natgillin/translations-raw huggingface dataset:
After reviewing all the available data, the CHMP considered that the different figures provided by the data sources (spontaneous reports, forensic and poison centres, national mortality statistics) showed overall a significant number of deaths in which dextropropoxyphene is present at toxic levels.
CHMP je po pregledu vseh razpoložljivih podatkov menil, da so različne številke iz virov podatkov (spontanih poročil, forenzičnih centrov, centrov za zastrupitve, nacionalnih statistik umrljivosti) skupno pokazale precejšnje število smrti, pri katerih je bil dekstropropoksifen prisoten v toksičnih ravneh.
Therefore, the CHMP concluded by majority that the benefit-risk balance of dextropropoxyphene containing medicinal products is negative and that its Opinion of 25 June 2009 should not be revised for oral/rectal dextropropoxyphene containing medicinal products and recommended the withdrawal of the Marketing Authorisations to be effective within the next 15 months of the Commission Decision in order to allow switching patients to safer alternatives, considering the extensive clinical use of dextropropoxyphene containing medicinal products and the wide patient exposure in some Member States.
Zato je CHMP z večino glasov zaključil, da je razmerje med koristmi in tveganji pri zdravilih, ki vsebujejo dekstroproposkifen, negativno, da mnenja o zdravilih, ki vsebujejo dekstropropoksifen za peroralno/rektalno uporabo z dne 25. junija 2009 ni potrebno ponovno pregledati in je priporočil, da se dovoljenja za promet z zdravilom umaknejo v 15 mesecih od odločbe Komisije, da se glede na obsežno klinično uporabo zdravil, ki vsebujejo dekstropropoksifen in velikega števila bolnikov, ki so temu zdravilu izpostavljeni v državah članicah, bolnikom omogoči prehod na varnejša alternativna zdravila.
Whilst there is a risk of fatal overdose, the CHMP considered that it is limited for the parenteral dextropropoxyphene medicinal products, given the administration under hospital setting (given by healthcare professionals) and the classification of these medicinal products as narcotic prescription (in the Member State where the product is authorised) and the lack of evidence of fatal overdose particularly of accidental overdose.
Čeprav obstaja verjetnost prevelikega odmerjanja s smrtnim izidom, je CHMP menil, da je omejena le na zdravila, ki vsebujejo parenteralni dekstropropoksifen, saj se zdravilo običajno prejema v bolnišnici (in ga daje usposobljeno zdravstveno osebje), ta zdravila pa so razvrščena kot narkotiki, ki se dobijo na recept (v državi članici, kjer je zdravilo odobreno), in ker ni dovolj dokazov o smrtnih izidih, zlasti pri nenamernem prevelikem odmerjanju.
Having considered the detailed grounds for re-examination provided by the group of MAHs in writing and in an oral explanation, the CHMP considered that the design of the proposed clinical study to demonstrate the superior efficacy for combination of dextropropoxyphene and paracetamol versus paracetamol alone was flawed, and even a well-designed study would not change the benefit-risk balance of the dextropropoxyphene medicinal products in view of the narrow therapeutic index.
Odbor CHMP je po proučitvi podrobnih razlogov za ponovno presojo, ki so jih pisno in z ustno razlago navedli imetniki dovoljenja za promet, menil, da je bila zasnova predlagane klinične študije, ki bi dokazala večjo učinkovitost kombinacije dektropropoksifena in paracetamola v primerjavi s paracetamolom samim, pomankljiva, in da tudi dobro zasnovana klinična študija ne bi spremenila razmerja med koristmi in tveganji pri zdravilih, ki vsebujejo dekstropropoksifen, glede na njihov ozek terapevtski indeks.
However, the key safety concern with dextropropoxyphene is that it has a very narrow therapeutic index under normal conditions of use: following overdose, cardiac arrhythmias (which cannot be reversed using naloxone) and opioid side effects (such as respiratory depression) are rapid in onset and often fatal - there is evidence that the case fatality rate is higher than, for example, for tricyclic antidepressants.
Vendar pa je z vidika varnosti največja skrb, ki jo povzroča dekstropropoksifen ta, da ima v normalnih pogojih uporabe zelo ozek terapevtski indeks: preveliki odmerki, srčne aritmije (ki jih ni mogoče ublažiti z naloksonom) in neželeni učinki opioidov (kot je respiratorna depresija) nastopijo hitro in so pogosto usodni.
The CHMP also considered that data collected from national poison centres have limitations in this situation as dextropropoxyphene can cause death extremely rapidly (in under an hour); if a patient dies before reaching medical attention, the poisons centre is unlikely to be contacted.
CHMP je menil, da so podatki, zbrani iz nacionalnih centrov za zastrupitve, v tem primeru omejeni, saj lahko dekstropropoksifen povzroči smrt zelo hitro (v roku ene ure).
Because of this, the most reliable data come from forensic analysis and national mortality statistics, and complete review of the fatal overdoses associated with dextropropoxyphene (alone and in combination with paracetamol/caffeine)
Zaradi tega najbolj zanesljivi podatki izhajajo iz forenzičnih analiz in nacionalnih statistik umrljivosti, celoten pregled primerov prevelikih odmerkov s smrtnim izidom, povezanih z dekstropropoksifenom (samim ali v kombinaciji s paracetamolom/kofeinom), pa podpira poglavitni zadržek, ki zadeva smrtno toksičnost zdravil, ki vsebujejo dekstropropoksifen ob normalnih pogojih uporabe zaradi njegovega ozkega terapevtskega indeksa.
The CHMP, having considered the matter as set out in the appended referral assessment report recommended the suspension of the Marketing Authorisations for all parenteral medicinal products referred to in Annex I to be effected within 15 months of the Commission Decision in order to allow healthcare professionals to prepare for a potential switch to using alternatives.. For the suspension to be lifted the Marketing Authorisation Holders would need to provide evidence of a patient population in which the benefit-risk balance of parenteral dextropropoxyphene medicinal products is positive.
CHMP je po obravnavi zadeve, kakor je navedena v priloženem ocenjevalnem poročilu napotitvenega postopka, priporočil umik dovoljenj za promet z vsemi parenteralnimi zdravili, navedenimi v Dodatku I, kar se izvede v 15 mesecih od odločbe Komisije, s čimer bo zdravstvenim delavcem omogočeno, da se pripravijo na morebiten prehod na alternativna zdravila.
Nevertheless, the CHMP also took the well-established narrow therapeutic index into account, as well as other known risks associated with the use of parenteral opioids and potentially associated with the use of parenteral dextropropoxyphene such as abuse and dependence and given that the efficacy of parenteral dextropropoxyphene containing medicinal products has not been established, the CHMP concluded that the benefit-risk balance for the parenteral dextropropoxyphene containing medicinal products was negative and recommended the suspension of the Marketing Authorisations to be effected within 15 months of the Commission Decision to allow healthcare professionals to prepare for a potential switch to using alternatives.
Ker učinkovitost zdravil, ki vsebujejo parenteralni dekstroproposkifen, ni bila dokazana, je CHMP zaključil, da je razmerje med koristmi in tveganji za zdravila, ki vsebujejo parenteralni dekstropropoksifen, negativno, in je priporočil, da se dovoljenja za promet z zdravilom umaknejo v 15 mesecih od odločbe Komisije, kar bi zdravstvenim delavcem omogočilo, da se pripravijo na prehod na alternativno zdravilo.
- The Committee considered that the efficacy of parenteral dextropropoxyphene containing medicinal products has not been established;
- Odbor je menil, da učinkovitost zdravil, ki vsebuje parenteralni dekstropropoksifen, ni bila ugotovljena; - Odbor je obravnaval tveganje prevelikega odmerjanja s smrtnim izidom z dekstropropoksifenom.
Member State Marketing Authorisation Holder Product Name
Imetnik dovoljenja za promet z zdravilom
Immediate Packaging Pack size bottle (HDPE)
(HDPE) plastični vsebnik
100 tablets
Farmacevtska oblika
ATC vet code: QI07AI08.
Oznaka ATC vet: QI07AI08.
Date of last renewal: 11/04/2019.
Datum zadnjega podaljšanja dovoljenja za promet: 11/04/2019.
Pharmacotherapeutic group: Immunologicals for canidae, live viral and inactivated bacterial vaccines.
Farmakoterapevtska skupina: Imunološka zdravila za pse (canidae), živa virusna in inaktivirana bakterijska cepiva.
Suspension: whitish colour with fine sediment.
Suspenzija: bele barve s finim sedimentom.
Duration of immunity: At least one year following the primary vaccination course for all components of Versican Plus Pi/L4.
Trajanje imunosti: Vsaj eno leto po osnovnem cepljenju proti vsem komponentam cepiva Versican Plus Pi/L4.
Reconstituted vaccine: pinkish or yellowish colour with a slight opalescence.
Rekonstituirano cepivo: rožnate ali rumenkaste barve, rahlo opalescentno.
Primary vaccination scheme: Two doses of Versican Plus Pi/L4 3-4 weeks apart from 6 weeks of age.
Osnovno cepljenje: Dva odmerka Versican Plus Pi/L4 v razmaku 3-4 tednov od starosti 6 tednov naprej.
The vaccine is intended for the active immunisation of healthy puppies and dogs against diseases caused by canine parainfluenza virus, Leptospira interrogans serogroup Australis serovar Bratislava, Leptospira interrogans serogroup Canicola serovar Canicola, Leptospira kirschneri serogroup Grippotyphosa serovar Grippotyphosa and Leptospira interrogans serogroup Icterohaemorrhagiae serovar Icterohaemorrhagiae.
Cepivo je namenjeno aktivni imunizaciji zdravih pasjih mladičev in odraslih psov proti boleznim, ki jih povzročajo virus pasje parainfluence, Leptospira interrogans serološka skupina Australis serovar Bratislava, Leptospira interrogans serološka skupina Canicola serovar Canicola, Leptospira kirschneri serološka skupina Grippotyphosa serovar Grippotyphosa, in Leptospira interrogans serološka skupina Icterohaemorrhagiae serovar Icterohaemorrhagiae.
− 4 weeks after the completion of primary course for Leptospira components.
− 3 tedne po zaključku osnovnega cepljenja proti CpiV in − 4 tedne po zaključku osnovnega cepljenja proti komponentam Leptospira.
Re-vaccination scheme: A single dose of Versican Plus Pi/L4 to be given annually.
Ponovno cepljenje: Enkratni odmerek Versican Plus Pi/L4 letno.
Lyophilisate: Trometamol Edetic acid Sucrose Dextran 70
Liofilizat: trometamol edetinska kislina saharoza dekstran 70
ALR ** titre ≥ 1:40
titer ALR** ≥ 1:40
− to prevent clinical signs and reduce infection and urinary excretion caused by L. kirschneri serogroup Grippotyphosa serovar Grippotyphosa.
− za preprečevanje kliničnih znakov, zmanjšanje okužbe in izločanja virusa z urinom, ki jih povzroča L. kirschneri, serološka skupina Grippotyphosa, serovar Grippotyphosa.
SPECIAL WARNING(S)
POSEB NO(A) OPOZORILO(A)
ALR ** titre ≥ 1:51
titer ALR** ≥ 1:51
− to prevent clinical signs and urinary excretion and reduce infection caused by L. interrogans serogroup Canicola serovar Canicola and L. interrogans serogroup Icterohaemorrhagiae serovar Icterohaemorrhagiae, and
− za preprečevanje kliničnih znakov, izločanja virusa z urinom in zmanjšanje okužb, ki jih povzroča L. interrogans, serološka skupina Canicola,serovar Canicola ter L. interrogans, serološka skupina Icterohaemorrhagiae, serovar Icterohaemorrhagiae in
PACKAGE LEAFLET: Versican Plus Pi/L4 lyophilisate and suspension for suspension for injection for dogs
Versican Plus Pi/L4 liofilizat in suspenzija za suspenzijo za injiciranje za pse
NAME OF THE VETERINARY MEDICINAL PRODUCT Versican Plus Pi/L4 lyophilisate and suspension for suspension for injection for dogs
NAVODILO ZA UPORABO Versican Plus Pi/L4 liofilizat in suspenzija za suspenzijo za injiciranje za pse
Name and address of the manufacturer responsible for batch release
Ime in naslov proizvajalca (proizvajalcev) zdravila, odgovornega (odgovornih) za sprosščanje serij: Bioveta, a.s.,
The Committee appointed Mr G. Johan Schefferlie as rapporteur and Dr Michael Holzhauser-Alberti as co-rapporteur.
Odbor je imenoval Johana Schefferliea kot poročevalca in dr. Michaela Holzhauser-Albertija kot soporočevalca.
International non-proprietary name (INN): tilmicosin
Mednarodno nelastniško ime (INN): tilmikozin
Oral explanations were given on 11 June 2013.
Ustna pojasnila so bila podana 11. junija 2013.
Written explanations were provided by the marketing authorisation holders on 18 September 2012, 11 February 2013 and 26 May 2013.
Pisna pojasnila so imetniki dovoljenja za promet z zdravilom predložili 18. septembra 2012, 11. februarja 2013 in 26. maja 2013.
The Committee adopted a positive opinion by consensus on 18 July 2013.
Odbor je 18. julija 2013 soglasno sprejel pozitivno mnenje.
The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II, together with the amended Summary of Product Characteristics, labelling and package leaflet in Annex III.
Seznam zadevnih imen zdravil je naveden v Prilogi I. Znanstveni zaključki so podani v Prilogi II skupaj s spremenjenim povzetkom glavnih značilnosti zdravila, označevanjem in navodilom za uporabo v Prilogi III.
Tilmicosin is a macrolide antibiotic synthesized from tylosin which has an antibacterial spectrum similar to tylosin with enhanced activity against Pasteurella multocida and Mannheimia haemolytica.
Tilmikozin je makrolidni antibiotik, sintetiziran iz tilozina, in ima podoben spekter protibakterijskega delovanja kot tilozin, vendar z okrepljenim delovanjem zoper bakteriji Pasteurella multocida in Mannheimia haemolytica.
Due to divergent national decisions taken by Member States concerning the authorisations of Micotil 300 Injectie and its associated names, on 24 April 2012 the Netherlands referred the issue to the CVMP under Article 34(1) of Directive 2001/82/EC, in order to resolve discrepancies in the product information across the European Union.
Zaradi različnih nacionalnih odločitev, ki so jih sprejele države članice v zvezi z odobritvijo zdravila Micotil 300 Injectie in povezana imena, je Nizozemska na podlagi člena 34(1) Direktive 2001/82/ES zadevo napotila v arbitražo na CVMP, da bi razrešila razhajanja v informacijah o zdravilu po vsej Evropski uniji.
Based on the currently available data, the CVMP considered that the benefit-risk profile of Micotil 300 Injectie and its associated names remains positive, subject to variation of the marketing authorisations in accordance with the recommended product information.
CVMP je na podlagi trenutno razpoložljivih podatkov menil, da razmerje med koristmi in tveganji zdravila Micotil 300 Injectie in povezana imena ostaja pozitivno pod pogojem, da se spremenijo dovoljenja za promet z zdravilom v skladu s priporočenimi informacijami o zdravilu.
Micotil 300 Injectie and its associated names are veterinary medicinal products authorised for use in the target species cattle, sheep and rabbits for treatment of various infections caused by microorganisms susceptible to tilmicosin.
Zdravilo Micotil 300 Injectie in povezana imena je zdravilo za uporabo v veterinarski medicini, odobreno za uporabo pri govedu, ovcah in kuncih za zdravljenje različnih okužb, ki jih povzročajo mikroorganizmi, občutljivi za tilmikozin.
Micotil 300 Injectie is a solution for injection containing tilmicosin with a strength of 300 mg per ml.
Zdravilo Micotil 300 Injectie je raztopina za injiciranje, ki vsebuje tilmikozin v jakosti 300 mg na mililiter.
18 October 2013
18. oktober 2013 EMA/539469/2013
Opinion following an Article 341 referral for Micotil 300 Injectie and its associated names
za zdravilo Micotil 300 Injectie in povezana imena
Opinion following an Article 340F referral for Micotil 300 Injectie and its associated names
Mnenje v zvezi z napotitvijo v skladu s členom 340F za zdravilo Micotil 300 Injectie in povezana imena EMA/696386/2013
Erysipelothrix rhusiopathiae, strain R32E11, ELISA > 3.34 IE50%
10 odmerkov (20 ml)
Target species
1 stekle no vialo z
Posaconazole SP 40 mg/ml Oral suspension Oral use
Posaconazole SP 40 mg/ml Peroralna suspenzija Peroralna uporaba Steklenička (steklo)
Content (concentration) Package size
Ovojnina Vsebina (koncentracija)
270 capsules blister (PVC/Aclar (PCTFE)) Initiation pack: 63 (1 x 21 and 2 x 21) tablets
270 kapsul začetno pakiranje: 63 (1 x 21 in 2 x 21) tablet
Immediate Packaging Pack size blister (PVC/PE/PCTFE/alu) Initiation pack: 63 (7 x 3 and 7 x 6) capsules blister (PVC/PE/PCTFE/alu) 252 x 1 capsules (unit dose)
(PVC/PE/PCTFE/alu) začetno pakiranje: 63 (7 x 3 in 7 x 6) kapsul
This overview was last updated in 03-2019
Pregled je bil nazadnje posodobljen 03-2019.
Further information on Instanyl can be found on the Agency's website: ema.europa.eu/medicines/Human/EPAR/Instanyl.
Nadaljnje informacije za zdravilo Instanyl so na voljo na spletni strani agencije: ema.europa.eu/medicines/Human/EPAR/Instanyl.
It is a well-known substance, which has been used to control pain for many years.
To je dobro znana snov, ki se že mnogo let uporablja za obvladovanje bolečin.
What measures are being taken to ensure the safe and effective use of Instanyl?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Instanyl?
Instanyl received a marketing authorisation valid throughout the EU on 20 July 2009.
Za zdravilo Instanyl je bilo 20. julija 2009 izdano dovoljenje za promet, veljavno po vsej EU.
The European Medicines Agency decided that Instanyl's benefits are greater than its risks and it can be authorised for use in the EU.
Evropska agencija za zdravila je zaključila, da so koristi zdravila Instanyl večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
What benefits of Instanyl have been showed in studies?
Kakšne koristi zdravila Instanyl so se pokazale v študijah?
Other information about Instanyl
Druge informacije o zdravilu Instanyl
As for all medicines, data on the use of Instanyl are continuously monitored.
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Instanyl stalno spremljajo.
Why is Instanyl authorised in the EU?
Zakaj je bilo zdravilo Instanyl odobreno v EU?
What are the risks associated with Instanyl?
Kakšna tveganja so povezana z zdravilom Instanyl?
The doctor should keep in mind the potential for Instanyl to be abused.
Zdravnik se mora zavedati, da obstaja možnost zlorabe zdravila Instanyl.
The medicine can only be obtained by ‘special' prescription.
Predpisovanje in izdaja zdravila je le na „poseben“ recept.
An overview of Instanyl and why it is authorised in the EU
Pregled zdravila Instanyl in zakaj je odobreno v EU
The company that markets Instanyl will also provide educational materials to be supplied to patients, doctors and pharmacists, explaining the correct and safe use of the medicine.
Podjetje, ki trži zdravilo Instanyl, bo priskrbelo izobraževalno gradivo za bolnike, zdravnike in farmacevte, kjer bo obrazložena pravilna in varna uporaba zdravila.
It is available in singledose containers and in multidose containers.
Na voljo je v enoodmernem ali večodmernem vsebniku.
Side effects reported with Instanyl are carefully evaluated and any necessary action taken to protect patients.
Neželeni učinki, o katerih so poročali pri zdravilu Instanyl, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
What is Instanyl what is it used for?
Kaj je zdravilo Instanyl in za kaj se uporablja?
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Instanyl have also been included in the summary of product characteristics and the package leaflet.
Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Instanyl upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
Side effects are similar to those of other medicines containing fentanyl, and measures have been put in place to minimise the risk of misuse and overdose.
Neželeni učinki so podobni kot pri drugih zdravilih, ki vsebujejo fentanil, uvedeni pa so tudi ukrepi za zmanjšanje tveganj zlorabe in prevelikega odmerjanja.
Because fentanyl has been in use for many years, the company presented data from the scientific literature, as well as from studies that it had carried out, which showed that Instanyl was more effective than placebo (a dummy treatment) at treating breakthrough pain in cancer patients.
Ker se fentanil uporablja že mnogo let, je podjetje predložilo podatke iz znanstvene literature, pa tudi podatke iz študij, ki jih je izvedlo samo in so pokazale, da je zdravilo Instanyl pri zdravljenju prebijajoče bolečine pri rakavih bolnikih učinkovitejše od placeba (zdravila brez učinkovine).
The most common side effects with Instanyl (which may affect up to 1 in 10 people) are somnolence (sleepiness), dizziness, headache, vertigo (a spinning sensation), flushing (reddening of the skin), hot flushes, throat irritation, nausea (feeling sick), vomiting and hyperhidrosis (excessive sweating).
Najpogostejši neželeni učinki zdravila Instanyl (ki se lahko pojavijo pri največ 1 od 10 bolnikov) so somnolenca (zaspanost), omotica, glavobol, vrtoglavica (občutek vrtenja), rdečica (pordelost kože), navali vročine, draženje v žrelu, navzeja (siljenje na bruhanje), bruhanje in hiperhidroza (prekomerno potenje).
In another main study, 128 patients were given increasing doses of Instanyl until the adequate dose for pain relief was reached.
V drugi glavni študiji je 128 bolnikov prejemalo čedalje večje odmerke zdravila Instanyl, dokler niso dosegli zadostnega olajšanja bolečine.
In a third study, which involved 139 patients and compared Instanyl with ‘transmucosal' fentanyl (absorbed through the lining of the mouth), patients who received Instanyl had faster pain relief than patients who received transmucosal fentanyl .
V tretji študiji, ki je vključevala 139 bolnikov in v kateri so zdravilo Instanyl primerjali s transmukoznim fentanilom (ki se absorbira skozi sluznico ustne votline), je pri bolnikih, ki so prejemali zdravilo Instanyl, do olajšanja bolečine prišlo hitreje kot pri bolnikih, ki so prejemali transmukozni fentanil.
Before starting treatment with Instanyl, the patient's long-term pain should be well controlled by opioid pain killers and they should have no more than 4 episodes of breakthrough pain a day.
Pred začetkom zdravljenja z zdravilom Instanyl mora biti dolgotrajna bolečina pri bolnikih dobro uravnana z opioidnimi protibolečinskimi zdravili in bolniki ne smejo imeti več kot štiri epizode prebijajoče bolečine na dan.
In one main study, 178 adult cancer patients with breakthrough pain took one spray of either Instanyl (50, 100 or 200 microgram) or placebo when they experienced breakthrough pain.
V eni glavni študiji je 178 odraslih bolnikov z rakom in prebijajočo bolečino ob pojavu prebijajoče bolečine prejemalo po en vpih zdravila Instanyl (50, 100 ali 200 mikrogramov) ali placeba.
Instanyl is available as a nasal spray (50, 100 and 200 micrograms per dose).
Zdravilo Instanyl je na voljo v obliki pršila za nos (50, 100 in 200 mikrogramov na odmerek).
The active substance in Instanyl, fentanyl, is an opioid.
Učinkovina v zdravilu Instanyl, fentanil, je opioid.
When the patient sprays Instanyl into the nose, a dose of fentanyl is absorbed into the blood stream through the blood vessels in the nose.
Ko si bolnik naprši zdravilo Instanyl v nos, se odmerek fentanila skozi krvne žile v nosu hitro absorbira v krvni obtok.
Treatment with Instanyl should be started by and remain under the supervision of a doctor who has experience in the management of opioid treatment in cancer patients.
Zdravljenje z zdravilom Instanyl sme uvesti in ves čas nadzorovati le zdravnik, ki ima izkušnje z vodenje zdravljenja z opioidi pri bolnikih z rakom.
Instanyl has been shown to provide rapid relief of pain in patients with cancer.
Za zdravilo Instanyl je bilo dokazano, da hitro olajša bolečine pri bolnikih z rakom.
If there has been insufficient pain relief, the same dose can be given again at the earliest after 10 minutes.
Če lajšanje bolečine ni zadostno, se lahko po preteku najmanj desetih minut znova uporabi enak odmerek.