natgillin/translations-raw huggingface dataset:
An additional dose is recommended for kittens living in high-risk areas for Feline Leukaemia Virus whose first dose was administered before 12 weeks of age.
Pri mačkah, ki živijo v območjih z velikim tveganjem za prenos virusa mačje leukemije in pri katerih je bil prvi odmerek dan pred starostjo 12 tednov, se priporoča dodaten odmerek.
When injected, this small exposure helps the cat’ s immune system to recognise and attack the viruses and bacterium.
Z injiciranjem zdravila izpostavimo mačko tem majhnim količinam, kar imunskemu sistemu mačke pomaga prepoznavati in napadati viruse in bakterijo.
Fevaxyn Pentofel has been studied against Feline Leukaemia, against respiratory diseases caused by Feline Rhinotracheitis virus, Feline Calicivirus and Feline Chlamydia psittaci, as well as against disease caused by Feline Panleukopenia virus.
Zdravilo Fevaxyn Pentofel so preučevali proti mačji leukemiji, boleznim dihal, ki jih povzročajo virusi mačjega rinotraheitisa, mačji calicivirusi ter mačja Chlamydia psittaci, in proti bolezni, ki jo povzroča virus mačje panleukopenije.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged What benefit has Fevaxyn Pentofel shown during the studies?
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 16 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Kakšne koristi je zdravilo Fevaxyn Pentofel izkazalo med raziskavami?
Fevaxyn Pentofel has been shown to be effective against Feline Leukaemia, against respiratory diseases caused by Feline Rhinotracheitis virus, Feline Calicivirus and Feline Chlamydia psittaci, as well as against disease caused by Feline Panleukopenia virus.
Dokazali so, da je zdravilo Fevaxyn Pentofel učinkovito proti mačji leukemiji, boleznim dihal, ki jih povzročajo virusi mačjega rinotraheitisa, mačji calicivirusi ter mačja Chlamydia psittaci, in proti bolezni, ki jo povzroča virus mačje panleukopenije.
In the trial to observe side effects, there were no side effects in 94.2% of cats for the first vaccination and no side effects observed for 99% of cats for the second vaccination.
V preskušanju, v katerem so opazovali neželene učinke, po prvem cepljenju ni bilo nobenih neželenih učinkov pri 94, 2% mačk, po drugem pa pri 99% mačk.
Some vaccinated cats may develop reactions to the vaccine, which include temporary fever, vomiting, anorexia (not eating), and/ or depression, which usually disappear within 24 hours.
Te reakcije navadno izginejo v 24 urah.
The Committee for Medicinal, Products for Veterinary Use (CVMP) agreed that the benefits of Fevaxyn Pentofel are greater than any risks to immunise healthy cats of 9 weeks or older against feline viruses.
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je mnenja, da so koristi zdravila Fevaxyn Pentofel pri imunizaciji zdravih mačk, starih 9 tednov ali več, proti mačjim virusom večje od z njim povezanih tveganj.
The European Commission granted a marketing authorisation valid throughout the European Union, for Fevaxyn Pentofel to Fort Dodge Laboratories Ireland on 5 February 1997.
Evropska komisija je dovoljenje za promet z zdravilom Fevaxyn Pentofel, veljavno po vsej Evropski uniji, odobrila družbi Fort Dodge Laboratories Ireland dne 5. februarja 1997.
EU Number
Pakiranje EU številka
Target Route of species administration
Ciljna živalska vrsta
Packaging
Način uporabe
Inactivated Feline Panleukopenia Virus (CU4 strain):
Inaktiviran virus mačje panleukopenije (sev CU4) R. P.
R. P. ≥ 9.5-≤ 12.25 Inactivated Feline Calicivirus (255 strain):
9. 50 – 12. 25 Inaktiviran mačji Calicivirus (sev 255) R. P.
R. P.≥ 1.65-≤ 2.15
1. 45 – 2. 0
3 ml disposable 1 ml polypropylene syringes sealed with rubber tips
Subkutana 3 ml aplikacija polipropilenska injekcijska brizga napolnjena z 1 ml cepiva.
10 pre-filled Not applicable syringes per cardboard box
Brizga je zaščitena gumijastim vrhom.
Inactivated Feline Rhinotracheitis virus (605 strain):
1 ml
Inactivated Chlamydophila felis (Cello strain):
10 napolnjenih injekcijskih brizg (10 odmerkov)
R. P.≥ 2.00-≤ 2.30
Navedba ni smiselna.
Cats
Inaktiviran virus mačje panleukopenije (sev CU4)
3 ml disposable 1 ml polypropylene syringes sealed with rubber tips
Subkutana 3 ml aplikacija polipropilenska
20 pre-filled Not applicable syringes per cardboard box
20 napolnjenih injekcijskih
Cats
1. 45 – 2. 0
25 pre-filled Not applicable syringes per cardboard box
25 napolnjenih injekcijskih brizg (25 odmerkov)
Fevaxyn Pentofel, solution for injection, for cats
Fevaxyn Pentofel, raztopina za injiciranje, za mačke
Per dose of 1ml (single dose syringe):
1 odmerek po 1 ml (enoodmerna brizga) vsebuje:
Active components Inactivated Feline Panleukopenia Virus (CU4 strain)
Zdravilne učinkovine Inaktiviran virus mačje panleukopenije, (sev CU4)
Relative Potency (R. P.) 9.50 - 12.25
Relativna potenca (R. P.) 9. 50 – 12. 25
Inactivated Feline Calicivirus (255 strain)
Inaktiviran mačji Calicivirus (sev 255)
1.65 – 2.15
1. 65 – 2. 15
Inactivated Feline Rhinotracheitis Virus (605 strain)
Inaktiviran virus mačjega rinotraheitisa (sev 605)
1.60 – 2.10
1. 60 – 2. 10
Inactivated Chlamydophila felis (Cello strain)
Inaktivirana Chlamydophila felis (sev Cello)
2.00 – 2.30
2. 00 – 2. 30
Inactivated Feline Leukemia Virus (61E strain) Adjuvants
Inaktiviran virus mačje leukemije (sev 61E) Dodatki
1.45 – 2.0
1. 45 – 2. 0
Ethylene/ Maleic Anhydride (EMA) Neocryl A640 Emulsigen SA
Etilen/ maleinski anhidrid (EMA) Neokril A640 Emulgator SA
For a full list of excipients, see Section 6.1
Za celoten seznam pomožnih snovi, glejte poglavje 6. 1.
S
Aktivna imunizacija zdravih mačk, starih 9 tednov ali več proti mačji panleukopeniji in virusom mačje levkemije ter proti respiratornim boleznim, ki jih povzročajo virusi mačjega rinotraheitisa, mačji calicivirusi in Chlamydophila felis.
4.4 Special warnings
2/ 20 4. 4 Posebna opozorila za vsako ciljno živalsko vrsto
Vaccination does not affect the course of FeLV infection in cats already infected with FeLV at the time of vaccination, implying that such cats will excrete FeLV irrespective of vaccination; consequently, these animals will constitute a hazard to susceptible cats in their environment.
Te mačke izločajo viruse ne glede na cepljenje in predstavljajo veliko nevarnost kot vektor okužb v okolju za druge mačke.
Test negative animals can be vaccinated, while test-positive cats should be isolated from other cats and retested within 1-2 months.
Mačke, ki so bile po testiranju negativne, se lahko cepijo, pozitivne pa se izolirajo od ostalih in ponovno testirajo čez 1- 2 meseca.
2/ 19 Cats positive at the second testing should be considered as being permanently infected with FeLV and should be handled accordingly.
Mačke, ki so tudi po drugem testiranju pozitivne, se tretira kot stalno okužene s povzročitelji FeLV in se z njimi ustrezno ravna.
See Section 4.4 for further details.
Za podrobne podatke, glejte poglavje 4. 4.
If you are accidentally injected with this product, seek prompt medical advice even if only a very small amount is injected and take the package insert with you.
Če vam je bilo to zdravilo nenamerno injicirano, se takoj posvetujte z zdravnikom, čeprav je bila injicirana le majhna količina in mu pokažite navodila za uporabo.
Vaccinated cats may develop post-vaccinal reactions including transient fever, vomiting, anorexia and/ or depression which usually disappear within 24 hours.
Zelo redko se lahko po cepljenju pojavijo reakcije kot so povišana telesna temperatura, bruhanje, anoreksija in/ ali depresija, ki običajno izginejo v 24 urah.
A local reaction with swelling, pain, pruritis or hair loss at the injections site may be observed.
Včasih se na mestu cepljenja pojavi oteklina, bolečina, srbenje ali izguba dlake.
See Section 4.5 for guidance about treatment.
Za navodila glede zdravljenja, glejte poglavje 4. 5.
Vaccination of pregnant queens is not recommended.
Varnost cepiva pri brejih mačkah ni bila raziskana, zato se ne priporoča cepljenja brejih mačk.
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 sočasni uporabi tega cepiva s katerim koli drugim zdravilom.
A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be decided on a case by case basis.
Odločitev o uporabi tega cepiva pred ali po uporabi drugega zdravila je odvisna od posameznega primera.
4.9 Amounts to be administered and administration route
3/ 20 4. 9 Odmerjanje in pot uporabe
3/ 19 Basic vaccination of cats 9 weeks and older: two doses at an interval of 3 to 4 weeks.
Osnovno cepljenje mačk, starih 9 tednov in več: dva odmerka v intervalu 3 do 4 tednov.
Revaccination: one vaccination annually.
Re- vakcinacija: eno cepljenje na leto
No undesirable effects other than those observed and mentioned in section 4.6 “ Adverse Reactions” have been observed.
Tudi preveliki odmerki niso povzročili nobenih drugih neželenih učinkov, kot tistih, ki so navedeni v poglavju "Neželeni učinki".
Fevaxyn Pentofel stimulates the development of active immunity against Feline Panleukopenia Virus, Feline Rhinotracheitis Virus, Feline Calicivirus, Chlamydophila felis and Feline Leukaemia Virus.
Cepivo stimulira nastanek aktivne imunosti proti virusom mačje panleukopenije, mačjega rinotraheitisa, mačjim calicivirusom, Chlamydophila felis. in virusom mačje leukemije.
Eagles Earles Minimal Essential Medium with Hepes buffer and Lactalbumin hydrolysate
Minimalni esencialni medij (MEM) Eagles Earles s Hepes pufrom in hidrolizatom laktabumina.
6.2 Incompatibilities
6. 2 Inkopatibilnosti
Do not mix with any other veterinary medicinal product.
Ne mešajte z nobenim drugim cepivom ali imunološkim zdravilom.
Store and transport refrigerated (2oC – 8 oC) Do not freeze.
Shranjujte in prevažajte pri temperaturi 2˚C- 8˚C.
Single dose disposable polypropylene syringes containing one dose (l ml) of vaccine.
Enoodmerna polipropilenska brizga, napolnjena z 1 ml cepiva.
Packaging:
4/ 20 Pakiranje:
4/ 19 6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
6. 6 Posebni varnostni ukrepi za odstranjevanje neporabljenega zdravila ali odpadnih snovi
Any unused product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with national requirements.
Vsako neporabljeno zdravilo ali odpadne snovi, ki nastanejo iz teh zdravil, je treba odstraniti v skladu z lokalnimi predpisi.
Fort Dodge Laboratories Ireland Finisklin Industrial Estate Sligo Ireland
Fort Dodge Laboratories Ireland Finisklin Industrial Estate Sligo, Irska
5 February 1997 Date of last renewal:
5. februar 1997 Datum zadnjega podaljšanja:
Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu
Podrobne informacije o tem zdravilu za uporabo v veterinarski medicini so na voljo na spletni strani Evropske agencije za zdravila (European Medicines Agency, EMEA) http: // www. emea. europa. eu /.
5/ 19 ANNEX II
5/ 20 DODATEK II
MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
IZDELOVALEC( IZDELOVALCI) BIOLOŠKE ZDRAVILNE UČINKOVINE (ZDRAVILNIH UČINKOVIN) IN IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVORNI ZA SPROŠČANJE SERIJE
CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION WITH REGARD TO SAFE AND EFFECTIVE USE
PREPOVED PRODAJE, OSKRBEIN/ ALI UPORABE
Names and addresses of the manufacturers of the biological active substances
Ime in naslov izdelovalcev bioloških zdravilnih učinkovin
Fort Dodge Charles City 2000 Rockford Road Charles City Iowa 50616 USA
Fort Dodge Animal Health 2000 Rockford Road Charles city Iowa 50616 USA
CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE PRODUCT
PREPOVED PRODAJE, OSKRBEIN/ ALI UPORABE
7/ 19 ANNEX III
7/ 20 DODATEK III
9/ 19 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
1.
Inactivated adjuvanted vaccine for cats.
Cepivo za mačke, liofilizirano, inaktivirano.
Per dose of 1ml:
1 odmerek (1 ml) vsebuje:
Inactivated FPV (RP 9.50 - 12.25); FCV (RP 1.65 – 2.15); FVR (RP 1.60 – 2.10); Chlam (RP 2.00 – 2.30); FeLV (RP 1.45 – 2.0)
1. 45 – 2. 0)
S
Aktivna imunizacija zdravih mačk, starih 9 tednov ali več proti mačji panleukopeniji in mačji leukemiji ter proti respiratornim boleznim, ki jih povzročajo virusi mačjega rinotraheitisa, mačji calicivirusi in Chlamydophila felis.
Administer aseptically by subcutaneous injection.
S sterilno iglo apliciramo vsebino brizge subkutano.
Accidental injection is dangerous – read package leaflet before use.
Nenamerno injiciranje je nevarno- pred uporabo preberite navodilo za uporabo.
Store and transport refrigerated (2°C - 8°C).
Shranjujte in prevažajte pri temperaturi 2˚C- 8˚C.
Keep the syringes in the outer carton in order to protect from light.
Brizgo shranjujte v zunanji ovojnini, da jo zaščitite pred svetlobo.
THE WORDS “ FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
BESEDILO ” SAMO ZA ŽIVALI ” IN POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE, če je navedba smiselna
EU/ 2/ 96/ 002/ 001 EU/ 2/ 96/ 002/ 002 EU/ 2/ 96/ 002/ 003
EU/ 2/ 96/ 001 10x 1 ml EU/ 2/ 96/ 002 20x 1 ml EU/ 2/ 96/ 003 25x 1 ml
10 x 1 ml 20 x 1 ml 25 x 1 ml
IZDELOVALČEVA ŠTEVILKA SERIJE
MANUFACTURER’ S BATCH NUMBER
Serija: {številka}
Batch
12/ 20 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
11/ 19 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
1 x 1 ml (1 odmerek)
Inactivated FPV, FCV, FVR, Chlam, FeLV
Inaktivirani FPV, FCV, FVR, Chlam, FeLV
SC
s. c. dajanje
Batch
Serija {številka}:
EXPIRY DATE
DATUM IZTEKA UPORABNOSTI ZDRAVILA
EXP {month/ year}
EXP{ mesec, leto}:
THE WORDS “ FOR ANIMAL TREATMENT ONLY”
BESEDILO ˝SAMO ZA ŽIVALI˝
13/ 19 PACKAGE LEAFLET FOR:
1.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM TER IMETNIKA DOVOLJENJA ZA PROIZVODNJO ZDRAVILA, ODGOVORNEGA ZA SPROSTITEV SERIJ V EGP
Marketing authorisation holder and manufacturer:
Imetnik dovoljenja za promet z zdravilom:
Inactivated Feline Leukaemia Virus (61E strain) Adjuvants
Inaktiviran virus mačje leukemije (sev 61E) Dodatki
For the active immunisation of healthy cats 9 weeks or older against Feline Panleukopenia and Feline Leukaemia viruses and against respiratory diseases caused by Feline Rhinotracheitis virus, Feline Calicivirus and Feline Chlamydophila felis.
Aktivna imunizacija zdravih mačk, starih 9 tednov ali več proti mačji panleukopeniji in mačji leukemiji ter proti respiratornim boleznim, ki jih povzročajo virusi mačjega rinotraheitisa, mačji calicivirusi in mačja Chlamydophila felis.
Vaccinated cats may develop post-vaccinal reactions including transient fever, vomiting, anorexia and/ or depression which usually disappear within 24 hours.
Zelo redko se lahko po cepljenju pojavijo reakcije kot so povišana telesna temperatura, bruhanje, anoreksija in/ ali depresija, ki običajno izginejo v 24 urah
1 ml.
Odmerek znaša 1 ml.
Store and transport refrigerated (2°C - 8°C).
Shranjujte in prevažajte pri temperaturi (2 °C – 8 °C).
Do not mix with any other veterinary medicinal product.
Ne mešajte z ostalimi zdravili.
Any unused product or waste material derived from such veterinary medicinal products should be disposed of in accordance with national requirements.
Glede odstranjevanja zdravil, ki jih ne uporabljate več, se posvetujte z veterinarjem.
Detailed information on this product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu
Podrobne informacije o tem zdravilu za uporabo v veterinarski medicini so na voljo na spletni strani Evropske agencije za zdravila (European Medicines Agency, EMEA) http: // www. emea. europa. eu /.
25 x 1 ml presentation:
10 x 1 ml pakiranje: kartonska škatla z 10 napolnjenimi enoodmernimi brizgami in z 10 sterilnimi iglami 20 x 1 ml pakiranje: kartonska škatla z 20 napolnjenimi enoodmernimi brizgami in z 20 sterilnimi iglami 25 x 1 ml pakiranje: kartonska škatla z 25 napolnjenimi enoodmernimi brizgami in z 25 sterilnimi iglami.
Box containing 25 single dose prefilled syringes and 25 sterile needles.
Ni nujno, da so v prometu vsa navedena pakiranja.
Italia Fort Dodge Veterinaria S. p. A.
19/ 20 Italia Fort Dodge Veterinaria S. p. A.
Flexicam contains meloxicam which belongs to a class of medicines having anti- inflammatory action.
Zdravilo Flexicam vsebuje meloksikam, ki spada v skupino zdravil s protivnetnim delovanjem.
Flexicam is presented as a pale green oral suspension (1.5mg/ ml) for dogs (to be given mixed with food) and a yellow solution for injection (5mg/ ml) for dogs and cats.
Zdravilo Flexicam je na voljo v obliki svetlo zelene peroralne suspenzije (1, 5 mg/ ml) za pse (ki se zmeša s hrano) in rumene raztopine za injiciranje (5 mg/ ml) za pse in mačke.
Flexicam is a ‘ generic’: this means that Flexicam is similar to a ‘ reference veterinary medicine ’ already authorised in the EU (Metacam 1.5 mg/ ml oral suspension).
To pomeni, da je zdravilo Flexicam podobno „ referenčnemu veterinarskemu zdravilu “, ki je že odobreno v EU (zdravilu Metacam 1, 5 mg/ ml peroralna suspenzija).
Studies have been carried out to prove that Flexicam is ‘ bioequivalent ’ to the reference veterinary medicine: this means that Flexicam is equivalent to Metacam 1.5 mg/ ml suspension in the way it is absorbed and used by the body.
Opravljene študije so pokazale, da je zdravilo Flexicam „ biološko enakovredno “ referenčnemu veterinarskemu zdravilu, to pomeni, da je zdravilo Flexicam enakovredno zdravilu Metacam 1, 5 mg/ ml suspenzija glede načina, kako ga telo absorbira in uporabi.
Alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders and reduction of post-operative pain and inflammation following orthopaedic and soft tissue surgery.
Psi: umirjanje vnetja in lajšanje bolečine pri akutnih in kroničnih mišično- skeletnih obolenjih ter lajšanje pooperativne bolečine in zmanjšanje vnetja po ortopedskih operacijah in operacijah mehkega tkiva.
Reduction of post-operative pain after ovariohysterectomy and minor soft tissue surgery.
Mačke: lajšanje pooperativne bolečine po ovariohisterektomiji in manjših operacijah mehkega tkiva.
How does Flexicam work?
Kako zdravilo Flexicam deluje?
Flexicam contains meloxicam, which belongs to a class of medicines called non-steroidal anti- inflammatory drugs (NSAIDs).
Zdravilo Flexicam vsebuje meloksikam, ki spada v skupino zdravil, ki jim pravimo nesteroidna protivnetna zdravila (NSPVZ).
What benefit has Flexicam shown during the studies?
Kako je bilo zdravilo Flexicam raziskano?
Flexicam is efficacious in alleviating the inflammation and pain in both acute and chronic musculo-skeletal disorders and reducing the post operative pain following orthopaedic and soft tissue surgery in dogs and in reducing the post-operative pain after ovariohysterectomy and minor soft tissue surgery in cats.
Zdravilo Flexicam je učinkovito pri umirjanju vnetja in lajšanju bolečine pri akutnih in kroničnih mišično- skeletnih obolenjih ter lajšanju pooperativne bolečine po ortopedskih operacijah in operacijah mehkega tkiva pri psih ter lajšanju pooperativne bolečine po ovariohisterektomiji in manjših operacijah mehkega tkiva pri mačkah.
Occasional side effects of Flexicam are those seen with NSAIDs, such as loss of appetite, vomiting, diarrhoea, blood appearing in the stools and apathy (lack of vitality).
Občasni neželeni učinki zdravila Flexicam so enaki kot pri drugih nesteroidnih protivnetnih zdravilih in vključujejo izgubo teka, bruhanje, drisko, kri v blatu in apatijo (pomanjkanje vitalnosti).
These side effects occur usually within the first week of treatment and are generally temporary.
Običajno se pojavijo v prvem tednu zdravljenja in so po navadi začasni.
Flexicam should also not be used in animals suffering from gastrointestinal or hemorrhagic disorders and impaired renal or hepatic function, animals with known hypersensitivity to NSAIDs, and animals less than 6 weeks of age or in cats of less than 2 kg.
Zdravilo Flexicam se ne sme uporabljati pri živalih z obolenji prebavil ali hemoragičnih obolenjih ter pri motnjah jetrne ali ledvične funkcije, živalih z ugotovljeno preobčutljivostjo na nesteroidna protivnetna zdravila ter živalih, mlajših od 6 tednov, ali mačkah, lažjih od 2 kg.
People with known hypersensitivity (allergic) to meloxicam should avoid contact with the product.
Osebe z znano preobčutljivostjo za (alergijo na) meloksikam naj se izogibajo stiku z zdravilom.
If the product is swallowed by a person, the advice of a doctor should be sought immediately.
Če zdravilo nenamerno zaužije človek, se je treba nemudoma posvetovati z zdravnikom.
The Committee for Medicinal Products for Veterinary Use (CVMP) considered that, in accordance with European Union requirements, Flexicam has been shown to be bioequivalent to Metacam 1.5 mg/ ml oral suspension.
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je menil, da se je zdravilo Flexicam v skladu z zahtevami Evropske unije izkazalo kot biološko enakovredno zdravilu Metacam 1, 5 mg/ ml peroralna suspenzija.
The CVMP concluded that the benefits of Flexicam exceed the risks for the alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders, reduction of post-operative pain and inflammation following orthopaedic and soft tissue surgery in dogs and reduction of post-operative pain after ovariohysterectomy and minor soft tissue surgery in cats and recommended that Flexicam be given a marketing authorisation.
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je zaključil, da so koristi zdravila Flexicam pri umirjanju vnetja in lajšanju bolečine pri akutnih in kroničnih mišično- skeletnih obolenjih, lajšanju pooperativne bolečine in vnetja po ortopedskih operacijah in operacijah mehkega tkiva pri psih ter lajšanju pooperativne bolečine po ovariohisterektomiji in manjših operacijah mehkega tkiva pri mačkah večje od z njim povezanih tveganj, in priporočil, da se za zdravilo Flexicam odobri dovoljenje za promet.
Other information about Flexicam:
Stran 2/ 3 ©EMEA 2008 Druge informacije o zdravilu Flexicam:
The European Commission granted a marketing authorisation valid throughout the European Union, for Flexicam to Omnipharm Ltd. on 10 April 2006 and an extension to Flexicam 5mg/ ml solution for injection on 9 December 2008.
Evropska komisija je dovoljenje za promet z zdravilom Flexicam, veljavno po vsej Evropski uniji, odobrila družbi Omnipharm Ltd dne 10. aprila 2006 ter podaljšanje za zdravilo Flexicam 5 mg/ ml raztopina za injiciranje dne 9. decembra 2008.
Page 2/ 2 ©EMEA 2008
Stran 3/ 3 ©EMEA 2008
oral
psi
Polyethylene bottle
peroralna
1
polietilenska 10 ml 1 steklenička
dogs oral
psi
32 ml 1
polietilenska 32 ml 1 steklenička
100 ml 1
polietilenska 100 ml 1 steklenička
dogs and sc/ iv cats
psi in mačke
Glass vial
podkožno ali intravensko
Flexicam 1.5 mg/ ml oral suspension for dogs
Flexicam 1, 5 mg/ ml, peroralna suspenzija za pse
Each ml of Flexicam 1.5 mg/ ml oral suspension contains:
1 ml peroralne suspenzije Flexicam 1, 5 mg/ ml vsebuje:
Oral suspension Flexicam is a pale green, uniform suspension containing 1.5 mg/ ml meloxicam
Peroralna suspenzija Flexicam je svetlo zelena homogena suspenzija, ki vsebuje 1, 5 mg/ ml meloksikama.
CLINICAL PARTICULARS:
KLINIČNI PODATKI