FLUVASTATIN Capsules (2019)
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Περιεχόμενα
Name of the medicinal product
Fluvastatin 20 mg hard Capsules.
Qualitative and quantitative composition
Each hard capsule contains 21.06 mg fluvastatin sodium corresponding to 20 mg fluvastatin. For the full list of excipients, see section 6.1.
Pharmaceutical form
Capsule, hard. Brown coloured hard gelatine capsule containing off-white to pale-yellow powder.
Therapeutic indications
Dyslipidaemia Treatment of adults with primary hypercholesterolaemia or mixed dyslipidaemia, as an adjunct to diet, when response to diet and other non-pharmacological treatments (e.g. exercise, weight ...
Posology and method of administration
Adults Dyslipidaemia Prior to initiating treatment with fluvastatin, patients should be placed on a standard cholesterol-lowering diet, which should be continued during treatment. Starting and maintenance ...
Contraindications
Fluvastatin is contraindicated: *in patients with known hypersensitivity to fluvastatin or to any of the excipients listed in section 6.1. in patients with active liver disease, or unexplained, persistent ...
Special warnings and precautions for use
Liver function Post marketing cases of fatal and non-fatal hepatic failures have been reported with some statins including fluvastatin. Although a causal relationship with fluvastatin treatment has not ...
Interaction with other medicinal products and other forms of interaction
Fibrates and niacin Concomitant administration of fluvastatin with bezafibrate, gemfibrozil, ciprofibrate or niacin (nicotinic acid) has no clinically relevant effect on the bioavailability of fluvastatin ...
Fertility, pregnancy and lactation
Women of childbearing potential Women of childbearing potential have to use effective contraception. If a patient becomes pregnant while taking Fluvastatin Capsules, therapy should be discontinued. Pregnancy ...
Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed.
Undesirable effects
The most commonly reported adverse drug reactions are mild gastrointestinal symptoms, insomnia and headache. Adverse drug reactions (Table 1) are listed by MedDRA system organ class. Within each system ...
Overdose
To date there has been limited experience with overdose of fluvastatin. Specific treatment is not available for fluvastatin overdose. Should an overdose occur, the patient should be treated symptomatically ...
Pharmacodynamic properties
Pharmacotherapeutic group: HMG-CoA reductase inhibitors ATC code: C10AA04 Fluvastatin, a fully synthetic cholesterol-lowering agent, is a competitive inhibitor of HMG-CoA reductase, which is responsible ...
Pharmacokinetic properties
Absorption Fluvastatin is absorbed rapidly and completely (98%) after oral administration of a solution to fasted volunteers. After oral administration of fluvastatin 80 mg prolonged-release tablets, and ...
Preclinical safety data
The conventional studies, including safety pharmacology, genotoxicity, repeated dose toxicity, carcinogenicity and toxicity on reproduction studies did not indicate other risks for the patient than those ...
List of excipients
Capsule contents: Calcium carbonate Cellulose microcrystalline Pregelatinised starch Talc Sodium hydrogen carbonate Magnesium stearate Hard gelatin capsule: Gelatin Titanium dioxide (E171) Iron oxide red ...
Incompatibilities
Not applicable.
Shelf life
Shelf life OPA/Al/PVC/Al blister: 3 years. HDPE bottle: 3 years. After first opening of the HDPE bottle: 4 months.
Special precautions for storage
OPA/Al/PVC/Al blister: Do not store above 25°C. HDPE bottle: Do not store above 25°C. For storage conditions after first opening of the medicinal product, see section 6.3. Store in the original package ...
Nature and contents of container
OPA/Al/PVC/Al blister: 14, 20, 28, 30, 50, 56, 84, 90, 98, 100, 490 hard capsules. HDPE bottle with PP cap: 98 hard capsules. Not all pack sizes may be marketed.
Special precautions for disposal and other handling
No special requirements. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
Sandoz Limited, Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR
Marketing authorization number(s)
PL 04416/0748
Date of first authorization / renewal of the authorization
30/11/2007
Date of revision of the text
06/09/2019
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