Panzo 40 Injection

Each Combi Pack Contains:

Part I

Pantoprazole for Injection BP…………………. 40mg

Each vial contains:

Pantoprazole Sodium Sesquihydrate BP……..40 mg

(as sterile Lyophilized bulk)

Equivalent to Pantoprazole

Part Il

Sodium Chloride Injection BP 0.9% w/v

(For reconstitution)

Each ml contains:

Sodium Chloride BP……………………9 mg

Water for Injections BP……………….q.S.

DESCRIPTION:

ZIFAM PANZO for Injection is supplied as a freeze-dried powder in a glass vial fitted with a rubber stopper and crimp seal containing Pantoprazole Sodium Sesquihydrate BP, equivalent to 40 mg of pantoprazole.

Mechanism of Action:

Pantoprazole is a Proton Pump Inhibitor (PPI) that suppresses the final step in gastric acid production by covalently binding to the (H+, K+)-ATPase enzyme system at the secretory surface of the gastric parietal cell. This effect leads to inhibition of both basal and stimulated gastric acid secretion irrespective of the stimulus. The binding to the (H+, K+)-ATPase results in a duration of antisecretory effect that persists longer than 24 hours for all doses tested.

Indications:

ZIFAM PANZO Injection is indicated for the treatment of gastric ulcer, duodenal ulcer, moderate and severe reflux esophagitis.

DOSAGE AND ADMINISTRATION:

Route of Administration: For V use only

Dosage:

ZIFAM PANZO Injection is recommended only in cases where the oral administration is not indicated. The recommended dose is intravenous administration of the content of one vial (40 mg Pantoprazole) once daily for 7 days.

Duodenal Ulcer:

Duodenal Ulcers generally heal within 2 weeks. If a 2-week period of treatment is not sufficient, healing will be achieved in almost all cases within a further 2 weeks.

Gastric Ulcer & Gastro-oesophageal reflux:

A 4 week period is usually required for the treatment of gastric ulcers & gastro-oesophageal reflux. If this is not sufficient, healing will usually be achieved within a further 4 weeks.

Elderly:

No dose adjustment is necessary in the elders.

Patients with Impaired Renal Function:

No dose adjustment is necessary in patients with impaired renal function.

Patients with Impaired Hepatic Function:

In patients with severe liver impairments, the daily dose should be reduced to 20 mg Pantoprazole. Also, in these patients the liver enzymes should be monitored during ZIFAM PANZO Injection therapy. In case of liver enzymes, it should be discontinued.

DIRECTION FOR RECONSTITUTION:

The content of the vial needs to be reconstituted with 10 ml of Sodium Chloride Injection BP 0.9% w/v before injection.

This freshly prepared solution should be administered intravenously over 2 to 15 minutes, either as a slow injection or it may be further diluted with 100 ml of Sodium Chloride Injection BP. 0.9% w/v or 5% Glucose Injection and administered as a short term infusion.

The duration of administration should be 2 to 15 minutes. The reconstituted solution must be used within 12 hours of preparation.

Adverse Effects:

Treatments with Pantoprazole can occasionally lead to headache or diarrhea.

Rarely nausea/vomiting, abdominal pain, flatulence, constipation, allergic reactions such as skin rash and pruritus may occur. Individual cases of oedema, blurred vision, fever, dizziness, thrombophlebitis, depression or myalgia subsiding after termination of therapy have been reported.

Contraindications:

ZIFAM PANZO Injection is contra indicated in patients with known hypersensitivity to the formulation.

Presentation:

ZIFAM PANZO Injection is available as combi pack with 1 vial of 40 mg &

•10 ml Sodium Chloride Injection BP 0.9% w/v as diluent.