GENERIC NAME OF THE MEDICINAL PRODUCT:

A. Methylprednisolone Sodium Succinate for Injection USP 2 gm (M-PREDNITAJ)
B. Methylprednisolone Sodium Succinate for Injection USP 1 gm (M-PREDNITAJ)
C. Methylprednisolone Sodium Succinate for Injection USP 500mg (M-PREDNITAJ)
D. Methylprednisolone Sodium Succinate for Injection USP 125 mg (M-PREDNITAJ)
E. Methylprednisolone Sodium Succinate for Injection USP 40 mg (M-PREDNITAJ)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

1) Methylprednisolone Sodium Succinate for Injection USP 2gm
Each vial contains:
Methylprednisolone Sodium Succinate USP
Eq. to Methylprednisolone……………………2g
b) Water For Injection USP……………………20ml

2) Methylprednisolone Sodium Succinate for Injection USP 1gm
Each vial contains:
Methylprednisolone Sodium Succinate USP
Eq. to Methylprednisolone……………………1g
b) Water For Injection USP……………………20ml


3) Methylprednisolone Sodium Succinate for Injection USP 500mg
Each vial contains:
Methylprednisolone Sodium Succinate USP
Eq. to Methylprednisolone……………………0.5g
b) Water For Injection USP……………………….10ml

4) Methylprednisolone Sodium Succinate for Injection USP 125mg
Each vial contains:
Methylprednisolone Sodium Succinate USP
Eq. to Methylprednisolone……………………125mg
b) Water For Injection USP……………………………5ml

5) Methylprednisolone Sodium Succinate for Injection USP 40mg
Each vial contains:
Methylprednisolone Sodium Succinate USP
Eq. to Methylprednisolone……………………40mg
b) Water For Injection USP…………………………..5ml

THERAPEUTIC INDICATIONS:

Methylprednisolone is a Corticosteroid that prevents the release of substances in the body that cause inflammation. Methylprednisolone is used to treat many different inflammatory conditions such as arthritis, lupus, psoriasis, ulcerative colitis, allergic disorders, gland (endocrine) disorders, and conditions that affect the skin, eyes, lungs, stomach, nervous system, or blood cells.

DIRECTION OF USE:

Reconstitute using Sterile Water for injection USP.
Reconstituted solution should be use immediately after preparation.
Read enclosed leaflet before reconstitution and use.

CAUTION & WARNING:

CAUTION: Do not use, if constituent solution content Particle/suspended material.
If any particle is visible after dissolving the content do not use & return for replacement.
WARNING: To be sold by the retail on the prescription of a registered medical practitioner only.

STORAGE & DOSAGE:

Storage: Store below 25°C. Protect from light. Do not freeze.

Keep out of reach of medicine children.

Read enclosed leaflet before reconstitution and use.

FLIP-OFF SEAL IS PROVIDED FOR TEMPER EVIDENCE

Dosage: As directed by Physician

Methylprednisolone Sodium Succinate for Injection USP Specifications:

Product Name:Methylprednisolone Sodium Succinate for Injection USP
Brand Name:M-Prednitaj
Strength:2gm, 1gm,  500mg, 125mg, 40mg
Dosage Form:Lyophilized Powder for Injection (Sterile)
Packing:1 Vial + WFI
Route of Administration:For I.V. used 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:Corticosteroid, Anti-inflammatory
Indication: Methylprednisolone is a Corticosteroid that prevents the release of substances in the body that cause inflammation. Methylprednisolone is used to treat many different inflammatory conditions such as arthritis, lupus, psoriasis, ulcerative colitis, allergic disorders, gland (endocrine) disorders, and conditions that affect the skin, eyes, lungs, stomach, nervous system, or blood cells.
Storage:Store below 25°C. Protect from light. Do not freeze.

Exporters of Methylprednisolone Sodium Succinate for Injection USP from India

Taj Pharmaceuticals is one of the largest manufacturer and exporters of Methylprednisolone Sodium Succinate for Injection USP. We provide best quality product, trusted by reputed healthcare personnel, and patients to many countries across the world. The injection is formulated in the world-class state-of-art infrastructure and is safe to use.

A corticosteroid hormone is methylprednisolone. When a similar medication cannot be consumed or when a rapid reaction is required, especially in individuals with severe medical conditions, an injectable form of methylprednisolone is utilized.

What for Methylprednisolone Sodium Succinate for Injection USP is used?

This drug is used to treat diseases of the skin, kidney, digestive tract, lungs, and immune system as well as problems like arthritis, blood disorders, severe allergic responses, and some malignancies. It lessens the immune system’s reaction to certain illnesses in order to lessen symptoms like pain, swelling, and allergic-like reactions.

How do use Methylprednisolone Sodium Succinate for Injection USP?

According to your doctor’s instructions, this drug is typically administered via gradual injection into a vein or right into a muscle. Your medical condition and treatment response will determine the dosage. Without first seeing your doctor, do not raise your dosage or use this medication more frequently than directed. Your condition won’t get better any faster, and your chance of experiencing negative effects will rise.

Learn full preparation and usage instructions from your healthcare provider if you plan to take this medication at home. Before using, visually inspect the product for any flecks or discoloration. The liquid should not be used if either is present. Learn proper disposal and storage practices for medical materials.

Side Effects

Below are mentioned some of the side effects that a patient might experience:

  • Easy bruising/bleeding
  • Slow wound healing
  • Puffy face
  • Unusual hair/skin growth
  • Fast/slow/irregular heartbeat
  • Muscle weakness/pain
  • Swelling of the ankles/feet/hands
  • Thinning skin
  • Unusual weight gain
  • Bone/joint pain
  • Vision problems
  • Mental/mood changes

Precautions

  • Without first consulting your doctor, do not discontinue using this drug. When this medication is abruptly stopped, certain conditions could get worse. It could be necessary to gradually reduce your dosage.
  • You can get withdrawal symptoms if you abruptly stop taking this drug. Your doctor might gradually reduce your dose in order to help prevent withdrawal.
  • If you have taken methylprednisolone frequently or in high dosages, withdrawal is more likely to occur. If you experience withdrawal, tell your doctor or pharmacist straight away.
  • If your disease doesn’t get better or gets worse, let your doctor know.
  • In case you are allergic to Methylprednisolone Sodium Succinate or any other medicine, let your doctor or healthcare provider know about it.

GENERIC NAME OF MEDICINAL PRODUCT:

  1. Methylprednisolone Sodium Succinate for Injection USP 2 gm (M-PREDNITAJ)
  2. Methylprednisolone Sodium Succinate for Injection USP 1 gm (M-PREDNITAJ)
  3. Methylprednisolone Sodium Succinate for Injection USP 500mg (M-PREDNITAJ)
  4. Methylprednisolone Sodium Succinate for Injection USP 125 mg (M-PREDNITAJ)
  5. Methylprednisolone Sodium Succinate for Injection USP 40 mg (M-PREDNITAJ)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

1) Methylprednisolone Sodium Succinate for Injection USP 2gm
Each vial contains:
Methylprednisolone Sodium Succinate USP
Eq. to Methylprednisolone……………………2g
b) Water For Injection USP……………………20ml

2) Methylprednisolone Sodium Succinate for Injection USP 1gm
Each vial contains:

Methylprednisolone Sodium Succinate USP
Eq. to Methylprednisolone……………………1g
b) Water For Injection USP……………………20ml

3) Methylprednisolone Sodium Succinate for Injection USP 500mg
Each vial contains:
Methylprednisolone Sodium Succinate USP
Eq. to Methylprednisolone……………………0.5g
b) Water For Injection USP……………………….10ml

4) Methylprednisolone Sodium Succinate for Injection USP 125mg
Each vial contains:
Methylprednisolone Sodium Succinate USP
Eq. to Methylprednisolone……………………125mg
b) Water For Injection USP……………………………5ml

5) Methylprednisolone Sodium Succinate for Injection USP 40mg
Each vial contains:
Methylprednisolone Sodium Succinate USP
Eq. to Methylprednisolone……………………40mg
b) Water For Injection USP…………………………..5ml

THERAPEUTIC INDICATION:

Methylprednisolone is a Corticosteroid that prevents the release of substances in the body that cause inflammation. Methylprednisolone is used to treat many different inflammatory conditions such as arthritis, lupus, psoriasis, ulcerative colitis, allergic disorders, gland (endocrine) disorders, and conditions that affect the skin, eyes, lungs, stomach, nervous system, or blood cells.

DIRECTION OF USE:

Reconstitute using Sterile Water for injection USP.

Reconstituted solution should be use immediately after preparation.

Read enclosed leaflet before reconstitution and use.

CAUTION & WARNING:

CAUTION: Do not use, if constituent solution content Particle/suspended material.

If any particle is visible after dissolving the content do not use & return for replacement.

Warning: To be sold by the retail on the prescription of a registered medical practitioner only.

STORAGE & DOSAGE:

Storage: Store below 25°C. Protect from light. Do not freeze.

Keep out of reach of medicine children.

Read enclosed leaflet before reconstitution and use.

FLIP-OFF SEAL IS PROVIDED FOR TEMPER EVIDENCE

Dosage: As directed by Physician

Methylprednisolone Sodium Succinate for Injection USP Regulatory Documents:

  • Certificate of Analysis (COA)
  • Stability Data (Accelerated stability / Long term stability / Zone 4b)
  • Free Sale Certificate (FSC)
  • CTD Dossier / ACTD Dossiers / eCTD Dossiers
  • Method of Analysis (MOA)
  • Certificate of Pharmaceuticals Product (COPP)

Methylprednisolone Sodium Succinate for Injection USP Export Market

Being a trusted Methylprednisolone Sodium Succinate Injection manufacturer and exporter, we formulate the injection with utmost care and is used to inject intravenously. The medicine is exported in various locations all over the world such as:

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

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

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

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

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

Manufacturing Standard Operating Procedure:

Other Large Volume Parenterals (LVPs):

Other Dry Powder Injections:

Other Liquid Injections: