CYCLOVAX Tablet (2019)
Βιβλιογραφική αναφορά
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Περιεχόμενα
1. Name of the medicinal product
Cyclovax 200 mg tablets.
2. Qualitative and quantitative composition
Each tablet contains 200 mg aciclovir. <u>Excipients with known effect:</u> This product contains 78 mg lactose. For full list of excipients, see section 6.1.
3. Pharmaceutical form
Tablet. Light blue, round, normal convex, scored tablets. The tablet can be divided into equal doses.
4.1. Therapeutic indications
Cyclovax tablets are indicated for the treatment of herpes simplex virus infections of the skin and mucous membranes including initial and recurrent genital herpes (excluding neonatal HSV and severe HSV ...
4.2. Posology and method of administration
Ensure that patients on high doses of aciclovir are adequately hydrated. Posology Adults Treatment of herpes simplex infections 200 mg aciclovir should be taken five times daily at approximately four-hourly ...
4.3. Contraindications
Cyclovax is contraindicated in patients known to be hypersensitive to aciclovir or valaciclovir, or to any of the excipients as listed in section 6.1.
4.4. Special warnings and precautions for use
Use in patients with renal impairment and in elderly patients Aciclovir is eliminated by renal clearance, therefore the dose must be adjusted in patients with renal impairment (see section 4.2 Posology ...
4.5. Interaction with other medicinal products and other forms of interaction
Aciclovir is eliminated primarily unchanged in the urine via active renal tubular secretion. Any drugs administered concurrently that compete with this mechanism may increase aciclovir plasma concentrations. ...
4.6. Fertility, pregnancy and lactation
Pregnancy The use of aciclovir should be considered only when the potential benefits outweigh the possibility of unknown risks. A post-marketing aciclovir pregnancy registry has documented pregnancy outcomes ...
4.7. Effects on ability to drive and use machines
There have been no studies to investigate the effect of aciclovir on driving performance or the ability to operate machinery. A detrimental effect on such activities cannot be predicted from the pharmacology ...
4.8. Undesirable effects
The frequency categories associated with the adverse events below are estimates. For most events, suitable data for estimating incidence were not available. In addition, adverse events may vary in their ...
4.9. Overdose
Symptoms Aciclovir is only partly absorbed in the gastrointestinal tract. Patients have ingested overdoses of up to 20 g aciclovir on a single occasion, usually without toxic effects. Accidental, repeated ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Antivirals for systemic use, Direct acting antivirals <b>ATC code:</b> J05AB01 Aciclovir is a synthetic purine nucleoside analogue with <em>in vitro</em> and <em>in vivo ...
5.2. Pharmacokinetic properties
Aciclovir is only partially absorbed from the gut. Mean steady state peak plasma concentrations (C<sup>ss</sup>max) following doses of 200 mg administered four-hourly were 3.1 microMol (0.7 micrograms/ml) ...
5.3. Preclinical safety data
Mutagenicity The results of a wide range of mutagenicity tests <em>in vitro</em> and <em>in vivo</em> indicate that aciclovir is unlikely to pose a genetic risk to man. Carcinogenicity Aciclovir was not ...
6.1. List of excipients
Lactose monohydrate Povidone Cellulose, microcrystalline Sodium starch glycolate (Type A) Sodium laurilsulfate Magnesium stearate Silica, colloidal anhydrous Talc Indigotine, indigo carmine aluminium lake ...
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
5 years.
6.4. Special precautions for storage
Store below 25˚C. Protect from light and moisture.
6.5. Nature and contents of container
PVC/Aluminium blisters. Pack sizes of 30, 100 and 1000 tablets. PP containers with PE closures. Pack sizes of 100, 500 and 1000 tablets. Not all pack sizes may be marketed.
6.6. Special precautions for disposal and other handling
No special instructions.
7. Marketing authorization holder
Remedica Ltd, Aharnon Strt., Limassol Industrial Estate, 3056 Limassol, Cyprus
8. Marketing authorization number(s)
12144
9. Date of first authorization / renewal of the authorization
Date of first authorization: 20 April 1989 Date of latest renewal: 30 September 2011
10. Date of revision of the text
06/05/2019
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