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Tirofiban Hydrochloride I.V. Injection 5mg/100ml (Aggrixtaj) Tirofiban Hydrochloride I.V. Injection 5mg/100ml Tirofiban Hydrochloride I.V. Injection 5mg/100ml Tirofiban Hydrochloride I.V. Injection 5mg/100ml Tirofiban Hydrochloride I.V. Injection 5mg/100ml Tirofiban Hydrochloride I.V. Injection 5mg/100ml
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Tirofiban Hydrochloride I.V. Injection (5mg/100ml) 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.

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.

PACKING:

StrengthPack Size
5mg100ml
12.5mg250ml

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.

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)

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.

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.

PACKING:

Strength Pack Size
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

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.