Addimag 240 mg/ml + 126 mg/ml Solution for Infusion for Cattle

Excipients:
Qualitative composition of excipients
and other constituents
Quantitative composition if that
information is essentialfor proper
administration of the veterinary
medicinal product
Boric acid (E284)48 mgGlucose monohydrate 165 mgHydrochloric acid (for pH adjustment)Sodium hydroxide (for pH adjustment)Water for injections
Clear, yellow to brown solution.
3. CLINICAL INFORMATION
3.1 Target species
Cattle
3.2 Indications for use for each target species
For the treatment of clinical hypomagnesaemia (grass tetany) accompanied by
deficiency of calcium and for the treatment of clinical hypocalcaemia (milk fever)
complicated by deficiency of magnesium.
3.3 Contraindications
Do not use in cases of hypercalcaemia and hypermagnesemia.
Do not use in cases of calcinosis in cattle.
Do not use following administration of high doses of vitamin D3.
Do not use in cases of chronic kidney insufficiency or in cases of circulatory or
cardiac disorders.
Do not use in cases of septicaemic processes in the course of acute mastitis in
cattle.
AN: 04352/2024 & 04355/2024Page 2 of 5
3.4 Special warnings
None.
3.5 Special precautions for use
Special precautions for safe use in the target species:
The medicinal product must be administered slowly, at body temperature.
During infusion, the heart rate, rhythm and circulation must be monitored. In case of
symptoms of overdosing (bradycardia, cardiac arrhythmia, fall in blood pressure,
agitation), the infusion should be stopped immediately.
Special precautions to be taken by the person administering the veterinary medicinal
product to animals:
Not applicable.
Special precautions for the protection of the environment:
Not applicable.
3.6 Adverse events
Cattle:
Undetermined frequency
(cannot be estimated from
available data)
Hypercalcaemia
1,2
;
increased respiratory rate
1,2
;
bradycardia
1,2
, tachycardia
1,2,3
, arrhythmia
1,2,4
;
muscle tremor
1,2
;
increased salivation
1,2
.
too rapid administration of the product may cause these effects.
transient.
increase in heart rate following initial bradycardia may indicate that overdosing has
occurred. In this case the administration should be stopped immediately.
especially ectopic ventricular beats.
Reporting adverse events is important. It allows continuous safety monitoring of a
veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to
either the marketing authorisation holder or its local representative or the national
competent authority via the national reporting system. See the package leaflet for
respective contact details.
3.7 Use during pregnancy, lactation or lay
The safety of the veterinary medicinal product has not been established during pregnancy
and lactation.
Pregnancy and lactation:
Use only according to the benefit/risk assessment by the responsible veterinarian.
AN: 04352/2024 & 04355/2024Page 3 of 5
3.8 Interaction with other medicinal products and other forms of interaction
Calcium increases the efficacy of cardiac glycosides and arrhythmias may occur if these
drugs are given together.
Calcium amplifies the cardiac effects of drugs and methylxanthines.
Glucocorticoids increase the renal excretion of calcium by way of vitamin D antagonism.
Do not administer inorganic phosphate solutions simultaneously or shortly after the
infusion.
3.9 Administration routes and dosage
Slow intravenous use.
These dosage instructions are given for guidance and must be adapted to the
individual deficit and actual circulatory conditions.
Administer approximately 15 - 20 mg Ca
2+
(0.37 – 0.49 mmol Ca
2+
) and 10 – 13 mg
Mg
2+
(0.41 - 0.53 mmol Mg
2+
) per kg bodyweight corresponding to approximately 0.7
- 0.9 ml of product per kg bodyweight.
If the animal’s weight cannot be determined accurately, but has to be estimated, the
following approach might be used:
Bottle size (ml)Weight (kg)Ca
2+
(mg/kg)Mg
2+
(mg/kg)500500-72514.8 – 21.510.4 – 15.1750750-10001