GENERIC NAME OF THE MEDICINAL PRODUCT:
A. Bosentan Tablets 62.5mg
B. Bosentan Tablets 125mg
B. Bosentan Tablets 125mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
A) Bosentan Tablets 62.5mg
Each film-coated tablet contains:
Bosentan Monohydrate
Equivalent to Bosentan……………62.5mg
Colours: Yellow Oxide Of Iron
B) Bosentan Tablets 125mg
Each film-coated tablet contains:
Bosentan Monohydrate
Equivalent to Bosentan…………125mg
Colours: Red Oxide Of Iron
Each film-coated tablet contains:
Bosentan Monohydrate
Equivalent to Bosentan……………62.5mg
Colours: Yellow Oxide Of Iron
B) Bosentan Tablets 125mg
Each film-coated tablet contains:
Bosentan Monohydrate
Equivalent to Bosentan…………125mg
Colours: Red Oxide Of Iron
THERAPEUTIC INDICATIONS:
Bosentan is used to treat pulmonary arterial hypertension (PAH, high blood pressure in the vessels that carry blood to the lungs) in adults and children 3 years of age and older. It may improve the ability to exercise and slow the worsening of symptoms in patients with PAH.
CAUTION & SCHEDULE:
CAUTION: Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
Tablet to be swallowed as a whole, and not to be chewed or crushed.
WARNING: Not to be sold by retail without the prescription of a registered medical practitioner.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
Tablet to be swallowed as a whole, and not to be chewed or crushed.
WARNING: Not to be sold by retail without the prescription of a registered medical practitioner.
STORAGE & DOSAGE:
Storage: Store at temperature not exceeding 30℃.
Store in cool, dry & dark place.
Protect from Light & moisture.
Dosage: As directed by the Physician.
Store in cool, dry & dark place.
Protect from Light & moisture.
Dosage: As directed by the Physician.
Bosentan Tablets 62.5mg Technical Specification:
| Product Name: | Bosentan Tablets 62.5mg |
| Brand Name: | Generic |
| Strength: | (62.5mg), (125mg) |
| Dosage Form: | Tablets (film-coated) |
| Route of Administration: | Via Oral Route |
| Packing: | 10 strips of 10 tablets each |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet) |
| Regulatory Documents: | COA, MOA, Stability Studies, GMP |
| Therapeutic use: | Endothelin Receptor Antagonists |
| Indication: | Bosentan is used to treat pulmonary arterial hypertension (PAH, high blood pressure in the vessels that carry blood to the lungs) in adults and children 3 years of age and older. It may improve the ability to exercise and slow the worsening of symptoms in patients with PAH. |
| Storage: | Store at temperature not exceeding 30℃. Store in cool, dry & dark place. Protect from Light & moisture. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Bosentan Tablets 62.5mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Bosentan Tablets 62.5mg
Each film-coated tablet contains:
Bosentan Monohydrate
Equivalent to Bosentan……………62.5mg
Colours: Yellow Oxide Of Iron
THERAPEUTIC INDICATIONS:
Bosentan is used to treat pulmonary arterial hypertension (PAH, high blood pressure in the vessels that carry blood to the lungs) in adults and children 3 years of age and older. It may improve the ability to exercise and slow the worsening of symptoms in patients with PAH.
CAUTION & SCHEDULE:
CAUTION: Read enclosed leaflet before use.
Keep medicine out of reach of children.
Tablet to be swallowed as a whole, and not to be chewed or crushed.
WARNING: Not to be sold by retail without the prescription of a registered medical practitioner.
STORAGE & DOSAGE:
Storage: Store at temperature not exceeding 30℃.
Store in cool, dry & dark place.
Protect from Light & moisture.
Dosage: As directed by the Physician.
