Atorvastatin Pfizer

Riik: Uus-Meremaa

keel: inglise

Allikas: Medsafe (Medicines Safety Authority)

Toimeaine:

Atorvastatin calcium 86.8mg Equivalent to 80 mg Atorvastatin;  

Saadav alates:

Upjohn New Zealand ULC

INN (Rahvusvaheline Nimetus):

Atorvastatin calcium 86.8 mg (Equivalent to 80 mg Atorvastatin)

Annus:

80 mg

Ravimvorm:

Film coated tablet

Koostis:

Active: Atorvastatin calcium 86.8mg Equivalent to 80 mg Atorvastatin   Excipient: Calcium carbonate Croscarmellose sodium Hyprolose Lactose monohydrate Magnesium stearate Microcrystalline cellulose Opadry white YS-1-7040 Polysorbate 80 Simeticone

Retsepti tüüp:

Prescription

Valmistatud:

Pfizer Ireland Pharmaceuticals

Näidustused:

Atorvastatin Pfizer is indicated as an adjunct to diet to reduce elevated total-C, LDL-C and TG levels in patients with primary hypercholesterolaemia or mixed dyslipidaemia where the primary abnormality is either elevated cholesterol or triglycerides when response to diet and other non-pharmacological measures is inadequate. Atorvastatin Pfizer is also indicated to reduce total-C and LDL-C in patients with heterozygous and homozygous familial hypercholesterolaemia.

Toote kokkuvõte:

Package - Contents - Shelf Life: Blister pack, Foil-Foil - 30 tablets - 36 months from date of manufacture stored at or below 25°C - Bottle, plastic, HDPE, CRC - 30 tablets - 36 months from date of manufacture stored at or below 25°C - Bottle, plastic, HDPE, CRC - 90 tablets - 36 months from date of manufacture stored at or below 25°C

Loa andmise kuupäev:

2014-08-20

Infovoldik

ATORVASTATIN PFIZER
®
1
ATORVASTATIN
PFIZER
®
_Atorvastatin calcium _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some of the
more common questions about
Atorvastatin Pfizer.
It does not contain all of 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 taking Atorvastatin
Pfizer against the benefits he/she
expects it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
MEDICINE.
You may need to read it again.
WHAT ATORVASTATIN
PFIZER IS USED FOR
Atorvastatin Pfizer is used to lower
high cholesterol levels.
Atorvastatin Pfizer is also used to
help reduce the risk of having a heart
attack or stroke in people who have
high blood pressure and coronary
heart disease (CHD) or who are at
risk of CHD. Examples of risk
factors for CHD include diabetes, a
history of stroke, or small blood
vessel disease.
_WHAT IS CHOLESTEROL? _
Everyone has cholesterol in their
blood. It is a type of blood fat
needed by the body for many things,
such as building the cell lining,
making bile acids (which help to
digest food) and some hormones.
However, too much cholesterol can
be a problem.
Cholesterol is present in many foods
and is also made in your body by the
liver. If your body makes too much
cholesterol or you have too much
cholesterol in your diet, then your
level becomes too high.
High cholesterol is more likely to
occur with certain diseases or if you
have a family history of high
cholesterol.
There are different types of
cholesterol. LDL, or low-density
lipoprotein, is the 'bad' cholesterol
that can block your blood vessels.
HDL, or high density lipoprotein,
cholesterol is the 'good' cholesterol
that is thought to remove the bad
cholesterol from the blood vessels.
When you have high levels of 'bad'
cholesterol in your blood, it may
begin to 'stick' to the inside of your
blood vessels instead of being

Toote omadused

Version: pfdatort10520
Supersedes: pfdatort10619
Page 1 of 24
NEW ZEALAND DATA SHEET
1. PRODUCT NAME
ATORVASTATIN PFIZER
®
10 mg, 20 mg, 40 mg and 80 mg tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 10 mg tablet contains 10 mg atorvastatin (as calcium)
Each 20 mg tablet contains 20 mg atorvastatin (as calcium)
Each 40 mg tablet contains 40 mg atorvastatin (as calcium)
Each 80 mg tablet contains 80 mg atorvastatin (as calcium)
Excipients with known effects:
•
Lactose monohydrate
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
ATORVASTATIN PFIZER tablets are white round film-coated tablets,
debossed with the
tablet strength on one side and ‘ATV’ on the other.
10 mg: debossed ‘10’ on one side and ‘ATV’ on the other
20 mg: debossed ‘20’ on one side and ‘ATV’ on the other
40 mg: debossed ‘40’ on one side and ‘ATV’ on the other
80 mg: debossed ‘80’ on one side and ‘ATV’ on the other
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
ATORVASTATIN PFIZER is indicated as an adjunct to diet to reduce
elevated total
cholesterol (total-C), low density lipoprotein cholesterol (LDL-C) and
triglycerides (TG) levels
in patients with primary hypercholesterolaemia or mixed dyslipidaemia
where the primary
abnormality is either elevated cholesterol or triglycerides when
response to diet and other non-
pharmacological measures is inadequate.
ATORVASTATIN PFIZER is also indicated to reduce total-C and LDL-C in
patients with
heterozygous and homozygous familial hypercholesterolaemia.
ATORVASTATIN PFIZER is indicated to increase plasma high density
lipoprotein cholesterol
(HDL-C) and decrease the LDL-C/HDL-C and total-C/HDL-C ratios.
Version: pfdatort10520
Supersedes: pfdatort10619
Page 2 of 24
ATORVASTATIN PFIZER is indicated as an adjunct to diet for the
treatment of patients with
elevated serum triglyceride levels (hypertriglyceridaemia), and for
the treatment of patients
with dysbetalipoproteinaemia who do not respond adequately to diet.
ATORVASTATIN PFIZER