natgillin/translations-raw huggingface dataset:
The efficacy in symptomatic relief of pain in osteoarthritis, of the existing alternatives, NSAIDs and paracetamol, is of similar magnitude as glucosamine (e. g. ref. review by Bjordal).
Bjordalov pregled).
6 Dose selection in this bibliographical application is made from experience from other related glucosamine products and the dose and posology chosen is the same as used in almost all performed studies.
Izbira odmerka v tej bibliografski vlogi je temeljila na izkušnjah iz drugih sorodnih glukozaminskih zdravil, izbrana odmerek in način odmerjanja pa sta bila enaka kot v skoraj vseh ostalih opravljenih raziskavah.
Therefore, a general caution was proposed to be included in the SPC.
6 Formalne raziskave medsebojnega delovanja med zdravili, ki vsebujejo glukozamin, niso bile izvedene, zaradi česar je predlagano, da se v SPC vključi splošno opozorilo.
- Whereas
- Ob upoštevanju naslednjega:
The scope of the referral was to discuss the benefit/ risk of glucosamine hydrochloride in the proposed indication The Summary of Products Characteristic, labelling and package leaflet proposed by the applicant has been assessed based on the documentation submitted and the scientific discussion within the Committee.
Namen napotitvenega postopka je bil razpravljati o razmerju med koristmi in tveganji glukozamin hidroklorida za predlagano indikacijo, Povzetek glavnih značilnosti zdravila, označevanje in Navodila za uporabo, ki jih je predlagal vlagatelj, so bili ovrednoteni na podlagi predložene dokumentacije in znanstvene razprave znotraj Odbora.
the CHMP has recommended by majority the granting of the Marketing Authorisation of Glucomed and associated names for the following indication: “ relief of symptoms in mild to moderate osteoarthritis of the knee”.
„ lajšanje simptomov blagega do zmernega osteoartritisa kolena “.
This SPC, labelling and package leaflet is the version that was annexed to the Commission Decision on this Article 29 referral for glucosamine hydrochloride containing medicinal products.
Ta Povzetek glavnih značilnosti zdravila, označevanje in navodila za uporabo so bili priloženi k odločbi Komisije v zvezi z napotitvenim postopkom, ki je bil sprožen v skladu z členom 29, za zdravila, ki vsebujejo glukozaminijevega klorida.
Glucomed and associated names (see Annex I) 625 mg tablets
Glucomed in povezana imena (Glejte Dodatek I) 625 mg tablete
Each tablet contains 625 mg of glucosamine (as glucosamine hydrochloride).
Vsaka tableta vsebuje 625 mg glukozamina (v obliki glukozaminijevega klorida).
For a full list of excipients, see section 6.1
Za celoten seznam pomožnih snovi glejte poglavje 6. 1
White to light beige, oval tablet marked with “ G” and a score line.
Bela do rahlo bež, ovalna tableta označena s črko “ G ” in razdelilno zarezo.
If no relief of symptoms is experienced after 2-3 months, continued treatment with glucosamine should be re-evaluated.
Če olajšanje bolečine ne nastopi po 2- 3 mesecih zdravljenja, je potrebno nadaljnje zdravljenje z glukozaminom ponovno ovrednotiti.
Children and Adolescents Glucomed is not recommended for use in children and adolescents below the age of 18, due to lack of data on safety and efficacy.
Otroci in mladostniki Zaradi pomanjkanja podatkov o varnosti in učinkovitosti uporaba zdravila Glucomed pri otrocih in mladostnikih pod 18 let ni priporočljiva.
Elderly No specific studies have been performed in the elderly, but according to clinical experience dosage adjustment is not required when treating otherwise healthy, elderly patients.
Starejši bolniki Pri starejših ljudeh niso bile opravljene posebne študije, vendar v skladu z dosedanjimi kliničnimi izkušnjami prilagajanje odmerkov pri starejših, sicer zdravih ljudeh, ni potrebno.
Impaired renal and/ or liver function In patients with impaired renal and/ or liver function no dose recommendations can be given, since no studies have been performed.
Bolniki z okvarjeno ledvično in jetrno funkcijo Pri bolnikih z okvarjeno ledvično ali jetrno funkcijo ali obojim niso bile opravljene posebne študije, zato pri tej skupini bolnikov ni posebnih priporočil glede odmerjanja.
9 Glucomed must not be given to patients who are allergic to shellfish as the active substance is obtained from shellfish.
10 Glucomed se ne sme dajati bolnikom, ki so alergični na lupinarje (školjke, polže ali rake), saj je učinkovina pridobljena iz lupinarjev.
In patients with a known risk factor for cardiovascular disease, monitoring of the blood lipid levels is recommended, since hypercholesterolemia has been observed in a few cases in patients treated with glucosamine.
Pri bolnikih z znanim tveganjem za srčno- žilne bolezni je priporočljivo spremljanje koncentracije lipidov v krvi, ker je bila hiperholesterolemija opažena v nekaj primerih pri bolnikih, ki so se zdravili z glukozaminom.
4.5 Interaction with other medicinal products and other forms of interaction Data on possible drug interactions with glucosamine is limited, but increased INR with coumarin anticoagulants (warfarin and acenocoumarol) has been reported.
4. 5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Podatki o možnem medsebojnem delovanju glukozamina in ostalih zdravil so omejeni, vendar so poročali o povečanem INR ob sočasni uporabi kumarinskih antikoagulantov (varfarin in acenokumarol).
Pregnancy There is no adequate data from the use of glucosamine in pregnant women.
Nosečnost Ni ustreznih podatkov o uporabi glukozamina pri nosečnicah.
Breast Feeding There is no data available on the excretion of glucosamine in human milk.
Dojenje Ni podatkov o izločanju glukozamina v humano mleko.
10 System Organ Class
11 Organski sistem Bolezni živčevja
Common (≥ 1/ 100 to < 1/ 10) Headache
Pogosto (≥1/ 100 do < 1/ 10) Glavobol
Uncommon (≥ 1/ 1,000 to < 1/ 100)
Občasno (≥1/ 1. 000 do < 1/ 100) -
Rare (≥ 1/ 10,000 to < 1/ 1000)
Redko (≥ 1/ 10. 000 do < 1/ 1. 000)
Tiredness Nausea
Utrujenost Slabost
Abdominal pain
Presnovne in prehranske motnje
Gastrointestinal disorders Skin and subcutaneous tissue
Abdominalna bolečina Slaba prebava Driska Zaprtje
Indigestion Diarrhoea Constipation
- Izpuščaj
Itching Flushing
Srbenje Pordelost kože
ATC code:
Druga nesteroidna protivnetna in protirevmatična zdravila, nesteroidna protivnetna zdravila ATC oznaka:
D-glucosamine has low acute toxicity.
D- glukozamin ima nizko akutno toksičnost.
11 Results from in vitro studies and in vivo studies in animals have shown that glucosamine reduces insulin secretion and induces insulin resistance, probably via glucokinase inhibition in the beta cells.
12 Podatki iz in vitro ter in vivo študij na živalih kažejo, da glukozamin zavira izločanje inzulina ter povzroča odpornost na inzulin, verjetno preko zaviranja glukokinaze v beta celicah.
Microcrystalline cellulose Hydroxypropyl cellulose Low substituted hydroxypropyl cellulose (L-HPC) Magnesium stearate
Mikrokristalna celuloza Hidroksipropilceluloza Delno substituirana hidroksipropilceluloza (L- HPC) Magnezijev stearat
PVC/ PVDC-aluminium blisters packed in paper cartons.
PVC/ PVDC- pretisni omoti iz aluminija pakirani v papirnate škatle.
Pack-sizes of 40, 60 or 180 tablets.
40, 60 ali 180 tablet.
HDPE tablet container with a silica gel desiccant in paper bags.
HDPE vsebnik za tablete s sušilnim sredstvom silikagelom v papirnatih vrečkah.
Pack-sizes of 60 or 180 tablets.
60 ali 180 tablet.
14 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
14 OZNAČEVANJE
Glucomed and associated names (see Annex I) 625 mg tablets [See Annex I – To be completed nationally] glucosamine
Glucomed in povezana imena (Glejte Dodatek 1) 625 mg tablete [Glejte Dodatek I – Izpolni država članica] glukozamin
1 tablet contains:
1 tableta vsebuje:
625 mg of glucosamine (as glucosamine hydrochloride).
625 mg glukozamina (v obliki glukozaminijevega klorida).
60 tablets 180 tablets
60 tablet 180 tablet
METHOD AND ROUTE(S) OF ADMINISTRATION
POSTOPEK IN POT UPORABE
Y
Uporabno do:
Store below 30˚ C
Shranjujte pri temperaturi do 30˚C.
O. box 438, 1327 Lysaker, Norway
O. box 438, 1327 Lysaker, Norveška
[To be completed nationally]
ŠTEVILKA DOVOLJENJA ZA PROMET
[To be completed nationally]
Izdaja zdravila je le na recept.
16 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
17 PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI
Paper cartons for the blister
Papirnate škatle za pretisne omote
40 tablets 60 tablets 180 tablets
40 tablet 60 tablet 180 tablet
18 MINIMUM PARTICULARS TO APPEAR ON BLISTER OR STRIPS
19 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
Blister text
Pretisni omot
Glucomed and associated names (see Annex I) 625 mg tablets [See Annex I – To be completed nationally] glucosamine
Glucomed in povezana imena (Glejte Dodatek 1) 625 mg tablete [Glejte Dodatek I – Izpolni država članica]
EXP:
Uporabo do:
19 PACKAGE LEAFLET
DRUGI PODATKI
INFORMATION FOR THE USER
21 NAVODILO ZA UPORABO
Glucomed and associated names 625 mg tablets [see Annex I – To be completed nationally]
Glucomed in povezana imena (Glejte Dodatek 1) 625 mg tablete [Glejte Dodatek I – Izpolni država članica]
What Glucomed is and what it is used for 2.
Kaj je zdravilo Glucomed in za kaj ga uporabljamo 2.
Before you take Glucomed 3.
Kaj morate vedeti, preden boste vzeli zdravilo Glucomed 3.
How to take Glucomed 4.
Kako jemati zdravilo Glucomed 4.
Possible side effects 5 How to store Glucomed 6.
Možni neželeni učinki 5 Shranjevanje zdravila Glucomed 6.
WHAT GLUCOMED IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO GLUCOMED IN ZA KAJ GA UPORABLJAMO
Glucomed belongs to the group of medicines called other anti-inflammatory and anti-rheumatic agents, non-steroids.
Glucomed spada v skupino zdravil, ki jih imenujemo druga protivnetna in protirevmatična zdravila, nesteroida zdravila.
Do not take Glucomed
Ne jemljite zdravila Glucomed
- if you are allergic (hypersensitive) to glucosamine or to any of the other ingredients of
- če ste alergični na (preobčutljivi za) glukozamin ali na katerokoli sestavino zdravila
Glucomed.
Glucomed.
- if you are allergic (hypersensitive) to shellfish, since glucosamine is manufactured from
- če ste alergični na (preobčutljivi za) lupinarje (školjke, polže, rake), ker je glukozamin
shellfish.
pridobljen iz lupinarjev.
Take special care with Glucomed
Bodite posebno pozorni pri uporabi zdravila Glucomed
- if you suffer from impaired glucose tolerance.
- če trpite zaradi okvarjene tolerance za glukozo.
More frequent controls of your blood glucose levels
Ob začetku zdravljenja z glukozaminom bo
may be necessary when starting treatment with glucosamine.
mogoče pri vas potrebna pogostejša kontrola koncentracij glukoze v krvi.
- if you have kidney or liver dysfunction, since no studies have been performed in such patients
Zaradi pomanjkanja študij pri takšnih bolnikih ni
dose recommendations cannot be given.
posebnih priporočil za odmerjanje.
- If you have a known risk factor for cardiovascular disease, since hypercholesterolemia has been
- če imate znan dejavnik tveganja za srčno- žilno bolezen, ker je bila pri nekaj bolnikih, ki so se
observed in a few cases in patients treated with glucosamine.
zdravili z glukozaminom, opažena hiperholesterolemija.
worsening of symptoms.
Morate se zavedati, da se simptomi lahko poslabšajo ob pričetku zdravljenja.
Taking other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines including medicines obtained without a prescription.
Uporaba drugih zdravil Obvestite svojega zdravnika ali farmacevta, če jemljete ali ste pred kratkim jemali katerokoli zdravilo, tudi če ste ga dobili brez recepta.
21 Taking Glucomed with food and drink You can take the tablets with or without food.
22 Uporaba zdravila skupaj s hrano in pijačo Zdravilo lahko zaužijete skupaj s hrano ali brez nje.
Pregnancy and breast-feeding
Nosečnost in dojenje Zdravila Glucomed se med nosečnostjo ne sme uporabljati.
Glucomed should not be used during pregnancy.
Uporaba glukozamina med dojenjem ni priporočljiva.
The use of glucosamine during breastfeeding is not recommended Ask your doctor or pharmacist for advice before taking any medicine.
Posvetujte se z zdravnikom ali s farmacevtom, preden vzamete katerokoli zdravilo.
The usual starting dose is 2 tablets (1250 mg glucosamine) once daily.
Običajen začetni odmerek je 2 tableti (1250 mg glukozamina) enkrat na dan.
If no relief of symptoms is experienced after 2-3 months, continued treatment with glucosamine should be re-evaluated.
Če olajšanje bolečine ne nastopi po 2- 3 mesecih zdravljenja, je potrebno nadaljnje zdravljenje z glukozaminom ponovno ovrednotiti
If you take more Glucomed than you should If you have taken large quantities you must consult your doctor or a hospital.
Če ste vzeli večji odmerek zdravila Glucomed, kot bi smeli Če ste zaužili velike količine zdravila, se morate posvetovati z vašim zdravnikom ali pokličite v bolnišnico.
If you forget to take Glucomed Do not take a double dose to make up for a forgotten dose.
Če ste pozabili vzeti zdravilo Glucomed Ne vzemite dvojnega odmerka, če ste pozabili vzeti prejšnji odmerek.
If you stop taking Glucomed Your symptoms may reoccur.
Če ste prenehali jemati zdravilo Glucomed Vaši simptomi se lahko ponovno pojavijo.
Common (≥ 1/ 100 to < 1/ 10): headache, tiredness, nausea, abdominal pain, indigestion, diarrhoea, constipation.
Pogosto (≥1/ 100 do < 1/ 10): glavobol, utrujenost, slabost, bolečina v trebuhu slaba prebava, driska, zaprtje.
Uncommon (≥ 1/ 1,000 to < 1/ 100): rash, itching, flushing.
Občasno (≥1/ 1. 000 do < 1/ 100): izpuščaj, srbenje, pordelost kože.
Do not use Glucomed after the expiry date which is stated on the blister/ carton or tablet container.
Zdravila Glucomed ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na ovojnini.
Keep the bottle or blister tightly closed.
Stekleničko ali pretisni omot shranjujte tesno zaprt.
Store below 30˚ C.
Shranjujte pri temperaturi do 30˚C.
What Glucomed contains
Kaj vsebuje zdravilo Glucomed
- The active substance is glucosamine.
- Zdravilna učinkovina je glukozamin.
Each tablet contains 625 mg of glucosamine (as glucosamine
Vsaka tableta vsebuje 625 mg glukozamina (v obliki
hydrochloride)
glukozaminijevega klorida)
- The other ingredients are microcrystalline cellulose, hydroxypropyl cellulose, low substituted
- Pomožne snovi so mikrokristalna celuloza, hidroksipropilceluloza, delno substituirana
hydroxypropyl cellulose (L-HPC) and magnesium stearate.
hidroksipropilceluloza (L- HPC) in magnezijev stearat.
What Glucomed looks like and content of the pack Glucomed is a white to light beige, oval tablet marked with “ G” and a score line.
Izgled zdravila Glucomed in vsebina pakiranja Glucomed je bela do rahlo bež, ovalna tableta označena s črko “ G ” in razdelilno zarezo.
PVC/ PVDC-aluminium blisters packed in paper cartons.
PVC/ PVDC- pretisni omoti iz aluminija pakirani v papirnatih škatlah.
Navamedic ASA Vollsveien 13 C, P. O. box 438, 1327 Lysaker, Norway
Navamedic ASA Vollsveien 13 C, P. O. box 438, 1327 Lysaker, Norveška
O. box 9113, Grønland, 0133 Oslo, Norway
O. box 9113, Grønland, 0133 Oslo, Norveška
Glucomed Glucomed Glucomed [To be completed nationally] Glucomed Glucomed Flexove
Avstrija Belgija Ciper Češka Danska Estonija Finska Francija Nemčija Grčija Madžarska
Glucomed Flexove Glucomed Glucomed Glucomed Glucomed Glucomed Flexove Glucomed Glucomed Glucomed Glucomed Glucomed [To be completed nationally]
Flexove Flexove Glucomed Flexove Glucomed Glucomed Glucomed [izpolni država članica] Glucomed Glucomed Flexove
London, 13 December 2006 EMEA/ 405628/ 2006
London, 13. december 2006 EMEA/ 405628/ 2006
OPINION FOLLOWING AN ARTICLE 29(4)1 REFERRAL FOR Glucomed and associated names International Non-Proprietary Name (INN): glucosamine hydrochloride
MNENJE V ZVEZI Z NAPOTITVIJO IZ ČLENA 29( 4) 1 za Glucomed in z njim povezana imena Mednarodno nelastniško ime (INN): glukozaminijev hidroklorid
Glucosamine was mainly introduced on the world-wide market as a food- supplement but with the aim to improve symptoms in patients with osteoarthritis or joint pain or function.
Glukozamin so začeli tržiti po vsem svetu kot prehransko dopolnilo, vendar z namenom lajšanja simptomov pri bolnikih z osteoartritisom ali bolečin v sklepih ali z namenom izboljšanja funkcije sklepov.
The applicant was asked to demonstrate efficacy of glucosamine in the intended indication “ relief of symptoms in mild to moderate osteoarthritis of the knee”.
Od predlagatelja so zahtevali, da dokaže učinkovitost glukozamina pri predvideni indikaciji “ lajšanje simptomov blagega do zmernega osteoartritisa kolena ”.
In addition the applicant was asked to justify the proposed dose and posology, to characterise the safety profile, including a discussion of reported adverse drug reactions, to justify the relevance of literature considering that the formulations of glucosamine sulphate (as the sodium chloride complex) used in the cited literature differ from the concerned application formulation and whether the differences in formulation will alter the efficacy and safety of the product, to elucidate the possibility of interactions with other medicinal products, and finally to show a positive risk/ benefit profile of glucosamine hydrochloride in the intended indication.
Poleg tega so predlagatelja tudi zaprosili, da utemelji predlagani odmerek in način odmerjanja, opredeli varnostni profil zdravila, vključno z razpravo o opaženih neželenih učinkih zdravila, utemelji relevantnost literature, ker formulacije glukozaminijevega sulfata (v obliki kompleksa z natrijevim kloridom), uporabljene v citirani literaturi, niso enake zadevni formulaciji za uporabo zdravila ter navede, ali bodo razlike v formulaciji vplivale na učinkovitost in varnost zdravila, opredeli možnost interakcij z drugimi zdravili in končno tudi dokaže pozitivno razmerje med koristmi in tveganji uporabe glukozaminijevega hidroklorida pri predvideni indikaciji.
Salmonson and the Co-Rapporteur was Dr Abadie.
Abadie.
During their September 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 Glucomed and associated names for the relief of symptoms in mild to moderate osteoarthritis of the knee, that there was no objection for the granting of a Marketing Authorisation and that the Summary of Product Characteristics, labelling and package leaflet of the Reference Member State
Na sestanku v septembru 2006 je bil CHMP ob upoštevanju vseh predloženih podatkov in znanstvene razprave v okviru Odbora mnenja, da je razmerje med koristmi in tveganji za zdravilo Glucomed in z njim povezana imena za lajšanje simptomov blagega do zmernega osteoartritisa kolena ugodno, da ni nikakršnih zadržkov za izdajo dovoljenja za promet z zdravilom in da je treba Povzetek glavnih
(44-20) 74 18 84 00 Fax (44-20) 74 18 86 13 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2006 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged should be amended.
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 86 13 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2006 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged. značilnosti zdravila, označevanje in navodila za uporabo referenčne države članice dopolniti.
The scientific conclusions are provided in Annex II, together with the Summary of Product Characteristics, labelling and package leaflet in Annex III.
Seznam zadevnih imen tega zdravila je podan v Dodatku I, znanstveni zaključki pa v Dodatku II, skupaj s Povzetkom glavnih značilnosti zdravila, označevanjem in navodili za uporabo v Dodatku III.
LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCT, ROUTE OF ADMINISTRATION AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
SEZNAM IMEN, FARMACEVTSKA OBLIKA, JAKOST ZDRAVILA, NAČIN UPORABE IN IMETNIKI DOVOLJENJ ZA PROMET V DRŽAVAH ČLANICAH
1 Member State EU/ EEA
1 Država članica EU/ EGP
Applicant
Ime vlagateljevega
(Invented)
(Lastniško) ime
Pharmaceutical Form Route of administration
Način uporabe
Organon Kloosterstraat 6 PO Box 20 5349 AB, Oss The Netherlands
Organon Kloosterstraat 6 PO Box 20 5349 AB, Oss Nizozemska
Implant Subcutaneous use
subkutana uporaba
Organon Kloosterstraat 6 PO Box 20 5340 BH, Oss The Netherlands
Organon Kloosterstraat 6 PO Box 20 5340 BH, Oss Nizozemska
Organon SA Immeuble Optima 10, rue Godefroy 92821 Puteaux Cedex, France
Organon SA Immeuble Optima 10, rue Godefroy 92821 Puteaux Cedex, Francija
Essex Pharma GmbH Thomas-Dehler-Straße 27 81737 Munich Germany
Essex Pharma GmbH Thomas- Dehler- Straße 27 81737 Munich Nemčija
N. V.
Organon Ireland Ltd.
Organon Kloosterstraat 6 PO Box 20 5340 BH, Oss The Netherlands
Dublin Irska
68mg
68 mg implant
Implanon 68 mg implant 68mg
68 mg
Organon Laboratories Ltd Cambridge Science Park Milton Road Cambridge CB4 0FL United Kingdom
Organon Laboratories Ltd Cambridge Science Park Milton Road Cambridge CB4 0FL Združeno kraljestvo
Implanon 68 mg 68mg
Implanon
3
68 mg
Applicant
implantat
(Invented) Name
subkutana uporaba
José Malhoa, 16B - 2° 1070-159 Lisboa Portugal
José Malhoa, 16B - 2° 1070- 159 Lisboa Portugalska
Ctra. de Hospitalet, 147-149 Cityparc Ronda de Dalt Edificio Amsterdam 08940 Cornellá de Llobregat, Barcelona Spain
Ctra. de Hospitalet, 147- 149 Cityparc Ronda de Dalt Edificio Amsterdam 08940 Cornellá de Llobregat, Barcelona Španija
Organon PO Box 20 5340 BH, Oss The Netherlands
Organon PO Box 20 5340 BH, Oss Nizozemska
The implant is a single rod of 4 cm length and 2 mm in diameter and contains 68 mg etonogestrel (ENG) dispersed in a matrix of ethylene vinyl acetate (EVA) co-polymer.
Implantant je paličica, dolga štiri cm, s premerom dva mm, z 68 mg etonogestrela (ENG), ki je razpršen v matrici kopolimera etilen- vinil acetata (EVA).
The ENG dose released by Implanon is equivalent to 60-70 μ g/ day shortly after insertion and decreases to about 40 μ g/ day at the start of the second year, and to about 25-30 μ g/ day at the end of the 3rd year.
Odmerek ENG, ki ga sprosti zdravilo Implanon, je enak 60 – 70 μg/ dan kmalu po vstavku in se zmanjša na približno 40 μg/ dan na začetku drugega leta ter na približno 25– 30 μg/ dan na koncu tretjega leta.
Implanon was approved in the EU during a MR procedure with the Netherlands (NL) as reference member state (RMS) and has been marketed since 1998 with the indication “ contraception”.
Zdravilo Implanon je bilo odobreno v EU med postopkom za medsebojno priznavanje z Nizozemsko kot referenčno državo članico in se je tržil od leta 1998 z označbo „ kontracepcija “.
A second European renewal was initiated in September 2007, in which a majority of EU member states agreed that the benefit/ risk profile continues to be positive and supported the recommendation of the RMS to grant another 5-year renewal.
Druga obnovitev se je v Evropi začela septembra 2005, pri tem pa je večina držav članic EU potrdila, da je razmerje koristi/ tveganja še vedno pozitivno, ter podprla predlog referenčne države članice za odobritev 5- letne obnovitve.
The issue was referred to the CMD (h) and an assessment was carried out by the RMS.
Zadeva je bila posredovana skupini CMD( h), referenčna država članica pa je izvedla oceno.
It is crucial - and should be self evident - that anyone, who performs insertions/ removals must be well trained and familiar with those procedures, as incorrect insertions will lead to removal problems.
Ključnega pomena je, kar bi moralo biti samo po sebi umevno, da mora biti oseba, ki implantant vstavlja/ odstranjuje, primerno usposobljena in seznanjena s temi postopki, saj zaradi nepravilnega vstavljanja pri odstranitvi nastanejo težave.
The information already included in section 4.4 of the SPC is considered sufficient.
Informacije, ki so že vključene v poglavju 4. 4 Povzetka glavnih značilnostih zdravila, štejejo za zadostne.