natgillin/translations-raw huggingface dataset:
0,5 mg Tablet
0,5 mg Tableta
50-984 Wrocław Poland
50-984 Wrocław Poland feksofenadinijev klorid
Donepezil/Generics
ESOMEPRAZOLE/ GENERICS
2,5 mg Tablet
2,5 mg Tableta
Alendronic acid ACIDO ALENDRONICO SEMANAL RANBAXY 70 mg COMPRIMIDOS EFG
Spain alendronska kislina ACIDO ALENDRONICO SEMANAL RANBAXY 70 mg COMPRIMIDOS EFG
Parque Expo, Edifício Atlantis, Avenida D. João II, Lote 1.06.2.2 C - 7.3 e 7.4
Parque Expo, Edifício Atlantis, Avenida D. João II, Lote 1.06.2.2 C - 7.3 e 7.4 1990-095 Lisboa Portugal atorvastatin
200 mg Capsule, hard Oral use
200 mg Kapsula, trda Peroralna uporaba
Ciprofloxacin
Germany ciprofloksacin
Alendronic acid Ácido alendrónico Labesfal tablet
Portugal alendronska kislina Ácido alendrónico Labesfal
Alendronic acid Alendronic Acid Once Weekly 70 mg Tablets
United Kingdom alendronska kislina Alendronic Acid Once Weekly 70 mg Tablets
Valsartan/Hydrochlorothiaz ide Fair-Med 160 mg/12.5 mg film-coated tablets.
Valsartan/Hydrochloroth iazide Fair-Med 160 mg/12.5 mg film-coated tablets.
Levodopa/carbidop a/entacapone
Portugal levodopa/karbidopa/ entakapon
Bendroflumethiazide Bendroflumetiazid Alternova
DK-4230 Skælskør Denmark bendroflumetiazid Bendroflumetiazid Alternova
Alendronic acid alendronic acid 70mg Once Daily Tablets
United Kingdom alendronska kislina alendronic acid 70mg Once Daily Tablets
Orodispersible tablet
Orodisperzibilna tableta
Clonazepam Clonazepam Sandoz 0,5 mg, tabletten
1327 AH Almere The Netherlands klonazepam Clonazepam Sandoz 0,5 mg, tabletten
0,06 mg Orodispersible tablet
0,06 mg Orodisperzibilna tableta
Alendronic acid alendronic acid 10mg Tablets
United Kingdom alendronska kislina alendronic acid 10mg Tablets
150 mg Capsule, hard Oral use
150 mg Kapsula, trda Peroralna uporaba
0,24 mg Orodispersible tablet
0,24 mg Orodisperzibilna tableta
Alendronic acid Alendroninezuur 70 Ranbaxy, tabletten 70 mg
Untied Kingdom alendronska kislina Alendroninezuur 70 Ranbaxy, tabletten 70 mg
Escitalopram oxalate
Greece escitalopramijev oksalat
Valsartan/hydrochl orothiazide
Germany valsartan/hidroklorot iazid
Teva Nederland B.V. Swensweg 5
Nizozemska Teva Nederland B.V.
2,5 mg Orodispersible tablet
2,5 mg Orodisperzibilna tableta
Clonazepam Clonazepam Sandoz 2 mg, tabletten
1327 AH Almere The Netherlands klonazepam Clonazepam Sandoz 2 mg, tabletten
Laboratórios Anova - Produtos Farmacêuticos, Lda.
Portugalska Laboratórios AnovaProdutos Farmacêuticos, Lda.
Venlagamma 37,50 mg 37,5 mg Prolongedreleased capsule, hard
Venlagamma 37,50 mg 37,5 mg Kapsula s podaljšanim sproščanjem, trda
Veluwezoom 22 1327 AH Almere The Netherlands
1327 AH Almere The Netherlands klobazam
Valsartan/Hydrochlorothiaz ide Fair-Med 320 mg/25 mg film-coated tablets
Valsartan/Hydrochloroth iazide Fair-Med 320 mg/25 mg film-coated tablets
Alendronic acid Alendroninezuur Accord 10mg Tabletten
United Kingdom alendronska kislina Alendroninezuur Accord 10mg Tabletten
Generics (UK) Ltd Station Close, Potters Bar Hertfordshire, EN6 1TL United Kingdom
Generics (UK) Ltd Station Close, Potters Bar Hertfordshire, EN6 1TL United Kingdom repaglinid
Fexofenadine
Portelinha
0,12 mg Orodispersible tablet
0,12 mg Orodisperzibilna tableta
Slovak Republic Alkaloid - INT d.o.o.
Portugalska Alkaloid - INT d.o.o.
Generis Farmacêutica, S. A. Rua João de Deus, 19 2700-487 Amadora Portugal
Portugalska Generis Farmacêutica, S. A. Rua João de Deus, 19
Donepezil Mylan 10 mg orodisperzibilne tablete
Donepezil Odis Mylan 10 mg Orodisperzibilna tableta
Valsartan/Hydrochlorothiaz ide Fair-Med 320 mg/12.5 mg film-coated tablets mg/12,5 mg
Valsartan/Hydrochloroth iazide Fair-Med 320 mg/12.5 mg film-coated tablets mg/12,5 mg
Bosentan Abdi 125 mg potahované tablety
Portugal bosentan monohidrat Bosentan Abdi 125 mg potahované tablety
Venlafaxina Eurogenus 37,5 mg Prolongedreleased capsule, hard
Venlafaxina Eurogenus 37,5 mg Kapsula s podaljšanim sproščanjem, trda
VENLAFAXINA PENSA 75 mg Prolongedreleased capsule, hard
VENLAFAXINA PENSA 75 mg Kapsula s podaljšanim sproščanjem, trda
Venlafaxina Eurogenus 75 mg Prolongedreleased capsule, hard
Venlafaxina Eurogenus 75 mg Kapsula s podaljšanim sproščanjem, trda
Venlafaxina Eurogenus 150 mg Prolongedreleased capsule, hard
Venlafaxina Eurogenus 150 mg Kapsula s podaljšanim sproščanjem, trda
VENLAFAXINA PENSA 150 mg Prolongedreleased capsule, hard
VENLAFAXINA PENSA 150 mg Kapsula s podaljšanim sproščanjem, trda
15 mg Gastro - resistant tablet
15 mg Gastrorezistentn a tableta
15 mg Prolongedreleased capsule, hard
15 mg Kapsula s podaljšanim sproščanjem, trda
Alendronic acid Alendroninezuur Accord 70mg Tabletten
United Kingdom alendronska kislina Alendroninezuur Accord 70mg Tabletten
Desloratadine
Croatia desloratadin
150mg Prolongedreleased capsule, hard
150mg Kapsula s podaljšanim sproščanjem, trda
75 mg Prolongedreleased capsule, hard
75 mg Kapsula s podaljšanim sproščanjem, trda
1526 Ljubljana Slovenia
1526 Ljubljana Slovenia trimetazidin hidroklorid
Donepezil
Portugal donepezil
Fluconazole 150mg capsule 150 mg Capsule, hard Oral use
Fluconazol Bluefish 150 mg Kapsula, trda Peroralna uporaba
VENLAFAXINE ORION 75 mg Prolongedreleased capsule, hard
VENLAFAXINE ORION 75 mg Kapsula s podaljšanim sproščanjem, trda
Venlagamma 150 mg 150 mg Prolongedreleased capsule, hard
VENLAGAMMA 150 MG 150 mg Kapsula s podaljšanim sproščanjem, trda
VENLAGAMMA 150 MG 150 mg Prolongedreleased capsule, hard
Venlagamma 150 mg 150 mg Kapsula s podaljšanim sproščanjem, trda
Trimetazidine dihydrochloride
Hungary trimetazidin dihidroklorid
Escitalopram Escitalopram PharmaS 10 mg filmom obložene tablete
Radnička cesta 47 Zagreb 10000 Croatia escitalopram Escitalopram PharmaS 10 mg filmom obložene tablete
Trimetazidine hydrochloride
United Kingdom trimetazidin hidroklorid
VENLAGAMMA 75 MG 75 mg Prolongedreleased capsule, hard
VENLAGAMMA 75 MG 75 mg Kapsula s podaljšanim sproščanjem, trda
Bosentan Abdi 62,5 mg potahované tablety
Portugal bosentan monohidrat Bosentan Abdi 62,5 mg potahované tablety
VENLAFAXINE ORION 37,5 mg Prolongedreleased capsule, hard
VENLAFAXINE ORION 37,5 mg Kapsula s podaljšanim sproščanjem, trda
37,5 mg Prolongedreleased capsule, hard
37,5 mg Kapsula s podaljšanim sproščanjem, trda
Belgium Takeda Belgium Gentsesteenweg 615
Takeda Belgium Gentsesteenweg 615 1080 Brussels Belgium alendronska kislina Alendromono
VENLAFAXINE ORION 150 mg Prolongedreleased capsule, hard
VENLAFAXINE ORION 150 mg Kapsula s podaljšanim sproščanjem, trda
Bosentan Sandoz 125 mg
Czech Republic bosentan monohidrat Bosentan Sandoz 125 mg
Desloratadine Labormed 2,5 mg Orodispersible tablet
Desloratadine Labormed 2,5 mg Orodisperzibilna tableta
Alendronic acid ALENDRONIC ACID ACCORD 70mg
United Kingdom alendronska kislina ALENDRONIC ACID ACCORD 70MG
Bosentan Sandoz 62,5 mg
Czech Republic bosentan monohidrat Bosentan Sandoz 62,5 mg
200 mg Modified - release capsule, hard
200 mg Kapsula s prirejenim sproščanjem, trda
Alendronic acid Ácido alendrónico Accord 70 mg tablet
United Kingdom alendronska kislina Alendronic Acid Accord 70 mg Tableta
150 mg Prolongedreleased capsule, hard
150 mg Kapsula s podaljšanim sproščanjem, trda
Alendronic acid ALENDRONATO AHCL
United Kingdom alendronska kislina ALENDRONATO AHCL 10 mg Tableta
Venlafaxina Bluepharma 37,5 mg Prolongedreleased capsule, hard
Venlafaxina Bluepharma 37,5 mg Kapsula s podaljšanim sproščanjem, trda
Tacpan 0.5 mg Hartkapseln 0,5 mg Capsule, hard Oral use
0,5 mg Kapsula, trda Peroralna uporaba
37,5 mg Prolongedrelease tablet
37,5 mg Tableta s podaljšanim sproščanjem
Donezil
Carnaxide
100 mg Tablet
10 mg Tableta
Venlafaxina Bluepharma 75 mg Prolongedreleased capsule, hard
Venlafaxina Bluepharma 75 mg Kapsula s podaljšanim sproščanjem, trda
Desloratadina Labesfal OD 2,5 mg Orodispersible tablet
Desloratadina Labormed 2,5 mg Orodisperzibilna tableta
Metoclopramide hydrochloride
United Kingdom metoklopramid hidroklorid
Venlafaxine Bluefish XL 75 mg Prolongedreleased capsule, hard
Venlafaxine Bluefish XL 75 mg Kapsula s podaljšanim sproščanjem, trda
Phenoxymethylpenicillin 250mg Film-coated Tablets
TW4 5DQ Middlesex United Kingdom fenoksimetil penicilin Phenoxymethylpenicillin 250mg Film-coated
Quetiapina Daquimed
Portugal kvetiapin
Venlafaxina Bluepharma 150 mg Prolongedreleased capsule, hard
Venlafaxina Bluepharma 150 mg Kapsula s podaljšanim sproščanjem, trda
Clindamycin hydrochloride
Slovenia trimetazidin dihidroklorid
30 mg Gastro - resistant tablet
30 mg Gastrorezistentn a tableta
Iceland ratiopharm GmbH Graf-Arco-Strasse 3 D-89079 Ulm Germany
Islandija ratiopharm GmbH Graf-Arco-Strasse 3 D-89079 Ulm Germany desloratadin
BOSENTAN SANDOZ 62,5 mg Film - coated tablet
BOSENTAN SANDOZ 62,5 mg Filmsko obložena tableta
Scored tablet
Filmom obalená tableta
France ratiopharm GmbH Graf-Arco-Strasse 3 D-89079 Ulm Germany
Francija ratiopharm GmbH Graf-Arco-Strasse 3 D-89079 Ulm Germany nebivolol
Venlafaxina Bluefish XR 75 mg Prolongedreleased capsule, hard
Venlafaxina Bluefish XR 75 mg Kapsula s podaljšanim sproščanjem, trda
Venlafaxine Bluefish XL 150 mg Prolongedreleased capsule, hard
Venlafaxine Bluefish XL 150 mg Kapsula s podaljšanim sproščanjem, trda
37,5 mg Prolongedrelease capsule
37,5 mg Kapsula s podaljšanim sproščanjem
Alendronic acid ACIDO ALENDRONICO SEMANAL PENSA 70 mg COMPRIMIDOS EFG
46015- Valencia (Valencia) Spain alendronska kislina ACIDO ALENDRONICO SEMANAL PENSA 70 mg COMPRIMIDOS EFG
Clindamycin Alternova
Germany levocetirizin
Norway ratiopharm GmbH Graf-Arco-Strasse 3 D-89079 Ulm Germany
Norveška ratiopharm GmbH Graf-Arco-Strasse 3 D-89079 Ulm Germany desloratadin
Irbesartan/hydroch lorothiazide
Romania irbesartan/hidrokloro tiazid
Germany ratiopharm GmbH Graf-Arco-Strasse 3 D-89079 Ulm Germany
Nemčija ratiopharm GmbH Graf-Arco-Strasse 3 D-89079 Ulm Germany nebivolol
VENLAFAXINE FAIR-MED 37,5 mg Prolongedrelease capsule, hard
Venlafaxine Fair-Med 37,5 mg Kapsula s podaljšanim sproščanjem, trda
REPAGLINIDE MYLAN 0,5 mg Tablet
REPAGLINIDE MYLAN 0,5 mg Tableta
75 mg Prolongedrelease capsule
75 mg Kapsula s podaljšanim sproščanjem
Fluconazole
Portugal flukonazol
Venlafaxina Bluefish XR 150 mg Prolongedreleased capsule, hard
Venlafaxina Bluefish XR 150 mg Kapsula s podaljšanim sproščanjem, trda
Wałbrzyska 13
Veluwezoom 22
Finland ratiopharm GmbH Graf-Arco-Strasse 3 D-89079 Ulm Germany
Finska ratiopharm GmbH Graf-Arco-Strasse 3 D-89079 Ulm Germany desloratadin
BOSENTAN SANDOZ 125 mg Film - coated tablet
BOSENTAN SANDOZ 125 mg Filmsko obložena tableta
VENLAFAXINE FAIR-MED 150 mg Prolongedrelease capsule, hard
Venlafaxine Fair-Med 150 mg Kapsula s podaljšanim sproščanjem, trda
Levetiracetam Levetiracetam-Generics 750 mg Film - coated tablet
Levetiracetam-Generics 750 mg Filmsko obložena tableta
Alendronic acid Alendromono
United Kingdom alendronska kislina Ácido alendrónico Accord
Venlafaxine hydrochloride
Portugal venlafaksinijev klorid Venlafaxina Labesfal
Cefpodoxima Alkaloid
Italy metoklopramid
75 mg Modified - release capsule, hard
75 mg Kapsula s prirejenim sproščanjem, trda
Fexofenadina Mylan 120 mg Film - coated tablet
Fexofenadina Mylan 120 mg Filmsko obložena tableta
Bosentan
Bulgaria bosentan
Levetiracetam Levetiracetam-Generics 500 mg Film - coated tablet
Levetiracetam-Generics 500 mg Filmsko obložena tableta
Desloratadine Ratiopharm 5 mg
Desloratadine Apotex 5 mg
This is repeated every 21 days for six courses or until the disease gets worse.
To je treba ponoviti na vsakih 21 dni, skupaj šestkrat ali dokler se stanje bolezni ne poslabša.
It is used on its own to treat patients with:
Uporablja se kot samostojno zdravilo za zdravljenje bolnikov:
The European Commission granted a marketing authorisation valid throughout the European Union for Potactasol to on 06 January 2011.
Evropska komisija je dovoljenje za promet z zdravilom Potactasol, veljavno po vsej Evropski uniji, izdala 6. januarja 2011.
The full EPAR for Potactasol can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Potactasol je na voljo na spletni strani agencije ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
What are the benefits and risks of Potactasol?
Kakšne so koristi in tveganja, povezani z zdravilom Potactasol?
The company has provided data from the published literature on topotecan.
Družba je predstavila podatke o topotekanu iz objavljene literature.
This is a summary of the European public assessment report (EPAR) for Potactasol.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Potactasol.
This means that Potactasol is similar to a ‘reference medicine' already authorised in the European Union (EU) called Hycamtin.
To pomeni, da je podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Hycamtin.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Potactasol.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil to zdravilo, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
For more information about treatment with Potactasol, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Potactasol preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
Treatment with Potactasol should only be given under the supervision of a doctor experienced in the use of chemotherapy.
Zdravljenje z zdravilom Potactasol lahko poteka samo pod nadzorom zdravnika, ki ima izkušnje z uporabo kemoterapije.
It is also used together with cisplatin (another cancer medicine) to treat women with cancer of the cervix, when the cancer has come back after radiotherapy, or when the disease is at an advanced stage (the cancer has spread beyond the cervix).
Zdravilo se uporablja tudi skupaj s cisplatinom (drugo vrsto zdravila proti raku) za zdravljenje žensk z rakom materničnega vratu, če se je rak znova pojavil po že končanem zdravljenju z obsevanjem ali če je bolezen v napredovalem stadiju (rak se je razširil zunaj materničnega vratu).
Other information about Potactasol
Druge informacije o zdravilu Potactasol
Because Potactasol is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Ker je zdravilo Potactasol generično zdravilo in je biološko enakovredno referenčnemu zdravilu, so koristi in tveganja enaki kot pri referenčnem zdravilu.
The Committee recommended that Potactasol be given marketing authorisation.
Odbor je priporočil, da se za zdravilo Potactasol izda dovoljenje za promet.
Potactasol also affects non-cancer cells, which causes side effects.
Zdravilo Potactasol vpliva tudi na nerakave celice, kar povzroča neželene učinke.
The CHMP concluded that, in accordance with EU requirements, Potactasol has been shown to be comparable to Hycamtin.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da je bilo v skladu z zahtevami EU dokazano, da je zdravilo Potactasol primerljivo z zdravilom Hycamtin.
It is available as a powder to be made up into a solution for infusion (drip) into a vein.
Na voljo je v obliki praška za pripravo raztopine za infundiranje (kapalne infuzije) v veno.
The dose of Potactasol to be used depends on the type of cancer that it is being used to treat and the patient's weight and height.
Odmerek zdravila Potactasol je odvisen od vrste raka, ki se zdravi, ter bolnikove telesne mase in višine.
When used with cisplatin in cervical cancer, Potactasol is given as an infusion on days 1, 2 and 3 (with cisplatin given on day 1).
Če se zdravilo Potactasol uporablja skupaj s cisplatinom za zdravljenje raka materničnega vratu, se daje v obliki infuzije 1., 2. in 3. dan (cisplatin se daje 1. dan).
For both ovarian and lung cancer, Potactasol is given every day for five days with a three-week interval between the start of each course.
Pri raku jajčnikov in pljučnem raku se zdravilo Potactasol daje vsak dan pet dni, čemur sledi tritedenski premor pred pričetkom novega cikla zdravljenja.
The active substance in Potactasol, topotecan, is a cancer medicine that belongs to the group ‘topoisomerase inhibitors'.
Zdravilna učinkovina zdravila Potactasol, topotekan, je zdravilo za zdravljenje raka, ki spada v skupino zaviralcev topoizomeraze.
Why has Potactasol been approved?
Zakaj je bilo zdravilo Potactasol odobreno?
When Potactasol is used on its own for ovarian cancer, it is given by infusion over 30 minutes.
Če se rak jajčnikov zdravi zgolj z zdravilom Potactasol, se ta daje z več kot 30-minutno infuzijo.
Therefore, the CHMP's view was that, as for Hycamtin, the benefit outweighs the identified risk.
Zato je menil, da njegove koristi, tako kot pri zdravilu Hycamtin, odtehtajo znana tveganja.
Potactasol is a ‘generic medicine'.
Zdravilo Potactasol je „generično zdravilo“.
Doses of Potactasol may need to be adjusted or treatment delayed, depending on side effects.
Glede na neželene učinke bo morda treba odmerke zdravila Potactasol prilagoditi ali zdravljenje odložiti.
Potactasol is a medicine that contains the active substance topotecan.
Potactasol je zdravilo, ki vsebuje zdravilno učinkovino topotekan.
No additional studies were needed as Potactasol is a generic medicine that is given by infusion and contains the same active substance as the reference medicine, Hycamtin.
Ker je zdravilo Potactasol generično zdravilo, ki se daje z infundiranjem in vsebuje isto zdravilno učinkovino kot referenčno zdravilo Hycamtin, niso bile potrebne nobene dodatne študije.
How has Potactasol been studied?
Kako je bilo zdravilo Potactasol raziskano?
What is Potactasol used for?
Za kaj se zdravilo Potactasol uporablja?
What is Potactasol?
Kaj je zdravilo Potactasol?
Potactasol is a cancer medicine.
Potactasol je zdravilo proti raku.
How is Potactasol used?
Kako se zdravilo Potactasol uporablja?
How does Potactasol work?
Kako zdravilo Potactasol deluje?
Route of Administration
Velikost pakiranja
The Member States must ensure that all conditions or restrictions with regard to the safe and effective use of the medicinal product as described below are implemented:
Države članice morajo zagotoviti uvedbo vseh pogojev ali omejitev v zvezi z varno in učinkovito uporabo medicinskih izdelkov, kot je opisano spodaj:
• Summary of Product Characteristics (SPC) and Package Leaflet and Labelling
• Povzetek lastnosti zdravila (SPC) z navodilom za uporabo in označbo
• The risk of opportunistic infections, in particular CMV viraemia • Recommendation to avoid vaccination with live vaccines for at least 12 months following o That treatment for hypersensitivity reactions, including measures for resuscitation should be available during administration o That the risk of infusion reactions is highest in first week of therapy o That if the reaction is moderate or severe dosing should continue at the same level (ie no dose escalation) until each dose is well tolerated o That if therapy is withheld for more than 7 days then MabCampath should be reinstituted with gradual dose escalation
o Da je tveganje infuzijskih reakcij reakcij najvišje v prvem tednu zdravljenja o Če je reakcija zmerna ali močna, se mora odmerna shema nadaljevati pri z enako stopnjo (to pomeni brez zvečanja odmerka), dokler bolnik odmerka ne prenese dobro o Če je bilo zdravljenje prekinjeno za več kot 7 dni, je treba MabCampath ponovno uvesti s postopnim stopnjevanjem odmerka
The Member States shall ensure that the MAH provides all doctors who are expected to prescribe MabCampath with a healthcare professional information pack containing the
Države članice bodo zagotovile, da bo imetnik dovoljenja za promet vsem zdravnikom, ki predpisujejo zdravilo MabCampath, priskrbel strokovno zdravstveno opisno dokumentacijo, ki bo vsebovala naslednje:
- To agree the details of an educational brochure with the MAH.
Dogovoriti se z imetnikom dovoljenja za promet o podrobnostih za izobraževalno brošuro.
This summary was last updated on 30/08/2012.
Povzetek je bil nazadnje posodobljen dne 30/08/2012.
It is a solution for injection (0.1 mg/ml and 0.5 mg/ml).
Zdravilo je raztopina za injiciranje (0,1 mg/ml in 0,5 mg/ml).
In addition, the blood pressure will increase before returning to normal or below normal.
Poleg tega se krvni tlak najprej poviša in se nato vrne na normalno raven ali pod njo.
The marketing authorisation was renewed on 2 August 2007.
Dovoljenje za promet z zdravilom je bilo podaljšano 2. avgusta 2007.
Dexdomitor dexmedetomidine
Dexdomitor deksmedetomidin
The duration and depth of sedation and analgesia depend on the dose that is used.
Trajanje in globina sedacije in analgezije sta odvisna od uporabljenega odmerka.
It works by preventing the release of the neurotransmitter noradrenaline from nerve cells in the body.
Deluje tako, da preprečuje sproščanje živčnega prenašalca noradrenalina iz živčnih celic telesa.
The European Commission granted a marketing authorisation valid throughout the European Union, for Dexdomitor on 30 August 2002.
Evropska komisija je dovoljenje za promet z zdravilom Dexdomitor, veljavno po vsej Evropski uniji, odobrila dne 30. avgusta 2002.
• Before inducing general anaesthesia.
• pred uvedbo splošne anestezije.
Dexmedetomidine is an alpha2-adrenoceptor agonist.
Deksmedetomidin, je agonist alfa2-adrenoreceptorja.
Pregnant women should take special care to avoid self-injection.
Nosečnice morajo biti še posebej previdne, da ne pride do samoinjiciranja zdravila.
The use of waterproof gloves is advisable.
Priporočljiva je uporaba nepropustnih rokavic.
Since noradrenaline is involved in maintaining alertness and arousal, reducing its release decreases the level of consciousness, including the sensation of pain.
Ker je noradrenalin udeležen pri vzdrževanju budnega stanja, zmanjšanje stopnje njegovega sproščanja zniža raven zavesti in občutek bolečine.
Other information about Dexdomitor:
Druge informacije o zdravilu Dexdomitor:
If contact does occur, rinsing with large amounts of water is advised.
Če do stika pride, je treba mesto izprati z veliko količino vode.
However, the person should not drive due to the risk of sedation and changes in blood pressure.
Vendar pa zaradi tveganja sedacije in sprememb krvnega tlaka oseba ne sme voziti.
The safety of the use of Dexdomitor has not been studied in puppies below 16 weeks of age or in kittens below 12 weeks of age.
Varnost uporabe zdravila Dexdomitor ni bila preverjena pri kužkih, mlajših od 16 tednov, ali muckah, mlajših od 12 tednov.
As for medetomidine, ‘good' or ‘excellent' analgesia was reached in about 40 to 50 % of the animals, supporting its used in non-invasive mildly to moderately painful procedures.
Kar zadeva medetomidin, so pri 40 do 50 % živali dosegli „dobro“ ali „odlično“ analgezijo, kar je v prid uporabi tega zdravila pri neinvazivnih, blago do zmerno bolečih posegih.
It is used in non-invasive procedures which do not involve breaking the skin or a body cavity.
Uporablja se pri neinvazivnih posegih, kar pomeni, da se pri postopku ne predre kože ali stene telesne votline;
The studies included dogs and cats of various ages and breeds, which were undergoing procedures requiring sedation or analgesia.
Študije so vključevale pse in mačke različnih starosti in pasem, na katerih so morali izvesti postopke, ki so zahtevali sedacijo ali analgezijo.
What benefit has Dexdomitor shown during the studies?
Kakšne koristi je zdravilo Dexdomitor izkazalo med študijami?
Dexmedetomidine is closely related to another substance used to sedate animals, medetomidine, that has been used in veterinary medicine for many years.
Deksmedetomidin je tesno povezan z drugo snovjo, ki se uporablja za sedacijo živali, medetomidinom, ki ga v veterinarskih zdravilih uporabljajo že dolga leta.
Vomiting may occur five to 10 minutes after injection or at the time of recovery.
Pet do deset minut po vbrizganju ali v času prenehanja delovanja zdravila lahko pride do bruhanja.