Sign in with your myHealthbox account

Forgot your password? or

MEGAPEN

Information leaflet

                                                        Irish Medicines Board




                                  Summary of Product Characteristics
 1 NAME OF THE VETERINARY MEDICINAL PRODUCT

 Megapen - Strep Injection.

 2 QUALITATIVE AND QUANTITATIVE COMPOSITION

  Each ml contains:
  Active substances
  Procaine Benzylpenicillin                        200 mg
  Dihydrostreptomycin Sulphate                     200 mg
  Excipient
  Methyl Parahydroxybenzoate                        1.0 mg
  Sodium Formaldehyde Sulfoxylate                  1.48 mg
  For a full list of excipients, see section 6.1

 3 PHARMACEUTICAL FORM

 Suspension for injection.
 A white aqueous solution


 4 CLINICAL PARTICULARS

 4.1 Target Species

 Bovine.

 4.2 Indications for use, specifying the target species

 For the treatment and control of infections caused by bacteria sensitive to procaine penicillin or dihydrostreptomycin
 sulphate.

 4.3 Contraindications

 Do not use in cases of known hypersensitivity to the active ingredients.
 Do not administer by the intravenous route.

 4.4 Special warnings for each target species

 None known.




______________________________________________________________________________________________________________________
Date Printed 28/04/2011                               CRN 7010620                                         page number: 1
                                                    Irish Medicines Board




 4.5 Special precautions for use

 Special precautions for use in animals
 Use of the product should be based on susceptibility testing of the bacteria isolated from the animal. If this is not
 possible, therapy should be based on local (regional, farm level) epidemiological information about susceptibility of the
 target bacteria.

 Special precautions to be taken by the person administering the veterinary medicinal product to animals
 Avoid direct contact with product. Use gloves when administering the product. Seek medicinal advice if symptoms
 such as skin rash, swelling of face, lips etc occurs.
 Penicillin and cephalosporins may cause hypersensitivity (allergy) following injection, inhalation, ingestion or skin
 contact. Hypersensitivity to penicillin may lead to cross sensitivity to cephalosporins and vice versa. Allergic reaction
 to these substances may occasionally be serious.

 1.     Do not handle this product if you know you are sensitised or if you have been advised not to work with such
 preparations.

 2.      Handle this product with great care to avoid exposure, taking all recommended precautions.

 3.      If you develop symptoms following exposure, such as a skin rash, you should seek medical advice and show the
 doctor this warning. Swelling of the face, lips and eyes or difficulty with breathing are more serious symptoms and
 require urgent medical attention.

 4.6 Adverse reactions (frequency and seriousness)

 Occasional hypersensitivity and/or anaphylactic reaction may occur.

 4.7 Use during pregnancy, lactation or lay

 This product may be used in lactating animals.

 4.8 Interaction with other medicinal products and other forms of interaction

 Concurrent administration with other antibiotics should be avoided.

 4.9 Amounts to be administered and administration route

 By intramuscular injection only.
 0.5ml to 1ml per 10 kg b.w.
 To ensure a correct dosage bodyweight should be determined as accurately as possible.

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

 None known.

 4.11 Withdrawal Period(s)

 Meat: 28 days.
 Milk: 72 hours.

 5 PHARMACOLOGICAL or IMMUNOLOGICAL PROPERTIES

      ATC Vet Code: QJ01 RA01.
      Pharmacotherapeutic group: Antibacterials for systemic use, penicillins, combinations with other antibacterials




______________________________________________________________________________________________________________________
Date Printed 28/04/2011                               CRN 7010620                                         page number: 2
                                                   Irish Medicines Board




 5.1 Pharmacodynamic properties

 Procaine Penicillin is a broad spectrum antibiotic, active against most gram+ve organisms. It is slowly absorbed after
 intramuscular injection and has prolonged antibacterial action. Dihydrostreptomycin is active against gram-ve
 organisms. The combination has synergistic action.

 6 PHARMACEUTICAL PARTICULARS

 6.1 List of excipients

 Methyl Parahydroxybenzoate
 Sodium Formaldehyde Sulfoxylate
 Disodium Edetate
 Povidone K30
 Cetrimide
 Sodium Carboxymethylcellulose
 Sodium Citrate
 Water for Injections

 6.2 Incompatibilities

 None known.

 6.3 Shelf-life

 Shelf-life of the veterinary medicinal product as packaged for sale: 2 years
 Shelf-life after first opening the immediate packaging: 28 days

 6.4 Special precautions for storage

 Do not store above 25oC. Protect from light.

 6.5 Nature and composition of immediate packaging

 100 ml Type II clear glass siliconised vial, sealed with brombutyl stopper and aluminium overseal.

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

 Any unused veterinary medicinal product or waste material derived from such veterinary medicinal product should be
 disposed of in accordance with national requirements.

 7 MARKETING AUTHORISATION HOLDER

 Franklin Pharmaceuticals Ltd.,
 Athboy Road,
 Trim,
 Co. Meath.




______________________________________________________________________________________________________________________
Date Printed 28/04/2011                               CRN 7010620                                         page number: 3
comments powered by Disqus

Alerts


There are no recent safety alerts related to this product.