Bosvate

국가: 뉴질랜드

언어: 영어

출처: Medsafe (Medicines Safety Authority)

유효 성분:

Bisoprolol fumarate 5mg;  

제공처:

Douglas Pharmaceuticals Limited

INN (International Name):

Bisoprolol fumarate 5 mg

복용량:

5 mg

약제 형태:

Tablet

구성:

Active: Bisoprolol fumarate 5mg   Excipient: Colloidal silicon dioxide Croscarmellose sodium Magnesium stearate Microcrystalline cellulose Sodium starch glycolate

패키지 단위:

Blister pack, PVC/PVdC-aluminium Sample pack, 10 tablets

수업:

Prescription

처방전 유형:

Prescription

Manufactured by:

Moehs Catalana SL

치료 징후:

Treatment of stable chronic heart failure with reduced systolic left ventricular function in addition to ACE inhibitors, and diuretics, and optionally cardiac glycosides.

제품 요약:

Package - Contents - Shelf Life: Blister pack, PVC/PVdC-aluminium Sample pack - 10 tablets - 3 years from date of manufacture stored at or below 25°C protect from light and moisture - Blister pack, PVC/PVdC-aluminium - 20 tablets - 3 years from date of manufacture stored at or below 25°C protect from light and moisture - Blister pack, PVC/PVdC-aluminium - 30 tablets - 3 years from date of manufacture stored at or below 25°C protect from light and moisture - Blister pack, PVC/PVdC-aluminium - 90 tablets - 3 years from date of manufacture stored at or below 25°C protect from light and moisture

승인 날짜:

2010-11-25

환자 정보 전단

Consumer Medicine Information 
BOSVATE 

BISOPROLOL FUMARATE 
Bosvate 2.5 mg, 5 mg, 10 mg tablets 

WHAT IS IN THIS LEAFLET 

Please read this leaflet carefully before you start using Bosvate Tablets. 

This leaflet answers some common questions about Bosvate Tablets. It does not 
contain all the available information. It does not take the place of talking to your 
doctor or pharmacist. 

All medicines have risks and benefits. Your doctor has weighed the risks of you using 
Bosvate Tablets against the benefits they expect it will have for you. 

This medicine has been prescribed for you. Do not pass it on to others. It may harm 
them, even if their symptoms are the same as yours. 

If any of the side effects get serious, or if you notice any side effects not listed in this 
leaflet, please tell your doctor or pharmacist. 

IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, ASK YOUR DOCTOR OR 
PHARMACIST. 

Keep this leaflet with the medicine. You may need to read it again. 

WHAT BOSVATE IS USED FOR 

The active substance in this medicine is bisoprolol fumarate.  Bisoprolol fumarate 
belongs to a group of medicines called beta-blockers. These medicines work by 
affecting the body’s response to some nerve impulses, especially in the heart. As a 
result, bisoprolol slows down the heart rate and makes the heart more efficient at 
pumping blood around the body. Heart failure occurs when the heart muscle is weak 
and unable to pump enough blood to supply the body's needs.  

Bisoprolol is used: 
•  To treat stable chronic heart failure.  It is used in combination with other 
medicines suitable for this condition (such as ACE-inhibitors, diuretics, and 
heart glycosides). 
•  In treatment of coronary heart�

제품 특성 요약

1 | P a g e
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
Bosvate® 1.25 mg, 2.5 mg, 3.75 mg, 5 mg, 7.5 mg, 10 mg Tablet
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Bosvate 1.25 mg: each tablet contains 1.25 mg bisoprolol fumarate
Bosvate 2.5 mg: each tablet contains 2.5 mg bisoprolol fumarate
Bosvate 3.75 mg: each tablet contains 3.75 mg bisoprolol fumarate
Bosvate 5 mg: each tablet contains 5 mg bisoprolol fumarate
Bosvate 7.5 mg: each tablet contains 7.5 mg bisoprolol fumarate
Bosvate 10 mg: each tablet contains 10 mg bisoprolol fumarate
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Bosvate 1.25 mg: White to off white round biconvex tablet
Bosvate 2.5 mg: White to off white round biconvex tablet with a break
line on one side
Bosvate 3.75 mg: White to off white round biconvex tablet
Bosvate 5 mg: White to off white round biconvex tablet with a break
line on one side
Bosvate 7.5 mg: White to off white round biconvex tablet with a break
line on one side
Bosvate 10 mg: White to off white round biconvex tablet with a break
line on one side.
The 2.5 mg, 5 mg, 7.5 mg, and 10 mg tablets can be divided into equal
halves.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
•
Treatment of stable chronic heart failure with reduced systolic left
ventricular function
in addition to ACE inhibitors, and diuretics, and optionally cardiac
glycosides (for
additional information see section 5.1).
•
Treatment of chronic, stable angina pectoris.
•
Treatment of essential hypertension.
4.2.
DOSE AND METHOD OF ADMINISTRATION
STABLE CHRONIC HEART FAILURE
Standard treatment of CHF consists of an ACE inhibitor (or an
angiotensin receptor blocker in
case of intolerance to ACE inhibitors), a beta-blocker, diuretics, and
when appropriate cardiac
2 | P a g e
glycosides. Patients should be stable (without acute failure) when
bisoprolol treatment is
initiated.
It is recommended that the treating physician should be experienced in
the management of
chronic heart failure.
Transient worsening of heart failure, hypotensi