Prasugrel HCl+Aspirin Tablets 10mg+75mg Technical Specification:
| Product Name: | Prasugrel HCl+Aspirin Tablets 10mg+75mg |
| Brand Name: | Generics |
| Strength: | (10mg+75mg) |
| Dosage Form: | Capsule (Hard-Gelatine) |
| Route of Administration: | Via oral Route |
| Packing: | 10s, 30s, 100s |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet) |
| Regulatory Documents: | COA, MOA, Stability Studies, GMP |
| Therapeutic use: | Anti-Platelet |
| Indication: | Prasugrel is used with aspirin by patients with heart disease (recent heart attack, unstable angina) who undergo a certain heart procedure (angioplasty). This medication helps to prevent other serious heart/blood vessel problems. (Procedure to open the blood vessels that supply blood to the heart) |
| Storage: | Protect from moisture at a temperature not exceeding 25˚C. Do not freeze. Keep the container tightly closed in order to protect from moisture. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Prasugrel HCl+Aspirin Tablet 10mg+75mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Prasugrel HCl+Aspirin Tablet 10mg+75mg
Each hard gelatin capsule contains:
Prasugrel Hydrochloride IP
Equivalent to Prasugrel…………………10mg
Colours: Red oxide of iron and Titanium Dioxide I.P.
(As Film-coated tablet)
Aspirin IP……………………………….75mg
Colours: Yellow Oxide of Iron
(As enteric coated tablet)
Approved Colours used in hard gelatin capsule shells.
THERAPEUTIC INDICATIONS:
Prasugrel is used with aspirin by patients with heart disease (recent heart attack, unstable angina) who undergo a certain heart procedure (angioplasty). This medication helps to prevent other serious heart/blood vessel problems. (Procedure to open the blood vessels that supply blood to the heart).
CAUTION & WARNING:
CAUTION: Read enclosed leaflet before use.
Keep medicine out of reach of children.
SWALLOW WHOLE DO NOT CHEW OR CRUSH.
Do not take this product during the last three months of pregnancy unless directed by a doctor.
ASPIRIN TAKEN NEAR THE TIME OF DELIVERY MAY CAUSE BLEEDING PROBLEMS TO BOTH MOTHER & CHILD.
Not to be used in children below 12 years of age except under medical advice.
SCHEDULE “H” Prescription Drug -Warning: Not to be sold by retail without the prescription of a Registered Medical Prescriber.
STORAGE & DOSAGE:
Storage: Protect from moisture at a temperature not exceeding 25˚C.Do not freeze. Keep the container tightly closed in order to protect from moisture.
Dosage: As directed by the Physician.
GENERIC NAME OF THE MEDICINAL PRODUCT:
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Each hard gelatin capsule contains:
Prasugrel Hydrochloride IP
Equivalent to Prasugrel…………………10mg
Colours: Red oxide of iron and Titanium Dioxide I.P.
(As Film coated tablet)
Aspirin IP……………………………….75mg
Colours: Yellow Oxide of Iron
(As enteric coated tablet)
Approved Colours used in hard gelatin capsule shells.
THERAPEUTIC INDICATIONS:
CAUTION & WARNING:
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SWALLOW WHOLE DO NOT CHEW OR CRUSH
Do not take this product during the last three months of pregnancy unless directed by a doctor. ASPIRIN TAKEN NEAR THE TIME OF DELIVERY MAY CAUSE BLEEDING PROBLEMS TO BOTH MOTHER & CHILD.
Not to be used in children below 12 years of age except under medical advice.
STORAGE & DOSAGE:
Dosage: As directed by the Physician.
