natgillin/translations-raw huggingface dataset:
Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, France, Germany, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Romania, Slovakia, Slovenia, Spain, United Kingdom - Zinnat
Avstrija, Belgija, Bolgarija, Ciper, Češka, Danska, Estonija, Francija, Nemčija, Madžarska, Irska, Italija, Latvija, Litva, Luksemburg, Malta, Nizozemska, Poljska, Romunija, Slovaška, Slovenija, Španija, Združeno kraljestvo - Zinnat
NAME OF THE MARKETING AUTHORISATION HOLDER [See Annex I - To be completed nationally]
IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM [izpolni država članica]
With the patient seated in an upright position, place the tip of the syringe just inside the patient's mouth, pointing towards the inside of the cheek.
Brizgo mu vstavite v usta, tako da bo njena konica usmerjena proti notranji strani lica.
6.6 Special precautions for disposal and other handling
POSEBNI VARNOSTNI UKREPI ZA ODSTRANJEVANJE NEUPORABLJENIH
• being sick • skin rashes.
• bruhanje; • kožni izpuščaji.
Cystitis
Dojenje
6 (3 x 2) prefilled pens (multipack)
6 (3 x 2) napolnjenih injekcijskih peresnikov (skupno pakiranje)
2 pre-filled pens
2 napolnjena injekcijska peresnika
Initiation pack: 1 pre-filled syringe (63 µg) + 1 pre-filled syringe (94 µg)
Velikost pakiranja začetno pakiranje: 1 napolnjena injekcijska brizga (63 µg)
European Medicines Agency recommends changes to the use of metoclopramide
Evropska agencija za zdravila priporoča spremembe pri uporabi metoklopramida
Patients who have any questions should discuss them with their doctor or pharmacist.
Bolniki, ki imajo kakršna koli vprašanja, naj se posvetujejo z zdravnikom ali farmacevtom.
Detailed recommendations for patients and healthcare professionals are available below.
Podrobna priporočila za bolnike in zdravstvene delavce so na voljo v nadaljevanju.
The review of metoclopramide-containing medicines was initiated in December 2011 at the request of France, under Article 31 of Directive 2001/83/EC.
Pregled zdravil, ki vsebujejo metoklopramid, je bil sprožen decembra 2011 na zahtevo Francije v skladu s členom 31 Direktive 2001/83/ES.
Metoclopramide-containing medicines have been authorised by national procedures in all the Member States of the EU and have been available for many years under different trade names.
Zdravila, ki vsebujejo metoklopramid, so bila odobrena po nacionalnih postopkih v vseh državah članicah EU in so že več let na voljo pod različnimi trgovskimi imeni.
Changes aim mainly to reduce the risk of neurological side effects
Spremembe so namenjene predvsem zmanjšanju tveganja za nevrološke neželene učinke
Use is contraindicated in children under 1 year of age.
Uporaba je kontraindicirana pri otrocih, mlajših od 1 leta.
• Metoclopramide should no longer be used in children under 1 year old.
• Metoklopramid se ne sme več uporabljati pri otrocih, mlajših od 1 leta.
• Extrapyramidal disorders constituted nearly half of all spontaneously reported adverse effects in a manufacturer database (1749 cases out of 4005, up to December 2011).
• Skoraj polovico vseh spontanih poročil o neželenih učinkih v podatkovni zbirki izdelovalca so predstavljale ekstrapiramidne motnje (1749 primerov od 4005, zabeleženih do decembra 2011).
The product information has been amended appropriately, and prescribers sent further communication at a national level.
Informacije o zdravilu so bile ustrezno spremenjene, zdravstvenim delavcem, ki predpisujejo ta zdravila, pa so poslali dodatno obvestilo na nacionalni ravni.
The reporting rate for these disorders was calculated to be 6 times higher in children than in adults, although it was not possible to accurately account for usage patterns in different age-groups.
Stopnja poročanja, izračunana za te motnje, je bila 6-krat višja pri otrocih kot pri odraslih, čeprav pri izračunu ni bilo mogoče natančno upoštevati vzorcev uporabe pri različnih starostnih skupinah.
Following this assessment and the issuing of the CHMP's original opinion, one of the companies producing metoclopramide-containing medicines exercised its legal right to ask for a re-examination of the opinion, which was duly carried out.
Potem ko je odbor CHMP ocenil razmerje in izdal prvotno mnenje, je ena od družb, ki izdelujejo zdravila, ki vsebujejo metoklopramid, izkoristila zakonsko pravico, da zahteva ponoven pregled mnenja, ki je bil nato tudi ustrezno opravljen.
• The recommended maximum dose of the medicine has been lowered in adults to a total of 30 mg a day, and some high dose products will be removed from the market as they will no longer be needed.
• Priporočeni največji odmerek zdravila pri odraslih je po novem manjši in znaša skupno 30 mg na dan, nekatera zdravila z veliko jakostjo pa bodo umaknjena s trga, saj ne bodo več potrebna.
This followed a review by the EU Member States of metoclopramide-containing medicines in children, under Article 45 of the Paediatric Regulation 1901/2006, which in 2010 identified the risk of neurological side effects and recommended a number of risk minimisation measures.
Povod zanj je bil pregled uporabe zdravil, ki vsebujejo metoklopramid, pri otrocih, ki so ga države članice EU leta 2010 opravile v skladu s členom 45 pediatrične uredbe št. 1901/2006 in med katerim so odkrili tveganje za nevrološke neželene učinke ter priporočili številne ukrepe za zmanjšanje tveganja.
Given the known risk of neurological and other adverse effects, particularly in children and young people, the Committee concluded that the indications for metoclopramide should be restricted to those involving short-term use, at a maximum dose of 0.5 mg per kg body weight daily, and where there is sufficient evidence of efficacy.
Zaradi znanega tveganja za nevrološke in druge neželene učinke, zlasti pri otrocih in mladostnikih, je odbor zaključil, da je treba indikacije za metoklopramid omejiti na tiste, ki dopuščajo kratkotrajno uporabo pri največjem odmerku 0,5 mg na kg telesne mase na dan in pri katerih obstajajo zadostni dokazi o učinkovitosti.
• If you are taking metoclopramide (especially for long-term conditions) you will have your treatment reviewed by your doctor at your next scheduled appointment, and in some cases you may be recommended a different treatment.
• Če jemljete metoklopramid (še zlasti za dolgotrajno zdravljenje), bo vaš zdravnik ob naslednjem obisku ponovno ocenil predpisano zdravljenje in v določenih primerih priporočil drugega.
ANSM asked the CHMP to review the benefits and risks of these medicines in all age groups and to recommend consistent indications across the EU.
Agencija ANSM je zaprosila odbor CHMP, da pregleda koristi in tveganja, povezana s temi zdravili, pri vseh starostnih skupinah in priporoči enotne indikacije za celotno EU.
• Intravenous formulations with concentrations above 5 mg/ml and suppositories containing 20 mg will also be withdrawn.
• Prav tako bodo umaknjeni intravenski pripravki s koncentracijo, večjo od 5 mg/ml, in svečke v odmerku 20 mg.
This included published studies and meta-analyses on the efficacy of metoclopramide and analyses of reports of suspected adverse reactions.
Pri tem so pregledali objavljene študije in metaanalize podatkov o učinkovitosti metoklopramida ter analize poročil o domnevnih neželenih učinkih.
• Intravenous doses should be administered as a slow bolus over at least 3 minutes to reduce the risk of adverse effects.
• Intravenske odmerke je treba dajati v obliki počasnega bolusa, ki traja najmanj 3 minute, saj se tako zmanjša tveganje za neželene učinke.
The CHMP recommendation was then sent to the European Commission, which adopted it with a final legally binding decision, valid throughout the European Union (EU), on 20 December 2013.
Odbor CHMP je priporočilo posredoval Evropski komisiji, ki ga je potrdila in dne 20. decembra 2013 sprejela končno pravno zavezujočo odločbo, ki velja za celotno Evropsko unijo (EU).
A dosing table for use in children will be included in the product information.
V informacije o zdravilu bo vključena razpredelnica za določanje odmerkov pri otrocih.
The French medicines agency therefore asked the CHMP to carry out an assessment of the benefit-risk balance in all populations, especially in children and the elderly.
Francoska agencija za zdravila je zato zaprosila odbor CHMP, da oceni razmerje med tveganji in koristmi pri vseh populacijah, še zlasti pa pri otrocih in starejših.
• The evidence also indicated efficacy in nausea and vomiting associated with acute migraine, but seemed to indicate that doses above 10 mg do not result in increased efficacy.
• Prav tako dokazi kažejo, da je učinkovit pri slabosti in bruhanju zaradi akutne migrene, vendar pa se zdi, da odmerki nad 10 mg ne izboljšajo njegove učinkovitosti.
On 24 October the European Medicines Agency's Committee on Medicinal Products for Human Use (CHMP) confirmed previously recommended changes to the use of metoclopramide-containing medicines in the European Union (EU), including restricting the dose and duration of use of these medicines to minimise the known risks of potentially serious neurological (brain and nerve) side effects.
Odbor za zdravila za uporabo v humani medicini (CHMP) pri Evropski agenciji za zdravila je dne 24. oktobra potrdil predhodno priporočene spremembe pri uporabi zdravil, ki vsebujejo metoklopramid, v Evropski uniji (EU), vključno z omejitvijo odmerka in trajanja zdravljenja, s katerimi se želi zmanjšati znana tveganja za potencialno resne nevrološke neželene učinke (učinke na možgane in živce).
The original review of metoclopramide was carried out at the request of the French medicines regulatory agency (ANSM), following continued safety concerns over side effects and concerns over efficacy.
Prvoten pregled metoklopramida je sprožila francoska regulativna agencija za zdravila (ANSM) zaradi stalnih varnostnih zadržkov, ki so se pojavljali v zvezi z neželenimi učinki, in pomislekov glede učinkovitosti.
The Agency's recommendations are based on a review of the benefit-risk of metoclopramide-containing products in all indications and populations.
Priporočila agencije temeljijo na pregledu razmerja med tveganji in koristmi zdravil, ki vsebujejo metoklopramid, pri vseh indikacijah in populacijah.
The effects of metoclopramide on gut motility may be of benefit when given orally with analgesics in this acute setting.
Učinki metoklopramida na gibljivost črevesa so lahko koristni, kadar se metoklopramid pri tem akutnem stanju daje peroralno skupaj z analgetiki.
• In other longer lasting conditions, the benefits of this medicine do not outweigh the risks of side effects.
• Pri drugih boleznih, ki zahtevajo daljše zdravljenje, koristi tega zdravila niso večje od tveganj za neželene učinke.
During the re-examination the Committee confirmed its recommendation that metoclopramide should only be authorised for short-term use (up to 5 days), that it should not be used in children below 1 year of age and that in children over 1 year of age it should only be used as a second-choice treatment (after other treatments have been considered or tried) for the prevention of delayed nausea and vomiting after chemotherapy and for the treatment of post-operative nausea and vomiting.
Odbor je med ponovnim pregledom potrdil priporočilo, da bi moral biti metoklopramid odobren samo za kratkotrajno uporabo (največ 5 dni), da se ne bi smel uporabljati pri otrocih, mlajših od 1 leta, in da bi se moral pri otrocih, starejših od 1 leta, uporabljati samo kot zdravilo druge izbire (potem ko se pretehta ali preskusi druge možnosti zdravljenja) za preprečevanje zapoznele slabosti in bruhanja zaradi kemoterapije ter za zdravljenje slabosti in bruhanja po operaciji.
• In order to minimise the risks of neurological and other adverse reactions, metoclopramide is now only licensed for short-term use (up to 5 days).
• Da bi zmanjšali tveganja za nevrološke in druge neželene učinke, je metoklopramid po novem odobren samo za kratkotrajno uporabo (največ 5 dni).
The risk of acute (short-term) neurological effects is higher in children, although tardive dyskinesia is reported more often in the elderly, and the risk is increased at high doses or with long-term treatment.
Tveganje za akutne (kratkotrajne) nevrološke neželene učinke je večje pri otrocih, čeprav o tardivni diskineziji pogosteje poročajo pri starejših, tveganje pa se poveča pri večjih odmerkih in pri dolgotrajnem zdravljenju.
It also stimulates the movement of the stomach and upper part of the bowel, speeding passage through the gut.
Poleg tega spodbuja gibanje želodca in zgornjega dela črevesa, s čimer skrajša čas prehoda skozi črevesje.
The evidence for intravenous metoclopramide in post-operative nausea and vomiting suggests it is as effective as other licensed treatments.
Dokazi o uporabi intravenskega metoklopramida pri slabosti in bruhanju po operaciji kažejo, da je prav tako učinkovit kot druga odobrena zdravila.
Therefore, it should no longer be used to treat conditions such as indigestion, heartburn and acid reflux, or chronic (long-term) disorders due to slow emptying of the stomach.
Zato se ne sme več uporabljati za zdravljenje bolezni, kot so na primer prebavne motnje, zgaga in refluks kisline, ali kroničnih (dolgotrajnih) motenj zaradi počasnega praznjenja želodca.
There have also been very rare cases of serious effects on the heart or circulation, particularly after injection.
Poleg tega so zabeležili tudi zelo redke primere resnih neželenih učinkov na srce in ožilje, ki so se pojavili predvsem po injiciranju.
Following the re-examination, the final CHMP recommendation was then sent to the European Commission, which adopted it with an EU-wide legally binding decision on 20 December 2013.
Potem ko je bil ponovni pregled zaključen, je odbor CHMP končno priporočilo posredoval Evropski komisiji, ki ga je potrdila in dne 20. decembra 2013 izdala pravno zavezujočo odločbo, ki velja za celotno EU.
There were also a significant number of reports of overdose in children, particularly with oral liquid formulations.
Zabeležili so tudi znatno število poročil o prevelikem odmerjanju pri otrocih, zlasti pri uporabi tekočih pripravkov za peroralno uporabo.
Metoclopramide is a medicine that acts as an antiemetic (a medicine used to relieve nausea and vomiting) by acting on the part of the brain that triggers the sensation of sickness.
Metoklopramid je zdravilo, ki deluje kot antiemetik (zdravilo, ki se uporablja za lajšanje slabosti in bruhanja), pri čemer vpliva na del možganov, ki sproži občutek slabosti.
It should no longer be used in chronic conditions such as gastroparesis, dyspepsia and gastro-oesophageal reflux disease, nor as an adjunct in surgical and radiological procedures.
Ne sme se več uporabljati pri kroničnih boleznih, kot so na primer gastropareza, dispepsija in gastroezofagealna refluksna bolezen, ter kot dodatek pri kirurških in radioloških posegih.
There was also some evidence suggestive of a role in radiotherapy-induced nausea and vomiting, although again it seemed to be less effective than the 5-HT3 antagonists.
Našli so tudi nekaj dokazov o tem, da metoklopramid ima vlogo pri slabosti in bruhanju zaradi radioterapije, vendar se ponovno zdi, da je manj učinkovit od antagonistov 5-HT3.
At the request of a manufacturer of higher strength oral solutions, the Committee reconsidered the evidence behind its view that oral solutions above 1 mg/ml should no longer be available, and the arguments and proposals to minimise the risk that were supplied by the company, specifically a restriction on the use of the higher strength solution in children.
Na zahtevo izdelovalca peroralnih raztopin z večjo jakostjo je odbor ponovno proučil dokaze, na podlagi katerih je presodil, da peroralne raztopine s koncentracijo nad 1 mg/ml ne smejo biti več na voljo, ter argumente in predloge v zvezi z zmanjšanjem tveganja, ki jih je podala družba, zlasti omejitev uporabe raztopin z večjo jakostjo pri otrocih.
Evidence to support a role as an adjunct in surgical and radiological procedures was also lacking.
Pomanjkljivi so bili tudi dokazi, ki bi podprli vlogo metoklopramida kot dodatka pri kirurških in radioloških posegih.
• There was no evidence of consistent benefit in gastroparesis, gastro-oesophageal reflux disease and dyspepsia, all of which are chronic conditions requiring prolonged treatment which puts patients at risk of chronic neurological side effects.
• Našli niso nobenih dokazov o doslednih koristih pri gastroparezi, gastroezofagealni refluksni bolezni in dispepsiji, kroničnih boleznih, ki zahtevajo dolgotrajno zdravljenje, zaradi katerega pri bolnikih obstaja tveganje za kronične nevrološke neželene učinke.
• Oral liquid formulations have been particularly associated with overdose in children.
• Tekoči pripravki za peroralno uporabo so bili posebno pogosto povezani s prevelikim odmerjanjem pri otrocih.
Other nervous system side effects may occur when metoclopramide is used for prolonged periods and may occur more often in the elderly.
Drugi neželeni učinki na živčni sistem se lahko pojavijo, kadar se metoklopramid uporablja dlje časa, in so pogostejši pri starejših.
Elderly patients seemed to be more at risk of potentially irreversible tardive dyskinesia after longer term treatment.
Zdi se, da pri starejših obstaja večje tveganje za potencialno trajno tardivno diskinezijo po dolgotrajnem zdravljenju.
Extrapyramidal disorders were more likely to occur after several doses, although usually early in treatment, and were less likely at slower infusion rates when metoclopramide was given intravenously.
Ekstrapiramidne motnje so se pogosteje pojavljale po večkratnih odmerkih, vendar v zgodnjem obdobju zdravljenja, redkeje pa pri počasnejšem infundiranju, kadar so metoklopramid dajali intravensko.
This followed a re-examination, at the request of a marketing authorisation holder, of the opinion originally given by the Committee on 26 July 2013.
Spremembe je odbor potrdil po ponovnem pregledu mnenja, prvotno izdanega dne 26. julija 2013, ki ga je zahteval imetnik dovoljenja za promet z zdravilom.
It is authorised for a variety of indications, which differ between EU Member States and is available in different formulations including as an injection (to be given into a vein or muscle), as tablets and oral liquids to be taken by mouth and as suppositories.
Odobren je za številne indikacije, ki se v posameznih državah članicah EU razlikujejo, in je na voljo v različnih oblikah: v obliki injekcije (ki se daje v veno ali mišico), tablet in peroralnih tekočin, ki se dajejo skozi usta, in svečk.
French medicines regulatory agency highlighted that despite various risk minimisation measures implemented over the years, side effects had continued to be reported.
Pregled, ki ga je leta 2011 na nacionalni ravni opravila francoska regulativna agencija za zdravila, pri otrocih, je pokazal, da so kljub različnim ukrepom za zmanjšanje tveganja, sprejetim v preteklih letih, še vedno poročali o neželenih učinkih.
In addition, the maximum recommended doses in adults and children should be restricted, and higher strength formulations, including oral liquids in strengths above 1 mg/ml, removed from the market.
Poleg tega je treba omejiti največje priporočene odmerke pri odraslih in otrocih, vse pripravke s koncentracijo, večjo od 1 mg/ml, vključno s tekočimi pripravki za peroralno uporabo, pa umakniti s trga.
The review confirmed the well-known risks of neurological effects such as short-term extrapyramidal disorders, a group of involuntary movement disorders that may include muscle spasms (often involving the head and neck) and tardive dyskinesia (uncontrollable movements such as grimacing and twitching).
Pregled je potrdil že znana tveganja za nevrološke neželene učinke, kot so na primer kratkotrajne ekstrapiramidne motnje, med katere sodijo različne motnje gibanja, ki lahko vključujejo mišične spazme (ki pogosto prizadenejo glavo in vrat) ter tardivno diskinezijo (nehoteni gibi, na primer grimase in trzanje).
It is given by injection, by mouth, or as suppositories.
Daje se z injiciranjem, skozi usta ali v obliki svečk.
Oral liquids containing more than 1 mg/ml will be withdrawn from the market, and oral doses of remaining formulations should be administered using an appropriately designed graduated oral syringe to ensure accuracy.
Tekoči pripravki za peroralno uporabo s koncentracijo, večjo od 1 mg/ml, bodo umaknjeni s trga, peroralne odmerke ostalih pripravkov pa je treba dajati z ustrezno graduirano brizgo za peroralno dajanje, ki bo zagotovila natančno odmerjanje.
• Patients who are currently taking regular metoclopramide should have their treatment reviewed at a routine (non-urgent) medical appointment.
• Pri bolnikih, ki redno jemljejo metoklopramid, je treba ob naslednjem (neurgentnem) obisku pri zdravniku ponovno oceniti predpisano zdravljenje.
• Data on the use of metoclopramide in acute chemotherapy-induced nausea and vomiting (CINV) were limited and suggested that metoclopramide was inferior to 5-HT3 antagonists and required high doses which are associated with a greatly increased risk of adverse effects.
• Podatki o uporabi metoklopramida pri akutni slabosti in bruhanju zaradi kemoterapije so omejeni in so pokazali, da je metoklopramid slabši od antagonistov 5-HT3 in da so potrebni veliki odmerki, ki so povezani z močno povečanim tveganjem za neželene učinke.
• Recommended use in children is therefore now restricted to prevention of nausea and vomiting that occurs in the days after treatment with anticancer medicines, or to treat nausea and vomiting after surgery, and only when other treatments do not work or cannot be used.
• Priporočena uporaba pri otrocih je zato po novem omejena na preprečevanje slabosti in bruhanja, ki se pojavita v dneh po zdravljenju z zdravili proti raku, ter na zdravljenje slabosti in bruhanja po operaciji, izključno kadar druge možnosti zdravljenja niso učinkovite ali pa jih ni mogoče uporabiti.
• Given very rare reports of serious cardiovascular reactions associated with metoclopramide, particularly via the intravenous route, special care should be taken in populations likely to be at increased risk, including the elderly, patients with cardiac conduction disturbances, uncorrected electrolyte imbalance or bradycardia, and those taking other drugs known to prolong QT interval.
• Zaradi zelo redkih resnih srčno-žilnih neželenih učinkov, povezanih z metoklopramidom, o katerih so poročali predvsem pri intravenski uporabi, je potrebna posebna previdnost pri populacijah, pri katerih bi lahko obstajalo povečano tveganje, vključno pri starejših, bolnikih z motnjami srčne prevodnosti, nezdravljenim neravnovesjem elektrolitov ali bradikardijo in tistih, ki jemljejo druga zdravila, ki podaljšajo interval QT.
• In adults, metoclopramide remains indicated for prevention of post-operative nausea and vomiting (PONV), radiotherapy-induced nausea and vomiting and delayed (but not acute) chemotherapyinduced nausea and vomiting, and for symptomatic treatment of nausea and vomiting including that associated with acute migraine (where it may also be used to improve absorption of oral analgesics).
• Pri odraslih je metoklopramid še naprej indiciran za preprečevanje slabosti in bruhanja po operaciji, slabosti in bruhanja zaradi radioterapije ter zapoznele (vendar ne akutne) slabosti in bruhanja zaradi kemoterapije ter za simptomatsko zdravljenje slabosti in bruhanja, vključno s slabostjo in bruhanjem zaradi akutne migrene (pri tem se lahko uporablja tudi za izboljšanje absorpcije peroralnih analgetikov).
Metoclopramide-containing medicines have been authorised separately in individual Member States of the EU, with differing licensed indications such as nausea and vomiting of various causes (for example after treatment with anticancer chemotherapy or radiotherapy, after surgery, or associated with migraine) and gastrointestinal motility disorders (conditions in which the normal passage of food through the gut is delayed).
Zdravila, ki vsebujejo metoklopramid, so bila v posameznih državah članicah EU odobrena ločeno in za različne indikacije, kot so na primer slabost in bruhanje zaradi različnih vzrokov (na primer po kemoterapiji ali radioterapiji za zdravljenje raka, po operaciji ali v povezavi z migreno) ter motnje gibljivosti prebavil (bolezni, pri katerih hrana počasneje prehaja skozi črevo kot običajno).