infusion solution, emulsion
What Olimel N12E is and what it is used for
Olimel N12E 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 electrolytes .
Olimel N12E is used to provide nutrition to adults and children over the age of two through a tube in a vein ( infusion ) when normal oral intake is not appropriate.
Olimel N12E should only be used under medical supervision.
What you need to know before you are given Olimel N12E
Olimel N12E should not be given:
- For premature babies, newborns and children younger than 2 years.
- If you are allergic to egg, soybean, 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 sugar in your blood).
- If you have an abnormally high plasma concentration of any electrolyte ( sodium , potassium , magnesium , calcium and / or 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 N12E.
If you receive nutritional solutions via infusion (TPN) too quickly, it 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 medicine contains soybean oil and egg phospholipids. Soybeans and egg protein can cause hypersensitivity reactions. Cross-allergic reactions between soybeans and peanut protein have been observed.
Olimel N12E contains glucose made from maize. It may cause hypersensitivity (allergic reactions) if you are allergic to maize or maize products (see section “Olimel N12E should not be given” above).
Breathing difficulties can also be a sign that small particles have formed that block blood vessel 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 N12E) by drip into a vein.
These medicines must not be given together, even if different infusion lines or infusion sites are used. Your doctor may give you Olimel N12E 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 developing 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 changes in fluid, vitamin, electrolyte, and mineral levels.
The balance between water and salt in the body and metabolic disorders will be corrected before the infusion begins. Your doctor will monitor your condition while you are 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, fibrosis, which can lead to liver failure, as well as gallbladder inflammation and gallstones in the gallbladder, have been reported in patients receiving intravenous nutrition. The cause of these diseases is considered to be due to several factors and can vary between different patients. If you get symptoms such as nausea, vomiting, abdominal pain, yellowing of the skin or eyes, contact your doctor to identify possible causes and contributing factors and possible 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 (blood clotting ability)
- 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)
- a serious infection (blood poisoning)
- come .
To monitor the effect and continuously monitor the safety of the infusion, your doctor may perform clinical and laboratory tests while you are receiving this medicine. If you are taking 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 during infusion you notice pain, burning sensation, or swelling of the skin at the infusion site, or if the infusion 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 rate of infusion one of Olimel N12E or give you medicines that control your blood sugar ( insulin ).
Olimel N12E 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 years of age, special care will be taken to give the correct dose. More safety measures will also be taken, as children have a higher susceptibility to infection. Additions of vitamins and trace elements are always required. Pharmaceutical forms adapted for children should be used.
Other medicines and Olimel N12E
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 any other medicines, including those without a prescription, to check that they are good to take at the same time.
Tell your doctor if you are taking or receiving any of the following medicines:
- Insulin
- Heparin .
Olimel N12E must not be given at the same time as blood through the same tube.
Olimel N12E contains calcium. It must not be given together with 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 N12E 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 N12E contains vitamin K. This does not normally affect blood thinners ( anticoagulants ) such as coumarin, but 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 N12E contains potassium. Particular caution should be exercised in patients taking diuretics, ACE inhibitors, or 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 are no adequate data from the use of Olimel N12E in pregnant and lactating women. If necessary, Olimel N12E can be considered as treatment during pregnancy and lactation. Olimel N12E should only be given to pregnant and lactating women after careful consideration.
Fertility
Sufficient data are not available.
Driving and using machines
Not relevant.
How Olimel N12E is given
Dosage
Olimel N12E should only be given to adults and children over two years of age.
Olimel N12E is an infusion solution, an emulsion given through a tube ( catheter ) into a vein in the breast.
Olimel N12E should reach room temperature before use.
Olimel N12E 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 that corresponds to your needs and your clinical condition.
Treatment can be continued for as long as needed, depending on your clinical condition.
Dosage – children over 2 years of age and adolescents
The doctor decides the dose and for how long the medicine should be given. It depends on the patient’s age, weight, height, medical condition, and the body’s ability to break down and assimilate the ingredients in Olimel N12E.
If you take more Olimel N12E than you should
If you have ingested too much medicine or if e.g. If a child has ingested the medicine by mistake, contact a doctor or hospital for risk assessment and advice.
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 N12E may cause nausea, vomiting, chills, headache, hot flashes, excessive sweating ( hyperhidrosis ), and 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 get rid of 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 side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you notice any change in how you feel during or after treatment, contact a doctor or nurse immediately.
The tests that your doctor performs while you are 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, or difficulty breathing, the infusion should be stopped immediately.
The following side effects have been reported with Olimel:
Common: may affect up to 1 in 10 users
- Palpitations ( tachycardia )
- Reduced appetite
- Increased concentration of fat in the blood (hypertriglyceridemia)
- Abdominal pain
- Diarrhea
- Nausea
- High blood pressure ( hypertension ).
Has 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 cause pain, irritation, swelling / edema, 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 people
- Impaired ability to get rid of fats (fat overload syndrome) which is associated with a 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 ( anemia )
- Low white blood cell count , which may increase the risk of infection ( leukopenia )
- Low platelet count , which may increase the risk of bruising and / or bleeding ( thrombocytopenia )
- Coagulation disorders that affect the blood’s ability to coagulate
- High blood fat levels ( hyperlipidemia )
- Storage of fat in the liver ( hepatomegaly )
- Impaired liver function
- Symptoms of central nervous system (eg coma ).
Has 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 N12E
Keep this medicine out of the sight and reach of children.
Use this medicine before the expiry date which is stated on the bag 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 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 14.2% (equivalent to 14.2 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), 17.5% (equivalent to 17.5 g / 100 ml) lipid emulsion (refined olive oil and refined soybean oil) and 27.5% (equivalent to 27.5 g / 100 ml) glucose solution (as glucose monohydrate) with calcium .
Other ingredients are:
| Section with lipid emulsion | Section with amino acid solution and electrolytes | Section with glucose solution and calcium |
| Purified egg phospholipids,glycerol , sodium oleate,sodium hydroxide (for pH adjustment), water forinjections | Glacial acetic acid (for pH adjustment), water forinjections | Hydrochloric acid (for pH adjustment), water forinjections |
What the medicine looks like and contents of the pack
Olimel N12E is an infusion solution , emulsion packaged in a bag in three sections. One section contains a lipid emulsion (fat emulsion), the other an amino acid solution with electrolytes and the third a glucose solution with calcium . The sections are separated by non-permanent seals. Before administration , the contents of the sections should be mixed by rolling the bag starting from the upper end until the seals are open.
Appearance before mixing:
- amino acid – and glucose solutions are clear, colorless or slightly yellow.
- the lipid emulsion is homogeneous and milky.
Appearance after mixing: 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 so that it is compatible with the ingredients and the approved additives.
To avoid contact with oxygen from the air, the bag is packed in an outer bag as an oxygen barrier. It contains a small bag with an oxygen absorber.
Pack sizes
650 ml bag: 1 carton with 10 bags
1000 ml bag: 1 carton with 6 bags
1500 ml bag: 1 carton with 4 bags
2000 ml bag: 1 carton with 4 bags
1 bag of 650 ml, 1000 ml, 1500 ml and 2000 ml.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Baxter Medical AB
Box 63
164 94 Kista
Manufacturer
Baxter SA
Boulevard René Branquart, 80
7860 Lessines
Belgium