Betaxolol 0.5% eye drops

Maa: Yhdistynyt kuningaskunta

Kieli: englanti

Lähde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiivinen ainesosa:

Betaxolol hydrochloride

Saatavilla:

DE Pharmaceuticals

ATC-koodi:

S01ED02

INN (Kansainvälinen yleisnimi):

Betaxolol hydrochloride

Annos:

5mg/1ml

Lääkemuoto:

Eye drops

Antoreitti:

Ocular

luokka:

No Controlled Drug Status

Prescription tyyppi:

Valid as a prescribable product

Tuoteyhteenveto:

BNF: 11060000

Valmisteyhteenveto

OBJECT 1
BETAXOLOL 0.5% EYE DROPS
Summary of Product Characteristics Updated 10-Mar-2017 | FDC
International Ltd
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1. Name of the medicinal product
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2. Qualitative and quantitative composition
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3. Pharmaceutical form
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4. Clinical particulars
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4.1 Therapeutic indications
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4.2 Posology and method of administration
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4.3 Contraindications
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4.4 Special warnings and precautions for use
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4.5 Interaction with other medicinal products and other forms of
interaction
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4.6 Fertility, pregnancy and lactation
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4.7 Effects on ability to drive and use machines
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4.8 Undesirable effects
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4.9 Overdose
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5. Pharmacological properties
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5.1 Pharmacodynamic properties
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5.2 Pharmacokinetic properties
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5.3 Preclinical safety data
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6. Pharmaceutical particulars
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6.1 List of excipients
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6.2 Incompatibilities
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6.3 Shelf life
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6.4 Special precautions for storage
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6.5 Nature and contents of container
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6.6 Special precautions for disposal and other handling
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7. Marketing authorisation holder
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8. Marketing authorisation number(s)
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9. Date of first authorisation/renewal of the authorisation
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10. Date of revision of the text
1. Name of the medicinal product
Betaxolol 0.5% Eye Drops
2. Qualitative and quantitative composition
Active Ingredient
Betaxolol
5.0 mg/ml
(as Betaxolol
hydrochloride
5.6 mg/ml)
Excipient(s) with known effect
Benzalkonium chloride 0.01%w/v
For a full list of excipients, see section 6.1
3. Pharmaceutical form
Eye drops, solution
4. Clinical particulars
4.1 Therapeutic indications
Reduction of elevated intraocular pressure in conditions such as
ocular hypertension and chronic open-
angle glaucoma.
4.2 Posology and method of administration
Adults (including the elderly): recommended therapy is one drop of
Betaxolol 0.5% Eye Drops to be
instilled into the affected eye(s) twice a day.
Children: No clinical studies have been performed to establish safety
and efficacy in children. Therefore,
this product is currently not recommended for use in childre