FrancophonIA/ELRC3.0 huggingface dataset:
English: Coated tablet White, round, biconvex, coated tablets with ‘2.5' debossing on one side and ‘OLZ' on the other.
Slovenian: Bele, okrogle, bikonveksne, obložene tablete z vtisnjeno oznako '2,5' na eni strani in 'OLZ' na drugi.
English: • Weight gain has been seen in patients taking OLANZAPINE CIPLA.
Slovenian: • Pri bolnikih, ki so jemali zdravilo OLANZAPIN CIPLA, so opazili porast telesne mase.
English: Olanzapine Cipla 7.5 mg coated tablets olanzapine
Slovenian: Olanzapin Cipla 7,5 mg obložene tablete olanzapin
English: How to take OLANZAPINE CIPLA
Slovenian: Kaj vsebuje zdravilo OLANZAPIN CIPLA
English: Olanzapine Cipla 10 mg coated tablets are white, round, biconvex, coated tablets with ‘OLZ 10' debossed on one side and ‘NEO' on the other.
Slovenian: OLANZAPIN CIPLA 10 mg obložene tablete so bele, okrogle, bikonveksne, obložene tablete z vtisnjeno oznako 'OLZ 10' na eni strani in 'NEO' na drugi.
English: Coated tablet White, round, biconvex, coated tablets with ‘OLZ 7.5' debossing on one side and ‘NEO' on the other.
Slovenian: Bele, okrogle, bikonveksne, obložene tablete z vtisnjeno oznako 'OLZ 7,5' na eni strani in 'NEO' na drugi.
English: Coated tablet White, round, biconvex, coated tablets with ‘OLZ 10' debossing on one side and ‘NEO' on the other.
Slovenian: Bele, okrogle, bikonveksne, obložene tablete z vtisnjeno oznako 'OLZ 10' na eni strani in 'NEO' na drugi.
English: Talk to your doctor or pharmacist before you take OLANZAPINE CIPLA.
Slovenian: Opozorila in previdnostni ukrepi Pred začetkom jemanja zdravila OLANZAPIN CIPLA se posvetujte s svojim zdravnikom ali s farmacevtom.
English: Each coated tablet contains 10 mg olanzapine.
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena obložena tableta vsebuje 10 mg olanzapina.
English: Cardiac disorders
Slovenian: Tardivne diskinezije
English: Excipient with known effect: Each coated tablet contains 161.3 mg lactose monohydrate For the full list of excipients, see section 6.1.
Slovenian: Pomožna snov z znanim delovanjem: Ena obložena tableta vsebuje 161.3 mg laktoza monohidrat Za celoten seznam pomožnih snovi glejte poglavje 6.1.
English: Each coated tablet contains 2.5 mg olanzapine.
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena obložena tableta vsebuje 2,5 mg olanzapina.
English: Each coated tablet contains 7.5 mg olanzapine.
Slovenian: 2 KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena obložena tableta vsebuje 7,5 mg olanzapina.
English: Olanzapine Cipla 10 mg coated tablets olanzapine
Slovenian: Olanzapin Cipla 10 mg obložene tablete olanzapin
English: Excipient with known effect: Each coated tablet contains 242 mg lactose monohydrate For the full list of excipients, see section 6.1.
Slovenian: Pomožna snov z znanim učinkom: Ena obložena tableta vsebuje 242 mg laktoza monohidrat Za celoten seznam pomožnih snovi glejte poglavje 6.1.
English: Olanzapine Cipla 5 mg coated tablets are white, round, biconvex, coated tablets with ‘OLZ 5' debossed on one side and ‘NEO' on the other.
Slovenian: OLANZAPIN CIPLA 5 mg obložene tablete so bele, okrogle, bikonveksne, obložene tablete z vtisnjeno oznako 'OLZ' na eni strani in 'NEO' na drugi.
English: Excipient with known effect: Each coated tablet contains 315 mg lactose monohydrate For the full list of excipients, see section 6.1.
Slovenian: Pomožna snov z znanim učinkom : Ena obložena tableta vsebuje 315 mg laktoza monohidrat Za celoten seznam pomožnih snovi glejte poglavje 6.1.
English: Acute symptoms such as sweating, insomnia, tremor, anxiety, nausea, or vomiting have been reported rarely ( ≥ 0.01% and < 0.1%) when olanzapine is stopped abruptly.
Slovenian: Redko (≥ 0,01 % in < 0,1 %) so pri nenadni prekinitvi zdravljenja z olanzapinom poročali o akutnih simptomih, kot so znojenje, nespečnost, tresenje, občutek tesnobe, slabost ali bruhanje.
English: Olanzapine Cipla 7.5 mg coated tablets
Slovenian: 1 IME ZDRAVILA Olanzapin Cipla 7,5 mg obložene tablete
English: Excipient with known effect: Each coated tablet contains 322.6 mg lactose monohydrate For the full list of excipients, see section 6.1.
Slovenian: Pomožna snov z znanim učinkom: Ena obložena tableta vsebuje 322.6 mg laktoza monohidrat Za celoten seznam pomožnih snovi glejte poglavje 6.1.
English: Olanzapine Cipla 2.5 mg coated tablets olanzapine
Slovenian: Olanzapin Cipla 2,5 mg obložene tablete olanzapin
English: 15 Changes in total fasting cholesterol levels from normal at baseline (< 4.39 mmol/l) to high
Slovenian: 15Pogosto so opazovali spremembe v ravneh celokupnega holesterola na tešče z normalnih osnovnih vrednosti (< 4,39 mmol/l), ki so se povišale na visoke (≥ 5,17 mmol/l).
English: Each coated tablet contains 5 mg olanzapine.
Slovenian: 2 KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena obložena tableta vsebuje 5 mg olanzapina.
English: Each coated tablet contains 15 mg olanzapine.
Slovenian: 2 KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena obložena tableta vsebuje 15 mg olanzapina.
English: Allergic reaction
Slovenian: Bolezni živčevja
English: Olanzapine Cipla 15 mg coated tablets olanzapine
Slovenian: Olanzapin Cipla 15 mg obložene tablete olanzapin
English: Olanzapine Cipla 5 mg coated tablets olanzapine
Slovenian: Olanzapin Cipla 5 mg obložene tablete olanzapin
English: Olanzapine Cipla 10 mg coated tablets
Slovenian: IME ZDRAVILA Olanzapin Cipla 10 mg obložene tablete
English: 3 Observed for fasting normal levels at baseline (< 5.17 mmol/l) which increased to high
Slovenian: 3Opazovano pri osnovnih normalnih ravneh na tešče (< 5,17 mmol/l), ki so se povišale na visoke (≥ 6,2 mmol/l).
English: PHARMACEUTICAL FORM AND CONTENTS
Slovenian: FARMACEVTSKA OBLIKA obložena tableta
English: Olanzapine Cipla 2.5 mg coated tablets
Slovenian: IME ZDRAVILA Olanzapin Cipla 2,5 mg obložene tablete
English: EU/1/07/426/001 - Olanzapine Cipla - 2.5 mg - coated tablets - 28 tablets per box EU/1/07/426/002 - Olanzapine Cipla - 2.5 mg - coated tablets - 56 tablets per box
Slovenian: EU/1/07/426/002 - Olanzapine Cipla - 2.5 mg - obložene tablete - 56 tablet na škatlo.
English: EU/1/07/426/010 - Olanzapine Cipla - 15 mg - coated tablets - 28 tablets per box EU/1/07/426/011 - Olanzapine Cipla - 15 mg - coated tablets - 56 tablets per box
Slovenian: EU/1/07/426/011 - Olanzapine Cipla - 15 mg - obložene tablete - 56 tablet na škatlo.
English: Renal and urinary disorders
Slovenian: Urinska inkontinenca, zastajanje urina
English: EU/1/07/426/005 - Olanzapine Cipla - 7.5 mg - coated tablets - 28 tablets per box EU/1/07/426/006 - Olanzapine Cipla - 7.5 mg - coated tablets - 56 tablets per box
Slovenian: EU/1/07/426/006 - Olanzapine Cipla - 7.5 mg - obložene tablete - 56 tablet na škatlo.
English: Olanzapine Cipla 15 mg coated tablets
Slovenian: 1 IME ZDRAVILA Olanzapin Cipla 15 mg obložene tablete
English: EU/1/07/426/010, 28 coated tablets EU/1/07/426/011, 56 coated tablets
Slovenian: EU/1/07/426/011 56 obloženih tablet
English: Other medicines and OLANZAPINE CIPLA
Slovenian: Shranjevanje zdravila OLANZAPIN CIPLA
English: EU/1/07/426/003 - Olanzapine Cipla - 5 mg - coated tablets - 28 tablets per box EU/1/07/426/004 - Olanzapine Cipla - 5 mg - coated tablets - 56 tablets per box
Slovenian: EU/1/07/426/004 - Olanzapine Cipla - 5 mg - obložene tablete - 56 tablet na škatlo.
English: Opadry Blue containing:
Slovenian: Kaj vsebuje navodilo:
English: Olanzapine Cipla 5 mg coated tablets
Slovenian: 1 IME ZDRAVILA Olanzapin Cipla 5 mg obložene tablete
English: EU/1/07/426/005, 28 coated tablets EU/1/07/426/006, 56 coated tablets
Slovenian: EU/1/07/426/006 56 obloženih tablet
English: Cytochromes P450
Slovenian: Paola, PLA 3000
English: Contains lactose monohydrate, see package leaflet for further information.
Slovenian: Vsebuje laktozo monohidrat.
English: EU/1/07/426/001, 28 coated tablets EU/1/07/426/002, 56 coated tablets
Slovenian: EU/1/07/426/001 28 obloženih tablet
English: Nervous system disorders
Slovenian: Splošno delovanje na osrednje živčevje
English: Updated certificates of analysis should also be provided.
Slovenian: Predložiti je treba tudi posodobljene certifikate analize.
English: The CHMP considers of extreme importance to retain coordination of the review of the conditions presently identified for the sites in Canada, Poland and Turkey.
Slovenian: CHMP meni, da je vzdrževanje koordinacije pregleda stanja, trenutno ugotovljenega na proizvodnih obratih v Kanadi, na Poljskem in v Turčiji, zelo pomembno.
English: Therefore, data in relation to the following conditions should be submitted and reviewed by the CHMP.
Slovenian: Zato je treba podatke v zvezi z naslednjimi pogoji predložiti v pregled CHMP.
English: The present opinion is the first of a series of entwined opinions, which may result subsequently in additional measures being requested for the sites subject of the current opinion.
Slovenian: Trenutno mnenje je prvo v vrsti prepletajočih se mnenj, zaradi katerih bodo posledično morda potrebni dodatni ukrepi, ki jih bodo morali izvesti v obratih, za katera bodo izdana mnenja.
English: Stability data, including long term and accelerated in products produced in accordance with EU specifications should be provided.
Slovenian: Predložiti je treba tudi podatke o stabilnosti, vključno z dolgoročnimi in pospešenimi, za zdravila, proizvedena v skladu s specifikacijami EU.
English: - Dextrose monohydrate
Slovenian: - dekstrozo monohidrat
English: Specifications for the excipients sodium hydroxide and hydrochloric acid should be stated along with the results of analysis.
Slovenian: Specifikaciji za pomožni snovi, natrijev hidroksid in klorovodikovo kislino, je treba navesti skupaj z rezultati analize.
English: - sodium chloride
Slovenian: - natrijev klorid
English: Conditions of the marketing authorisation
Slovenian: Priloga IV Pogoji dovoljenja za promet z zdravilom
English: - Sodium S-Lactate
Slovenian: - natrijev S-laktat
English: The excipients water for injections and sodium hydroxide are controlled according to the United States Pharmacopoeia.
Slovenian: Pomožni snovi, voda za injekcije in natrijev klorid, se kontrolirata v skladu z farmakopejo ZDA.
English: Suppliers of active substance listed below have not previously been used in EU product and active substance master files (ASMF's) or equivalent data packages should be submitted for these suppliers.
Slovenian: Dobavitelji v nadaljevanju navedenih zdravilnih učinkovin predhodno še niso dobavljali za zdravila v EU in za te dobavitelje mora biti predložena glavna dokumentacija za zdravilno učinkovino ali ustrezni podatkovni paketi.
English: All drug substances should be supported by active substance master files or appropriate data and comply with European Pharmacopoeia (Ph.
Slovenian: Vse zdravilne učinkovine morajo biti ustrezno podprte z glavno dokumentacijo ali ustreznimi podatki ter v skladu z zahtevami Evropske farmakopeje.
English: An appropriate change management plan should be submitted within three weeks of Commission Decision.
Slovenian: Ustrezni načrt za upravljanje sprememb je treba predložiti v roku treh tednov po odločitvi Komisije.
English: The maximum batch size at Lublin should be stated and the actual validation data for these batch sizes should be provided within three weeks of Commission Decision.
Slovenian: V roku treh tednov po odločitvi Komisije je treba navesti največjo velikost serije, proizvedene v Lublinu, in dejanske podatke o validaciji za te velikosti serij.
English: A change management plan, including timelines for implementation should be submitted within one week of Commission Decision.
Slovenian: Načrt upravljanja sprememb, vključno s časovnimi okviri za izvajanje je treba predložiti v roku enega tedna po odločitvi Komisije.
English: Canadian manufacturing site The MAH should address the following:
Slovenian: Kanadski proizvodni obrat Imetnik dovoljenja za promet z zdravilom mora upoštevati naslednje:
English: A change management plan, including timelines for implementation should be submitted within three week of Commission Decision.
Slovenian: Načrt upravljanja sprememb, vključno s časovnimi okviri za izvajanje, je treba predložiti v roku treh tednov po odločitvi Komisije.
English: For glucose anhydrous the limit test for endotoxin in the drug substance should be tightened prior to the release of PD solutions to the EU market under the EU marketing authorisation.
Slovenian: Za brezvodno glukozo je treba pred izdajanjem raztopin za PD na trg EU v skladu z dovoljenji za promet z zdravilom v EU okrepiti mejni preizkus za endotoksine v zdravilni učinkovini.
English: Turkish manufacturing site The MAH should address the following:
Slovenian: Turški proizvodni obrat Imetnik dovoljenja za promet z zdravilom mora upoštevati naslednje:
English: This should be submitted prior to the release of PD solutions to the EU market under the EU marketing authorisation.
Slovenian: To mora biti predloženo pred izdajanjem raztopine za PD na trg EU v skladu z dovoljenjem za promet z zdravilom EU.
English: Polish manufacturing site The MAH should address the following:
Slovenian: Poljski proizvodni obrat Imetnik dovoljenja za promet z zdravilom mora upoštevati naslednje:
English: The following conditions (identified below per site) should be fulfilled by the marketing authorisation holder.
Slovenian: Imetnik dovoljenja za promet z zdravilom mora izpolniti v nadaljevanju navedene pogoje (določene za vsak obrat)
English: In addition, where applicable, they should be tested and shown to comply with the European Pharmacopoeia (Ph.Eur.
Slovenian: Poleg tega pa je pred izdajanjem raztopin za PD na trg EU, kadar je primerno, te treba skladu z dovoljenjem za promet z zdravilom v EU testirati in dokazati njihovo usklajenost z Evropsko farmakopejo.
English: prior to the release of PD solutions to the EU market under the EU marketing authorisation.
Slovenian: Deklaracija mora biti predložena pred izdajanjem raztopine za PD na trg EU v skladu z dovoljenjem za promet z zdravilom EU.
English: These should be tested and results submitted to shown they comply with the Ph. Eur.
Slovenian: Pred izdajanjem raztopin za PD na trg EU v skladu z dovoljenji za promet z zdravilom EU ju je treba testirati in rezultate predložiti, da je jasno razvidna njihova skladnost z Evropsko farmakopejo.
English: Packaging Content Package size
Slovenian: Način uporabe Ovojnina Vsebina Velikost pakiranja
English: Guinea pigs: No data available.
Slovenian: Morski prašički: Podatki niso na voljo.
English: EXP {month/year} 3 ml:
Slovenian: EXP {mesec/leto} 3 ml:
English: The excipients listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required, or considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
Slovenian: Pomožne snovi, navedene v poglavju 6.1 SPC so bodisi dovoljenje snovi, za katere tabela 1 priloge Uredbe Komisije (EU) št. 37/2010 določa, da MRL ni potreben ali pa ne spadajo v področje uporabe Uredbe (ES) št. 470/2009, kadar so uporabljene tako kot v tem zdravilu za uporabo v veterinarski medicini.
English: Can Parellada Industrial 08228 Terrassa, Barcelona SPAIN
Slovenian: Can Parellada Industrial 08228 Terrassa, Barcelona ŠPANIJA
English: Wash the small container with water and dry prior to the next use.
Slovenian: Majhen vsebnik operite z vodo in ga posušite pred naslednjo uporabo.
English: The active substance in Metacam is an allowed substance as described in table 1 of the annex to Commission Regulation (EU) No 37/2010:
Slovenian: C. NAVEDBA NAJVIŠJIH DOVOLJENIH KOLIČIN OSTANKOV ZDRAVILA (MRL) Učinkovina v zdravilu Metacam je dovoljena snov, kot je opisana v tabeli 1 priloge k Uredbi Komisije (EU) št. 37/2010:
English: The metabolism is qualitatively similar in rats, mini-pigs, humans, cattle and pigs although quantitatively there are differences.
Slovenian: Presnavljanje je kakovostno pri podganah, mini prašičih, ljudeh, govedih in prašičih podobno, količinsko pa se razlikuje.
English: Metacam chewable tablets can be administered with or without food, are flavoured and are taken by most dogs voluntarily.
Slovenian: Zdravilo Metacam žvečljive tablete lahko dajemo s hrano ali brez nje, imajo dodano aromo in jih večina psov vzame prostovoljno.
English: Chronic musculoskeletal disorders in cats: Response to long-term therapy should be monitored at regular intervals by a veterinary surgeon.
Slovenian: Kronična mišično-skeletna obolenja pri mačkah: Odzivanje na dolgotrajno zdravljenje mora v rednih razmikih spremljati veterinar.
English: 7 tablets 84 tablets 252 tablets
Slovenian: 7 tablet 84 tablet 252 tablet
English: Metacam alone will not provide adequate pain relief during the dehorning procedure.
Slovenian: Samo zdravilo Metacam ne zagotavlja ustreznega lajšanja bolečine med postopkom odstranjevanja rogov.
English: The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch.
Slovenian: V natisnjenem navodilu za uporabo zdravila morata biti navedena ime in naslov proizvajalca, odgovornega za sproščanje zadevne serije.
English: Treatment of calves with Metacam 20 minutes before dehorning reduces post-operative pain.
Slovenian: Zdravljenje telet z zdravilom Metacam 20 minut pred odstranitvijo rogov zmanjša pooperativno bolečino.
English: The major metabolites found in all species were the 5-hydroxy- and 5-carboxymetabolites and the oxalyl-metabolite.
Slovenian: Poglavitni presnovki, ki so jih odkrili pri vseh vrstah, so 5-hidroksi- in 5karboksi-presnovki ter oksalil-presnovek.
English: This product for dogs should not be used in cats as it is not suitable for use in this species.
Slovenian: Tega zdravila za pse ne smemo uporabljati pri mačkah, ker za to živalsko vrsto ni primerno.
English: When the product is used according to the recommended dosage regime the oral bioavailability is approximately 98 %.
Slovenian: Če dajemo zdravilo po priporočeni shemi odmerjanja, je njegova peroralna biološka uporabnost približno 98-odstotna.
English: For longer term treatment, once clinical response has been observed (after ≥ 4 days), the dose of Metacam can be adjusted to the lowest effective individual dose reflecting that the degree of pain and inflammation associated with chronic musculo-skeletal disorders may vary over time.
Slovenian: Za dolgotrajnejše zdravljenje lahko, ko se pokaže klinični odziv (po ≥ 4 dneh), odmerek zdravila Metacam prilagodimo, tako da določimo najmanjši učinkoviti individualni odmerek ob upoštevanju, da se lahko jakost bolečine in vnetja pri kroničnih mišično-skeletnih obolenjih s časom spreminjata.
English: As for other species investigated, the main pathway of meloxicam biotransformation in cat is oxidation.
Slovenian: Tako kot pri drugih raziskanih vrstah je glavna pot biološke transformacije meloksikama pri mačkah oksidacija.
English: Advice on correct administration Shake well before use.
Slovenian: Nasvet za pravilno uporabo Pred uporabo dobro pretresite.
English: Number of chewable tablets mg/kg
Slovenian: Število žvečljivih tablet mg/kg
English: The suspension can be given using either the drop dispenser of the bottle (for very small breeds) or the measuring syringe provided in the package.
Slovenian: Suspenzijo lahko dajemo s kapalko plastenke (zelo majhnim pasmam) ali s priloženo merilno brizgo.
English: Instructions for opening the child-resistant blisters:
Slovenian: Navodila za odpiranje za otroke varnih pretisnih omotov:
English: This treatment can be considered in cats undergoing surgery where no oral follow-up treatment is possible e.g. feral cats.
Slovenian: To zdravljenje pride v poštev pri operativnih posegih na mačkah, pri katerih ni možno peroralno nadaljevalno zdravljenje, na primer pri neudomačenih mačkah.
English: Round mottled beige biconvex tablet, scored on the upper side with embedded code either "M10" or "M25" on one side.
Slovenian: Okrogla vzorčasta bež bikonveksna tableta z zarezo na zgornji strani in vtisnjeno oznako bodisi "M10" ali "M25" na eni strani.
English: In cattle a slight transient painless swelling at the injection site was observed in most animals in laboratory studies.
Slovenian: Pri govedu so opazili prehodno nebolečo oteklino na mestu injiciranja pri večini živali v laboratorijskih študijah.
English: 14 days
Slovenian: 14 dni.
English: In cases of MMA with severely disturbed general demeanour (e.g. anorexia) the use of Metacam 20 mg/ml solution for injection is recommended.
Slovenian: V primerih MMA z močno motenim vedenjem (npr. pri anoreksiji) se priporoča uporaba zdravila Metacam 20 mg/ml raztopina za injiciranje.
English: The dose can, at the discretion of the veterinarian, be titrated up to 0.5 mg/kg in individual cases.
Slovenian: Odmerek se lahko v posameznih primerih po presoji veterinarja titrira do 0,5 mg/kg.
English: Each bottle is packed in a cardboard box and is equipped with a polypropylene measuring syringe.
Slovenian: Vsaka plastenka je zapakirana v kartonski škatli in opremljena s polipropilensko merilno brizgo.
English: Post-operative use in cats and guinea pigs: In case additional pain relief is required, multimodal pain therapy should be considered.
Slovenian: Postoperativna uporaba pri mačkah in morskih prašičkih: Če bolečine ne moremo omiliti, je treba razmisliti o zdravljenju z dodatnim zdravilom.
English: The suspension should be given directly into the mouth using a standard 1 ml syringe graduated with ml scale and 0.01 ml increments.
Slovenian: Suspenzijo je mogoče dajati z uporabo standardne 1 ml brizge, ki ima ml lestvico in 0,01 ml porasta.
English: In very rare cases anaphylactoid reactions, which may be serious (including fatal), may occur and should be treated symptomatically.
Slovenian: Zelo redko se lahko pojavijo anafilaktične reakcije, ki so lahko resne (vključno s smrtnimi) in jih je treba zdraviti simptomatsko.
English: Single intramuscular injection before surgery.
Slovenian: Enkratna intramuskularna injekcija pred operacijo.
English: In case of overdose, adverse reactions, as listed in section 4.6, are expected to be more severe and more frequent.
Slovenian: Pri prevelikem odmerku lahko pričakujemo resnejše in pogostejše neželene reakcije, opisane v poglavju 4.6.
English: Each bottle is packed in a cardboard box and is equipped with a 1 ml polypropylene measuring syringe which has a kg-body weight scale for cats (2 to 10 kg) and a pictogram showing a cat.
Slovenian: Vsaka plastenka je pakirana v kartonski škatli skupaj z 1-mililitrsko polipropilensko merilno brizgo, ki ima skalo z oznakami telesne mase v kilogramih za mačke (2 do 10 kg) in piktogram mačke.
English: The safety of doses exceeding 0.6 mg/kg has, however, not been evaluated in guinea pigs.
Slovenian: Vendar pa varnost pri odmerkov, ki presegajo 0,6 mg/kg, ni bila ocenjena pri morskih prašičih.
English: Shelf life of the veterinary medicinal product as packaged for sale (20 ml, 50 ml, 100 ml or 250 ml vials): 3 years.
Slovenian: Rok uporabnosti zdravila v pakiranju za prodajo (viale po 20 ml, 50 ml, 100 ml ali 250 ml): 3 leta.
English: Cardboard boxes containing 7, 84 or 252 tablets in Alu/Alu child-resistant blisters.
Slovenian: Škatle vsebujejo 7, 84 ali 252 tablet v za otroke varnih pretisnih omotih iz Al/Al.
English: In guinea pigs, an overdose of 0.6 mg/kg body weight administred during 3 days followed by a dose of 0.3 mg/kg during 6 additional days did not cause adverse events typical for meloxicam.
Slovenian: Pri morskih prašičkih prevelik odmerek 0,6 mg/kg telesne mase, ki je bil dan v treh dneh po po odmerku 0,3 mg/kg med dodatnimi 6 dnevi ni povzročil neželenih stranskih dogodkov, značilnih za meloksikam.
English: For dogs weighing less than 4 kg the use of Metacam oral suspension for dogs is recommended.
Slovenian: Za pse z manjšo telesno maso od 4 kg priporočamo uporabo zdravila Metacam peroralna suspenzija za pse.
English: The safety of doses exceeding 0.6 mg/kg has not been evaluated in guinea pigs.
Slovenian: Varnost odmerkov, ki presegajo 0,6 mg/kg, ni bila ocenjena pri morskih prašičih.
English: CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Slovenian: POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA Ni smiselno.