Ethambutol 400mg tablets

Country: Միացյալ Թագավորություն

language: անգլերեն

source: MHRA (Medicines & Healthcare Products Regulatory Agency)

active_ingredient:

Ethambutol hydrochloride

MAH:

Genus Pharmaceuticals Holdings Ltd

ATC_code:

J04AK02

INN:

Ethambutol hydrochloride

dosage:

400mg

pharmaceutical_form:

Oral tablet

administration_route:

Oral

class:

No Controlled Drug Status

prescription_type:

Valid as a prescribable product

leaflet_short:

BNF: 05010900; GTIN: 5030451001146

PIL

ETHAMBUTOL TABLETS 400MG
ETHAMBUTOL TABLETS 400MG
ETHAMBUTOL TABLETS 400MG

SPC

OBJECT 1
ETHAMBUTOL 400MG TABLETS
Summary of Product Characteristics Updated 18-Mar-2019 | Genus
Pharmaceuticals
•
1. Name of the medicinal product
•
2. Qualitative and quantitative composition
•
3. Pharmaceutical form
•
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
•
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)
•
9. Date of first authorisation/renewal of the authorisation
•
10. Date of revision of the text
1. Name of the medicinal product
Myambutol Tablets 400mg
Ethambutol Tablets 400mg
2. Qualitative and quantitative composition
Each Ethambutol Tablet contains 400mg of Ethambutol Hydrochloride
(EP).
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Grey coated tablets
4. Clinical particulars
4.1 Therapeutic indications
The primary treatment and re-treatment of tuberculosis and for
prophylaxis in cases of inactive
tuberculosis or large-tuberculin-positive reaction. Ethambutol should
only be used in conjunction with
other anti-tuberculous drugs to which the patients organisms are
susceptible.
4.2 Posology and method of administration
_Route of administration: _Oral
_Posology_
The dosage of Ethambutol must be adjusted according to the body weight
of the patient.
_Adults_
_For primary treatment and prophylaxis: _Ethambutol shoul