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CLINIMIX N17G35 SOLUTION FOR INFUSION

Active substance(s): AMINO ACID MIXTURE D / GLUCOSE MONOHYDRATE / GLYCINE

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Clinimix, solution for infusion
UK Package Leaflet Consolidated

Page 1 of 21
Dec 2013

Package leaflet: Information for the patient








Read all of this leaflet carefully before this medicine is administered, 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 doctor or nurse.
If you get any side effects, talk to your doctor or nurse. This includes any possible side effects
not listed in this leaflet. See section 4.

What is in this leaflet:
1.
2.
3.
4.
5.
6.

What CLINIMIX is and what it is administered for
What you need to know before CLINIMIX is administered
How CLINIMIX is administered
Possible side effects
How to store CLINIMIX
Contents of the pack and other information

1.

What CLINIMIX is and what it is administered for

CLINIMIX is a solution for infusion. It is supplied in a bag with 2 chambers. One chamber contains an
amino acid solution [For formulations with electrolytes only] and the second
contains a glucose solution [For formulations with electrolytes only]. The
chambers are separated by a non-permanent seal. Just before administration, the contents of the
chambers are mixed together by rolling the top of the bag to open the seals.
CLINIMIX is administered to provide nutrition in adults and children by a tube into a vein when
normal feeding by mouth is not suitable.
CLINIMIX must only be administered under medical supervision.

Baxter Confidential

Clinimix, solution for infusion
UK Package Leaflet Consolidated

2.

Page 2 of 21
Dec 2013

What you need to know before CLINIMIX is administered

CLINIMIX shall not be administered if
-

-

you are allergic to any of the ingredients of this medicine (listed in section 6).
your body has problems using certain amino acids.
you have too much sugar in your blood (severe hyperglycaemia),
your blood is excessively acid (metabolic acidosis due to an excess of lactate),
(hypernatraemia, hyperkalemia, hypermagnesemia, hypercalcemia and/or hyperphosphatemia)>
[For formulations with electrolytes only].
For formulations with electrolytes only:

In all cases, your doctor will base his/her decision on whether you should receive this medicine on
factors such as age, weight and clinical condition, together with the results of any tests performed.
Warnings and precautions
Talk to your doctor or nurse before CLINIMIX is administered.
If any abnormal signs or symptoms of an allergic reaction develop, such as fever, chills, skin rashes or
difficulty in breathing, excessive sweating, nausea or headache, tell the doctor or the nurse: the
infusion will be stopped immediately. Your doctor will monitor your condition while you receive this
medicine and may change the dosage or give you additional nutrients such as lipids, vitamins,
electrolytes and trace elements if he/she feels it is appropriate.
Certain medications and illnesses can increase the risk of developing infection or sepsis (bacteria in
the blood). There is a particular risk of infection or sepsis when a tube (intravenous catheter) is placed
in your vein. Your doctor will carefully watch you for any signs of infection. Using aseptic (germ
free) techniques when placing and maintaining the catheter and when making the nutritional formula
can reduce the risk of infection.
If you are severely malnourished such that you need to receive feeding through a vein, it is
recommended that parenteral nutrition is started slowly and carefully.
Your doctor will monitor your condition at the onset of the infusion, particularly if you currently have
liver, kidney, adrenal, heart or circulation problems. Your doctor should also be aware of severe
conditions affecting how your body handles sugars, fats, proteins or salt (metabolic disorders).
Should any abnormal sign occur, including venous irritation, the infusion must be stopped.
To check the effectiveness and ongoing safety of the administration, your doctor will perform clinical
and laboratory tests while you are receiving this medicine. If you are given this medicine for several
weeks, your blood will be monitored on a regular basis. In particular, in case of glucose intolerance,
blood and urine glucose should be monitored on a routine basis, and, if you are a diabetic patient,
insulin dosage may have to be adapted.
Other medicines and CLINIMIX
Tell your doctor if you are taking or using, have recently taken or used or might take or use any other
medicines.
For formulations with electrolytes only: CLINIMIX with electrolytes contains calcium. It should not
be given together with the antibiotic ceftriaxone because particles may form.
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Clinimix, solution for infusion
UK Package Leaflet Consolidated

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Dec 2013

For formulations with electrolytes only: Due to the potassium content of CLINIMIX, special care
should be taken in patients treated with potassium-saving diuretics (e.g, amiloride, spironolactone,
triamterene) angiotensin converting enzyme (ACE) inhibitors, angiotensin II receptor antagonists or
the immunosuppressants tacrolimus or cyclosporine in view of the risk of hyperkalemia.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask
your doctor for advice before this medicine is administered.

3.

How CLINIMIX is administered

Before the product is administered, the non-permanent seal between the two compartments should be
broken and the contents of the two compartments should be mixed.
CLINIMIX can be given in adults and children.
It is a solution for infusion, to be administered via a plastic tube into a vein in your arm or into a large
vein in your chest.
Dosage - Adults and Children
Your doctor will decide the dose you will need and for how long it will be given. This will depend on
age, weight and height, clinical condition, daily fluid volume, energy and nitrogen requirements.
Always take CLINIMIX exactly as your doctor has told you. You should check with your doctor if
you are not sure.
The prescription may be continued for as long as it is needed, depending upon your clinical condition.
The infusion of one bag usually lasts between 8 and 24 hours.
If more CLINIMIX was administered than should have been
If the dose given is too high or the infusion too fast, you may have an increased volume of circulating
blood or your blood may become too acid. The glucose content may increase the glucose in your blood
and urine. Giving too high a volume may cause nausea, vomiting, shivering, and electrolyte
disturbances, in such situations the infusion should be stopped immediately.
In some severe cases, your doctor may have to give you temporary renal dialysis to help your kidneys
eliminate the excess product.
To prevent these events occurring, your doctor will regularly monitor your condition and test your
blood parameters.
If you have any further questions on the use of this product, ask your doctor.

4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. If you
notice any changes in the way you feel during or after the treatment, tell your doctor or nurse straight
away.
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Clinimix, solution for infusion
UK Package Leaflet Consolidated

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Dec 2013

The tests your doctor will perform while the medicine is administered to you should minimise the risk
of side effects.
If any abnormal signs or symptoms of an allergic reaction develop, such as abnormally low or high
blood pressure, appearance of a blue or purple coloration of the skin, abnormally high heart rate,
breathing difficulties, vomiting, nausea, skin rashes, raised body temperature, excessive sweating
chills, and shivering, the infusion will be stopped immediately.
Other side effects have been noticed, occurring more or less frequently:
• Anaphylaxis (a serious allergic reaction that is rapid in onset and may cause death)
• High blood level of glucose, ammonia and nitrogen-containing compounds
• Impairment of hepatic functions, abnormal blood test for the liver function
• Inflammation of the gall bladder, the presence of gallstones in the gallbladder
• Vein inflammation at infusion site, venous irritation, pain, irritation, warmth, swelling
• Presence of glucose in urine
• Diabetic coma
• Formation of small particles blocking lung blood vessels
Reporting of side effects
If you get any side effects, talk to your 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.
IRELAND
FREEPOST,
Pharmacovigilance Section,
Irish Medicines Board,
Kevin O’Malley House,
Earlsfort Centre,
Earlsfort Terrace,
Dublin 2,
Ireland.
Tel: +353 1 6764971,
Fax: +353 1 6762517,
Website: www.imb.ie
e-mail: imbpharmacovigilance@imb.ie
UK
Via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
5.

How to store CLINIMIX

Keep this medicine out of the sight and reach of children.
This medicine should not be administered after the expiry date, which is stated on the container and
the outer packaging (MM/YYYY). The expiry date refers to the last day of that month.
Do not freeze.
Keep the container in the outer carton.
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.

Baxter Confidential

Clinimix, solution for infusion
UK Package Leaflet Consolidated

6.

Page 5 of 21
Dec 2013

Contents of the pack and other information

What CLINIMIX contains
The active substances for each bag of the reconstituted solution are:
[For CLINIMIX N9G15E]
Active substances
L-alanine
L-arginine
Glycine
L-histidine
L-isoleucine
L-leucine
L-lysine
(as lysine hydrochloride)
L-methionine
L-phenylalanine
L-proline
L-serine
L-threonine
L-tryptophan
L-tyrosine
L-valine
Sodium acetate, 3H2O
Dibasic potassium phosphate
Sodium chloride
Magnesium chloride, 6H2O
Glucose anhydrous
(as glucose monohydrate)
Calcium chloride, 2H2O

1l
5.70 g
3.17 g
2.84 g
1.32 g
1.65 g
2.01 g
1.60 g
(2.00 g)
1.10 g
1.54 g
1.87 g
1.38 g
1.16 g
0.50 g
0.11 g
1.60 g
2.16 g
2.61 g
1.12 g
0.51 g
75 g
(83 g)
0.33 g

1.5 l
8.54 g
4.75 g
4.25 g
1.98 g
2.48 g
3.02 g
2.39 g
(2.99 g)
1.65 g
2.31 g
2.81 g
2.06 g
1.73 g
0.74 g
0.17 g
2.39 g
3.23 g
3.92 g
1.68 g
0.77 g
113 g
(124 g)
0.50 g

2l
11.38 g
6.32 g
5.66 g
2.64 g
3.30 g
4.02 g
3.19 g
(4.00 g)
2.20 g
3.08 g
3.74 g
2.75 g
2.31 g
0.99 g
0.22 g
3.19 g
4.31 g
5.22 g
2.24 g
1.02 g
150 g
(165 g)
0.66 g

1l
5.70 g
3.17 g
2.84 g
1.32 g
1.65 g
2.01 g
1.60 g
(2.00 g)
1.10 g
1.54 g
1.87 g
1.38 g
1.16 g
0.50 g
0.11 g
1.60 g
2.16 g
2.61 g
1.12 g

1.5 l
8.54 g
4.75 g
4.25 g
1.98 g
2.48 g
3.02 g
2.39 g
(2.99 g)
1.65 g
2.31 g
2.81 g
2.06 g
1.73 g
0.74 g
0.17 g
2.39 g
3.23 g
3.92 g
1.68 g

2l
11.38 g
6.32 g
5.66 g
2.64 g
3.30 g
4.02 g
3.19 g
(4.00 g)
2.20 g
3.08 g
3.74 g
2.75 g
2.31 g
0.99 g
0.22 g
3.19 g
4.31 g
5.22 g
2.24 g

[For CLINIMIX N9G20E]
Active substances
L-alanine
L-arginine
Glycine
L-histidine
L-isoleucine
L-leucine
L-lysine
(as lysine hydrochloride)
L-methionine
L-phenylalanine
L-proline
L-serine
L-threonine
L-tryptophan
L-tyrosine
L-valine
Sodium acetate, 3H2O
Dibasic potassium phosphate
Sodium chloride

Baxter Confidential

Clinimix, solution for infusion
UK Package Leaflet Consolidated

Magnesium chloride, 6H2O
Glucose anhydrous
(as glucose monohydrate)
Calcium chloride, 2H2O

Page 6 of 21
Dec 2013

0.51 g
100 g
(110 g)
0.33 g

0.77 g
150 g
(165 g)
0.50 g

1.02 g
200 g
(220 g)
0.66 g

1l
7.25 g
4.03 g
3.61 g
1.68 g
2.10 g
2.56 g
2.03 g
(2.54 g)
1.40 g
1.96 g
2.38 g
1.75 g
1.47 g
0.63 g
0.14 g
2.03 g
100 g
(110 g)

1.5 l
10.87 g
6.04 g
5.41 g
2.52 g
3.15 g
3.83 g
3.05 g
(3.80 g)
2.10 g
2.94 g
3.57 g
2.63 g
2.21 g
0.95 g
0.21 g
3.05 g
150 g
(165 g)

2l
14.49 g
8.05 g
7.21 g
3.36 g
4.20 g
5.11 g
4.06 g
(5.07 g)
2.80 g
3.92 g
4.76 g
3.50 g
2.94 g
1.26 g
0.28 g
4.06 g
200 g
(220 g)

1l
7.25 g
4.03 g
3.61 g
1.68 g
2.10 g
2.56 g
2.03 g
(2.54 g)
1.40 g
1.96 g
2.38 g
1.75 g
1.47 g
0.63 g
0.14 g
2.03 g
2.58 g
2.61 g
0.94 g
0.52 g
100 g
(110 g)
0.33 g

1.5 l
10.87 g
6.04 g
5.41 g
2.52 g
3.15 g
3.83 g
3.05 g
(3.80 g)
2.10 g
2.94 g
3.57 g
2.63 g
2.21 g
0.95 g
0.21 g
3.05 g
3.86 g
3.92 g
1.41 g
0.77 g
150 g
(165 g)
0.50 g

2l
14.49 g
8.05 g
7.21 g
3.36 g
4.20 g
5.11 g
4.06 g
(5.07 g)
2.80 g
3.92 g
4.76 g
3.50 g
2.94 g
1.26 g
0.28 g
4.06 g
5.15 g
5.22 g
1.88 g
1.02 g
200 g
(220 g)
0.66 g

[For CLINIMIX N12G20]
Active substances
L-alanine
L-arginine
Glycine
L-histidine
L-isoleucine
L-leucine
L-lysine
(as lysine hydrochloride)
L-methionine
L-phenylalanine
L-proline
L-serine
L-threonine
L-tryptophan
L-tyrosine
L-valine
Glucose anhydrous
(as glucose monohydrate)
[For CLINIMIX N12G20E]
Active substances
L-alanine
L-arginine
Glycine
L-histidine
L-isoleucine
L-leucine
L-lysine
(as lysine hydrochloride)
L-methionine
L-phenylalanine
L-proline
L-serine
L-threonine
L-tryptophan
L-tyrosine
L-valine
Sodium acetate, 3H2O
Dibasic potassium phosphate
Sodium chloride
Magnesium chloride, 6H2O
Glucose anhydrous
(as glucose monohydrate)
Calcium chloride, 2H2O
[For CLINIMIX N14G30]
Baxter Confidential

Clinimix, solution for infusion
UK Package Leaflet Consolidated

Active substances
L-alanine
L-arginine
Glycine
L-histidine
L-isoleucine
L-leucine
L-lysine
(as lysine hydrochloride)
L-methionine
L-phenylalanine
L-proline
L-serine
L-threonine
L-tryptophan
L-tyrosine
L-valine
Glucose anhydrous
(as glucose monohydrate)

Page 7 of 21
Dec 2013

1l
8.80 g
4.89 g
4.38 g
2.04 g
2.55 g
3.11 g
2.47 g
(3.08 g)
1.70 g
2.38 g
2.89 g
2.13 g
1.79 g
0.77 g
0.17 g
2.47 g
150 g
(165 g)

1.5 l
13.20 g
7.34 g
6.57 g
3.06 g
3.83 g
4.66 g
3.70 g
(4.62 g)
2.55 g
3.57 g
4.34 g
3.19 g
2.68g
1.15 g
0.26 g
3.70 g
225 g
(248 g)

2l
17.60 g
9.78 g
8.76 g
4.08 g
5.10 g
6.20 g
4.93 g
(6.16 g)
3.40 g
4.76 g
5.78 g
4.25 g
3.57 g
1.53 g
0.34 g
4.93 g
300 g
(330 g)

1l
8.80 g
4.89 g
4.38 g
2.04 g
2.55 g
3.11 g
2.47 g
(3.08 g)
1.70 g
2.38 g
2.89 g
2.13 g
1.79 g
0.77 g
0.17 g
2.47 g
2.97 g
2.61 g
0.77 g
0.51 g
150 g
(165 g)
0.33 g

1.5 l
13.20 g
7.34 g
6.57 g
3.06 g
3.83 g
4.66 g
3.70 g
(4.62 g)
2.55 g
3.57 g
4.34 g
3.19 g
2.68g
1.15 g
0.26 g
3.70 g
4.46 g
3.92 g
1.16 g
0.77 g
225 g
(148 g)
0.50 g

2l
17.60 g
9.78 g
8.76 g
4.08 g
5.10 g
6.20 g
4.93 g
(6.16 g)
3.40 g
4.76 g
5.78 g
4.25 g
3.57 g
1.53 g
0.34 g
4.93 g
5.94 g
5.22 g
1.54 g
1.02 g
300 g
(330g)
0.66 g

1l
10.35 g
5.75 g
5.15 g
2.40 g

1.5 l
15.53 g
8.63 g
7.73 g
3.60 g

2l
20.70 g
11.50 g
10.30 g
4.80 g

[For CLINIMIX N14G30E]
Active substances
L-alanine
L-arginine
Glycine
L-histidine
L-isoleucine
L-leucine
L-lysine
(as lysine hydrochloride)
L-methionine
L-phenylalanine
L-proline
L-serine
L-threonine
L-tryptophan
L-tyrosine
L-valine
Sodium acetate, 3H2O
Dibasic potassium phosphate
Sodium chloride
Magnesium chloride, 6H2O
Glucose anhydrous
(as glucose monohydrate)
Calcium chloride, 2H2O
[For CLINIMIX N17G35]
Active substances
L-alanine
L-arginine
Glycine
L-histidine

Baxter Confidential

Clinimix, solution for infusion
UK Package Leaflet Consolidated

L-isoleucine
L-leucine
L-lysine
(as lysine hydrochloride)
L-methionine
L-phenylalanine
L-proline
L-serine
L-threonine
L-tryptophan
L-tyrosine
L-valine
Glucose anhydrous
(as glucose monohydrate)

Page 8 of 21
Dec 2013

3.00 g
3.65 g
2.90 g
(3.63 g)
2.00 g
2.80 g
3.40g
2.50 g
2.10 g
0.90 g
0.20 g
2.90 g
175 g
(193 g)

4.50 g
5.48 g
4.35 g
(5.44 g)
3.00 g
4.20 g
5.10 g
3.75 g
3.15 g
1.35 g
0.30 g
4.35 g
263 g
(289 g)

6.00 g
7.30 g
5.80 g
(7.25 g)
4.00 g
5.60 g
6.80 g
5.00 g
4.20 g
1.80 g
0.40 g
5.80 g
350 g
(385 g)

1l
10.35 g
5.75 g
5.15 g
2.40 g
3.00 g
3.65 g
2.90 g
(3.63 g)
2.00 g
2.80 g
3.40g
2.50 g
2.10 g
0.90 g
0.20 g
2.90 g
3.40 g
2.61 g
0.59 g
0.51 g
175 g
(193 g)
0.33 g

1.5 l
15.53 g
8.63 g
7.73 g
3.60 g
4.50 g
5.48 g
4.35 g
(5.44 g)
3.00 g
4.20 g
5.10 g
3.75 g
3.15 g
1.35 g
0.30 g
4.35 g
5.10 g
3.92
0.88 g
0.77 g
263 g
(289 g)
0.50 g

2l
20.70 g
11.50 g
10.30 g
4.80 g
6.00 g
7.30 g
5.80 g
(7.25 g)
4.00 g
5.60 g
6.80 g
5.00 g
4.20 g
1.80 g
0.40 g
5.80 g
6.80 g
5.22 g
1.17 g
1.02 g
350 g
(385 g)
0.66 g

[For CLINIMIX N17G35E]
Active substances
L-alanine
L-arginine
Glycine
L-histidine
L-isoleucine
L-leucine
L-lysine
(as lysine hydrochloride)
L-methionine
L-phenylalanine
L-proline
L-serine
L-threonine
L-tryptophan
L-tyrosine
L-valine
Sodium acetate, 3H2O
Dibasic potassium phosphate
Sodium chloride
Magnesium chloride, 6H2O
Glucose anhydrous
(as glucose monohydrate)
Calcium chloride, 2H2O

The other ingredients are:
- acetic acid, hydrochloric acid (to adjust pH of the solution),
- water for injections.
What CLINIMIX looks like and contents of the pack
CLINIMIX is a solution for infusion packaged in a two-chamber bag, which is a multi-layer plastic
bag. The inner (contact) layer of the bag material is designed to be compatible with the constituents
and authorised additives.
Prior to the reconstitution, the amino acid and the glucose solutions are clear and colourless or slightly
yellow. After the reconstitution, the solution is clear and colourless or slightly yellow too.

Baxter Confidential

Clinimix, solution for infusion
UK Package Leaflet Consolidated

Page 9 of 21
Dec 2013

To prevent contact with oxygen from the air the bag is packaged in an oxygen barrier overpouch,
which contains an oxygen absorber sachet.
Pack sizes
1000 ml bag: carton with 8 bags
1000 ml: 1 bag
1500 ml bag: carton with 6 bags
1500 ml: 1 bag
2000 ml bag: carton with 4 bags
2000 ml: 1 bag
Not all pack sizes may be marketed.
Marketing Authorisation Holder
For any information about CLINIMIX, please contact the Marketing Authorisation Holder:
Baxter Healthcare Ltd
Caxton Way
Thetford
Norfolk
IP24 3SE
The United Kingdom
Manufacturers
Baxter Healthcare, Caxton way, Thetford, Norfolk IP24 3SE, The United Kingdom
Baxter, Boulevard René Branquart, 80, 7860 Lessines, Belgium
This medicinal product is authorised in the Member States of the EEA under the following
names:
[For CLINIMIX N9G15E]
[For CLINIMIX N9G20E]
[For CLINIMIX N12G20]
[For CLINIMIX N12G20E]
[For CLINIMIX N14G30]
[For CLINIMIX N14G30E]
[For CLINIMIX N17G35]
[For CLINIMIX N17G35E]
In some countries it is registered under a different trade name, as described below:
Austria:

[For CLINIMIX N9G15E]
For CLINIMIX N17G35E]

Germany:

[For CLINIMIX N12G20E]
[For CLINIMIX N14G30E]
[For CLINIMIX N17G35E]

This leaflet was last revised in 12/2013
--------------------------------------------------------------------------------------------------------------------------Baxter Confidential

Clinimix, solution for infusion
UK Package Leaflet Consolidated

Page 10 of 21
Dec 2013

The following information is intended for healthcare professionals only:
1.

QUANTITATIVE COMPOSITION

After the contents of the two compartments have been mixed, the composition of the binary mixture,
for all available bag sizes, provides the following:
[For CLINIMIX N9G15E]

Nitrogen (g)
Amino acids (g)
Glucose (g)
Total calories (kcal)
Glucose calories (kcal)
Sodium (mmol)
Potassium (mmol)
Magnesium (mmol)
Calcium (mmol)
Acetate (mmol)
Chloride (mmol)
Phosphate as HPO42- (mmol)
pH
Osmolarity (mOsm/l)

1l
4.6
28
75
410
300
35
30
2.5
2.3
50
40
15

1.5 l
6.8
41
113
615
450
53
45
3.8
3.4
75
60
23
6
845

2l
9.1
55
150
820
600
70
60
5.0
4.5
100
80
30

1l
4.6
28
100
510
400
35
30
2.5
2.3
50
40
15

1.5 l
6.8
41
150
765
600
53
45
3.8
3.4
75
60
23
6
980

2l
9.1
55
200
1020
800
70
60
5.0
4.5
100
80
30

[For CLINIMIX N9G20E]

Nitrogen (g)
Amino acids (g)
Glucose (g)
Total calories (kcal)
Glucose calories (kcal)
Sodium (mmol)
Potassium (mmol)
Magnesium (mmol)
Calcium (mmol)
Acetate (mmol)
Chloride (mmol)
Phosphate as HPO42- (mmol)
pH
Osmolarity (mOsm/l)

Baxter Confidential

Clinimix, solution for infusion
UK Package Leaflet Consolidated

Page 11 of 21
Dec 2013

[For CLINIMIX N12G20]

Nitrogen (g)
Amino acids (g)
Glucose (g)
Total calories (kcal)
Glucose calories (kcal)
Acetate (mmol)
Chloride (mmol)
pH
Osmolarity (mOsm/l)

1l
5.8
35
100
540
400
27
15

1.5 l
8.7
53
150
810
600
41
22
6
920

2l
11.6
70
200
1080
800
54
29

1l
5.8
35
100
540
400
35
30
2.5
2.3
60
40
15

1.5 l
8.7
53
150
810
600
53
45
3.8
3.4
90
60
23
6
1060

2l
11.6
70
200
1080
800
70
60
5.0
4.5
120
80
30

1l
7.0
43
150
770
600
34
17

1.5 l
10.5
64
225
1155
900
51
26
6
1270

2l
14.0
85
300
1540
1200
68
34

1l
7.0
43
150
770
600
35

1.5 l
10.5
64
225
1155
900
53

2l
14.0
85
300
1540
1200
70

[For CLINIMIX N12G20E]

Nitrogen (g)
Amino acids (g)
Glucose (g)
Total calories (kcal)
Glucose calories (kcal)
Sodium (mmol)
Potassium (mmol)
Magnesium (mmol)
Calcium (mmol)
Acetate (mmol)
Chloride (mmol)
Phosphate as HPO42- (mmol)
pH
Osmolarity (mOsm/l)

[For CLINIMIX N14G30]

Nitrogen (g)
Amino acids (g)
Glucose (g)
Total calories (kcal)
Glucose calories (kcal)
Acetate (mmol)
Chloride (mmol)
pH
Osmolarity (mOsm/l)
[For CLINIMIX N14G30E]

Nitrogen (g)
Amino acids (g)
Glucose (g)
Total calories (kcal)
Glucose calories (kcal)
Sodium (mmol)

Baxter Confidential

Clinimix, solution for infusion
UK Package Leaflet Consolidated

Potassium (mmol)
Magnesium (mmol)
Calcium (mmol)
Acetate (mmol)
Chloride (mmol)
Phosphate as HPO42- (mmol)
pH
Osmolarity (mOsm/l)

Page 12 of 21
Dec 2013

30
2.5
2.3
70
40
15

45
3.8
3.4
105
60
23
6
1415

60
5.0
4.5
140
80
30

1l
8.3
50
175
900
700
43
20

1.5 l
12.4
75
263
1350
1050
65
30
6
1490

2l
16.5
100
350
1800
1400
86
40

1l
8.3
50
175
900
700
35
30
2.5
2.3
75
40
15

1.5 l
12.4
75
263
1350
1050
53
45
3.8
3.4
113
60
23
6
1625

2l
16.5
100
350
1800
1400
70
60
5.0
4.5
150
80
30

[For CLINIMIX N17G35]

Nitrogen (g)
Amino acids (g)
Glucose (g)
Total calories (kcal)
Glucose calories (kcal)
Acetate (mmol)
Chloride (mmol)
pH
Osmolarity (mOsm/l)

[For CLINIMIX N17G35E]

Nitrogen (g)
Amino acids (g)
Glucose (g)
Total calories (kcal)
Glucose calories (kcal)
Sodium (mmol)
Potassium (mmol)
Magnesium (mmol)
Calcium (mmol)
Acetate (mmol)
Chloride (mmol)
Phosphate as HPO42- (mmol)
pH
Osmolarity (mOsm/l)

2.

POSOLOGY AND METHOD OF ADMINISTRATION

Only administer the product after the non-permanent seal between the two compartments has been
broken and the contents of the two compartments have been mixed.
Dosage and infusion rate
The dosage is chosen according to the metabolic needs, the energy expenditure, and the clinical status
of the patient.
In adults, the requirements range from 0.16 g of nitrogen/kg/d (approximately 1 g of amino acid/kg/d)
to 0.35 g of nitrogen/kg/d (approximately 2 g of amino acid/kg/d).

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Clinimix, solution for infusion
UK Package Leaflet Consolidated

Page 13 of 21
Dec 2013

In infants, the requirements range from 0.35 g of nitrogen/kg/d (approximately 2 g of amino acid/kg/d)
to 0.45 g of nitrogen/kg/d (approximately 3 g of amino acid/kg/d).
The calorie requirements range from 25 kcal/kg/d to 40 kcal/kg/d, depending on the nutritional status
of the patient and the degree of catabolism.
The rate of administration should be adjusted according to the dosage, the characteristics of the
infused solution, the total volume intake per 24 hours and the duration of the infusion.
The infusion time should be higher than 8 hours. Normally, the flow rate is increased gradually during
the first hour without exceeding <3> [For CLINIMIX N9G15E] <2.5> [For CLINIMIX N9G20E,
N12G20, N12G20E] <1.7> [For CLINIMIX N14G30, N14G30E] <1.4> [For CLINIMIX N17G35
& N17G35E] ml per kilogram of bodyweight per hour, and the maximal dose is <40> [For
CLINIMIX N9G15E, N9G20E, N12G20, N12G20E, N14G30, N14G30E] <30> [For CLINIMIX,
N17G35 & N17G35E] ml per kilogram of bodyweight per day.
Route of administration
The choice of the peripheral or central vein depends on the final osmolarity of the mixture. The
general accepted limit for peripheral infusion is about 800 mOsm/l but it varies considerably with the
age and the general condition of the patient and the characteristics of the peripheral veins.

3.

SPECIAL WARNINGS AND PRECAUTIONS FOR USE

WARNINGS
Hypersensitivity/infusion reactions including hypotension, hypertension, peripheral cyanosis,
tachycardia, dyspnoea, vomiting, nausea, urticaria, rash, pruritus, erythema, hyperhidrosis, pyrexia,
and chills have been reported with CLINIMIX formulations.
Anaphylaxis has been reported with other parenteral nutrition products.
Special clinical monitoring is required at the beginning of any intravenous infusion. Should any
abnormal sign or symptom occur, e.g. for hypersensitivity or infusion reaction, the infusion must be
stopped immediately.
Solutions containing glucose should be used with caution, if at all, in patients with known allergy to
corn or corn products.
Pulmonary vascular precipitates have been reported in patients receiving parenteral nutrition. In some
cases, fatal outcomes have occurred. Excessive addition of calcium and phosphate increases the risk of
the formation of calcium phosphate precipitates. Precipitates have been reported even in the absence
of phosphate salt in the solution. Precipitation distal to the in-line filter and suspected in vivo
precipitate formation have also been reported.
If signs of pulmonary distress occur, the infusion should be stopped and medical evaluation initiated.
In addition to inspection of the solution, the infusion set and catheter should also periodically be
checked for precipitates.
Infection and sepsis may occur as a result of the use of intravenous catheters to administer parenteral
formulations, poor maintenance of catheters or contaminated solutions. Immunosuppression and other
factors such as hyperglycaemia, malnutrition and/or their underlying disease state may predispose
patients to infectious complications.

Baxter Confidential

Clinimix, solution for infusion
UK Package Leaflet Consolidated

Page 14 of 21
Dec 2013

Careful symptomatic and laboratory monitoring for fever/chills, leukocytosis, technical complications
with the access device, and hyperglycaemia can help recognize early infections.
The occurrence of septic complications can be decreased with heightened emphasis on aseptic
technique in catheter placement, maintenance, as well as aseptic technique in nutritional formula
preparation.
Refeeding severely undernourished patients may result in the refeeding syndrome that is characterized
by the shift of potassium, phosphorus, and magnesium intracellularly as the patient becomes anabolic.
Thiamine deficiency and fluid retention may also develop. Careful monitoring and slowly increasing
nutrient intakes while avoiding overfeeding can prevent these complications.
Hypertonic solutions may cause venous irritation if infused into a peripheral vein. The choice of a
peripheral or central vein depends on the final osmolarity of the mixture.
The general accepted limit for peripheral infusion is about 800 mOsm/l but it varies considerably with
the age and the general condition of the patient and the characteristics of the peripheral veins.
Do not connect bags in series in order to avoid air embolism due to possible residual air contained in
the primary bag.
PRECAUTIONS
Severe water and electrolyte equilibration disorders, severe fluid overload states, and severe metabolic
disorders should be corrected before starting the infusion.
Metabolic complications may occur if the nutrient intake is not adapted to the patient's requirements,
or the metabolic capacity of any given dietary component is not accurately assessed. Adverse
metabolic effects may arise from administration of inadequate or excessive nutrients or from
inappropriate composition of an admixture for a particular patient's needs.
Frequent clinical evaluation and laboratory determinations are necessary for correct monitoring during
administration. These should include ionogram and kidney and liver function tests.
The electrolyte requirements of patients receiving the solutions should be carefully determined and
monitored especially for the electrolyte-free solutions.
Glucose intolerance is a common metabolic complication in severely stressed patients. With the
infusion of the products, hyperglycaemia, glycosuria, and hyperosmolar syndrome may occur. Blood
and urine glucose should be monitored on a routine basis and for diabetics insulin dosage should be
adapted, if necessary.
Use with caution in patients with renal insufficiency, particularly if hyperkalaemia is present, because
of the risk of developing or worsening metabolic acidosis and hyperazotemia if extra-renal waste
removal is not being performed. Fluid and electrolyte status should be closely monitored in these
patients. In case of severe kidney failure, specially formulated amino acid solutions should be
preferred.
Caution should be exercised in administering CLINIMIX to patients with adrenal insufficiency.
Care should be taken to avoid circulatory overload particularly in patients with pulmonary oedema,
cardiac insufficiency and/or failure. Fluid status should be closely monitored.
In patients with pre-existing liver disease or hepatic insufficiency, apart from routine liver function
tests, possible symptoms of hyperammonaemia should be controlled.
Baxter Confidential

Clinimix, solution for infusion
UK Package Leaflet Consolidated

Page 15 of 21
Dec 2013

Hepatobiliary disorders including cholestasis, hepatic steatosis, fibrosis and cirrhosis, possibly leading
to hepatic failure, as well as cholecystitis and cholelithiasis are known to develop in some patients on
parenteral nutrition. The aetiology of these disorders is thought to be multifactorial and may differ
between patients. Patients developing abnormal laboratory parameters or other signs of hepatobiliary
disorders should be assessed early by a clinician knowledgeable in liver diseases in order to identify
possible causative and contributory factors, and possible therapeutic and prophylactic interventions.
Increase in blood ammonia levels and hyperammonemia may occur in patients receiving amino acid
solutions. In some patients this may indicate the presence of a congenital disorder of amino acid
metabolism (see section 4.3 of the SmPC) or hepatic insufficiency.
Blood ammonia should be measured frequently in newborns and infants to detect hyperammonemia,
which may indicate the presence of a congenital abnormality of amino acid metabolism.
Depending on extent and aetiology, hyperammonemia may require immediate intervention.
A too rapid infusion of amino acid may result in nausea, vomiting and chills. In such cases,
discontinue the infusion immediately.
In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of
decreased hepatic, renal, or cardiac function, and of concomitant disease or drug therapy.
Paediatric population
• There have been no studies performed in the paediatric population.
• See above regarding monitoring for hyperammonemia in paediatric patients.
4.

PRACTICAL INFORMATION ON PREPARATION AND HANDLING

Warning: Administer the product only after breaking the seal and mixing the contents of both
compartments.

1.

2.

Tear from the top to open
the overpouch.

4.

3.

Peel the front of the
overpouch to reveal the
CLINIMIX bag. Discard
the overpouch and oxygen
absorber sachet.
5.

Place the bag flat on a
horizontal and clean
surface with the handle in
front of you.
6.

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Clinimix, solution for infusion
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Lift the hanger area to
remove the solution from
the top of the bag. Firmly
roll the bag until the peal
seal is fully open
(approximately half way).

Page 16 of 21
Dec 2013

Mix by turning the bag
upside-down at least 3
times.

Hang the bag. Twist off
the protector from the
administration outlet.
Firmly plug the spike
connector.

Use only if the solution is clear, colourless or slightly yellow and if the container is undamaged.
CLINIMIX should be at room temperature before use.
CLINIMIX activation can be performed in the overpouch or after its removal.
For single use only.
Do not store partly used containers and discard all equipment after use.
Do not reconnect partially used bag.
Do not connect in series.
Supplementation
Lipids, vitamins and trace elements should be provided to patients receiving parenteral nutrition for a
long period.
If additives are necessary, compatibilities should be checked and the stability of mixtures should be
controlled.
The supplementation can be made after opening the peel seal (once the two solutions have been
mixed) for all additives. CLINIMIX may be supplemented with:
-

Lipid emulsions (for example ClinOleic) at a rate of 50 to 250 ml per litre of CLINIMIX

[For CLINIMIX N9G15E]

Nitrogen (g)
Amino acids (g)
Glucose (g)
Lipid (g)
Total calories (kcal)
Glucose calories (kcal)
Lipid calories (kcal)
Glucose/lipids Ratio
Sodium (mmol)
Potassium (mmol)
Magnesium (mmol)
Calcium (mmol)
Acetate (mmol)
Chloride (mmol)
Phosphate as HPO42(mmol)
pH
Osmolarity (mOsm/l)

CLINIMIX N9G15E 1 L + 100 mL lipids
20%
4.6
28
75
20
610
300
200
60/40
35
30
2.5
2.3
50
40
15

CLINIMIX N9G15E 1.5 L + 100 mL lipids
20%
6.8
41
113
20
815
450
200
69/31
53
45
3.8
3.4
75
60
23

CLINIMIX N9G15E 2 L + 250 mL lipids
20%
9.1
55
150
50
1320
600
500
55/45
70
60
5.0
4.5
100
80
30

6
795

6
810

6
785

Baxter Confidential

Clinimix, solution for infusion
UK Package Leaflet Consolidated

Page 17 of 21
Dec 2013

[For CLINIMIX N9G20E]

Nitrogen (g)
Amino acids (g)
Glucose (g)
Lipid (g)
Total calories (kcal)
Glucose calories (kcal)
Lipid calories (kcal)
Glucose/lipids Ratio
Sodium (mmol)
Potassium (mmol)
Magnesium (mmol)
Calcium (mmol)
Acetate (mmol)
Chloride (mmol)
Phosphate as HPO42(mmol)
pH
Osmolarity (mOsm/l)

CLINIMIX N9G20E 1 L + 100 mL lipids
20%
4.6
28
100
20
710
400
200
67/33
35
30
2.5
2.3
50
40
15

CLINIMIX N9G20E 1.5 L + 250 mL lipids
20%
6.8
41
150
50
1265
600
500
55/45
53
45
3.8
3.4
75
60
23

CLINIMIX N9G20E 2 L + 250 mL lipids
20%
9.1
55
200
50
1520
800
500
62/38
70
60
5.0
4.5
100
80
30

6
915

6
880

6
900

[For CLINIMIX N12G20]

Nitrogen (g)
Amino acids (g)
Glucose (g)
Lipids (g)
Total calories (kcal)
Glucose calories (kcal)
Lipid calories (kcal)
Glucose/lipids Ratio
Acetate (mmol)
Chloride (mmol)
pH
Osmolarity (mOsm/l)

CLINIMIX N12G20 1 L + 100 mL lipids
20%
5.8
35
100
20
740
400
200
67/33
27
15
6
860

[For CLINIMIX N12G20E]
CLINIMIX N12G20E
1 L + 100 mL lipids
20%
Nitrogen (g)
5.8
Amino acids (g)
35
Glucose (g)
100
Lipid (g)
20
Total calories (kcal)
740
Glucose calories (kcal)
400
Lipid calories (kcal)
200
Glucose/lipids Ratio
67/33

CLINIMIX N12G20 1.5 L + 250 mL lipids
20%
8.7
53
150
50
1310
600
500
55/45
41
22
6
830

CLINIMIX N12G20E
1.5 L + 250 mL lipids
20%
8.7
53
150
50
1310
600
500
55/45

Baxter Confidential

CLINIMIX N12G20
2 L+ 250 mL lipids
20%
11.6
70
200
50
1580
800
500
62/38
54
29
6
850

CLINIMIX N12G20E 2 L + 250 mL lipids
20%
11.6
70
200
50
1580
800
500
62/38

Clinimix, solution for infusion
UK Package Leaflet Consolidated

Sodium (mmol)
Potassium (mmol)
Magnesium (mmol)
Calcium (mmol)
Acetate (mmol)
Chloride (mmol)
Phosphate as HPO42(mmol)
pH
Osmolarity (mOsm/l)

Page 18 of 21
Dec 2013

35
30
2.5
2.3
60
30
15

53
45
3.8
3.4
90
60
23

70
60
5.0
4.5
120
80
30

6
990

6
950

6
975

CLINIMIX N14G30 –
1 L + 250 mL lipids
20%
7.0
43
150
50
1270
600
500
55/45
34
17
6
1075

CLINIMIX N14G30 1.5 L + 250 mL lipids
20%
10.5
64
225
50
1655
900
500
64/36
51
26
6
1130

CLINIMIX N14G30 –
2 L + 500 mL lipids
20%
14.0
85
300
100
2540
1200
1000
55/45
68
34
6
1075

CLINIMIX N14G30E
1.5 L + 250 mL lipids
20%
10.5
64
225
50
1655
900
500
64/36
53
45
3.8
3.4
105
60
23

CLINIMIX N14G30E 2 L + 500 mL lipids
20%
14.0
85
300
100
2540
1200
1000
55/45
70
60
5.0
4.5
140
80
30

6
1255

6
1190

[For CLINIMIX N14G30]

Nitrogen (g)
Amino acids (g)
Glucose (g)
Lipid (g)
Total calories (kcal)
Glucose calories (kcal)
Lipid calories (kcal)
Glucose/lipids Ratio
Acetate (mmol)
Chloride (mmol)
pH
Osmolarity (mOsm/l)

[For CLINIMIX N14G30E]
CLINIMIX N14G30E
1 L + 250 mL lipids
20%
Nitrogen (g)
7.0
Amino acids (g)
43
Glucose (g)
150
Lipid (g)
50
Total calories (kcal)
1270
Glucose calories (kcal)
600
Lipid calories (kcal)
500
Glucose/lipids Ratio
55/45
Sodium (mmol)
35
Potassium (mmol)
30
Magnesium (mmol)
2.5
Calcium (mmol)
2.3
Acetate (mmol)
70
Chloride (mmol)
40
2Phosphate as HPO4
15
(mmol)
pH
6
Osmolarity (mOsm/l)
1190

[For CLINIMIX N17G35]
Baxter Confidential

Clinimix, solution for infusion
UK Package Leaflet Consolidated

Nitrogen (g)
Amino acids (g)
Glucose (g)
Lipid (g)
Total calories (kcal)
Glucose calories (kcal)
Lipid calories (kcal)
Glucose/lipids Ratio
Acetate (mmol)
Chloride (mmol)
pH
Osmolarity (mOsm/l)

Page 19 of 21
Dec 2013

CLINIMIX N17G35 1 L + 250 mL lipids
20%
8.3
50
175
50
1400
700
500
58 / 42
43
20
6
1255

[For CLINIMIX N17G35E]
CLINIMIX N17G35E
1 L + 250 mL lipids
20%
Nitrogen (g)
8.3
Amino acids (g)
50
Glucose (g)
175
Lipid (g)
50
Total calories (kcal)
1400
Glucose calories (kcal)
700
Lipid calories (kcal)
500
Glucose/lipids Ratio
58 / 42
Sodium (mmol)
35
Potassium (mmol)
30
Magnesium (mmol)
2.5
Calcium (mmol)
2.3
Acetate (mmol)
75
Chloride (mmol)
40
Phosphate as HPO4215
(mmol)
pH
6
Osmolarity (mOsm/l)
1360
-

CLINIMIX N17G35 2 L + 500 mL lipids
20%
16.5
100
350
100
2800
1400
1000
58 / 42
86
40
6
1255

CLINIMIX N17G35E
1.5 L + 500 mL lipids
20%
12.4
75
263
100
2350
1050
1000
51 / 49
53
45
3.8
3.4
113
60
23

CLINIMIX N17G35E
2 L + 500 mL lipids
20%
16.5
100
350
100
2800
1400
1000
58 / 42
70
60
5.0
4.5
150
80
30

6
1290

6
1360

Electrolytes: per litre of CLINIMIX

Up to a final
concentration of
-

CLINIMIX N17G35 1.5 L + 500 mL lipids
20%
12.4
75
263
100
2350
1050
1000
51 / 49
65
30
6
1195

Sodium

Potassium

Magnesium

Calcium

80 mmol

60 mmol

5.6 mmol

3.0 mmol

10 µmol
0.14 µmol
38 µmol
0.44 µmol
0.5 µmol

Zinc
Manganese
Cobalt
Molybdenum
Iron

77 µmol
2.5 µmol
0.0125 µmol
0.13 µmol
10 µmol

Trace elements: per litre of CLINIMIX

Up to a final
concentration of

Copper
Chromium
Fluorine
Selenium
Iodine

Baxter Confidential

Clinimix, solution for infusion
UK Package Leaflet Consolidated

-

Page 20 of 21
Dec 2013

Vitamins: per litre of CLINIMIX

Up to a final
concentration of

vitamin A
vitamin B6
vitamin D
vitamin B12
vitamin E
vitamin PP
vitamin K

1750 IU
2.27 mg
110 IU
3.0 µg
5.1 mg
23 mg
75 µg

Biotin
vitamin B1
Folic acid
vitamin B2
vitamin C
vitamin B5

35 µg
1.76 mg
207 µg
2.07 mg
63 mg
8.63 mg

Stability data for supplementation of CLINIMIX with other marketed lipid emulsions and other
additives or nutrients are available upon request.
If some light creaming is observed, mix thoroughly the admixture by gentle agitation to get a uniform
emulsion before the infusion.
Additions should be performed under aseptic conditions.
Additions can be made with a syringe or a transfer set.


Addition with a syringe or a transfer set fitted with a needle
Prepare the injection site (the single port, see Figure 2 or 4 in the SmPC).
Puncture the port and inject.
Mix the solutions and the additives.



Addition with a transfer set fitted with a spike
Please refer to the “Directions for use” of the lipid transfer set used.
Connect the spike to the transfusion site (the longest port).

Incompatibilities
Additives may be incompatible, refer to the manufacturer for further details.
If additives are necessary, compatibilities should be checked and the stability of mixtures should be
controlled.
The solution should not be administered with, before, or after an administration of blood through the
same equipment because of the possibility of pseudoagglutination.
[For Clinimix formulations with electrolytes:]CLINIMIX [N9G15E] [N9G20E] [N12G20E]
[N14G30E] [N17G35E] contains calcium ions which pose additional risk of coagulation precipitated
in citrate anticoagulated/preserved blood or components.
As with any parenteral nutrition admixture, calcium and phosphate ratios must be considered. Excess
addition of calcium and phosphate, especially in the form of mineral salts, may result in the formation
of calcium phosphate precipitates.
As for other calcium-containing infusion solutions, concomitant treatment with ceftriaxone and
CLINIMIX [N9G15E] [N9G20E] [N12G20E] [N14G30E] [N17G35E] is contraindicated in newborns
(≤28 days of age), even if separate infusion lines are used (risk of fatal ceftriaxone calcium salt
precipitation in the neonate’s bloodstream).
In patients older than 28 days (including adults), ceftriaxone must not be administered simultaneously
with intravenous calcium-containing solutions, including CLINIMIX [N9G15E] [N9G20E]
[N12G20E] [N14G30E] [N17G35E], through the same infusion line.
If the same infusion line is used for sequential administration, the line must be thoroughly flushed with
a compatible fluid between infusions.

Baxter Confidential

Clinimix, solution for infusion
UK Package Leaflet Consolidated

5.

Page 21 of 21
Dec 2013

SHELF LIFE

2 years when stored in the overpouch.
It is recommended that the product be used immediately after the non-permanent seal between the 2
chambers have been opened. However, once reconstituted (i.e. internal non-permanent seal opened),
stability of the reconstituted emulsion has been demonstrated for a maximum of 7 days between 2°C
and 8°C followed by a maximum of 48 h at temperature not exceeding 25°C.
When additions have been made, from a microbiological point of view, the admixture 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 additions
have been made under controlled and validated aseptic conditions. If longer storage periods are
required in exceptional circumstances, the company can be contacted as chemical and physical in-use
stability data for 7 days at 2-8°C followed by 48 hours below 25°C are available for the products listed
in the previous section.

Baxter Confidential

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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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