SLOW DERALIN 160 MG

国家: 以色列

语言: 英文

来源: Ministry of Health

有效成分:

PROPRANOLOL HYDROCHLORIDE

可用日期:

ABIC LTD.

ATC代码:

C07AA05

药物剂型:

CAPSULES

组成:

PROPRANOLOL HYDROCHLORIDE 160 MG

给药途径:

PER OS

处方类型:

Required

厂商:

TEVA PHARMACEUTICAL INDUSTRIES LTD, ISRAEL

治疗组:

PROPRANOLOL

治疗领域:

PROPRANOLOL

疗效迹象:

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.

授权日期:

2010-05-31

资料单张

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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产品特点

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