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Transcript
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.