Dabigatran Etexilate (Mesylate) Capsules 150mg
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Dabigatran Etexilate (Mesylate) Capsules 150mg Technical Specification:

Product Name: Dabigatran Etexilate (Mesylate) Capsules 150mg
Brand Name: Generic
Strength: (75mg), (110mg), (150mg)
Dosage Form: Capsules (Hard Celullose)
Route of Administration: Via Oral Route
Packing: 10s, 60s, 100s, 500s
Pack Insert/Leaflet: PIL (Patient Information Leaflet)
Documents: COA, MOA, Stability Studies, GMP
Therapeutic use: Anticoagulant
Indication: Dabigatran is used to decrease the risk of stroke and blood clots in patients with a serious heart rhythm problem called nonvalvular atrial fibrillation.
Storage: Store below 30°C. Protect from Light and moisture.

GENERIC NAME OF THE MEDICINAL PRODUCT:

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Dabigatran Etexilate Mesylate Capsules 75mg
    Each hard Cellulose Capsule contains:
    Dabigatran Etexilate Mesylate 86.48mg
    Equivalent to
    Dabigatran Etexilate……………….75mg
    Excipients……………………………….q.s.
    Approved colours used in capsule shells.
  • Dabigatran Etexilate Mesylate Capsules 110mg
    Each hard Cellulose Capsule contains:
    Dabigatran Etexilate Mesylate 126.83mg
    Equivalent to
    Dabigatran Etexilate……………….110mg
    Excipients……………………………….q.s.
    Approved colours used in capsule shells.
  • Dabigatran Etexilate Mesylate Capsules 150mg
    Each hard Cellulose Capsule contains:
    Dabigatran Etexilate Mesilate 172.95mg
    Equivalent to
    Dabigatran Etexilate……………….150mg
    Excipients……………………………….q.s.
    Approved colours used in capsule shells.

THERAPEUTIC INDICATIONS:

Dabigatran is used to decrease the risk of stroke and blood clots in patients with a serious heart rhythm problem called nonvalvular atrial fibrillation. Dabigatran is also used to treat blood clots in the veins of your legs (deep vein thrombosis) or lungs (pulmonary embolism) and to reduce the risk of them occurring again. This medication may also be used to prevent these blood clots from forming after hip replacement surgery.

CAUTION & SCHEDULE:

CAUTION:

Read enclosed leaflet before use.

Keep medicine out of reach of children.

SWALLOW CAPSULE WHOLE.

SCHEDULE: SCHEDULE H: TO BE SOLD BY RETAIL ON THE PRESCRIPTION OF CARDIOLOGISTS, ORTHOPEDIC SURGEONS, NEUROLOGISTS, INTENSIVE CARE SPECIALISTS, SURGEONS AND HEMATOLOGISTS ONLY.

STORAGE & DOSAGE:

STORAGE: Store below 30°C. Protect from Light and moisture.

DOSAGE: As directed by the Physician.

GENERIC NAME OF THE MEDICINAL PRODUCT:

A. Dabigatran Etexilate Mesylate Capsules 75mg
B. Dabigatran Etexilate Mesylate Capsules 110mg
C. Dabigatran Etexilate Mesylate Capsules 150mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

a)Dabigatran Etexilate Mesylate Capsules 75mg
Each hard Cellulose Capsule contains:
Dabigatran Etexilate Mesylate 86.48mg
Equivalent to
Dabigatran Etexilate……………….75mg
Excipients……………………………….q.s.
Approved colours used in capsule shells.

b)Dabigatran Etexilate Mesylate Capsules 110mg
Each hard Cellulose Capsule contains:
Dabigatran Etexilate Mesylate 126.83mg
Equivalent to
Dabigatran Etexilate……………….110mg
Excipients……………………………….q.s.
Approved colours used in capsule shells.

c)Dabigatran Etexilate Mesilate Capsules 150mg
Each hard Cellulose Capsule contains:
Dabigatran Etexilate Mesilate 172.95mg
Equivalent to
Dabigatran Etexilate……………….150mg
Excipients……………………………….q.s.
Approved colours used in capsule shells.

THERAPEUTIC INDICATIONS:

Dabigatran is used to decrease the risk of stroke and blood clots in patients with a serious heart rhythm problem called nonvalvular atrial fibrillation. Dabigatran is also used to treat blood clots in the veins of your legs (deep vein thrombosis) or lungs (pulmonary embolism) and to reduce the risk of them occurring again. This medication may also be used to prevent these blood clots from forming after hip replacement surgery.

CAUTION & SCHEDULE:

CAUTION: Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SWALLOW CAPSULE WHOLE.

SCHEDULE: SCHEDULE H: TO BE SOLD BY RETAIL ON THE PRESCRIPTION OF A CARDIOLOGISTS, ORTHOPADIC SURGEONS, NEUROLOGISTS, INTENSIVE CARE SPECIALISTS, SURGEONS AND HEMATOLOGIST ONLY.

STORAGE & DOSAGE:

Storage: Store below 30°C.
Protect from Light and moisture.

Dosage: As directed by the Physician.