natgillin/translations-raw huggingface dataset:
Iloperidone is thought to block receptors for the neurotransmitters dopamine and 5hydroxytryptamine (also called serotonin), which play a role in schizophrenia. 
Iloperidon naj bi zaviral receptorje za živčna prenašalca dopamin in 5-hidroksitriptamin (imenovan tudi serotonin), ki imata pomembno vlogo pri shizofreniji.
The CHMP also noted that the medicine starts to have its effects after 2 to 3 weeks of treatment, which is a concern when treating sudden (acute) episodes of schizophrenia. 
Prav tako je opozoril, da zdravilo začne učinkovati po dveh do treh tednih zdravljenja, kar je zaskrbljujoče, če se zdravijo nenadne (akutne) epizode shizofrenije.
At the time of the initial recommendation, the CHMP considered that the effectiveness of Fanaptum in studies was modest. 
V času izdaje prvotnega priporočila je odbor CHMP menil, da je bila učinkovitost zdravila Fanaptum v študijah zmerna.
Fanaptum was expected to be used to treat schizophrenia in adults. 
Zdravilo Fanaptum naj bi se uporabljalo za zdravljenje shizofrenije pri odraslih.
It measured the time until the patient's symptoms came back (first relapse). 
V študiji so merili čas do ponovitve simptomov pri bolnikih (prvi relaps).
The longterm study, involving 193 patients, compared Fanaptum with placebo. 
V dolgotrajni študiji, v kateri je sodelovalo 193 bolnikov, so zdravilo Fanaptum primerjali s placebom.
Finally, the CHMP was concerned that Fanaptum is broken down in the body by liver enzymes whose activity is reduced in certain patients and by certain other medicines. 
Nazadnje je izpostavil zaskrbljenost, da se zdravilo Fanaptum v telesu razgrajuje s pomočjo jetrnih encimov, katerih delovanje je zmanjšano pri nekaterih bolnikih in pri uporabi določenih drugih zdravil.
Neurotransmitters are substances that nerve cells use to communicate with neighbouring cells. 
Živčni prenašalci so kemične snovi, ki omogočajo medsebojno sporazumevanje sosednjih živčnih celic.
In terms of safety, the CHMP was concerned about the medicine's effects on the heart: Fanaptum causes QT prolongation, a change in the heart's electrical activity which can cause a life-threatening abnormality of heart rhythm. 
V zvezi z varnostjo je odbor izpostavil zaskrbljenost glede učinkov zdravila na srce: zdravilo Fanaptum povzroča podaljšanje intervala QT, tj. spremembo električne dejavnosti srca, ki lahko povzroči smrtno nevaren nenormalen srčni ritem.
Therefore, the CHMP concluded that the benefits of Fanaptum did not outweigh its risks and maintained its previous recommendation that the medicine be refused marketing authorisation. 
Posledično je sklenil, da koristi zdravila Fanaptum ne odtehtajo z njim povezanih tveganj, in ohranil svoje prvotno priporočilo, da se dovoljenje za promet z njim zavrne.
However, the CHMP was still concerned about the risk of QT prolongation and considered that the measures proposed would not appropriately address this risk in clinical practice. 
Kljub temu je odbor izrazil zaskrbljenost glede podaljšanja intervala QT in menil, da predlagani ukrepi niso ustrezna rešitev za zmanjšanje tveganja v klinični praksi.
In addition, the Committee was still concerned by the modest effectiveness of Fanaptum and its delayed onset of action. 
Poleg tega je še enkrat izrazil zaskrbljenost glede zmerne učinkovitosti zdravila Fanaptum in njegovega zakasnjenega delovanja.
The active substance in Fanaptum, iloperidone, is an antipsychotic medicine. 
Zdravilna učinkovina v zdravilu Fanaptum, iloperidon, je antipsihotik.
Fanaptum is a medicine that contains the active substance iloperidone. 
Fanaptum je zdravilo, ki vsebuje zdravilno učinkovino iloperidon.
Refusal of the marketing authorisation for Fanaptum (iloperidone) 
Zavrnitev vloge za pridobitev dovoljenja za promet z zdravilom Fanaptum (iloperidon)
The company that applied for authorisation is Vanda Pharmaceuticals Ltd. 
Vlogo za pridobitev dovoljenja za promet z zdravilom je predložila družba Vanda Pharmaceuticals Ltd.
What was Fanaptum expected to be used for? 
Za kaj naj bi se zdravilo Fanaptum uporabljalo?
The short-term study, involving 567 patients, compared Fanaptum with the schizophrenia medicine ziprasidone and with placebo (a dummy treatment). 
V kratkotrajni študiji, v kateri je sodelovalo 567 bolnikov, so zdravilo Fanaptum primerjali z ziprasidonom (zdravilom za zdravljenje shizofrenije) in placebom (zdravilom brez zdravilne učinkovine).
What is Fanaptum? 
Kaj je zdravilo Fanaptum?
How does Fanaptum work? 
Kako zdravilo Fanaptum deluje?
The measures included restricting use to patients whose treatment with another antipsychotic did not work or was no longer tolerated, and prohibiting use in patients who cannot effectively break down the medicine or are taking certain other medicines. 
Odbor CHMP je med ponovnim pregledom znova proučil podatke, ki jih je predložila družba, in njen predlog, da se uvedejo nekateri novi ukrepi za obvladovanje tveganja za podaljšanje intervala QT. Ti ukrepi zajemajo omejitev uporabe zdravila zgolj na bolnike, pri katerih zdravljenje z drugimi antipsihotiki bodisi ni bilo učinkovito bodisi jih niso prenašali, in prepoved uporabe zdravila pri bolnikih, pri katerih je razgradnja zdravila ovirana ali ki jemljejo določena druga zdravila.
A clinical response is normally seen within 3-4 days. 
Klinični odziv je običajno opazen v roku 3-4 dni.
Do not use in dogs less than 6 weeks of age. 
Ne uporabite pri psih, starih manj kot 6 tednov.
Please carefully follow the instructions of the veterinarian. 
Skrbno upoštevajte veterinarjeva navodila.
Treatment should be discontinued after 10 days at the latest if no clinical improvement is apparent. 
Zdravljenje je treba prekiniti najkasneje po 10 dneh, če ni opaznega kliničnega izboljšanja.
Each ml contains: 
En mililiter vsebuje:
Date of first authorisation: 23/02/2012 
Datum pridobitve dovoljenja za promet : 23/02/2012
Approximately 97 % of meloxicam is bound to plasma proteins. 
Približno 97 % meloksikama se veže na plazemske beljakovine.
This product is for dogs and should not be used in cats as it is not suitable for use in this species. 
To je zdravilo za pse, zato ga ne smete uporabljati za mačke, saj ni primerno za to živalsko vrsto.
Meloxicam is eliminated with a half-life of 24 hours. 
Meloksikam se izloča z razpolovno dobo 24 ur.
These side effects occur generally within the first treatment week and are in most cases transient and disappear following termination of the treatment but in very rare cases may be serious or fatal. 
Ti neželeni učinki se običajno pojavijo v prvem tednu zdravljenja in so povečini prehodni ter izginejo po prekinitvi zdravljenja, vendar pa so v zelo redkih primerih lahko hudi ali smrtni.
In vitro and in vivo studies demonstrated that meloxicam inhibits cyclooxygenase-2 (COX-2) to a greater extent than cyclooxygenase-1 (COX-1). 
S študijami in vitro in in vivo so dokazali, da meloksikam zavira ciklooksigenazo-2 (COX-2) v večji meri kot ciklooksigenazo-1 (COX-1).
Remove Cap 
Odstranite pokrov
Use during pregnancy and lactation: See section "Contraindications". 
Uporaba v obdobju brejosti in laktacije: Glejte poglavje "Kontraindikacije".
All major metabolites have been shown to be pharmacologically inactive. 
Pokazalo se je, da so vsi bistveni presnovki farmakološko neaktivni.
For longer term treatment, once a clinical response has been observed (after ≥ 4 days), the dose of the product 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. 
Pri dolgotrajnejšem zdravljenju lahko, ko opazite klinični odziv (po 4 dneh ali več), odmerek zdravila prilagodite na najmanjši še učinkoviti individualni odmerek, pri čemer upoštevajte, da se lahko stopnja bolečine in vnetja, povezana s kroničnimi mišično-skeletnimi obolenji, s časom spreminja.
Shake gently before use. 
Pred uporabo nežno pretresite.
In the case of overdose symptomatic treatment should be initiated. 
V primeru prevelikega odmerjanja je treba uvesti simptomatsko zdravljenje.
RevitaCAM must not be administered in conjunction with other NSAIDs or glucocorticosteroids. 
Zdravila RevitaCAM se ne sme dati v kombinaciji z drugimi NSAID ali glukokortikosteroidi.
Meloxicam is predominantly found in plasma and is also a major biliary excretion product whereas urine contains only traces of the parent compound. 
Meloksikam je najti pretežno v plazmi in je hkrati glavni produkt biliarnega izločanja, medtem ko vsebuje urin le sledove starševske spojine.
Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as there is a potential risk of increased renal toxicity. 
Izogibajte se uporabi pri dehidriranih, hipovolemičnih ali hipotenzivnih živalih, saj obstaja možnost tveganja za povečano toksičnost za ledvice.
Approximately 75 % of the administered dose is eliminated via faeces and the remainder via urine. 
Približno 75 % uporabljenega odmerka se izloči v blatu, preostanek pa v urinu.
Meloxicam is completely absorbed following oromucosal administration and maximal plasma concentrations are obtained after approximately 4.5 hours. 
Meloksikam se povsem absorbira po oralnem dajanju, in doseže maksimalne koncentracije v plazmi po približno 4,5 urah.
The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals displaying adverse reaction(s) during the course of one treatment) - common (more than 1 but less than 10 animals in 100 animals) - uncommon (more than 1 but less than 10 animals in 1,000 animals ) - rare (more than 1 but less than 10 animals in 10,000 animals) - very rare (less than 1 animal in 10,000 animals, including isolated reports). 
Pogostost neželenih učinkov je določena po naslednjem dogovoru: - zelo pogosti (pri več kot 1 živali od 10 živali med enim ciklom zdravljenja) - pogosti (pri več kot 1 a manj kot 10 živali od 100 živali) - občasni (pri več kot 1 a manj kot 10 živali od 1.000 živali) - redki (pri več kot 1 a manj kot 10 živali od 10.000 živali) - zelo redki (pri manj kot 1 živali od 10.000 živali, vključujoč posamezne primere).
Other NSAIDs, diuretics, anticoagulants, aminoglycoside antibiotics and substances with high protein binding may compete for binding and thus lead to toxic effects. 
Drugi NSAID, diuretiki, antikoagulanti, aminoglikozidni antibiotiki in snovi, ki se močno vežejo na beljakovine, lahko tekmujejo za vezavo in tako povzročijo toksične učinke.
The MAH must ensure that the system of pharmacovigilance as described in Part 1 of the marketing authorisation application, is in place and functioning before and whilst the product is on the market. 
Imetnik dovoljenja za promet mora zagotoviti, da je sistem farmakovigilance, predložen kot je opisan v delu I vloge za pridobitev dovoljenja za promet, vzpostavljen in deluje, preden da zdravilo v promet in ves čas trženja zdravila.
Overdose (symptoms, emergency procedures, antidotes): In case of overdose symptomatic treatment should be initiated. 
Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi): V primeru prevelikega odmerjanja je treba uvesti simptomatsko zdravljenje.
EU/2/12/138/001 6 ml/10 ml vial EU/2/12/138/002 11 ml/20 ml vial EU/2/12/138/003 33 ml/50 ml vial EU/2/12/138/004 3 ml/10 ml vial EU/2/12/138/005 3 ml/20 ml vial EU/2/12/138/006 8 ml/50 ml vial 
EU/2/12/138/001 6 ml/10 ml stekleni viali EU/2/12/138/002 11 ml/20 ml stekleni viali EU/2/12/138/003 33 ml/50 ml stekleni viali EU/2/12/138/004 3 ml/10 ml stekleni viali EU/2/12/138/005 3 ml/20 ml stekleni viali EU/2/12/138/006 8 ml/50 ml stekleni viali
Maintenance dosage range meloxicam delivered (mg/kg)* 
Razpon dostavljenega vzdrževalnega odmerka meloksikama (mg/kg)*
Do not use this veterinary medicinal product after the expiry date which is stated on the carton and the vial. 
Zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na škatli in viali.
Oromucosal spray Yellow colloidal dispersion 
Oralno pršilo rumena koloidna disperzija
When the product is used according to the recommended dosage regime, steady state concentrations of meloxicam in plasma are reached on the second day of treatment. 
Če se zdravilo uporablja po priporočenem režimu odmerjanja, so koncentracije meloksikama v stanju dinamičnega ravnotežja v plazmi dosežene drugi dan zdravljenja.
Pre-treatment with anti-inflammatory substances may result in additional or increased adverse effects and accordingly a treatment-free period with such veterinary medicinal products should be observed for at least 24 hours before commencement of treatment. 
Predhodno zdravljenje s protivnetnimi učinkovinami lahko povzroči dodatne neželene učinke ali jih okrepi, zato morate upoštevati vsaj 24-urno obdobje brez uporabe takih zdravil za uporabo v veterinarski medicini, preden začnete zdravljenje.
In case of pump failure, wipe nozzle and then re-prime the pump as described above. 
Če razpršilnik ne deluje, obrišite šobo in nato razpršilnik pripravite, kot je opisano zgoraj.
Spray RevitaCAM into dog's mouth 
Zdravilo RevitaCAM razpršite v gobec psa
Store the vial in an upright position. 
Vialo shranjujte v pokončnem položaju.
Meloxicam is metabolised to an alcohol, an acid derivative and to several polar metabolites. 
Meloksikam se presnovi v alkohol, derivat kisline in v številne polarne presnovke.
In some dogs sneezing, coughing/gagging or drooling may be observed immediately after treatment administration. 
Pri nekaterih psih so takoj po dajanju zdravila opazili kihanje, kašljanje/davljenje ali slinjenje.
People with known hypersensitivity to Non Steriodal Anti-inflammatory Drugs (NSAIDs) should avoid contact with the veterinary medicinal product. 
Osebe z znano preobčutljivostjo na nesteroidna protivnetna zdravila (NSAID) naj se izogibajo stiku z zdravilom.
If RevitaCAM is not used for two days or more, re-prime with one or more sprays or until a fine spray appears. 
Če zdravila RevitaCAM dva ali več dni ne uporabljate, ponovite postopek priprave z enim ali več pritiski ali dokler se ne pojavijo drobne razpršene kapljice.
* For the initial treatment of a single dose of 0.2 mg meloxicam/kg body weight, the above maintenance doses should be doubled. 
* Pri začetnem zdravljenju z enkratnim odmerkom 0,2 mg meloksikama/kg telesne mase podvojite zgornje vzdrževalne odmerke.
Avoid direct contact between the product and skin, if accidental exposure occurs wash hands immediately with soap and water. 
Preprečite nenamerni neposredni stik med zdravilom in kožo, ob nenamerni izpostavitvi roke takoj umijte z milom in vodo.
To prime the pump depress at least 10 times prior to first use or until a fine spray appears. 
Za pripravo razpršilnika pred prvo uporabo nanj pritisnite vsaj 10-krat ali dokler se ne prikažejo drobno razpršene kapljice.
Alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders. 
Ublažitev vnetja in bolečine pri akutnih in kroničnih mišično-skeletnih obolenjih.
To administer RevitaCAM, the dog's top lip should be grasped and gently pulled away exposing the gums. 
Za dajanje zdravila RevitaCAM primite zgornjo ustnico psa in jo nežno povlecite stran, da se prikaže dlesen.
The treatment-free period, however, should take into account the pharmacological properties of the products used previously. 
Pri določanju obdobja brez zdravljenja upoštevajte farmakološke lastnosti predhodno uporabljenih zdravil.
Pharmacotherapeutic group: Antiinflammatory and antirheumatic products, non-steroids (oxicams) ATCvet Code: 
Farmakoterapevtska skupina: protivnetna in protirevmatična zdravila, nesteroidna (oksikami) Oznaka ATCvet:
There is a linear relationship between the dose administered and plasma concentration observed in the therapeutic dose range. 
V terapevtskem razponu odmerjanja obstaja linearno razmerje med danim odmerkom in opazovano koncentracijo v plazmi .
Ethyl alcohol Polycarbophil Boric acid Potassium chloride Hydrochloric acid Sodium hydroxide Water, purified 
6.1 Seznam pomožnih snovi etanol polikarbofil borova kislina kalijev klorid klorovodikova kislina natrijev hidroksid voda, prečiščena
Alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders in dogs. 
Ublažitev vnetja in bolečine pri akutnih in kroničnih mišično-skeletnih obolenjih pri psih.
Particular care should be taken with regard to the accuracy of dosing. 
Bodite posebno pozorni na pravilno odmerjanje.
Manufacturer for the batch release: Abbott Logistics B.V., Minervum 7201, Breda 4817 ZJ, THE NETHERLANDS 
Izdelovalec, odgovoren za sprostitev serije: Abbott Logistics B.V., Minervum 7201, Breda 4817 ZJ, NIZOZEMSKA
Immediately after administration of the spray use a moist paper towel or tissue to clean the tip of the pump. 
Takoj po dajanju pršila očistite konico razpršilnika z vlažno papirnato brisačo ali robčkom.
EXP {month/year} Shelf-life of opened vial: 6 months 
EXP {mesec/leto} Odprto vialo porabite v roku: 6 mesecev
Do not use in pregnant or lactating animals. 
Ne uporabite pri brejih živalih ali živalih v laktaciji.
Do not use in animals suffering from gastrointestinal disorders such as irritation and haemorrhage, impaired hepatic, cardiac or renal function and haemorrhagic disorders. 
Ne uporabite pri živalih z boleznimi prebavil, kot so draženje in krvavitve, okvarjenim delovanjem jeter, srca ali ledvic in hemoragičnimi obolenji.
D. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION 
D. DRUGI POGOJI IN ZAHTEVE KI JIH MORA IZPOLNITI IMETNIK DOVOLJENJA ZA PROMET Z ZDRAVILOM
The mist should be directed to the back and towards the gums and/or inner cheek, mucosal surfaces. 
Pršenje usmerite nazaj in proti sluznicam dlesni in/ali notranjih ličnic.
The mouth should not be opened any wider than necessary to facilitate application. 
Gobca ne razpirajte bolj, kot je potrebno za nanos pršila.
Marketing authorisation holder: Zoetis Belgium SA, Rue Laid Burniat 1, 1348 Louvain-la-Neuve, BELGIUM 
Imetnik dovoljenja za promet z zdravilom: Zoetis Belgium SA, Rue Laid Burniat 1, 1348 Louvain-la-Neuve, BELGIJA
Allow the pump to fully reflate before administering consecutive sprays. 
Razpršilnik naj se do konca napolni z zrakom, preden ponovite pršenje.
Medicines should not be disposed of via wastewater or household waste but in accordance with local requirements. 
Ne odvrzite zdravila v odpadno vodo ali v gospodinjske odpadke.
If adverse reactions occur, treatment should be discontinued and the advice of the veterinarian should be sought. 
Posebni previdnostni ukrepi za uporabo pri živalih Če se pojavijo neželeni učinki, je treba zdravljenje prekiniti in se posvetovati z veterinarjem.
The pump should be depressed fully, ensuring no mist escapes from the mouth. 
Na razpršilnik pritisnite do konca in ne dovolite, da bi razpršene kapljice uhajale iz gobca.
Wipe pump with tissue to prevent clogging 
Razpršilnik obrišite z robčkom, da se ne zamaši
Active substance: Meloxicam 5 mg 
Zdravilna učinkovina: meloksikam 5 mg
Name and address of the manufacturer(s) responsible for batch release 
Ime in naslov izdelovalca (izdelovalcev) zdravila, odgovornega (odgovornih) za sprostitev serije
Treatment is to be continued once daily by oromucosal administration (at 24-hour intervals) at a maintenance dose of 0.1 mg meloxicam/kg body weight (see dosing table). 
Zdravljenje začnite z enim odmerkom 0,2 mg meloksikama/kg telesne mase prvi dan. Nadaljujte zdravljenje z vzdrževalnim odmerkom 0,1 mg meloksikama/kg telesne mase z dajanjem pršila na ustno sluznico enkrat na dan (v 24-urnih presledkih) (glejte preglednico odmerjanja).
Excipients: Ethyl alcohol 150 mg 
Pomožna snov: etanol 150 mg
Typical adverse drug reactions of Non Sterioidal Anit-Inflammatory Drugs (NSAIDs) such as loss of appetite, vomiting, diarrhoea, faecal occult blood, apathy and renal failure have occasionally been reported. 
Občasno so poročali o običajnih neželenih učinkih nesteroidnih protivnetnih zdravil (NSAID), kot so izguba apetita, bruhanje, driska, prikrita kri v blatu, apatija in ledvična odpoved.
A. MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE 
A. IMETNIK(I) DOVOLJENJ(A) ZA IZDELAVO ZDRAVILA, ODGOVOREN(ODGOVORNI) ZA SPROSTITEV SERIJE
Meloxicam is a non-steroidal anti-inflammatory drug (NSAID) of the oxicam class which acts by inhibition of prostaglandin synthesis, thereby exerting anti-inflammatory, analgesic, anti-exudative and antipyretic effects. 
Njegovo delovanje temelji na zaviranju sinteze prostaglandinov, kar ima protivnetne, analgetične, antieksudativne in antipiretične učinke.
Typical adverse drug reactions of NSAIDs such as loss of appetite, vomiting, diarrhoea, faecal occult blood, apathy and renal failure have occasionally been reported. 
Občasno so poročali o običajnih neželeni učinki na NSAID, kot so izguba apetita, bruhanje, driska, prikrita kri v blatu, apatija in ledvična odpoved.
Special precautions to be taken by the person administering the veterinary medicinal product to animals 
Posebni previdnostni ukrepi, ki jih mora izvajati oseba, ki živalim daje zdravilo Po dajanju zdravila si umijte roke.
OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 
DRUGI POGOJI IN ZAHTEVE KI JIH MORA IZPOLNITI IMETNIK
10 ml glass vial containing either 3ml or 6 ml 20 ml glass vial containing either 3ml or 11ml 50 ml glass vial containing either 8 ml or 33 ml Not all pack sizes may be marketed. 
20-mililitrska steklena viala vsebuje 3 ml ali 11 ml razpršilnik za 100 µl 50-mililitrska steklena viala vsebuje 8 ml ali 33 ml razpršilnik za 215 µl Ni nujno, da so v prometu vsa navedena pakiranja.
Special precautions to be taken by the person administering the veterinary medicinal product to animals: 
Posebni previdnostni ukrepi, ki jih mora izvajati oseba, ki živalim daje zdravilo: Po dajanju zdravila si umijte roke.
Prime pump by spraying into tissue 
Črpalko pripravite s pršenjem v robček
RevitaCAM 5 mg/ml oromucosal spray for Dogs Meloxicam 
RevitaCAM 5 mg/ml oralno pršilo za pse meloksikam
RevitaCAM 5 mg/ml oromucosal spray for Dogs 
RevitaCAM 5 mg/ml oralno pršilo za pse
Shelf-life of the veterinary medicinal product as packaged for sale: 30 months Shelf-life after first opening the immediate packaging: 6 months 
Rok uporabnosti zdravila v pakiranju za prodajo: 30 mesecev.
EXP {month/year}> Shelf-life of opened vial: 6 months Once broached, use by … 
Odprto vialo porabite v roku: 6 mesecev Načeto zdravilo porabite do …
50 ml glass vial containing either 8 ml or 33 ml 
50-mililitrski stekleni viali vsebuje 8 ml ali 33 ml razpršilnik za 215 µl
Oromucosal Spray 
Meloksikam
Insert pump into vial 
Vstavite razpršilnik v vialo Vialo nežno pretresite
20 ml glass vial containing either 3ml or 11ml 
20-mililitrski stekleni viali vsebuje 3 ml ali 11 ml razpršilnik za 100 µl
PACKAGE LEAFLET FOR: RevitaCAM 5mg/ml oromucosal spray for Dogs 
NAVODILO ZA UPORABO RevitaCAMcam 5 mg/ml oralno pršilo za pse
10 ml glass vial containing either 3ml or 6 ml 
10-mililitrska steklena viala vsebuje 3 ml ali 6 ml razpršilnik za 50 µl
Veterinary medicinal product subject to prescription 
POGOJI DOVOLJENJA ZA PROMET Z ZDRAVILOM TER OMEJITVE
CARTON 
Presnova
90 (3 x 30) tablets (multipack) 
90 (3 × 30) filmsko obloženih tablet (skupno pakiranje)
30 x 1 tablets (unit dose) 
30 x 1 tableta (enojno pakiranje)
Invented name Strength Pharmaceutical Form Route of Administration 
Farmacevtska oblika
It contains inactivated (killed) whole virus of two equine influenza (flu) strains (‘A/equine-2/South Africa/4/03' and ‘A/equine-2/Newmarket/2/93'). 
Vsebuje inaktivirana (uničena) cela virusa dveh sevov influence (gripe) konj („A/konjski-2/Južna Afrika/4/03“ in „A/konjski-2/Newmarket/2/93“).
The swelling is expected to decrease within two days. 
Oteklina naj bi izginila v dveh dneh.
In very rare cases fever may occur for one day, and up to three days in exceptional circumstances. 
V zelo redkih primerih se lahko pojavi povišana telesna temperatura, ki traja en dan, oziroma izjemoma do tri dni.
Equine influenza is a highly contagious disease that is very common in horses but that rarely causes death. 
Influenca konj je zelo nalezljiva bolezen, ki je pri konjih zelo pogosta, vendar redko povzroči pogin.
These equine influenza viruses have been inactivated so that they can no longer cause disease. 
Ti virusi so bili inaktivirani, tako da ne morejo povzročiti bolezni.