GENERIC NAME OF THE MEDICINAL PRODUCT:
A. Tirofiban Hydrochloride I.V. Injection (5mg/100ml or 50mcg/ml) (Aggrixtaj)
B. Tirofiban Hydrochloride I.V. Injection (12.5mg/250ml or 50mcg/ml) (Aggrixtaj)
B. Tirofiban Hydrochloride I.V. Injection (12.5mg/250ml or 50mcg/ml) (Aggrixtaj)
QUALITATIVE AND QUANTITATIVE COMPOSITION:
A. Tirofiban Hydrochloride I.V. Injection (5mg/100ml or 50mcg/ml)
Composition:
Each 100 ml contains:
Tirofiban Hydrochloride
Eq. to Tirofiban……………………………5mg
Sodium Chloride BP……………………0.9%w/v
Water for Injection USP…………………q.s.
B. Tirofiban Hydrochloride I.V. Injection (12.5mg/250ml or 50mcg/ml)
Composition:
Each 250 ml contains:
Tirofiban Hydrochloride
Eq. to Tirofiban……………………………12.5mg
Sodium Chloride BP……………………2.25%w/v
Water for Injection USP…………………q.s.
Composition:
Each 100 ml contains:
Tirofiban Hydrochloride
Eq. to Tirofiban……………………………5mg
Sodium Chloride BP……………………0.9%w/v
Water for Injection USP…………………q.s.
B. Tirofiban Hydrochloride I.V. Injection (12.5mg/250ml or 50mcg/ml)
Composition:
Each 250 ml contains:
Tirofiban Hydrochloride
Eq. to Tirofiban……………………………12.5mg
Sodium Chloride BP……………………2.25%w/v
Water for Injection USP…………………q.s.
THERAPEUTIC INDICATIONS:
Tirofiban is indicated for the prevention of early myocardial infarction in adult patients presenting with acute coronary syndromes without ST elevation (NSTE-ACS) with the last episode of chest pain occurring within 12 hours and with ECG changes and/or elevated cardiac enzymes.
Also prevent blood clots which can cause heart attacks or other health problems associated with excessive clotting.
Also prevent blood clots which can cause heart attacks or other health problems associated with excessive clotting.
PACKING:
Strength Pack Size
5mg-- 100ml
12.5mg-- 250ml
5mg-- 100ml
12.5mg-- 250ml
DIRECTION OF USE:
To be used with Non-pyrogenic I.V. administration set with aseptic technique.
For I.V. use only.
Single Bolus + Short Infusion
Last up to 18hours
For I.V. use only.
Single Bolus + Short Infusion
Last up to 18hours
CAUTION & WARNING:
CAUTION: It is dangerous to take this preparation except in accordance with the medical advice.
Not to be sold by retail without the prescription of a Registered Medical Practitioner.
WARNING: Do not use the bottle if plastic bag is missing or tampered.
Not to be sold by retail without the prescription of a Registered Medical Practitioner.
WARNING: Do not use the bottle if plastic bag is missing or tampered.
STORAGE & DOSAGE:
Storage: Store at 25°C with excursions permitted between 15°C -20°C.
Do not freeze.
Protect from light during storage.
STERILE, NON-PYROGENIC, SINGLE DOSE CONTAINER.
Keep medicine out of reach of children.
FOR HUMAN USE ONLY
Read enclosed leaflet before use.
Dosage: As directed by the Physician.
Do not freeze.
Protect from light during storage.
STERILE, NON-PYROGENIC, SINGLE DOSE CONTAINER.
Keep medicine out of reach of children.
FOR HUMAN USE ONLY
Read enclosed leaflet before use.
Dosage: As directed by the Physician.
Tirofiban Hydrochloride I.V. Injection (12.5mg/250ml) Technical Specification:
| Product Name: | Tirofiban Hydrochloride I.V. Injection |
| Brand Name: | Aggrixtaj |
| Strength: | (5mg/100ml or 50mcg/ml), (12.5mg/250ml or 50mcg/ml) |
| Dosage Form: | I.V. Infusion Bottle (LVP) |
| Packing: | 100mL, 250mL IV Bottle |
| Route of Administration: | For I.V. use only |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) |
| Regulatory Documents: | COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier |
| Therapeutic use: | Antiplatelet Agents – Cardiovascular (Glycoprotein IIb/IIIa Inhibitors). |
| Indication: | Tirofiban is indicated for the prevention of early myocardial infarction in adult patients presenting with acute coronary syndromes without ST elevation (NSTE-ACS) with the last episode of chest pain occurring within 12 hours and with ECG changes and/or elevated cardiac enzymes. |
| Storage: | Store at 25°C with excursions permitted between 15°C -20°C. Do not freeze. Protect from light during storage. |
Tirofiban Hydrochloride I.V. Injection (12.5mg/250ml) Manufacturers and Suppliers in India:
Taj Pharmaceuticals is of the prominent Tirofiban Hydrochloride I.V. Injection (12.5mg/250ml) Manufacturers in India that brings the best quality products. Our company Taj Pharma carries a rich experience in the niche manufacturing of Tirofiban Hydrochloride I.V. Injection (12.5mg/250ml)
Taj Pharmaceuticals is a reputed manufacturer and Tirofiban Hydrochloride I.V. Injection (12.5mg/250ml) Suppliers in India prefer Taj Pharma is best known for the topmost standards and consistent quality of its products.
Taj Pharma is a well-known Tirofiban Hydrochloride I.V. Injection (12.5mg/250ml) Manufacturer in India that gives the assurance of high- quality and high standards. Strict quality control ensures that every batch of medicine brings a harmonious standard.
Tirofiban Hydrochloride I.V. Injection (12.5mg/250ml) manufactured at Taj Pharma follows USP (United States Pharmacopeia); i.e. the product is manufactured to comply with USP quality standards which are considered the Best in the world. Further, Taj Pharma uses Tirofiban Hydrochloride I.V. Injection (12.5mg/250ml) grade best active ingredient to manufacture its Injections to comply with international standards of European products.
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Tirofiban Hydrochloride I.V. Injection (5mg/100ml or 50mcg/ml) (Aggrixtaj)
- Tirofiban Hydrochloride I.V. Injection (12.5mg/250ml or 50mcg/ml) (Aggrixtaj)
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Tirofiban Hydrochloride I.V. Injection (5mg/100ml or 50mcg/ml)
Composition:
Each 100 ml contains:
Tirofiban Hydrochloride
Eq. to Tirofiban……………………………5mg
Sodium Chloride BP……………………0.9%w/v
Water for Injection USP…………………q.s. - Tirofiban Hydrochloride I.V. Injection (12.5mg/250ml or 50mcg/ml)
Composition:
Each 250 ml contains:
Tirofiban Hydrochloride
Eq. to Tirofiban……………………………12.5mg
Sodium Chloride BP……………………2.25%w/v
Water for Injection USP…………………q.s.
THERAPEUTIC INDICATIONS:
Tirofiban is indicated for the prevention of early myocardial infarction in adult patients presenting with acute coronary syndromes without ST elevation (NSTE-ACS) with the last episode of chest pain occurring within 12 hours and with ECG changes and/or elevated cardiac enzymes.
Also prevent blood clots which can cause heart attacks or other health problems associated with excessive clotting.
DIRECTION OF USE:
To be used with Non-pyrogenic I.V. administration set with aseptic technique.
For I.V. use only.
Single Bolus + Short Infusion
Last up to 18hours
CAUTION & WARNING:
CAUTION: It is dangerous to take this preparation except in accordance with the medical advice.
Not to be sold by retail without the prescription of a Registered Medical Practitioner.
WARNING: Do not use the bottle if plastic bag is missing or tampered.
STORAGE & DOSAGE:
Storage: Store at 25°C with excursions permitted between 15°C -20°C. Do not freeze. Protect from light during storage.
STERILE, NON-PYROGENIC, SINGLE DOSE CONTAINER.
Keep medicine out of reach of children.
FOR HUMAN USE ONLY
Read enclosed leaflet before use.
Dosage: As directed by the Physician.
As Tirofiban Hydrochloride I.V. Injection 12.5mg/250ml Exporters; We can cater to export business queries from the following geographies. We are exporting our Tirofiban Hydrochloride I.V. Injection 12.5mg/250ml product in Following Countries:
Russia and CIS Countries: Azerbaijan, Armenia, Belarus, Georgia, Kazakhstan, Kyrgyzstan, Moldova, Russia, Tajikistan, Turkmenistan, Uzbekistan, and Ukraine
GCC/ Middle East Countries: Saudi Arabia, Yemen, Oman, Bahrain, UAE, Lebanon, Jordan, Iraq.
African Countries: Nigeria, Tanzania, Sudan, Zambia, Benin, Angola, Liberia
Southeast Asia: Cambodia, Indonesia, Laos, Malaysia, Myanmar, Philippines, Singapore, Thailand, Vietnam, Brunei Darussalam
Other Asian Countries: Nepal, Myanmar, Malaysia, Cambodia, Bhutan, Sri Lanka, Mauritius
Tirofiban Hydrochloride I.V. Injection 12.5mg/250ml Regulatory Documents:
- Certificate of Analysis (COA)
- Method of Analysis (MOA)
- Stability Data (Accelerated stability / Long term stability / Zone 4b)
- CTD Dossier / ACTD Dossiers / eCTD Dossiers
- Certificate of Pharmaceuticals Product (COPP)
- Free Sale Certificate (FSC)
