GENERIC NAME OF THE MEDICINAL PRODUCT:
A. Milrinone Lactate Injection USP 10mg/10ml (MILYRATAJ-IV)
B. Milrinone Lactate Injection USP 20mg/20ml (MILYRATAJ-IV)
C. Milrinone Lactate Injection USP 50mg/50ml (MILYRATAJ-IV)
B. Milrinone Lactate Injection USP 20mg/20ml (MILYRATAJ-IV)
C. Milrinone Lactate Injection USP 50mg/50ml (MILYRATAJ-IV)
QUALITATIVE AND QUANTITATIVE COMPOSITION:
A. Milrinone Lactate Injection USP 10mg/10ml
Each ml contains:
Milrinone Lactate USP
Equivalent to
Milrinone…………………………..1mg
Dextrose Anhydrous USP…..47mg
Water for Injection USP……….q.s
*No preservatives
B. Milrinone Lactate Injection USP 20mg/20ml
Each ml contains:
Milrinone Lactate USP
Equivalent to
Milrinone…………………………..1mg
Dextrose Anhydrous USP…..47mg
Water for Injection USP……….q.s
*No preservatives
C. Milrinone Lactate Injection USP 50mg/50ml
Each ml contains:
Milrinone Lactate USP
Equivalent to
Milrinone…………………………..1mg
Dextrose Anhydrous USP…..47mg
Water for Injection USP……….q.s
*No preservatives
Each ml contains:
Milrinone Lactate USP
Equivalent to
Milrinone…………………………..1mg
Dextrose Anhydrous USP…..47mg
Water for Injection USP……….q.s
*No preservatives
B. Milrinone Lactate Injection USP 20mg/20ml
Each ml contains:
Milrinone Lactate USP
Equivalent to
Milrinone…………………………..1mg
Dextrose Anhydrous USP…..47mg
Water for Injection USP……….q.s
*No preservatives
C. Milrinone Lactate Injection USP 50mg/50ml
Each ml contains:
Milrinone Lactate USP
Equivalent to
Milrinone…………………………..1mg
Dextrose Anhydrous USP…..47mg
Water for Injection USP……….q.s
*No preservatives
THERAPEUTIC INDICATIONS:
Milrinone Lactate Injection is used for the short-term treatment of heart failure. It works by making your heart beat stronger and by relaxing certain blood vessels so that the amount of blood that is pumped from the heart is increased. This effect may help with symptoms of heart failure (such as shortness of breath, tiredness).
DIRECTION OF USE:
For Intravenous use only.
See package insert for full prescribing information.
See package insert for full prescribing information.
CAUTION & WARNING:
CAUTION: Do not use if any foreign particulate matter is visible.
Discard unused portion.
DO NOT ACCEPT IF VIAL SEAL IS BROKEN.
KEEP OUT OF REACH AND SIGHT OF CHILDREN.
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 ACCEPT IF VIAL SEAL IS BROKEN.
KEEP OUT OF REACH AND SIGHT OF CHILDREN.
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 at 20°C to 25°C (68°F to 77°F).
Do not freeze.
Protect from light.
Keep all medicines out of reach of children.
Dosage: As directed by the Physician.
Do not freeze.
Protect from light.
Keep all medicines out of reach of children.
Dosage: As directed by the Physician.
Milrinone Lactate Injection USP 10mg/10ml Technical Specification:
| Product Name: | Milrinone Lactate Injection USP |
| Brand Name: | MILYRATAJ-IV |
| Strength: | 10mg/10ml, 20mg/20ml, 50mg/50ml |
| Dosage Form: | Liquid Injection |
| Packing: | 1mg/1ml-10ml Single Dose Vial/Ampoule 1mg/1ml-20ml Single Dose Vial/Ampoule 1mg/1ml-50ml Single Dose Vials |
| 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: | Anti-Hypotensive, Vasodilators |
| Indication: | Milrinone Lactate Injection is used for the short-term treatment of heart failure. It works by making your heart beat stronger and by relaxing certain blood vessels so that the amount of blood that is pumped from the heart is increased. This effect may help with symptoms of heart failure (such as shortness of breath, tiredness). |
| Storage: | Store at 20°C to 25°C (68°F to 77°F). Do not freeze. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Milrinone Lactate Injection USP 10mg/10ml (MILYRATAJ-IV)
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Milrinone Lactate Injection USP 10mg/10ml
Each ml contains:
Milrinone Lactate USP
Equivalent to
Milrinone…………………………..1mg
Dextrose Anhydrous USP…..47mg
Water for Injection USP……….q.s
*No preservatives
THERAPEUTIC INDICATIONS:
Milrinone Lactate Injection is used for the short-term treatment of heart failure. It works by making your heart beat stronger and by relaxing certain blood vessels so that the amount of blood that is pumped from the heart is increased. This effect may help with symptoms of heart failure (such as shortness of breath, tiredness).
DIRECTION OF USE:
For Intravenous use only.
See package insert for full prescribing information.
CAUTION & WARNING:
CAUTION: Do not use if any foreign particulate matter is visible.
Discard unused portion.
DO NOT ACCEPT IF VIAL SEAL IS BROKEN.
KEEP OUT OF REACH AND SIGHT OF CHILDREN.
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 at 20°C to 25°C (68°F to 77°F).
Protect from light.
Do not freeze.
Dosage: As directed by the Physician.
