200 mg / ml infusion solution , emulsion
Medium-chain triglycerides / soybean oil, refined / omega ‑ 3 ‑ acid triglycerides
What Lipoplus is and what it is used for
Lipoplus is an emulsion of oils in water. The oils in Lipoplus add energy and contain essential fatty acids that your body needs to grow or recover.
Lipoplus is used to provide patients with fat as an intravenous drip, because they can not eat food normally or because the normal intake is not enough.
Lipoplus is intended for adults, premature and full-term newborns, infants, toddlers, children, and adolescents.
What you need to know before you are given Lipoplus
Lipoplus must NOT be used
if you have any of the following conditions:
- if you are allergic to eggs, fish, peanuts or soy protein or any of the other ingredients of this medicine (listed in section 6)
- if you have high levels of fat in your blood (severe hyperlipidemia characterized by hypertriglyceridemia )
- if you have a condition where the blood does not clot normally (severe coagulopathy )
- if you have impaired bile flow (intrahepatic cholestasis)
- if you have severe liver failure
- if you have severe kidney failure and do not receive artificial kidney treatment (haemofiltration or dialysis treatment)
- if you have a blood vessel blockage due to a blood clot or fat ( acute thromboembolic event, fat embolism)
- if you have abnormally high levels of acid in your blood ( acidosis ).
People with any of the following conditions should generally not receive artificial nutrition via an intravenous drip ( parenteral nutrition):
- life-threatening blood circulation problems such as in case of collapse or shock
- acute phase of myocardial infarction or stroke ( stroke )
- unstable metabolism ( metabolism ) e.g. due to diabetes mellitus , whole body infection (severe sepsis ) or coma of unknown cause
- insufficient oxygen supply to tissue are
- disturbances in the body’s salt balance
- dehydration or excess fluid in the body
- fluid accumulation in the lungs ( acute pulmonary edema )
- severe heart failure (uncompensated heart failure ).
Warnings and cautions
Talk to your doctor before giving Lipoplus.
Monitoring
- During infusion one, the doctor should monitor the amount of fat (serum triglycerides) in your blood. If your blood fat levels rise too much, your doctor may reduce the infusion rate or stop the infusion .
- While you are receiving this fluid, your doctor should check your fluid balance, blood salt content and acid-base balance. Liver and kidney function as well as blood clotting ability are monitored and blood cell counts are performed.
- If you show signs of an allergic reaction (such as fever, shaking, rash or breathing problems) while receiving this medicine, your doctor should stop the infusion immediately .
Additional actions
- Before receiving this medicine, your doctor will correct any disturbances in your body’s fluid and salt balance and acid-base balance.
- In addition to Lipoplus, you can also get carbohydrate and amino acid solutions to prevent metabolic conditions where your blood becomes acidic (metabolic acidosis ).
- To complete your intravenous nutrition, you can also get carbohydrate and amino acid solutions. Healthcare professionals can also take steps to ensure that you get enough fluids, electrolytes , vitamins and trace elements.
Elderly patients
Under certain conditions, the body’s ability to use fat properly may be impaired. Your doctor is aware that some of these conditions (eg heart or kidney function) are particularly common in elderly patients.
Patients with heart or kidney problems
If you have heart or kidney problems, your doctor will take special care when you are given this medicine.
Patients with impaired lipid metabolism
In some conditions, the body’s ability to use fat properly may be impaired and your blood fat levels may be too high. Therefore, the doctor must know:
- if you have diabetes mellitus
- if you have inflammation of the pancreas ( pancreatitis )
- if you have impaired liver or kidney function ( kidney failure , liver failure)
- if you have hypothyroidism ( hypothyroidism )
- if you have blood poisoning ( sepsis )
- if you have a condition that involves a combination of three or more of the following: increased amount of fat around the abdomen, decreased amount of good cholesterol ( HDL-C ), increased amount of fat in the blood, high blood pressure and elevated blood sugar (metabolic syndrome).
If your ability to use fat properly is impaired, your doctor should closely monitor your blood fat levels (serum triglycerides).
Children and young people
In infants at risk of jaundice, your doctor should monitor blood lipid levels (serum triglycerides) and bilirubin levels. Your doctor may need to adjust your daily fat dose.
During infusion one, the solution should be protected from the light used in light treatment to reduce the emergence of potentially harmful substances (triglyceride hydroperoxides).
When used to treat newborns and children under 2 years of age, the solution (in bottles and administration set) should be protected from light exposure until the administration is completed. If Lipoplus is exposed to ambient light, especially after the addition of trace elements and/or vitamins, peroxides and other degradation products are formed, which can be reduced if the product is protected from light exposure.
Other medicines and Lipoplus
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Lipoplus may interact with certain other medicines. Tell your doctor if you are taking or are taking certain medicines that prevent unwanted blood clots, such as
- heparin
- coumarins, e.g. warfarin .
It may be necessary to check the coagulation of one in your blood through regular blood tests.
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.
Pregnancy
If you are pregnant, you will only be given this medicine if your doctor considers it necessary for your recovery. There is no information on the use of Lipoplus in pregnant women.
Breast-feeding
Breast-feeding is not recommended for mothers receiving parenteral nutrition.
Driving and using machines
You receive the medicine in controlled conditions, ie in a hospital or under other medical supervision, which normally excludes driving a car or using machines.
Lipoplus contains sodium
This medicine contains 59.8 mg of sodium (the main ingredient in table salt/table salt) per 1000 ml. This corresponds to 3% of the maximum recommended daily sodium intake for adults.
How to use Lipoplus
Dosage
Your doctor will decide how much of this medicine you need and how long your treatment time with the medicine must be.
The daily doses are adjusted according to your needs, your age, and your body weight. The doses are usually determined based on “grams of fat per kg of body weight”. You will be careful that the doses used and the infusion rate is right for you so that you do not exceed your body’s capacity to use the added fat.
How is Lipoplus given?
Lipoplus is given as an intravenous drip as part of a nutritional program. For this purpose, a small tube ( catheter ) is placed in a vein through which the fat emulsion can be given either separately or together with other liquids.
When used to treat newborns and children under 2 years of age, the solution (in bottles and administration sets) should be protected from exposure to light until the administration is completed (see section 2).
If you take more Lipoplus than you should
If you have received too much Lipoplus, you may have an abnormally high level of fat in your blood ( hyperlipidemia ), your blood may become too acidic (metabolic acidosis ) or you may suffer from a so-called fat overload syndrome. For symptoms of obesity syndrome, see section 4 Possible side effects.
If you have been given too much Lipoplus, the infusion will be stopped immediately. Infusion one does not restart until you have recovered. It may be necessary for your doctor to adjust your daily fat dose. The doctor decides on any further treatment.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects can be serious. If any of the following side effects occur, contact your doctor immediately so that the supply of the medicine can be stopped:
Very rare: may affect up to 1 in 10,000 people
- allergic reactions, such as skin reactions, shortness of breath, swelling of the lips, mouth and throat, difficulty breathing
- breathing problems ( dyspnoea )
- bluish discoloration of the skin (cyanosis).
Other side effects are
Very rare: may affect up to 1 in 10,000 people
- fat overload syndrome (see “Fat Overload Syndrome” below)
- increased tendency for coagulation in the blood (hypercoagulation)
- abnormally high blood fat content ( hyperlipidemia )
- abnormally high blood sugar ( hyperglycaemia )
- high content of acidic substances in the blood (metabolic acidosis )
- decrease or increase in blood pressure et
- drowsiness
- nausea, vomiting, loss of appetite
- headache
- hemorrhage
- redness ( erythema )
- fever
- sweating
- feeling cold, chills.
Rare: may affect up to 1 in 1,000 people
- pain in the back, skeleton, chest and lumbar region.
Has been reported: occurs in an unknown number of users
- impaired bile flow (cholestasis)
- decreased white blood cell count ( leukopenia )
- decreased platelet count ( thrombocytopenia ).
If you get any of these side effects, the infusion will be stopped.
Fat overload syndrome
You can suffer from a fat overload syndrome if you have received too much Lipoplus or if your body has problems using fat. Your body’s ability to use fat can be affected by a sudden change in your condition (due to kidney problems or an infection ). The symptoms usually disappear if the infusion is stopped. Fat overload syndrome is characterized by the following symptoms:
- high levels of fat in the blood ( hyperlipidemia )
- fever
- fat accumulations in the liver or other organs (fat infiltration)
- liver enlargement ( hepatomegaly ) which can sometimes be accompanied by jaundice (jaundice)
- enlarged spleen ( splenomegaly )
- decreased number of red blood cells ( anemia )
- decreased white blood cell count ( leukopenia )
- decreased platelet count ( thrombocytopenia )
- disorders of blood coagulation
- decay of blood cells ( hemolysis )
- increased number of immature red blood cells (reticulocytosis)
- abnormal results in liver function tests
- loss of consciousness ( coma ).
How to store Lipoplus
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label and outer carton. The expiration date is the last day of the specified month.
Lipoplus should be used immediately after opening the package.
Do not store above 25 ° C.
Store in the original package. Sensitive to light.
Do not freeze. Discard the package if it is accidentally frozen.
Do not use this medicine if you notice:
- large oil droplets in emulsion one or two separate layers of liquid
- discoloration
- damage to the container or closure.
When used to treat newborns and children under 2 years of age, the solution (in bottles and administration sets) should be protected from exposure to light until the administration is completed (see section 2).
Contents of the pack and other information
Content declaration
- The active substances in 1000 ml Lipoplus 200 mg / ml are:
| Medium chain triglyceride s | 100.0 g |
| Soybean oil, refined | 80.0 g |
| Omega ‑ 3 ‑ acid triglycerides | 20.0 g |
| This gives the following content of essential fatty acids per liter: | |
| Linoleic acid (omega ‑ 6) | 38.4 – 46.4 g |
| Alpha-linoleic acid (omega ‑ 3) | 4.0 – 8.8 g |
| Eicosapentaenoic acid and docosahexaenoic acid (omega ‑ 3) | 8.6 – 17.2 g |
| 200 mg/ml (20%) corresponds to the total amount of triglycerides. | |
| Energy [kJ / l (kcal / l)] | 7990 (1910) |
| Osmolality [mOsm / kg], approx | 410 |
| Acidity or alkalinity (titration to pH 7.4) [mmol / l NaOH or HCl ] | <0.5 |
| pH | 6.0 – 8.5 |
| The other ingredients are glycerol, egg phospholipids for injection, all- rac -α-tocopherol, ascorbyl palmitate, sodium oleate, sodium hydroxide (for pH adjustment), and water for injections. |
What the medicine looks like and contents of the pack
Lipoplus is a milky white, sterile oil-in-water emulsion for infusion (given by venous drip).
It is delivered in glass bottles with rubber stoppers, pack sizes:
10 × 100 ml, 1 × 250 ml, 10 × 250 ml, 1 × 500 ml, 10 × 500 ml, 1 × 1000 ml, 6 × 1000 ml
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
B. Braun Melsungen AG
Carl-Braun-Straße 1
34212 Melsungen
Germany
Postal address
34209 Melsungen
Germany
For any information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:
B. Braun Medical AB
Box 110
182 12 Danderyd