Malta - anglès - Medicines Authority

fresenius kabi italia s.r.l via camagre 41, 37063 isola della scala (vr) , italy - poly, hydroxyethyl, starch, potassium chloride, magnesium chloride, hexahydrate, sodium acetate, trihydrate, sodium chloride - solution for infusion - sodium acetate trihydrate 4.63 g sodium chloride 6.02 g magnesium chloride hexahydrate 0.3 g poly(o-2-hydroxyethyl)starch 60 g potassium chloride 0.3 g - blood substitutes and perfusion solutions

Nova Zelanda - anglès - Medsafe (Medicines Safety Authority)

fresenius kabi new zealand limited - hydroxyethyl starch 130/0.4 60 g/l; magnesium chloride hexahydrate 0.3 g/l;  ; potassium chloride 0.3 g/l; sodium acetate trihydrate 4.63 g/l;  ; sodium chloride 6.02 g/l;  ;  ;   - solution for infusion - 6 % - active: hydroxyethyl starch 130/0.4 60 g/l magnesium chloride hexahydrate 0.3 g/l   potassium chloride 0.3 g/l sodium acetate trihydrate 4.63 g/l   sodium chloride 6.02 g/l       excipient: hydrochloric acid sodium hydroxide water for injection - treatment of hypovolaemia due to acute blood loss when chrystlloids alone are not considered sufficient. the use of volulyte is not a substitute for the appropriate use of packed red blood cells or fresh frozen plasma.

Nova Zelanda - anglès - Medsafe (Medicines Safety Authority)

fresenius kabi new zealand limited - hydroxyethyl starch 130/0.4 6% (molar substitution 0.38-0.45, av. mwt. 130,000 daltons); sodium chloride 0.9%; hydroxyethyl starch 130/0.4 6% (molar substitution 0.38-0.45, av. mwt. 130,000 daltons) - solution for infusion - active: hydroxyethyl starch 130/0.4 6% (molar substitution 0.38-0.45, av. mwt. 130,000 daltons) sodium chloride 0.9% excipient: hydrochloric acid sodium hydroxide water for injection active: hydroxyethyl starch 130/0.4 6% (molar substitution 0.38-0.45, av. mwt. 130,000 daltons) excipient: hydrochloric acid sodium chloride sodium hydroxide water for injection - treatment of hypovolaemia due to acute blood loss when chrystlloids alone are not considered sufficient. the use of voluven is not a substitute for the appropriate use of packed red blood cells or fresh frozen plasma.

Irlanda - anglès - HPRA (Health Products Regulatory Authority)

baxter healthcare limited - hydroxyethyl starch sodium chloride potassium chloride calcium chloride dihydrate magnesium chloride dihydrate sodium acetate trihydrate - solution for infusion - 6 per cent

Irlanda - anglès - HPRA (Health Products Regulatory Authority)

baxter healthcare limited - hetastarch sodium chloride - solution for infusion - 6 %w/v

Austràlia - anglès - Department of Health (Therapeutic Goods Administration)

guerbet australia pty ltd - ioversol, quantity: 678 mg/ml (equivalent: iodine, qty 320 mg/ml) - injection, solution - excipient ingredients: trometamol; sodium calcium edetate; water for injections; trometamol hydrochloride; sodium hydroxide - this product accepted for registration as 'currently supplied' at the time of commencement of the act. indications approved as specified in the letter of 19 april 1993 from dr h. arora are as follows: optiray is indicated in adults for angiography throughout the cardiovascular system by conventional or digital subtraction techniques. these include cerebral, coronary, peripheral, visceral and renal arteriography, aortography, left ventriculography and venography. optiray may be used in intravenous excretory urography. optiray 320 is indicated in children (excluding neonates) for angiography, contrast enhanced computed tomographic imaging of the head and body, and intravenous excretory urography.

Austràlia - anglès - Department of Health (Therapeutic Goods Administration)

guerbet australia pty ltd - ioversol, quantity: 678 mg/ml (equivalent: iodine, qty 320 mg/ml) - injection, solution - excipient ingredients: trometamol; sodium calcium edetate; water for injections; trometamol hydrochloride; sodium hydroxide - this product accepted for registration as 'currently supplied' at the time of commencement of the act. indications approved as specified in the letter of 19 april 1993 from dr h. arora are as follows: optiray is indicated in adults for angiography throughout the cardiovascular system by conventional or digital subtraction techniques. these include cerebral, coronary, peripheral, visceral and renal arteriography, aortography, left ventriculography and venography. optiray may be used in intravenous excretory urography. optiray 320 is indicated in children (excluding neonates) for angiography, contrast enhanced computed tomographic imaging of the head and body, and intravenous excretory urography.

Austràlia - anglès - Department of Health (Therapeutic Goods Administration)

guerbet australia pty ltd - ioversol, quantity: 678 mg/ml (equivalent: iodine, qty 320 mg/ml) - injection, solution - excipient ingredients: trometamol; sodium calcium edetate; water for injections; trometamol hydrochloride; sodium hydroxide - this product accepted for registration as 'currently supplied' at the time of commencement of the act. indications approved as specified in the letter of 19 april 1993 from dr h. arora are as follows: optiray is indicated in adults for angiography throughout the cardiovascular system by conventional or digital subtraction techniques. these include cerebral, coronary, peripheral, visceral and renal arteriography, aortography, left ventriculography and venography. optiray may be used in intravenous excretory urography. optiray 320 is indicated in children (excluding neonates) for angiography, contrast enhanced computed tomographic imaging of the head and body, and intravenous excretory urography.

Austràlia - anglès - Department of Health (Therapeutic Goods Administration)

guerbet australia pty ltd - ioversol, quantity: 678 mg/ml (equivalent: iodine, qty 320 mg/ml) - injection, solution - excipient ingredients: trometamol; sodium calcium edetate; water for injections; trometamol hydrochloride; sodium hydroxide - this product accepted for registration as 'currently supplied' at the time of commencement of the act. indications approved as specified in the letter of 19 april 1993 from dr h. arora are as follows: optiray is indicated in adults for angiography throughout the cardiovascular system by conventional or digital subtraction techniques. these include cerebral, coronary, peripheral, visceral and renal arteriography, aortography, left ventriculography and venography. optiray may be used in intravenous excretory urography. optiray 320 is indicated in children (excluding neonates) for angiography, contrast enhanced computed tomographic imaging of the head and body, and intravenous excretory urography.

Austràlia - anglès - Department of Health (Therapeutic Goods Administration)

guerbet australia pty ltd - ioversol, quantity: 678 mg/ml (equivalent: iodine, qty 320 mg/ml) - injection, solution - excipient ingredients: trometamol; sodium calcium edetate; water for injections; trometamol hydrochloride; sodium hydroxide - this product accepted for registration as 'currently supplied' at the time of commencement of the act. indications approved as specified in the letter of 19 april 1993 from dr h. arora are as follows: optiray is indicated in adults for angiography throughout the cardiovascular system by conventional or digital subtraction techniques. these include cerebral, coronary, peripheral, visceral and renal arteriography, aortography, left ventriculography and venography. optiray may be used in intravenous excretory urography. optiray 320 is indicated in children (excluding neonates) for angiography, contrast enhanced computed tomographic imaging of the head and body, and intravenous excretory urography.