qanastek/EMEA-V3 huggingface dataset:
Immediately before administration, the solution should be inspected visually for undissolved particulate matter and discoloration.
Eżatt qabel tingħata, is- soluzzjoni għandha tiġi eżaminata viżwalment biex tiċċekkja jekk hemmx xi frak li ma inħallx jew telf ta ’ kulur.
The solution should be clear and colourless to light yellow.
It- soluzzjoni għandha tkun ċara u bejn bla kulur u isfar ċar.
Do not use solutions that are discoloured or have deposits.
Tużax soluzzjoni li tilfet il- kulur jew għandha xi depożiti.
Any unused product or waste material should be disposed of in accordance with local requirements.
Kwalunkwe prodott mhux użat jew skart għandu jintrema skond il- ħtiġiet lokali.
EU/ 1/ 01/ 186/ 001 (500 IU) EU/ 1/ 01/ 186/ 002 (1000 IU)
EU/ 1/ 01/ 186/ 001 EU/ 1/ 01/ 186/ 002
3 July 2001 Renewal of authorisation:
3 ta ’ Lulju 2001 Tiġdid ta ’ l- awtorizzazzjoni:
3 July 2006
3 ta ’ Lulju 2006
DATE OF REVISION OF TEXT
DATA TA ’ META ĠIET RIVEDUTA L- KITBA
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
MANIFATTUR TAS- SUSTANZA BIJOLOĠIKA ATTIVA U SID L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL- ĦRUĠ TAL- LOTT
9 A MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
MANIFATTUR TAS- SUSTANZA BIJOLOĠIKA ATTIVA U SID L - AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL- ĦRUĠ TAL - LOTT
B CONDITIONS OF THE MARKETING AUTHORISATION
KUNDIZZJONIJIET TA 'L- AWTORIZZAZZJONI GĦALL- KUMMERĊ
Medicinal product subject to restricted medical prescription (See Annex I:
Prodott mediċinali jingħata b' riċetta ristretta tat- tabib (Ara Sezzjoni I:
Summary of Product Characteristics, 4.2)
Karatteristiċi tal- Prodott fil - Qosor, 4. 2)
Not Applicable.
Ma jgħoddx f’ dan il- każ.
Official batch release: in accordance with Article 114 of Directive 2001/ 83/ EC, the official batch release will be undertaken by a state laboratory or a laboratory designated for that purpose.
Ħruġ tal- lott uffiċjali: skond Artiklu 114 tad- Direttiva 2001/ 83/ EC kif emendata, il- ħruġ tal- lott uffiċjali isir minn laboratorju ta 'l- Istat jew laboratorju ieħor li jiġi maħtur għal dak il- għan.
12 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND ON THE IMMEDIATE PACKAGING
12 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
BOX VIAL OF POWDER 500 IU BOX VIAL OF POWDER 1000 IU
KAXXA BI FJALA TA ’ TRAB TA ’ 500 IU KAXXA BI FJALA TA ’ TRAB TA ’ 1000 IU
Nonafact 100 IU/ ml powder and solvent for solution for injection Human coagulation factor IX
Fattur IX ta ’ koagulazzjoni umana.
1 vial:
Fjala waħda:
500 IU human coagulation factor IX (100 IU/ ml after reconstitution).
500 IU ta ’ fattur IX ta ’ koagulazzjoni umana (100 IU/ ml wara r- rikostituzzjoni).
1000 IU human coagulation factor IX (100 IU/ ml after reconstitution).
1000 IU ta ’ fattur IX ta ’ koagulazzjoni umana (100 IU/ ml wara r- rikostituzzjoni).
contains: sodium chloride, histidine and sucrose
Fih: sodium chloride, histidine u sucrose.
solvent: water for injections
Solvent: ilma għall- injezzjonijiet.
powder and solvent for solution for injection
Trab u solvent għal soluzzjoni għall- injezzjoni.
contents:
Kontenut:
1 vial of powder for solution for injection 1 vial water for injections 5 ml 1 vial water for injections 10 ml
Fjala ta ’ trab għal soluzzjoni għall- injezzjoni Fjala ta ’ ilma għall- injezzjonijiet 5 ml Fjala ta ’ ilma għall- injezzjonijiet 10 ml
reconstitute with 5 ml of water for injections; reconstitute with 10 ml of water for injections; the product should be used immediately; single dose administration only
Jingħata f’ doża waħda biss.
for intravenous use
Għal użu fil- vini.
read the package leaflet before use
Aqra l- fuljett ta ’ tagħrif qabel l- użu.
keep out of the reach and sight of children
Żomm fejn ma jintlaħaqx u ma jidhirx mit- tfal.
do not use if the solution is not totally clear or if the powder is not totally reconstituted
Tużax jekk is- soluzzjoni mhix ċara għal kollox jew jekk it- trab mhuwiex totalment rikostitwit.
store in a refrigerator (at 2°C – 8°C), do not freeze keep the container in the outer carton, in order to protect from light
Aħżen fi friġġ (2°C – 8°C), tiffriżax Żomm il- kontenitur fil- kartuna ta ’ barra, sabiex tipproteġi mid- dawl
BATCH NUMBER
NUMRU TAL- LOTT TAL - MANIFATTUR
batch:
Lott:
medicinal product subject to medical prescription
Prodott mediċinali jingħata bir- riċetta tat- tabib.
INFORMATION IN BRAIILE
INFORMAZZJONI BIL- BRAILLE
VIAL OF POWDER 500 IU VIAL OF POWDER 1000 IU
FJALA TA ’ TRAB TA ’ 500 IU FJALA TA ’ TRAB TA ’ 1000 IU
Nonafact 100 IU/ ml powder for solution for injection Human coagulation factor IX for intravenous use
Fattur IX ta ’ koagulazzjoni umana.
reconstitute with 5 ml of water for injections; reconstitute with 10 ml of water for injections; administer immediately; read the package leaflet before use
Injetta immedjatament.
{number}
(numru)
500 IU (100 IU/ ml after reconstitution) 1 vial:
Fjala waħda:
1000 IU (100 IU/ ml after reconstitution)
1000 IU (100 IU/ ml wara r- rikostituzzjoni).
VIAL OF SOLVENT 5 ml VIAL OF SOLVENT 10 ml
FJALA TA ’ SOLVENT TA ’ 5 ml FJALA TA ’ SOLVENT TA ’ 10 ml
Water for injections
Ilma għall- injezzjonijiet.
for reconstitution of Nonafact read the package leaflet before use
Aqra l- fuljett ta ’ tagħrif qabel l- użu.
batch:
Lot:
Nonafact 100 IU/ ml Powder and solvent for solution for injection Human coagulation factor IX
Nonafact 100 IU/ ml Trab u solvent għall- injezzjoni Fattur IX ta ’ koagulazzjoni umana
You may need to read it again. • If you have further questions, please ask your doctor or your pharmacist. • 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.
Jista ’ jkollok bżonn terġa ’ taqrah. • Jekk ikollok aktar mistoqsijiet, jekk jogħġbok staqsi lit- tabib jew lill- ispiżjar tiegħek. • Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li m’ humiex imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib jew lill- ispiżjar tiegħek.
Powder The active substance is human coagulation factor IX.
Trab Is- sustanza attiva hija fattur IX ta ’ koagulazzjoni umana.
The product contains 100 International Units (IU) per ml (500 IU/ 5 ml or 1000 IU/ 10 ml) human coagulation factor IX when reconstituted with 5 ml or 10 ml, respectively, of water for injections.
Il- prodott fih 100 Unità Internazzjonali (IU) għal kull ml (500 IU/ 5 ml jew 1000 IU/ 10ml) ta ’ fattur IX ta ’ koagulazzjoni umana meta jkun rikostitwit b’ 5 ml jew 10 ml, rispettivament, ta ’ ilma għall - injezzjonijiet.
The other ingredients are sodium chloride, sucrose and histidine.
L- ingredjenti l- oħra huma sodium chloride, sucrose u histidine.
Solvent Water for injections.
Solvent Ilma għall- injezzjonijiet.
What Nonafact is and what it is used for 2.
X’ inhu Nonafact u għalxiex jintuża 2.
Before you use Nonafact 3.
Qabel ma tuża Nonafact 3.
How to use Nonafact 4.
Kif għandek tuża Nonafact 4.
How to store Nonafact 6.
Kif taħżen Nonafact 6.
WHAT NONAFACT IS AND WHAT IT IS USED FOR
X’ INHU NONAFACT U GĦALXIEX JINTUŻA
Nonafact can be administered to prevent and treat bleeding in patients suffering from haemophilia B (a congenital lack of active factor IX).
Nonafact jista ’ jingħata sabiex jipprevjeni u jikkura l - fsada (ħruġ ta ’ demm) f’ pazjenti li jbatu mill - emofilja B (nuqqas konġenitu ta ’ forma attiva ta ’ fattur IX).
Factor IX is a normal constituent of human blood.
Il- fattur IX huwa kostitwent normali tad - demm uman.
A deficiency of factor IX causes blood coagulation problems, which may lead to bleeding in joints, muscles or internal organs.
Nuqqas ta ’ fattur IX jikkawża problemi ta ’ koagulazzjoni fid- demm, li jistgħu jwasslu għal fsada fil- ġogi, fil- muskoli jew fl- organi nterni.
The administration of Nonafact can compensate for this deficiency.
Nonafact jagħmel tajjeb għal dan in- nuqqas.
BEFORE YOU USE NONAFACT
QABEL MA TUŻA NONAFACT
- if you are hypersensitive (allergic) to the active substance, human coagulation factor IX.
Tużax Nonafact: • jekk inti allerġiku/ a (tbagħti minn sensittività eċċessiva) għas- sustanza attiva, fattur IX ta koagulazzjoni umana. • jekk inti allerġiku/ a (tbagħti minn sensittività eċċessiva) għas- sustanzi oħra jew għal proteini tal - ġrieden.
Take special care with Nonafact:
Oqgħod attent ħafna b’ Nonafact:
See your doctor immediately, if bleeding does not stop as expected.
Kellem lit- tabib tiegħek immedjatament, jekk il- fsada ma ’ tieqafx kif mistenni.
After it has been dissolved in the supplied water for injections, the product should be clear.
Wara li jinħall fl- ilma għall- injezzjonijiet provdut, il- prodott għandu jkun ċar.
Check this immediately prior to administration.
Iċċekkja dan immedjatament qabel l- użu.
The product must not be administered if any cloudiness, lumps or particulate matter are visible.
Il- prodott m’ għandux jintuża jekk jidher li jkun imdadar, bil- boċoċ jew jekkjidher xi frak ieħor.
In rare cases, Nonafact can give rise to a severe allergic reaction (anaphylactic shock).
F’ każijiet rari, Nonafact jista ’ jikkawża reazzjoni allerġika serja (xokk anafilattiku).
If, after administration, you develop hypersensitive reactions like hives, itching and rash, chest tightness, wheezing and light headedness contact your physician immediately.
Jekk, wara l - injezzjoni, tiżviluppa xi reazzjonijiet ipersensittivi bħal ħorriqija, ħakk u raxx, għafsa fis- sider, tħarħir u rasek ħafifa, ikkuntattja lit- tabib tiegħek immedjatament.
If you have previously experienced hypersensitivity in response to the administration of blood or a blood product, Nonafact
Jekk ġieli kellek ipersensittività wara li
18 should only be administered when absolutely necessary (in life-threatening situations).
18 ngħatalek id- demm jew xi prodott tad- demm, Nonafact għandu jingħata biss jekk ikun assolutament neċessarju (meta hemm ir- riskju għall- ħajja ta ’ l- individwu).
This must be carried out in hospital or under the careful supervision of a doctor.
Dan għandu jingħata biss fl- isptar u taħt is- sorveljanza stretta ta ’ tabib.
Individuals with haemophilia B who receive factor IX preparations, should be monitored for the development of neutralising antibodies against factor IX (inhibitors) (see Possible side effects).
Individwi li jbatu minn emofilja B li qed jirċievu sustanzi ta ’ fattur IX, għandhom ikunu monitorjati għall- iżvilupp ta ’ anti- korpi newtralizzanti kontra l- fattur IX (inibituri) (ara Effetti oħra li jistgħu jinħassu).
Your doctor will check your blood regularly for the presence of these antibodies, especially if you experienced a severe allergic reaction with the previous use of a factor IX product.
It- tabib jeżamina d- demm tiegħek regolarment biex jiċċekkja jekk hemmx dawn l- anti - korpi, speċjalment jekk kellek reazzjoni allerġika serja bl- użu preċedenti ta ’ prodott ta ’ fattur IX.
Activity-neutralising antibodies (inhibitors) is a very rare event in previously treated patients receiving factor IX-containing products.
Il- presenza ta ’ anti- korpi li jinnewtralizzaw l- attività (inibituri) hija xi ħaġa rari ħafna f’ pazjenti li kienu kkurati fil- passat u li qegħdin jieħdu prodotti li fihom l- fattur IX.
There is a slight risk that higher doses of Nonafact will cause clots to form in blood vessels, resulting in thrombosis.
Hemm riskju żgħir li dożi ogħla ta ’ Nonafact jikkawżaw demm magħqud fil- vini jew fl- arterji, li jirriżulta fi trombożi.
If you suffer from a liver or cardiac disease or if you have recently had surgery, there is an increased risk for coagulation complications.
Jekk tbati minn mard tal- fwied jew tal- qalb jew jekk għadek kif għamilt xi operazzjoni, hemm riskju akbar għal komplikazzjonijiet ta ’ koagulazzjoni.
This also applies to newborn babies and patients with an increased risk of thrombosis or “ DIC”, disseminated intravascular coagulation, a disease in which the blood coagulation system is disturbed.
Dan japplika wkoll għat - trabi tat- twelid u għal pazjenti li qiegħdin f’ riskju akbar ta ’ trombożi jew “ DIC ”, koagulazzjoni intravaskulari mifruxa, li hija marda fejn is- sistema ta ’ koagulazzjoni tad- demm titħawwad.
Your doctor will consider whether administration of Nonafact imposes a risk for coagulation complications.
It- tabib tiegħek jara jekk Nonafact ipoġġikx f’ riskju għal komplikazzjonijiet ta ’ koagulazzjoni.
When medicines are made from human blood or plasma, certain measures are put in place to prevent infections being passed on to patients.
Meta l- mediċini jkunu magħmula mid- demm uman jew mill- plażma umana, jittieħdu ċerti miżuri biex tiġi evitata l- mogħdija ta ’ infezzjonijiet lill- pazjenti.
These include careful selection of blood and plasma donors to make sure those at risk of carrying infections are excluded, and the testing of each donation and pools of plasma for signs of virus/ infections.
Dawn jinkludu l- għażla b’ attenzjoni ta ’ donaturi tad- demm uman u tal- plażma umana, biex jiġi żgurat li dawk li jkollhom riskju li jġorru l - infezzjonijiet jiġu esklużi, u l- ittestjar ta ’ kull donazzjoni u tal- ġabra ta ‘ plażma għal sinjali ta ’ virus/ infezzjonijiet.
Manufacturers of these products also include steps in the processing of the blood or plasma that can inactivate or remove viruses.
Waqt l- ipproċessar tad- demm jew tal- plażma, il- manifatturi ta ’ dawn il- prodotti jieħdu ukoll miżuri sabiex iwaqqfu jew ineħħu l- virusis.
Despite these measures, when medicines prepared from human blood or plasma are administered, the possibility of passing on infection cannot be totally excluded.
Minkejja dawn il- miżuri, meta jingħataw mediċini magħmula mid- demm uman jew mill- plażma umana, il- possibbiltà ta ’ tixrid ta ’ infezzjoni ma tistax tiġi totalment eskluża.
This also applies to any unknown or emerging viruses or other types of infections The measures taken are considered effective for enveloped viruses such as human immunodeficiency virus (HIV), hepatitis B virus and hepatitis C virus, and for the non-enveloped hepatitis A and parvovirus B19 viruses.
Dan japplika ukoll għall- virusis li m’ humiex magħrufa jew li jkunu għadhom qegħdin jitfaċċaw, jew tipi oħra ta ’ infezzjoni.
Your doctor may recommend that you consider vaccination against hepatitis A and B if you regularly/ repeatedly receive human plasma-derived coagulation factor IX
Il- miżuri mittieħda huma kkunsidrati bħala effettivi għall- virusis imgeżwrin, bħall- immunodeficiency virus uman (HIV), il- virus ta ’ l- epatite B u l- virus ta ’ l- epatite C, u għall- virusis ta ’ l- epatite A u l - paravirus B19 li m’ humiex imgezwra.
It is strongly recommended that every time you receive a dose of Nonafact the name and batch number of the product are recorded in order to maintain a record of the batches used.
Huwa rrakkomandat ħafna li kull darba illi inti tirċievi doża ta ’ Nonafact, jitniżżel u jinżamm l- isem u n- numru tal- lott tal- prodott biex jinżamm reġistru tal- lottijiet użati.
There is no experience of the treatment of previously untreated patients with Nonafact.
Ma hemm l- ebda esperjenza tal- kura ta ’ pazjenti li ma ġewx trattati qabel b’ Nonafact.
There are insufficient data to recommend the use of Nonafact in children less than 6 years of age.
Għad m’ hemmx tagħrif biżżejjed biex jiġi rakkomandat l- użu ta ’ Nonafact fi tfal ta ’ età iżgħar minn 6 snin.
There are no known interactions between Nonafact and other medicinal products.
Ma hemm l- ebda interazzjonijiet magħrufa bejn Nonafact u prodotti mediċinali oħra.
Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, even those not prescribed.
Jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta
Pregnancy and breast-feeding:
Tqala u Treddiegħ:
Based on the rare occurrence of haemophilia B in women, experience regarding the use of factor IX during pregnancy and breast-feeding is not available.
Minħabba li emofilja B hija rari ħafna fin- nisa, m’ hemmx esperjenza dwar l- użu ta ’ fattur IX fit- tqala u f’ nisa li jkunu qegħdin ireddgħu.
Therefore, factor IX should be used by pregnant or breast-feeding women only if clearly indicated.
Għalhekk, il- fattur IX għandu jintuża f’ nisa tqal u li qegħdin ireddgħu biss jekk hemm indikazzjoni ċara għalih.
Ask your doctor or pharmacist for advice before taking any medicine.
Itlob għall- parir tat- tabib jew ta ’ l- ispiżjar tiegħek qabel tieħu xi mediċina.
Nonafact has no known effects on the ability to drive and to use machines.
19 Nonafact m’ għandu l- ebda effett magħruf fuq is- sewqan u l- użu ta ’ makkinarju.
Information about some of the ingredients of Nonafact:
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Nonafact:
19 This medicinal product contains 75mmol/ l sodium chloride per dose.
Dan il- prodott mediċinali fih 75mmol/ l klorur tas- sodju f’ kull doża.
To be taken into consideration by patients on a controlled sodium diet.
Dan għandu jitqies u jiġi kkunsidrat minn pazjenti li qegħdin fuq dieta ta 'sodju kkontrollata.
HOW TO USE NONAFACT
KIF GĦANDEK TUŻA NONAFACT
Dosage:
Id- Doża:
Your doctor will decide how much Nonafact you require.
It- tabib tiegħek jiddeċiedi kemm għandek bżonn Nonafact.
The exact dose will depend on the seriousness of the clinical situation, your body weight and the amount of factor IX in your blood.
Id- doża eżatta tiddependi fuq kemm hija serja l- qagħda klinika, il- piż tiegħek u l- ammont ta ’ fattur IX fid- demm tiegħek.
If you have to undergo surgery or have a tooth extracted, inform your doctor or dentist that you have factor IX deficiency.
Jekk tkun se tagħmel xi operazzjoni jew taqla ’ xi sinna, avża lit- tabib jew lid- dentist tiegħek li tbati min- nuqqas ta ’ fattur IX.
They will then ensure that factor IX is administered to you, should this prove necessary.
Huma mbagħad jassiguraw li jingħatalek il- fattur IX, jekk dan ikun neċessarju.
It is important that the concentration of factor IX in your blood is checked regularly.
Huwa importanti li l- konċentrazzjoni tal- fattur IX fid- demm tiegħek jiġi iċċekkjat regolarment.
If you are administered 1 IU per kilogram of body weight, the concentration of factor IX in your blood will increase by 1.1% of normal activity.
Jekk jingħatalek 1 IU għal kull kilogramma ta ’ piż tal- ġisem, il- konċentrazzjoni tal- fattur IX fid- demm tiegħek tiżdiedlek b’ 1. 1% ta ’ l- attività normali.
The required dosage is determined using the following formula:
Id- doża meħtieġ tiġi ikkalkulata bl- użu tal- formola li ġejja:
Required units = body weight (kg) x desired factor IX rise (%) (IU/ dl) x 0.9
Unitajiet meħtieġa = piż tal- ġisem (kg) x żieda mixtieqa ta ’ fattur IX (%) (IU/ dl) x 0. 9
Your doctor will determine the dose of Nonafact you need and how frequently you should use it depending on the situation.
It- tabib tiegħek jikkalkula d- doża ta ’ Nonafact li għandek bżonn u kemm il- darba għandek teħodha skond is- sitwazzjoni.
The following table can be used to guide dosing in bleeding episodes and surgery:
It- tabella li gejja tista ’ tintuża bħala gwida tad- doża f’ każijiet ta ’ fsada u kirurġija:
Degree of bleeding / Type of surgical procedure
Il- Grad ta ’ emorraġija / Tip ta ’ proċedura kirurġika
Factor IX level Frequency of doses (hours)/ Duration required (%) of therapy (days) (IU/ dl)
Livell ta ’ Fattur IX meħtiġ (%) (IU/ dl)
Bleeding Early signs of bleeding in joints, muscle bleeding or oral bleeding
Emorraġija Emartrożi bikrija, fsada mill - muskolu jew orali
Repeat every 24 hours.
Irrepeti kull 24 siegħa.
At least 1 day, until the bleeding episode as indicated by pain is resolved or healing is achieved.
Mill- inqas ġurnata waħda sakemm l- episodju ta ’ fsada, kif indikat mill- uġigħ, itaffi jew ikun hemm fejqan.
More extensive bleeding in joints, muscle bleeding or haematoma
Emartrożi aktar estensiva, fsada mill- muskolu jew ematoma
Repeat infusion every 24 hours for 3-4 days or more until pain and acute disability are resolved.
Irrepeti l- infużjoni kull 24 siegħa għal 3- 4 ijiem jew aktar sakemm l - uġigħ u d- disabilità akuta jgħaddu.
Life threatening bleeding Surgery
Emorraġiji serji li jipperikolaw il - ħajja Kirurġija
Repeat infusion every 8 to 24 hours until threat is resolved.
Irrepeti l- infużjoni kull 8 sa 24 siegħa sakemm ir- riskju jiġi kontrollat.
30-60 80-100
30– 60
Every 24 hours, at least 1 day, until healing is achieved.
Kull 24 siegħa, mill- inqas ġurnata waħda, sakemm ikun hemm fejqan.
Repeat infusion every 8-24 hours until adequate wound healing, then
Irrepeti l- infużjoni kull 8- 24 siegħa sakemm il- ferita tagħlaq sewwa,
(pre- and
operazzjoni)
therapy for at least another 7 days.
inqas 7 ijiem oħra.
During the course of treatment it is advised that the concentrations of factor IX in your blood are checked regularly.
20 Huwa rrakkomandat li matul il- kura l- konċentrazzjonijiet ta ’ fattur IX fid- demm tiegħek jiġi iċċekkjat regolarment.
Particularly with major surgery, it is important that the concentrations of factor IX in your blood are checked carefully before and after the operation.
B’ mod partikoralr f’ kirurġija maġġuri, huwa importanti ħafna li l- konċentrazzjonijiet ta ’ fattur IX fid- demm tiegħek jiġu iċċekkjati sew qabel u wara l- operazzjoni.
20 For long-term prevention of bleeding in individuals with severe haemophilia B, doses of 20 IU to 40 IU of factor IX per kilogram body weight should be given at intervals of 3 to 4 days.
Għall- prevenzjoni fit- tul ta ’ fsada f’ individwi b’ emofilja B serja, għandhom jingħataw dożi ta ’ 20 IU sa 40 IU ta ’ fattur IX għal kull kilogramma ta ’ piż tal- ġisem f’ intervalli ta ’ bejn 3 u 4 ijiem.
In some cases, especially in younger patients, shorter dosage intervals or higher doses may be necessary.
F’ ċerti każijiet, speċjalmenti f’ pazjenti iżgħar, jista ’ jkun hemm bżonn ta intervalli iqsar ta ’ doża jew dożi ogħla.
If you have the impression that the effect of Nonafact is too strong or too weak, talk to your doctor.
Jekk għandek l- impressjoni li l- effett ta ’ Nonafact huwa qawwi wisq jew dgħajjef wisq, kellem lit - tabib tiegħek.
Individuals with haemophilia B may develop antibodies (inhibitors) against factor IX.
Individwi li qed ibatu minn emofilja B jistgħu jiżviluppaw anti- korpi (inibituri) kontra l - fattur IX.
As a result, the factor IX product used becomes inactivated (see Possible side effects).
B’ riżultat ta ’ dan, il- prodott ta ’ fattur IX jiġi inattivat (ara ‘ Effetti oħra li jistgħu jinħassu ’).
It is advised that the treatment of this serious condition be taken care of in a haemophilia treating centre where an appropriate dose will be determined.
Huwa rrakkomandat li l- kura ta ’ din il- kondizzjoni serja tingħata f’ ċentru li jitratta l- emofilja fejn tiġi determinata d- doża adattata.
The administration of factor IX can repress these inhibitors.
It- teħid tal- fattur IX tista ’ trażżan dawn l- inibituri.
Instructions for use:
Tagħrif għall- użu:
Dissolving the powder
Biex jinħall it- trab
The powder should be dissolved in the supplied amount of water for injections.
It- trab għandu jinħall fl- ammont ta ’ ilma għall- injezzjonijiet provdut.
The solution should not be too cold when it is administered.
It- soluzzjoni m’ għandiex tkun kiesħa wisq meta tingħata.
In addition, the powder will dissolve more readily if both vials are first allowed to reach room temperature (15°C – 25°C).
Barra minn hekk, it- trab jinħall aktar malajr jekk iż- żewġ fjali l- ewwel jitħallew jilħqu temperatura tal- kamra ta ’ bejn 15°C u 25°C.
Remove from the refrigerator and allow the two vials to reach room temperature (15°C – 25°C).
Oħroġ iż- żewġ fjali mill- friġġ u ħallihom joqgħodu sakemm jilħqu t- temperatura tal- kamra bejn 15°C u 25°C.
Disinfect the surface of the stoppers of both vials with a gauze soaked in 70% alcohol.
Iddiżinfetta s- superfiċi tat- tappijiet taż- żewġ fjali b’ garża mxarrba b’ alkoħol 70%.
Remove the protective sheath from one end of a transfer needle and pierce the stopper of the vial containing water for injections.
Neħħi l- kopertura prottettiva minn- naħa waħda tal- labra ta ’ trasferiment u taqqab it- tapp tal - fjala li fiha l- ilma għall- injezzjonijiet.
Remove the protective sheath from the other end of the transfer needle.
Neħħi l- kopertura prottettiva min- naħa l- oħra tal- labra tat- trasferiment.
Tilt the product vial when transferring the solvent to allow the solvent to flow down the side of the vial.
Mejjel il- fjala tal- prodott waqt li tkun qed titrasferixxi s- solvent biex tħalli s- solvent jinżel mal - ġenb tal- fjala.
Swirl the vial gently to completely dissolve the powder.
Dawwar il- fjala bil- mod biex it- trab jinħall kompletament.
Do not shake!
Tħawwadx bis- saħħa!
The powder dissolves within 5 minutes to produce a clear, colourless to light-yellow solution.
It- trab jinħall f’ 5 minuti biex jipproduċi soluzzjoni li hija ċara, bejn bla kulur u isfar ċar.
Immediately before administration, the solution should be inspected: the solution should be clear and must be free of lumps.
Eżatt qabel tingħata, is- soluzzjoni għandha tiġi eżaminata: is- soluzzjoni għandha tkun ċara u mingħajr boċoċ.
Once dissolved, the product should be used immediately (at least within 3 hours).
Ladarba tinħall, il- prodott għandu jintuża immedjatament (għall- inqas fi żmien 3 sigħat).
Nonafact should never be mixed with other medicinal products.
Nonafact ma għandu qatt jitħallat ma ’ prodotti mediċinali oħra.
Using a hypodermic needle and syringe, draw the dissolved product out of the vial.
Bl- użu ta ’ labra ipodermika u siringa, tella ’ l- prodott maħlul minn ġol- fjala.
3.
Nonafact għandu jiġi injettat direttament f’ vina 3.
2 ml per minute).
Injetta l- prodott maħlul bil- mod ħafna (bejn wieħed u ieħor 2 ml kull minuta).
Any unused product or waste material must be discarded as instructed by your doctor or pharmacist.
Kwalunkwe prodott li ma ntużax jew skart għandu jintrema kif jgħidlek it- tabib jew l- ispiżjar tiegħek.
Duration of treatment:
It- Tul tal- kura
Haemophilia B is a chronic disease, therefore lifelong treatment with a factor IX product may be necessary.
Emofilja B hija marda kronika, għalhekk jista ’ jkollok bżonn kura għal għomrok bi prodott ta ’ fattur IX.
If you use more Nonafact than you should:
21 Jekk tuża Nonafact aktar milli suppost:
No symptoms of overdose with human coagulation factor IX have been reported.
L- ebda sintomi ta ’ doża eċċessiva bil- fattur IX koagulazzjoni umana ma ġew rrapurtati.
As with all medicinal products derived from human blood, the use of Nonafact can cause allergic reactions which may include swelling of the larynx, burning and stinging at the infusion site, chills, flushing, hives, itching and rash, headache, tiredness, nausea, restlessness, fast heart beat, chest tightness, tingling, vomiting, wheezing.
Bħal kull prodott mediċinali derivat mid- demm uman, l- użu ta ’ Nonafact jista ’ jikkawża reazzjonijiet allerġiċi li jistgħu jinkludu nefħa fil- larinġi, ħruq u tingiż fil- post ta ’ l- infużjoni, tkexkix ta ’ bard, fwawar, ħorriqija, ħakk u raxx, uġigħ ta ’ ras, għejja, dardir, nuqqas ta ’ sabar, taħbit mgħaġġel tal- qalb, għafsa fis- sider, tnemnim, remettar, tħarħir.
You should discuss the possible side effects with your doctor in order to know how to recognise them and what to do if they occur.
Għandek tiddiskuti dawn l- effetti mat- tabib tiegħek sabiex tkun tista ’ tagħrafhom u tkun taf x’ għandek tagħmel jekk jinħassu.
Where necessary, mild allergic reactions, such as hives, can be treated with antihistamines (medicinal products which counteract allergies).
Meta jkun hemm bżonn, reazzjonijiet allerġiċi ħfief, bħall- ħorriqija, jistgħu jiġu kkurati bl- antistamini (prodotti mediċini li jaħdmu kontra l- allerġija).
In the case of a severe allergic reaction (anaphylactic shock), immediately stop the administration of the product and contact your doctor immediately.
Fil- każ ta ’ reazzjoni allerġika serja (xokk anafilattiku), waqqaf il- prodott immedjatament u kkuntattja lit- tabib tiegħek immedjatament.
There is a very slight risk that Nonafact will cause clots to form in blood vessels, resulting in thrombosis.
Hemm riskju żgħir ħafna li Nonafact jikkawża l- formazzjoni ta ’ demm magħqud fil- vini u fl- arterji, li jirriżulta fi trombożi.
The use of Nonafact may also produce an increase in body temperature in rare cases.
Nonafact jista ’ wkoll itella ’ it- temperatura tal- ġisem f’ każijiet rari.
Your body may develop antibodies (inhibitors) against factor IX, which will inactivate Nonafact.
Il- ġisem tiegħek jista ’ jiżviluppa anti- korpi (inibituri) kontra l- fattur IX, li jwaqqfu lil Nonafact milli jaħdem.
Your doctor will check your blood regularly for the presence of these antibodies.
It- tabib tiegħek jiċċekkjalek d- demm regolarment biex jara jekk hemmx dawn l- anti- korpi.
Contact your doctor immediately if you suspect that the product is becoming progressively less effective.
Ikkuntattja lit- tabib tiegħek immedjatament jekk tissuspetta li l- prodott qiegħed ikun anqas effettiv.
This will show itself as an increased tendency to bleed.
Dan jidher billi jkun hemm tendenza akbar ta ’ fsada.
If you need therapy for repressing antibodies (inhibitors) this should be taken care of in a haemophilia treating centre.
Jekk ikollok bżonn il- kura biex trażżan dawn l- anti- korpi (inibituri), din għandha tingħata f’ ċentru speċjalizzat ta ’ l- emofilja.
You will be closely monitored for any possible side effect during this treatment.
Hemmhekk tkun monitorjat mill- qrib għal kwalunkwe effett ieħor possibbli waqt dan il- kura.
If you should experience one of these side effects, you are advised to contact your doctor.
Jekk tħoss xi wieħed minn dawn l- effetti, ikkuntattja lit- tabib tiegħek.
If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.
Jekk tinduna b’ xi effetti oħra li mhux imniżżlin f’ dan il- fuljett, jekk jogħġbok għarraf lit- tabib jew lill- ispiżjar tiegħek.
HOW TO STORE NONAFACT
KIF TAĦŻEN NONAFACT
Do not use after the expiry date stated on the label and carton.
M’ għandekx tuża wara d- data ta ’ skadenza li tidher fuq it- tikketta u fuq il- kartuna.
Keep the vial in the outer carton in order to protect from light.
Żomm il- fjala fil- kartuna ta ’ barra sabiex tipproteġi kontra d- dawl.
From a microbiological point of view the product, once dissolved, should be used immediately.
Mil- lat mikrobijoloġiku, il- prodott, ladarba jinħall, għandu jintuża immedjatament.
Immediately before administration, check that the solution is clear.
Eżatt qabel l- użu, iċċekkja li s- soluzzjoni hija ċara.
The product must not be used if any cloudiness, lumps or particulate matter are visible.
Il- prodott m’ għandux jintuża jekk ikun imdardar, jew jekk jidhru xi boċoċ jew xi trab.
Nonafact 100 IU/ ml human coagulation factor IX
Nonafact 100 IU/ ml fattur IX koagulazzjoni umana
What Nonafact contains
X’ fih Nonafact:
- The active substance is human coagulation factor IX
- Is- sustanza attiva hi fattur IX koagulazzjoni umana
- The other ingredients are sodium chloride, sucrose, histidine and water for injections.
- Is- sustanzi l- oħra huma l- kloru tas- sodju, s- sukrożju, histidine u ilma għall- injezzjonijiet.
What Nonafact looks like and contents of the pack
Id- dehra ta ’ Nonafact u l- kontenut tal- pakkett:
Nonafact is presented as a powder and a solvent for solution for injection (vial of 5 ml or 10 ml)
22 Nonafact huwa provdut bħala trab u solvent għal soluzzjoni għall- injezzjoni (fjala ta ’ 5 ml jew 10 ml)
Nonafact consists of a carton containing: • A vial of Nonafact containing 500 IU or 1000 IU of factor IX • A vial water for injections containing 5 ml or 10 ml
Nonafact jikkonsisti f’ pakkett tal- kartun li fih: • Fjala ta ’ Nonafact li fiha 500 IU jew 1000 IU ta ’ fattur IX • Fjala ta ’ ilma għall- injezzjonijiet li fih 5 ml jew 10 ml
22 Marketing Authorisation Holder and Manufacturer
Sid l- Awtorizazzjoni għall- kummerċ u l- Manifattur:
Sanquin, Plesmanlaan 125 NL-1066 CX Amsterdam
Sanquin, Plesmanlaan 125 NL- 1066 CX Amsterdam, Olanda
This leaflet was last approved
Dan il- fuljett kien l- aħħar approvat f ’
If you want more information on the basis of the CHMP recommendations, read the Scientific Discussion (also part of the EPAR).
Jekk teħtieġ iktar tagħrif dwar il- kundizzjoni medika jew it- trattament tiegħek, aqra l- Fuljett ta 'Tagħrif (li hu wkoll parti mill- EPAR) jew ikkonsulta lit- tabib jew lill- ispiżjar tiegħek Jekk tixtieq aktar informazzjoni abbażi tar- rakkomandazzjonijiet ta ’ CHMP, aqra d- Diskussjoni Xjentifika (ukoll parti mill- EPAR).
What is Norvir?
X' inhu Norvir?
Norvir is medicine containing the active substance ritonavir.
Norvir hu mediċina li jkun fiha s- sustanza attiva ritonavir.
It is available as an oral solution (80 mg/ ml) and as white capsules (100 mg).
Tiġi bħala soluzzjoni orali (80 mg/ ml) u bħala kapsuli bojod (100 mg).
What is Norvir used for?
Għalxiex jintuża Norvir?
Norvir is an antiviral medicine.
Norvir hu mediċina antivirali.
It is used in combination with other antiviral medicines to treat adults and children over two years of age who are infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
Jintuża flimkien ma 'mediċini oħra fit- trattament ta' adulti jew tfal li jkollhom iktar minn sentejn li jkunu infettati bil- virus uman ta ’ l- immunodefiċenzja tip 1 (HIV- 1), virus li jikkawża s- sindromu ta ’ l- immunodefiċenzja akkwiżita (AIDS).
How is Norvir used?
Kif jintuża Norvir?
Treatment with Norvir should be given by a doctor who has experience in the treatment of HIV infection.
It- trattament b' Norvir għandu jinbeda minn tabib li jkollu esperjenza fil- ġestjoni ta 'l- infezzjoni ta' l - HIV.
It must be taken with food.
Għandu jittieħed ma 'l- ikel.
Norvir is used in two ways: • It is used as a ‘ pharmacokinetic enhancer ’ (booster) to increase the levels of other antiviral medicines that belong to the same group as Norvir (protease inhibitors), i. e. amprenavir, atazanavir, fosamprenavir, lopinavir, saquinavir, tipranavir and darunavir.
Norvir jintuża b' żewġ modi: • Jintuża bħala 'booster farmakokinetiku' biex iżid il- livelli ta 'mediċini antivirali oħra li jagħmlu parti mill- istess grupp bħal Norvir (inibituri proteażi), jiġifieri, amprenavir, atazanavir, fosamprenavir, lopinavir, saquinavir, tipranavir u darunavir.
The standard dose for adults is 100 or 200 mg, once or twice a day.
Id- doża standard għall- adulti hi ta '100 jew 200 mg, darba jew darbtejn kuljum.
The dose depends on which other protease inhibitor is being taken.
Id- doża tiddependi fuq liema inibitur proteażi jkun qed jingħata.
For more information, see the Package Leaflet provided with the other medicine. • Norvir can also be used as an antiviral medicine.
Għal aktar tagħrif, ara l- Fuljett ta 'Tagħrif ipprovvdut mal- mediċina • Norvir jista' jintuża wkoll bħala mediċina antivirali.
The recommended dose for adults is 600 mg twice a day.
Id- doża rakkomandata għall- adulti hi ta '600 mg darbtejn kuljum.
For children, the recommended dose depends on the body surface area (calculated using the child ’ s height and weight).
Għat- tfal, id- doża rakkomandata tiddependi mill- erja tas- superfiċje tal - ġisem (li tiġi kkalkulata skond it- toqol u t- tul tat- tifel jew tifla).
Treatment should start with a low dose that is gradually increased over the first 14 days of treatment.
It- trattament għandu jinbeda b' doża żgħira u jiżdied gradwalment matul l- ewwel 14- il jum ta 'trattament.
How does Norvir work?
Kif jaħdem Norvir?
The active ingredient in Norvir, ritonavir, is a protease inhibitor.
Is- sustanza attiva ta 'Norvir, ritonavir, hija inibitur proteażi.
Ritonavir blocks a viral enzyme called protease, which is involved in the reproduction of HIV.
Ritonavir jimblokka enzim virali msejjaħ proteażi li għandu x' jaqsam mar- riproduzzjoni ta 'l- HIV.
When the enzyme is blocked, the virus does not reproduce normally, slowing down the spread of infection.
Meta l- enzim jiġi mblukkat, il- virus ma jirriproduċix ruħu bħas- soltu, u dan inaqqas il- firxa ta 'l- infezzjoni..
Ritonavir also blocks the activity of a liver enzyme called CYP3A, which is very important in the breakdown of medicines, including some other protease inhibitors.
Ritonavir jimblokka wkoll l - attività ta 'enzim tal- fwied magħruf bħala CYP3A, li hu importanti ħafna fit- tkissir ta' mediċini, inkluż xi inibituri proteażi oħra.
By slowing down the rate at which these medicines are broken down, it can increase their levels in the blood and increase their antiviral activity.
Billi jnaqqas ir- rata li bihom jitkissru dawn il- mediċini, jista 'jżid il- livelli tagħhom fid- demm u jżid l- attività antivirali tagħhom.
Norvir, taken in combination with other antiviral medicines, reduces the amount of HIV in the blood and keeps it at a low level.
Norvir, meħud flimkien ma 'mediċini antivirali oħra, inaqqas l- ammont ta' HIV fid- demm u jżommu f' livell baxx.
Norvir does not cure HIV infection or AIDS, but it may delay the damage to the immune system and the development of infections and diseases associated with AIDS.
Norvir ma jfejjaqx infezzjoni ta 'l- HIV jew l- AIDS, iżda jista' jtawwal iż- żmien qabel ma ssir ħsara lis- sistema immunitarja u l- iżvilupp ta 'infezzjonijiet u mardiet marbuta ma' l- AIDS.
How has Norvir been studied?
Kif ġie studjat Norvir?
Norvir has been studied in two main studies, involving 1,446 patients.
Norvir ġie studjat f' żewġ studji ewlenin, li fihom ħadu sehem 1, 446 pazjent.
The first study compared 600 mg Norvir taken twice a day with placebo (a dummy treatment) in 1,090 adults, as an add-on to the antiviral medicines the patients were already taking.
L- ewwel studju qabbel it - teħid ta '600 mg Norvir darbtejn kuljum mal- plaċebo (trattament finta) f' 1, 090 adult bħala żieda mal - mediċini antivirali li l- pazjent ikun qed jieħu diġà.
The main measure of effectiveness was the number of patients whose disease worsened or who died.
Il- mezz ewlieni tal- kejl ta 'l- effikaċja kien l- għadd ta' pazjenti li l- marda tagħhom qalbet għall- agħar jew li mietu.
The second study compared the same dose of Norvir taken alone, to zidovudine (another antiviral medicine) and to the combination of Norvir and zidovudine, in 356 treatment-naïve adults (who had not taken treatment for HIV infection before).
It- tieni studju qabbel l- istess doża ta 'Norvir meħuda weħidha, ma' zidovudine (mediċina antivirali oħra) u l- kombinazzjoni ta 'Norvir u zidovudine, f’ 356 adult li ma kinux ħadu trattament għall- infezzjoni ta' l- HIV qabel.
The main measure of effectiveness was the change in the levels of HIV in the blood (viral load) and CD4 T-cell levels in the blood (CD4 cell count).
Il- mezz ewlieni tal- kejl ta 'l- effikaċja kien it- tibdil fil- livelli ta' l- HIV fid- demm (tagħbija virali) u taċ- ċelloli- T CD4 fid- demm (n- numru taċ- ċelloli CD4).
CD4 T-cells are white blood cells that are important in helping to fight infections, but which are killed by HIV.
Iċ- ċelloli- T CD4 huma ċelloli tad- demm bojod li għandhom sehem importanti fil- ġlieda kontra l- infezzjonijiet, iżda li jinqatlu mill- HIV.
The effects of Norvir as an antiviral medicine in combination with other antiviral medicines were also studied in four studies of children.
L- effetti ta 'Norvir bħala mediċina antivirali flimkien ma' mediċini antivirali oħra ġew studjati wkoll f' erba 'studji fit- tfal.
The use of Norvir as a pharmacokinetic enhancer is supported by clinical studies of the other medicines that it is used with.
L- użu ta 'Norvir bħala booster farmakokinetiku hu appoġġat minn studji kliniċi dwar mediċini oħra li jintuża magħhom.
What benefit has Norvir shown during the studies?
X' benefiċċji ta 'Norvir intwerew f' dawn l- istudji?
In the first study, 16% of the Norvir-treated patients (86 out of 543) experienced a worsening of disease or died, compared with 33% of the patients taking placebo (181 out of 547).
Fl- ewwel studju, 16% mill- pazjenti (86 minn 543) ittrattati b' Norvir qalbu għall- agħar jew mietu, meta mqabbla ma '33% tal- pazjenti tal- grupp tal- plaċebo (181 minn 547).
In the second study, patients taking Norvir had greater reductions in viral load and increases in CD4 cell counts than those taking zidovudine alone.
Fit- tieni studju, il- pazjenti li kienu qed jieħdu Norvir kellhom tnaqqis fit- tagħbija virali u żidiet fin- numru taċ- ċelloli CD4 ikbar minn dawk li kienu qed jieħdu zidovudine biss.
The combination of Norvir and zidovudine was less effective than Norvir alone, although the reasons for this were unclear.
Il- kombinazzjoni ta 'Norvir u zidovudine kienet inqas effettiva minn Norvir waħdu, għalkemm ma kienx ċar għalfejn seħħ dan.
Norvir, in combination with other antiviral medicines, could also reduce viral loads in children.
Norvir, meħud flimkien ma 'mediċini antivirali oħra, jista' jnaqqas ukoll it- tagħbija virali fit- tfal.
What is the risk associated with Norvir?
X' riskji huma assoċjati ma 'Norvir?
When it is used as a pharmacokinetic enhancer, the side effects of Norvir depend on the other antiviral medicine being taken.
Meta jintuża bħala booster farmakokinetiku, l- effetti sekondarji ta 'Norvir jiddependu mill- mediċina antivirali l- oħra li tkun qed tittieħed.
Some medicines cannot be taken with Norvir when it is used in this way.
Xi mediċini ma jistgħux jittieħdu ma 'Norvir meta jintuża b' dan il- mod.
See the Package Leaflet provided with the other medicine for full details.
Għad- dettalji kollha, ara l- Fuljett ta 'Tagħrif ipprovvdut mal- mediċina.
When it is used as an antiviral medicine, the most common side effects with Norvir (seen in more than 1 patient in 10) are taste perversion (a bad taste in the mouth), circumoral and peripheral paraesthesia (abnormal sensations around the mouth, or in the hands or feet), headache, abdominal (tummy) pain, nausea (feeling sick), diarrhoea, vomiting and asthenia (weakness).
Meta jintuża bħala mediċina antivirali, l- iktar effetti sekondarji komuni ma 'Norvir (li dehru f' iktar minn pazjent wieħed minn kull għaxra) huma togħma ħażina fil- ħalq, sensazzjonijiet anormali madwar il- ħalq, jew fl- idejn u fis- saqajn, uġigħ ta' ras, uġigħ ta 'żaqq, dardir, dijarrea, remettar u astenija (djufija).
For the full list of all side effects reported with Norvir, see the Package Leaflet.
Għal- lista sħiħa ta 'effetti sekondarji rrappurtati ma' Norvir, ara l- Fuljett ta 'Tagħrif.
Norvir should not be used in people who may be hypersensitive (allergic) to ritonavir or any of the other ingredients.
Norvir m' għandux jintuża minn persuni li jkunu allerġiċi għal ritonavir jew għal xi sustanza oħra tiegħu.
It should not be used in patients who have severe problems with their liver.
M' għandux jintuża minn pazjenti li jkollhom problemi severi fil- fwied.
Norvir should not be used as an antiviral medicine by patients taking any of the following medicines: • alfuzosin (used to treat benign prostatic hyperplasia [BPH, enlarged prostate gland]); • meperidine, piroxicam, propoxyphene (used to relieve pain); • amiodarone, bepridil, encainide, flecainide, propafenone, quinidine (used to correct irregular heartbeat); • fusidic acid, voriconazole (at ritonavir doses of 400 mg twice a day or more), rifabutin (used to treat infections); • astemizole, terfenadine (commonly used to treat allergy symptoms - these medicines may be available without a prescription); • clozapine, pimozide (used to treat mental illness); • dihydroergotamine, ergonovine, ergotamine, methylergonovine (used to treat migraine headache); • cisapride (used to relieve certain stomach problems); • lovastatin, simvastatin (used to lower cholesterol in the blood); • clorazepate, diazepam, estazolam, flurazepam, midazolam (when taken by mouth), triazolam (used to relieve anxiety or difficulty sleeping); • St John’ s wort (a herbal preparation used to treat depression).
Norvir m' għandux jintuża bħala mediċina antivirali minn pazjenti li jkunu qed jieħdu xi waħda minn dawn il- mediċini: • alfuzosin (użat fit- trattament tat- tikbir beninn tal- prostata [BPH]), • meperidine, piroxicam, propoxyphene (użat għas- serħan mill- uġigħ): • amiodarone, bepridil, encainide, flecainide, propafenone, quinidine (użati fil- korrezzjoni ta 'taħbit irregolari tal- qalb): • fusidic acid, voriconazole (meta ritonavir jintuża f' dożi ta' 400mg darbtejn kuljum), rifabutin (użat fit- trattament ta 'infezzjonijiet): • astemizole, terfenadine (sikwit użati fit- trattament ta' sintomi ta 'l- allerġiji - dawn il- mediċini jistgħu jinkisbu mingħajr riċetta medika): • clozapine, pimozide (użati fit- trattament ta' mard mentali): • dihydroergotamine, ergonovine, ergotamine, methylergonovine (użati fit- trattament ta 'emigranji): • cisapride (użat biex inaqqas ċerti problemi fl- istonku): • lovastatin, simvastatin (użati biex inaqqsu l- kolesterol fid- demm): • clorazepate, diazepam, estazolam, flurazepam, midazolam, triazolam (użati għas- serħan mill - ansjetà jew diffikultà fl- irqad): • St John’ s wort (preparazzjoni tal- ħxejjex użata fit- trattament tad- dipressjoni).
Caution is also needed by patients taking Norvir at the same time as other medicines.
Meta Norvir jingħata lil pazjenti li jkunu qegħdin jieħdu mediċini oħra, dan għandu jsir b' kawtela kbira.
2/ 3 As with other anti-HIV medicines, patients taking Norvir may be at risk of lipodystrophy (changes in the distribution of body fat), osteonecrosis (death of bone tissue) or immune reactivation syndrome (symptoms of infection caused by the recovering immune system).
2/ 3 Bħal mediċini oħra ta 'kontra l- HIV, il- pazjenti li jkunu qed jieħdu Norvir jista' jkollhom riskju ta 'lipodistrofija (tibdiliet fid- distribuzzjoni tax- xaħam fid- demm), ostjonekrożi (mewt ta' tessut ta ’ l - għadam) jew sindromu tar- riattivazzjoni tas- sistema immunitarja (sintomi ta 'infezzjoni kkawżati minn sistema immunitarja li tkun qed tirkupra).
Patients who have problems with their liver (including hepatitis B or C infection) may be at an elevated risk of liver damage when taking Norvir.
Il- pazjenti li jkollhom problemi bil- fwied (inkluż l- Epatite B u Ċ) jista 'jkollhom riskju elevat ta' ħsara lill- fwied meta jieħdu Norvir.
Why has Norvir been approved?
Għaliex ġie approvat Norvir?
The Committee for Medicinal Products for Human Use (CHMP) decided that Norvir’ s benefits are greater than its risks in combination with other antiretroviral agents for the treatment of HIV-1 infected patients.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu Mill- Bniedem (CHMP) iddeċieda li Norvir għandu iktar benefiċċji milli riskji meta użat flimkien ma 'sustanzi antiretrovirali oħra fit- trattament ta' pazjenti infettati bl- HIV- 1.
The Committee recommended that Norvir be given marketing authorisation.
Il- Kumitat irrakkomanda li Norvir jingħata awtorizzazzjoni għat- tqegħid fis- suq.
Norvir was originally authorised under ‘ Exceptional Circumstances’, because, for scientific reasons, limited information was available at the time of approval.
Norvir oriġinarjament kien awtorizzat taħt Ċirkustanzi ta 'Eċċezzjoni, għax, għal raġunijiet xjentifiċi, kien hemm biss tagħrif limitat disponibbli fi żmien l- approvazzjoni.
As the company had supplied the additional information requested, the ‘ Exceptional Circumstances ’ ended on 13 March 2001.
Billi l- kumpanija pprovvdiet it - tagħrif addizzjonali mitlub, iċ- Ċirkustanzi ta 'Eċċezzjoni ntemmu fit- 13 ta' Marzu 2001.
Other information about Norvir:
Tagħrif ieħor dwar Norvir:
The European Commission granted a marketing authorisation valid throughout the European Union for Norvir to Abbott Laboratories Limited on 26 August 1996.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq għal Norvir valida fl- Unjoni Ewropea kollha lil Abbott Laboratories Limited fis- 26 ta 'Awwissu 1996.
The marketing authorisation was renewed on 26 August 2001 and on 26 August 2006.
L- awtorizzazzjoni għat - tqegħid fis- suq iġġeddet fis- 26 ta 'Awwissu 2001 u fis- 26 ta' Awwissu 2006.
The full EPAR for Norvir can be found here.
L- EPAR sħiħ għal Norvir jista 'jiġi kkonsultat hawn.
Norvir 80 mg/ ml oral solution
Norvir 80mg/ ml - soluzzjoni orali
Each ml of oral solution contains 80 mg of ritonavir.
Kull ml ta ’ soluzzjoni orali fih 80 mg ritonavir.
Alcohol (43% v/ v) Polyoxyl 35 Castor Oil Sunset Yellow (E110)
Alkoħol (43% v/ v) Polyoxyl 35 żejt ir- riġnu Isfar lewn inżul ix- xemx (E110)
The solution is a practically clear, orange solution for oral administration.
Is- soluzzjoni hija prattikament trasparenti u ta ’ kulur oranġjo u tittieħed mill- ħalq.