natgillin/translations-raw huggingface dataset:
After 4 weeks of treatment Duaklir Genuair implied improvement versus placebo in change from baseline in morning pre-dose (trough) FRC, the primary endpoint, but the difference was not statistically significant (-0.125 L; 95% CI=(-0.259, 0.010); p=0.069*).
Po 4 tednih zdravljenja je zdravilo Duaklir Genuair v primerjavi s placebom nakazovalo izboljšanje spremembe jutranje (najnižje) FRC pred odmerkom v primerjavi z izhodiščem, kar je bil primarni opazovani dogodek, vendar sprememba ni bila statistično značilna (-0,125 l, 95 % IZ: -0,259, 0,010, p = 0,069*).
a) Before first use, tear open the sealed bag and remove the inhaler.
a) Pred prvo uporabo je treba raztrgati zavarjeno vrečko in odstraniti inhalator.
Duaklir Genuair reduced the use of rescue medication over 6 months compared to placebo (by 0.9 puffs per day [p<0.0001]), aclidinium (by 0.4 puffs/day [p<0.001]) and formoterol (by 0.2 puffs/day [p=0.062]).
V 6 mesecih zdravljenja je zdravilo Duaklir Genuair zmanjšalo uporabo reševalnega zdravila v primerjavi s placebom (za 0,9 vpiha na dan [p < 0,0001]), aklidinijem (za 0,4 vpiha/dan [p < 0.001]) in formoterolom (za 0,2 vpiha/dan [p = 0,062]).
High doses of Duaklir Genuair may lead to exaggerated anticholinergic and/or β2-adrenergic signs and symptoms; the most frequent of which include blurred vision, dry mouth, nausea, muscle spasm, tremor, headache, palpitations and hypertension.
Najpogostejši znaki in simptomi vključujejo zamegljen vid, suha usta, navzeo, mišične krče, tresavico, glavobol, palpitacije in hipertenzijo.
The percentages of patients with clinically meaningful improvements in TDI focal score (defined as an increase of at least 1 unit) were higher with Duaklir Genuair than with placebo in ACLIFORM-COPD (64.8% compared to 45.5%; p<0.001) and AUGMENT (58.1% compared to 36.6%; p<0.0001).
Odstotki bolnikov s klinično pomembnim izboljšanjem skupne ocene TDI (določene kot povečanje za vsaj 1 enoto) so bili višji pri uporabi zdravila Duaklir Genuair kot pri uporabi placeba v študiji ACLIFORM-COPD (64,8 % v primerjavi s 45,5 %; p<0,001) in študiji AUGMENT (58,1 % v primerjavi s 36,6 %; p<0,0001).
In study ACLIFORM-COPD, only a small decrease in SGRQ total score compared to placebo was observed due to an unexpectedly large placebo response (p=0.598) and the percentages of patients who achieved clinically meaningful improvements from baseline were 55.3% with Duaklir Genuair and 53.2% with placebo (p=0.669).
V študiji ACLIFORM-COPD opazili zgolj rahlo zmanjšanje skupne ocene SGRQ v primerjavi s placebom zaradi nepričakovano visokega odziva na placebo (p = 0,589), odstotki bolnikov, pri katerih je prišlo do klinično pomembnega izboljšanja od izhodiščne vrednosti, pa je znašalo 55,3 % ob uporabi zdravila Duaklir Genuair in 53,2 % pri uporabi placeba (p = 0,669).
What Duaklir Genuair contains - The active substances are aclidinium and formoterol fumarate dihydrate.
Kaj vsebuje zdravilo Duaklir Genuair - Učinkovini sta aklidinij in formoterolijev fumarat dihidrat.
Uncommon - Fast heart beat (tachycardia) - Chest pain or tightness in the chest (angina pectoris) - Blurred vision - Changes in the sound of the voice (dysphonia) - Difficulty passing urine or a feeling that your bladder has not completely emptied (urinary retention) - An abnormal heart trace (QT interval prolongation) potentially leading to an abnormal heart rhythm - Distorted sense of taste (dysgeusia) - Throat irritation - Inflammation of the mouth (stomatitis) - Increased blood pressure - Agitation - Rash - Itching of the skin
Občasni - hiter srčni utrip (tahikardija), - bolečina v prsnem košu ali stiskanje v prsnem košu (angina pektoris), - zamegljen vid, - spremembe v glasu (disfonija), - težave pri uriniranju ali občutek neizpraznjenega mehurja (zastajanje urina), - nepravilni elektrokardiogram (podaljšanje intervala QT), ki lahko vodi v nepravilno bitje srca, - moteno okušanje (disgevzija), - draženje žrela, - vnetje ustne sluznice (stomatitis),
Show the packaging of Duaklir Genuair.
Pokažite ovojnino zdravila Duaklir Genuair.
Duaklir Genuair 340 micrograms /12 micrograms inhalation powder
Duaklir Genuair 340 mikrogramov/12 mikrogramov prašek za inhaliranje
The percentage of patients in AUGMENT who achieved a clinically meaningful improvement from baseline in SGRQ total score (defined as a decrease of at least 4 units) was higher with Duaklir Genuair than with placebo (58.2% compared to 38.7%, respectively; p<0.001).
Odstotek bolnikov, vključenih v študijo AUGMENT, pri katerih je prišlo do klinično pomembnega izboljšanja od izhodiščne vrednosti skupne ocene SGRQ (opredeljena kot zmanjšanje za vsaj 4 enote), je bila višja pri uporabi zdravila Duaklir Genuair kot pri uporabi placeba (58,2 % v primerjavi s 38,7 %; p<0,001).
Talk to your doctor, pharmacist or nurse before using Duaklir Genuair, if you have any of the following conditions/symptoms: - If you have asthma.
Če imate katerega od naštetih stanj/simptomov, se pred začetkom uporabe zdravila Duaklir Genuair posvetujte z zdravnikom, farmacevtom ali medicinsko sestro: - če imate astmo.
Duaklir Genuair also showed improvements in exercise endurance time compared to placebo after 8 weeks of treatment (55 seconds [95% CI=5.6, 104.8; p=0.0292]; baseline value: 456 seconds).
Zdravilo Duaklir Genuair je po 8 tednih zdravljenja v primerjavi s placebom doseglo tudi izboljšanje obremenitvene vzdržljivosti (55 sekund, 95 % IZ: 5,6, 104,8, p = 0,0292; izhodiščna vrednost 456 sekund).
In the pooled analysis of these two studies, Duaklir Genuair showed greater improvements in SGRQ total score compared to formoterol (-1.7 units; p=0.018) or aclidinium (-0.79 units, p=0.273).
V zbirni analizi teh dveh študij je uporaba zdravila Duaklir Genuair v primerjavi s formoterolom (-1,7 enote; p = 0,018) ali aklidinijem (-0,79 enote, p = 0,273) pokazala večje izboljšanje skupne ocene SGRQ.
In study ACLIFORM-COPD, Duaklir Genuair showed improvements in FEV1 at 1 hour post-dose relative to placebo and aclidinium of 299 ml and 125 ml, respectively (both p<0.0001) and improvements in trough FEV1 relative to placebo and formoterol of 143 ml and 85 ml, respectively (both p<0.0001).
V študiji ACLIFORM-COPD so pri zdravilu Duaklir Genuair opazili izboljšave v vrednosti FEV1 eno uro po odmerku v primerjavi s placebom 299 ml in aklidinijem 125 ml (oba p < 0,0001) ter izboljšave v najnižji vrednosti FEV1 v primerjavi s placebom 143 ml in formoterolom 85 ml (oba p < 0,0001).
In study AUGMENT, Duaklir Genuair showed improvements in FEV1 at 1 hour post-dose relative to placebo and aclidinium of 284 ml and 108 ml (both p<0.0001), respectively, and improvements in trough FEV1 relative to placebo and formoterol of 130 ml (p<0.0001) and 45 ml (p=0.01), respectively.
V študiji AUGMENT so pri zdravilu Duaklir Genuair opazili izboljšave v vrednosti FEV1 eno uro po odmerku v primerjavi s placebom 284 ml in aklidinijem 108 ml (oba p < 0,0001) ter izboljšave v najnižji vrednosti FEV1 v primerjavi s placebom 130 ml (p < 0,0001) in formoterolom 45 ml (p = 0,01).
How to use Duaklir Genuair
Kako uporabljati zdravilo Duaklir Genuair
Improvements in the PROactive total score were observed in patients treated with Duaklir Genuair compared with placebo (p=0.0002).
Pri bolnikih, zdravljenih z zdravilom Duaklir Genuair, so v primerjavi s placebom ugotovili izboljšanje celotne ocene PROactive (p = 0,0002).
In addition, a higher percentage of patients receiving Duaklir Genuair responded with a clinically meaningful improvement in SGRQ total score compared to aclidinium and formoterol (56.6% compared to 53.9% and 52.2%, respectively; p=0.603 and p=0.270, respectively).
Delež bolnikov, pri katerih je prišlo do klinično pomembnega izboljšanja skupne ocene SGRQ, je bil poleg tega večji pri tistih, ki so prejemali zdravilo Duaklir Genuair, v primerjavi s tistimi, ki so prejemali aklidinij ali formoterol (56,6 % v primerjavi s 53,9 % in 52,2 %; p = 0,603 in p = 0,270).
A total of 1222 patients were treated with Duaklir Genuair 340 micrograms /12 micrograms.
Zdravilo Duaklir Genuair 340 mikrogramov/12 mikrogramov je skupaj prejemalo 1.222 bolnikov.
In addition, a higher percentage of patients receiving Duaklir Genuair responded with a clinically meaningful improvement in TDI focal score compared to either aclidinium or formoterol (61.9% compared to 55.7% and 57.0%, respectively; p=0.056 and p=0.100, respectively).
Delež bolnikov, pri katerih je prišlo do klinično pomembnega izboljšanja skupne ocene indeksa TDI, je bil večji pri tistih, ki so prejemali zdravilo Duaklir Genuair, v primerjavi s tistimi, ki so prejemali aklidinij ali formoterol (61,9 % v primerjavi s 55,7 % in 57,0 %; p = 0,056 in p = 0,100).
The peak plasma concentrations at steady state of aclidinium and formoterol observed in patients with COPD treated with Duaklir Genuair twice daily for 5 days were reached within 5 minutes post-inhalation and were 128 pg/ml and 17 pg/ml, respectively.
Največje plazemske koncentracije aklidinija 128 pg/ml in formoterola 17 pg/ml v stanju dinamičnega ravnovesja so bile dosežene v 5 minutah po inhalaciji pri bolnikih s KOPB, ki so pet zaporednih dni prejemali zdravilo Duaklir Genuair dvakrat na dan.
Manufacturer: Industrias Farmacéuticas Almirall, S.A.
Ime in naslov izdelovalca, odgovornega za sproščanje serij Industrias Farmacéuticas Almirall, S.A.
Duaklir Genuair showed improvements compared to placebo in lung volumes at 2-3h post dose (FRC=-0.366 L [95% CI=-0.515, -0.216; p<0.0001]; residual volume [RV]=-0.465 L [95% CI=0.648, -0.281; p<0.0001] and inspiratory capacity [IC]= 0.293 L [95% CI=0.208, 0.378; p<0.0001]).
Zdravilo Duaklir Genuair je v primerjavi s placebom doseglo izboljšanje pljučnih volumnov 2 do 3 ure po odmerku (FRC = -0,366 l, 95 % IZ: -0,515, -0,216, p < 0,0001; rezidualni volumen [RV]= -0,465 l,
Each delivered dose (the dose leaving the mouthpiece) contains 396 micrograms aclidinium bromide equivalent to 340 micrograms of aclidinium and 11.8 micrograms of formoterol fumarate dihydrate.
En dostavljen odmerek (odmerek, ki pride iz ustnika) vsebuje 396 mikrogramov aklidinijevega bromida, kar ustreza 340 mikrogramom aklidinija, in 11,8 mikrograma formoterolijevega fumarat dihidrata.
What Duaklir Genuair is
Kaj je zdravilo Duaklir Genuair
What Duaklir Genuair is used for
Za kaj zdravilo Duaklir Genuair uporabljamo
Dry mouth has been observed with medicines like Duaklir Genuair.
Pri zdravilih, kot je zdravilo Duaklir Genuair, so opazili pojav suhih ust.
Duaklir Genuair 340 micrograms/12 micrograms inhalation powder aclidinium/formoterol fumarate dihydrate
Duaklir Genuair 340 mikrogramov/12 mikrogramov prašek za inhaliranje aklidinij/formoterolijev fumarat dihidrat
No clinically relevant effects of Duaklir Genuair on ECG parameters (including QT-interval) compared with aclidinium, formoterol and placebo were seen in Phase III studies of 6 to 12 months duration conducted in approximately 4,000 patients with COPD.
V 6- do 12-mesečnih študijah 3. faze pri približno 4.000 bolnikih s KOPB niso opazili nobenih klinično pomembnih učinkov zdravila Duaklir Genuair na parametre elektrokardiograma (vključno z intervalom QT) v primerjavi z aklidinijem, formoterolom in placebom.
Duaklir Genuair 340 mcg/12 mcg inhalation powder aclidinium/formoterol fumarate dihydrate
Duaklir Genuair 340/12 μg prašek za inhaliranje aklidinij/formoterolijev fumarat dihidrat za inhaliranje
NN:
Začetek:
Duaklir Genuair is unlikely to affect your ability to drive or use machines.
Vpliv na sposobnost upravljanja vozil in strojev Malo verjetno je, da bi zdravilo Duaklir Genuair vplivalo na vašo sposobnost upravljanja vozil in strojev.
You should not use this medicine to treat a sudden attack of breathlessness or wheezing.
Zdravilo Duaklir Genuair je indicirano za vzdrževalno (dolgotrajno) zdravljenje KOPB in ga ne smete uporabljati za zdravljenje nenadnega napada zadihanosti ali piskajočega dihanja.
Milk: 5 days.
Mleko: 5 dni.
No data on overdosing are available.
Podatki o predoziranju niso na voljo.
Wash the udder if it is dirty.
Operite vime, če je umazano.
Similar concentrations were reached at 12 and 24 hours after a second infusion at a 24 hour interval.
Podobne koncentracije so bile dosežene v 12 in 24 urah po drugi infuziji v 24 urnem presledku.
Pirlimycin has a basic pKa (8.5).
Pirlimicin ima bazično pKa (8,5).
Norbrook Laboratories Limited Station Works, Camlough Road, Newry, County Down, BT35 6JP
Station Works, Camlough Road, Newry, County Down, BT35 6JP
This means it will be more active in an acid environment and tends to concentrate, relative to plasma, in areas with lower pH, such as abscesses.
To pomeni, da je bolj učinkovit v kislem okolju in se koncentrira, glede na plazmo, v področjih z nizkim pH, kot so abscesi.
Of the dose infused, 10-13% is excreted in the urine, and 24-30% via the faeces; the remainder is excreted in the milk.
Po vnosu enkratnega odmerka se 10-13 % zdravila izloči z urinom in 24-30% z iztrebki, preostanek pa se izloči z mlekom.
Gram-positive isolates with an MIC > 2 µg/ml are to be considered resistant.
Grampozitivni izolati z MIC>2 μg/ml se štejejo kot rezistentni.
Date of last renewal: 08/02/2006
Datum zadnjega podaljšanja dovoljenja za promet: 08/02/2006
After intramammary infusion, mean parent concentrations in milk were 10.3 µg/ml at 12 hours and 0.77 µg/ml at 24 hours.
Po intramamarni infuziji je bila koncentracija v mleku 10,3 μg/ml v 12 urah in 0,77 μg/ml v 24 urah.
Any unused veterinary medical product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with the local requirements.
Vsako neporabljeno zdravilo za uporabo v veterinarski medicini ali odpadne snovi, ki nastanejo iz teh zdravil, je treba odstraniti v skladu z lokalnimi zahtevami.
Antiinfectious agents/ Antibiotics
učinkovine proti infekcijam/anti biotiki
Do not treat cows with palpable udder changes due to chronic subclinical mastitis.
Ne zdravite krav, ki imajo otipljive spremembe na vimenu zaradi kroničnega subkliničnega mastitisa.
Resistance against pirlimycin.
Rezistenca na pirlimicin.
The active substance in Pirsue 5mg/ml intramammary solution for cattle is an allowed substance as described in table 1 of the annex to Commission Regulation (EU) No 37/2010:
C. NAVEDBA NAJVIŠJIH DOVOLJENIH KOLIČIN OSTANKOV ZDRAVILA (MRL) Zdravilna učinkovina v PIRSUE 5 mg/ml intramamarna raztopina za govedo je dovoljena učinkovina kot je navedena v tabeli 1(dovoljene snovi) priloge Uredbe Komisije (EU) št.37/2010:
The treatment consists of eight infusions of one syringe every 24 hours.
Zdravljenje je sestavljeno iz osmih vnosov, en injektor vsakih 24 ur.
MANUFACTURER'S BATCH NUMBER Lot{number}
PROIZVAJALČEVA ŠTEVILKA SERIJE Lot {številka}
Wash hands and any exposed skin with soap and water and remove contaminated clothing immediately after use.
Ob morebitnem stiku rok ali kože z intramamarno raztopino, si morate umiti roke z vodo in milom in odstraniti onesnažena oblačila takoj po uporabi.
Cross-resistance may occur between pirlimycin and other lincosamides or macrolides.
Možna je navzkrižna rezistenca med pirlimicinom in ostalimi linkozamidi ali makrolidi.
Enteric bacteria such as E. coli are intrinsically resistant to pirlimycin.
Črevesne bakterije kot so E. Coli so intrizično rezistentne na pirlimicin.
Gently insert the cannula into the teat canal; carefully infuse the product.
Nežno vstavite konico injektorja v seskov kanal; previdno vnesite zdravilo.
Intramammary use.
Intramamarna uporaba.
DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/).
DATUM ZADNJE ODOBRITVE NAVODIL ZA UPORABO Podrobne informacije o tem zdravilu so na voljo na spletni strani Evropske agencije za zdravila (European Medicines Agency) http://www.ema.europa.eu/
The product is indicated for use in lactating dairy cows and can be used during pregnancy.
Zdravilo je namenjeno zdravljenju krav v laktaciji in se lahko uporablja v obdobju brejosti.
The following instructions should therefore be followed carefully.
Natančno upoštevajte navodila za uporabo.
Meat and offal: 23 days.
Meso in organi: 23 dni.
Do not use this veterinary medicinal product after the expiry date which is stated on the label and the container.
Zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na nalepki oziroma zunanji ovojnini.
Push plunger with continuous pressure gently and slowly to dispense entire contents into the gland and massage the quarter to distribute the product into the milk cistern.
Potiskajte bat injektorja z enakomernim pritiskom, nežno in počasi, da izpraznite celotno vsebino v mlečno žlezo in masirajte vimensko četrt tako dolgo, da se zdravilo razporedi po mlečni cisterni.
Ensure adequate cleansing of the teat (and udder - if needed) before infusion.
Pred vnosom zagotovite ustrezno čiščenje seskov (in vimena, če je to potrebno).
Infuse one syringe (50 mg pirlimycin) into each infected quarter.
Vnesite vsebino enega injektorja (50 mg pirlimicina) v vsako okuženo vimensko četrt.
Keep the syringes in the original container.
Shranjujte injektorje v originalni ovojnini.
Hold eyelids open to ensure complete contact with water.
Veke držite široko odprte, da zagotovite spiranje celotne površine z vodo.
Pirlimycin has been shown to accumulate in polymorphonuclear cells, however, intracellular killing of Staphylococcus aureus was not demonstrated.
Pirlimicin se kopiči v polimorfonuklearnih celicah, kljub temu pa intracelularno ne ubija bakterije Staphylococcus aureus.
Medicines should not be disposed of via wastewater or household waste.
Ne odvrzite zdravila v odpadno vodo ali med godpodinjske odpadke.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 29/01/2001
Datum pridobitve dovoljenja za promet: 29/01/2001
Care must be taken not to introduce pathogens into the teat in order to reduce the risk of E. coli infections.
Pazite, da pri vnosu ne vnašate patogenih mikroorganizmov, saj s tem zmanjšate možnost infekcije z E. coli.
Also packaged as 120 x 10 ml syringes in a plastic bucket.
Injektorji so pakirani tudi kot 120 x 10 ml injektorjev v plastičnem vedru.
Pirlimycin hydrochloride is a semi-synthetic lincosamide antibiotic.
Pirlimicin hidroklorid je polsintetični antibiotik iz skupine linkozamidov.
Cattle (lactating dairy cows)
Govedo (krave v laktaciji).
They work by binding to the 50S ribosomal subunit, therefore hindering the aminoacyl-tRNA binding and inhibiting the peptidyltransferase reaction, which interferes with protein synthesis within the bacteria.
Delujejo tako, da preprečuje sintezo beljakovin s tem, da se veže na podenoto bakterijskega ribosoma (50S), s tem zavirajo vezavo aminoacilne-tRNK, kar pri občutljivih bakterijah povzroči moteno aktivnost peptidiltransferaze.
Treatment of infections due to Gram-negative bacteria such as E. coli.
Zdravljenje infekcij, ki jih povzročajo gramnegativne bakterija kot je E.coli.
Where necessary, wash teats thoroughly with warm water containing a suitable dairy cleansing agent and dry them thoroughly.
Kadar je treba, temeljito operite vime s toplo vodo, ki vsebuje primerno čistilno sredstvo (namenjeno čiščenju vimena) in ga nato temeljito osušite.
Other provisions
DRUGE INFORMACIJE
The lincosamides (clindamycin, lincomycin, and pirlimycin) inhibit protein synthesis in Gram-positive and in anaerobic bacteria as well as in Mycoplasma spp.
linkomicin in pirlimicin) inhibirajo sintezo beljakovin pri grampozitivnih in anaerobnih bakterijah kot tudi pri Mycoplasmi spp.
The teat end should be cleaned until no more dirt appears on the swab.
Konico seska čistite toliko časa, da na krpi ne ostajajo več sledovi umazanije.
Administration: by intramammary infusion only.
Način uporabe: samo intramamarno.
The excipients listed in section 6.1 of the SPC are considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
Pomožne snovi, navedene v poglavju 6.1 SPC, ne spadajo v področje uporabe Uredbe (ES) št.
Clean hands before handling the cow's udder.
Pred prijemanjem vimena si operite roke.
ATC vet code: QJ51FF90
Farmakoterapevtska skupina: Antibiotiki za intramamarno uporabo Oznaka ATC vet: QJ51FF90
For the treatment of subclinical mastitis in lactating cows due to Gram-positive cocci susceptible to pirlimycin including staphylococcal organisms such as Staphylococcus aureus, both penicillinase-positive and penicillinase-negative, and coagulase-negative staphylococci; streptococcal organisms including Streptococcus agalactiae, Streptococcus dysgalactiae and Streptococcus uberis.
Za zdravljenje subkliničnega mastitisa pri kravah v obdobju laktacije, ki ga povzročajo grampozitivni koki, občutljivi na pirlimicin, vključno s stafilokoki kot so Staphylococcus aureus (penicilinaza pozitivni, penicilinaza negativni in koagulaza negativni stafilokoki), streptokoki, vključno s Streptococcus agalctiae, Streptococcus dysgalactiae in Streptococcus uberis.
Do not touch cleaned teat ends before administering the infusion substance.
Čistih konic seskov se ne dotikajte vse do vnosa zdravila.
MARKETING AUTHORISATION NUMBER(S) EU/2/00/027/001
ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/00/027/001
Insertion: Remove the white end cap by pulling straight up.
Vnos: s potegom odstranite bel pokrovček.
STATEMENT OF ACTIVE SUBSTANCES Pirlimycin hydrochloride equivalent to 50 mg pirlimycin per 10 ml syringe
Pirlimicin hidroklorid, ekvivalentno 50 mg pirlimicina na 10 ml injektor.
DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION Intramammary use
ODMERKI ZA POSAMEZNE ŽIVALSKE VRSTE TER POT(I) IN NAČIN UPORABE ZDRAVILA
Flush eyes with water for 15 minutes immediately after exposure.
Če pride infuzija v kontakt z očmi, moramo oči spirati z vodo 15 minut.
MARKETING AUTHORISATION NUMBER(S) EU/2/00/027/001-003
ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/00/027/001-003
Pirlimycin Bovine 100 µg/kg 100 µg/kg
100 μg/kg 100 μg/kg 1000 μg/kg 400 μg/kg 100 μg/kg meso maščoba jetra ledvica mleko
PACKAGE LEAFLET: Pirsue 5 mg/ml intramammary solution for cattle
Pirsue 5 mg/ml intramamarna raztopina za govedo
Avoid contact with the solution.
Izogibajte se direktnemu stiku z intramamarno raztopino.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS {label on the syringe}
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
Following infusion, dip all teats with a disinfectant teat dip.
Po končanem vnosu, vse seske potopite v razkužilno kopel za seske.
NAME OF THE VETERINARY MEDICINAL PRODUCT Pirsue 5 mg/ml intramammary solution for cattle
NAVODILO ZA UPORABO Pirsue 5 mg/ml intramamarna raztopina za govedo
Disinfect teat end using a suitable cleansing agent.
Konico seska nato razkužite s primernim čistilnim sredstvom.
Use a separate disinfectant towelette for each teat.
Za čiščenje vsakega seska uporabimo nov razkužilni robček.
Name and address of the manufacturers responsible for batch release
Ime in naslov proizvajalca(proizvajalcev) zdravila, odgovornega (odgovornih) za sproščanje serij
Anhydrous citric acid
Brezvodna citronska kislina Natrijev citrat Voda za injekcije
PACKAGE SIZE 8 x 10 ml intramammary syringes 24 x 10 ml intramammary syringes 120 x 10 ml intramammary syringes
PODATKI NA ZUNANJI OVOJNINI 8×10 ml injekorji
WITHDRAWAL PERIOD(S) Meat and offal: 23 days.
4.11 Karenca Meso in organi: 23 dni.
4.8 Interaction with other medicinal products and other forms of interaction
4.8 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Možna je navzkrižna rezistenca med pirlimicinom in ostalimi linkozamidi ali makrolidi.
Susceptibility testing of the target bacteria should be carried out prior to treatment.
Posebni previdnostni ukrepi za uporabo pri živalih Pred uporabo zdravila je priporočljivo narediti antibiogram.
PARTICULARS TO APPEAR ON THE OUTER PACKAGE 8 x 10 ml syringes in an outer carton box 24 x 10 ml syringes in an outer carton box, including 3 package inserts 120 x 10 ml syringes in a plastic bucket, including 15 package inserts
24×10 ml injektorji, dodana 3 navodila za uporabo 120×10 ml injektorji, dodanih 15 navodil za uporabo