Hipracal-Fm
PACKAGE LEAFLET
1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT
LABORATORIOS HIPRA, SA.
Avda. La Selva, 135.
17170 - AMER (Girona) Spain.
2. NAME OF THE VETERINARY MEDICINAL PRODUCT
HIPRACAL-FM, solution for infusion
3. STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENTS
Each ml contains :
Active substances:
Calcium gluconate…………………………………………………………...175.0 mg
Magnesium chloride…………………………………………………………..21.9 mg
(as magnesium chloride hexahydrate)
Excipients:
Glucose monohydrate………………………………………………………..110.0 mg
Sodium hypophosphite………………………………………………………..40.5 mg
Boric acid (E-284)…..………………………………………………………...35.8 mg
Water for injections to…………………………………………………………..1.0 ml
INDICATIONS
Paresis puerperalis and other conditions with hypocalcemia in cattle. The magnesium of the veterinary medicinal product is beneficial in hypomagnesemia.
5. CONTRAINDICATIONS
Do not use in hyperexcited animals.
6. ADVERSE REACTIONS
Intravenous administration can cause phlebitis and/or clotting at infusion site. To avoid this problem, the infusion should be administered through an intravenous catheter. Bradycardia and cardiac arrhythmia might appear if the intravenous infusion is given too fast. The infusion shall then be interrupted until normalization of cardiac rhythm. These two symptoms should be controlled before and during treatment.
If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon.
7. TARGET SPECIES
Cattle.
8. DOSAGE FOR EACH SPECIES, ROUTE AND METHOD OF ADMINISTRATION
Slowly by intravenous infusion. General dosage is 1 ml per kg bodyweight (15.6 mg calcium and 2.6 mg magnesium per kg b.w.) given consideration to the clinical status of the animal to be treated.
In hypomagnesemic conditions additional magnesium may have to be administered intravenously or subcutaneously according to the clinical status of the animal.
9. ADVICE ON CORRECT ADMINISTRATION
- The solution shall have reached body temperature before administration in large quantities.
- If tachypnea, tachycardia or bradycardia occurs, the infusion shall be interrupted until the cardiac rhythm is normalized.
10. WITHDRAWAL PERIOD
Zero days.
11. SPECIAL STORAGE PRECAUTIONS
Do not store above 25 C. Keep the container in the outer carton. Do not freeze.
The veterinary medicinal product should be used immediately and not stored after opening.
Do not use after the expiry date stated on the label.
Keep out of the reach and sight of children.
12. SPECIAL WARNINGS
- High doses during longer periods can cause nausea, muscle weakness, bradycardia, tachycardia and arrhythmia.
- Do not administer the product with tetracyclines, sodium carbonate, streptomycin sulphate or dihydrostreptomicin sulphate. Calcium gluconate increase the activity of methylxanthines on the heart.
- It can be used during pregnancy and lactation.
13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY
Ask your veterinary surgeon how to dispose of medicines no longer required. These measures should help to protect the environment.
14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
2009-01-14
15. OTHER INFORMATION
Presentation:1x 500 ml and 12 x 500 ml. To facilitate the hang up of the bottle, a ring is attached in the bottom.
Not all pack sizes may be marketed.
For animal treatment only.