GENERIC NAME OF THE MEDICINAL PRODUCT:

Mesalazine Foam Enema BP 1gm

QUALITATIVE AND QUANTITATIVE COMPOSITION:

Mesalazine Foam Enema BP 1gm
Each actuation delivers:
Mesalazine BP ……………1 gm
Each canister contains 82 gm of Mesalazine foam enema which is sufficient for 14 sprays actuations (equivalent to 7 doses).

THERAPEUTIC INDICATIONS:

Mesalazine Foam Enema BP 1gm belongs to a class of drugs called 'Anti-inflammatory drugs' used to treat ulcerative colitis and Crohn’s disease. It works by inhibiting the production of certain chemical substances such as prostaglandins that cause pain and swelling. Thereby, it reduces inflammation (swelling) in the intestines and provides relief from symptoms such as stomach pain or bleeding.

CAUTION:

CAUTION: Pressurised canister containing propellant. Protect from sunlight and do not expose to temperatures above 50°C. Do not spray on a naked flame or incandescent material. Keep away from source of ignition. Do not pierce or burn even after use.
Read instructions before use.
DO NOT THROW AWAY ANY MEDICINES VIA WASTE WATER OR HOUSEHOLD WASTE. ASK YOUR PHARMACIST HOW TO THROW AWAY MEDICINES YOU NO LONGER USE.
Shake well before use. Aerosol rectal foam caution extremely flammable.
DO NOT REFRIGERATE OR FREEZE
CAUTION EXTREMELY FLAMMABLE
KEEP MEDICINE OUT OF REACH OF CHILDREN.

STORAGE & DOSAGE:

STORAGE: Do not store above 25°C.
Do not refrigerate or freeze.
Protect from Light.
Keep out of reach of children.
Shake well before use.
DOSAGE: As directed by physician.
The contents of the canister must be used within 12 weeks after first opening.
NOTE: This pack contains:
• Canister
• 14 Applicators
• Disposable bags for used Applicators

Mesalazine Foam Enema BP Technical Specification:

Product Name:Mesalazine Foam Enema BP
Brand Name:Meslataj Foam
Strength:1gm
Dosage Form:Rectal foam
Route of Administration:Rectal
Packing:1 Aerosol canister + 14 Rectal applicators + Disposable bags for used Applicators
Pack Insert/Leaflet:PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics)
Documents:COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier
Therapeutic use:Anti-inflammatory drugs, Treatment of ulcerative colitis
Indication: It is used to treat active mild to moderate ulcerative colitis, proctitis or proctosigmoiditis (inflammation of the rectum and bowel).
Storage:Do not store above 25°C. Do not refrigerate. Protect from Light.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Mesalazine Foam Enema BP 1gm

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Mesalazine Foam Enema BP 1gm
    Each actuation delivers:
    Mesalazine BP ……………1 gm
    Each canister contains 82 gm of Mesalazine foam enema which is sufficient for 14 sprays actuations (equivalent to 7 doses).

THERAPEUTIC INDICATIONS:

Mesalazine Foam Enema BP 1gm belongs to a class of drugs called Anti-inflammatory drugs used to treat ulcerative colitis and Crohn’s disease. It works by inhibiting the production of certain chemical substances such as prostaglandins that cause pain and swelling. Thereby, it reduces inflammation (swelling) in the intestines and provides relief from symptoms such as stomach pain or bleeding.

CAUTION:

CAUTION: Pressurised canister containing propellant. Protect from sunlight and do not expose to temperatures above 50°C. Do not spray on a naked flame or incandescent material. Keep away from source of ignition. Do not pierce or burn even after use.

Read instructions before use.

DO NOT THROW AWAY ANY MEDICINES VIA WASTE WATER OR HOUSEHOLD WASTE. ASK YOUR PHARMACIST HOW TO THROW AWAY MEDICINES YOU NO LONGER USE.

Shake well before use. Aerosol rectal foam caution extremely flammable.

DO NOT REFRIGERATE OR FREEZE

CAUTION EXTREMELY FLAMMABLE

Keep medicine out of reach of children.

STORAGE & DOSAGE:

STORAGE: Do not store above 25°C.

Do not refrigerate or freeze.

Protect from Light.

Keep out of reach of children.

Shake well before use.

Dosage: As directed by physician.

The contents of the canister must be used within 12 weeks after first opening.

NOTE: This pack contains:

  • Canister
  • 14 Applicators
  • Disposable bags for used Applicators