Calmafusion, 380mg/60mg/50mg, solution for infusion for cattle, sheep and pigs

Quốc gia: Ai-len

Ngôn ngữ: Tiếng Anh

Nguồn: HPRA (Health Products Regulatory Authority)

Thành phần hoạt chất:

Calcium gluconate for injection; Magnesium chloride hexahydrate; Boric acid

Sẵn có từ:

Interchemie Werken De Adelaar Eesti AS.

Mã ATC:

QA12AX

INN (Tên quốc tế):

Calcium gluconate for injection; Magnesium chloride hexahydrate; Boric acid

Liều dùng:

380.0, 60.0, 50.0 milligram(s)/millilitre

Dạng dược phẩm:

Solution for infusion

Loại thuốc theo toa:

POM: Prescription Only Medicine as defined in relevant national legislation

Khu trị liệu:

Calcium, combinations with vitamin D and/or other drugs

Tình trạng ủy quyền:

Authorised

Ngày ủy quyền:

2020-01-17

Đặc tính sản phẩm

Health Products Regulatory Authority
25 March 2021
CRN009Y0X
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Calmafusion, 380mg/60mg/50mg, solution for infusion for cattle, sheep
and pigs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml contains:
​
ACTIVE SUBSTANCES:
​
​
Calcium gluconate for injection
​380 mg (equivalent to 34.0 mg or 0.85 mmol of Ca
2+
)
​
Magnesium chloride hexahydrate
​60 mg (equivalent to 7.2 mg or 0.30 mmol of Mg
2+
)
​
Boric acid
​50 mg
EXCIPIENTS:
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for infusion.
Clear, colourless to yellowish brown solution.
pH of the solution 3.0 - 4.0
Osmolality 2040 – 2260 mOsm/kg
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle, sheep, pigs.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Treatment of acute hypocalcaemia complicated by deficiency of
magnesium.
4.3 CONTRAINDICATIONS
Do not use in cases of hypercalcaemia and hypermagnesemia.
Do not use in cases of calcinosis in cattle and sheep.
Do not use following administration of high doses of vitamin D
3
.
Do not use in cases of chronic kidney insufficiency or in cases of
circulatory or cardiac disorders.
Do not use in cattle suffering septicaemic processes in the course of
acute mastitis in cattle.
Do not administer inorganic phosphate solutions simultaneously or
shortly after the infusion.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
In case of acute hypomagnesaemia, the administration of a solution
with a higher concentration of magnesium may be
necessary.
4.5 SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
The medicinal product must be administered only slowly intravenously.
The solution should be warmed to body temperature before
administration.
During the infusion, the heart rate, rhythm and circulation must be
monitored. In case of symptoms of overdosing (cardiac
arrhythmia, fall in blood pressure, agitation), the infusion should be
stopped immediately.
Health Products Regulato