Calciject 20 CMD Solution for Injection

Summary of Product characteristics

                                13 March 2008
AN: 01250/2007
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Calciject 20 CMD Solution for Injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
Contains
Calcium
Borogluconate
20%
w/v,
Magnesium
Hypophosphite
Hexahydrate 5% w/v and Glucose Monohydrate 22% w/v.
Each 400ml contains:
5.92g
calcium
(provided
by
calcium
gluconate
and
calcium
borogluconate),
1.84g
magnesium
(provided
by
magnesium
hypophosphate
hexahydrate)
and
80g
glucose
as
glucose
monohydrate. Also contains 3.40% w/v boric acid.
EXCIPIENTS:
Chlorocresol
0.10
For a full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Solution for injection
A clear pale yellow solution.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Sheep
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For
the
treatment
of
hypocalcaemia
complicated
by
deficiency
of
magnesium with accompanying hypoglycaemia. In the treatment of
pregnancy toxaemia and other metabolic imbalances in periparturient
sheep.
13 March 2008
AN: 01250/2007
4.3
CONTRAINDICATIONS
Not to be administered by intravenous or intramuscular routes.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
No special warning.
4.5
SPECIAL PRECAUTIONS FOR USE
(I) SPECIAL PRECAUTIONS FOR USE IN ANIMALS
The
solution
should
be
warmed
to
body
temperature
before
administration.
(II) SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING
THE VETERINARY MEDICINAL PRODUCT TO ANIMALS
Care should be taken to avoid accidental self-injection.
4.6
ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
None.
4.7
USE DURING PREGNANCY, LACTATION OR LAY
Can be safely administered to pregnant and lactating animals.
4.8
INTERACTION
WITH
OTHER
MEDICINAL
PRODUCTS
AND
OTHER
FORMS
OF
INTERACTION
None.
4.9
AMOUNTS TO BE ADMINISTERED AND ADMINISTRATION ROUTE
The
solution
should
be
warmed
to
body
temperature
before
administration
by
subcutaneous
injection
only.
Observe
aseptic
precautions.
Sheep:
50 - 80 ml
Message site gently after administration.
4.10
OVERDOSE
(SYMPTOMS,
EMERGENCY
PROCED
                                
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