VAMIN 14 - patient leaflet, side effects, dosage

Vamin

Read all of this leaflet carefully before you are given 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 side effects not listed in this leaflet.

See section 4.

What is in this leaflet:

• 1. What is Vamin 14 and what it is used for

• 2. What you need to know before you receive Vamin 14

• 3. How you are given Vamin 14

• 4. Possible side effects

• 5. How to store Vamin 14

• 6. Contents of the pack and other information

1. what vamin 14 is and what it is used for

Vamin 14 provides nourishment into your blood stream when you cannot eat normally. It provides amino acids, which your body will use to make proteins (to build and repair muscles, organs, and other body structures).

Vamin 14 is typically mixed with salts, fats, carbohydrates and vitamins, which together provide complete nutritional needs.

In this leaflet this solution will be referred to as Vamin 14.

2. what you need to know before you are given vamin 14

Do not use Vamin 14 if:

• a known allergy (hypersensitivity) to Vamin 14 or any of the ingredients of Vamin 14 mentioned in section 6 (for symptoms of an allergic reaction please refer to section 4).
• seriously reduced liver function
• reduced kidney function (ureamia) and are not on dialysis or another form of blood filtration treatment

Inform your doctor if any of the above conditions apply to you before treatment with Vamin 14.

Warnings and precautions

Talk to your doctor or pharmacist before using Vamin 14.

When used in children below 2 years, the solution (in bags and administration sets) should be protected from light exposure until administration is completed. Exposure of Vamin 14 to ambient light, especially after admixtures with trace elements and/or vitamins, generates peroxides and other degradation products that can be reduced by protection from light exposur.e

Before giving you this medicine your doctor should know if you suffer from:

• cardiac insufficiency- the heart can’t pump enough blood throughout the body or any other heart problems
• a condition where your body has problems using proteins or amino acids
• high potassium levels (hyperkalaemia)
• high sodium levels (hypernatraemia)
• acidosis- higher than normal blood pH levels
• any liver and kidney problems

Your doctor may want to do regular blood tests to check your condition. Vamin 14 should be given with caution to patients with electrolyte retention e.g. impaired renal function and to those with cardiac disease requiring electrolyte restriction or drug therapy e.g. digitalis. Potassium replacement should be carefully controlled as plasma potassium levels may not be directly related to tissue levels.

The doctor or nurse will check that the solution is particle free before it is administered to you.

Other medicines and Vamin 14

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

Amino acid solutions may precipitate acute folate deficiency and folic acid should be given daily.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. The doctor will decide if you should receive Vamin 14.

Driving and using machines

Vamin 14 has no effect on driving or using machines.

• 3. How you are given Vamin 14

You will receive your medicine by intravenous infusion (IV drip) into a vein.

The amount and rate at which the infusion is given depends on your requirements.

Your doctor will decide on the correct dose for you to receive.

Dosage

Adults and Elderly:

The recommended dose of Vamin 14 for adults is up to 1 litre (1000ml) every 24 hours and may need to be lowered if you have heart, liver or kidney problems or are frail or elderly.

Each litre should be given over a period of at least 8 hours.

Children and adolescents

When used children below 2 years, the solution (in bags and administration sets) should be protected from light exposure until administration is completed (see section 2).

If it is considered appropriate by doctors, this medicine can be given to infants and children. The dose given to the child will depend on their particular condition and will be decided by the doctor. Doctors may feel that another medicine is more appropriate in infants.

If you receive too much Vamin 14

It is very unlikely that you will receive more infusion than you should as your doctor or nurse will monitor you during the treatment. However if you think that you have received too much Vamin14, inform your doctor or nurse immediately.

The effects of an overdose may include nausea, vomiting, flushing and sweating.

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

4. possible side effects

Like all medicines, Vamin 14 can cause side effects, although not everybody gets them.

All medicines can cause allergic reactions although serious allergic reactions are very rare. If you get any of the following symptoms after receiving this medicine, you should contact your doctor immediately:

• – skin rash

• – swelling (particularly of the lips, face, eyelids, tongue, and throat).

• – breathlessness

• – collapse

• – thrombosis (the formation of a clot) in the vein where the injection is given

The symptoms of thrombosis include:

• – pain, swelling and redness at the blood clot site

• – an itchy rash at the clot site

• – warm skin around the clot

• – a mild fever

• – major veins that stand out from your skin

The following side effects have been observed when infusion was administered too quickly:

• being sick
• sweating
• flushing

Other side effects include:

• folate deficiency- shortage of a vitamin known as folic acid
• abnormal liver test results- these will get back to normal after the treatment with Vamin 14 is finished
• cholestasis- a condition in which bile is not flowing properly from the liver to the intestines
• soreness and tenderness of the vein

5. how to store vamin 14

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

Store below 25°C.

Your doctor and hospital pharmacist are responsible for the correct storage, use and disposal of Vamin 14.

Do not use this medicine after the expiry date which is stated on the label. The expiry date refers to the last day of that month. The solution should not be used if it is not clear of particles. Do not throw away medicines via wastewater. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

When used in children below 2 years, the solution (in bags and administration sets) should be protected from light exposure until administration is completed (see section 2).

6. contents of the pack and other information

What Vamin 14 solution for infusion contains

Each 1000 ml of Vamin 14 contains the following active ingredients:

Amino Acids	Amount	Lysine	6.8 grams	Salts
Alanine	12 grams	Methionine	4.2 grams	Potassium	50 mmol
Arginine	8.4 grams	Phenylalanine	5.9 grams	Magnesium	8 mmol
Aspartic acid	2.5 grams	Proline	5.1 grams	Acetate	135 mmol
Cysteine/cystine	420 milligrams	Serine	3.4 grams	Sodium	100 mmol
Glutamic aci	4.2 grams	Threonine	4.2 grams	Calcium	5 mmol
Glycine	5.9 grams	Tryptophan	1.4 grams	Sulphate	8 mmol
Histidine	5.1 grams	Tyrosine	170 milligrams	Chlorid	100 mmol
Isoleucine	4.2 grams	Valine	5.5 grams
Leucine	5.9 grams

Vamin 14 also contains glacial acetic acid and water for injections.

What Vamin 14 looks like and contents of pack

Vamin 14 is a clear, colourless to slightly yellow solution of amino acids and salts. It is available in glass bottles with a rubber closure that contain 500 ml or 1000 ml of solution.

Not all pack sizes may be marketed.

Marketing authorisation holder

Fresenius Kabi Limited

Cestrian Court

Eastgate Way

Manor Park

Runcorn

Cheshire

WA71NT UK

This leaflet was last revised in September 2019