TRYZAN CAPS 10 ramipril 10mg capsules blister pack

国家: 澳大利亚

语言: 英文

来源: Department of Health (Therapeutic Goods Administration)

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资料单张 资料单张 (PIL)
07-07-2022
产品特点 产品特点 (SPC)
07-07-2022
公众评估报告 公众评估报告 (PAR)
30-11-2017

有效成分:

ramipril, Quantity: 10 mg

可用日期:

Alphapharm Pty Ltd

INN(国际名称):

Ramipril

药物剂型:

Capsule, hard

组成:

Excipient Ingredients: pregelatinised maize starch; titanium dioxide; indigo carmine; purified water; sorbitan monolaurate; erythrosine; Gelatin; iron oxide black; sodium lauryl sulfate; propylene glycol; brilliant blue FCF; butan-1-ol; quinoline yellow; allura red AC; SD alcohol 45; SD alcohol 3-A

给药途径:

Oral

每包单位数:

10, 21, 7 (starter), 30

处方类型:

(S4) Prescription Only Medicine

疗效迹象:

Treatment of hypertension. Data are currently not available to support the use of Tryzan Caps in renovascular hypertension. Post myocardial infarction heart failure. Prevention of progressive renal failure in patients with persistent proteinuria in excess of 1 g/day. For reducing the risk of myocardial infarction, stroke, cardiovascular death or the need for revascularisation procedures in patients 55 years of age or more who have clinical evidence of coronary artery disease, stroke, or peripheral vascular disease. For reducing the risk of myocardial infarction, stroke, cardiovascular death or revascularisation procedures in diabetic patients 55 years or more with one or more of the following risk factors: systolic blood pressure >160 mmHg or diastolic blood pressure >90 mmHg (or on antihypertensive treatment); total cholesterol >5.2 mmol/L; HDL cholesterol <0.9 mmol/L; current smoker; known microalbuminuria; any evidence of previous vascular disease

產品總結:

Visual Identification: Hard gelatin capsule with white opaque body and blue opaque cap. The body has 'G' and cap has 'RM 10' both printed in black. Capsules contain a white to off-white powder.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

授权状态:

Registered

授权日期:

2007-06-28

资料单张

                                TRYZAN
® CAPS;
TRYZAN
® TABS
_ramipril_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about TRYZAN.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have benefits and
risks. Your doctor has weighed the
risks of you taking TRYZAN against
the benefits expected for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, TALK TO YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
MEDICINE.
You may need to read it again.
WHAT TRYZAN IS USED
FOR
TRYZAN contains the active
ingredient ramipril. It belongs to a
group of medicines called
angiotensin converting enzyme
(ACE) inhibitors.
TRYZAN is used to treat:
•
high blood pressure
(hypertension)
•
some heart conditions such as
heart failure after a heart attack
•
kidney problems in some patients
TRYZAN is also used to reduce the
risk of cardiovascular problems and
complications in patients aged 55
years or more with heart or blood
vessel disease, or diabetes.
HYPERTENSION
TRYZAN is used to lower high
blood pressure (hypertension).
Everyone has blood pressure. This
pressure helps get your blood all
around your body. Your blood
pressure may be different at different
times of the day and can be
influenced by how busy or worried
you are. You have hypertension
when your blood pressure stays
higher than is needed, even when you
are calm and relaxed.
There are usually no symptoms of
hypertension. The only way of
knowing that you have hypertension
is to have your blood pressure
checked on a regular basis. If high
blood pressure is not treated it can
lead to serious health problems,
including stroke, heart disease and
kidney failure.
HEART FAILURE AFTER A HEART ATTACK
TRYZAN may be used after a heart
attack. A heart attack occurs when
one of the major blood vessels
supplying blood to your heart
becomes blocked. This means that
your heart muscle cannot receive the
oxygen it needs and becomes
damaged. This may lead to further
problems, su
                                
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产品特点

                                AUSTRALIAN PRODUCT INFORMATION
TRYZAN
® CAPS
TRYZAN
® TABS
_ramipril _
1
NAME OF THE MEDICINE
ramipril
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each TRYZAN CAPS capsule contains ramipril 1.25 mg, 2.5 mg, 5 mg or 10
mg as the active ingredient.
Each TRYZAN TABS tablet contains ramipril 1.25 mg, 2.5 mg, 5 mg or 10
mg as the active ingredient.
Excipient with known effect:
TRYZAN CAPS contain phenylalanine and sulfites.
TRYZAN TABS contain sugars as lactose.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
TRYZAN CAPS
TRYZAN CAPS 1.25:
Each TRYZAN CAPS 1.25 capsule has a white opaque body and a yellow
opaque
cap. The body has ‘G’ and the cap has ‘RM 1.25’ printed in
black ink. Capsules
contain a white to off-white powder.
TRYZAN CAPS 2.5:
Each TRYZAN CAPS 2.5 capsule has a white opaque body and an orange
opaque
cap. The body has ‘G’ and the cap has ‘RM 2.5’ printed in
black ink. Capsules
contain a white to off-white powder.
TRYZAN CAPS 5:
Each TRYZAN CAPS 5 capsule has a white opaque body and a swedish
orange
opaque cap. The body has ‘G’ and the cap has ‘RM 5’ printed in
black ink.
Capsules contain a white to off-white powder.
TRYZAN CAPS 10:
Each TRYZAN CAPS 10 capsule has a white opaque body and a blue opaque
cap. The body has ‘G’ and the cap has ‘RM 10’ printed in black
ink. Capsules
contain a white to off-white powder.
TRYZAN TABS
TRYZAN TABS 1.25:
white to off-white, capsule-shaped, uncoated, flat tablets.
TRYZAN TABS 2.5:
yellow, capsule-shaped, uncoated, flat tablets, scored on one side and
side walls,
marked R2.
TRYZAN TABS 5:
pink, capsule-shaped, uncoated, flat tablets, scored on one side and
side walls,
marked R3.
TRYZAN TABS 10:
white to off-white, capsule-shaped, uncoated, flat tablets, scored on
one side and
side walls, marked R4.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
•
Treatment of hypertension. Data are currently not available to support
the use of ramipril in renovascular
hypertension
•
Post myocardial infa
                                
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