TAKS Solution for injection or infusion Ref.[28266] Active ingredients: Diclofenac

Posology

Adults

Taks ampoules (given im or iv) should not be given for more than two days; if necessary, treatment can be continued with Taks 50mg tablets.

Intramuscular injection

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.

One ampoule once, or in severe cases twice,daily intramuscularly by deep intragluteal injection into the upper outer quadrant. If two injections daily are required, it is recommended that alternate buttocks are used. Alternatively, one ampoule of 75mg can be combined with Almiral 50mg tablets up to the maximum daily dosage of 150mg.

For renal colic, one ampoule (75mg) intramuscularly, a further ampoule may be administered, if necessary, 30 minutes later. The recommended maximum daily dose of Taks is 150mg.

Intravenous infusion

Immediately before initiating an intravenous infusion, Taks must be diluted with 100-500ml of either sodium chloride solution (0.9%) or glucose solution (5%). Both solutions should be buffered with sodium bicarbonate solution (0.5ml 8.4% or 1ml 4.2%). Only clear solutions should be used.

Taks must not be given as an intravenous bolus injection.

Two alternative regimens are recommended:

• treatment of moderate to severe post-operative pain, 75mg should be infused continuously over a period of 30 minutes to 2 hours. If required treatment can be repeated after 4-6 hours not exceeding 150mg within any period of 24 hours.
• prevention of post-operative pain, infuse a loading dose of 25mg-50mg after surgery over 15 minutes to 1 hour, followed by a continuous infusion of 5mg per hour up to the maximum daily dosage (150mg).

The total daily dose, by all routes of administration, should not exceed 150mg.

Elderly

Although the pharmacokinetics of diclofenac are not impaired to any clinically relevant extent in the elderly, nonsteroidal anti-inflammatory drugs should be used with particular caution in such patients who generally are more prone to adverse reactions. In particular it is recommended that the lowest effective dosage should be used, especially in frail elderly patients or those with low body weight (see also section 4.4) and the patient should be monitored for GI bleeding during NSAID therapy.

Hepatic or renal impairment

Diclofenac is contraindicated in patients with severe hepatic or renal impairment (see section 4.3). No specific studies have been carried out in patients with hepatic or renal impairment, therefore, no specific dose adjustment recommendations can be made. Caution is advised when administering diclofenac to patients with mild to moderate hepatic or renal impairment (see section 4.3 and 4.4).

Paediatric population

The use of Taks ampoules is not recommended in children.

Method of administration

Intramuscular injection and intravenous infusion.

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

The recommended maximum daily dose of Taks is 150mg.

Symptoms

There is no typical clinical picture resulting from diclofenac over dosage. Over dosage can cause symptoms such as headache, nausea, vomiting, epigastric pain, gastrointestinal bleeding, diarrhoea, dizziness, disorientation, excitation, coma, drowsiness, tinnitus, fainting or convulsions. In the case of significant poisoning acute renal failure and liver damage are possible.

Therapeutic measures

Patients should be treated symptomatically as required. Within one hour of ingestion of a potentially toxic amount, activated charcoal should be considered. Alternatively, in adults gastric lavage should be considered within one hour of ingestion of potentially toxic amounts. Frequent or prolonged convulsions should be treated with intravenous diazepam. Other measures may be indicated by the patients clinical condition.

3 years.

Taks does not require any special storage conditions, when stored in original package.

Taks solution for injection or infusion is presented in single use amber type 1 glass ampoule containing 3ml of diclofenac sodium 25mg/ml, in packs of five or ten ampoules.

Taks ampoules are for single use. Open with aseptic precautions. Do not mix with other injection solutions.

For preparation of infusion solutions, Taks should be used to freshly prepare the infusion solution which should be used at once. Infusion solutions should not be stored after preparation.