APO-PRAVASTATIN pravastatin sodium 40 mg tablets blister pack

Ülke: Avustralya

Dil: İngilizce

Kaynak: Department of Health (Therapeutic Goods Administration)

Aktif bileşen:

pravastatin sodium, Quantity: 40 mg

Mevcut itibaren:

Arrotex Pharmaceuticals Pty Ltd

INN (International Adı):

pravastatin sodium

Farmasötik formu:

Tablet, uncoated

Kompozisyon:

Excipient Ingredients: lactose monohydrate; microcrystalline cellulose; croscarmellose sodium; magnesium stearate; iron oxide yellow; brilliant blue FCF

Uygulama yolu:

Oral

Paketteki üniteler:

30 tablets

Reçete türü:

(S4) Prescription Only Medicine

Terapötik endikasyonlar:

As an adjunct to diet for the treatment of hypercholesterolaemia. Prior to initiating therapy with pravastatin, secondary causes of hypercholesterolaemia (e.g. poorly controlled diabetes mellitus, hypothyroidism, nephritic syndrome, dysproteinaemias, obstructive liver disease, other drug therapy, alcoholism) should be identified and treated. Patients with previous myocardial infarction including those who have normal (4.0 to 5.5 mmol / L) serum cholesterol levels. Patients with unstable angina pectoris. As an adjunct to diet and lifestyle modification for the treatment of heterozygenous familial hypercholesterolaemia in children and adolescent patients aged 8 years and older.

Ürün özeti:

Visual Identification: Light green, round, unscored tablets, imprinted "APO" on one side and "PRA" over "40" on the other side.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Yetkilendirme durumu:

Registered

Yetkilendirme tarihi:

2006-06-06

Bilgilendirme broşürü

APO-PRAVASTATIN
1
APO-PRAVASTATIN
_Contains the active ingredient pravastatin (as pravastatin sodium) _
CONSUMER MEDICINE INFORMATION
_FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055 _
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about this medicine. It does
not contain all the available
information. It does not take the
place of talking to your doctor.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking this medicine
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT THIS MEDICINE IS
USED FOR
The name of your medicine is APO-
Pravastatin. It contains the active
ingredient pravastatin (as pravastatin
sodium).
It is used to treat people who have:
•
high blood cholesterol levels (in
combination with changes in diet)
•
had a heart attack (including
people whose blood cholesterol
levels are normal)
•
had an episode of unstable
angina.
If you have had a heart attack, an
episode of unstable angina, or you
have too much cholesterol in your
blood, then you have an increased
risk of a blood clot forming in your
blood vessels and causing a
blockage. In these people, pravastatin
can reduce the risk of having a
stroke, further heart disease, or
needing a bypass operation.
Pravastatin works by lowering high
blood cholesterol levels
(hypercholesterolaemia). It is more
effective if it is taken with a
cholesterol lowering diet.
It is also used to treat children and
adolescent patients aged 8 years and
older who have heterozygous familial
hypercholesterolaemia (an inherited
disorder which produces high blood
cholesterol levels).
There is not enough information to
recommend the use of this medicine
in children less than 8 years of age.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed this
medicine for another reason.
This medicine is availabl

Ürün özellikleri

1
AUSTRALIAN PRODUCT INFORMATION
APO-PRAVASTATIN
(PRAVASTATIN SODIUM) TABLET
1
NAME OF THE MEDICINE
Pravastatin sodium.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10 mg, 20 mg, 40 mg or 80 mg of pravastatin
sodium, as the active
ingredient.
EXCIPIENTS WITH KNOWN EFFECT
Lactose monohydrate
For the full list of excipients see section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
10 MG TABLETS:
Light pink, round, unscored tablets, imprinted “APO” on one side
and “PRA” over “10” on the
other side.
20 MG TABLETS:
Off-white to light yellow, round, unscored tablets, imprinted
“APO” on one side and “PRA” over
“20” on the other side.
40 MG TABLETS:
Light green, round, unscored tablets, imprinted “APO” on one side
and “PRA” over “40” on the
other side.
80 MG TABLETS:
Off-white to light yellow, round, unscored tablets, imprinted
“APO” on one side and “PRA” over
“80” on the other side.
2
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Pravastatin is indicated:
•
as an adjunct to diet for the treatment of hypercholesterolaemia.
Prior to initiating therapy
with pravastatin, secondary causes of hypercholesterolaemia (e.g.
poorly controlled
diabetes mellitus, hypothyroidism, nephrotic syndrome,
dysproteinaemias, obstructive
liver disease, other drug therapy, alcoholism) should be identified
and treated.
•
in patients with previous myocardial infarction including those who
have normal (4.0 to 5.5
mmol/L) serum cholesterol levels.
•
in patients with unstable angina pectoris (see section 5.1
PHARMACODYNAMIC PROPERTIES
- CLINICAL TRIALS).
•
as an adjunct to diet and lifestyle modification for the treatment of
heterozygous familial
hypercholesterolaemia in children and adolescent patients aged 8 years
and older (see
section 5.1 PHARMACODYNAMIC PROPERTIES - CLINICAL TRIALS).
4.2
DOSE AND METHOD OF ADMINISTRATION
APO-Pravastatin tablets are intended for oral administration
DOSAGE
Prior to initiating pravastatin, the patient should be placed on a
standard ch