Document: Alphalipid emulsion for infusion ENG PL change

• Alphalipid emulsion for infusion PL
• Alphalipid emulsion for infusion ENG PL

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Alphalipid

200 mg/ml emulsion for infusion

Refined soya-bean oil

Read all of this leaflet carefully before you start using this medicine because it contains important information for you. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1. What Alphalipid is and what it is used for

2. What you need to know before you use Alphalipid

3. How to use Alphalipid

4. Possible side effects

5. How to store Alphalipid

6. Contents of the pack and other information

1. What Alphalipid is and what it is used for

Alphalipid is an emulsion for infusion that belongs to the medicinal group called solutions for parenteral nutrition, fat emulsions. This medicine contains soya-bean oil as the active substance.

Alphalipid is indicated as a source of calories and essential fatty acids for patients requiring parenteral nutrition (nutrition taken into the body by means other than through the digestive tract).

2. What you need to know before you use Alphalipid

Do not use Alphalipid:

• if you are allergic to soya, egg or peanut protein or any of the other ingredients of this medicine (listed in section 6)

• if you have an acute shock (resulting from heavy blood loss or allergic reaction)

• if you have very high levels of fat in your blood (severe hyperlipidaemia)

• if you have seriously reduced liver function

• if you have a defect in your blood clotting system (haemophagocytotic syndrome)

Warnings and precautions

Talk to your doctor before using Alphalipid if you suffer from a condition where your body has problems breaking down fat properly, such as:

• kidney problems

• uncontrolled diabetes

• any pancreas problems

• reduced liver function

• thyroid problems – hypothyroidism

• sepsis (a severe condition in which bacteria and their toxins circulate in the blood and start to damage the organs)

If during infusion you get a fever, rash, shiver or have difficulty breathing tell the healthcare professional immediately. These symptoms might be caused by an allergic reaction or show that you have been given too much of the medicine. Please see also section 4 “Possible side effects”.

This medicine may affect the results of certain laboratory tests you may have. It is important to tell any doctor doing tests that you are being given Alphalipid.

Children and adolescents

If the patient is a newborn or premature infant with jaundice or suspected to have high blood pressure in the lung blood vessels, Alphalipid should be given with caution.

Other medicines and Alphalipid

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

Inform your doctor if you are taking

• insulin for the treatment of diabetes, as insulin can affect the body’s system of breaking down fat.

• a drug known as heparin which is used to prevent the formation and aid in the dispersion of blood clots, as heparin can affect the body’s system of breaking down fat.

• medicines preventing blood clotting of the coumarine type (e.g. warfarin), because Vitamin K₁ which is contained in soya-bean oil could affect the ability of blood to clot in this case.

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 using this medicine.

The doctor will assess the potential risk for the foetus or infant and he will inform you if the treatment with this medicine is advisable.

Driving and using machines

There is no sign that Alphalipid could affect the ability of driving and using machines.

Alphalipid contains sodium

This medicinal product contains 0.65 mmol sodium (15 mg) per 500 ml i.e. essentially ‘sodium- free’.

3. How to use Alphalipid

Alphalipid will be given by a doctor or under the supervision of a doctor who carefully checks the amount of the medicine you get.

You will be given this medicinal product by infusion into a vein (intravenous infusion). The rate of infusion and infusion amount you get will depend on your particular needs, the treated disease and the maximum daily dose. Your doctor will decide what the appropriate dose in your case is.

If you are given more Alphalipid than you should

Your doctor will monitor you during the treatment. It is very unlikely that you will receive more infusion than you should.

In case of overdose there is a risk of taking in too much fat. This is called “fat overload syndrome”. See section 4 “Possible side effects” for more information.

If you believe that you have been given too much Alphalipid, inform your doctor immediately.

The infusion may either be stopped immediately or continued with a reduced dosage.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Uncommon side effects (may affect up to 1 in 100 people)

• fever

• chills

• nausea (feeling sick)

• flushing

Rare side effects(may affect up to 1 in 1,000 people)

• serious allergic reactions (anaphylactic reaction)

• headache

• abdominal pain

• tiredness

• loss of red blood cells or breakdown of red blood cells (haemolysis)

• increased number of immature red blood cells (reticulocytosis)

• reduction in blood platelets (thrombocytopenia) in long-term treatment in infants

• high or low blood pressure

• skin rash and hives (urticaria)

• problems with the liver (hepatic impairment) including transient changes in liver function

• rapid breathing

• prolonged, painful erections in men

Fat overload syndrome

This might happen when your body has problems breaking down fat because of having too muchAlphalipid. It may also happen because of a sudden change in your condition (such as kidney problems or infection). Possible symptoms are fever, increased levels of fat in your blood, cells and tissues, disorders in various organs and coma. All these symptoms will usually disappear if the infusion is discontinued.

Reporting of side effects

If you get any side effects, talk to your doctor.This includes any possible side effects not listed in this leaflet.

You can also report side effects directly via the national reporting system listed in Appendix V*. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Alphalipid

You will not have to store this medicine. This medicine is stored under the responsibility of the doctor.

The following information is intended for the doctor only:

Keep this medicine out of the sight and reach of children.

Alphalipid must not be used after the expiry date which is stated on the carton and the bottle after “EXP”.The expiry date refers to the last day of that month.

Alphalipid must not be used if it is noticed any leaking in the container or phase separation of the emulsion.

After opening the container, the emulsion should be administered immediately.

. Do not freeze.

6. Contents of the pack and other information

What Alphalipid contains

The active substance is refined soya-bean oil.

1000 ml of the emulsion contain 200 g of refined soya-bean oil.

The other ingredients are: purified egg yolk phospholipids, glycerol, sodium oleate, sodium hydroxide and water for injections.

What Alphalipid looks like and contents of the pack

Alphalipid is a milky white emulsion for infusion. It is packed in glass bottles.

Pack sizes:

Glass bottle: 20 x 100 ml

20 x 250 ml

10 x 500 ml

Marketing Authorisation Holder

Alpha Pharmaceuticals GmbH

Hauptstraße 61 A

16348 Wandlitz

Germany

Manufacturer

FORMULA GmbH

Goerzallee 305 b

14167 Berlin

Germany

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

Germany: Alphalipid

Sweden: Alphalipid

This leaflet was last revised in 2015-10-09

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The following information is intended for healthcare professionals only:

Alphalipid is an emulsion ready to be administered by intravenous route.

Alphalipid will be given by a physician or under the supervision of a physician.

The patient’s ability to eliminate the infused fat should determine the dosage.

Treatment monitoring

Adults:where intravenous fat emulsion is indicated for more than a week, the patient’s ability to eliminate fat should be checked. A sample of blood should be taken before the start of the infusion and centrifuged. If the plasma is milky or opalescent, the planned infusion should be postponed. Be aware that hypertriglyceridaemia may pass undetected with this method. In patients in whom impaired fat tolerance may be expected, measurement of the serum triglyceride concentration is therefore recommended. The elimination of fat should be checked daily in the medical conditions mentioned in section 4.4 of the summary of product characteristics.

Paediatric population:in infants treated with Alphalipid the ability to eliminate fat should be tested regularly. In infants receiving long-term parenteral nutrition, particularly premature infants, platelet count, liver function and serum triglycerides should be monitored daily. Specific measurement of the serum triglyceride concentration is recommended for this group.

In general, the following dosage can be considered:

Adults

The patient’s ability to eliminate the infused fat should determine the dosage (see Treatment monitoring above).

The quantity of fat administered intravenously should normally not exceed 3 g/kg bodyweight/day. The highest permitted infusion rate is 1.6 ml/min, equivalent to an infusion time of at least 5 hours for 500 ml.

Paediatric population

The child’s ability to eliminate fat should determine the dosage (see Treatment monitoring above).

The recommended daily dose is 0.5‑4 g fat/kg bodyweight. The infusion rate should not exceed 0.17 g fat/kg bodyweight/hour (4 g fat/kg per 24 hours). In premature and very low birth weight infants Alphalipid should preferably be administered continuously over 24 hours. The initial dosage should be 0.5‑1 g fat/kg bodyweight/day. The dose should then be increased gradually by 0.5‑1 g fat/kg bodyweight/day up to 2 g fat/kg bodyweight/day. The dosage may be increased to 4 g/kg/day only under close monitoring of serum triglyceride concentrations, liver function and oxygen saturation.

Do not use Alphalipid if there is any leaking in the container or if you notice phase separation of the emulsion.

After opening the container, the emulsion should be administered immediately. Any unused product should be discarded.

The presence of Alphalipid in blood samples may interfere with certain laboratory measurements.

Compounding

Alphalipid may be compounded with medicinal products containing amino acids, glucose and electrolyte solutions under aseptic conditions to produce Intradialytic Parenteral Nutrition (IDPN) and Total Parenteral Nutrition (TPN) admixtures.

Medicinal products with the volume of 5 ml and more should be mixed with Alphalipid at once, using an automatic filling system. Volumes below 5 ml may be added separately to the pre-mixture. These processes should be executed under aseptic conditions (see section 6.3 of the summary of product characteristics).

The table below shows the highest concentration of components for which the chemical and physical stability has been demonstrated (see section 6.3 of the summary of product characteristics):

Water for injections can be used to adjust the target concentrations of the corresponding components.

Shelf life after compounding:

Chemical and physical in-use stability has been demonstrated for 4 weeks at 25°C under light protection.

From a microbiological point of view, the product 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 compounding has taken place in controlled and validated aseptic conditions.

Do not freeze the compounded emulsion.

This medicinal product must not be mixed with other medicinal products except those mentioned above.