BI PRETERAX 4/1.25 mg/mg Tablets
देश: आयरलैंड
भाषा: अंग्रेज़ी
स्रोत: HPRA (Health Products Regulatory Authority)
उत्पाद विशेषताएं
(SPC)
27-04-2024
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:
PERINDOPRIL TERT-BUTYLAMINE SALT INDAPAMIDE
थमां उपलब्ध:
Les Laboratoires Servier
INN (इंटरनेशनल नाम):
PERINDOPRIL TERT-BUTYLAMINE SALT INDAPAMIDE
डोज़:
4/1.25 mg/mg
फार्मास्यूटिकल फॉर्म:
Tablets
प्रिस्क्रिप्शन प्रकार:
Product subject to prescription which may be renewed (B)
प्राधिकरण का दर्जा:
Withdrawn
प्राधिकरण की तारीख:
2014-09-23
उत्पाद विशेषताएं
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Bi Preterax 4mg/1.25mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One tablet contains 3.338 mg perindopril corresponding to 4 mg perindopril tert-butylanine and 1.25 mg indapamide.
Excipient: 61.55 mg lactose monohydrate.
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Tablet.
White, rod-shaped tablet
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of essential hypertension,
Bi Preterax
4 mg/1.25 mg Tablets is indicated in patients whose blood pressure is
not adequately controlled on perindopril alone.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Oral route
One Bi Preterax 4 mg/1.25 mg tablet per day as a single dose, preferably to be taken in the morning, and before a meal.
When possible individual dose titration with the components is recommended. Bi Preterax 4 mg/1.25 mg tablet should
be used when blood pressure is not adequately controlled on Preterax 2 mg/0.625 mg Tablets (where available).When
clinically appropriate, direct change from monotherapy to Bi Preterax 4 mg/1.25 mg Tablets tablet may be considered.
_Elderly (see section 4.4)_
Treatment should be initiated after considering blood pressure response and renal function.
_Patients with renal impairment (see section 4.4)_
In severe renal impairment (creatinine clearance below 30 ml/min), treatment is contraindicated.
In patients with moderate renal impairment (creatinine clearance 30-60 ml/min), it is recommended to start treatment
with the adequate dosage of the free combination.
In patients with creatinine clearance greater than or equal to 60 ml/min, no dose modification is required. Usual
medical follow-up will include frequent monitoring of creatinine and potassium.
_Patients with hepatic impairment (see sections 4.3
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