FrancophonIA/ELRC3.0 huggingface dataset:
English: In contrast to conventional preparations containing the Botulinum toxin type A complex, Xeomin contains pure (150 kD) neurotoxin since it is free of complexing proteins.
Slovenian: V nasprotju z običajnimi zdravili s kompleksom botulinskega toksina tipa A vsebuje zdravilo Xeomin čisti nevrotoksin (150 kD) brez beljakovin, ki tvorijo komplekse.
English: The only severe case of dysphagia occurred in the Botox group.
Slovenian: Edini resni primer disfagije je nastopil v skupini, zdravljeni z zdravilom Botox.
English: It is possible that these side effects may also occur with Xeomin:
Slovenian: Možno je, da se ti neželeni učinki pojavijo tudi pri uporabi zdravila Xeomin:
English: The vial must be discarded, if the vacuum does not pull the solvent into the vial.
Slovenian: Če vakuum vehikla ne povleče v vialo, morate vialo zavreči.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR 1 VIAL WHEN THIS IS PART/COMPONENT OF A MULTIPACK WITH 2, 3, 6 VIALS
Slovenian: ŠKATLA ZA 1 VIALO, KADAR JE TO DEL/SESTAVNI DEL PAKIRANJA Z 2, 3, 6 VIALAMI
English: One death (colon carcinoma), assessed as unrelated to study treatment (Botox), was reported during the Phase II cervical dystonia study.
Slovenian: faze za cervikalno distonijo so poročali o enem smrtnem primeru (karcinom kolona), ki je bil ocenjen kot nepovezan z obravnavanim zdravljenem (Botox).
English: It has not been investigated whether secondary non-response due to the development of antibodies is less frequent under Xeomin therapy than under treatment with conventional preparations containing the Botulinum toxin type A complex.
Slovenian: Ni bilo raziskano, ali je sekundarna odsotnost odziva zaradi nastanka protiteles pri zdravljenju z zdravilom Xeomin manj pogosta kot pri zdravljenju z običajnimi zdravili, ki vsebujejo kompleks botulinskega toksina tipa A. Če se bolnik ne odziva, je treba pretehtati možnost uporabe drugih oblik zdravljenja.
English: The applicant is requested to submit the results of all scheduled HDA tests of the upper limb spasticity study (MRZ 0410) and the cervical dystonia study (MRZ 0408) after unblinding of the respective studies.
Slovenian: Od vlagatelja je bilo zahtevano, da po razkritju zadevnih študij predloži rezultate vseh načrtovanih testov HDA iz študije spastičnosti v zgornjih okončinah (MRZ 0410) in študije cervikalne distonije (MRZ 0408).
English: Your doctor should not use Xeomin if the vial reconstituted according to the instructions has a cloudy appearance or contains e.g. floccular or particulate matter.
Slovenian: Zdravnik ne sme uporabiti zdravila Xeomin, če je rekonstituirana raztopina, pripravljena po navodilih, videti motna ali če vsebuje kosmiče ali delce.
English: Phase III study in blepharospasm, (MRZ
Slovenian: Študija III. faze za blefarospazem (MRZ
English: drooping eyelid (ptosis), dry eyes
Slovenian: povešene veke (ptoza), suhe oči
English: Side effects may occur from misplaced injections of Xeomin temporarily paralysing nearby muscle groups.
Slovenian: Neželeni učinki se lahko pojavijo zaradi injiciranja zdravila Xeomin v napačno mesto, kar začasno ohromi bližnje skupine mišic.
English: Increased doses of Botulinum neurotoxin type A may result in pronounced neuromuscular paralysis distant from the injection site.
Slovenian: Povečani odmerki botulinskega nevrotoksina tipa A lahko povzročijo izrazito nevromuskulatorno paralizo na mestih, ki so oddaljena od mesta injiciranja.
English: Merz Pharmaceuticals GmbH Eckenheimer Landstraße 100 60318 Frankfurt/Main Germany
Slovenian: Merz Pharmaceuticals GmbH Eckenheimer Landstraße 100 60318 Frankfurt/Main Nemčija
English: Foreign substances in your lungs may lead to an inflammation or infection (pneumonia).Your doctor will give you special medical treatment if needed (e.g. in the form of artificial nutrition).
Slovenian: Zdravnik vas bo po potrebi ustrezno zdravil (npr. v obliki umetnega hranjenja).
English: • In the upper limb spasticity study (MRZ 0410) 144 patients entered the second injection cycle, in which doses up to 400 U of Xeomin are administered.
Slovenian: • v študijo spastičnosti v zgornjih okončinah (MRZ 0410) je 144 bolnikov vključenih v drugi cikel injiciranja, v katerem se daje do 400 e zdravila Xeomin;
English: Patients with related adverse effects
Slovenian: Bolniki, ki so imeli z zdravljenjem povezane neželene dogodke
English: The muscle mass and the degree of hypertrophy or atrophy are factors to be taken into consideration when selecting the appropriate dose.
Slovenian: Pri izbiri ustreznega odmerka je treba upoštevati dejavnike, kot sta mišična masa in stopnja hipertrofije ali atrofije.
English: In the upper limb spasticity study (MRZ 0410) 144 patients entered the 2nd injection cycle, in which doses up to 400 U of Xeomin are administered.
Slovenian: V študiji spastičnosti v zgornjih okončinah (MRZ 0410) je 144 bolnikov vključenih v drugi cikel injiciranja, v katerem se daje do 400 enot zdravila Xeomin.
English: generalised weakness, flu like symptoms, malaise, dizziness, numbness, sleepiness (drowsiness), nasal inflammation (rhinitis), upper respiratory tract infection, nausea, oral dryness, skin sores, stiffness, increased muscle tone (hypertonia)
Slovenian: splošna šibkost, simptomi, podobni gripi, slabotnost, omotica, otrplost, zaspanost (dremavost), vnetje nosu (rinitis), okužba zgornjih dihal, slabost, suha usta, rane na koži, otrdelost, povečana napetost mišic (hipertonija)
English: A female patient developed a nerve lesion affecting the arm (brachial plexopathy) two days after injection of a conventional preparation containing the Botulinum toxin type A complex for the treatment of twisted neck, with recovery after five months.
Slovenian: Pri eni bolnici se je razvila lezija živca, ki je prizadela roko dva dni po injiciranju običajnega pripravka s kompleksom botulinskega toksina tipa A za zdravljenje zvitega vratu.
English: What Xeomin contains
Slovenian: Kaj vsebuje zdravilo xeomin
English: Some of the therapeutic and/or side effects of Xeomin may also interfere with the ability to drive and operate machinery.
Slovenian: Zaradi nekaterih terapevtskih ali neželenih učinkov ali obojega lahko zdravilo Xeomin vpliva tudi na sposobnost vožnje in upravljanja strojev.
English: Considering the data from the non-clinical studies, the early Phase I study and its conclusions, and the Phase II study - although limited conclusions could be drawn from it, the dosage of Xeomin in both Phase III studies was based on the established dose of Botox.
Slovenian: faze - četudi je bilo na njeni podlagi mogoče priti le do omejenih zaključkov - je odmerjanje zdravila Xeomin v obeh študijah III. faze temeljilo na odmerku, določenem za zdravilo Botox.
English: Unopened vial: Do not store above 25°C For storage conditions of the reconstituted medicinal product, see section 6.3.
Slovenian: Za pogoje shranjevanja rekonstituiranega zdravila glejte poglavje 6.3.
English: disease of the vision nerve, usually associated with an increased pressure inside the eye (angle closure glaucoma), corneal ulceration
Slovenian: bolezen optičnega živca, po navadi povezana z zvišanim tlakom v notranjosti očesa
English: Swallowing difficulties may persist for two to three weeks after injection, but has been reported in one case to last five months.
Slovenian: Težave pri požiranju lahko trajajo dva do tri tedne po injiciranju, v enem primeru pa so poročali tudi o pet mesecev trajajočih težavah.
English: Xeomin is presented as a powder for solution for injection.
Slovenian: Zdravilo Xeomin je prašek za raztopino za injiciranje.
English: Uncommon: breathing difficulties (dyspnoea), double vision (diplopia), drooping eyelid (ptosis), voice alteration, fever
Slovenian: težave pri dihanju (dispneja), dvojni vid (diplopija), povešene veke (ptoza), sprememba glasu, zvišana telesna temperatura
English: The applicant submitted three non-clinical, two Phase I, one Phase II and one Phase III studies to demonstrate that a safe posology has been established for Xeomin.
Slovenian: Vlagatelj je z namenom dokazati, da je bilo za zdravilo Xeomin določeno varno odmerjanje, predložil tri neklinične študije, dve študiji I. faze, eno II.
English: Publications of clinical studies have been mentioned
Slovenian: Tabela 1: Seznam kliničnih študij
English: - The paralytic efficacy of Xeomin and Botox was analysed by electromyography (EMG) in vivo in male monkeys after a single intramuscular injection of 16 LDU/kg in the left gluteus medius muscle.
Slovenian: 32 LDU/kg); - vpliv zdravil Xeomin in Botox na motiliteto (statične in aktivne gibe) je bil ocenjen v okviru študije akutne intravenske toksičnosti pri miših z odmerki do 68 LDU/kg; - paralitična učinkovitost zdravil Xeomin in Botox je bila analizirana z elektromiografijo (EMG) in vivo na samcih opic po enkratni intramuskularni injekciji 16 LDU/kg v levo srednjo glutealno mišico.
English: Strength
Slovenian: utrujenost
English: Due to the nature of the diseases being treated, the ability to drive and to operate machines can be reduced.
Slovenian: Sposobnost upravljanja vozil in strojev je lahko zmanjšana zaradi narave bolezni, zaradi katere se zdravite.
English: nausea, oral dryness Skin and subcutaneous tissue disorders Common:
Slovenian: navzea, suha usta Bolezni kože in podkožja Pogosti:
English: Thus, related adverse effects occurred more frequently in the Xeomin group compared to Botox.
Slovenian: Torej so bili z zdravljenjem povezani neželeni dogodki pogostejši v skupini z zdravilom Xeomin kot v skupini z zdravilom Botox.
English: However, as one of the two positive results four weeks after 1st injection and before 2nd injection was found in a patient pretreated with
Slovenian: Vendar pa z ozirom na dejstvo, da je bil en od dveh pozitivnih rezultatov 4 tedne po 1. injiciranju in pred 2. injiciranjem ugotovljen pri bolniku, predhodno zdravljenem z zdravilom Botox, ter da so podatki še vedno slepi, iz teh rezultatov ni mogoče sklepati o imunogenosti zdravila Xeomin.
English: Dysphagia may persist for two to three weeks after injection, but has been reported in one case to last five months.
Slovenian: Disfagija lahko traja dva do tri tedne po injiciranju, v enem primeru pa so poročali o petmesečni disfagiji.
English: Uncommon: speech disorders (dysphonia), weakness (asthenia), muscle pain (myalgia), headache, shaking (tremor), eye pain, diarrhoea, dry mouth, vomiting, inflammation of the colon (colitis), skin rash, skin redness (erythema), itching (pruritus), sweating increased, skeletal pain, injection site inflammation, injection site tenderness
Slovenian: motnje govora (disfonija), šibkost (astenija), bolečine v mišicah (nialgija), glavobol, tresenje (tremor), bolečina v očesu, driska, suha usta, bruhanje, vnetje debelega črevesa (kolitis), kožni izpuščaj, rdečica kože (eritem), srbenje (pruritus), povečano potenje, bolečine v kosteh, vnetje na mestu injiciranja, občutljivost na mestu injiciranja
English: Barnes MP, Best D, Kidd L, Roberts B, Stark S, Weeks P, et al.
Slovenian: 3 Barnes MP, Best D, Kidd L, Roberts B, Stark S, Weeks P, et al. The use of Botulinum toxin type-B in the treatment of patients who have become unresponsive to Botulinum toxin type-A -- initial experiences.
English: Usually, the first onset of effect is observed within four days after injection.
Slovenian: Prvi učinek je po navadi viden štiri dni po injiciranju.
English: Swallowing difficulties can last for up to two to three weeks after injection, for one patient a duration of up to five months is known.
Slovenian: Težave pri požiranju lahko trajajo dva do tri tedne po injiciranju, pri enem bolniku pa so poročali tudi o pet mesecev trajajočih težavah.
English: The median first onset of effect is observed within seven days after injection.
Slovenian: Mediana opažanja pojava prvega učinka je sedem dni po injiciranju.
English: Usually, the first onset of effect is observed within seven days after injection.
Slovenian: Prvi učinek je po navadi viden sedem dni po injiciranju.
English: Tell your doctor immediately or go to the casualty department at your nearest hospital if you suffer from any of these symptoms.
Slovenian: Če imate katerega koli od navedenih simptomov, takoj obvestite zdravnika ali pojdite na oddelek za nujno zdravniško pomoč pri najbližji bolnišnici.
English: A similar dose-efficacy response relationship has been demonstrated for Xeomin and Botox after one injection in spasmodic torticollis Phase III study.
Slovenian: V študiji III. faze za spastični tortikolis je bila dokazana podobna povezava med odmerkom in učinkom za zdravili Xeomin in Botox po eni injekciji.
English: Both Phase I studies showed equal doses of Xeomin to be as effective as Botox in the EMG measurements; it was clearly demonstrated that the paralytic effects of Xeomin and Botox increased with ascending doses and a comparable trend was seen in a Phase II study.
Slovenian: Obe študiji I. faze sta pokazali, da so pri meritvi z EMG odmerki zdravila Xeomin enako učinkoviti kot enaki odmerki zdravila Botox.
English: The median first onset of effect is observed within four days after injection.
Slovenian: Mediana opažanja pojava prvega učinka je štiri dni po injiciranju.
English: • The active substance is Clostridium Botulinum neurotoxin type A (150 kD), free of complexing proteins
Slovenian: • zdravilna učinkovina je nevrotoksin bakterije Clostridium Botulinum tipa A (150 kD), brez beljakovin, ki tvorijo komplekse
English: Powder for solution for injection
Slovenian: prašek za raztopino za injiciranje za intramuskularno uporabo
English: Uncommon: facial paralysis, facial muscle weakness, inflammation of the cornea (keratitis), everted margin of the lid (ectropion), double vision (diplopia), inverted margin of the lid (entropion), visual disturbance, blurred vision, dizziness, inflammatory skin reaction (dermatitis), tiredness
Slovenian: ohromelost obraza, šibkost obraznih mišic, vnetje roženice (keratitis), obrnjenost roba veke navzven (aktropij), dvojni vid (diplopija), obrnjenost roba veke navznoter (entropij), motnje vida, zamegljen vid, omotica, vnetna reakcija na koži (dermatitis), utrujenost
English: Ecchymosis easily occurs in the soft tissues of the eyelid.
Slovenian: V mehkih tkivih očesne veke lahko pride do ekhimoze.
English: PHARMACEUTICAL FORM AND CONTENTS Powder for solution for injection 1 vial
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA Prašek za pripravo raztopine za injiciranje.
English: U U U U
Slovenian: Xeomin skupaj
English: Uncommon: muscle weakness, pins and needles (paraesthesia), headache, inflammation of the conjunctiva (conjunctivitis), dry mouth, skin rash, inflicted injury
Slovenian: mišična šibkost, mravljinčenje (parestezija), glavobol, vnetje veznice (konjunktivitis), suha usta, kožni izpuščaj, poškodbe
English: WHAT XEOMIN IS AND WHAT IT IS USED FOR Xeomin is a medicine that relaxes the muscles.
Slovenian: Xeomin je zdravilo, ki sprošča mišice.
English: Erythema multiforme, urticaria, psoriasis-like rash, pruritus, and allergic reactions have been described with the use of conventional preparations containing the Botulinum toxin type A complex, but their causal relationship remains unclear.
Slovenian: Pri uporabi običajnih zdravil s kompleksom botulinskega toksina tipa A so poročali o multiformnem eritemu, urtikariji, izpuščaju, podobnem psoriazi, pruritusu in alergijskih reakcijah, vendar je vzročnoposledična povezava neznana.
English: HOW TO STORE XEOMIN
Slovenian: SHRANJEVANJE ZDRAVILA XEOMIN
English: PHARMACEUTICAL FORM AND CONTENTS Powder for solution for injection 6 vials
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA Prašek za raztopine za injiciranje.
English: Twisted neck (spasmodic torticollis)
Slovenian: Ukrivljen vrat (spastični tortikolis)
English: Reconstituted solution: Store in a refrigerator (2 - 8°C) Your doctor will reconstitute the medicine with physiological saline before use.
Slovenian: Rekonstituirana raztopina: Shranjujte v hladilniku (2 °C-8 °C).
English: NAME OF THE MEDICINAL PRODUCT Xeomin 100 LD50 units powder for solution for injection [See Annex I - To be completed nationally]
Slovenian: IME ZDRAVILA Xeomin 100 enot LD50 prašek za raztopino za injiciranje
English: Various forms of skin eruptions (erythema multiforme, urticaria, psoriasis-like rash), itching, and allergic reactions have been described with the use of conventional preparations containing the Botulinum toxin type A complex, but their causal relationship remains unclear.
Slovenian: Pri uporabi običajnih zdravil s kompleksom botulinskega toksina tipa A so poročali o različnih oblikah kožnih izbruhov (multiformnem eritemu), srbenju, izpuščaju, podobnem psoriazi, pruritusu in alergijskih reakcijah, vendar je vzročno-posledična povezava neznana.
English: One case with severe dysphagia was reported in the Botox group.
Slovenian: V skupini z zdravilom Botox so poročali o enem primeru resne disfagije.
English: Blepharospasm The following adverse reactions were reported with Xeomin:
Slovenian: Blefarospazem Pri zdravljenju z zdravilom Xeomin so poročali o naslednjih neželenih učinkih:
English: Xeomin is injected into the medial and lateral orbicularis oculi of the upper lid and the lateral orbicularis oculi of the lower lid. Additional sites in the brow area, the lateral orbicularis and in the upper facial area may also be injected if spasms here interfere with vision.
Slovenian: Zdravilo Xeomin se injicira v medialno in lateralno očesno orbikularno mišico zgornje veke ter lateralno očesno orbikularno mišico spodnje veke.
English: superficial punctate keratitis, lagophthalmos, eye irritation, photophobia, lacrimation Uncommon: keratitis, ectropion, diplopia, entropion, visual disturbance, blurred vision Rare:
Slovenian: keratitis, ektropij, diplopija, entropij, motnje vida, zamegljen vid Redki: otekanje očesnih vek
English: PHARMACEUTICAL FORM Powder for solution for injection White powder
Slovenian: FARMACEVTSKA OBLIKA Prašek za raztopino za injiciranje.
English: The powder is white.
Slovenian: Bel prašek
English: Content (concentration)
Slovenian: Farmacevtska oblika Pot uporabe zdravila vsebina (koncentracija)
English: Eyelid spasm (blepharospasm) The following side effects were reported with Xeomin:
Slovenian: Krči vek (blefarospazem) Pri zdravljenju z zdravilom Xeomin so poročali o naslednjih neželenih učinkih:
English: Botulinum neurotoxin type A blocks cholinergic transmission at the neuromuscular junction by inhibiting the release of acetylcholine.
Slovenian: Farmakoterapevtska skupina: Mišični relaksanti s perifernim delovanjem, Oznaka ATC: M03AX01 Botulinski nevrotoksin tipa A blokira holinergični prenos na nevromuskularnih ploščicah, tako da zavira sproščanje acetilholina.
English: • the posology of Xeomin
Slovenian: • odmerjanje zdravila Xeomin,
English: No more than 50 U should be given at any one injection site.
Slovenian: Uporabijo se lahko odmerki do 300 e.. Na enem mestu injiciranja se ne sme dati odmerek, večji od 50 e..
English: 1.25 U
Slovenian: Faza 1b
English: rhinitis, upper respiratory tract infection Uncommon: dyspnoea, voice alteration
Slovenian: rinitis, okužbe zgornjih dihal
English: Gastrointestinal disorders Common:
Slovenian: disfonija Bolezni prebavil Pogosti:
English: Diplopia may develop as a result of Botulinum neurotoxin type A diffusion into the inferior oblique.
Slovenian: Kot posledica difuzije botulinskega nevrotoksina tipa A v inferiorno poševno zrklno mišico se lahko razvije diplopija.
English: • in patients suffering from amyotrophic lateral sclerosis or other diseases which result in peripheral neuromuscular dysfunction
Slovenian: Zdravilo Xeomin je treba uporabljati previdno: če se pojavijo kakršne koli motnje strjevanja krvi če bolniki prejemajo antikoagulante pri bolnikih z amiotrofično lateralno sklerozo ali drugimi boleznimi, ki povzročajo periferno nevromuskulatorno disfunkcijo pri izrazito šibkih ali atrofičnih ciljnih mišicah
English: Your body may develop antibodies after you received Botulinum toxin type A preparations.
Slovenian: Po zdravljenju s pripravki botulinskega toksina tipa A lahko pride do nastanka protiteles v vašem telesu.
English: 1 vial contains 100 LD50 units Clostridium Botulinum neurotoxin type A (150 kD), free of complexing proteins.
Slovenian: 1 viala vsebuje 100 enot LD50 nevrotoksina bakterije Clostridium Botulinum tipa A (150 kD), brez beljakovin, ki tvorijo komplekse.
English: • eyelid spasm (blepharospasm)
Slovenian: • krči vek (blefarospazem),
English: Spasmodic torticollis The following adverse reactions were reported with Xeomin:
Slovenian: Spastični tortikolis Pri zdravljenju z zdravilom Xeomin so poročali o naslednjih neželenih učinkih:
English: • twisted neck (spasmodic torticollis)
Slovenian: TWSTRS: Toronto Western Spasmodic Torticollis Rating Scale (lestvica za oceno spazmičnega tortikolisa Toronto Western)
English: Nervous system disorders Uncommon: dizziness, facial paralysis
Slovenian: omotica, obrazna paraliza
English: Eyelid spasm (blepharospasm)
Slovenian: Krči vek (blefarospazem)
English: Xeomin100 LD50 units powder for solution for injection Clostridium Botulinum neurotoxin type A (150 kD), free of complexing proteins
Slovenian: Xeomin 100 enot LD50, prašek za raztopino za injiciranje nevrotoksin bakterije Clostridium Botulinum tipa A (150 kD), brez beljakovin, ki tvorijo komplekse
English: Dysphagia appears to be dose-dependent.
Slovenian: Videti je, da je odvisna od odmerka.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION 1 vial contains 100 LD50 units* of Clostridium Botulinum neurotoxin type A (150 kD), free of complexing proteins.
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN 1 viala vsebuje 100 enot LD50 nevrotoksina bakterije Clostridium Botulinum tipa A (150 kD), brez beljakovin, ki tvorijo komplekse.
English: dysphagia Uncommon: diarrhoea, dry mouth, vomiting, colitis
Slovenian: diareja, suha usta, bruhanje, kolitis Bolezni kože in podkožja Občasni:
English: Intubation and assisted ventilation will become necessary until improvement if paralysis of the respiratory muscles occurs.
Slovenian: Če pride do paralize dihalnih mišic, sta nujni intubacija in umetna ventilacija.
English: BEFORE YOU USE XEOMIN
Slovenian: KAJ MORATE VEDETI, PREDEN BOSTE UPORABILI ZDRAVILO XEOMIN
English: Nervous system disorders Uncommon: headache, tremor
Slovenian: glavobol, tremor
English: General disorders and administration site conditions Uncommon: asthenia, injection site inflammation, injection site tenderness
Slovenian: astenija, vnetje na mestu injiciranja, občutljivost na mestu injiciranja
English: Medical supervision for up to several days and assisted ventilation may be necessary.
Slovenian: Morda bosta nujna nekajdnevni zdravniški nadzor in umetno dihanje.
English: Xeomin100 LD50 units powder for solution for injection Clostridium Botulinum neurotoxin type A (150kD), free of complexing proteins For intramuscular use.
Slovenian: Xeomin 100 enot LD50 prašek za raztopino za injiciranje nevrotoksin bakterije Clostridium Botulinum tipa A (150 kD), brez beljakovin, ki tvorijo komplekse
English: PACKAGE LEAFLET
Slovenian: vzporedno preizkušanje
English: b) Distribution of the active substance in patients:
Slovenian: Splošne značilnosti zdravilne učinkovine:
English: This does not affect the safety or effectiveness of the medicine.
Slovenian: To ne vpliva na zdravje in učinkovitost zdravila.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Stronghold on 25 November 1999.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Stronghold, veljavno po vsej Evropski uniji, izdala 25. novembra 1999.
English: Shampooing or soaking the animal two hours or more after treatment did not affect the medicine's effectiveness.
Slovenian: Šamponiranje ali močenje dlake živali dve uri ali več po zdravljenju ni vplivalo na učinkovitost zdravila.
English: Other information about Stronghold:
Slovenian: Druge informacije o zdravilu Stronghold:
English: It must also not be used in cats that are suffering from another disease or that are weakened and underweight for their size and age.
Slovenian: Prav tako se ne sme uporabljati pri mačkah, ki imajo katero koli drugo bolezen ali so oslabljene oziroma podhranjene glede na svojo velikost in starost.