NORVIR 100 MG TABLETS

Land: Israel

Sprache: Englisch

Quelle: Ministry of Health

Wirkstoff:

RITONAVIR

Verfügbar ab:

ABBVIE BIOPHARMACEUTICALS LTD, ISRAEL

ATC-Code:

J05AE03

Darreichungsform:

FILM COATED TABLETS

Zusammensetzung:

RITONAVIR 100 MG

Verabreichungsweg:

PER OS

Verschreibungstyp:

Required

Hergestellt von:

ABBVIE DEUTSCHLAND GMBH & CO. KG, GERMANY

Therapiegruppe:

RITONAVIR

Therapiebereich:

RITONAVIR

Anwendungsgebiete:

Is indicated alone or in combination with other antiretroviral agents for the treatment of patients with HIV infection when therapy is warranted based on clinical and/or immunological evidence of disease progression

Berechtigungsdatum:

2017-04-30

Gebrauchsinformation

."اذإ ءاودلا لامعتسإ زوجي لا" 2 ةرقفلا
:ماعطلاو ءاودلا لامعتسإ
.ماعطلا عم ةيوس ريﭬرون صارقأ لوانت بجي
:ةبوصخلاو عاضرلإا ،لمحلا مهملا نم ،لمحلل نيططخت وأ لماح كنأب
نيدقتعت ،
ً
لاماح تنك اذإ
.ءاودلا اذه لوانت لبق كلذ لوح ج
ِ
لاعملا بيبطلا يريشتست نأ
ً
ادج
ةلاعفلا ةداملا ،
ritonavir
( ريﭬانوتير لامعتسإ لوح باهسإب
تامولعم كلانه
ريﭬانوتير نيقلت لماوحلا ءاسنلا ،ماع
لكشب .لمحلا ةرتف للاخ )ريﭬرون يف
)
booster
( ضفخنم يئاود رادقمب لمحلا نم ىلولأا
ةثلاثلا رهشلأا دعب
ريﭬرون نأ رهظي مل .زآيتورپلا تاطبثم
ةليصف نم ىرخأ ةيودأ عم ةيوس
.ناكسلا ةماعل ةنراقملاب ةيقلخ بويع
روطت ةيلامتحإ نم داز دق
كلذو
HIV
سوريڤل تلاماحلا ءاسنلا ىدل عاضرلإا هب
ىصوملا ريغ نم
.ملأا بيلح ربع عيضرلا ىلإ لقتني دق
سوريڤلا نلأ
ج
ِ
لاعملا بيبطلا ةراشتسإ كيلعف ،عاضرلإل
نيططخت وأ ،ةعضرم تنك اذإ
.نكمي ام عرسأب
:تانكاملا لامعتسإو ةقايسلا
اذهب كيلع رثؤي ءاودلا نأب رعشت تنك اذإ
.راودلا ببسي نأ ريﭬرون نأش نم
.تانكاملا لامعتسإو ةقايسلا نع
عانتملإا بجي ،لكشلا
:ءاودلا تابكرم ضعب نع ةماه تامولعم
لوميليم 1 نم لقأ ىلع ءاودلا اذه يوتحي
.مويدوص ىلع ريﭬرون يوتحي
.'مويدوصلا نم
ٍ
لاخ' ربتعي كلذلو ،صرق لك يف مويدوص )غلم
23(
؟ءاودلا لامعتسإ ةيفيك .3
.بيبطلا تاميلعت بسح رضحتسملا لامعتسإ
ً
امئاد ب

Fachinformation

NOR API SEP 23 CL
Page 1 of 31
PRESCRIBING INFORMATION
1.
NAME OF THE MEDICINAL PRODUCT
Norvir® 100 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 100 mg ritonavir.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
White to off white, oval, debossed with “NK” on one side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
NORVIR is indicated alone or in combination with other antiretroviral
agents for the treatment of patients
with HIV-infection when therapy is warranted based on clinical and/or
immunological evidence of disease
progression.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Ritonavir should be administered by physicians who are experienced in
the treatment of HIV infection.
Ritonavir film-coated tablets are administered orally and should be
ingested with food (see section 5.2).
Norvir film-coated tablets should be swallowed whole and not chewed,
broken or crushed.
Posology
_Ritonavir dosed as a pharmacokinetic enhancer _
When ritonavir is used as a pharmacokinetic enhancer with other
protease inhibitors the prescribing
information for the particular protease inhibitor must be consulted.
The following HIV-1 protease inhibitors have been approved for use
with ritonavir as a pharmacokinetic
enhancer at the noted doses.
_Adults_
Amprenavir 600 mg twice daily with ritonavir 100 mg twice daily.
Atazanavir 300 mg once daily with ritonavir 100 mg once daily.
Fosamprenavir 700 mg twice daily with ritonavir 100 mg twice daily.
NOR API SEP 23 CL
Page 2 of 31
Lopinavir co-formulated with ritonavir (lopinavir/ritonavir) 400
mg/100 mg or 800 mg/200 mg.
Saquinavir 1000 mg twice daily with ritonavir 100 mg twice daily in
ART experienced patients. Initiate
treatment with saquinavir 500 mg twice daily with ritonavir 100 mg
twice daily for the first 7 days, then
saquinavir 1000 mg twice daily with ritonavir 100 mg twice daily in
ART-naïve patients.
Tipranavir 500 mg twice daily with ritonavir 200 mg twice daily.
Tipranavir with riton