- Muhammad Nadeem
- March 7, 2022
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G16E Infusion solution, emulsion
What Numeta G16E is and what it is used for
Numata 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.
Numata G16E is provided as a three-chamber bag where the separate chambers contain:
- 50 mg / ml glucose solution (sugar)
- 5.9 mg / ml amino acid solution and electrolytes ( protein building blocks and salts)
- 12.5 mg / ml lipid emulsion (fat)
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.
The Numata G16E must be used under medical supervision.
What you need to know before your child receives Numeta G16E
Your child should not receive the Numeta G16E in the following cases:
When two solutions are mixed in the bag (“2 in 1”):
- if your child is allergic to egg protein, soy, peanuts or any of the ingredients in the glucose or amino acid chamber (listed in section 6).
- if your child’s body can not utilize the building blocks of protein .
- if your child has high blood levels of any of the electrolytes contained in Numeta G16E.
- If your baby is newborn (<28 days of age), Numeta G16E (or other calcium -containing solutions ) must not be given concomitantly with ceftriaxone (an antibiotic ), even if separate infusion lines are used. There is a risk of particles forming in the newborn’s bloodstream, which can be fatal.
- if your child has hyperglycaemia (too high blood sugar).
When three solutions are mixed in the bag (“3 in 1”).
- in all the above situations mentioned for “2 in 1” and the following:
- if your child has high blood fat levels.
In all cases, the physician should base his decision on possible treatment with Numeta G16E on factors such as age, weight, and clinical condition. The doctor will also take into account the results of any tests performed.
Warnings and cautions
Talk to your child’s doctor or nurse before giving your child Numeta G16E.
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. If Numeta G16E is exposed to ambient light, especially after the addition of trace elements and/or vitamins, peroxides and other degradation products are formed, which can be reduced if the product is protected from light exposure.
Allergic reactions:
The infusion must be stopped immediately if any signs or symptoms of an allergic reaction (such as fever, sweating, chills, headache, rash, or difficulty breathing) develop. This medicine contains soybean oil, which in rare cases may cause hypersensitivity reactions. In less common cases, it has been seen that some people who are allergic to peanut protein are also allergic to soy protein.
Numata G16E contains glucose made from corn starch. Numata G16E should be used with caution in patients with known allergies to maize or maize products.
Risk of particulate matter with ceftriaxone (an antibiotic):
A certain antibiotic, 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. Your doctor will know about this and will not give them to you together, not even through different infusion tubes or at different infusion sites.
However, the doctor may give calcium and 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 infusions, to avoid particle formation.
Formation of small particles in the blood vessels of the lungs:
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.
Infection and blood poisoning:
Your doctor will closely monitor your child for any signs of infection. The 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 infection.
Sometimes children can develop infection and sepsis (bacteria in the blood) when they have a tube in a vein ( intravenous catheter ). Some medicines and diseases may increase the risk of developing infection or sepsis. Patients who need parenteral nutrition (feeding via a tube into a blood vessel) may find it easier to develop an infection due to their medical condition.
Fat overload syndrome
Fat overload syndrome has been reported for similar drugs. If your body has reduced or decreased ability to get rid of the fats in Numata G16E, “fat overload syndrome” may occur (see section 4, Possible side effects ).
Changes in blood chemical levels:
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. Extra fluid in the tissues and swelling may also develop. It is recommended that parenteral nutrition be started slowly and carefully.
Elevated levels of magnesium in the blood
The amount of magnesium in Numata G16E can cause elevated levels of magnesium in the blood. Signs of this may include weakness, slow reflexes, nausea, vomiting, low blood calcium levels, difficulty breathing, low blood pressure, and irregular heartbeat. As 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 magnesium in the blood, including impaired kidney function. If the magnesium levels in the blood are elevated, the infusion will be stopped or reduced.
Monitoring and adjustment:
Your doctor will closely monitor and adjust the dose of Numata G16E to suit your child’s special needs if the child has the following conditions:
- severe post-traumatic stress disorder
- severe diabetes mellitus (diabetes)
- shock
- heart attack
- severe infection
- certain types of coma
Use with caution in:
Numata G16E should be used with caution if the child has:
- pulmonary edema (fluid in the lungs) or heart failure
- severe liver problems
- difficulty in absorbing nutrients
- high blood sugar
- kidney problems
- severe metabolic disorders (when various substances are not normally broken down in the body)
- coagulation disease (disorders of the blood’s ability to coagulate)
The baby’s fluid status, liver values , and/or blood values will be closely monitored.
Other medicines and Numeta G16E
Tell your doctor if your child is taking, has recently taken, or might take any other medicines.
Numata G16E must not be given at the same time as:
- ceftriaxone (an antibiotic ), also via different infusion lines due to the risk of particle formation.
- blood through the same infusion set due to the risk of pseudoagglutination (that the red blood cells clot together).
- ampicillin, phosphenytoin or furosemide via the same infusion lines due to the risk of particle formation.
Coumarin and warfarin (blood thinners):
Your doctor will closely monitor your child if the child is being treated with coumarin and warfarin. Olive and soybean oil naturally contain vitamin K1. Vitamin K1 can interact with drugs such as coumarin and warfarin. It is a blood-thinning drug that is used to prevent blood from clotting.
Laboratory tests:
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.
Interaction with Numeta G16E and medicines that may affect potassium levels/degradation:
Numata G16E contains potassium. High levels of potassium in the blood can cause abnormal heart rhythms. Particular caution should be exercised in patients taking diuretics ( diuretics ) or ACE inhibitors (medicines for high blood pressure ), angiotensin II receptor antagonists (medicines for high blood pressure ), or immunosuppressive medicines (medicines that can inhibit the body’s normal immune system ) . . These types of drugs can raise potassium levels.
How to get Numeta G16E
Your child should always receive Numeta G16E according to their doctor’s instructions. Consult a doctor if you are unsure.
Age groups
Numata G16E has been developed to meet the nutritional needs of full-term newborn infants and children up to 2 years of age.
Your doctor will decide if this medicine is suitable for your child.
Administration
This medicine is an emulsion for infusion. It is given through a plastic tube into a vein in your baby’s armor into a large vein in your baby’s breast.
Your child’s doctor may choose not to give lipids to you (fats) to your child. The bag with Numeta G16E is designed so that only the seal between the chambers with amino acids/electrolytes and glucose can be broken if necessary. The closure between the chambers of amino acids and lipids then remains intact. The contents of the bag can then be infused without lipids.
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 the administration is complete (see section 2).
Dosage and duration of treatment
Your child’s doctor decides what dose the child should receive and for how long the medicine should be given. Dose one depends on the child’s nutritional needs. Dosage one 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. Extra nutrients or protein can also be given, either by mouth or as an infusion into the bloodstream.
If your child has been given too much Numeta
If you have ingested too much medicine or if e.g. If a child has ingested the medicine by mistake, contact a doctor or hospital for risk assessment and advice.
Symptoms
Too much of this medicine or giving it too fast can lead to the following:
- nausea
- vomiting
- overindulge
- electrolyte disturbances (inappropriate amounts of electrolyte in your blood)
- signs of hypervolemia (increased circulating blood volume)
- acidosis (increased acidity of the blood).
In such situations, the infusion must be stopped immediately. Your child’s doctor will determine if further action is required.
To prevent this, your doctor should regularly monitor your child’s condition and test your child’s blood counts during treatment.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you notice any change in how your child feels during or after treatment, contact a doctor or nurse immediately.
The tests that your doctor performs while your child is taking this medicine should minimize the risk of side effects.
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:
- sweating
- overindulge
- headache
- rash
- breathing difficulties
Other side effects that have been observed are:
Common: may affect up to 1 in 10 users
- Low level of phosphate in the blood ( hypophosphatemia )
- High blood sugar ( hyperglycaemia )
- High calcium levels in the blood ( hypercalcaemia )
- High blood triglyceride levels ( hypertriglyceridemia )
- Electrolyte disturbances ( hyponatremia ).
Uncommon: may affect up to 1 in 100 people
- High levels of fats in the blood ( hyperlipidemia )
- Conditions where bile can not flow from the liver to the duodenum (bile stasis). The duodenum is one of the intestines
Has been reported: occurs in an unknown number of users (These side effects have only been reported for Numeta G13E and G16E administered peripherally and in insufficient dilution).
- Skin necrosis
- Soft tissue injury
- Leakage of the drug outside the blood vessel (extravasation).
The following side effects have been reported with other parenteral nutrition drugs:
Decreased or limited ability to get rid of the fats in Numata G16E can lead to “fat overload syndrome”. The following signs and symptoms of this syndrome are usually reversible when the infusion of one of the lipid emulsions is stopped:
- Sudden and abrupt deterioration of the patient’s medical condition.
- High blood fat levels ( hyperlipidemia )
- Fever
- Fatty infiltration of the liver ( hepatomegaly )
- Impaired liver function
- Decreased number of red blood cells ( anemia ), which can lead to pale skin and cause weakness or shortness of breath.
- Low white blood cell count ( leukopenia ), which may increase the risk of infection.
- Low platelet count ( thrombocytopenia ), which may increase the risk of bruising and / or bleeding.
- Coagulation disorders that affect the blood’s ability to coagulate.
- Coma , which requires hospitalization.
Formation of small particles that can block the blood vessels in the lungs ( pulmonary vascular deposits) or difficulty breathing.
How to store Numeta G16E
Keep this medicine out of the sight and reach of children.
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 the administration is complete (see section 2).
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.
Do not freeze.
Store in the outer bag.
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.
Contents of the package and other information
What the medicine looks like and contents of the pack
Numata G16E is supplied in a bag with three chambers. Each bag contains a sterile combination of a glucose solution, an amino acid solution for children with electrolytes, and a lipid emulsion as described below.
| Package size | 50 g / 100 ml glucose solution | 5.9 g / 100 ml amino acid solution with electrolytes | 12.5 g / 100 ml lipid emulsion |
|---|---|---|---|
| 500 ml | 155 ml | 221 ml | 124 ml |
Appearance before preparation:
- The solutions in the amino acid and glucose chambers are clear, colorless or slightly yellow.
- The lipid emulsion chamber contains a homogeneous liquid with a milk-like appearance.
Appearance after preparation:
- The 2 in 1 solution for infusion is clear, colorless or pale yellow
- “3 in 1” emulsion for infusion is homogeneous and milky
The bag with three chambers is made of multilayer plastic.
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.
Pack sizes
500 ml bag: 6 pcs in each carton.
1 bag with 500 ml.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Manufacturer
Baxter SA
Boulevard Rene Branquart, 80
7860 Lessines
Belgium
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