AKIS Solution for injection Ref.[6787] Active ingredients: Diclofenac

Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4 Special warnings and precautions for use).

Posology

Adults

AKIS Solution for Injection can be administered either by intramuscular, subcutaneous or. intravenous bolus injection. AKIS is for short-term treatment only and should not be given for more than two days.

For mild and moderate grades of pain a lower dose may be sufficient. A dose of 75 mg may be needed for severe pain such as renal colic. Exceptionally and in severe cases a second dose of 75 mg can be administered after 6 hours. A dose of 150 mg must not be exceeded within any 24 hour period.

If more than one daily injection of AKIS is required, (up to a maximum, daily dose of 150 mg) it is advisable to change the injection area for subsequent injections. If necessary, one injection of AKIS can be used with other dosage forms of diclofenac up to the maximum daily dosage of 150mg.

Special populations

Elderly

The elderly are at increased risk of serious adverse reactions (see section 4.4 and 5.2). If an NSAID is considered necessary, the lowest effective dose should be used and for the shortest possible duration. The patient should be monitored regularly for GI bleeding during NSAID therapy. The recommended maximum daily dose of AKIS Solution for Injection is 150 mg.

Patients with renal impairment

Hydroxypropyl-β-cyclodextrin (HPβCD), an excipient in AKIS Solution for Injection, is mainly eliminated through glomerular filtration. Therefore, patients with severe renal impairment (defined as creatinine clearance below 30 ml/min) should not be treated with AKIS Solution for Injection. (See section 4.4 and 5.2). In patients with renal impairment the lowest effective dose should be used.

Patients with severe hepatic or cardiac failure

AKIS Solution for Injection is contraindicated in patients with severe hepatic or cardiac impairment (see section 4.3). Caution is advised when administering AKIS Solution for Injection to patients with mild to moderate hepatic impairment as well as to patients with a history of hypertension and/or mild to moderate congestive heart failure (see section 4.4). Also, patients with significant risk factors for cardiovascular events (e.g. hypertension, hyperlipidaemia, diabetes mellitus, smoking) should only be treated with diclofenac after careful consideration (see section 4.4).

Paediatric population

The safety and efficacy of AKIS Solution for Injection in children aged 0-18 years has not been established.

Method of administration

AKIS Solution for Injection should only be administered by a healthcare professional. It can be administered intramuscularly or subcutaneously, into clean healthy tissue, or by intravenous bolus injection.

A single ampoule must be used rather than two ampoules to make up a known dose e.g. a single 75 mg injection rather than a 25mg and a 50 mg injection or a 50mg injection rather than two 25 mg injections.

Intramuscularly

The following directions for intramuscular injection must be adhered to in order to avoid damage to a nerve or other tissue at the injection site. A deep intragluteal injection into the upper outer quadrant of the buttock must be administered. If two injections daily are required, it is advised that the alternative buttock be used for the second injection. The product should be injected slowly to minimise local tissue damage.

Subcutaneously

The injection must be administered into the subcutaneous tissue, preferably in the upper part of the gluteus or in the upper part of the thigh. If two injections daily are required, it is advisable to rotate the injection area between the gluteus and the thigh. The needle must be fully introduced into the thickness of the skin fold which forms between the thumb and the index finger. Care should be taken to ensure that a blood vessel has not been entered. The product should be injected slowly and at a steady rate. Keep the skin folded between the fingers during injection.

By intravenous use

AKIS Solution for Injection can be administered by intravenous bolus injection. Two alternative regimens are recommended:

• For the treatment of moderate to severe post–operative pain, 75 mg should be injected intravenously. If necessary, treatment may be repeated after 4 to 6 hours, not exceeding 150 mg within any period of 24 hours.
• For the prevention of post-operative pain, a loading dose of 25 mg to 50 mg administered as a 5 to 60 second intravenous bolus after surgery, followed by additional injections up to a maximum daily dose of 150 mg. If necessary, treatment may be repeated after 4 to 6 hours, not exceeding 150 mg within any period of 24 hours.

AKIS must not be given by intravenous (i.v.) infusion.

Please refer to section 6.6 for instructions for use and handling.

Symptoms

There is no typical clinical picture resulting from diclofenac over dosage. Over dosage can cause symptoms such as vomiting, gastrointestinal haemorrhage, diarrhoea, dizziness, tinnitus or convulsions. In the event of significant poisoning, acute renal failure and liver damage are possible.

Therapeutic measures

Management of acute poisoning with NSAIDs, including diclofenac, essentially consists of supportive measures and symptomatic treatment. Supportive measures and symptomatic treatment should be given for complications such as hypotension, renal failure, convulsions, gastrointestinal disorder, and respiratory depression.

Special measures such as forced diuresis, dialysis or haemo-perfusion are probably of no help in eliminating NSAIDs, including diclofenac, due to the high protein binding and extensive metabolism.

2 years.

The medicinal product must be used immediately after opening any remaining solution must be discarded.

Store below 25°C. Do not refrigerate or freeze.

Store in the original packaging in order to protect from light.

Transparent type I glass ampoule.

Package of 1, 3 and 5 ampoules.

Not all pack sizes may be marketed.

An additional overfill is included in each ampoule to ensure that 1.0 mL of solution can be extracted.

Ampoules: No special requirements.

The product should not be used if crystals or precipitates are observed.

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