Consumer medicine information

What is in this leaflet

This leaflet answers some common questions about Sodium Ascorbate Solution Injection for Intravenous Infusion.

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 giving Sodium Ascorbate Solution Injection against the benefits they expect it will have for you.

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

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

What Sodium Ascorbate Solution Injection is used for

Sodium Ascorbate Solution Injection contains the active ingredient sodium ascorbate (Vitamin C).

Sodium Ascorbate Solution Injection may be prescribed if you have a diagnosed Vitamin C deficiency and are unable to absorb sufficient Vitamin C when taking it by mouth.

Your doctor may have prescribed Sodium Ascorbate Solution Injection for another reason. Ask your doctor if you have any questions about why Sodium Ascorbate Solution Injection has been prescribed for you.

Sodium Ascorbate Solution Injection is not addictive.

Before you have Sodium Ascorbate Solution Injection

When you must not use it:

Do not have Sodium Ascorbate Solution Injection given if:

• You have a known allergy to Vitamin C
  If you have had an allergic reaction to vitamin C before, you may be allergic to Sodium Ascorbate Solution Injection.
• You have kidney disease or kidney stones
  There have been a few cases where injected vitamin C has made kidney disease worse.
• The packaging is torn or shows signs of tampering
• The expiry date (Exp.) printed on the pack has passed
  If you have this medicine after the expiry date, it may not work and it may be harmful to you.

If you are not sure whether you should have Sodium Ascorbate Solution Injection given, talk to your doctor.

Before you have it injected:

If you have any of the following medical illnesses or conditions, you must tell your doctor. Your doctor will discuss the risks and benefits of using Sodium Ascorbate Solution Injection if you have any of these illnesses or conditions.

• Tell your doctor if you have had an allergy to any of the ingredients in this medicine, any other medicines or any other substances, such as foods, preservatives or dyes.
• Tell your doctor if you have kidney disease or kidney stones.
• Tell your doctor if you have haemochromatosis, thalassaemia, polycythemia, leukaemia or sideroblastic anaemia due to enhanced absorption of dietary iron.
• Tell your doctor if you have high uric acidity.
• Tell your doctor if you have high sodium levels.
• Tell your doctor if you have Sickle Cell Anaemia.
• Tell your doctor if you have G6PD (Glucose-6-phosphate dehydrogenase Deficiency.
• Tell your doctor if you are pregnant or breastfeeding

Your doctor will discuss the risks and benefits of using Sodium Ascorbate Solution Injection while pregnant or breastfeeding

If you have not told your doctor about any allergies you might have, tell them before you have Sodium Ascorbate Solution Injection given.

If Taking Other Medicines:

Tell your doctor if you are taking any other medicines, including medicines that you buy without a prescription from your pharmacy, supermarket or health food shop.

Some medicines and Sodium Ascorbate Solution Injection may interfere with each other. These include:

• Aspirin
• Iron Oral Supplements
• Alcohol
• Amphetamine or other antidepressants
• Dicoumarol or Warfarin, medicines used to prevent blood clots
• Ethinyloestradiol, a medicine used in oral contraceptives
• Desferrioxamine, a medicine used to lower iron stores
• Isoprenaline, a medicine used as a heart medication
• Mexiletine, a medicine used as a heart medication and for nerve pain
• Barbiturates or primidone, medicines used as sedatives
• Fluphenazine, a medicine used in psychiatric treatment.

These medicines may be affected by Sodium Ascorbate Solution Injection, or may affect how well it works.

Your doctor or pharmacist will advise you and decide whether or not to give you Sodium Ascorbate Solution Injection.

How Sodium Ascorbate Solution Injection is given

Sodium Ascorbate Solution Injection will be infused (slowly injected) intravenously (into a vein) by your doctor. Your doctor will decide the best way to do this.

How much is given:

Your doctor will tell you how much Sodium Ascorbate Solution Injection will need to be given.

How long to use it:

Each person will respond differently to Sodium Ascorbate Solution Injection.

Your doctor will advise you about the length of treatment with Sodium Ascorbate Solution Injection.

If you forget an appointment or need to change an appointment:

You will need to make another appointment as soon as possible.

If you are not sure what to do, contact your doctor or pharmacist as soon as possible.

If too much is given (overdose):

Your doctor should be the only person to inject Sodium Ascorbate Solution Injection.

But if you think that you or anyone else may have been given too much Sodium Ascorbate Solution Injection immediately telephone your doctor or Poisons Information Centre (telephone 13 11 26) or go to accident and emergency at your nearest hospital. Do this even if there are no signs of discomfort or poisoning.

While you are being treated with Sodium Ascorbate Solution Injection

Things you must do:

Tell all doctors, dentists and pharmacists who are treating you that you are being treated with Sodium Ascorbate Solution Injection.

Tell your doctor if you feel that giving Sodium Ascorbate Solution Injection is not helping your condition.

Be sure to keep all appointments with your doctor so that your progress can be checked.

Things you must not do:

Do not inject Sodium Ascorbate Solution Injection yourself.

Do not take any other medicines, whether they require a prescription or not, without first telling your doctor or consulting a pharmacist.

Things to be careful of:

Each person will respond differently while being given Sodium Ascorbate Solution Injection.

It is common to become dehydrated or feel thirsty while being given Sodium Ascorbate Solution Injection. You should drink plenty of water during and after your injection.

Sometimes people feel dizzy or faint during an injection of Sodium Ascorbate Solution Injection. If this happens, immediately tell the person giving you the injection.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are given or being treated with Sodium Ascorbate Solution Injection.

Sodium Ascorbate Solution Injection helps most people with Vitamin C deficiency and related disorders, but it may have unwanted side effects in a few people. All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.

Ask your doctor or pharmacist to answer any questions you may have.

If any of the following happen, tell your doctor immediately, or go to accident and emergency at your nearest hospital:

• shortness of breath, troubled breathing, tightness of chest, wheezing
• reddened skin
• fever
• general weakness or discomfort
• skin rash or itching
• nausea, vomiting, diarrhoea, or abdominal pain
• headache or dizziness

These are rare allergic side effects and may require urgent medical attention.

This is not a complete list of all possible side effects. Others may occur in some people and there may be some side effects not yet known.

Tell your doctor if you notice anything else that is making you feel unwell, even if it is not on this list.

Ask your doctor or pharmacist if you don’t understand anything in this list.

Do not be alarmed by this list of possible side effects.

You should not experience any of them.

How to Store Sodium Ascorbate Solution Injection

Unopened bags or vials of Sodium Ascorbate Solution Injection are to be stored at 2 °C to 8 °C (Refrigerate. Do not freeze).

Keep out of reach of children.

This product is for SINGLE USE in one patient on one occasion. only. It is for use in one patient on one occasion only and any left over must be discarded.

Product Description

What it looks like:

Sodium Ascorbate Solution Injection comes in plastic bags or glass vials (bottles).

Sodium Ascorbate Solution Injection is a clear and colourless or slightly straw coloured solution. When it is first made it is less straw coloured and as it gets older and toward the end of the expiry date it becomes more straw coloured.

Sodium Ascorbate Solution Injection is packed in the following sizes and concentrations:

• 30 g in 100 mL Vial or Bag
• 15 g in 50 mL Vial or Bag
• 15 g in 100 mL Vial or Bag
• 45 g in 500 mL Bag

Ingredients:

Sodium Ascorbate Solution Injection does not contain gluten, lactose, sucrose, tartrazine or any other azo dyes.

All bags or vials of Sodium Ascorbate Solution Injection contain the following Ingredients:

Active Ingredient:

Sodium ascorbate

Other Ingredients

Water for injections.

Supplier

Biological Therapies Sodium Ascorbate Solution Injection for Intravenous Infusion is supplied and manufactured in Australia by:

Biological Therapies
A Division of Orthomolecular Medisearch Laboratories Pty Ltd.
Suite 5, 20-30 Malcolm Road
Braeside VIC 3195
Australia
Tel: +61 3 9587 3948
Fax: +61 3 9587 1720
Website: www.biologicaltherapies.com.au
Email: [email protected]

Australian Registration Numbers:

Biological Therapies Sodium Ascorbate Solution Injection for Intravenous Infusion

30 g in 100 mL Vial - AUST R 47757

15 g in 50 mL Vial - AUST R 22283

15 g in 100 mL Vial - AUST R 22282

30 g in 100 mL Bag - AUST R 47750

15 g in 50 mL Bag - AUST R 22254

15 g in 100 mL Bag - AUST R 22284

45 g in 500 mL Bag – AUST R 22286

Date this document last updated: 27 September 2018

Published by MIMS December 2018

1 Name of Medicine

Sodium ascorbate.

2 Qualitative and Quantitative Composition

Each Biological Therapies Sodium Ascorbate Injection for Intravenous Infusion contains sodium ascorbate and water for injections. See Table 1.
All of the Sodium Ascorbate Solution Injections mentioned in this product information sheet are hypertonic and single use. The pack sizes for these products are as described in Tables 2-5.

Summary information.

3 Pharmaceutical Form

Biological Therapies Sodium Ascorbate Injection for Intravenous Infusion is a clear and colourless to straw coloured solution with a pH range of 6.0 to 8.0. Presentation is in plastic bags or glass vials.
Biological Therapies Sodium Ascorbate Solution Injection for Intravenous Infusion is a sterile, non pyrogenic concentrated solution in sterile Water for Injections.

4 Clinical Particulars

4.1 Therapeutic Indications

Biological Therapies Sodium Ascorbate Injections are indicated for the treatment of vitamin C deficiency when oral treatment is not feasible.

4.2 Dose and Method of Administration

Treatment of ascorbate deficiency is usually achieved with oral ascorbate. Biological Therapies Sodium Ascorbate Solution Injection for Intravenous Infusion may be used when oral treatment is not feasible. The recommended dose in adults is 100-500 mg daily, and in children, 100-300 mg daily. Treatment may continue for up to three weeks.
Single entry only should be made into the bag or vial and the appropriate dose removed under strict aseptic conditions. The dose may then be given as a straight push or added to an infusion bag of sterile water for injections, saline or dextrose.
If the solution is injected too concentrated and/or too quickly into a small vein, there may be substantial pain in the vein. It is recommended if possible, to only inject into a large vein, usually the cubital vein although the veins on the back of the hand have been used. Pain can be minimised by slowing the infusion rate, or by diluting the infusion, initially 50:50 with sterile water for injections. Further dilution and/or slowing of the infusion rate may be necessary for patients with fine veins or who are unable to tolerate the pain. Where veins are very fine or very damaged even diluting to isotonicity may be required. Isotonic strength is 30 grams sodium ascorbate in 1000 mL of sterile water for injections. Gently massaging the arm along the course of the vein can also help relieve pain. Pain may also be reduced by warming the IV solution to near body temperature.
Care should be exercised to avoid extravasation during the infusion. If this occurs with the hypertonic infusion it can cause quite severe pain. Under these circumstances the needle should be withdrawn and an ice pack (wrapped in cloth) applied to the injection site. Pressure over the site should be maintained for 5 to 10 minutes during which time the pain will usually subside. Provided the patient (and the doctor) are amenable, the other cubital vein may then be tried. Pain usually limits the amount infused/ injected extravenously resulting in no long term after effects. However, if pain is blocked and extravasation occurs then significant sclerosing and/or ulceration could occur.

4.3 Contraindications

Biological Therapies Sodium Ascorbate Solution Injection for Intravenous Infusion is contraindicated in those persons who have shown hypersensitivity to any component of this preparation.

4.4 Special Warnings and Precautions for Use

Use with caution in the following circumstances.

1. Hyperoxaluria.

2. Iron overload and iron absorption.

3. Hypernatraemia, congestive cardiac failure or severely impaired kidney function.

4. Uricosuria.

5. Sickle cell crisis.

6. Glucose-6-phosphate dehydrogenase (G6PD) deficiency.

Use in the elderly.

Paediatric use.

Effects on laboratory tests.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Aspirin.

Dicoumarol.

Warfarin.

Ethinyloestradiol.

Iron (oral).

Desferrioxamine.

Isoprenaline.

Alcohol.

Disulfiram.

Mexiletine.

Barbiturates or primidone.

Fluphenazine and other phenothiazines.

Amphetamine and tricyclic antidepressants.

General.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

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)

Reported adverse effects include the following.

Body as a whole.

Gastrointestinal.

Haematological.

Metabolic.

Neurological.

Renal.

Skin.

Reporting suspected adverse effects.

4.9 Overdose

There have been a few reports of renal failure reportedly due to excessive oxalate formation following massive doses of intravenous vitamin C. However, some doubt has recently been cast upon the laboratory methods for determination of oxalate. Vitamin C is inherently unstable in body fluids once these are removed from the body or post mortem without homeostatic control mechanisms, resulting in the in vitro formation of oxalate. Also, many of the earlier test methods for estimation of oxalate have subsequently been found to be overestimated as a result of interference by vitamin C. Nevertheless, because the increase in oxalate excretion is controversial, care should be exercised in those patients with renal impairment or who exhibit hyperoxaluria. It may be wise during prolonged sodium ascorbate infusion to monitor kidney function.
Within the many decades of clinical use of sodium ascorbate infusion, there have been no reported severe overdosage effects, other than pain or a transient lightheaded feeling. This lightheadedness may be related to the hypoglycaemic action of vitamin C. This feeling usually passes after 15 to 20 minutes and is helped by eating fruit, having a meal or drinking some fruit juice.
Haemolytic anaemia has been reported in few cases of individuals with glucose-6-phosphate dehydrogenase deficiency.

Treatment of overdosage.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Vitamin C, a water soluble vitamin, is essential for the synthesis of collagen and intracellular material. Vitamin C deficiency develops when dietary intake is inadequate. It is rare in adults, but may occur in infants, alcoholics or the elderly. Deficiency leads to the development of a well defined syndrome known as scurvy. This is characterised by capillary fragility, bleeding (especially from small blood vessels and the gums), normocytic or macrocytic anaemia, cartilage and bone lesions and slow healing of wounds. Body stores of vitamin C in health are about 1.5 to 3 g. Symptoms of deficiency develop when body stores are less than 0.5 g.

Mechanism of action/ effect.

Clinical trials.

5.2 Pharmacokinetic Properties

Absorption.

Distribution.

Metabolism.

Excretion.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

Water for injections.

6.2 Incompatibilities

Sodium ascorbate (as ascorbic acid injection) is reported to be incompatible with ferric salts, oxidising agents, and salts of heavy metals, particularly copper.
Injections of sodium ascorbate are reported to be incompatible with aminophylline, bleomycin sulfate, erythromycin lactobionate, nafcillin sodium, doxapram hydrochloride, cephazolin sodium, nitrofurantoin sodium, conjugated oestrogens, and sulphafurazole diethanolamine. Incompatibility, dependent on pH or concentration, has been reported with chloramphenicol sodium succinate, chlorothiazide sodium, hydrocortisone sodium succinate and penicillin G potassium.

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 at 2°C to 8°C. (Refrigerate. Do not freeze.) Biological Therapies Sodium Ascorbate Solution should not be used if there is visible turbidity or crystallisation. Normal colour is colourless to straw coloured. However, under extreme conditions or postexpiry date the solution gradually darkens to very dark yellow and finally orange/ brown. Excessive darkening is an indication of increased breakdown.

6.5 Nature and Contents of Container

Container type:

Vials.

Bags.

Vial products.

Bag products.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

6.7 Physicochemical Properties

C₆H₇O₆Na. Molecular weight = 198.11.

Chemical structure.

CAS number.

7 Medicine Schedule (Poisons Standard)

Unscheduled.

Summary Table of Changes