REMERON TABLET 30 mg
देश: सिंगापुर
भाषा: अंग्रेज़ी
स्रोत: HSA (Health Sciences Authority)
सूचना पत्रक
(PIL)
13-03-2014
इस उत्पाद के लिए कुछ दस्तावेज़ वर्तमान में उपलब्ध नहीं हैं, आप हमारी ग्राहक सेवा को अनुरोध भेज सकते हैं और जैसे ही हम उन्हें प्राप्त करने में सक्षम होंगे, हम आपको सूचित करेंगे।
अनुरोध भेजा।
अनुरोध भेजा।
सक्रिय संघटक:
MIRTAZAPINE
थमां उपलब्ध:
MSD PHARMA (SINGAPORE) PTE. LTD.
ए.टी.सी कोड:
N06AX11
डोज़:
30 mg
फार्मास्यूटिकल फॉर्म:
TABLET, FILM COATED
प्रशासन का मार्ग:
ORAL
प्रिस्क्रिप्शन प्रकार:
Prescription Only
द्वारा बनाया गया:
N V ORGANON
प्राधिकरण की तारीख:
1997-06-02
सूचना पत्रक
1
S-CCDS-MK8246-ALL-022014
REMERON® Tablets (mirtazapine)
15, 30 and 45mg
1. NAME OF THE MEDICINAL PRODUCT
Remeron 15 mg film-coated tablets
Remeron 30 mg film-coated tablets
Remeron 45 mg film-coated tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Remeron
15 mg film-coated tablet contains 15 mg of mirtazapine.
Each
Remeron 30 mg film-coated tablet contains 30 mg of mirtazapine.
Each Remeron
45 mg film-coated tablet contains 45 mg of mirtazapine.
Excipients:
Each Remeron 15 mg film-coated tablet contains not more than
114 mg lactose
(as monohydrate).
Each Remeron 30 mg film-coated tablet contains not more than
228 mg lactose
(as monohydrate).
Each Remeron 45 mg film-coated tablet contains not more than
342 mg lactose
(as monohydrate).
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film-coated tablet.
15 mg film-coated tablet:
Oval, biconvex, yellow, scored and marked with ‘Organon’ on
one side and a
code on the other side (TZ over 3) on both sides of the
score.
The tablet can be divided into equal halves.
30 mg film-coated tablet:
2
Oval, biconvex, red-brown, scored and marked with
‘Organon’ on one side and a
code on the other side (TZ over 5) on both sides of the
score.
The tablet can be divided into equal halves.
45 mg film-coated tablet:
Oval, biconvex, white and marked with ‘Organon’ on one side and a code on the
other side (TZ over 7).
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
Episode of major depression.
4.2 Posology and method of administration
Adults
Treatment should begin with 15 mg daily. The dosage generally needs to be
increased to obtain
an optimal clinical response. The effective daily dose is
usually between 15
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