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CLINIMIX N14G30E SOLUTION FOR INFUSION

Active substance(s): AMINO ACID MIXTURE D / CALCIUM CHLORIDE DIHYDRATE / DIBASIC POTASSIUM PHOSPHATE / GLUCOSE MONOHYDRATE / GLYCINE / MAGNESIUM CHLORIDE HEXAHYDRATE / SODIUM ACETATE / SODIUM CHLORIDE

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DATE
PLANT APPROVAL
HALLE ONLY
N/A

EMEA ARTWORK DESIGN CENTRE

RA TO APPROVE LAYOUT
AND FORMAT

Other medicines and CLINIMIX

ARTWORK APPROVAL

2nd DRAFT

N/A

N/A

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.

Country

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.

Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctoror 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.

1. What CLINIMIX is and what it is administered for
2. What you need to know before CLINIMIX is administered
3. How CLINIMIX is administered
4. Possible side effects
5. How to store CLINIMIX
6. Contents of the pack and other information

Tell your doctor if you are taking or using, have recently taken or used or might take
or use any other medicines.

1. WHAT CLINIMIX IS AND WHAT IT IS ADMINISTERED FOR

ARTWORK DESIGN CENTRE

Date: 07 May 2015

Version: 02

PR1:

CLINIMIX is administered to provide nutrition in adults and children by a tube into a
vein when normal feeding by mouth is not suitable.

Artworker: Wendy Martin

Errors: Yes/No

Comments:

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.

Size
Text
Format
Barcode(s)
Edge Code
BGS Y N NA
Trademark Y N NA
Sign...........................:
Date...........................:

CLINIMIX with electrolytes contains calcium. It should not be given together with the
antibiotic ceftriaxone because particles may form.

CLINIMIX is a solution for infusion. It is supplied in a bag with 2 chambers. One chamber
contains an amino acid solution with electrolytes and the second contains a glucose
solution with calcium chloride. 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.

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.

CLINIMIX must only be administered under medical supervision.

2. WHAT YOU NEED TO KNOW BEFORE CLINIMIX IS ADMINISTERED

3. HOW CLINIMIX IS ADMINISTERED

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

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.

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.

Warnings and precautions

Always take CLINIMIX exactly as your doctor has told you. You should check with your
doctor if you are not sure.

Talk to your doctor or nurse before CLINIMIX is administered.

The prescription may be continued for as long as it is needed, depending upon your
clinical condition.

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.

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.

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.

In some severe cases, your doctor may have to give you temporary renal dialysis to
help your kidneys eliminate the excess product.

CLINIMIX with electrolytes contains calcium. It should not be given together with the
antibiotic ceftriaxone because particles may form.

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.
1

TH-30-01-771

Draft: 2nd

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.

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),
your blood level of sodium, potassium, magnesium, calcium and/or
phosphorus is too high (hypernatraemia, hyperkalemia, hypermagnesemia,
hypercalcemia and/or hyperphosphatemia),
In children less than 28 days of age, ceftriaxone must not be co-administered
with calcium-containing IV solutions, because particles may form.

PR2:

CLINIMIX shall not be administered if



N/A

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.

What is in this leaflet:







Name





Signature

Read all of this leaflet carefully before this medicine is
administered, because it contains important information for you.

Date

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
CLINIMIX N14G30E, SOLUTION FOR INFUSION

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

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.

Manufacturers

Do not freeze.
Keep the container in the outer carton.

Baxter Healthcare Ltd, Caxton way, Thetford, Norfolk, IP24 3SE, The United Kingdom
Baxter, Boulevard René Branquart, 80, 7860 Lessines, Belgium

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.

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

6. CONTENTS OF THE PACK AND OTHER INFORMATION

Clinimix N14G30E, Solution for Infusion

What CLINIMIX contains

In some countries it is registered under a different trade name, as described below:

The active substances for each bag of the reconstituted solution are:

Germany: Clinimix 4,5 % G-E

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

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

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

This leaflet was last revised in 05/2015

Baxter and Clinimix are trademarks of Baxter International Inc.
2

TH-30-01-771

EMEA ARTWORK DESIGN CENTRE

Date:

Not all pack sizes may be marketed.

Version:02

Date:

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

ARTWORK APPROVAL

2nd DRAFT

Sign:

Pack sizes

UK
Via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard

Active substances
L-alanine
L-arginine
Glycine
L-histidine
L-isoleucine
L-leucine
L-lysine
(as lysine hydrochloride)
L-methionine

Sign:

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

DATE
PLANT APPROVAL
HALLE ONLY
N/A

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.

RA TO APPROVE LAYOUT
AND FORMAT

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.
To prevent contact with oxygen from the air the bag is packaged in an oxygen barrier
overpouch, which contains an oxygen absorber sachet.

N/A

What CLINIMIX looks like and contents of the pack

Country

The other ingredients are:
• acetic acid, hydrochloric acid (to adjust pH of the solution),
• water for injections.

N/A

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

Name

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.

2l
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
(330 g)
0.66 g

N/A

The tests your doctor will perform while the medicine is administered to you should
minimise the risk of side effects.

1.5 l
3.57 g
4.34 g
3.19 g
2.68 g
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

Signature

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.

1l
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

Date

Active substances
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

4. POSSIBLE SIDE EFFECTS

Sign:

Date:

Date:

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.

2. POSOLOGY AND METHOD OF ADMINISTRATION

Dosage and infusion rate

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.

The dosage is chosen according to the metabolic needs, the energy expenditure, and
the clinical status of the patient.

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.

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).
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 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.

Only administer the product after the non-permanent seal between the two compartments
have been broken and the contents of the two compartments have been mixed.

Do not connect bags in series in order to avoid air embolism due to possible residual
air contained in the primary bag.

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.

PRECAUTIONS

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.

Severe water and electrolyte equilibration disorders, severe fluid overload states, and
severe metabolic disorders should be corrected before starting the infusion.

The infusion time should be higher than 8 hours. Normally, the flow rate is increased
gradually during the first hour without exceeding 1.7 ml per kilogram of bodyweight per
hour, and the maximal dose is 40 per kilogram of bodyweight per day.

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.

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.

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.

3. SPECIAL WARNINGS AND PRECAUTIONS FOR USE
WARNINGS

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.

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.

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.

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.

Caution should be exercised in administering CLINIMIX to patients with adrenal
insufficiency.
3

TH-30-01-771

Version:02

Sign:

Careful symptomatic and laboratory monitoring for fever/chills, leukocytosis, technical
complications with the access device, and hyperglycemia can help recognize early
infections.

6
1415

EMEA ARTWORK DESIGN CENTRE

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.

DATE
PLANT APPROVAL
HALLE ONLY
N/A

In patients older than 28 days (including adults), ceftriaxone must not be administered
simultaneously with intravenous calcium-containing solutions, including CLINIMIX
N14G30E, through the same infusion line (e.g., via a Y-connector). If the same infusion
line is used for sequential administration, the line must be thoroughly flushed with a
compatible fluid between infusions.

ARTWORK APPROVAL

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.

2l
14.0
85
300
1540
1200
70
60
5.0
4.5
140
80
30

2nd DRAFT
RA TO APPROVE LAYOUT
AND FORMAT

1.5 l
10.5
64
225
1155
900
53
45
3.8
3.4
105
60
23

N/A

pH
Osmolarity (mOsm/l)

1l
7.0
43
150
770
600
35
30
2.5
2.3
70
40
15

Country

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)

N/A

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

Name

1. QUANTITATIVE COMPOSITION

N/A

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.

Signature

The following information is intended for healthcare professionals
only:

Date

CLINIMIX N14G30E, SOLUTION FOR INFUSION

5. 6.

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.

Date:

If additives are necessary, compatibilities should be checked and the stability of
mixtures should be controlled.

4. PRACTICAL INFORMATION ON PREPARATION AND HANDLING

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:

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



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

1. 2.

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)

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

3. 4.

pH
Osmolarity (mOsm/l)


CLINIMIX
N14G30E
1 l + 250 ml
lipids 20%
7.0
43
150
50

CLINIMIX
N14G30E
1.5 l + 250 ml
lipids 20%
10.5
64
225
50

CLINIMIX
N14G30E
2 l + 500 ml
lipids 20%
14.0
85
300
100

1270
600
500
55/45

1655
900
500
64/36

2540
1200
1000
55/45

35
30
2.5
2.3
70
40
15

53
45
3.8
3.4
105
60
23

70
60
5.0
4.5
140
80
30

6
1190

6
1255

6
1190

Electrolytes: per litre of CLINIMIX

Up to a final
concentration of

Sodium

Potassium

Magnesium

Calcium

80 mmol

60 mmol

5.6 mmol

3.0 mmol

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).
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TH-30-01-771

EMEA ARTWORK DESIGN CENTRE

Date:

Lipids, vitamins and trace elements should be provided to patients receiving
parenteral nutrition for a long period.

Paediatric population
• There have been no studies performed in the paediatric population.
• See above regarding monitoring for hyperammonemia in paediatric patients.

Version:02

Sign:

Supplementation

Sign:

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.

ARTWORK APPROVAL

A too rapid infusion of amino acid may result in nausea, vomiting and chills. In such
cases, discontinue the infusion immediately.

DATE
PLANT APPROVAL
HALLE ONLY
N/A

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.

2nd DRAFT

N/A

RA TO APPROVE LAYOUT
AND FORMAT

N/A

CLINIMIX activation can be performed in the overpouch or after its removal.

Country

Name

CLINIMIX should be at room temperature before use.

Depending on extent and aetiology, hyperammonemia may require immediate
intervention.


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


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.

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.


Tear from the top to open the overpouch.



N/A


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


Signature

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) or hepatic
insufficiency.

Date

In patients with pre-existing liver disease or hepatic insufficiency, apart from routine
liver function tests, possible symptoms of hyperammonaemia should be controlled.



Trace elements: per litre of CLINIMIX

Date:

Date:

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.
CLINIMIX N14G30E 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 N14G30E 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
N14G30E, through the same infusion line (see section Warnings).
If the same infusion line is used for sequential administration, the line must be
thoroughly flushed with a compatible fluid between infusions.

5. 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.
5

TH-30-01-771

Version:02

Sign:



Sign:

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.

EMEA ARTWORK DESIGN CENTRE

If some light creaming is observed, mix thoroughly the admixture by gentle agitation
to get a uniform emulsion before the infusion.

DATE
PLANT APPROVAL
HALLE ONLY
N/A

Stability data for supplementation of CLINIMIX with other marketed lipid emulsions
and other additives or nutrients are available upon request.

ARTWORK APPROVAL

RA TO APPROVE LAYOUT
AND FORMAT

Up to a final
concentration of

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

2nd DRAFT

N/A

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

Vitamins: per litre of CLINIMIX

Country

Biotin
vitamin B1
Folic acid
vitamin B2
vitamin C
vitamin B5

N/A

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

Name

77 µmol
2.5 µmol
0.0125 µmol
0.13 µmol
10 µmol

N/A

Zinc
Manganese
Cobalt
Molybdenum
Iron

Signature



10 µmol
0.14 µmol
38 µmol
0.44 µmol
0.5 µmol

Date

Up to a final
concentration of

Copper
Chromium
Fluorine
Selenium
Iodine

EMEA ARTWORK DESIGN CENTRE
ARTWORK APPROVAL
2nd DRAFT

N/A

DATE
PLANT APPROVAL
HALLE ONLY
N/A
N/A

RA TO APPROVE LAYOUT
AND FORMAT
Name
N/A

Country
Signature

Sign:
Date:

Date:

Version:02
Sign:

TH-30-01-771

6

Date

Baxter, Clinimix and ClinOleic are trademarks of Baxter International Inc.

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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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