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Equilis StrepE

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Summary for the public


What is Equilis StrepE?

Equilis StrepE is a vaccine which contains the active substance live deletion mutant Streptococcus equi bacteria. No adjuvant or preservative is included. Equilis StrepE is available as a lyophilisate (freeze-dried pellet) which is made up into a suspension for injection. The vaccine is provided together with the solvent, applicator and a syringe with needle. This is the first vaccine to be licensed for horses in the EU against strangles.


What is Equilis StrepE used for?

Equilis StrepE is used to vaccinate horses against the respiratory disease caused by the bacteria Streptococcus equi. The highly contagious and common disease caused by this bacterium is commonly called ‘strangles’. In strangles, the lymph nodes in the head can become large enough to block the airway, causing the horse to have difficulty breathing. This is a highly contagious disease and a common bacterial infection in horses. Equilis StrepE reduces the clinical signs of disease and the occurrence of lymph node abscesses (collections of pus).


How does Equilis StrepE work?

Equilis StrepE is a vaccine. Vaccines work by ‘teaching’ the immune system (the body’s natural defences) how to defend itself against diseases. Equilis StrepE contains small amounts of a type of bacterium called S. equi. When a horse is given the vaccine, the immune system recognises the bacteria as ‘foreign’ and makes antibodies against them. In the future, the immune system will be able to produce antibodies more quickly when it is again exposed to the bacteria. The bacterium strain included in Equilis StrepE has had some genes removed, so that it grows less well inside the horse’s body and is less likely to cause disease. This makes it suitable for use in a vaccine.


How has Equilis StrepE been studied?

The vaccine is given as a 0.2-ml injection into the inside of the upper lip. The effectiveness of Equilis StrepE has been studied in safety studies and one main field study. The horses had not had any disease including strangles in the past and had never been vaccinated. The results of the safety trials demonstrate that Equilis StrepE is safe for horses from four months of age onwards, as the local and systemic reactions observed after single, repeated dose and overdose treatment were considered acceptable. Horses from four months of age should receive a second injection after four weeks. All horses should be revaccinated every three months to maintain immunity. 

Equilis StrepE is only for use in healthy horses that are at risk of S. equi infection due to contact with horses from areas where the bacterium is known to be present. 


What benefit has Equilis StrepE shown during the studies?

The studies demonstrated that Equilis StrepE is effective in the active immunisation of horses from 4 months of age against Streptococcus equi to reduce clinical signs and occurrence of lymph node abscesses. Fewer of the horses receiving Equilis StrepE had symptoms of strangles. They also had fewer abscesses and fewer lymph nodes affected.


What is the risk associated with Equilis StrepE?

Only healthy horses which are at risk of infection should be vaccinated. After injection, swelling will develop at the injection site within four hours and the injection site may become warm or painful. The reaction is greatest at two to three days after injection, but the area affected should not be larger than 3 by 8 cm. The swelling should disappear within three weeks and should have no effect on the horse’s appetite, nor cause it any discomfort. In very rare case an abscess and discharge may develop at the injection site, and the lymph nodes in the head may enlarge, which may be painful for a short while. An increase in body temperature of up to 2°C may occur on the day of vaccination. In rare cases, loss of appetite, fever and shivering may be observed. In very rare cases depression may develop.


What are the precautions for the person who gives the medicine or comes into contact with the animal?

In case of accidental self-injection, which can cause inflammation with severe pain and swelling, seek medical advice immediately and show the Package Leaflet or the label to the doctor, even if only a small amount has been injected.


What is the time to allow before the animal can be slaughtered and the meat used for human consumption (withdrawal period)?

The withdrawal period is zero days.


Why has Equilis StrepE been approved?

The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Equilis StrepE exceed the risks for immunisation of horses against S. equi to reduce clinical signs and occurrence of lymph node abscesses, and recommended that Equilis StrepE be given a marketing authorisation. The benefit-risk balance may be found in module 6 of this EPAR.


Other information about Equilis StrepE

The European Commission granted a marketing authorisation valid throughout the European Union for Equilis StrepE to Intervet International B.V. on 7 May 2004. Information on the prescription status of this product may be found on the label/outer package.

Authorisation details
Name: Equilis StrepE
EMEA Product number: EMEA/V/C/000078
Active substance: live deletion mutant Streptococcus equi strain TW928
INN or common name: Live vaccine against Streptococcus equi.
Species: Horses
ATCvet Code: QI05AE
Marketing Authorisation Holder: Intervet International BV
Revision: 6
Date of issue of Market Authorisation valid throughout the European Union: 07/05/2004
Contact address:
Intervet International B.V.
Wim de Körverstraat 35
5831 AN Boxmeer
The Netherlands



Product Characteristics

ANNEX I

SUMMARY OF PRODUCT CHARACTERISTICS


1.
NAME OF VETERINARY THE MEDICINAL PRODUCT
Equilis StrepE, lyophilisate for suspension for injection, for horses
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Per dose of 0.2 ml vaccine:
Active substance:
Live deletion mutant Streptococcus equi strain TW928 10 9.0 to 10 9.4 cfu 1
Solvent:
Water for injections
Excipients:
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Lyophilisate for suspension for injection
4.
CLINICAL PARTICULARS
4.1 Target species
Horses
4.2 Indications for use, specifying the target species
For immunisation of horses against Streptococcus equi to reduce clinical signs and occurrence of
lymph node abscesses.
Onset of immunity : The onset of immunity is established as 2 weeks after basic vaccination.
Duration of immunity : The duration of immunity is up to 3 months .
The vaccine is intended for use in horses for which a risk of Streptococcus equi infection has been
clearly identified, due to contact with horses from areas where this pathogen is known to be present,
e.g. stables with horses that travel to shows and/or competitions in such areas, or stables that obtain or
have livery horses from such areas.
4.3 Contraindications
None
4.4 Special warnings
Shedding of the vaccine strain from the injection site can be observed for a period of four days after
vaccination.
1 Colony forming units
2/23
 
From literature, it is known that a very low number of horses may develop purpura haemorrhagica if
they are vaccinated shortly after infection. Purpura haemorrhagica has not been observed in any of the
safety studies performed during development of Equilis StrepE. As the incidence of purpura
haemorrhagica is very low, its occurrence cannot be ruled out completely.
4.5 Special precautions for use
Special precautions for use in animals
Only healthy horses should be vaccinated.
Ensure that the lyophilisate is completely reconstituted before use.
Basic vaccination performed during an outbreak is not efficacious, because immunity is insufficient
until basic vaccination has been completed.
Special precautions to be taken by the person administering the veterinary medicinal product to
animals
Special care must be taken when connecting the applicator to the needle to avoid needle-stick injuries.
In case of accidental self injection, seek medical advice immediately and show the package insert or
the label to the physician.
To the user:
This product contains a live bacterial deletion mutant with a limited growth potential in mammalian
tissue. Accidental self injection may result in an inflammatory reaction with severe pain and swelling.
If you are accidentally injected with this product seek prompt medical advice even if only a very small
amount is injected and take the package insert with you.
To the physician:
This product contains a live auxotrophic deletion mutant Streptococcus equi vaccine strain with
attenuated virulence. However, the bacterial compounds of this product can cause an inflammatory
reaction with intense and painful swelling after accidental injection.
Antiinflammatory therapy is indicated even if only a very small amount of the product in injected. An
additional antibiotic treatment should be considered for safety reasons. The sensitivity of the vaccine
strain to antibiotics is listed below (SPC under section 4.8)
4.6 Adverse reactions (frequency and seriousness)
After vaccination a diffusely swollen reaction, which may be warm or painful, develops at the
injection site within 4 hours. The reaction is maximal at 2-3 days post vaccination with a maximum
area of 3 cm by 8 cm. This swelling resolves completely within 3 weeks and normally has no effect on
the appetite of the vaccinated animal and causes no apparent discomfort. The vaccine organism may
establish a small suppurative inflammation locally at the injection site, leading to a disruption of the
overlaying lip mucosa and subsequent discharge fluid and inflammatory cells. A slight cloudy
discharge commonly occurs from the mucosal injection site at 3 or 4 days post vaccination.
Slight enlargements, which may be transient painful, of the retropharyngeal and mandibular lymph
nodes may occur for a few days after vaccination. In very rare cases an abscess may develop at the
injection site or in the regional lymph nodes.
Further, an increase in rectal temperature up to 2°C may occur on the day of vaccination. In rare cases,
inappetance, fever and shivering may be observed. In very rare cases depression may develop.
3/23
4.7 Use during pregnancy, lactation or lay
Do not use in pregnant or lactating mares.
4.8 Interaction with other medicinal products and other forms of interaction
Limited information is available on the safety and efficacy from the use of this vaccine with any other.
It is therefore recommended that no other vaccines should be administered concurrently or
simultaneously.
Do not use antibiotics within one week after vaccination.
The vaccine strain is resistant to aminoglycosides, sulphonamides, flumequine, and trimetroprim-sulfa
combinations.
The vaccine strain is sensitive to penicillins, tetracyclines, macrolides and lincomycin.
4.9 Amounts to be administered and administration route
Submucosal vaccination with 0.2 ml of reconstituted product.
C). Aseptically reconstitute the lyophilisate with
0.3 ml of the sterile solvent provided. Do NOT shake and wait 1 minute after addition of the solvent.
Withdraw 0.2 ml of the reconstituted vaccine into the syringe provided (see Figure 1) and connect the
applicator to the needle (see Figure 2). Restrain the animal’s head, lift the upper lip and insert the
needle into the inside of the upper lip until the applicator rests on the lip. Administer the whole
contents of the syringe into the inside of the upper lip (see Figure 3).
°
Figure 1
Figure 2
Figure 3
4/23
Allow the solvent to reach room temperature (15 - 25
Vaccination scheme:
Basic vaccination: horses from 4 months of age onwards receive two vaccinations of one dose with a
4 week interval.
Revaccination:
Revaccinate every three months to maintain immunity.
A priming response is maintained for up to six months after basic vaccination. Therefore only a single
dose of vaccine is needed to restore immunity.
It is recommended that all horses stabled together are vaccinated.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
In addition to the clinical signs given under section 4.6, vaccination with a ten times overdose may
induce an abscess in one of the submandibular lymph nodes. The abscesses drain purulent material
from 2 weeks after vaccination, but heal without intervention within a month thereafter . Furthermore,
an increase in rectal temperature up to 2.5 °C may occur on the day of vaccination. Slight apathy may
occasionally be observed one day after vaccination.
4.11 Withdrawal period(s)
Zero days.
5.
IMMUNOLOGICAL PROPERTIES
ATC vet code: QI05AE live bacterial vaccine
To stimulate immunity against Streptococcus equi .
The vaccine strain is a deletion mutant with a limited growth potential in mammalian tissue. It is able
to multiply locally at the submucosal injection site during a short period and is shed into the oro-nasal
cavity during a few days, but the vaccine strain does not survive on the oro-nasal mucosa and does not
disseminate systemically at the recommended dose.
In the challenge studies performed by Intervet, insufficient protection was seen in approximately one
quarter of horses vaccinated with the recommended dose.
6.
PHARMACEUTICAL PARTICULARS
6.1 List of excipients
NAO-1 stabiliser
Water for injections
6.2 Incompatibilities
Do not mix with any other veterinary medicinal products except the solvent supplied for use with the
vaccine.
6.3 Shelf life
Lyophilisate and solvent: 18 months.
5/23
Reconstituted vaccine should be used within 4 hours.
6.4 Special precautions for storage
C). Protect from light.
Solvent: This medicinal product does not require any special storage conditions.
°
C – 8
°
6.5 Nature and composition of immediate packaging
Each package of Equilis StrepE contains: 10 vials with lyophilisate and 10 vials of 0.5 ml solvent,
each in 3 ml Type I glass vials closed with a halogenobutyl rubber stopper and sealed with a coded
aluminium cap, 10 applicators, 10 syringes with needle.
6.6 Special precautions for the disposal of unused veterinary medicinal products or waste
materials derived from the use of such products
Dispose of waste material by boiling, incineration or immersion in an appropriate disinfectant
approved for use by the competent authorities.
7.
MARKETING AUTHORISATION HOLDER
Intervet International B.V.
Wim de Körverstraat 35
NL - 5831 AN Boxmeer
The Netherlands
8.
MARKETING AUTHORISATION NUMBER(S)
EU/2/04/043/001
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
7.05.2004 / 27.04.2009
10. DATE OF REVISION OF THE TEXT
27.04.2009
PROHIBITION OF SALE, SUPPLY AND/OR USE
Not applicable
6/23
Lyophilisate: Store refrigerated (2
ANNEX II
A.
MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR
BATCH RELEASE
B.
CONDITIONS OR RESTRICTIONS OF THE MARKETING
AUTHORISATION HOLDER REGARDING SUPPLY OR USE
C.
CONDITIONS OR RESTRICTIONS OF THE MARKETING
AUTHORISATION HOLDER WITH REGARD TO SAFE AND EFFECTIVE
USE
D.
STATEMENT OF THE MRLs
7/23
A. MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE
Intervet International B.V.
Wim de Körverstraat 35
NL - 5831 AN Boxmeer
The Netherlands
B. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION
HOLDER REGARDING SUPPLY OR USE
Veterinary medicinal product subject to prescription.
C. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION
HOLDER WITH REGARD TO SAFE AND EFFECTIVE USE
Not applicable.
D. STATEMENT OF THE MRLs
Substance
MRL status
Comments
Streptococcus equi strain
Not within the scope of Council
Regulation (EC) 2377/90
Active principles of biological
origin intended to produce
active or passive immunity are
not within the scope of the
Regulation
Water for injections
Not within the scope of Council
Regulation (EC) 2377/90
8/23
 
ANNEX III
LABELLING AND PACKAGE LEAFLET
9/23
A. LABELLING
10/23
PARTICULARS TO APPEAR ON THE OUTER PACKAGE
1.
NAME OF VETERINARY THE MEDICINAL PRODUCT
Equilis StrepE, lyophilisate for suspension for injection, for horses
2.
STATEMENT OF ACTIVE AND OTHER SUBSTANCE
Per dose of 0.2 ml vaccine:
Live deletion mutant Streptococcus equi strain TW928 10 9.0 to 10 9.4 cfu
3.
PHARMACEUTICAL FORM
Lyophilisate for suspension for injection
4.
PACKAGE SIZE
10 x 1 dose of vaccine
10 x 1 dose of solvent
10 applicators
10 syringes with needle
5.
TARGET SPECIES
Horses.
6.
INDICATION(S)
For immunisation of horses against Streptococcus equi to reduce clinical signs and occurrence of
lymph node abscesses.
7.
METHOD AND ROUTE(S) OF ADMINISTRATION
After reconstitution administer 0.2 ml submucosally to the inside of the upper lip.
Read the package insert before use.
8.
WITHDRAWAL PERIOD
Zero days.
9.
SPECIAL WARNING(S), IF NECESSARY
Not applicable.
11/23
 
10. EXPIRY DATE
EXP solvent {month/year}
EXP vaccine {month/year}
11. SPECIAL STORAGE CONDITIONS
C). Protect from light.
Solvent: This medicinal product does not require any special storage conditions.
Reconstituted vials should be used within 4 hours.
°
C – 8
°
12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE
MATERIALS
Dispose of waste material by boiling, incineration or immersion in an appropriate disinfectant
approved for use by the competent authorities.
13. THE WORDS "FOR ANIMAL TREATMENT ONLY"
For animal treatment only.
14. THE WORDS "KEEP OUT OF THE REACH AND SIGHT OF CHILDREN"
Keep out of the reach and sight of children.
15. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Intervet International B.V.
Wim de Körverstraat 35
NL - 5831 AN Boxmeer
16. MARKETING AUTHORISATION NUMBER(S)
EU/2/04/043/001
17. MANUFACTURER'S BATCH NUMBER
<batch>{number}
12/23
Lyophilisate: Store refrigerated (2
 
PARTICULARS TO APPEAR ON THE INNER BOX WITH VACCINE
1.
NAME OF VETERINARY THE MEDICINAL PRODUCT
Equilis StrepE, lyophilisate for suspension for injection, for horses
2.
STATEMENT OF ACTIVE AND OTHER SUBSTANCE
Per dose of 0.2 ml vaccine:
Live deletion mutant Streptococcus equi strain TW928 10 9.0 to 10 9.4 cfu
3.
PHARMACEUTICAL FORM
Lyophilisate for suspension for injection
4.
PACKAGE SIZE
10 x 1 dose
5.
TARGET SPECIES
Horses
6.
INDICATION
For immunisation against Streptococcus equi
7.
METHOD AND ROUTE OF ADMINISTRATION
For submucosal injection after reconstitution
8.
WITHDRAWAL PERIOD
Zero days.
9.
SPECIAL WARNINGS
Not applicable.
10. EXPIRY DATE
Exp {month/year}
13/23
 
11. SPECIAL STORAGE CONDITIONS
C). Protect from light.
Reconstituted vials should be used within 4 hours.
°
C – 8
°
12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED VETERINARY
MEDICINAL PRODUCTS OR WASTE MATERIALS
Dispose of waste material by boiling, incineration or immersion in an appropriate disinfectant approved
for use by the competent authorities.
13. THE WORDS "FOR ANIMAL TREATMENT ONLY"
For animal treatment only.
14. THE WORDS "KEEP OUT OF THE REACH AND SIGHT OF CHILDREN"
Keep out of the reach and sight of children.
15. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Intervet International B.V.
Wim de Körverstraat 35
NL - 5831 AN Boxmeer
16. MARKETING AUTHORISATION NUMBER(S)
EU/2/04/043/001
17. MANUFACTURER'S BATCH NUMBER
<batch>{number}
14/23
Store refrigerated (2
 
PARTICULARS TO APPEAR ON THE INNER BOX WITH SOLVENT
1.
NAME OF VETERINARY THE MEDICINAL PRODUCT
Equilis StrepE - solvent
2.
PACKAGE SIZE
10 x 1 dose
3.
TARGET SPECIES
Horses.
4.
METHOD AND ROUTE OF ADMINISTRATION
See package leaflet.
5.
WITHDRAWAL PERIOD
Zero days.
6.
EXPIRY DATE
Expiry date: {month/year}
7.
SPECIAL STORAGE CONDITIONS
This medicinal product does not require any special storage conditions.
Reconstituted vials should be used within 4 hours.
8.
THE WORDS "FOR ANIMAL TREATMENT ONLY"
For animal treatment only.
9.
THE WORDS "KEEP OUT OF THE REACH AND SIGHT OF CHILDREN"
Keep out of the reach and sight of children.
15/23
 
10. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Intervet International B.V.
Wim de Körverstraat 35
NL - 5831 AN Boxmeer
11. MARKETING AUTHORISATION NUMBER(S)
EU/2/04/043/001
12. MANUFACTURER'S BATCH NUMBER
<lot>{number}
16/23
 
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
Label of the vaccine (small vial)
1.
NAME OF VETERINARY THE MEDICINAL PRODUCT
Equilis StrepE
2.
QUANTITY OF THE ACTIVE SUBSTANCE
Live Streptococcus equi .
3.
CONTENTS BY WEIGHT, BY VOLUME OR NUMBER OF DOSES
1 dose
4.
ROUTE OF ADMINISTRATION
For submucosal use.
5.
WITHDRAWAL PERIOD
Zero days.
6.
BATCH NUMBER
<Batch> {number}
7.
EXPIRY DATE
Exp: {month/year}
8.
THE WORDS “FOR ANIMAL TREATMENT ONLY”
For animal treatment only.
17/23
 
Label of the solvent (small vial)
1.
NAME OF VETERINARY THE MEDICINAL PRODUCT
Equilis StrepE - solvent
2.
CONTENTS BY WEIGHT, BY VOLUME OR NUMBER OF DOSES
1 dose
3.
ROUTE OF ADMINISTRATION
See package insert.
4.
BATCH NUMBER
<Batch> {number}
5.
WITHDRAWAL PERIOD
Zero days.
6.
EXPIRY DATE
Exp {month/year}
7.
THE WORDS “FOR ANIMAL TREATMENT ONLY”
For animal treatment only.
18/23
 
B. PACKAGE LEAFLET
19/23
PACKAGE LEAFLET
Equilis StrepE, lyophilisate for suspension for injection, for horses
1.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE, IF DIFFERENT
Intervet International B.V.
Wim de Körverstraat 35
NL - 5831 AN Boxmeer
The Netherlands
2.
NAME OF VETERINARY THE MEDICINAL PRODUCT
Equilis StrepE, lyophilisate for suspension for injection, for horses
3.
STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENT(S)
Per dose of 0.2 ml vaccine:
Live deletion mutant Streptococcus equi strain TW928 10 9.0 to 10 9.4 cfu 1
4.
INDICATION(S)
For immunisation of horses against Streptococcus equi to reduce clinical signs and occurrence of
lymph node abscesses.
The onset of immunity is established as two weeks after vaccination. The duration of immunity is up
to 3 months.
The vaccine is intended for use in horses for which a risk of Streptococcus equi infection has been
clearly identified, due to contact with horses from areas where this pathogen is known to be present,
e.g. stables with horses that travel to shows and/or competitions in such areas, or stables that obtain or
have livery horses from such areas.
5.
CONTRAINDICATIONS
Do not use in pregnant or lactating mares.
6
ADVERSE REACTIONS
After vaccination a diffusely swollen reaction, which may be warm or painful, develops at the
injection site within 4 hours. The reaction is maximal at 2-3 days post vaccination with a maximum
area of 3 cm by 8 cm. This swelling resolves completely within 3 weeks and normally has no effect on
the appetite of the vaccinated animal and causes no apparent discomfort. The vaccine organism may
establish a small suppurative inflammation locally at the injection site, leading to a disruption of the
overlaying lip mucosa and subsequent discharge fluid and inflammatory cells. A slight cloudy
discharge commonly occurs from the mucosal injection site at 3 or 4 days post vaccination.
1 Colony forming units
20/23
Slight enlargements, which may be transient painful, of the retropharyngeal and mandibular lymph
nodes may occur for a few days after vaccination. In very rare cases an abscess may develop at the
injection site or in the regional lymph nodes.
Further, an increase in rectal temperature up to 2°C may occur on the day of vaccination. In rare cases,
inappetance, fever and shivering may be observed. In very rare cases depression may develop.
If you notice any serious effects or other effects not mentioned in this leaflet, please inform your
veterinary surgeon.
7
TARGET SPECIES
Horses
8.
DOSAGE FOR EACH SPECIES, ROUTES AND METHOD OF ADMINISTRATION
Submucosal vaccination of 0.2 ml of reconstituted product.
Basic vaccination : Horses from 4 months of age onwards receive two vaccinations of one dose with a
4 week interval.
Revaccination: Revaccinate every three months to maintain immunity.
A priming response is maintained for up to six months after basic vaccination. Therefore only a single
dose of vaccine is needed to restore immunity.
It is recommended that all horses stabled together are vaccinated.
9
ADVICE ON CORRECT ADMINISTRATION
C). Aseptically reconstitute the freeze-dried
vaccine with 0.3 ml of the sterile solvent provided. Do NOT shake and wait 1 minute after addition of
the solvent. Withdraw 0.2 ml of the reconstituted vaccine into the syringe provided with the vaccine
(see Figure 1) and connect the applicator to the needle (see Figure 2). Restrain the animal’s head, lift
the upper lip and insert the needle into the inside of the upper lip until the applicator rests on the lip.
Administer the whole contents of the syringe into the inside of the upper lip (see Figure 3).
°
Figure 1
21/23
Allow the solvent to reach room temperature (15 - 25
Figure 2
Figure 3
10. WITHDRAWAL PERIOD
Zero days.
11. SPECIAL STORAGE CONDITIONS
C). Protect from light.
Solvent: This medicinal product does not require any special storage conditions.
Reconstituted vials should be used within 4 hours.
°
C – 8
°
12. SPECIAL WARNINGS
Do not mix with any other veterinary medicinal products except the solvent supplied for use with the
vaccine.
Do not use antibiotics within one week after vaccination.
The vaccine strain is resistant to aminoglycosides, sulphonamides, flumequine, and trimetroprim-sulfa
combinations.
The vaccine strain is sensitive to penicillins, tetracyclins, macrolides and lincomycin.
Special precautions for use in animals
Only healthy horses should be vaccinated.
Ensure that the lyophilisate is completely reconstituted before use.
Basic vaccination performed during an outbreak is not efficacious, because immunity is insufficient
until basic vaccination has been completed.
22/23
Keep out of reach and sight of children.
Lyophilisate: Store refrigerated (2
Special precautions to be taken by the person administering the veterinary medicinal product to
animals
Special care must be taken when connecting the applicator to the needle to avoid needle-stick injuries.
In case of accidental self injection, seek medical advice immediately and show the package insert or
the label to the physician
To the user:
This product contains a live bacterial deletion mutant with a limited growth potential in mammalian
tissue. Accidental self injection may result in an inflammatory reaction with severe pain and swelling.
If you are accidentally injected with this product seek prompt medical advice even if only a very small
amount is injected and take the package insert with you.
To the physician:
This product contains a live auxotrophic deletion mutant Streptococcus equi vaccine strain with
attenuated virulence. However, the bacterial compounds of this product can cause an inflammatory
reaction with intense and painful swelling after accidental injection.
Antiinflammatory therapy is indicated even if only a very small amount of the product in injected. An
additional antibiotic treatment should be considered for safety reasons. The sensitivity of the vaccine
strain to antibiotics is listed above.
13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE
MATERIAL, IF ANY
Dispose of waste material by boiling, incineration or immersion in an appropriate disinfectant
approved for use by the competent authorities.
14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST REVISED
27.04.2009
15. OTHER INFORMATION
For animal treatment only.
Limited information is available on the safety and efficacy from the use of this vaccine with any other.
It is therefore recommended that no other vaccines should be administered concurrently or
simultaneously.
The vaccine strain is a deletion mutant with a limited growth potential in mammalian tissue. It is able
to multiply locally at the submucosal injection site during a short period and is shed into the oro-nasal
cavity during a few days, but the vaccine strain does not survive on the oro-nasal mucosa and does not
dissiminate systemically at the recommended dose.
Shedding of the vaccine strain from the injection site can be observed for a period of four days after
vaccination.From literature, it is known that a very low number of horses may develop purpura
haemorrhagica if they are vaccinated shortly after infection. Purpura haemorrhagica has not been
observed in any of the safety studies performed during development of Equilis StrepE. As the
incidence of purpura haemorrhagica is very low, its occurrence cannot be ruled out completely.
For any information about this veterinary medicinal product, please contact the Marketing
Authorisation Holder.
23/23


Source: European Medicines Agency



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