ASPAVOR Film-coated tablet
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Περιεχόμενα
1. Name of the medicinal product
ASPAVOR 10 (tablets).
ASPAVOR 20 (tablets).
ASPAVOR 40 (tablets).
2. Qualitative and quantitative composition
ASPAVOR 10:
Each tablet contains atorvastatin calcium trihydrate, equivalent to 10 mg atorvastatin.
ASPAVOR 20:
Each tablet contains atorvastatin calcium trihydrate, equivalent to 20 mg atorvasta...
3. Pharmaceutical form
ASPAVOR 10:
A white, elliptical, film-coated tablet, debossed with '10' on one side and 'PD 155' on the other.
ASPAVOR 20:
A white, elliptical, film-coated tablet, debossed wi...
4.1. Therapeutic indications
ASPAVOR is indicated as an adjunct to diet for reduction of elevated total-cholesterol, LDL-cholesterol, apolipoprotein-B, and triglyceride levels in patients with primary hypercholesterolaemia; mi...
4.2. Posology and method of administration
The patient should be placed on a standard cholesterol-lowering diet before receiving ASPAVOR and should continue on this diet during treatment with ASPAVOR.
The usual starting dose is 10 mg once a...
4.3. Contraindications
Hypersensitivity to any component of this medication.
Active liver disease or unexplained persistent elevations of serum transaminases (see WARNINGS and SIDE EFFECTS AND SPECIAL PRECAUTIONS).
ASPAV...
4.4. Special warnings and precautions for use
Liver Effects
Persistent elevations (>3 times the upper limit of normal (ULN) occurring on 2 or more occasions) in serum transaminases occurred in 0,7% of patients who received atorvastatin in c...
4.5. Interaction with other medicinal products and other forms of interaction
As with other HMG-CoA reductase inhibitors the risk of myopathy during treatment with ASPAVOR is increased with concurrent administration of immunosuppressive drugs, fibric acid derivatives, macrol...
4.8. Undesirable effects
Atorvastatin is generally well-tolerated. Adverse reactions have usually been mild and transient. Less than 2% of patients were discontinued from clinical trials due to side effects attributed to a...
4.9. Overdose
There is nospecific treatment for atorvastatin overdosage. In the event of an overdose, the patient should be treated symptomatically, and supportive measures instituted as required. Due to extensi...
5.1. Pharmacodynamic properties
Pharmacological classification:
A 7.5 Serum-cholesterol reducer
Atorvastatin is a selective, competitive inhibitor of HMG-CoA reductase, the rate-limiting enzyme that converts 3-hydroxy-3-methyl-g...
5.2. Pharmacokinetic properties
Absorption
Following oral administration; maximum plasma concentrations occur within 1 to 2 hours. The absolute bioavailability of atorvastatin (parent substance) is approximately 12% and the syste...
6.4. Special precautions for storage
Store in a cool (below 25°C), dry place.
STORE ALL MEDICINES OUT OF REACH OF CHILDREN.
6.5. Nature and contents of container
Silver colouredpolyamide/aluminium foil/PVC blister (foil blister) that are packed in an outer cardboard carton with a package insert. ASPAVOR tablets are available in pack sizes of 28, 30, 56, 60,...
7. Marketing authorization holder
Pharmacia South Africa (Pty) Limited, 85 Bute Lane, Sandton, 2196, South Africa
8. Marketing authorization number(s)
ASPAVOR 10: A39/7.5/0017
ASPAVOR 20: A39/7.5/0018
ASPAVOR 40: A39/7.5/0019
9. Date of first authorization / renewal of the authorization
01 December 2006
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