Ethambutol 100mg tablets

Nazione: Regno Unito

Lingua: inglese

Fonte: MHRA (Medicines & Healthcare Products Regulatory Agency)

Compra

Foglio illustrativo Foglio illustrativo (PIL)
06-01-2023
Scheda tecnica Scheda tecnica (SPC)
29-01-2019

Principio attivo:

Ethambutol hydrochloride

Commercializzato da:

Genus Pharmaceuticals Holdings Ltd

Codice ATC:

J04AK02

INN (Nome Internazionale):

Ethambutol hydrochloride

Dosaggio:

100mg

Forma farmaceutica:

Oral tablet

Via di somministrazione:

Oral

Classe:

No Controlled Drug Status

Tipo di ricetta:

Valid as a prescribable product

Dettagli prodotto:

BNF: 05010900; GTIN: 5030451001139

Foglio illustrativo

                                ETHAMBUTOL TABLETS 100MG
ETHAMBUTOL TABLETS 100MG
                                
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Scheda tecnica

                                OBJECT 1
ETHAMBUTOL 100MG 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
•
4.1 Therapeutic indications
•
4.2 Posology and method of administration
•
4.3 Contraindications
•
4.4 Special warnings and precautions for use
•
4.5 Interaction with other medicinal products and other forms of
interaction
•
4.6 Fertility pregnancy and lactation
•
4.7 Effects on ability to drive and use machines
•
4.8 Undesirable effects
•
4.9 Overdose
•
5. Pharmacological properties
•
5.1 Pharmacodynamic properties
•
5.2 Pharmacokinetic properties
•
5.3 Preclinical safety data
•
6. Pharmaceutical particulars
•
6.1 List of excipients
•
6.2 Incompatibilities
•
6.3 Shelf life
•
6.4 Special precautions for storage
•
6.5 Nature and contents of container
•
6.6 Special precautions for disposal and other handling
•
7. Marketing authorisation holder
•
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 100mg
Ethambutol Tablets 100mg
2. Qualitative and quantitative composition
Each Ethambutol Tablet contains 100mg of Ethambutol Hydrochloride
(EP).
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Slightly mottled yellow 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 prophylaxi
                                
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