overdose expiry

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ΠΑΡΑΡΤΗΜΑ 1: ΠΕΡΙΛΗΨΗ ΤΩΝ ΧΑΡΑΚΤΗΡΙΣΤΙΚΩΝ ΤΟΥ ΠΡΟΪΟΝΤΟΣ
1. Name of the veterinary medicinal product:
Metaphosol , 20%, solution for injection for cattle
2. Qualitative and quantitative composition:
1 ml solution for injection contains:
Active substance(s):
Toldimfos sodium trihydrate
(equivalent to toldimfos sodium
200.0 mg
160.7 mg)
Excipients(s):
Benzyl alcohol
Sodium metabisulphite
For a full list of Excipients, see section 6.1.
3. Pharmaceutical form:
Solution for injection
4. Clinical particulars:
4.1 Target specie(s):
Cattle
4.2 Indications for use:
As relief for:
 Puerperal disturbances
 Improvement of the conception rate
4.3 Contraindications:
None known
4.4 Special warnings for each target species:
None
4.5 Special precautions for use:
Special precautions for use in animals:
None
Special precautions to be taken by the person administering the veterinary
medicinal product to animals:
None
4.6 Adverse reactions (frequency and seriousness):
None known
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4.7 Use during pregnancy, lactation or lay:
Not applicable.
4.8 Interaction with other medicinal products and other forms of interaction:
None known.
4.9 Amounts to be administered and administration route:
By intramuscular injection:
2 mg toldimfos sodium/kg b.w./day
equivalent to 1.25 ml Metaphosol per 100 kg b.w./day
the administration has to be repeated daily until a clinical effect is obvious
or rather up to max. 10 applications.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary:
Not applicable.
4.11 Withdrawal period(s):
Cattle:
Edible tissues:
Milk:
0 days
0 days
5. Pharmacological particulars
Pharmacotherapeutic group: minerals
ATCvet Code: QA12CX90
5.1 Pharmacodynamic particulars:
Toldimfos is an organic α-amino phosphorous compound.
The precise mode of action of toldimfos is unknown. Toldimfos has only a
low toxic potential and no teratogenic, mutagenic or carcinogenic
characteristics.
5.2 Pharmacokinetic particulars:
Following intramuscular injection of toldimfos in cattle at a dosage level of
10 mg/kg b.w., peak plasma concentrations were observed within 10 – 20
minutes. The mean half-life of toldimfos is serum was 1.07 h in calves and
1.15 h in dairy cows. The mean residence time for toldimfos in blood in
calves was 3.6 h, in cows 3.1 h. toldimfos is eliminated as the parent
compound in the urine. The major fraction of the administered dose is
eliminated within 6 hours, whilst at the 24 hour time-point, only
concentrations in the range of the limit of detection are observed.
Repeated dosing did not lead to bio-accumulation of the test compound.
Elimination of the compound in milk was extremely low, with levels below
the limit of quantification of the analytical technique (limit of quantification
for milk 0.15 μg / kg) at most time points.
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6. Pharmaceutical particulars
6.1 List of Excipients:
In addition to the Excipients mentioned in point 2, the veterinary medicinal
product contains the following substances: sodium hydrogen carbonate,
sodium carbonate anhydrous, propylene glycol, water for injections.
6.2 Incompatibilities:
Not known.
6.3 Shelf-life:
The veterinary medicinal product must not be used after the expiry date
stated on the label and on the outer package.
6.3.1 on the finished product: 36 months
6.3.2 after preparing the ready-made formulation: not applicable
6.3.3 after first opening the container: 14 days
6.4 Special precautions for storage:
Store below 25°C!
Protect from light!
6.5 Nature and composition of immediate packaging:
Glass vial, brown coloured, hydrolytic resistance of type II, closed with
brombutyl caoutchouc stoppers.
6.6 Special precautions for the disposal of unused veterinary medicinal
product of waste materials derived from the use of such products:
Any unused veterinary medicinal product or waste material derived from
such veterinary medicinal products should be disposed of in accordance
with local requirements.
7.Marketing authorisation holder: Demetrios Christoforou Ltd
Tseriou Avenue 169
2048,Strovolos,Nicosia
8.Marketing authorisation number(s):16669
9.Date of first authorisation/Renewal of the authorisation:3/9/1996
10.Date of revision of the text:30/7/2010
11.Legal status:
On prescription
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