LOCOID Cream (2021)

Βιβλιογραφική αναφορά

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Περιεχόμενα

1. Name of the medicinal product

Locoid cream.

2. Qualitative and quantitative composition

1 gram of Locoid Cream contains 1 mg of hydrocortisone butyrate. Excipient(s) with known effect: Cetostearyl alcohol (7.2% w/w), Butyl parahydroxybenzoate (0.05% w/w), Propyl parahydroxybenzoate ...

3. Pharmaceutical form

Cream. White cream.

4.1. Therapeutic indications

Locoid Cream is indicated in adults, children and infants above 3 months of age. The product is recommended for treatment of inflammatory skin disorders not caused by micro-organisms e.g. eczema, dermatitis ...

4.2. Posology and method of administration

Posology Adults and older people A thin and even layer should be applied to the affected area of the skin, 1 to 2 times daily. The same dose is used for adults and older people, as clinical evidence would ...

4.3. Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. This preparation is contraindicated in the presence of untreated viral, fungal, yeast or parasitic infections, ...

4.4. Special warnings and precautions for use

Locoid should not be applied to the eyelids in view of the risk of glaucoma simplex or subcapsular cataract. Keep away from the eyes. Application under occlusion should be restricted to dermatoses involving ...

4.5. Interaction with other medicinal products and other forms of interaction

No interaction studies have been performed.

4.6. Fertility, pregnancy and lactation

Pregnancy There are no or limited amount of data from the use of hydrocortisone butyrate in pregnant women. Animal studies are insufficient with respect to reproductive toxicity of hydrocortisone 17-butyrate ...

4.7. Effects on ability to drive and use machines

None known.

4.8. Undesirable effects

In clinical studies, cases of skin irritation and hypersensitivity were reported. The most frequently reported adverse reactions post-marketing are hypersensitivity and skin reactions such as erythema, ...

4.9. Overdose

Excessive use under occlusive dressings may produce adrenal suppression. No special procedures or antidote. Treat any adverse effects symptomatically.

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: Corticosteroid ATC code: D07AB02 Hydrocortisone butyrate is a potent topical corticosteroid.

5.2. Pharmacokinetic properties

The topical activity has been demonstrated in vivo using the McKenzie-Stoughton test.

5.3. Preclinical safety data

Topical administration of corticosteroids to pregnant animals can cause abnormalities of foetal development including cleft palate and intra-uterine growth retardation. There may therefore be a very small ...

6.1. List of excipients

Cetostearyl alcohol Macrogol 25 Cetostearyl ether Paraffin, light liquid White Soft Paraffin Butyl parahydroxybenzoate Propyl parahydroxybenzoate (E216) Citric Acid anhydrous (E330) Sodium Citrate anhydrous ...

6.2. Incompatibilities

None stated.

6.3. Shelf life

3 years.

6.4. Special precautions for storage

Do not store above 25°C. Do not refrigerate or freeze.

6.5. Nature and contents of container

Collapsible aluminium tubes containing either 30 g, 50 g, 100 g or 200 g packed in a carton. Not all pack sizes may be marketed.

6.6. Special precautions for disposal and other handling

No special requirements.

7. Marketing authorization holder

LEO Pharma A/S, Industriparken 55, DK-2750 Ballerup, Denmark

8. Marketing authorization number(s)

PL 05293/0010

9. Date of first authorization / renewal of the authorization

Date of first authorisation: 28 September 1973 Date of latest renewal: 24 August 2010

10. Date of revision of the text

1 February 2021

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