G16E\u00a0Infusion\u00a0solution,\u00a0emulsion<\/p>\n\n\n\n
Numata G16E is an\u00a0emulsion\u00a0that contains nutrition specially designed for full-term, newborn babies and children up to 2 years.\u00a0It is given through a tube that is placed in your child’s vein when your child can not get all the nutrition he or she needs by eating.<\/p>\n\n\n\n
Numata G16E is provided as a three-chamber bag\u00a0where the separate chambers contain:<\/p>\n\n\n\n
Depending on your child’s needs, two or three of these solutions are mixed inside the infusion bag, before the medicine is given to your child.<\/p>\n\n\n\n
The Numata G16E must be used under medical supervision.<\/p>\n\n\n\n
When two solutions are mixed in the bag (\u201c2 in 1\u201d):<\/strong><\/p>\n\n\n\n When three solutions are mixed in the bag (\u201c3 in 1\u201d).<\/strong><\/p>\n\n\n\n In all cases, the physician should base his decision on possible treatment with Numeta G16E on factors such as age, weight, and clinical condition.\u00a0The doctor will also take into account the results of any tests performed.<\/p>\n\n\n\n Talk to your child’s doctor or nurse before giving your child Numeta G16E.<\/p>\n\n\n\n When used to treat newborns and children under 2 years of age, the solution (in sachets and administration sets) should be protected from light exposure until the administration is complete.\u00a0If Numeta G16E is exposed to ambient light, especially after the addition of trace elements and\/or\u00a0vitamins, peroxides and other degradation products are formed, which can be reduced if the product is protected from light exposure.<\/p>\n\n\n\n Allergic reactions:<\/strong><\/p>\n\n\n\n The infusion\u00a0must be stopped immediately if any signs or symptoms of\u00a0an allergic reaction\u00a0(such as fever, sweating, chills, headache, rash, or difficulty breathing) develop.\u00a0This medicine contains soybean oil, which in rare cases may cause\u00a0hypersensitivity reactions.\u00a0In less common cases, it has been seen that some people who are allergic to peanut protein are also allergic to soy protein.<\/p>\n\n\n\n Numata G16E contains\u00a0glucose\u00a0made from corn starch.\u00a0Numata G16E should be used with caution in patients with known\u00a0allergies\u00a0to maize or maize products.<\/p>\n\n\n\n Risk of particulate matter with ceftriaxone (an antibiotic):<\/strong><\/p>\n\n\n\n A certain\u00a0antibiotic, called ceftriaxone, must not be mixed or given at the same time as calcium-containing solutions (including Numeta G16E) as it is given to you as a drip into a vein.\u00a0Your doctor will know about this and will not give them to you together, not even through different infusion tubes or at different infusion sites.<\/p>\n\n\n\n However, the doctor may give\u00a0calcium\u00a0and ceftriaxone one after the other if infusion tubes are used at different infusion sites, or if the infusion tubes are replaced, or rinsed thoroughly with a physiological saline solution between the\u00a0infusions, to avoid particle formation.<\/p>\n\n\n\n Formation of small particles in the blood vessels of the lungs:<\/strong><\/p>\n\n\n\n Breathing difficulties may be a sign that small particles have formed that block the blood vessels in the lungs ( pulmonary vascular deposits). Talk to your doctor or nurse if your child has difficulty breathing. They will decide on appropriate measures.<\/p>\n\n\n\n Infection and blood poisoning:<\/strong><\/p>\n\n\n\n Your doctor will closely monitor your child for any signs of\u00a0infection.\u00a0The use of aseptic technology (a technology free of bacteria) when placing and maintaining the catheter, as well as when preparing the nutrient solution, can reduce the risk of\u00a0infection.<\/p>\n\n\n\n Sometimes children can develop\u00a0infection\u00a0and\u00a0sepsis\u00a0(bacteria in the blood) when they have a tube in a vein (\u00a0intravenous\u00a0catheter\u00a0).\u00a0Some medicines and diseases may increase the risk of\u00a0developing\u00a0infection\u00a0or\u00a0sepsis.\u00a0Patients who need\u00a0parenteral\u00a0nutrition (feeding via a tube into a blood vessel) may find it easier to develop an\u00a0infection\u00a0due to their medical condition.<\/p>\n\n\n\n Fat overload syndrome<\/strong><\/p>\n\n\n\n Fat overload syndrome has been reported for similar drugs.\u00a0If your body has reduced or decreased ability to get rid of the fats in Numata G16E, \u201cfat overload syndrome\u201d may occur (see section 4, Possible\u00a0side effects\u00a0).<\/p>\n\n\n\n Changes in blood chemical levels:<\/strong><\/p>\n\n\n\n Your doctor will monitor and monitor your baby’s fluid levels, blood chemical balance, and other blood levels, as the supply of nutrients to someone who is severely malnourished can sometimes lead to changes in blood chemical levels.\u00a0Extra fluid in the\u00a0tissues\u00a0and swelling may also develop.\u00a0It is recommended that\u00a0parenteral\u00a0nutrition be started slowly and carefully.<\/p>\n\n\n\n Elevated levels of magnesium in the blood<\/strong><\/p>\n\n\n\n The amount of\u00a0magnesium\u00a0in Numata G16E can cause elevated levels of\u00a0magnesium\u00a0in the blood.\u00a0Signs of this may include weakness, slow reflexes, nausea, vomiting, low blood calcium levels, difficulty breathing, low\u00a0blood pressure,\u00a0and irregular heartbeat.\u00a0As these signs can be difficult to detect, your baby’s blood levels may be monitored by your doctor, especially if your baby has risk factors for elevated levels of\u00a0magnesium\u00a0in the blood, including impaired kidney function.\u00a0If the magnesium levels in the blood are elevated, the\u00a0infusion\u00a0will be stopped or reduced.<\/p>\n\n\n\n Monitoring and adjustment:<\/strong><\/p>\n\n\n\n Your doctor will closely monitor and adjust the\u00a0dose\u00a0of Numata G16E to suit your child’s special needs if the child has the following conditions:<\/p>\n\n\n\n Use with caution in:<\/strong><\/p>\n\n\n\n Numata G16E should be used with caution if the child has:<\/p>\n\n\n\n The baby’s fluid status, liver values \u200b\u200b, and\/or blood values \u200b\u200bwill be closely monitored.<\/p>\n\n\n\n Tell your doctor if your child is taking, has recently taken, or might take any other medicines.<\/p>\n\n\n\n Numata\u00a0<\/strong>\u00a0G16E\u00a0must not be given at the same time as:<\/strong><\/p>\n\n\n\n Coumarin and warfarin (blood thinners):<\/strong><\/p>\n\n\n\n Your doctor will closely monitor your child if the child is being treated with coumarin and\u00a0warfarin.\u00a0Olive and soybean oil naturally contain\u00a0vitamin\u00a0K1.\u00a0Vitamin\u00a0K1 can\u00a0interact\u00a0with drugs such as coumarin and\u00a0warfarin.\u00a0It is a blood-thinning drug that is used to prevent blood from clotting.<\/p>\n\n\n\n Laboratory tests:<\/strong><\/p>\n\n\n\n The lipids in this emulsion may affect the results of certain laboratory tests. Laboratory samples can be taken after 5 to 6 hours if no additional lipids are given.<\/p>\n\n\n\n Interaction\u00a0with Numeta\u00a0G16E\u00a0\u00a0and medicines that may affect potassium levels\/degradation:<\/strong><\/p>\n\n\n\n Numata G16E contains\u00a0potassium.\u00a0High levels of\u00a0potassium\u00a0in the blood can cause abnormal heart rhythms.\u00a0Particular caution should be exercised in patients taking\u00a0diuretics\u00a0(\u00a0diuretics\u00a0) or\u00a0ACE inhibitors\u00a0(medicines for high\u00a0blood pressure\u00a0), angiotensin\u00a0II receptor antagonists (medicines for high\u00a0blood pressure\u00a0), or immunosuppressive medicines (medicines that can\u00a0inhibit the\u00a0body’s normal immune system\u00a0) .\u00a0.\u00a0These types of drugs can raise potassium levels.<\/p>\n\n\n\n Your child should always receive Numeta G16E according to their doctor’s instructions. Consult a doctor if you are unsure.<\/p>\n\n\n\n Age groups<\/strong><\/p>\n\n\n\n Numata G16E has been developed to meet the nutritional needs of full-term newborn infants and children up to 2 years of age.<\/p>\n\n\n\n Your doctor will decide if this medicine is suitable for your child.<\/p>\n\n\n\n Administration<\/strong><\/p>\n\n\n\n This medicine is an\u00a0emulsion\u00a0for\u00a0infusion.\u00a0It is given through a plastic tube into a vein in your baby’s armor into a large vein in your baby’s breast.<\/p>\n\n\n\n Your child’s doctor may choose not to give\u00a0lipids\u00a0to you (fats) to your child.\u00a0The bag with Numeta G16E is designed so that only the seal between the chambers with amino acids\/electrolytes and\u00a0glucose\u00a0can be broken if necessary.\u00a0The closure between the chambers of\u00a0amino acids\u00a0and\u00a0lipids\u00a0then remains intact.\u00a0The contents of the bag can then be infused without\u00a0lipids.<\/p>\n\n\n\n When used to treat newborns and children under 2 years of age, the solution (in sachets and administration sets) should be protected from exposure to light until\u00a0the administration\u00a0is complete (see section 2).<\/p>\n\n\n\n Dosage and duration of treatment<\/strong><\/p>\n\n\n\n Your child’s doctor decides what\u00a0dose\u00a0the child should receive and for how long the medicine should be given.\u00a0Dose\u00a0one depends on the child’s nutritional needs.\u00a0Dosage\u00a0one is determined based on the child’s weight, medical condition, and the body’s ability to break down and assimilate the ingredients in Numata G16E.\u00a0Extra nutrients or\u00a0protein\u00a0can also be given, either by mouth or as\u00a0an infusion\u00a0into the bloodstream.<\/p>\n\n\n\n If you have ingested too much medicine or if e.g.\u00a0If a child has ingested the medicine by mistake, contact a doctor or hospital for risk assessment and advice.<\/p>\n\n\n\n Symptoms<\/strong><\/p>\n\n\n\n Too much of this medicine or giving it too fast can lead to the following:<\/p>\n\n\n\n In such situations, the infusion must be stopped immediately. Your child’s doctor will determine if further action is required.<\/p>\n\n\n\n To prevent this, your doctor should regularly monitor your child’s condition and test your child’s blood counts during treatment.<\/p>\n\n\n\n Like all medicines, this medicine can cause\u00a0side effects, although not everybody gets them.<\/p>\n\n\n\n If you notice any change in how your child feels during or after treatment, contact a doctor or nurse immediately.<\/p>\n\n\n\n The tests that your doctor performs while your child is taking this medicine should minimize the risk of\u00a0side effects.<\/p>\n\n\n\n If signs of an allergic reaction occur, the infusion should be stopped immediately and a doctor consulted. This can be serious and the symptoms can be:<\/p>\n\n\n\n Other side effects that have been observed are:<\/p>\n\n\n\n Common: may affect up to 1 in 10 <\/em>users<\/em><\/p>\n\n\n\n Uncommon: may affect up to 1 in 100 <\/em>people<\/em><\/p>\n\n\n\n Has been reported: occurs in an unknown number of users<\/em> (These side effects have only been reported for Numeta G13E and G16E administered peripherally and in insufficient dilution).<\/p>\n\n\n\n The following side effects have been reported with other parenteral nutrition drugs:<\/p>\n\n\n\n Decreased or limited ability to get rid of the fats in Numata G16E can lead to “fat overload syndrome”.\u00a0The following signs and symptoms of this syndrome are usually\u00a0reversible\u00a0when\u00a0the infusion\u00a0of one of the lipid emulsions is stopped:<\/p>\n\n\n\n Formation of small particles that can block the blood vessels in the lungs ( pulmonary vascular deposits) or difficulty breathing.<\/p>\n\n\n\n Keep this medicine out of the sight and reach of children.<\/p>\n\n\n\n When used to treat newborns and children under 2 years of age, the solution (in sachets and administration sets) should be protected from exposure to light until\u00a0the administration\u00a0is complete (see section 2).<\/p>\n\n\n\n Do not use this medicine after the expiry date which is stated on the bag and the outer carton after EXP. The expiration date is the last day of the specified month.<\/p>\n\n\n\n Do not freeze.<\/p>\n\n\n\n Store in the outer bag.<\/p>\n\n\n\n Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.<\/p>\n\n\n\n Numata G16E is supplied in a bag with three chambers.\u00a0Each bag contains a\u00a0sterile\u00a0combination of a glucose solution, an amino acid solution for children with\u00a0electrolytes,\u00a0and a lipid emulsion as described below.<\/p>\n\n\n\n Appearance before preparation:<\/p>\n\n\n\n Appearance after preparation:<\/p>\n\n\n\n The bag with three chambers is made of multilayer plastic.<\/p>\n\n\n\n To avoid contact with air, the Numata G16E is packaged in an outer bag with an oxygen barrier that contains an oxygen-absorbing bag and oxygen indicator.<\/p>\n\n\n\n Pack sizes<\/strong><\/p>\n\n\n\n 500 ml bag: 6 pcs in each carton.<\/p>\n\n\n\n 1 bag with 500 ml.<\/p>\n\n\n\n Not all pack sizes may be marketed.<\/p>\n\n\n\n Manufacturer<\/strong><\/p>\n\n\n\n Baxter SA<\/p>\n\n\n\n Boulevard Rene Branquart, 80<\/p>\n\n\n\n 7860 Lessines<\/p>\n\n\n\n Belgium<\/p>\n","protected":false},"excerpt":{"rendered":" Numeta G16E is an emulsion that contains nutrition specially designed for full-term, newborn babies and children up to 2 years. It is given through a tube that is placed in your child’s vein when your child can not get all the nutrition he or she needs by eating.<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"cybocfi_hide_featured_image":"","footnotes":""},"categories":[2200,15581],"tags":[19307,19303,19310,19308,19306,19309,19304,19305],"class_list":["post-19301","post","type-post","status-publish","format-standard","hentry","category-medicines","category-n","tag-benefits-of-numeta-g16e","tag-numeta-g16e","tag-numeta-g16e-dosage","tag-numeta-g16e-nutrition","tag-numeta-g16e-side-effects","tag-numeta-g16e-usage","tag-what-is-numeta-g16e","tag-what-numeta-g16e-is-used-for"],"_links":{"self":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/19301","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/comments?post=19301"}],"version-history":[{"count":4,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/19301\/revisions"}],"predecessor-version":[{"id":19336,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/19301\/revisions\/19336"}],"wp:attachment":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/media?parent=19301"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/categories?post=19301"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/tags?post=19301"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}Warnings and cautions<\/h2>\n\n\n\n
Other medicines and Numeta G16E<\/h2>\n\n\n\n
How to get Numeta G16E<\/h2>\n\n\n\n
If your child has been given too much Numeta<\/h2>\n\n\n\n
Possible side effects<\/h2>\n\n\n\n
How to store Numeta G16E<\/h2>\n\n\n\n
Contents of the package and other information<\/h2>\n\n\n\n
What the medicine looks like and contents of the pack<\/h2>\n\n\n\n
Package size<\/strong><\/th> 50 g \/ 100 ml glucose solution<\/strong><\/th> 5.9 g \/ 100 ml amino acid solution with electrolytes<\/strong><\/th> 12.5 g \/ 100 ml lipid emulsion<\/strong><\/th><\/tr><\/thead> 500 ml<\/td> 155 ml<\/td> 221 ml<\/td> 124 ml<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n Marketing Authorization Holder and Manufacturer<\/h2>\n\n\n\n