Description
100 mg/ml, injection solution for horses, cattle, swine, sheep, dogs, cats and foxes
Active substance and excipient content
Ascorbic acid 100 mg/ml
Therapeutic indications
Vitamin C deficiency, as an adjuvant in antibiotic treatment, in digestive disorders, in pregnancy and exposure to stress, weakness and fatigue. As an adjuvant in urinary infections.
Contraindications
Oxalithiasis.
Adverse reactions
In animals with predisposition for formation of kidney stones, parenteral administration of ascorbic acid may lead to urolithiasis.
Any adverse reactions emerged after administration of the product or any observed symptoms not listed in the leaflet (including symptoms reported in humans following exposure to the product) should be reported to the competent veterinarian, Marketing Authorization Holder or the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products. The report form should be downloaded from https://www.urpl.gov.pl (Department of Veterinary Medicinal Products).
Amount to be administered per species, method and route of administration
The product is administered intravenously or intramuscularly in the following daily doses:
Cattle, horses 5‑10 mg/kg b.w. i.e. 0.05 – 0.1 ml/kg b.w.
Swine, sheep 8‑16 mg/kg b.w. i.e. 0.08 – 0.16 ml/kg b.w.
Dogs, cats, foxes 10–20 mg/kg b.w. i.e. 0.1 – 0.2 ml/kg b.w.
Administer the product for 5-7 days (administration of ½ dose twice a day is recommended).
Indications for proper administration
When used intravenously, the product should be warmed to body temperature and injected slowly.
Withdrawal period
Edible tissues:
Horse, cattle, swine, sheep – zero days
Milk:
Cattle, sheep – zero days
Dogs, cats, foxes – not applicable
Special precautions for storage
Keep out of the reach and sight of children.
Store below +25°C. Protect from light. Do not freeze.
Do not use the veterinary medicinal product after the expiry date stated on the label. The expiry date refers to the last day of the given month.
Shelf life after the first opening of the container: 28 days.
Special warnings
Special precautions for use in animals:
Intramuscular administration may lead to local irritation (especially in horses).
Extreme pain may occur during the injection.
Acidic reaction of urine may lead to crystallisation of urates, oxalates and citrates with consequent formation of calculi in the urinary system.
In animals with diagnosed diabetes and in conditions of excessive iron absorption from the gastrointestinal tract, ascorbates should not be administered in doses higher than the recommended doses.
Parenteral administration of ascorbic acid in doses exceeding indications leads to false positive laboratory test results, indicating the presence of glucose in blood.
Special caution should be taken when administering vitamin C in combination with deferoxamine in old animals. When the two drugs have to be used simultaneously, administration of ascorbic acid is recommended two hours after infusion of deferoxamine.
When used intravenously, the product should be warmed to body temperature and injected slowly.
Special precautions to be taken by the person administering the veterinary medicinal product to animals:
Accidental self-injection poses no threat to the person administering the drug.
Pregnancy and lactation:
No contraindications for pregnancy or lactation.
Interactions with other medicinal products or other forms of interactions:
Ascorbic acid intensifies the effect of antithrombotic coumarin anticoagulants. It increases iron absorption. Flavonic glycosides intensify the effect of vitamin C.
Ascorbic acid reduces the antibacterial effect of amino glycoside antibiotics and macrolides by increasing the acidic reaction of urine. Simultaneous administration of vitamin C and deferoxamine, an iron-binding drug, used in hemochromatosis and post-transfusion hemosiderosis, may lead to occurrence of iron ions excess, mainly in myocardial cells, which causes arrhythmia and impaired conductivity. Intravenous injection of ascorbic acid shortens the half life of salicylamide.
Simultaneous administration of oxytocin and ascorbic acid reduces the ability of ascorbic acid to penetrate through the placenta into the foetus.
Overdose (symptoms, emergency procedures, antidotes):
Administration of ascorbic acid in doses exceeding indications may lead to urine acidity, which leads to impairment of excretion of weak acids and bases. Vitamin C overdose may cause diarrhoea and reduce absorption of anticoagulant drugs from the gastrointestinal tract.
Multiple administration of ascorbic acid in doses exceeding 4 g may lead to inactivation of vitamin B12, temporary reduction of phagocytic and cidal effects of neutrophils, excessive iron ions absorption and formation of kidney stones.
Pharmaceutical incompatibilities:
Ascorbic acid displays chemical incompatibility with sodium bicarbonate, sodium salicylate, sodium nitrate, theobromine, hexamethylenetetramine (methenamine), chlorpromazine hydrochloride, methylprednisolone sodium succinate.
Do not combine ascorbic acid solution with other veterinary medicinal products intended for injection.
Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
Medicines should not be disposed of via wastewater or household waste.
Ask your veterinary surgeon how to dispose of medicines no longer required. These measures should help to protect the environment.
Shelf life
2 years.
Packaging
100 ml orange glass bottles.
For animal treatment only.
Subject to medical prescription – prescription drug
Tobe administered under veterinary supervision.
Other information
For any information on this veterinary medicinal product, please contact the local representative of the marketing authorisation holder.
Name and address of the manufacturer responsible for batch release:
Biowet Puławy Sp. z o.o.
ul. H. Arciucha 2, 24-100 Puławy
Tel/fax: 81 886 33 53
2014-12-12 SPC
CPLW 2014.12.12
27.7.2017 r.
