qanastek/EMEA-V3 huggingface dataset:
Data were provided on the pharmaceutical quality, the tolerance of the product in dogs, and its safety in humans (people in contact with the product) and the environment.
Ġiet provduta informazzjoni dwar il- kwalità farmaċewtika, it- tolleranza tal- prodott fil- klieb, u s- sigurtà fil- bnedmin (persuni f’ kuntatt mal- prodott) u l- ambjent.
Studies were carried out in dogs, comparing the effectiveness of SevoFlo to that of other anaesthetic agents, such as isoflurane (another anaesthetic gas), thiopental, propofol, and ketamine plus diazepam, and SevoFlo’ s effectiveness at both inducing and maintaining anaesthesia was investigated.
Saru studji fuq klieb, li qabblu l- effettività ta ’ SevoFlo ma ’ dik ta ’ aġenti anestetiċi oħra, bħal isoflurane (gass anestetiku ieħor), thiopental, propofol, u ketamine ma ’ diazepam, u ġiet investigata l - effettività ta ’ SevoFlo fl- induzzjoni u l- manteniment ta ’ l- anestesija.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 47 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged What benefit has SevoFlo shown during the studies?
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 47 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged X’ siwi ntwera minn SevoFlo waqt l- istudji?
In the studies, SevoFlo was equally efficacious when compared to other anaesthetic agents.
Meta ġie mqabbel ma ’ aġenti anestetiċi oħra, SevoFlo kien effikaċi daqshom.
SevoFlo was shown to produce a relatively rapid and smooth induction of anaesthesia in dogs, followed by a good recovery.
Intwera li SevoFlo jista ’ jipproduċi induzzjoni anestetika relattivament rapida u bla intoppi fil- klieb, segwita b’ irkupru tajjeb.
Studies showed that sevoflurane could safely be used with several other medicines commonly used in dogs before or during operations.
L- istudji wrew li sevoflurane jista ’ faċilment jintuża ma ’ diversi mediċini oħra li ġeneralment jintużaw fil- klieb qabel jew waqt l- operazzjonijiet.
What is the risk associated with SevoFlo?
X’ inhu r- riskju assoċjat ma ’ SevoFlo?
The most frequently reported side effects associated with SevoFlo administration in dogs are low blood pressure, abnormally rapid breathing, muscle tenseness, excitation, a temporary inability to breathe, small muscle twitches, and vomiting.
L- aktar effetti sekondarji komuni rapportati assoċjati ma ’ l- għoti ta ’ SevoFlo fil- klieb huma pressjoni tad- demm baxxa, teħid tan- nifs aktar mgħaġġel, twebbis tal- muskoli, eċitament, nuqqas temporanju fil- ħila fit- teħid tan- nifs, ġbid żgħir fil- muskoli, u remettar.
The dose used for very old or very sick dogs may need to be adjusted.
Id- doża użata fuq klieb xjuħ ħafna jew morda ħafna għandha mnejn teħtieġ li tiġi aġġustata.
SevoFlo should not be used in pregnant or lactating bitches or in dogs less than 12 weeks of age as there is limited clinical experience.
SevoFlo m’ għandux jintuża fi klieb li huma tqal jew li qegħdin ireddgħu jew ġriewi li għandhom inqas minn 12- il ġimgħa peress li hemm esperjenza klinika ristretta.
SevoFlo should not be used in dogs with a known or suspected sensitivity to such anaesthetics.
SevoFlo m’ għandux jintuża fi klieb li huma magħrufa jew jkun hemm suspett li huma sensittivi għal anestetiċi bħal dawn.
For a full list of all side-effects reported with SevoFlo, see the Package Leaflet.
Għal- lista sħiħa ta ’ effetti sekondarji rapportati b’ SevoFlo, ara l- Fuljett ta ’ Tagħrif
What are the precautions for the person who gives the medicine or comes into contact with the animal?
X’ inhuma l- prekawzjonijiet għall- persuna li tamministra l- mediċina jew li tiġi f’ kuntatt ma ’ l- annimal?
This veterinary medicine has been developed especially for dogs and is not intended for use in humans.
Din il- mediċina veterinarja ġiet żviluppata b’ mod partikolari għall- klieb u m’ għandhiex tintuża mill - bnedmin.
As sevoflurane is a general anaesthetic, human exposure to sevoflurane vapour may cause symptoms such as shivering, nausea, headaches, low blood pressure, decreased heart rate and even reduced breathing.
Peress li sevoflurane huwa anestetiku ġenerali, l- espożizzjoni minn bniedem għal fwar ta ’ sevoflurane tista ’ tikkawża sintomi bħal tertir, dardir, uġigħ ta ’ ras, pressjoni tad- demm baxxa, ritmu iktar baxx tat- taħbit tal- qalb kif ukoll tnaqqis fit- teħid tan- nifsijiet.
Care must therefore be taken to remove any spillage immediately, the vapour should not be inhaled, and all contact with the product by mouth must be avoided.
Għalhekk, għandha tingħata attenzjoni sabiex kull tixrid jitneħħa minnufih, m’ għandux jittieħed nifs mill- fwar, u kull kuntatt tal- prodott mill- ħalq għandu jiġi evitat.
Pregnant and breast-feeding women should not have any contact with the product and should also avoid operating rooms and animal recovery areas where the product is being, or has recently been, used.
Nisa tqal jew li qed ireddgħu m’ għandhomx ikollhom kuntatt mal- prodott u għandhom jevitaw ukoll li jidħlu fi kmamar ta ’ l- operazzjonijiet u f’ żoni fejn l- annimali jkunu qegħdin jirkupraw fejn ikun għadu kif intuża jew intuża reċentament il- prodott.
In case of accidental contact with the skin or eyes, or for more information, the Package Leaflet should be consulted.
F’ każ ta ’ kuntatt aċċidentali mal- ġilda jew ma ’ l- għajnejn, jew għal aktar tagħrif, għandu jiġi kkonsultat il- Fuljett ta ’ Tagħrif.
Why has SevoFlo been approved?
Għaliex ġie approvat SevoFlo?
The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of SevoFlo exceed the risks in relation to its use for the induction and maintenance of anaesthesia in dogs and recommended that SevoFlo be given a marketing authorisation.
Il- Kumitat dwar il- Prodotti Mediċinali għal Użu Veterinarju (CVMP) ikkonkluda li s- siwi ta ’ SevoFlo jisboq ir- riskji fir- rigward ta ’ l- użu tiegħu għal induzzjoni u ż- żamma ta ’ l- anestesija fil- klieb u rrakomanda li SevoFlo jingħata l- awtorizzazzjoni tal- kummerċ.
The benefit-risk balance may be found in module 6 of this EPAR.
Il- bilanċ bejn is- siwi u r- riskju jinstab fil- modulu 6 ta ’ dan l- EPAR.
Other information about SevoFlo:
Tagħrif ieħor dwar SeveFlo:
The European Commission granted a marketing authorisation valid throughout the European Union, for SevoFlo to Abbott Laboratories Ltd on 11 December 2002.
Il- Kummissjoni Ewropea tat awtorizzazzjoni tal- kummerċ valida fl- Unjoni Ewropea kollha, għal SevoFlo lil Abbott Laboratories Ltd fil- 11 ta ’ Diċembru 2002.
Information on the prescription status of this product may be found on the outer package.
Tagħrif dwar l- istatus tal- preskrizzjoni ta ’ dan il- prodott jinstab fuq il- pakkett ta ’ barra.
This summary was last updated in March 2007.
Dan is- sommarju ġie aġġornat l- aħħar f’ Marzu 2007
Inhalation vapour, liquid
Fwar li jittieħed Klieb man- nifs, likwidu
Inhalation use
Għal biex jinġibed man- nifs
Bottle (polyethylene naphthalate) with Quik-Fil (II) closure
Flixkun (polyethylene naphthalate) magħluq bil- Quik- Fil II)
SevoFlo 100% Inhalation vapour, liquid for dogs.
SevoFlo 100% Fwar jittieħed man- nifs, likwidu għal klieb.
Each bottle contains 250 ml sevoflurane (100%).
Kull flixkun fih 250 ml sevoflurane (100%).
Inhalation vapour, liquid.
Fwar jittieħed man- nifs, likwidu.
4.2 Indications for use, specifying the target species
4. 2 Indikazzjoni għal użu tal- prodott li jispeċifikaw l- ispeċi li fuqhom se jintuża l- prodott
For the induction and maintenance of anaesthesia.
Għal induzzjoni u ż- żamma t’ anesteżija
Do not use in dogs with known hypersensitivity to sevoflurane or other halogenated anaesthetic agents.
Tużax fuq klieb li huma magħrufa li għandhom sensittività eċċessiva għal sevoflurane jew sustanzi oħra ta ’ illupjar ħaloġenati.
Do not use in pregnant and lactating bitches (see section 4.7).
Tużax fi klieb li huma tqal jew qed ireddgħu (ara sezzjoni 4. 7).
Do not use in dogs with a known or suspected genetic susceptibility to malignant hyperthermia.
Tużax fi klieb li huma magħrufa jew suspettati li għandhom suxxetibilità ġenetika għal żieda fit - temperatura għolja malinna.
Do not use in dogs less than 12 weeks of age.
Tużax fuq klieb li huma ta ’ anqas minn 12- il ġimgħa.
4.4 Special warnings for each target species
4. 4 Twissijiet speċjali gal kull speċi li għaliha hu indikat il- prodott
Special precautions for use in animals Halogenated volatile anaesthetics can react with dry carbon dioxide (CO2) absorbents to produce carbon monoxide (CO) that may result in elevated levels of carboxyhaemoglobin in some dogs.
Prekawzjonijiet speċjali għall- użu fl- annimali Loppji volatili ħaloġenati jistgħu jirreaġixxu ma assorbenti ta ’ diossidu tal- karbonju (CO2) niexef sabiex jipproduċu monossidu tal- karbonju (CO) li jista ’ jirriżulta f’ livelli ogħla ta ’ carboxyhaemoglobin f’ ċerti klieb.
In order to minimise this reaction in rebreathing anaesthetic circuits, SevoFlo should not be passed through soda lime or barium hydroxide that has been allowed to dry out.
Sabiex titnaqqas din ir- reazzjoni f’ ċirkuwiti li jinkludi teħid ta ’ nifs mill- ġdid, SevoFlo m’ għandux jiġi mgħoddi minn soda lime jew barium hydroxide li tkun tħalla jinxef.
The exothermic reaction that occurs between inhalation agents (including sevoflurane) and CO2 absorbents is increased when the CO2 absorbent becomes desiccated, such as after an extended period of dry gas flow through the CO2 absorbent canisters.
Ir- reazzjoni esotermika li sseħħ bejn l- aġenti li jittieħdu bin- nifs (inkluż sevoflurane) u assorbenti tal- CO2, tiżdied, meta l- assorbent tal- CO2 jinxef bħalma jiġri f’ każ ta ’ perjodu estiż ta ’ influss ta ’ gass niexef li jgħaddi miċ- ċilindri li jassorbu l- CO2.
Rare cases of excessive heat production, smoke and/ or fire in the anaesthetic machine have been reported during the use of a desiccated CO2 absorbent and sevoflurane.
Każijiet rari ta ’ produzzjoni ta ’ sħana eċċessiva, duħħan u/ jew nar fit- tagħmir anestetiku ġew rappurtati meta ntuża sevoflurane flimkien mal- assorbent niexef tal- CO2.
An unusual decrease in the expected depth of anaesthesia compared to the vaporiser setting may indicate excessive heating of the CO2 absorbent canister.
Tnaqqis mhux tas- soltu fil- profondità mistennija ta ’ l- anesteżija meta mqabbel ma ’ l- ikkalibrar tal- fawwar jista ’ jindika sħana eċċessiva taċ- ċilindru li jassorbi CO2.
If it is suspected that the CO2 absorbent may be desiccated, it must be replaced.
Jekk ikun hemm suspett li l- assorbent tal- CO2 jista ’ jkun niexef, dan għandu jiġi mibdul.
The colour indicator of most CO2 absorbents does not necessarily change as a result of desiccation.
L- indikatur tal- kulur tal- biċċa l- kbira ta ’ l- assorbenti tal- CO2 mhux bil- fors jibdel il- kulur bħala riżultat ta ’ nixfa.
Therefore, the lack of significant colour change should not be taken as an assurance of adequate hydration.
Għalhekk in- nuqqas ta ’ bidla sostanzjali fil- kulur m’ għandhiex tittieħed bħala assikurazzjopni li hemm l- umdita.
CO2 absorbents should be replaced routinely regardless of the state of the colour indicator.
L- assorbenti tal- CO2 ta ’ l- indikatur.
2/ 24 1,1,3,3,3-pentafluoro-2-(fluoromethoxy)propene (C4H2F6O), also known as Compound A, is produced when sevoflurane interacts with soda lime or barium hydroxide.
1, 1, 3, 3, 3- pentafluoro- 2 - (fluoromethoxy) propene (C4H2F6O), magħruf ukoll bħala Kompost A, jiġi ffurmat meta s- sevoflurane jitħallat ma soda lime jew barium hydroxide.
Reaction with barium hydroxide results in a greater production of Compound A than does the reaction with soda lime.
Ir- reazzjoni mal- barium hydroxide tipproduċi aktar Kompost A milli dik mal- soda lime.
Its concentration in a circle absorber system increases with increasing sevoflurane concentrations and with decreasing fresh gas flow rates.
Il- konċentrazzjoni tagħha f’ sistema ta ’ assorbenza ċirkulari tiżdid f’ konċentrazzjonijiet ogħla ta ’ sevoflurane u bi tnaqqis ta ’ influss ta ’ gass frisk.
Sevoflurane degradation in soda lime has been shown to increase with temperature.
Id- degradazzjoni tas- sevoflurane fis- soda lime ġiet murija li tiżdied bit- temperatura.
Since the reaction of carbon dioxide with absorbents is exothermic, this temperature increase will be determined by the quantities of CO2 absorbed, which in turn will depend on fresh gas flow in the anaesthetic circle system, metabolic status of the dog and ventilation.
Filwaqt li r- reazzjoni tal- karbonju diossidu mal- assorbenti hija eżotermika, din iż- żieda fit- temperatura għandha tiġi stabbilita mill- kwantitajiet ta ’ CO2 assorbit, li minn hekk tiddependi mill- influss ta ’ gass frisk fis- sistema tonda anestetika, l- istat metaboliku tal- kelb u l- ventilazzjoni.
Although Compound A is a dose-dependent nephrotoxin in rats, the mechanism of this renal toxicity is unknown.
Għalkemm Kompost A huwa tossiku għal kliewi fil- ġrieden skond id- doża, il- mekkaniżmu tat- tossiċità fil- kliewi mhux magħruf.
Long- duration, low-flow sevoflurane anaesthesia should be avoided due to the risks of Compound A accumulation.
Dewmien żejjed, u influss tal- loppju sevoflurane bil- mod għandu jiġi evitat minħabba r- riskju ta ’ żieda fil- Kompost A.
During maintenance of anaesthesia, increasing the concentration of sevoflurane produces a dose- dependent decrease in blood pressure.
Matul iż- żamma ta ’ l- anesteżija, żieda fil- konċentrazzjoni ta ’ sevoflurane tipproduċi nuqqas ta ’ pressjoni fid- demm li hu dipendenti fuq id- doża.
Due to sevoflurane's low solubility in blood, these haemodynamic changes may occur more rapidly than with other volatile anaesthetics.
Minħabba li s- sevoflurane għandu solubilità baxxa fid- demm, dawn il- bidliet emodinamiċi jistgħu jiġru aktar malajr minn loppji oħra volatili.
Arterial blood pressure should be monitored at frequent intervals during sevoflurane anaesthesia.
Il- pressjoni tad- demm fl- arterji għandha tiġi sorveljata f’ intervalli ta ’ spiss bil- loppju sevoflurane.
Facilities for artificial ventilation, oxygen enrichment and circulatory resuscitation should be immediately available.
Faċilitajiet għal ventilazzjoni artifiċjali, ġenerazzjoni ta ’ ossiġnu frisk, u resuxxitazzjoni ċirkulatorja għandhom ikunu disponibbli f’ kull ħin.
Excessive decreases in blood pressure or respiratory depression may be related to the depth of anaesthesia and may be corrected by decreasing the inspired concentration of sevoflurane.
Tbaxxija żejjed fil- pressjoni tad- demm jew nuqqas ta ’ nifs jistgħu jkunu relatati mal- profondità tal- anesteżija u jistgħu jiġu kkoreġuti bit- tnaqqis ta ’ konċentrazzjoni inspirata ta ’ sevoflurane.
The low solubility of sevoflurane also facilitates rapid elimination by the lungs.
Is- solubilità baxxa ta ’ sevoflurane tiffaċilita wkoll l- eliminazzjoni ta ’ malajr mill- pulmuni.
The nephrotoxic potential of certain NSAIDs, when used in the perioperative period, may be exacerbated by hypotensive episodes during sevoflurane anaesthesia.
Il- possibilità nefrotossika ta ’ ċerti NSAID, meta dawn jintużaw waqt iż- żmien operattiv, jistgħu jaggravaw b’ fażijiet ipotensivi waqt l- illupjar bis- sevoflurane.
In order to maintain renal blood flow, prolonged episodes of hypotension (mean arterial pressure below 60 mmHg) should be avoided in dogs during sevoflurane anaesthesia.
Sabiex jinżamm l- influss ta ’ demm fil- kliewi, perijodi fit- tul ta ’ pressjoni baxxa fl- arterji (inqas minn 60 mmHg) għandhom jiġu evitati fil- klieb matul loppju bis- sevoflurane.
If malignant hyperthermia develops, the anaesthetic supply should be interrupted immediately and 100% oxygen administered using fresh anaesthetic hoses and a rebreathing bag.
Jekk tiżviluppa temperatura għolja bla kontroll, il- loppju għandu jiġi mwaqqaf minnufiħ u jingħata 100% ossiġnu b’ tubi tal- loppju ġodda u użu ta ’ borża li tieħu n- nifs minnha.
Appropriate treatment should readily be instituted.
Kura xierqa għandha tiġi mogħtija malajr.
Compromised or debilitated dogs Doses of sevoflurane may need adjustment for geriatric or debilitated dogs.
Dożi ta ’ sevoflurane għandhom mnejn ikollhom jiġu kkalibrati għall- klieb xjuħ jew dgħajfa.
Doses required for maintenance anaesthesia may need to be reduced by approximately 0.5% in geriatric dogs (i. e.
Id- dożi meħtieġa għaż- żamma ta ’ anesteżija jistgħu jkollhom jitnaqqsu b’ xi 0. 5% fil- klieb xjuħ (i. e.
2.8% to 3.1% in premedicated geriatric dogs and 3.2 to 3.3% in unpremedicated geriatric dogs).
2. 8% sa 3. 1% fil- klieb xjuħ li ngħatalhom trattament qabel u 3. 2 sa 3. 3% fi klieb xjuħ biss, li ma ngħatalhomx trattament qabel).
Limited clinical experience in administering sevoflurane to dogs with renal, hepatic and cardiovascular insufficiency suggests that sevoflurane may be safely used in these conditions.
Esperjenza klinika ristretta, fl- għoti tas- sevoflurane lill- klieb b’ insuffiċenza fil- kliewi, fwied u s- sistema karjovaskolari turi li sevoflurane jista ’ jiġi amministrat f’ dawn il- kondizzjonijiet.
However, it is recommended that such animals be monitored carefully during sevoflurane anaesthesia.
Madankollu, huwa rakkomandat li dawn l- annimali għandhom jiġu sorveljati b’ attenzjoni waqt l- illupjar bis- sevoflurane.
Sevoflurane may cause a small increase in intracranial pressure (ICP) under conditions of normocapnia.
Sevoflurane jista ’ jikkawża żieda żgħira fil- pressjoni tal- moħħ (ICP) taħt kundizzjonijiet ta ’ normokapnija.
In dogs with head injuries or other conditions placing them at risk from increased ICP, it is recommended that hypocapnia be induced by means of controlled hyperventilation as a means of preventing changes in ICP.
Dawk il- klieb bi ġrieħi f’ rashom jew kondizzjonijiet oħra li jpoġġuhom f’ riskju minħabba żieda fl- ICP, hu rakkomandat li ipokapnija tiġi mibdija permezz ta ’ iperventilazzjoni kontrollata bħala mezz biex jiġi evitat tibdil fl- ICP.
Special precautions to be taken by the person administering the veterinary medicinal product to animals In order to minimise exposure to sevoflurane vapour, the following recommendations are made: • Use a cuffed endotracheal tube when possible for the administration of SevoFlo during maintenance anaesthesia. • Avoid using masking procedures for prolonged induction and maintenance of general anaesthesia. • Ensure that operating rooms and animal recovery areas are provided with adequate ventilation or scavenging systems to prevent the accumulation of anaesthetic vapour. • All scavenging/ extraction systems must be adequately maintained. • Pregnant and breast-feeding women should not have any contact with the product and should avoid operating rooms and animal recovery areas. • Care should be taken when dispensing SevoFlo, with immediate removal of any spillage. • Do not inhale the vapour directly.
Biex tnaqqas l- espożizzjoni għall- fwar ta ’ sevoflurane, qed jiġu mogħtija dawn ir- rakkomandazzjonijiet li ġejjin: • Uża tubu endotrakeali mxammar fejn hu possibli għal għoti ta ’ SevoFlo waqt iż- żamma ta ’ l- anesteżija. • Evita li tuża maskri għal induzzjoni fit- tul u żamma ta ’ anesteżija ġenerali. • Żgura li l- kmamar ta ’ l- operazzjoni u l- lokal ta ’ irkupru għall- annimali għandhom ventilazzjoni xierqa jew sistema ta ’ tindif li tevita li jinġemgħa fwar tal- loppju. • Is- sistemi kollha tat- tindif u l- bdil tal- arja għandhom ikunu miżmuma kif suppost. • Nisa tqal jew li jreddgħu m’ għandu jkollhom l- ebda kuntatt mal- prodott u ma għandhomx jersqu lejn il- kmamar ta ’ l- operazzjoni jew żoni ta ’ irkupru ta ’ l- annimali. • It- teħid tas- SevoFlo irid isir b’ attenzjoni, u f’ każ ta ’ tixrid għandu jitneħħa minnufiħ. • Tiġbidx il- fwar direttament bin- nifs. • Evita kuntatt mal- ħalq. • Aġenti anestetiċi ħaloġenati jistgħu jagħmlu ħsara lill- fwied.
This is an idiosyncratic response very occasionally seen after repeated exposure. • From an environmental point of view, it is considered good practice to use charcoal filters with scavenging equipment.
Dan hu riżultat idjosinkratiku li kultant jidher wara espożizzjoni ta ’ diversi drabi. • Bħala konsiderazzjoni ambjentali, hija prattika tajba li jintużaw filtri tal- faħam mat- tagħmir li jnaddaf.
Direct exposure to eyes may result in mild irritation.
Kuntatt dirett mal- għajnejn jista ’ jikkawża ħruq ħafif.
If eye exposure occurs, the eye should be flushed with plenty of water for 15 minutes.
Jekk ikun hemm espożizzjoni mal- għajn, laħlaħ b’ ħafna ilma għal 15- il minuta.
Medical attention should be sought if irritation persists.
Jekk il- ħruq ma jmurx fittex il- għajnuna ta ’ tabib.
In case of accidental contact with the skin, wash affected area with abundant water.
Fil- każ ta ’ kuntatt aċċidentali mal- ġilda, laħlaħ il- parti affetwata b’ ħafna ilma..
Symptoms of human overexposure (inhalation) to sevoflurane vapour include respiratory depression, hypotension, bradycardia, shivering, nausea and headache.
Sintomi ta ’ espożizzjoni żejda min- nies (bix- xamm) għal fwar ta’ sevoflurane jinkludu qtugħ ta ’ nifs, pressjoni baxxa, bradikardja, rogħda, dardir u wġigħ ta ’ ras.
If these symptoms occur, the individual should be removed from the source of exposure and medical attention sought.
Jekk dawn is- sintomi sseħħu, l- individwu għandu jitneħħa mil- lok fejn hu espost u tiġi mfittxija attenzjoni medika.
Maintain a patent airway and give symptomatic and supportive treatment.
Iftaħ passaġġ ta ’ l- arja u agħti trattament simptomatiku u ta ’ appoġġ.
The most frequently reported adverse reactions associated with SevoFlo administration were hypotension, followed by tachypnoea, muscle tenseness, excitation, apnoea, muscle fasciculations and emesis.
L- aktar effetti mhux mixtieqa rapportati li huma assoċjati ma ’ l- amministrazzjoni ta ’ SevoFlo kienu pressjoni baxxa, sussegwit b’ nifs mgħaġġel, tensjoni fil- muskoli, eċċitament, qtugħ ta ’ nifs, faxxikli fil- muskoli, u remettar.
Sevoflurane causes dose-dependant respiratory depression, therefore respiration should be closely monitored during sevoflurane anaesthesia and the inspired concentration of sevoflurane adjusted accordingly.
Sevoflurane jikkawża tnaqqis respiratorju dipendentement fuq id- doża mogħtija, għalhekk in- nifs irid jiġi mgħasses mill- qrib waqt l- illupjar bis- sevoflurane, u l- konċentrazzjoni ta ’ sevoflurane aġġustata skond kif meħtieġ.
The use of some anaesthetic regimens that include sevoflurane may result in bradycardia that is reversible with anticholinergics.
L- użu ta ’ ċerti reġimi ta ’ terapija li jinkludu sevoflurane jistgħu jikkawżaw bradikarja li hi riversibbli bl- antikolinerġiċi.
Infrequent adverse reactions include paddling, retching, salivation, cyanosis, premature ventricular contractions and excessive cardiopulmonary depression.
Xi reazzjonijiet oħra mhux mixtieqa, mhux rapportati daqshekk spiss jinkludu ċaflis, taqlieħ, tbeżliq, tibdil fil- kulur (lejn l- ikħal), kontrazzjonijiet ventrikulari prematuri, u dipressjoni qawwija kardjopulmonari.
Transient elevations in aspartate aminotransferase (AST), alanine aminotransferase (ALT), lactate dehydrogenase (LDH), bilirubin and white blood cell counts may occur with sevoflurane, as with the use of other halogenated anaesthetic agents.
Elevazzjoni temporanja fl- aspartate aminotransferase (AST), alanine aminotransferase (ALT), lactate dehydrogenase (LDH), bilirubin, u l- għadd ta ’ ċelloli bojod fid- demm jistgħu jiġru bħala riżultat ta ’ sevoflurane, kif ukoll bl- użu ta ’ aġenti anestetiċi ħaloġenati oħra.
Hypotension during sevoflurane anaesthesia may result in decreased renal blood flow.
It- tbaxxija fil- pressjoni tad- demm li tista ’ tirriżulta waqt it- teħid bil- loppju sevoflurane, tista ’ tnaqqas l- influss tad- demm fil- kliewi.
The possibility of sevoflurane triggering episodes of malignant hyperthermia in susceptible dogs cannot be ruled out.
Il- possibilità li sevoflurane jikkaġuna każi ta ’ ipertermija mhix ikkontrollata fi klieb suxxetibli ma għandhiex tiġi eskluża.
4.7 Use during pregnancy or lactation
4. 7 Użu fit- Tqala, jew fi żmien il- ħalib
Do not use during pregnancy and lactation because the safety of the veterinary medicinal product has not been established during pregnancy and lactation.
M’ għandekx tuża waqt it- tqala u t- treddigħ peress li s- sigurtà tal- prodott mediċinali veterinarju għadha ma ġietx stabbilita waqt it- tqala jew it- treddigħ.
However, there is limited clinical experience of the use of sevoflurane, after propofol induction, in bitches undergoing caesarean section, without any ill effects being detected in either the bitch or the puppies.
Madankollu hemm esperjenza klinika ristretta dwar l - użu ta ’ sevoflurane, wara l- induzzjoni bi propofol, fuq klieb nisa waqt ċesarji, mingħajr effetti ħżiena kemm fuq il- kelba jew fuq il- ġriewi.
Use only according to the risk/ benefit assessment of the responsible veterinarian.
Uża biss b’ konformità ma ’ l- analiżi dwar ir- riskju/ siwi tal - veterinarju responsabbli.
4/ 24 4.8 Interaction with other medicinal products and other forms of interaction
4. 8 Effetti fuq prodotti mediċinali oħra jew effetti oħra
Intravenous Anaesthetics:
Loppju fil- Vini tad- Demm:
Sevoflurane administration is compatible with the intravenous barbiturates and propofol.
Il- għoti tas- Sevoflurane huwa kompattibli mal- barbiturati u propofol li jingħataw fil- vina.
The concurrent administration of thiopental, however, may slightly increase sensitivity to adrenaline- induced cardiac arrhythmias.
L- għoti konġunt ma 'thiopental, madankollu jista ’ iżid is- sensittività għal arritmiji tal- qalb indotti bl- adrenalina.
Benzodiazepines and Opioids:
Benzodijażepini u Opijojdi:
Sevoflurane administration is compatible with benzodiazepines and opioids commonly used in veterinary practice.
Sevoflurane huwa kompatibbli ma ’ benzodijażepini u opijojdi wżati ta ’ spiss fix- xogħol veterinarju.
In common with other inhalational anaesthetics, the MAC of sevoflurane is reduced by the concurrent administration of benzodiazepines and opioids.
Bħalma hu komuni f’ loppji oħra bin- nifs, il- MAC tas- sevoflurane jitnaqqas bil- għoti konġunt ta ’ benżodijażepini u opijojdi.
Phenothiazines and alpha-2-agonists:
Phenothiazines u alpha- 2- agonists:
Sevoflurane is compatible with phenothiazines and alpha-2-agonists commonly used in veterinary practice.
Sevoflurane huwa kompattibli ma ’ phenothiazines u alfa- 2- agonisti użati ta ’ spiss fil- prattika veterinarja.
Α lpha-2-agonists have an anaesthetic sparing effect and therefore the dose of sevoflurane should be reduced accordingly.
Àlpha- 2- agonisti għandhom effett kemmxejn ta ’ loppju u għalhekk id- doża tas- sevoflurane għandha titnaqqas kif meħtieġ.
Limited data are available on the effects of the highly potent alpha-2- agonists (medetomidine and romifidine) as premedication.
Hemm informazzjoni ristretta disponibbli fuq l- effetti qawwija ta ’ l- agonisti alpha- 2, (medetomidine u romifidine) bħala trattament mediku ta ’ qabel.
Therefore they should be used with caution.
Għaldaqstant dawn għandhom jintużaw b’ kawtela.
Bradycardia may develop when alpha-2-agonists are used with sevoflurane.
Meta alpha- 2- agonisti jintużaw ma ’ sevoflurane jista ’ jkun hemm bradikardja.
Bradycardia can be reversed by the administration of anticholinergics.
Bradikardja hija riversibbli bit- teħid ta ’ antikolinerġiċi.
Anticholinergics:
Antikolinerġiċi:
Studies using sevoflurane anaesthetic protocols that included atropine or glycopyrrolate as premedicants showed these anticholinergics to be compatible with sevoflurane in dogs.
Studji li saru fi protokolli tal- loppju ta ’ sevoflurane li kienu jinkludu l- atropina jew glycopyrrolate bħala trattamenti mediċinali ta ’ qabel urew li dawn l- antikolinerġiċi huma kompattibli ma ’ sevoflurane fil- klieb.
In a laboratory study, the use of an acepromazine/ oxymorphone/ thiopental/ sevoflurane anaesthetic regimen resulted in prolonged recoveries in all the dogs treated, compared to recoveries in dogs anaesthetised with sevoflurane alone.
Fi studju fil- laboratorju, l- użu ta ’ reġimen anestetiku ta ’ acepromazine / oxymorphone / thiopental / sevoflurane rriżulta f’ dewmien fil- fejqan tal- klieb kollha li kienu ttrattati bihom, meta mqabblin ma ’ fejqan fi klieb li kienu lluppjati b’ sevoflurane biss.
The use of sevoflurane with nondepolarising muscle relaxants has not been evaluated in dogs.
L- użu ta’ sevoflurane ma ’ aġenti oħra mhux depolariżżanti li jirilassaw il- muskoli ma ġiex valutat fuq il- klieb.
However, in humans the use of sevoflurane increases both the intensity and duration of neuromuscular blockade induced by nondepolarising muscle relaxants.
Madankollu, l- użu tas- sevoflurane fil- bniedem iżid kemm l- intensità u t- tul ta ’ l- imblokk newromuskolari taħt l- effett ta ’ rilassanti tal- muskoli mhux depolariżżanti.
Inspired Concentration:
Konċentrazzjoni Inspirata:
SevoFlo should be administered via a vaporiser specifically calibrated for use with sevoflurane so that the concentration delivered can be accurately controlled.
SevoFlo għandu jiġi amministrat permezz tal- fawwâr ikkalibrat speċifikament għal użu ma ’ sevoflurane sabiex il- konċentrazzjoni fornuta tkun ikkontrollata bi preċiżjoni.
SevoFlo contains no stabiliser and does not affect the calibration or operation of these vaporisers in any way.
SevoFlo ma fihx stabilizzatur u ma jaffettwax il- kalibrazzjoni jew ħidma ta ’ dawn il- fawwâra b’ ebda mod.
The administration of sevoflurane must be individualised based on the dog's response.
It- teħid ta ’ sevoflurane għandu jkun individwalizzat skond ir- rispons tal- kelb.
Premedication:
Trattament Mediku ta ’ Qabel:
The necessity for and choice of premedication is left to the discretion of the veterinarian.
Il- bżonn għal u l- għażla ta ’ trattament mediku ta ’ qabel għandha titħalla f’ idejn it- tabib veterinarju.
Preanaesthetic doses for premedicants may be lower than the label directions for their use as a single medication.
Dożi ta ’ loppju minn qabel, għal trattament mediku minn qabel jistgħu jkunu aktar baxxi mill- istruzzjonijiet mogħtija fuq it- tikketta għall- użu tagħhom bħala trattament ewlieni.
Induction of anaesthesia:
L- Għoti tal- Loppju:
For mask induction using sevoflurane, inspired concentrations of 5 to 7% sevoflurane with oxygen are employed to induce surgical anaesthesia in the healthy dog.
L- użu ta ’ maskra għal induzzjoni minn sevoflurane, f’ konċentrazzjoni ispirata ta ’ 5 sa 7% sevoflurane bl- ossiġnu għandu jingħata biex jinbeda l- illuppjar kirurġiku fuq kelb b’ saħħtu.
These concentrations can be expected to produce surgical anaesthesia within 3 to 14 minutes and may be set initially, or may be achieved gradually over the course of 1 to 2 minutes.
Dawn il- konċentrazzjonijiet għandhom iwasslu għal anesteżija kirurġika fi żmien bejn 3 sa 14- il minuta, u jistgħu jiġu ssettjati mill- bidu, jew jiġu meħudin matul il- kors ta ’ 1 jew 2 minuti.
The use of premedicants does not affect the concentration of sevoflurane required for induction.
L- użu ta ’ trattamenti mediċiniali ta’ qabel ma jaffetwax il- konċentrazzjoni ta ’ sevoflurane meħtieġa fil- bidu għal induzzjoni.
Maintenance of anaesthesia:
Iż- Żamma ta ’ l- Anesteżija:
Sevoflurane may be used for maintenance anaesthesia following mask induction with sevoflurane or following induction with injectable agents.
Sevoflurane jista ’ jintuża biex tinżamm l- anesteżija wara l- induzzjoni bil- maskra bi sevoflurane jew sussegwentement wara l- induzzjoni b’ mediċini oħra permezz ta ’ titqib.
The concentration of sevoflurane necessary to maintain anaesthesia is less than that required for induction.
Id- doża meħtieġa ta ’ sevoflurane biex tinżamm l- anesteżija hi inqas minn dik meħtieġa għal induzzjoni.
5/ 24 Surgical levels of anaesthesia in the healthy dog may be maintained with inhaled concentrations of 3.3 to 3.6% in the presence of premedication.
Livelli kirurġiċi ta ’ anesteżija f’ kelb b’ saħħtu jistgħu jinżammu b’ konċentrazzjonijiet miġbuda minn nifs ta ’ bejn 3. 3 sa 3. 6% meta tkun ġiet amministrata pre- medikazzjoni.
In the absence of premedication, inhaled concentrations of sevoflurane in the range 3.7 to 3.8% will provide surgical levels of anaesthesia in the healthy dog.
Fejn ma kienx hemm pre- medikazzjoni, konċentrazzjonijiet ta ’ sevoflurane fin- nifs ta ’ bejn 3. 7 u 3. 8% għandhom jipprovdu livell kirurġiku ta ’ loppju f’ kelb b’ saħħtu.
The presence of surgical stimulation may require an increase in the concentration of sevoflurane.
Minħabba l- preżenza ta ’ stimulazzjoni kirurġika, jista ’ jkun hemm bżonn żieda fil- konċentrazzjoni ta’ sevoflurane.
The use of injectable induction agents without premedication has little effect on the concentrations of sevoflurane required for maintenance.
L- użu ta’ aġenti permezz ta ’ titqib li jinduċu, mingħajr pre- medikazzjoni għandu ftit effett fuq il- konċentrazzjonijiet ta ’ sevoflurane meħtieġ biex tinżamm l- anesteżija.
Anaesthetic regimens that include opioid, alpha-2-agonist, benzodiazepine or phenothiazine premedication will allow the use of lower sevoflurane maintenance concentrations.
Reġimi anestetiċi li jinkludi pre- medikazzjoni bl- opijojdi, alpha- 2- agonist, benzodijażepini jew phenothiazine jippermettu l- użu ta ’ konċentrazzjonijiet aktar baxxi ta ’ sevoflurane sabiex tinżamm anesteżija.
SevoFlo overdose may result in profound respiratory depression.
Doża eċċessiva ta ’ SevoFlo tista ’ toħloq nuqqas respiratorju qawwi.
Therefore, respiration must be monitored closely and supported when necessary with supplementary oxygen and/ or assisted ventilation.
Għalhekk, in- nifs għandu jiġi sorveljat sewwa u jekk ikun meħtieġ jiġi appoġjat b’ ossiġnu u/ jew assistenza għal ventilazzjoni.
In cases of severe cardiopulmonary depression, administration of sevoflurane should be discontinued, the existence of a patent airway ensured, and assisted or controlled ventilation with pure oxygen initiated.
F’ każ ta ’ dipressjoni kardjopulmonari serja, l- għoti ta ’ sevoflurane għandu jitwaqqaf, tiġi żgurata l- preżenza ta ’ passaġġ tal- arja, u tinbeda il- ventilazzjoni mgħejjuna jew ikkontrollata b’ ossiġnu pur.
Cardiovascular depression should be treated with plasma expanders, pressor agents, antiarrhythmic agents or other appropriate techniques.
Dipressjoni karjovaskulari għandha tiġi ttrattata bi plasma expanders, b’ agenti li jistimulaw il- pressjoni, aġenti kontra l- arritmiji u teknikalitajiet oħra xierqa.
Due to sevoflurane's low solubility in blood, increasing the concentration may result in rapid haemodynamic changes (dose-dependent decreases in blood pressure) compared to other volatile anaesthetics.
Minħabba li sevoflurane ma tantx jinħall fid- demm, żieda fid- doża tista ’ tikkaġuna tibdil emodinamiku malajr (tnaqqis fil- pressjoni tad- demm dipendentement fuq id- doża) meta mqabbel ma ’ loppji oħra volatili.
Excessive decreases in blood pressure or respiratory depression may be corrected by decreasing or discontinuing the inspired concentration of sevoflurane.
Nuqqas eċċessiv fil- pressjoni tad- demm jew dipressjoni fir- respirazzjoni jistgħu jiġu kkoreġuti billi titnaqqas jew titwaqqaf l- intensità tad- doża ta ’ sevoflurane.
Pharmacotherapeutic group: inhalation anaesthetic, ATCvet code:
Loppju jittieħed min- nifs, Kodiċi ATĊ veterinarja:
Sevoflurane is an inhalational anaesthetic agent, having a light odour, for induction and maintenance of general anaesthesia.
5. 1 Kwalitajiet Farmakodinamiċi Sevoflurane huwa loppju li jittieħed bin- nifs, għandu riħa ħafifa, biex jinduċi u jżomm stat ta ’ anesteżija ġenerali.
The Minimum Alveolar Concentration (MAC) of sevoflurane in dogs is 2.36%.
Il- Konċentrazzjoni Alveolari Minima (MAC) ta ’ sevoflurane għal klieb hi 2. 36%.
Multiples of MAC are used as a guide for surgical levels of anaesthesia, which are typically 1.3 to 1.5 times the MAC value.
Multiplikazzjonijiet tal- MAC jintużaw bħala gwida għal livelli kirurġiċi ta ’ loppju, li tipikament huma minn 1. 3 sa 1. 5 drabi tal- valur tal- MAC.
Sevoflurane produces unconsciousness by its action on the central nervous system.
Sevoflurane iraqqad permezz ta ’ l- effett tiegħu fuq is- sistema nervuża ċentrali.
Sevoflurane produces only modest increases in cerebral blood flow and metabolic rate, and has little or no ability to potentiate seizures.
Sevoflurane jipproduċi biss żieda żgħira fl- influss ċerebrali tad- demm u fir- rata metabolika, u ftit jew xejn jista ’ jwassal biex jikkawża aċċessjoni.
Sevoflurane may increase intracranial pressure at concentrations of 2.0 MAC and above under normal partial pressures of carbon dioxide (normocapnia), but intracranial pressure has been shown to remain within normal range at sevoflurane concentrations of up to 1.5 MAC if hypocapnia is induced by hyperventilation.
Sevoflurane jista ’ jżid il- pressjoni fil- moħħ, f’ konċentrazzjonijiet ta ’ 2. 0 MAC jew aktar, f’ każi normali ta ’ pressjoni parzjali ta ’ dijossidu tal- karbonju, iżda l- pressjoni intrakranjali ntweriet li baqgħet fil- firxa normali, f’ konċentrazzjonijiet ta ’ sevoflurane sa ’ 1. 5 MAC jekk tiġi indotta ipokapnija permezz ta ’ l- iperventilazzjoni.
Sevoflurane has a variable effect on heart rate, which tends to increase from baseline at low MAC and fall back with increasing MAC.
Sevoflurane għandu effett varju fuq ir- rata ta ’ taħbit tal- qalb, bit- tendenza tkun żieda mill- linja ta ’ bażi ta ’ riferiment fil- każ ta ’ MAC baxxa u taqa ’ lura biż- żieda tal- MAC.
Sevoflurane causes systemic vasodilation and produces dose- dependent decreases in mean arterial pressure, total peripheral resistance, cardiac output and possibly the strength of myocardial contraction and speed of myocardial relaxation.
Sevoflurane jikkawża twessiegħ sistemiku tal- vini u arterji u jipproduċi tnaqqis: fil- medja tal- pressjoni arterjali, dipendentement fuq id- doża, fir- reżistenza periferali sħiħa, volum tad- demm li joħroġ mill- qalb u possibilment fis- saħħa tal- kontrazzjoni muskolari tal- qalb u l- veloċità ta ’ rilassament tal- muskoli tal- qalb.
Sevoflurane has a depressive effect on respiration characterised by a fall in ventilation frequency.
Sevoflurane għandu effett li jnaqqas ir- respirazzjoni, karateriżżat f’ waqa ’ fil- frekwenza ta ’ kemm tieħu nifs.
Respiratory depression may lead to respiratory acidosis and respiratory arrest (at sevoflurane concentrations of 2.0 MAC and above) in spontaneously breathing dogs.
In- nuqqas respiratorju jista ’ jwassal għal aċidosi respiratorja u waqfien respiratorju (b’ doża ta ’ 2. 0 MAC ta ’ sevoflurane jew aktar) fi klieb li jieħdu n- nifs spontanjament.
6/ 24 Concentrations of sevoflurane below 2.0 MAC result in a small net increase in total liver blood flow.
Konċentrazzjoni ta ’ sevoflurane ta ’ inqas minn 2. 0 MAC jirriżulta f’ żieda żgħira netta fl- influss sħiħ ta ’ demm fil- fwied.
Hepatic oxygen delivery and consumption were not significantly altered at concentrations up to 2.0 MAC.
Ossiġnu fornut u kkunsmat fil- fwied ma tantx nbidel f’ konċentrazzjonijiet sa 2. 0 MAC.
Sevoflurane administration adversely affects the autoregulation of renal blood flow in dogs.
It- teħid ta ’ sevoflurane jaffettwa ħażin l- awtoregolazzjoni ta ’ l- influss tad- demm fil- kliewi tal- klieb.
As a result, renal blood flow falls in a linear fashion with increasing hypotension in sevoflurane anaesthetised dogs.
Bħala riżultat l- influss tad- demm fil- kliewi jonqos f’ mod lineari bit- tnaqqis fil- pressjoni fi klieb illupjati bis- sevoflurane.
Nevertheless, renal oxygen consumption, and hence renal function, are preserved at mean arterial pressures above 40 mmHg.
Madankollu, it- teħid ta ’ ossiġnu mill- kliewi, u sussegwentemnt il- funzjoni tal- kliewi, tinżamm kostanti bi pressjoni arterjali ta ’ ’ l fuq minn 40 mmHg.
A minimal amount of sevoflurane is required to be dissolved in the blood before the alveolar partial pressure is in equilibrium with the arterial partial pressure because of the low solubility of sevoflurane in blood (blood/ gas partition coefficient at 30°C is 0.63 to 0.69).
Ammont minimu ta ’ sevoflurane fid- demm hu meħtieġ biex il- pressjoni parzjali alveolari tkun f’ ekwilibriju mal- pressjoni parzjali arterjali minħabba s- solubilità baxxa ta ’ sevoflurane fid- demm (koeffiċjenza diviżorja demm/ gas f’ temperatura ta ’ 30°C hi bejn 0. 63 u 0. 69).
During sevoflurane induction, there is a rapid increase in alveolar concentration towards the inspired concentration, with the ratio of inspired to end-tidal concentration of sevoflurane reaching a value of 1 within 10 minutes.
Waqt l- induzzjoni b’ sevoflurane, hemm żieda ta ’ malajr fil- konċentrazzjoni alveolari li twassal lejn il- konċentrazzjoni inspirata, bil- proporzjon ta ’ konċentrazzjoni ispiratorja għal dik ta ’ l- imbatt ta’ sevoflurane tkun ta ’ 1 fi żmien 10 minuti.
Anaesthetic induction is correspondingly rapid and the depth of anaesthesia changes rapidly with changes in anaesthetic concentration.
L- induzzjoni bil- loppju hu għaldaqstant mgħaġġel u l- livell ta ’ anesteżija jinbidel malajr flimkien ma ’ tibidliet fil- konċentrazzjoni anestetika.
Sevoflurane is metabolised to a limited extent in the dog (1 to 5%).
Sevoflurane huwa metaboliżżat b’ mod ristrett fil- klieb (1 sa 5%).
The principle metabolites are hexafluoroisopropanol (HFIP) with release of inorganic fluoride and CO2.
Il- metaboliti prinċipali huma hexafluoroisopropanol (HFIP) bl- eliminazzjoni ta ’ florid inorganiku u CO2.
Fluoride ion concentrations are influenced by the duration of anaesthesia and the concentration of sevoflurane.
Il- konċentrazzjonijiet tal- joni tal- florid huma influwenzati bit- tul ta ’ l- anesteżija u l- konċentrazzjoni ta ’ sevoflurane.
Once formed, HFIP is rapidly conjugated with glucuronic acid and eliminated as a urinary metabolite.
La darba jifforma, HFIP jingħaqad malajr ma ’ l- aċidu glukuroniku u jiġi eliminat bħala metabolit fl- urina.
No other metabolic pathways for sevoflurane have been identified.
Għadhom ma ġewx identifikati rotot metaboliċi oħra għas- sevoflurane.
In dogs exposed to 4% sevoflurane for 3 hours, mean peak maximum serum fluoride concentrations of 20.0 ± 4.8 µmol/ l have been observed after 3 hours of anaesthesia.
Fi klieb esposti għal 3 sigħat b’ 4% sevoflurane, ġiet osservata medja ta ’ konċentrazzjonijiet massimi ta ’ florid fis- sirum ta ’ 20. 0 ± 4. 8 µmol/ l wara 3 sigħat t’ anesteżija.
Serum fluoride fell quickly after anaesthesia ended and had returned to baseline by 24 hours post-anaesthesia.
Il- florid fis- sirum niżel malajr wara li twaqqfet l- anesteżija u rritorna fil- livell bażi fi żmien 24 siegħa wara l- anesteżija.
The elimination of sevoflurane is biphasic in nature, with an initial rapid phase and a second, slower phase.
L- eliminazzjoni ta ’ sevoflurane hi magħmula minn żewġ fażijiet, bl- ewwel fażi tkun mgħaġġla, u t- tieni fażi aktar bil- mod.
Parent compound (the dominant fraction) is eliminated via the lungs.
Is- sustanza oriġinali (il- parti dominanti) hija eliminata mill- pulmun.
The half-life for the slow elimination phase is approximately 50 minutes.
Il- half - life ta ’ l- eliminazzjoni tal- fażi bil- mod hi ta ’ madwar 50 minuta.
Elimination from blood is largely complete within 24 hours.
L- eliminazzjoni mid- demm tkun kważi mitmuma fi żmien 24 siegħa.
The elimination time from adipose tissue is more prolonged than from the brain.
Iż- żmien ta ’ eliminazzjoni mit- tessut xaħmi hu itwal minn dak tal- moħħ.
6.3 Shelf life
6. 3 Żmien ta ’ kemm il- prodott idum tajjeb.
3 years
3
Do not refrigerate.
Taħżinx fil- friġġ.
Keep the bottle tightly closed.
Żomm il- flixkun magħluq tajjeb.
7/ 24 6.5 Nature and composition of immediate packaging
6. 5 In- natura u l- għamla ta ’ l- ewwel ippakkjar
SevoFlo is presented in a cardboard box containing a 250 ml polyethylene naphthalate (PEN) bottle with a Quik-Fil closure.
SevoFlo huwa ppreżentat f’ kaxxa tal- kartun li jkun fiha flixkun ta ’ 250 ml ta ’ polyethylene naphthalate (PEN) li jingħalaq b’ għatu Quik- Fil.
6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
6. 6 Prekawzjonijiet speċjali għar- rimi tal- prodotti mediċinali veterinarji mhux użata jew materjal ieħor gar- rimi li huwa derivat minn dawn il- prodotti
MARKETING AUTHORISATION NUMBER(S)
NUMRU TA ’ AWTORIZZAZZJONI TAL- KUMMERĊ
11 December 2002 Date of last renewal:
11 ta ’ Dicembru 2002 Data ta ’ l- aħħar tiġdid:
Not applicable.
Mhux applikabbli ANNESS II
MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
SID / SIDIEN TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI MILL- HRUĠ TAL- LOTT
STATEMENT OF THE MRLs
DIKJARAZZJONI TA ’ L- MRLs A.
Name and address of the manufacturer(s) responsible for batch release
Isem u indirizz tal- manufattur responsabbli mill- ħruġ tal- lott( i)
Aesica Queenborough Limited Queenborough Kent ME11 5EL United Kingdom
Aesica Queenborough Limited Queenborough Kent ME11 5EL Ir- Renju Unit
CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE PRODUCT
KONDIZZJONIJIET JEW RESTRIZZJONIJIET TA ’ TAL- KUMMERĊ DWAR L- UŻU SIGUR U EFFETTIV
10/ 24 ANNEX III
ANNESS III
LABELLING AND PACKAGE LEAFLET
TIKETTA U L- FULJETT TA ’ TAGĦRIF FIL- PAKETT A.
12/ 24 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
TIKKETTA TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
SevoFlo 100% Inhalation vapour, liquid for dogs. sevoflurane
SevoFlo 100% Fwar jittieħed man- nifs, likwidu għal klieb sevoflurane
100% sevoflurane
100% sevoflurane
Inhalation vapour, liquid
Fwar jittieħed man- nifs, likwidu
For induction and maintenance of anaesthesia.
Għal induzzjoni u manteniment ta ’ anesteżija
Administer by inhalation using a vaporiser calibrated for sevoflurane.
Qabel l- użu aqra l- fuljett li jinsab fil- pakkett, Agħti bit- teħid tan- nifs permezz ta ’ fawwar ikkalibrat għal sevoflurane
Do not use in dogs with known hypersensitivity to sevoflurane or other halogenated anaesthetic agents.
Tużax fuq klieb li huma magħrufin li għandhom sensittività eċċessiva għal sevoflurane jew sustanzi oħra ta ’ llupjar ħaloġenati.
Do not use in dogs with a known or suspected genetic susceptibility to malignant hyperthermia.
Tużax fi klieb li huma tqal jew qed ireddgħu Tużax fi klieb li huma magħrufin jew suspettati li għandhom suxxetibilità ġenetika għal żieda fit- temperatura għolja malinna.
13/ 24 Do not use in dogs less than 12 weeks of age.
Tużax fuq klieb li huma ta ’ anqas minn 12- il ġimgħa
For operator warnings - read the package leaflet before use.
Għal twissijiet lill- operatur aqra l- fuljett ta ’ tagħrif fil- pakkett qabel l- użu
Keep the bottle tightly closed.
Taħżinx f' temperatura ’ l fuq minn 25°C Tagħmlux fil- friġġ Żomm il- flixkun magħluq tajjeb
Any unused veterinary medicinal product or waste materials derived from the veterinary medicinal product should be disposed of in accordance with local regulations.
Mediċina veterinarja li ma ġietx użata jew prodotti oħra li ntużaw għal din il- mediċina għandhom jintremew skond kif titlob il- liġi tal- pajjiz.
Abbott Laboratories Ltd Queenborough Kent ME11 5EL United Kingdom
Abbott Laboratories Ltd Queenborough Kent ME11 5EL Ir- Renju Unit
14/ 24 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE
Lott {numru} DETTALJI LI GĦANDHOM JIDHRU FUQ L- IPPAKKJAR EWLIENI
For operator warnings – read the package leaflet before use.
Tużax fi klieb li huma tqal jew qed ireddgħu jew fi klieb li huma ta ’ anqas minn 12- il ġimgħa Għal twissijiet lill- operatur aqra l- fuljett ta ’ tagħrif fil- pakkett qabel l- użu 10.
Keep the bottle tightly closed.
Taħżinx f' temperatura l- fuq minn 25°C Tagħmlux fil- friġġ Żomm il- flixkun magħluq tajjeb
For animal treatment only - to be supplied only on veterinary prescription.
Għal Trattament ta ’ l- Annimali Biss - għandu jingħata biss bi preskrizzjoni medika veterinarja.
Lot {number}
Lott {numru} B.
17/ 24 PACKAGE LEAFLET SevoFlo Inhalation vapour, liquid for dogs, 100% sevoflurane
FULJETT TA 'TAGĦRIF FIL- PAKKETT FULJETT TA ’ TAGĦRIF FIL- PAKKETT SevoFlo Fwar jittieħed man- nifs, likwidu għal klieb, 100% sevoflurane
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT
1 L- ISEM U L- INDIRIZZ TAS- SID TA ’ L- AWTORIZZAZZJONI TA ’ L- KUMMERĊ, U L- ISEM U L- INDIRIZZ TAS- SID TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI LI JĦALLI L- KONSENJA TMUR FIS- SUQ, JEKK DIFFERENTI
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
DIKJARAZZJONI TAS- SUSTANZA ATTIVA U INGREDJENT IEĦOR