GENERIC NAME OF THE MEDICINAL PRODUCT:

A. Glycopyrrolate Injection USP 0.2mg/1ml
B. Glycopyrrolate Injection USP 0.4mg/2ml
C. Glycopyrrolate Injection USP 1mg/5ml
D. Glycopyrrolate Injection USP 4mg/20ml

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A. Glycopyrrolate Injection USP 0.2mg/1ml
Each ml contains:
Glycopyrrolate USP………….0.2mg
Benzyl Alcohol USP……………..0.9%w/v
Water for Injection USP……..q.s

B. Glycopyrrolate Injection USP 0.4mg/2ml
Each ml contains:
Glycopyrrolate USP…………0.2mg
Benzyl Alcohol USP……………0.9%w/v
Water for Injection USP……q.s

C. Glycopyrrolate Injection USP 1mg/5ml
Each ml contains:
Glycopyrrolate USP………….0.2mg
Benzyl Alcohol USP…………….0.9%w/v
Water for Injection USP…….q.s

D. Glycopyrrolate Injection USP 4mg/20ml
Each ml contains:
Glycopyrrolate USP………….0.2mg
Benzyl Alcohol USP…………….0.9%w/v
Water for Injection USP…….q.s


THERAPEUTIC INDICATIONS:

Glycopyrrolate injection is used before and during surgery to lessen mouth, throat, or stomach secretion (eg, saliva, stomach acid), or to prevent heart rhythm problems (during anesthesia, intubation, or surgery), or unwanted effects caused by certain medicines (eg, neostigmine, pyridostigmine).

DIRECTION OF USE:

For Intramuscular or Intravenous Administration.
Refer package insert for full prescribing information.

CAUTION & WARNING:

CAUTION: Do not use if any foreign particulate matter is visible.
NOT FOR USE IN NEWBORNS.
CONTAINS BENZYL ALCOHOL.
DISCARD UNUSED PORTION.
KEEP OUT OF REACH AND SIGHT OF CHILDREN.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
Warning: Not to be sold by retail without the prescription of a Registered Medical Practitioner.

STORAGE & DOSAGE:

Storage: Store at 20°C to 25°C (68°F to 77°F);excursions permitted to 15°C to 30°C(59°F to 86°F). Protect from light.
Keep all medicines out of reach of children.
Dosage: As directed by the Physician.

Glycopyrrolate Injection USP 4mg/20ml Technical Specification:

Product Name:Glycopyrrolate Injection USP
Brand Name:Generic
Strength:0.2mg/1ml 0.4mg/2ml,  1mg/5ml,  4mg/20ml
Dosage Form:Liquid Injection
Packing:0.2mg/1ml(Single Dose Vial/Ampoule)
0.4mg/2ml(Single Dose Vial/Ampoule)
1mg/5ml(Multiple Dose Vial)
4mg/20ml(Multiple Dose Vial/Ampoule)
Route of Administration:For I.M./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:Anticholinergic, Premedication Agent
Indication: Glycopyrrolate injection is used before and during surgery to lessen mouth, throat, or stomach secretion (eg, saliva, stomach acid), or to prevent heart rhythm problems (during anesthesia, intubation, or surgery), or unwanted effects caused by certain medicines (eg, neostigmine, pyridostigmine).
Storage:Store at 20°C to 25°C (68°F to 77°F);excursions permitted to 15°C to 30°C(59°F to 86°F). Protect from light.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Glycopyrrolate Injection USP 4mg/20ml

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Glycopyrrolate Injection USP 4mg/20ml
    Each ml contains:
    Glycopyrrolate USP………….0.2mg
    Benzyl Alcohol USP……..…..0.9%w/v
    Water for Injection USP……..q.s

THERAPEUTIC INDICATIONS:

Glycopyrrolate injection is used before and during surgery to lessen mouth, throat, or stomach secretion (eg, saliva, stomach acid), or to prevent heart rhythm problems (during anesthesia, intubation, or surgery), or unwanted effects caused by certain medicines (eg, neostigmine, pyridostigmine).

DIRECTION OF USE:

For Intramuscular or Intravenous Administration.
Refer package insert for full prescribing information.

CAUTION & Warning:

CAUTION: Do not use if any foreign particulate matter is visible.
NOT FOR USE IN NEWBORNS.
CONTAINS BENZYL ALCOHOL.
DISCARD UNUSED PORTION.
KEEP OUT OF REACH AND SIGHT OF CHILDREN.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.

Warning: Not to be sold by retail without the prescription of a Registered Medical Practitioner.

STORAGE & DOSAGE:

Storage: Store at 20°C to 25°C (68°F to 77°F);excursions permitted to 15°C to 30°C(59°F to 86°F). Protect from light.
Keep all medicines out of reach of children.

Dosage: As directed by the Physician.