N5E infusion solution, emulsion
What Is Olimel And What Olimel Used For
Olimel N5E is an infusion solution . It is provided in a bag with three sections. One section contains a glucose solution with calcium, the other contains a lipid emulsion, and the third contains an amino acid solution with other electrolytes.
Olimel N5E provides nutrition to adults and children over two through a vein ( infusion ) tube when normal oral intake is not appropriate. Olimel N5E should only be used under medical supervision.
What You Need To Know Before You Are Given Olimel N5E
Do Not Use Olimel N5E:
- To premature babies, newborns and children younger than 2 years.
- If you are allergic (hypersensitive) to eggs, soybean protein, peanut protein or corn/corn products (see also section “Warnings and precautions” below) or any of the other ingredients of this medicine (listed in section 6).
- If you know with your body that your body can not utilize certain amino acids.
- If you have particularly high levels of fat in your blood.
- If you have hyperglycaemia (too much blood sugar).
- If you have an abnormally high plasma concentration of any electrolyte ( sodium, potassium, magnesium, calcium and phosphorus).
In all cases, the doctor will base his decision on whether you should receive this medicine on factors such as age, weight, and medical condition, along with the results of any tests performed.
Warnings And Cautions
Talk to your doctor or nurse before giving you Olimel N5E. Receiving nutritional solutions via infusion (TPN) too quickly can lead to injury or death.
The infusion must be stopped immediately if any abnormal signs or symptoms of an allergic reaction (such as sweating, fever, chills, headache, rash, or difficulty breathing) develop. This product contains soybean oil and egg phospholipids. In rare cases, soybean and egg protein can cause hypersensitivity reactions. Cross-allergic reactions between soybean protein and peanut protein have been observed.
Olimel medicine contains glucose made from maize. It may cause hypersensitivity (allergic reactions) if you are allergic to maize or maize products (see section “Do not use Olimel N5E” above).
Breathing difficulties can also signify that small particles have formed, blocking blood vessels in the lungs (precipitation in the pulmonary vessels). If you experience difficulty breathing, talk to a doctor or nurse. They will decide on appropriate measures.
Ceftriaxone (an antibiotic ) must not be mixed or co-administered with solutions containing calcium (including Olimel N5E) by drip into a vein. These medicines must not be given together, even if different infusion lines or sites are used. Your doctor may give you Olimel N5E and ceftriaxone one after the other if infusion tubes are used at different infusion sites or if the infusion tubing is replaced or rinsed thoroughly with a physiological saline solution between the infusions to avoid precipitation (particles formed by ceftriaxone calcium salt).
Some medications and conditions can increase the risk of developing an infection or sepsis (bacteria in the blood). The risk of infection or sepsis is particularly high when a tube ( intravenous catheter ) is inserted into the vein. Your doctor will monitor you closely and pay attention to any signs of infection. Patients who need parenteral nutrition (nutrition through a tube in the vein) may be at greater risk of infection due to their disease state. The risk of infection can be reduced by using “aseptic technology” (“bacteria-free technology”) when placing and caring for the catheter and when preparing the nutrient solution (TPN).
If you are severely malnourished so that you need to be nourished by a vein, your doctor will start treatment slowly. Your doctor will also monitor you closely to avoid sudden fluid, vitamin, electrolyte, and mineral changes.
The balance between water and salt in the body and disorders of metabolism will be corrected before infusion one. Your doctor will monitor your condition while receiving the medicine and may change your dose or give you additional nutrients, e.g. vitamins, electrolytes and trace elements, if he/she deems it appropriate.
Liver disease, including problems getting rid of bile (cholestasis), fatty liver, and fibrosis (connective tissue formation), can lead to liver failure, gallbladder inflammation and gallstones in the gallbladder, have been reported in patients receiving intravenous nutrition. The cause of these diseases is considered due to several factors and can vary between patients. If you get symptoms such as
- Nausea
- Vomiting
- Abdominal pain
- Yellowing of the skin or eyes
Contact your doctor to identify possible causes, contributing factors, treatments, and preventive measures. The doctor should be aware of the following conditions:
- Severe kidney problems. Also, tell your doctor if you are receiving dialysis or any other type of blood purification
- Severe liver problems
- Problems with blood coagulation
- Adrenal glands that do not function properly (adrenal insufficiency). The adrenal glands are triangular glands located on top of the kidneys.
- Heart failure
- Lung disease
- Water accumulation in the body (hyperhydration)
- Insufficient amount of water in the body ( dehydration )
- Untreated high blood sugar ( diabetes mellitus )
- Heart attack or shock due to sudden heart failure
- Severe metabolic acidosis (when the blood is too acidic)
- Generalized infection ( septicemia )
- Coma
To check the effect and continuously monitor that the infusion is safe, the doctor performs clinical tests and laboratory tests while you are receiving this medicine. If you take this medicine for several weeks, your blood status will be monitored regularly.
If your body has a reduced ability to get rid of the fats in this medicine, “fat overload syndrome” may occur (see section 4, Possible side effects ).
If the infusion site hurts, burns or swells during infusion one, or if the infusion one is leaking, tell your doctor or nurse. Infusion one is stopped immediately and started in another vein.
If your blood sugar gets too high, your doctor should adjust the infusion rate to one of Olimel N5E or give you medicines that control your blood sugar ( insulin ).
Olimel N5E can only be given via a tube ( catheter ) into a large vein in the chest (central vein).
Children And Young People
If your child is under 18, special care will be taken to give the correct dose. More safety measures will also be taken, as children are more susceptible to infection. Additions of vitamins and trace elements are always required. Pharmaceutical forms adapted for children should be used.
Other Medicines And Olimel N5E
Tell your doctor if you are taking or using or have recently taken or used or might take or use any other medicines. In normal cases, it is not a problem to use other medicines at the same time as this medicine. Tell your doctor if you are taking or have recently taken any other medicines, including those obtained without a prescription, to ensure that they can be taken simultaneously.
Tell your doctor if you are taking or receiving any of the following medicines:
- Insulin
- Heparin
Olimel N5E must not be given at the same time as blood through the same tube. Olimel N5E contains calcium. It must not be given together or through the same tube as ceftriaxone (an antibiotic ), as particles can then form. If the same tubing is used to give you these medicines one after the other, it should be rinsed thoroughly.
Olimel N5E must not be given in the same infusion line or mixed with ampicillin ( antibiotic ) or fosphenytoin ( antiepileptic ) due to the risk of precipitation.
The olive and soybean oil in Olimel N5E contains vitamin K. This does not normally affect blood thinners ( anticoagulants ) such as coumarin. Still, you should tell your doctor if you are taking blood thinners.
The fats in this mixture may affect the results of some laboratory tests if blood samples are taken before the fats have disappeared from your bloodstream (usually, they have disappeared 5 to 6 hours after the end of the infusion ).
Olimel N5E contains potassium. Particular caution should be exercised in patients taking diuretics, ACE inhibitors, angiotensin II receptor antagonists (medicines for high blood pressure ) or immunosuppressive medicines. These types of drugs can increase potassium levels in the blood.
Pregnancy And Breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.
There is no adequate data on using Olimel N5E in pregnant and lactating women. Olimel N5E may be considered for treatment during pregnancy and lactation. Olimel N5E should only be given to pregnant and lactating women after careful consideration.
Driving And Using Machines
Not relevant.
How Olimel N5E Is Given
- Dosage
- Olimel N5E should only be given to adults and children over two years of age.
- Olimel N5E is an infusion solution or emulsion given via a tube ( catheter ) into a vein in the breast.
- Olimel N5E should reach room temperature before use.
- Olimel N5E is for single use only.
- Giving a bag via infusion usually takes between 12 and 24 hours.
- Dosage – adults
- Your doctor will specify a flow rate corresponding to your needs and clinical condition.
- Depending on your clinical condition, treatment can be continued for as long as needed.
- Dosage – children over 2 years of age and adolescents
- The doctor decides the dose and how long the medicine should be given. It depends on age, weight, height, medical condition, and the body’s ability to break down and assimilate the ingredients in Olimel N5E.
If you take more Olimel N5E, then you should
If the dose is too high or the infusion is too fast, the amino acids can make the blood too acidic, and signs of hypervolemia (increase in circulating blood volume) may occur. Blood glucose levels in the blood and urine may increase, hyperosmolar syndrome (too high viscosity in the blood) may develop, and the fat content may increase the number of triglycerides in the blood. Excessive infusion or excessive volume of Olimel N5E may cause
- Nausea
- Vomiting
- Chills
- Headache
- Hot flashes
- Excessive sweating ( hyperhidrosis )
- Disturbances in the electrolyte balance
If any of these occur, the infusion must be stopped immediately. In some severe cases, the doctor may need to give temporary kidney dialysis to help the kidneys eliminate the excess product.
To prevent this, your doctor will monitor your condition and test your blood counts regularly. Ask your doctor for further questions on how to use this product.
Possible Olimel Side Effects
This medicine can cause side effects like all medicines, although not everybody gets them. Contact a doctor or nurse immediately if you notice any change in how you feel during or after treatment. The tests your doctor performs while taking this medicine should minimize the risk of side effects.
If any abnormal signs or symptoms of an allergic reaction develop, e.g.
- Sweating
- Fever
- Chills
- Headache
- Rash
- Difficulty breathing
- The infusion should be stopped immediately.
The following side effects have been reported with Olimel N5E:
Common: may affect up to 1 in 10 users:
- Palpitations ( tachycardia )
- Reduced appetite
- Increased concentration of fat in the blood ( hypertriglyceridemia )
- Abdominal pain
- Diarrhoea
- Nausea
- High blood pressure ( hypertension ).
Been reported: occurs an unknown number of users:
- Hypersensitivity reactions include
- Sweating
- Fever
- Chills
- Headache
- Rash (redness (erythematous)
- Lumpy skin (papular)
- Blisters on the skin ( pustular )
- Mottled skin (macular)
- Generalized rash)
- Itching
- Hot flashes
- Difficulty breathing
- Infusion leakage to surrounding tissue (extravasation) which may result in pain
- Irritation
- Swelling/oedema
- Redness ( erythema ) /
- Heat
- Dead tissue cells (skin necrosis) or blisters/vesicles
- Inflammation
- Thickened or tightening skin
- Vomiting.
The following side effects have been reported with similar parenteral nutrition drugs:
Very rare: may affect up to 1 in 10,000 users:
- Impaired ability to get rid of fats (fat overload syndrome) which are associated with sudden and abrupt deterioration of the patient’s medical condition. The following signs of fat overload syndrome usually disappear when the infusion of one of the lipid emulsions is stopped:
- Fever
- Decreased number of red blood cells that can lead to pale skin, weakness and shortness of breath (anaemia)
- Low white blood cell count, which may increase the risk of infection ( leukopenia )
- Low platelet count, which may increase the risk of bruising and bleeding ( thrombocytopenia )
- Coagulation disorders that affect the blood’s ability to clot
- High blood fat levels ( hyperlipidemia )
- Storage of fat in the liver ( hepatomegaly )
- Impaired liver function
- Symptoms of the central nervous system (e.g. coma ).
Been reported: occurs an unknown number of users:
- Allergic reactions
- Abnormal blood tests to check liver function
- Problems getting rid of bile (cholestasis)
- Enlarged liver ( hepatomegaly )
- Liver disease associated with parenteral nutrition (see section 2, “Warnings and Precautions”)
- Jaundice (jaundice)
- Decreased platelet count (thrombocytopenia)
- Increased nitrogen levels in the blood (azotemia)
- Elevated liver enzymes
- Formation of small particles that can block blood vessels in the lungs (precipitation in the pulmonary vessels) and cause pulmonary embolism and difficulty breathing.
How To Store Olimel N5E
- Keep this medicine out of sight and reach of children.
- Use this medicine before the expiry date stated on the container and the outer carton after EXP. The expiration date is the last day of the specified month.
- Do not freeze.
- Store in the outer bag.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer required. These measures will help to protect the environment.
Contents Of The Pack And Other Information
Content Declaration
The active substances in each bag of reconstituted emulsion are 8.2% (equivalent to 8.2 g / 100 ml) L-amino acid solution (alanine, arginine, glycine, histidine, isoleucine, leucine, lysine (as lysine acetate), methionine, phenylalanine, proline, serine, threonine, tryptophan, tyrosine, valine, aspartic acid, glutamic acid) with electrolytes ( sodium, potassium, magnesium, phosphate, acetate, chloride), 20% (equivalent to 20 g / 100 ml) lipid emulsion (refined olive oil and refined soybean oil) and 28.75% (equivalent to 28.75 g / 100 ml) glucose solution (as glucose monohydrate) with calcium.
Other ingredients are:
| Section with lipid emulsion | Section with the amino acid solution | Section with glucose solution |
|---|---|---|
| Purified egg phospholipids, glycerol, sodium oleate, sodium hydroxide (for pH adjustment), water for injections | Concentrated acetic acid (for pH adjustment), water for injections | Hydrochloric acid (for pH adjustment), water for injections |
What The Medicine Looks Like And Contents Of The Pack
What the medicine looks like and the contents of the pack
- Olimel N5E is an infusion solution, an emulsion packaged in a bag in three sections. One section contains a fat emulsion, the other an amino acid solution with electrolytes, and the third a glucose solution with calcium. Non-permanent seals separate the sections. Before administration, the contents of the sections should be mixed by rolling the bag from the upper end until the seals are open.
- Appearance before mixing :
- Amino acid – and glucose solutions are clear, colourless or slightly yellow.
- The fat emulsion is homogeneous and milky.
- Appearance after mixing: a homogeneous milky mixture
- The bag with three sections is made of multilayer plastic. The inner layer of the bag material (the contact layer) is designed to be compatible with the ingredients and the approved additives.
- The bag is packed in an outer bag as an oxygen barrier to avoid contact with oxygen from the air. It contains a small bag with an oxygen absorber.
- Pack sizes
- 1500 ml bag: 1 carton with 4 bags
- 2000 ml bag: 1 carton with 4 bags
- 2500 ml bag: 1 carton with 2 bags
- 1 bag of 1500 ml, 2000 ml, and 2500 ml
- Not all pack sizes may be marketed.
Marketing Authorization Holder And Manufacturer
Baxter Medical AB
Box 63
164 94 Kista
Manufacturer
Baxter SA
Boulevard René Branquart, 80
7860 Lessines
Belgium