STELLAMUNE MYCOPLASMA

Ireland - English - HPRA (Health Products Regulatory Authority)

Active ingredient:
Mycoplasma hyopneumoniae strain p-5722-3
Available from:
Elanco Animal Health, Eli Lilly and Company Limited
ATC code:
QI09AB13
INN (International Name):
Mycoplasma hyopneumoniae strain p-5722-3
Dosage:
Not Currently Available
Pharmaceutical form:
Emulsion for injection
Prescription type:
POM: Prescription Only Medicine as defined in relevant national legislation
Therapeutic group:
Pigs
Therapeutic area:
mycoplasma
Therapeutic indications:
Immunological
Authorization status:
Authorised
Authorization number:
VPA10047/019/001
Authorization date:
2011-01-07

Read the complete document

Summary of Product Characteristics

1 NAME OF THE VETERINARY MEDICINAL PRODUCT

STELLAMUNE MYCOPLASMA

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each 2 ml dose contains

Active Substance

Inactivated Mycoplasma hyopneumoniae

at least 10,529 RU* at release to ensure 6000 RU* throughout shelf-life.

* = Relative ELISA Units

Adjuvants

Liquid paraffin

0.09 ml

Excipients

Thiomersal

0.185 mg

For a full list of excipients, see section 6.1

3 PHARMACEUTICAL FORM

Emulsion for injection

4 CLINICAL PARTICULARS

4.1 Target Species

Fattening pigs from one week of age.

4.2 Indications for use, specifying the target species

For active immunisation of fattening pigs to reduce lung lesion scores caused by Mycoplasma hyopneumoniae

infection. Protection against Mycoplasma hyopneumoniae reduces the impact of secondary bacterial infection with

Pasteurella multocida, offering improved health and economic benefits. Immunity is acquired two weeks following the

second vaccination and protection lasts throughout the fattening period.

4.3 Contraindications

The use of immunosuppressant drugs or procedures is contraindicated within one month of vaccination.

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4.4 Special warnings for each target species

Vaccinate only healthy animals.

In any animal population, a small number of individuals may fail to respond fully to vaccination.

Since Stellamune Mycoplasma is only recommended for reduction of lung lesions scores caused by Mycoplasma

hyopneumoniae infection it is important that all animals in a herd should be vaccinated to reduce the spread of the

disease.

Use of the vaccine should be combined with high management standards to maximise the benefits of vaccination.

4.5 Special precautions for use

Special precaution(s) for use in animals

None.

Special precautions to be taken by the person administering the veterinary medicinal product to animals

To the user:

This

product contains

mineral

oil.

Accidental

injection/self

injection may result

in severe

pain and swelling,

particularly if injected into a joint or finger,

and in rare cases could result in the loss of the affected finger if prompt

medical attention is not given.

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 leaflet with you.

If pain persists for more than 12 hours after medical examination, seek medical advice again.

To the physician:

This product contains mineral oil. Even if small amounts have been injected, accidental injection with this product can

cause intense swelling, which may, for example, result in ischemic necrosis and even the loss of a digit. Expert,

PROMPT, surgical attention is required and may necessitate early incision and irrigation of the injected area, especially

where there is involvement of finger pulp or tendon.

4.6 Adverse reactions (frequency and seriousness)

Hypersensitivity reactions can occasionally occur after the administration of Stellamune Mycoplasma (tremor,

vomiting, dyspnoea). These reactions on very rare occasions can result in mortality. Such reactions are more likely in

piglets born to dams vaccinated during pregnancy with an oil-containing Aujeszky or Aujeszky/Influenza vaccine.

However, the reported incidence of these reactions is low even in piglets born to such dams.

If an anaphylactic reaction occurs, administer adrenaline or other appropriate medication.

Administration of the vaccine may be followed by a mild injection site reaction.

These reactions are limited to swelling

(0.5-2 cm in diameter) with or without redness, and mild tenderness to direct pressure.

The reactions have not been

observed to cause alterations of normal behaviour in affected pigs. The reactions resolve spontaneously within a few

days, do not cause blemishes of the carcass at slaughter, and no remedial action need be taken.

Transient (7-10 days duration) temperature increases (of the order of 1°C - 2°C) can also occur post vaccination.

4.7 Use during pregnancy, lactation or lay

Not to be used during pregnancy and lactation.

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4.8 Interaction with other medicinal products and other forms of interaction

No information is available on the safety and efficacy from the concurrent use of this vaccine with any other.

It is

therefore recommended that no other vaccine should be administered within 14 days before or after vaccination with

the product.

4.9 Amounts to be administered and administration route

The vaccine is to be administered at the rate of 2 ml by the deep intramuscular route, preferably behind the ear and

through a clean site.

Basic vaccination. Two doses should be given to piglets. The 1st dose at one week of age (minimum) and the 2nd dose

2-4 weeks later.

Shake the vial before use. Use only sterile needles and syringes for administration.

It may be desired to vaccinate older pigs (3 – 6 weeks old) against Mycoplasma hyopneumoniae infection, especially if

they are to be moved from premises where the incidence of the disease is low to premises where the disease incidence

is higher. In this case each pig should be vaccinated twice, with an interval between doses of 2 – 4 weeks, before

shipping. However, it should be remembered that pigs vaccinated for the first time at more than one week of age may

already have pulmonary changes due to Mycoplasma infection and that therefore, the protection conferred by

vaccination may not be as strong as that seen when piglets are vaccinated.

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

Post vaccination reactions following an overdose are similar to those following a single dose (see 4.6).

4.11 Withdrawal Period(s)

Zero days.

5 PHARMACOLOGICAL or IMMUNOLOGICAL PROPERTIES

ATC Vet code QI09AB13

To stimulate active immunisation against Mycoplasma hyopneumoniae.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Liquid paraffin

Soya Lecithin

Polysorbate 80

Sorbitan Mono-oleate

Thiomersal

Sodium EDTA

Buffered Saline

6.2 Incompatibilities

Do not mix with any other medicinal product.

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6.3 Shelf-life

Shelf-life of the veterinary medicinal product as packaged for sale: 3 years

In use shelf-life: use immediately

6.4 Special precautions for storage

Store in a refrigerator (+2° C to +8° C).

Do not freeze. Protect from light.

6.5 Nature and composition of immediate packaging

Carton containing a Type I glass vial containing 10 doses (20 ml) or 50 doses (100 ml) or a plastic bottle containing 10

doses (20 ml), 50 doses (100 ml) or 125 doses (250 ml), closed with a rubber stopper and sealed with an aluminium

cap.

Not all pack sizes may be marketed.

6.6 Special precautions for the disposal of unused veterinary medicinal products or waste materials

Any unused product or waste material should be disposed of in accordance with national requirements.

7 MARKETING AUTHORISATION HOLDER

Elanco Animal Health,

Eli Lilly & Company ltd

Lilly House

Priestly Road

Basingstoke

Hampshire RG24 9NL

United Kingdom

8 MARKETING AUTHORISATION NUMBER(S)

VPA 10047/019/001

9 DATE OF THE FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 4

November 2002

Date of last renewal: 3

November 2007

10 DATE OF REVISION OF THE TEXT

May 2015

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