DAIVOBET Gel (2019)
Βιβλιογραφική αναφορά
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
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Περιεχόμενα
1. Name of the medicinal product
Dovobet 50 microgram/g + 0.5 mg/g gel.
2. Qualitative and quantitative composition
One gram of gel contains 50 micrograms of calcipotriol (as monohydrate) and 0.5 mg of betamethasone (as dipropionate). <u>Excipient with known effect:</u> Butylhydroxytoluene (E321) 160 micrograms/g gel. ...
3. Pharmaceutical form
Gel. An almost clear, colourless to slightly off-white gel.
4.1. Therapeutic indications
Topical treatment of scalp psoriasis in adults. Topical treatment of mild to moderate non-scalp plaque psoriasis vulgaris in adults.
4.2. Posology and method of administration
Posology Dovobet gel should be applied to affected areas once daily. The recommended treatment period is 4 weeks for scalp areas and 8 weeks for non-scalp areas. If it is necessary to continue or restart ...
4.3. Contraindications
Hypersensitivity to the active substances or to any of the excipients listed in section 6.1. Dovobet is contraindicated in erythrodermic, exfoliative and pustular psoriasis. Due to the content of calcipotriol, ...
4.4. Special warnings and precautions for use
Effects on endocrine system Dovobet gel contains a potent group III steroid and concurrent treatment with other steroids must be avoided. Adverse reactions found in connection with systemic corticosteroid ...
4.5. Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed with Dovobet.
4.6. Fertility, pregnancy and lactation
Pregnancy There are no adequate data from the use of Dovobet in pregnant women. Studies in animals with glucocorticoids have shown reproductive toxicity (see section 5.3), but a number of epidemiological ...
4.7. Effects on ability to drive and use machines
Dovobet has no or negligible influence on the ability to drive and use machines.
4.8. Undesirable effects
The estimation of the frequency of adverse reactions is based on a pooled analysis of data from clinical studies including post-authorisation safety studies and spontaneous reporting. The most frequently ...
4.9. Overdose
Use above the recommended dose may cause elevated serum calcium which subsides when treatment is discontinued. The symptoms of hypercalcemia include polyuria, constipation, muscle weakness, confusion and ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Antipsoriatics. Other antipsoriatics for topical use, Calcipotriol, combinations <b>ATC Code:</b> D05AX52 Calcipotriol is a vitamin D analogue. In vitro data suggest that ...
5.2. Pharmacokinetic properties
The systemic exposure to calcipotriol and betamethasone dipropionate from topically applied Dovobet gel is comparable to Dovobet ointment in rats and minipigs. Clinical studies with radiolabelled ointment ...
5.3. Preclinical safety data
Studies of corticosteroids in animals have shown reproductive toxicity (cleft palate, skeletal malformations). In reproduction toxicity studies with long-term oral administration of corticosteroids to ...
6.1. List of excipients
Paraffin, liquid Polyoxypropylene stearyl ether Castor oil, hydrogenated Butylhydroxytoluene (E321) All-rac-α-tocopherol
6.2. Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
6.3. Shelf life
3 years. Bottle: After first opening: 6 months. Applicator: After first opening: 6 months.
6.4. Special precautions for storage
Do not refrigerate. Bottle: Keep in the outer carton in order to protect from light.
6.5. Nature and contents of container
Bottles: High-density polyethylene bottles with low-density polyethylene nozzle and a high-density polyethylene screw cap. The bottles are placed in cartons. <u>Pack sizes:</u> 15 g, 30 g, 60 g, 80 g, ...
6.6. Special precautions for disposal and other handling
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
7. Marketing authorization holder
LEO Pharma A/S, Industriparken 55, DK-2750 Ballerup, Denmark
8. Marketing authorization number(s)
PL 05293/0005
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 25 September 2008 Date of latest renewal: 1 October 2015
10. Date of revision of the text
October 2019
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