natgillin/translations-raw huggingface dataset:
Common side effects (affects 1 to 10 users in 100) include: • vomiting, diarrhoea, constipation, stomach ache, bloated feeling, indigestion, loss of appetite • depression, difficulty in concentrating, excessive feeling of well being • increased sensitivity to sound and noise, blurred or double vision • low blood pressure, flushing/ feeling hot, slow shallow breathing, feeling weak, feeling faint, reduced sensitivity to touch, numbness or tingling • runny or blocked nose, dry mouth, sore throat, itching of the skin, skin rash, irritation under the tongue
Pogosti neželeni učinki (prizadenejo 1 do 10 bolnikov na 100) so: • bruhanje, driska, zaprtost, bolečine v želodcu, občutek napihnjenosti, slaba prebava, izguba apetita • depresija, težave s koncentracijo, pretirana dobra volja • povečana občutljivost za zvoke in za hrup, zabrisan ali dvojen vid • nizek krvni tlak, vročinski vali / zardevanje, počasno in plitko dihanje, občutek slabosti in omedlevice, zmanjšana občutljivost za dotik, odrevenelost ali ščemenje • izcedek iz nosu ali zamašen nos, suha usta, boleče grlo, srbeča koža, kožni spuščaj, razdraženost pod jezikom
Other known side effects associated with fentanyl products include: • Very common side effects (affects more than 1 user in 10 people): excessive sweating • Common side effects (affects 1 to 10 users in 100): feeling confused, feeling anxious or nervous, hallucinations, abnormal thinking, muscle twitching, difficulty sleeping, strange dreams, tongue or taste problems, flushing, mouth ulcers/ blisters, blockage of the gut, difficulty swallowing, being accident-prone • Uncommon side effects (affects 1 to 10 users in 1,000): feeling restless, feeling detached, moodswings, trembling, difficulty speaking, being forgetful, loss of coordination, vertigo, slow or fast heartbeat, high blood pressure, difficulty breathing, slow or shallow breathing, asthma, bloating, wind, thirst, difficulty going to the toilet, change in frequency of going to the toilet, feeling unwell • Rare side effects (affects 1 to 10 users in 10,000): hiccups • Very rare side effects (affects less than 1 user in 10,000): irregular heartbeat, stopping breathing, blood in the saliva, decrease in amount of urine, painful contraction of the bladder
Drugi znani neželeni učinki, ki so povezani z zdravili na osnovi fentanila, so: • Zelo pogosti neželeni učinki (prizadenejo več kot 1 bolnika na 10): pretirano potenje • Pogosti neželeni učinki (prizadenejo 1 do 10 bolnikov na 100): zmedenost, strah, nervoznost, halucinacije, nenormalne misli, trzajoče mišice, težave s spanjem, čudne sanje, težave z jezikom ali okusom, vročinski valovi, rane/ mehurji v ustih, blokada črevesja, težave pri požiranju, nagnjenost k nezgodam • Občasni neželeni učinki (prizadenejo 1 do 10 bolnikov na 1. 000): nemir, občutek odtujenosti, nihajoče razpoloženje, trepetanje, težave pri govoru, pozabljivost, izguba koordinacije, vrtoglavica, počasen ali hiter srčni utrip, visok krvni tlak, težave pri dihanju, počasno ali plitko dihanje, astma, napihnjenost, vetrovi, žeja, težave pri opravljanju potrebe, spremembe v pogostnosti opravljanja potrebe, slabo počutje • Redki neželeni učinki (prizadenejo 1 do 10 bolnikov na 10. 000): kolcanje • Zelo redki neželeni učinki (prizadenejo manj kot 1 bolnika na 10. 000): nereden srčni utrip, prenehanje dihanja, kri v slini, zmanjšana količina urina, boleče krčenje mehurja
HOW TO STORE RAPINYL
SHRANJEVANJE ZDRAVILA RAPINYL
The pain-relieving medicine in Rapinyl is very strong and could be life-threatening if taken accidentally by a child.
Učinkovina za lajšanje bolečin v zdravilu Rapinyl je zelo močna in lahko ogrozi življenje, če ga po nesreči vzame otrok.
Rapinyl must be kept out of the reach and sight of children.
Rapinyl shranjujte nedosegljivo otrokom.
The active substance is fentanyl.
Ena podjezična tableta vsebuje:
One sublingual tablet contains 50 micrograms fentanyl (as citrate) 100 micrograms fentanyl (as citrate) 200 micrograms fentanyl (as citrate) 300 micrograms fentanyl (as citrate) 400 micrograms fentanyl (as citrate) 600 micrograms fentanyl (as citrate) 800 micrograms fentanyl (as citrate)
50 mikrogramov fentanila v obliki fentanilijevega citrata 100 mikrogramov fentanila v obliki fentanilijevega citrata 200 mikrogramov fentanila v obliki fentanilijevega citrata 300 mikrogramov fentanila v obliki fentanilijevega citrata 400 mikrogramov fentanila v obliki fentanilijevega citrata 600 mikrogramov fentanila v obliki fentanilijevega citrata 800 mikrogramov fentanila v obliki fentanilijevega citrata
The 50 microgram tablet is a white pentagon-shaped tablet.
400 mikrogramska Podjezična tableta je bela tableta v obliki romba.
The 100 microgram tablet is a white round tablet The 200 microgram tablet is a white oval-shaped tablet The 300 microgram tablet is a white triangle-shaped tablet The 400 microgram tablet is a white diamond-shaped tablet The 600 microgram tablet is a white “ D” -shaped tablet The 800 microgram tablet is a white capsule-shaped tablet
800 mikrogramska Podjezična tableta je bela tableta v obliki kapsule.
[See Annex I - To be completed nationally] {Name and address }< {tel }> < {fax }> < {e-mail }>
Imetnik dovoljenja za promet: < [Glejte Dodatek I - Izpolni država članica] > {Name and address} < {tel.} > < {fax} > < {e- mail} >
Recip AB Lagervägen 7 136 50 Haninge Sweden Tel. +46 8 6025200
41 Proizvajalec Recip AB Lagervägen 7 136 50 Haninge Švedska Tel. +370 5 260 39 26 +46 8 6025200
This leaflet was last approved in {MM/ YYYY}.
Navodilo je bilo nazadnje odobreno {MM/ YYYY}.
38 ANNEX IV
42 DODATEK IV
39 The National Competent Authorities, coordinated by the Reference Member State, shall ensure that the following conditions are fulfilled by the Marketing Authorisation Holders:
43 Pristojni nacionalni organi, katerih delovanje bo usklajevala referenčna država članica, morajo zagotoviti, da imetnik dovoljenja za promet z zdravilom izpolni naslednje pogoje:
The Applicant commits to provide the following information to the National Competent Authority of the Reference Member State:
Predlagatelj se obveže, da bo pristojnemu nacionalnemu organu referenčne države članice zagotovil naslednje informacije:
Analysis of the 30% and 50% responder rates at 10 and 15 minutes for the study EN-3267- 005,
Analizo 30% in 50% odzivnostne stopnje pri 10 in 15 minutah, iz študije EN- 3267- 005, o
Final results of studies EN3267-005 and 3267-007, including detailed exposure of patients and full safety analysis.
Končne rezultate študije EN3267- 005 in 3267- 007, vključno z natančno izpostavljenostjo o bolnikov in celovito analizo o varnosti.
London, 12 September 2008 EMEA/ CHMP/ 495857/ 2008
London, 12. september 2008 EMEA/ CHMP/ 495855/ 2008
OPINION FOLLOWING AN ARTICLE 29(4)1 REFERRAL FOR
MNENJE V ZVEZI Z NAPOTITVIJO V SKLADU S ČLENOM 29( 4) 1 ZA ZDRAVILO
The Decentralised Procedure, SE/ H/ 575/ 07/ DC, started on 1 September 2006.
Decentralizirani postopek SE/ H/ 575/ 07/ DC se je začel 1. septembra 2006.
Significant difference has been identified with regard to the need for further clinical efficacy and safety data for the evaluation of the benefit/ risk and the lack of PK data under normal conditions of use of the product.
Pomembne razlike so bile ugotovljene v zvezi s potrebo po nadaljnjih podatkih o klinični učinkovitosti in varnosti za oceno koristi/ tveganj ter s pomanjkanjem podatkov o farmakokinetiki v normalnih okoliščinah uporabe zdravila.
The arbitration procedure started on 18 October 2007 with the adoption of a list of questions.
Poročevalec je bil dr.
During their June 2008 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 Rapinyl and associated names, that the objections raised by Germany, France, Norway and 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.
Med srečanjem junija 2008 je CHMP na podlagi vseh predloženih podatkov in znanstvene razprave v okviru Odbora predstavil svoje mnenje, da je razmerje med koristmi ter tveganji za zdravilo Rapinyl in povezana imena ugodno ter da ugovori, ki so jih podali Nemčija, Francija, Norveška in Združeno kraljestvo, ne smejo preprečiti odobritve dovoljenja za promet z zdravilom, pa tudi da je treba povzetek glavnih značilnosti zdravila, označevanje in navodila za uporabo referenčne države članice spremeniti.
LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTES OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVILA, POTI UPORABE ZDRAVILA, IMETNIKOV DOVOLJENJA ZA PROMET Z ZDRAVILOM V DRŽAVAH ČLANICAH
Marketing Authorisation INN Holder
Imetnik dovoljenja za promet
Mirtazapine Mirtazapine Mirtazapine Mirtazapine Mirtazapine
Mirtazapine
Film-coated tablets Film-coated tablets Film-coated tablets Orodispersible tablets Orodispersible tablets
5349AB Oss, The Netherlands
Oral use Oral use Oral use Oral use Oral use
Filmsko obložene tablete
Orodispersible tablets
Filmsko obložene tablete
Mirtazapine
Mirtazapine Remergon SolTab 15 mg
Box 20, 5340 BH Oss, The Netherlands
Box
Film-coated tablets Film-coated tablets Film-coated tablets Orodispersible tablets
Filmsko obložene tablete
REMERON SOLTAB 45 MG
45 mg
Orodispersible tablets Orodispersible tablets Orodispersible tablets
Orodisperzibilne tablete
Oral use Oral use Oral use
DK - 2740 Skovlunde, Denmark
Film-coated tablets
Peroralna uporaba
Mirtazapine Mirtazapine Mirtazapine
Mirtazapine Remeron
Film-coated tablets Film-coated tablets Film-coated tablets
Filmsko obložene tablete
Oral use Oral use Oral use
Imetnik dovoljenja za promet
The Netherlands
Izmišljeno ime
Oral use
Mirtazapine
Orodispersible tablets Orodispersible tablets
Orodisperzibilne tablete
Mirtazapine Mirtazapine
Peroralna uporaba
Film-coated tablets Film-coated tablets
Filmsko obložene tablete
Oy Organon Ab
Mirtazapine Remeron
Mirtazapine Mirtazapine
Filmsko obložene tablete
Remeron Mirtazon
Mirtazapine Remeron
Oral Solution Film-coated tablets
Perorala raztopina
3 Member State
Oy Organon Ab Maistraatinportti 2
Marketing Authorisation INN Holder
Mirtazapine Mirtazon
Invented Name
Filmsko obložene tablete
Strength
Peroralna uporaba
Pharmaceutical Form
00240 Helsinki, Finland
Content (concentration)
Orodisperzibilne tablete
Maistraatinportti 2 00240 Helsinki, Finland
Peroralna uporaba
Mirtazapine Mirtazapine Mirtazapine
Mirtazapine Mirtazon Smelt
Norset Norset Norset
Peroralna uporaba
15 mg 30 mg 15 mg
4 Država članica
Film-coated tablets Film-coated tablets Orodispersible tablets
Imetnik dovoljenja za promet
Oral use Oral use Oral use
Vsebina (koncentracija)
Oral solution
Perorala raztopina
4 Member State
Grčija
Invented Name
Mirtazapine
Strength
Remeron
Pharmaceutical Form
15 mg
Content (concentration)
Peroralna uporaba
Film-coated tablets Film-coated tablets Film-coated tablets
Imetnik dovoljenja za promet
Orodispersible tablets Orodispersible tablets Oral Solution
Orodisperzibilne tablete
Film-coated tablets Film-coated tablets Orodispersible tablets
Filmsko obložene tablete
Film-coated tablets
Filmsko
Remeron Remeron
Peroralna uporaba
Orodispersible tablets Orodispersible tablets
Mirtazapine Remeron 15 mg/ ml 15
Oral use Oral use
Izmišljeno ime
Mirtazapine Organon Laboratories Ltd, Mirtazapine Cambridge Science Park,
Organon Laboratories Ltd, Cambridge Science Park,
Remeron Zispin® tablets
Zispin® film - coated tablets
15 mg/ ml film-coated
15 mg
Oral Solution Film-coated tablets
Filmsko obložene tablete
orodispersible tablets
Orodisperzibilne tablete
Ireland
Peroralna uporaba
Remeron Remeron Remeron Mirtazapina Organon Mirtazapina Organon Mirtazapina Organon
Mirtazapine Remeron
15 mg 30 mg 45 mg 15 mg 30 mg 45 mg
45 mg
Orodispersible tablets Orodispersible tablets Orodispersible tablets Orodispersible tablets Orodispersible tablets Orodispersible tablets
7 Država članica
Oral use Oral use Oral use Oral use Oral use Oral use
Imetnik dovoljenja za promet
Latvia
INN
N. V.
Jakost
Organon, Kloosterstraat 6, P. O.
Farmacevtska oblika
Box 20, NL 5340 AB Oss,
Pot uporabe zdravila
Film-coated tablets Orodispersible tablets Orodispersible tablets
Orodisperzibilne tablete
Oral use Oral use Oral use
Orodisperzibilne tablete
The Netherlands
Peroralna uporaba
Film-coated tablets
Kloosterstraat 6, P. O.
Oral use
Filmsko
Marketing Authorisation INN Holder
Mirtazapine Remeron Sol Tab
Orodispersible tablets Orodispersible tablets
Filmsko obložene tablete
Oral use Oral use Oral use Oral use
Orodisperzibilne tablete
15 mg per tablet 30 mg per tablet 45 mg per tablet 15 mg per tablet
Peroralna uporaba
Orodispersible Tablets
Orodisperzibilne tablete
Norway
Filmsko
N. V.
Peroralna
30 mg per tablet 45 mg per tablet 15 mg per tablet
9 Država članica
Member State
Imetnik dovoljenja za promet
45 mg per tablet
Peroralna uporaba
30 mg per tablet
15 mg
Portugal
Peroralna uporaba
Organon Portuguesa Produtos Químicos e Farmacêuticos, Lda Av.
Farmacêuticos, Lda Av.
José Malhoa, 16-B -2º
José Malhoa, 16- B - 2º
Mirtazapina Organon Mirtazapina Organon Remeron
Mirtazapina Organon
1070-159 Lisboa
1070- 159 Lisboa Portugal
Remeron SolTab
Remeron
30 mg 45 mg 15 mg/ ml
15 mg
990 mg/ 66 ml
Peroralna uporaba
Mirtazon Mirtazon Mirtazon
Remeron SolTab
Box
Peroralna uporaba
Remeron SolTab 15 15 mg mg
Remeron SolTab
Oral use
Orodisperzibilne tablete
20, 5340 BH Oss,
Peroralna uporaba
Remeron SolTab 30 30 mg mg
Remeron
Orodispersible tablets
15 mg/ ml
Oral use
Perorala
8 Member State
Peroralna
Marketing Authorisation INN Holder
990 mg/ 66 ml
Invented Name
raztopina
Strength
uporaba
Pharmaceutical Form
Aacifar Produtos Químicos e
Route of administration
Orodisperzibilne tablete
The Netherlands
José Malhoa, 16- B - 2º
Remeron mg
30 mg
SolTab 45
Peroralna uporaba
45 mg
10 Država članica
Orodispersible tablets
Imetnik dovoljenja za promet
Oral use
INN
Box 20, 5340 BH Oss,
Pot uporabe zdravila
Mirtazapine Mirtazapine Mirtazapine
Vsebina (koncentracija)
REMERON REMERON REMERON
1070- 159 Lisboa Portugal
15 mg 30 mg 45 mg
Mirtazapine Mirtazon
Film-coated tablets Film-coated tablets Film-coated tablets
Orodisperzibilne tablete
REMERON 15 mg
15 mg
Soltab
Peroralna
Orodispersible tablets
tablete
REMERON 30 mg
Remeron 30 mg
Soltab
SolTab
REMERON 45 mg
Mirtazapine
45 mg
Remeron 45 mg REMERON
15 mg
SolTab 15 mg
Llobregat Barcelona, Spain N. V.
Slovaška Republika
Orodispersible tablets Orodispersible tablets Oral solution Orodispersible tablets Orodispersible tablets Orodispersible tablets
30 mg
Box 20, NL - 5340 BH Oss, The Netherlands
The Netherlands
Remeron Remeron Remeron
REMERON
Tablets Tablets Tablets
Filmsko obložene tablete
Remeron Remeron-S
REMERON Soltab 15 mg
15 mg/ ml 15 mg
15 mg
Oral solution Orodispersible tablets
Orodisperzibilne tablete
9 Member State
REMERON Soltab 30 mg
Marketing Authorisation INN Holder
Orodisperzibilne tablete
Invented Name
Peroralna uporaba
Pharmaceutical Form
REMERON Soltab 45 mg
Content (concentration)
Ctra.
Remeron-S Remeron-S Mirtazapin Imi Pharma
Rexer
Orodispersible tablets Orodispersible tablets Tablets
Filmsko obložene tablete
Tablets
Filmsko obložene tablete
Mirtazapine
08940 Cornellá de Llobregat Barcelona,
MirtazapinImi Pharma
Mirtazapine Rexer
United Kingdom
Spain
Mirtazapine
Mirtazapine Rexer Flas
Film-coated tablets
Orodisperzibilne tablete
Milton Road, Cambridge, CB4 0FL
Peroralna uporaba
Film-coated tablets
11 Država članica
United Kingdom
Pot uporabe zdravila
Zispin SolTab 15mg orodispersible tablet
Mirtazapina Organon
Oral use
20, 5340 BH Oss,
Zispin SolTab 45mg orodispersible tablet
Mirtazapina Organon
45 mg per tablet
Švedska
11 SCIENTIFIC CONCLUSIONS
Box
Remeron tablets 15, 30 and 45 mg Remeron orodispersible tablets 15, 30 and 45 mg Remeron oral solution 15 mg/ ml
Remeron
The SPC proposals by the company were mainly based upon this MRP.
15 mg
SPC Section 4.1 Therapeutic Indications
Filmsko obložene tablete
This proposal was adopted by the applicant/ MAH and the issue was resolved.
Peroralna uporaba
SPC Section 4.2 Posology and Method of Administration
20, 5340 BH Oss,
Additionally, the CHMP considered that the clearance of mirtazapine may be decreased in patients with moderate to severe renal impairment (creatinine clearance < 40 ml/ min).
Remeron
This FDA Guidance was superseded in 1998.
Filmsko obložene tablete
SPC Section 4.3 Contraindications
Peroralna uporaba
The amount of phenylalanine is low in Remeron orodispersible tablets.
The Netherlands
The CHMP considered that the explanations provided appear scientifically sound and justified, noting that the aspartame content of the product is adequately addressed in the proposed form
Mirtazapine
MAO-inhibitors are therefore relatively contra-indicated with Remeron.
Remeron
13 The CHMP considered that a contraindication is acceptable, given the marginal influence on noradrenaline and serotonin levels and the post-marketing experience available to date.
45 mg
SPC Section 4.5 Special Warnings and precautions for use
Filmsko obložene tablete
The low number of post-marketing reports does not justify this either.
Peroralna uporaba
As a conclusion to the discussion, the following text was subsequently agreed between the CHMP and the applicant/ MAH to include the following: deletion of reference to section 4.3 for serotonin syndrome, deletion of “ other” and the addition of “ venlafaxine” in the text below.
Mirtazapine Remeron
Pharmacodynamic interactions Mirtazapine should not be administered concomitantly with MAO inhibitors or within two weeks after discontinuation of MAO inhibitor therapy.
15 mg/ ml
Pharmacodynamic interactions
Peroralna raztopina
after discontinuation of MAO inhibitor therapy.
Peroralna uporaba
- In addition, as with SSRIs, co-administration with other serotonergic active substances (L-
990 mg/ 66 ml
tryptophan, triptans, tramadol, linezolid, SSRIs, venlafaxine, lithium and St.
Mirtazapine Remeron- S
- Mirtazapine may increase the sedating properties of benzodiazepines and other sedatives (notably
Orodisperzibilne tablete
most antipsychotics, antihistamine H1 antagonists, opioids).
Peroralna uporaba
- Mirtazapine may increase the CNS depressant effect of alcohol.
Mirtazapine Remeron- S
international normalized ratio (INR) in subjects treated with warfarin.
Orodisperzibilne tablete
Pharmacokinetic interactions.
Peroralna uporaba
Pharmacokinetic interactions
Mirtazapine Remeron- S
twofold, resulting in a decrease in average plasma mirtazapine concentration of 60% and 45%, respectively.
Orodisperzibilne tablete
- Co-administration of the potent CYP3A4 inhibitor ketoconazole increased the peak plasma
Peroralna uporaba
levels and the AUC of mirtazapine by approximately 40% and 50% respectively.
Mirtazapine Mirtazapin IP
- When cimetidine (weak inhibitor of CYP1A2, CYP2D6 and CYP3A4) is administered with
15 mg
mirtazapine, the mean plasma concentration of mirtazapin may increase more than 50%.
Filmsko obložene tablete
- No significant pharmacokinetic interactions are expected between mirtazapine and other
Peroralna uporaba
Mirtazapine does not significantly inhibit or induce CYP iso-enzymes.
Mirtazapine Mirtazapin IP
treatment of mirtazapine with paroxetine, amitriptyline, or risperidone or lithium.
Filmsko obložene tablete
SPC 4.8 Undesirable Effects
Peroralna uporaba
Accordingly hyponatraemia and SIADH are already described under 4.4 Special warnings.
Mirtazapine Mirtazapin IP
For consistency, the CHMP considered that these undesirable effects should also be stated under 4.8 (Undesirable Effects).
45 mg
This proposal was adopted by the applicant/ MAH and the issue was resolved.
Filmsko obložene tablete
Package Leaflet
Peroralna uporaba
The following amendments to the PIL were recommended, in line with the changes made to the SPC.
Organon Laboratories Ltd, Cambridge Science Park,
15 a.
Mirtazapine 15mg 15 mg Tablets
BEFORE YOU TAKE REMERON
Filmsko obložene tablete
Do not take Remeron while you are pregnant.
Peroralna uporaba
BEFORE YOU TAKE REMERON Take care when taking Remeron in combination with:
12 Država članica
If you get a combination of these symptoms, talk to your doctor immediately.
Imetnik dovoljenja za promet
The CHMP considered that the proposed wording under bullet point a and b were acceptable.
INN
GROUNDS FOR AMENDMENT OF THE SUMMARY(IES) OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET
Izmišljeno ime
- the scope of the referral was the harmonisation of the Summaries of Products Characteristics,
Pot uporabe zdravila
labelling, package leaflet and Module 3.
Vsebina (koncentracija)
- the Summaries of Products Characteristic, labelling, package leaflet and Module 3 proposed by the
Milton Road, Cambridge, CB4 0FL
Marketing Authorisation Holders have been assessed based on the documentation submitted and the scientific discussion within the Committee,
Mirtazapine
the CHMP has recommended the amendment of the Marketing Authorisations for which the Summary of Product Characteristics, labelling and package leaflet are set out in Annex III for Remeron and associated names (see Annex I).
Mirtazapine 30mg Tablets
16 ANNEX III
30 mg
SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET
Filmsko obložene tablete
17 SUMMARY OF PRODUCT CHARACTERISTICS
Peroralna uporaba
NAME OF THE MEDICINAL PRODUCT
United Kingdom
[See Annex I - To be completed nationally]
Mirtazapine 45mg Tablets
2.
45 mg
QUALITATIVE AND QUANTITATIVE COMPOSITION
Filmsko obložene tablete
Each Remeron 45 mg orodispersible tablet contains 45 mg of mirtazapine.
Peroralna uporaba
PHARMACEUTICAL FORM
Peroralna raztopina
Round, white, standard bevelled-edge, coded with ‘ TZ/ 4’ on one side.
Orodisperzibilne tablete
CLINICAL PARTICULARS
Peroralna uporaba
4.1 Therapeutic indications
13 DODATEK II
Treatment of episodes of major depression.
ZNANSTVENI ZAKLJUČKI IN PODLAGA, KI JIH JE PREDSTAVILA EVROPSKA AGENCIJA ZA ZDRAVILA
4.2 Posology and method of administration
14 ZNANSTVENI ZAKLJUČKI
Adults The effective daily dose is usually between 15 and 45 mg; the starting dose is 15 or 30 mg.
SPLOŠNI POVZETEK ZNANSTVENEGA VREDNOTENJA ZDRAVILA REMERON IN Z NJIM POVEZANIH IMEN (GLEJTE DODATEK I)
Mirtazapine begins to exert its effect in general after 1-2 weeks of treatment.
Zdravilo Remeron (mirtazapin) je bilo v skladu s členom 30 (1) Direktive 2001/ 83/ ES napoteno v postopek uskladitve povzetkov glavnih značilnosti zdravila.
Treatment with an adequate dose should result in a positive response within 2-4 weeks.
Mirtazapin je indiciran za stanje hude depresije.
If there is no response within a further 2-4 weeks, then treatment should be stopped.
Napotitev je vložil predlagatelj, s ciljem uskladiti glavna neskladja med državami članicami EU v zvezi s povzetki glavnih značilnosti zdravila, navodili za uporabo, označevanji in modulom 3 navedenih zdravil, ki vsebujejo zdravilno učinkovino mirtazapin:
In elderly patients an increase in dosing should be done under close supervision to elicit a satisfactory and safe response.
Remeron tablete 15, 30 in 45 mg Remeron orodisperzibilne tablete 15, 30 in 45 mg Remeron peroralna raztopina 15 mg/ ml
Children and adolescents under the age of 18 years Remeron should not be used in children and adolescents under the age of 18 years (see section 4.4).
Uporabljena so bila tudi priporočila delovne skupine za farmakovigilanco v zvezi z osnovnim povzetkom glavnih značilnosti zdravila za antidepresive.
19 Renal impairment The clearance of mirtazapine may be decreased in patients with moderate to severe renal impairment (creatinine clearance < 40 ml/ min).
Pregledani so bili tudi napotitveni povzetki glavnih značilnosti zdravila v skladu s smernicami Evropske Komisije (EK) o povzetkih glavnih značilnosti zdravila, iz oktobra 2005.
This should be taken into account when prescribing Remeron to this category of patients (see section 4.4).
V postopku uskladitve je bilo največ pozornosti namenjene naslednjim delom informacij o zdravilu.
Hepatic impairment The clearance of mirtazapine may be decreased in patients with hepatic impairment.
Terapevtske indikacije