Ethambutol 400mg tablets

Država: Velika Britanija

Jezik: angleščina

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

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Navodilo za uporabo Navodilo za uporabo (PIL)
06-01-2023
Lastnosti izdelka Lastnosti izdelka (SPC)
30-01-2019
Javno poročilo o oceni Javno poročilo o oceni (PAR)
20-04-2020

Aktivna sestavina:

Ethambutol hydrochloride

Dostopno od:

Genus Pharmaceuticals Holdings Ltd

Koda artikla:

J04AK02

INN (mednarodno ime):

Ethambutol hydrochloride

Odmerek:

400mg

Farmacevtska oblika:

Oral tablet

Pot uporabe:

Oral

Razred:

No Controlled Drug Status

Tip zastaranja:

Valid as a prescribable product

Povzetek izdelek:

BNF: 05010900; GTIN: 5030451001146

Navodilo za uporabo

                                ETHAMBUTOL TABLETS 400MG
ETHAMBUTOL TABLETS 400MG
ETHAMBUTOL TABLETS 400MG
                                
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Lastnosti izdelka

                                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
•
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 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
                                
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