GENERIC NAME OF THE MEDICINAL PRODUCT:
A. Adenosine Injection USP 6mg/2ml
B. Adenosine Injection USP 12mg/4ml
C. Adenosine Injection USP 60mg/20ml
D. Adenosine Injection USP 90mg/30ml
B. Adenosine Injection USP 12mg/4ml
C. Adenosine Injection USP 60mg/20ml
D. Adenosine Injection USP 90mg/30ml
QUALITATIVE AND QUANTITATIVE COMPOSITION:
A. Adenosine Injection USP 6mg/2ml
Each ml contains:
Adenosine USP………………..3mg
Sodium Chloride USP……….9mg
Water for Injection USP……q.s
*No preservatives
B. Adenosine Injection USP 12mg/4ml
Each ml contains:
Adenosine USP ………………..3mg
Sodium Chloride USP……….9mg
Water for Injection USP ……q.s
*No preservatives
C. Adenosine Injection USP 60mg/20ml
Each ml contains:
Adenosine USP ………………..3mg
Sodium Chloride USP……….9mg
Water for Injection USP ……q.s
*No preservatives
D. Adenosine Injection USP 90mg/30ml
Each ml contains:
Adenosine USP ………………..3mg
Sodium Chloride USP……….9mg
Water for Injection USP ……q.s
*No preservatives
Each ml contains:
Adenosine USP………………..3mg
Sodium Chloride USP……….9mg
Water for Injection USP……q.s
*No preservatives
B. Adenosine Injection USP 12mg/4ml
Each ml contains:
Adenosine USP ………………..3mg
Sodium Chloride USP……….9mg
Water for Injection USP ……q.s
*No preservatives
C. Adenosine Injection USP 60mg/20ml
Each ml contains:
Adenosine USP ………………..3mg
Sodium Chloride USP……….9mg
Water for Injection USP ……q.s
*No preservatives
D. Adenosine Injection USP 90mg/30ml
Each ml contains:
Adenosine USP ………………..3mg
Sodium Chloride USP……….9mg
Water for Injection USP ……q.s
*No preservatives
THERAPEUTIC INDICATIONS:
Adenosine Injection is indicated for the following. Conversion to sinus rhythm of paroxysmal supraventricular tachycardia (PSVT), including that associated with accessory bypass tracts (Wolff-Parkinson-White Syndrome).
DIRECTION OF USE:
For Rapid Bolus Intravenous Use.
Please refer accompanying package insert for detailed dosage, direction for use and precautions.
Please refer accompanying package insert for detailed dosage, direction for use and precautions.
CAUTION & WARNING:
CAUTION: The solution must be clear and particle free at the time of use.
Discard unused portion.
Do not refrigerate as crystallization may occur, if crystallization has occurred, dissolve crystals by warming to room temperature.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
Warning: Not to be sold by retail without the prescription of a Registered Medical Practitioner.
Discard unused portion.
Do not refrigerate as crystallization may occur, if crystallization has occurred, dissolve crystals by warming to room temperature.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
Warning: Not to be sold by retail without the prescription of a Registered Medical Practitioner.
STORAGE & DOSAGE:
Storage: Store below 20 to 25°C (68°F to 77°F) excursions permitted between 15°C to 30°C (59°F to 86°F).
Protect from light and moisture.
Do not refrigerate.
Keep all medicines out of reach of children.
Dosage: As directed by the Physician.
Protect from light and moisture.
Do not refrigerate.
Keep all medicines out of reach of children.
Dosage: As directed by the Physician.
Adenosine Injection USP 60mg/20ml Technical Specification:
| Product Name: | Adenosine Injection USP |
| Brand Name: | Generic |
| Strength: | 6mg/2ml, 12mg/4ml, 60mg/20ml, 90mg/30ml |
| Dosage Form: | Liquid Injection (Sterile and Nonpyrogenic) |
| Packing: | 3mg/ml- 2ml Single Dose Ampoule/Vial 3mg/ml- 4ml Single Dose Ampoule/Vial 3mg/ml- 20ml Single Dose Ampoule/Vial 3mg/ml- 30ml Single Dose Ampoule/Vial |
| Route of Administration: | For Rapid Bolus Intravenous Use |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) |
| Regulatory Documents: | COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier |
| Therapeutic use: | Anti-Arrhythmic |
| Indication: | Adenosine Injection is indicated for the following. Conversion to sinus rhythm of paroxysmal supraventricular tachycardia (PSVT), including that associated with accessory bypass tracts (Wolff-Parkinson-White Syndrome). |
| Storage: | Store below 20 to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F). Do not refrigerate. Protect from light and moisture. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Adenosine Injection USP 60mg/20ml
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Adenosine Injection USP 60mg/20ml
Each ml contains:
Adenosine USP………………..3mg
Sodium Chloride USP……….9mg
Water for Injection USP……q.s
*No preservatives
THERAPEUTIC INDICATIONS:
Adenosine Injection is indicated for the following. Conversion to sinus rhythm of paroxysmal supraventricular tachycardia (PSVT), including that associated with accessory bypass tracts (Wolff-Parkinson-White Syndrome).
DIRECTION OF USE:
For Rapid Bolus Intravenous Use.
Please refer accompanying package insert for detailed dosage, direction for use and precautions.
CAUTION & Warning:
CAUTION: The solution must be clear and particle free at the time of use.
Discard unused portion.
Do not refrigerate as crystallization may occur, if crystallization has occurred, dissolve crystals by warming to room temperature.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
Warning: Not to be sold by retail without the prescription of a Registered Medical Practitioner.
STORAGE & DOSAGE:
Storage: Store below 20 to 25°C (68°F to 77°F) excursions permitted between 15°C to 30°C (59°F to 86°F).
Protect from light and moisture.
Do not refrigerate.
Keep all medicines out of reach of children.
Dosage: As directed by the Physician.
