Atropine Sulphate Injection USP 1mg Technical Specification:
| Product Name: | Atropine Sulphate Injection USP 1mg |
| Brand Name: | Generics |
| Strength: | 0.25mg, 0.5mg, 1mg |
| Dosage Form: | Liquid Injection (Sterile) |
| Packing: | 1 Pre-filled Syringe (Advanced) |
| Route of Administration: | Subcutaneous route, intravenous route during hemodialysis. Do not inject intramuscularly. |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) |
| Documents: | COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier |
| Therapeutic use: | Cholinergic, Toxicity Antidotes |
| Indication: | Atropine Sulfate Injection, USP, is indicated for temporary blockade of severe or life-threatening muscarinic effects, e.g., as an antisialagogue, an anti-vagal agent, an antidote for organophosphorus or muscarinic mushroom poisoning, and to treat brady systolic cardiac arrest. |
| Storage: | Store at or below 25°C. Do not freeze prefilled syringe. |
GENERIC NAME OF MEDICINAL PRODUCT
- Atropine Sulphate Injection USP ( 1mg)
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Atropine Sulphate Injection USP ( 1mg)
Each pre-filled syringe contains:
Atropine Sulphate USP……………… 1mg
Water for Injection BP……………q.s.
THERAPEUTIC INDICATION:
Atropine Sulfate Injection, USP, is indicated for temporary blockade of severe or life-threatening muscarinic effects, e.g., as an antisialagogue, an anti-vagal agent, an antidote for organophosphorus or muscarinic mushroom poisoning, and to treat brady systolic cardiac arrest.
Atropine Injection belongs to a class of drugs known as ‘anticholinergics’, primarily use to treat bradycardia (slow heart rate). It also helps to restore a normal heartbeat in cardiac arrest cases.
In addition to this, it is also used to treat myopia (leads to blurry vision) and uveitis (inflammation of the eye).
DIRECTION OF USE:
Subcutaneous route, intravenous route during hemodialysis. Do not inject intramuscularly.
*Do not remove Gray Safety Release until ready to use.
Do not use later than the date of expiry.
CAUTION AND WARNING:
CAUTION: The injection should be discard if any visible particle appears.
*Never touch the Tip (Needle End)
For use in Nerve agent & Insecticide poising.
Atropine reduces secretion in the mouth & respiratory passage, relieves airway construction, and may reduce centrally-mediated respiratory paralysis.
WARNING: Not to be sold by retail without the prescription of a registered Medical Practitioner.
Keep medicines out of reach of children.
STORAGE AND DOSAGE:
STORAGE: Store at or below 25°C. Do not freeze prefilled syringe.
DOSAGE: As directed by Physician.
For further information see enclosed package insert.
GENERIC NAME OF THE MEDICINAL PRODUCT:
A. Atropine Sulphate Injection USP (0.25mg)
B. Atropine Sulphate Injection USP (0.5mg)
C. Atropine Sulphate Injection USP (1mg)
B. Atropine Sulphate Injection USP (0.5mg)
C. Atropine Sulphate Injection USP (1mg)
QUALITATIVE AND QUANTITATIVE COMPOSITION:
A. Atropine Sulphate Injection USP (0.25mg)
Each pre-filled syringe contains:
Atropine Sulphate USP………………0.25mg
Water for Injection BP……………q.s.
B. Atropine Sulphate Injection USP (0.5mg)
Each pre-filled syringe contains:
Atropine Sulphate USP………………0.5mg
Water for Injection BP……………q.s.
C. Atropine Sulphate Injection USP (1mg)
Each pre-filled syringe contains:
Atropine Sulphate USP………………1mg
Water for Injection BP……………q.s.
Each pre-filled syringe contains:
Atropine Sulphate USP………………0.25mg
Water for Injection BP……………q.s.
B. Atropine Sulphate Injection USP (0.5mg)
Each pre-filled syringe contains:
Atropine Sulphate USP………………0.5mg
Water for Injection BP……………q.s.
C. Atropine Sulphate Injection USP (1mg)
Each pre-filled syringe contains:
Atropine Sulphate USP………………1mg
Water for Injection BP……………q.s.
THERAPEUTIC INDICATIONS:
Atropine Sulfate Injection, USP, is indicated for temporary blockade of severe or life-threatening muscarinic effects, e.g., as an antisialagogue, an anti-vagal agent, an antidote for organophosphorus or muscarinic mushroom poisoning, and to treat brady systolic cardiac arrest.
Atropine Injection belongs to a class of drugs known as ‘anticholinergics’, primarily use to treat bradycardia (slow heart rate). It also helps to restore a normal heartbeat in cardiac arrest cases.
In addition to this, it is also used to treat myopia (leads to blurry vision) and uveitis (inflammation of the eye).
Atropine Injection belongs to a class of drugs known as ‘anticholinergics’, primarily use to treat bradycardia (slow heart rate). It also helps to restore a normal heartbeat in cardiac arrest cases.
In addition to this, it is also used to treat myopia (leads to blurry vision) and uveitis (inflammation of the eye).
DIRECTION OF USE:
Subcutaneous route, intravenous route during hemodialysis. Do not inject intramuscularly.
*Do not remove Gray Safety Release until ready to use.
Do not use later than the date of expiry.
*Do not remove Gray Safety Release until ready to use.
Do not use later than the date of expiry.
CAUTION & WARNING:
CAUTION: The injection should be discard if any visible particle appears.
*Never touch the Tip (Needle End)
For use in Nerve agent & Insecticide poising.
Atropine reduces secretion in the mouth & respiratory passage, relieves airway construction, and may reduce centrally-mediated respiratory paralysis.
WARNING: Not to be sold by retail without the prescription of a registered Medical Practitioner.
Keep medicines out of reach of children.
*Never touch the Tip (Needle End)
For use in Nerve agent & Insecticide poising.
Atropine reduces secretion in the mouth & respiratory passage, relieves airway construction, and may reduce centrally-mediated respiratory paralysis.
WARNING: Not to be sold by retail without the prescription of a registered Medical Practitioner.
Keep medicines out of reach of children.
STORAGE & DOSAGE:
STORAGE: Store at or below 25°C. Do not freeze prefilled syringe.
DOSAGE: As directed by Physician.
For further information see enclosed package insert.
DOSAGE: As directed by Physician.
For further information see enclosed package insert.
