Ülke: Yeni Zelanda
Dil: İngilizce
Kaynak: Medsafe (Medicines Safety Authority)
Indometacin sodium trihydrate 1.061mg Equivalent to Indomethacin 1 mg
Viatris Limited
Indometacin sodium trihydrate 1.061 mg (Equivalent to Indomethacin 1 mg)
1 mg
Powder for injection
Active: Indometacin sodium trihydrate 1.061mg Equivalent to Indomethacin 1 mg
Prescription
Sequent Scientific Limited
Indomethacin is indicated for the closure of patent ductus arteriosus in premature babies. Clear-cut clinical evidence of a haemodynamically significant patent ductus arteriosus should be present, such as respiratory distress, a continuous murmur, a hyperactive precordium, cardiomegaly and pulmonary plethora on chest x-ray. Indomethacin should only be used in a hospital under supervision of a specialist neonatologist.
Package - Contents - Shelf Life: Vial, glass, 2 mL USP Type l tubular flint vial, rubber stopper, 3 vials/carton - 3 dose units - 18 months from date of manufacture stored at or below 25°C protect from light and moisture
2014-05-26
Page 1 of 2 NEW ZEALAND CONSUMER MEDICINE INFORMATION INDOMETHACIN AGILA _INDOMETHACIN SODIUM TRIHYDRATE POWDER FOR INJECTION 1 MG _ _ _ WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Indomethacin Agila. It does not contain all the available information. It does not take the place of talking to your baby’s doctor. All medicines have risks and benefits. Your baby’s doctor has weighed the risks of using Indomethacin Agila against the benefits they expect it will have for your baby. IF YOU HAVE ANY CONCERNS ABOUT THIS MEDICINE, TALK TO YOUR BABY’S DOCTOR. KEEP THIS LEAFLET. You may need to read it again. WHAT INDOMETHACIN AGILA IS USED FOR Indomethacin Agila contains the active ingredient indomethacin sodium trihydrate. While a baby is inside its mother's womb it does not need to use its lungs. An unborn baby has a blood vessel called a ductus arteriosus near the heart which allows the baby's blood to bypass the lungs and circulate to the rest of the body. When the baby is born and starts using his/her lungs, the ductus arteriosus spontaneously closes up. However, in some cases this does not happen. The medical term for this condition is 'patent ductus arteriosus', i.e. an open ductus arteriosus. If the ductus arteriosus is not closed it can cause problems for your baby. Indomethacin Agila, when given to your baby, can help to close the ductus arteriosus. It is not known exactly how indomethacin works, but it is believed that it closes a ductus arteriosus by inhibiting the production of prostaglandin, a naturally occurring chemical in the body which keeps the ductus arteriosus open. This medicine is used only in a hospital under the supervision of a specialist neonatologist. BEFORE BEING GIVEN INDOMETHACIN AGILA _WHEN IT MUST NOT BE _ _USED _ INDOMETHACIN AGILA SHOULD NOT BE GIVEN TO BABIES IF: they have a suspected or established untreated infection they are bleeding, especially if the bleeding is inside the skull or the intestines they have other heart problems which req Belgenin tamamını okuyun
Page 1 of 18 NEW ZEALAND DATA SHEET INDOMETHACIN AGILA _INDOMETHACIN SODIUM TRIHYDRATE POWDER FOR INJECTION 1 MG _ _ _ DESCRIPTION Indomethacin Agila (indomethacin sodium trihydrate (also known as indometacin sodium trihydrate)) for intravenous administration is lyophilised indomethacin sodium trihydrate. Indomethacin sodium trihydrate is designated chemically as 1_H_-Indole-3-acetic acid, 1-(4-chlorobenzoyl)-5- methoxy-2-methyl-, sodium salt, trihydrate. Its molecular weight is 433.82 g/mol. Its molecular formula is C 19 H 15 ClNNaO 4 .3H 2 O and Its structural formula is: CAS Number: 74252-25-8 Each vial contains indomethacin sodium trihydrate equivalent to 1 mg indomethacin as a sterile white to yellow lyophilised powder or plug. Variations in the size of the lyophilised plug and the intensity of colour have no relationship to the quality or amount of indomethacin present in the vial. pKa value for Indomethacin is 4.5. Indomethacin Agila contains no other excipients. PHARMACOLOGY Indomethacin is a non-steroidal anti-inflammatory agent which inhibits prostaglandin synthesis. Although the exact mechanism of action through which indomethacin causes closure of a patent ductus arteriosus is not known, it is believed to be through inhibition of prostaglandin synthesis. Indomethacin has been shown to be a potent inhibitor of prostaglandin synthesis, both _ in vitro_ and _ in vivo._ In human newborns with certain congenital heart malformations, PGE 1 dilates the ductus arteriosus. In fetal and newborn lambs, E type prostaglandins have also been shown to maintain the patency of the ductus, and as in human newborns, indomethacin causes its constriction. Studies in premature infants with patent ductus arteriosus indicated that, after the first dose of intravenous indomethacin, there was a transient reduction in cerebral blood flow velocity and cerebral blood flow. Similar decreases in mesenteric blood flow and velocity have been observed. The clinical significance of these effects has not been established. Page 2 of 18 _ Belgenin tamamını okuyun