Χώρα: Αυστραλία
Γλώσσα: Αγγλικά
Πηγή: Department of Health (Therapeutic Goods Administration)
alanine, Quantity: 16 g/L; glycylglutamine monohydrate, Quantity: 30.27 g/L (Equivalent: glutamine, Qty 20 g); histidine, Quantity: 6.8 g/L; methionine, Quantity: 5.6 g/L; tryptophan, Quantity: 1.9 g/L; threonine, Quantity: 5.6 g/L; lysine acetate, Quantity: 12.7 g/L (Equivalent: glycine, Qty 10.27 g; Equivalent: lysine, Qty 9 g); valine, Quantity: 7.3 g/L; arginine, Quantity: 11.3 g/L; glycyltyrosine dihydrate, Quantity: 3.45 g/L (Equivalent: tyrosine, Qty 2.28 g; Equivalent: glycine, Qty 0.94 g); serine, Quantity: 4.5 g/L; proline, Quantity: 6.8 g/L; glutamic acid, Quantity: 5.6 g/L; leucine, Quantity: 7.9 g/L; isoleucine, Quantity: 5.6 g/L; aspartic acid, Quantity: 3.4 g/L; phenylalanine, Quantity: 5.85 g/L
Fresenius Kabi Australia Pty Ltd
Injection, intravenous infusion
Excipient Ingredients: water for injections; citric acid
Intravenous
1000mL
Not scheduled. Not considered by committee
GLAMIN provides amino acids as part of parenteral nutrition therapy, when oral or enteral nutrition is impossible, insufficient or contraindicated especially in patients with a moderate or severe catabolic status.
Visual Identification: Clear, colourless.; Container Type: Bottle; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius
Registered
2002-05-29
Page 1 of 3 GLAMIN ® Amino acid / Dipeptide 13.4% Solution CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common question about Glamin. 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 being given Glamin 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 GLAMIN IS USED FOR Glamin is a 13.4% amino acid/dipeptide 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. Glamin is usually given together with carbohydrates, fats, salts, trace elements and vitamins to provide a complete intravenous diet. Your doctor may have prescribed Glamin for another reason. Ask your doctor if you have any questions about why Glamin has been prescribed for you. BEFORE YOU ARE GIVEN GLAMIN You should NOT be given Glamin if You have an allergy to Glamin or any of the ingredients listed at the end of this leaflet. You have an inability to break down amino acids, for example an inherited condition known as phenylketonuria. You have severe liver failure. You have severe kidney failure (if dialysis facilities are not available). You are suffering from a very serious problem with your blood circulation. You have too much fluid in your body. You have too much acid in your blood, also called metabolic acidosis. There is not en Διαβάστε το πλήρες έγγραφο
Australian Product Information – Glamin ® (amino acids/dipeptides) solution for infusion Page 1 of 8 1 NAME OF THE MEDICINE Alanine, arginine, aspartic acid, glutamic acid, glycylglutamine monohydrate, glycyltyrosine dihydrate, histidine, isoleucine, leucine, lysine acetate, methionine, phenylalanine, proline, serine, threonine, tryptophan, valine. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Glamin is an amino acid/dipeptide 13.4% solution for intravenous infusion. Glamin is an electrolyte-free, clear and colourless to slightly yellow amino acid solution which contains glutamine and tyrosine as glycyl dipeptides for total parenteral intravenous nutrition. Content (per 1000 mL) Active Ingredients Alanine 16.00 g Arginine 11.30 g Aspartic acid 3.40 g Glutamic acid 5.60 g Glycylglutamine monohydrate _ _ _(equivalent.to glycine 10.27 g & glutamine 20.0 g)_ 30.27 g Glycyltyrosine dihydrate _ _ _(equivalent.to glycine 0.94 g & tyrosine 2.28 g)_ 3.45 g Histidine 6.80 g Isoleucine 5.60 g Leucine 7.90 g Lysine acetate _(equivalent.to lysine 9.0 g)_ 12.70 g Methionine 5.60 g Phenylalanine 5.85 g Proline 6.80 g Serine 4.50 g Threonine 5.60 g Tryptophan 1.90 g Valine 7.30 g 1000 mL of Glamin supplies: • Amino acids and dipeptides 134 g • Total Nitrogen 22.4 g • Energy content 2300 kJ (540 kcal) Theoretical osmolarity 1040 mOsm Theoretical osmolality 1140 mOsm/kg water Density 1.0414 g/cm 3 pH approximately 5.8 For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Injection, intravenous infusion. Page 2 of 8 4 CLINICAL PARTICULARS 4.1 Therapeutic indications Glamin provides amino acids as part of parenteral nutrition therapy, when oral or enteral nutrition is impossible, insufficient or contraindicated especially in patients with a moderate to severe catabolic status. 4.2 Dose and method of administration Dosage The dosage of Glamin will depend on the patient’s amino acid requirements . Generally, 1 – 2 g amino acids/dipeptides (corresponding to 0.17 – 0.34 g N) per kg body w Διαβάστε το πλήρες έγγραφο