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SPC, UK: BETNOVATE Lotion (2018)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Betnovate Lotion.

Qualitative and quantitative composition

Betamethasone Valerate 0.122% w/w. Excipients with known effect: Cetostearyl alcohol. For the full list of excipients, see section 6.1.

Pharmaceutical form

Lotion.

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. Lotions are especially appropriate for treatment of hairy areas or when a minimal application to a large area is required. Apply thinly and gently rub in using only enough ...

Contraindications

Hypersensitivity to the active substance or any of the excipients listed in section 6.1. The following conditions should not be treated with betamethasone valerate: Untreated cutaneous infections:Rosacea. ...

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 ...

Fertility, 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 drug reactions (ADRs) are listed below by MedDRA system organ class and by frequency. Frequencies are defined as: very common (≥1/10), common (≥1/100 and <1/10), uncommon (≥1/1,000 and <1/100), ...

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

Methyl Hydroxybenzoate BP Xanthan Gum USP Cetostearyl Alcohol BP Liquid Paraffin BP Isopropyl Alcohol BP Glycerol BP Macrogol cetostearyl ether BP Sodium citrate BP Citric Acid Monohydrate BP Purified ...

Incompatibilities

None known.

Shelf life

Shelf life: 36 months.

Special precautions for storage

Store below 25°C. Keep container tightly closed when not in use. Contents are flammable. Keep away from fire, flame or heat.

Nature and contents of container

White High Density Polyethylene (HDPE) GF4750 and Remafin white CEG 020 container with a polyethylene nozzle and a polyethylene cap. Pack size: 20 ml; 100 ml. Not all pack sizes may be marketed.

Special precautions for disposal and other handling

No special requirements.

Marketing authorization holder

Glaxo Wellcome UK Limited, T/A Glaxo Laboratories and/or GlaxoSmithKline UK, Stockley Park West, Uxbridge, Middlesex, UB11 1BT

Marketing authorization number(s)

PL 10949/0044

Date of first authorization / renewal of the authorization

Date of first authorisation: 1 February 1993 Date of latest renewal: 26 September 2007

Date of revision of the text

25<sup>th</sup> January 2018

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