Šalis: Naujoji Zelandija
kalba: anglų
Šaltinis: Medsafe (Medicines Safety Authority)
Alanine 12 g/L; ; ; ; Arginine 8.4 g/L (L-Arginine); ; ; Aspartic acid 2.5 g/L (L-Aspartic acid); ; ; Cysteine 0.42 g/L (L-Cysteine); Glutamic acid 4.2 g/L (L-Glutamic acid); ; ; Glycine 5.9 g/L (as aminoacetic acid); ; ; ; Histidine 5.1 g/L (L-Histidine); ; ; ; Isoleucine 4.2 g/L (L-Isoleucine); ; ; ; Leucine 5.9 g/L (L-Leucine); ; ; ; Lysine acetate 6.8 g/L equivalent to -Lysine 6.8 g/L; ; ; Methionine 4.2 g/L (L-Methionine); ; ; Phenylalanine 5.9 g/L (L-Phenylalanine); ; ; ; Proline 5.1 g/L (L-Proline); ; Serine 3.4 g/L (L-Serine); ; ; ; ; Threonine 4.2 g/L (L-Threonine); ; ; ; Tryptophan 1.4 g/L (L-Tryptophan); ; Tyrosine 0.17 g/L (L-Tyrosine); Valine 5.5 g/L (L-Valine); ; ;
Fresenius Kabi New Zealand Limited
Alanine 12 g/L
Solution for infusion
Active: Alanine 12 g/L Arginine 8.4 g/L (L-Arginine) Aspartic acid 2.5 g/L (L-Aspartic acid) Cysteine 0.42 g/L (L-Cysteine) Glutamic acid 4.2 g/L (L-Glutamic acid) Glycine 5.9 g/L (as aminoacetic acid) Histidine 5.1 g/L (L-Histidine) Isoleucine 4.2 g/L (L-Isoleucine) Leucine 5.9 g/L (L-Leucine) Lysine acetate 6.8 g/L equivalent to -Lysine 6.8 g/L Methionine 4.2 g/L (L-Methionine) Phenylalanine 5.9 g/L (L-Phenylalanine) Proline 5.1 g/L (L-Proline) Serine 3.4 g/L (L-Serine) Threonine 4.2 g/L (L-Threonine) Tryptophan 1.4 g/L (L-Tryptophan) Tyrosine 0.17 g/L (L-Tyrosine) Valine 5.5 g/L (L-Valine) Excipient: Glacial acetic acid Water for injection
Bottle, glass, 1x500ml, 500 mL
General sale
General sale
Amino GmbH
Intravenous supply of amino acids to patients with moderately increased requirements who are unable to receive sufficient amounts of protein enterally
Package - Contents - Shelf Life: Bottle, glass, - 500 mL - 24 months from date of manufacture stored at or below 25°C - Bottle, glass, - 1000 mL - 24 months from date of manufacture stored at or below 25°C
1986-07-31
Page 1 of 2 VAMIN ® 14, 14EF, 18EF Amino Acids Solution CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Vamin. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you given Vamin against the benefits this medicine is expected to have for you. IF YOU HAVE ANY CONCERNS ABOUT THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. _KEEP THIS LEAFLET_. You may need to read it again. WHAT VAMIN IS USED FOR Vamin contains amino acids and is an intravenous infusion, which is given as a part of intravenous nutritional therapy. When the intake of nutrients or food into the mouth or directly into the gut is not possible or it is not enough to supply the body’s needs then intravenous nutrients or foods can be given. This is especially important for people whose bodies are under physical stress from illness or recent surgery. During illness or after surgery the body requires nutrition or food. Amino acids are the building blocks used by the body to make proteins. Vamin is usually given together with carbohydrates, fats, salts, trace elements and vitamins to provide a complete intravenous diet. Your doctor may have prescribed Vamin for another reason. Ask your doctor if you have any questions about why Vamin has been prescribed for you. BEFORE YOU ARE GIVEN VAMIN _WHEN SHOULD YOU NOT BE GIVEN _ _VAMIN ? _ You should NOT be given Vamin if You have severe liver damage. You have an allergy to Vamin or any of the ingredients listed at the end of this leaflet. You have an inability to break down amino acids. You have severe kidney disease or impaired kidney function. You have too much fluid in your body. You have too much potassium in your blood, also called hyperkalaemia. You have multi system organ failure or severe sepsis. If you are not sure whether any of these apply to you, check with your doctor. _ YOU MUST T Perskaitykite visą dokumentą
NEW ZEALAND DATA SHEET Page 1 of 8 1 PRODUCT NAME Vamin 14 - Solution for Infusion Vamin 14 Electrolyte Free - Solution for Infusion Vamin 18 Electrolyte Free - Solution for Infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Clear, colourless to slightly yellow solution. Table 1. Vamin 14 Vamin 14 Electrolyte Free Vamin 18 Electrolyte Free g/L % of total amino acids g/L % of total amino acids g/L % of total amino acids Isoleucine 4.2 4.92 4.2 4.92 5.6 4.92 Leucine 5.9 6.92 5.9 6.92 7.9 6.94 Valine 5.5 6.45 5.5 6.45 7.3 6.41 Phenylalanine 5.9 6.92 5.9 6.92 7.9 6.94 Methionine 4.2 4.92 4.2 4.92 5.6 4.92 Lysine 6.8 1 7.97 6.8 2 7.97 9.0 2 7.90 Threonine 4.2 4.92 4.2 4.92 5.6 4.92 Tryptophan 1.4 1.64 1.4 1.64 1.9 1.67 Cysteine 0.42 3 0.49 0.42 0.49 0.56 0.49 Histidine 5.1 5.98 5.1 5.98 6.8 5.97 Tyrosine 0.17 0.20 0.17 0.20 0.23 0.17 Alanine 12.0 14.06 12.0 14.06 16.0 14.05 Arginine 8.4 9.85 8.4 9.85 11.3 9.92 Aspartic acid 2.5 2.93 2.5 2.93 3.4 2.99 Glutamic acid 4.2 4.92 4.2 4.92 5.6 4.92 Glycine 5.9 6.92 5.9 6.92 7.9 6.94 Proline 5.1 5.98 5.1 5.98 6.8 6.97 Serine 3.4 3.99 3.4 3.99 4.5 3.95 Total Nitrogen 13.5 13.5 18.0 Amino acid concentration (% by weight) 8.5 8.5 11.4 1 as hydrochloride 2 as acetate 3 as hydrochloride monohydrate Table 2. Vamin 14 Vamin 14 Electrolyte Free Vamin 18 Electrolyte Free Calcium Gluconate H 2 O 2.24 g/L Potassium chloride 3.73 g/L Sodium acetate 3H 2 O 13.6 g/L Magnesium sulfate 7H 2 O 1.97 g/L Page 2 of 8 Table 2. Vamin 14 Vamin 14 Electrolyte Free Vamin 18 Electrolyte Free Osmolality mOsm/kg H 2 O 1145 810 1130 pH 5.4 – 5.8 5.4 – 5.8 5.4 – 5.8 Na + (mmol/1000 mL) 100 K + (mmol/1000 mL) 50 Ca ++ (mmol/1000 mL) 5 Mg ++ (mmol/1000 mL) 8 Cl - (mmol/1000 mL) 100 Acetate (mmol/1000 mL) 135 Sulfate (mmol/1000 mL) 8 For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Injection, intravenous infusion. 4 CLINICAL PARTICULARS 4.1 Therapeutic indications Vamin 14, Vamin 14 Electrolyte Free Intravenous supply of amino acids to patients with moderately Perskaitykite visą dokumentą