natgillin/translations-raw huggingface dataset:
Adults (including the elderly) and children from 6 months of age should be given a single dose of 0.5 millilitres.
Odrasli (vključno s starostniki) in otroci od 6. meseca starosti dalje prejmejo enkraten odmerek 0, 5 ml.
Booster doses If you are still thought to be at risk of infection with yellow fever (e.g. you still travel to or are living in areas where yellow fever can be caught or could be infected through your work) a booster dose with 0.5 millilitres of vaccine is recommended every 10 years.
49 Poživitveni odmerki Če še vedno obstaja tveganje za okužbo z rumeno mrzlico (npr. če še vedno potujete ali živite na področjih, kjer se lahko okužite z rumeno mrzlico, ali če bi se lahko okužili pri svojem delu), se priporoča poživitveni odmerek 0, 5 ml cepiva vsakih 10 let.
48 STAMARIL should usually be given as an injection just underneath the skin.
STAMARIL se običajno uporabi v obliki injekcije tik pod kožo.
Alternatively, it can be given as an injection into muscle if that is in the official recommendations for the area in which you live.
Druga možnost je, da se injicira v mišico, če je tako navedeno v uradnih priporočilih za področje, na katerem živite.
Your doctor or nurse will take care that STAMARIL is not injected into a blood vessel.
Vaš zdravnik ali medicinska sestra bosta pozorna, da cepiva STAMARIL ne bosta injicirala v žilo.
If you have any further questions on the use of this vaccine, ask your doctor.
Če imate dodatna vprašanja o uporabi tega zdravila, se posvetujte s svojim zdravnikom.
Like all medicines, STAMARIL can cause side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi zdravilo STAMARIL neželene učinke, ki pa se ne pojavijo pri vseh ljudeh.
The most common side effects (in more than 1 in 10 adults vaccinated) seen in a clinical trial were problems around the injection site (such as redness, bruising, pain or discomfort, swelling or appearance of a hard lump) and headache.
Najpogostejši neželeni učinki (pri več kot 1 na 10 cepljenih odraslih oseb), ki so jih opazili v klinični raziskavi, so bile težave v okolici vbodnega mesta (na primer rdečina, podplutba, bolečina ali neugodje, oteklina ali zatrdlina) in glavobol.
Other side effects that occured in more than one in a hundred people vaccinated in a trial were feeling or being sick, diarrhoea, muscle pains, fever and weakness.
Drugi neželeni učinki, ki so se pojavili pri več kot eni na sto cepljenih oseb v klinični raziskavi, so obsegali občutek slabosti ali slabost, drisko, bolečine v mišicah, vročino in oslabelost.
Side effects that occurred in more than one in a thousand people were painful joints and stomach pains.
Neželeni učinki, ki so se pojavili pri več kot eni na tisoč cepljenih oseb, so bili boleči sklepi in bolečine v trebuhu.
Other side effects that have sometimes been reported during routine use of STAMARIL have included:
Drugi neželeni učinki, ki so jih zabeležili pri rutinski uporabi cepiva STAMARIL, vključujejo:
- Swollen glands
- Otekle bezgavke
- Serious allergic reactions that could include rash, itching or hives on the skin, swelling of the
- Hude alergične reakcije, ki lahko vključujejo izpuščaj, srbenje ali koprivnico na koži, oteklino
face, lips, tongue or other parts of the body, difficulty swallowing or breathing and loss of consciousness.
obraza, ustnic, jezika ali drugih delov telesa, težko požiranje ali dihanje in izgubo zavesti.
- Symptoms affecting the brain and nerves that have occurred within one month after vaccination
- Simptome prizadetosti možganov in živcev, ki se pojavijo v enem mesecu po cepljenju in se včasih
and have sometimes been fatal.
končajo s smrtnim izidom.
These include high fever with headache and confusion, lethargy, stiff neck, and inflammation of brain and nerve tissues.
Ti simptomi vključujejo visoko vročino z glavobolom in zmedenostjo, zaspanost, otrdel vrat in vnetje možganov in živčnih tkiv.
Sometimes fits, loss of movement in part or all of the body or more localised difficulties with movement or feeling have been seen.
Včasih so opazili krče, izgubo sposobnosti za premikanje dela telesa ali celotnega telesa ali lokalizirane težave s premikanjem ali čutili.
- Symptoms that can resemble infection with the yellow fever virus that usually appear within 10
- Simptome, ki so podobni okužbi z virusom rumene mrzlice in se običajno pojavijo v 10 dneh po
days after vaccination and may have a fatal outcome.
cepljenju, v nekaterih primerih se končajo tudi s smrtnim izidom.
It generally begins with feeling tired, fever, headache, muscle pain and sometimes low blood pressure.
V splošnem se začnejo z občutkom utrujenosti, vročino, glavobolom, bolečinami v mišicah in včasih z nizkim krvnim tlakom.
It may then go on to a severe muscle and liver disorder, drops in numbers of some types of blood cells resulting in unusual bruising or bleeding and increased risk of infections, and loss of normal functioning of the kidneys and lungs.
Lahko napredujejo v resno mišično in jetrno bolezen z zmanjšanjem števila določenih vrst krvničk, ki povzroči neobičajne podplutbe ali krvavitve in poveča tveganje za okužbe, ter okvaro normalnega delovanja ledvic in pljuč.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, nurse or pharmacist.
Če neželeni učinek postane resen ali če opazite kakršenkoli neželeni učinek, ki ni naveden v tem navodilu, vas prosimo, da obvestite svojega zdravnika, medicinsko sestro ali farmacevta.
HOW TO STORE STAMARIL
SHRANJEVANJE CEPIVA STAMARIL
Do not use STAMARIL after the expiry date which is stated on the carton.
Zdravila STAMARIL ne smete uporabljajte po datumu izteka roka uporabnosti, ki je naveden na ovojnini poleg oznake » Uporabno do: «.
Keep the vial and syringe in the outer carton in order to protect from light.
Shranjujte vialo in brizgalko v zunanjem ovoju zaradi zaščite pred svetlobo.
Medicines should not be disposed of via wastewater or household waste.
50 Zdravil se ne sme odvreči v odpadne vode ali med gospodinjske odpadke.
49 What STAMARIL contains
Kaj vsebuje zdravilo STAMARIL
The active ingredient in the vaccine is Yellow fever virus of the 17 D-204 strain (grown in hens eggs) that is live but has been weakened so that it does not cause yellow fever in healthy persons.
Zdravilna učinkovina v cepivu je Virus rumene mrzlice seva 17 D- 204 (vzgojen na kokošjih jajcih), ki je živ, vendar oslabljen, tako da pri zdravih osebah ne povzroči rumene mrzlice.
Each dose of half a millilitre contains not less than 1000 LD50 units of the virus, which is a measure of the actions of the virus in animals.
Vsak odmerek po pol mililitra vsebuje vsaj 1000 LD50 enot virusa, kar je merilo za učinkovanje virusa pri živalih.
Solvent: sodium chloride and water for injections.
Prašek: laktoza monohidrat, sorbitol E4 20, L- histidinijev klorid monohidrat, L- alanin, natrijev klorid, kalijev klorid, natrijev hidrogenfosfat dihidrat, kalijev dihidrogenfosfat, kalcijev klorid dihidrat, magnezijev sulfat heptahidrat Vehikel: natrijev klorid, voda za injekcije
What STAMARIL looks like and contents of the pack
Izgleda zdravila STAMARIL in vsebina pakiranja
The vaccine is a powder for suspension for injection contained in a single dose vial.
Cepivo se nahaja v obliki praška za suspenzijo za injiciranje v viali z enkratnim odmerkom.
Before use, the beige to orange beige powder is mixed with the sodium chloride solvent provided in a syringe to make a beige to pink beige suspension.
Pred uporabo se beige do oranžno- beige prašek zmeša z raztopino natrijevega klorida, ki je priložena v napolnjeni injekcijski brizgi, tako da nastane beige do rožnato- beige suspenzija.
STAMARIL is available in packs of 1, 10 and 20 with or without needles.
STAMARIL je na razpolago v pakiranjih po 1, 10 in 20, z iglami ali brez njih.
< [To be completed nationally] > [This section is not to be harmonised]
< [Se izpolni za vsako državo] > [Ta odsek se ne harmonizira]
Manufacturer Sanofi Pasteur SA – 2 avenue Pont Pasteur 69007 – Lyon – France
Sanofi Pasteur SA – 2, avenue Pont Pasteur 69007 – Lyon – Francija
< {Name of the Member State} > < {Name of the medicinal product} > < {Name of the Member State} > < {Name of the medicinal product} >
< {ime države članice} > < {ime zdravila} > < {ime države članice} > < {ime zdravila} >
< [See Annex I - To be completed nationally] > [For referral procedures, as appropriate]
< [Glejte Dodatek I - se izpolni za vsako državo] > [Za ustrezne postopke napotitve]
This leaflet was last approved in {MM/YYYY}.
Navodilo je bilo odobreno {MM/ YYYY}.
< [To be completed nationally] >
< [Se izpolni za vsako državo] >
Detailed information on this medicine is available on the web site of {name of MA/Agency}.
Podrobne informacije o tem zdravilu so na razpolago na spletni strani {ime imetnika dovoljenja za promet/ agencije}
50 PACKAGE LEAFLET
51 NAVODILO ZA UPORABO
The package leaflet will be completed nationally
Navodilo bo določeno nacionalno
51 PACKAGE LEAFLET:
52 NAVODILO ZA UPORABO:
removed for any reason
53
Booster doses If you are still thought to be at risk of infection with yellow fever (e.g. you still travel to or are living in areas where yellow fever can be caught or could be infected through your work) a booster dose with 0.5 millilitres of vaccine is recommended every 10 years.
54 Poživitveni odmerki Če še vedno obstaja tveganje za okužbo z rumeno mrzlico (npr. če še vedno potujete ali živite na področjih, kjer se lahko okužite z rumeno mrzlico, ali če bi se lahko okužili pri svojem delu), se priporoča poživitveni odmerek 0, 5 ml cepiva vsakih 10 let.
53 STAMARIL should usually be given as an injection just underneath the skin.
STAMARIL se običajno uporabi v obliki injekcije tik pod kožo.
Keep the vials of powder and solvent in the outer carton in order to protect from light.
Shranjujte vialo in brizgalko v zunanjem ovoju zaradi zaščite pred svetlobo.
After reconstitution, the product must be used within 6 hours.
55 Uporabite takoj po rekonstituciji.
Medicines should not be disposed of via wastewater or household waste.
Zdravil se ne sme odvreči v odpadne vode ali med gospodinjske odpadke.
54 What STAMARIL contains
Kaj vsebuje zdravilo STAMARIL
The vaccine is a powder for suspension for injection contained in a 10 doses vial.
Cepivo se nahaja v obliki praška za suspenzijo za injiciranje v viali z 10 odmerki.
Before use, the beige to orange beige powder is mixed with the sodium chloride solvent provided in a vial to make a beige to pink beige suspension.
Pred uporabo se beige do oranžno- beige prašek zmeša z raztopino natrijevega klorida, ki je priložena v drugi viali, tako da nastane beige do rožnato- beige suspenzija.
STAMARIL is available in packs of 10.
STAMARIL je na razpolago v zavojih po 10.
< [To be completed nationally] > [This section is not to be harmonised.]
< [Se izpolni za vsako državo] > [Ta odsek se ne harmonizira]
Detailed information on this medicine is available on the web site of {name of MA/Agency}
56 Podrobne informacije o tem zdravilu so na razpolago na spletni strani {ime imetnika dovoljenja za promet/ agencije}
SUMMARY INFORMATION ON REFERRAL OPINION PURSUANT TO ARTICLE 30 OF COUNCIL DIRECTIVE 2001/ 83/ EC FOR
POVZETEK MNENJA PO POSTOPKU, IZVEDENEM V SKLADU S ČLENOM 30 DIREKTIVE SVETA 2001/ 83/ ES ZA
STAMARIL and associated names (See Annex I)
STAMARIL in z njim povezana imena (Glej Dodatek I)
Live attenuated yellow fever virus
Živ, oslabljen virus rumene mrzlice
On 11 August 2005, Sanofi Pasteur MSD on behalf of all the Marketing Authorisation Holders (see Annex I) presented to the EMEA a referral under Article 30 of Directive 2001/ 83/ EC, as amended, in order to harmonise the national SPCs of the medicinal product STAMARIL and associated names.
Dne 11. avgusta 2005 je Sanofi Pasteur MSD v imenu vseh imetnikov dovoljenj za promet (glej Dodatek I) na EMEA predložil predlog za postopek v skladu s členom 30 Direktive 2001/ 83/ ES, kot je bila spremenjena, za uskladitev nacionalnih Povzetkov glavnih značilnosti (SPC) zdravila STAMARIL in z njim povezanih imen.
The CHMP having considered the Rapporteur and the Co-Rapporteur assessment reports, the scientific discussion within the Committee and the comments from the Marketing Authorisation Holders (MAH), was of the opinion that the benefit/ risk ratio of STAMARIL and associated names is considered to be positive in the following indications:
Ob upoštevanju poročil o oceni zdravila poročevalca in so- poročevalca, znanstvenih razprav znotraj odbora in pripomb imetnikov dovoljenj za promet z zdravilom (MAH) je CHMP menil, da je razmerje med koristmi in tveganji zdravila STAMARIL in z njim povezanih imen pozitivno v naslednjih indikacijah:
Active immunisation against yellow fever in persons from 9 months of age: • Travelling to, passing through or living in an endemic area. • Travelling to any country that requires an International Certificate of Vaccination for entry (which may or may not depend on the previous itinerary). • Handling potentially infectious materials (e. g. laboratory personnel).
aktivna imunizacija proti rumeni mrzlici pri osebah, starih več kot 9 mesecev: • ki potujejo, se prehodno zadržujejo ali živijo na endemičnem področju, • ki potujejo v katerokoli državo, ki za vstop zahteva Mednarodno potrdilo o cepljenju (kar je lahko odvisno ali neodvisno od predhodnega potovalnega načrta) • ki rokujejo s potencialno kužnimi snovmi (npr. laboratorijsko osebje).
The scientific conclusions are provided in Annex II together with the amended SPC in Annex III.
Znanstveni zaključki so podani v Dodatku II skupaj z dopolnjenim Povzetkom glavnih značilnosti zdravila (SPC) v Dodatku III.
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, PREDLAGATELJEV IN IMETNIKOV DOVOLJENJA ZA PROMET Z ZDRAVILOM V DRŽAVAH ČLANICAH
SANOFI-AVENTIS GMBH
SANOFI- AVENTIS GMBH OSTERREICH SATURN Tower Leonard- Bernstein- Straße 10 A- 1220 Dunaj Avstrija
Tabletten
1. 25 mg 2. 5 mg 5 mg 10 mg
2.5 mg 5 mg 10 mg
peroralna uporaba
AstraZeneca Österreich GmbH Schwarzenbergplatz 7
AstraZeneca Österreich GmbH Schwarzenbergplatz 7 A- 1037 Dunaj Avstrija
A-1037 Wien Austria
peroralna uporaba
AstraZeneca Österreich GmbH Schwarzenbergplatz 7 A-1037 Wien Austria
AstraZeneca Österreich GmbH Schwarzenbergplatz 7 A- 1037 Wien Avstrija
SANOFI-AVENTIS BELGIUM Culliganlaan 1C B-1831 Diegem Belgium
SANOFI- AVENTIS BELGIUM Culliganlaan 1C B- 1831 Diegem Belgija
Boulevard de la Plaine, 9 B-1050 Bruxelles
Boulevard de la Plaine, 9 B- 1050 Bruselj
prolonged-release tablet
prolonged- release tablet
oral
peroralna uporaba
2 Member State EU/ EEA
2 Država članica
NV AstraZeneca SA Ramace 1,25 mg Egide Van Ophemstraat 110 Ramace 2,5 mg B-1180 Brussels Ramace 5 mg Belgium
Egide Van Ophemstraat 110 B- 1180 Bruselj Belgija
1,25 mg 2,5 mg 5 mg
Ramace 2, 5 mg Ramace 5 mg
8, Sofia 1303 Bulgaria
8, Sofia 1303 Bolgarija
Oral
peroralna uporaba
SANOFI-AVENTIS CYPRUS LTD Triatec 14 Charalambou Mouskou street 2015 – Nicosia Cyprus
SANOFI- AVENTIS CYPRUS LTD 14 Charalambou Mouskou street 2015 – Nicosia Ciper
Czech Republic
Češka Češka
Tritace 1.25 Evropská 2590/ 33c Tritace 2.5 16000 Praha 6 Tritace 5 Czech Republic Tritace 10
Evropská 2590/ 33c 16000 Praga 6 Češka AVENTIS PHARMA DEUTSCHLAND GMBH Industriepark Höchst 65926 Frankfurt am Main Nemčija
AVENTIS PHARMA RAMIPRIL WINTHROP DEUTSCHLAND GMBH Industriepark Höchst 65926 Frankfurt am Main Germany
Tritace 1. 25 Tritace 2. 5 Tritace 5 Tritace 10 RAMIPRIL WINTHROP
Capsule
tableta kapsula
Oral
peroralna uporaba peroralna uporaba
SANOFI-AVENTIS DENMARK Triatec A/ S Slotsmarken 13 DK-2970 Hoersholm Denmark
SANOFI- AVENTIS DENMARK A/ S Slotsmarken 13 DK- 2970 Hoersholm Danska
SANOFI-AVENTIS DENMARK Triatec A/ S Slotsmarken 13 DK-2970 Hoersholm
SANOFI- AVENTIS DENMARK A/ S Slotsmarken 13 DK- 2970 Hoersholm Danska
3 Member State EU/ EEA
3 Država članica
139 E/ 2 11317 Tallinn Estonia
139 E/ 2 11317 Talin Estonija
SANOFI-AVENTIS Cardace DEUTSCHLAND GMBH Industriepark Hoechst D-65926 Frankfurt am Main Germany
SANOFI- AVENTIS DEUTSCHLAND GMBH Industriepark Hoechst D- 65926 Frankfurt am Main Nemčija
SANOFI-AVENTIS OY Cardace Huopalahdentie 24 00350 Helsinki Finland
SANOFI- AVENTIS OY Huopalahdentie 24 00350 Helsinki Finska
SANOFI-AVENTIS OY Ramipril medgenerics Huopalahdentie 24 Ramipril medgenerics 00350 Helsinki Ramipril medgenerics Finland Ramipril medgenerics
SANOFI- AVENTIS OY Huopalahdentie 24 00350 Helsinki Finska
1.25 mg tabletti 2.5 mg tabletti 5 mg tabletti 10 mg tabletti
Ramipril medgenerics 2. 5 mg tabletti Ramipril medgenerics 5 mg tabletti Ramipril medgenerics 10 mg tabletti
Tablet
Triatec 1. 25 mg comprime
France
tableta
1.25 mg 2.5 mg 5 mg 10 mg
peroralna uporaba
Tablet
Francija
Triateckit, comprime sécable
SANOFI AVENTIS FRANCE 1- 13, boulevard Romain Rolland 75014 Pariz Francija
Ramikit, comprime sécable
Triatec 2. 5 mg comprime sécable Triatec 5 mg comprime sécable Triatec 10 mg comprime sécable Triateckit, comprime sécable Ramikit, comprime sécable
2.5 mg / 5 mg/ 10mg
2. 5 mg 5 mg 10 mg 2. 5 mg / 5 mg / 10 mg 2. 5 mg / 5 mg / 10mg
SANOFI AVENTIS FRANCE 1-13, boulevard Romain Rolland
SANOFI AVENTIS FRANCE 1- 13, boulevard Romain Rolland 75014 Pariz Francija
Triatec faible 1,25 mg, gélule Triatec 2.5 mg, gélule
Triatec faible 1, 25 mg, gélule Triatec 2. 5 mg, gélule Triatec 5 mg, gélule
4
4 Država članica
Member State EU/ EEA
Imetnik dovoljenja za promet z zdravilom
Marketing Authorisation Holder (Invented) name
Izmišljeno ime
5 mg
peroralna uporaba
SANOFI AVENTIS FRANCE RAMIPRIL WINTHROP 1.25 MG 1-13, boulevard Romain Rolland RAMIPRIL WINTHROP 2.5 MG, F-75014 Paris COMPRIME SECABLE
SANOFI AVENTIS FRANCE 1- 13, boulevard Romain Rolland F- 75014 Paris Francija
1.25 mg 2.5 mg
RAMIPRIL WINTHROP 2. 5 MG, COMPRIME SECABLE RAMIPRIL WINTHROP 5 MG, COMPRIME SECABLE RAMIPRIL WINTHROP 10 MG, COMPRIME SECABLE
RAMIPRIL WINTHROP 10 MG, COMPRIME SECABLE
tableta
10 mg
peroralna uporaba
SANOFI-AVENTIS Ramipril protect 2,5 mg Tabletten DEUTSCHLAND GMBH Ramipril protect 5 mg Tabletten Industriepark Hoechst Ramipril protect 10 mg Tabletten D-65926 Frankfurt am Main Ramipril protect startset Germany
SANOFI- AVENTIS DEUTSCHLAND GMBH Industriepark Hoechst D- 65926 Frankfurt am Main Nemčija
2.5 mg 5 mg 10 mg 2.5 mg/ 5mg / 10mg
Ramipril protect 5 mg Tabletten Ramipril protect 10 mg Tabletten Ramipril protect startset
Oral
5 mg 10 mg 2. 5 mg / 5mg / 10mg
WINTHROP ARZNEIMITTEL Ramilich 2.5 mg Tabletten GmbH Ramilich 5 mg Tabletten Urmitzer Str.
5 56218 Mülheim- Kärlich Nemčija
5 Member State EU/ EEA
5 Država članica
Route of administration
kapsula, trda
DEUTSCHLAND GmbH 65926 Frankfurt am Main Germany
AVENTIS PHARMA DEUTSCHLAND GmbH 65926 Frankfurt am Main Nemčija
Germany
tablete
AstraZeneca GmbH Tinsdaler Weg 183 22880 Wedel
AstraZeneca GmbH
Vesdil Vesdil Vesdil
Vesdil
1,25 mg Tabletten 2,5 mg Tabletten N 2,5 mg Tabletten
1, 25 mg Tabletten
1,25 mg 2,5 mg 2,5 mg
Tinsdaler Weg 183
Tablets
Vesdil
Oral
2, 5 mg
Germany
Vesdil
Vedil 5 mg Tabletten Vesdil N 5 mg Tabletten Vesdil protect 10 mg Tabletten
N 2, 5 mg Tabletten
5 mg 5 mg 10 mg
5 mg
Greece
Vedil 5 mg Tabletten Nemčija 5 mg Vesdil N 5 mg Tabletten 10 mg Vesdil protect 10 mg Tabletten Grčija
SANOFI-AVENTIS AEBE 348, Syngrou Av. - Building A 176 74 Kallithea Greece
SANOFI- AVENTIS AEBE 348, Syngrou Av. - Building A 176 74 Kallithea Grčija
Tablet
tableta tableta
Zentiva HU Kft
Zentiva HU Kft Népfürdo u. 22 1138 Budapest Madžarska
Tablet
Islandija
Member State EU/ EEA
Država članica
Népfürdo u.22 Ramipril - Zentiva 2.5mg 1138 Budapest Ramipril - Zentiva 5mg Hungary Ramipril - Zentiva 10mg -
tableta
Ireland
Irska sanofi- aventis Ireland Ltd.
Citywest Tritace 1.25mg tablets Business Campus, Dublin 24, Tritace 2.5mg tablets Ireland Tritace 5mg tablets Tritace 10mg tablets
Business Campus, Dublin 24,
1.25mg 2.5 mg 5 mg 10 mg
Tritace 2. 5mg tablets
Tablet
Ireland
Tritace 1.25mg capsules Citywest Business Campus Tritace 2.5mg capsules Dublin 24 Tritace 5mg capsules Ireland Tritace 10mg capsules
Citywest Business Campus Dublin 24 Irska
Capsule
kapsula tableta
Loavel 1.25mg Citywest Business Campus Loavel 2.5mg Dublin 24 Loavel 5mg Ireland Loavel 10mg
Citywest Business Campus Dublin 24 Irska
1.25mg 2.5 mg 5 mg 10 mg
Loavel 2. 5mg Loavel 5mg Loavel 10mg
Loavel 1.25mg capsules Citywest Business Campus Loavel 2.5mg capsules Dublin 24 Loavel 5mg capsules Ireland Loavel 10mg capsules
Citywest Business Campus Dublin 24 Irska
Ramipril 1.25mg tablets Citywest Business Campus Ramipril 2.5mg tablets Dublin 24 Ramipril 5mg tablets Ireland Ramipril 10mg tablets
Citywest Business Campus Dublin 24 Irska
Ramipril 1.25mg capsules Citywest Business Campus Ramipril 2.5mg capsules Dublin 24 Ramipril 5mg capsules Ireland Ramipril 10mg capsules
Citywest Business Campus Dublin 24 Irska
1.25 mg 2.5 mg 5. mg 10 mg
Ramipril 2. 5mg capsules Ramipril 5mg capsules Ramipril 10mg capsules
SANOFI-AVENTIS SPA Triatec 1,25 Viale Bodio, 37/ b Triatec 20158 Milano Triatec 5
Viale Bodio, 37/ b
1.25 mg 2.5 mg 5 mg
Triatec 5
7 Member State EU/ EEA
7 Država članica
AstraZeneca S. p. A Palazzo Volta Via Francesco Sforza 20080 Basiglio (MI) Italy
AstraZeneca S. p. A Palazzo Volta Via Francesco Sforza 20080 Basiglio (MI) Italija
Viale Dell’ Arte, 69 I – 00144 Roma Italy
Viale Dell ’ Arte, 69 I – 00144 Rim Italija
sanofi-aventis Latvia SIA Kr. Valdemara 33-8 LV1010 - Riga Latvia
sanofi- aventis Latvia SIA Kr. Valdemara 33- 8 LV1010 - Riga Latvija
SANOFI-AVENTIS BELGIUM Culliganlaan 1C B-1831 Diegem
SANOFI- AVENTIS BELGIUM Culliganlaan 1C B- 1831 Diegem Belgija
8 Member State EU/ EEA
8
Strength
Država članica
Pharmaceutical Form
Imetnik dovoljenja za promet z zdravilom
Route of administration
Izmišljeno ime
Belgium
Jakost
Luxembourg
Farmacevtska oblika
1,25 mg 2,5 mg 5 mg
Pot uporabe zdravila
Tablet
Tritace 1. 25
Malta
tableta
-
peroralna uporaba
Tritace 2.5 Kampenringweg 45 D-E (toren D Tritace 5 en E) Tritace 10 NL-2803 PE Gouda The Netherlands
Kampenringweg 45 D- E (toren D en E) NL- 2803 PE Gouda Nizozemska
Box 2043 NL-2800 BD Gouda The Netherlands Netherlands
Box 2043 NL- 2800 BD Gouda Nizozemska
Kampenringweg 45 D-E (toren D en E) NL-2803 PE Gouda The Netherlands
Kampenringweg 45 D- E (toren D en E) NL- 2803 PE Gouda Nizozemska
SANOFI-AVENTIS NORGE AS Strandveien 15 P. O. Box 133 NO-1325 Lysaker Norway
SANOFI- AVENTIS NORGE AS Strandveien 15 P. O. Box 133 NO- 1325 Lysaker Norveška
SANOFI-AVENTIS NORGE AS Strandveien 15 P. O. Box 133 NO-1325 Lysaker
SANOFI- AVENTIS NORGE AS Strandveien 15 P. O. Box 133 NO- 1325 Lysaker Norveška
1.25 mg 2.5 mg 5 mg 10 mg
Pot uporabe zdravila
SANOFI-AVENTIS Tritace 2.5 DEUTSCHLAND GMBH Tritace 5 D-65926 Frankfurt am Main Tritace 10 Germany
D- 65926 Frankfurt am Main Nemčija
Sanofi-Aventis Produtos Triatec Farmacêuticos, s. a.
Sanofi- Aventis Produtos Farmacęuticos, s. a.
Empreendimento Lagoas Park, Edifício 7 - 3º Piso 2740-244 Porto Salvo Portugal
Empreendimento Lagoas Park, Edifício 7 - 3ş Piso 2740- 244 Porto Salvo Portugalska
AVENTIS PHARMA Tritace DEUTSCHLAND GMBH Brüningstraße 50 65926 Frankfurt am Main Germany
AVENTIS PHARMA DEUTSCHLAND GMBH Brüningstraße 50 65926 Frankfurt am Main Nemčija
50, Zenra 5 sector 3 Zenra 10 Bucuresti ROMANIA
50, sector 3 Bucuresti ROMUNIJA
10 Member State EU/ EEA
Slovaška
Marketing Authorisation Holder (Invented) name
Žilinská 7- 9 81105 Bratislava Slovaška
Pharmaceutical Form
1. 25 mg 2. 5 mg 5 mg 10 mg
SANOFI-AVENTIS SLOVAKIA Tritace s. r. o.
Dunajska cesta 119 1000 Ljubljana
Ž ilinská 7-9 81105 Bratislava Slovak Republic
Tritace 1, 25 mg teblete Tritace 2, 5 mg tablete Tritace 5 mg tablete
1.25 mg 2.5 mg 5 mg 10 mg
1. 25 mg 2. 5 mg 5 mg
Oral
Jakost
Slovenia
Farmacevtska oblika
SANOFI-AVENTIS D. O. O.
Pot uporabe zdravila
Tritace 1,25 mg teblete Dunajska cesta 119 Tritace 2,5 mg tablete 1000 Ljubljana Tritace 5 mg tablete Slovenia Tritace 10 mg tablete Tritace Startset
Tritace 10 mg tablete Tritace Startset
1.25 mg 2.5 mg 5 mg 10 mg 2,5 mg/ 5 mg/ 10 mg
10 mg 2, 5 mg / 5 mg / 10 mg
Tablet
Španija
Acovil Josep Pla 2 08019 Barcelona Spain
Josep Pla 2 08019 Barcelona Španija
sanofi-aventis AB Triatec Box 14142 167 14 Bromma Sweden
sanofi- aventis AB Box 14142 167 14 Bromma Švedska