Vasopressin Injection USP Synthetic 20 Units/1ml (Trazissin) Technical Specification:
| Product Name: | Vasopressin Injection USP Synthetic |
| Brand Name: | Trazissin |
| Strength: | 50units/1ml, 20Units/1ml, 10units/0.5ml, 0.6units/1ml, 0.4units/1ml |
| Dosage Form: | Liquid Injection |
| Packing: | Single Dose Ampoule/ Multi Dose Vial & Ampoule |
| Route of Administration: | For I.V /I.M. /S.C. 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: | Antidiabetic |
| Indication: | Vasopressin injection is used to control the frequent urination, increased thirst, and loss of water caused by diabetes insipidus. It is also used to prevent and treat abdominal or stomach distension that occurs after surgery. It is also used in abdominal or stomach roentgenography. It is a hormone produced in the body and acts on the kidneys to reduce the flow of urine. It is also used to increase blood pressure in adults with vasodilatory shock (eg, post-cardiotomy, sepsis) who remain to have low blood pressure after receiving fluids and medicines. |
| Storage: | Store in a refrigerator at 2°C to 8°C (36°F to 46°F). Do not freeze. Protect from light. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Vasopressin Injection USP Synthetic 20Units/1ml (Trazissin)
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Vasopressin Injection USP Synthetic 20Units/1ml
Each ml contains:
Vasopressin USP………………………………………20Units
Sodium Chloride USP………………………………9mg
Chlorobutanol USP………………………………….0.5%w/v
(as preservative)
Water for Injection USP………………………….q.s
THERAPEUTIC INDICATIONS:
Vasopressin injection is used to control the frequent urination, increased thirst, and loss of water caused by diabetes insipidus. It is also used to prevent and treat abdominal or stomach distension that occurs after surgery. It is also used in abdominal or stomach roentgenography. It is a hormone produced in the body and acts on the kidneys to reduce the flow of urine. It is also used to increase blood pressure in adults with vasodilatory shock (eg, post-cardiotomy, sepsis) who remain to have low blood pressure after receiving fluids and medicines.
DIRECTION OF USE:
For Intravenous infusion or Intramuscular Intravenous or Subcutaneous use only.
Use only after reading the directions on pack insert.
CAUTION & WARNING:
CAUTION: Must be diluted prior to use.
This injection should not be used if it contains visible particulate matter.
Discard unused portion.
Warning: To be sold by retail on the prescription of an Oncologist/Specialist only.
STORAGE & DOSAGE:
Storage: Store in a refrigerator at 2°C to 8°C (36°F to 46°F).
Do not freeze.
Protect from light.
Keep all medicines out of reach of children.
Dosage: As directed by the Physician.
Note:
After initial entry into the vial, remaining contents must be refrigerated and used within 30 days. (Multi dose vial)
After initial entry in to the vial, the remaining contents must be used within 48 hours. (Single dose vial)
Discard prepared infusion solutions after 18 hours at room temperature or 24 hours refrigerated.
GENERIC NAME OF THE MEDICINAL PRODUCT:
A. Vasopressin Injection USP Synthetic 50Units/1ml
B. Vasopressin Injection USP Synthetic 20Units/1ml
C. Vasopressin Injection USP Synthetic 10Units/0.5ml
D. Vasopressin Injection USP Synthetic 0.6Units/1ml
E. Vasopressin Injection USP Synthetic 0.4Units/1ml
B. Vasopressin Injection USP Synthetic 20Units/1ml
C. Vasopressin Injection USP Synthetic 10Units/0.5ml
D. Vasopressin Injection USP Synthetic 0.6Units/1ml
E. Vasopressin Injection USP Synthetic 0.4Units/1ml
QUALITATIVE AND QUANTITATIVE COMPOSITION:
1. Vasopressin Injection USP Synthetic 50Units/1ml
Each ml contains:
Vasopressin USP………………………………………50Units
Sodium Chloride USP………………………………9mg
Chlorobutanol USP………………………………….0.5%w/v
(as preservative)
Water for Injection USP………………………….q.s
2. Vasopressin Injection USP Synthetic 20Units/1ml
Each ml contains:
Vasopressin USP………………………………………20Units
Sodium Chloride USP………………………………9mg
Chlorobutanol USP………………………………….0.5%w/v
(as preservative)
Water for Injection USP………………………….q.s
3. Vasopressin Injection USP Synthetic 10Units/0.5ml
Each 0.5ml contains:
Vasopressin USP………………………………………10Units
Sodium Chloride USP………………………………9mg
Chlorobutanol USP………………………………….0.5%w/v
(as preservative)
Water for Injection USP………………………….q.s
4. Vasopressin Injection USP Synthetic 0.6Units/1ml
Each ml contains:
Vasopressin USP………………………………………0.6Units
Sodium Chloride USP………………………………9mg
Chlorobutanol USP………………………………….0.5%w/v
(as preservative)
Water for Injection USP………………………….q.s
5. Vasopressin Injection USP Synthetic 0.4Units/1ml
Each ml contains:
Vasopressin USP………………………………………0.4Units
Sodium Chloride USP………………………………9mg
Chlorobutanol USP………………………………….0.5%w/v
(as preservative)
Water for Injection USP………………………….q.s
Each ml contains:
Vasopressin USP………………………………………50Units
Sodium Chloride USP………………………………9mg
Chlorobutanol USP………………………………….0.5%w/v
(as preservative)
Water for Injection USP………………………….q.s
2. Vasopressin Injection USP Synthetic 20Units/1ml
Each ml contains:
Vasopressin USP………………………………………20Units
Sodium Chloride USP………………………………9mg
Chlorobutanol USP………………………………….0.5%w/v
(as preservative)
Water for Injection USP………………………….q.s
3. Vasopressin Injection USP Synthetic 10Units/0.5ml
Each 0.5ml contains:
Vasopressin USP………………………………………10Units
Sodium Chloride USP………………………………9mg
Chlorobutanol USP………………………………….0.5%w/v
(as preservative)
Water for Injection USP………………………….q.s
4. Vasopressin Injection USP Synthetic 0.6Units/1ml
Each ml contains:
Vasopressin USP………………………………………0.6Units
Sodium Chloride USP………………………………9mg
Chlorobutanol USP………………………………….0.5%w/v
(as preservative)
Water for Injection USP………………………….q.s
5. Vasopressin Injection USP Synthetic 0.4Units/1ml
Each ml contains:
Vasopressin USP………………………………………0.4Units
Sodium Chloride USP………………………………9mg
Chlorobutanol USP………………………………….0.5%w/v
(as preservative)
Water for Injection USP………………………….q.s
THERAPEUTIC INDICATIONS:
Vasopressin injection is used to control the frequent urination, increased thirst, and loss of water caused by diabetes insipidus. It is also used to prevent and treat abdominal or stomach distension that occurs after surgery. It is also used in abdominal or stomach roentgenography. It is a hormone produced in the body and acts on the kidneys to reduce the flow of urine. It is also used to increase blood pressure in adults with vasodilatory shock (eg, post-cardiotomy, sepsis) who remain to have low blood pressure after receiving fluids and medicines.
DIRECTION OF USE:
For Intravenous infusion or Intramuscular Intravenous or Subcutaneous use only.
Use only after reading the directions on pack insert.
Use only after reading the directions on pack insert.
CAUTION & WARNING:
CAUTION: Must be diluted prior to use.
This injection should not be used if it contains visible particulate matter. Discard unused portion.
Warning: To be sold by retail on the prescription of an Oncologist/Specialist only.
This injection should not be used if it contains visible particulate matter. Discard unused portion.
Warning: To be sold by retail on the prescription of an Oncologist/Specialist only.
STORAGE & DOSAGE:
Storage: Store in a refrigerator at 2°C to 8°C (36°F to 46°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.
