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SPC, UK: Betnovate Cream (2012)

Αναφορές

Βιβλιογραφική αναφορά

Στοιχεία εκδότη

Εκδότης :
GlaxoSmithKline UK
Διεύθυνση :
Stockley Park West, Uxbridge, Middlesex, UB11 1BT
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
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Δωρεάν εγγραφή

Name of the medicinal product

Betnovate Cream.

Qualitative and quantitative composition

Betamethasone Valerate BP 0.122% W/W.

Pharmaceutical form

Aqueous Cream.

Therapeutic indications

Betamethasone valerate is a potent topical corticosteroid indicated for adults, elderly and children over 1 year for the relief of the inflammatory and pruritic manifestations of steroid responsive dermatoses. ...

Posology and method of administration

Route of administration: Cutaneous Creams are especially appropriate for moist or weeping surfaces. Apply thinly and gently rub in using only enough to cover the entire affected area once or twice daily ...

Contraindications

Hypersensitivity to the active substance or any of the excipients in the product. The following conditions should not be treated with betamethasone valerate: Untreated cutaneous infections Rosacea Acne ...

Special warnings and precautions for use

Betamethasone valerate should be used with caution in patients with a history of local hypersensitivity to other corticosteroids. Local hypersensitivity reactions (see section 4.8) may resemble symptoms ...

Interaction with other medicinal products and other forms of interaction

Co-administered drugs that can inhibit CYP3A4 (e.g. ritonavir, itraconazole) have been shown to inhibit the metabolism of corticosteroids leading to increased systemic exposure. The extent to which this ...

Pregnancy and lactation

Fertility There are no data in humans to evaluate the effect of topical corticosteroids on fertility. Pregnancy There are limited data from the use of betamethasone valerate in pregnant women. Topical ...

Effects on ability to drive and use machines

There have been no studies to investigate the effect of betamethasone valerate on driving performance or the ability to operate machinery. A detrimental effect on such activities would not be anticipated ...

Undesirable effects

Adverse events are listed below by system organ class and frequency. Frequencies are defined as: very common (≥1/10), common (≥1/100 and <1/10), uncommon (≥1/1000 and <1/100), rare (≥1/10,000 and <1/1000) ...

Overdose

Symptoms and signs Topically applied betamethasone valerate may be absorbed in sufficient amounts to produce systemic effects. Acute overdosage is very unlikely to occur, however, in the case of chronic ...

Pharmacodynamic properties

Pharmacotherapeutic group: Corticosteroids, potent (group III) ATC code: D07AC Mechanism of action Topical corticosteroids act as anti-inflammatory agents via multiple mechanisms to inhibit late phase ...

Pharmacokinetic properties

Absorption Topical corticosteroids can be systemically absorbed from intact healthy skin. The extent of percutaneous absorption of topical corticosteroids is determined by many factors, including the vehicle ...

Preclinical safety data

Reproductive toxicity Subcutaneous administration of betamethasone valerate to mice or rats at doses ≥0.1 mg/kg/day or rabbits at doses ≥12 micrograms/kg/day during pregnancy produced foetal abnormalities ...

List of excipients

Chlorocresol BP Cetomacrogol 1000 BP Cetostearyl Alcohol BP White Soft Paraffin BP Liquid Paraffin BP Sodium Acid Phosphate BP Phosphoric Acid BP Sodium Hydroxide BP Purified Water BP

Incompatibilities

None known.

Shelf life

Tubes: 36 Months 500gm pots: 18 months

Special precautions for storage

Store below 25°C.

Nature and contents of container

15gm, 30gm and 100gm collapsible aluminium tubes internally coated with an epoxy resin based lacquer and closed with a cap. 500mg opaque high density polythene pots with black urea formaldehyde screw caps ...

Special precautions for disposal and other handling

No special instructions.

Marketing authorization holder

Glaxo Wellcome UK Ltd. T/A GlaxoSmithKline UK Stockley Park West, Uxbridge, Middlesex UB11 1BT

Marketing authorization number(s)

PL10949/0014

Date of first authorization / renewal of the authorization

24 October 1997

Date of revision of the text

02/08/2012