natgillin/translations-raw huggingface dataset:
ProMeris Duo 100.5 mg + 100.5 mg Spot-on for small dogs ProMeris Duo 199.5 mg + 199.5 mg Spot-on for medium sized dogs ProMeris Duo 499.5 mg + 499.5 mg Spot-on for medium/large sized dogs ProMeris Duo 799.5 mg + 799.5 mg Spot-on for large dogs ProMeris Duo 999 mg + 999mg Spot-on for extra large dogs
ProMeris Duo 100,5 mg + 100,5 mg kožni nanos za majhne pse ProMeris Duo 199,5 mg + 199,5 mg kožni nanos za srednje pse ProMeris Duo 499,5 mg + 499,5 mg kožni nanos za srednje/velike pse ProMeris Duo 799,5 mg + 799,5 mg kožni nanos za velike pse ProMeris Duo 999 mg + 999 mg kožni nanos za zelo velike pse
STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENTS Active substances
NAVEDBA ZDRAVILNE(IH) UČINKOVIN(E) IN DRUGEIH SESTAVIN Zdravilne učinkovine
Most lice are killed within 7 days.
Večino uši pobije v 7
If ill effects are noted following exposure to the product, seek immediate medical assistance, and show the product packaging to the physician.
V primeru bolezenskih znakov po izpostavitvi zdravilu se takoj posvetujte z zdravnikom in mu pokažite navodila za uporabo ali ovojnino.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Posebni previdnostni ukrepi, ki jih mora izvajati oseba, ki živalim daje zdravilo Zdravilo shranjujte nedosegljivo otrokom.
PARTICULARS TO APPEAR ON THE OUTER PACKAGE Carton box for 1 blister card - Carton box for 2 blister cards
PODATKI NA ZUNANJI OVOJNINI Kartonasta škatla z 1 blistrom - Kartonasta škatla z 2 blistroma
Weight Range of Dog (kg)
Razpon tel.mase psa (kg)
This product should not be administered by children.
Zdravila ne smejo dajati otroci.
*Due to limited space on the packaging, the abbreviations "S", "M", "M/L", "L" and "XL", which represent "small", “medium”,” medium/large”, “large” and “extra large”, respectively, are used on the blister foil and applicator pipettes.
* Zaradi omejenega prostora na ovojnini so na foliji in merilnih kapalkah uporabljene oznake: S (za majhne pse), M (za srednje pse), M/L (za srednje/velike pse), L (za velike pse) in XL (za zelo velike pse).
Name and address of the manufacturer responsible for batch release
Ime in naslov izdelovalca(izdelovalcev) zdravila, odgovornega za sprostitev serije
The application of the veterinary medicinal product may produce a local, temporary oily appearance and clumping or spiking of the hair at the application site.
Nanos zdravila lahko povzroči začasen lokalen masten izgled in vozlanje in zlepljanje dlake na mestu nanosa.
The veterinary medicinal product will prevent flea infestation for up to 6 weeks and tick infestation for 4 weeks following a single administration.
Zdravilo po enkratnem dajanju ščiti pred bolhami do 6 tednov in pred klopi do 4 tedne.
Do not administer to puppies under 8 weeks of age.
Ne dajati psom, mlajšim od 8 tednov.
PHARMACEUTICAL FORM Spot-on solution A clear, yellow to amber solution
FARMACEVTSKA OBLIKA Kožni nanos, raztopina Bistra, rumena do jantarna raztopina
Part the hair and apply the contents of the pipette to a single spot on the skin of the dog at the base of the skull.
Razprite dlako in nanesite vsebino pipete na eno mesto kože vratu na zatilju glave psa. Konico merilne kapalke nastavite na kožo in iztisnite celotno vsebino.
Each unit dose (pipette) of ProMeris Duo delivers: ProMeris Duo Spot-on for Dogs
Vsak odmerek (merilna kapalka) ProMeris Duo vsebuje: ProMeris Duo kožni nanos za pse
Children should not be allowed to have contact with treated animals until the application site is dry.
Otroci ne smejo biti v stiku z živaljo, dokler mesto nanosa ni suho.
It is important to apply the dose to an area where the animal cannot lick it off and to make sure that animals do not lick each other following treatment.
Odmerek nanesite na mesto, kjer ga žival ne more polizati.
Avoid contact with the eyes of the dog and avoid oral ingestion by the dog.
Preprečite, da bi zdravilo prišlo v stik z očmi psa in da bi ga pes pojedel.
Pharmacotherapeutic group: Ectoparasiticides for topical use, ATC Vet Code QP 53AD51
Farmakoterapevtska skupina: Ektoparazitiki za lokalno uporabo, oznaka ATC vet QP53AD51 Metaflumizon je insekticid, ki po sestavi spada v skupino semikarbazonov.
If the product accidentally gets into eyes, they should be thoroughly flushed with water.
Če zdravilo pride v stik z očmi, jih dobro sperite z veliko količino čiste vode.
and lice (Trichodectes canis) in dogs.
in ušivosti (Trichodectes canis)
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY OR USE Veterinary medicinal product subject to prescription The holder of this marketing authorisation must inform the European Commission about the marketing plans for the medicinal product authorised by this decision.
Skladno s sklepom mora imetnik dovoljenja za promet obvestiti Evropsko komisijo o načrtih trženja zdravila.
Box of 1 or 2 blister card of 3 x 0.67 ml pipettes Box of 1 or 2 blister card of 3 x 1.33 ml pipette Box of 1 or 2 blister card of 3 x 3.33 ml pipettes Box of 1 or 2 blister card of 3 x 5.33 ml pipettes Box of 1 or 2 blister card of 3 x 6.66 ml pipettes
Škatla z 1 ali 2 blistroma s 3 x 0,67 ml merilnimi kapalkami Škatla z 1 ali 2 blistroma s 3 x 1,33 ml merilnimi kapalkami Škatla z 1 ali 2 blistroma s 3 x 3,33 ml merilnimi kapalkami Škatla z 1 ali 2 blistroma s 3 x 5,33 ml merilnimi kapalkami Škatla z 1 ali 2 blistroma s 3 x 6,66 ml merilnimi kapalkami
STATEMENT OF ACTIVE AND OTHER SUBSTANCES Each 6.66 ml pipette delivers:
Vsaka 6,66 ml merilna kapalka vsebuje:
STATEMENT OF ACTIVE AND OTHER SUBSTANCES Each 0.67 ml pipette delivers:
Vsaka 0,67 ml merilna kapalka vsebuje:
MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Izdelovalec, odgovoren za sproščanje serije
MINIMUM PARTICULARS TO APPEAR ON PIPETTES for medium/large sized dogs
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MERILNIH KAPALKAH za srednje/velike pse
CONTENTS BY WEIGHT, BY VOLUME OR NUMBER OF DOSES 999 mg + 999 mg
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ODMERKOV 999 mg + 999 mg
Active substance: 100.5 mg metaflumizone and 100.5 mg amitraz
Zdravilne učinkovine: 100,5 mg metaflumizona in 100,5 mg amitraza
CONTENTS BY WEIGHT, BY VOLUME OR NUMBER OF DOSES 100.5 mg + 100.5 mg
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ODMERKOV 100,5 mg + 100,5 mg
CONTENTS BY WEIGHT, BY VOLUME OR NUMBER OF DOSES 799.5 mg + 799.5 mg
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ODMERKOV 799,5 mg + 799,5 mg
Active substance: 999 mg metaflumizone and 999 mg amitraz
Zdravilne učinkovine: 999 mg metaflumizona in 999 mg amitraza
Dermal exposure to the product should therefore be avoided.
Zato se je treba izogibati stiku zdravila s kožo.
C. STATEMENT OF THE MRLs Not applicable.
KARENCA Navedba ni smiselna
CONTENTS BY WEIGHT, BY VOLUME OR NUMBER OF DOSES 199.5 mg + 199.5 mg
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ODMERKOV 199,5 mg + 199,5 mg
The solvent in ProMeris Duo may stain certain materials including leather, fabrics, plastics and finished surfaces.
Topilo v zdravilu Promeris Duo lahko pusti madeže na nekaterih materialih, vključno z usnjem,
NAME OF THE VETERINARY MEDICINAL PRODUCT ProMeris Duo XL
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI ProMeris Duo XL
Active substance: 199.5 mg metaflumizone and 199.5 mg amitraz
Zdravilne učinkovine: 199,5 mg metaflumizona in 199,5 mg amitraza
For use only under the supervision of a veterinary supervision.
NASVET O PRAVILNI UPORABI ZDRAVILA Uporabljajte samo pod nadzorom veterinarja.
CONTENTS BY WEIGHT, BY VOLUME OR NUMBER OF DOSES 499.5 mg + 499.5 mg
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ODMERKOV 499,5 mg + 499,5 mg
However, prolonged, intense exposure to water should be avoided.
Zdravilo učinkuje tudi, če se žival zmoči, vendar pa se je treba izogniti daljšemu, močnemu izpostavljanju vodi.
NAME OF THE VETERINARY MEDICINAL PRODUCT ProMeris Duo 499.5 mg + 499.5 mg Spot-on for medium/large sized dogs {10.1 - 25.0 kg}
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI ProMeris Duo 499,5 mg + 499,5 mg kožni nanos za srednje/velike pse {10,1 - 25,0 kg}
Active substance: 799.5 mg metaflumizone and 799.5 mg amitraz
Zdravilne učinkovine: 799,5 mg metaflumizona in 799,5 mg amitraza
NAME OF THE VETERINARY MEDICINAL PRODUCT ProMeris Duo 100.5 mg + 100.5 mg Spot-on for small dogs {≤ to 5 kg}
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI ProMeris Duo 100,5 mg + 100,5 mg kožni nanos za majhne pse{≤ 5 kg}
ProMeris Duo Spot-on for Medium/Large Sized Dogs (10.1 - 25.0 kg)*
ProMeris Duo kožni nanos za srednje/velike pse (10,1 - 25,0 kg)*
Active substance: 499.5 mg metaflumizone and 499.5 mg amitraz
Zdravilne učinkovine: 499,5 mg metaflumizona in 499,5 mg amitraza
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS FOIL 0.67ml
OVOJNINAH FOLIJA 0,67 ml
Box of 1 blister card of 3 x 6.66 ml pipettes Box of 2 blister cards of 3 x 6.66 ml pipettes
VELIKOST PAKIRANJA Škatla z 1 blistrom s 3 x 6,66 ml merilnimi kapalkami Škatla z 2 blistroma s 3 x 6,66 ml merilnimi kapalkami
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS FOIL 6.66ml
OVOJNINAH FOLIJA 6.66 ml
STATEMENT OF ACTIVE AND OTHER SUBSTANCES Each 5.33 ml pipette delivers:
Vsaka 5,33 ml merilna kapalka vsebuje:
ProMeris Duo Spot-on for Extra Large Dogs (40.1 - 50.0 kg)*
ProMeris Duo kožni nanos za zelo velike pse (40,1 - 50,0 kg)*
NAME OF THE VETERINARY MEDICINAL PRODUCT ProMeris Duo 799.5 mg + 799.5 mg Spot-on for large dogs {25.1 - 40.0 kg}
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI ProMeris Duo 799,5 mg + 799,5 mg kožni nanos za velike pse {25,1 - 40,0 kg}
MINIMUM PARTICULARS TO APPEAR ON PIPETTES for small dogs
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MERILNIH KAPALKAH za male pse
ProMeris Duo for Small Dogs 5.1 - 10.0 ProMeris Duo Medium Sized Dogs 10.1 - 25.0 ProMeris Duo Spot-on for Medium/Large Sized Dogs 25.1 - 40.0 ProMeris Duo Spot-on for Large Dogs 40.1 - 50.0 ProMeris Duo Spot-on for Extra Large Dogs
ProMeris Duo za majhne pse ProMeris Duo za srednje pse ProMeris Duo za srednje/velike pse ProMeris Duo za velike pse ProMeris Duo za zelo velike pse
Box of 1 blister card of 3 x 0.67 ml pipettes Box of 2 blister cards of 3 x 0.67 ml pipettes
VELIKOST PAKIRANJA Škatla z 1 blistrom s 3 x 0,67 ml merilnimi kapalkami Škatla z 2 blistroma s 3 x 0,67 ml merilnimi kapalkami
MARKETING AUTHORISATION NUMBER(S) EU/2/06/065/009 - 1 blister card of 3 pipettes of 6.66 ml EU/2/06/065/010 - 2 blister cards of 3 pipettes of 6.66 ml
ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/06/065/009 - 1 blister s 3 merilnimi kapalkami po 6,66 ml EU/2/06/065/010 - 2 blistra s 3 merilnimi kapalkami po 6,66 ml
STATEMENT OF ACTIVE AND OTHER SUBSTANCES Each 1.33 ml pipette delivers:
Vsaka 1,33 ml merilna kapalka vsebuje:
NAME OF THE VETERINARY MEDICINAL PRODUCT ProMeris Duo M/L
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI ProMeris Duo M/L
NAME OF THE VETERINARY MEDICINAL PRODUCT ProMeris Duo 999 mg + 999 mg Spot-on for extra large dogs {40.1 - 50.0 kg}
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI ProMeris Duo 999 mg + 999 mg kožni nanos za zelo velike pse {40,1 - 50,0 kg}
NAME OF THE VETERINARY MEDICINAL PRODUCT ProMeris Duo 199.5 mg + 199.5 mg Spot-on for medium sized dogs {5.1 - 10.0 kg}
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI ProMeris Duo 199,5 mg + 199,5 mg kožni nanos za srednje pse {5,1 - 10,0 kg}
STATEMENT OF ACTIVE AND OTHER SUBSTANCES Each 3.33 ml pipette delivers:
Vsaka 3,33 ml merilna kapalka vsebuje:
The use of protective gloves while handling the product is recommended.
Med dajanjerm je priporočljiva uporaba rokavic.
NAME OF THE VETERINARY MEDICINAL PRODUCT ProMeris Duo S
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI ProMeris Duo S
NAME OF THE VETERINARY MEDICINAL PRODUCT ProMeris Duo M
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI ProMeris Duo M
MARKETING AUTHORISATION NUMBER(S) EU/2/06/065/001 - 1 blister card of 3 pipettes of 0.67ml EU/2/06/065/002 - 2 blister cards of 3 pipettes of 0.67ml
ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/06/065/001 - 1 blister s 3 merilnimi kapalkami po 0,67ml EU/2/06/065/002 - 2 blistra s 3 merilnimi kapalkami of 0,67ml
5.1 - 10.0 ProMeris Duo Medium Sized Dogs 10.1 - 25.0 ProMeris Duo for Medium/Large Sized Dogs 25.1 - 40.0 ProMeris Duo for Large Dogs 40.1 - 50.0 ProMeris Duo for Extra Large Dogs
ProMeris Duo za srednje pse ProMeris Duo za srednje/velike pse ProMeris Duo za velike pse ProMeris Duo za zelo velike pse
Box of 1 blister card of 3 x 1.33 ml pipettes Box of 2 blister cards of 3 x 1.33 ml pipettes
VELIKOST PAKIRANJA Škatla z 1 blistrom s 3 x 1,33 ml merilnimi kapalkami Škatla z 2 blistroma s 3 x 1,33 ml merilnimi kapalkami
Box of 1 blister card of 3 x 5.33 ml pipettes Box of 2 blister cards of 3 x 5.33 ml pipettes
VELIKOST PAKIRANJA Škatla z 1 blistrom s 3 x 5,33 ml merilnimi kapalkami Škatla z 2 blistroma s 3 x 5,33 ml merilnimi kapalkami
Allow the application site to dry before permitting contact with such materials.
tkaninami, plastiko in lakiranimi površinami, zato zagotovite, da se mesto nanosa posuši, preden pride v stik s takimi površinami.
MARKETING AUTHORISATION NUMBER(S) EU/2/06/065/007 - 1 blister card of 3 pipettes of 5.33 ml EU/2/06/065/008 - 2 blister cards of 3 pipettes of 5.33 ml
ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/06/065/007 - 1 blister s 3 merilnimi kapalkami po 5,33 ml EU/2/06/065/008 - 2 blistra s 3 merilnimi kapalkami po 5,33 ml
MINIMUM PARTICULARS TO APPEAR ON PIPETTES for large dogs
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MERILNIH KAPALKAH za velike pse
ProMeris Duo Spot-on for Large Dogs (25.1 - 40.0 kg)*
ProMeris Duo kožni nanos za velike pse (25,140,0 kg)*
Spot-on solution
Razpon tel.mase
MARKETING AUTHORISATION NUMBER(S) EU/2/06/065/005 - 1 blister card of 3 pipettes of 3.33 ml EU/2/06/065/006 - 2 blister cards of 3 pipettes of 3.33 ml
ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/06/065/005 - 1 blister s 3 merilnimi kapalkami po 3,33 ml EU/2/06/065/006 - 2 blistra s 3 merilnimi kapalkami po 3,33 ml
MINIMUM PARTICULARS TO APPEAR ON PIPETTES for medium sized dogs
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MERILNIH KAPALKAH za srednje pse
NAME OF THE VETERINARY MEDICINAL PRODUCT ProMeris Duo L
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI ProMeris Duo L
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS FOIL 5.33ml
OVOJNINAH FOLIJA 5.33 ml
Box of 1 blister card of 3 x 3.33 ml pipettes Box of 2 blister cards of 3 x 3.33 ml pipettes
VELIKOST PAKIRANJA Škatla z 1 blistrom s 3 x 3,33 ml merilnimi kapalkami Škatla z 2 blistroma s 3 x 3,33 ml merilnimi kapalkami
MARKETING AUTHORISATION NUMBER(S) EU/2/06/065/003 - 1 blister card of 3 pipettes of 1.33ml EU/2/06/065/004 - 2 blister cards of 3 pipettes of 1.33ml
EU/2/06/065/003 - 1 blister s 3 merilnimi kapalkami po 1,33ml EU/2/06/065/004 - 2 blistra s 3 merilnimi kapalkami po 1,33ml
MINIMUM PARTICULARS TO APPEAR ON PIPETTES for extra large dogs
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MERILNIH KAPALKAH za zelo velike pse
PACKAGE SIZE
Velikost merilne kapalke
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS FOIL 3.33ml
OVOJNINAH FOLIJA 3.33 ml
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS FOIL 1.33ml
OVOJNINAH FOLIJA 1.33 ml
In addition, injections do not need to be given frequently because the implant stays in the eye for several months.
Poleg tega injekcij ni treba dajati pogosto, saj vsadek v očesu ostane več mesecev.
• blockage of the veins carrying blood from the back of the eye;
• zaporo ven, ki prenašajo kri iz očesnega ozadja;
Further information on Ozurdex can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/ozurdex.
Nadaljnje informacije za zdravilo Ozurdex so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/ozurdex.
Patients were followed up for 3 years and could be given repeat treatment if appropriate.
Bolnike so spremljali do tri leta, po potrebi pa so zdravljenje ponovili.
The bleeding is thought to be caused by the injection procedure and not by the medicine itself.
Krvavitev naj bi bila posledica postopka injiciranja in ne samega zdravila.
Further treatments can be given if the patient's condition improves but then gets worse and if the doctor believes that the patient will benefit from further treatment.
Zdravljenje se lahko nadaljuje, če se bolnikovo stanje izboljša in nato poslabša, zdravnik pa meni, da bo bolniku nadaljnje zdravljenje koristilo.
Ozurdex received a marketing authorisation valid throughout the European Union on 27 July 2010.
Za zdravilo Ozurdex je bilo 27. julija 2010 izdano dovoljenje za promet, veljavno po vsej EU.
What measures are being taken to ensure the safe and effective use of Ozurdex?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Ozurdex?
• damage to blood vessels caused by diabetes in patients who have an artificial lens in their eye or in whom other treatment did not work or was unsuitable.
• poškodbo krvnih žil, ki jo povzroča sladkorna bolezen, pri bolnikih z umetno lečo v očesu ali pri bolnikih, pri katerih drugo zdravljenje ni bilo učinkovito ali primerno.
In addition, the company that makes Ozurdex will ensure that patients are provided an information pack, including a booklet and an audio CD.
Poleg tega bo družba, ki izdeluje zdravilo Ozurdex, poskrbela, da bolniki prejmejo komplet informacij, vključno s knjižico in avdio CD-jem.
Therefore the use of Ozurdex in patients with macular oedema related to diabetes was restricted to these two groups.
Zato so uporabo zdravila Ozurdex pri bolnikih z makularnim edemom, povezanim s sladkorno boleznijo, omejili na ti dve skupini.
The implant is made of a material that dissolves over several months while gradually releasing the dexamethasone.
Vsadek je narejen iz materiala, ki se v nekaj mesecih raztopi in pri tem postopoma sprošča deksametazon.
Side effects reported with Ozurdex are carefully evaluated and any necessary action taken to protect patients.
Neželeni učinki, o katerih so poročali pri zdravilu Ozurdex, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
An overview of Ozurdex and why it is authorised in the EU
Pregled zdravila Ozurdex in zakaj je odobreno v EU
Each implant is in an applicator and contains 700 micrograms of the active substance, dexamethasone.
Vsak vsadek je v aplikatorju in vsebuje 700 mikrogramov učinkovine deksametazon.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Ozurdex have been included in the summary of product characteristics and the package leaflet.
Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Ozurdex upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
Other information about Ozurdex
Druge informacije o zdravilu Ozurdex
As for all medicines, data on the use of Ozurdex are continuously monitored.
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Ozurdex stalno spremljajo.
It must also not be used in certain cases where the back of the membrane that surrounds the lens (the lens capsule) is torn.
Prav tako se ne sme uporabljati v določenih primerih, kadar je raztrgan zadnji del membrane (kapsula leče), ki obdaja lečo.
The active substance in Ozurdex, dexamethasone, belongs to a group of anti-inflammatory medicines known as corticosteroids.
Učinkovina v zdravilu Ozurdex, deksametazon, spada v skupino protivnetnih zdravil, znanih kot kortikosteroidi.
In the overall group of patients with macular oedema related to diabetes the Agency noted that the benefit was modest and was outweighed by the risks, including the development of cataracts.
Za celotno skupino bolnikov z makularnim edemom, povezanim s sladkorno boleznijo, je agencija poudarila, da so bile koristi skromne in da so bila tveganja, vključno s pojavom katarakt, večja od koristi.
For more information about using Ozurdex, see the package leaflet or contact your doctor or pharmacist.
Za več informacij glede uporabe zdravila Ozurdex glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
It works by entering cells and blocking the production of vascular endothelial growth factor (VEGF) and prostaglandins, substances that are involved in inflammation.
Deluje tako, da vstopi v celice in zavira nastajanje vaskularnega endotelijskega rastnega faktorja (VEGF) in prostaglandinov, tj. snovi, ki sodelujejo pri vnetju.
Why is Ozurdex authorised in the EU?
Zakaj je bilo zdravilo Ozurdex odobreno v EU?
Eyesight was measured using the ‘best corrected visual acuity' (BCVA) indicating how well a person can see (after they have been given corrective lenses).
Vid so merili z „najboljšo vidno ostrino s korekcijo“ (BCVA), ki kaže, kako dobro oseba vidi (z uporabo korekcijskih leč).
Macular oedema is swelling in the macula, the central part of the retina (the light-sensing layer at the back of the eye), which can reduce the central part of a person's vision and affect tasks such as reading and driving.
Makularni edem je otekanje makule, osrednjega dela mrežnice (plasti v ozadju očesa, ki zaznava svetlobo), ki lahko zmanjša osrednji del vida posameznika in vpliva na dejavnosti, kot sta branje in vožnja.
Patients whose vision is getting worse and is not improved by Ozurdex should also not receive any more implants.
Bolniki, pri katerih se vid poslabša in se z zdravilom Ozurdex ne izboljša, prav tako ne smejo prejeti dodatnih vsadkov.
What benefits of Ozurdex have been shown in studies?
Kakšne koristi zdravila Ozurdex so se pokazale v študijah?
Ozurdex injection causes only minor trauma to the eyeball and the increase in intraocular pressure is considered to be manageable.
Injiciranje zdravila Ozurdex povzroči manjšo poškodbo zrkla, zvišanje intraokularnega tlaka pa velja za obvladljivo.
Ozurdex must not be used in patients who have or are thought to have ocular or periocular infections (infections in or around the eyes) and in patients with advanced glaucoma (damage to the nerve of the eye usually caused by high pressure inside the eye) that is not adequately controlled with medicines alone.
Zdravilo Ozurdex se ne sme uporabljati pri bolnikih, ki imajo ali pri katerih obstaja sum, da imajo očesne ali periokularne okužbe (okužbe v očesu ali okoli njega), ter pri bolnikih z napredovalim glavkomom (poškodbo očesnega živca, ki je običajno posledica visokega tlaka v očesu), ki samo z zdravili ni ustrezno nadzorovan.
In two main studies involving a total of 1,267 adults Ozurdex was more effective than the sham treatment at improving patients' eyesight.
V dveh glavnih študijah, ki sta skupaj vključevali 1 267 odraslih, je bilo zdravilo Ozurdex učinkovitejše od navideznega zdravljenja pri izboljševanju vida bolnikov.
The most common side effects with Ozurdex (which may affect more than 1 in 10 people) are increased intraocular pressure (the pressure inside the eye), conjunctival haemorrhage (bleeding from the membrane over the white of the eye) and cataract (clouding of the lens - in patients with uveitis and with diabetes).
Najpogostejši neželeni učinki zdravila Ozurdex (ki se lahko pojavijo pri več kot 1 od 10 bolnikov) so zvišan intraokularni tlak (tlak znotraj očesa), krvavitev iz veznice (krvavitev iz membrane, ki prekriva beločnico) in katarakta (zameglitev leče - pri bolnikih z uveitisom in sladkorno boleznijo).
This ensures that adequate amounts of dexamethasone reach the area inside the eye where the inflammation in macular oedema and uveitis occurs.
To zagotovi, da zadostna količina deksametazona doseže predel v očesu, v katerem je prišlo do makularnega edema in uveitisa.
However, in those with an artificial lens in the affected eye or who previously have not responded to or are unsuitable for other non-corticosteroid treatments, the benefits of Ozurdex were considered to outweigh the risks.
Vendar pa je bilo ocenjeno, da pri bolnikih z umetno lečo v prizadetem očesu ali pri tistih, ki se predhodno niso odzvali na druga kortikosteroidna zdravila oziroma ta niso primerna zanje, koristi zdravila Ozurdex odtehtajo njegova tveganja.
What is Ozurdex and what is it used for?
Kaj je zdravilo Ozurdex in za kaj se uporablja?