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Date: Thursday, May 30, 2024 5:55

Description: Bimeda logo
Release 3.70
Megacal-M Solution for Injection
 
Species: Cattle
Therapeutic indication: Pharmaceuticals: Dietary supplements and fluid metabolites: Mineral replacements - injectable
Active ingredient: Calcium Gluconate, Magnesium Hypophosphite
Product:Megacal M Solution for Injection
Product index: Megacal M Solution for Injection
Cattle - milk: Zero days
Cattle - meat: Zero days
Incorporating:
Qualitative and quantitative composition
Active Substance
Calcium (as Calcium Gluconate)
4.6g/100ml
Magnesium (as Magnesium Hypophosphite)
0.8g/100ml
Pharmaceutical form
A colourless to pale yellow solution for injection.
Clinical particulars
Target species
Cattle.
Indications for use
For treatment of hypocalcaemia and as an aid in raising blood magnesium levels where a deficiency may be expected.
Contra-indications
Known hypersensitivity to the active ingredients.
Known cases of cardiac arrhythmia or severe toxaemia.
Special warnings for each target species
The product should be administered with care particularly where concurrent toxaemia exists. In recumbent cows with poor peripheral circulation, administer appropriate calcium therapy intravenously.
Special precautions for use in animals
Warm the product to body temperature before administration.
When the intravenous route is being used, extreme caution must be taken to ensure slow administration.
This product does not contain an antimicrobial preservative. Any solution remaining in the vial after withdrawal of the required dose should be discarded.
Special precautions to be taken by the person administering the product to animals
Care should be taken to avoid accidental self-injection. If accidental self-injection occurs, seek medical advice.
Eye Contact: immediately flush the eye with copious amounts of clean running water.
Skin contact: Wash the affected area thoroughly. If irritation occurs seek medical advice.
Ingestion: If accidentally swallowed, seek urgent medical attention and show product label and / or pack insert to the doctor.
ADVICE TO DOCTOR: For treatment advice contact the National Poisons Information Service (NPIS) or your local Poisons Information Centre.
Adverse reactions
None known.
Use during pregnancy and lactation
Safe for use during pregnancy and lactation.
Interactions
None known.
Amounts to be administered and administration route
By subcutaneous or slow intravenous injection.
Cattle – 100 - 200ml.
Large volumes should be divided between multiple sites. Massage sites gently.
Overdose
The product is for treatment of acute deficiency in a life threatening situation and overdosage within the recommended guidelines is unlikely.
Withdrawal periods
Meat – Zero days
Milk – Zero hours
Pharmacological particulars
This product is intended to restore blood calcium levels in cases of hypocalcaemia.
Pharmaceutical particulars
Excipients
Boric Acid
Water for Injection
Sodium Hydroxide (For pH adjustment)
Acetic Acid (For pH adjustment)
Major incompatibilities
None known.
Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 3 years.
Special precautions for storage
Store below 25°C. Protect from light.
Immediate packaging
A 100ml clear glass vial with nitryl rubber bung and gold seal containing a clear, colourless to pale yellow sterile solution.
Disposal
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed if in accordance with local requirements.
Marketing Authorisation Holder (if different from distributor)
Ballinskelligs Veterinary Products,
Ballinskelligs,
Co. Kerry,
Ireland.
Marketing Authorisation Number
Vm 12828/4000
Significant changes
Date of the first authorisation or date of renewal
01/02/1999
Date of revision of the text
January 2015
Any other information
Nil.
Legal category
Legal category: POM-VPS