Consumer medicine information

Vamin 14, 14EF, 18EF

Isoleucine; Leucine; Valine; Phenylalanine; Methionine; Lysine; Threonine; Tryptophan; Cysteine; Histidine; Tyrosine; Alanine; Arginine; Aspartic acid; Glutamic acid; Glycine; Proline; Serine

BRAND INFORMATION

Brand name

Vamin 14, Vamin 14 Electrolyte Free, Vamin 18 Electrolyte Free

Active ingredient

Isoleucine; Leucine; Valine; Phenylalanine; Methionine; Lysine; Threonine; Tryptophan; Cysteine; Histidine; Tyrosine; Alanine; Arginine; Aspartic acid; Glutamic acid; Glycine; Proline; Serine

Schedule

Unscheduled

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Vamin 14, 14EF, 18EF.

What is in this leaflet

This leaflet answers some common questions about Vamin. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you given Vamin against the benefits this medicine is expected to have for you.

If you have any concerns about this medicine, ask your doctor or pharmacist.

Keep this leaflet. You may need to read it again.

What Vamin is used for

Vamin contains amino acids and is an intravenous infusion, which is given as a part of intravenous nutritional therapy. When the intake of nutrients or food into the mouth or directly into the gut is not possible or it is not enough to supply the body’s needs then intravenous nutrients or foods can be given. This is especially important for people whose bodies are under physical stress from illness or recent surgery. During illness or after surgery the body requires nutrition or food. Amino acids are the building blocks used by the body to make proteins. Vamin is usually given together with carbohydrates, fats, salts, trace elements and vitamins to provide a complete intravenous diet.

Your doctor may have prescribed Vamin for another reason. Ask your doctor if you have any questions about why Vamin has been prescribed for you.

Before you are given Vamin

When should you NOT be given Vamin ?

You should NOT be given Vamin if

  • You have severe liver damage.
  • You have an allergy to Vamin or any of the ingredients listed at the end of this leaflet.
  • You have an inability to break down amino acids.
  • You have severe kidney disease or impaired kidney function.
  • You have too much fluid in your body.
  • You have too much potassium in your blood, also called hyperkalaemia.
  • You have multi system organ failure or severe sepsis.

If you are not sure whether any of these apply to you, check with your doctor.

You must tell your doctor:

  • If you have any allergies to any other medicines or any other substances, such as foods, preservatives or dyes.
  • You are suffering from a blood disease or an infection of the blood.
  • If you are pregnant or intend to become pregnant. Your doctor will discuss the risks and benefits of using Vamin during pregnancy.
  • If you are breastfeeding or plan to breastfeed. Your doctor will discuss the risks and benefits of using Vamin when breastfeeding.
  • If you are under 18 years of age.

If you have not told your doctors about any of the above, tell them before you are given Vamin.

Taking other medicines.

Some medicines can interact or interfere with each other. There are currently no known medicines, which can interfere or be affected by Vamin.

Use in Children

There is currently not enough information to recommend the use of Vamin in newborns, infants or children.

How is Vamin given

Vamin is given as a continuous infusion into a central vein. An electronic pump may be used to control the speed of the infusion of drip. Vamin is usually given as a mixture with glucose, fats, salts, trace elements and vitamins. Vamin must only be given by a doctor or nurse.

How much is given

Your doctor will decide what dose you will receive. This will depend on your condition, any other diseases you may have and your body weight.

Your doctor will also calculate your requirements for energy, salts, trace elements and vitamins.

How long it is given

The infusion will be continued for as long as your condition requires.

Side Effects

Vamin, like all other nutrient solutions which are given intravenously, may cause side effects in some people. When Vamin is correctly administered, there should be no adverse effects however if you experience anything unusual during treatment, tell your doctor immediately.

The adverse effects that occur during overdose (see below) are usually reversible and regress when therapy is discontinued. Infusion via central veins in general may have an increased risk of infection.

If you are given too much (overdose)

This rarely happens as Vamin is usually administered under the care of a trained professional in a hospital or clinic setting.

However, if you are given Vamin too quickly or too much, you may experience the following side effects: feeling sick (nausea and vomiting) or shivering.

Your doctor has information on how to recognise and treat an overdose. Ask your doctor if you have any concerns.

Otherwise immediately contact your doctor or a Poisons Information Centre in your country.

Australia: 13 11 26
New Zealand: 0800 764 766

While you are given Vamin

Your doctor will order blood and urine tests while you are given Vamin to monitor your progress. From the results, your dose of Vamin may be adjusted.

Storage

Vamin will be stored in the pharmacy or on the ward. The infusion solution is kept in a cool dry place protected from light, where the temperature stays below 25°C.

Product Description

Vamin is a clear, colourless to slightly yellow solution, which is supplied in glass bottles.

The amino acids present in the formulation are:

Alanine
Aspartic acid
Arginine
Cysteine
Glutamic acid
Glycine
Histidine
Isoleucine
Leucine
Lysine
Methionine
Phenylalanine
Proline
Serine
Threonine
Tryptophan
Tyrosine
Valine

The other ingredients are glacial acetic acid and water for injections.

Vamin 14 contains electrolytes as well whereas Vamin 14EF and Vamin 18EF do not contain electrolytes.

Vamin does not contain gluten, lactose, sucrose, tartrazine or any other azo dyes.

Vamin 14, 14EF and 18EF comes in two pack sizes and can be identified by the AUST R numbers;

Vamin 14 500mL: 14456
Vamin 14 1000mL: 48240

Vamin 14EF 500mL: 14455
Vamin 14EF 1000mL: 48235

Vamin 18EF 500mL: 14454
Vamin 18EF 1000mL: 48237

It may be supplied from the pharmacy as a mixture of Vamin, glucose, fats and vitamins. In this case it would be a milky white mixture in a plastic bag.

Sponsor

Fresenius Kabi Australia Pty Limited
Level 2, 2 Woodland Way
Mount Kuring-gai NSW 2080
Australia
Telephone: (02) 9391 5555

Fresenius Kabi New Zealand Limited
60 Pavilion Drive
Airport Oaks, Auckland 2022
New Zealand
Freecall: 0800 144 892

® = Registered Trademark

Date of information

This leaflet was prepared in September 2016.

Published by MIMS August 2017

BRAND INFORMATION

Brand name

Vamin 14, Vamin 14 Electrolyte Free, Vamin 18 Electrolyte Free

Active ingredient

Isoleucine; Leucine; Valine; Phenylalanine; Methionine; Lysine; Threonine; Tryptophan; Cysteine; Histidine; Tyrosine; Alanine; Arginine; Aspartic acid; Glutamic acid; Glycine; Proline; Serine

Schedule

Unscheduled

 

1 Name of Medicine

Vamin 14.

Alanine, arginine, aspartic acid, cysteine hydrochloride monohydrate, glutamic acid, glycine, histidine, isoleucine, leucine, lysine hydrochloride, methionine, phenylalanine, proline, serine, threonine, tryptophan, tyrosine, valine, calcium gluconate monohydrate, magnesium sulfate heptahydrate, potassium chloride, sodium acetate trihydrate.

Vamin 14 Electrolyte Free and Vamin 18 Electrolyte Free.

Alanine, arginine, aspartic acid, cysteine, glutamic acid, glycine, histidine, isoleucine, leucine, lysine acetate, methionine, phenylalanine, proline, serine, threonine, tryptophan, tyrosine, valine.

2 Qualitative and Quantitative Composition

Clear, colourless to slightly yellow solution. See Table 1 and Table 2.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Injection, intravenous infusion.

4 Clinical Particulars

4.1 Therapeutic Indications

Vamin 14, Vamin 14 Electrolyte Free.

Intravenous supply of amino acids to patients with moderately increased requirements who are unable to receive sufficient amounts of protein enterally.

Vamin 18 Electrolyte Free.

Intravenous supply of amino acids specially to patients with highly increased requirement who are unable to receive sufficient amounts of protein enterally. Vamin 18 is also indicated where there is a need to control the total amount of fluid being given to a patient.
Vamin 18 has been shown to reduce nitrogen loss in patients with major burns without sepsis.
Vamin 14 and 18 should be administered by personnel experienced in intravenous nutrition.

4.2 Dose and Method of Administration

Dosage.

Total daily dose of the solution should be adjusted to the individual patient's metabolic requirements for clinical response. The determination of nitrogen balance and accurate daily bodyweights corrected for fluid balance are probably the best means of assessing individual nitrogen requirements (see Section 4.4 Special Warnings and Precautions for Use, Clinical monitoring). It is essential that a carefully prepared protocol based on current medical practices be carried out only by personnel experienced in parenteral nutrition.

Adults.

Up to 1 litre intravenously per day depending upon calculated protein requirements. The infusion time of 1 litre of amino acid solution should be eight hours or more.
Reliable intravenous pump or drip controls are needed to obtain the desired control over the infusion rate. The protein requirement for Vamin 14 and Vamin 18 will need to be calculated in accordance with an appropriate schedule (see Section 4.4 Special Warnings and Precautions for Use, Clinical monitoring) (Lee and Hartley, 1975).
Usual amino acid requirements are of the order of 1 to 2 g/kg/24 hours although the losses may increase in catabolic state to 3 g/kg/24 hours or more. It is not possible nor desirable to compensate large losses at the time but during recovery.

Use in the elderly.

Dosage as for adults except when hepatic or renal insufficiency is present.
Accepted values for the amount of energy required per g nitrogen are 150 to 200 Kcal/g (150:1 to 200:1 Kcal/g N) for normally metabolising man and 163:1 Kcal/g N for post-operative nonseptic patients. Patients with major burns are hypermetabolic and formulas in use recommend 20 Kcal/kg plus 70 Kcal per % burn for energy, and 1 g/kg plus 3 g per % burn for protein. Because of the need to control fluid input, concentrated amino acid solutions will be required in some of these patients.

Impaired liver function.

Contraindicated in patients with severe liver diseases. Conservative doses should be given to patients with known or suspected hepatic dysfunction as serum amino acid imbalance, hyperammonaemia, stupor and coma may result. Should symptoms of hyperammonaemia develop, administration should be discontinued and the patient's clinical status re-evaluated.

Method of administration.

Strongly hypertonic nutrient solutions are best administered by a catheter into the low superior vena cava or right atrium. Glucose-saline solutions should be used until radiological confirmation of the site of the catheter tip is obtained.
There are no data on the compatibility of Vamin 14 and 18 with other parenteral products.

4.3 Contraindications

In the case of Vamin 14 (with electrolytes): severe liver damage.
Hyperkalaemia: Severe renal disease or impaired renal function; parenteral nutrition should only be administered when fluid and electrolyte balance can be maintained.
The supply of amino acids can result in increased ureagenesis and methods should be available to cope with this, viz. dialysis.

4.4 Special Warnings and Precautions for Use

Vamin 14 and 18 have low cysteine and tyrosine content and are not designed for paediatric use.
A turbid solution should not be infused. The contents of each bottle are for a single infusion only. Any remaining solution should be discarded.
Vamin 14 and 18 have not been tested in patients with hepatic failure, hepatic encephalopathy or multi system organ failure. In severe sepsis or other highly catabolic (greater than 150 g/day) states, these formulations may not be optimal.

Monitoring during administration.

When Vamin 14 and 18 infusions are administered to patients, clinical and laboratory observations must be made regularly and routinely to ensure safety. Severely ill, metabolically unstable patients require close and special monitoring.

Caloric requirements.

It is essential to provide for appropriate caloric supply concurrently if parenterally administered amino acids are to be retained by the body and utilised maximally for protein synthesis. Concentrated glucose solutions or fat emulsions are effective sources of such calories. In septic patients, fat and glucose utilisation are impaired, and glucose and Intralipid should be given as tolerated.

Clinical monitoring.

A basic outline of monitoring requirements is given below; for full details see Transactions of Australian Society for Parenteral and Enteral Nutrition. (Vol. 1 P.32 September, 1984).

1 Four hourly check.

a) Patient - comfort, conscious state, change in overall condition, vital signs.
b) Infusion apparatus and rate.

2 Daily assessment.

a) Balance chart - nitrogen (or protein equivalent); glucose (or other carbohydrate used as energy source); fat (as lipid emulsion); total non-protein energy; electrolytes; fluid.
b) For calculation of daily nitrogen requirements see, e.g. Lee and Hartley. Postgrad. Med. J. 1975; 51: 441-5.
c) Full blood examination if sepsis suspected.

3 Alternative day assessment.

a) Routine clinical chemistry screen (until patient clinically and metabolically stable then twice weekly.
b) Full blood examination: prior to therapy and then 2-3 times weekly.

4 Weekly assessment.

Extra clinical chemistry to assess renal and hepatic function and bone mineral status.

5 Specific assessments.

Trace metals, vitamins, amino acids, coagulation studies, blood cultures, blood gases and 24-hour urine analysis should be carried out whenever clinically indicated.

Catheter management.

A chest radiograph is mandatory after insertion of a central intravenous catheter to check positioning of the catheter tip and to exclude pneumothorax caused by the insertion technique.

Placement of central venous catheters.

Strongly hypertonic nutrient solutions must be administered by a catheter inserted into the low superior vena cava. Insertion into the right atrium may be a controversial matter and only soft catheters must be used for this. Radiographic confirmation of the correct position of the tip of the central venous catheter must be obtained before the infusion of hypertonic nutrient solutions. Infusion of hypertonic solutions into a catheter misplaced up the internal jugular will lead to major thrombosis. Repeat X-rays are advisable every 14 days, unless there is any clinical suspicion of dislodgement, in which a chest X-ray is immediately indicated.

Complications arising from the techniques of administration.

The most serious problems of central vein parenteral nutrition are related to the techniques of administration of the nutrition solution. Sepsis or septicaemia are the most important complications.
Prevention of infection requires specialised care of the central catheter, infusion line and nutrition bottle. Antibiotics may be necessary; however, catheter sepsis can only be cured by removal of the catheter.
Pneumothorax and haemothorax are complications which may occur during catheter placement. Large vein thrombosis is a possible complication of vena cava catheterisation. The insertion of a central venous catheter through the femoral vein should be avoided because of complications. Extravasation of nutrition solution may cause tissue damage and possibly necrosis. Other complications, e.g. arterial puncture and transection, injury to branchial plexus, formation of arteriovenous fistula, cardiac arrhythmia and catheter embolus can be avoided by careful technique.

Complications.

Complications associated with rate of delivery.

The common metabolic disorders associated with too rapid delivery of nutrition solutions are hyperglycaemia, glycosuria and aminoaciduria, leading to dehydration. Conversely, hypoglycaemia may occur if the solution is suddenly slowed or stopped. A constant delivery rate is essential to prevent these complications. Hyperammonaemia has been reported as a complication of parenteral nutrition.

Hypophosphataemia.

Inadequate phosphate administration may cause haemolysis and neurological signs. When commencing intravenous nutrition 25 to 50 mmol/day may be required reducing to 10 to 25 mmol/day when the patient is established.

Hyperchloraemic metabolic acidosis.

A reported complication of parenteral nutrition may occur with administration of Vamin solutions.

Fluid balance.

Care should be taken to avoid hypervolaemia particularly in patients with cardiac insufficiency and pulmonary disorders. Hypertonic glucose solutions should not be used.

Vitamin supplementation.

With long term hyperalimentation or in patients with overt or suspected deficiency attention should be paid to appropriate vitamin supplementation. See Transaction of Australian Society for Parenteral and Enteral Nutrition. 1984, 1, 23-24.
Deficiency of essential fatty acids has been shown to occur within 7 to 10 days of fat free total parenteral nutrition. It is, therefore, recommended that a fat emulsion preparation be used as a source of essential fatty acid for any patient who is on total parenteral nutrition by the central route for longer than 7 days.

Use in hepatic impairment.

See Section 4.3 Contraindications.

Use in renal impairment.

See Section 4.3 Contraindications.

Use in the elderly.

No data available.

Paediatric use.

Vamin 14 and 18 have low cysteine and tyrosine content and are not designed for paediatric use.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

No data available.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No data available.
There have been successful pregnancies in patients on parenteral nutrition. However, safety of Vamin 14 and Vamin 18 in pregnancy has not been established.
 There is no information on the use of Vamin 14 and Vamin 18 in nursing mothers.

4.7 Effects on Ability to Drive and Use Machines

The effects of this medicine on a person's ability to drive and use machines were not assessed as part of its registration.

4.8 Adverse Effects (Undesirable Effects)

Infusion that is too rapid may cause fever, chills, nausea and vomiting. Complications which may occur with administration for intravenous amino acid preparations are:

Allergic reactions.

Hypersensitivity to one more amino acids.

Biochemical.

Increased serum AST and ALT; increased BUN and serum alkaline phosphatase; electrolyte imbalances particularly hypokalaemia and hypophosphataemia; hyperammonaemia; decreased serum osmolality; acid-base imbalances; hyperchloraemic metabolic acidosis.

Cardiovascular.

Disturbances of venous circulation; large vein thrombosis, catheter embolus, septicaemia, cardiac arrhythmias.

Gastrointestinal.

Nausea.

Injection site.

Catheter sepsis; localised inflammation; damage to vein walls, thrombophlebitis; extravasation of parenteral solution.

Respiratory.

Pneumothorax; haemothorax.

Reporting suspected adverse effects.

Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at www.tga.gov.au/reporting-problems.

4.9 Overdose

For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Vamin 14, Vamin 14 Electrolyte Free and Vamin 18 Electrolyte Free contain all 18 essential and non-essential amino acids but in different concentrations. One litre of Vamin 14 and Vamin 14 Electrolyte Free contains amino acids corresponding to nitrogen 13.5 g.
Vamin 18 Electrolyte Free is a more concentrated solution containing nitrogen 18 g (for details see Section 2 Qualitative and Quantitative Composition). Vamin 14 and 18 are appropriate for patients who have an increased protein turnover and hence requirement, but are utilising relatively normal metabolic pathways. The essential amino acid to total nitrogen ratio (E/T ratio) is 2.82 for both formulations.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

Metabolism.

Vamin amino acid solutions provide a source of 8 essential and 10 non-essential amino acids for metabolic processes involved in protein synthesis. Amino acids in excess of immediate requirements are either metabolised in alternative pathways, catabolized and/or excreted.
Initial distribution of most amino acids takes place via the central vascular compartment and extravascular water and transported into cells. Amino acids actively transported into cells where incorporation into proteins, conversion to other amino acids, degradation for fuel or deamination occurs.
For metabolism and requirements for individual amino acids please refer to standard biochemical texts.

Excretion.

Amino acids are excreted in the renal tubules and an active transport mechanism is responsible for resorbing amino acids from the glomerular filtrate and returning them to the circulation. There is an upper limit to the capacity of this active transport system beyond which excess amino acids are excreted in the urine.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

No data available.

6 Pharmaceutical Particulars

6.1 List of Excipients

Glacial acetic acid; water for injections.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Store below 25°C.

6.5 Nature and Contents of Container

Glass bottle:

Vamin 14.

500 mL (AUST R 14456), 1000 mL (AUST R 48240).

Vamin 14 Electrolyte Free.

500 mL (AUST R 144556), 1000 mL (AUST R 48235).

Vamin 18 Electrolyte Free.

500 mL (AUST R 14454), 1000 mL (AUST R 48237).

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of in accordance with local requirements.

6.7 Physicochemical Properties

The physicochemical properties of this medicine were not assessed as part of its registration.

7 Medicine Schedule (Poisons Standard)

Unscheduled.

Summary Table of Changes