natgillin/translations-raw huggingface dataset:
Very rare adverse reactions:
NUSPOJAVE Vrlo rijetke nuspojave:
The active substances being a principle of biological origin intended to produce active immunity is not within the scope of Regulation (EC) No 470/2009.
Djelatne tvari koje se sastoj od tvari biološkog podrijetla, namijenjene za stvaranje aktivne imunosti i na koje se ne primjenjuju odredbe Uredbe (EK) br. 470/2009.
Date of first authorisation: 11/02/2009 Date of last renewal: 10/02/2014
Datum posljednjeg produljenja odobrenja: 10/02/2014
In some cases, there may also be pain at the inoculation site that spontaneously subsides in a maximum of 4 days.
U nekim slučajevima, na mjestu cijepljenja može se pojaviti i bol, koja spontano popusti nakon najviše 4 dana.
Administer one dose (2 ml) by deep intramuscular injection in the neck muscles at 45 days before the expected parturition date and 1 month thereafter administer a second dose (at least 10 days before calving).
Primijeniti jednu dozu (2 ml) dubokom intramuskularnom injekcijom u vratne mišiće 45 dana prije očekivanog termina poroda i još jednu dozu po proteku 1 mjeseca (a najmanje 10 dana prije teljenja).
Sodium alginate Calcium chloride, dihydrate Simeticone
Natrijev alginat Klacijev klorid dihidrat Simetikon
NAME OF THE VETERINARY MEDICINAL PRODUCT
NAZIV VETERINARSKO MEDICINSKOG PROIZVODA
Store and transport refrigerated (2 °C - 8 °C).
Čuvati i prevoziti rashlađeno (2 °C - 8 °C).
If you are accidentally injected with this veterinary medicinal product, seek prompt medical advice even if only a very small amount is injected and take the package leaflet with you.
Ukoliko ste nehotično injicirani ovim veterinarsko-medicinskim proizvodom, potražite hitnu medicinsku pomoć čak ako je injicirana vrlo mala količina i sa sobom ponesite uputu o VMP.
Accidental injection is dangerous - read the package leaflet before use.
Nehotično injiciranje je opasno - vidi uputu o VMP prije primjene.
Pregnancy and lactation: Can be used during pregnancy and lactation.
Primjena tijekom graviditeta i laktacije: Može se primijeniti tijekom graviditeta i laktacije.
For herd immunisation of healthy cows and heifers, in dairy cattle herds with recurring mastitis problems, to reduce the incidence of sub-clinical mastitis and the incidence and the severity of the clinical signs of clinical mastitis caused by Staphylococcus aureus, coliforms and coagulase-negative staphylococci.
Imunizacija stada zdravih krava i junica, u stadima mliječnih krava gdje se opetovano javlja problem mastitisa, da bi se umanjila učestalost subkliničkog mastitisa te učestalost i težina kliničkih znakova kliničkog mastitisa, koje uzrokuju Staphylococcus aureus, koliformne bakterije i koagulaza-negativni stafilokoki.
Name and address of the manufacturer of the biological active substances
Naziv i adresa proizvođača biološki djelatne(ih) tvari
1 dose (2 ml) 5 doses (10 ml) 25 doses (50 ml)
1 doza (2 ml) 5 doza (10 ml) 25 doza (50 ml)
The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reactions) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Učestalost nuspojava je određena sukladno sljedećim pravilima: - vrlo česte (više od 1 na 10 tretiranih životinja pokazuju nuspojavu(e)) - česte (više od 1 ali manje od 10 tretiranih životinja na 100 životinja) - manje česte (više od 1 ali manje od 10 tretiranih životinja na 1.000 životinja) - rijetke (više od 1 ali manje od 10 tretiranih životinja na 10.000 životinja) - vrlo rijetke (manje od 1 životinje na 10.000 tretiranih životinja, uključujući izolirane slučajeve).
Pharmacotherapeutic group: Immunologicals for bovidae, inactivated bacterial vaccines for cattle.
Farmakoterapijska grupa: imunološki pripravci za goveda, inaktivirana bakterijska cjepiva za goveda.
Ivory-coloured homogeneous emulsion.
Homogena emulzija boje slonovače.
- A mean transient increase in body temperature of about 1 °C, in some cows up to 2 °C, may occur in the first 24 hours after injection based on post-authorisation pharmacovigilance reporting.
U prvih 24 sata nakon injiciranja može doći do prolaznog porasta tjelesne temperature, prosječno za otprilike 1 C, a u nekih krava do 2 C, temeljem izvješća farmakovigilanciji nakon dobivanja odobrenja za stavljanje u promet.
THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, IF APPLICABLE
13. RIJEČI “SAMO ZA PRIMJENU NA ŽIVOTINJAMA I UVJETI ILI OGRANIČENJA U POGLEDU OPSKRBE I PRIMJENE
The injections should be preferably administered on the alternate sides of the neck.
Po mogućnosti, injiciranje treba obaviti naizmjenično na obje strane vrata.
EU/2/08/092/001 1 glass vial 1 dose EU/2/08/092/002 10 glass vials 1 dose EU/2/08/092/003 20 glass vials 1 dose EU/2/08/092/004 1 glass vial 5 doses EU/2/08/092/005 10 glass vials 5 doses EU/2/08/092/006 1 glass vial 25 doses EU/2/08/092/007 10 glass vials 25 doses EU/2/08/092/008 1 PET vial of 5 doses
EU/2/08/092/004 1 staklena bočica s 5 doza EU/2/08/092/005 10 staklenih bočica s 5 doza EU/2/08/092/006 1 staklena bočica s 25 doza EU/2/08/092/007 10 staklenih bočica s 25 doza EU/2/08/092/008 1 PET bočica s 5 doza EU/2/08/092/009 1 PET bočica s 25 doza EU/2/08/092/010 1 PET bočica s 125 doza
The vials are closed with a rubber stopper and aluminium cap.
Ampule su zatvorene gumenim čepom i aluminijskim prstenom.
To stimulate active immunity against Staphylococcus aureus, coliforms and coagulase-negative staphylococci.
Poticanje aktivne imunosti protiv Staphylococcus aureus, koliformnih bakterija i koagulazenegativnih stafilokoka.
E. coli J5 inactivated > 50 RED60 (Rabbit effective dose in 60% of the animals (serology)).
E. coli J5 inaktivirana > 50 RED60 (djelotvorna doza u kunića, u 60% životinja (serološki nalaz)).
Polyethylene (PET) vials of 10, 50 and 250 ml.
Polietilenske (PET) ampule od 10, 50 i 250 ml.
One dose contains: E. coli J5 inactivated; S. aureus (CP8) strain SP 140 inactivated.
E.coli J5 inaktivirana; S.aureus (CP8) soj SP 140 inaktiviran.
Incompatibilities: Do not mix with any other veterinary medicinal product.
Inkompatibilnosti: Ne miješati s bilo kojim drugim cjepivom ili veterinarsko-medicinskim proizvodom.
Allow the vaccine to reach a temperature of 15 °C to 25 °C before administration.
Prije primjene pričekajte da cjepivo dostigne temperaturu od 15 °C do 25 °C.
1 vial of 1 dose (2 ml) 10 vials of 1 dose (2 ml) 20 vials of 1 dose (2 ml) 1 vial of 5 doses (10 ml) 10 vials of 5 doses (10 ml) 1 vial of 25 doses (50 ml) 10 vials of 25 doses (50 ml) 1 vial of 125 doses (250 ml) 125 doses (250 ml)
1 bočica s 1 dozom (2 ml) 10 bočica s 1 dozom (2 ml) 20 bočica s 1 dozom (2 ml) 1 bočica s 5 doza (10 ml) 10 bočica s 5 doza (10 ml) 1 bočica s 25 doza (50 ml) 10 bočica s 25 doza (50 ml) 1 bočica s 125 doza (250 ml)
Withdrawal period: Zero days.
KARENCIJE Karencija: nula dana.
- Anaphylactic-type reactions may occur in some sensitive animals which might be life-threatening based on post-authorisation pharmacovigilance reporting.
- Kod nekih osjetljivih životinja može doći do po život opasnih reakcija anafilaktičkog tipa, temeljem izvješća farmakovigilanciji nakon dobivanja odobrenja za stavljanje u promet.
PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard boxes, PET vial (250 ml)
PODACI NA VANJSKOM PAKOVANJU Kartonske kutije, PET ampule (250 ml)
EU/2/08/092/001-010
BROJ(EVI) ODOBRENJA ZA STAVLJANJE U PROMET EU/2/08/092/001-010
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
6.6 Posebne mjere opreza prilikom odlaganja neupotrebljenog veterinarsko-medicinskog proizvoda ili otpadnih materijala dobivenih primjenom tih proizvoda Bilo koji neupotrebljeni veterinarsko-medicinski proizvod ili otpadni materijali dobivenih primjenom tih veterinarsko-medicinskih proizvoda trebaju se odlagati u skladu s lokalnim propisima.
HIPRA FRANCE Tél.
France HIPRA FRANCE
SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE MATERIALS, IF ANY
13. POSEBNE MJERE OPREZA PRILIKOM ODLAGANJA NEUPOTREBLJENOG PROIZVODA ILI OTPADNIH MATERIJALA, AKO IH IMA
STARTVAC is an ivory-coloured homogeneous emulsion for injection.
STARTVAC je homogena emulzija za injekciju boje slonovače.
If you notice any serious effects or other effects not mentioned in this package leaflet, please inform your veterinary surgeon.
Ako zamijetite bilo koju ozbiljnu nuspojavu ili druge nuspojave koje nisu opisane u uputi o VMP,
Even if small amounts have been injected, accidental injection with this product can cause intense swelling, which may, for example, result in ischaemic necrosis and even the loss of a digit.
U slučaju nehotičnog injiciranja ovim proizvodom, čak ako je injicirana i vrlo mala količina, ona može prouzročiti intenzivno oticanje, koje, na primjer, može rezultirati ishemičnom nekrozom i čak gubitkom prsta.
Benzyl alcohol Liquid paraffin Sorbitan monooleate Polysorbate 80
Sorbitan monooleat Polisorbat 80
Benzyl alcohol…………….......................................................... 21 mg. For the full list of excipients, see section 6.1.
Benzilni alkohol…………….......................................................... 21 mg
* RED60: Rabbit effective dose in 60% of the animals (serology).
* RED60: djelotvorna doza u kunića, u 60% životinja (serološki nalaz).
Laboratorios Hipra, S.A. (CIAMER) Carretera C-63, km 48.300, Polígono Industrial El Rieral 17170 Amer (Girona) Spain
Laboratorios Hipra, S.A. (CIAMER) Carretera C-63, km 48.300,
** RED80: Rabbit effective dose in 80% of the animals (serology).
** RED80: djelotvorna doza u kunića, u 80% životinja (serološki nalaz).
Expert, PROMPT, surgical attention is required and may necessitate early incision and irrigation of the injected area, especially where there is involvement of finger pulp or tendon.
HITNO je potreban stručni kirurški pregled koji može zahtijevati preventivnu inciziju i ispiranje injiciranog područja, napose u području jagodice prsta ili tetiva.
EXP Once opened, use within a 10-hour period, stored at 15-25 ºC.
Jednom otvoreno pakovanje, primijeniti u roku od 10 sati, čuvano između 15-25 ºC.
Batch{number}
Lot {broj}
Shelf life after first opening the immediate packaging: 10 hours stored at 15 °C to 25 ºC.
Rok valjanosti poslije prvog otvaranja unutarnjeg pakovanja: 10 sati čuvano između 15 °C do 25 ºC.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS PET vials (10 ml, 50 ml) and glass vials (2 ml, 10 ml, 50 ml)
PET ampule (10 ml, 50 ml) i staklene ampule (2 ml, 10 ml, 50 ml)
Liquid paraffin: 18.2 mg
18,2 mg Pomoćna tvar:
S. aureus (CP8) strain SP 140 inactivated, expressing slime associated antigenic complex (SAAC) > 50 RED80 (In 80% of the animals).
S. aureus (CP8) soj SP 140 inaktiviran, koji izražava kompleks antigena pridružen sluzi (SAAC) > 50 RED80 (u 80% životinja). parafin, tekući: 18,2 mg benzilni alkohol: 21 mg
EU/2/08/092/009 1 PET vial of 25 doses EU/2/08/092/010 1 PET vial of 125 doses
16. BROJ(EVI) ODOBRENJA ZA STAVLJANJE U PROMET EU/2/08/092/001 1 staklena bočica s 1 dozom EU/2/08/092/002 10 staklenih bočica s 1 dozom EU/2/08/092/003 20 staklenih bočica s 1 dozom
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
4.10 Predoziranje (simptomi, hitni postupci, antidoti), ako je nužno Nakon primjene dvostruke doze cjepiva nisu zapažene nuspojave osim onih navedenih u dijelu 4.6.
Shelf life after first opening the immediate packaging: 10 hours stored at 15 ºC to 25 ºC.
Rok valjanosti poslije prvog otvaranja unutarnjeg pakovanja: 10 sati čuvano između 15 ºC i 25 C.
STARTVAC emulsion for injection for cattle
STARTVAC emulzija za injekcije za goveda.
No adverse reactions other than those mentioned in section “Adverse reactions” were observed after the administration of a double dose of vaccine.
Nakon primjene dvostruke doze cjepiva nisu zapažene nuspojave osim onih navedenih u dijelu “Nuspojave”.
THE WORDS “KEEP OUT OF THE SIGHT AND REACH OF CHILDREN”
11. POSEBNE MJERE PRI ČUVANJU Čuvati izvan pogleda i dosega djece.
PACKAGE LEAFLET FOR: STARTVAC emulsion for injection for cattle
UPUTA O VMP: STARTVAC emulzija za injekciju za goveda.
Tel: (+48) 22 642 33 06
HIPRA POLSKA Sp.z.o.o. Tel: (+48) 22 642 33 06
HIPRA UK AND IRELAND, Ltd. Tel: (+44) 0115 912 4320
Hipra Italia S.r.l. Tel: ( +39) 030 7241821
Hrvatska
KARENCIJE
Type I colourless glass vials of 3, 10 and 50 ml.
I od 3, 10 i 50 ml.
- Cardboard box with 1 and 10 glass vials of 25 doses.
- Kartonska kutija s 1 i 10 staklenih bočica s 25 doza.
- Cardboard box with 1 and 10 glass vials of 5 doses.
- Kartonska kutija s 1 i 10 staklenih bočica s 5 doza.
WITHDRAWAL PERIODS
ROK VALJANOSTI
- Cardboard box with 1 PET vial of 125 doses.
- Kartonska kutija s 1 PET bočicom s 125 doza.
Escherichia coli J5 inactivated ............................................................................. > 50 RED60* Staphylococcus aureus (CP8) strain SP 140 inactivated, expressing slime associated antigenic complex (SAAC) ............. …………………………………………… > 50 RED80**
Escherichia coli J5 inaktivirana .......................................................................... > 50 RED60 *
Cardboard box with 20 glass vials of 1 dose.
- Kartonska kutija s 20 staklenih bočica, s 1 dozom.
Hipra Italia S.r.l.
United Kingdom HIPRA UK AND IRELAND, Ltd.
Escherichia coli (J5) inactivated .......................................................................... > 50 RED60* Staphylococcus aureus (CP8) strain SP 140 inactivated, expressing slime associated antigenic complex (SAAC)........................................................................ ........................................ > 50 RED80** * RED60: Rabbit effective dose in 60% of the animals (serology).
Staphylococcus aureus (CP8) soj SP 140 inaktiviran, koji izražava kompleks antigena pridružen sluzi (SAAC) .................. …………………………………………… > 50 RED80 **
Special warnings for each target species: The whole herd should be immunised.
12. POSEBNO(A) UPOZORENJE(A) Posebna upozorenja za svaku od ciljnih vrsta životinja:
Cardboard box with 10 glass vials of 5 doses.
- Kartonska kutija s 10 staklenih bočica, s 5 doza.
HIPRA POLSKA Sp.z.o.o.
Deutschland HIPRA DEUTSCHLAND GmbH
Cardboard box with 1 glass vial of 5 doses.
- Kartonska kutija s 1 staklenom bočicom, s 5 doza.
Cardboard box with 10 glass vials of 1 dose.
- Kartonska kutija s 10 staklenih bočica, s 1 dozom.
Pack sizes: - Cardboard box with 1, 10 and 20 glass vials of 1 dose.
- Kartonska kutija s 1, 10 i 20 staklenih bočica s 1 dozom.
Store and transport refrigerated.
11. POSEBNI UVIJETI ČUVANJA Čuvati i prevoziti rashlađeno Zaštititi od svjetla.
Cardboard box with 1 glass vial of 1 dose.
- Kartonska kutija s 1 staklenom bočicom, s 1 dozom.
- Cardboard box with 1 PET vial of 25 doses.
- Kartonska kutija s 1 PET bočicom s 25 doza.
- Cardboard box with 1 PET vial of 5 doses.
- Kartonska kutija s 1 PET bočicom s 5 doza.
Special precautions for use in animals: Vaccinate healthy animals only.
Posebne mjere opreza prilikom primjene na životinjama:
Danmark
SPAIN
5 years
5 godina.
An additional 5 deaths were reported subsequently.
Naknadno je prijavljeno još 5 smrtnih slučajeva.
Date of first authorisation: 14th November 2016
Datum prvog odobrenja: 14. studeni 2016
It is not possible to determine whether these events are related directly to these factors or to other factors.
Ne može se utvrditi jesu li ti događaji izravno povezani s tim faktorima rizika ili s drugim faktorima.
- if you are taking riociguat.
- ako uzimate riocigvat.
1047 Budapest Hungary
1047 Budimpešta Mađarska
An updated RMP should be submitted: • At the request of the European Medicines Agency;
Ažurirani RMP treba dostaviti: na zahtjev Europske agencije za lijekove;
Elderly (≥65 years)
Stariji (≥65godina)
Paediatric population (1 year to 17 years)
Pedijatrijska populacija (1 do 17 godina)
The causes of deaths were related to PAH.
Uzroci smrti bili su povezani s PAH-om.
Most, but not all, of these patients had pre-existing cardiovascular risk factors.
U većine, ali ne i svih tih bolesnika već su postojali kardiovaskularni faktori rizika.
Your doctor may tell you to reduce the dose over a few days before stopping completely.
Liječnik će Vam možda reći da smanjite dozu tijekom nekoliko dana prije nego što potpuno prestanete uzimati lijek.
Tmax was estimated at approximately 1 hour and was almost independent from body weight.
Procjenjuje se da Tmax iznosi približno 1 sat i da je gotovo neovisan o tjelesnoj težini.
You should be aware of how you react to the medicine before you drive or use machines.
Trebali biste znati kako reagirate na ovaj lijek prije nego što počnete voziti ili upravljati strojevima.
- take medicines for erectile dysfunction.
- uzimate lijekove za erektilnu disfunkciju
Sildenafil is rapidly absorbed.
Sildenafil se brzo apsorbira.
MedDRA system organ class (V.14.0)
MedDRA klasifikacija organskih sustava (V.14.0)
95% confidence interval
Procijenjena razlika Interval pouzdanosti 95%
Children Granpidam should not be given to children below 1 year of age.
Djeca Granpidam se ne smije davati djeci mlađoj od 1 godine.
The improvement in 6MWD was apparent after 4 weeks of treatment and this effect was maintained at weeks 8 and 12.
Poboljšanje 6MWD-a bilo je vidljivo nakon 4 tjedna liječenja i taj je učinak bio održan u 8. i u 12. tjednu.
Tell your doctor if you are taking any of these medicines.
Obavijestite svog liječnika ako uzimate neki od tih lijekova.
n=29 for placebo group
n = 29 za skupinu koja je primala placebo
In cases of overdose, standard supportive measures should be adopted as required.
U slučaju predoziranja, po potrebi je potrebno primijeniti standardne suportivne mjere.
90 tablets 300 tablets 15x1 tablet 90x1 tablet 300x1 tablet
90 tableta 300 tableta 15x1 tableta 90x1 tableta 300x1 tableta
Cardiovascular risk factors
Kardiovaskularni faktori rizika
Clinical efficacy as measured by 6-minute walk distance could be less in elderly patients.
Klinička djelotvornost mjerena 6-minutnom postignutom udaljenošću hodom može biti manja u starijih bolesnika.
Alpha-blockers
Alfa-blokatori
Other medicines and Granpidam
Drugi lijekovi i Granpidam
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Obavijestite svog liječnika ili ljekarnika ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove:
The duration of treatment was 12 weeks.
Liječenje je trajalo 12 tjedana.
In the event of an erection that persists longer than 4 hours, the patient should seek immediate medical assistance.
U slučaju erekcije koja traje dulje od 4 sata, bolesnik treba zatražiti hitnu medicinsku pomoć.
The safety and efficacy of sildenafil in children below 1 year of age has not been established.
Sigurnost i djelotvornost sildenafila u djece mlađe od 1 godine nisu ustanovljene.
Many events were reported to occur during or shortly after sexual intercourse and a few were reported to occur shortly after the use of sildenafil without sexual activity.
Prijavljeno je da su mnogi od tih događaja nastupili tijekom ili ubrzo nakon spolnog odnosa, a nekoliko ih je prijavljeno ubrzo nakon uzimanja sildenafila bez seksualne aktivnosti.
Granpidam can cause a serious increase in the effects of these medicines.
Granpidam može uzrokovati ozbiljno pojačanje učinaka tih lijekova.
If you are pregnant, or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku ili ljekarniku za savjet prije nego uzmete ovaj lijek.
Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy and embryonal/foetal development.
Ispitivanja na životinjama ne ukazuju na izravne ili neizravne štetne učinke na trudnoću i razvoj embrija/fetusa.
Wessling Hungary Kft Fòti ùt 56., Budapest 1047, Hungary or
Wessling Hungary Kft Fòti ùt 56., Budimpešta 1047, Mađarska ili
What Granpidam is and what it is used for
Što je Granpidam i za što se koristi
If you are taking riociguat or are unsure tell your doctor.
Ako uzimate riocigvat ili niste sigurni obratite se svom liječniku.
Granpidam passes into your breast milk at very low levels and would not be expected to harm your baby.
Granpidam se izlučuje u majčino mlijeko u vrlo malim količinama i ne očekuje se da bi mogao naškoditi Vašem dojenčetu.
Tablets should be taken approximately 6 to 8 hours apart with or without food.
Tablete treba uzimati u razmaku od oko 6 do 8 sati, s hranom ili bez nje.
Its effect is more potent on PDE5 than on other known phosphodiesterases.
Njegov učinak na PDE5 snažniji je nego na druge poznate fosfodiesteraze.
Sage House, 319 Pinner Road, North Harrow, Middlesex HA1 4HF, United Kingdom or
Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF Ujedinjeno Kraljevstvo ili
Physicians should advise patients who forget to take Granpidam to take a dose as soon as possible and then continue with the normal dose.
Liječnici trebaju savjetovati bolesnicima koji zaborave uzeti Granpidam da uzmu dozu što prije, a zatim nastave s uobičajenom dozom.
If you forget to take Granpidam, take a dose as soon as you remember, then continue to take your medicine at the usual times.
Ako ste zaboravili uzeti Granpidam, uzmite dozu čim se sjetite, a zatim nastavite uzimati lijek u uobičajeno vrijeme.
The duration of treatment was 16 weeks.
Liječenje je trajalo 16 tjedana.
The subsequent effect on efficacy is unknown.
Nije poznat posljedični učinak na djelotvornost.
Serious adverse events were reported in 94 (41%) of the 229 subjects receiving sildenafil.
Ozbiljne nuspojave prijavljene su u 94 (41%) od 229 ispitanika koji su primali sildenafil.
These reports included dizziness and lightheadedness, but not syncope.
Te su prijave uključivale omaglicu i ošamućenost, no ne i sinkopu.
The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Zahtjevi za podnošenje periodičkih izvješća o neškodiljvosti za ovaj lijek definirani su u referentnom popisu datuma EU (EURD popis) predviđenom člankom 107.c stavkom 7. Direktive 2001/83/EZ i svim sljedećim ažuriranim verzijama objavljenima na europskom internetskom portalu za lijekove.
The results of the main analysis (combined dose groups versus placebo) were not statistically significant (p = 0.056) (see Table 2).
Rezultati glavne analize (kombinirane doze sildenafila u odnosu na placebo) nisu bili statistički značajni (p = 0,056) (vidjeti Tablicu 2).
Of the 278 patients randomised, 277 patients received at least 1 dose of study drug.
Od 278 randomiziranih bolesnika, 277 ih je primilo najmanje 1 dozu ispitivanog lijeka.
Granpidam can cause dizziness and can affect vision.
Granpidam može izazvati omaglicu i može utjecati na vid.
What Granpidam is and what it is used for What you need to know before you take Granpidam How to take Granpidam
Što je Granpidam i za što se koristi Što morate znati prije nego počnete uzimati Granpidam
The use of sildenafil in other forms of PAH is not recommended.
Ne preporučuje se primjena sildenafila u drugim oblicima PAH-a.
- if you have recently had a stroke, a heart attack or if you have severe liver disease or very low blood pressure (<90/50 mmHg).
- ako ste nedavno imali moždani udar ili srčani udar, ili ako imate tešku bolest jetre ili vrlo nizak krvni tlak (< 90/50 mmHg).
Do not stop taking Granpidam unless your doctor tells you to.
Nemojte prestati uzimati Granpidam ako Vam tako ne kaže liječnik.
If you take more medicine than you have been told to take contact your doctor immediately.
Ako uzmete više lijeka nego što Vam je preporučeno, odmah se javite svom liječniku.
What you need to know before you take Granpidam
Što morate znati prije nego počnete uzimati Granpidam