DESCRIPTION
Famotidine Injection, is supplied as a sterile concentrated solution for intravenous injection. Each mL of the solution contains 10 mg of famotidine and the following inactive ingredients: L-aspartic acid 4 mg, mannitol 20 mg, Water for Injection q.s. 1 mL.
INDICATIONS AND USAGE
Famotidine Injection, supplied as a concentrated solution for intravenous injection, is intended for intravenous use only. Famotidine Injection is indicated in some hospitalized patients with pathological hypersecretory conditions or intractable ulcers, or as an alternative to the oral dosage forms for short term use in patients who are unable to take oral medication for the following conditions:
Short term treatment of active duodenal ulcer. Most adult patients heal within 4 weeks; there is rarely reason to use famotidine at full dosage for longer than 6 to 8 weeks. Studies have not assessed the safety of famotidine in uncomplicated active duodenal ulcer for periods of more than 8 weeks.
Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of an active ulcer. Controlled studies in adults have not extended beyond one year.
Short term treatment of active benign gastric ulcer. Most adult patients heal within 6 weeks. Studies have not assessed the safety or efficacy of famotidine in uncomplicated active benign gastric ulcer for periods of more than 8 weeks.
Short term treatment of gastroesophageal reflux disease (GERD). Famotidine is indicated for short term treatment of patients with symptoms of GERD (see CLINICAL PHARMACOLOGY IN ADULTS, CLINICAL STUDIES). Famotidine is also indicated for the short term treatment of esophagitis due to GERD including erosive or ulcerative disease diagnosed by endoscopy (see CLINICAL PHARMACOLOGY IN ADULTS, CLINICAL STUDIES).
Treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison Syndrome, multiple endocrine adenomas) (see CLINICAL PHARMACOLOGY IN ADULTS, CLINICAL STUDIES).
CONTRAINDICATIONS
Hypersensitivity to any component of these products. Cross sensitivity in this class of compounds has been observed. Therefore, Famotidine Injection should not be administered to patients with a history of hypersensitivity to other H2-receptor antagonists.
Our factory
This product is produced in our GMP factory, all our facility has past China GMP, and also officially certificated by more than ten countries' MOH.
Our Service
We can specially develop the products per customers' specification.
We can offer OEM service with customers' private brands and labels.
We can offer excellent after-sale service and professional technical support.
Our Quality control system
In manufacturing, quality is what sustains our life. Starting from the material selection, there are many factors that contribute to the quality control process. Our manufacturing facility is GMP certified. Quality Control (QC) and monitoring procedures are built into every aspect of our work.
Our Quality Control System is outlined below:
Initial inspection (such as raw material, excipients, package materials, etc.)
In-process inspection (make sure that each testing items should be qualified )
Final inspection before shipment of each order.
Provide temperature control recorder when it is necessary for special market before loading.
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We can provide regulatory documents
GMP Certificate / CE Certificate
Free sales certificate
Certificate of Pharmaceutical Products
Manufacture License
CTD Dossier.