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

Why Taj Pharmaceuticals?

Taj Pharmaceuticals is the go-to choice for Mesalazine Foam Enema in the treatment of inflammatory bowel disease (IBD). Backed by a solid commitment to quality, Taj Pharma adheres rigorously to stringent regulatory standards, ensuring the utmost safety and efficacy of their product. Healthcare providers benefit from a dependable supply chain, competitive pricing options, and responsive customer support when selecting Taj Pharma for Mesalazine Foam Enema. Experience a pharmaceutical partner dedicated to improving the lives of individuals with IBD, enhancing patient care through a trusted and proven solution. Discover why healthcare providers prefer Taj Pharma for Mesalazine Foam Enema in IBD treatment. Taj Pharmaceuticals guarantees quality, adhering to strict regulations, ensuring patient safety. Benefit from a reliable supply chain, competitive pricing, and responsive support. Choose Taj Pharma for trusted, effective care.

What is Mesalazine Foam Enema and its uses?

Mesalazine Foam Enema is a medication used in the treatment of inflammatory bowel diseases (IBD), primarily ulcerative colitis. It contains the active ingredient mesalazine, also known as 5-aminosalicylic acid (5-ASA). Here are its primary uses and related information:

  • Treatment of Ulcerative Colitis: Mesalazine Foam Enema is primarily used to manage and induce remission in patients with ulcerative colitis, a chronic inflammatory bowel disease that affects the lining of the colon and rectum. It helps reduce inflammation and alleviate symptoms such as diarrhea, abdominal pain, and rectal bleeding.
  • Anti-Inflammatory Action: Mesalazine, the active ingredient in the enema, works locally within the colon and rectum. It has anti-inflammatory properties that help control and suppress the inflammatory response characteristic of ulcerative colitis.
  • Topical Application: Unlike some other forms of mesalazine, such as oral tablets or capsules, Mesalazine Foam Enema is administered as a rectal foam. This allows the medication to be delivered directly to the site of inflammation, providing a targeted and localized treatment.
  • Maintenance Therapy: In addition to inducing remission, Mesalazine Foam Enema may also be used as maintenance therapy to prevent flare-ups and maintain long-term control of ulcerative colitis.
  • Reducing Symptoms: The medication helps alleviate the symptoms associated with ulcerative colitis, including diarrhea, rectal bleeding, urgency, and abdominal discomfort, thereby improving the patient’s quality of life.
  • Limited Systemic Absorption: Because the medication is administered rectally, it has limited systemic absorption, reducing the risk of systemic side effects often associated with oral mesalazine formulations.

It’s important to note that the use of Mesalazine Foam Enema should be directed and monitored by a healthcare provider, as the dosage and treatment duration will depend on the severity of the condition and the individual patient’s response to therapy. Additionally, the enema should be administered as instructed in the product labeling or as prescribed by a healthcare professional to ensure its effectiveness in treating ulcerative colitis.

How Does Mesalazine Foam Enema Work?

Mesalazine Foam Enema is an anti-inflammatory medication used in the treatment of inflammatory bowel diseases (IBD), primarily ulcerative colitis. Its mechanism of action involves several key processes:

  • Local Anti-Inflammatory Action: Mesalazine, also known as 5-aminosalicylic acid (5-ASA), is the active ingredient in Mesalazine Foam Enema. When administered rectally as a foam, it acts locally within the colon and rectum, where the inflammation associated with ulcerative colitis is most prominent.
  • Inhibition of Inflammatory Mediators: Mesalazine exerts its anti-inflammatory effects by inhibiting the production of inflammatory mediators such as prostaglandins and leukotrienes. These substances play a role in the inflammatory response within the intestinal lining.
  • Scavenging Free Radicals: Mesalazine has antioxidant properties, which means it can help neutralize harmful free radicals produced during the inflammatory process. By reducing oxidative stress in the intestinal mucosa, it contributes to the resolution of inflammation.
  • Restoring Epithelial Barrier Function: Inflammatory bowel diseases like ulcerative colitis often disrupt the protective mucosal barrier of the colon and rectum. Mesalazine helps restore this barrier function by promoting the healing of damaged tissues and reducing further inflammation.
  • Immunomodulation: Mesalazine is believed to have immunomodulatory effects, meaning it can help regulate the immune response in the gut. In ulcerative colitis, the immune system mistakenly targets the intestinal lining, leading to chronic inflammation. Mesalazine may help dampen this immune response.
  • Symptom Relief: By reducing inflammation and promoting healing in the colon and rectum, Mesalazine Foam Enema can alleviate the symptoms of ulcerative colitis. These symptoms may include diarrhea, abdominal pain, rectal bleeding, and urgency.

It’s important to note that Mesalazine Foam Enema is designed for rectal administration, allowing for targeted delivery of the medication to the inflamed areas. This localized treatment minimizes systemic absorption and reduces the risk of systemic side effects often associated with oral mesalazine formulations. The dosage and duration of Mesalazine Foam Enema treatment are determined by healthcare providers based on the severity of the condition and the individual patient’s response to therapy.

Benefits of Mesalazine Foam Enema:

  • Effective Treatment for Ulcerative Colitis: Mesalazine Foam Enema is highly effective in managing ulcerative colitis, a chronic inflammatory bowel disease. It helps induce and maintain remission, reducing the frequency and severity of disease flares.
  • Localized Action: As a rectal foam, Mesalazine is applied directly to the inflamed areas of the colon and rectum. This localized treatment provides targeted therapy, minimizing systemic absorption and reducing the risk of systemic side effects.
  • Symptom Relief: Mesalazine Foam Enema effectively alleviates the distressing symptoms of ulcerative colitis, including diarrhea, abdominal pain, rectal bleeding, and urgency. Patients experience improved quality of life as these symptoms are controlled.
  • Maintenance Therapy: In addition to inducing remission, Mesalazine Foam Enema is used for maintenance therapy, helping to prevent disease relapses and extend periods of symptom-free remission.
  • Safety Profile: Mesalazine Foam Enema is generally well-tolerated, with most side effects being mild and transient. Its safety profile makes it suitable for long-term use in the management of ulcerative colitis.

Side Effects of Mesalazine Foam Enema:

  • Local Irritation: Some patients may experience local irritation, discomfort, or a feeling of fullness when using Mesalazine Foam Enema. These side effects are usually temporary and can be minimized by following proper administration techniques.
  • Allergic Reactions: Although rare, allergic reactions to mesalazine can occur. Symptoms may include skin rash, itching, swelling, or difficulty breathing. If any signs of an allergic reaction are observed, medical attention should be sought immediately.
  • Gastrointestinal Symptoms: Mesalazine Foam Enema may cause mild gastrointestinal symptoms such as nausea, vomiting, abdominal pain, or diarrhea in some individuals. These side effects are typically transient.
  • Headache: Headache is an infrequent side effect associated with mesalazine use, but it is generally mild and resolves on its own.
  • Renal Function Changes: In rare cases, mesalazine can affect renal function, leading to changes in kidney parameters. Regular monitoring is recommended to detect any potential renal issues.
  • Blood Disorders: Very rarely, mesalazine can lead to blood disorders such as decreased white blood cell count or platelet count. Monitoring of blood counts is advisable during long-term therapy.

It’s important to note that while Mesalazine Foam Enema offers effective treatment for ulcerative colitis, the decision to use it should be made by a healthcare provider based on the individual patient’s condition and medical history. Any side effects or concerns should be promptly reported to a healthcare professional for evaluation and appropriate management. Mesalazine Foam Enema is generally considered a safe and well-tolerated option for individuals with ulcerative colitis.

Frequently Asked Questions About Mesalazine Foam Enema:

Certainly, here are some frequently asked questions (FAQs) about Mesalazine Foam Enema:

  1. What is Mesalazine Foam Enema?

Mesalazine Foam Enema is a medication used in the treatment of inflammatory bowel diseases (IBD), primarily ulcerative colitis. It contains the active ingredient mesalazine (5aminosalicylic acid) and is administered rectally as a foam.

  1. How does Mesalazine Foam Enema work?

Mesalazine exerts its antiinflammatory effects locally within the colon and rectum. It inhibits the production of inflammatory mediators, reduces oxidative stress, and helps restore the mucosal barrier, all of which contribute to the resolution of inflammation in ulcerative colitis.

  1. What are the primary uses of Mesalazine Foam Enema?

Mesalazine Foam Enema is primarily used to induce and maintain remission in patients with ulcerative colitis, a type of inflammatory bowel disease. It helps control symptoms such as diarrhea, abdominal pain, rectal bleeding, and urgency.

  1. How is Mesalazine Foam Enema administered?

Mesalazine Foam Enema is administered rectally. Patients typically insert the foam into the rectum using a specialized applicator. The dosage and administration frequency are determined by the treating healthcare provider.

  1. Is Mesalazine Foam Enema suitable for longterm use?

Yes, Mesalazine Foam Enema is often used as a longterm maintenance therapy to prevent disease relapses in individuals with ulcerative colitis. Its safety profile makes it suitable for extended use under medical supervision.

  1. What are the common side effects of Mesalazine Foam Enema?

Common side effects may include local irritation, discomfort, nausea, vomiting, mild abdominal pain, and headache. These side effects are usually mild and temporary.

  1. Are there any serious side effects or risks associated with Mesalazine Foam Enema?

While serious side effects are rare, Mesalazine can rarely affect renal function and lead to blood disorders or allergic reactions. Monitoring by a healthcare provider is essential to detect and manage any potential issues.

  1. Can Mesalazine Foam Enema be used during pregnancy or breastfeeding?

The use of Mesalazine Foam Enema during pregnancy or breastfeeding should be discussed with a healthcare provider. The benefits and potential risks should be carefully considered.

  1. How quickly does Mesalazine Foam Enema work to alleviate symptoms?

The onset of symptom relief can vary among individuals. Some patients may experience improvement within a few weeks, while others may require several weeks of treatment to achieve remission.

  1. Is Mesalazine Foam Enema a replacement for other forms of mesalazine medication?

Mesalazine Foam Enema is a rectal formulation and is typically used in addition to other oral forms of mesalazine. The choice of formulation depends on the location and extent of inflammation in ulcerative colitis.

Patients with questions or concerns about Mesalazine Foam Enema should consult their healthcare provider for personalized guidance and treatment recommendations.

As Mesalazine Foam Enema Exporters; We can cater to export business queries from the following geographies. We are exporting our Mesalazine Foam Enema product in the Following Countries-

Russia and CIS Countries: Azerbaijan, Armenia, Belarus, Georgia, Kazakhstan, Kyrgyzstan, Moldova, Russia, Tajikistan, Turkmenistan, Uzbekistan and Ukraine

GCC/ Middle East Countries: Saudi Arabia, Yemen, Oman, Bahrain, UAE, Lebanon, Jordan, and Iraq.

African Countries: Nigeria, Tanzania, Sudan, Zambia, Benin, Angola, Liberia

Southeast Asia: Cambodia, Indonesia, Laos, Malaysia, Myanmar, Philippines, Singapore, Thailand, Vietnam, Brunei Darussalam

Other Asian Countries: Nepal, Myanmar, Malaysia, Cambodia, Bhutan, Sri Lanka, Mauritius

Mesalazine Foam Enema Regulatory Documents:

  • Certificate of Analysis (COA)
  • Method of Analysis (MOA)
  • Stability Data (Accelerated stability / Long-term stability / Zone 4b)
  • CTD Dossier / ACTD Dossiers / eCTD Dossiers
  • Certificate of Pharmaceuticals Product (COPP)
  • Free Sale Certificate (FSC)
Contact the most reliable manufacturer of Mesalazine Foam Enema, Taj Pharmaceuticals Limited, to get bulk quantities at a reasonable price.

To Place Orders:

Direct line: +91 8448 444 095 / WhatsApp +91 74 0000 9975 / 74 0000 9976
E-Mail: info@tajpharma.com 
Toll free: 1-800-222-434 / Toll free: 1-800-222-825
General EPA BX: +91 22 2637 4592 / +91 22 2637 4593
Fax No: +91 22 2634 1274