natgillin/translations-raw huggingface dataset:
Signs related to the nervous system can be treated with e.g. atropine (salivation) and diazepam (muscle tremors/fasciculation/cramp).
Za zdravljenje simptomov, povezanih z živčnim sistemom, se lahko uporabi npr. atropin (slinjenje) in diazepam (mišični tremor / fascikulacije / krči).
If clinical signs of poisoning occur, seek veterinary advice immediately and show this package leaflet to your veterinarian.
Če se pojavijo klinični znaki zastrupitve, poiščite takoj nasvet veterinarja in pokažite to navodilo za uporabo.
Permethrin belongs to the Type I class of pyrethroids, which are acaricides and insecticides with repellent activity.
Permetrin spada v skupino piretroidov tipa I, to so akaricidi in insekticidi z repelentnim delovanjem.
• do not handle treated animals until the application site is dry;
• ne dotikajte se zdravljenih živali, dokler mesto nanosa ni suho,
All dogs in a household should be treated with a suitable flea product.
Vse pse v gospodinjstvu je treba zdraviti z ustreznimi zdravili za zatiranje bolh.
Do not use in cases of known hypersensitivity to the active substances or to any of the excipients.
Ne uporabljajte v primerih znane preobčutljivosti na učinkovine ali na katero od pomožnih snovi.
Pentobarbital, phenobarbital or propofol might be indicated if repeated occasions of cramp/tremors occur.
Fentobarbital, fenobarbital ali propofol se indicirani v primeru pojava ponavljajočih se primerov krčev / tremorjev.
Local and/or systemic reactions have been observed in some people after exposure to the product such as: local skin reactions; nasal or throat/mouth irritation; neurological signs; respiratory signs; gastrointestinal signs or other systemic signs.
Pri nekaterih ljudeh so se po izpostavljenosti zdravilu pojavile lokalne in/ali sistemske reakcije kot na primer lokalne reakcije na koži, draženje v nosu ali grlu/ustih, nevrološki znaki, respiratorni znaki, gastrointestinalni znaki ali drugi sistemski znaki.
PACKAGE LEAFLET: Activyl Tick Plus spot-on solution for dogs
NAVODILO ZA UPORABO: Activyl Tick Plus kožni nanos, raztopina za pse
Cardboard box with 1, 4 or 6 sachets; each sachet contains one unit-dose pipette.
Kartonska škatla z 1, 4 ali 6 vrečkami, vsaka vrečka vsebuje eno merilno kapalko z enim odmerkom.
Laboratory studies in rats, mice and rabbits with indoxacarb and permethrin have not produced any evidence of teratogenic, foetotoxic or materno toxic effects.
Z laboratorijskimi študijami na živalih (podgane, miši in zajci) z indoksakarbom in permetrinom niso bili dokazani teratogeni in fetotoksični učinki ter toksični učinki na mater.
Care should be taken to avoid contact of the veterinary medicinal product with the eyes of the dog.
Paziti je treba, da zdravilo za uporabo v veterinarski medicini ne pride v oči psa.
Store the pipettes in the original package in order to protect from moisture and light.
Shranjujte merilno kapalko v originalni ovojnini za zaščito pred vlago in svetlobo.
Danger - Do not use in cats.
Nevarnost - Ne uporabite pri mačkah.
Indoxacarb is a pro- drug that requires bioactivation by enzymes in susceptible insects to exert its pharmacodynamic effects.
Indoksakarb je prozdravilo, ki ga morajo bioaktivirati encimi insekta, da začne farmakodinamsko učinkovati.
THE WORDS “FOR ANIMAL TREATMENT ONLY”
BESEDILO “SAMO ZA ŽIVALI” Samo za živali
One ml contains 150 mg indoxacarb and 480 mg permethrin.
En ml vsebuje 150 mg indoksakarba in 480 mg permetrina.
The veterinary product should not enter water courses.
Zdravilo za uporabo v veterinarski medicini ne sme priti v vodotoke.
The product provides repellent (anti-feeding) activity against sand flies, thus preventing the repelled parasites from taking a blood meal.
Zdravilo zagotavlja repelentno delovanje (preprečevanje hranjemja) proti peščenim muham in tako preprečuje, da bi se paraziti hranili s krvjo.
Environmental properties
Okoljski podatki
SPECIAL WARNING(S)
POSEBNO(A) OPOZORILO(A)
Following a single spot-on application of the product, indoxacarb and permethrin can still be detected in both skin and hair coat after 4 weeks post-treatment.
Po enkratnem nanosu raztopine indoksakarb in permetrin še vedno lahko odkrijemo tako v koži kot v dlaki 4 tedne po nanosu.
Do not use on dogs in case of known hypersensitivity to the active substances or any of the excipients.
Ne uporabljajte v primeru znane preobčutljivosti za zdravilno učinkovino ali katero od pomožnih snovi.
If symptoms occur, seek medical advice and show the package leaflet to the physician.
Če se pojavijo znaki, poiščite zdravniški nasvet in pokažite zdravniku navodilo za uporabo.
Following a single administration, the veterinary medicinal product will prevent further flea infestation for 4 weeks and prevent tick re-infestation (through an acaricidal effect) with I. ricinus and R. sanguineus for 5 and 3 weeks, respectively; repellent (anti-feeding) activity against sand flies will last for 3 weeks.
Po eni nanosu bo zdravilo za uporabo v veterinarski medicini preprečilo nadaljnjo infestacijo z bolhami do 4 tednov in preprečilo ponovno infestacijo (preko akaricidnega učinka) z I. ricinus do 5 tednov in z R. sanguineus do 3 tedne.
Transitory erythema, hair loss or itching at the application site were commonly observed in clinical studies.
Prehodna rdečina, izpadanje dlake ali srbenje na mestu nanosa se je pogosto pojavljalo v kliničnih študijah.
Indoxacarb and permethrin may have harmful effects on aquatic organisms.
Indoksakarb in permetrin lahko škodljivo delujeta na vodne organizme.
However, potential transmission of infectious disease by sand flies cannot be excluded if conditions are unfavourable.
Vendar pa ni mogoče izkljućiti, da bi peščene muhe v neugodnih pogojih prenašale nalezljive bolezni.
INDICATION(S)
NAVEDBA UČINKOVIN(E)
The absorbed indoxacarb and permethrin are extensively metabolised by the liver to a variety of metabolites.
Absorbirani indoksakarb in permetrin se razgradita v jetrih v vrsto metabolitov.
6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
6.6 Posebni varnostni ukrepi za odstranjevanje neporabljenega zdravila ali odpadnih snovi
The recommended dose for dogs is 15 mg indoxacarb and 48 mg permethrin per kg bodyweight, equivalent to 0.1 ml/kg bodyweight.
Priporočeni odmerek za pse je 15 mg indoksakarba in 48 mg permetrina na kg telesne mase, kar ustreza 0,1 ml/kg telesne mase.
− rare (more than 1 but less than 10 animals in 10,000 animals treated)
Pogostost neželenih učinkov je določena po naslednjem dogovoru: - zelo pogosti (neželeni učinki se pokažejo pri več kot 1 od 10 zdravljenih živali) - pogosti (pri več kot 1, toda manj kot 10 živali od 100 zdravljenih živali) - občasni (pri več kot 1, toda manj kot 10 živali od 1.000 zdravljenih živali) - redki (pri več kot 1, toda manj kot 10 živali od 10.000 zdravljenih živali) - zelo redki (pri manj kot 1 živali od 10.000 zdravljenih živali, vključno s posameznimi primeri).
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
B. POGOJI TER OMEJITVE GLEDE OSKRBE IN UPORABE Brez Rp-Vet.
Dogs 1.2 - 5 kg Dogs 5.1 - 10 kg Dogs 10.1 - 20 kg Dogs 20.1 - 40 kg Dogs 40.1 - 60 kg
Psi 1,2 - 5 kg Psi 5,1 - 10 kg Psi 10,1 - 20 kg Psi 20,1 -40 kg Psi 40,1 - 60 kg
In case of exposure of this type seek veterinary advice immediately.
Če pride do takega stika, nemudoma obiščite veterinarja.
Shelf life of the veterinary medicinal product as packaged for sale: 3 years.
Rok uporabnosti zdravila za uporabo v veterinarski medicini v pakiranju za prodajo: 3 leta 6.4 Posebna navodila za shranjevanje
However, a reproductive toxicity study conducted in the dog at three times the recommended therapeutic dose did reveal a significant reduction in the live pup ratio; the clinical significance of this latter finding is unknown as no studies were carried out in dogs using the recommended therapeutic dose.
Vendar pa je študija reprodukcijske toksičnosti pri psih pri trikratnem priporočenem terapevtskem odmerku pokazala pomembno zmanjšanje števila živih mladičev.
It is important to ensure that cats do not groom the site of application on a dog which has been treated with this product.
Pomembno je, da mačke ne pridejo v stik z mestom nanosa (ne morejo lizati dlake na mestu nanosa) na psu, ki je bil zdravljen s tem zdravilom.
Care should be taken to apply the product to intact skin.
Paziti je treba, da nanašate zdravilo na nepoškodovano kožo.
The recommended minimum dose is 15 mg indoxacarb/kg bodyweight and 48 mg/kg permethrin, equivalent to 0.1 ml spot-on solution per kg bodyweight.
Priporočeni minimalni odmerek je 15 mg indoksakarba/kg telesne mase in 48 mg/kg permetrina, kar ustreza 0,1 ml kožnega nanosa na kg telesne mase.
Gastrointestinal signs (e.g. emesis (vomiting), diarrhoea or anorexia (loss of appetite), reversible neurological signs (e.g. tremor (shakiness) or ataxia (unsteady movement)) or lethargy (drowsiness) have been observed in very rare cases.
V zelo redkih primerih se pojavijo gastrointestinalni znaki (npr. bruhanje, diareja ali anoreksija (izguba apetita)), reverzibilni nevrološki znaki (npr. tremor (tresenje) ali ataksija (nestabilno gibanje) ali letargija (zaspanost) .
Advice for the veterinarian: Intravenous infusion of electrolytes should be provided to stabilize vital functions if clinical signs of poisoning occur (e.g. hypersalivation, tremor, muscle cramp).
Nasvet za veterinarje: Če se pojavijo klinični znaki zastrupitve (npr. preveliko izločanje sline, tremor, mišični krč) je za stabilizacijo vitalnih funkcij treba zagotoviti intravensko infuzijo elektrolitov.
Treatment of flea infestations (Ctenocephalides felis); the product has persistent insecticidal efficacy for up to 4 weeks against Ctenocephalides felis.
INDIKACIJA(E) Zdravljenje infestacije z bolhami (Ctenocephalides felis); zdravilo deluje insekticidno do 4 tedne na
QUANTITY OF THE ACTIVE SUBSTANCE(S)
KOLIČINA UČINKOVIN(E)
The sachet is child-resistant.
Vrečka je varna za otroke.
Intervet International BV
IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Intervet International BV
Volume of unit dose (ml)
Enkratni odmerek (ml)
METHOD AND ROUTE(S) OF ADMINISTRATION For spot-on use.
NAČIN IN POT(I) UPORABE Kožni nanos.
Very small dogs (1.2 - 5 kg) Small dogs (5.1 - 10 kg) Medium dogs (10.1 - 20 kg) Large dogs (20.1 - 40 kg) Extra large dogs (40.1 - 60 kg)
Zelo majhni psi (1,2 - 5 kg) Majhni psi (5,1 - 10 kg) Srednje veliki psi (10,1 - 20 kg) Veliki psi (20,1 - 40 kg) Zelo veliki psi (40,1 - 60 kg)
Stored pipettes must be kept in the child-resistant sachet.
Merilne kapalke morate hraniti v vrečkah, ki so varne za otroke.
Sand flies
bolhe klopi peščene muhe
Ticks
Brejost
One treatment provides repellent (anti-feeding) activity against sand flies (Phlebotomus perniciosus) for up to 3 weeks.
Repelentno delovanje (preprečevanje hranjenja) proti peščenim muham traja do 3 tedne.
A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
A. PROIZVAJALEC (PROIZVAJALCI) ZDRAVILA, ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJ
40.1 - 60 Extra large dogs
20,1 - 40 veliki psi
One pipette delivers:
En enkratni odmerek v kapalki vsebuje:
For very small dogs (1.2 - 5 kg) For small dogs (5.1 - 10 kg) For medium dogs (10.1 - 20 kg) For large dogs (20.1 - 40 kg) For extra large dogs (40.1 - 60 kg)
Za zelo majhne pse (1,2 - 5 kg) Za majhne pse (5.1 - 10 kg) Za srednje velike pse (10,1 - 20 kg) Za velike pse (20,1 - 40 kg) Za zelo velike pse (40,1 - 60 kg)
Gastrointestinal signs (e.g. emesis, diarrhoea or anorexia), reversible neurological signs (e.g. tremor or ataxia) or lethargy have been observed in very rare cases.
V zelo redkih primerih se pojavijo gastrointestinalni znaki (npr. bruhanje, diareja ali anoreksija), reverzibilni nevrološki znaki (npr. tremor ali ataksija) ali letargija.
Keep the used pipette out of sight and reach of children.
Uporabljena merilna kapalka naj ne bo v dosegu otrok.
Pyrethroids affect the voltage-gated sodium channels in vertebrates and non- vertebrates.
Piretroidi delujejo na napetostno občutljive natrijeve kanale pri vretenčarjih in nevretenčarjih.
Fertility: Do not use in breeding dogs.
Plodnost: Ne uporabljajte pri vzrejnih psih.
1 pipette 4 pipettes 6 pipettes
VELIKOST PAKIRANJA 1 merilna kapalka 4 merilne kapalke 6 merilnih kapalk
Overdose
ZDRAVILA
Cardboard box of 1 pipette of 0.5 ml, 1 ml, 2 ml, 4 ml or 6 ml.
Kartonska škatla z 1 merilno kapalko po 0,5 ml, 1 ml, 2 ml, 4 ml ali 6 ml
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS SACHET
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
Apply the product only to the skin surface and on intact skin.
Zdravilo je potrebno nanesti na suho in nepoškodovano kožo.
Lactation: Do not use in lactating dogs.
Laktacija: Ne uporabite pri psicah v obdobju laktacije.
Do not apply an excessive amount of solution at any one spot in order to prevent run-off. Should run-off occur, re-application is not necessary.
Ne nanašajte prevelike količine raztopine na eno mesto, de ne bi zdravilo teklo po dlaki živali.
10.1 - 20 Medium dogs 20.1 - 40 Large dogs
5,1 - 10 majhni psi 10,1 - 20 srednje veliki psi
EXP {month/year}
DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA EXP (mesec/leto)
SPECIAL WARNING(S), IF NECESSARY
POSEBNO(A) OPOZORILO(A), ČE JE/SO POTREBNO(A) Pred uporabo preberite navodilo za uporabo.
Pharmacotherapeutic group: Ectoparasiticides for topical use, incl.
Farmakoterapevtska skupina: Učinkovine proti ektoparazitom za lokalno zdravljenje, vključno z insekticidi; permetrin, kombinacije.
The major route of excretion is in faeces for indoxacarb and both in urine and faeces for permethrin.
V glavnem se metaboliti indoksakarba izločajo z blatom, metaboliti permetrina pa z urinom in s fecesom.
PACKAGE SIZE
Uporabljena velikost kapalk
Pregnancy:
Odmerjanje:
BATCH NUMBER
ŠTEVILKA SERIJE Serija {številka}
Keep pipettes in the original packaging until ready to use.
Merilne kapalke do uporabe shranjujte v originalni ovojnini.
Special precautions to be taken by the person administering the veterinary medicinal product to animals:
Posebni previdnostni ukrepi, ki jih mora izvajati oseba, ki živalim daje zdravilo: Merilne kapalke shranjujte v originalni ovojnini do uporabe.
Activyl Tick Plus 75 mg + 240 mg for dogs 1.2 - 5 kg Activyl Tick Plus 150 mg + 480 mg for dogs 5.1 - 10 kg Activyl Tick Plus 300 mg + 960 mg for dogs 10.1 - 20 kg Activyl Tick Plus 600 mg + 1920 mg for dogs 20.1 - 40 kg Activyl Tick Plus 900 mg + 2880 mg for dogs 40.1 - 60 kg
Activyl Tick Plus 150 mg + 480 mg za pse 5,1 - 10 kg Activyl Tick Plus 300 mg + 960 mg,za pse 10,1 - 20 kg Activyl Tick Plus 600 mg + 1920 mg za pse 20,1 - 40 kg
Intravenous infusion of electrolytes should be provided to stabilize vital functions if clinical signs of poisoning occur (e.g. hypersalivation, tremor, muscle cramp).
Če se pojavijo klinični znaki zastrupitve (npr. povečano izločanje sline, tremor, mišični krč) je za stabilizacijo vitalnih funkcij treba zagotoviti intravensko infuzijo elektrolitov.
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER (pipette label)
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
Activyl Tick Plus 75 mg + 240 mg spot-on solution for very small dogs (1.2 - 5 kg) Activyl Tick Plus 150 mg + 480 mg spot-on solution for small dogs (5.1 - 10 kg) Activyl Tick Plus 300 mg + 960 mg spot-on solution for medium dogs (10.1 - 20 kg) Activyl Tick Plus 600 mg + 1920 mg spot-on solution for large dogs (20.1 - 40 kg) Activyl Tick Plus 900 mg + 2880 mg spot-on solution for extra large dogs (40.1 - 60 kg)
Activyl Tick Plus 75 mg + 240 mg, kožni nanos, raztopina za zelo majhne pse (1,2 - 5 kg) Activyl Tick Plus 150 mg + 480 mg, kožni nanos, raztopina za majhne pse (5,1 - 10 kg) Activyl Tick Plus 300 mg + 960 mg, kožni nanos, raztopina za srednje velike pse (10,1 -20 kg) Activyl Tick Plus 600 mg + 1920 mg, kožni nanos, raztopina za velike pse (20,1 - 40 kg) Activyl Tick Plus 900 mg + 2880 mg, kožni nanos, raztopina za zelo velike pse (40,1 do 60 kg)
One unit-dose pipette holds 0.5 ml, 1 ml, 2 ml, 4 ml, or 6 ml spot-on solution.
Vsaka merilna kapalka z enim odmerkom vsebuje 0,5 ml, 1 ml, 2 ml, 4 ml ali 6 ml raztopine kožnega nanosa.
Cardboard box of 4 pipettes of 0.5 ml, 1 ml, 2 ml, 4 ml or 6 ml.
Kartonska škatla s 4 merilnimi kapalkami po 0,5 ml, 1 ml, 2 ml, 4 ml ali 6 ml Kartonska škatla s 6 merilnimi kapalkami po 0,5 ml, 1 ml, 2 ml, 4 ml ali 6 ml
Activyl Tick Plus 75 mg + 240 mg spot-on solution for very small dogs Activyl Tick Plus 150 mg + 480 mg spot-on solution for small dogs Activyl Tick Plus 300 mg + 960 mg spot-on solution for medium dogs Activyl Tick Plus 600 mg + 1920 mg spot-on solution for large dogs Activyl Tick Plus 900 mg + 2880 mg spot-on solution for extra large dogs
Activyl Tick Plus 75 mg + 240 mg kožni nanos, raztopina za zelo majhne pse Activyl Tick Plus 150 mg + 480 mg kožni nanos, raztopina za majhne pse Activyl Tick Plus 300 mg + 960 mg kožni nanos, raztopina za srednje velike pse Activyl Tick Plus 600 mg + 1920 mg kožni nanos, raztopina za velike pse Activyl Tick Plus 900 mg + 2880 mg kožni nanos, raztopina za zelo velike pse
PHARMACEUTICAL FORM
FARMACEVTSKI PODATKI
Do not use in pregnant dogs.
Ne uporabite pri psicah v obdobju brejosti.
For application to the dog's skin only.
Nanos na kožo.
Spot-on use.
Pot uporabe:
insecticides; permethrin, combinations.
FARMACEVTSKA OBLIKA Kožni nanos, raztopina.
It is important to ensure that the product is applied to an area where the dog cannot lick it off, and to ensure that other animals do not lick the treatment sites following application.
Zdravljeno žival je Dokler se mesto nanosa ne posuši je potrebno zdravljeno žival ločiti od preostalih živali.
THE WORDS “KEEP OUT OF THE SIGHT AND REACH OF CHILDREN”
BESEDILO “ZDRAVILO SHRANJUJTE NEDOSEGLJIVO OTROKOM ” Zdravilo shranjujte nedosegljivo otrokom.
Date of first authorisation: 22 January 2001 Date of latest renewal: 29 November 2010
Datum prve odobritve: 22. januar 2001 Datum zadnjega podaljšanja: 29. november 2010
The potential risk for humans is unknown.
Potencialno tveganje za ljudi ni znano.
n = 38 n = 39 n = 36 n = 36 n = 37
n = 38 n = 39 n = 36 n = 36
This can be due to the high dosages usually used in this population.
To je lahko posledica visokih odmerkov, ki se običajno uporabijo pri tej populaciji.
If this happens, do not drive or use any tools or machines.
Če se to zgodi, ne upravljajte vozil, orodja ali strojev.
Before having an operation
Pred operacijo
There were 77 subjects enrolled into the first study and 109 subjects into the second.
V prvi študiji je bilo vključenih 77 oseb, v drugi pa 109 oseb.
This means it is essentially “sodium free”.
To pomeni, da je v bistvu »brez natrija«.
You may need urgent medical treatment.
Mogoče boste potrebovali nujno medicinsko zdravljenje.
The risk of spreading of effect is greater than in adults, and more frequently severe.
Tveganje za širjenje učinka je večje in pogosto bolj resno kot pri odraslih.
Results of comparisons of the primary and secondary efficacy variables are summarised in Table 1.
Rezultati primerjanja primarnih in sekundarnih variabel učinkovitosti so povzeti v preglednici 1.
Other side effects include:
Med drugimi neželenimi učinki so:
The available reports indicate that the product has been used in the paediatric population.
Razpoložljiva poročila kažejo, da je bilo zdravilo uporabljeno pri pediatrični populaciji.
On these scales, scores of 50 indicate no change, 0 much worse, and 100 much better.
Na teh lestvicah je vrednost 50 pomenila, da ni bilo spremembe, 0 je bilo hudo poslabšanje, 100 pa veliko izboljšanje.
The dosing frequency should therefore be adapted based on the clinical assessment/response of an individual patient.
Zato je treba pogostnost odmerjanja prilagoditi na podlagi klinične ocene/odziva posameznega bolnika.
The risks, which can include death, may outweigh the potential benefits.
Tveganje, ki lahko vključuje smrt bolnika, je lahko večje od možnih koristi.
In these studies, the average dosing frequency was approximately every 12 weeks.
V teh študijah je bila povprečna pogostnost odmerjanja približno vsakih 12 tednov.
In the event of an overdose, general medical supportive measures should be instituted.
V primeru prevelikega odmerjanja morate uporabiti splošne zdravstvene podporne ukrepe.
This warning includes use in children and in any other indication besides cervical dystonia.
To opozorilo vključuje uporabo pri otrocih in vsako drugo indikacijo, razen cervikalne distonije.
Wear waterproof gloves and soak up the liquid with an appropriate absorbent.
Nosite nepremočljive rokavice in popivnajte tekočino z ustreznim absorbentom.
The frequency of these side effects is not known.
Pogostnost teh neželenih učinkov ni znana.
Intramuscular use.
Intramuskularna uporaba.
Injections should be repeated as required to maintain good function and minimise pain.
Injiciranje morate po potrebi tudi ponavljati, da bi zagotovili dobro delovanje in čim bolj zmanjšali bolečine.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Obvestite svojega zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
The following information is intended for healthcare professionals only: INSTRUCTIONS FOR USE, HANDLING AND DISPOSAL
Naslednje informacije so namenjene samo zdravstvenemu osebju: NAVODILA ZA PRIPRAVO IN RAVNANJE Z ZDRAVILOM IN ODLAGANJE
Specifically, these studies showed approximately 19-25% seroconverted within 18 months of initiation of treatment, increasing to approximately 33-44% with up to 45 months of treatment.
Natančneje rečeno so te študije pokazale, da je približno 19-25 % bolnikov serokonvertiralo v 18 mesecih po uvedbi zdravljenja, ta delež pa se je do 45. meseca zdravljenja zvečal na približno 33-44 %.
General precaution:
Splošni previdnostni ukrepi:
Very Common
Zelo pogosti
This leaflet was last revised in <{MM/YYYY}> <{month YYYY}> Other sources of information
Navodilo je bilo nazadnje revidirano dne <{MM/LLLL}> <{mesec LLLL}> Drugi viri informacij
Case reports are more likely to be serious in children (40%) compared to those in adults and older people (12%), possibly as a result of using an inappropriately high dosage for the child (see section 4.9).
Večja verjetnost je, da so poročila o primerih resnejša pri otrocih (40 %) v primerjavi z odraslimi in starejšimi ljudmi (12 %), kar je morda posledica uporabe neprimerno/neustrezno visokega odmerka pri otrocih (glejte poglavje 4.9).
You may feel pain at the place where you had the injection, but this should wear off after a few minutes.
Morda boste čutili bolečino na mestu injiciranja, vendar bi ta po nekaj minutah morala prenehati.
These include dysphagia and breathing difficulties.
To vključuje disfagijo in težave z dihanjem.
They may happen days to weeks after you have had the injection.
Lahko se pojavijo več dni do več tednov po injekciji.
Cases of overdose (some with signs of systemic toxicity) have been reported.
Poročali so o primerih prevelikega odmerjanja (nekaterih z znaki sistemske toksičnosti).
However, the pharmacological characteristics do not indicate any need to adjust the dose.
Vendar farmakološke lastnosti ne kažejo na to, da bi morali odmerek prilagajati.
The dose resulting in death was 2400 U/kg.
Smrtni odmerek je bil 2400 E/kg.
The medicinal product is ready to use and no reconstitution is required.
Zdravilo je pripravljeno za uporabo in rekonstitucija ni potrebna.
ANNEX II A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
PRILOGA II A. IZDELOVALEC BIOLOŠKE ZDRAVILNE UČINKOVINE IN IZDELOVALEC, ODGOVOREN ZA SPROŠČANJE SERIJ B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET Z ZDRAVILOM D. POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA
As with other botulinum toxins spontaneous recovery will occur over a period of time.
Kot pri drugih botulinskih toksinih čez čas pride do spontanega okrevanja.