देश: आयरलैंड
भाषा: अंग्रेज़ी
स्रोत: HPRA (Health Products Regulatory Authority)
L-isoleucine; L-leucine; L-valine; L-lysine; L-methionine; L-threonine; L-tryptophan; L-arginine; L-histidine; L-alanine; L-aspartic acid; Cysteine; L-glutamic acid; Glycine; L-proline; L-serine; L-tyrosine; Ornithine hydrochloride; Taurine; L-phenylalanine
Baxter Holding B.V.
B05BA; B05BA01
L-isoleucine; L-leucine; L-valine; L-lysine; L-methionine; L-threonine; L-tryptophan; L-arginine; L-histidine; L-alanine; L-aspartic acid; Cysteine; L-glutamic acid; Glycine; L-proline; L-serine; L-tyrosine; Ornithine hydrochloride; Taurine; L-phenylalanine
10 percent
Solution for infusion
Product subject to prescription which may not be renewed (A)
Solutions for parenteral nutrition; amino acids
Marketed
1995-05-19
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT PRIMENE 10% SOLUTION FOR INFUSION Amino Acid Intravenous Infusion READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOUR CHILD IS GIVEN THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOUR CHILD Keep this leaflet. You may need to read it again. If you have any further questions, ask the doctor or nurse. If your child gets any side effects talk to the doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Primene is and what it is used for 2. What you need to know before your child is given Primene 3. How your child will be given Primene 4. Possible side effects 5. How Primene is stored 6. Contents of the pack and other information Throughout this leaflet Primene 10% Solution for Infusion will be called Primene. 1. WHAT PRIMENE IS AND WHAT IT IS USED FOR Primene is a sterile solution which contains: amino acids – these are the building blocks which your body uses to make proteins. The amino acids in Primene are listed in section 6. Primene is used in Children, infants and the newborn at term or born prematurely to give your child food (nutrition) straight into the blood, when your child cannot take enough food by his or her mouth. Your doctor will check your child has all the nutrition that they need for good health. If necessary, your child may also have vitamins (such as folic Acid), minerals, fatty acids (the building blocks of fats), electrolytes (salts) and sugar solutions (such as glucose) at the same time as PRIMENE. 2. WHAT YOU NEED TO KNOW BEFORE YOUR CHILD IS GIVEN PRIMENE PRIMENE MUST NOT BE GIVEN TO YOUR CHILD IF: Your child is allergic (hypersensitive) to any of the ingredients of this medicine (listed in section 6). Your child’s body has a problem s using the building blocks of proteins. Your child will not be given Primene if any of the above applies. WARNINGS AND PRECAUTIONS Talk to the doctor or nurse before Primene. Your doctor will make sure t पूरा दस्तावेज़ पढ़ें
Health Products Regulatory Authority 22 October 2019 CRN009D2X Page 1 of 8 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Primene 10% Solution for Infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each litre of infusion solution contains: L‐Isoleucine 6.70 g L‐Leucine 10.00 g L‐Valine 7.60 g L‐Lysine 11.00 g L‐Methionine 2.40 g L‐Threonine 3.70 g L‐Tryptophan 2.00 g L‐Arginine 8.40 g L‐Histidine 3.80 g L‐Alanine 8.00 g L‐Aspartic Acid 6.00 g L‐Cysteine 1.89 g L‐Glutamic Acid 10.00 g Glycine 4.00 g L‐Proline 3.00 g L‐Serine 4.00 g L‐Tyrosine 0.45 g L‐Ornithine Hydrochloride 3.18 g Taurine 0.60 g L‐Phenylalanine 4.20 g For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for infusion. A clear, colourless solution. Primene 10% has an osmolarity of 780 mOsmol/L 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS In the prophylaxis and therapy of protein deficiency in neonates, infants and children, when adequate oral administration is not possible. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Parenteral nutrition initiation and duration as well as dosage (dose and rate of administration) depends on a patient's • age, weight, clinical condition, • nitrogen requirements, Health Products Regulatory Authority 22 October 2019 CRN009D2X Page 2 of 8 • ability to metabolize the constituents of Primene, • additional nutrition that may be provided parenterally and/or enterally. The usual range is 1.5 – 3.5g amino‐acids/kg/day 0.230 – 0.53g nitrogen/kg/24 hours 15–30ml of solution/kg/day The infusion rate should not exceed 0.05ml/kg/min. The infusion rate should be started at a reduced flow rate and then can be increased gradually during the first hour. The flow rate must be adjusted taking into account the dose being administered, the daily volume intake, and the duration of the infusion. Neonates and Infants: continuous infusion (over 24 hours). Children: continuous infusion (over 24 hours) or cyclic infusion (over about 1 पूरा दस्तावेज़ पढ़ें