- Muhammad Nadeem
- March 7, 2022
- No Comments
G19E Infusion solution, emulsion
What Numeta G19E is and what it is used for
Numata G19E is an emulsion that contains nutrition specially designed for children older than 2 years and adolescents up to 18 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 G19E is supplied 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 G19E must be used under medical supervision.
What you need to know before your child receives Numeta G19E
Your child should not receive the Numeta G19E 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 G19E.
- 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 doctor should base his decision on possible treatment with Numeta G19E 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 G19E.
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 G19E contains glucose made from corn starch. Numata G19E 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 G19E) 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 G19E, “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.
Monitoring and adjustment:
Your doctor will closely monitor and adjust the dose of Numata G19E 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 G19E 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 G19E
Tell your doctor if your child is taking, has recently taken, or might take any other medicines.
Numata G19E 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 G19E and medicines that may affect potassium levels/degradation:
Numata G19E 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 ( antihypertensive drugs ), angiotensin II receptor antagonists ( antihypertensive drugs ), or immunosuppressive drugs (drugs that may inhibit the body’s normal immune system). These types of drugs can raise potassium levels.
Pregnancy, breastfeeding and fertility
There are no adequate data from the use of Numata G19E in pregnant or lactating women. The physician should carefully consider the potential risks and benefits for each patient before prescribing Numeta G19E.
How to get Numeta G19E
Your child should always receive Numeta G19E according to their doctor’s instructions. Consult a doctor if you are unsure.
Age groups
Numata G19E has been developed to meet the nutritional needs of children older than 2 years and adolescents up to 18 years.
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 G19E 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.
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 G19E. 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 G19E
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 G19E 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 red blood cell count ( 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 G19E
Keep this medicine out of the sight and reach of children.
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.
6. Contents of the package and other information
What the medicine looks like and contents of the pack
Numata G19E 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 |
|---|---|---|---|
| 1000 ml | 383 ml | 392 ml | 225 ml |
Appearance before preparation:
- The solutions in the amino acid and glucose chambers are clear, colorless or slightly yellow.
- The chamber with the lipid emulsion 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 the air, the Numata G19E is packaged in an outer bag with an oxygen barrier that contains an oxygen-absorbing bag and an oxygen indicator.
Pack sizes
1000 ml bag: 6 pcs in each carton.
1 bag with 1000 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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