AMPI-DRY

AMPI-DRY

  • Anhydrous Ampicillin 3 g or 5 g (under Sodium Ampicillin form)
  • Injectable powder
  • Bottles of 3 g and 5 g
Cattle
Horses

PACKAGE LEAFLET

NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE, IF DIFFERENT

PRODIVET Pharmaceuticals sa/nv
Hagbenden 39C
B -4731 EYNATTEN

NAME OF THE VETERINARY MEDICINAL PRODUCT

AMPI-DRY®, injectable powder

STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)

Active substance: Anhydrous Ampicillin 3 g or 5 g (under Sodium Ampicillin form)
Excipients: There are no other components

INDICATION(S)

Treatment of infections caused by micro-organisms susceptible to Ampicillin in tissues where the distribution of the antibiotic in the infectious site is in effective concentration, within the limits of its pharmacokinetic characteristics.

CONTRAINDICATIONS

A Penicillin hypersensitivity is an absolute contra-indication.
Infections caused by micro-organisms producing penicillinase.
Do not administer in rabbits, guinea pigs, gerbils, hamsters or other animals that have a known Penicillin sensitivity.

ADVERSE REACTIONS

Sometimes hypersensitivity reactions to Penicillins may occur (Allergic reaction). The antidotes generally used in that case are epinephrine and corticosteroids.
As for other large spectrum antibiotics, superinfections due to resistant strains may occur. The animal must consequently be maintained under observation, in order to detect the possible development of an intercurrent infection. In this case, the treatment must be interrupted immediately and appropriate measures must be taken.
If you notice any serious effects or other effects not mentioned in this package leaflet, please inform your veterinary surgeon.

TARGET SPECIES

AMPI-DRY® is intended for horses and bovines (adults and calves).

DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION

To ensure a correct dosage, the body weight must be determined as exactly as possible.
Bovine: Intravenous injection of 25 mg/kg BW of anhydrous Ampicillin, means 15 ml of injectable solution of Ampi-dry® per 100 kg (2,5g of anhydrous Ampicillin).
The injections will be repeated every 6 hours, during a maximum of 5 consecutive days.
Horses: Intravenous injection of 30 mg/kg BW of anhydrous Ampicillin, means 18 ml of injectable solution of Ampi-dry® per 100 kg (3 g of anhydrous ampicillin).
The injections will be repeated every 6 hours, during a maximum of 5 consecutive days.

Preparation of the injectable solution

Vial of 3 g: add 16 ml of water for injectable preparations Ph. Eur., solubilize completely; that gives 18 ml of solution with a concentration of 166 mg of anhydrous Ampicillin per ml.
Vial of 5 g: add 26,5 ml of water for injectable preparations Ph. Eur., solubilize completely; that gives 30 ml of solution with a concentration of 166 mg of anhydrous Ampicillin per ml.

Route of administration

AMPI-DRY® may only be administrated by slow intravenous injection.

ADVICE ON CORRECT ADMINISTRATION

Special precautions for use in animals:

  • Do solubilize AMPI-DRY® powder only with water for (sterile) injectable preparations.
  • Check that the powder is completely solubilized.
  • Inject medication slowly under strict aseptic conditions.
  • The selection of resistance to antibiotics of some pathogenic organisms may vary; the use of the product should be based on sensitivity tests.

Interactions with other substances

Do not administer concomitantly with or after bacteriostatic substances.

Overdose (symptoms, emergency measures, antidotes), if necessary

No toxic clinical signs, except rare reactions of hypersensitivity treated by adrenalin and corticosteroids.

Incompatibilities

In the absence of studies of compatibility, this veterinary medicinal product should not be mixed with other veterinary medicinal products.

Use during pregnancy or lactation

No contraindication.

WITHDRAWAL PERIOD

Cattle : Meat and meat offals: 3 days. Milk: 48 hours (4 milkings).
Horses : Meat and meat offals: 4days.

SPECIAL STORAGE PRECAUTIONS

Keep out of the sight and reach of children.
Store below 25 °C.
Shelf life after reconstitution of the injectable solution: the product should be used immediately after reconstitution and the reconstituted solution should not be stored.
Store in the original package and protect from light.

SPECIAL WARNING(S)

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

Avoid self-injection. Penicillins and cephalosporines can cause hypersensitivity after injection, inhalation, ingestion or cutaneous contact. Hypersensitivity to penicillins can lead to cross-reactions with the cephalosporines and conversely. The allergic reactions towards these substances are occasionally severe. Do not handle this product if you are sensitized, or if one disadvised you to work with these preparations. In case of contact with the eyes or the skin, rinse immediately with water.
In case of cutaneous reactions, ask a medical advice and show these instructions to the doctor. The swelling of the face, the lips, the eyes or dyspnea, are more serious symptoms and require urgent medical  attention.

For the doctor:

This drug contains Ampicilline in form of sodium salt.

SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE
MATERIAL, IF ANY

Medicines should not be disposed of via wastewater or household waste.
Any unutilised veterinary medicinal product or waste derived from this drug must be eliminated in accordance with the local requirements.

DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED

September 2016

OTHER INFORMATION

PRODIVET Pharmaceuticals S.A./N.V.
Hagbenden 39c
B - 4731 EYNATTEN
Tél : 00 32 (0)87 85 20 25
Fax : 00 32 (0)87 86 68 20
info@prodivet.com
 
BE-V104097
 
Available on prescription only

 
Ampi-dry NOT-GB-V3-20160905