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NUMETA G16%E EMULSION FOR INFUSION

Active substance(s): ALANINE / ARGININE / ASPARTIC ACID / CALCIUM CHLORIDE DIHYDRATE / CYSTEINE / GLUCOSE MONOHYDRATE / GLUTAMIC ACID / GLYCINE / HISTIDINE / ISOLEUCINE / LEUCINE / LYSINE MONOHYDRATE / MAGNESIUM ACETATE TETRAHYDRATE / METHIONINE / OLIVE OIL REFINED / ORNITHINE HYDROCHLORIDE

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Package leaflet: Information for the user
NUMETA G16%E 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 G16%E emulsion for infusion but will be referred to as NUMETA through
the remainder of this leaflet.

What is in this leaflet:
1. What NUMETA is and what it is used for
2. What you need to know before your child is given NUMETA
3. How NUMETA is given
4. Possible side effects
5. How to store NUMETA
6. Contents of the pack and other information

1. What NUMETA is and what it is used for
NUMETA G16%E 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.

2. What you need to know before your child is given NUMETA
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 their blood).
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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 their 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 G16%E) 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 G16%E, 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:
• severe post-traumatic conditions
• severe diabetes mellitus
• shock
• heart attack
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• severe infection
• certain types of coma
Use with caution:
NUMETA should be used with caution if your child has:
• pulmonary oedema (fluid in the lungs) or heart failure.
• severe liver problems.
• problems in using nutrients.
• high blood sugar.
• kidney problems.
• severe metabolic disorders (when the body cannot break down substances in a normal way).
• blood clotting disorders.
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 fats 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 fats 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.

3. How NUMETA is given
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 G16%E 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 fats 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 fat chambers remains intact in this case. The content of the bag
can then be infused without fats.
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.

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If your child is given too much NUMETA
Symptoms
Too much of this medicine, or giving it too quickly may result in the following:
• nausea (feeling sick)
• vomiting
• shivering
• electrolyte disturbances (improper amounts of electrolytes in the blood)
• signs of hypervolemia (increase of circulating blood volume)
• acidosis (increased acidity of the blood)
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:
• sweating
• shivering
• headache
• skin rashes
• breathing difficulties
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 fat level in the blood (hyperlipidaemia)
• Condition where bile cannot flow from the liver to the duodenum, a part of the intestines (cholestasis).
The following side effects have been reported with other products for parenteral nutrition:
The reduced or limited ability to remove the fats 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 fat emulsion is stopped:
• Sudden and abrupt worsening of the patient’s medical condition
• High levels of fats in the blood (hyperlipidaemia)
• Fever
• Liver enlargement and 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). BE-30-02-553
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By reporting side effects you can help provide more information on the safety of this medicine.
United Kingdom:
Yellow Card Scheme
www.mhra.gov.uk/yellowcard
Republic of Ireland:
HPRA Pharmacovigilance,
Earlsfort Terrace,
IRE – Dublin 2.
Tel: +353 1 6764971,
Fax: +353 1 6762517,
Website: www.hpra.ie;
E-mail: medsafety@hpra.ie

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.
Container size

500 mL

50% glucose solution

5.9% amino acids
solution with
electrolytes

155 mL

221 mL

12.5% lipid emulsion

124 mL

The active substances for each bag of the reconstituted emulsion are:
Ingredient (per bag)

2-in-1
376 mL

Per 2-in-1 or 3-in-1 admixture
Active substance
Alanine
Arginine
Aspartic acid
Cysteine
Glutamic acid
Glycine
Histidine
Isoleucine
Leucine
Lysine monohydrate
equivalent to Lysine
Methionine
Ornithine hydrochloride
equivalent to Ornithine
Phenylalanine
Proline
Serine

1.03 g
1.08 g
0.77 g
0.24 g
1.29 g
0.51 g
0.49 g
0.86 g
1.29 g
1.59 g
1.42 g
0.31 g
0.41 g
0.32 g
0.54 g
0.39 g
0.51 g
5a

500 mL

3-in-1
500 mL
1.03 g
1.08 g
0.77 g
0.24 g
1.29 g
0.51 g
0.49 g
0.86 g
1.29 g
1.59 g
1.42 g
0.31 g
0.41 g
0.32 g
0.54 g
0.39 g
0.51 g
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Ingredient (per bag)

2-in-1
376 mL

Per 2-in-1 or 3-in-1 admixture
Active substance
Taurine
Threonine
Tryptophan
Tyrosine
Valine
Sodium chloride
Potassium acetate
Calcium chloride dihydrate
Magnesium acetate tetrahydrate
Sodium glycerophosphate, hydrated
Glucose monohydrate
equivalent to Glucose anhydrous
Olive oil, refined + Soya bean oil, refined

500 mL

0.08 g
0.48 g
0.26 g
0.10 g
0.98 g
0.30 g
1.12 g
0.46 g
0.33 g
0.98 g
85.25 g
77.50 g


3-in-1
500 mL
0.08 g
0.48 g
0.26 g
0.10 g
0.98 g
0.30 g
1.12 g
0.46 g
0.33 g
0.98 g
85.25 g
77.50 g
15.5 g

The other ingredients are purified egg phosphatide, glycerol, sodium oleate, l-malic acid, hydrochloric
acid, sodium hydroxide, water for injections.
Appearance before reconstitution:
• The solutions in the amino acids and glucose chambers are clear, colorless or slightly yellow
• The fat 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
Baxter Healthcare Limited
Caxton Way, Thetford,
Norfolk, IP24 3SE,
UNITED KINGDOM
Manufacturer
BAXTER S.A.
BOULEVARD RENE BRANQUART, 80
7860 LESSINES
BELGIUM
This leaflet was last revised in 04/2016

For information about NUMETA or to request this leaflet in formats such as audio
or large print please contact the Marketing Authorisation Holder:
Tel: +44 (0)1635 206345.

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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:
• The non-permanent seals are intact. This is indicated by no mixture of any of the three chambers
• The amino acids solution and the glucose solution are clear, colorless, or slightly yellow without
visible particles
• The lipid emulsion is a uniform liquid with a milky white appearance.
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 use the bag if the colour of the oxygen absorber
does not match the reference colour printed next to the OK symbol.
To open: Remove the protective
overpouch. Discard the overpouch
and oxygen absorber.

Mixing: The product should be at room temperature when the non-permanent seals are broken. Place
the bag onto a flat clean surface. Do not use the bag if the contents have been mixed due to unintended
breaking of compartment seals during transport.
Activating the 3 chamber bag (mixing of 3 solutions)

Start rolling the bag from
the D-hanger side.

Apply pressure until peal
seals open.

Then change direction by rolling the
bag towards the D-hanger, continue
until the seal is completely opened.
Proceed the same way to complete
the opening of the second peel seal.

Turn the bag over at least
three times to mix the contents
thoroughly. The appearance of
the mixed solution should be a
milky‑white emulsion.

Remove the protective cap from
the administration site and
insert the administration set.

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Activating the 2 chambers (mixing 2 solutions)

To mix only 2 solutions,
roll the bag from the top
(hanger end) corner of
the seal separating the
solutions. Apply pressure
to open the seal separating
the glucose and amino
acids compartments.

Orient the bag such
that the lipid emulsion
compartment is nearest to
the operator. Roll the bag
while protecting the lipid
emulsion compartment in
the palms of the hands.

Apply pressure with one hand and
roll the bag toward the tubes.

Change direction by rolling
the bag towards the top
(hanger end). Press with
the other hand, continuing
until the seal separating the
amino acids and glucose
solutions is completely
opened.

Turn the bag over at
least three times to mix
the content thoroughly.
The appearance of the
mixed solution should be
clear, colorless or slightly
yellow.

Remove the protective cap from the
administration site and insert the
administration set.

The flow rate should be increased gradually during the first hour. The administration flow rate must be
adjusted based on the following factors:
• the dose being administered
• the daily volume intake
• the duration of the infusion.
Shelf Life after the Solutions are Mixed
Use the product immediately after the non-permanent seals between the two or three chambers have
been opened. Stability studies of the mixtures have been performed for 7 days between 2°C and 8°C
followed by 48 hours at 30°C.
Shelf life after supplementation (electrolytes, trace elements, vitamins, water):
For specific admixtures in-use stability of the Numeta formulation has been demonstrated for 7 days
between 2°C and 8°C followed by 48 hours at 30°C.
From a microbiological point of view, the product should be used immediately. If not used immediately,
in-use storage times and conditions prior to use are the responsibility of the user and would normally not
be longer than 24 hours at 2 to 8°C, unless reconstitution /dilution /supplementation has taken place in
controlled and validated aseptic conditions.
Do not use NUMETA if the bag is damaged. A damaged bag looks like this:
• The non-permanent seals are broken
• Any one of the chambers contains a mixture of any of the solutions
• The amino acids solution and the glucose solution are not clear, colorless, or slightly yellow, and/or
contain visible particles
• The lipid emulsion is not a uniform liquid with a milky white appearance.
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.

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What NUMETA G16%E contains
Ingredient (per bag)

2-in-1
376 mL

Per 2-in-1 or 3-in-1 admixture
Active substance
Alanine
Arginine
Aspartic acid
Cysteine
Glutamic acid
Glycine
Histidine
Isoleucine
Leucine
Lysine monohydrate
equivalent to Lysine
Methionine
Ornithine hydrochloride
equivalent to Ornithine
Phenylalanine
Proline
Serine
Taurine
Threonine
Tryptophan
Tyrosine
Valine
Sodium chloride
Potassium acetate
Calcium chloride dihydrate
Magnesium acetate tetrahydrate
Sodium glycerophosphate, hydrated
Glucose monohydrate
equivalent to Glucose anhydrous
Olive oil, refined + Soya-bean oil, refined

1.03 g
1.08 g
0.77 g
0.24 g
1.29 g
0.51 g
0.49 g
0.86 g
1.29 g
1.59 g
1.42 g
0.31 g
0.41 g
0.32 g
0.54 g
0.39 g
0.51 g
0.08 g
0.48 g
0.26 g
0.10 g
0.98 g
0.30 g
1.12 g
0.46 g
0.33 g
0.98 g
85.25 g
77.50 g


3b

500 mL

3-in-1
500 mL
1.03 g
1.08 g
0.77 g
0.24 g
1.29 g
0.51 g
0.49 g
0.86 g
1.29 g
1.59 g
1.42 g
0.31 g
0.41 g
0.32 g
0.54 g
0.39 g
0.51 g
0.08 g
0.48 g
0.26 g
0.10 g
0.98 g
0.30 g
1.12 g
0.46 g
0.33 g
0.98 g
85.25 g
77.50 g
15.5 g

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NUMETA solution/emulsion contains the following:
Characteristic (per 100 mL)
Per 2-in-1 or 3-in-1 admixture
Volume (mL)
Nitrogen (g)
Amino acids (g)
Glucose (g)
Lipids (g)
Energy:
Total calories (kcal)
Non-protein calories (kcal)
Glucose calories (kcal)
Lipid calories (kcal)
Electrolytes:
Sodium (mmol)
Potassium (mmol)
Magnesium (mmol)
Calcium (mmol)
Phosphate a (mmol)
Acetate (mmol)
Chloride (mmol)
Malate (mmol)
pH
Osmolarity (mOsm/l)

2-in-1
376
0.52
3.5
20.6
n.a.

500 mL

3-in-1
500
0.39
2.6
15.5
3.1

96
82
82
n.a.

103
93
62
31

3.1
3.0
0.41
0.82
0.85
3.9
3.7
1.1
5.5
1585

2.4
2.3
0.31
0.62
0.87
2.9
2.8
0.86
5.5
1230

a

Phosphate for 3-in-1 admixtures includes phosphorus from lipid emulsion (egg phospholipids)
n.a.: not applicable

The other ingredients are:
L-Malic acid a
Hydrochloric acid a
Purified egg phosphatide
Glycerol
Sodium oleate
Sodium hydroxide a
Water for injections
a

for pH adjustment

Baxter and Numeta are trademarks of Baxter International Inc.

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Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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