Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
INDOMETACIN SODIUM TRIHYDRATE
Lundbeck Pharmaceuticals Ireland
INDOMETACIN SODIUM TRIHYDRATE
1 Milligram
Pdr for Soln for Injection
Withdrawn
2012-03-01
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Indocid PDA 1 mg Powder for Solution for injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Indocid’ PDA contains 1.25 mg of the active ingredient indometacin sodium trihydrate equivalent to 1.0 mg of Indometacin. For excipients, see section 6.1. 3 PHARMACEUTICAL FORM Powder for solution for injection A sterile, off-white to yellow lyophilised powder for solution for injection. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS ‘Indocid’ PDA is indicated for the closure of patent ductus arteriosus in premature babies. For use in specialised premature baby units of hospitals. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _For intravenous use only._ A course of therapy is defined as three intravenous doses of ‘Indocid’ PDA given at 12- to 24-hour intervals, with careful attention to urinary output. If anuria or marked oliguria (urinary output of 0.6 ml/kg/hour) is evident at the time of the scheduled second or third dose, ‘Indocid’ PDA must not be given until laboratory studies indicate that renal function has returned to normal. Dosage recommendations depend closely on the age of the infant: If the ductus arteriosus is closed or significantly reduced in size 48 hours after the first course of therapy, no further treatment is necessary. If the ductus arteriosus reopens, a second course of therapy may be given. If the condition is unchanged after the second course of therapy, surgery may then be necessary. If severe adverse reactions occur, stop the treatment. For instructions for dilution and rate of infusion, see section 6.6. _Dosage (mg/kg)_ _Age at 1st dose_ _1st_ _2nd_ _3rd_ Less than 48 hours 0.2 0.1 0.1 2-7 days 0.2 0.2 0.2 Over 7 days 0.2 0.25 0.25 IRISH MEDICINES BOARD ______________________________ Read the complete document