Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2020 Publisher: Napp Pharmaceuticals Limited, Cambridge Science Park, Milton Road, Cambridge, CB4 0GW, United Kingdom
For the relief of severe pain in cancer.
Palladone injection is indicated in adults and adolescents aged >12 years.
Intravenous injection or infusion.
Subcutaneous injection or infusion.
The medicinal product is to be visually inspected prior to use. Only clear solutions free from particles should be used.
After opening, this medicinal product should be used immediately (please refer to section 6.3).
For instructions on dilution of the medicinal product before administration, see section 6.6.
The dosing of Palladone injection has to be adjusted to the patients' severity of pain and to their individual response. The dose should be titrated until optimum analgesic effect is achieved.
While the dose to be administered should be sufficient to achieve appropriate analgesia, the aim should also be to keep the dose as small as possible in the individual case.
Palladone injection should not be administered longer than absolutely necessary. If long-term treatment is required careful and regular monitoring should control whether and to what degree further treatment is necessary. When a patient no longer requires therapy with hydromorphone, it may be advisable to taper the daily dose gradually to prevent withdrawal symptoms.
Palladone 10 mg/ml is not suitable for initial opioid therapy. This higher strengths may only be used as individual doses in patients who have no longer sufficiently responded to lower doses of hydromorphone preparations (Palladone 2 mg) or comparably strong analgesics within the scope of chronic pain therapy. The reservoir of a pain pump can also be filled with individual doses of 10 mg/ml as the dose control is secured by the pump calibration.
| Age | Bolus | Infusion |
|---|---|---|
| Adults and adolescents (>12 years) | ||
| subcutaneous (s.c.) use | 1-2 mg s.c. every 3-4 hours | 0.15-0.45 mg/h 0.004 mg/kg bodyweight/h |
| intravenous (i.v.) use | 1-1.5 mg i.v. every 3-4 hours to be injected slowly over at least 2-3 minutes | 0.15-0.45 mg/h 0.004 mg/kg bodyweight/h |
| PCA (s.c. and i.v.) | 0.2 mg bolus, stop interval 5-10 min. | |
| Paediatric population (<12 years) | Not recommended | |
The dose should be based on the following ratio: 3 mg of oral hydromorphone is equivalent to 1 mg of intravenously administered hydromorphone. It must be emphasised that this is a guide to the dose required. Inter-patient variability requires that each patient is carefully titrated to the appropriate dose.
Palladone injection is not recommended for use in children under 12 years of age as the safety and efficacy has not yet been established. No data are available.
Elderly patients (as a rule over 75 years) may require a lower dosage than other adults to achieve adequate analgesia.
These patients may require lower doses than other patient groups to achieve adequate analgesia. They should be carefully titrated to clinical effect (see Section 5.2).
Signs of hydromorphone intoxication and overdose include miosis, bradycardia, respiratory depression, hypotension, somnolence progressing to stupor and coma, and pneumonia aspiration. Circulatory failure and deepening coma may occur in more severe cases and may lead to a fatal outcome. Patients should be informed of the signs and symptoms of overdose and to ensure that family and friends are also aware of these signs and to seek immediate medical help if they occur.
In unconscious patients with respiratory arrest intubation and assisted respiration may be required. An opioid antagonist (e.g. naloxone 0.4 mg) should be administered intravenously. Individual administration of the antagonist should be repeated at 2 to 3-minute intervals as necessary.
Close monitoring (at least for 24 hours) is required, since the effect of the opioid antagonist is shorter than that of hydromorphone, so that repeated occurrence of the signs of overdose like respiratory insufficiency are to be expected.
3 years unopened.
After opening, use immediately.
Chemical and physical in-use stability has been demonstrated for 7 days at 4°C, 25°C and 37°C except for diluted solutions in polycarbonate syringes which should not be stored beyond 24 hours (see section 6.6).
From a microbiological point of view, the product should be used immediately. If not used immediately, in use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless opening/dilution has taken place in controlled and validated aseptic conditions.
Do not store above 25°C.
The ampoules should be stored in the outer carton in order to protect from light.
For storage conditions after first opening of the medicinal product, see section 6.3.
Type 1, clear, neutral glass ampoules in packs of 5 × 1 ml ampoules.
No evidence of incompatibility was observed between Palladone injection and representative brands of injectable forms of the following drugs, when stored in high and low dose combinations in polypropylene syringes over a 24 hour period at ambient temperature (25°C).
Hyoscine butylbromide
Hyoscine hydrobromide
Dexamethasone sodium phosphate
Haloperidol
Midazolam hydrochloride
Metoclopramide hydrochloride
Levomepromazine hydrochloride
Glycopyrronium bromide
Ketamine hydrochloride
No evidence of incompatibility was observed between Palladone injection, undiluted or diluted with sodium chloride 9 mg/ml (0.9%) solution for infusion, glucose 50 mg/ml (5%) solution for infusion or water for injections, and representative brands of polypropylene syringes, polyethylene and PVC tubing and PVC or EVA infusion bags.
Incompatibilities were observed with diluted solutions of 50 mg/ml when stored in polycarbonate syringes beyond 24 hours at 25°C. Whereas no evidence of incompatibility was found when the same precautions were stored at 4°C up to 7 days.
Inappropriate handling of the undiluted solution after opening of the original ampoule, or of the diluted solutions may compromise the sterility of the product.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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