FrancophonIA/ELRC3.0 huggingface dataset:
English: Section 4.3 and 4.6 of the SPC of the reference product in the UK contains the information that the product is contraindicated in pregnancy, for women capable of childbearing or for nursing mothers.
Slovenian: Poglavji 4.3 in 4.6 SPC referenčnega izdelka v Združenem kraljestvu vsebujeta informacijo, da je izdelek kontraindiciran v nosečnosti, za ženske v rodni dobi ali za doječe matere.
English: The Marketing Authorisation Holder provided written explanations on 13 October 2005.
Slovenian: Imetnik dovoljenja za promet z zdravilom je posredoval pisna pojasnila 13. oktobra 2005.
English: The list of the product names concerned is given in Annex I. The scientific conclusions are provided in Annex II, together with the Summary of Product Characteristics in Annex III.
Slovenian: Seznam zadevnih imen izdelkov je podan v Dodatku I. Znanstveni zaključki so podani v Dodatku II, skupaj z dopolnjenim Povzetkom glavnih značilnosti zdravila v Dodatku III.
English: Significant differences have been identified with regard to the proposed SPC compared to the SPC of the reference product in the UK.
Slovenian: V zvezi s predlaganim Povzetkom glavnih značilnosti zdravila (SPC) so bile prepoznane pomembne razlike v primerjavi s SPC referenčnega izdelka v Združenem kraljestvu.
English: COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) OPINION FOLLOWING AN ARTICLE 29(2)1 REFERRAL FOR Nifedipine Pharmamatch 30 and 60 mg International Non-Proprietary Name (INN): Nifedipine
Slovenian: ODBOR ZA ZDRAVILA ZA UPORABO V HUMANI MEDICINI (CHMP) MNENJE V ZVEZI Z NAPOTITVIJO IZ ČLENA 29(2)1 ZA Nifedipine Pharmamatch 30 in 60 mg Mednarodno nelastniško ime (INN): nifedipin
English: During the January 2006 meeting, the CHMP, in the light of the overall data submitted and the scientific discussion within the Committee, was of the opinion that the benefit/risk ratio is favourable for Nifedipine Pharmamatch retard 30 and 60 mg tablets, that the objections raised by United Kingdom should not prevent the granting of a Marketing Authorisation and that the Summary of Product Characteristics, labelling and package leaflet of the Reference Member State should be amended.
Slovenian: Med svojim zasedanjem januarja 2006 je CHMP z ozirom na vse posredovane podatke in znanstveno razpravo v okviru Odbora, sprejel mnenje, da je razmerje med tveganji in koristmi za zdravilo Nifedipine Pharmamatch retard 30 mg in 60 mg tablete ugodno, da naj ugovori, podani s strani Združenega kraljestva, ne preprečijo podelitve dovoljenja za promet z zdravilom, ter da je treba Povzetek glavnih značilnosti zdravila, Označevanje in Navodilo za uporabo referenčne države članice dopolniti.
English: Nifedipine Pharmamatch 30 and 60 mg prolonged release tablets (nifedipine) is 1,4 - dihydropyridine calcium antagonist used for symptomatic treatment of chronic stable angina pectoris as monotherapy or in combination with a beta-blocker and in the treatment of patients with light to moderate essential hypertension.
Slovenian: Zdravilo Nifedipine Pharmamatch retard 30 mg in 60 mg tablete s podaljšanim sproščanjem (nifedipin) je 1,4-dihidropiridinski zaviralec kalcijevih kanalčkov, namenjen za simptomatsko zdravljenje kronične stabilne angine pektoris v monoterapiji ali v kombinaciji z zaviralcem beta ter za zdravljenje bolnikov z blago do zmerno esencialno hipertenzijo.
English: Pharmamatch BV submitted applications for mutual recognition of Nifedipine Pharmamatch retard 30 and 60 mg tablets on the basis of the marketing authorisation granted by the Netherlands on 29 November 2004.
Slovenian: Podjetje Pharmamatch BV je predložilo vloge za medsebojno priznavanje dovoljenja za promet, ki ga je 29. novembra 2004 Nizozemska podelila za zdravilo Nifedipine Pharmamatch retard 30 mg in 60 mg tablete.
English: Do not give this medicine to children or adolescents under 18 years of age.
Slovenian: Otroci in mladostniki Zdravila ne dajajte otrokom ali mladostnikom, mlajšim od 18 let.
English: Date of first authorisation:
Slovenian: Datum prve pridobitve:
English: Frequency of the adverse reactions is defined as: 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), not known (cannot be estimated from the available data).
Slovenian: Pogostnost neželenih učinkov je opredeljena kot: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1000 do < 1/100), redki (≥ 1/10.000 do < 1/1000), zelo redki (< 1/10.000), neznana (ni mogoče oceniti iz razpoložljivih podatkov).
English: This is particularly important if you are taking the following medicines which may interact with Senstend:
Slovenian: To je zlasti pomembno, če jemljete katero od naslednjih zdravil, ki lahko medsebojno deluje z zdravilom Senstend:
English: What Senstend is and what it is used for
Slovenian: Kaj je zdravilo Senstend in za kaj ga uporabljamo
English: • Inability to develop or maintain an erection
Slovenian: • nezmožnost doseganja in vzdrževanja erekcije;
English: However, there may be some exposure in female partners of men treated with Senstend.
Slovenian: Vendar lahko pride do določene izpostavljenosti ženskih partnerk moških, ki se zdravijo z zdravilom Senstend.
English: In serious cases of overdose, symptoms may include fits, low blood pressure, slowed breathing, stopped breathing and altered heart beat.
Slovenian: V hujših primerih prevelikega odmerjanja lahko med simptome spadajo krči, nizek krvni tlak, upočasnjeno dihanje, zaustavitev dihanja in spremenjen srčni utrip.
English: There is limited data on the efficacy and safety of Senstend in patients 65 years and over.
Slovenian: Podatki o učinkovitosti in varnosti zdravila Senstend pri bolnikih, starih 65 let in več, so omejeni.
English: Senstend has no or negligible influence on the ability to drive and use machines.
Slovenian: Zdravilo Senstend nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
English: Absorption of Senstend in conjunctival tissues has not been determined.
Slovenian: Absorpcija zdravila Senstend v konjunktivalna tkiva ni bila določena.
English: Symptoms of using too much Senstend are listed below.
Slovenian: Simptomi uporabe prevelikega odmerka zdravila Senstend so navedeni spodaj.
English: Aim the container away from faces to avoid contact with eyes, nose, mouth and ears.
Slovenian: Vsebnik usmerite stran od obrazov, da preprečite stik z očmi, nosom, usti in ušesi.
English: Elderly Dosage adjustments are not required in the elderly.
Slovenian: Starejši Pri starejših prilagajanje odmerkov ni potrebno.
English: • Tingling of the skin around the mouth and numbness of the tongue
Slovenian: • mravljinčenje kože okrog ust in omrtvelost jezika;
English: The efficacy of Senstend was demonstrated in two multi-centre, multinational, randomised, double-blind, placebo controlled studies, both followed by an open-label phase.
Slovenian: Učinkovitost zdravila Senstend je bila dokazana v dveh multicentričnih, multinacionalnih, randomiziranih, dvojno slepih, s placebom kontroliranih študijah, ki jima je sledila odprta faza.
English: Human exposure from Senstend is 20-30 fold less than the minimum dose that did not result in tumours and 200 fold less than the minimum dose that did result in tumours.
Slovenian: Izpostavljenost pri ljudeh zaradi zdravila Senstend je 20- do 30-krat manjša od najmanjšega odmerka, ki ni povzročil nastanka tumorjev, in 200-krat manjša od najmanjšega odmerka, ki je povzročil nastanek tumorjev.
English: Hypersensitivity of the patient or their partner to the active substances or to any of the excipients listed in section 6.1.
Slovenian: Preobčutljivost bolnika ali njegove partnerke na zdravilni učinkovini ali katero koli pomožno snov, navedeno v poglavju 6.1.
English: Pharmacotherapeutic group: Anaesthetics, amides, ATC code: N01BB20
Slovenian: Farmakoterapevtska skupina: anestetiki, amidi, oznaka ATC: N01BB20
English: • a high temperature
Slovenian: • visoka telesna temperatura.
English: EU/1/19/1387/001 EU/1/19/1387/002
Slovenian: EU/1/19/1387//002
English: Senstend should not come into contact with a damaged ear drum.
Slovenian: Zdravilo Senstend ne sme priti v stik s poškodovanim ušesnim bobničem.
English: The potential for reduction of sperm motility following the clinical use of the medicinal product can not be excluded; therefore it is not possible to state whether Senstend would prevent pregnancy.
Slovenian: Potenciala za zmanjšanje gibljivosti semenčic po klinični uporabi zdravila ni mogoče izključiti; zato ni mogoče opredeliti, ali zdravilo Senstend preprečuje nosečnost.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Senstend in all subsets of the paediatric population in primary premature ejaculation (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z zdravilom Senstend za vse podskupine pediatrične populacije s primarno prezgodnjo ejakulacijo (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: Other medicines and Senstend
Slovenian: Druga zdravila in zdravilo Senstend
English: However this study did not reproduce the circumstances of clinical use, as the concentration of Senstend in direct contact with the sperm would be many fold lower.
Slovenian: Vendar v tej študiji niso poustvarili okoliščin klinične uporabe, saj bi bila koncentracija zdravila Senstend v neposrednem stiku s spermo velikokrat manjša.
English: Senstend is not indicated for use by women.
Slovenian: Zdravilo Senstend ni indicirano za uporabo pri ženskah.
English: If you use Senstend with condoms, you may be more likely to be unable to develop or maintain an erection.
Slovenian: Če zdravilo Senstend uporabljate skupaj s kondomi, lahko obstaja večja verjetnost za nezmožnost doseganja in vzdrževanja erekcije.
English: Senstend is not recommended for use whilst your partner is pregnant unless you use a male condom, as listed above, to prevent exposure of the unborn child.
Slovenian: Uporaba zdravila Senstend ni priporočljiva, če je vaša partnerka noseča, razen če uporabite moški kondom, kot je navedeno zgoraj, da preprečite izpostavljenost nerojenega otroka.
English: Care should be taken not to allow Senstend to come in contact with the eye, as it may cause eye irritation.
Slovenian: Paziti je treba, da zdravilo Senstend ne pride v stik z očmi, saj lahko povzroči draženje oči.
English: During the 3 months of the double-blind treatment phase, the geometric mean IELT increased from 0.58 to 3.17 minutes in the Senstend group and from 0.56 to 0.94 minutes in the placebo group.
Slovenian: V času 3-mesečne dvojno slepe faze zdravljenja se je geometrična sredina IELT povečala z 0,58 na 3,17 minut pri skupini, ki je prejemala zdravilo Senstend, in z 0,56 na 0,94 minut pri skupini, ki je prejemala placebo.
English: For all of the three monthly assessments completed by the subjects, there was a significant difference between Senstend and placebo (p < 0.0001).
Slovenian: Pri vseh od treh mesečnih ocen, ki so jih izpolnili preiskovanci, je prišlo do pomembne razlike med zdravilom Senstend in placebom (p < 0,0001).
English: The clinically significant increases in IELT were paralleled by significant differences in the IPE scores (p < 0.0001).
Slovenian: Klinično pomembna povečanja IELT so sovpadala z občutnimi razlikami med rezultati IPE (p < 0,0001).
English: Senstend is a combination of two medicines: lidocaine and prilocaine.
Slovenian: Zdravilo Senstend je kombinacija dveh zdravil (lidokaina in prilokaina).
English: As a precautionary measure, it is preferable to avoid the use of Senstend during pregnancy unless effective male barrier contraceptive measures are taken in order to avoid potential foetal exposure.
Slovenian: Kot previdnostni ukrep se je bolje izogibati uporabi zdravila Senstend med nosečnostjo, razen če se uporablja učinkovita moška pregradna kontracepcijska metoda, da se prepreči potencialna izpostavljenostploda.
English: Anaemia related conditions
Slovenian: Stanja, povezana z anemijo
English: Any barrier contraceptives (e.g. male or female condom), which are made from polyurethane-based material cannot be guaranteed to protect against disease or pregnancy when you are also using Senstend.
Slovenian: Pregradne metode kontracepcije (npr. moški ali ženski kondom), izdelane iz materiala na osnovi poliuretana, ne zagotavljajo zaščite pred boleznimi ali nosečnostjo, kadar sočasno uporabljate zdravilo
English: Also contains: norflurane
Slovenian: SEZNAM POMOŽNIH SNOVI Vsebuje tudi: norfluran
English: Adjusted mean change scores (Senstend vs. placebo) at Month 3 were 8.2 vs. 2.2 for the ejaculatory control score, 7.2 vs. 1.9 for the sexual satisfaction score, and 3.7 vs. 1.1 for the distress score.
Slovenian: Prilagojeni rezultati spremembe sredine (zdravilo Senstend v primerjavi s placebom) so bili v 3. mesecu 8,2 v primerjavi z 2,2 za rezultat nadzora nad ejakulacijo, 7,2 v primerjavi z 1,9 za rezultat zadovoljstva s spolnim odnosom in 3,7 v primerjavi z 1,1 za rezultat osebne stiske.
English: The recommended dose of Senstend is 3 sprays (3 sprays = 1 dose) on the head of the penis before sexual intercourse.
Slovenian: Priporočen odmerek zdravila Senstend je 3 razpršitve (3 razpršitve = 1 odmerek) na glavico penisa pred spolnim odnosom.
English: Lidocaine and prilocaine are excreted in human milk, but at therapeutic doses of Senstend no effects on the breastfed newborns/infants are anticipated due to active substance transfer from the male patient to his female partner.
Slovenian: Lidokain in prilokain se izločata v materino mleko, vendar pri terapevtskih odmerkih zdravila Senstend ni pričakovati nobenega vpliva na dojene novorojenčke/dojenčke zaradi prenosa zdravilne učinkovine z moškega bolnika na njegovo partnerko.
English: A study in rats showed that Senstend caused a reduction in sperm motility.
Slovenian: V študiji na podganah so zabeležili, da je zdravilo Senstend povzročilo zmanjšanje gibljivosti semenčic.
English: The plasma levels of lidocaine and prilocaine in male and female subjects were below the level associated with toxicity (5,000 ng/ml).
Slovenian: Ravni lidokaina in prilokaina v plazmi pri moških in ženskih preiskovancih so bile pod ravnjo, povezano s toksičnostjo (5000 ng/ml).
English: • failure to ejaculate during sexual intercourse
Slovenian: • nezmožnost ejakulacije med spolnim odnosom;
English: 66.2% of Senstend-treated subjects and 18.8% of placebo-treated subjects achieved a mean IELT > 2 minutes.
Slovenian: 66,2 % preiskovancev, ki so prejemali zdravilo Senstend, in 18,8 % preiskovancev, ki so prejemali placebo, je doseglo sredino IELT > 2 minuti.
English: At each of the three monthly assessments all subjects completed a Premature Ejaculation Profile (PEP) questionnaire relating to perceived control over ejaculation, personal distress related to ejaculation, satisfaction with sexual intercourse, and interpersonal difficulty relating to ejaculation.
Slovenian: Pri vsaki od treh mesečnih ocen so vsi preiskovanci izpolnili vprašalnik profila prezgodnje ejakulacije (PEP) glede osebno opaženega nadzora nad ejakulacijo, osebne stiske v povezavi z ejakulacijo, zadovoljstva s spolnim odnosom in medosebnih težav v zvezi z ejakulacijo.
English: How to use Senstend
Slovenian: Kako uporabljati zdravilo Senstend
English: Methaemoglobinaemia may be accentuated in patients already taking medicinal products known to induce the condition, e.g. sulphonamides, acetanilid, aniline dyes, benzocaine, chloroquine, dapsone, metoclopramide, naphthalene, nitrates and nitrites, nitrofurantoin, nitroglycerin, nitroprusside, pamaquine, para-aminosalicylic acid, phenobarbital, phenytoin, primaquine and quinine (see section 4.4).
Slovenian: Methemoglobinemija se lahko poudari pri bolnikih, ki že jemljejo zdravila, za katera je znano, da povzročajo takšno stanje, na primer sulfonamidi, acetanilid, anilinske barve, benzokain, klorokin, dapson, metoklopramid, naftalen, nitrati in nitriti, nitrofurantoin, nitroglicerin, nitroprusid, pamakin, paraaminosalicilna kislina, fenobarbital, fenitoin, primakin in kinin (glejte poglavje 4.4).
English: In a carcinogenicity study of rats exposed to 2,6-xylidine in utero, postnatally and throughout their lifetime, tumours in the nasal cavity, subcutaneous tumours and liver tumours were observed.
Slovenian: V študiji karcinogenosti pri podganah, izpostavljenih 2,6-ksilidinu in utero po povrženju in skozi celotno življenjsko dobo, so opazili tumorje v nosni votlini, podkožne tumorje in tumorje na jetrih.
English: Senstend may reduce the possibility of pregnancy, but is not a reliable contraceptive.
Slovenian: Zdravilo Senstend lahko zmanjša možnost zanositve, vendar ni zanesljiv kontraceptiv.
English: Prilocaine was not genotoxic and the carcinogenic potential of prilocaine has not been studied.
Slovenian: Prilokain ni bil genotoksičen in karcinogeni potencial prilokaina ni bil raziskan.
English: In carcinogenicity studies of o-toluidine in rats, mice and hamsters, tumours were observed in several organs.
Slovenian: Pri študijah karcinogenosti o-toluidina pri podganah, miših in hrčkih so opazili tumorje v več organih.
English: The prilocaine metabolite o-toluidine has genotoxic potential in vitro.
Slovenian: Presnovek prilokaina, o-toluidin, ima genotoksičen potencial in vitro.
English: What you need to know before you use Senstend Do not use Senstend
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Senstend
English: Senstend may also come into contact with other mucous membranes such as your, or your partner's, mouth, nose and throat, causing them to feel slightly numb for a short while.
Slovenian: Zdravilo Senstend lahko pride v stik tudi z drugimi sluznicami, na primer ust, nosu in žrela vas ali vaše partnerke, kar za kratek čas povzroči rahlo omrtvelost.
English: Vulvovaginal discomfort or burning sensation caused discontinuation of treatment in 0.3% of subjects.
Slovenian: Zaradi neprijetnega ali pekočega občutka v vulvovaginalnem področju je prišlo do prekinitve zdravljenja pri 0,3 % preiskovancev.
English: Although the systemic availability of prilocaine by cutaneous absorption of Senstend is low, caution should be exercised in patients with anaemia, congenital or acquired methaemoglobinaemia or patients on concomitant therapy known to produce such conditions.
Slovenian: Čeprav je sistemska razpoložljivost prilokaina z dermalno absorpcijo zdravila Senstend nizka, je potrebna previdnost pri bolnikih z anemijo, prirojeno ali pridobljeno methemoglobinemijo in pri bolnikih, ki prejemajo sočasno zdravljenje, za katerega je znano, da povzroča takšna stanja.
English: What Senstend is and what it is used for What you need to know before you use Senstend How to use Senstend
Slovenian: Kaj je zdravilo Senstend in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Senstend Kako uporabljati zdravilo Senstend Možni neželeni učinki
English: Talk to your doctor or pharmacist before using Senstend - if you, or your sexual partner, have been diagnosed with a genetic disease or other condition affecting your red blood cells (glucose-6-phosphate deficiency, anaemia or methaemoglobinaemia); - if you have a history of medicine sensitivities, especially if you are not certain which medicine causes sensitivity; - if you suffer from severe liver problems.
Slovenian: Pred začetkom uporabe zdravila Senstend se posvetujte z zdravnikom ali farmacevtom: - če so vam ali vaši spolni partnerki postavili diagnozo genetske bolezni ali drugega stanja, ki vpliva na vaše rdeče krvne celice (pomanjkanje glukoza-6-fosfat dehidrogenaze, anemija ali methemoglobinemija); - če imate občutljivost na zdravila v anamnezi, zlasti če niste prepričani, katero zdravilo občutljivost povzroča; - če imate resne težave z jetri.
English: Patients allergic to paraaminobenzoic acid derivatives (procaine, tetracaine, benzocaine, etc.) have not shown cross sensitivity to lidocaine and/or prilocaine; however, Senstend should be used with caution in patients with a history (or partner with a history) of sensitivities to medicinal products, especially if the aetiologic medicinal product is uncertain.
Slovenian: Pri bolnikih, ki so alergični na derivate paraaminobenzojske kisline (prokain, tetrakain, benzokain itd.), niso zabeležili navzkrižne občutljivosti na lidokain in/ali prilokain; vendar je potrebna previdnost pri uporabi zdravila Senstend pri bolnikih (ali njihovih partnerkah) s preobčutljivostmi na zdravila v anamnezi, zlasti kadar etiologija zdravila ni znana.
English: In an in vitro study of rats Senstend has shown a reduction in sperm motility when 22.5 mg lidocaine and 7.5 mg prilocaine (i.e. the amount in 1 human dose) was in direct contact with rat sperm.
Slovenian: V študiji in vitro pri podganah je zdravilo Senstend zmanjšalo gibljivost semenčic, kadar je bil odmerek 22,5 mg lidokaina in 7,5 mg prilokaina (tj. količina 1 odmerka pri človeku) v neposrednem stiku s podganjo spermo.
English: Clinical trials have shown Senstend to increase the intra-vaginal ejaculatory latency time (IELT), increase control over ejaculation and reduce the feelings of distress in patients with premature ejaculation as measured by the Index of Premature Ejaculation (IPE).
Slovenian: V kliničnih preskušanjih so zabeležili, da zdravilo Senstend poveča trajanje intravaginalne ejakulacijske latence (IELT), poveča nadzor nad ejakulacijo ter zmanjša občutek osebne stiske pri bolnikih s prezgodnjo ejakulacijo, kar so izmerili z indeksom prezgodnje ejakulacije (Index of Premature Ejaculation, IPE).
English: In Senstend-treated subjects, IELT and IPE scores increased at the first measured timepoint.
Slovenian: Pri preiskovancih, ki so prejemali zdravilo Senstend, so se rezultati IELT in IPE povišali pri prvi izmerjeni časovni točki.
English: 85.2% of subjects in the Senstend group achieved a mean IELT of > 1 minute over the course of 3 months of treatment with it, whereas 46.4% of the placebo subjects had a mean IELT of > 1 minute.
Slovenian: 85,2 % preiskovancev iz skupine, ki je prejemala zdravilo Senstend, je doseglo sredino IELT > 1 minuto v času 3-mesečnega zdravljenja z zdravilom, medtem ko je sredino IELT > 1 minuto doseglo 46,4 % preiskovancev, ki so prejemali placebo.
English: The lidocaine metabolite 2,6-xylidine has genotoxic potential in vitro.
Slovenian: Presnovek lidokaina 2,6-ksilidin ima genotoksičen potencial in vitro.
English: There is no relevant use of Senstend in the paediatric population for the indication of treatment of primary premature ejaculation in adult men.
Slovenian: Ustrezne uporabe zdravila Senstend pri pediatrični populaciji za indikacijo zdravljenja primarne prezgodnje ejakulacije pri odraslih moških ni.
English: Senstend sprayed onto mucous membranes of the patient or their partner, such as the mouth, nose and throat, or transferred onto female genitalia or anal lining, could be absorbed and temporary local numbness/anaesthesia is likely to result.
Slovenian: Če se zdravilo Senstend razprši v sluznice bolnika ali njegove partnerke, na primer ust, nosu ali žrela, ali prenese na ženska spolovila ali analne dele, se lahko absorbira in povzroči začasno lokalno omrtvelost/anestezijo.
English: Patients or their partner with glucose-6-phosphate dehydrogenase deficiency or congenital or idiopathic methaemoglobinaemia are more susceptible to medicinal product-induced methaemoglobinaemia (see section 4.5).
Slovenian: Bolniki ali njihove partnerke s pomanjkanjem glukoza-6-fosfat dehidrogenaze ali prirojeno ali idiopatično methemoglobinemijo so dovzetnejši za methemoglobinemijo zaradi uporabe zdravil (glejte poglavje 4.5).
English: If you use more Senstend than you should
Slovenian: Če ste uporabili večji odmerek zdravila Senstend, kot bi smeli: