post-vaccination with no other generalised clinical signs is commonly observed.
Pogosto se pri živalih po cepljenju pojavi zmerno povečanje rektalne temperature za do 1,2 °C, ki traja 4 dni po cepljenju brez drugih generaliziranih kliničnih znakov.
Do not warm the product before use.
Pred uporabo cepiva ne grejte.
The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated ) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Pogostost neželenih učinkov je določena po naslednjem dogovoru: zelo pogosti (neželeni učinki se pokažejo pri več kot 1 od 10 zdravljenih živali) pogosti (pri več kot 1, toda manj kot 10 živali od 100 zdravljenih živali) občasni (pri več kot 1, toda manj kot 10 živali od 1.000 zdravljenih živali) redki (pri več kot 1, toda manj kot 10 živali od 10.000 zdravljenih živali) zelo redki (pri manj kot 1 živali od 10.000 zdravljenih živali, vključno s posameznimi primeri).
No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product.
Ni podatkov o varnosti ter učinkovitosti ob uporabi tega imunološkega zdravila s katerim koli drugim zdravilom za uporabo v veterinarski medicini.
Maximum three of the following purified, inactivated foot-and-mouth disease virus strains:
Največ tri od spodaj navedenih prečiščenih, inaktiviranih sevov virusa slinavke in parkljevke:
Vaccination of cattle with strains O1 Manisa, O1 BFS, A22 Iraq, A24 Cruzeiro, A Turkey 14/98, Asia1 Shamir and SAT2 Saudi Arabia resulted in a reduction of clinical signs in animals exposed to infection.
S študijami je dilo dokazano, da cepljenje goveda s sevi O1 Manisa, O1 BFS, A22 Iraq; A24 Cruzeiro, A Turkey 14/98, Asia 1 Shamir in SAT2 Saudi Arabia, dokazano zmanjša pojavnost kliničnih znakov pri živalih, izpostavljenih okužbi.
No antibodies to NSP were detected using the PrioCHECK FMDV NS test kit:
Z uporabo PrioCHECK FMDV NS testa niso bila zaznana protitelesa proti NSP:
Pigs: for intramuscular use.
Prašiči: intramuskularno.
CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ODMERKOV 10 odmerkov
Following repeated administration at short intervals, the intensity and frequency of these reactions may be increased.
Po večkratnem dajanju v kratkih časovnih intervalih se lahko intenziteta teh reakcij povečal.
EU/2/13/153/001- 850
ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/13/153/001- 850
EU/2/13/153/001-850
ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/13/153/001-850
Homogenize the content of the vial by gentle mixing before the insertion of needle.
Homogenizirajte vsebino stekleničke z nežnim tresenjem pred prebadanjem z iglo.
A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
A. PROIZVAJALEC BIOLOŠKIH UČINKOVIN IN PROIZVAJALEC ZDRAVILA, ODGOVOREN ZA SPROŠČANJE SERIJ
Shelf life of the veterinary medicinal product not containing strain Asia1 Shamir as packaged for sale: 6 months.
Rok uporabnosti zdravila, ki ne vsebuje seva Asia1 Shamir, v pakiranju za prodajo: 6 mesecev.
MANUFACTURER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. STATEMENT OF THE MRLs
PRILOGA II A. PROIZVAJALEC BIOLOŠKIH UČINKOVIN IN PROIZVAJALEC ZDRAVILA, ODGOVOREN ZA SPROŠČANJE SERIJ B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE C. NAVEDBA NAJVIŠJIH DOVOLJENIH KOLIČIN OSTANKOV ZDRAVILA (MRL)
Zero days.
Karenca: Nič dni.
Shelf life of the veterinary medicinal product containing strain Asia1 Shamir as packaged for sale: 2 months.
Rok uporabnosti zdravila, ki vsebuje sev Asia1 Shamir, v pakiranju za prodajo: 2 meseca.
Duration of immunity: vaccination of cattle, sheep and pigs induced the production of neutralising antibodies that persisted for at least 6 months.
Trajanje imunosti: cepljenje goveda, ovc in prašičev inducira nastanek nevtralizacijskih protiteles, ki vztrajajo vsaj 6 mesecev.
Liquid paraffin 537 mg. White emulsion after shaking.
Tekoči parafin 537 mg.
10 doses 25 doses
25 odmerkov
FMD antigen ≥ 6 PD50 per strain
KOLIČINA UČINKOVIN(E) FMD antigen ≥ 6 PD50 na sev
Sodium chloride Potassium dihydrogen phosphate Potassium chloride Disodium phosphate anhydrous Potassium hydroxide Water for injections.
6.1 Seznam pomožnih snovi parafin, tekoči manid monooleat polisorbat 80 trometamol natrijev klorid kalijev dihidrogenfosfat kalijev klorid natrijev hidrogenfosfat, brezvodni kalijev hidroksid voda za injekcije
Pigs from 2 weeks of age:
Prašiči od 2 tednov starosti dalje:
Vaccination of pigs with strains O Taiwan 3/97 and A22 Iraq resulted in a reduction of clinical signs in animals exposed to infection.
Cepljenje prašičev s sevoma O Taiwan 3/97 in A22 Iraq zmanjša pojavnost kliničnih znakov pri živalih, izpostavljenih okužbi.
Emulsion for injection.
FARMACEVTSKA OBLIKA Emulzija za injiciranje.
Active immunisation of cattle, sheep and pigs from 2 weeks of age against foot-and-mouth disease to reduce clinical signs.
Aktivna imunizacija goveda, ovc in prašičev od 2 tednov starosti proti bolezni slinavke in parkljavke za zmanjšanje kliničnih znakov.
Pack sizes: - Cardboard box with 1 bottle of 10, 25, 50, 100 or 150 doses; - Cardboard box with 10 bottles of 10, 25, 50, 100 or 150 doses.
Velikosti pakiranj: - Kartonska škatla s stekleničko po 10, 25, 50, 100 ali 150 odmerkov; - Kartonska škatla z 10 stekleničkami po 10, 25, 50, 100 ali 150 odmerkov.
Vaccination of sheep with strain O1 Manisa resulted in a reduction of clinical signs in animals exposed to infection.
Cepljenje ovc s sevom O1 Manisa zmanjša pojavnost kliničnih znakov pri živalih, izpostavljenih okužbi.
Vaccination of pigs with strain Asia1 Shamir resulted in a reduction of clinical signs and virus shedding in animals exposed to infection.
Cepljenje prašičev s sevom Asia1 Shamir zmanjša pojavnost kliničnih znakov in izločanje virusa pri živalih, izpostavljenih okužbi.
one dose of 2 ml, by intramuscular route.
en odmerek po 2 ml, intramuskularno Priporočljiva je uporaba multiplega injektorja.
To stimulate active immunity of cattle, sheep and pigs against purified, inactivated foot-and-mouth disease virus strain antigens related to those contained in the vaccine.
Za stimulacijo aktivne imunosti proti prečiščenim, inaktiviranim antigenom sevov virusa slinavke in parkljevke pri govedu, ovcah in prašičih (sorodnim antigenom z antigeni v cepivu).
Sheep from 2 weeks of age:
Ovce od 2tednov starosti dalje:
Cattle and sheep: SC.
NAČIN IN POT(I) UPORABE Govedo in ovce: SC
This is best achieved by inverting the vial several times base over apex.
Najboljša homogenizacija je dosežena z večkratnim obračanjem stekleničke.
Cattle, sheep: SC. Pigs: IM.
POT(I) UPORABE ZDRAVILA Govedo, ovce: SC Prašiči: IM
Liquid paraffin ............................................................................................................................. 537 mg.
Dodatek: Tekoči parafin ............................................................................................................................... 537 mg
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE Bottle of 50, 100 and 150 doses
PODATKI NA ZUNANJI OVOJNINI Steklenička s 50, 100 ali 150 odmerkov
PACKAGE LEAFLET: AFTOVAXPUR DOE emulsion for injection for cattle, sheep and pigs
NAVODILO ZA UPORABO: AFTOVAXPUR DOE emulzija za injiciranje za govedo, ovce in prašiče
Cardboard box with 1 bottle of 10, 25, 50, 100 or 150 doses Cardboard box with 10 bottles of 10, 25, 50, 100 or 150 doses
Kartonska škatla z 10 stekleničkami po 10, 25, 50, 100 ali 150 odmerkov.
Cattle and sheep: for subcutaneous use.
NAČIN IN POT(I) UPORABE Govedo in ovce: subkutano.
Special warnings for each target species:
Posebna opozorila za vsako ciljno živalsko vrsto: Cepite le zdrave živali.
Inactivated FMD antigen, ≥ 6 cattle PD50 per strain.
NAVEDBA UČINKOVIN(E) IN DRUGIH SNOVI Inaktivirani antigeni FMD, ≥6 ZO50 za govedo na sev
EXP {month/year} Once broached use immediately.
Po prvem odprtju stične ovojnine uporabite takoj.
Purified, inactivated foot-and-mouth disease virus strain antigens, at least 6 PD50* per strain.
Prečiščeni, inaktivirani antigeni virusa slinavke in parkljevke, vsaj 6 ZO50 * na sev *ZO50 - 50% zaščitnega odmerka pri govedu, pri govedu, kot določa Ph. Eur monografija 0063.
Paraffin, liquid
Z uporabo PrioCHECK
AFTOVAXPUR DOE emulsion for injection for cattle, sheep and pigs
Emulzija za injiciranje za govedo, ovce in prašiče
No adverse reactions except those mentioned in section “adverse reactions” were observed after the administration of a double dose to calves, lambs and piglets.
Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi) (če je potrebno): Po dajanju dvakratnega odmerka pri teletih, jagnjetih in pujskih niso bili opisani nobeni drugi neželeni učinki, razen omenjenih v poglavju Neželeni učinki.
Cattle, sheep and pigs
CILJNE ŽIVALSKE VRSTE Govedo, ovce in prašiči
No adverse reactions except those mentioned in section 4.6 were observed after the administration of a double dose to calves, lambs and piglets.
Po dajanju dvakratnega odmerka pri teletih, jagnjetih in pujskih niso bili opisani nobeni drugi neželeni učinki, razen omenjenih v poglavju 4.6.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Bottle of 10 or 25 doses
Steklenička z 10 ali 25 odmerki
(*) equivalent to titre prior to inactivation (log 10)
(*) enakovredno titru pred inaktivacijo (log 10)
S.C. TERAPIA S.A. Str. Fabricii nr. 124 Cluj Napoca România
Str. Fabricii nr. 124 Cluj Napoca România
TRIMETAZIDIN VIM SPECTRUM 20 mg, capsule 20 mg
TRIMETAZIDIN VIM SPECTRUM 20 mg, capsule 20 mg kapsula
PREDUCTAL MR 35 mg filmsko oblozene tablete s prirejenim sproscanjem
PREDUCTAL MR 35 mg filmsko oblozene tablete s prirejenim sproscanjem filmsko obložena tableta s prirejenim sproščanjem
Vastarel 35 mgFilmtabletten mit veränderter Wirkstofffreisetzung
Vastarel 35 mgFilmtabletten mit veränderter Wirkstofffreisetzung filmsko obložena tableta s prirejenim sproščanjem peroralna uporaba
TRIMETAZIDIN SERVIER 35 mg filmsko obložene tablete s prirejenim sproščanjem
TRIMETAZIDIN SERVIER 35 mg filmsko obložene tablete s prirejenim sproščanjem filmsko obložena tableta s prirejenim sproščanjem peroralna uporaba
Marketing authorisation holder
Imetnik dovoljenja za promet z zdravilom Ime zdravila
Trimetazidina Bluepharma 20 mg Comprimidos
Trimetazidina Bluepharma 20 mg Comprimidos obložena tableta
20 mg/ml
20 mg/ml kapljice
Trimetazidina Jaba 20 mg Comprimidos revestidos
Trimetazidina Jaba 20 mg Comprimidos revestidos obložena tableta
TRIMETAZIDINA 20 mg, drajeuri
TRIMETAZIDINA 20 mg, drajeuri obložena tableta
Poland ratiopharm GmbH Graf-Arco-Strasse 3 Ulm, 89079
Poljska ratiopharm GmbH Graf-Arco-Strasse 3 Ulm, 89079
Trimetazidina Baldacci 20 mg Comprimidos
Trimetazidina Baldacci 20 mg Comprimidos obložena tableta
Trimetazidina Generis 20 mg Comprimidos Revestidos 20 mg
Trimetazidina Generis 20 mg Comprimidos Revestidos 20 mg obložena tableta
Coated tablets
Predozone obložena tableta
TRIMETAZIDINE ZYDUS 20 mg/ml
TRIMETAZIDINE ZYDUS 20 mg/ml peroralna raztopina
TRIMETAZIDINE SANDOZ 20 mg/ml
TRIMETAZIDINE SANDOZ 20 mg/ml peroralna raztopina
Controlled release tablet Oral use
filmsko obložena tableta s prirejenim sproščanjem peroralna uporaba
TRIMETAZIDINE WINTHROP 20 mg/ml
TRIMETAZIDINE WINTHROP 20 mg/ml peroralna raztopina
TRIMETAZIDINE BIOGARAN 20 mg/ml
TRIMETAZIDINE BIOGARAN 20 mg/ml peroralna raztopina
Hungary ratiopharm GmbH Graf-Arco-Strasse 3 89079 Ulm Germany
Madžarska ratiopharm GmbH Graf-Arco-Strasse 3 89079 Ulm Germany
Bulgaria ratiopharm GmbH Graf-Arco-Strasse 3 89079 Ulm Germany
Bolgarija ratiopharm GmbH Graf-Arco-Strasse 3 89079 Ulm Germany
Prolonged-release filmcoated tablet
Trimetazidine filmsko obložena tableta s podaljšanim sproščanjem
Trimetazidina Mepha 20 mg Comprimidos Revestidos 20 mg
Trimetazidina Mepha 20 mg Comprimidos Revestidos obložena tableta
Slovak Republic ratiopharm GmbH Graf-Arco-Strasse 3 89079 Ulm Germany
Slovaška ratiopharm GmbH Graf-Arco-Strasse 3 89079 Ulm Germany
Trimetazidina Labesfal 20 mg Comprimidos Revestidos 20 mg
Trimetazidina Labesfal 20 mg Comprimidos Revestidos obložena tableta
TRIMETAZIDINE MYLAN 20 mg/ml
TRIMETAZIDINE MYLAN 20 mg/ml peroralna raztopina
Modified-release film coated tablet
filmsko obložena tableta s prirejenim sproščanjem
TRIMETAZIDINE IGEN 20 mg/ml
TRIMETAZIDINE IGEN 20 mg/ml peroralne kapljice, raztopina
Very rarely, allergic reactions, sometimes severe, have been reported.
Zelo redko so poročali o alergičnih reakcijah, včasih tudi hudih.
1 February 2016 EMA/492394/2015 Corr. 1
oktober 2015 EMA/828149/2015
Linseed should only be used in adults and adolescent aged over 12 years.
Seme navadnega lana se lahko uporablja samo pri odraslih in mladostnikih, starejših od 12 let.
This means that there are bibliographic data providing scientific evidence of linseed's effectiveness and safety when used in this way, covering a period of at least 10 years in the EU.
To pomeni, da obstajajo podatki iz literature z znanstvenimi dokazi o njegovi učinkovitosti in varnosti pri uporabi na navedeni način, ki zajemajo obdobje vsaj 10 let v EU.
This effect may reduce gastrointestinal discomfort.
Ta učinek lahko zmanjša nelagodje v prebavilih.
This summary is not intended to provide practical advice on how to use medicines containing linseed.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o uporabi zdravil, ki vsebujejo seme navadnega lana.
These include bulging of the belly.
Mednje sodi napihnjen trebuh.
Although an early clinical study on linseed for the treatment of gastrointestinal discomfort is available, it was too limited to be used them as evidence and the HMPC's conclusions for this indication are based on the medicines' long-standing use.
Čeprav je na voljo zgodnja klinična študija o semenu navadnega lana za zdravljenje nelagodja v prebavilih, je ta nezadostna, da bi se lahko uporabila kot dokaz učinkovitosti, zato zaključki odbora HMPC za to indikacijo temeljijo na dolgotrajni uporabi teh zdravil.
This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of linseed.
To je povzetek znanstvenih zaključkov Odbora za zdravila rastlinskega izvora (HMPC) v zvezi z medicinsko uporabo semena navadnega lana.
Linseed must not be used in patients who have difficulty swallowing or have any throat problems.
Seme navadnega lana se ne sme uporabljati pri bolnikih, ki imajo težave s požiranjem ali kakršne koli težave z grlom.