Document: Numeta G16E emulsion for infusion ENG PL change

• Numeta G16E emulsion for infusion PL
• Numeta G16E emulsion for infusion ENG PL

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Package leaflet: Information for the user

Numeta G16E emulsion for infusion

This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.

• If you have any further questions, ask your child’s doctor, pharmacist or nurse.

• If your child gets any side effects, talk to your child’s doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

The medicine is called Numeta G16E emulsion for infusion but will be referred to as Numeta through the remainder of this leaflet.

What is in this leaflet:

Numeta G16E is a specialised nutrition emulsion designed for full term newborns and children up to 2 years. It is given through a tube which is placed in your child’s vein, when your child is not able to eat all of his or her nutrition by mouth.

Numeta is presented in the form of a three chamber bag in which the separate chambers contain:

a 50 % glucose solution

a 5.9% paediatric amino acid solution, with electrolytes

a 12.5% lipid (fat) emulsion

Depending on your child’s needs, two or three of these solutions are mixed together in the bag before it is given to your child.

Numeta must only be used under medical supervision.

Your child should not be given Numeta, in the following cases:

With 2 solutions mixed together in the bag (“2 in 1”):

• If your child is allergic to egg proteins, soya, peanuts or to any ingredient in the glucose or amino acids chamber (listed in section 6).

• If your child’s body has problems using building blocks of protein.

• If your child has high concentrations of any of the electrolytes included in Numeta in their blood.

• If your child is newborn (≤28 days of age), Numeta (or other calcium containing solutions) must not be given at the same time as ceftriaxone (an antibiotic), even if separate infusion lines are used. There is a risk of particle formation in the newborn´s bloodstream which may be fatal.

• If your child has hyperglycaemia (especially high levels of sugar in his/her blood).

With 3 solutions mixed together in the bag (“3 in 1”).

• All of the above situations mentioned for the “2 in 1” plus the following:

• If your child has especially high level of fats in his/her blood.

In all cases, your doctor will base their decision on whether your child should receive this medicine on factors such as age, weight and clinical condition. Your doctor will also consider the results of any tests performed.

Warnings and precautions

Talk to your child’s doctor or nurse before they are given Numeta.

Allergic Reactions:

The infusion must be stopped immediately if any signs or symptoms of an allergic reaction (such as fever, sweating, shivering, headache, skin rashes, or difficulty breathing) develop. This medicinal product contains soybean oil, which may rarely cause hypersensitivity reactions. Uncommonly, it has been observed that some people who are allergic to peanut proteins are also allergic to soybean proteins.

Risk of particle formation with ceftriaxone (antibiotic):

A certain antibiotic named ceftriaxone must not be mixed or given simultaneously with any calcium containing solutions (including Numeta G16E) given to you by a drip into your vein.

Your doctor knows this and will not give you them together even via different infusion lines or different infusion sites.

However, your doctor may give calcium and ceftriaxone sequentially one after another if infusion lines at different sites are used or if the infusion lines are replaced or were thoroughly flushed with physiological salt solution between the infusions to avoid precipitation.

Formation of small particles in blood vessels of the lungs:

Difficulty breathing could also be a sign that small particles have formed, blocking blood vessels in the lungs (pulmonary vascular precipitates). If your child experiences any difficulty breathing, tell your child’s doctor or nurse. They will decide of a course of action to be taken.

Infection and Sepsis:

Your doctor will carefully watch your child for any signs of infection. An “aseptic technique” (germ free technique) when placing and maintaining the catheter as well as when making the nutritional formula can reduce the risk of infection.

Occasionally, children can develop infection and sepsis (bacteria in the blood) when they have a tube in their vein (intravenous catheter). Certain medications and illnesses can increase the risk of developing infection or sepsis. Patients who require parenteral nutrition (giving nutrition through a tube in your child’s vein) can be more likely to develop infection from their medical conditions.

Fat overload syndrome:

Fat overload syndrome has been reported with similar products. The reduced or limited ability of the body to remove the fats contained in Numeta may result in a "fat overload syndrome" (see section 4 – Possible Side Effects).

Changes in blood chemistry levels:

Your doctor will check and monitor your child’s fluids, blood chemistries and other blood levels since occasionally, refeeding someone who is severely undernourished can result in changes in blood chemistry levels. Extra fluid in the tissues and swelling can also develop. It is recommended that parenteral nutrition is started slowly and carefully.

Elevated levels of Magnesium in blood

The amount of magnesium in Numeta G16E, may cause elevated levels of magnesium in blood. The signs of this could include weakness, slow reflexes, nausea, vomiting, low calcium levels in blood, breathing difficulties, low blood pressure and irregular heartbeat. As these signs may be difficult to detect, your child´s blood values may be monitored by their doctor, in particular if your child has risk factors for elevated levels of magnesium in blood, including impaired renal function. If blood magnesium levels are elevated, the infusion will be stopped or reduced.

Monitoring and Adjustment:

Your doctor will be closely monitoring and adjusting Numeta to meet your child’s individual needs if they have the following conditions:

Use with caution:

Numeta should be used with caution if your child has:

Your child´s fluid status, liver test values and/or blood values will be closely monitored.

Other medicines and Numeta

Tell your doctor if your child is taking or using, has recently taken or used or might take or use any other medicines.

Numeta must not be given at the same time as:

• blood through the same infusion tubing due to the risk of pseudoagglutination (red blood cells becoming stuck together in a stack).

• ceftriaxone (an antibiotic) because of the risk of particle formation.

Coumarin and warfarin (Anticoagulants):

Your doctor will carefully watch your child if they are taking coumarin or warfarin. Olive and soybean oil have a natural content of vitamin K1. Vitamin K1 may interfere with drugs such as coumarin and warfarin. These drugs are anticoagulants used to prevent clotting of the blood.

Laboratory tests:

The lipids contained in this emulsion may interfere with the results of certain laboratory tests. Laboratory tests may be performed after a period of 5 to 6 hours when no additional lipids are administered.

Interactions of Numeta on drugs that may affect potassium levels/metabolism:

Numeta contains potassium. High levels of blood potassium may cause abnormal heart rhythm. Special care should be taken in patients taking diuretics (drugs to reduce fluid retention) or ACE inhibitors (drugs for high blood pressure)or angiotensin II receptor antagonists (drugs for high

blood pressure) or immunosuppressants(drugs that may lower the body’s normal immune defences).These types of drugs may increase potassium levels.

Your child should always be given Numeta exactly as the doctor has indicated. Check with your doctor if you are not sure.

Age groups

Numeta G16E has been designed to meet the nutritional needs of full term newborns and children up to 2 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 in a vein in your child’s arm or in a large vein in your child’s chest.

Your child’s doctor may choose not to give lipids to your child. The design of the Numeta bag allows only the peel seal between the amino acids/electrolyte and glucose chambers to be broken if necessary. The peel seal between the amino acids and lipid chambers remains intact in this case. The content of the bag can then be infused without lipids.

Dosage and duration of treatment

Your child’s doctor will decide the dose and for how long it will be given. The dosage depends on the nutrition needs of your child. The dosage will be based on your child’s weight, medical condition, and on their body’s ability to break down and use the ingredients in Numeta. Additional nutrition or proteins given orally/enterally may also be given.

If your child is given too much Numeta

Symptoms

Too much of this medicine, or giving it too quickly may result in the following:

In such situations, the infusion must be stopped immediately. Your child’s doctor will decide if additional actions are required.

To prevent these events occurring, the doctor will regularly monitor your child’s condition and test their blood levels during treatment.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not every child gets them.

If you notice any changes in the way your child feels during or after the treatment, tell your doctor or nurse straight away.

The tests your doctor will perform while your child is taking the medicine should minimise the risk of side effects.

If signs of an allergic reaction occur, the infusion shall be stopped and a doctor contacted immediately. This can be serious and the signs may include:

Other side effects that have been noticed are:

Common: may affect up to 1 in 10 people

• Low phosphate level in the blood (hypophosphataemia)

• High sugar level in the blood (hyperglycaemia)

• High calcium level in the blood (hypercalcaemia)

• High triglycerides level in the blood (hypertriglyceridaemia)

• Electrolyte disturbance (hyponatraemia)

Uncommon: may affect up to 1 in 100 people

• High lipid level in the blood (hyperlipidaemia)

• Condition where bile cannot flow from the liver to the duodenum (cholestasis). The duodenum is a part of the intestines.

The following side effects have been reported with other products for parenteral nutrition:

The reduced or limited ability to remove the lipids contained in Numeta may result in a "fat overload syndrome”. The following signs and symptoms of this syndrome are usually reversible when the infusion of the lipid emulsion is stopped:

• Sudden and abrupt worsening of the patient’s medical condition

• High levels of fats in the blood (hyperlipidaemia)

• Fever

• Liver fatty infiltration (hepatomegaly)

• Worsening liver function

• Reduction in red blood cells which can make the skin pale and cause weakness or breathlessness (anaemia)

• Low white blood cell count, which can increase the risk of infection (leukopenia)

• Low platelet count which can increase the risk of bruising and/or bleeding (thrombocytopenia)

• Coagulation disorders which effect the ability of the blood to clot

• Coma, requiring hospitalisation.

Formation of small particles which may lead to blockage of blood vessels in the lungs (pulmonary vascular precipitates) or difficulty breathing.

Reporting of side effects

If your child gets any side effects talk to your child’s doctor or nurse. This includes any possible side effects not listed in this leaflet.

You can also report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine.

[to be completed nationally according to the national reporting system listed in Appendix V]

5. How to store Numeta

Keep this medicine out of the sight and reach of children when not being administered.

Do not use this medicine after the expiry date which is stated on the bag and the outer packaging (MM/YYYY). The expiry date refers to the last day of that month.

Do not freeze.

Store in the overpouch.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Numeta looks like and contents of the pack

Numeta is presented in the form of a triple-chamber bag. 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.

Appearance before reconstitution:

• The solutions in the amino acids and glucose chambers are clear, colorless or slightly yellow

• The lipid emulsion chamber is a uniform and milky-white liquid

Appearance after reconstitution:

• “2 in 1” solution for infusion is clear, colorless or slightly yellow

• “3 in 1” emulsion for infusion is uniform and milky-white

The three-compartment bag is a multi-layer plastic bag.

To prevent air contact, Numeta is packaged in an oxygen barrier overpouch that may also contain an oxygen absorber.

Pack sizes

500 mL bag: 6 units per cardboard box

1 bag of 500 mL

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

{Name and address} [To be completed nationally]

Manufacturer

BAXTER S.A.

BOULEVARD RENE BRANQUART, 80

7860 LESSINES

BELGIUM

This medicinal product is authorised in the Member States of the EEA under the following names:

Austria Germany	Numeta G 16 % E Emulsion zur Infusion
Belgium Luxembourg	NUMETZAH G16%E, émulsion pour perfusion
France	NUMETAH G16 %E émulsion pour perfusion
Denmark Norway Sweden	Numeta G16E
Czech Republic Greece	NUMETA G 16 % E
Netherlands	NUMETA G16%E emulsie voor infusie
Ireland United Kingdom	Numeta G16%E, Emulsion for Infusion
Italy	NUMETA G16%E emulsione per infusione
Finland	Numeta G16E infuusioneste, emulsio
Poland	NUMETA G 16 % E
Portugal	Numeta G16%E
Spain	NUMETA G16%E, emulsión para perfusión

This leaflet was last revised 2016-04-08.

The following information is intended for medical or healthcare professionals only*

*Please observe that in certain cases this product may be administered at home by parents or other caregivers. In such cases parents/caregivers should read the following information.

No additions to the bag should be made without first checking the compatibility. Formation of particles or breaking down of the lipid emulsion could result. This can lead to blockage of the blood vessels.

Numeta should be at room temperature before use.

Before taking Numeta, the bag will be prepared as shown below.

Confirm that the bag is not damaged. Use the bag only if it is not damaged. An undamaged bag looks like this:

Before opening the overpouch, check the colour of the oxygen absorber . The oxygen absorber is a coloured disc that may be included in the overpouch. Check the reference colour printed next to the OK symbol in the printed area of the indicator label. Do not be use the bag if the colour of the oxygen absorber does not match the reference colour printed next to the OK symbol.