Introduction

Company name: VetaPharma Ltd

Address: Sherburn Enterprise Park

Sherburn-in-Elmet

Leeds

LS25 6NB

Telephone: 01977 680100

Fax: 01977 685111

Email: enquiries@vetapharma.co.uk

Website: www.vetapharma.co.uk

Presentation

Clear, sterile injectable solution. Each ml contains 0.315 mg fentanyl citrate Ph Eur (equivalent to 0.2 mg fentanyl base) and 10 mg fluanisone BP (Vet). Each ml also contains 0.5mg methyl parahydroxybenzoate Ph Eur and 0.05mg propyl parahydroxybenzoate Ph Eur as preservatives.

Uses

Hypnorm is a neuroleptanalgesic for use in mice, rats, rabbits and guinea pigs. Fentanyl is an analgesic of the morphine type. Fluanisone is a neuroleptic of the butyrophenone group.

Satisfactory sedation, immobilisation and analgesia is obtained for minor operations and diagnostic techniques for which muscle relaxation is not required. It may be used in reduced quantities in conjunction with benzodiazepines to produce anaesthesia with muscle relaxation for major surgery.

In common with the use of other anaesthetic agents in small mammals, it is essential to maintain normothermia during any procedure.

Dosage and administration

Hypnorm alone

Mice: 0.01 ml/30 g body weight (0.105 mg/kg body weight fentanyl citrate and 3.333 mg/kg body weight fluanisone) by intraperitoneal injection.

Rats: 0.4 ml/kg body weight (0.126 mg/kg body weight fentanyl citrate and 4 mg/kg body weight fluanisone) by intramuscular or intraperitoneal injection.

Rabbits: 0.5 ml/kg body weight (0.158 mg/kg body weight fentanyl citrate and 5 mg/kg body weight fluanisone) by intramuscular injection.

Guinea pigs: 1 ml/kg body weight (0.315 mg/kg body weight fentanyl citrate and 10 mg/kg body weight fluanisone) by intramuscular injection.

The duration of sedation and immobilisation is approximately 30-60 minutes. Analgesic effects may persist.

Hypnorm-benzodiazepine combinations

Hypnorm and diazepam

Mice: 0.01 ml Hypnorm /30 g body weight (0.105 mg/kg body weight fentanyl citrate and 3.333 mg/kg body weight fluanisone) by intraperitoneal injection with 5 mg/kg body weight diazepam by intraperitoneal injection.

Rats: 0.3ml Hypnorm/kg body weight (0.095 mg/kg body weight fentanyl citrate and 3 mg/kg body weight fluanisone) by intramuscular injection with 2.5 mg/kg body weight diazepam by intraperitoneal injection.

Rabbits: 0.3 ml Hypnorm/kg body weight (0.095 mg/kg body weight fentanyl citrate and 3 mg/kg body weight fluanisone) by intramuscular injection with 2 mg/kg body weight diazepam by intraperitoneal or intravenous injection.

Guinea pigs: 1 ml Hypnorm/kg body weight (0.315 mg/kg body weight fentanyl citrate and 10 mg/kg body weight fluanisone) by intramuscular injection with 2.5 mg/kg body weight diazepam by intraperitoneal injection.

This combination of drugs provides good surgical anaesthesia with muscle relaxation for about 20-40 minutes.

Hypnorm and midazolam

Clinical experience has shown that at appropriate dilutions, midazolam is miscible with Hypnorm. Midazolam 5 mg/ml and Hypnorm are each diluted with an equal volume of Water for Injection prior to mixing. The resulting mixture contains 1.25 mg/ml midazolam, 2.5 mg/ml fluanisone and 0.079 mg/ml fentanyl citrate and is administered as a single intraperitoneal injection.

Mice: 10 ml/kg body weight

Rats: 2.7 ml/kg body weight

Guinea pigs: 8 ml/kg body weight

Rabbits: 0.3 ml Hypnorm/kg body weight (0.095 mg/kg body weight fentanyl citrate and 3 mg/kg body weight fluanisone) by intramuscular injection with 2.0 mg/kg body weight midazolam by intraperitoneal injection.

This combination of drugs provides good surgical anaesthesia with muscle relaxation for about 20-40 minutes.

Contra-indications, warnings, etc

With overdose respiratory depression can occur; in this case administration of a reversing agent and oxygen administration may be required. Narcotic antagonists such as naloxone, or partial agonists such as buprenorphine, may be used as reversing agents.

Do not use in animals intended for human consumption.

No information available on use during pregnancy or lactation.

Keep out of reach of children. For animal treatment only.

Operator warnings

Avoid all contact with skin, eyes and mouth.

Wash off splashes from skin or eyes immediately.

Wash hands and/or exposed skin after use/handling and before eating, drinking or smoking.

In case of accidental self-injection seek medical attention immediately and show the Hypnorm label and/or pack insert to the doctor.

No information is available on use during pregnancy or breast-feeding.

Pharmaceutical precautions

Do not store above 25°C. Following withdrawal of the first dose, use the contents of the vial within 28 days. Discard any unused material. Dispose of any unused product and empty containers in accordance with guidance from your local waste regulation authority.

Legal category

POM-V CD(Sch 2)

Packaging Quantities

1 x 10ml and 5 x 10 ml colourless glass injection vials.

Further information

In common with the use of other anaesthetic agents in small mammals, it is essential to maintain normothermia during any procedure.

Unused product and empty containers should be disposed of in accordance with national requirements.

Marketing authorisation number

Vm21757/4000.

Distributed by

VetaPharma Ltd.

Sherburn Enterprise Park.

Sherburn-in-Elmet.

LEEDS LS25 6NB.

UK.

Tel: +44 (0)1977 680100.

Fax: +44 (0)1977 685111.

E-mail: enquiries@vetapharma.co.uk.

Web: www.vetapharma.co.uk.

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