GENERIC NAME OF THE MEDICINAL PRODUCT:

A. Atropine Sulphate Injection USP (0.4 mg/mL)
B. Atropine Sulphate Injection USP (0.6 mg/mL)
C. Atropine Sulphate Injection USP (1 mg/mL)
D. Atropine Sulphate Injection USP (8 mg/20mL)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A. Atropine Sulphate Injection USP (0.4 mg/mL)
Each ml contains:
Atropine Sulphate USP………………0.4mg
Water for Injection USP……………q.s.

B. Atropine Sulphate Injection USP (0.6 mg/mL)
Each ml contains:
Atropine Sulphate USP………………0.6mg
Water for Injection USP……………q.s.

C. Atropine Sulphate Injection USP (1 mg/mL)
Each ml contains:
Atropine Sulphate USP………………1mg
Water for Injection USP……………q.s.


D. Atropine Sulphate Injection USP (8 mg/20mL)
Each ml contains:
Atropine Sulphate USP………………8mg
Water for Injection USP……………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).

PACKING:

1ml, 20ml

DIRECTION OF USE:

For I.M/I.V/S.C. use.
Do not use later than the date of expiry.

CAUTION AND WARNING:

CAUTION: The injection should be discard if any visible particle appears.
Do not use the injection if the contents are not clear or contains visible particulate matter after reconstitution.
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.
SNAP-OFF AMPOULES

STORAGE AND DOSAGE:

STORAGE: Store below 25°C, Protected from light.
DOSAGE: As directed by Physician.
For further information see enclosed package insert.

Atropine Sulphate Injection USP (1 mg/mL) Technical Specification:

Product Name:Atropine Sulphate Injection USP 1 mg/mL
Brand Name:Generics
Strength:0.4 mg/mL, 0.6 mg/mL, 1 mg/mL, 8 mg/20mL
Dosage Form:Liquid Injection (Sterile)
Packing:1ml, 20ml
Route of Administration:For I.M/I.V/S.C. Use
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 below 25°C, Protected from light.

GENERIC NAME OF MEDICINAL PRODUCT

  • Atropine Sulphate Injection USP (1 mg/mL)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Atropine Sulphate Injection USP (1 mg/mL)
    Each ml contains:
    Atropine Sulphate USP………………1mg
    Water for Injection USP……………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).

PACKING:

1ml, 20ml

DIRECTION OF USE:

For I.M/I.V/S.C. use.

Do not use later than the date of expiry.

CAUTION AND WARNING:

CAUTION: The injection should be discard if any visible particle appears.

Do not use the injection if the contents are not clear or contains visible particulate matter after reconstitution.

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.

SNAP-OFF AMPOULES

STORAGE AND DOSAGE:

STORAGE: Store below 25°C, Protected from light.

DOSAGE: As directed by Physician.

For further information see enclosed package insert.