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Nevofam Nevofam – L freeze-dried ampoule 20 mg, 2 freeze-dried ampoules + 2 diluent ampoules Nevofam tablet 20 mg, 60 tablets Nevofam tablet 40 mg, 30 tablets COMPOSITION: Each freeze-dried ampoule contains 20 mg famotidine Each tablet contains 2040 mg famotidine. PHARMACOLOGICAL PROPERTIES: A histamine H2 receptor antagonist. Inhibits gastric acid secretion stimulated by food, histamine, pentagastrin and other stimulants. Inhibits gastric acid secretion stimulated by food, histamine, pentagastrin or other stimulants. Administered once a day and well tolerated. Low incidence of side effects. INDICATIONS: Various pathological gastric hypersecretory conditions such as Zollinger-Ellison syndrome, multiple endocrine adenomatosis Persistent peptic ulcer Prophylaxis of aspiration pneumonia Patients unable to take oral therapy Gastroesophageal reflux Various pathological hypersecretory conditions such as multiple endocrine adenoma CONTRAINDICATIONS: Is contraindicated in patients hypersensitive to famotidine. WARNINGS AND PRECAUTIONS: In patients with severe renal failure (creatinine clearance < 10 mL / min) lower doses or longer dosage intervals may be required. Safety of administration in children and in pregnant or nursing women has not been established. SIDE EFFECTS / ADVERSE EFFECTS: Headache (%4,7), dizziness (%1,3), diarrhea (%1,7) and constipation (%1,2) the most commonly observed side effects. DRUG INTERACTIONS: Famotidine is a weak inhibitor of liver cytochrome P-450 enzyme system and does not markedly interact with drugs metabolized by this enzyme system. DOSAGE AND ADMINISTRATION: Nevofam – L freeze-dried ampoule 20 mg: In duodenal ulcers and pathological hypersecretory conditions like Zollinger-Ellison syndrome: 20 mg / 5 mL every 12 hours is given within 2 minutes. Intravenous infusion solutions: 20 mg Nevofam-L freezedried ampoule for injection is diluted to 100 mL with appropriate IV solutions and administered over 15-20 minutes. Prophylaxis of aspiration pneumonia: 20 mg is administered intramuscularly both the night before and the morning of the surgical procedure. NEVOFAM 20-40 MG tablet: Duodenal ulcers: 40 mg once a day at bed time for 4 to 8 weeks. Prophylaxis in recurrent duodenal ulcers: 20 mg once a day at bed time. Benign gastric ulcers; 40 mg once a day at bed time for 6 to 8 weeks. Pathological hypersecretory conditions including Zollinger-Ellison syndrome: 20 mg every 6 hours. Overdosage: Gastric lavage and supportive therapy is recommended. STORAGE CONDITIONS: Should be kept out of reach of children, at room temperature (< 25ºC) and in its package. Sold on prescription. Contact to our company for detailed information. AVAILABLE FORMS: NEVOFAM-L for injection 20 mg - 2 freeze-dried ampoules + 2 diluent ampoules NEVOFAM tablet 20 mg, 60-tablet blister packs NEVOFAM tablet 40 mg, 30-tablet blister packs Sold under prescription. Please contact our company for detailed information. NAME AND ADDRESS OF THE AUTHORISATION HOLDER: Mustafa Nevzat Ilac Sanayii A.Ş. Prof. Dr. Bülent Tarcan Sok., Pak Iş Merkezi No: 5/1 34349 Gayrettepe/Istanbul. NAME AND ADDRESS OF THE MANUFACTURING COMPANY: Mustafa Nevzat Ilac Sanayii A.Ş. Çobançeşme Mah. Sanayi Cad. No.13 Yenibosna-Istanbul.