YODIMASPEN EXTEMPORANEA injectable suspension 2*15 ml

Cattle: Treatment of mastitis caused by Streptococcus uberis, Streptococcus dysgalactie, Sterptococcus agalactiae and Staphylococcus aureus (non-beta-lactamase producers) sensitive to benzylpenicillin.

TECHNICAL SHEET OR SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
YODIMASPEN
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 g vial of the powder contains:
Active substance:
Penetamate iohydrate ………………………………………………………………………………………………….5,0 g
(equivalent to 5 MIU of benzylpenicillin)
Each vial of solvent (15 ml) contains:
Excipients:
Methyl parahydroxybenzoate (E 218) ……………………………………………………………………. 27,0mg
Propyl parahydroxybenzoate (E 216) ………………………………………………………………..2,7 mg
Other excipients, qs
Each 10 g vial of the powder contains:
Active substance:
Penetamate iohydrate ……………………………………………………………………………………………..10,0 g
(equivalent to 10 MIU of benzylpenicillin)
Each vial of solvent (30 ml) contains:
Excipients:
Methyl parahydroxybenzoate (E 218) ……………………………………………………………………. 54,0mg
Propyl parahydroxybenzoate (E 216) ………………………………………………………………..5,4 mg
Other excipients, qs
For the full list of excipients, see section 6.1
Each ml of the reconstituted suspension contains 272,72 mg of penetamate hydrochloride.
3. PHARMACEUTICAL FORM
Powder and solvent for suspension for injection.
4. CLINICAL DATA
4.1 Target species
Cattle (lactating cows).
4.2 Indications for use, specifying the target species
Cattle: Treatment of mastitis caused by Streptococcus uberis, Streptococcus dysgalactie, Sterptococcus
agalactiae and Staphylococcus aureus (non-producers of beta-lactamases) sensitive to benzylpenicillin.

4.3 Contraindications
Do not use in animals with known hypersensitivity to penicillins, cephalosporins and/or any of the excipients.
4.4 Special warnings for each target species
Do not administer intravenously in any case.
4.5 Special precautions for use
Special precautions for use in animals
The use of penetamate (iohydrate) for the treatment of mastitis must be accompanied by hygienic measures and
sanitary measures that prevent reinfection.
The effectiveness of the drug could be reduced when more than two quarters are affected.
Good clinical practice advises basing treatment on susceptibility tests of bacteria isolated from
sick animals. If this is not possible, treatment should be based on local epidemiological information.
(regional, export level) on the susceptibility of different strains of bacterial species
usually implicated in mastitis.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Penicillins and cephalosporins may cause hypersensitivity (allergic) reactions after injection,
inhalation, ingestion or skin contact. Cross hypersensitivity reactions are observed between
cephalosporins and penicillins.
Do not handle the product if you are allergic to penicillins and/or cephalosporins.
In case of ingestion or accidental self-injection consult a doctor immediately and show him the package leaflet or
the label.
Handle the product with care to avoid accidental self-injection, as well as contact with the skin or
eyes, taking specific precautions.
Wear gloves and wash hands after using the product.
If accidental skin or eye exposure occurs, rinse immediately with plenty of water.
Do not smoke, eat or drink while handling the product.
If symptoms appear after exposure, such as a skin rash, consult a doctor and present these
warnings. Swelling of the face, lips or eyes or respiratory distress are more serious signs that require
urgent medical attention.
4.6 Adverse reactions (frequency and seriousness)
Animals must be closely monitored after administration to treat any type of
adverse reaction. Symptoms range from mild skin reactions with hives and dermatitis to shock
severe anaphylactic with tremors, vomiting, hypersalivation, gastrointestinal disturbances, and laryngeal edema. usually
occur, above all, in old cattle. In these cases, the administration of the drug will be suppressed and the
will administer symptomatic treatment.

Superinfections by resistant microorganisms may occur, consequent to treatment.
4.7 Use during pregnancy, lactation or lay
Contraindications have not been described during these periods.
4.8 Interaction with other medicinal products and other forms of interaction
Anti-inflammatories such as salicylates, produce an increase in the elimination half-life of penethamate
(iodhydrate). In case of joint administration, adjust the dose of antibacterial.
Do not use in conjunction with other antibacterials with which it has no proven additive or synergistic effect.
4.9 Amounts to be administered and administration route
Route of administration: Deep intramuscular.
Dose: 15 mg or 15.000 IU of penetamate iohydrate per kg of body weight/day (equivalent to 5,5 ml of medication
reconstituted /100 kg bw), for 3 consecutive days.
Directions for use: Use a sterile syringe and add the diluent to the powder vial. Shake vigorously to
achieve a homogeneous suspension.
Once the suspension is reconstituted, administer the recommended daily dose every 24 hours, up to a total of three
administrations.
The weight of the animals should be determined as accurately as possible to avoid underdosing.
Do not inject more than 10 ml at the same point of application.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
Some of the symptoms described in the section on adverse reactions may appear, see section 4.6.
4.11 Wait times
Meat: 5 days.
Milk: 4 days.
5. PHARMACOLOGICAL PROPERTIES
Pharmacotherapeutic group: Beta-lactam antibacterials. Penicillins.
ATCvet: QJ01CE90
5.1 Pharmacodynamic properties
The active substance of the drug, penethamate iohydrate, is a prodrug that releases benzylpenicillin.
Chemically it is a diethylaminoethanol ester of benzylpenicillin.
Mechanism of action
It works by blocking the biosynthesis of the bacterial wall. Attaches by covalent binding after opening of the beta nucleus –
lactam, and inactivates penicillin-binding proteins (PBPs) located on the inner surface of the membrane
bacterial. PBPs (transpeptidases, carbopeptidases, endopeptidases) are enzymes involved in the stages
terminals of bacterial wall synthesis. Benzylpenicillin is only active against bacteria in the growth phase.
multiplication.

Its spectrum of action corresponds to that of benzylpenicillin, which is active against Streptococcus agalactiae
Streptococcus dysgalactiae Streptococcus uberis y Staphylococcus aureus non-producers of beta-lactamases.
Resistance: Some microorganisms become resistant through the production of beta-lactamases (more
specifically penicillinases), which cleave the beta-lactam ring of penicillins, rendering them inactive.
5.2 Pharmacokinetic data
Following intramuscular administration of penethamate (iohydrate) to dairy cows, the highest levels of
concentration are reached quickly in blood and milk (3 and 7 hours, respectively). The antibacterial is
Hydrolyzes in blood by 90% and in milk by 98%. This hydrolysis produces diethylaminoethanol and
benzylpenicillin, which is the therapeutically active molecule. The distribution is rapid and complete by the organism,
with special affinity for lung and mammary tissues. It crosses the placenta and slowly enters the
fetal circulation from the mother. Comparative studies with other penicillins have shown that penetamate
(iohydrate) gives concentrations in milk 4 times higher than the rest, after administration of identical doses. HE
excreted mainly in the urine.
6. PHARMACEUTICAL DATA
6.1 List of excipients
Vial with the powder:
Not applicable
Vial with solvent:
Methyl parahydroxybenzoate (E 218)
Propyl parahydroxybenzoate (E 216)
Polysorbate 80
citric acid monohydrate
Soda citrato
Water for injections
6.2 Incompatibilities
They have not been described.
6.3 Validity period
Shelf life of the veterinary medicinal product packaged for sale: 3 years.
Shelf-life after first opening the immediate packaging: immediate use.
Shelf-life after reconstitution according to instructions: 7 days in the refrigerator.
6.4. Special storage precautions
This veterinary medicinal product does not require special storage conditions.
The reconstituted solution should be stored in a refrigerator (between 2ºC and 8ºC).
6.5 Nature and composition of immediate packaging
Powder: Clear glass vials, type I (5 g) and type II (10 g) quality (European Pharmacopoeia) with rubber stopper
gray bromobutyl and aluminum (silver) colored metal cap with colored FLIP-OFF aperture ring

Diluent: Clear glass vials, type I (15 ml) and type II (30 ml) quality (European Pharmacopoeia), with plastic stopper.
gray bromobutyl rubber and aluminum (silver) colored metal cap with FLIP-OFF opening ring
the color blue.
Formats:
Box with 1 vial of 15 ml solvent and 1 vial of 5,0 g powder
Box with 2 vials of 15 ml solvent and 2 vials of 5,0 g powder
Box with 4 vials of 15 ml solvent and 4 vials of 5,0 g powder
Box with 12 vials of 15 ml solvent and 12 vials of 5,0 g powder
Box with 1 vial of 30 ml solvent and 1 vial of 10,0 g powder
Box with 2 vials of 30 ml solvent and 2 vials of 10,0 g powder
Box with 4 vials of 30 ml solvent and 4 vials of 10,0 g powder
Box with 12 vials of 30 ml solvent and 12 vials of 10,0 g powder
Not all formats may be marketed.

Any unused veterinary medicinal product or residues derived from it must be disposed of in accordance
with local regulations.
7. MARKETING AUTHORIZATION HOLDER
LABORATORIES CALIER, SA
C/. Barcelona, ​​26 (Plà del Ramassà)
Les Franqueses Del Valles, (Barcelona)
8. MARKETING AUTHORIZATION NUMBER
2532 ESP
9. DATE OF THE FIRST AUTHORIZATION/RENEWAL OF THE AUTHORIZATION
First authorization date: September 21, 1987
Last renewal date: May 8, 2012
10. DATE OF REVISION OF THE TEXT
February 25th 2016
PROHIBITION OF SALE, DISPENSATION AND/OR USE OR
Dispensing conditions: Medicine subject to a veterinary prescription.
Administration conditions: Administration under control or supervision of the veterinarian.

See technical sheet