Ethambutol 100mg tablets

Riik: Suurbritannia

keel: inglise

Allikas: MHRA (Medicines & Healthcare Products Regulatory Agency)

Osta kohe

Infovoldik Infovoldik (PIL)
06-01-2023
Toote omadused Toote omadused (SPC)
29-01-2019
Avaliku hindamisaruande Avaliku hindamisaruande (PAR)
20-04-2020

Toimeaine:

Ethambutol hydrochloride

Saadav alates:

Genus Pharmaceuticals Holdings Ltd

ATC kood:

J04AK02

INN (Rahvusvaheline Nimetus):

Ethambutol hydrochloride

Annus:

100mg

Ravimvorm:

Oral tablet

Manustamisviis:

Oral

Klass:

No Controlled Drug Status

Retsepti tüüp:

Valid as a prescribable product

Toote kokkuvõte:

BNF: 05010900; GTIN: 5030451001139

Infovoldik

                                ETHAMBUTOL TABLETS 100MG
ETHAMBUTOL TABLETS 100MG
                                
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Toote omadused

                                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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