Elimination

Following either intravenous or intramuscular administration, 50% of Glycopyrronium Bromide is excreted in the urine in 3 hours in non-uraemic individuals; renal elimination is considerably prolonged in patients with uraemia. Appreciable amounts are excreted in bile. In 48 hours, 85% has been excreted into the urine. About 80% of the excreted amount is as unchanged Glycopyrronium Bromide or active metabolites. Although the elimination half-life of Glycopyrronium Bromide from plasma is within 75 minutes, quantifiable levels may remain up to 8 hours after administration.

5.3 Preclinical safety data

Animal studies on acute toxicity and repeat dose toxicity do not show relevant effects of glycopyrronium bromide in addition to those already described in other sections of the SmPC.

Reproductive toxicity of glycopyrronium bromide has been only insufficiently characterized in animal studies. Data available from rat and mouse studies did not reveal teratogenic effects. Diminished rates of conception and of survival at weaning were observed in rats in a dose-related manner. Studies in dogs suggest that the decreased conception rate may be due to a diminished seminal secretion which is evident at high doses of glycopyrronium bromide. The clinical relevance of these findings is unclear.

6. Pharmaceutical particulars

6.1 List of excipients

Sodium Chloride

Hydrochloric Acid (for pH-adjusment)

Water for Injections

6.2 Incompatibilities

Glycopyrronium Bromide Injection has been shown to be physically incompatible with the following agents commonly used in anaesthetic practice: diazepam, dimenhydrinate, methohexital sodium, pentazocine, pentobarbital sodium and thiopental sodium.

This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.

6.3 Shelf life

2 years

Once opened, use immediately and discard any remaining contents

6.4 Special precautions for storage

This medicinal product does not require any special storage conditions.

6.5 Nature and contents of container

Clear Type I glass ampoules: 10 x 1ml ampoules or 10 x 3ml ampoules packed in a cardboard carton.

Not all pack sizes may be marketed

6.6 Special precautions for disposal and other handling

For single use only. Discard any remaining contents after use.

Glycopyrronium Bromide Injection has been shown to be physically compatible with the following agents commonly used in anaesthetic practice: butorphanol, lorazepam, droperidol and fentanyl citrate, levorphanol tartrate, pethidine hydrochloride, morphine sulphate, neostigmine, promethazine and pyridostigmine.

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

7. Marketing authorisation holder

Martindale Pharmaceuticals Ltd

Bampton Road

Harold Hill

Romford

Essex

RM3 8UG

UK

8. Marketing authorisation number(s)

PL 00156/0115

9. Date of first authorisation/renewal of the authorisation

Date of first authorisation in: 7th September 2007

10. Date of revision of the text

25/02/2018