qanastek/EMEA-V3 huggingface dataset:
If Zactran comes in direct contact with the eyes, they should be flushed immediately with clean water.
F’ każ li jkun hemm kuntatt dirett ta ’ Zactran mal- għajnejn, dawn għandhom jitlaħalħu minnufih b’ ilma nadif.
Similarly, if Zactran comes into direct contact with skin the affected area should be washed immediately with clean water.
Bl- istess mod, jekk ikun hemm kuntatt dirett ta ’ Zactran mal- ġilda, il- parti milquta għandha titlaħlaħ minnufih b’ ilma nadif.
In case of accidental self-injection, medical advice should be sought immediately and the package leaflet or the label should be presented to the physician.
Fil- każ li wieħed jinjetta lilu nnifsu b’ mod aċċidentali, wieħed għandu jfittex parir mediku minnufih u għandu juri l- fuljett ta ’ tagħrif jew it- tikketta lit- tabib.
What is the time to allow before the animal can be slaughtered and the meat used for human consumption (withdrawal period)?
Kemm irid jgħaddi żmien qabel ma l- annimal ikun jista ’ jinqatel u l- laħam tiegħu jintuża għall - konsum mill- bniedem (perjodu ta ’ rtirar)?
After the last administration of Zactran, cattle should not be slaughtered for 64 days.
Wara li jingħata Zactran għall- aħħar darba, il- bovini ma jistgħux jinqatlu sa 64 ġurnata wara.
What is the time to allow before milk can be taken from the animal for human consumption?
Kemm irid jgħaddi żmien qabel ma jkun jista ’ jittieħed ħalib mill- annimal għall- konsum mill - bniedem?
As the safety of Zactran in breeding animals has not been studied, the medicine should not be used in lactating cows or heifers producing milk for human consumption.
Minħabba li ma ġietx studjata s- sigurtà ta ’ Zactran fit- trattament ta ’ annimali tar- refgħa, ma għandux jintuża f’ baqar li qegħdin jitħallbu jew f’ erieħ li jipproduċu l- ħalib għall- konsum mill- bniedem.
It should also not be used in pregnant cows or heifers which are intended to produce milk for human consumption within 2 months of calving.
Ma għandux jintuża wkoll f- baqar jew erieħ waqt it- tqala li hu maħsub li jintuża biex jipproduċu ħalib għall- konsum mill- bniedem fi żmien xahrejn wara li jildu l- frieħ.
Why has Zactran been approved?
Għaliex ġie approvat Zactran?
The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Zactran exceeded the risks for the therapeutic and preventive treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida and Histophilus somni, (the presence of the disease in the herd should be established before preventive treatment) and recommended that Zactran should be given a marketing authorisation.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu Veterinarju (CVMP) ikkonkluda li l- benefiċċji ta ’ Zactran huma akbar mir- riskji tiegħu għat- trattament terapewtiku u preventiv tal- marda respiratorja tal- bovini (BRD) assoċjata ma ’ Mannheimia haemolytica, Pasteurella multocida and Histophilus somni, (il- preżenza tal- marda f’ merħla għandha tiġi stabbilita qabel it - trattament preventiv) u irrakkomanda li Zactran jingħata awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Zactran:
Aktar tagħrif dwar Zactran:
The European Commission granted a marketing authorisation valid throughout the European Union, for Zactran to Merial on 24/ 07/ 2008.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida madwar l- Unjoni Ewropea għal Zactran lil Merial fi 24/ 07/ 2008.
Information on the prescription status of this product may be found on the label/ outer package.
L- informazzjoni dwar l- istat tal- preskrizzjoni ta ’ dan il- prodott tista ’ tiġi kkonsultata fuq it- tikketta jew fuq il- qoxra tal- pakkett.
This summary was last updated in July 2008.
Dan is- sommarju ġie aġġornat l- aħħar fi:
EMEA Number
Numru ta ’ l- UE Isem
Content
kummerċjali
Package size
Amministrazzjoni
Withdrawal period
pakkett Tiżmim
Solution for injection
Soluzzjoni għal Bovini injezzjoni
Cattle
Taħt il- ġilda
Subcutaneous use
Kaxxa tal - kartun bi fjal wieħed
Cardboard box with one vial
Fjal tal - ħġieġ
64 days.
64 ġurnata.
Not permitted for use in lactating animals.
Mhux permess li jintuża f’ annimali li qed jaħilbu.
ZACTRAN 150mg/ ml solution for injection for cattle
ZACTRAN soluzzjoni ta ’ 150mg/ ml għal injezzjoni għall- bovini.
One ml contains:
Kull ml għandu:
Colourless to pale yellow solution.
Soluzzjoni bla kulur sa isfar ċar.
Cattle
Bovini.
Therapeutic and preventive treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida and Histophilus somni.
Kura terapewtika u preventiva tal- marda respiratorja fil- bovini assoċjata mal- Mannheimia haemolytica, Pasteurella multocida u Histophilus somni.
The presence of the disease in the herd should be established before preventive treatment.
Qabel tinbeda l- kura preventiva għandu jiġi stabbilit li hemm il- marda fil- merħla.
Do not use in case of hypersensitivity to macrolide antibiotics or to any of the excipients.
Tużax f' każijiet ta 'sensittivita għall- antibjotiċi makrolidi jew għal xi wieħed mill- ingredjenti mhux attivi.
Do not use the product simultaneously with other macrolides or lincosamides (see section 4.8).
Tużax il- prodott flimkien ma makrolidi oħra jew linkosamidi (ara sezzjoni 4. 8).
Do not use in lactating cattle producing milk for human consumption.
Tużax f’ baqar tal- ħalib li qed jipproduċu l - ħalib għall- konsum uman.
Do not use in pregnant cows or heifers, which are intended to produce milk for human consumption, within 2 months of expected parturition.
Tużax f' baqar jew għerieh ħbiela li huma intenzjonati li jipproduċu l- ħalib għall- konsum uman sa fi żmien xahrejn mid- data mistennija tat- twelid.
Use of the veterinary medicinal product should be based on susceptibility testing and take into account official and local policies on the use of antimicrobials in farm animals.
L- użu tal- prodott mediċinali veterinarju għandu jkun ibbażat fuq testijiet ta ’ suxxettibilità u jieħu f’ kunsiderazzjoni d- direttivi uffiċċjali u lokali fuq l- użu ta ’ antimikrobiċi fl- annimali ta ’ l- irziezet.
2/ 17 Special precautions to be taken by the person administering the veterinary medicinal product to animals
2/ 18 Prekawzjonijiet speċjali li għandhom jittieħdu mill- persuna li tamministra l- prodott mediċinali veterinarju lill- annimali
People with known hypersensitivity to the macrolide class should avoid contact with the veterinary medicinal product.
Nies li huma sensittivi għall- klassi tal- makrolidi għandhom jevitaw li jmissu l- prodott mediċinali veterinarju.
Gamithromycin may cause irritation to eyes or/ and skin.
Evita kuntatt mal- ġilda jew ma ’ l- għajnejn.
Avoid contact with skin or eyes If eye exposure occurs, flush eyes immediately with clean water.
F’ każ li jkun hemm kuntatt ma ’ l- għajnejn aħsel l - għajnejn minnufih b’ ilma nadif.
If skin exposure occurs, wash the affected area immediately with clean water.
F’ każ li jkun hemm kuntatt mal- ġilda, aħsel il- parti effettwata minnufih b’ ilma nadif.
In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
F' każ li tinjetta lilek innifsek fittex tabib mal- ewwel u qis li turih il- pakkett jew il- fuljett ta 'informazzjoni li jkun fih ġewwa.
During clinical trials no treatment related abnormalities were observed except some transient injection site swellings.
Waqt il- provi kliniċi, ma ġie osservat xejn li hux normali ħlief għal xi nefħa transitorja fil- post tal - injezzjoni.
Visible injection site swellings may develop in up to 45% of treated animals associated with occasional, slight pain evident for one day.
Nefħiet visibbli fil- post tal- injezzjoni jistgħu jiżviluppaw f’ sa 45% tal- annimali li ħadu l - kura, assoċjati ma ftit uġigħ xi kultant evidenti għal jum wieħed.
The swellings typically resolve within 3 to 14 days but may persist in some animals for up to 35 days after treatment.
In- nefħiet tipikament jinżlu fi żmien 3 sa 14 il- ġurnata iżda f’ xi annimali jistgħu jippersistu sa 35 ġurnata wara l- kura.
Based on laboratory animal data, gamithromycin has not produced any evidence of selective developmental or reproductive effects.
Minn informazzjoni bażata fuq studji fuq annimali fil- laboratorju, il- gamithromycin ma pprovdiex evidenza ta 'effetti selettivi ta ’ l- iżvilupp jew riproduttivita.
The safety of gamithromycin during pregnancy and lactation has not been evaluated in cattle.
Is- sigurtà tal- gamithromycin waqt it- tqala u fi żmien il- ħalib ma ġietx stabbilita fil- bovini.
Use only according to the risk/ benefit assessment by the responsible veterinarian.
Uża biss skond kif il- veterinarju responsabbli iqis il - benefiċċju / riskju tal- prodott.
Cross resistance may occur with other macrolides.
Jista jkun hemm reżistenza nkruċjata ma makrolidi oħra.
Avoid simultaneous administration of antimicrobials with a similar mode of action such as other macrolides or lincosamides.
Evita li tamministra flimkien antimikrobiċi li għandhom l- istess mod t’ azzjoni bħal makrolidi oħra jew linkosamidi.
A single subcutaneous injection of 6 mg gamithromycin/ kg body weight (equivalent to 1 ml/ 25 kg body weight) in the neck.
Injezzjoni waħda taħt il- ġilda ta ’ 6 mg gamithromycin/ kg ta ’ piż tal- ġisem (ekwivalenti għal 1ml/ 25 kg piż tal- ġisem) fl- għonq.
For treatment of cattle over 250 kg body weight, divide the dose so that no more than 10 ml are injected at one site.
Għall- kura ta ’ bovini ‘ l fuq minn 250 kg ta ’ piż tal- ġisem, aqsam id- doża sabiex ma jiġux injettati iżjed minn 10 ml fl- istess post.
To ensure correct dosage body weight should be determined as accurately as possible to avoid underdosing.
Biex tassikura dożaġġ korrett, il- piż tal- ġisem għandu jiġi stabbilit b’ mod preċiż kemm jista jkun biex ma tingħatax doża nieqsa.
Clinical studies have demonstrated the wide margin of safety for gamithromycin injection in cattle.
Studji kliniċi urew marġini wiesgħa ta ’ sigurta ’ għal injezzjoni ta ’ gamithromycin fil- bovini.
In a young adult cattle study, gamithromycin was administered by subcutaneous injection at 6, 18, and 30 mg/ kg (1, 3, and 5 times the recommended dose) and repeated three times at 0, 5 and 10 days (three times the recommended duration of use).
Fi studju dwar bovini adulti żgħar, gamithromycin ġie amministrat b’ injezzjoni taħt il- ġilda ta ’ 6, 18 u 30 mg/ kg (darba, tlieta u ħames darbiet id- doża rakkomandata) u ripetuta tliet darbiet 0, 5 u 10 jiem (tliet darbiet tat- tul ta ’ l- użu rakkomandat).
Injection site reactions were noted in a dose related manner.
Reazzjonijiet relatati mad- doża ġew osservati fil- post tal - injezzjoni.
64 days
64 ġurnata.
3/ 17 5.
3/ 18 Mhux permess li jintuża f' annimali li qed jaħilbu, u li l- ħalib tagħhom qed jintuża għall- konsum tan - nies.
QJ01FA95
Makrolidi, Kodici ATĊ veterinarja QJ01FA95
Gamithromycin is an azalide, 15-membered semisynthetic macrolide class antibiotic with uniquely positioned alkylated nitrogen at 7a-position of the lactone ring.
Gamithromycin huwa Azalide, antibjotiku semisintetiku tal- klassi 15- membered tal- makrolidi b ’ alkylated nitrogen ippożizzjonat fil- pożizzjoni 7a taċ- ċirku lactone.
This special chemistry facilitates rapid absorption at physiological pH and a long duration of action at the target tissue, lung.
Din il- kimika speċjali tiffaċilita assorbiment ta ’ malajr f’ pH fisjoloġiku u azzjoni fit- tul fit- tessut immirat, il- pulmun.
Macrolides in general have both bacteriostatic and bactericidal action mediated through disruption of bacterial protein synthesis.
Il- makrolidi ġeneralment għandhom azzjoni kemm batterjostatika kif ukoll batterjoċidjali medjata billi tkun imfixkla s- sintesi tal- proteina tal- batterji.
Macrolides inhibit bacterial protein biosynthesis by binding to the 50S ribosomal subunit and by preventing peptide chain elongation.
Il- Makrolidi iwaqqfu l- biosintesi tal- proteina tal - batterji billi jintrabtu mal- 50S ribosomal subunit u jimpedixxu żieda fit- tul tal- katina peptide.
The in vitro data show that gamithromycin acts in a bactericidal manner.
L - informazzjoni in vitro turi li l- gamithromycin jaġixxi b’ mod li joqtol il- batterji.
The broad spectrum antimicrobial activity of gamithromycin includes Mannheimia haemolytica, Pasteurella multocida and Histophilus somni, the bacterial pathogens most commonly associated with BRD.
L- attivita ’ kontra l- mikrobi li tkopri spektrum wiesgħa tal- gamithromycin tinkludi Mannheimia haemolytica, Pasteurella multocida u Histophilus somni, il- patoġeni batterjali li huma ġeneralment assoċjati mal- BRD (il- marda respiratorja tal- bovini).
The MIC and MBC data are reported from a representative sample of isolates from field materials within different geographic EU areas.
L- informazzjoni dwar il- MIC u l- MBC ġejja minn kampjun rappresentattiv ta ’ batterji iżolati provenjenti minn wesgħat f’ żoni ġeografikament differenti ta ’ l- Unjoni Ewropea.
Species
Speċi
Three mechanisms are generally considered responsible for resistance to the macrolide class of compounds.
Tliet mekkanismi huma ġeneralment meqjusa responsabbli għar- resistenza għall- klassi tal- makrolidi.
This is often referred to as MLSB resistance as it affects macrolides, lincosamides and streptogramins.
Din ta ’ sikwit hija msejħa resistenza MLS peress li teffettwa l- makrolidi, il- linkosamidi u lis - steptogramini.
The mechanisms involve the alteration of the ribosomal target site, the utilization of active efflux mechanism and the production of inactivating enzymes.
Il- mekkaniżmi jinvolvu t- tibdil tal- post ribosomali immirat, l- użu ta ’ mekkaniżmu tal - effluss attiv u l- produzzjoni ta ’ enżimi li jinattivaw lis- sustanza.
Gamithromycin administered subcutaneously into the neck of cattle at single dosage of 6 mg/ kg body weight, resulted in rapid absorption with peak plasma concentrations observed after 30 to 60 min with a long plasma half-life (> 2 days).
Il- gamithromycin amministrat taħt il- ġilda fl- għonq tal- bovini f’ doża waħda ta ’ 6mg/ kg ta ’ piż tal - ġisem, irriżulta f’ assorbiment ta ’ malajr b’ konċentrazzjonijiet massimi fil- plasma osservati wara 30 sa 60 minuta b’ half- life tal- plasma twila (> jumejn).
The bioavailability of the drug was > 98% with no gender differences.
Il- biodisponibilità tal- mediċina kienet > 98% mingħajr differenzi ta ’ sess.
The volume of distribution at steady-state was 25 l/ kg.
Il- volum tad- distribuzzjoni fiss kien ta ’ 25 l/ kg.
Gamithromycin levels in lung reached a maximum in less than 24 hr, with lung-to-plasma ratio of > 264 indicating that the drug was absorbed rapidly into the target tissue for BRD.
Il- livelli tal - Gamithromycin fil- pulmun laħqu il- massimu f’ inqas minn 24 siegħa, b’ ratio fil- pulmun għall- plasma ta ’ > 264 li jindikaw li l- mediċina ġiet assorbita malajr mit- tessut immirat għal BRD.
In vitro plasma protein binding studies determined that the mean concentration of the free drug was 74%.
Studji in vitro dwar l- abbinar tal- proteini mal- plasma wrew li l- konċentrazzjoni medja tal- mediċina libera kienet ta ’ 74%.
Biliary excretion of the unchanged drug was the major route of elimination.
Il- mod prinċipali għat- tneħħija tal- mediċina mhux alterata kienet fil- bili (tal - fwied).
In the absence of compatibility studies, this veterinary medicinal product should not be mixed with other veterinary medicinal products.
Fin- nuqqas ta ’ studji dwar kompattibilità, dan il- prodott mediċinali veterinarju ma jistax jintuża flimkien ma prodotti mediċinali veterinarji oħra.
4/ 17 Shelf life after first opening the immediate packaging:
Żmien li l- prodott jibqa ’ tajjeb wara li jkun tneħħa mill- ewwel ippakkjar:
Type 1 glass vial with a chlorobutyl rubber stopper and an aluminum cap.
Fjal tal- ħġieġ ta ’ Tip I bi stopper tal- chlorobutyl u b’ tapp ta ’ l- aluminjum.
Box containing 1 vial of 100, 250 or 500 ml Not all pack sizes may be marketed.
Kaxxa li fiha fjal ta ’ 100, 250 jew 500 ml Mhux id- daqsijiet kollha tal- pakket jistgħu jitpoġġew fis- suq
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.
Mediċina veterinarja li ma ġietx użata jew prodotti oħra li ntużaw għal din il- mediċina għandhom jintremew skond kif jitolbu r- regolamenti tal- pajjiż.
MERIAL 29 avenue Tony Garnier F - 69007 Lyon France
MERIAL 29 avenue Tony Garnier F- 69007 Lyon France
CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION REGARDING SUPPLY OR USE
KUNDIZZJONIJIET JEW RESTRIZZJONIJIET TA 'L - AWTORIZZAZZJONI TAL- KUMMERĊ FUQ IL - PROVISTA JEW L- UŻU
Gamithromycin is included in Annex III of Council Regulation (EEC) No 2377/ 90 in accordance with the following table:
Gamithromycin huwa inkluż fl- Anness III tar- Regolament tal- Kunsill (KE) Nru 2377/ 90 skond it - tabella li jmiss:
Pharmacologically Marker residue active substance
farmakoloġikament attiva
Animal species
jimmarka
MRLs
l- annimal
Target tissues
mmirati
Other provisions
oħrajn
Bovine
Xaħam
Fat Liver Kidney
Fwied Kliewi
Provisional MRLs expire on 1.7.2009 Not for use in animals producing milk for human consumption
Jiskadu fl- 1. 7. 2009 Mhux għall- użu f’ annimali li jipproduċu ħalib għall- konsum uman
Annex II of Council Regulation (EEC) No 2377/ 90:
Anness II tar- Regolament tal- Kunsill (KE) Nru 2377/ 90:
Pharmacologically active substance(s) Monothioglycerol 1 Succinic Acid (E 363) 2 Glycerol Formal 3
Succinic Acid (E 363) ²
Animal species All food animal species All food animal species All food animal species
Kull speċi ta ’ l- annimal għall- ikel
Other provisions
Glycerol Formal ³
L290 of 05.12.1995 2 OJ No.
Kull speċi ta ’ l- annimal għall- ikel
L5 of 09.01.1997
¹ OJ numru L. 290 tal- 5. 12. 1995 ² OJ numru L. 61 tat- 18. 03. 1995 ³ OJ numru L5 tad- 9. 01. 1997
9/ 17 PARTICULARS TO APPEAR ON THE OUTER PACKAGE AND ON THE IMMEDIATE PACKAGE (except 100 ml trilingual)
10/ 18 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA 'BARRA U FUQ IL- PAKKETT IMMEDJAT (ħlief 100 ml bi tliet lingwi)
{BOX and VIAL}
{KAXXA u FJAL}
ZACTRAN 150 mg/ ml solution for injection for cattle Gamithromycin
ZACTRAN soluzzjoni ta ’ 150mg/ ml għal injezzjoni għall- bovini.
1 ml contains 150 mg of gamithromycin 1 mg of monothioglycerol
1 ml fih 150mg ta ’ gamithromycin 1 mg ta ’ monothioglycerol
Single subcutaneous injection of 6 mg gamithromycin/ kg body weight (equivalent to 1 ml/ 25 kg body weight).
Injezzjoni waħda taħt il- ġilda ta ’ 6 mg gamithromycin/ kg ta ’ piż tal- ġisem (ekwivalenti għal 1ml/ 25 kg piż tal- ġisem).
Withdrawal period Meat and offal:
Laħam u ġewwieni:
64 days Not permitted for use in lactating animals producing milk for human consumption.
64 ġurnata.
Do not use in pregnant cows or heifers, which are intended to produce milk for human consumption, within 2 months of expected parturition.
Mhux permess għall- użu f’ annimali tal- ħalib li qed jipproduċu l - ħalib għall- konsum uman.
People with known hypersensitivity to the macrolide class should avoid contact with the product.
Nies li huma sensittivi għall- klassi tal- makrolidi għandhom jevitaw li jmissu l- prodott.
Gamithromycin may cause irritation to eyes or/ and skin.
Gamithromycin jista jikkawża irritazzjoni fl- għajnejn u/ jew fil- ġilda.
Avoid contact with skin or eyes.
Evita kuntatt mal- ġilda jew ma ’ l- għajnejn.
If eye exposure occurs, flush eyes immediately with clean water.
F’ każ li jkun hemm kuntatt ma ’ l- għajnejn aħsel l - għajnejn minnufih b’ ilma nadif.
In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
F' każ li tinjetta lilek innifsek fittex tabib mal- ewwel u qis li turih il- fuljett ta 'informazzjoni fil - pakkett jew it- tikketta.
EXP Once opened, use within 28 days.
EXP La darba jinfetaħ uża fi żmien 28 ġurnata.
Dispose of waste material in accordance with local requirements.
Armi l- materjal li ma ġiex użat skond kif jitolbu r- regolamenti tal- pajjiż.
For animal treatment only - to be supplied only on veterinary prescription.
Għall- kura tal- annimali biss - għandu jingħata biss bi preskrizzjoni veterinarja.
MERIAL 29 avenue Tony Garnier F - 69007 Lyon France
MERIAL 29 avenue Tony Garnier F – 69007 Lyon France
12/ 17 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE
13/ 18 TAGĦRIF LI GĦANDU JIDHER FUQ L- IPPAKKJAR IMMEDJAT
{VIAL}
{FJAL}
QUANTITY OF THE ACTIVE SUBSTANCE
KWANTITÀ TAS- SUSTANZA ATTIVA / SUSTANZI ATTIVI
Withdrawal period.
Żmien ta ’ Tiżmim.
EXP Once opened, use within 28 days.
EXP Jekk infetaħ uża fi żmien 28 ġurnata.
For animal treatment only
Għall- kura tal- annimali biss.
ZACTRAN 150mg/ ml solution for injection for cattle
15/ 18 FULJETT TA ’ TAGĦRIF FIL- PAKKETT ZACTRAN soluzzjoni ta ’ 150mg/ ml għal injezzjoni għall- bovini
MERIAL 29 avenue Tony Garnier F - 69007 Lyon France
MERIAL 29 avenue Tony Garnier F- 69007 Lyon
MERIAL 4, Chemin du Calquet F - 31057 Toulouse Cedex France
MERIAL 4, Chemin du Calquet F- 31057 Toulouse Cedex
ZACTRAN 150mg/ ml solution for injection for cattle Gamithromycin
ZACTRAN soluzzjoni ta ’ 150mg/ ml għal injezzjoni għall- bovini Gamithromycin 150 mg/ ml
STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENT
3 DIKJARAZZJONI TAS- SUSTANZA ATTIVA U INGREDJENT IEĦOR
1 ml contains 150 mg of gamithromycin 1 mg of monothioglycerol
1ml fih 150 mg ta ’ gamithromycin 1mg ta ’ monothioglycerol
Do not use in case of hypersensitivity to a certain type of antibiotics called macrolides or to any of the excipients.
Tużax f' każijiet ta 'sensittivita għal ċertu tip ta ’ antibjotiċi li huma mgħajjta makrolidi jew għal xi wieħed mill- ingredjenti mhux attivi.
Do not use this product simultaneously with other macrolides or antibiotics known as lincosamides.
Tużax dan il- prodott simultanjament ma makrolidi oħra jew antibjotiċi magħrufa bħala linkosamidi.
Do not use in pregnant cows or heifers, which are intended to produce milk for human consumption, within 2 months of expected parturition.
Tużax f' annimali ħbiela li huma intenzjonati li jipproduċu l- ħalib għall- konsum uman fi żmien xahrejn mid- data mistennija tat- twelid.
Transient injection site swellings with occasional slight pain.
Xi nefħiet transitorji fil- post tal- injezzjoni u okkażjonalment bi ftit uġigħ.
If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinarian.
Jekk tinnota xi effetti serji jew effetti oħra mhux msemmija f’ dan il- fuljett, jekk jogħġbok informa lit - tabib veterinarju tiegħek.
DOSAGE FOR EACH SPECIES, ROUTE AND METHOD OF ADMINISTRATION
8 DOŻA GĦAL KULL SPEĊI, MOD U METODU TA 'AMMINISTRAZZJONI
A single subcutaneous injection of 6 mg gamithromycin/ kg body weight (equivalent to 1 ml/ 25 kg body weight) in the neck.
Injezzjoni waħda taħt il- ġilda ta ’ 6 mg gamithromycin/ kg ta ’ piż tal- ġisem (ekwivalenti għal ml/ 25 kg piż tal- ġisem) fl- għonq.
For treatment of cattle over 250 kg body weight, divide the dose so that no more than 10 ml are injected at one site.
Għall- kura ta ’ bovini ‘ l fuq minn 250 kg ta ’ piż tal- ġisem, aqsam id- doża sabiex mhux iżjed minn 10 ml jiġu njettati fl- istess post.
Withdrawal period.
Perjodu ta 'Tiżmim.
Do not use in pregnant cows or heifers, which are intended to produce milk for human consumption, within 2 months of expected parturition
Mhux permess li jintuża f' annimali li qed jaħilbu, u li l- ħalib tagħhom qed jintuża għall- konsum tan- nies.
This veterinary medicinal product does not require any special storage conditions.
Dan il- prodott mediċinali veterinarju m’ għandux bżonn ta ’ kundizzjonijiet speċjali għall- ħażna.
Shelf-life after first opening the container:
Tużax wara d- data tal- iskadenza li hemm fuq il- fjal Żmien li l- prodott jibqa ’ tajjeb wara li jkun infetaħ il- kontenitur għall- ewwel darba:
Use according to the benefit/ risk assessment by the responsible veterinarian.
Uża biss skond kif il- veterinarju responsabbli iqis il- benefiċċju / riskju tal- prodott.
For the user:
Għal min se juża l- prodott:
Avoid contact with skin or eyes.
Evita kuntatt mal- ġilda jew ma ’ l- għajnejn..
Cross resistance may occur with other macrolides.
Jista jkun hemm reżistenza inkruċjata ma makrolidi oħra.
ZACTRAN should not be mixed with other medicinal products.
Zactran m’ għandux jitħallat ma prodotti mediċinali oħra.
Ask your veterinary surgeon how to dispose of medicines no longer required.
Saqsi lil kirurgu veterinarju tiegħek dwar kif l- aħjar li tarmi l- mediċini li ma jkunux aktar meħtieġa minnek.
These measures should help to protect the environment.
Dawn il- miżuri għandhom jgħinu biex jitħares l- ambjent.
Not all pack sizes may be marketed.
Kaxxa li fiha fjal ta ’ 100, 250 jew 500 ml; Mhux id- daqsijiet kollha tal- pakkett jistgħu qegħdin fis- suq.
Tradename Strength
Isem kummerċjali Qawwa
50 mg
ZUBRIN 50 mg
Oral lyophilisate
Lajofiliżejt jittieħed mill- ħalq
Blister (alu/ alu)
Strixxi (alu/ alu)
1 blister (10 oral lyophilisates)
bi strixxa (ta ’ għaxar lajofiliżejt li jittieħdu mill- ħalq) (10 oral lyophilisates)
Oral use
strixxi
3 blisters (30 oral lyophilisates)
tlett strixxi (b’ tletin lajofiliżejt li jittieħdu mill- ħalq) (30 oral lyophilisates)
Not applicable
Mhux applikabbl
6 blisters (60 oral lyophilisates)
sitt strixxi (b’ sittin lajofiliżejt li jittieħdu mill- ħalq) (60 oral lyophilisates)
Zubrin 50 mg oral lyophilisates for dogs Zubrin 100 mg oral lyophilisates for dogs Zubrin 200 mg oral lyophilisates for dogs
Zubrin 50 mg lajofiliżejt jittieħed mill- ħalq, għall- klieb Zubrin 100 mg lajofiliżejt jittieħed mill- ħalq, għall- klieb Zubrin 200 mg lajofiliżejt jittieħed mill- ħalq, għall- klieb
Active substance
Sustanzi Attivi
50 mg / oral lyophilisate
50 mg / lajofiliżejt jittieħed mill- ħalq
100 mg / oral lyophilisate 200 mg / oral lyophilisate
100 mg / lajofiliżejt jittieħed mill- ħalq 200 mg / lajofiliżejt jittieħed mill - ħalq
For a full list of excipients, see
Għal- lista sħiħa ta ’ l- ingredjenti (mhux attivi), ara s- sezzjoni 6. 1.
Oral lyophilisates
Lajofiliżejt jittieħed mill- ħalq
4.2 Indications for use
4. 2 Indikazzjoni għall- użu tal- prodott
Reduction of inflammation and relief of pain caused by acute and chronic musculoskeletal disorders.
Tnaqqis tal- infjammazzjoni u serħan mill- uġiegħ li jkun ġej minn diżordnijiet akuti fil- muskoli u l - għadam skeletali.
Do not use in pregnant or lactating dogs or in bitches intended for breeding.
Tużax fi klieb waqt it- tqala jew li qed ireddgħu jew klieb nisa intenzjonati għar- razza.
Use is contraindicated in animals suffering from cardiac or hepatic disease, or where there is a history of gastrointestinal ulceration, or bleeding, or where there is hypersensitivity to the product.
M’ għandux jintuża fuq klieb li jbatu minn mard tal- qalb jew tal- fwied, f’ każi ta ’ brix fl- istonku u l - imsaren, f’ każ ta ’ telf ta ’ demm jew jekk hemm allerġija għall- prodott.
Do not use in dehydrated, hypovolaemic or hypotensive dogs, as there is an increased risk of renal toxicity.
Tużahx jekk il- kelb ikun ixxotta, ikollu volum baxx ta ’ demm, jew ibati minn pressjoni baxxa, għaliex dawn jistgħu jgħollu r- riskju ta ’ tossiċita fil- kliewi.
Special care should be taken when treating dogs with marked renal insufficiency.
Wieħed għandu jagħti każ speċjali meta il- klieb li qed jiġu kkurati jkollhom xi nuqqas fis- sistema tal - kliewi.
Use in animals less than 6 months of age, with a weight below 5 kg, or in aged animals, may involve additional risk.
Ir- riskju jista ’ jkun ikbar jekk il- prodott jintuża f’ annimali ta ’ anqas minn 6 xhur, jew b’ piż ta ’ anqas minn 5 kg, jew f’ annimali xjuħ.
If such use cannot be avoided, close veterinary supervision to monitor for gastrointestinal blood loss is necessary.
F’ każ li l- użu ma jistax jiġi evitat, huwa neċessarju li jkun hemm veterinarju jgħasses għal telf ta ’ demm fis- sistema gastro- intestinali.
If side effects occur, treatment should be discontinued and the advice of a veterinary surgeon should be sought.
Jekk ikun hemm xi effetti mhux mixtieqa, il- kura għandha titwaqqaf u wieħed għandu jfittex parir tat - tabib veterinarju.
2 Special precautions to be taken by the person administering the medicinal product to animals
2 Prekawzjonijiet speċjali li għandhom jittieħdu mill- persuna li tamministra l- prodott mediċinali veterinarju lill- annimali
Tepoxalin is not water-soluble and becomes very sticky upon wetting.
Tepoxalin ma ddubx fl- ilma u ssir twaħħal ħafna meta tixxarrab.
If the oral lyophilisate disintegrates prematurely, wash hands thoroughly.
Jekk il- lajofiliżejt tinħall qabel il - waqt, aħsel idejk sew.
In case of ingestion of a number of oral lyophilisates by a person, the advice of a doctor should be sought immediately.
F’ każ li xi ħadd jibla ’ numru ta ’ lajofiliżejt, għandu jittieħed parir mediku minnufih.
Vomiting or diarrhoea may occur due to treatment.
Jista ’ jkun hemm remettar jew sliħ waqt il- kura.
Alopecia and erythema may also occur occasionally.
Okkażjonalment jista ’ jkun hemm ukoll telf ta ’ pil u eritema.
Typical undesirable side-effects associated with NSAIDs are vomiting, soft faeces/ diarrhoea, blood in faeces, reduced appetite and lethargy.
Effetti tipiċi mhux mixtieqa u marbuta mal- użu ta ’ mediċini anti- infjammatorji li mhumiex sterojdi bħal remettar, ippurgar artab/ sliħ, demm fl- ippurgar, nuqqas t’ aptit u telqa.
If there are such undesirable effects, treatment should be discontinued immediately.
Jekk ikun hemm dawn l - effetti mhux mixtieqa, il- kura għandha titwaqqaf minnufih.
In rare cases, particularly in older or in sensitive dogs, these undesirable effects may be serious or fatal.
F’ każi rari, l- aktar fi klieb xjuħ jew dawk sensittivi, dawn l- effetti jistgħu ikun serji kif ukoll fatali.
During clinical trial testing of the product, the incidence of gastrointestinal reactions (diarrhoea/ vomiting) was 10%.
Il- frekwenza ta ’ reazzjonijiet gastro- intestinali (sliħ/ remettar) waqt testijiet kliniċi fuq il- prodott, kienet ta ’ 10%.
Do not use in pregnant or lactating bitches.
M’ għandux jintuża fit- tqala u fi klieb li qed ireddgħu.
Tepoxalin must not be administered in conjunction with other NSAIDs or glucocorticosteroids.
Tepoxalin m’ għandhiex tingħata flimkien ma ’ mediċini anti- infjammatorji li mhumiex sterojdi oħra jew glukokortikosterojdi.
Other NSAIDs, diuretics, anticoagulants and substances with high plasma protein binding may compete for binding leading to potentially toxic effects.
Mediċini anti- infjammatorji li mhumiex sterojdi, dijuretiċi, antikoagulanti u sustanzi li jabbinaw mal- proteini tad- demm f’ ammonti kbar, jistgħu jikkompetu biex jabbinaw, u dan jista ’ jwassal għal effetti tossiċi.
10 mg tepoxalin per kg bodyweight once daily.
10 mg Tepoxalin għal kull kg piż darba kuljum.
The duration of treatment is dependent on clinical response.
It- tul tal- kura jiddependi mill- progress kliniku.
After a treatment period of 7-10 days, the condition of the dog should be re- evaluated in order to establish the need for continuation of treatment.
Wara perjodu ta ’ trattament ta ’ bejn 7 u 10 tijiem, il- kundizzjoni tal- kelb għandha terġa ’ tiġi evalwata biex jiġi stabbilit għandhiex titkompla l- kura.
Long term treatment should be under regular veterinary supervision.
Kura fit- tul għandha dejjem issir taħt superviżjoni ta ’ veterinarju.
The weight of the animal should be accurately determined before start of treatment.
L- annimal għandu jintiżen sew qabel tibda il- kura.
Peel back foil to reveal a single oral lyophilisate in the form of a round tablet.
Qaxxar l- istrixxa biex tikxef sustanza waħda ta ’ lajofiliżejt, f’ forma ta ’ pillola tonda.
Ensure hands are dry to prevent the tablet from sticking to fingers.
Kun ċert li jdejk huma xotti biex tevita li l- pillola teħel ma ’ subgħajk.
Push the bottom of the blister and the tablet will pop out.
Agħfas l- istrixxa mill- qiegħ biex il- pillola tinbeżaq ‘ il barra.
Place the tablet in the dog’ s mouth.
Qiegħed il- pillola f’ ħalq il- kelb.
The tablet will disintegrate upon contact with moisture.
Il- pillola tiddiżintegra hekk kif tmiss ma ’ l- umdu.
Keep the mouth of the dog closed for a few seconds to ensure complete tablet wetting.
Żomm il- ħalq tal- kelb magħluq għal ftit sekondi biex ikun żgurat li l- pillola ixxarbet kollha.
Administer to dogs within 1-2 hours after feeding.
Agħtiha lill- kelb bejn siegħa u sagħtejn wara l- ikel.
When this is not possible, or when dogs resist having the product placed directly into the mouth, put the tablet immediately before administration into a small amount of moistened food, or in a moist treat.
Meta dan mhux possibbli, jew jekk il- kelb jirreżisti li l - prodott jitqiegħed direttament f’ ħalqu, eżatt qabel tamministra, qiegħed il- pillola fi ftit ikel umdu, jew f’ xi ħaġa li jħobb il- kelb u hi mxarrba.
Ensure the food or treat containing the medication is completely consumed.
Wieħed għandu jkun ċert li l- ikel jew it- trattament li fih il - mediċina, jittieħed kollu.
At doses of 30 mg/ kg and above, oral administration of tepoxalin is associated with discoloured faeces ranging in colour from white to yellow, which is the result of unabsorbed drug.
L- użu tat- Tepoxalin mill- ħalq f’ dożi ta ’ 30 mg/ kg jew aktar, huwa marbut ma ’ ippurgar b’ kulur li jvarja minn abjad għal isfar, bħala riżultat ta ’ mediċina mhix assorbita.
NSAID overdosage is characterised by vomiting, soft faeces/ diarrhoea, blood in faeces, reduced appetite and lethargy.
Doża eċċessiva ta ’ mediċini anti- infjammatorji li mhumiex sterojdi hija kkaratteriżata minn remettar, ippurgar artab/ sliħ, demm fl- ippurgar, nuqqas t’ aptit u telqa.
In the case of overdosage discontinue therapy.
F’ każ ta ’ dożaġġ eċċessiv waqqaf il- kura.
If gastrointestinal bleeding is suspected, administer gastric protectants.
Jekk wieħed jissuspetta telf ta ’ demm fis- sistema gastro- intestinali, għandhom jingħataw prodotti li jipproteġu l- istonku.
If vomiting continues, administer anti-emetics.
Jekk ir- remettar ikompli, agħti trattament anti- emetiku adattat.
Monitor the hematocrit frequently.
Iċċekkja l - ħematokrit ta ’ spiss.
Maintain the animal on intravenous fluids and, if necessary, administer whole blood.
Żomm l- annimal bi trattament ta ’ fluidi għad- diżidrazzjoni fil- vina u jekk hemm bżonn amministra d- demm.
4.11 Withdrawal period
3 4. 11 Perjodu ta ’ Tiżmim
Anti-inflammatory Products, Non Steroids ATCvet code:
Kodiċi ATC veterinarja:
Tepoxalin is a dual cyclooxygenase / 5-lipoxygenase inhibitor with anti-inflammatory activity.
Tepoxalin hija sustanza li timblokka is- cyclooxygenase u l- 5- lipoxygenase u għandha attività kontra l - infjammazzjoni.
Oral administration of 10 mg tepoxalin / kg bodyweight results in inhibition of prostaglandin and leukotriene synthesis.
10 mg Tepoxalin mogħtija mill- ħalq għal kull kg piż jirriżulta f’ impediment tas - sintesi ta ’ prostaglandin u lewkotrajin.
Tepoxalin is rapidly (Tmax of approximately 2 hours) absorbed after oral administration in dogs.
5. 2 Tagħrif Farmakokinetiċi
At a therapeutic dose of 10 mg/ kg, the Cmax of tepoxalin was 1.08 ± 0.37 µg/ ml in dogs fed a low fat meal and 1.19 ± 0.29 µg/ ml in dogs fed a high fat meal.
B’ doża terapewtika ta ’ 10 mg / kg, is- Cmax tat- Tepoxalin kienet ta ’ 1. 08 ± 0. 37 µg/ ml fi klieb mitmugħa ikla b ’ xaħam baxx u ta ’ 1. 19 ± 0. 29 µg/ ml fi klieb mitmugħa ikla b’ ħafna xaħam.
Absorption of tepoxalin is facilitated via administration to dogs in a fed state.
Tepoxalin tiġi assorbita aħjar jekk tingħata wara l- ikel.
Tepoxalin is extensively converted to its acid metabolite.
Ħafna mit- Tepoxalin tinbidel fil- forma aċida tagħha.
The acid metabolite is a potent, active cyclooxygenase inhibitor and prolongs the activity of the parent compound.
Din il- forma aċida timpedixxi l- azzjoni tas- cyclooxygenase attiv u b’ hekk ittawwal l- effett tas- sustanza oriġinali.
Plasma concentrations of the acid metabolite are higher than those of the parent compound in the dog.
Il - konċentrazzjoni tal- forma aċida fil- plażma tal- kelb hija ogħla minn dik tas- sustanza oriġinali.
No accumulation of tepoxalin or its acid metabolite was detected after multiple dosing over a broad dose range.
Meta Tepoxalin tingħata aktar minn darba u fuq firxa wiesgħa ta ’ dożi, ma nstabet l- ebda akkumulazzjoni, la ta ’ Tepoxalin u l- anqas tal- forma aċida taghħa.
Tepoxalin and its metabolites are highly protein-bound, more than 98%.
Aktar minn 98% ta ’ Tepoxalin u l- metaboliti tagħha jabbinaw mal- proteini tad- demm.
Tepoxalin and its metabolites are excreted in the faeces (99%).
Tepoxalin u l- prodotti tagħha jiġu eliminati fl- ippurgar (99%).
Gelatin Mannitol
Ġelatina Mannitol
Zubrin oral lyophilisates are supplied in boxes with foil blisters.
Lajofiliżejt ta ’ Zubrin jiġu fi strixxi ġo kaxxi.
Each blister contains 10 oral lyophilisates.
Kull strixxa fiha 10 lajofiliżejt.
The oral lyophilisates are available in the following pack sizes:
Il- lajofiliżejt, jiġu f’ pakketti b’ dawn il- qisien:
1 box containing 1, 3 or 6 blisters.
kaxxa li fiha strixxa waħda jew tlett strixxi kaxxa fiha strixxa waħda, tlett strixxi jew sitt strixxi.
4 6.6 Special precautions for the disposal of unused veterinary medicinal products or waste materials derived from the use of such products
4 6. 6 Prekawzjonijiet speċjali għar- rimi tal- prodotti mediċinali veterinarji mhux użata jew materjal ieħor għar- rimi li huwa derivat minn dawn il- prodotti
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with the local requirements.
Mediċina veterinarja li ma ġietx użata jew prodotti oħra li rriżultaw mill- użu ta ’ din il- mediċina għandhom jintremew skond kif titlob il- liġi tal- pajjiż.
S-P Veterinary Shire Park Welwyn Garden City Hertfordshire AL7 1TW United Kingdom
S- P Veterinary Shire Park Welwyn Garden City Hertfordshire AL7 1TW Renju Unit
13 March 2001
13 ta ’ Marzu 2001
Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu.
Informazzjoni dettaljata dwar dan il- prodott mediku veterinarju tinstab fuq il- websajt ta ’ l- Aġenzija Ewropea għall- Mediċini (EMEA) http: // www. emea. europa. eu.
PROHIBITION OF SALE, SUPPLY AND/ OR USE
PROJBIZZJONI TA ’ BEJGĦ, PROVISTA U/ JEW UŻU
Not applicable
Mhux Applikabbli
MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
SID L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI MILL - ĦRUĠ TAL- LOTT
{50 mg oral lyophilisate}
{50 mg lajofiliżejt li jittieħed mill- ħalq}
Zubrin 50 mg oral lyophilisates for dogs
Zubrin 50 mg lajofiliżejt li jittieħed mill- ħalq, għall- klieb
50 mg / oral lyophilisate
50 mg / lajofiliżejt li jittieħed mill- ħalq
Oral lyophilisates
Lajofiliżejt li jittieħed mill- ħalq
10 oral lyophilisates (EU/ 2/ 00/ 028/ 002) 30 oral lyophilisates (EU/ 2/ 00/ 028/ 003)
10 lajofiliżejt li jittieħdu mill- ħalq (EU/ 2/ 00/ 028/ 002) 30 lajofiliżejt li jittieħed mill- ħalq (EU/ 2/ 00/ 028/ 003)
10 mg/ kg of body weight once daily.
10 mg/ kg piż darba kuljum.
After a treatment period of 7-10 days, the condition of the dog should be re-evaluated in order to establish the need for continuation of treatment.
Wara perjodu ta ’ trattament ta ’ bejn 7 u 10 tijiem, il - kundizzjoni tal- kelb għandha terġa ’ tiġi evalwata biex jiġi stabbilit għandhiex titkompla l- kura.
When this is not possible, or when dogs resist having the product placed directly into the mouth, put the tablet immediately before administration into a small amount of moistened food, or in a moist treat.
Meta dan mhux possibbli, jew jekk il- kelb jirreżisti li l- prodott jitqiegħed direttament f’ ħalqu, eżatt qabel tamministra, qiegħed il- pillola fi ftit ikel umdu, jew f’ xi ħaġa li jħobb il- kelb u hi mxarrba.
Ensure the food or treat containing the medication is completely consumed.
Wieħed għandu jkun ċert li l- ikel jew it - trattament li fih il- mediċina, jittieħed kollu.
Ensure hands are dry to prevent the oral lyophilisate from sticking to fingers
Kun ċert li jdejk huma xotti biex tevita li l- pillola teħel ma ’ subgħajk.
THE WORDS “ FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
IL- KLIEM "GĦAL TRATTAMENT TA ’ L- ANNIMALI BISS ” U KONDIZZJONIJIET JEW RESTRIZZJONIJIET DWAR IL- PROVISTA U L- UŻU, JEKK APPLIKABBLI
Marketing Authorisation Holder
Sid ta ’ l- Awtorizzazzjoni tal- Kummerċ
EU/ 2/ 00/ 028/ 002 (1 blister) EU/ 2/ 00/ 028/ 003 (3 blisters)
EU/ 2/ 00/ 028/ 002 (Strixxa waħda) EU/ 2/ 00/ 028/ 003 (Tlett strixxi)
{100 mg oral lyophilisate}
{100 mg lajofiliżejt li jittieħed mill- ħalq}
Zubrin 100 mg oral lyophilisates for dogs
Zubrin 100 mg lajofiliżejt li jittieħed mill- ħalq, għall- klieb
100 mg / oral lyophilisate
100 mg / lajofiliżejt li jittieħdu mill- ħalq
Oral lyophilisates
Lajofiliżejt li jittieħdu mill- ħalq
10 oral lyophilisates (EU/ 2/ 00/ 028/ 004) 30 oral lyophilisates (EU/ 2/ 00/ 028/ 005)
10 lajofiliżejt li jittieħdu mill- ħalq (EU/ 2/ 00/ 028/ 004) 30 lajofiliżejt li jittieħdu mill- ħalq (EU/ 2/ 00/ 028/ 005)
EU/ 2/ 00/ 028/ 004 (1 blister) EU/ 2/ 00/ 028/ 005 (3 blisters)
EU/ 2/ 00/ 028/ 004 (Strixxa waħda) EU/ 2/ 00/ 028/ 005 (Tlett strixxi)
{200 mg oral lyophilisate}
{200 mg lajofiliżejt li jittieħed mill- ħalq}
Zubrin 200 mg oral lyophilisates for dogs
Zubrin 200 mg lajofiliżejt li jittieħed mill- ħalq, għall- klieb
200 mg / oral lyophilisate
200 mg / lajofiliżejt li jittieħed mill- ħalq
10 oral lyophilisates (EU/ 2/ 00/ 028/ 006) 30 oral lyophilisates (EU/ 2/ 00/ 028/ 007) 60 oral lyophilisates (EU/ 2/ 00/ 028/ 008)
10 lajofiliżejt li jittieħdu mill- ħalq (EU/ 2/ 00/ 028/ 006) 30 lajofiliżejt li jittieħdu mill- ħalq (EU/ 2/ 00/ 028/ 007) 60 lajofiliżejt li jittieħdu mill- ħalq (EU/ 2/ 00/ 028/ 008)
For animal treatment only - to be supplied only on veterinary prescription
Għal Trattament ta ’ l- Annimali Biss għandu jingħata biss bi preskrizzjoni medika.
EU/ 2/ 00/ 028/ 006 (1 blister) EU/ 2/ 00/ 028/ 007 (3 blisters) EU/ 2/ 00/ 028/ 008 (6 blisters)
EU/ 2/ 00/ 028/ 006 (Strixxa waħda) EU/ 2/ 00/ 028/ 007 (Tlett strixxi) EU/ 2/ 00/ 028/ 008 (Sitt strixxi)
15 MINIMUM PARTICULARS TO APPEAR ON BLISTER
15 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- BLISTERS JEW L- ISTRIPS
Zubrin 50 mg oral lyophilisates for dogs Zubrin 100 mg oral lyophilisates for dogs Zubrin 200 mg oral lyophilisates for dogs Tepoxalin
Zubrin 50 mg lajofiliżejt li jittieħed mill- ħalq, għall- klieb Zubrin 100 mg lajofiliżejt li jittieħed mill- ħalq, għall- klieb Zubrin 200 mg lajofiliżejt li jittieħed mill- ħalq, għall- klieb Tepoxalin
17 PACKAGE LEAFLET
17 FULJETT TA ’ TAGĦRIF FIL- PAKKETT Zubrin lajofiliżejt jittieħed mill- ħalq, għall- klieb
Manufacturer for the Batch Release:
Manifattur li jħalli l- konsenja tmur fis- suq:
100 mg / oral lyophilisate 200 mg / oral lyophilisate
100 mg / lajofiliżejt jittieħed mill- ħalq 200 mg / lajofiliżejt jittieħed mill- ħalq
Do not use if your dog • is pregnant or lactating or in bitches intended for breeding • has cardiac or hepatic disease • has had gastrointestinal ulceration or bleeding • is hypersensitive to the product • is dehydrated, hypovolaemic or hypotensive, as there is an increased risk of renal toxicity.
Tużax jekk il- kelb/ a tiegħek • hija tqiela jew qed tredda ’ jew klieb nisa intenzjonati għar- razza • għandu/ ha tal- qalb jew tal- fwied • għandu/ ha brix fl- istonku u l- imsaren, jew telf ta ’ demm • għandu/ ha allerġija għall- prodott • ikun/ tkun ixxotta/ t, ikollu/ ha volum baxx ta ’ demm, jew ibati/ tbati minn pressjoni baxxa, għaliex dawn jistgħu jgħollu r- riskju ta ’ tossiċita fil- kliewi.
During clinical trial testing of the product, the incidence of gastrointestinal reactions (diarrhoea/ vomiting) occurred in 1 out of 10 animals.
Il- frekwenza ta ’ reazzjonijiet gastro- intestinali (sliħ/ remettar) waqt testijiet kliniċi fuq il- prodott, kienet ta ’ 1 minn kull 10 annimali.
If you notice any other side effects, please inform your veterinary surgeon.
Jekk tinnota xi effetti oħra mhux mextieqa, jekk jogħġbok informa lill- veterinarju tiegħek.
10 mg/ kg once daily.
10 mg/ kg piż darba kuljum.
Keep the mouth of the dog closed for a few seconds to ensure complete tablet wetting.
Żomm il- ħalq tal- kelb magħluq għal ftit sekondi biex ikun żgurat li l - pillola ixxarbet kollha.
Ensure the food or treat containing the medication is completely consumed.
Wieħed għandu jkun ċert li l- ikel jew it- trattament li fih il- mediċina, jittieħed kollu.
Ensure hands are dry to prevent the oral lyophilisate from sticking to fingers.
Kun ċert li jdejk huma xotti biex ma tħallix li l- pillola teħel ma ’ subġħajk.
Tepoxalin is not water- soluble and becomes very sticky upon wetting.
Tepoxalin ma ddubx fl- ilma u ssir twaħħal ħafna meta tixxarrab.
If the oral lyophilisate disintegrates prematurely, wash hands thoroughly.
Jekk il- lajofiliżejt tinħall qabel il- waqt, aħsel idejk sew.
Do not use after the expiry date, which is stated on the blister.
Tużax wara d- data tal- iskadenza fuq l- istrixxa.
Special care should be taken when treating dogs with marked renal insufficiency Tepoxalin must not be administered in conjunction with other NSAIDs or glucocorticosteroids, diuretics or anticoagulants.
Tepoxalin m’ għandhiex tingħata flimkien ma ’ mediċini anti- infjammatorji li mhumiex sterojdi jew mediċini kontra l- uġiegħ, glukokortikosterojdi, dijuretiċi jew antikoagulanti.
19 If side effects occur, treatment should be discontinued and the advice of a veterinary surgeon should be sought.
Jekk ikun hemm xi effetti mhux mixtieqa, il- kura għandha titwaqqaf u wieħed għandu jfittex parir veterinarju.
Ask your veterinary surgeon how to dispose of medicines no longer required.
Saqsi lil veterinarju tiegħek dwar kif l- aħjar li tarmi l- mediċini li mA jkunux aktar meħtieġa minnek.
For any information about this veterinary medicinal product, please contact the local representative of the Marketing Authorisation Holder.
Għal kull tagħrif ieħor dwar dan il- prodott mediċinali veterinarju, jekk jogħġbok ikkuntattja lir - rappreżentant lokali tas- sid ta ’ l- Awtorizzazzjoni biex il- prodott jitpoġġa fuq is- suq.