Ülke: İrlanda
Dil: İngilizce
Kaynak: 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 Healthcare Limited
B05BA; B05BA01
L-isoleucine; L-leucine; L-valine; L-lysine; L-methionine; L-threonine; L-tryptophan; L-arginine; L-histidine; L-alanine; L-aspa
10 percent
Solution for infusion
Product subject to prescription which may not be renewed (A)
Solutions for parenteral nutrition; amino acids
Not 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 Belgenin tamamını okuyun
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: 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, 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 H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _D_ _a_ _t_ _e_ _ _ _P_ _r_ _i_ _n_ _t_ _e_ _d_ _ _ _3_ _0_ _/_ _1_ _1_ _/_ _2_ _0_ _1_ _7_ _C_ _R_ _N_ _ _ _2_ _1_ _9_ _2_ _0_ _0_ _8_ _p_ _a_ _g_ _e_ _ _ _n_ _u_ _m_ _b_ _e_ _r_ _:_ _ _ _1_ • nitrogen requirements, • ability to metabolize the constituents of Primene, • additional nutrition that may be provided parenterally and/or enterally. The usual range is Belgenin tamamını okuyun