natgillin/translations-raw huggingface dataset:
Ved indgivelse sammen med butorphanol (0, 1 mg/ kg) til dyb sedation og analgesi, er den intramuskulære dosis 300 mikrogram pr. kvadratmeter legemsoverflade.
When administering in conjunction with butorphanol (0.1 mg/ kg) for deep sedation and analgesia, the intramuscular dose is 300 micrograms/ square metre body surface area.
Dosis af dexmedetomidin ved præmedicinering er 125 - 375 mikrogram pr. kvadratmeter legemsoverflade, som indgives 20 minutter inden induktion ved anæstesikrævende procedurer.
The premedication dose of dexmedetomidine is 125 – 375 micrograms/ square metre body surface area, administered 20 minutes prior to induction for procedures requiring anaesthesia.
Separat brug, sedation og analgesi
Dogs Single-use sedation and analgesia
20 Hunde
20 Dogs
(mk/ kg) 28, 1 25 23 19, 6 16, 8 15, 7 14, 6 13, 4 12, 6 12 11, 6 11 10, 5 10, 1 9, 8 9, 5 9, 3 9 8, 7
(ml) (mcg/ kg) 0.04 28.1 0.05 25 0.07 23 0.1 19.6 0.13 16.8 0.15 15.7 0.17 14.6 0.2 13.4 0.23 12.6 0.25 12 0.27 11.6 0.3 11 0.33 10.5 0.35 10.1 0.38 9.8 0.4 9.5 0.42 9.3 0.45 9 0.47 8.7
KATTE:
CATS:
Doseringen til katte er 40 mikrogram dexmedetomidinhydrochlorid pr. kg legemsvægt, svarende til en dosisvolumen på 0, 08 ml Dexdomitor pr. kg legemsvægt. ved anvendelse under ikke- invasive, let til moderat smertefulde procedurer, der kræver fiksering, bedøvelse og analgesi.
The dosage for cats is 40 micrograms dexmedetomidine hydrochloride/ kg bw equal to a dose volume 0.08 ml Dexdomitor/ kg bw when used for non-invasive, mildly to moderately painful procedures requiring restraint, sedation and analgesia.
(mikrogram/ kg) 40 40 40 40 40 40
(mcg/ kg) 40 40 40 40 40 40
21 9 OPLYSNINGER OM KORREKT ANVENDELSE
ADVICE ON CORRECT ADMINISTRATION
Der kan forekomme cornea- uklarhed hos katte under sedationen.
In cats corneal opacities may occur during sedation.
Efter indgivelse af 40 microgram dexmedetomidin / kg legemsvægt intramuskulært samtidigt med 5 mg ketamin / kg legemsvægt til katte, fordobles maksimum koncentrationen af dexmedetomidin, men Tmax påvirkes ikke deraf.
After administration of 40 micrograms dexmedetomidine/ kg bw intramuscularly concurrently with 5 mg ketamine / kg bw to cats, the maximum concentration of dexmedetomidine increased twofold but there was no effect on T max.
Indgivelse af atipamezol efter dexmedetomidin ophæver hurtigt virkningen og forkorter på den måde opvågningstiden.
22 Administration of atipamezole after dexmedetomidine rapidly reverses the effects and thus shortens the recovery period.
Hundene er normalt vågne og står op inden for 15 minutter.
Within 15 minutes dogs are normally awake and standing
22 Yderligere oplysninger om bivirkninger findes under afsnittet ” Bivirkninger ”.
For information on adverse reactions, see section Adverse reactions.
Hyppig og regelmæssig overvågen af åndedræts - og hjertefunktion skal foretages på den bedøvede patient.
Frequent and regular monitoring of respiratory and cardiac function should be performed.
Dosisvolumen af atipamezol ved en koncentration på 5 mg/ ml svarer til den dosisvolumen af Dexdomitor, som blev givet til hunden, uanset indgivelsesvej.
The dose volume of atipamezole at the concentration of 5 mg/ ml equals the dose volume of Dexdomitor that was given to the dog, regardless of route of administration of Dexdomitor.
I tilfælde af overdosering, eller hvis virkningerne af dexmedetomidin bliver potentielt livstruende, er den relevante antagonist atipamezol, injiceret intramuskulært, ved følgende dosis:
In cases of overdosage, or if the effects of dexmedetomidine become potentially life- threatening, the appropriate antagonist is atipamezole, administered by intramuscular injection, at the following dose:
KØR IKKE SELV, da bedøvelse og ændringer i blodtrykket kan forekomme.
In case of accidental oral intake or self-injection, seek medical advice immediately and show the package insert to the physician but DO NOT DRIVE as sedation and changes in blood pressure may occur.
Undgå at produktet kommer i kontakt med huden, øjnene og slimhinderne.
Avoid skin, eye or mucosal contact; the use of impermeable gloves is advisable.
Hvis produktet kommer i kontakt med huden eller slimhinderne skal det berørte område straks vaskes med rigeligt vand.
In case of skin or mucosal contact, wash the exposed skin immediately after exposure with large amounts of water and remove contaminated clothes that are in direct contact with skin.
Forurenet beklædning, som er i kontakt med huden, skal fjernes.
In case of eye contact, rinse abundantly with fresh water.
Dette skyldes at sammentrækninger af livmoderen og fald i fosterets blodtryk kan opstå efter en systemisk eksponering.
If pregnant women handle the product, special caution should be observed not to self-inject as uterine contractions and decreased foetal blood pressure may occur after accidental systemic exposure.
Dosisafhængig sedation, respiratorisk depression, bradykardi, hypotension, tør mund og hyperglykæmi.
Dexdomitor is an α 2-adrenoreceptor agonist, symptoms after absorption may involve clinical effects including dose-dependent sedation, respiratory depression, bradycardia, hypotension, a dry mouth, and hyperglycaemia.
23 13.
23 13.
Tlf.: +32 (0) 2- 554 62 11
Tél/ Tel: +32 (0)2-554 62 11
Magyarország Pfizer Kft Tlf.: +36 1 488 3695
Magyarország Pfizer Kft Tel: +36 1 488 3695
Česká republika Pfizer Animal Health Tlf.: +420 283 004 111
Č eská republika Pfizer Animal Health Tel: +420 283 004 111
Nederland Pfizer Animal Health BV Tlf.: +31 (0) 10- 4064600
Nederland Pfizer Animal Health BV Tel: +31 (0)10-4064600
Deutschland Pfizer GmbH Tlf.: +49 (0) 721 610 101
Deutschland Pfizer GmbH Tel: +49(0)721 610 101
Österreich Pfizer Corporation Austria GesmbH Tel.: +43 (0) 1 521 157 20
Österreich Pfizer Corporation Austria GesmbH Tel: +43 (0)1 521 157 20
Polska Pfizer Trading Polska sp. z. o. o Tlf.: +48 22 335 6200
Polska Pfizer Trading Polska sp. z. o. o Tel: +48 22 335 6200
España Pfizer Salud Animal Tlf: +34 91 490 9900
España Pfizer Salud Animal Tel: +34 91 490 9900
Tlf.: +351 214 235 500
Tel: +351 214 235 500
France Pfizer Tel: +33 (0) 1 58 07 46 00
France Pfizer Tél: +33 (0)1 58 07 46 00
24 Ireland Pfizer Heathcare Ireland, trading as:
24 Ireland Pfizer Heathcare Ireland, trading as:
Animal Health Tlf.: +353 (0) 1 467 6500
Animal Health Tel: +353 (0)1 467 6500
Slovenija Pfizer Luxembourg SARL Tlf.: +386 (0) 1 52 11 670
Slovenija Pfizer Luxembourg SARL Tel: +386 (0)1 52 11 670
Pfizer Anímal Health Tlf.: +421 2 3355 5500
Pfizer Animal Health Tel: +421 2 3355 5500
Suomi/ Finland Orion Pharma Eläinlääkkeet Puh/ Tln: +358 010 4261
Suomi/ Finland Orion Pharma Eläinlääkkeet Puh/ Tln: +358 (0)10 4261
Sverige Orion Pharma Animal Health Tlf.: +46 (0) 8- 623 64 40
Sverige Orion Pharma Animal Health Tln: +46 (0)8-623 64 40
Latvija Pfizer Animal Health Tlf. +370 5 269 17 96
Latvija Pfizer Animal Health Tel. +370 5 269 17 96
United Kingdom Pfizer Ltd Tlf.: +44 (0) 1304 616161
United Kingdom Pfizer Ltd Tel: +44 (0)1304 616161
Lietuva Pfizer Animal Health Tlf. +370 5 269 17 96
Lietuva Pfizer Animal Health Tel. +370 5 269 17 96
Hvis du ønsker yderligere oplysninger om baggrunden for CVMP’ s anbefalinger, kan du læse den faglige drøftelse (også en del af denne EPAR).
If you want more information on the basis of the CVMP recommendations, read the Scientific Discussion (also part of the EPAR).
Det fås som oral opløsning til kyllinger og kalkuner (100 mg/ ml), som tabletter til hunde (15 mg, 50 mg, 100 mg og 150 mg) og som opløsning til injektion til kvæg og hunde (50 mg/ ml).
It is available as an oral solution for chickens and turkeys (100 mg/ ml), as tablets for dogs (15 mg, 50 mg, 100 mg and 150 mg), and as a solution for injection for cattle and dogs (50 mg/ ml).
Dicural anvendes til behandling af infektioner forårsaget af bakterier: • Til kyllinger og kalkuner anvendes Dicural til behandling af bestemte infektioner, som påvirker luftvejene (lunger og luftsække).
Dicural is used to treat infections caused by bacteria: • in chickens and turkeys, Dicural is used to treat certain infections affecting the respiratory system (lungs and air sacs).
Til både kyllinger og kalkuner gives lægemidlet i drikkevandet i fem dage • Til hunde anvendes Dicural til behandling af akutte (kortvarige) blæreinfektioner og til behandling af pyodermi (en hudinfektion med udslæt og pustler).
For both chickens and turkeys it is given in the drinking water for five days; • in dogs, Dicural is used to treat acute (short-lived) infections of the bladder and to treat pyoderma (a skin infection with a rash and raised lumps).
På den første dag af behandlingen kan det indgives som injektion under huden, hvorefter man går over til tabletformen • Til kvæg anvendes Dicural til behandling af infektioner, der påvirker lungerne og åndedrættet (viruspneumoni og kalvepneumoni).
On the first day of treatment, it can be given by injection under the skin before switching to the tablets; • in cattle, Dicural is used to treat infections affecting the lungs and breathing (shipping fever and calf pneumonia).
Det aktive stof i Dicural, difloxacin, tilhører en gruppe af antibiotika kaldet "fluoroquinoloner".
The active substance in Dicural, difloxacin, belongs to a group of antibiotics called ‘ fluoroquinolones’.
Difloxacin virker ved at blokere et enzym kaldet "DNA- gyrase", som spiller en vigtig rolle for, at bakterier kan lave kopier af deres eget DNA.
Difloxacin works by blocking an enzyme called ‘ DNA gyrase’, which is important in allowing bacteria to make copies of their DNA.
Den fuldstændige liste med bakterier, som Dicural har en aktiv virkning mod, findes i produktresuméet.
In dogs, four main trials looked at the effects of Dicural in treating bladder infections.
Hos høns og kalkuner er der foretaget ni hovedundersøgelser med fugle, der havde luftvejsinfektioner.
Reproduction is authorised provided the source is acknowledged. at its effects in treating pyoderma: two compared it with enrofloxacin and one compared it with amoxicillin and clavulanic acid.
Dette omfatter små - og mellemstore racer til og med 8 måneder, større racer op til 1 år og meget store racer op til 18 måneder.
This includes small- and medium-sized breeds up to and including eight months of age, large breeds up to one year of age and giant breeds up to 18 months of age.
Ved håndtering af Dicural oral opløsning til kyllinger og kalkuner skal der anvendes handsker og ansigtsbeskyttelse for at undgå irritation af huden eller øjnene.
When handling Dicural oral solution for chickens and turkeys, use gloves and a face- protecting device to avoid irritation of the skin or eyes.
Udvalget anbefalede udstedelse af markedsføringstilladelse for Dicural.
The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Dicural are greater than the risks for the treatment and recommended that Dicural be given a marketing authorisation.
Europa- Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Dicural til Fort Dodge Animal Health Holland den 16. januar 1998.
The European Commission granted a marketing authorisation valid throughout the European Union, for Dicural to Fort Dodge Animal Health Holland on 16 January 1998.
Markedsføringstilladelsen blev fornyet den 16. januar 2003 og den 16. januar 2008.
The marketing authorisation was renewed on 16 January 2003 and on 16 January 2008.
Oplysninger om udleveringsbestemmelser for dette produkt findes på emballagen.
Information on the prescription status of this product may be found on the label/ outer package.
Dette sammendrag blev sidst ajourført i 10- 2008.
This summary was last updated in October 2008.
Side 3/ 3
Page 2/ 2
Lægemiddel - form
Strength
Dyrearter, som læge - midlet er beregnet til
Pharmaceutical Form
Indgivelsesvej
Target species
Dicural 100 mg/ ml
100 mg/ ml Oral solution
HDPE- flaske
Bottle (HDPE)
1 flaske
1,000 ml 1 bottle
EU/ 2/ 97/ 003/ 003 EU/ 2/ 97/ 003/ 004
EU/ 2/ 97/ 003/ 003 Dicural
Oral opløsning Tabletter,
100 mg/ ml Oral solution
Kyllinger og kalkuner Hunde
Chickens and turkeys
I drikkevand Oral
In drinking water
HDPE- flaske Blister
Bottle (HDPE)
1000 ml
1,000 ml
Æske med 6 flasker 10 tabletter
Pack of 6 bottles
24 timer Ikke relevant
24 hours
EU/ 2/ 97/ 003/ 005
EU/ 2/ 97/ 003/ 004 Dicural EU/ 2/ 97/ 003/ 005 Dicural
10 tablets
15 mg Coated tablets 15 mg Coated tablets
Tabletter, overtrukne
Dogs Dogs
Blister (PVC/ alumini um)
Blister (PVC/ Alu) Blister (PVC/ Alu)
20 tablets
10 tablets 20 tablets
Indgivelsesvej Emballage
Not applicable Not applicable
Indhold
EU/ 2/ 97/ 003/ 006 Dicural EU/ 2/ 97/ 003/ 007 Dicural EU/ 2/ 97/ 003/ 008 Dicural EU/ 2/ 97/ 003/ 009 Dicural EU/ 2/ 97/ 003/ 010 Dicural EU/ 2/ 97/ 003/ 011 Dicural EU/ 2/ 97/ 003/ 012 Dicural EU/ 2/ 97/ 003/ 013 Dicural EU/ 2/ 97/ 003/ 014 Dicural EU/ 2/ 97/ 003/ 015 Dicural
150 mg Tabletter, overtrukne
15 mg 50 mg 50 mg 50 mg 100 mg 100 mg 100 mg 150 mg 150 mg 150 mg
Hunde
Coated tablets Coated tablets Coated tablets Coated tablets Coated tablets Coated tablets Coated tablets Coated tablets Coated tablets Coated tablets
150 mg Tabletter, overtrukne
Dogs Dogs Dogs Dogs Dogs Dogs Dogs Dogs Dogs Dogs
Oral anvendelse
Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use
100 tablets
Blister (PVC/ Alu) Blister (PVC/ Alu) Blister (PVC/ Alu) Blister (PVC/ Alu) Blister (PVC/ Alu) Blister (PVC/ Alu) Blister (PVC/ Alu) Blister (PVC/ Alu) Blister (PVC/ Alu) Blister (PVC/ Alu)
Ikke relevant
100 tablets Not applicable 10 tablets Not applicable 20 tablets Not applicable 100 tablets Not applicable 10 tablets Not applicable 20 tablets Not applicable 100 tablets Not applicable 10 tablets Not applicable 20 tablets Not applicable 100 tablets Not applicable
50 mg/ ml Injektionsvæske, opløsning
50 mg/ ml
1 hætteglas
1 vial Cattle:
46 dage Hunde:
46 days Dogs: not applicable
Injektionsvæske, Kvæg opløsning
Solution for injection
1 hætteglas
1 vial 46 days
Dicural 100 mg/ ml oral opløsning til kyllinger og kalkuner
Dicural 100 mg/ ml oral solution for chickens and turkeys
Se afsnit 6. 1 for en fuldstændig fortegnelse over hjælpestoffer.
For a full list of excipients, see section 6.1
Kyllinger (slagtekyllinger og fremtidige avlshøns) Kalkuner (unge kalkuner med en kropsvægt på op til 2 kg)
Chickens (broilers and future breeders) Turkeys (young turkeys up to 2 kg body weight)
Hos kyllinger og kalkuner er Dicural indiceret til behandling af kroniske luftvejsinfektioner forårsaget af difloxacin- følsomme stammer af Escherichia coli og Mycoplasma gallisepticum.
Dicural oral solution is indicated for treatment of chronic respiratory infections caused by sensitive strains of Escherichia coli and Mycoplasma gallisepticum.
Hos kalkuner er Dicural tillige indiceret til behandling af infektioner forårsaget af Pasteurella multocida.
Dicural oral solution is also indicated for the treatment of infections caused by Pasteurella multocida.
Da der ikke er udført studier, som omfatter klinisk lamme dyr, bør Dicural, ikke anvendes hos dyr med konstateret ben- svækkelse eller dyr med osteoporose.
Since no studies were performed in clinically lame birds, Dicural should not be used in birds with existing leg-weakness or in birds suffering from osteoporosis.
4. 4 Særlige advarsler < for hver enkelt dyreart, som lægemidlet er beregnet til >
4.4 Special warnings for each target species
Særlige forsigtighedsregler vedrørende brug til dyr Stærk afhængighed af en enkelt gruppe antibiotika kan resultere i resistensudvikling i en bakteriel population.
Special precautions for use in animals Heavy reliance on a single class of antibiotics may result in the induction of resistance in a bacterial population.
2/ 65 De officielle og lokale krav vedrørende håndtering af antimikrobielt materiale bør tages i betragtning, når dette produkt anvendes.
Official and local antimicrobial policies should be taken into account when the product is used.
Hvis dette produkt ikke anvendes i overensstemmelse med anvisningerne i produktresumeet, kan det øge udbredelsen af bakterier, der er resistente over for fluoroquinoloner, og det kan nedsætte effekten af behandling med andre quinoloner på grund af potentiel krydsresistens.
2/ 64 Use of the product deviating from the instructions given in the SPC may increase the prevalence of bacteria resistant to the fluoroquinolones and may decrease the effectiveness of treatment with other quinolones due to the potential for cross resistance.
Særlige forsigtighedsregler for personer, som indgiver lægemidlet til dyr Personer med kendt overfølsomhed over for quinoloner bør undgå enhver kontakt med præparatet.
Special precautions to be taken by the person administering the veterinary medicinal product to animals People with a known hypersensitivity to quinolones should avoid any contact with the product.
For at undgå irritation af hud og/ eller øjne anbefales det at bruge handsker og ansigtsmaske under håndtering af præparatet.
In order to avoid irritation of skin and/ or eyes, use gloves and a face-protecting device when handling this product.
Må ikke anvendes i æglægningsperioden til og/ eller inden for 4 uger forud for æglægningsperiodens begyndelse.
Do not use in birds in lay and/ or within 4 weeks before the onset of the laying period.
4. 8 Interaktion med andre lægemidler og andre former for interaktion
4.8 Interaction with other veterinary medicinal products and other forms of interaction
4. 9 Dosering og indgivelsesvej
4.9 Amounts to be administered and administration route.
Dicural, oral opløsning skal indgives dagligt via drikkevandet i en sådan mængde, at dosis er 10 mg/ kg kropsvægt.
Dicural oral solution must be administered daily in the drinking water in such a concentration that the dose is 10 mg/ kg bodyweight.
1000 liter vand:
Taking into account the content of difloxacin in the oral solution (10%w/ v), the following calculation should be made to determine the volume (ml) to be added for each 1000 litres of water:
antallet af dyr i huset X gennemsnitlig vægt af individuelle dyr (kg) X 100 ---------------------------------------------------------------------------------------------- samlet vandforbrug i huset den foregående dag (liter)
number of animals in the house X mean weight of individual animal (kg) X 100 ----------------------------------------------------------------------------------------------------- total water consumption of the house on the previous day (litres)
Der bør tilberedes frisk medicineret drikkevand hver dag.
The medicated drinking water should be prepared freshly each day.
Ved koncentrationer på 0, 03% (=300 ml i 1000 liter) og derover i vandet kan smagen af kalkunkødet påvirkes.
At concentrations in the water of 0.03% (= 300 ml in 1000 litres) or greater, palatability for turkeys may be affected.
4. 10 Overdosering (symptomer, nødforanstaltninger, modgift), om nødvendigt
4.10 Overdose (symptoms, emergency procedures, antidotes)
Sikkerhedsundersøgelser med kyllinger og kalkuner har vist, at difloxacinhydrochlorid synes at være ufarlig for fuglene ved indgivelse i drikkevandet af 30 mg/ kg (kyllinger) eller 22 mg/ kg (kalkuner) i tre gange den anbefalede behandlingsvarighed (15 på hinanden følgende dage).
Target animal safety studies in chickens and turkeys demonstrated that, when administered in drinking water at 30 mg/ kg (chickens) or 22 mg/ kg (turkeys) for three times the recommended duration (15 consecutive days), difloxacin hydrochloride appeared to be safe for the birds.
4. 11 Tilbageholdelsestid
4.11 Withdrawal periods
Kød og indmad (kyllinger og kalkuner):
Meat and offal (chickens and turkeys):
Må ikke anvendes til æglæggende fugle, hvis æg er bestemt til menneskeføde.
Not authorised for use in laying birds producing eggs for human consumption.
3/ 65 5.
3/ 64 5.
Infektionssygdomme, systemiske midler; antimikrobielle midler til systemisk brug, quinoloner
Pharmacotherapeutic group: general anti-infectives for systemic use; antibacterials for systemic use, quinolone antibacterials.
ATCvet- kode:
ATC vet code:
QJ01MA 94
QJ01MA94
Difloxacinhydrochlorid virker baktericidt via hæmning af bakteriel DNA- gyrase.
Difloxacin hydrochloride is bactericidal in activity and acts by inhibition of bacterial DNA gyrase.
Vævsdistributionen er meget stor, som påvist ved væv- til- plasma - forhold.
Difloxacin is well distributed throughout the animal body, as was demonstrated by the tissue to plasma ratios.
Der opnås difloxacin- koncentrationer svarende til eller større end MIC for de aktuelle patogener i alle relevante væv og opretholdes, så længe medicineringen vedvarer.
Difloxacin concentrations equal to or greater than the MICs for the relevant pathogens are achieved in all relevant tissues and maintained for as long as medication is continued.
7 timer.
It is well distributed in the body (Vd = 4.7 l/ kg) and has a plasma elimination half-life of approximately 7 hours.
200 ng/ ml.
Following continuous oral dosing with Dicural oral solution at 10 mg/ kg/ day for five consecutive days the mean difloxacin steady state plasma concentrations are approximately 200 ng/ ml.
Væv- til- plasma- forholdet spænder fra 0, 6 (abdominalfedt), 2, 4 (lunge), 4, 5 (muskel) til 14, 1 (lever).
Tissue to plasma ratios range from 0.6 (abdominal fat), 2.4 (lung), 4.5 (muscle) to 14.1 (liver).
7 timer.
It is very well distributed in the body (Vd = 9.9 l/ kg) and has a plasma elimination half-life of approximately 7 hours.
60 ng/ ml.
Following continuous oral dosing of Dicural oral solution at 10 mg/ kg/ day for five consecutive days the mean difloxacin steady state plasma concentrations are approximately 60 ng/ ml.
Væv- til- plasma- forholdet spænder fra 2, 5 (abdominalfedt), 3, 7 (muskel), 4, 8 (lunge) til 36, 5 (lever).
Tissue to plasma ratios range from 2.5 (abdominal fat), 3.7 (muscle), 4.8 (lung) to 36.5 (liver).
Hos begge arter kan difloxacin konjugeres (glucuronideres eller sulfateres), demetyleres til sarafloxacin eller oxideres til N- oxid- difloxacin.
In both species difloxacin may be conjugated (glucuronidated or sulphated), desmethylated into sarafloxacin or oxidised into N-oxide-difloxacin.
De øvrige metabolitter er i forhold hertil af mindre betydning.
The main metabolites are hydrolysable conjugates of difloxacin, the other metabolites are proportionally minor ones.
FARMACEUTISKE OPLYSNINGER
4/ 64 6.2 Incompatibilities
Der bør ikke tilsættes klor (f. eks. ved anvendelse af vand- klorerende stoffer) eller brintoverilte til det drikkevand, der anvendes sammen med dette produkt.
No additional chlorine, for example from the use of water chlorinators, or hydrogen peroxide should be added to the drinking water used with this product..
4/ 65 6. 3 Opbevaringstid
6.3 Shelf-life
Opbevaringstid efter første åbning af beholderen (hvor dette er relevant):
Shelf life after first opening the container:
1 måned
1 month.
Hvide HDPE- flasker med skruelåg indeholdende 250 ml eller 1 liter Dicural oral opløsning.
White HDPE bottles with a screw cap containing 250 ml or 1 litre of Dicural oral solution.
Skruelåget på 1 literflasken kan bruges som målebæger.
The screw cap on the 1 litre bottle can be used as a measuring device.
6. 6 Eventuelle særlige forholdsregler ved bortskaffelse af ubrugte veterinærlægemidler eller affaldsmaterialer fra brugen af sådanne
6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products, if any
Fort Dodge Animal Health Holland C. J. van Houtenlaan 36 1381 CP Weesp Nederlandene
Fort Dodge Animal Health Holland C. J. van Houtenlaan 36 1381 CP Weesp The Netherlands
DATO FOR FØRSTE TILLADELSE/ FORNYELSE AF TILLADELSEN
DATE OF RENEWAL OF THE AUTHORISATION
DATO FOR ÆNDRING AF TEKSTEN {måneder/ år} eller < måneder/ år >
DATE OF REVISION OF THE TEXT
Nærmere oplysninger om dette veterinærlægemiddel er tilgængelige på webstedet for Det Europæiske Lægemiddelagentur (EMEA) http: // www. emea. europa. eu /
Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu/
FORBUD MOD SALG, UDLEVERING OG/ ELLER BRUG
5/ 64 PROHIBITION OF SALE, SUPPLY AND/ OR USE
5/ 65 1.
6/ 64 1.
difloxacin (som hydrochlorid) difloxacin (som hydrochlorid)
difloxacin (as hydrochloride) difloxacin (as hydrochloride)