SLOW DERALIN 160 MG
البلد: إسرائيل
اللغة: الإنجليزية
المصدر: Ministry of Health
نشرة المعلومات
(PIL)
06-06-2018
خصائص المنتج
(SPC)
18-08-2016
تقرير التقييم الجمهور
(PAR)
18-08-2016
العنصر النشط:
PROPRANOLOL HYDROCHLORIDE
متاح من:
ABIC LTD.
ATC رمز:
C07AA05
الشكل الصيدلاني:
CAPSULES
تركيب:
PROPRANOLOL HYDROCHLORIDE 160 MG
طريقة التعاطي:
PER OS
نوع الوصفة الطبية :
Required
المصنعة من قبل:
TEVA PHARMACEUTICAL INDUSTRIES LTD, ISRAEL
المجموعة العلاجية:
PROPRANOLOL
المجال العلاجي:
PROPRANOLOL
الخصائص العلاجية:
Management of angina pectoris. Control of essential and renal hypertension and essential tremor.As an adjunct in the management of tachycardias and arrhythmias due to thyrotoxicosis and thyrotoxic crises. Migraine prophylaxis.
تاريخ الترخيص:
2010-05-31
نشرة المعلومات
Deralin-07-05-12-AH/JO
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Propranolol HCl 10 mg
Propranolol HCl 40 mg
Lactose monohydrate, magnesium stearate, gelatin, carmine powder.
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Propranolol HCl 80 mg
Propranolol HCl 160 mg
In a sustained release form
In a sustained release form
Microcrystalline cellulose, ethylcellulose, hypromellose, erythrosine,
black iron oxide, red iron oxide, titanium
dioxide, water, gelatin.
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اقرأ الوثيقة كاملة
خصائص المنتج
SLOW DERALIN CAPSULES 3. 4. 2012, RH
"
ע עבקנ הז ןולע טמרופ
"
רשואו קדבנ ונכותו תואירבה דרשמ י
."
רשואמ ןולע
:
לירפא
2012
.
“This leaflet format has been determined by the Ministry of Health
and the content thereof has been checked and
approved.” Date of approval: April 2012.
PHYSICIANS’ PRESCIBING INFORMATION
SLOW DERALIN
CAPSULES
1.
NAME OF THE MEDICINAL PRODUCT
`SLOW DERALIN' 80 Capsules
`SLOW DERALIN' 160 Capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Propranolol Hydrochloride 80mg, or 160mg.
in a sustained-release formulation.
3.
PHARMACEUTICAL FORM
CLEAR PINK BODY AND OPAQUE LAVENDER CAP; CAPSULES CONTAINING WHITE TO
PALE CREAM
COLOURED SPHEROIDS.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
1.
Management of angina pectoris.
2.
Control of essential and renal hypertension, and essential tremor.
3.
As
an
adjunct
in
the
management
of
tachycardias
and
arrhythmias
due
to
thyrotoxicosis and thyrotoxic crises.
4.
Migraine prophylaxis.
4.2 DOSAGE AND METHOD OF ADMINISTRATION
Since
the
half-life
may
be
increased
in
patients
with
significant
hepatic
or
renal
impairment, care should be taken when starting treatment and selecting
the initial dose.
As with any other potent beta-blocking agent, the optimum dosage of
Slow Deralin has to
be determined individually for each patient.
Food
may
slow
the
hepatic
metabolism
of
propranolol
therapy,
enhancing
its
bioavailability. In order to standardize conditions, it is recommended
that Slow Deralin
should be taken with meals.
As a guide for the correct dosage, bradycardia (usually less than 45
beats/minute) is
indicative that dosage should not be further increased.
SLOW DERALIN CAPSULES 3. 4. 2012, RH Page 2 of 10
2
If patients are switched from Deralin to Slow Deralin, care should be
taken to assure that
the desired therapeutic effect is maintained. Slow Deralin should not
be considered a
simple mg-for mg substitute for Deralin.
Slow Deralin has different kinetics and produces lower blood levels.
Re
اقرأ الوثيقة كاملة
