natgillin/translations-raw huggingface dataset:
{Invented name} is contraindicated in patients with severe renal impairment (GFR < 30 ml/min/1.73m2) and in patients in the perioperative liver transplantation period (see section 4.3).
Zdravilo {Lastniško ime} je kontraindicirano pri bolnikih s hudo okvaro ledvic (glomerulna filtracija (GFR) < 30 ml/min/1,73 m2) in pri bolnikih v perioperativnem obdobju presaditve jeter (glejte poglavje 4.3).
However if use is required you should only receive one dose of {Invented name} during a scan and you should not receive a second injection for at least 7 days.
Če pa je uporaba potrebna, lahko prejmete le en odmerek zdravila {lastniško ime} med slikanjem, nato pa mora do naslednjega slikanja miniti vsaj 7 dni.
{Invented name} is contraindicated in patients with severe renal impairment (GFR <30ml/min/1.73m2), in patients in the perioperative liver transplantation period and in neonates up to 4 weeks of age (see section 4.4).
Zdravilo {Lastniško ime} je kontraindicirano pri bolnikih s hudo okvaro ledvic (glomerulna filtracija (GFR) < 30 ml/min/1,73 m2), pri bolnikih v perioperativnem obdobju presaditve jeter in pri novorojenčkih do četrtega tedna starosti (glejte poglavje 4.4).
[If use is permitted in neonates and infants add a statement on use in neonates and infants]
[Če se dovoli uporaba pri novorojenčkih in dojenčkih, se doda izjava o uporabi pri novorojenčkih in dojenčkih]
POSSIBLE SIDE EFFECTS [Use currently approved text with the addition of information on NSF]
MOŽNI NEŽELENI UČINKI [odobreno besedilo z dodatnim besedilom o NSF]
{Invented name} should only be used in patients with severe renal impairment (GFR < 30 ml/min/1.73m2) and in patients in the perioperative liver transplantation period after careful risk/benefit assessment and if the diagnostic information is essential and not available with noncontrast enhanced MRI (see section 4.4).
Zdravilo {izmišljeno ime} se lahko uporablja pri bolnikih s hudo okvarjenim delovanjem (GFR <30 ml/min/1,73 m2) in pri bolnikih v perioperativnem obdobju presaditve jeter le po skrbni oceni koristi in tveganja in če je diagnostična informacija ključna ter je ni možno pridobiti z magnetnoresonančnim slikanjem (MRS) brez uporabe kontrastnega sredstva (glejte poglavje 4.4).
Due to immature renal function in infants up to 1 year of age, {Invented name} should only be used in these patients after careful consideration at a dose not exceeding {x} mmol/kg body weight.
Zaradi nezrelega delovanja ledvic pri dojenčkih do enega leta starosti, se zdravilo {Lastniško ime} lahko uporablja pri teh bolnikih le po skrbni presoji v odmerkih, ki ne presegajo {x} mmol/kg telesne mase.
solution for injection (vial)
Raztopina za injiciranje (viala)
There have been reports of nephrogenic systemic fibrosis (which causes hardening of the skin and may affect also soft tissue and internal organs) associated with use of other gadolinium-containing contrast agents.
Poročali so o nefrogeni sistemski fibrozi (ki povzroči otrdelost kože in lahko prizadene mehka tkiva ter notranje organe), ki je povezana z uporabo drugih kontrastnih sredstev, ki vsebujejo gadolinij.
As there is a possibility that NSF may occur with {Invented name}, it should therefore only be used in patients with severe renal impairment and in patients in the perioperative liver transplantation period after careful risk/benefit assessment and if the diagnostic information is essential and not available with non-contrast enhanced MRI.
Ker obstaja možnost pojava NSF zaradi zdravila {izmišljeno ime}, se ga lahko uporablja pri bolnikih s hudo okvarjenim delovanjem ledvic in bolnikih v perioperativnem obdobju presaditve jeter le po skrbni oceni koristi in tveganja in če je diagnostična informacija ključna ter je ni možno pridobiti z magnetnoresonančnim slikanjem (MRS) brez uporabe kontrastnega sredstva.
• your kidneys do not work properly
• imate okvarjeno delovanje ledvic,
Use of {Invented name} should be avoided in patients with severe renal impairment (GFR < 30 ml/min/1.73m2) and in patients in the perioperative liver transplantation period unless the diagnostic information is essential and not available with non-contrast enhanced MRI (see section 4.4).
Zdravila {izmišljeno ime} se ne sme uporabiti pri bolnikih s hudo okvarjenim delovanjem ledvic (GFR <30 ml/min/1,73 m2) in bolnikih v perioperativnem obdobju presaditve jeter, razen če je diagnostična informacija ključna ter je ni možno pridobiti z magnetnoresonančnim slikanjem (MRS) brez uporabe kontrastnega sredstva (glejte poglavje 4.4).
As there is a possibility that NSF may occur with {Invented name}, it should therefore be avoided in patients with severe renal impairment and in patients in the perioperative liver transplantation period unless the diagnostic information is essential and not available with non-contrast enhanced MRI.
Ker obstaja možnost pojava NSF zaradi zdravila {izmišljeno ime}, se je njegovi uporabi pri bolnikih s hudo okvarjenim delovanjem ledvic in bolnikih v perioperativnem obdobju presaditve jeter treba izogibati, razen če je diagnostična informacija ključna ter je ni možno pridobiti z magnetnoresonančnim slikanjem (MRS) brez uporabe kontrastnega sredstva.
[If use is only authorised in infants above the age of 6 months add the following statement]
[Če se zdravilo odobri le za dojenčke, starejše od 6 mesecev, se doda naslednja izjava]
RO-Romania
Romunija
4.3 Contraindications [Use currently approved text with addition of contraindication below]
[odobreno besedilo z dodatnimi kontraindikacijami navednimi spodaj]
Take special care with {Invented name}: [Use currently approved text with addition of the information on the NSF]
Bodite posebno pozorni pri uporabi zdravila {Lastniško ime} [odobreno besedilo z dodatnim besedilom o NSF]
Prior to administration of {Invented name}, all patients should be screened for renal dysfunction by obtaining laboratory tests.
Pred uporabo zdravila {Lastniško ime} je treba pri vseh bolnikih na podlagi laboratorijskih preiskav oceniti delovanje ledvic.
[If use is authorised in infants add the following statement]
[Če je odobrena uporaba pri dojenčkih, je treba dodati naslednje besedilo]
287 mg/ml Gadodiamid
287 mg/ml Gadodiamid Raztopina za injiciranje
There have been reports of nephrogenic systemic fibrosis (which causes hardening of the skin and may affect also soft tissue and internal organs) most of which were in patients who received {Invented name} together with other gadolinium-containing contrast agents.
Poročali so o nefrogeni sistemski fibrozi (ki povzroči otrdelost kože in lahko prizadene mehka tkiva ter notranje organe), večinoma pri bolnikih, ki so sočasno z zdravilom {lastniško ime} prejeli druga kontrastna sredstva, ki vsebujejo gadolinij.
[If use is restricted by age for a particular indication add a statement on use in neonates and infants and specify the indication and age at which use is not recommended]
[Če se uporaba za določeno indikacijo omeji s starostjo, se doda izjava o uporabi pri novorojenčkih in dojenčkih z navedbo indikacije in starosti, pri kateri uporaba ni priporočena]
CZ - Czech Republic
Češka
[If use is permitted in infants, add a statement on use in infants]
[če je uporaba dovoljena pri dojenčkih, je treba dodati besedilo o uporabi zdravila pri dojenčkih]
Due to immature renal function in infants up to 1 year of age, {Invented name} should only be used in patients 6 to 12 months of age after careful consideration.
Zaradi nezrelega delovanja ledvic pri dojenčkih do enega leta starosti, se zdravilo {Lastniško ime} lahko uporablja pri bolnikih v starosti od 6 do 12 mesecev le po skrbni presoji.
ANNEX III AMENDMENTS TO THE SUMMARY OF PRODUCT CHARACTERISTICS AND PACKAGE LEAFLETS
DODATEK III POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA, OZNAČEVANJE IN NAVODILO ZA UPORABO
There have been reports of nephrogenic systemic fibrosis (which causes hardening of the skin and may affect also soft tissue and internal organs) in patients who received {Invented name} together with other gadolinium-containing contrast agents.
Poročali so o nefrogeni sistemski fibrozi (ki povzroči otrdelost kože in lahko prizadene mehka tkiva ter notranje organe) pri bolnikih, ki so sočasno z zdravilom {lastniško ime} prejeli druga kontrastna sredstva, ki vsebujejo gadolinij.
AMENDMENTS TO BE INCLUDED IN THE RELEVANT SECTIONS OF THE SUMMARY OF PRODUCT CHARACTERISTICS FOR LOW RISK GADOLINIUM-CONTAINING CONTRAST AGENTS (gadoteric acid, gadoteridol, gadobutrol)
POPRAVKI, KI MORAJO BITI VKLJUČENI V USTREZNA POGLAVJA POVZETKA GLAVNIH ZNAČILNOSTI ZDRAVILA ZA KONTRASTNA SREDSTVA Z GADOLINIJEM Z MAJHNIM TVEGANJEM (gadoterna kislina, gadoteridol, gadobutrol)
Isolated cases of nephrogenic systemic fibrosis (NSF) have been reported with {Invented name} (see section 4.4).
Po uporabi zdravila {izmišljeno ime} so poročali o posameznih primerih nefrogene sistemske fibroze (NSF) (glejte poglavje 4.4).
Isolated cases of nephrogenic systemic fibrosis (NSF) have been reported with {Invented name} in patients co-administered other gadolinium-containing contrast agents (see section 4.4).
Po uporabi zdravila {izmišljeno ime} so poročali o posameznih primerih nefrogene sistemske fibroze (NSF) pri bolnikih, ki so sočasno prejeli druga kontrastna sredstva, ki vsebujejo gadolinij (glejte poglavje 4.4).
[If use is restricted for use in children greater than 1 year of age, specify the indication and age at which use is not recommended]
[če je uporaba omejena pri otrocih, ki so stari več kot eno leto, je treba opredeliti indikacijo in starost pri kateri se uporaba ne priporoča]
[If use is restricted by age for a particular indication, add a statement on use in neonates and infants and specify the indication and age at which use is not recommended]
[če je uporaba pri posamezni indikaciji omejena s starostjo, je treba dodati besedilo o uporabi pri novorojenčkih in dojenčkih in opredeliti indikacijo in starost pri kateri se uporaba ne priporoča]
[Use currently approved text with the addition of information on impaired renal function]
[Uporabi se trenutno odobreno besedilo z informacijami o odstranjevanju]
• you have recently had, or soon expect to have, a liver transplant
• so vam pred kratkim presadili jetra ali takšen poseg pričakujete v kratkem.
GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS AND PACKAGE LEAFLETS
PODLAGA ZA DOPOLNILO POVZETKA GLAVNIH ZNAČILNOSTI ZDRAVILA IN NAVODIL ZA UPORABO
[Use currently approved text with the addition of information on use in neonates and infants]
[Uporabi se trenutno odobreno besedilo, razen za informacije o okvarjenem delovanju ledvic, uporabi pri novorojenčkih, dojenčkih in starostnikih]
As kidney function is immature in infants up to 1 year of age, {Invented name} will only be used in patients 6 to 12 months of age after careful consideration by the doctor.
Zaradi nezrelega delovanja ledvic pri dojenčkih do enega leta starosti, se bo zdravilo {Lastniško ime} pri bolnikih v starosti od 6 do 12 mesecev uporabilo le po skrbni presoji zdravnika.
[If use is permitted in neonates and infants, add a statement on use in neonates and infants]
[če je uporaba dovoljena pri novorojenčkih in dojenčkih, je treba dodati besedilo o uporabi zdravila pri novorojenčkih in dojenčkih]
Continuing breast feeding or discontinuing {Invented name} for a period of 24 hours after administration, should be at the discretion of the doctor and lactating mother.
Zdravnik in mati, ki doji, se odločita o nadaljevanju ali prekinitvi dojenja za 24 ur po uporabi zdravila {izmišljeno ime}.
4.4 Special warnings and precautions for use [With the exception of information on impaired renal function, use in neonates and infants and use in the elderly, use currently approved text]
[odobreno besedilo, razen podatkov glede motenega delovanja ledvic, uporabe pri novorojenčkih in dojenčkih ter uporabe pri starejših bolnikih]
Due to immature renal function in neonates up to 4 weeks of age and infants up to 1 year of age, {Invented name} should only be used in these patients after careful consideration.
Zaradi nerazvite ledvične funkcije pri novorojenčkih do 4 tednov starosti in dojenčkih do 1 leta starosti se lahko zdravilo{lastniško ime} pri teh bolnikih uporablja le po skrbni presoji zdravnika.
Due to immature renal function in infants up to 1 year of age, {Invented name} should only be used in these patients after careful consideration.
Zaradi nezrelega delovanja ledvic pri dojenčkih do enega leta starosti, se zdravilo {Lastniško ime} lahko uporablja pri teh bolnikih le po skrbni presoji.
[If use is restricted for use in children greater than 1 year of age specify the indication and age at which use is not recommended]
[Če se omeji uporaba za otroke, starejše od 1 leta, se doda navedba indikacije in starosti, pri kateri uporaba ni priporočena]
Take special care with {Invented name}: [Use currently approved text with the addition of information on impaired renal function, use in neonates and infants and use in the elderly]
KAJ MORATE VEDETI, PREDEN BOSTE PREJELI ZDRAVILO {lastniško ime} Bodite posebno pozorni pri uporabi zdravila {lastniško ime}: [Uporabi se trenutno odobreno besedilo z dodatkom informacije o okvarjenem delovanju ledvic, uporabi pri novorojenčkih, dojenčkih in starostnikih] Obvestite svojega zdravnika, če:
4.2 Posology and method of administration [Use currently approved text with the addition of guidance for special populations (patients with renal impairment, neonates, infants and the elderly)]
[Uporabi se trenutno odobreno besedilo z dodatkom priporočil za posebne populacije (bolniki z okvarjenim delovanjem ledvic, novorojenčki, dojenčki in starostniki)]
IS - Iceland
Islandija
PL - Poland
Poljska
Cases of nephrogenic systemic fibrosis (NSF) have been reported with other gadolinium-containing contrast agents (see section 4.4).
Po uporabi kontrastnih sredstev, ki vsebujejo gadolinij, so poročali o primerih nefrogene sistemske fibroze (NSF) (glejte poglavje 4.4).
{Invented name} should not be used in newborn babies up to the age of 4 weeks.
Zdravila {Lastniško ime} se ne sme uporabljati pri novorojenčkih do četrtega tedna starosti.
{Invented name} should also not be used in newborn babies up to the age of 4 weeks.
Zdravila {Lastniško ime} se ne sme uporabljati tudi pri novorojenčkih do četrtega tedna starosti.
Breast-feeding should be discontinued for at least 24 hours after the administration of {Invented name}.
Po aplikaciji zdravila {Lastniško ime} je treba dojenje prekiniti za najmanj 24 ur.
AMENDMENTS TO BE INCLUDED IN THE RELEVANT SECTIONS OF THE SUMMARY OF PRODUCT CHARACTERISTICS FOR MEDIUM RISK GADOLINIUM-CONTAINING CONTRAST AGENTS (gadoxetic acid, gadobenic acid)
POPRAVKI, KI MORAJO BITI VKLJUČENI V USTREZNA POGLAVJA POVZETKA GLAVNIH ZNAČILNOSTI ZDRAVILA ZA KONTRASTNA SREDSTVA Z GADOLINIJEM S SREDNJIM TVEGANJEM (gadoksetna kislina, gadobenska kislina)
{Invented name} should also not be given to newborn babies up to the age of 4 weeks.
Zdravila {Lastniško ime} prav tako ne smejo prejeti novorojenčki do četrtega tedna starosti.
Cases of nephrogenic systemic fibrosis (NSF) have been reported with {Invented name} (see section
Pri uporabi zdravila {Lastniško ime} so poročali o primerih nefrogene sistemske fibroze (NSF) (glejte poglavje 4.4)
Isolated cases of nephrogenic systemic fibrosis (NSF) have been reported with {Invented name}, most of which were in patients co-administered other gadolinium-containing contrast agents (see section or
Po uporabi zdravila {izmišljeno ime} so poročali o posameznih primerih nefrogene sistemske fibroze (NSF) večinoma pri bolnikih, ki so sočasno prejeli druga kontrastna sredstva, ki vsebujejo gadolinij (glejte poglavje 4.4).
SE - Sweden
Švedska
Due to immature renal function in neonates up to 4 weeks of age and infants up to 1 year of age, {Invented name} should only be used in these patients after careful consideration at a dose not exceeding {X} mmol/kg body weight.
Zdravilo {izmišljeno ime} se lahko zaradi nerazvite ledvične funkcije pri novorojenčkih do 4 tednov starosti in dojenčkih do 1 leta starosti uporablja le po skrbni presoji in v odmerku, ki ne presega {x} mmol/kg telesne mase.
solution for injection in pre-filled syringe intravenous use
Raztopina za injiciranje v vložku Intravenska uporaba
Solution for injection (pre-filled syringe)
Raztopina za injiciranje, (Iijekcijska brizga, vložek)
BE - Belgium
Belgija
AMENDMENTS TO BE INCLUDED IN THE RELEVANT SECTIONS OF THE SUMMARY OF PRODUCT CHARACTERISTICS FOR HIGH RISK GADOLINIUM-CONTAINING CONTRAST AGENTS (gadodiamide, gadopentetic acid)
DODATEK BO VKLJUČEN V USTREZNA POGLAVJA POVZETKOV GLAVNIH ZNAČILNOSTI ZDRAVIL, KI VSEBUJEJO GADOLINIJ IN PRI KATERIH OBSTAJA VISOKA STOPNJA TVEGANJA (gadodiamid, gadopentetna kislina)
4.9 Overdose [Use currently approved text with the addition of haemodialysis wording]
[Uporabi se trenutno odobreno besedilo z dodatkom besedila o hemodializi]
Impaired renal function
Motnje delovanja ledvic
The safety of {Invented name} in persons under 18 years has not yet been tested.
[Če se zdravilo ne odobri za novorojenčke in dojenčke, se doda naslednja izjava] Varnost zdravila {lastniško ime} pri osebah, mlajših od 18 let, ni preskušena.
If you have moderate kidney problems, you should only receive one dose of {Invented name} during a scan and you should not receive a second injection for at least 7 days.
Če imate zmerno okvaro ledvic, lahko med slikanjem prejmete le en odmerek zdravila {Lastniško ime}.
SK - Slovakia
Slovaška
As kidney function is immature in infants up to 1 year of age, {Invented name} will only be used in infants after careful consideration by the doctor.
Zaradi nezrelega delovanja ledvic pri dojenčkih do enega leta starosti, se bo zdravilo {Lastniško ime} pri teh bolnikih uporabilo le po skrbni presoji zdravnika.
AMENDMENTS TO BE INCLUDED IN THE RELEVANT SECTIONS OF THE SECTIONS OF THE PACKAGE LEAFLET FOR HIGH RISK GADOLINIUM-CONTAINING CONTRAST AGENTS (gadodiamide, gadopentetic acid)
DODATEK BO VKLJUČEN V USTREZNA POGLAVJA NAVODIL ZA UPORABO ZDRAVIL, KI VSEBUJEJO GADOLINIJ IN PRI KATERIH OBSTAJA VISOKA STOPNJA TVEGANJA (gadodiamid, gadopentetna kislina)
BACKGROUND INFORMATION *
OSNOVNE INFORMACIJE *
The Member states competent Authorities will continue to keep the product under regular review.
Pristojni organi držav članic bodo nadaljevali z rednim nadziranjem izdelka.
This review was finalised in June 2006.
Ta pregled je bil zaključen junija 2006.
The final opinion was converted into a Decision by the European Commission on 7 September 2007.
Končno mnenje je bilo spremenjeno v Odločbo Evropske komisije dne 7. septembra 2007.
The Rapporteur and Co-Rapporteur appointed were Dr Rossi and Dr Calvo-Rojas respectively.
Poročevalec oz. soporočevalec sta bila dr. Rossi oz. dr. Calvo-Rojas.
This review, which concluded in October 2005, did not reveal any new safety concerns for the class of NSAIDs as a whole.
Ta pregled, ki je bil zaključen oktobra 2005, ni razkril novih pomislekov glede varnosti razreda NSAID kot celote.
COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) OPINION FOLLOWING AN ARTICLE 31(2) REFERRAL
MNENJE ODBORA ZA ZDRAVILA ZA UPORABO V HUMANI MEDICINI (CHMP), V ZVEZI Z NAPOTITVIJO V SKLADU S ČLENOM 31(2) ZA
On 2 August 2006, the European Commission referred the matter to the EMEA under Article 31 of Directive 2001/83/EC, as amended, for piroxicam containing medicinal products.
Dne 2. avgusta 2006 je Evropska komisija Evropski agenciji za zdravila v skladu s členom 31 Direktive 2001/83/ES, kot je bila spremenjena, predložila napotitev za zdravila, ki vsebujejo piroksikam.
International Non-Proprietary Name (INN): piroxicam
Mednarodno nelastniško ime (INN): piroksikam
∗ Notes: the information given in this document and annexes reflects only the CHMP Opinion dated 21 June 2007.
* Opombe: Informacije v tem dokumentu in dodatkih odražajo zgolj mnenje CHMP z dne 21 junija 2007.
The referral procedure started on the 21 September 2006.
Napotitveni postopek se je začel 21. septembra 2006.
Further to a request from the European Commission the CHMP reviewed safety data on non-selective NSAIDs.
Na podlagi zahteve Evropske komisije je CHMP preučil podatke o varnosti neselektivnih NSAID.
The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II, together with the amended product information in Annex III and the conditions of the Marketing Authorisation in Annex IV.
Seznam zadevnih imen izdelkov je podan v Dodatku I. Znanstveni zaključki so podani v Dodatku II, skupaj z dopolnjenimi informacijami o izdelku v Dodatku III in Pogoji dovoljenja za promet v Dodatku IV.
Piroxicam is authorised in the European Union following national marketing procedures.
Piroksikam je v Evropski uniji odobren na podlagi nacionalnih postopkov za pridobitev dovoljenja za promet z zdravilom.
The MAHs presented oral explanations to the CHMP on 22 and 23 May 2007.
Ustna pojasnila so odboru CHMP podali 22. in 23. maja 2007.
Written explanations were provided by the Marketing Authorisation Holders (MAH) on 18 December 2006 and 13 April 2007.
Imetniki dovoljenj za promet z zdravilom so podali pisna pojasnila 18. decembra 2006 in 13. aprila 2007.
PIROXICAM CONTAINING MEDICINAL PRODUCTS
ZDRAVILA, VSEBUJOČA PIROKSIKAM
Piroxicam is a non-steroidal anti-inflammatory drug (NSAID) with anti-inflammatory, analgesic and antipyretic properties.
Piroksikam je nesteroidno protivnetno zdravilo (NSAID) s protivnetnimi, analgetičnimi in antipiretičnimi lastnostmi.
The CHMP considered that the assessment raised concerns on the benefit/risk balance of piroxicam and informed the European Commission accordingly.
CHMP je menil, da ocena vzbuja pomisleke glede razmerja med koristmi in tveganji za piroksikam, ter je skladno s tem obvestil Evropsko komisijo.
The reasons for referral concerned the risk of gastrointestinal and skin reactions.
Razlog za napotitev je bilo tveganje za gastrointestinalne in kožne reakcije.
However a need to further evaluate the benefit/risk balance of some non-selective NSAIDs including piroxicam was identified.
Ugotovljena pa je bila potreba po nadaljnji presoji razmerja med koristmi in tveganji za nekatera neselektivna nesteroidna protivnetna zdravila, vključno s piroksikamom.
The review found that limited epidemiological data and spontaneous adverse drug reaction data provided a signal of increased risk of gastrointestinal and skin reactions (including life-threatening bullous reactions) for piroxicam relative to other non-selective NSAIDs.
Pregled je pokazal, da omejeni epidemiološki podatki in podatki iz spontanih poročil o neželenih učinkih zdravila nakazujejo na povečano tveganje za gastrointestinalne in kožne reakcije (vključno s smrtno nevarnimi buloznimi reakcijami) glede na druge neselektivne NSAID.
A number of restrictions on use, contraindications and strengthened warnings have been added to the Summary Product Characteristics and Package Leaflet in relation to gastrointestinal and skin safety.
V Povzetek glavnih značilnosti zdravila in Navodilo za uporabo je bilo dodanih več omejitev uporabe, kontraindikacij in dodatnih opozoril v zvezi z varnostjo za prebavni trakt in kožo.
Based on the available data the CHMP considered that the benefit/risk balance for systemic formulations of piroxicam is positive in the treatment of symptomatic relief of osteoarthritis, rheumatoid arthritis or ankylosing spondylitis; however the CHMP considered that the benefit/risk balance of piroxicam in the treatment of acute conditions is negative and that these indications should be revoked.
Na podlagi predloženih podatkov je CHMP menil, da je razmerje med koristmi in tveganji za sistemske formulacije piroksikama pri simptomatskem lajšanju osteoartritisa, revmatoidnega artritisa ali ankiloznega spondilitisa pozitivno.
Treatment can be repeated once a month.
Zdravljenje se lahko ponovi enkrat mesečno.
These usually disappear within 24 hours after administration.
Ti znaki običajno izginejo v 24 urah po dajanju zdravila.
Further information on Vectra 3D can be found on the Agency's website: ema.europa.eu/medicines/veterinary/EPAR/vectra-3d.
Nadaljnje informacije o zdravilu Vectra 3D so na voljo na spletni strani agencije: ema.europa.eu/medicines/veterinary/EPAR/vectra-3d.