Iron Sucrose Injection USP 100mg/5ml Technical Specification:
| Product Name: | Iron Sucrose Injection USP 100mg/5ml |
| Brand Name: | Venotaj |
| Strength: | 50mg/2.5ml, 100mg/5ml, 200mg/10ml |
| Dosage Form: | Liquid Injection (Ampule) |
| Packing: | 1 Ampule |
| 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: | Nutritional Supplements |
| Indication: | Iron sucrose injection is used treat iron-deficiency anaemia in people with chronic kidney disease. |
| Storage: | Store at 25°C. Store in a cool & dry place. Protect from light. Do not freeze. |
GENERIC NAME OF MEDICINAL PRODUCT:
- Iron Sucrose Injection USP 100mg/5ml
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Iron Sucrose Injection USP 100mg/5ml
Each 5ml Contains:
Ferric Hydroxide in Complex with Sucrose
Eq. to elemental Iron……………………….100mg
Water for Injection USP…………….………q. s
THERAPEUTIC INDICATIONS:
Iron sucrose injection is used treat iron-deficiency anemia (a lower-than-normal number of red blood cells due to too little iron) in people with chronic kidney disease (damage to the kidneys which may worsen over time and may cause the kidneys to stop working).
DIRECTION OF USE:
Venotaj Injection is for Intravenous infusion, the injection must be diluted with 0.9% Sodium Chloride Injection to a concentration of 0.5 to 2.0 mg of elemental iron per ml.
Shake well before use.
Use Immediately after dilution.
CAUTION & WARNING:
CAUTION: Before using check for absence of sediments. The Injection Should be discard if any visible particle appears.
For Deep Intramuscular Use.
WARNING: To be sold by retail on the prescribed of a registered medical partitioner only.
Any portion of the content remaining after use MUST be discard.
PRECAUTION: Strict aseptic administration technique must be followed.
STORAGE & DOSAGE:
Storage: Store at 25°C.
Store in a cool & dry place.
Protect from light.
Do not freeze.
KEEP ALL MEDICINES OUT OF REACH OF CHILDREN.
Dosage: As directed by Physician.
GENERIC NAME OF THE MEDICINAL PRODUCT:
A. Iron Sucrose Injection USP 50mg/2.5ml
B. Iron Sucrose Injection USP 100mg/5ml
C. Iron Sucrose Injection USP 200mg/10ml
B. Iron Sucrose Injection USP 100mg/5ml
C. Iron Sucrose Injection USP 200mg/10ml
QUALITATIVE AND QUANTITATIVE COMPOSITION:
A. Iron Sucrose Injection USP 50mg/2.5ml
a) Each 2.5ml Contains:
Ferric Hydroxide in Complex with Sucrose
Eq. to elemental Iron……...……………….50mg
b) Water for Injection USP…………….………q. s
B. Iron Sucrose Injection USP 100mg/5ml
a) Each 5ml Contains:
Ferric Hydroxide in Complex with Sucrose
Eq. to elemental Iron……………………….100mg
b) Water for Injection USP…………….………q. s
C. Iron Sucrose Injection USP 200mg/10ml
a) Each 10ml Contains:
Ferric Hydroxide in Complex with Sucrose
Eq. to elemental Iron……………………….200mg
b) Water for Injection USP…………….………q. s
a) Each 2.5ml Contains:
Ferric Hydroxide in Complex with Sucrose
Eq. to elemental Iron……...……………….50mg
b) Water for Injection USP…………….………q. s
B. Iron Sucrose Injection USP 100mg/5ml
a) Each 5ml Contains:
Ferric Hydroxide in Complex with Sucrose
Eq. to elemental Iron……………………….100mg
b) Water for Injection USP…………….………q. s
C. Iron Sucrose Injection USP 200mg/10ml
a) Each 10ml Contains:
Ferric Hydroxide in Complex with Sucrose
Eq. to elemental Iron……………………….200mg
b) Water for Injection USP…………….………q. s
THERAPEUTIC INDICATIONS:
Iron sucrose injection is used treat iron-deficiency anemia (a lower-than-normal number of red blood cells due to too little iron) in people with chronic kidney disease (damage to the kidneys which may worsen over time and may cause the kidneys to stop working).
DIRECTION OF USE:
Venotaj Injection is for Intravenous infusion, the injection must be diluted with 0.9% Sodium Chloride Injection to a concentration of 0.5 to 2.0 mg of elemental iron per ml.
Shake well before use.
Use Immediately after dilution.
Shake well before use.
Use Immediately after dilution.
CAUTION & WARNING:
CAUTION: Before using check for absence of sediments.
The Injection Should be discard if any visible particle appears.
For Deep Intramuscular Use.
WARNING: To be sold by retail on the prescribed of a registered medical partitioner only.
Any portion of the content remaining after use MUST be discard.
PRECAUTION: Strict aseptic administration technique must be followed.
The Injection Should be discard if any visible particle appears.
For Deep Intramuscular Use.
WARNING: To be sold by retail on the prescribed of a registered medical partitioner only.
Any portion of the content remaining after use MUST be discard.
PRECAUTION: Strict aseptic administration technique must be followed.
STORAGE & DOSAGE:
Storage: Store at 25°C.
Store in a cool & dry place.
Protect from light.
Do not freeze.
KEEP ALL MEDICINES OUT OF REACH OF CHILDREN.
Dosage: As directed by Physician.
Store in a cool & dry place.
Protect from light.
Do not freeze.
KEEP ALL MEDICINES OUT OF REACH OF CHILDREN.
Dosage: As directed by Physician.
