natgillin/translations-raw huggingface dataset:
The most frequently (seen in ≥ 1% of patients ) reported adverse reactions associated with the use of olanzapine in clinical trials were somnolence, weight gain, eosinophilia, elevated prolactin, cholesterol, glucose and triglyceride levels (see section 4.4), glucosuria, increased appetite, dizziness, akathisia, parkinsonism, leukopenia, neutropenia (see section 4.4), dyskinesia, orthostatic hypotension, anticholinergic effects, transient asymptomatic elevations of hepatic aminotransferases (see section 4.4), rash, asthenia, fatigue, pyrexia, arthralgia, increased alkaline phosphatase, high gamma glutamyltransferase, high uric acid, high creatine phosphokinase and oedema.
Najpogosteje poročani (opažene pri  1 % bolnikov) neželeni učinki, povezani z uporabo olanzapina v kliničnih preskušanjih, so bili zaspanost, povečanje telesne mase, eozinofilija, zvišane ravni prolaktina, holesterola, glukoze in trigliceridov (glejte poglavje 4.4), glikozurija, povečan apetit, omotica, akatizija, parkinsonizem, levkopenija, nevtropenija (glejte poglavje 4.4), diskinezija, ortostatska hipotenzija, antiholinergični učinki, prehodna asimptomatska zvišanja jetrnih aminotransferaz (glejte poglave 4.4), izpuščaj, astenija, utrujenost, pireksija, artralgija, zvišana alkalna fosfataza, visoka raven gama-glutamiltransferaze, visoka raven sečne kisline, visoka raven kreatin-fosfokinaze in edem.
A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
A. IZDELOVALCI ZDRAVILA, ODGOVORNI ZA SPROŠČANJE SERIJE Ime in naslov izdelovalca, odgovornega za sproščanje serije Pharmadox Healthcare Limited
NAME OF THE MARKETING AUTHORISATION HOLDER
7 IMETNIK DOVOLJENJA ZA PROMET
weeks).
2 leti.
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNIH OMOTIH ALI DVOJNI TRAKOVI
Common side effects (may affect up to 1 in 10 people) include changes in the levels of some blood cells circulating fats and early in treatment, temporary increases in liver enzymes; increases in the level of sugars in the blood and urine; increases in levels of uric acid and creatine phosphokinase in the blood; feeling more hungry; dizziness; restlessness; tremor;; unusual movements(dyskinesias); constipation; dry mouth; rash; loss of strength; extreme tiredness; water retention leading to swelling of the hands, ankles or feet; fever; joint pain; and sexual dysfunctions such as decreased libido in males and females or erectile dysfunction in males..
Pogosti neželeni učinki (lahko prizadenejo do 1 od 10 bolnikov) vključujejo spremembe v ravneh nekaterih krvnih celic maščob v krvnem obtoku in v začetnih obdobjih zdravljenja, začasno povišanje jetrnih encimov, zvišanja v ravni sladkorjev v krvi in urinu zvišanja v ravni sečne kisline in kreatinfosfokinaze v krvi, večji občutek lakote, omotico, nemirnost, tresenje, nenavadne gibe (diskinezijo), zaprtje, suha usta, izpuščaj, izgubo moči, hudo utrujenost, zadrževanje vode, ki vodi v otekanje rok, gležnjev ali nog, vročino, bolečine v sklepih ter spolne disfunkcije, kot na primer zmanjšan libido pri moških in ženskah ter erektilna disfunkcija pri moških.
Cold-formed aluminium blisters in cartons of 7, 28 or 56 tablets per carton.
Hladno-oblikovani aluminijasti pretisni omoti v škatlah po 7, 28 ali 56 tablet.
Olanzapine Cipla 15 mg
Olanzapin Cipla 15 mg
Tablet coat
obložena tableta
Cold-formed aluminium blisters in cartons of 28 or 56 tablets per carton.
Hladno-oblikovani aluminijasti pretisni omoti v škatlah po 28 ali 56 tablet.
Uncommon side effects (may affect up to 1 in 100 people) include hypersensitivity (e.g. swelling in the mouth and throat, itching, rash); diabetes or the worsening of diabetes, occasionally associated with ketoacidosis (ketones in the blood and urine) or coma; seizures, usually associated with a history of seizures (epilepsy); muscle stiffness or spasms (including eye movements); problems with speech; slow heart rate; sensitivity to sunlight; bleeding from the nose; abdominal distension; memory loss or forgetfulness;urinary incontinence; lack of ability to urinate; hair loss; absence or decrease in menstrual periods; and changes in breasts in males and females such as an abnormal production of breast milk or abnormal growth.
otekanje v ustih in grlu, srbenje, izpuščaj), sladkorno bolezen ali poslabšanje sladkorne bolezni, občasno povezano s ketoacidozo (ketoni v krvi in urinu) ali komo, krče, običajno povezane s krči (epileptičnimi napadi) v preteklosti, mišično okorelost ali krče (vključno z obračanjem zrkel), težave pri govoru,upočasnjen srčni utrip, občutljivost za sončno svetlobo, krvavitev iz nosa, trebušno distenzijo, izgubo spomina ali pozabljivost, urinsko inkontinenco, težave pri mokrenju, izgubo las, odsotnost ali zmanjšanje menstruacij ter spremembe na prsih pri moških in ženskah, kot na primer nenormalno nastajanje mleka v prsih ali nenormalna rast prsi.
Neuroleptic malignant syndrome (see section Discontinuation symptoms7, 12
Nevroleptični maligni sindrom (glejte poglavje 4.4) 12
EU/1/07/426/007, 7 coated tablets EU/1/07/426/008, 28 coated tablets EU/1/07/426/009, 56 coated tablets
EU/1/07/426/007 7 obloženih tablet EU/1/07/426/008 28 obloženih tablet EU/1/07/426/009 56 obloženih tablet
Olanzapine Cipla 5 mg
Olanzapin Cipla 5 mg
• High blood sugar and high levels of fat (triglycerides and cholesterol) have been seen in patients taking OLANZAPINE CIPLA.
• Pri bolnikih, ki so jemali zdravilo OLANZAPIN CIPLA, so opazili visok nivo sladkorja v krvi in visok nivo maščob (trigliceridov in holesterola).
Respiratory, thoracic and mediastinal disorders
Bolezni dihal, prsnega koša in mediastinalnega prostora Epistaksa9
CARTON OF COATED TABLETS IN BLISTERS
PODATKI NA ZUNANJI OVOJNINI ŠKATLA Z OBLOŽENIMI TABLETAMI V PRETISNIH OMOTIH
Tardive Dyskinesia
Ledvična okvara
There is a risk of feeling drowsy when you are given OLANZAPINE CIPLA.
Vpliv na sposobnost upravljanja vozil in strojev Obstaja tveganje, da se boste po tem, ko ste dobili zdravilo OLANZAPIN CIPLA, počutili zaspane.
What OLANZAPINE CIPLA looks like and contents of the pack Olanzapine Cipla 2.5 mg coated tablets are white, round, biconvex, coated tablets with ‘2.5' debossed on one side and ‘OLZ' on the other.
Izgled OLANZAPIN CIPLA in vsebina pakiranja OLANZAPIN CIPLA 2,5 mg obložene tablete so bele, okrogle, bikonveksne, obložene tablete z vtisnjeno oznako '2,5' na eni strani in 'OLZ' na drugi.
Coated tablet Blue, elliptical, convex, coated tablets with ‘NEO' debossed on one side and plain on the other side.
Modre, eliptične, konveksne, obložene tablete z vtisnjeno oznako 'NEO' na eni in brez oznake na drugi strani.
Hyperglycaemia and/or development or exacerbation of diabetes occasionally associated with ketoacidosis or coma has been reported uncommonly, including some fatal cases (see section 4.8).
Občasno so poročali o hiperglikemiji in/ali razvoju ali poslabšanju sladkorne bolezni, občasno povezanih s ketoacidozo ali komo, vključujoč nekaj primerov s smrtnim izidom (glejte poglavje 4.84).
Olanzapine Cipla 2.5 mg
OlanzapinCipla 2,5 mg
Only take other medicines while you are on OLANZAPINE CIPLA if your doctor tells you that you can. You might feel drowsy if OLANZAPINE CIPLA is taken in combination with antidepressants or medicines taken for anxiety or to help you sleep (tranquillisers).
Če jemljete zdravilo OLANZAPIN CIPLA v kombinaciji z zdravili za zdravljenje depresije, zdravili za zdravljenje občutkov tesnobe ali zdravili, ki vam pomagajo spati (pomirjevala), se lahko počutite zaspani.
Patients with known risk for narrow-angle glaucoma.
Bolniki z ugotovljenim tveganjem za glavkom z zaprtim zakotjem.
Olanzapine Cipla 7.5 mg coated tablets are white, round, biconvex, coated tablets with ‘OLZ 7.5' debossed on one side and ‘NEO' on the other.
OLANZAPIN CIPLA 7,5 mg obložene tablete so bele, okrogle, bikonveksne, obložene tablete z vtisnjeno oznako 'OLZ 7,5' na eni strani in 'NEO' na drugi.
Hepato-biliary disorders Transient, asymptomatic elevations of hepatic aminotransferases
Bolezni jeter, žolčnika in žolčevodov Prehodna asimptomatska zvišanja jetrnih aminotransferaz (ALT, AST), posebno na
Excipient with known effect: Each coated tablet contains 80.7 mg lactose monohydrate For the full list of excipients, see section 6.1.
Pomožna snov z znanim učinkom: Ena obložena tableta vsebuje 80.7 mg laktoza monohidrat Za celoten seznam pomožnih snovi glejte poglavje 6.1.
Indigo carmine aluminium lake (E132) Brilliant blue FCF aluminium lake (E133) Iron oxide black (E172)
Obloga tablete Opadry modri vsebuje: hipromelozo (E464) titanov dioksid (E171) makrogol 6000 barvilo indigotin (E132) barvilo modro FCF (E133) Črni železov oksid (E172)
Tablet core
Obloga tablete.
Olanzapine Cipla 15 mg coated tablets are blue, elliptical, convex, coated tablets with ‘NEO' debossed on one side and plain on the other side.
OLANZAPIN CIPLA 15 mg obložene tablete so modre, okrogle, eliptične, obložene tablete z vtisnjeno oznako 'NEO' na eni in brez oznake na drugi strani.
Coated tablet White, round, biconvex, coated tablets with ‘2.5' debossing on one side and ‘OLZ' on the other.
Bele, okrogle, bikonveksne, obložene tablete z vtisnjeno oznako '2,5' na eni strani in 'OLZ' na drugi.
• Weight gain has been seen in patients taking OLANZAPINE CIPLA.
• Pri bolnikih, ki so jemali zdravilo OLANZAPIN CIPLA, so opazili porast telesne mase.
Olanzapine Cipla 7.5 mg coated tablets olanzapine
Olanzapin Cipla 7,5 mg obložene tablete olanzapin
How to take OLANZAPINE CIPLA
Kaj vsebuje zdravilo OLANZAPIN CIPLA
Olanzapine Cipla 10 mg coated tablets are white, round, biconvex, coated tablets with ‘OLZ 10' debossed on one side and ‘NEO' on the other.
OLANZAPIN CIPLA 10 mg obložene tablete so bele, okrogle, bikonveksne, obložene tablete z vtisnjeno oznako 'OLZ 10' na eni strani in 'NEO' na drugi.
Coated tablet White, round, biconvex, coated tablets with ‘OLZ 7.5' debossing on one side and ‘NEO' on the other.
Bele, okrogle, bikonveksne, obložene tablete z vtisnjeno oznako 'OLZ 7,5' na eni strani in 'NEO' na drugi.
Coated tablet White, round, biconvex, coated tablets with ‘OLZ 10' debossing on one side and ‘NEO' on the other.
Bele, okrogle, bikonveksne, obložene tablete z vtisnjeno oznako 'OLZ 10' na eni strani in 'NEO' na drugi.
Talk to your doctor or pharmacist before you take OLANZAPINE CIPLA.
Opozorila in previdnostni ukrepi Pred začetkom jemanja zdravila OLANZAPIN CIPLA se posvetujte s svojim zdravnikom ali s farmacevtom.
Each coated tablet contains 10 mg olanzapine.
KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena obložena tableta vsebuje 10 mg olanzapina.
Cardiac disorders
Tardivne diskinezije
Excipient with known effect: Each coated tablet contains 161.3 mg lactose monohydrate For the full list of excipients, see section 6.1.
Pomožna snov z znanim delovanjem: Ena obložena tableta vsebuje 161.3 mg laktoza monohidrat Za celoten seznam pomožnih snovi glejte poglavje 6.1.
Each coated tablet contains 2.5 mg olanzapine.
KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena obložena tableta vsebuje 2,5 mg olanzapina.
Each coated tablet contains 7.5 mg olanzapine.
2 KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena obložena tableta vsebuje 7,5 mg olanzapina.
Olanzapine Cipla 10 mg coated tablets olanzapine
Olanzapin Cipla 10 mg obložene tablete olanzapin
Excipient with known effect: Each coated tablet contains 242 mg lactose monohydrate For the full list of excipients, see section 6.1.
Pomožna snov z znanim učinkom: Ena obložena tableta vsebuje 242 mg laktoza monohidrat Za celoten seznam pomožnih snovi glejte poglavje 6.1.
Olanzapine Cipla 5 mg coated tablets are white, round, biconvex, coated tablets with ‘OLZ 5' debossed on one side and ‘NEO' on the other.
OLANZAPIN CIPLA 5 mg obložene tablete so bele, okrogle, bikonveksne, obložene tablete z vtisnjeno oznako 'OLZ' na eni strani in 'NEO' na drugi.
Excipient with known effect: Each coated tablet contains 315 mg lactose monohydrate For the full list of excipients, see section 6.1.
Pomožna snov z znanim učinkom : Ena obložena tableta vsebuje 315 mg laktoza monohidrat Za celoten seznam pomožnih snovi glejte poglavje 6.1.
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.
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.
Olanzapine Cipla 7.5 mg coated tablets
1 IME ZDRAVILA Olanzapin Cipla 7,5 mg obložene tablete
Excipient with known effect: Each coated tablet contains 322.6 mg lactose monohydrate For the full list of excipients, see section 6.1.
Pomožna snov z znanim učinkom: Ena obložena tableta vsebuje 322.6 mg laktoza monohidrat Za celoten seznam pomožnih snovi glejte poglavje 6.1.
Olanzapine Cipla 2.5 mg coated tablets olanzapine
Olanzapin Cipla 2,5 mg obložene tablete olanzapin
15 Changes in total fasting cholesterol levels from normal at baseline (< 4.39 mmol/l) to high
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).
Each coated tablet contains 5 mg olanzapine.
2 KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena obložena tableta vsebuje 5 mg olanzapina.
Each coated tablet contains 15 mg olanzapine.
2 KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena obložena tableta vsebuje 15 mg olanzapina.
Allergic reaction
Bolezni živčevja
Olanzapine Cipla 15 mg coated tablets olanzapine
Olanzapin Cipla 15 mg obložene tablete olanzapin
Olanzapine Cipla 5 mg coated tablets olanzapine
Olanzapin Cipla 5 mg obložene tablete olanzapin
Olanzapine Cipla 10 mg coated tablets
IME ZDRAVILA Olanzapin Cipla 10 mg obložene tablete
3 Observed for fasting normal levels at baseline (< 5.17 mmol/l) which increased to high
3Opazovano pri osnovnih normalnih ravneh na tešče (< 5,17 mmol/l), ki so se povišale na visoke (≥ 6,2 mmol/l).
PHARMACEUTICAL FORM AND CONTENTS
FARMACEVTSKA OBLIKA obložena tableta
Olanzapine Cipla 2.5 mg coated tablets
IME ZDRAVILA Olanzapin Cipla 2,5 mg obložene tablete
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
EU/1/07/426/002 - Olanzapine Cipla - 2.5 mg - obložene tablete - 56 tablet na škatlo.
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
EU/1/07/426/011 - Olanzapine Cipla - 15 mg - obložene tablete - 56 tablet na škatlo.
Renal and urinary disorders
Urinska inkontinenca, zastajanje urina
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
EU/1/07/426/006 - Olanzapine Cipla - 7.5 mg - obložene tablete - 56 tablet na škatlo.
Olanzapine Cipla 15 mg coated tablets
1 IME ZDRAVILA Olanzapin Cipla 15 mg obložene tablete
EU/1/07/426/010, 28 coated tablets EU/1/07/426/011, 56 coated tablets
EU/1/07/426/011 56 obloženih tablet
Other medicines and OLANZAPINE CIPLA
Shranjevanje zdravila OLANZAPIN CIPLA
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
EU/1/07/426/004 - Olanzapine Cipla - 5 mg - obložene tablete - 56 tablet na škatlo.
Opadry Blue containing:
Kaj vsebuje navodilo:
Olanzapine Cipla 5 mg coated tablets
1 IME ZDRAVILA Olanzapin Cipla 5 mg obložene tablete
EU/1/07/426/005, 28 coated tablets EU/1/07/426/006, 56 coated tablets
EU/1/07/426/006 56 obloženih tablet
Cytochromes P450
Paola, PLA 3000
Contains lactose monohydrate, see package leaflet for further information.
Vsebuje laktozo monohidrat.
EU/1/07/426/001, 28 coated tablets EU/1/07/426/002, 56 coated tablets
EU/1/07/426/001 28 obloženih tablet
Nervous system disorders
Splošno delovanje na osrednje živčevje
Updated certificates of analysis should also be provided.
Predložiti je treba tudi posodobljene certifikate analize.
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.
CHMP meni, da je vzdrževanje koordinacije pregleda stanja, trenutno ugotovljenega na proizvodnih obratih v Kanadi, na Poljskem in v Turčiji, zelo pomembno.
Therefore, data in relation to the following conditions should be submitted and reviewed by the CHMP.
Zato je treba podatke v zvezi z naslednjimi pogoji predložiti v pregled CHMP.
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.
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.
Stability data, including long term and accelerated in products produced in accordance with EU specifications should be provided.
Predložiti je treba tudi podatke o stabilnosti, vključno z dolgoročnimi in pospešenimi, za zdravila, proizvedena v skladu s specifikacijami EU.
- Dextrose monohydrate
- dekstrozo monohidrat
Specifications for the excipients sodium hydroxide and hydrochloric acid should be stated along with the results of analysis.
Specifikaciji za pomožni snovi, natrijev hidroksid in klorovodikovo kislino, je treba navesti skupaj z rezultati analize.
- sodium chloride
- natrijev klorid
Conditions of the marketing authorisation
Priloga IV Pogoji dovoljenja za promet z zdravilom
- Sodium S-Lactate
- natrijev S-laktat
The excipients water for injections and sodium hydroxide are controlled according to the United States Pharmacopoeia.
Pomožni snovi, voda za injekcije in natrijev klorid, se kontrolirata v skladu z farmakopejo ZDA.
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.
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.
All drug substances should be supported by active substance master files or appropriate data and comply with European Pharmacopoeia (Ph.
Vse zdravilne učinkovine morajo biti ustrezno podprte z glavno dokumentacijo ali ustreznimi podatki ter v skladu z zahtevami Evropske farmakopeje.
An appropriate change management plan should be submitted within three weeks of Commission Decision.
Ustrezni načrt za upravljanje sprememb je treba predložiti v roku treh tednov po odločitvi Komisije.
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.
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.
A change management plan, including timelines for implementation should be submitted within one week of Commission Decision.
Načrt upravljanja sprememb, vključno s časovnimi okviri za izvajanje je treba predložiti v roku enega tedna po odločitvi Komisije.
Canadian manufacturing site The MAH should address the following:
Kanadski proizvodni obrat Imetnik dovoljenja za promet z zdravilom mora upoštevati naslednje:
A change management plan, including timelines for implementation should be submitted within three week of Commission Decision.
Načrt upravljanja sprememb, vključno s časovnimi okviri za izvajanje, je treba predložiti v roku treh tednov po odločitvi Komisije.
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.
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.
Turkish manufacturing site The MAH should address the following:
Turški proizvodni obrat Imetnik dovoljenja za promet z zdravilom mora upoštevati naslednje:
This should be submitted prior to the release of PD solutions to the EU market under the EU marketing authorisation.
To mora biti predloženo pred izdajanjem raztopine za PD na trg EU v skladu z dovoljenjem za promet z zdravilom EU.
Polish manufacturing site The MAH should address the following:
Poljski proizvodni obrat Imetnik dovoljenja za promet z zdravilom mora upoštevati naslednje:
The following conditions (identified below per site) should be fulfilled by the marketing authorisation holder.
Imetnik dovoljenja za promet z zdravilom mora izpolniti v nadaljevanju navedene pogoje (določene za vsak obrat)
In addition, where applicable, they should be tested and shown to comply with the European Pharmacopoeia (Ph.Eur.
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.
prior to the release of PD solutions to the EU market under the EU marketing authorisation.
Deklaracija mora biti predložena pred izdajanjem raztopine za PD na trg EU v skladu z dovoljenjem za promet z zdravilom EU.
These should be tested and results submitted to shown they comply with the Ph. Eur.
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.
Packaging Content Package size
Način uporabe Ovojnina Vsebina Velikost pakiranja
Guinea pigs: No data available.
Morski prašički: Podatki niso na voljo.
EXP {month/year} 3 ml:
EXP {mesec/leto} 3 ml:
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.
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.
Can Parellada Industrial 08228 Terrassa, Barcelona SPAIN
Can Parellada Industrial 08228 Terrassa, Barcelona ŠPANIJA
Wash the small container with water and dry prior to the next use.
Majhen vsebnik operite z vodo in ga posušite pred naslednjo uporabo.
The active substance in Metacam is an allowed substance as described in table 1 of the annex to Commission Regulation (EU) No 37/2010:
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:
The metabolism is qualitatively similar in rats, mini-pigs, humans, cattle and pigs although quantitatively there are differences.
Presnavljanje je kakovostno pri podganah, mini prašičih, ljudeh, govedih in prašičih podobno, količinsko pa se razlikuje.
Metacam chewable tablets can be administered with or without food, are flavoured and are taken by most dogs voluntarily.
Zdravilo Metacam žvečljive tablete lahko dajemo s hrano ali brez nje, imajo dodano aromo in jih večina psov vzame prostovoljno.
Chronic musculoskeletal disorders in cats: Response to long-term therapy should be monitored at regular intervals by a veterinary surgeon.
Kronična mišično-skeletna obolenja pri mačkah: Odzivanje na dolgotrajno zdravljenje mora v rednih razmikih spremljati veterinar.
7 tablets 84 tablets 252 tablets
7 tablet 84 tablet 252 tablet
Metacam alone will not provide adequate pain relief during the dehorning procedure.
Samo zdravilo Metacam ne zagotavlja ustreznega lajšanja bolečine med postopkom odstranjevanja rogov.