natgillin/translations-raw huggingface dataset:
EU/2/05/054/006 2 pipettes EU/2/05/054/007 4 pipettes
EU/ 2/ 05/ 054/ 006 2 pipeti EU/ 2/ 05/ 054/ 007 4 pipete
27 PARTICULARS TO APPEAR ON THE OUTER PACKAGE Profender spot-on solution for medium cats Outer carton, pack size of 12 (20, 40 or 80) pipettes
26 PODATKI NA ZUNANJI OVOJNINI Profender, kožni nanos, raztopina za srednje velike mačke Škatla z 12 (20, 40 ali 80) pipetami
12 pipettes 20 pipettes 40 pipettes 80 pipettes
12 pipet 20 pipet 40 pipet 80 pipet
EU/2/05/054/008 12 pipettes EU/2/05/054/009 20 pipettes EU/2/05/054/010 40 pipettes EU/2/05/054/011 80 pipettes
EU/ 2/ 05/ 054/ 008 12 pipet EU/ 2/ 05/ 054/ 009 20 pipet EU/ 2/ 05/ 054/ 010 40 pipet EU/ 2/ 05/ 054/ 011 80 pipet
30 PARTICULARS TO APPEAR ON THE OUTER PACKAGE Profender spot-on solution for large cats Outer carton, pack size of 2 (or 4) pipettes
28 PODATKI NA ZUNANJI OVOJNINI Profender, kožni nanos, raztopina za velike mačke Škatla z 2 (ali 4) pipetami
Profender spot-on solution for large cats
Profender, kožni nanos, raztopina za velike mačke
Each 1.12 ml pipette contains:
Ena 1, 12 ml pipeta vsebuje:
24 mg emodepside, 96 mg praziquantel 5.4 mg/ml butylhydroxyanisole (E320; as antioxidant)
24, 0 mg emodepsida, 96, 0 mg prazikvantela 5, 4 mg/ ml butilhidroksianizola (E 320 kot antioksidant)
EU/2/05/054/012 2 pipettes EU/2/05/054/013 4 pipettes
EU/ 2/ 05/ 054/ 012 2 pipeti EU/ 2/ 05/ 054/ 013 4 pipete
32 PARTICULARS TO APPEAR ON THE OUTER PACKAGE Profender spot-on solution for large cats Outer carton, pack size of 12 (20 or 40) pipettes
30 PODATKI NA ZUNANJI OVOJNINI Profender, kožni nanos, raztopina za velike mačke Škatla z 12 (20 ali 40) pipetami
EU/2/05/054/014 12 pipettes EU/2/05/054/015 20 pipettes EU/2/05/054/016 40 pipettes
EU/ 2/ 05/ 054/ 014 12 pipet EU/ 2/ 05/ 054/ 015 20 pipet EU/ 2/ 05/ 054/ 016 40 pipet
34 PARTICULARS TO APPEAR ON THE OUTER PACKAGE Profender spot-on solution for cats Outer carton, Multi-dose bottle
32 PODATKI NA ZUNANJI OVOJNINI Profender, kožni nanos, raztopina za mačke Škatla s steklenico z več odmerki
21.4 mg/ml emodepside, 85.8 mg/ml praziquantel 5.4 mg/ml butylhydroxyanisole (E320; as antioxidant)
21, 4 mg/ ml emodepsida, 85, 8 mg/ ml prazikvantela 5, 4 mg/ ml butilhidroksianizola (E 320 kot antioksidant)
3 months
EXP {mesec/ leto} Rok uporabnosti po prvem odpiranju vsebnika je 3 mesece.
36 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Profender spot-on solution for small cats Pipette label
34 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH Profender, kožni nanos, raztopina za majhne mačke Etiketa na pipeti
Profender for cats (≥ 0.5 – 2.5 kg)
Profender za mačke (≥ 0, 5 – 2, 5 kg)
EXP {month/year}
EXP{ mesec/ leto}
37 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Profender spot-on solution for medium cats Pipette label
35 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH Profender, kožni nanos, raztopina za srednje velike mačke Etiketa na pipeti
Profender for cats (> 2.5 –5 kg)
Profender za mačke (> 2, 5 – 5 kg)
38 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Profender spot-on solution for large cats Pipette label
36 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH Profender, kožni nanos, raztopina za velike mačke Etiketa na pipeti
Profender for cats (> 5 – 8 kg)
Profender za mačke (> 5 - 8 kg)
39 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Profender spot-on solution for cats Bottle label
37 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH Profender, kožni nanos, raztopina za mačke Etiketa na steklenici
21.4 mg/ml emodepside, 85.8 mg/ml praziquantel
21, 4 mg/ ml emodepsida, 85, 8 mg/ ml prazikvantela.
EXP {month/year}
DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA
Once opened, use by…………….{leave space for the date to be inserted}.
EXP{ mesec/ leto} Rok uporabnosti po prvem odpiranju vsebnika je …….
40 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Profender spot-on solution for small cats blister
38 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU Profender, kožni nanos, raztopina za majhne mačke Pretisni omot
Profender for small cats (≥0.5 - 2.5 kg)
Profender za majhne mačke (≥ 0, 5 – 2, 5kg)
{month/year}
{mecec/ leto}
41 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Profender spot-on solution for medium cats blister
39 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU Profender, kožni nanos, raztopina za srednje velike mačke Pretisni omot
Profender for medium cats (> 2.5 - 5 kg)
Profender za srednje velike mačke (> 2, 5 – 5 kg)
42 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Profender spot-on solution for large cats blister
40 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU Profender, kožni nanos, raztopina za velike mačke Pretisni omot
Profender for large cats (> 5 - 8 kg)
Profender za velike mačke (> 5 - 8 kg)
43 PARTICULARS TO APPEAR ON THE OUTER PACKAGE Profender 15 mg / 3 mg Tablets for Small Dogs Outer carton, pack size of 2 (or 4) tablets
41 PODATKI NA ZUNANJI OVOJNINI Profender 15 mg/ 3 mg tablete za majhne pse Zunanji karton z 2 (ali 4) tabletami
Profender 15 mg / 3 mg modified-release Tablets for Small Dogs
Profender 15 mg/ 3 mg tablete s prirejenim sproščanjem za majhne pse
Dewormer against roundworms and tapeworms.
Zdravilo za odpravljanje glist in trakulj.
Read package leaflet.
Odstranjevanje neporabljenega zdravila: preberite navodilo za uporabo.
EU/2/05/054/018 2 tablets EU/2/05/054/019 4 tablets
EU/ 2/ 05/ 054/ 018 za 2 tableti EU/ 2/ 05/ 054/ 019 za 4 tablete
45 PARTICULARS TO APPEAR ON THE OUTER PACKAGE Profender 15 mg / 3 mg Tablets for Small Dogs Outer carton, pack size of 10 (24 or 50) tablets
43 PODATKI NA ZUNANJI OVOJNINI Profender 15 mg/ 3 mg tablete za majhne pse Zunanji karton z 10 (24 ali 50) tabletami
10 tablets 24 tablets 50 tablets
10 tablet 24 tablet 50 tablet
EU/2/05/054/020 10 tablets EU/2/05/054/021 24 tablets EU/2/05/054/022 50 tablets
EU/ 2/ 05/ 054/ 020 za 10 tablet EU/ 2/ 05/ 054/ 021 za 24 tablet EU/ 2/ 05/ 054/ 022 za 50 tablet
47 PARTICULARS TO APPEAR ON THE OUTER PACKAGE Profender 50 mg / 10 mg Tablets for Medium Dogs Outer carton, pack size of 2 (or 4) tablets
45 PODATKI NA ZUNANJI OVOJNINI Profender 50 mg/ 10 mg tablete za srednje velike pse Zunanji karton z 2 (ali 4) tabletami
Profender 50 mg / 10 mg modified-release Tablets for Medium Dogs
Profender 50 mg/ 10 mg tablete s prirejenim sproščanjem za srednje velike pse
EU/2/05/054/023 2 tablets EU/2/05/054/024 4 tablets
EU/ 2/ 05/ 054/ 023 za 2 tableti EU/ 2/ 05/ 054/ 024 za 4 tablete
49 PARTICULARS TO APPEAR ON THE OUTER PACKAGE Profender 50 mg / 10 mg Tablets for Medium Dogs Outer carton, pack size of 6 (24 or 102) tablets
47 PODATKI NA ZUNANJI OVOJNINI Profender 50 mg/ 10 mg tablete za srednje velike pse Zunanji karton z 6 (24 ali 102) tabletami
6 tablets 24 tablets 102 tablets
6 tablet 24 tablet 102 tableti
EU/2/05/054/025 6 tablets EU/2/05/054/026 24 tablets EU/2/05/054/027 102 tablets
EU/ 2/ 05/ 054/ 025 za 6 tablet EU/ 2/ 05/ 054/ 026 za 24 tablet EU/ 2/ 05/ 054/ 027 za 102 tableti
51 PARTICULARS TO APPEAR ON THE OUTER PACKAGE Profender 150 mg / 30 mg Tablets for Large Dogs Outer carton, pack size of 2 tablets
49 PODATKI NA ZUNANJI OVOJNINI Profender 150 mg/ 30 mg tablete za velike pse Zunanji karton z 2 tabletama
Profender 150 mg / 30 mg modified-release Tablets for Large Dogs
Profender 150 mg/ 30 mg tablete s prirejenim sproščanjem za velike pse
EXP {month/year}
50 EXP {mesec/ leto}
EU/2/05/054/028 2 tablets
EU/ 2/ 05/ 054/ 028 za 2 tableti
53 PARTICULARS TO APPEAR ON THE OUTER PACKAGE Profender 150 mg / 30 mg Tablets for Large Dogs Outer carton, pack size of 4 (24 or 52) tablets
51 PODATKI NA ZUNANJI OVOJNINI Profender 150 mg/ 30 mg tablete za velike pse Zunanji karton z 4 (24 ali 52) tabletami
30 mg emodepside, 150 mg Praziquantel.
emodepsid 30 mg, prazikvantel 150 mg
4 tablets 24 tablets 52 tablets
4 tablete 24 tablet 52 tablet
EU/2/05/054/029 4 tablets EU/2/05/054/030 24 tablets EU/2/05/054/031 52 tablets
EU/ 2/ 05/ 054/ 029 za 4 tablete EU/ 2/ 05/ 054/ 030 za 24 tablet EU/ 2/ 05/ 054/ 031 za 52 tablet
55 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Profender 15 mg / 3 mg Tablets for Small Dogs Blister
53 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU Profender 15 mg/ 3 mg tablete za majhne pse Pretisni omot
56 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Profender 50 mg / 10 mg Tablets for Medium Dogs Blister
54 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU Profender 50 mg/ 10 mg tablete za srednje velike pse Pretisni omot
57 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Profender 150 mg / 30 mg Tablets for Large Dogs Blister
55 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU Profender 150 mg/ 30 mg tablete za velike pse Pretisni omot
59 [Single-dose pipettes]
57 [Enoodmerna pipeta]
PACKAGE LEAFLET Profender spot-on solution for small cats Profender spot-on solution for medium cats Profender spot-on solution for large cats
NAVODILO ZA UPORABO Profender, kožni nanos, raztopina za majhne mačke Profender, kožni nanos, raztopina za srednje velike mačke Profender, kožni nanos, raztopina za velike mačke
Profender contains 21.4 mg/ml emodepside and 85.8 mg/ml praziquantel.
Profender vsebuje 21, 4 mg/ ml emodepsida in 85, 8 mg/ ml prazikvantela.
5.4 mg/ml butylhydroxyanisole (E320; as antioxidant)
5, 4 mg/ ml butilhidroksianizol (E 320 kot antioksidant)
Roundworms (Nematodes) Toxocara cati (mature adult, immature adult, L4 and L3) Toxascaris leonina (mature adult, immature adult and L4) Ancylostoma tubaeforme (mature adult, immature adult and L4)
58 Gliste (Nematodi) Toxocara cati (zrele, nezrele oblike, ličinke L4, L3), Toxascaris leonina (zrele, nezrele oblike, ličinke L4), Ancylostoma tubaeforme (zrele, nezrele oblike, ličinke L4).
Tapeworms (Cestodes) Dipylidium caninum (adult) Taenia taeniaeformis (adult) Echinococcus multilocularis (adult)
Trakulje (Cestodi) Dipylidium caninum (zrele oblike), Taenia taeniaeformis (zrele oblike), Echinococcus multilocularis (zrele oblike).
In very rare cases following administration of Profender transient alopecia, pruritus and/or inflammation were observed at the application site.
V posameznih primerih se je po aplikaciji Profenderja na mestu nanosa pojavilo prehodno izpadanje dlak, pruritis in/ ali vnetje.
Body Weight of Cat (kg)
Telesna masa mačke (kg) ≥0, 5 – 2, 5
Pipette size to be used
Vrsta pipete Profender za majhne mačke
Emodepside (mg/kg bw)
Enota (ml) Emodepsid (mg/ kg t. m.) 0, 35 3 - 15
Praziquantel (mg/kg bw)
Prazikvantel (mg/ kg t. m.) 12 - 60
≥0.5 - 2.5 > 2.5 - 5 > 5 - 8
> 2, 5 - 5 > 5 - 8
3 - 15 3-6 3 - 4.8
0, 70 3- 6 1, 12 3 – 4, 8
Hold pipette in upright position, twist and pull off cap and use the opposite end of the cap to break the seal.
Vzemite pipeto iz ovojnine, držite jo navpično, zavrtite in snemite pokrov, obrnite ga in prebodite plastično zaporo na pipeti.
Part the fur on the cat’s neck at the base of the skull until the skin is visible.
59 Mački razmaknite dlako na zatilju, da bo vidna koža.
Do not use after the expiry date stated on the label and carton.
Zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na etiketi in zunanji ovojnini.
62 If the product accidentally gets into eyes, they should be thoroughly flushed with plenty of water.
Če zdravilo pride v stik z očmi, jih temeljito sperite z vodo.
Frequent users of the product (for example, veterinarians, professional cat breeders) should wear disposable gloves when administering the product.
60 Osebe, ki zdravilo pogosto nanašajo (npr. veterinarji, vzreditelji mačk), naj pri nanašanju uporabljajo zaščitne rokavice za enkratno uporabo.
Profender can be used during pregnancy and lactation.
Profender se lahko uporablja v obdobju brejosti in laktacije.
As Echinococcosis is a notifiable disease to the OIE, specific guidelines on the treatment and follow-up, and on the safeguard of persons, need to be obtained from the relevant competent authority.
Ker je treba ehinokokozo obezno prijaviti Mednarodnemu uradu za kužne bolezni, je treba upoštevati smernice za zdravljenje in zaščito ljudi, ki jih izda pristojen organ.
Danmark Bayer A/S, Bayer HealthCare Animal Health Division Nørgaardsvej 32 DK-2800 Kgs.
61 Danmark Bayer A/ S, Bayer HealthCare Animal Health Division Nørgaardsvej 32 DK- 2800 Kgs.
Italia Bayer S.p.A.
62 Italia Bayer S. p. A.
65 [Multi-dose bottle]
63 [Steklenica z več odmerki]
PACKAGE LEAFLET Profender spot-on solution for cats
NAVODILO ZA UPORABO Profender, kožni nanos, raztopina za mačke
Profender contains 21.4 mg/ml emodepside and 85.8 mg/ml praziquantel.
Profender vsebuje 21, 4 mg/ ml emodepsida in 5, 8 mg/ ml prazikvantela.
Roundworms (Nematodes) Toxocara cati (mature adult, immature adult, L4 and L3) Toxascaris leonina (mature adult, immature adult and L4) Ancylostoma tubaeforme (mature adult, immature adult and L4)
Gliste (Nematodi) Toxocara cati (zrele, nezrele oblike, ličinke L4, L3), Toxascaris leonina (zrele, nezrele oblike, ličinke L4), Ancylostoma tubaeforme (zrele, nezrele oblike, ličinke L4).
of Cat (kg) ≥0.5 - 2.5 > 2.5 - 5 > 5 - 8
≥0, 5 – 2, 5
(mg/kg bw) 12 - 60 12 - 24 12 - 19.2
12 – 19, 2
Take a standard disposable 1 ml syringe with luer nozzle and connect it to the adapter (3).
Vzemite običajno 1 ml brizgo z luerjevim nastavkom in jo povežite z nastavkom (3).
67 Application on the base of the skull will minimise the ability of the cat to lick the product off.
Nanos na zatilje preprečuje, da bi mačka zdravilo polizala.
3 months
Rok uporabnosti zdravila po prvem odpiranju vsebnika je 3 mesece.
Profender can be used during pregnancy and lactation.
66 Profender se lahko uporablja v obdobju brejosti in laktacije.
Ελλάδα ALAPIS ABEE GR–19300, Ασπρόπυργος Αττικής, Τ.Θ.
67 Ελλάδα ALAPIS ABEE GR– 19300, Ασπρόπυργος Αττικής, Τ. Θ.
Ireland Bayer Limited, Animal Health Division The Atrium, Blackthorn Road IRL - Dublin 18 Tel: +353 1 2999313
Ireland Bayer Limited, Animal Health Division The Atrium, Blackthorn Road IRL - Dublin Tel: +353 1 2999313
71 PACKAGE LEAFLET Profender Modified-Release Tablets for Dogs
69 NAVODILO ZA UPORABO Profender tablete s prirejenim sproščanjem za pse
Marketing authorisation holder:
Imetnik dovoljenja za promet z zdravilom in izdelovalec:
Profender 15 mg/3 mg modified-release Tablets for Small Dogs Profender 50 mg/10 mg modified-release Tablets for Medium Dogs Profender 150 mg/30 mg modified-release Tablets for Large Dogs
Profender 15 mg/ 3 mg tablete s prirejenim sproščanjem za majhne pse Profender 50 mg/ 10 mg tablete s prirejenim sproščanjem za srednje velike pse Profender 150 mg/ 30 mg tablete s prirejenim sproščanjem za velike pse
Praziquantel / Emodepside
Emodepsid / Prazikvantel
STATEMENT OF THE ACTIVE SUBSTANCES
NAVEDBA ZDRAVILNIH UČINKOVIN IN DRUGIH SESTAVIN
Echinococcus multilocularis (mature adult and immature) Echinococcus granulosus (mature adult and immature)
Echinococcus multilocularis (zrele, nezrele oblike) 70 Echinococcus granulosus (zrele, nezrele oblike)
Profender is to be administered at a minimum dose of 1 mg/kg body weight emodepside and 5 mg/kg body weight praziquantel, according to the following dosage table.
Uporabimo tabelo za odmerjanje.
1 > 1.5> 3> 4.5> 6> 10> 15> 20> 30> 45
1 > 1, 5 > 3 > 4, 5 > 6
1 .5 3 4.5 6 10 15 20 30 45 60
1, 5 3 4, 5 6 10
Do not use after the expiry date stated on the carton or blister.
Zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na ovojnini ali pretisnem omotu.
For example overnight fasting is recommended if the dog is to be treated in the morning.
Priporočamo postenje preko noči, če boste dali tableto psu zjutraj.
The safety of this veterinary medicinal product has not been investigated in pregnant and lactating dogs.
Varnost zdravila v obdobju brejosti in laktacije ni bila raziskana.
Therefore, the veterinary medicinal product should only be used in such animals according to a benefit/risk assessment by the responsible veterinarian.
Pri teh psih zdravilo uporabite samo v primeru, ko je odgovorni veterinar ocenil razmerje korist/ tveganje.
Temporary trembling, incoordination and depression were occasionally observed when the veterinary product was administered at overdoses of up to 5 times the recommended dose.
Pri zaužitju 5- kratnega terapevtskega odmerka se je občasno pojavilo prehodno mišično drgetanje, nekoordiniranost gibov in potrtost.
Co-treatment with other drugs that are P-glycoprotein substrates/inhibitors (for example, ivermectin and other antiparasitic macrocyclic lactones, erythromycin, prednisolone and cyclosporine) could give rise to pharmacokinetic drug interactions.
Sočasno zdravljenje s pripravki, ki so substrati/ inhibitorji P - glikoproteinov (npr. ivermektin in drugi protiparazitarni makrociklični laktoni, eritromicin, prednizolon in ciklosporin), lahko povzroči farmakokinetične interakcije.
ProMeris Duo is an ‘ ectoparasiticide’.
ProMeris Duo je „ ektoparaziticid “.
This means that it will kill parasites that live on or in the skin or in the fur of animals, such as fleas, ticks, lice and Demodex mites (mites that cause demodicosis or ‘ mange’).
To pomeni, da uničuje zajedavce, ki živijo na koži, v njej ali v dlaki živali, kot so denimo bolhe, klopi, uši in garjavci Demodex (iz rodu pršic, ki povzročajo demodikozo, kožno bolezen).
It can also be used as part of a treatment strategy for the control of flea allergy dermatitis, an allergic reaction to flea bites.
Lahko se uporablja tudi kot del strategije zdravljenja za obvladovanje alergijskega dermatitisa, ki ga povzročajo bolhe, t. j. alergijske reakcije na ugrize bolh.
The effectiveness was measured looking at the number of live ticks or number of fleas on the dogs up to two months after application.
Psi različnih pasem, starosti in telesnih mas so
The effectiveness was 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel.
Reproduction is authorised provided the source is acknowledged. measured looking at the clinical signs and the number of Demodex mites in skin scrapings taken every four weeks, for several weeks following monthly administration of the treatment.
Učinkovitost so merili s štetjem živih klopov ali bolh na psih do dveh mesecev po uporabi zdravila.
A further study compared the effectiveness of ProMeris Duo with that of fipronil (another medicine for the treatment of lice).
Psi so bili zdravljeni z zdravilom ProMeris Duo ali s kombinacijo imidaklopridina in moksidektina (drugega zdravila, ki je bilo v EU odobreno za to indikacijo).
The effectiveness was measured by looking at the number of lice on the dogs after treatment.
Učinkovitost so merili s proučevanjem kliničnih znakov in števila garjavcev Demodex v vzorcih kože, ki so bili odvzeti vsake štiri tedne, nekaj tednov po mesečnem zdravljenju.
This medicine is specifically developed for dogs and should not be used in any other animal species.
Zdravilo ProMeris Duo ne sme zaiti v površinske vode, ker je lahko nevarno za vodne organizme.
Avoid touching the skin with the pipette’ s contents.
Pazite, da vsebina kapalke ne pride v stik s kožo.
Why has ProMeris Duo been approved?
Stran 2/ 3 ©EMEA 2009 Zakaj je bilo zdravilo ProMeris Duo odobreno?
The European Commission granted a marketing authorisation valid throughout the European Union for ProMeris Duo to Fort Dodge Animal Health on 19 December 2006.
12.
This summary was last updated on 19 February 2009.
Ta povzetek je bil nazadnje posodobljen 19.
Page 2/ 2 ©EMEA 2009
2009.
100.5 mg metaflumizone and 100.5 mg amitraz
100, 5 mg metaflumizona Kožne kapljice, Psi in 100, 5 mg amitraza raztopina
1 blister card of 3 pipettes
1 blister pipetami
Not applicable
Navedba smiselna
2 blister cards of 3 pipettes
2 blistra pipetami
199.5 mg metaflumizone and 199.5 mg amitraz
199. 5 mg metaflumizona Kožne kapljice, Psi in 199, 5 mg amitraza raztopina
199.5 mg metaflumizone and 199.5 mg amitraz
199, 5 mg metaflumizona Kožne kapljice, Psi in 199, 5 mg amitraza raztopina
499.5 mg metaflumizone and 499.5 mg amitraz
499, 5 mg metaflumizona Kožne kapljice, Psi in 499, 5 mg amitraza raztopina
799.5 mg metaflumizone and 799.5 mg amitraz
799, 5 mg metaflumizona Kožne kapljice, Psi in 799, 5 mg amitraza raztopina
999 mg metaflumizone and 999 mg amitraz
999 mg metaflumizona in Kožne kapljice, Psi 999 mg amitraza raztopina
1/ 39 1.
1/ 38 1.
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 100, 5 mg + 100, 5 mg Spot- on za majhne pse ProMeris Duo 199, 5 mg + 199, 5 mg Spot- on za srednje pse ProMeris Duo 499, 5 mg + 499, 5 mg Spot- on za srednje/ velike pse ProMeris Duo 799, 5 mg + 799, 5 mg Spot- on za velike pse ProMeris Duo 999 mg + 999 mg Spot- on za zelo velike pse
Active substances Each ml contains 150 mg metaflumizone and 150 mg amitraz.
Zdravilne učinkovine 1 ml vsebuje 150 mg metaflumizona in 150 mg amitraza.
ProMeris Duo Spot-on for Dogs
ProMeris Duo Spot- on za pse za majhne pse (≤ 5 kg)
Volume (ml)
Volumen (ml) 0, 67
for Small Dogs (≤ 5 kg) for Medium Sized Dogs - (5.1 – 10.0 kg) for Medium/ Large Sized Dogs (10.1 – 25.0 kg) for Large Dogs (25.1 – 40.0 kg) for Extra Large Dogs (40.1 – 50.0 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)
Spot-on solution A clear, yellow to amber solution
Kožne kapljice, raztopina Bistra, rumena do jantarna raztopina
Dogs over 8 weeks of age
Psi starejši od 8 tednov
Do not administer to puppies under 8 weeks of age.
Ne dajajte psom mlajšim od 8 tednov.
Do not administer to cats Do not administer to sick or debilitated dogs or dogs suffering from heat stress.
Ne dajajte bolnim ali slabotnim psom, ali psom, prizadetim zaradi vročinskega stresa.
2/ 39 4.4 Special warnings
2/ 38 4. 4 Posebna opozorila
Avoid contact with the eyes of the dog and avoid oral ingestion by the dog.
Izogibajte se, da bi zdravilo prišlo v stik z očmi psa in da bi ga pes pojedel.
The veterinary medicinal product remains effective if the animal becomes wet.
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 vode.
If the dog requires shampooing, it is better to do so before applying the veterinary medicinal product.
Če je psa potrebno skopati, je to bolje opraviti pred dajanjem zdravila.
For optimum control of flea problems in a multi-pet household, all pets in the household should be treated with a suitable insecticide.
Za optimalno kontrolo bolhavosti v gospodinjstvu z več živalmi, bi bilo treba vse živali v tem gospodinjstvu tretirati s primernim insekticidom.
It is important to apply the dose to an area where the animal cannot lick it off and to make sure that animals do not lick each other following treatment.
Preprečite medsebojno lizanje zdravljenih živali.
Care should be taken to ensure that the content of the pipette or the applied dose does not come into contact with the eyes or mouth of the recipient and/ or other animals.
Poskrbite, da vsebina merilne kapalke ali nanešen odmerek ne pride v stik z očmi ali usti zdravljene živali in/ ali drugih živali.
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.
To minimise the potential for inhalation, it is recommended that the product is applied in open air or in well ventilated rooms.
Da se zmanjša možnost inhalacije, je priporočljivo zdravilo dajati v odprtem prostoru ali v dobro prezračevanem prostoru..
3/ 39 If ill effects are noted following exposure to the product, seek immediate medical assistance, and show the product packaging to the physician.
V primeru bolezenskih znakov po izpostavitvi zdravilu se takoj posvetujte z zdravnikom in mu pokažite navodila za uporabo ali ovojnino.