GENERIC NAME OF THE MEDICINAL PRODUCT:
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Each pre-filled syringe contains:
Atropine Sulphate USP………………2mg
Pralidoxime chloride……………….600mg
Water for Injection BP……………q.s.
THERAPEUTIC INDICATIONS:
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:
*Do not remove Gray Safety Release until ready to use.
Do not use later than the date of expiry.
CAUTION & WARNING:
*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:
DOSAGE: As directed by Physician.
For further information see enclosed package insert.
Atropine Sulphate & Pralidoxime Injection (2mg/600mg) Technical Specification:
| Product Name: | Atropine Sulphate & Pralidoxime Injection |
| Brand Name: | Generics |
| Strength: | 2mg/600mg |
| 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 Sulphate & Pralidoxime Injection is indicated for the treatment of poisoning by organophosphorus nerve agents as well as organophosphorus insecticides in adults and pediatric patients weighing more than 41 kg. |
| Storage: | Store at or below 25°C. Do not freeze prefilled syringe. |
GENERIC NAME OF MEDICINAL PRODUCT
- Atropine Sulphate & Pralidoxime Injection (2mg/600mg)
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Atropine Sulphate & Pralidoxime Injection (2mg/600mg)
Each pre-filled syringe contains:
Atropine Sulphate USP………………2mg
Pralidoxime chloride……………….600mg
Water for Injection BP……………q.s.
THERAPEUTIC INDICATION:
Atropine Sulphate & Pralidoxime Injection is indicated for the treatment of poisoning by organophosphorus nerve agents as well as organophosphorus insecticides in adults and pediatric patients weighing more than 41 kg.
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.
