ALMIRAL Solution for injection / infusion Ref.[28119] Active ingredients: Diclofenac

Posology

Adults

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

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 advised that the alternative buttock be used for the second injection.

Alternatively, one ampoule of 75mg can be combined with other dosage forms of Almiral (tablets or suppositories) up to the maximum daily dosage of 150mg.

Renal colic: One 75mg ampoule intramuscularly. A further ampoule may be administered after 30 minutes if necessary. The recommended maximum daily dose of Almiral is 150mg.

Intravenous infusion

Immediately before initiating an intravenous infusion, Almiral 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.

Almiral must not be given as an intravenous bolus injection.

Two alternative regimens are recommended:

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

The recommended maximum daily dose of Almiral is 150mg.

Paediatric population

Almiral ampoules are not recommended for use in children.

Elderly

Although the pharmacokinetics of diclofenac are not impaired to any clinically relevant extent in elderly patients, non-steroidal 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 be used in frail elderly patients or those with a low body weight (see also section 4.4) and the patient should be monitored for GI bleeding during NSAID therapy.

Renal impairment

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

Hepatic impairment

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

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).

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.

This medicinal product does not require any special temperature storage conditions. Almiral should be stored in the original package. Do not refrigerate or freeze.

Almiral is presented in single use amber type I glass ampoule containing 3 ml of diclofenac sodium 25 mg/ml, in packs of five, ten and one hundred ampoules.

Not all pack sizes may be marketed.

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

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

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