Sheptaclox

Main information

  • Trade name:
  • Sheptaclox DC Intramammary Suspension
  • Pharmaceutical form:
  • Intramammary suspension
  • Prescription type:
  • POM-V - Prescription Only Medicine – Veterinarian
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Sheptaclox DC Intramammary Suspension
    United Kingdom
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • Cattle
  • Therapeutic area:
  • Antimicrobial intramammary

Other information

Status

  • Source:
  • VMD - Veterinary Medicines Directorate
  • Authorization status:
  • Expired
  • Authorization number:
  • 41687/4002
  • Authorization date:
  • 06-04-2000
  • Last update:
  • 18-09-2017

Summary of Product characteristics

Revised: October 2012

AN: 00749/2012

SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Sheptaclox DC Intramammary Suspension.

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each 4.5g syringe contains:

Active Substances:             mg

Cloxacillin (as Benzathine Cloxacillin) 500 

Ampicillin (as Ampicillin Trihydrate) 250 

Excipients:

For a full list of excipients, see section 6.1

3. PHARMACEUTICAL FORM

Intramammary suspension.

An off-white suspension for intramammary infusion

4. CLINICAL PARTICULARS

4.1 Target species

Dairy cattle

4.2 Indications for use, specifying the target species

For routine use in cows at drying off, to treat intramammary infections and to 

assist in preventing new infections occurring during the dry period.  It also 

aids in reducing the incidence of summer mastitis in dry cows and heifers at 

risk.  Amongst the organisms found to be sensitive to Ampicillin and Cloxacillin

are:

Streptococcus agalactiae

Streptococcus spp.

Staphylococcus spp.

Arcanobacterium spp.

Escherichia coli

4.3 Contraindications

Not to be used in cows with known hypersensitivity to the active substances.

Page 1 of 5

Revised: October 2012

AN: 00749/2012

4.4 Special Warnings for each target species

No special warnings

4.5 Special precautions for use

i. Special precautions for use in animals

When infusing heifers it is important that the syringe nozzle is not 

introduced into the teat.  The animal should be properly restrained.  The 

teat orifice is located and the nozzle of the syringe placed against it but 

NOT inserted

ii. Special precautions to be taken by the person administering the veterinary 

medicinal product to animals

Protective gloves should always be worn when infusing heifers, to avoid 

skin contact with the product.

Penicillins and cephalosporins may cause hypersensitivity (allergy) 

following injection, inhalation, ingestion or skin contact.  Hypersensitivity to 

penicillins may lead to cross reactions 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 or eyes or difficulty in breathing are more serious symptoms 

and require urgent medical attention.

Wash hands after use.

4.6 Adverse reactions (frequency and seriousness)

No known undesirable effects.

4.7 Use during pregnancy, lactation or lay

The product can be safely administered to pregnant animals.

4.8       Interaction with other medicinal products and other forms of interaction

None known

Page 2 of 5

Revised: October 2012

AN: 00749/2012

4.9 Amounts to be administered and administration route

Dry off therapy:  After the final milking of a lactation, clean and disinfect the 

teats and introduce the contents of one tube into each quarter via the teat 

canal.

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

Not applicable.

4.11 Withdrawal period

Do not use in cows which have a very short dry period.

Not intended for use within 49 days of calving.

Milk for human consumption may only be taken from 156 hours after calving.  

Should a cow calve earlier than 49 days after the last treatment, milk for 

human consumption may only be taken from 49 days plus 156 hours after the 

last treatment. Should a cow calve earlier than 49 days after treatment consult

your veterinary surgeon

In cows suffering from hypocalcaemia it may be necessary to withold milk for 

a longer period than that stated above.  In such cases, milk should be 

withheld until the levels of antibiotics are below the maxium accepted residue 

levels, i.e. 0.003 mcg/ml for cloxacillin and 0.004 mcg/ml for ampicillin.

Animals must not be slaughtered for human consumption during treatment. 

Cattle may be slaughtered for human consumption only after 28 days from the

last treatment.

The product must not be used in the treatment of lactating cows. Should this 

occur  milk should be discarded for 30 days, following which time milk should 

be tested until antibiotic can no longer be detected.

5. PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: Antibacterials for intramammary use, Beta-

lactam antibacterials, penicillins, for intramammary use, Combinations of 

penicillins and / or beta-lactamase inhibitors.

ATC Vet Code:  QJ51CR50

5.1 Pharmacodynamic properties

Cloxacillin is active against Penicillin G resistant staphylococci.  Ampicillin 

possesses antibacterial activity against Gram-positive and Gram-negative 

bacteria.  Both antibiotics bind to membrane bound proteins known as 

penicillin-binding proteins (PBP's) and are bactericidal.

Page 3 of 5

Revised: October 2012

AN: 00749/2012

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Aluminium stearate

Paraffin, Liquid 

6.2 Incompatibilities

None known

6.3 Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 2 years.

6.4 Special precautions for storage

Do not store above 25°C.

The syringe must only be used once.  Part used syringes must be discarded.

6.5 Nature and composition of immediate packaging

4.5g white low density polyethylene syringe barrel and piston with white low 

density poltethylene cap (snap-on) closure, supplied in cartons of 40 and 100 

syringes.

Not all pack sizes may be marketed.

6.6 Special precautions for the disposal of unused veterinary medicinal 

product or waste materials derived from the use of such products

Any unused veterinary medicinal product or waste material derived from such 

veterinary medicinal products should be disposed of in accordance with local 

requirements.

7. MARKETING AUTHORISATION HOLDER

Listow Limited

9 Belgrave Square

London

SW1X 8PH

8. MARKETING AUTHORISATION NUMBER(S)

Vm

 41687/4002

9. DATE OF FIRST AUTHORISATION

Date: 6 April 2000 

Page 4 of 5

Revised: October 2012

AN: 00749/2012

10. DATE OF REVISION OF THE TEXT

           Date: October 2012

Page 5 of 5

Document Outline

4-1-2018

Ampicillin and Sulbactam for Injection USP 1.5 g/vial by Auromedics: Recall - Presence of Glass Particles in Vial

Ampicillin and Sulbactam for Injection USP 1.5 g/vial by Auromedics: Recall - Presence of Glass Particles in Vial

Administration of glass particulate may result in local irritation or swelling in response to the foreign material. More serious potential outcomes would include blockage and clotting in blood vessels, which may be life-threatening.

FDA - U.S. Food and Drug Administration

3-1-2018

Auromedics Pharma LLC Issues Voluntary Nationwide Recall of Product Ampicillin and Sulbactam for Injection USP 1.5 g/ Vial, Due to Presence of Glass Particles in the Vial

Auromedics Pharma LLC Issues Voluntary Nationwide Recall of Product Ampicillin and Sulbactam for Injection USP 1.5 g/ Vial, Due to Presence of Glass Particles in the Vial

AuroMedics Pharma LLC is voluntarily recalling lot AFO l 17001-A, Expiry date Dec 2018, of Ampicillin and Sulbactam for Injection USP, 1.5 g (equivalent to 1 g ampicillin as the sodium salt plus 0.5 g Sulbactam as the sodium salt) in a Single-Dose vial, to the hospital level. The product has been found to contain glass particles.

FDA - U.S. Food and Drug Administration

15-2-2018

AMPICILLIN Capsule [REMEDYREPACK INC.]

AMPICILLIN Capsule [REMEDYREPACK INC.]

Updated Date: Feb 15, 2018 EST

US - DailyMed

2-2-2018

AMPICILLIN Capsule [Denton Pharma, Inc.]

AMPICILLIN Capsule [Denton Pharma, Inc.]

Updated Date: Feb 2, 2018 EST

US - DailyMed

23-1-2018

AMPICILLIN AND SULBACTAM Injection, Powder, For Solution [Sagent Pharmaceuticals]

AMPICILLIN AND SULBACTAM Injection, Powder, For Solution [Sagent Pharmaceuticals]

Updated Date: Jan 23, 2018 EST

US - DailyMed

19-12-2017

DRY-CLOX (Cloxacillin Benzathine) Gel [Boehringer Ingelheim Vetmedica, Inc]

DRY-CLOX (Cloxacillin Benzathine) Gel [Boehringer Ingelheim Vetmedica, Inc]

Updated Date: Dec 19, 2017 EST

US - DailyMed

28-11-2017

AMPICILLIN Injection, Powder, For Solution [WG Critical Care, LLC]

AMPICILLIN Injection, Powder, For Solution [WG Critical Care, LLC]

Updated Date: Nov 28, 2017 EST

US - DailyMed

20-11-2017

AMPICILLIN (Ampicillin Sodium) Injection, Powder, For Solution [Sandoz Inc]

AMPICILLIN (Ampicillin Sodium) Injection, Powder, For Solution [Sandoz Inc]

Updated Date: Nov 20, 2017 EST

US - DailyMed

14-11-2017

AMPICILLIN SODIUM Injection, Powder, For Solution [Mylan Institutional LLC]

AMPICILLIN SODIUM Injection, Powder, For Solution [Mylan Institutional LLC]

Updated Date: Nov 14, 2017 EST

US - DailyMed

14-11-2017

AMPICILLIN Injection, Powder, For Solution [Mylan Institutional LLC]

AMPICILLIN Injection, Powder, For Solution [Mylan Institutional LLC]

Updated Date: Nov 14, 2017 EST

US - DailyMed

1-11-2017

AMPICILLIN SODIUM Injection, Powder, For Solution [GC Hanford Manufacturing Company]

AMPICILLIN SODIUM Injection, Powder, For Solution [GC Hanford Manufacturing Company]

Updated Date: Nov 1, 2017 EST

US - DailyMed

20-10-2017

AMPICILLIN Injection, Powder, For Solution [Sagent Pharmaceuticals]

AMPICILLIN Injection, Powder, For Solution [Sagent Pharmaceuticals]

Updated Date: Oct 20, 2017 EST

US - DailyMed

31-8-2017

AMPICILLIN (Ampicillin Sodium) Injection, Powder, For Solution [Sandoz GmbH]

AMPICILLIN (Ampicillin Sodium) Injection, Powder, For Solution [Sandoz GmbH]

Updated Date: Aug 31, 2017 EST

US - DailyMed

2-8-2017

AMPICILLIN Injection, Powder, For Suspension [GC Hanford Manufacturing Company]

AMPICILLIN Injection, Powder, For Suspension [GC Hanford Manufacturing Company]

Updated Date: Aug 2, 2017 EST

US - DailyMed

27-7-2017

AMPICILLIN Capsule [PD-Rx Pharmaceuticals, Inc.]

AMPICILLIN Capsule [PD-Rx Pharmaceuticals, Inc.]

Updated Date: Jul 27, 2017 EST

US - DailyMed

26-7-2017

AMPICILLIN Capsule AMPICILLIN Suspension [Par Pharmaceutical]

AMPICILLIN Capsule AMPICILLIN Suspension [Par Pharmaceutical]

Updated Date: Jul 26, 2017 EST

US - DailyMed

29-6-2017

AMPICILLIN (Ampicillin Sodium) Injection, Powder, For Solution [Hospira, Inc]

AMPICILLIN (Ampicillin Sodium) Injection, Powder, For Solution [Hospira, Inc]

Updated Date: Jun 29, 2017 EST

US - DailyMed