qanastek/EMEA-V3 huggingface dataset:
GENERAL CLASSIFICATION FOR SUPPLY
bas: neparasti sapņ apjukums, dī i,
Medicinal product subject to medical prescription.
cijas, galvassā hiperkinē hipotensija, pes, ze,
15.
ana š
INSTRUCTIONS ON USE
nija, rēanā
16.
bas
INFORMATION IN BRAILLE
reakcijas.
Oprymea 0.18 mg
tu tī
62 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND IMMEDIATE PACKAGING
abā grupā Par vismaz vienu blakusparā bu ziņ 63% pacientu pramipeksola grupā 52% pacientu
BOX for blisters
placebo grupā.
NAME OF THE MEDICINAL PRODUCT
miegainī bezmiegu, aizcietē
Oprymea 0.18 mg tablets Pramipexole
jumiem, halucinā m, galvassā cijā
2.
ā
STATEMENT OF ACTIVE SUBSTANCE(S)
pramipeksola grupāsalī, dzinot ar placebo).
Each tablet contains 0.18 mg pramipexole equivalent to 0.25 mg pramipexole dihydrochloride monohydrate.
bas
3.
s,
LIST OF EXCIPIENTS
rsniedz
PHARMACEUTICAL FORM AND CONTENTS
diskinē Hipotensiju novē terapijas sā
90 tablets
ā 5%) ots
METHOD AND ROUTE(S) OF ADMINISTRATION
galvassā m, reiboni un nogurumu.
Read the package leaflet before use.
attiecī 10, 5%), nekā rieš (6, 7% un attiecī 7, 3%).
Oral use
vī iem
6.
gi
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE REACH AND SIGHT OF CHILDREN
1. un 2. tabulā apkopoti ziņ ojumi par zā blakusparā bā kas saņ
Keep out of the reach and sight of children.
Tabulā apkopotas zā blakusparā bas, kas novē
7.
dī
OTHER SPECIAL WARNING(S), IF NECESSARY
pacientu, kas ā ti ar k rstē
EXPIRY DATE
dzinot ar placebo, vai
EXP
mī
SPECIAL STORAGE CONDITIONS
blakusparā bas bija vieglas lī mē
Store in the original package in order to protect from light.
bija tendence izzust arī ja terapija tika turpinā
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
Blakusparā bas, par kurā ziņ ļ biež( ≥ Orgā sistē
11.
mas
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Kuņa un zarnu trakta traucē
63 KRKA, d. d., Novo mesto, Š marješ cesta 6, 8501 Novo mesto, Slovenia ka
12, 6
12.
mas
MARKETING AUTHORISATION NUMBER(S)
Pramipeksols N = 1923 (%)
EU/ 1/ 08/ 469/ 009
Psihiskie traucē
13.
jumi
BATCH NUMBER
3, 5 3, 0 6, 6 8, 2
Batch
mas
14.
jumi
15.
jumi
INSTRUCTIONS ON USE
Aizcietējumi
16.
5, 5
INFORMATION IN BRAILLE
Vispā ji traucē
Oprymea 0.18 mg
jumi un reakcijas
64 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND IMMEDIATE PACKAGING
6, 1
BOX for blisters
ievadī š vietā
1.
anas
NAME OF THE MEDICINAL PRODUCT
Perifē tū ra ska
Oprymea 0.18 mg tablets Pramipexole
Pramipeksola lietoš ir saistī ar miegainī (8, 6%), nereti tā
STATEMENT OF ACTIVE SUBSTANCE(S)
laikā pē ņ miega epizodē (0, 1%).
Each tablet contains 0.18 mg pramipexole equivalent to 0.25 mg pramipexole dihydrochloride monohydrate.
Pramipeksols var būsaistī ar dzimumtieksmes traucē 0, 4%).
3.
ts
LIST OF EXCIPIENTS
Pacientiem, kas Parkinsona slimī terapijā
PHARMACEUTICAL FORM AND CONTENTS
agonistus, ieskaitot pramipeksolu, na
100 tablets
ī i paš
METHOD AND ROUTE(S) OF ADMINISTRATION
hiperseksualitā kas pē terapijas pā
Read the package leaflet before use.
rtraukš parasti ir atgriezeniska. anas
Oral use
niskā
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE REACH AND SIGHT OF CHILDREN
agonistu farmakodinamisko profilu, ietverot sliktu dūu, vemš hiperkinē halucinā uzbudinā
65 KRKA, d. d., Novo mesto, Š marješ cesta 6, 8501 Novo mesto, Slovenia ka
vniekiem konstatē ka pramipeksols nomā ja,
12.
Klī
EU/ 1/ 08/ 469/ 010
Kontrolē klī
Oprymea 0.18 mg
terapiju ar ju
66 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
motorā funkcijas uzlaboš levodopas terapijas laikā
BLISTER/ (Al/ Al)
dī jos).
Oprymea 0.18 mg tablets Pramipexole
5. 2 Farmakokinē s ī ī tiskā pašbas
NAME OF THE MARKETING AUTHORISATION HOLDER
kiem pramipeksols ļ vā saistā ar oti ji s
KRKA
ciju
EXPIRY DATE
Cilvē organismā
EXP
mē
4.
m,
BATCH NUMBER
ū cē st
Batch
jais
OTHER
rtiķ
67 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND IMMEDIATE PACKAGING
teratogē ž m un truš tač bija embriotoksisks ž m, ja to lietoja mā toksiskā
BOX for blisters
Š pašpējumā
NAME OF THE MEDICINAL PRODUCT
m 2 mg/ kg (sā un ja, nā urkā
Oprymea 0.35 mg tablets Pramipexole
FARMACEITISKĀ Ī Ī S PAŠBAS
2.
pa
STATEMENT OF ACTIVE SUBSTANCE(S)
Blisteri (Al/ Al folija):
Each tablet contains 0.35 mg pramipexole equivalent to 0.5 mg pramipexole dihydrochloride monohydrate.
Neizlietotā zā vai citus izlietotos materiā jā cina atbilstošvietē m prasī m.
LIST OF EXCIPIENTS
REĢISTRĀCIJAS APLIECĪ BAS Ī NIEKS PAŠ
PHARMACEUTICAL FORM AND CONTENTS
REĢISTRĀCIJAS NUMURS
20 tablets
20 tabletes:
METHOD AND ROUTE(S) OF ADMINISTRATION
REĢISTRĀCIJAS/ PĀRREĢISTRĀCIJAS DATUMS
Read the package leaflet before use.
TEKSTA PĒ JĀ PĀ DĒ S RSKATĪANAS DATUMS Š
Oral use
ļ entū
6.
jas
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE REACH AND SIGHT OF CHILDREN
:
Keep out of the reach and sight of children.
http: // www. emea. europa. eu /.
OTHER SPECIAL WARNING(S), IF NECESSARY
RAŽ ANAS LICENCES Ī NIEKS, KURŠATBILD PAR
8.
OŠ
EXP
PAŠ
SPECIAL STORAGE CONDITIONS
REĢISTRĀCIJAS APLIECĪ BAS NOSACĪ JUMI
Store in the original package in order to protect from light.
RAŽ ANAS LICENCES Ī NIEKS, KURŠATBILD PAR SĒ
10.
OŠ
11.
PAŠ
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Raž ja, kas atbild par sē izlaidi, nosaukums un adrese otā rijas
68 KRKA, d. d., Novo mesto, Š marješ cesta 6, 8501 Novo mesto, Slovenia ka
Krka, d. d., Novo mesto Šmarješ cesta 6 ka 8501 Novo mesto Slovēnija
MARKETING AUTHORISATION NUMBER(S)
UZLIKTI REĢISTRĀCIJAS PALIECĪBAS
EU/ 1/ 08/ 469/ 011
Ī NIEKAM PAŠ
13.
DI
BATCH NUMBER
LIETOŠANU
Batch
istrā
14.
ļu
GENERAL CLASSIFICATION FOR SUPPLY
š sā anas, kā tā laikā anas kš arī s
Medicinal product subject to medical prescription.
m atbilst atsauces zā PSUR iesniegš plā ļu anas nam.
15.
44 A.
INSTRUCTIONS ON USE
MARĶ JUMA TEKSTS Ē
16.
DA
INFORMATION IN BRAILLE
ZĀ U NOSAUKUMS Ļ
Oprymea 0.35 mg
Oprymea 0, 088 mg tabletes Pramipexole
69 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND IMMEDIATE PACKAGING
AKTĪ S( O) VIELAS( U) NOSAUKUMS( I) UN DAUDZUMS( I) VĀ
BOX for blisters
Iekšī lietoš
NAME OF THE MEDICINAL PRODUCT
DINĀJUMI, JA NEPIECIEŠAMS
Oprymea 0.35 mg tablets Pramipexole
Ī I UZGLABĀ ANAS NOSACĪ
2.
PA
STATEMENT OF ACTIVE SUBSTANCE(S)
PIEMĒROJAMS)
Each tablet contains 0.35 mg pramipexole equivalent to 0.5 mg pramipexole dihydrochloride monohydrate.
KRKA, d. d., Novo mesto, Šmarješ cesta 6, 8501 Novo mesto, Slovē
3.
ka
LIST OF EXCIPIENTS
Recepš zā u les.
PHARMACEUTICAL FORM AND CONTENTS
Oprymea 0, 088 mg tabletes Pramipexole
METHOD AND ROUTE(S) OF ADMINISTRATION
LIETOŠANAS METODE UN IEVADĪANAS VEIDS Š
Read the package leaflet before use.
Pirms lietoš izlasiet lietoš instrukciju.
Oral use
anai.
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE REACH AND SIGHT OF CHILDREN
DINĀJUMI PAR ZĀ U UZGLABĀ ANU BĒ Ļ Š RNIEM NEPIEEJAMĀUN
Keep out of the reach and sight of children.
Uzglabābē t rniem nepieejamā neredzamā
OTHER SPECIAL WARNING(S), IF NECESSARY
DINĀJUMI, JA NEPIECIEŠAMS
EXPIRY DATE
Derī lī gs dz:
9.
PA
SPECIAL STORAGE CONDITIONS
Uzglabāoriģ lā
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
BAS PASĀKUMI, IZNĪCINOT NEIZLIETOTO PREPARĀ
11.
TU
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
REĢISTRĀCIJAS APLIECĪ BAS Ī NIEKA NOSAUKUMS UN ADRESE PAŠ
70 12.
nija
Batch
Sē rija:
GENERAL CLASSIFICATION FOR SUPPLY
IZSNIEGŠANAS KĀ BA RTĪ
Medicinal product subject to medical prescription.
Recepš zā u les.
INSTRUCTIONS ON USE
NORĀ JUMIMPAR LIETOŠ
71 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND IMMEDIATE PACKAGING
49 INFORMACIJA, KAS JĀNORĀ UZ ARĒ
BOX for blisters
JĀIEPAKOJUMA
Oprymea 0.35 mg tablets Pramipexole
Oprymea 0, 088 mg tabletes Pramipexole
STATEMENT OF ACTIVE SUBSTANCE(S)
AKTĪ S( O) VIELAS( U) NOSAUKUMS( I) UN DAUDZUMS( I) VĀ
Each tablet contains 0.35 mg pramipexole equivalent to 0.5 mg pramipexole dihydrochloride monohydrate.
Katra tablete satur 0, 088 mg pramipeksola, kas atbilst 0, 125 mg pramipeksola dihidrohlor ī monohidrā
LIST OF EXCIPIENTS
PALĪ GVIELU SARAKSTS
PHARMACEUTICAL FORM AND CONTENTS
ZĀ U FORMA UN SATURS Ļ
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
IZMANTOTOS MATERIĀ LUS, KAS BIJUŠ SASKARĒAR Š PREPARĀ (JA
72 KRKA, d. d., Novo mesto, Š marješ cesta 6, 8501 Novo mesto, Slovenia ka
KRKA, d. d., Novo mesto, Šmarješ cesta 6, 8501 Novo mesto, Slovē
73 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND IMMEDIATE PACKAGING
51 INFORMACIJA, KAS JĀNORĀ UZ ARĒ
90 tablets
90 tabletes
74 KRKA, d. d., Novo mesto, Š marješ cesta 6, 8501 Novo mesto, Slovenia ka
KRKA, d. d., Novo mesto, Šmarješ cesta 6, 8501 Novo mesto, Slovē
75 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND IMMEDIATE PACKAGING
53 INFORMACIJA, KAS JĀNORĀ UZ ARĒ
76 KRKA, d. d., Novo mesto, Š marješ cesta 6, 8501 Novo mesto, Slovenia ka
KRKA, d. d., Novo mesto, Šmarješ cesta 6, 8501 Novo mesto, Slovē
77 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
55 MINIMĀLĀINFORMĀCIJA, IZVIETOJAMA UZ BLISTERA VAI PLĀKSNĪ TES
BLISTER/ (Al/ Al)
BLISTERS (Al/ Al)
NAME OF THE MARKETING AUTHORISATION HOLDER
REĢISTRĀCIJAS APLIECĪ BAS Ī NIEKA NOSAUKUMS PAŠ
EXPIRY DATE
DERĪ GUMA TERMIŅŠ
EXP
Der. lī dz:
78 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND IMMEDIATE PACKAGING
56 INFORMACIJA, KAS JĀNORĀ UZ ARĒ
Oprymea 0.7 mg tablets Pramipexole
Oprymea 0, 18 mg tabletes Pramipexole
Each tablet contains 0.7 mg pramipexole equivalent to 1 mg pramipexole dihydrochloride monohydrate.
Katra tablete satur 0, 18 mg pramipeksola, kas atbilst 0, 25 mg pramipeksola dihidrohlor ī monohidrā
5.
PA
METHOD AND ROUTE(S) OF ADMINISTRATION
PIEMĒROJAMS)
Read the package leaflet before use.
KRKA, d. d., Novo mesto, Šmarješ cesta 6, 8501 Novo mesto, Slovē
Oral use
Sē rija:
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE REACH AND SIGHT OF CHILDREN
Katra tablete satur 0, 18 mg pramipeksola, kas atbilst 0, 25 mg pramipeksola dihidrohlor ī monohidrā
Keep out of the reach and sight of children.
Pirms lietoš izlasiet lietoš instrukciju.
7.
PA
OTHER SPECIAL WARNING(S), IF NECESSARY
PIEMĒROJAMS)
EXPIRY DATE
Sē rija:
EXP
ta.
SPECIAL STORAGE CONDITIONS
ZĀ U FORMA UN SATURS Ļ
Store in the original package in order to protect from light.
Pirms lietoš izlasiet lietoš instrukciju.
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
Katra tablete satur 0, 18 mg pramipeksola, kas atbilst 0, 25 mg pramipeksola dihidrohlorī monohidrā
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
LIETOŠANAS METODE UN IEVADĪANAS VEIDS Š
79 KRKA, d. d., Novo mesto, Š marješ cesta 6, 8501 Novo mesto, Slovenia ka
Ī I BRĪ
MARKETING AUTHORISATION NUMBER(S)
PIEMĒROJAMS)
13.
ta.
BATCH NUMBER
100 tabletes
Batch
anai.
14.
PAŠ
GENERAL CLASSIFICATION FOR SUPPLY
Ī I UZGLABĀ ANAS NOSACĪ
Medicinal product subject to medical prescription.
inā iepakojumālai aizsargā no gaismas., tu
INSTRUCTIONS ON USE
SĒRIJAS NUMURS
INFORMATION IN BRAILLE
NORĀ JUMIMPAR LIETOŠ
80 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND IMMEDIATE PACKAGING
66 MINIMĀLĀINFORMĀCIJA, IZVIETOJAMA UZ BLISTERA VAI PLĀKSNĪ TES
BOX for blisters
ZĀ U NOSAUKUMS Ļ
NAME OF THE MEDICINAL PRODUCT
DERĪ GUMA TERMIŅŠ
Oprymea 0.7 mg tablets Pramipexole
Oprymea 0, 35 mg tabletes Pramipexole
Each tablet contains 0.7 mg pramipexole equivalent to 1 mg pramipexole dihydrochloride monohydrate.
ZĀ U NOSAUKUMS Ļ
82 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND IMMEDIATE PACKAGING
71 INFORMACIJA, KAS JĀNORĀ UZ ARĒ
Each tablet contains 0.7 mg pramipexole equivalent to 1 mg pramipexole dihydrochloride monohydrate.
Katra tablete satur 0, 35 mg pramipeksola, kas atbilst 0, 5 mg pramipeksola dihidrohlorī monohidrā
84 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND IMMEDIATE PACKAGING
73 INFORMACIJA, KAS JĀNORĀ UZ ARĒ
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICI NAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
BAS PASĀKUMI, IZNĪCINOT NEIZLIETOTO PREPARĀ
86 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND IMMEDIATE PACKAGING
75 INFORMACIJA, KAS JĀNORĀ UZ ARĒ
87 12.
nija
88 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
77 MINIMĀLĀINFORMĀCIJA, IZVIETOJAMA UZ BLISTERA VAI PLĀKSNĪ TES
89 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND IMMEDIATE PACKAGING
78 INFORMACIJA, KAS JĀNORĀ UZ ARĒ
Oprymea 1.1 mg tablets Pramipexole
Oprymea 0, 7 mg tabletes Pramipexole
Each tablet contains 1.1 mg pramipexole equivalent to 1.5 mg pramipexole dihydrochloride monohydrate.
Katra tablete satur 0, 7 mg pramipeksola, kas atbilst 1 mg pramipeksola dihidrohlorī monohidrā
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE REACH AND SIGHT OF CHILDREN
Katra tablete satur 0, 7 mg pramipeksola, kas atbilst 1 mg pramipeksola dihidrohlorī monohidrā
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
Katra tablete satur 0, 7 mg pramipeksola, kas atbilst 1 mg pramipeksola dihidrohlorī monohidrā
KRKA, d. d., Novo mesto, Š marješ cesta 6, 8501 Novo mesto, Slovenia ka
Ī I BRĪ
90 12.
90 tabletes
EU/ 1/ 08/ 469/ 021
EU/ 1/ 08/ 469/ 019
BATCH NUMBER
CITI Ī I BRĪ
Batch
87 11.
14.
ANU
GENERAL CLASSIFICATION FOR SUPPLY
INFORMĀCIJA BRAILA RAKSTĀ
Medicinal product subject to medical prescription.
Pirms lietoš izlasiet lietoš instrukciju.
91 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND IMMEDIATE PACKAGING
91 INFORMACIJA, KAS JĀNORĀ UZ ARĒ
Oprymea 1.1 mg tablets Pramipexole
Oprymea 1, 1 mg tabletes Pramipexole
Each tablet contains 1.1 mg pramipexole equivalent to 1.5 mg pramipexole dihydrochloride monohydrate.
Katra tablete satur 1, 1 mg pramipeksola, kas atbilst 1, 5 mg pramipeksola dihidrohlorī monohidrā
92 12.
nija
93 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND IMMEDIATE PACKAGING
93 INFORMACIJA, KAS JĀNORĀ UZ ARĒ
Each tablet contains 1.1 mg pramipexole equivalent to 1.5 mg pramipexole dihydrochloride monohydrate.
Katra tablete satur 1, 1 mg pramipeksola, kas atbilst 1, 5 mg pramipeksola dihidrohlor ī monohidrā
94 12.
nija
95 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND IMMEDIATE PACKAGING
95 INFORMACIJA, KAS JĀNORĀ UZ ARĒ
96 12.
nija
97 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND IMMEDIATE PACKAGING
97 INFORMACIJA, KAS JĀNORĀ UZ ARĒ
98 12.
nija
99 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
99 MINIMĀLĀINFORMĀCIJA, IZVIETOJAMA UZ BLISTERA VAI PLĀKSNĪ TES
101 PACKAGE LEAFLET:
101 LIETOŠANAS INSTRUKCIJA:
INFORMATION FOR THE USER
INFORMACIJA ZĀ U LIETOTĀ
Oprymea 0.088 mg tablets Oprymea 0.18 mg tablets Oprymea 0.35 mg tablets Oprymea 0.7 mg tablets Oprymea 1.1 mg tablets Pramipexole
Oprymea 0, 088 mg tabletes Oprymea 0, 18 mg tabletes Oprymea 0, 35 mg tabletes Oprymea 0, 7 mg tabletes Oprymea 1, 1 mg tabletes Pramipexole
Read all of this leaflet carefully before you start taking this medicine.
anas uzmanī izlasiet visu instrukciju. gi
- Keep this leaflet.
- Saglabā š instrukciju!
You may need to read it again.
jams, ka vē k vajadzē to pā lā s
- If you have any further questions, ask your doctor or pharmacist.
jumi, vaicā ā jiet rstam vai farmaceitam.
- This medicine has been prescribed for you.
- Šs zā ir parakstī Jums.
Do not pass it on to others.
Nedodiet tā citiem.
It may harm them, even
t aunumu pat tad, ja š cilvē iem
if their symptoms are the same as yours.
lī gi simptomi. dzī - Ja Jū novē
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
rojat jebkā blakusparā bas, kas š instrukcijā minē vai kā no minē m das dī ajā nav tas da
please tell your doctor or pharmacist.
rstam vai farmaceitam.
In this leaflet:
Š instrukcijā uzzinā
1.
t:
Before you take Oprymea 3.
1 Kas ir Oprymea un kā nolū to lieto dam kam 2 Pirms Oprymea lietoš anas 3 Kā lietot Oprymea 4 Iespē s blakusparā bas
How to take Oprymea 4.
5 Kā uzglabāOprymea t 6 Sī ka informā
Possible side effects 5.
KAS IR OPRYMEA UN KĀDAM NOLŪKAM TO LIETO
How to store Oprymea 6.
Oprymea pieder zā grupai, ko sauc par dopamī agonistiem.
Further information
Tie stimulē ļ
WHAT OPRYMEA IS AND WHAT IT IS USED FOR
dopamī receptorus na
Stimulation of the dopamine receptors triggers nerve impulses in the brain that help to control body movements.
smadzenē Dopamī receptoru stimulēana ierosina nervu impulsus smadzenē kas palī kontrolē
Oprymea is used to treat the symptoms of primary Parkinson's disease.
To var lietot monoterapijā
It can be used alone or in combination with levodopa.
kombinā ar levodopu. cijā
BEFORE YOU TAKE OPRYMEA
PIRMS OPRYMEA LIETOŠANAS
DO NOT take Oprymea
Nelietojiet OPRYMEA šdos gadī
- If you are allergic (hypersensitive) to pramipexole or any of the other ingredients of Oprymea
- Ja Jums ir paaugstinā jutī (alerģ pret pramipeksolu vai kā citu Oprymea sastā u (skatī
(see section 6.
apakš punktu 6. ” Sī ka informā
"Further information").
cija ”).
Take special care with Oprymea Tell your doctor if you have or have had or develop any medical conditions or symptoms, especially any of the following:
Ī a piesardzī lietojot Oprymea, nepiecieš šdos gadī paš Pastā savam ā
- Kidney disease.
- nieru slimī ba;
- Hallucinations (seeing, hearing or feeling things that are not there).
- halucinā cijas (neesoš lietu redzēana, dzirdē vai sajuš
Most hallucinations are
šana
visual.
ana).
- Dyskinesia (e. g. abnormal, uncontrolled movements of the limbs).
- diskinē (piemē
If you have advanced
ram, patoloģ iskas, nekontrolē
Parkinson’ s disease and are also taking levodopa, you might develop dyskinesia during the uptitration of Oprymea.
jamas ekstremitāu kustī Ja Jums ir progresē a š bas).
- Sleepiness and episodes of suddenly falling asleep.
Parkinsona slimī un lietojat arī
- Behavioural changes (e. g. pathological gambling), increased libido (e. g. increased sexual
levodopu, Jums var attī ties diskinē ja stī
desire), binge eating.
Jū sā ā š ar zija, s kat rstēanu
- Psychosis (e. g. comparable with symptoms of schizophrenia).
- miegainī un pē ņ iemigš epizodes;
- Vision impairment.
- uzvedī pā
You should have regular eye examinations during treatment with Oprymea.
bas rmaiņ (piemē patoloģ tieksme uz azartspē m), palielinā dzimumtieksme
102
rēanā 102
- Severe heart or blood vessels disease.
- redzes traucē jumi.
You will need to have your blood pressure checked
Jums jā regulā acu izmeklēana ā š laikā Oprymea;
regularly, especially at the beginning of treatment.
- smaga sirds vai asinsvadu slimī Jums regulā jā rbauda asinsspiedienu, ī i ā š sā
This is to avoid postural hypotension (a fall in blood pressure on standing up).
Tas jādara, lai izvairī no ortostatiskas hipotensijas (asinsspiediena samazināanā pieceļ
Children and adolescents Oprymea is not recommended for use in children or adolescents under 18 years.
Oprymea nav ieteicams bē rniem un pusaudž lī 18 gadu vecumam. iem dz
Taking other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines.
stiet rstam vai farmaceitam par visā zā m, kuras lietojat vai pē jā uz zā m, augu preparā
This includes medicines, herbal remedies, health foods or supplements that you have obtained without a prescription.
rstniecisku uzturu vai uztura bagā tā tinā jiem, ko var iegā ties bez receptes. dā
You should avoid taking Oprymea together with antipsychotic medicines.
Jums jā izvairā no Oprymea lietoš kopā antipsihotiskiem lī iem.
Take care if you are taking the following medicines:
Uzmanieties, ja lietojat šdas zā
- cimetidine (to treat excess stomach acid and stomach ulcers);
- cimetidī (mazina pā rī kuņa skā un ā kuņa člu);
- amantadine (which can be used to treat Parkinson’ s disease).
- amantadī (var lietot Parkinsona slimī ā š
If you are taking levodopa, the dose of levodopa is recommended to be reduced when you start treatment with Oprymea.
Ja Jū lietojat levodopu, ieteicams samazinālevodopas devu, sā ā š ar Oprymea.
Take care if you are using any medicines that calm you down (have a sedative effect) or if you drink alcohol.
Š gadī
In this cases Oprymea may effect your ability to drive and operate machinery.
jumos Oprymea darbī var ietekmēJū spē vadītransportlī us un apkalpot mehā
Taking Oprymea with food and drink You should be cautious while drinking alcohol during treatment with Oprymea.
Jums jā ro piesardzī lietojot alkoholu ā š laikā Oprymea.
Oprymea can be taken with or without food.
Oprymea var lietot ēanas laikā tukš dūāTabletes jā
The tablets should be taken with water.
lieto, uzdzerot ūdeni.
Pregnancy and breast-feeding Ask your doctor or pharmacist for advice before taking any medicine.
ā vai farmaceitu. rstu
Tell your doctor if you are pregnant, think you might be pregnant or if you intend to become pregnant.
rstam, ja Jums ir iestā jusies grū tniecī Jū domā ka Jums varē būiestā
Your doctor will then discuss with you if you should continue to take Oprymea.
nojat grūtniecī Jū ā pā bu. su rsts rrunā to
The effect of Oprymea on the unborn child is not known.
ar Jums, ja Jums jā s turpina Oprymea lietoš
Therefore, do not take Oprymea if you are pregnant unless your doctor tells you to do so.
Oprymea ietekme uz nedzimuš bē nav zinā Tā ļ ā Jums nav ieteicis to lietot. rsts
Oprymea is not recommended during breast-feeding.
ma. dēnelietojiet Oprymea, ja esat grū tniece, ja vien
Oprymea can reduce the production of breast milk.
Tas var
Also, it can pass into the breast milk and can reach your baby.
izdalī mā pienā to var saņ Jū bē Ja Oprymea lietoš ir nepiecieš
If treatment with Oprymea is unavoidable, breast-feeding must be stopped.
ar krū jā rtrauc. ti pā
Driving and using machines Oprymea can cause hallucinations (seeing, hearing or feeling things that are not there).
Oprymea var izraisīhalucinā (neesoš lietu redzēanu, dzirdēanu vai sajuš
If affected, do not drive or use machines.
Ja tānotiek,
Oprymea has been associated with sleepiness and episodes of suddenly falling asleep, particularly in patients with Parkinson’ s disease.
Oprymea lietoš saistī ar miegainī raš un pē ņ iemigš epizodē ī i pacientiem ar
If you experience these side effects, you must not drive or operate machinery.
Parkinsona slimī Ja Jums rodas š blakusparā bas, Jū nedrī vadītransportlī us vai apkalpot
Please tell your doctor if this occurs.
bu.
3.
ī
HOW TO TAKE OPRYMEA
dzekļ
Always take Oprymea exactly as your doctor has told you.
Ja tā rodas, Jums tas jā
You should check with your doctor or pharmacist if you are not sure.
pastā ā sta rstam.
Parkinson’ s disease The daily dose is to be taken divided into 3 equal doses.
KĀLIETOT OPRYMEA
103 During the first week, the usual dose is 1 tablet Oprymea 0.088 mg three times a day (equivalent to 0.264 mg daily):
Neskaidrī gadī
1st week Number of tablets Total daily dose (mg)
deva ir 1 Oprymea 0, 088 mg tablete trīreizes dienā s (atbilst 0, 264 mg dienā):
1 tablet Oprymea 0.088 mg three times a day 0.264
1. nedē ļa
This will be increased every 5 – 7 days as directed by your doctor until your symptoms are controlled (maintenance dose).
To var palielinā ik pē 5 – 7 dienā kānorā jis ā (balstdeva).
2nd week
2. nedē
3rd week
3. nedē ļa
Number of tablets
1 Oprymea 0, 18 mg tablete trī s
1 tablet Oprymea 0.18 mg three times a day OR 2 tablets Oprymea 0.088 mg three times a day
1 Oprymea 0, 35 mg tablete trīreizes s
1 tablet Oprymea 0.35 mg three times a day OR 2 tablets Oprymea 0.18 mg three times a day
reizes dienā VAI 2 Oprymea 0, 088 mg tabletes trīreizes dienā
Total daily dose (mg)
dienā VAI 2 Oprymea 0, 18 mg tabletes trīreizes s
0.54
s
1.1
dienā
The usual maintenance dose is 1.1 mg per day.
Kopē
Lowest maintenance dose
dienas deva (mg)
Highest maintenance dose
jā
Number of tablets
0, 54
1 tablet Oprymea 1.1 mg three times a day
Parastā balstdeva ir 1, 1 mg dienā Tač Jū devu var palielināpat vairā Ja tas nepiecieš Jū ā
Total daily dose (mg)
dienas deva (mg)
You can take Oprymea with or without food.
Oprymea var lietot ēanas laikā neatkarī no ē
Swallow the tablets with water.
Norijiet tabletes, uzdzerot
Patients with kidney disease If you have moderate or severe kidney disease, your doctor will prescribe a lower dose.
Tas nozī, ka Jums
In this case, you will have to take the tablets only once or twice a day.
bū jā zā tikai vienu vai divas reizes dienāJa Jums ir vidē smaga nieru slimī parastā kuma
If you have moderate kidney disease, the usual starting dose is 1 tablet Oprymea 0.088 mg twice a day.
deva ir 1 Oprymea 0, 088 mg tablete divas reizes dienāSmagas nieru slimī gadī
In severe kidney disease, the usual starting dose is just 1 tablet Oprymea 0.088 mg a day.
deva ir tikai 1 Oprymea 0, 088 mg tablete
If you take more Oprymea than you should If you accidentally took too many tablets:
Ja esat lietojis vairā Oprymea nekā
- Contact your doctor or nearest hospital casualty department immediately for advice.
k Ja nejaušesat lietojis par daudz tableš
- You may experience vomiting, restlessness, or any of the side effects as described in section 4.
- nekavē joties sazinieties ar savu ā vai tuvā s slimnī neatliekamā palī bas nodaļ
"Possible side effects".
saņ emtu padomu;
Simply leave out that dose completely and then take your next dose at the right time.
- Jums var rasties vemš nemiers vai jebkura no blakusparā bā kas aprakstī 4. punktā
Do not take a double dose to make up for a forgotten tablet.
s blakusparā bas ”. jamā
If you stop taking Oprymea Do not stop taking Oprymea without first talking to your doctor.
Ja esat aizmirsis lietot Oprymea Neuztraucieties.
If you have to stop taking this medicine, your doctor will reduce the dose gradually.
Vienkā i izlaidiet š devas lietoš un lietojiet nā
This reduces the risk of worsening symptoms.
kamo devu paredzē laikā tajā.
If you suffer from Parkinson’ s disease you should not stop treatment with Oprymea abruptly.
Nelietojiet dubultu devu, lai aizvietotu aizmirsto tableti.
A sudden stop could cause you to develop a medicinal condition called neuroleptic malignant syndrome which may represent a major health risk.
Ja Jū pā s rtraucat lietot Oprymea Nepā rtrauciet Oprymea lietoš bez konsultā devu samazinā pakā
The symptoms include:
cijas ar
- akinesia (loss of muscle movement),
ā Ja Jums jā rtrauc lietot rstu. pā
- rigid muscles,
š zā Jū ā ī les, su rsts s
- fever,
- drudzis,
- unstable blood pressure,
- nestabils asinsspiediens,
- tachycardia (increased heart rate),
- tahikardija (paā ta sirdsdarbī
- confusion,
- apjukums, - nomā apziņ stā
- depressed level of consciousness (e. g. coma).
ram, koma).
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Ja Jums ir kā jautā par šprodukta lietoš jautā savam ā
4.
ī
POSSIBLE SIDE EFFECTS
rstam vai farmaceitam.
Like all medicines, Oprymea can cause side effects, although not everybody gets them.
pat citas zā Oprymea var izraisīblakusparā bas, kaut arī visiem tā izpauž Blakusparā bu
Evaluation of these side effects is based on the following frequencies:
novē š balstā uz šdu biež
Very common:
umu:
Common:
i:
Uncommon:
Retā
Rare:
k:
Very rare:
Ļ reti:
Not known:
rstē
affects more than 1 user in 10 affects 1 to 10 users in 100 affects 1 to 10 users in 1,000 affects 1 to 10 users in 10,000 affects less than 1 user in 10,000 frequency cannot be estimated from available data
oti Mazā nekā no 10 000 ā tiem pacientiem, ieskaitot atsevišus gadī
You may experience the following side effects (regardless of indication):
Jums var rasties šdas blakusparā bas (neatkarī no lietoš indikā
Very common:
cijas):
- Dyskinesia (e. g. abnormal, uncontrolled movements of the limbs)
ram, patoloģ iskas, nekontrolē
- Dizziness
- reibonis,
- Nausea (sickness)
- slikta dūa (nelabums),
- Hypotension (low blood pressure)
- hipotensija (zems asinsspiediens).
Common:
Biež i: - halucinā - apjukums,
- Hallucinations (seeing, hearing or feeling things that are not there)
cijas (neesoš lietu redzēana, dzirdē vai sajuš u š šana
- Confusion
- miega pā - nogurums,
- Changes in sleep pattern, such as sleeplessness (insomnia) and sleepiness
rmaiņ piemē bezmiegs un miegainī as, ram, ba,
- Tiredness (fatigue)
- pā rī šidruma uzkrāanā parasti kā s (perifē tū
- Excess of fluid, usually in the legs (peripheral oedema)
ra ska),
- Headache
- galvassā
- Abnormal dreams
- patoloģ sapņ
- Constipation
- aizcietē Retā k:
Uncommon:
iski jums.
- Paranoia (e. g. excessive fear for one’ s own well-being)
i,
- Delusion
- paranoja - murgi,
- Excessive daytime sleepiness and suddenly falling asleep
ram, lielas bailes par kā labklābu), da jī
- Hyperkinesia (increased movements and inability to keep still)
- pā rī miegainī dienas laikā pē ņ iemigš
- Weight increase
anas epizodes,
- Increased sexual desire (e. g. increased libido)
- hiperkinē (palielinā kustī
- Allergic reactions (e. g. rash, itching, hypersensitivity)
gums un nespē palikt mierā ja
Unknown frequency:
- ķ ermeņ masas palielināanā
- Pathological gambling, especially in patients with Parkinson’ s disease taking high doses of
- dzimumtieksmes palielināanā (piemē paaugstinā dzimumtieksme),
Oprymea
ram,
- Hypersexuality
- alerģ iskas reakcijas (piemē Biež nezinā ums ms:
- Abnormal behaviour
ram, izsitumi, nieze, paaugstinā
- Increased eating (binge eating, hyperphagia)
jutī reakcijas). tas bas
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
- patoloģ tieksme uz azartspē m, ī i pacientiem ar Parkinsona slimī lietojot
HOW TO STORE OPRYMEA
KĀUZGLABĀ OPRYMEA T
Do not use Oprymea after the expiry date which is stated on the packaging.
Nelietot Oprymea pē derī
The expiry date refers to the last day of that month.
guma termiņ beigā kas norā ts uz iepakojuma.
Store in the original package in order to protect from light.
uz norā tā neš pē jo dienu. dī mē a dē
Medicines should not be disposed of via wastewater or household waste.
inā iepakojumālai pasargā no gaismas., tu
Ask your pharmacist how to dispose of medicines no longer required.
Zā nedrī izmest kopā saimniecī atkritumiem vai kanalizā.
These measures will help to protect the environment.
Š pasā
6.
ie
FURTHER INFORMATION
SĪ KA INFORMĀ
What Oprymea contains
Ko Oprymea satur
- The active substance is pramipexole.
- Aktī viela ir pramipeksols.
Each tablet contains 0.088 mg, 0.18 mg, 0.35 mg, 0.7 mg
Katra tablete satur 0, 088 mg, 0, 18 mg, 0, 35 mg, 0, 7 mg vai 1, 1 mg
or 1.1 mg pramipexole as 0.125 mg, 0.25 mg, 0.5 mg, 1 mg or 1.5 mg pramipexole dihydrochloride monohydrate, respectively.
vā pramipeksola, attiecī 0, 125 mg, 0, 25 mg, 0, 5 mg, 1 mg vai 1, 5 mg pramipeksola dihidrohlorī monohidrā veidā
- The other ingredients are mannitol, maize starch, pregelatinised maize starch, povidone K25,
ciete, povidons K25, bezū zas
colloidal anhydrous silica and magnesium stearate.
koloidā silī dioksī un magnija stearā
What Oprymea looks like and contents of the pack Tablets of 0.088 mg are white, round, with bevelled edges and imprint "P6" on one side of the tablet.
Oprymea ā jais izskats un iepakojums rē 0, 088 mg tabletes ir baltas, apaļ ar nošeltā malā un uzdruku „ P6 ” vienā
Tablets of 0.18 mg are white, oval, with bevelled edges, both sides scored, with imprint "P7" on both halves of one side of the tablet.
0, 18 mg tabletes ir baltas, ovā ar nošeltā malā un dalī uz abā dalī
The tablet can be divided into equal halves.
juma da ļ ir uzdruka „ P7 ”.
Tablets of 0.35 mg are white, oval, with bevelled edges, both sides scored, with imprint "P8" on both halves of one side of the tablet.
0, 35 mg tabletes ir baltas, ovā ar nošeltā malā un dalī uz abā dalī
The tablet can be divided into equal halves.
juma da ļ ir uzdruka „ P8 ”.
Tablets of 0.70 mg are white, round, with bevelled edges, both sides scored, with imprint "P9" on both halves of one side of the tablet.
0, 7 mg tabletes ir baltas, apaļ ar nošeltā malā un dalī abā dalī
The tablet can be divided into equal halves.
m juma daļ ir uzdruka „ P9 ”.
Tablets of 1.1 mg are white, round, with bevelled edges, both sides scored.
ām baltas, apaļ ar nošeltā malā un dalī
The tablet can be divided into equal halves.
juma lī abā pusē Tableti var sadalī niju s s. t
Boxes of 20, 30, 60, 90 and 100 tablets in blisters of 10 tablets are available.
Pieejamas kā as ar 20, 30, 60, 90 un 100 tabletē blisteros pa 10 tabletē
Marketing Authorisation Holder and Manufacturer KRKA, d. d., Novo mesto, Š marješ cesta 6, 8501 Novo mesto, Slovenia ka
KRKA, d. d., Novo mesto, Šmarješ cesta 6, 8501 Novo mesto, Slovē
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
dzam kontaktē ar Reģ cijas apliecī ī nieka ties istrā bas paš
This leaflet was last approved in
Š lietoš ī anas instrukcija akceptē. ta
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http://www.emea.europa.eu/.
Sī ka informā par š zā m ir pieejama Eiropas zā aģ ras (EMEA) mā lapā
What is Optaflu?
Kas ir Optaflu?
Optaflu is a vaccine, which is available as a suspension for injection in a pre-filled syringe.
Optaflu ir vakcīna, kas ir pieejama kā suspensija injekcijām pilnšļircēs.
The vaccine contains the inactivated ‘ surface antigen ’ from three different strains (types) of influenza (flu) virus as active substances (A/ Solomon Islands/ 3/ 2006, A/ Wisconsin/ 67/ 2005 and B/ Malaysia/ 2506/ 2004).
Kā aktīvo vielu vakcīna satur inaktivētu „ virsmas antigēnu ” no trim dažādiem gripas vīrusu celmiem (veidiem) (A/ Zālamana Salas/ 3/ 2006, A/ Viskonsīna/ 67/ 2005 un B/ Malaizija/ 2506/ 2004).
What is Optaflu used for?
Kāpēc lieto Optaflu?
Optaflu is used to vaccinate adults against flu, especially those who are at an increased risk of developing complications of the disease.
Optaflu lieto pieaugušo vakcinēšanai pret gripu, jo īpaši to pieaugušo, kuriem ir paaugstināts slimības komplikāciju risks.
How is Optaflu used?
Kā lieto Optaflu?
Optaflu is given as one injection of 0.5 ml into the muscle at the top of the arm.
Optaflu ievada kā vienu 0, 5 ml injekciju augšdelma muskulī.
How does Optaflu work?
Kā Optaflu darbojas?
Optaflu is a vaccine.
Optaflu ir vakcīna.
Vaccines work by ‘ teaching’ the immune system (the body’ s natural defences) how to defend itself against a disease.
Vakcīnas darbojas, „ apmācot ” imūnsistēmu (ķermeņa dabisko aizsardzību), kā aizsargāties pret slimību.
Optaflu contains fragments from the surface of three different strains of flu virus.
Optaflu satur virsmas fragmentus no trīs dažādu gripas vīrusu celmiem.
The antibodies will then help to protect against the disease caused by these strains of the flu virus.
Tad antivielas palīdzēs aizsargāties pret šo gripas vīrusu celmu izraisīto slimību.
Each year, the World Health Organization (WHO) makes recommendations on which flu strains should be included in vaccines for the upcoming flu season, and these virus strains need to be included in Optaflu before the vaccine can be used.
Katru gadu Pasaules Veselības organizācija (PVO) sniedz ieteikumus, kuri gripas vīrusu celmi jāiekļauj vakcīnās nākamajai gripas sezonai un šie vīrusu celmi jēiekļauj Optaflu pirms vakcīnas lietošanas.
Optaflu currently contains fragments of the virus strains that are expected to cause flu in the 2007/ 2008 season, according to the recommendations from the WHO for the northern hemisphere and from the European Union (EU).
Pašlaik Optaflu satur to vīrusu celmu fragmentus, par kuriem ir izstrādātas prognozes, ka šie vīrusu celmi izraisīs gripu 2007. / 2008. gada sezonā saskaņā ar PVO ieteikumiem attiecībā uz ziemeļu puslodi un saskaņā ar Eiropas Savienības (ES) ieteikumiem.
The virus strains in Optaflu will be need to be replaced again before the vaccine can be used in subsequent seasons.
Optaflu esošos vīrusu celmus, pirms vakcīnu varēs sākt lietot nākamajās sezonās, atkal vajadzēs aizvietot.
The viruses used in Optaflu are grown in mammal cells, unlike those in other flu vaccines, which are grown in hen’ s eggs.
Pirms uzsākt pētījumus ar cilvēkiem, Optaflu iedarbību pārbaudīja eksperimentālos modeļos.
© European Medicines Agency, 2008.
©European Medicines Agency, 2007.
The effects of Optaflu were first tested in experimental models before being studied in humans.
Reproduction is authorised provided the source is acknowledged. galvenajā pētījumā, kurā piedalījās 2654 pieaugušie, no kuriem aptuveni puse bija vecāka gadagājuma cilvēki (vecāki par 60 gadiem).
The effects of Optaflu were compared to those of a similar flu vaccine that was made in eggs.
Optaflu iedarbību salīdzināja ar līdzīgas vakcīnas iedarbību, kuras vīrusu celmus audzēja vistu olās.
The study compared the ability of the two vaccines to trigger the production of antibodies (immunogenicity), by comparing antibody levels before injection and three weeks afterwards.
Pētījumā salīdzināja abu vakcīnu spēju rosināt antivielu veidošanos (imunogenitāti), salīdzinot antivielu līmeni pirms injekcijas un to līmeni trīs nedēļas vēlāk.
The immunogenicity of the current formulation of the vaccine has been confirmed in 135 adults, around half of whom were elderly.
Esošās vakcīnas imunogenitāti apstiprināja 135 pieaugušajiem, no kuriem apmēram puse bija vecāka gadugājuma cilvēki.
What benefit has Optaflu shown during the studies?
Kāds ir Optaflu iedarbīgums šajos pētījumos?
In the original main study, both Optaflu and the comparator vaccine brought about adequate levels of antibodies for protection against all three flu strains, as defined in criteria laid down by the Committee for Medicinal Products for Human Use (CHMP) for flu vaccines produced in cell culture.
Sākotnējā galvenajā pētījumā gan Optaflu, gan salīdzināmā vakcīna rosināja aptuveni vienādus antivielu līmeņus aizsardzībā pret visiem trim gripas vīrusu celmiem, kā noteikts kritērijos, ko paredzējusi Cilvēkiem paredzēto zāļu komiteja (CHMP) attiecībā uz gripas vakcīnām, kas veidotas šūnu barotnē.
The two vaccines were similar in triggering the production of antibodies, both in adults 60 years of age and below, and in the elderly.
Abas vakcīnas līdzīgi rosināja antivielu veidošanos gan pieaugušajos vecumā līdz 60 gadiem, gan vecākos pacientos.
The current formulation of Optaflu for the 2007/ 2008 season brought about similar antibody responses against the three flu strains included in the vaccine to those seen in the main study.
Esošā Optaflu vakcīna 2007. / 2008. gada sezonai izraisīja līdzīgu antivielu reakciju pret trim gripas vīrusu celmiem, kuri iekļauti vakcīnā, kuru injicēja galvenajā pētījumā iesaistītajiem pacientiem.
What is the risk associated with Optaflu?
Kāds pastāv risks, lietojot Optaflu?
The most common side effects with Optaflu (seen in more than 1 patient in 10) are headache, erythema (reddening of the skin), pain, malaise (feeling unwell) and fatigue (tiredness).
Visbiežāk novērotās nevēlamās Optaflu blakusparādības (vairāk nekā vienam pacientam no desmit), ir galvassāpes, eritēma (ādas apsarkums), sāpes, savārgums (slikta pašsajūta) un nogurums.
These side effects usually disappear within one to two days without treatment.
Šīs blakusparādības parasti pazūd vienas līdz divu dienu laikā bez ārstēšanas.
For the full list of all side effects reported with Optaflu, see the Package Leaflet.
Pilns visu Optaflu izraisīto blakusparādību apraksts ir atrodams zāļu lietošanas pamācībā.
Optaflu should not be used in people who may be hypersensitive to the active substances or any of the other ingredients.
Optaflu nedrīkst lietot cilvēki ar paaugstinātu jutību pret aktīvajām vielām vai kādu citu vakcīnas sastāvdaļu.
Why has Optaflu been approved?
Kāpēc Optaflu tika apstiprinātas?
The CHMP decided that Optaflu’ s benefits are greater than its risks for the prophylaxis of influenza for adults, especially those who run an increased risk of associated complications.
CHMP secināja, ka pacienta ieguvums, lietojot Optaflu gripas profilaksē pieaugušo vidū, jo īpaši to, kuri pakļauti paaugstinātam ar gripu saistītu komplikāciju riskam, pārsniedz šo zāļu radīto risku.
The Committee recommended that Optaflu be given marketing authorisation.
Komiteja ieteica izsniegt Optaflu reģistrācijas apliecību.
Other information about Optaflu:
Cita informācija par Optaflu.
The European Commission granted a marketing authorisation valid throughout the EU for Optaflu to Novartis Vaccines and Diagnostics GmbH & Co.
Eiropas Komisija 2007. gada 1. jūnijā izsniedza Optaflu reģistrācijas apliecību, kas derīga visā ES, uzņēmumam Novartis Vaccines and Diagnostics GmbH & Co.
KG on 1 June 2007.
KG.
The full EPAR for Optaflu can be found here.
Pilns Optaflu EPAR teksts ir atrodams šeit.
Suspension for injection in pre- filled syringe
Suspensija injekcijai pilnšļircē
1 pre-filled syringe (Luer Cone)
1 pilnšļirce (Luer Cone)
10 pre-filled syringes (Luer Cone)
10 pilnšļirces (Luer Cone)
2 x 10 pre-filled syringes (Luer Cone)
2 x 10 pilnšļirces (Luer Cone)
1 pre-filled syringe (Luer Cone) + 1 needle
1 pilnšļirce (Luer Cone) + 1 adatu
10 pre-filled syringes (Luer Cone) + 10 needles
10 pilnšļirces (Luer Cone) + 10 adatas
2 x 10 pre-filled syringes (Luer Cone) + 20 needles
2 x 10 pilnšļirces (Luer Cone) + 20 adatas
1 pre-filled syringe (Luer Lock)
1 pilnšļirce (Luer Lock)
10 pre-filled syringes (Luer Lock)
10 pilnšļirces (Luer Lock)
2 x 10 pre-filled syringes (Luer Lock)
2 x 10 pilnšļirces (Luer Lock)
1/ 2 1 Influenza virus surface antigens (haemagglutinin and neuraminidase)*, inactivated, of the following strains:
1 Gripas vīrusa virsmas antigēni (hemaglutinīns un neiraminidāze) *, inaktivēti, satur šādus celmus:
A/ Solomon Islands/ 3/ 2006 (H1N1) like strain (A/ Solomon Islands/ 3/ 2006, IVR-145) A/ Wisconsin/ 67/ 2005 (H3N2) like strain (A/ Wisconsin/ 67/ 2005, NYMC X161B) B/ Malaysia/ 2506/ 2004 like strain (B/ Malaysia/ 2506/ 2004)
A/ Salomonu salas/ 3/ 2006 (H1N1) tipa celms (A/ Salomonu salas/ 3/ 2006, IVR- 145) A/ Viskonsina/ 67/ 2005 (H3N2) tipa celms (A/ Viskonsina/ 67/ 2005, NYMC X161B) B/ Malaizija/ 2506/ 2004 tipa celms (B/ Malaizija/ 2506/ 2004)
15 micrograms HA** 15 micrograms HA** 15 micrograms HA** per 0.5 ml dose
15 mikrogrami HA ** 15 mikrogrami HA ** 15 mikrogrami HA ** 0, 5 ml devā
* propagated in Madin Darby Canine Kidney (MDCK) cells ** haemagglutinin
* pavairoti Madin Darby Canine Kidney (MDCK) šūnās ** hemaglutinīns
Optaflu suspension for injection in pre-filled syringe Influenza vaccine (surface antigen, inactivated, prepared in cell cultures)
Optaflu suspensija injekcijām pilnšļircē Gripas vakcīna (virsmas antigēns, inaktivēts, audzēts šūnu kultūrās) Influenza vaccine (surface antigen, inactivated, prepared in cell culture)
(2007/ 2008 season)
(2007. / 2008. g. sezona)
Influenza virus surface antigens (haemagglutinin and neuraminidase)*, inactivated, of the following strains:
Gripas vīrusa virsmas antigēni (hemaglutinīns un neiraminidāze) *, inaktivēti, satur šādus celmus:
A/ Solomon Islands/ 3/ 2006 (H1N1) like strain (A/ Solomon Islands/ 3/ 2006, IVR-145)
A/ Salomonu salas/ 3/ 2006 (H1N1) tipa celms (A/ Salomonu salas/ 3/ 2006, IVR- 145)
15 micrograms HA**
15 mikrogrami HA **
A/ Wisconsin/ 67/ 2005 (H3N2) like strain
A/ Viskonsina/ 67/ 2005 (H3N2) tipa celms
(A/ Wisconsin/ 67/ 2005, NYMC X161B)
(A/ Viskonsina/ 67/ 2005, NYMC X161B)
B/ Malaysia/ 2506/ 2004 like strain (B/ Malaysia/ 2506/ 2004) ………………………………………. * propagated in Madin Darby Canine Kidney (MDCK) cells ** haemagglutinin
B/ Malaizija/ 2506/ 2004 tipa celms (B/ Malaizija/ 2506/ 2004)
15
15 mikrogrami HA ** 0, 5 ml devā
micrograms HA** per 0.5 ml dose
…………………………………………………………………………………. * pavairoti Madin Darby Canine Kidney (MDCK) šūnās ** hemaglutinīns
The vaccine complies with the WHO recommendation (northern hemisphere) and EU decision for the 2007/ 2008 season.
Vakcīna atbilst PVO rekomendācijai (Ziemeļu puslodei) un ES slēdzienam par 2007. / 2008. g. sezonu.
Suspension for injection in pre-filled syringe Clear to slightly opalescent.
Dzidra līdz viegli opalescējošai.
Prophylaxis of influenza for adults, especially in those who run an increased risk of associated complications.
Gripas profilakse pieaugušajiem, īpaši, ja ir paaugstināts saistīto komplikāciju risks.
The use of Optaflu should be based on official recommendations.
Optaflu lietošanai jāpamatojas uz oficiālām rekomendācijām.
Immunisation should be carried out by intramuscular (into the deltoid muscle) injection.
Imunizācijai jānotiek intramuskulāras injekcijas veidā (deltveida muskulī).
Children and adolescents (< 18 years of age):
Bērni un pusaudži (līdz 18 gadiem):
Optaflu is not recommended for use in children and adolescents below 18 years due to the lack of data on safety and efficacy (see section 5.1).
Optaflu nav ieteicams lietošanai bērniem un pusaudžiem līdz 18 gadu vecumam, jo nav pietiekamas informācijas par drošību un vai efektivitāti (skatīt apakšpunktu 5. 1).
Immunisation shall be postponed in patients with febrile illness or acute infection.
Imunizāciju nepieciešams atlikt, ja pacientam novēro saslimšanu ar paaugstinātu temperatūru vai akūtu infekciju.
As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic event following the administration of the vaccine.
Tāpat kā pēc citu injicējamu vakcīnu ievadīšanas nepieciešamības gadījumā, ja retos gadījumos novēro anafilaktiskas reakcijas, atbilstošai ārstēšanai un novērošanai vienmēr jābūt ātri pieejamai.
Optaflu should under no circumstances be administered intravascularly.
Optaflu nekādos apstākļos nedrīkst ievadīt intravaskulāri.
Antibody response in patients with endogenous or iatrogenic immunosuppression may be insufficient.
Antivielu atbildes reakcija pacientiem ar endogēnu vai jatrogēnu imūnsupresiju var būt nepietiekama.
Optaflu may be given at the same time as other vaccines.
Optaflu iespējams ievadīt vienlaicīgi ar citām vakcīnām.
Immunisation should be carried out on separate limbs.
Imunizācija būtu jāveic, izmantojot citu ekstremitāti.
It should be noted that adverse reactions may be intensified.
Jāatzīmē, ka iespējama blakusparādību pastiprināšanās.
The immunological response may be diminished if the patient is undergoing immunosuppressant treatment.
Imūnā atbilde var būt samazināta, ja pacients saņem imūnsupresīvu terapiju.
Following influenza vaccination, false positive results in serology tests using the ELISA method to detect antibodies against HIV-1, Hepatitis C and especially HTLV-1 have been observed.
Pēc pretgripas vakcinācijas ir novēroti viltus pozitīvi seroloģijas testu rezultāti, lietojot ELISA metodi HIV- 1, hepatīta C un īpaši HTLV- 1 antivielu noteikšanai.
The Western Blot technique disproves the results.
Western blot metode pierāda rezultātus kā nepatiesus.
The transient false positive reactions may be due to the IgM response to the vaccine.
Vakcīnas radītās IgM atbildes dēļ var būt pārejošas viltus pozitīvas reakcijas.
The safety of Optaflu in pregnancy and breast-feeding has not been assessed in pre-clinical studies or in clinical trials.
Optaflu drošība grūtniecības un zīdīšanas laikā preklīniskajos pētījumos vai klīniskajos pētījumos netika novērtēta.
In general data from influenza vaccinations in pregnant women do not indicate adverse fetal and maternal outcomes attributable to the vaccine.
Kopumā dati par gripas vakcināciju grūtniecēm nenorāda, ka uz vakcīnu ir attiecināma nelabvēlīga ietekme uz māti un augli.
The use of Optaflu may be considered from the second trimester of pregnancy.
Optaflu lietošana ir apsverama, sākot no grūtniecības otrā trimestra.
For pregnant women with medical conditions that increase their risk of complications from influenza, administration of the vaccine is recommended, irrespective of their stage of pregnancy.
Grūtniecēm ar veselības traucējumiem, kas palielina komplikāciju risku gripas ietekmē, vakcīnas nozīmēšana ir rekomendēta, neatkarīgi no grūtniecības termiņa.
Optaflu may be used during lactation.
Optaflu var lietot zīdīšanas periodā.
The vaccine is unlikely to produce an effect on the ability to drive and use machines.
Vakcīnai nav raksturīga ietekme uz spēju vadīt transportlīdzekļus un apkalpot mehānismus.
Adverse reactions from clinical trials:
Blakusparādības klīniskajos pētījumos:
The safety of the Optaflu has been assessed in six randomized, active controlled clinical trials performed as part of the development program.
Optaflu drošību novērtēja sešos randomizētos, aktīvi kontrolētos klīniskajos pētījumos, kas bija daļa no attīstības programmas.
Overall 3439 single doses of Optaflu were administered to 2366 adults aged 18 – 60 years of age and to 1073 elderly (aged 61 years or older).
Kopumā tika ievadītas 3 439 Optaflu devas, 2 366 pieaugušajiem pacientiem vecumā no 18 – 60 gadiem un 1 073 gados vecākiem pacientiem (61 gadus veciem un vecākiem).