ISOTRETINOIN Capsules, soft (2019)
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Περιεχόμενα
Name of the medicinal product
Isotretinoin 20mg Capsules. Rizuderm 20mg Capsules.
Qualitative and quantitative composition
Each capsule contains 20mg isotretinoin. Excipients with known effect: Contains soya bean oil (refined, hydrogenated and partially hydrogenated) maltitol and sorbitol. For the full list of excipients, ...
Pharmaceutical form
Capsules, soft. Red/orange soft capsules marked P20.
Therapeutic indications
Severe forms of acne (such as nodular or conglobate acne or acne at risk of permanent scarring), resistant to adequate courses of standard therapy with systemic antibacterials and topical therapy. Some ...
Posology and method of administration
Posology Isotretinoin should only be prescribed by or under the supervision of physicians with expertise in the use of systemic retinoids for the treatment of severe acne and a full understanding of the ...
Contraindications
Isotretinoin is contraindicated in women who are pregnant or breastfeeding. (see section 4.6 Fertility, pregnancy and lactation). Isotretinoin is contraindicated in women of childbearing potential unless ...
Special warnings and precautions for use
Teratogenic effects Isotretinoin is a powerful human teratogen inducing a high frequency of severe and life threatening birth defects. <u>Isotretinoin is strictly contraindicated in:</u> Pregnant women. ...
Interaction with other medicinal products and other forms of interaction
Patients should not take vitamin A as concurrent medication due to the risk of developing hypervitaminosis A. Cases of benign intracranial hypertension (pseudotumor cerebri) have been reported with concomitant ...
Pregnancy and lactation
Pregnancy Pregnancy is an absolute contraindication to treatment with isotretinoin (see section 4.3 Contraindications). Women of childbearing potential have to use effective contraception one month before, ...
Effects on ability to drive and use machines
Isotretinoin could potentially have an influence on the ability to drive and use machines. A number of cases of decreased night vision have occurred during isotretinoin therapy and in rare instances have ...
Undesirable effects
Some of the side effects associated with the use of isotretinoin are dose-related. The side effects are generally reversible after altering the dose or discontinuation of treatment, however some may persist ...
Overdose
Isotretinoin is a derivative of vitamin A. Although the acute toxicity of isotretinoin is low, signs of hypervitaminosis A could appear in cases of accidental overdose. Manifestations of acute vitamin ...
Pharmacodynamic properties
Pharmacotherapeutic group: Retinoids for treatment of acne ATC code: D10BA01 Mechanism of action Isotretinoin is a stereoisomer of all-trans retinoic acid (tretinoin). The exact mechanism of action of ...
Pharmacokinetic properties
Absorption The absorption of isotretinoin from the gastro-intestinal tract is variable and dose-linear over the therapeutic range. The absolute bioavailability of isotretinoin has not been determined, ...
Preclinical safety data
Acute toxicity The acute oral toxicity of isotretinoin was determined in various animal species. LD<sub>50</sub> is approximately 2000 mg/kg in rabbits, approximately 3000 mg/kg in mice, and over 4000 ...
List of excipients
<u>Capsule contents:</u> Refined soya-bean oil Yellow beeswax Hydrogenated soya-bean oil Partially hydrogenated vegetable oil <u>Capsule shell:</u> Gelatin Glycerol Ttitanium dioxide E171 Ferric oxide ...
Incompatibilities
Not applicable.
Shelf life
Two years.
Special precautions for storage
Do not store above 25°C. Store in the original package.
Nature and contents of container
PVC/PE/PVdC aluminium blisters in cardboard carton containing either 30 or 56 capsules
Special precautions for disposal and other handling
Return any unused Isotretinoin capsules to the pharmacist.
Marketing authorization holder
Alliance Pharmaceuticals Limited, Avonbridge House, Bath Road, Chippenham, Wiltshire, SN15 2BB, UK
Marketing authorization number(s)
PL 16853/0133
Date of first authorization / renewal of the authorization
18/10/2004 / 01/06/2016
Date of revision of the text
18/04/2019
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