natgillin/translations-raw huggingface dataset:
There is no relevant use of NUCEIVA in the paediatric population.
Pediatrična populacija Zdravilo NUCEIVA ni namenjeno uporabi pri pediatrični populaciji.
In the event of overdose the patient should be medically monitored for symptoms of excessive muscle weakness or muscle paralysis.
Ravnanje pri prevelikem odmerjanju V primeru prevelikega odmerjanja mora biti bolnik pod zdravniškim nadzorom, da se ugotovijo morebitni simptomi prekomerne mišične oslabelosti ali mišične paralize.
- the muscles to be injected are weak or wasted; - you have a bleeding disorder as injection may lead to bruising.
- imate okužbo na predlaganem mestu injiciranja; - so mišice, v katere naj bi se injiciralo zdravilo, šibke ali oslabljene; - imate motnje strjevanja krvi, saj injiciranje lahko povzroči modrice.
If you have any difficulty in breathing, swallowing or speaking after receiving NUCEIVA contact your doctor immediately.
Če imate po prejemu zdravila NUCEIVA težave pri dihanju, požiranju ali govoru, se takoj posvetujte z zdravnikom.
Application related adverse reactions
Neželeni učinki, povezani z aplikacijo
No cases of systemic toxicity resulting from accidental injection of botulinum toxin type A have been observed.
Primeri sistemske toksičnosti zaradi nenamernega injiciranja botulinskega toksina tipa A niso bili ugotovljeni.
- If the operator injures himself (cuts, pricks himself), proceed as above and take the appropriate medical steps according to the dose injected.
- Če pri injiciranju zdravila poškodujete sebe (se urežete, zbodete), ukrepajte v skladu z zgoraj navedenim in sprejmite ustrezne medicinske ukrepe.
How to use NUCEIVA
Kako uporabljati zdravilo NUCEIVA
The use of NUCEIVA is not recommended during pregnancy and in women able to have children who are not using contraception.
Uporaba zdravila NUCEIVA ni priporočljiva med nosečnostjo in pri ženskah v rodni dobi, ki ne uporabljajo kontracepcije.
Once reconstituted, NUCEIVA should only be used to treat a single patient, during a single session.
Zdravilo NUCEIVA se po rekonstituciji lahko uporabi za zdravljenje samo enega bolnika med eno terapijo.
• Two injections should be administered in each corrugator muscle (inferior medial and superior medial aspect) and 1 injection in the procerus muscle for a total dose of 20 Units.
• po dve injiciranji je treba dati v vsako mišico nagubalko obrvi (m. corrugator supercilii) (navzdol medialno in navzgor medialno) ter eno injiciranje v mišico m. procerus v skupnem odmerku 20 enot;
Muscle twitching, musculoskeletal pain, myalgia, neck pain
Mišično trzanje, mišično-skeletna bolečina, mialgija, bolečine v vratu
Immediately after use, unused reconstituted NUCEIVA solution for injection in the vial and/or the syringe must be inactivated, prior to disposal, with 2 mL of dilute sodium hypochlorite solution at 0.5% or 1% available chlorine.
Neuporabljeno rekonstituirano raztopino zdravila NUCEIVA za injiciranje v viali in/ali brizgi morate takoj po uporabi in preden jo zavržete inaktivirati z 2 mililitroma 0,5 % razredčene raztopine natrijevega hipoklorita ali 1 % prostim klorom.
Unit doses for NUCEIVA are not interchangeable with those used for other preparations of botulinum toxin.
Odmerki enot zdravila NUCEIVA niso zamenljivi z odmerki, ki se uporabljajo pri drugih zdravilih z botulinskim toksinom.
NUCEIVA is not recommended during pregnancy and in women of childbearing potential not using contraception.
Zdravila NUCEIVA ni priporočljivo uporabljati med nosečnostjo in pri ženskah v rodni dobi, ki ne uporabljajo kontracepcije.
Skin and subcutaneous tissue disorders
Bolezni kože in podkožja Srbenje
Glabellar Line Scale (GLS); 0=no lines, 1=mild, 2=moderate, 3=severe Two days after injection, 12.2% (6/49) of placebo, 57.0% (139/244) Botox treated patients and 54.2% (130/240) of NUCEIVA were considered by investigators as treatment responders (none or mild severity at maximum frown).
Raziskovalci so menili, da se je dva dni po injiciranju na zdravljenje odzvalo 12,2 % (6/49) bolnikov, zdravljenih s placebom, 57,0 % (139/244) bolnikov, zdravljenih z zdravilom Botox, in 54,2 % (130/240) bolnikov, zdravljenih z zdravilom NUCEIVA (brez gub ali blaga izraženost pri najmočnejšem mrščenju).
• If splashed into the eyes, rinse eyes thoroughly with plenty of water or with an eye wash solution.
• če zdravilo pride v oči, oči temeljito sperite z veliko vode ali raztopino za spiranje oči.
Dysaesthesia, head discomfort, hypoaesthesia, paraesthesia, sensory disturbance
Disestezija, neprijeten občutek v glavi, hipestezija, mravljinčenje, senzorične motnje
Immediately after use, and prior to disposal, unused reconstituted NUCEIVA solution in the vial and/or the syringe must be inactivated, with 2 mL of dilute sodium hypochlorite solution at 0.5% or 1% (Javel solution) and should be disposed of in accordance with local requirements.
Neuporabljeno rekonstituirano raztopino zdravila NUCEIVA v viali in/ali brizgi morate takoj po uporabi in preden jo zavržete inaktivirati z 2 mililitroma 0,5 % ali 1 % razredčene raztopine natrijevega hipoklorita (javelske raztopine), nato pa zavreči v skladu z lokalnimi predpisi.
Powder for solution for injection.
FARMACEVTSKA OBLIKA Prašek za raztopino za injiciranje.
Amount of diluent added to 100 Unit vial (sodium chloride 9 mg/ml (0.9%) solution for injection) 2.5 mL
Količina vehikla, dodanega 100 enotam viale (0,9 % (9 mg/ml) raztopina natrijevega klorida za injiciranje) 2,5 ml
These include application and injection site bruising, injection site pain and injection site swelling.
Vključujejo modrice na mestu aplikacije in injiciranja, bolečino na mestu injiciranja in oteklino na mestu injiciranja.
Care should be taken to ensure that NUCEIVA is not injected into a blood vessel when it is injected in the vertical lines between the eyebrows seen at maximum frown (also known as glabellar lines) (see section 4.4).
Paziti je treba, da se zdravilo NUCEIVA med injiciranjem v vertikalne gube med obrvmi, vidne pri najmočnejšem mrščenju (znane tudi kot glabelarne gube), ne injicira v krvno žilo (glejte poglavje 4.4).
100 Units
100 oseb)
NUCEIVA injections also reduced the severity of glabellar lines at rest, an exploratory endpoint.
Z injiciranjem zdravila NUCEIVA se zmanjša tudi izraženost glabelarnih gub v mirovanju, eksplorativni opazovani dogodek.
Responders for the Primary Efficacy Endpoint
Bolniki, ki so se odzvali, kar zadeva primarni opazovani dogodek učinkovitosti
Adverse reactions possibly related to the spread of toxin distant from the site of administration have been reported very rarely with botulinum toxin (e.g. muscle weakness, breathing difficulties, dysphagia or constipation) (see section 4.4).
Zelo redko so poročali o neželenih učinkih, ki so morebitno povezani s širjenjem botulinskega toksina daleč od mesta aplikacije (npr. mišična oslabelost, težave z dihanjem, disfagija ali zaprtost) (glejte poglavje 4.4).
Muscle atrophy is expected after repeated botulinum treatment secondary to the flaccid paralysis of the treated muscles.
Po ponovljenem zdravljenju z botulinom se poleg flakcidne paralize zdravljenih mišic pričakuje atrofija mišic.
- If splashed into the eyes, rinse eyes thoroughly with plenty of water or with an eye wash solution.
- če zdravilo pride v oči, oči temeljito sperite z veliko vode ali raztopino za spiranje oči.
Table 1 The NUCEIVA related adverse reactions are classified by System Organ Class and frequency defined as follows: Very common (≥ 1/10); common (≥ 1/100 to <1/10); uncommon (≥ 1/1,000 to <1/100); rare (≥ 1/10,000 to <1/1,000); very rare (<1/10,000).
občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000) in zelo redki (< 1/10.000).
NUCEIVA has a minor or moderate influence on the ability to drive and use machines.
4.7 Vpliv na sposobnost vožnje in upravljanja strojev Zdravilo NUCEIVA ima blag ali zmeren vpliv na sposobnost vožnje in upravljanja strojev.
Generalised disorders of muscle activity (e.g. myasthenia gravis or Eaton Lambert Syndrome) Infection or inflammation at the proposed injection sites.
Preobčutljivost na učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1; splošne motnje mišične dejavnosti (npr. miastenija gravis ali Lambert-Eatonov sindrom); okužba ali vnetje na predlaganih mestih injiciranja.
Resulting dose (Units per 0.1 mL) 4.0 U
Dobljeni odmerek (enot na 0,1 ml) 4,0 enote
• Lateral corrugator injections should be placed at least 1 cm above the bony supraorbital ridge.
• lateralni injiciranji v m. corrugator je treba opraviti vsaj 1 cm nad obrvnim lokom.
The anatomy and anatomical land marks of procerus corrugator supercilli muscles and the surrounding vasucular and nervous structures in the glabellar region must be understood prior to administration of NUCEIVA.
Pred dajanjem zdravila NUCEIVA je treba razumeti anatomijo in anatomske orientacijske točke mišic procerus in corrugator supercilli ter okolišnje žilne in živčne strukture na glabelarnem predelu.
4.9 Overdose
4.9 Preveliko odmerjanje Simptomi prevelikega odmerjanja
2.5 mL of sodium chloride 9 mg/ml (0.9%) solution for injection is drawn up into a syringe in order to obtain a reconstituted solution for injection at a concentration of 4 Units/0.1 mL.
V brizgo potegnite 2,5 ml 0,9 % (9 mg/ml) raztopine natrijevega klorida za injiciranje, da dobite rekonstituirano raztopino za injiciranje v koncentraciji 4 enote/0,1 ml.
NUCEIVA is not recommended for use in patients over 65 years of age.
Uporaba zdravila NUCEIVA pri bolnikih, starejših od 65 let, ni priporočljiva.
Admission to hospital should be considered in patients presenting with symptoms of botulinum toxin type A poisoning (generalised weakness, ptosis, diplopia, swallowing and speech disorders, or paresis of the respiratory muscles).
Bolnike s simptomi zastrupitve z botulinskim toksinom tipa A (splošna oslabelost, ptoza, diplopija, motnje pri požiranju in govoru ali pareza dihalnih mišic) je treba sprejeti v bolnišnico.
NUCEIVA 100 Units powder for solution for injection
IME ZDRAVILA NUCEIVA 100 enot prašek za raztopino za injiciranje
• If splashed on skin, wash with a solution of sodium hypochlorite and then rinse thoroughly with plenty of water.
• če zdravilo poškropite po koži, površino umijte z raztopino natrijevega hipoklorita in nato temeljito sperite z veliko vode;
Botulinum toxin units are not interchangeable from one product to another.
Enote botulinskega toksina med posameznimi zdravili niso zamenljive.
Inject the diluent slowly into the vial with a needle through the rubber stopper and gently rotate the vial avoiding bubble formation.
Vehikel počasi z iglo injicirajte v vialo skozi gumijasti pokrovček, pri čemer vialo nekajkrat nežno krožno zavrtite, da preprečite nastajanje mehurčkov.
Side effects possibly related to the spread of botulinum toxin from the site of injection can occur very rarely (e.g. muscle weakness, difficulty in swallowing or food or liquid entering the airways).
Opozorila in previdnostni ukrepi Neželeni učinki, ki so morebiti povezani s širjenjem botulinskega toksina z mesta injiciranja, se lahko pojavijo zelo redko (npr. mišična oslabelost, težave pri požiranju, vstop hrane ali tekočine v dihalne poti).
Bleeding disorders
Hemoragične motnje
- If a vial is broken, carefully collect the pieces of glass and wipe up the product as stated above,
- če se viala razbije, pazljivo zberite koščke stekla in zdravilo pobrišite, kot je navedeno zgoraj, pri čemer pazite, da se ne urežete;
- you see no significant improvement of your lines one month after your first course of treatment; - you suffer from certain diseases affecting your nervous system (such as amyotrophic lateral sclerosis or motor neuropathy); - you have inflammation at the proposed injection site(s);
- imate določene bolezni, ki so prizadele vaš živčni sistem ( npr. amiotrofično lateralno sklerozo ali motorično nevropatijo);
- Contaminated surfaces must be cleaned with an absorbent material soaked in a solution of sodium hypochlorite (Javel solution) and then dried.
- kontaminirane površine je treba očistiti z absorpcijskim materialom, namočenim v raztopini natrijevega hipoklorita (javelska raztopina), in nato posušiti;
NUCEIVA Vs. BOTOX
NUCEIVA v primerjavi z zdravilom BOTOX
NUCEIVA has not been detected in the peripheral blood following intramuscular injection at the recommended dose.
5.2 Farmakokinetične lastnosti Zdravilo NUCEIVA po njegovem intramuskularnem injiciranju v priporočenem odmerjanju v periferni krvi ni bilo zaznano.
Doses recommended are different from other botulinum toxin preparations.
Priporočeni odmerki se razlikujejo od odmerkov drugih zdravil z botulinskim toksinom.
Pruritis
Driska
Diplopia, dry eye, eyelid sensory disorder
Diplopija, suhe oči, senzorične motnje očesne veke
Baseline GLS Score at Maximum Contraction
Izhodiščni rezultati GLS pri najmočnejšem mrščenju
Denominators are based on the number of subjects with the specified baseline severity at rest who also had both baseline and Day 30 GLS scores at maximum contraction by investigator assessment
Imenovalci temeljijo na številu oseb z določeno izhodiščno izraženostjo v mirovanju, pri katerih je bil na voljo tako izhodiščni rezultat GLS kot rezultat GLS na 30. dan pri najmočnejšem mrščenju na podlagi raziskovalčeve ocene.
• Contaminated surfaces must be cleaned with an absorbent material soaked in a solution of sodium hypochlorite (Javel solution) and then dried.
• kontaminirane površine je treba očistiti z absorpcijskim materialom, namočenim v raztopini natrijevega hipoklorita (javelska raztopina), in nato posušiti;
Doses recommended in units are different from other botulinum toxin preparations.
Priporočeni odmerki v enotah se razlikujejo od odmerkov drugih zdravil z botulinskim toksinom.
Read the package leaflet before use
POSTOPEK UPORABE Pred uporabo preberite priloženo navodilo!
The solution is prepared by injecting the solvent slowly into the vial with a needle through the rubber stopper and by gently rotating the vial avoiding bubble formation.
Raztopina se pripravi s počasnim injiciranjem vehikla v vialo z iglo skozi gumijasti pokrovček, pri čemer se vialo nekajkrat nežno krožno zavrti, da se prepreči nastajanje mehurčkov.
Powder for solution for injection 1 vial
FARMACEVTSKA OBLIKA IN VSEBINA prašek za raztopino za injiciranje 1 viala
NUCEIVA is not recommended in breast-feeding women.
Uporaba zdravila NUCEIVA ni priporočljiva pri ženskah, ki dojijo.
NUCEIVA 100 Units powder for solution for injection botulinum toxin type A
NUCEIVA 100 enot prašek za raztopino za injiciranje botulinski toksin tipa A
NUCEIVA is reconstituted with sodium chloride 9 mg/ml (0.9%) solution for injection .
Zdravilo NUCEIVA se rekonstituira z 0,9 % (9 mg/ml) raztopino natrijevega klorida za injiciranje.
2 (Moderate) Number Percentage 3 (Severe) Number Percentage Glabellar Line Scale (GLS); 0=no lines, 1=mild, 2=moderate, 3=severe.
Lestvica za glabelarne gube (GLS); 0 = brez gub, 1 = blaga izraženost, 2 = zmerna izraženost, 3 =
Care should be taken to ensure that NUCEIVA is not injected into a blood vessel when it is injected in the glabellar lines seen at maximum frown (see section 4.2).
Paziti je treba, da se zdravilo NUCIEVA med injiciranjem v glabelarne gube, vidne pri najmočnejšem mrščenju, ne injicira v krvno žilo (glejte poglavje 4.2).
Denominators are based on the number of subjects with the specified baseline severity at maximum contraction who had both baseline and Day 30 GLS scores at maximum contraction by investigator assessment
Imenovalci temeljijo na številu oseb z določeno izhodiščno izraženostjo pri najmočnejšem mrščenju, pri katerih je bil na voljo tako izhodiščni rezultat kot rezultat na 30. dan pri najmočnejšem mrščenju na podlagi raziskovalčeve ocene
• Any spillage must be wiped up: either with an absorbent material soaked in a solution of sodium hypochlorite (Javel solution) in the case of the vacuum-dried product, or with a dry absorbent material in the case of the reconstituted product.
• vsako razlitje je treba pobrisati: vakuumsko posušeni prašek z absorpcijskim materialom, namočenim v raztopini natrijevega hipoklorita (javelski raztopini), rekonstituirano zdravilo pa s suhim absorpcijskim materialom;
- If splashed, wash with a solution of sodium hypochlorite and then rinse thoroughly with plenty of water.
- če zdravilo poškropite po koži, površino umijte z raztopino natrijevega hipoklorita in nato temeljito sperite z veliko vode;
Finally, the toxin is released into the cytosol with progressive inhibition of acetylcholine release.
Proces spremlja progresivno zaviranje sproščanja acetilholina.
Antibody formation
Nastajanje protiteles
Caution should be taken when the targeted muscle shows pronouced weakness or atrophy.
Če ciljna mišica izkazuje izrazito šibkost ali atrofijo, je potrebna previdnost.
Four Units (4 U/ 0.1 mL) are administered in each of the 5 injection sites (see Figure 1): 2 injections in each corrugator muscle (inferior medial and superior medial aspect) and 1 injection in the procerus muscle for a total dose of 20 Units.
Priporočeni odmerek injiciranja na mišično mesto je 4 enote/0,1 ml. Pet mest injiciranja (glejte sliko 1): po dve injiciranji v vsako mišico nagubalko obrvi (m. corrugator) (medialno navzdol in medialno navzgor) ter eno injiciranje v mišico m. procerus v skupnem odmerku 20 enot.
If you get hives, swelling, including swelling of the face or throat, wheezing, feeling faint or shortness of breath, contact your doctor immediately.
Če dobite koprivnico, začnete otekati, vključno z otekanjem obraza ali grla, hropsti,
In pregnant rats, daily intramuscular injections of 0.5, 1, or 4 Units/kg during the period of organogenesis (from gestation days 6 to 16), did not induce significant test article-related toxicological effects on the dams and on embryo-fetal development.
Pri brejih podganah dnevno intramuskularno injiciranje 0,5, 1 ali 4 enot/kg v obdobju organogeneze (od 6. do
How NUCEIVA is injected
Kako se zdravilo NUCEIVA injicira
Sensory disturbance, head discomfort, dry eye, eyelid swelling, eye swelling, muscle twitching, injection site: redness, pain, tingling
Motnje čutil, neprijeten občutek v glavi, suhe oči, otekanje očesnih vek, mišično trzanje, mesto injiciranja: rdečica, bolečina, ščemenje
Pharmacotherapeutic group: Muscle relaxants, other muscle relaxants, peripherally acting agents, ATC code: M03AX01.
5.1 Farmakodinamične lastnosti Farmakoterapevtska skupina: mišični relaksanti, drugi periferno delujoči mišični relaksanti, oznaka
The vial has to be discarded if the vacuum does not pull the solvent into the vial.
Če vakuum ne vsrka vehikla v vialo, vialo zavrzite.
Dermal cyst, erythema, photosensitivity reaction, skin mass, skin tightness
preobčutljivostna reakcija na svetlobo, kožni vozliči, zategovanje kože
Table 4 - Exploratory Efficacy Endpoint - Glabellar Line Scale Score of 0 (none) or 1 (mild) at Day 30 by Investigator Assessment at Maximum Contraction for NUCEIVA Treated Subjects, by Baseline GLS Categories at Rest, ITT Population
Preglednica 4 - Eksplorativni opazovani dogodek učinkovitosti - rezultat po lestvici za glabelarne gube 0 (brez gub) ali 1 (blaga izraženost) pri najmočnejšem mrščenju, na podlagi ocene, ki jo je opravil raziskovalec na 30. dan, za osebe, zdravljene z zdravilom NUCEIVA, glede na izhodiščne kategorije GLS v mirovanju, populacija ITT
Table 2 - Primary Efficacy Endpoint - Glabellar Line Scale Score of 0 (none) or 1 (mild) at Day 30 by Investigator Assessment at Maximum Contraction, PP Population
Preglednica 2 - Primarni opazovani dogodek učinkovitosti - rezultat po lestvici za glabelarne gube 0 (brez gub) ali 1 (blaga izraženost) pri najmočnejšem mrščenju, na podlagi ocene, ki jo je opravil raziskovalec na 30. dan, za populacijo PP
- If you have any side effects, talk to your doctor or pharmacist.
- Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom ali farmacevtom.
- Very rarely, an allergic reaction can occur after the injection of botulinum toxin.
- Po injiciranju botulinskega toksina se zelo redko lahko pojavi alergijska reakcija.
Patients with unrecognised neuromuscular disorders may be at increased risk of clinically significant systemic effects, including severe dysphagia and respiratory compromise from typical doses of botulinum toxin type A. In some of these cases, dysphagia has lasted several months and required placement of a gastric feeding tube (see section 4.3).
Pri bolnikih z neprepoznanimi živčno-mišičnimi motnjami je lahko pri običajnih odmerkih botulinskega toksina tipa A tveganje za pojav klinično pomembnih sistemskih učinkov večje, vključno z resno disfagijo in dihalno stisko.
Table 5 - Exploratory Efficacy Endpoint - Glabellar Line Scale Score >/=2 points better at day 30 by Investigator Assessment At Rest, PP Population
Preglednica 5 - Eksplorativni opazovani dogodek učinkovitosti - za >/=2 točki boljši rezultat na lestvici za glabelarne gube v mirovanju na 30. dan na podlagi ocene raziskovalca, populacija PP Bolniki, ki so se odzvali, kar zadeva eksplorativni opazovani dogodek učinkovitosti
Antibodies to botulinum toxin type A may develop during treatment with botulinum toxin.
Med zdravljenjem z botulinskim toksinom se lahko razvijejo protitelesa proti botulinskemu toksinu tipa A. Nekatera nastala protitelesa so nevtralizacijska, zaradi česar je lahko zdravljenje z botulinskim toksinom tipa A neuspešno.
Muscle weakness, dizziness, and visual disturbance with this medicine could make driving or the use of machines dangerous.
Vpliv na sposobnost upravljanja vozil in strojev Pri tem zdravilu je lahko zaradi oslabelosti mišic, omotice in motnje vida upravljanje vozil ali strojev nevarno.
IM
ALI
How to store NUCEIVA
Shranjevanje zdravila NUCEIVA
Eyelid ptosis
OVOJNINAH VIALA
Application site bruising, influenza like illness, injection site bruising, injection site pain, injection site swelling
Pojav modric na mestu injiciranja, bolezen, podobna gripi, pojav modric na mestu injiciranja,
Package leaflet: Information for the user NUCEIVA 100 Units powder for solution for injection botulinum toxin type A
Navodilo za uporabo NUCEIVA 100 enot prašek za raztopino za injiciranje botulinski toksin tipa A
NUCEIVA is presented as a white powder for solution for injection in a transparent glass vial.
Izgled zdravila NUCEIVA in vsebina pakiranja Zdravilo NUCEIVA je na voljo v prozorni stekleni viali kot bel prašek za raztopino za injiciranje.
INFORMATION IN BRAILLE UNIQUE IDENTIFIER - 2D BARCODE UNIQUE IDENTIFIER - HUMAN READABLE DATA
EDINSTVENA OZNAKA - DVODIMENZIONALNA ČRTNA KODA Vsebuje dvodimenzionalno črtno kodo z edinstveno oznako.
Epinephrine (adrenaline) or any other anti-anaphylactic measures should therefore be available.
Po injiciranju botulinskega toksina lahko zelo redko nastopi anafilaktična reakcija, zato morajo biti na voljo epinefrin (adrenalin) ali drugi ukrepi proti anafilaktičnim reakcijam.
As per the dilution table below, the amount of sodium chloride 9 mg/ml (0.9%) solution for injection is drawn up into a syringe in order to obtain a reconstituted solution at a concentration of 4 Units/0.1 mL.
V skladu s spodnjo preglednico za redčenje v brizgo potegnite količino 0,9 % (9 mg/ml) raztopine natrijevega klorida za injiciranje, da dobite rekonstituirano raztopino v koncentraciji 4 enote/0,1 ml. Količina vehikla (0,9 % (9 mg/ml) raztopina natrijevega klorida za injiciranje), dodanega 100 enotam viale
Read the package leaflet before use Intramuscular use Single use
POSTOPEK IN POT(I) UPORABE ZDRAVILA Pred uporabo preberite priloženo navodilo!
Visit your doctor immediately if you find it difficult to swallow, to speak or to breathe after treatment.
Če imate po zdravljenju težave pri požiranju, govoru ali dihanju, takoj obiščite zdravnika.
No cases of ingestion of botulinum toxin type A have been reported.
O primerih zaužitja botulinskega toksina tipa A se ni poročalo.
Glabellar lines
Glabelarne gube
Asthopenia, blepharospasm, brow ptosis, eyelid oedema, eye swelling, vision blurred
Astenopija, blefarospazem,
- Too frequent or excessive dosing may lead to antibody formation.
- Prepogosto ali preveliko odmerjanje lahko povzroči nastajanje protiteles, zaradi česar lahko botulinski toksin tipa A preneha delovati tudi pri uporabi za druge namene.
NUCEIVA contains sodium
Zdravilo NUCEIVA vsebuje natrij.