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Ascorbic Acid Pascoe 150 mg/ml Concentrate for solution for injection / infusion

⚠ This medicine appears to have been discontinued

The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.

If you were prescribed this medicine, other products containing Ascorbic acid may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.

Active substance: Ascorbic acid
Source: electronic medicines compendium (emc)
Official leaflet: Read the PIL on emc

What it is and what it is used for

for

Ascorbic Acid Pascoe 150 mg/ml Concentrate for solution for injection / infusion is intended for the treatment of clinical vitamin C deficiency states not amenable to dietary supply or intake of vitamin C preparations. Ascorbic Acid Pascoe 150 mg/ml Concentrate for solution for injection / infusion contains the essential active substance ascorbic acid (vitamin C) that cannot be produced internally by the human body. Ascorbic Acid Pascoe 150 mg/ml Concentrate for solution for injection / infusion is indicated in adults.

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2.

What you need to know before you take it

e Ascorbic Acid Pascoe 150 mg/ml Concentrate for solution for injection / infusion

Do not use Ascorbic Acid Pascoe 150 mg/ml Concentrate for solution for injection / infusion: –

if you are allergic to vitamin C or any of the other ingredients of this medicine (listed in section 6) if you suffer from oxalate urolithiasis (a type of kidney or bladder stones) or hyperoxaluria (a condition, where you have too much oxalate in your urine) if you suffer from an iron storage disorder/iron overload (e. g. thalassemia, hemochromatosis, sideroblastic anemia, erythrocyte concentrate transfusions) if you have a severe renal insufficiency (impaired kidney function) if you have a glucose-6-phosphate dehydrogenase deficiency/defect (inherited disorder of red blood cell metabolism) if you are under 12 years of age

Warnings and precautions Talk to your doctor before using Ascorbic Acid Pascoe 150 mg/ml Concentrate for solution for injection / infusion. Take special care with Ascorbic Acid Pascoe 150 mg/ml Concentrate for solution for injection / infusion –

if you have been advised to follow a low salt (sodium) diet. 1 vial of 50 ml of the product contains 972 mg sodium.

–

if you had difficulties in breathing in the past, such as a bronchospasm or a lung disease. If this applies to you, your doctor will choose a lower starting dose.

–

if you need to perform certain laboratory tests (such as tests for glucose, uric acid, creatinine, inorganic phosphate): Ascorbic acid might influence the test results and thus lead to false results. In this case, your doctor will inform you if for 1 day before such a test is conducted, no vitamin C should be given to you.

Note for diabetic patients: Parenterally administered ascorbic acid interferes with the blood glucose determination assay. During your treatment with Ascorbic Acid Pascoe 150 mg/ml Concentrate for solution for injection / infusion, it is important that you pay attention to your daily intake of water (approximately 1.5 – 2 l per day). In order to reduce the risk for formation of kidney or urinary stones, it is recommended to avoid any additional oxalate-rich food (e .g. rhubarb, spinach, beetroot, etc.) during your treatment with Ascorbic Acid Pascoe 150 mg/ml Concentrate for solution for injection / infusion. If you have suffered from recurring kidney stones in the past, a maximum daily dose of 100-200 mg vitamin C should not be exceeded, as there is an increased risk for the formation of calcium oxalate stones. Children and adolescents Children under 12 years should not receive more than 5-7 mg ascorbic acid/kg body weight per day. High doses of Ascorbic Acid Pascoe 150 mg/ml Concentrate for solution for injection / infusion are contraindicated in children under 12 years. There are no data available on the use of Ascorbic Acid Pascoe 150 mg/ml Concentrate for solution for injection / infusion in adolescents.

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Other medicines and Ascorbic Acid Pascoe 150 mg/ml Concentrate for solution for injection / infusion The following medicinal drugs reduce the concentration of vitamin C in your body and thus might reduce the effectiveness of Ascorbic Acid Pascoe 150 mg/ml Concentrate for solution for injection / infusion –

–

–

Acetylsalicylic acid (anti-inflammatory drug) such as aspirin Nicotine from cigarettes Alcohol Appetite suppressants (e.g. fenfluramine) Iron (taken as food supplement) Medicines used to treat epilepsy (e.g. phenytoin) Oral contraceptives which contains oestrogen (e.g. "the pill") antibiotics (e.g. tetracycline) Fluphenazine (for mental disorders): Blood concentrations might decrease due to Vitamin C therapy

The simultaneous intake of vitamin C with desferrioxamine mesilate t/Desferal (used in case of iron overload) can cause a disturbance of the heart function. Large doses of vitamin C may lower the effectiveness of oral anticoagulants. Note for patients with kidney failure: Aluminium antacids in combination with vitamin C may lead to higher blood aluminium levels. Due to lack of comprehensive clinical data, higher dosages of vitamin C should take place time-displaced to chemotherapy or radiotherapy. Is vitamin C infused before the chemo-/radiotherapy, a temporal distance of 24 hours is recommended. If vitamin C is administered after chemo-/radiotherapy, an interval of at least 24 hours should be maintained. For chemotherapeutics where it takes > 6 hours until the concentration of the active substance in the blood plasma has been reduced by half (= half-life), an interval of 3-4 half-lives should be maintained. Ascorbic Acid Pascoe 150 mg/ml Concentrate for solution for injection / infusion with food and drink No interactions are expected. 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. Ascorbic acid is excreted in the unborn child's circulation and in breastmilk. Daily doses of 100 to 500 mg ascorbic acid should not be exceeded in pregnant women and nursing mothers. Due to its high vitamin C content, do not use Ascorbic Acid Pascoe 150 mg/ml Concentrate for solution for injection / infusion if you are pregnant or if you are breast-feeding. There are no studies on the influence on fertility. Driving and using machines

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If side effects like dizziness, nausea or troubled vision occur (see section 4. "Possible side effects"), your ability to drive or use machinery may be affected. Ascorbic Acid Pascoe 150 mg/ml Concentrate for solution for injection / infusion contains sodium Each injection vial of Ascorbic Acid Pascoe 150 mg/ml Concentrate for solution for injection / infusion contains 42.3 mmol (972 mg) sodium. To be taken into consideration by patients on a controlled sodium diet. 3.

How to take it

Ascorbic Acid Pascoe 150 mg/ml Concentrate for solution for injection / infusion

Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. The recommended dose is: Adults: The usual dose is 0.5 to 1.0 g ascorbic acid (corresponding to 3.3 – 6.7 ml concentrate). Severe trauma or surgery can require higher daily dosages of at least 3 g ascorbic acid to restore normal plasma levels. Depending on the disease situation, up to 7.5 g ascorbic acid (50 ml concentrate) per day may be used for infusion. Paediatric population: Children younger than 12 years of age must not receive more than 5-7 mg ascorbic acid/kg body weight per day. High doses of Ascorbic Acid Pascoe 150 mg/ml Concentrate for solution for injection / infusion are contraindicated in children under 12 years. There are no data available on the use of Ascorbic Acid Pascoe 150 mg/ml Concentrate for solution for injection / infusion in adolescents. Method of administration For slow injection or infusion into a vein. Ascorbic Acid Pascoe 150 mg/ml Concentrate for solution for injection / infusion has to be diluted before use. For the dilution instruction please see the section "The following information is intended for healthcare professionals only" at the end of the document. Ascorbic Acid Pascoe 150 mg/ml Concentrate for solution for injection / infusion will be given by your doctor. The duration of use depends on the course of the illness and the results of laboratory tests.

If you use more Ascorbic Acid Pascoe 150 mg/ml Concentrate for solution for injection / infusion than you should For the risk of kidney stone formation see under section 2."Warnings and precautions". If you forget to use Ascorbic Acid Pascoe 150 mg/ml Concentrate for solution for injection / infusion Consult your doctor to decide on the further dosage. If you stop using Ascorbic Acid Pascoe 150 mg/ml Concentrate for solution for injection / infusion

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By stopping the use of this medicine, you jeopardize the success of the treatment! If you experience unpleasant side effects, discuss the further treatment with your doctor. 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. If you experience any of the following side effect, contact you doctor immediately, usually he will promptly discontinue the injection/infusion. Very rare: may affect up to 1 in 10,000 people

  • Respiratory hypersensitivity reactions, e.g. shortness of breath.
  • Skin hypersensitivity reactions, e.g. rash, hives, itching.
  • Transient circulation problems (e.g. dizziness, nausea, headache, troubled vision)
  • Reactions such as chills and elevated temperature were observed in patients with acute infections
  • Gastrointestinal disorders e.g. nausea, vomiting, diarrhoea
  • Renal oxalate calculi
  • Increase in urination Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme. Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store By reporting side effects you can help provide more information on the safety of this medicine.

5.

How to store it

Ascorbic Acid Pascoe 150 mg/ml Concentrate for solution for injection / infusion

Do not store above 25oC Keep the vial in the outer carton in order to protect it from light. The preservative-free concentrate for solution for injection/infusion is for single use only. It has to be used immediately after opening. Any unused solution must be discarded. 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 carton and label. The expiry date refers to the last day of that month. 6.

Contents of the pack and other information

What Ascorbic Acid Pascoe 150 mg/ml Concentrate for solution for injection / infusion contains –

The active substance is: ascorbic acid 1 vial with 50 ml solution for injection/ infusion contains 7.5 g ascorbic acid

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–

The other ingredients are: Sodium bicarbonate and water for injections 50 ml of the product contain 972 mg sodium

What Ascorbic Acid Pascoe 150 mg/ml Concentrate for solution for injection / infusion looks like and contents of the pack Ascorbic Acid Pascoe 150 mg/ml Concentrate for solution for injection / infusion is a clear, light yellow concentrate for solution for intravenous injection/infusion. Each pack contains 1 vial with 50 ml of concentrate for solution for injection/infusion. Marketing Authorisation Holder Pascoe pharmazeutische Präparate GmbH Schiffenberger Weg 55 35394 Giessen Germany Manufacturer Pascoe pharmazeutische Präparate GmbH Europastr. 2 35394 Giessen Germany

This medicinal product is authorised in the Member States of the EEA under the following names: Austria:Vitamin C Pascoe, 150mg/ml Konzentrat zur Herstellung einer Injektions-/Infusionslösung Denmark: Ascorbinsyre Pascoe Finland: Ascorbic Acid Pascoe 150 mg/ml Kontsentraatti injektioneste- / infuusioliuosta varten Luxembourg: Pascorbin 150mg/ml Konzentrat zur Herstellung einer Injektions-/Infusionslösung Malta: Ascorbic Acid Pascoe 150 mg/ml Concentrate for solution for injection/infusion Norway: Vitamin C Pascoe Portugal: Pascorbin 150 mg/ml Concentrado para solução injectável / para perfusão Sweden : Ascorbic Acid Pascoe 150 mg/ml Koncentrat för injektionsvätska, lösning United Kingdom: Ascorbic Acid Pascoe 150 mg/ml Concentrate for solution for injection / infusion This leaflet was last revised in August 2020.

The following information is intended for healthcare professionals only: Instructions for use/handling Prior to use, Ascorbic Acid Pascoe 150 mg/ml Concentrate for solution for injection / infusion must be diluted with NaCL solution. A dilution ratio of one part of Ascorbic Acid Pascoe 150 mg/ml Concentrate for solution for injection / infusion plus 2 parts of isotonic saline solution is recommended.

Frequently asked questions about Ascorbic Acid Pascoe 150 mg/ml Concentrate for solution for injection / infusion

How do I take Ascorbic Acid Pascoe 150 mg/ml Concentrate for solution for injection / infusion?

Ascorbic Acid Pascoe 150 mg/ml Concentrate for solution for injection / infusion comes as injection containing 150mg/ml. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.

What is the active substance in Ascorbic Acid Pascoe 150 mg/ml Concentrate for solution for injection / infusion?

The active substance in Ascorbic Acid Pascoe 150 mg/ml Concentrate for solution for injection / infusion is ascorbic acid.

Where does this information come from?

This leaflet reproduces the patient information leaflet approved for Ascorbic Acid Pascoe 150 mg/ml Concentrate for solution for injection / infusion, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.

Can I get Ascorbic Acid Pascoe 150 mg/ml Concentrate for solution for injection / infusion without a prescription?

Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.

About this leaflet

The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.

Medical disclaimer: This page is for information only and does not replace advice from your doctor or pharmacist. Always read the leaflet supplied with your medicine. If you are unwell, call NHS 111; in an emergency, call 999.

Medicines with the same active substance: Ascorbic acid (13 medicines)
See every medicine containing this substance, or browse the full A–Z of active substances.
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
Technical information intended for healthcare professionals (doctors and pharmacists). The Summary of Product Characteristics (SmPC) is the official document approved by the MHRA/EMA. It does not replace the patient leaflet or a doctor’s advice.

4.1. Therapeutic indications

Treatment of clinical vitamin C deficiency states not amenable to dietary supply or oral replacement therapy.

Ascorbic Acid Pascoe 150 mg/ml Concentrate for solution for injection / infusion is indicated in adults.

4.2. Posology and method of administration

Posology

Adults:

The usual dose is 0.5 to 1.0 g ascorbic acid (corresponding to 3.3 – 6.7 ml concentrate). Severe trauma or surgery can require daily dosages of at least 3 g ascorbic acid to restore normal plasma levels. Depending on the disease situation, up to 7.5 g ascorbic acid (50 ml concentrate) per day may be used for infusion.

Paediatric population:

Children under 12 years of age should not receive more than 5-7 mg ascorbic acid/kg body weight per day. High doses of Ascorbic Acid Pascoe 150 mg/ml Concentrate for solution for injection / infusion are contraindicated in children under 12 years (see section 4.3). No data are available on the use of Ascorbic Acid Pascoe 150 mg/ml Concentrate for solution for injection / infusion in adolescents.

Method of administration

For slow intravenous injection or infusion after dilution.

For instructions on dilution prior to administration, see section 6.6.

The injection/infusion therapy must be performed by a physician.

The duration of use depends on the course of the illness and the results of laboratory tests.

Instructions for handling:

The vial with preservative-free concentrate for solution for injection/infusion is for single use only. It has to be used immediately after opening. Any unused solution must be discarded.

4.3. Contraindications

- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

- Oxalate urolithiasis, hyperoxaluria

- Iron storage disorders/iron overload (e. g. thalassemia, hemochromatosis, sideroblastic anemia, erythrocyte concentrate transfusions)

- Renal insufficiency (KDIGO GFR stages G4 and 5 (< 30ml/min/1.73m2)

- Glucose-6-phosphate dehydrogenase deficiency/defect

- Children under 12 years of age: high doses of vitamin C (see section 4.2)

4.4. Special warnings and precautions for use

Renal insufficiency (KDIGO GFR stage G3 (30 to < 60 ml/min/1.73 m2)

Patients with impaired kidney function have a higher risk of oxalate precipitation in urine due to vitamin C supplementation. Therefore, a strict monitoring of renal function (e.g. GFR, albumin) should be done.

Patients with a predisposition for the formation of renal calculi are at risk for the development of calcium oxalate stones when using high-dose vitamin C. It is recommended not to exceed a daily vitamin C intake of 100-200 mg in patients with a history of recurrent kidney stone formation.

Each injection vial of Ascorbic Acid Pascoe 150 mg/ml Concentrate for solution for injection / infusion contains 42.3 mmol (972 mg) sodium. This has to be taken into consideration by patients on a controlled sodium diet.

Adequate fluid intake has to be assured (approximately 1.5 – 2 l per day).

It is also recommended to avoid additional oxalate-rich foods during therapy with ascorbic acid.

In isolated cases, patients with a history of difficulty breathing (such as obstructive or restrictive bronchial and lung disease) may experience acute dyspnea when treated with high-dosed (≥7.5 g) of Ascorbic Acid Pascoe 150 mg/ml Concentrate for solution for injection / infusion. Lower initial doses are therefore recommended in these patients.

Note:

After the administration of gram doses, the ascorbic acid level in the urine may rise as much that the performance of tests for certain clinical-chemical parameters (glucose, uric acid, creatinine, inorganic phosphate) may be affected and the tests may yield false results. Testing for occult blood in the feces may also yield false-negative results.

Note to be considered in the treatment of diabetic patients:

Parenterally administered ascorbic acid interferes with the blood glucose determination assay.

4.5. Interaction with other medicinal products and other forms of interaction

Drugs which induce tissue desaturation of ascorbic acid include acetylsalicylic acid, nicotine from cigarettes, alcohol, several appetite suppressants, iron, phenytoin, some anti-convulsant drugs, the oestrogen component of oral contraceptives and tetracycline.

Large doses of ascorbic acid may cause the urine to become acidic causing unexpected renal tubular reabsorption of acidic drugs, thus producing an exaggerated response. Conversely, basic drugs may exhibit decreased reabsorption resulting in a decreased therapeutic effect. Large doses may reduce the response to oral anticoagulants.

It has been reported that concurrent administration of ascorbic acid and fluphenazine has resulted in decreased fluphenazine plasma concentrations.

Ascorbic acid given in addition to desferrioxamine in patients with iron overload to achieve better iron excretion may worsen iron toxicity, particularly to the heart, early on in the treatment when there is excessive tissue iron. Therefore, it is recommended that in patients with normal cardiac function ascorbic acid should not be given for the

first month after starting desferrioxamine. Ascorbic acid should not be given in conjunction with desferrioxamine in patients with cardiac dysfunction.

Acetylsalicylic acid can, taken in combination with high dosed of ascorbic acid, reduce the absorption of ascorbic acid and decreases urinary excretion. The clinical importance of this is uncertain.

Patients with kidney failure given aluminium antacids and oral citrate can develop a potentially fatal encephalopathy due to marked rise in blood aluminium levels. There is evidence that vitamin C may interact similarly.

Oral contraceptives lower serum levels of ascorbic acid.

Ascorbic acid is a strong reducing agent and interferes with numerous laboratory tests based on oxidation - reduction reactions. Specialised references should be consulted for specific information on laboratory test interferences caused by ascorbic acid.

Usually a timely distance of 1 day between administration of Ascorbic Acid Pascoe 150 mg/ml Concentrate for solution for injection / infusion and the laboratory test should be considered.

Due to lack of comprehensive clinical data, higher dosages of vitamin C should take place time-displaced to chemotherapy or radiotherapy. Is vitamin C infused before the chemo-/radiotherapy, a temporal distance of 24 hours is recommended. If vitamin C is administered after chemo-/radiotherapy, an interval of at least 24 hours should be maintained. For chemotherapeutics with a half-life > 6 hours, an interval of 3-4 half- lives should be maintained

4.6. Fertility, pregnancy and lactation

Pregnancy and breastfeeding:

Ascorbic acid crosses the placental barrier and is excreted in breastmilk.

Daily doses of 100 to 500 mg ascorbic acid should not be exceeded in pregnant women and nursing mothers. Due to its high vitamin C content, Ascorbic Acid Pascoe 150 mg/ml Concentrate for solution for injection / infusion is not suited for the use in pregnancy and lactation.

Fertility

There are no studies on the influence on fertility.

4.7. Effects on ability to drive and use machines

No studies on the effects on the ability to drive and use machines have been performed. However, if undesirable side effects occur as described in 4.8 (dizziness, blurred vision), the ability to drive and use machines may be impaired.

4.8. Undesirable effects

Adverse events are categorized by frequency as follows:

Very common (≥1/10)

Common (≥1/100 to <1/10)

Uncommon (≥1/1,000 to <1/100)

Rare (≥1/10,000 to <1/1,000)

Very rare (<1/10,000),

Not known (cannot be estimated from the available data)

Respiratory, thoracic and mediastinal disorders:

Very rare:

Respiratory hypersensitivity reactions, e.g. dyspnoea/respiratory distress.

Skin and subcutaneous tissue disorders:

Very rare:

Cutaneous hypersensitivity reactions, e.g. exanthema, urticaria, pruritus.

Vascular disorders:

Very rare:

Transient circulation problems (e.g. dizziness, nausea, cephalgia, impaired vision)

Infections and infestations:

Very rare:

Reactions such as chills and elevated temperature were observed in patients with acute infections.

Gastrointestinal disorders:

Very rare:

Large doses may cause gastrointestinal disorders, e. g. nausea, vomiting, diarrhoea.

Renal and urinary disorders:

Very rare:

Large doses may result in hyperoxaluria and renal oxalate calculi may form if the urine becomes acidic.

Very rare:

Doses of 600 mg or more daily have a diuretic action.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation 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 the Yellow Card Scheme

Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store .

4.9. Overdose

For the risk of formation of renal calculi see section 4.4.

🇷🇴 Known in Romania as

Medicines sold in Romania with the same active substance: Cunoscut în România ca

  • VITAMINA C ARENA 750 mg prescriptionACIDUM ASCORBICUM · injection / infusion
  • VITAMINA C ZENTIVA 100 mg/ml prescriptionACIDUM ASCORBICUM · injection / infusion
  • VITAMINA C GALENIKA 100 mg/ml prescriptionACIDUM ASCORBICUM · injection / infusion
  • ACID ASCORBIC ARENA 750 mg prescriptionACIDUM ASCORBICUM · injection / infusion
  • VITAMINA C ARENA 100 mg/ml prescriptionACIDUM ASCORBICUM · injection / infusion
  • VITAMINA C ARENA 200 mg/ml prescriptionACIDUM ASCORBICUM · injection / infusion

Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Romanian medicines in the UK →

🇵🇱 Known in Poland as

Medicines sold in Poland with the same active substance: W Polsce znany jako

  • Vitaminum C Biowet PuławyAcidum ascorbicum · injection / infusion
  • VICIAcidum ascorbicum · injection / infusion
  • Acidum ascorbicum DelfarmaAcidum ascorbicum · injection / infusion
  • Vitaminum C Swiss2CareAcidum ascorbicum · injection / infusion
  • Vitaminum C NeupharmAcidum ascorbicum · injection / infusion
  • Acidum ascorbicum Aga KommerzAcidum ascorbicum · injection / infusion

Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →

💬 Ask about this leaflet

Ask anything about Ascorbic Acid Pascoe 150 mg/ml Concentrate for solution for injection / infusion. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.

Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.

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