natgillin/translations-raw huggingface dataset:
In case of accidental spillage onto skin, wash off immediately with soap and water.
Po dajanju si dobro umijte roke. Če zdravilo pride v stik s kožo, jo takoj dobro sperite z milom in vodo.
Do not smoke, drink or eat while handling the product.
3/ 38 Med dajanjem zdravila je prepovedano kaditi, piti ali jesti.
Known side-effects of amitraz and metabolites, such as sedation, lethargy, CNS depression, hyperglycaemia, bradycardia and slow, shallow breathing may be observed in a small number of animals.
Pri manjšem številu živali lahko opazimo znane neželene učinke amitraza in metabolitov, kot so sedacija, letargija, depresija CŽS, hiperglikemija, bradikardija in počasno, plitko dihanje.
Most of these signs are due to alpha-2-adreno-receptor agonist effects.
Večina teh znakov je posledica agonističnih učinkov na alfa- 2- adreno- receptorje.
Signs are usually transitory and generally resolved without treatment within 24 hours.
Znaki so ponavadi prehodni in izginejo brez zdravljenja v 24 urah.
If symptoms are severe or persist the alpha-2-adreno-receptor antagonist atipamezole hydrochloride may be used at a dose of 0.2 mg/ kg bodyweight by intramuscular injection to reverse these side-effects.
Če so simptomi resni ali trajajo dalj časa, se lahko uporabi antagonist alfa- 2- adreno- receptorjev atipamezol hidroklorid v odmerku 0, 2 mg/ kg telesne mase intramuskularno, da neželeni učinki izginejo.
This is not a sign of intoxication and disappears within minutes without treatment.
To ni znak zastrupitve in izgine v nekaj minutah po zdravljenju.
This is normal and will generally resolve within a few days after administration, though may persist longer on rare occasions.
To je normalno in se razgradi v nekaj dneh po dajanju.
Treatment with other products containing amitraz is not recommended whilst the dog is being treated with ProMeris Duo Spot-On for Dogs.
Zdravljenje z drugimi zdravili, ki vsebujejo amitraz, ni priporočljivo, ko pse tretirate s ProMeris Duo Spot- on za pse.
The recommended minimum dose is 20 mg/ kg bodyweight for each of metaflumizone and amitraz, equivalent to 0.133ml/ kg bodyweight.
Priporočen minimalni odmerek za metaflumizon in za amitraz je 20 mg/ kg telesne mase, kar ustreza 0, 133 ml/ kg telesne mase.
Weight Range of
Razpon tel. mase
Dog (kg)
psa (kg)
ProMeris Duo ProMeris Duo ProMeris Duo ProMeris Duo ProMeris Duo
ProMeris Duo za majhne pse
for Small Dogs Medium Sized Dogs for Medium/ Large Sized Dogs for Large Dogs for Extra Large Dogs
ProMeris Duo za srednje pse
0.67 1.
1, 33
33 5.33 6.66
3, 33 5, 33 6, 66
For dogs more than 50 kg, use a combination of two pipettes that most closely matches the body weight.
Pri psih težjih od 50 kg uporabite kombinacijo dveh merilnih kapalk, ki najbolj ustrezata njihovi telesni masi.
Hold the pipette upright, bend the tip of the pipette to break the tip along the scored line.
Držite merilno kapalko pokonci, ter upognite konico tako, da se le ta zlomi po zarezani črti.
Part the hair and apply the contents of the pipette to a single spot on the skin of the dog at the base of the skull.
4/ 38 Razprite dlako in nanesite vsebino pipete na eno mesto kože vratu na zatilju glave psa.
Do not apply the veterinary medicinal product to the surface of the dog’ s hair coat.
Zdravila ne nanašajte na površino dlake.
For optimal control of flea and/ or tick infestation the product should be administered at monthly intervals throughout the flea and/ or tick season, or the treatment schedule can be based on the local epidemiological situation.
Za optimalno kontrolo bolhavosti in/ ali klopavosti lahko med sezono bolh in/ ali klopov zdravilo nanašate v mesečnih intervalih, lahko pa načrt zdravljenja temelji na lokalni epidemiološki situaciji.
Most lice are killed within 7 days.
Večino uši pobije v 7 dnevih.
The veterinary medicinal product will prevent flea infestation for up to 6 weeks and tick infestation for 4 weeks following a single administration.
Zdravilo po enkratni aplikaciji ščiti pred bolhami do 6 tednov in pred klopi do 4 tedne.
5/ 39 4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
4. 10 Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi), če je potrebno
No adverse effects were observed in healthy dogs and puppies aged 8 weeks and older treated 7 times at two-week intervals with 3-5 times the recommended dose.
Pri zdravih psih in mladičkih starih 8 tednov ali več zdravljenih 7- krat v dvotedenskih intervalih s 3 – 5- kratnim priporočenim odmerkom ni bilo opaziti neželenih stranskih učinkov.
The risk of experiencing adverse effects may however increase when overdosing, so animals should always be treated with the correct pipette size according to body weight.
Vendar pa se tveganje za pojav neželenih stranskih učinkov pri prevelikem odmerjanju poveča, zato je treba živali vedno zdraviti z ustrezno velikostjo pipete glede na njihovo telesno maso.
Known side-effects of amitraz and metabolites are sedation, lethargy, CNS depression, hyperglycaemia, bradycardia and slow, shallow breathing.
Znani neželeni stranski učinki amitraza in metabolitov so sedacija, letargija, depresija CŽS, hiperglikemija, bradikardija in počasno, plitko dihanje.
Most of these signs are due to alpha-2- adreno-receptor agonist effects.
Večina the znakov je posledica alfa- 2- adreno - receptor agonističnih učinkov.
If symptoms are severe or persist the alpha-2-adreno-receptor antagonist atipamezole hydrochloride may be used at a dose of 0.2 mg/ kg bodyweight by intramuscular injection to reverse these side- effects.
Če so simptomi resni ali trajajo dalj časa, se lahko uporabi antagonist alfa- 2- adreno- receptorjev atipamezol hidroklorid v odmerku 0, 2 mg/ kg telesne mase intramuskularno, da neželeni učinki izginejo.
5.
5/ 38 5.
ATC Vet Code QP 53AD51
Oznaka ATC vet QP 53AD51
After topical administration at a single site at the base of the skull, both metaflumizone and amitraz levels in plasma were too low to allow the calculation of standard pharmacokinetic parameters.
Po topikalnem dajanju ne eno mesto na zatilju so bili nivoji metaflumizona in amitraza v plazmi prenizki, da bi omogočali izračun standardnih farmakokinetičnih parametrov.
See section 6.6
Glej poglavje 6. 6.
N, N-Diethyl-m-toluamide 1-Methoxy-2-propyl-acetate Dimethyl sulfoxide 1, 8-Cineole Gamma-hexalactone
N, N- dietil- m- toluamid 1- metoksi- 2- propil- acetat Dimetilsulfoksid 1, 8- Cineol Gama- heksalakton
Shelf life of the veterinary medicinal product as package for sale:
Rok uporabnosti zdravila v pakiranju za prodajo:
Do not store above 25 °C
Ne shranjujte pri temperaturi nad 25ºC.
6.5 Nature and composition of immediate packaging
6/ 38 6. 5 Vrsta ovojnine in vsebina
All blisters in a box are the same size.
Vsi blistri v škatlici so enake velikosti.
Box of 1 or 2 blister card of 3 x 0.67 ml pipettes Box of 1 or 2 blister card of 3 x 1.33 ml pipette Box of 1 or 2 blister card of 3 x 3.33 ml pipettes Box of 1 or 2 blister card of 3 x 5.33 ml pipettes Box of 1 or 2 blister card of 3 x 6.66 ml pipettes
Škatla z 1 ali 2 blistroma s 3 x 0, 67 ml merilnimi kapalkami Škatla z 1 ali 2 blistroma s 3 x 1, 33 ml merilnimi kapalkami Škatla z 1 ali 2 blistroma s 3 x 3, 33 ml merilnimi kapalkami Škatla z 1 ali 2 blistroma s 3 x 5, 33 ml merilnimi kapalkami Škatla z 1 ali 2 blistroma s 3 x 6, 66 ml merilnimi kapalkami
The veterinary medicinal product should not enter watercourses, as this may be dangerous for fish and other aquatic organisms.
Zdravilo za uporabo v veterinarski medicini ne sme priti v vodotoke, ker je lahko nevareno za ribe in druge vodne organizme.
Fort Dodge Animal Health Holland C. J. van Houtenlaan 36 1381 CP Weesp, The Netherlands
Fort Dodge Animal Health Holland C. J. van Houtenlaan 36 1381 CP Weesp, Nizozemska
8/ 39 ANNEX II
7/ 38 DODATEK II
9/ 39 A.
8/ 38 A.
Via Franco Gorgone 95030 Catania Italy
Via Franco Gorgone 95030 Catania Italija
10/ 39 ANNEX III
9/ 38 DODATEK III
11/ 39 A.
10/ 38 A.
12/ 39 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
11/ 38 PODATKI NA ZUNANJI OVOJNINI
ProMeris Duo 100.5 mg + 100.5 mg Spot-on for small dogs {≤ to 5 kg}
ProMeris Duo 100, 5 mg + 100, 5 mg Spot- on za majhne pse{ ≤ 5 kg}
Each 0.67 ml pipette delivers:
Vsaka 0, 67 ml merilna kapalka vsebuje:
100.5 mg metaflumizone and 100.5 mg amitraz
100, 5 mg metaflumizona in 100, 5 mg amitraza
Box of 1 blister card of 3 x 0.67 ml pipettes Box of 2 blister cards of 3 x 0.67 ml pipettes
Škatla z 1 blistrom s 3 x 0, 67 ml merilnimi kapalkami Škatla z 2 blistroma s 3 x 0, 67 ml merilnimi kapalkami
For dogs over 8 weeks of age.
Za pse starejše od 8 tednov.
13/ 39 9.
12/ 38 9.
Do not administer to puppies under 8 weeks of age.
Ne dajati psom mlajšim od 8 tednov.
For further information see package leaflet.
Za nadaljnje informacije glej navodilo za uporabo.
EXP {month/ year}
EXP {month/ year}
Do not store above 25°C
Ne shranjujte pri temperaturi nad 25ºC
Marketing authorisation holder Fort Dodge Animal Health C. J. van Houtenlaan 36 1381 CP Weesp The Netherlands
Imetnik dovoljenja za promet Fort Dodge Animal Health C. J. van Houtenlaan 36 1381 CP Weesp Nizozemska
EU/ 2/ 06/ 065/ 001 – 1 blister card of 3 pipettes of 0.67ml EU/ 2/ 06/ 065/ 002 – 2 blister cards of 3 pipettes of 0.67ml
EU/ 2/ 06/ 065/ 001 – 1 blister s 3 merilnimi kapalkami po 0, 67ml EU/ 2/ 06/ 065/ 002 – 2 blistra s 3 merilnimi kapalkami of 0, 67ml
14/ 39 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
13/ 38 PODATKI NA ZUNANJI OVOJNINI
ProMeris Duo 199.5 mg + 199.5 mg Spot-on for medium sized dogs {5.1 – 10.0 kg}
ProMeris Duo 199, 5 mg + 199, 5 mg Spot- on za srednje pse {5, 1 – 10, 0 kg}
Each 1.33 ml pipette delivers:
Vsaka 1, 33 ml merilna kapalka vsebuje:
199.5 mg metaflumizone and 199.5 mg amitraz
199, 5 mg metaflumizona in 199, 5 mg amitraza
Box of 1 blister card of 3 x 1.33 ml pipettes Box of 2 blister cards of 3 x 1.33 ml pipettes
Škatla z 1 blistrom s 3 x 1, 33 ml merilnimi kapalkami Škatla z 2 blistroma s 3 x 1, 33 ml merilnimi kapalkami
15/ 39 10.
14/ 38 10.
EU/ 2/ 06/ 065/ 003 – 1 blister card of 3 pipettes of 1.33ml EU/ 2/ 06/ 065/ 004 – 2 blister cards of 3 pipettes of 1.33ml
EU/ 2/ 06/ 065/ 003 – 1 blister s 3 merilnimi kapalkami po 1, 33ml EU/ 2/ 06/ 065/ 004 – 2 blistra s 3 merilnimi kapalkami po 1, 33ml
16/ 39 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
15/ 38 PODATKI NA ZUNANJI OVOJNINI
ProMeris Duo 499.5 mg + 499.5 mg Spot-on for medium/ large sized dogs {10.1 – 25.0 kg}
ProMeris Duo 499, 5 mg + 499, 5 mg Spot- on za srednje/ velike pse {10, 1 – 25, 0 kg}
Each 3.33 ml pipette delivers:
Vsaka 3, 33 ml merilna kapalka vsebuje:
499.5 mg metaflumizone and 499.5 mg amitraz
499, 5 mg metaflumizona in 499, 5 mg amitraza
Box of 1 blister card of 3 x 3.33 ml pipettes Box of 2 blister cards of 3 x 3.33 ml pipettes
Škatla z 1 blistrom s 3 x 3, 33 ml merilnimi kapalkami Škatla z 2 blistroma s 3 x 3, 33 ml merilnimi kapalkami
17/ 39 9.
16/ 38 9.
Do not administer to puppies under 8 weeks of age.
Ne dajati psičkom mlajšim od 8 tednov.
EU/ 2/ 06/ 065/ 005 – 1 blister card of 3 pipettes of 3.33 ml EU/ 2/ 06/ 065/ 006 – 2 blister cards of 3 pipettes of 3.33 ml
EU/ 2/ 06/ 065/ 005 – 1 blister s 3 merilnimi kapalkami po 3, 33 ml EU/ 2/ 06/ 065/ 006 – 2 blistra s 3 merilnimi kapalkami po 3, 33 ml
18/ 39 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
17/ 38 PODATKI NA ZUNANJI OVOJNINI
ProMeris Duo 799.5 mg + 799.5 mg Spot-on for large dogs {25.1 – 40.0 kg}
ProMeris Duo 799, 5 mg + 799, 5 mg Spot- on za velike pse {25, 1 – 40, 0 kg}
Each 5.33 ml pipette delivers:
Vsaka 5, 33 ml merilna kapalka vsebuje:
799.5 mg metaflumizone and 799.5 mg amitraz
799, 5 mg metaflumizona in 799, 5 mg amitraza
Box of 1 blister card of 3 x 5.33 ml pipettes Box of 2 blister cards of 3 x 5.33 ml pipettes
Škatla z 1 blistrom s 3 x 5, 33 ml merilnimi kapalkami Škatla z 2 blistroma s 3 x 5, 33 ml merilnimi kapalkami
19/ 39 9.
18/ 38 9.
EU/ 2/ 06/ 065/ 007 – 1 blister card of 3 pipettes of 5.33 ml EU/ 2/ 06/ 065/ 008 – 2 blister cards of 3 pipettes of 5.33 ml
EU/ 2/ 06/ 065/ 007 – 1 blister s 3 merilnimi kapalkami po 5, 33 ml EU/ 2/ 06/ 065/ 008 – 2 blistra s 3 merilnimi kapalkami po 5, 33 ml
20/ 39 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
19/ 38 PODATKI NA ZUNANJI OVOJNINI
ProMeris Duo 999 mg + 999 mg Spot-on for extra large dogs {40.1 – 50.0 kg}
ProMeris Duo 999 mg + 999 mg Spot- on za zelo velike pse {40, 1 – 50, 0 kg}
Each 6.66 ml pipette delivers:
Vsaka 6, 66 ml merilna kapalka vsebuje:
Box of 1 blister card of 3 x 6.66 ml pipettes Box of 2 blister cards of 3 x 6.66 ml pipettes
Škatla z 1 blistrom s 3 x 6, 66 ml merilnimi kapalkami Škatla z 2 blistroma s 3 x 6, 66 ml merilnimi kapalkami
21/ 39 9.
20/ 38 9.
EU/ 2/ 06/ 065/ 009 – 1 blister card of 3 pipettes of 6.66 ml EU/ 2/ 06/ 065/ 010 – 2 blister cards of 3 pipettes of 6.66 ml
EU/ 2/ 06/ 065/ 009 – 1 blister s 3 merilnimi kapalkami po 6, 66 ml EU/ 2/ 06/ 065/ 010 – 2 blistra s 3 merilnimi kapalkami po 6, 66 ml
22/ 39 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
21/ 38 PODATKI, KI OVOJNINAH
FOIL 0.67 ml
FOLIJA 0, 67 ml
ProMeris Duo 100.5 mg + 100.5 mg Spot-on for small dogs {≤ to 5 kg}
ProMeris Duo 100, 5 mg + 100, 5 mg Spot- on za majhne pse{ ≤ to 5 kg}
Metaflumizone 100.5 mg and amitraz 100.5 mg
Metaflumizon 100, 5 mg in amitraz 100, 5 mg
Spot-on use
Samo za zunanjo uporabo
23/ 39 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
22/ 38 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
FOIL 1.33 ml
FOLIJA 1, 33 ml
ProMeris Duo 199.5 mg + 199.5 mg Spot-on for medium sized dogs {5.1-10.0 kg}
ProMeris Duo 199, 5 mg + 199, 5 mg Spot- on za srednje pse {5, 1- 10, 0 kg}
Metaflumizone 199.5 mg and amitraz 199.5 mg
Metaflumizon 199, 5 mg in amitraz 199, 5 mg
24/ 39 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
23/ 38 PODATKI, KI OVOJNINAH
FOIL 3.33 ml
FOLIJA 3, 33 ml
ProMeris Duo 499.5 mg + 499.5 mg Spot-on for medium/ large sized dogs {10.1– 25.0 kg}
ProMeris Duo 499, 5 mg + 499, 5 mg Spot- on za srednje/ velike pse {10, 1– 25, 0 kg}
Metaflumizone 499.5 mg and amitraz 499.5 mg
Metaflumizon 499, 5 mg in amitraz 499, 5 mg
25/ 39 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
24/ 38 PODATKI, KI OVOJNINAH
FOIL 5.33 ml
FOLIJA 5, 33 ml
Metaflumizone 799.5 mg and amitraz 799.5 mg
Metaflumizon 799, 5 mg in amitraz 799, 5 mg
26/ 39 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
25/ 38 PODATKI, KI OVOJNINAH
FOIL 6.66 ml
FOLIJA 6,. 66 ml
Metaflumizone 999 mg and amitraz 999 mg
Metaflumizon 999 mg in amitraz 999 mg
27/ 39 MINIMUM PARTICULARS TO APPEAR ON PIPETTES
26/ 38 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MERILNIH KAPALKAH
EXP {month/ year} >
EXP {month/ year} >
LOT {number}
LOT {number}
28/ 39 MINIMUM PARTICULARS TO APPEAR ON PIPETTES
27/ 38 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MERILNIH KAPALKAH
PrMeris Duo M
PrMeris Duo M
29/ 39 MINIMUM PARTICULARS TO APPEAR ON PIPETTES
28/ 38 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MERILNIH KAPALKAH
for medium/ large sized dogs
za srednje/ velike pse
30/ 39 MINIMUM PARTICULARS TO APPEAR ON PIPETTES
29/ 38 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MERILNIH KAPALKAH
31/ 39 MINIMUM PARTICULARS TO APPEAR ON PIPETTES
30/ 38 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MERILNIH KAPALKAH
32/ 39 B.
31/ 38 B.
33/ 39 PACKAGE LEAFLET
32/ 38 NAVODILO ZA UPORABO
ProMeris Duo 100.5 mg + 100.5 mg Spot-on for small dogs ProMeris Duo 199.5 mg + 199.5 mg Spot-on for medium sized dogs ProMeris Duo 499.5 mg + 499.5 mg Spot-on for medium/ large sized dogs ProMeris Duo 799.5 mg + 799.5 mg Spot-on for large dogs ProMeris Duo 999 mg + 999mg Spot-on for extra large dogs
ProMeris Duo Spot- on za pse
Marketing authorisation holder Fort Dodge Animal Health C. J. van Houtenlaan 36 1381 CP Weesp The Netherlands
Imetnik dovoljenja za promet z zdravilom Fort Dodge Animal Health C. J. van Houtenlaan 36 1381 CP Weesp Nizozemska
Manufacturer for the batch release Wyeth Lederle Italia S. p. A.
Izdelovalec, odgovoren za sproščanje serije Wyeth Lederle Italia S. p. A.
18, Via Franco Gorgone 95030 Catania Italy
18, Via Franco Gorgone 95030 Catania Italija
100.5
ProMeris Duo Spot- on za pse za majhne pse (≤ 5 kg)
ProMeris Duo Spot-on for Medium Sized Dogs - (5.1 – 10.0 kg)
Volumen (ml) 0, 67
199.5
Metaflumizon (mg) 100, 5
199.5
Amitraz (mg) 100, 5
ProMeris Duo Spot-on for Medium/ Large Sized Dogs (10.1 – 25.0 kg)
za srednje pse - (5, 1 – 10, 0 kg) za srednje/ velike pse (10, 1 – 25, 0 kg) za velike pse (25, 1 – 40, 0 kg) za zelo velike pse (40, 1 – 50, 0 kg)
ProMeris Duo Spot-on for Large Dogs (25.1 – 40.0 kg)
1, 33 3, 33 5, 33 6, 66
799.5
199, 5 499, 5 799, 5 999
5.
33/ 38 5.
ADVERSE REACTION
NEŽELENI UČINKI
Most of these signs are due to alpha-2-adreno-receptor agonist effects.
Večina teh znakov je posledica alfa- 2- adreno- receptor agonističnih učinkov.
If symptoms are severe or persist the alpha-2-adreno-receptor antagonist atipamezole hydrochloride may be used at a dose of 0.2 mg/ kg bodyweight by intramuscular injection to reverse these side-effects.
Če so simptomi resni ali vztrajajo, se lahko uporabi antagonist alfa- 2- adreno- receptorjev atipamezol hidroklorid v odmerku 0, 2 mg/ kg telesne mase intramuskularno, da neželeni učinki izginejo.
This is normal and will generally resolve within a few days after administration, though may persist longer on rare occasions.
Te spremembe ne vplivajo na varnost ali učinkovitost zdravila.
These changes do not affect the safety or efficacy of the veterinary medicinal product.
Če opazite kakršne koli resne stranske učinke ali druge učinke, ki niso omenjeni v teh navodilih za uporabo, obvestite svojega veterinarja.
The recommended minimum dose is 20 mg/ kg bodyweight for each of metaflumizone and amitraz, equivalent to 0.133ml/ kg bodyweight.
Priporočen minimalni odmerek za oba metaflumizon in amitraz je 20 mg/ kg telesne mase, kar ustreza 0, 133 ml/ kg telesne mase.
ProMeris Duo
ProMeris Duo za majhne pse
ProMeris Duo
ProMeris Duo za srednje pse
ProMeris Duo Spot-on for Medium/ Large Sized Dogs
ProMeris Duo za srednje/ velike pse ProMeris Duo za velike pse ProMeris Duo za zelo velike pse
For dogs more than 50 kg, use a combination of two pipettes that most closely matches the body weight.
34/ 38 Pri psih težjih od 50 kg uporabite kombinacijo dveh merilnih kapalk, ki najbolj ustrezata njihovi telesni masi.
Do not apply the medicine to the surface of the dog’ s hair coat.
Zdravila ne nanašajte na površino dlake.
For optimal control of flea and/ or tick infestation the veterinary medicinal product should be administered at monthly intervals throughout the flea and/ or tick season, or the treatment schedule can be based on the local epidemiological situation.
Za optimalno kontrolo bolhavosti in/ ali klopavosti lahko med sezono bolh in/ ali klopov zdravilo nanašate v mesečnih intervalih, lahko pa načrt zdravljenja temelji na lokalni epidemiološki situaciji.
36/ 39 For treatment of demodicosis, the product should be administered at monthly intervals until clinical signs resolve.
Za zdravljenje demodikoze dajajte zdravilo v mesečnih intervalih dokler klinični znaki ne izginejo.
The veterinary medicinal product remains effective if the animal becomes wet.
35/ 38 Zdravilo učinkuje tudi, če se žival zmoči.
However, prolonged, intense exposure to water should be avoided.
Vendar pa se je treba izogniti daljši, močni izpostavitvi vodi.
Do not store above 25 °C.
Ne shranjujte pri temperaturi nad 25ºC.
Do not use after the expiry date stated on the carton after “ EXP”.
Zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na ovojnini po “ EXP ”.
Stored pipettes must be kept in the intact foil package.
Shranjene pipete je treba hraniti v nepoškodovanem folijastem pakiranju.
37/ 39 Amitraz is a monoamine oxidase inhibitor (MOAI); therefore, people taking MOAI-containing medication should take particular care when handling this product.
Amitraz je inhibitor monoamin oksidaze (MOAI); zato morajo ljudje, ki delajo z zdravilom, ravnati pazljivo.
13.
36/ 38 13.
38/ 39 België/ Belgique/ Belgien:
37/ 38 België/ Belgique/ Belgien:
Magyarország Malta Nederland Norge Österreich Polska Portugal România Slovenija Slovenská republika Suomi/ Finland Sverige United Kingdom
Magyarország Malta Nederland Norge Österreich Polska Portugal România Slovenija Slovenská republika Suomi/ Finland Sverige United Kingdom United Kingdom
ScanVet Eläinlääkkeet Oy Ceva Vetpharma AB Fort Dodge Animal Health Limited
ScanVet Eläinlääkkeet Oy Ceva Vetpharma AB Fort Dodge Animal Health Limited Fort Dodge Animal Health Limited
0800 4555554 Tlf: +47 22 76 72 50 Tel: + 49 2405 454 100 Tel.: +48 61 426 49 20 Tel: + 34 91 598 1336 Tel.: +40 21 300 17 80 Tel: +386 1 2800672 Tel: + 420 311 545 011 Puh/ Tel: + 358 (0)3 630 3100 Tel: + 46 (0)46 12 81 00 Tel: + 44 (0)1489 781 711
0800 4555554 Tlf: +47 22 76 72 50 Tel: + 49 2405 454 100 Tel.: +48 61 426 49 20 Tel: + 34 91 598 1336 Tel.: +40 21 300 17 80 Tel: +386 1 2800672 Tel: + 420 311 545 011 Puh/ Tel: + 358 (0) 3 630 3100 Tel: + 46 (0) 46 12 81 00 Tel: + 44 (0) 1489 781 711 Tel: + 44 (0) 1489 781 711
39/ 39
38/ 38
EMEA/ V/ C/ 107 EMEA/ CVMP/ 431317/ 2006
EMEA/ V/ C/ 107 EMEA/ CVMP/ 13187/ 2007
ProMeris is an “ ectoparasiticide”, this means that it will kill parasites that live on the skin or in the fur of animals, such as fleas and ticks.
ProMeris je “ ektoparaziticid ”, to pomeni, da uničuje zajedalce, ki živijo na koži ali v dlaki živali, kot so denimo bolhe in klopi.
It can also be used as part of a treatment strategy for the control of Flea Allergy Dermatitis, an allergic reaction of cats to flea bites.
Lahko se uporablja tudi kot del strategije zdravljenja za obvladovanje alergijskega dermatitisa, ki ga povzročajo bolhe, t. j. alergijske reakcije mačk na ugrize bolh.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 47 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2006 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged The field trial was conducted in cats at 24 veterinary practices of different geographic regions in Germany and France.
Predloženi so bili podatki o farmacevtski kakovosti, varnosti zdravila za mačke ter njegovi varnosti za ljudi (za ljudi, ki pridejo v stik z zdravilom) in okolje.
Other information about ProMeris:
2/ 3 ©EMEA 2006 Druge informacije o zdravilu ProMeris:
The European Commission granted a marketing authorisation valid throughout the European Union, for ProMeris Duo to Fort Dodge Animal Health on 19.12.2006..
Evropska komisija je dovoljenje za promet z zdravilom ProMeris Duo, veljavno po vsej Evropski uniji, odobrila družbi Fort Dodge Animal Health dne 19. 12. 2006.
This summary was last updated on 19.12.2006.
Ta povzetek je bil nazadnje posodobljen 19. 12. 2006.
Target Route of species administration
Poti dajanja
Package size Withdrawal Period
živalske vrste
2 blister cards Not of 3 pipettes applicable
2 blistra s 3 pipetami
ProMeris 160 mg Spot-on solution for small cats ProMeris 320 mg Spot-on solution for large cats
ProMeris 160 mg Spot- on raztopina za majhne mačke ProMeris 320 mg Spot- on raztopina za velike mačke
Active substances Each ml contains 200 mg metaflumizone.
Zdravilne učinkovine 1 ml vsebuje 200 mg metaflumizona.
Each unit dose (pipette) of ProMeris delivers:
Vsak odmerek (merilna kapalka) ProMeris- a vsebuje:
(ml)
Volumen (ml)
ProMeris for Small Cats (≤ 4 kg)
mačke (≤ 4 kg) ProMeris za velike mačke
qs to 100 ml
do 100 ml
Spot-on solution A clear, yellow to amber solution
Kožne kapljice, raztopina Bistra, rumena do jantarna raztopina.
Cats over 8 weeks of age.
Mačke starejše od 8 tednov.
Do not administer to kittens under 8 weeks of age.
Ne dajajte mačkam mlajšim od 8 tednov.
Avoid contact with the eyes of the cat and avoid oral ingestion by the animal.
Izogibajte se, da bi zdravilo prišlo v stik z očmi mačke, ali da bi ga žival pojedla..
In sick or debilitated animals, use only according to the benefit/ risk assessment.
Pri bolnih ali izčrpanih živalih uporabite zdravilo le v skladu z oceno razmerja koristi/ tveganja odgovornega veterinarja.