natgillin/translations-raw huggingface dataset:
CVMP Guideline on requirements for concurrent administration of immunological veterinary medicinal products (EMEA/CVMP/550/02-FINAL) - http://www.ema.europa.eu/pdfs/vet/iwp/055002en.pdf
CVMP Guideline on requirements for concurrent administration of immunological veterinary medicinal products (EMEA/CVMP/550/02-FINAL) (Smernica CVMP glede zahtev za sočasno uporabo imunoloških zdravil za uporabo v veterinarski medicini) - http://www.ema.europa.eu/pdfs/vet/iwp/055002en.pdf vedno vidni vsi klinični znaki (na živali ne vplivajo drugi dejavniki) tako kot v terenskih študijah.
Product name
Lastniško ime Jakost
Whereas: - the CVMP considered that stability of the mixed product up to 1 hour after mixing as claimed on the Summary of Product Characteristics was supported by the data provided, - the CVMP considered that the safety and efficacy of the mixed vaccine regarding the Mycoplasma hyopneumoniae component were sufficiently supported by the data provided, the CVMP has recommended the granting of the variation of the Marketing Authorisations for Porcilis M Hyo and associated names (see Annex I).
- CVMP meni, da so predloženi podatki zadostno podprli varnost in učinkovitost mešanega cepiva z vidika komponente Mycoplasma hyopneumoniae; je CVMP priporočil odobritev spremembe dovoljenj za promet z zdravilom Porcilis M Hyo in povezanimi imeni (glejte Dodatek I).
No information is available on the safety and efficacy of the use of Porcilis M Hyo mixed with Porcilis PRRS in breeding animals or during pregnancy.
O varnosti in učinkovitosti uporabe Porcilisa M Hyo, pomešanega s cepivom Porcilis PRRS, pri vzrejnih živalih in med brejostjo ni podatkov.
According to the advised vaccination schedule, Porcilis M Hyo and Porcilis PRRS are used simultaneously for the first time at the second administration of Porcilis M Hyo.
Glede na priporočeno shemo cepljenja se zdravili Porcilis M Hyo in Porcilis PRRS uporabljata sočasno od drugega dajanja zdravila Porcilis M Hyo dalje.
- Second vaccination: Porcilis M Hyo mixed with Porcilis PRRS from 4 weeks of age.
- drugo cepljenje: mešanica zdravil Porcilis M Hyo in Porcilis PRRS od starosti 4 tednov dalje.
Belgium Intervet International bv Wim de
Nizozemska Intervet International bv Wim de
It should be borne in mind that PRRS is a multifactorial disease and therefore all clinical signs may not always be seen in laboratory studies (animals kept free from other agents) as in field studies.
Zavedati se je treba, da je prašičji reprodukcijski in respiratorni sindrom (PRRS) multifaktorska bolezen, zato v laboratorijskih študijah niso
CARBAJOSA DE LA SAGRADA
CARBAJOSA DE LA SAGRADA 37188 SALAMANCA Španija
Porcilis PRRS
Porcilis PRRS Porcilis M Hyo
Boxmeer
Ciper
Porcilis M. Hyo, suspension injectable
Porcillis M.Hyo inaktivirani koncentrat celic mikoplazme
The product literature of Porcilis PRRS should also be consulted before administration of the mixed product.
Pred dajanjem mešanega cepiva je treba prebrati informacije o cepivu Porcilis PRRS.
Germany Intervet Deutschland GmbH
Unterschleißheim Nemčija
Porcilis M hyo, suspensão para injecção
PORCILIS Mhyo inaktivirani koncentrat celic mikoplazme
Annex I List of the names, pharmaceutical form, strengths of the medicinal products, route of administration, marketing authorisation holders in the member states
SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVILA, POTI UPORABE ZDRAVILA, IMETNIKOV DOVOLJENJA ZA PROMET Z ZDRAVILOM V DRŽAVAH
Czech Republic
Država članica
(Reference is made to the pictogram of a dog in section 1).
(sklic na piktogram psa v poglavju 1).
Date of first authorisation: 10/12/2019.
Datum pridobitve dovoljenja za promet: 10/12/2019.
2 tubes 10 tubes 20 tubes
2 tubi 10 tub 20 tub
The maximum clinical response may not be seen until 28 days after administration.
Do največjega kliničnega odziva lahko pride šele po 28 dneh po dajanju zdravila.
1 dose (1 ml) contains:
En odmerek (1 ml) vsebuje:
The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
- zelo pogosti (neželeni učinki se pokažejo pri več kot 1 od 10 zdravljenih živali) - pogosti (pri več kot 1, toda manj kot 10 živali od 100 zdravljenih živali) - občasni (pri več kot 1, toda manj kot 10 živali od 1.000 zdravljenih živali) - redki (pri več kot 1, toda manj kot 10 živali od 10.000 zdravljenih živali) - zelo redki (pri manj kot 1 živali od 10.000 zdravljenih živali, vključno s posameznimi primeri)
ATCvet code: QS02CA91
Oznaka ATC vet: QS02CA91
Shake well before use for 5 seconds.
Pred uporabo dobro stresajte 5 sekund.
Shelf life of the veterinary medicinal product as packaged for sale: 18 months
Rok uporabnosti zdravila v pakiranju za prodajo: 18 mesecev
In cases of parasitic otitis, an appropriate acaricidal treatment should be implemented.
V primeru parazitarnega vnetja sluhovoda je treba uvesti ustrezno akaricidno zdravljenje.
EU/2/19/246/001 (2 tubes) EU/2/19/246/002 (10 tubes) EU/2/19/246/003 (20 tubes)
EU/2/19/246/002 (10 tub) EU/2/19/246/003 (20 tub)
Do not use in case of hypersensitivity to the active substances, to other corticosteroids or to any of the excipients.
Ne uporabite v primerih preobčutljivosti na učinkovine, na druge kortikosteroide ali na katero koli pomožno snov.
Like other corticosteroids, it has antiinflammatory and anti-pruritic properties.
Kot ostali kortikosteroidi ima protivnetne in antipruritične lastnosti.
Mometasone furoate is a corticosteroid with high potency.
Mometazonfuroat je kortikosteroid z visoko jakostjo.
May be harmful after ingestion.
Lahko je škodljivo po zaužitju.
Studies to determine the effect on fertility in dogs have not been conducted.
Študije, ki bi pokazale, kakšen je vpliv na plodnost pri psih, niso bile narejene.
Clear, colourless to yellow, slightly viscous liquid.
Bistra, brezbarvna do rumena, rahlo viskozna tekočina.
To avoid this risk for the owners, it is recommended that this veterinary product is administered only by veterinarians or under their close supervision.
Da bi se izognili tveganju za lastnike se priporoča, da zdravilo daje veterinar ali pa pod njegovim neposrednim nadzorom.
The extent of transcutaneous absorption of topical medications is determined by many factors including the integrity of the epidermal barrier.
Obseg perkutane absorpcije topikalnih zdravil določajo številni dejavniki vključno z integriteto epidermalne pregrade.
Whenever possible, the use of the veterinary medicinal product should be based on identification of infecting organisms and susceptibility testing.
Kadarkoli je možno, mora uporaba tega zdravila temeljiti na identifikaciji organizma odgovornega za okužbo in testiranju občutljivosti.
Pack sizes: 2, 10 or 20 tubes.
Pakiranje: 2, 10 ali 20 tub.
The recommended dosage is 1 single-dose container (i.e. 1 ml of solution) per infected ear.
Priporočen odmerek je 1 enoodmerni vsebnik (tj. 1 ml raztopine) v vsako prizadeto uho.
Insert the applicator nozzle into the affected external ear canal and squeeze the entire contents into the ear.
Šobo aplikatorja vstavite v prizadet zunanji ušesni kanal in iztisnite celotno vsebino v uho.
Do not use this veterinary medicinal product after the expiry date which is stated on the outer carton and container label after EXP.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na zunanji škatli in ovojnini po EXP.
Florfenicol is a bacteriostatic antibiotic which acts by inhibiting protein synthesis, through binding to and acting on the 50S ribosomal subunit of bacteria.
Florfenikol je bakteriostatski antibiotik, ki deluje z zaviranjem sinteze beljakovin, preko vezave in delovanja na 50S ribosomalno podenoto bakterije.
After 3 weekly administrations of up to 5x the recommended posology, the test product induced slight erythema in one or both ears that returned to normal within 48 hours.
Po 3-eh tednih dajanja do 5x priporočenega odmerjanja, je testirano zdravilo izzvalo rahlo rdečino v enem ali obeh ušesih, ki so se vrnila v normalno stanje po 48-ih urah.
Other potentially treatment-related effects included mild changes to aspartate aminotransferase (AST), total protein, cholesterol, inorganic phosphorus, creatinine and calcium.
Drugi možni z zdravljenjem povezani učinki so vključevali rahle spremembe aspartat aminotransferaze (AST), celokupnih proteinov, holesterola, anorganskega fosforja, kreatinina in kalcija.
Bacterial and fungal otitis is often secondary to other conditions.
Bakterijsko in glivično vnetje sluhovoda je pogosto sekundarno zaradi drugih stanj.
Restrain the dog's head to prevent shaking, for 2 minutes.
Zadržite glavo psa, da mu preprečite tresenje z glavo za 2 minuti.
The veterinary medicinal product is a fixed combination of three active substances (corticosteroid, antifungal and antibiotic).
Zdravilo je fiksna kombinacija treh učinkovin (kortikosteroida, antimikotika in antibiotika).
Single treatment.
Enkratno zdravljenje.
Inflammation can increase the transcutaneous absorption of veterinary medicinal products across the skin adjacent to the external opening of the ear canal.
Vnetje lahko poveča perkutano absorpcijo zdravila preko kože v bližini odpiranja zunanjega ušesnega kanala.
Propylene carbonate Propylene glycol Ethanol (96 per cent) Macrogol 8000
Seznam pomožnih snovi propilen karbonat propilenglikol etanol, 96-odstotni makrogol 8000
The safety of the veterinary medicinal product has not been established in dogs less than 3 months of age.
Varnost zdravila pri psih, mlajših od treh mesecev, ni bila dokazana.
After application, gently massage the base of the ear for 30 seconds to allow distribution of the solution.
Po dajanju zdravila 30 sekund nežno masirajte bazo ušesa, da omogočite porazdelitev raztopine.
Although no potential for skin irritation was indicated by experimental studies, contact of the product with the skin should be avoided.
Čeprav eksperimentalne študije niso pokazale možnosti za draženje kože, se moramo izogibati izpostavljenosti zdravila s kožo.
Terbinafine hydrochloride is an allylamine with a pronounced fungicidal activity.
Terbinafinijev klorid je alilamin z izrazito fungicidno aktivnostjo.
Its spectrum of activity includes Gram-positive and Gram-negative bacteria including Staphylococcus pseudintermedius (MIC90 of 2 μg/ml).
Njegov spekter delovanja zajema grampozitivne in gramnegativne bakterije, vključno s Staphylococcus pseudintermedius (MIC90 pri 2 μg/ml).
Terbinafine hydrochloride has a different mode of action to azole antifungals, therefore there is no cross-resistance with azole antifungals.
Terbinafinijev klorid ima drugačen način delovanja kot azolni antimikotiki, zato ni navzkrižne odpornosti z drugimi azolnimi antimikotiki.
Ears must be cleaned before administration of the product.
Ušesa je potrebno pred prvim dajanjem zdravila očistiti.
Accidental eye exposure may occur when the dog shakes its head during or just after administration.
Do nenamerne izpostavljenosti oči lahko pride kadar pes stresa z glavo med ali tik po dajanju zdravila.
In case of accidental ocular exposure, flush the eyes thoroughly with water for 10 to 15 minutes.
V primeru nenamernega stika z očmi, temeljito spirajte oči z vodo 10 do 15
Decreased cortisol levels were observed after product instillation in tolerance studies (before and after ACTH stimulation), indicating that mometasone furoate is absorbed and enters the systemic circulation.
V študijah tolerance so po vkapavanju zdravila opazili zmanjšano koncentracijo kortizola (pred stimulacijo z ACTH in po njej), kar kaže na to, da se mometazon furoat absorbira in vstopi v sistemski krvni obtok.
Bayer Animal Health GmbH 51368 Leverkusen Germany
Bayer Animal Health GmbH 51368 Leverkusen
For the full list of excipients, see section 6.1.
Pomožna(pomožne) snov(i): Za celoten seznam pomožnih snovi, glejte poglavje 6.1.
Re-evaluate the dog if hearing loss or signs of vestibular dysfunction are observed during treatment.
Med zdravljenjem je potrebno ponovno oceniti psa ali je prišlo do izgube sluha ali znakov vestibularne disfunkcije.
Carton containing 2, 10 or 20 blisters.
Škatla vsebuje 2, 10 ali 20 pretisnih omotov.
In clinical trials, only saline was used for ear cleaning before treatment initiation with the veterinary medicinal product.
V kliničnih raziskavah se je za čiščenje ušes pred dajanjem zdravila uporabljala le fiziološka raztopina.
Systemic absorption of the three active substances was determined after single co-administration into one ear canal of healthy beagle dogs.
5.2 Farmakokinetični podatki Sistemska absorbcija treh učinkovin je bila ugotovljena po enkratnem sočasnem dajanju v en ušesni kanal zdravih psov pasme Beagle.
After the administration, wet ears or clear discharge can be observed which is not related to the disease pathology.
Po aplikaciji zdravila, se lahko opazi mokra ušesa ali bister izcedek, ki pa nista povezana s patologijo bolezni.
It selectively inhibits the early synthesis of ergosterol, which is an essential component of the membrane of yeasts and fungi including Malassezia pachydermatis (MIC90 of 1 μg/ml).
Selektivno zavira zgodnjo sintezo ergosterola, ki je glavna komponenta membrane kvasovk in glivic, vključno z glivico Malassezia pachydermatis (MIC90 pri 1 μg/ml).
Prolonged and intensive use of topical corticosteroid preparations is known to trigger systemic effects, including suppression of adrenal function (see section 4.10).
Dolgotrajna in intezivna uporaba topikalnih kortikosteroidov lahko povzroči sistemske učinke vključno s supresijo delovanja nadledvične žleze (glejte poglavje 4.10).
FexA codes for a membrane associated efflux system (affecting both florfenicol and chloramphenicol efflux) and is found in chromosomes as well as in plasmids.
FexA kodira sistem izlivne (efflux) črpalke membrane (vpliva tako na izliv florfenikola kot kloramfenikola) in ga najdemo v kromosomih in tudi v plazmidih.
Pharmacotherapeutic group: Otologicals/Corticosteroids and anti-infectives in combination.
Farmakoterapevtska skupina: Zdravila za ušesne bolezni/kortikosteroidi v kombinaciji s protimikrobnimi učinkovinami.
Decreased in vitro susceptibility to terbinafine has been reported for strains of Malassezia pachydermatis which form biofilms.
Poročali so o zmanjšani in vitro občutljivosti na terbinafin za seve glivice Malassezia pachydermatis, ki tvorijo biofilm.
In case of accidental skin contact, wash exposed skin thoroughly with water.
V primeru nenamernega stika s kožo, izpostavljeno kožo temeljito sperite z vodo.
Use with caution in dogs with a suspected or confirmed endocrine disorder (i.e., diabetes mellitus; hypo- or hyperthyroidism, etc.).
Uporabljajte previdno pri psih s sumom na ali s potrjeno endokrino motnjo (tj. sladkorno boleznijo, hipo- ali hipertiroidizmom, itd.).
Compatibility with ear cleaners, other than saline solution, has not been demonstrated.
Združljivost s čistili za ušesa, razen s fiziološko raztopino, ni bila dokazana.
In animals with a history of recurrent otitis externa, the underlying causes of the condition such as allergy or anatomical conformation of the ear must be addressed in order to avoid ineffective treatment with a veterinary medicinal product.
Pri živalih z anamnezo ponavljajočega se vnetja zunanjega sluhovoda je potrebno primarne dejavnike, kot je npr. alergija ali anatomska oblika ušesa, ustrezno obravnavati, da se izognemo neučinkovitemu zdravljenju z zdravilom.
Avoid ingestion of the product including hand-to-mouth exposure.
Izogibajte se zaužitju zdravila vključno z njegovim vnosom preko rok v usta.
Ataxia, internal ear disorder, nystagmus, emesis, application site erythema, hyperactivity, anorexia and application site inflammation were reported very rarely in spontaneous (pharmacovigilance) reports.
Ataksija, motnje notranjega ušesa, nistagmus, bruhanje, rdečina na mestu nanosa, hiperaktivnost, neješčnost in vnetje na mestu nanosa so bili poročani zelo redko v spontanih (farmakovigilančnih) poročilih.
Single-use sealed laminated tube containing 1 ml solution, with polypropylene cap and separate LDPE applicator nozzle packed in a transparent plastic blister.
Enoodmerna neprodušna laminirana tuba ki vsebuje 1 ml raztopine s polipropilenskim pokrovčkom in ločeno LDPE šobo aplikatorja zapakirana v pretisni omot.
Before the veterinary medicinal product is applied, the external auditory canal must be examined thoroughly to ensure that the ear drum is not perforated.
Zunanji sluhovod je potrebno pred dajanjem zdravila temeljito pregledati, da se prepričamo, da bobnič ni predrt.
Prolonged and intensive use of topical corticosteroid preparations is known to trigger systemic effects, including suppression of adrenal function.
Dolgotrajna in intezivna uporaba topikalnih kortikosteroidov lahko povzroči sistemske učinke vključno s supresijo delovanja nadledvične žleze.
Vocalisation, head shaking and application site pain shortly after product application have been reported very rarely in spontaneous (pharmacovigilance) reports.
O vokalizaciji, stresanju glave in bolečini na mestu nanosa kmalu po nanosu zdravila so poročali zelo redko v spontanih (farmakovigilančnih) poročilih.
Caution should be taken to prevent the veterinary medicinal product from getting into the eyes of the dog being treated e.g. by restraining the dog's head to prevent shaking (see section 4.9).
Posebna previdnost je potrebna, da se prepreči stik zdravila z očmi psa, ki se zdravi tako, da zadržite glavo psa in mu onemogočite tresenje (glejte poglavje 4.9).
Target animal safety was not studied in dogs under 4 kg bodyweight.
Varnost ciljnih živalskih vrst ni bila raziskana pri psih lažjih do 4 kg, vendar v kliničnih študijah niso bile opažene nobene težave z varnostjo pri psih lažjih od 4 kg.
In case of exposure to the eye, rinse with plenty of water.
V primeru izpostavljenosti z očmi temeljito sperite z obilico vode.
Caution should be taken to prevent the veterinary medicinal product from getting into the eyes of the dog being treated e.g. by restraining the dog's head to prevent shaking (see section “advice on correct administration”).
Posebna previdnost je potrebna, da se prepreči stik zdravila z očmi psa, ki se zdravi tako, da zadržite glavo psa in mu onemogočite tresenje (glejte poglavje “ Nasvet o pravilni uporabi zdravila”).
The main findings observed at the 1X dose were decreases in cortical response to ACTH stimulation, decreased absolute lymphocyte and eosinophil counts, and decreased adrenal weight.
Glavne ugotovitve, opažene pri enkratnem odmerku, so bile zmanjšan kortikalni odziv na stimulacijo z ACTH, zmanjšano absolutno število limfocitov in eozinofilcev ter zmanjšana masa nadledvične žleze.
If symptoms develop, seek medical advice and show the package leaflet or the label to the physician.
Če se znaki pojavijo, se takoj posvetujte z zdravnikom in mu pokažite navodilo za uporabo ali ovojnino.
Use of the veterinary medicinal product deviating from the instructions given in the package leaflet may increase the prevalence of bacteria resistant to florfenicol and fungi resistant to terbinafine and may decrease the effectiveness of treatment with other antibiotics and antifungal agents.
Uporaba zdravila, ki odstopa od navodil navedenih v navodilu za uporabo, lahko poveča razširjenost bakterij, odpornih proti florfenikolu, in glivic, odpornih proti terbinafinu, ter lahko zmanjša učinkovitost zdravljenja z drugimi antibiotiki in antimikotiki.
6.2 Major incompatibilities
prečiščena voda 6.2 Glavne inkompatibilnosti
Auricular administration of up to five times the recommended dose at biweekly intervals for a total of three treatments was generally well tolerated.
Avrikularna uporaba petkratnega priporočenega odmerka v dvotedenskih presledkih za skupno 3
Use of the veterinary medicinal product deviating from the instructions given in the Summary of Product Characteristics (SPC) may increase the prevalence of bacteria resistant to florfenicol and fungi resistant to terbinafine and may decrease the effectiveness of treatment with other antibiotics and antifungal agents.
Uporaba zdravila, ki odstopa od navodil v Povzetku glavnih značilnosti zdravila, lahko poveča razširjenost bakterij, odpornih proti florfenikolu, in glivic, odpornih proti terbinafinu, ter lahko zmanjša učinkovitost zdravljenja z drugimi antibiotiki in antimikotiki.
For the treatment of acute canine otitis externa or acute exacerbations of recurrent otitis caused by mixed infections of susceptible strains of bacteria sensitive to florfenicol (Staphylococcus pseudintermedius) and fungi sensitive to terbinafine (Malassezia pachydermatis).
Za zdravljenje akutnega vnetja zunanjega sluhovoda ali akutnega poslabšanja ponavljajočega se vnetja zunanjega sluhovoda, ki ga povzročajo sevi bakterij občutljivi na florfenikol (Staphylococcus pseudintermedius) in glivice občutljive na terbinafin (Malassezia pachydermatis).
Administration by a veterinarian surgeon or under their close supervision.
Zdravilo daje veterinar ali pa dajanje poteka pod njegovim neposrednim nadzorom.
One dose (1 ml) contains 16.7 mg florfenicol, 16.7 mg terbinafine hydrochloride (equivalent to 14.9 mg terbinafine base) and 2.2 mg mometasone furoate.
En odmerek (1 ml) vsebuje 16,7 mg florfenikola, 16,7 mg terbinafinijevega klorida (kar ustreza bazi 14,9 mg terbinafina) in 2,2 mg mometazonfuroata.
Appropriate measures (e.g. wearing safety glasses during administration, massaging the ear canal well after administration to ensure even distribution of product, restraining the dog after administration) are needed to avoid exposure to the eyes.
Ustrezni ukrepi so potrebni, da se izogne izpostavljenost oči (npr. nošenje zaščitnih očal med dajanjem zdravila, masiranje ušesnega kanala po dajanju, da se zagotovi enakomerna porazdelitev zdravila, z omejevanjem gibanja glave psu po dajanju zdravila).
is low (MIC90 > 128 µg/ml).
Pseudomonas spp je in vitro delovanje florfenikola nizko (MIC90 >128 μg/ml).
The most prominent effects were consistent with glucocorticoid administration; specific observations included suppression of the adrenal cortical response to ACTH-stimulation, decreased adrenal weight and atrophy of the adrenal cortex, decreased absolute lymphocyte and eosinophil counts, increased absolute neutrophil count, increased liver weight with hepatocellular enlargement/cytoplasmic change, and decreased thymus weight.
Najbolj vidni učinki so bili skladni z dajanjem glukokortikoidov; posebna opažanja so vključevala zmanjšanje adrenalnega kortikalnega odziva na stimulacijo ACTH, zmanjšanje mase nadledvične žleze in atrofijo skorje nadledvične žleze, zmanjšano absolutno število limfocitov in eozinofilcev,
Mean peak plasma concentrations (Cmax) were low with 1.73 ng/ml florfenicol, 0.35 ng/ml mometasone furoate and 7.83 ng/ml terbinafine HCl reached at the tmax of 24 h, 0.5 h and 20 h after treatment, respectively.
Povprečne najvišje plazemske koncentracije (Cmax) so bile nizke, in sicer 1,73 ng/ml za florfenikol, 0,35 ng/ml za mometazonfuroat in 7,83 ng/ml za terbinafin HCL,
This combination is intended for the treatment of acute otitis when mixed infections caused by Staphylococcus pseudintermedius susceptible to florfenicol and Malassezia pachydermatis susceptible to terbinafine have been demonstrated.
Ta kombinacija je namenjena le zdravljenju akutnega vnetja sluhovoda, potem ko so bile prikazane mešane okužbe, ki jih povzročajo Staphylococcus pseudintermedius občutljive na florfenikol in
In case of accidental ingestion seek medical advice immediately and show the package leaflet or the label to the physician.
V primeru nenamernega zaužitja se takoj posvetujte z zdravnikom in mu pokažite navodilo za uporabo ali ovojnino.
Ear drops, solution.
Kapljice za uho, raztopina.
While holding the single-use container in an upright position, remove the cap. Use the upper end of the cap to completely break the seal and then remove cap from the single-use container.
Uporabite zgornji del konice pokrovčka, da boste popolnoma predrli tesnilo in nato odstranite pokrovček iz vsebnika.