PRIMENE 10 %

Israel - English - Ministry of Health

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Active ingredient:
GLYCINE; L- ALANINE; L- ASPARTIC ACID; L- CYSTEINE; L- GLUTAMIC ACID; L- ISOLEUCINE; L- LEUCINE; L- LYSINE; L- METHIONINE; L- ORNITHINE HYDROCHLORIDE; L- PHENYLALANINE; L- PROLINE; L- SERINE; L- THREONINE; L- TRYPTOPHAN; L- TYROSINE; L- VALINE; L-ARGININE; L-HISTIDINE; TAURINE
Available from:
TEVA MEDICAL MARKETING LTD.
ATC code:
B05XB03
Pharmaceutical form:
SOLUTION FOR INFUSION
Composition:
L- VALINE 0.76 G / 100 ML; L- TYROSINE 0.045 G / 100 ML; L- TRYPTOPHAN 0.2 G / 100 ML; L- THREONINE 0.37 G / 100 ML; TAURINE 0.06 G / 100 ML; L- SERINE 0.4 G / 100 ML; L- PROLINE 0.3 G / 100 ML; L- PHENYLALANINE 0.42 G / 100 ML; L- ORNITHINE HYDROCHLORIDE 0.318 G / 100 ML; L- METHIONINE 0.24 G / 100 ML; L- LYSINE 1.1 G / 100 ML; L- LEUCINE 1.0 G / 100 ML; L- ISOLEUCINE 0.67 G / 100 ML; L-HISTIDINE 0.38 G / 100 ML; GLYCINE 0.4 G / 100 ML; L- GLUTAMIC ACID 1.0 G / 100 ML; L- CYSTEINE 0.189 G / 100 ML; L- ASPARTIC ACID 0.6 G / 100 ML; L-ARGININE 0.84 G / 100 ML; L- ALANINE 0.8 G / 100 ML
Administration route:
I.V
Prescription type:
Required
Manufactured by:
BAXTER S.A., BELGIUM
Therapeutic group:
LYSINE
Therapeutic area:
LYSINE
Therapeutic indications:
Primene 10 % is indicated in 1) children and infants 2) neonates at term or premature of normal or low birth weight when oral or enteral nutrition is impossible insufficient or contraindicated.
Authorization number:
123 47 30286 20
Authorization date:
2014-08-31

:ךיראת

רבוטקוא

2019

ה/דבכנ ת/חקור ,ה/אפור

ןולעב םיאבה םינוכדעה לע העידומ עבט תרבח אפורל

רישכתה לש

ןמירפ

®

%

10

PRIMENE

®

10% Solution for Infusion

Contains:

Each liter of the infusion solution contains:

L-Isoleucine

6.70 g

L-Leucine

10.0 g

L-Valine

7.60 g

L-Lysine

11.00 g

L-Methionine

2.40 g

L-Phenylalanine

4.20 g

L-Threonine

3.70 g

L-Tryptophan

2.00 g

L-Arginine

8.40 g

L-Histidine

3.80 g

L-Alanine

8.00 g

L-Aspartic Acid

6.00 g

L-Cysteine

1.89 g

L-Glutamic Acid

10.00 g

Glycine

4.00 g

L-Proline

3.00 g

L-Serine

4.00 g

L-Tyrosine

0.45 g

L-Ornithine Hydrochloride

3.18 g

Taurine

0.6 g

אפורל ןולעב םינוכדע

------------------------------------------------------------------------------------------------------------

:םושירה תדועתב הרשואש יפכ היוותה

Primene 10 % is indicated in 1) children and infants 2) neonates at term or premature of normal or

low birth weight when oral or enteral nutrition is impossible insufficient or contraindicated.

עידוהל וננוצרב םינולעהש

כדוע ונ םיירקיעה םינוכדעה םילולכ ןלהלש טוריפב ,

תונמוסמ תופסות( דבלב םודאב

:)

:אפורל ןולעב םינוכדע

[…]

4.4

Special warnings and precautions for use

Allergic Reactions / Hypersensitivity Reactions

Anaphylactic/anaphylactoid reactions and other hypersensitivity/infusion reactions have been

reported with amino acid solutions administered as a component of parenteral nutrition (see

section 4.8). The infusion must be stopped immediately if any signs or symptoms of a

reaction develop.

Precipitates in Patients Receiving Parenteral Nutrition

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 has 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.

Infectious complications

Infection and sepsis may occur as a result of intravenous catheters used 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.

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 Syndrome in Patients Receiving Parenteral Nutrition

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

Hypertonic infusion solutions may cause irritation of the vein, vein damage, and thrombosis

when administered into a peripheral vein (see section 4.8).

In view of its osmolality, Primene 10% should not be infused alone into a peripheral vein.

General Monitoring

Monitoring should be appropriate to the patient’s clinical situation and condition, and should

include determinations of water and electrolyte balance, serum osmolarity, acid/base balance,

blood glucose levels, blood ammonia levels, and liver and kidney function.

Metabolic Effects

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.

Hepatic function

Patients on parenteral nutrition may experience hepatic complications (including cholestasis,

hepatic steatosis, fibrosis and cirrhosis, possibly leading to hepatic failure, as well as

cholecystitis and cholelithiasis) and should be monitored accordingly. The etiology 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

by a clinician knowledgeable in liver diseases in order to identify possible causative and

contributory factors, and possible therapeutic and prophylactic interventions.

Amino acid solutions should be used with caution in patients with pre-existing liver disease

or liver insufficiency.

Liver function parameters should be closely monitored in these patients, and they should be

monitored for possible symptoms of hyperammonaemia.

Increase in blood ammonia levels and hyperammonaemia 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.

Blood ammonia should be measured frequently in newborns and infants to detect

hyperammonaemia.

Depending on extent and etiology, hyperammonaemia may require immediate intervention.

Renal effects

Azotaemia has been reported with parenteral administration of solutions containing amino

acids, and may occur in particular in the presence of renal impairment.

Use with caution in patients with renal insufficiency (with e.g., uraemia). Nitrogen tolerance

may be altered and dosage may have to be adjusted. Fluid and electrolyte status should be

closely monitored in these patients.

Additional precautions

Infusion site reactions have occurred with the use of parenteral nutrition. They include

infusion site thrombophlebitis and venous irritation, as well as severe reactions (with, e.g.,

necrosis and blistering) when associated with extravasation. See section 4.8. Patients should

be monitored accordingly.

Severe water and electrolyte disorders, severe fluid overload states, and severe

metabolic disorders should be corrected before starting the infusion.

Use with caution in patients with pulmonary oedema or heart failure. Fluid status

should be closely monitored.

4.5

Interaction with other medicinal products and other forms of interaction

No interaction studies have been performed.

The compatibility and stability of nutritive mixtures should be confirmed before

administration.

4.6

Fertility, pregnancy and lactation

There are no adequate data from the use of Primene in pregnant or lactating women.

Healthcare Professionals should carefully consider the potential risks and benefits for

each specific patient before administering Primene.

[…]

4.8

Undesirable effects

The adverse reactions listed below have been identified from post-marketing reports of

Primene administered as a component of parenteral nutrition. The frequency of the adverse

drug reactions listed in this section cannot be estimated from the available data.

Tabulated summary of adverse reactions

System Organ Class

(SOC)

Preferred MedDRA Term

frequency

IMMUNE SYSTEM

DISORDERS

Hypersensitivity reaction manifested by:

Face oedema,

Eyelid oedema,

Rash

Not known

Adverse reactions reported with parenteral amino acid products include:

Azotaemia, Hyperammonaemia.

Adverse reactions reported with parenteral nutrition to which the amino acid component may

play a causal or contributory role include:

Anaphylactic/anaphylactoid reactions, including skin, gastrointestinal, and severe

circulatory (shock) and respiratory manifestations as well as other

hypersensitivity/infusion reactions, including pyrexia, chills, hypotension,

hypertension, arthralgia, myalgia, urticaria, pruritus, erythema, and headache.

Hepatic failure, Hepatic cirrhosis, Hepatic fibrosis, Cholestasis, Hepatic steatosis,

Blood bilirubin increased, Hepatic enzyme increased; Cholecystitis,

Cholelithiasis.

Raised blood urea nitrogen in children with renal insufficiency.

Metabolic acidosis.

Pulmonary vascular precipitates.

Necrosis, blistering, swelling, scarring, skin discoloration at the infusion site associated

with extravasation (See also infusion site reaction statement in section 4.4).

Infusion site thrombophlebitis; Venous irritation (infusion site phlebitis, pain, erythema,

warmth, swelling, induration).

Amino acid solutions may precipitate acute folic acid deficiency which should be

corrected by supplements.

[…]

4.9

Overdose

In the event of inappropriate administration (overdose, and/or infusion rate higher

than recommended), hypervolaemia, electrolyte disturbances, acidosis and/or

azotaemia may occur. In such situations, the infusion must be stopped immediately. If

medically appropriate, further intervention may be indicated to prevent clinical

complications.

[…]

6.2

Incompatibilities

Additives may be incompatible.

Do not add other medicinal products or substances without first confirming their

compatibility and the stability of the resulting preparation.

Excessive addition of calcium and phosphate increases the risk of the formation of

calcium phosphate precipitates (see section 4.4).

The addition of trace elements may cause formation of visible particulate matter (see

section 6.6).

[…]

6.6

Special precautions for disposal and other handling

Visually inspect the container. Only use if the container is undamaged and the solution is

clear.

Discard if the container is leaking or if the solution is discoloured, cloudy or contains

a precipitate.

Aseptic conditions must be observed throughout the preparation and use of Primene

10%.

For single use only.

If additions are made to the container:

Ensure stability and compatibility of additives. Consult with pharmacist.

Prepare the injection site of the container as appropriate.

Puncture the injection site and inject the additives using an injection needle or a

reconstitution device/transfer set, as appropriate.

Mix content of the container and the additives thoroughly.

Inspect final solution for discoloration and particulate matter.

Confirm the integrity of the container. Only use if the container is undamaged and

the solution is clear.

Any unused portion of Primene should be discarded and should not be used for

subsequent admixing.

Ensure proper storage requirements of additives are followed.

Administration of the infusion:

Allow the solution to reach room temperature before use.

The use of a final filter is required during administration of all formulations

containing Primene and trace elements (including copper, iron, or zinc) for removal

of visible particulate matter which has been observed in the infusion line for some

formulations.

For 2 in 1 (amino acid and carbohydrate) parenteral nutrition solutions, use a <1.2

micron filter for removal of particulate matter that may be formed with the use of

trace elements (e.g. copper). For 3 in 1 (lipid, amino acid, and carbohydrate)

parenteral nutrition solutions, use a 1.2 micron filter for particulate matter removal.

Perform visual inspections for cloudiness or precipitation of the TPN solution,

infusion set, catheter and in-line filter after compounding, prior to administration and

periodically during administration. If discolouration or precipitation is noted in the

filter, perform blood levels of copper (or other trace elements) where medically

relevant.

Discard any unused contents. Do not reconnect any partially used container.

Do not connect containers in series in order to avoid air embolism due to possible

residual air in the primary container.

Primene must not be infused through the same tubing with blood or blood

components unless there is documentation that it is safe.

Attach administration set. Refer to ‘Instructions for Use’ accompanying the set.

ולעה

ן

אפורל

תואירבה דרשמ לש טנרטניאה רתאבש תופורתה רגאמב םוסרפל חלשנ

http://www.health.gov.il

.עבט תרבחל הינפ י"ע ספדומ ולבקל ןתינו ,

SUMMARY OF PRODUCT CHARACTERISTICS

Primene 10% Solution for Infusion

1. NAME OF THE MEDICINAL PRODUCT

Primene 10%

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each liter of the infusion solution contains:

L-Isoleucine

6.70 g

L-Leucine

10.0 g

L-Valine

7.60 g

L-Lysine

11.00 g

L-Methionine

2.40 g

L-Phenylalanine

4.20 g

L-Threonine

3.70 g

L-Tryptophan

2.00 g

L-Arginine

8.40 g

L-Histidine

3.80 g

L-Alanine

8.00 g

L-Aspartic Acid

6.00 g

L-Cysteine

1.89 g

L-Glutamic Acid

10.00 g

Glycine

4.00 g

L-Proline

3.00 g

L-Serine

4.00 g

L-Tyrosine

0.45 g

L-Ornithine Hydrochloride

3.18 g

Taurine

0.6 g

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Solution for infusion.

A clear, colourless solution.

Primene 10% has a pH of 5.5 and an osmolarity of 780 mOsmol/L.

4. CLINICAL PARTICULARS

4.1 Therapeutic indications

Primene 10% is indicated in 1) children and infants 2) neonates, at term

or premature, of normal or low birth weight when oral or enteral nutrition is

impossible, insufficient or contraindicated.

4.2 Posology and method of administration

Posology

According to the child’s weight, age and protein catabolism:

Posology

Maximal administration

rate

g/kg/day

ml/kg/day

ml/kg/min

1.5 to 3.5 g of amino acids or

0.23 to 0.53 g of nitrogen

15 to 35

0.05

A too fast administration of amino acids may result in nausea, vomiting and

tremors. In these cases, the infusion must be discontinued immediately. The

administration rate should never exceed 0.05 ml/kg/min.

Routes of administration

Primene 10% alone: deep intravenous administration.

Primene 10% by co-administration or as a mixture: according to the final

osmolarity of the solution infused: superficial or deep intravenous administration.

Duration and administration rate

Neonates and infants up to 2 years: continuous infusion over 24 hours.

Children up to 12 years: - continuous infusion over 24 hours;

- cyclic infusion over approximately 12 hours.

The administration rate will depend on the posology, the solution infused, the

total volume intake per 24 hours and the infusion duration.

Method of administration

Primene 10% is administered with an energy supply that is adjusted to the

child’s needs, by co-administration or as a mixture.

When used in neonates and children below 2 years of age, the solution (in

bottles and administration sets) should be protected from light exposure until

administration is completed (see sections 4.4, 6.3 and 6.6).

4.3 Contraindications

Primene 10% is contraindicated in patients with:

hypersensitivity to any of the active substances or to any of the excipients

listed in section 6.1.

congenital abnormality of amino acid metabolism.

4.4 Special warnings and precautions for use

Allergic Reactions / Hypersensitivity Reactions

Anaphylactic/anaphylactoid

reactions

other

hypersensitivity/infusion

reactions have been reported with amino acid solutions administered as a

component of parenteral nutrition (see section 4.8). The infusion must be

stopped immediately if any signs or symptoms of a reaction develop.

Precipitates in Patients Receiving Parenteral Nutrition

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 has 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.

Infectious complications

Infection and sepsis may occur as a result of intravenous catheters

used 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.

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 Syndrome in Patients Receiving Parenteral Nutrition

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

Hypertonic infusion solutions may cause irritation of the vein, vein damage,

and thrombosis when administered into a peripheral vein (see section 4.8).

In view of its osmolality, Primene 10% should not be infused alone into a

peripheral vein.

General Monitoring

Monitoring

should

appropriate

patient’s

clinical

situation

condition, and should include determinations of water and electrolyte balance,

serum osmolarity, acid/base balance, blood glucose levels, blood ammonia

levels, and liver and kidney function.

Metabolic Effects

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.

Hepatic function

Patients

parenteral

nutrition

experience

hepatic

complications

(including

cholestasis,

hepatic

steatosis,

fibrosis

cirrhosis,

possibly

leading to hepatic failure, as well as cholecystitis and cholelithiasis) and

should be monitored accordingly. The etiology 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 by a clinician knowledgeable in liver diseases in order to

identify possible causative and contributory factors, and possible therapeutic

and prophylactic interventions.

Amino acid solutions should be used with caution in patients with pre-existing

liver disease or liver insufficiency.

Liver function parameters should be closely monitored in these patients, and

they should be monitored for possible symptoms of hyperammonaemia.

Increase in blood ammonia levels and hyperammonaemia 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.

Blood ammonia should be measured frequently in newborns and infants to

detect

hyperammonaemia.

Depending on extent and etiology, hyperammonaemia may require immediate

intervention.

Renal effects

Azotaemia has been reported with parenteral administration of solutions

containing amino acids, and may occur in particular in the presence of renal

impairment.

Use with caution in patients with renal insufficiency (with e.g., uraemia).

Nitrogen tolerance may be altered and dosage may have to be adjusted. Fluid

and electrolyte status should be closely monitored in these patients.

Additional precautions

Light exposure of solutions for intravenous parenteral nutrition, especially

after admixture with trace elements and/or vitamins, may have adverse

effects on clinical outcomes in neonates, due to the generation of peroxides

and other degradation products. When used in neonates and children

below 2 years of age, Primene 10% should be protected from ambient light

until administration is completed (see sections 4.2, 6.3 and 6.6).

Infusion site reactions have occurred with the use of parenteral nutrition.

They include infusion site thrombophlebitis and venous irritation, as well as

severe reactions (with, e.g., necrosis and blistering) when associated with

extravasation. See section 4.8. Patients should be monitored accordingly.

Severe water and electrolyte disorders, severe fluid overload states, and

severe metabolic disorders should be corrected before starting the infusion.

Use with caution in patients with pulmonary oedema or heart failure. Fluid

status should be closely monitored.

60060520

4.5 Interaction with other medicinal products and other forms of interaction

No interaction studies have been performed.

The compatibility and stability of nutritive mixtures should be confirmed before

administration.

4.6 Fertility, pregnancy and lactation

There are no adequate data from the use of Primene 10% in pregnant or lactating

women. Healthcare Professionals should carefully consider the potential risks

and benefits for each specific patient before administering Primene 10%.

4.7 Effects on ability to drive and use machines

There is no information of the effects of Primene 10% on the ability to drive or

operate other heavy machinery.

4.8 Undesirable effects

The adverse reactions listed below have been identified from post-marketing

reports of Primene 10% administered as a component of parenteral nutrition.

The frequency of the adverse drug reactions listed in this section cannot be

estimated from the available data.

Tabulated summary of adverse reactions

System Organ

Class (SOC)

Preferred MedDRA Term

frequency

IMMUNE SYSTEM

DISORDERS

Hypersensitivity reaction manifested by:

Face oedema,

Eyelid oedema,

Rash

Not known

Adverse reactions reported with parenteral amino acid products include:

Azotaemia, Hyperammonaemia.

Adverse reactions reported with parenteral nutrition to which the amino acid

component may play a causal or contributory role include:

Anaphylactic/anaphylactoid reactions, including skin, gastrointestinal, and

severe circulatory (shock) and respiratory manifestations as well as other

hypersensitivity/infusion

reactions,

including

pyrexia,

chills,

hypotension,

hypertension, arthralgia, myalgia, urticaria, pruritus, erythema, and headache.

Hepatic failure, Hepatic cirrhosis, Hepatic fibrosis, Cholestasis, Hepatic

steatosis, Blood bilirubin increased, Hepatic enzyme increased; Cholecystitis,

Cholelithiasis.

Raised blood urea nitrogen in children with renal insufficiency.

Metabolic acidosis.

Pulmonary vascular precipitates.

Necrosis, blistering, swelling, scarring, skin discoloration at the infusion site

associated with extravasation (See also infusion site reaction statement in

section 4.4).

Infusion site thrombophlebitis; Venous irritation (infusion site phlebitis, pain,

erythema, warmth, swelling, induration).

Amino acid solutions may precipitate acute folic acid deficiency which should

be corrected by supplements.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal

product is important. It allows continued monitoring of the benefit/risk balance

of the medicinal product. Any suspected adverse events should be reported

to the Ministry of Health according to the National Regulation by using an

online form:

https://sideeffects.health.gov.il

4.9 Overdose

In the event of inappropriate administration (overdose, and/or infusion rate

higher than recommended), hypervolaemia, electrolyte disturbances, acidosis

and/or azotaemia may occur. In such situations, the infusion must be stopped

immediately. If medically appropriate, further intervention may be indicated to

prevent clinical complications.

There is no specific antidote for overdose. Emergency procedures should

include appropriate corrective measures.

5. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Solutions for parenteral nutrition - amino acids

ATC Code: B05BA01

Primene 10% is a solution of 20 L-Amino Acids, intended to correspond

qualitatively and quantitatively to the protein needs of the child:

contains all essential or semi-essential amino acids for the child;

contains relatively high lysine content;

contains Taurine;

contains relatively low Methionine content;

contains reduced Phenylalanine and Proline content.

8 Essential Amino Acids

= 47.5 per cent

Total Amino Acids

Branched Chain Amino Acids

= 24 per cent

Total Amino Acids

Clinical Trials have shown that in combination with a balanced energy supply

Primene 10% allows for satisfactory growth in terms of height and weight as

well as satisfactory psychomotor development in the child.

Primene 10% is deliberately formulated without electrolytes in order not to

interfere with specific electrolyte therapy.

5.2 Pharmacokinetic Properties

Primene 10% is administered intravenously and is therefore immediately

available in the blood stream.

5.3 Preclinical Safety Data

Not applicable.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

L-Malic Acid (for pH adjustment)

Water for Injections

6.2 Incompatibilities

Primene 10% may be part of the composition of nutritive mixtures, combining

carbohydrates, lipids, electrolytes, trace elements and vitamins, on condition

that compatibility and stability should be checked prior to administration.

Additives may be incompatible.

Do not add other medicinal products or substances without first confirming

their compatibility and the stability of the resulting preparation.

Excessive addition of calcium and phosphate increases the risk of the

formation

calcium

phosphate

precipitates

(see

section

4.4).

The addition of trace elements may cause formation of visible particulate

matter (see section 6.6).

6.3 Shelf Life

The expiry date of the product is indicated on the packaging materials.

When used in neonates and children below 2 years of age, the solution (in

bottles and administration sets) should be protected from light exposure until

administration is completed (see sections 4.2, 4.4 and 6.6).

6.4 Special precautions for storage

Do not store above 25°C. Protect from light.

6.5 Nature and Contents of Container

Type II Glass Bottles with an elastomeric stopper containing 100ml, 250ml of

solution. Not all pack sizes may be marketed.

6.6 Special precautions for disposal and other handling

Visually inspect the container. Only use if the container is undamaged and

the solution is clear.

Discard if the container is leaking or if the solution is discoloured, cloudy or

contains a precipitate.

Aseptic conditions must be observed throughout the preparation and use of

Primene 10%.

For single use only.

If additions are made to the container:

Ensure stability and compatibility of additives. Consult with pharmacist.

Prepare the injection site of the container as appropriate.

Puncture the injection site and inject the additives using an injection needle or

a reconstitution device/transfer set, as appropriate.

Mix content of the container and the additives thoroughly.

Inspect final solution for discoloration and particulate matter.

Confirm the integrity of the container. Only use if the container is undamaged

and the solution is clear.

Any unused portion of Primene 10% should be discarded and should not be

used for subsequent admixing.

Ensure proper storage requirements of additives are followed.

Administration of the infusion:

When used in neonates and children below 2 years of age, protect from light

exposure until administration is completed. Exposure of Primene 10% to

ambient light, especially after admixture with trace elements and/ or vitamins,

generates peroxides and other degradation products that can be reduced by

protection from light exposure (see sections 4.2, 4.4 and 6.3).

Allow the solution to reach room temperature before use.

The use of a final filter is required during administration of all formulations

containing Primene 10% and trace elements (including copper, iron, or zinc)

for removal of visible particulate matter which has been observed in the

infusion line for some formulations.

For 2 in 1 (amino acid and carbohydrate) parenteral nutrition solutions, use

a <1.2 micron filter for removal of particulate matter that may be formed

with the use of trace elements (e.g. copper). For 3 in 1 (lipid, amino acid,

and carbohydrate) parenteral nutrition solutions, use a 1.2 micron filter for

particulate matter removal.

Perform

visual

inspections

cloudiness

precipitation

solution, infusion set, catheter and in-line filter after compounding, prior to

administration and periodically during administration. If discolouration or

precipitation is noted in the filter, perform blood levels of copper (or other

trace elements) where medically relevant.

Discard any unused contents. Do not reconnect any partially used container.

Do not connect containers in series in order to avoid air embolism due to

possible residual air in the primary container.

Primene 10% must not be infused through the same tubing with blood or

blood components unless there is documentation that it is safe.

Attach administration set. Refer to ‘Instructions for Use’ accompanying the set.

7. LICENCE HOLDER AND MANUFACTURER

Licence Holder

Teva Medical Marketing Ltd., Haorgim St 8, Ashdod.

Manufacturer

Baxter S.A, Lessines, Belgium.

8. REGISTRATION NUMBER

123.47.30286

Revised in May 2020

DOR-Pri-SPC-0520-08

:ךיראת

רבמצד

2019

ה/דבכנ ת/חקור ,ה/אפור

ןולעב םיאבה םינוכדעה לע העידומ עבט תרבח אפורל

רישכתה לש

ןמירפ

®

%

10

PRIMENE

®

10% Solution for Infusion

Contains:

Each liter of the infusion solution contains:

L-Isoleucine

6.70 g

L-Leucine

10.0 g

L-Valine

7.60 g

L-Lysine

11.00 g

L-Methionine

2.40 g

L-Phenylalanine

4.20 g

L-Threonine

3.70 g

L-Tryptophan

2.00 g

L-Arginine

8.40 g

L-Histidine

3.80 g

L-Alanine

8.00 g

L-Aspartic Acid

6.00 g

L-Cysteine

1.89 g

L-Glutamic Acid

10.00 g

Glycine

4.00 g

L-Proline

3.00 g

L-Serine

4.00 g

L-Tyrosine

0.45 g

L-Ornithine Hydrochloride

3.18 g

Taurine

0.6 g

אפורל ןולעב םינוכדע

------------------------------------------------------------------------------------------------------------

:םושירה תדועתב הרשואש יפכ היוותה

Primene 10 % is indicated in 1) children and infants 2) neonates at term or premature of normal or

low birth weight when oral or enteral nutrition is impossible insufficient or contraindicated.

עידוהל וננוצרב םינולעהש

כדוע ונ תונמוסמ תופסות( דבלב םיירקיעה םינוכדעה םילולכ ןלהלש טוריפב , םודאב

:)

כדע :אפורל ןולעב םינו

[…]

4.4 Special warnings and precautions for use

[…]

Additional precautions

Light exposure of solutions for intravenous parenteral nutrition, especially after admixture

with trace elements and/or vitamins, may have adverse effects on clinical outcomes in

neonates, due to the generation of peroxides and other degradation products. When used in

neonates and children below 2 years of age, Primene should be protected from ambient light

until administration is completed (see sections 6.3, and 6.6).

[…]

6.3.

Shelf Life

The expiry date of the product is indicated on the packaging materials.

When used in neonates and children below 2 years of age, the solution (in bottles and

administration sets) should be protected from light exposure until administration is completed

(see sections 4.4 and 6.6).

[…]

6.6

Special precautions for disposal and other handling

When used in neonates and children below 2 years of age, protect from light exposure until

administration is completed. Exposure of Primene to ambient light, especially after admixture

with trace elements and/ or vitamins, generates peroxides and other degradation products that

can be reduced by protection from light exposure (see sections 4.4 and 6.3).

ולעה

ן

אפורל

תואירבה דרשמ לש טנרטניאה רתאבש תופורתה רגאמב םוסרפל חלשנ

http://www.health.gov.il

.עבט תרבחל הינפ י"ע ספדומ ולבקל ןתינו ,

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