Chester Clinic

 

Prolia.co.uk

Automatic Needle Guard (ANG) Pre-filled Syringe Training GuideIntroduction This ANG pre-filled syringe is used like a conventional syringe. Administer the medication by pushing the plunger all the way down. After delivering the full injection, a needle guard is automatically activated as you release pressure from the plunger, safely covering the injection needle. The ANG pre-filled syringe is disposed of as you would a conventional syringe.
Syringe labelUsed syringe X xx
X
X Exp:
• Ensure that you have read the package leaflet instructions provided with this product before use • For a more comfortable injection, leave the pre-filled syringe at room temperature for about 30 minutes before injecting • Based upon the package leaflet instructions, select and prepare an appropriate injection site ADMINISTER INJECTION & DEPLOY NEEDLE GUARD
Remove grey needle cover.
A Pinch the injection site to create a firm surface.
It is important to keep skin pinched when injecting. X xx
X
X Exp:
Hold the pinch. INSERT needle into skin.
B PUSH plunger with slow and constant pressure until
you feel or hear a "snap". Push all the way down through the snap. X xx
X
X Exp:
It's important to push down through the "snap" to deliver the full dose. C RELEASE your thumb. Then LIFT syringe off skin.
X xx
X
X Exp:
After releasing the plunger, the pre-filled syringe safety guard will safely cover the injection needle. Patient support service sponsored by Discard used pre-filled syringe and other supplies in a sharps disposal container.
29.11.2013 14:52:08

PROLIA (denosumab) Brief Prescribing Information Please refer to the Summary of Product Characteristics which may cause allergic reactions. Interactions: Prolia (SmPC) before prescribing Prolia. Pharmaceutical Form: did not affect the pharmacokinetics of midazolam, which Pre-filled syringe with automatic needle guard containing is metabolized by cytochrome P450 3A4 (CYP3A4). There 60 mg of denosumab in 1 ml solution for injection for are no clinical data on the co-administration of denosumab single use only. Contains sorbitol (E420). Indication: and hormone replacement therapy (HRT), however the Treatment of osteoporosis in postmenopausal women potential for pharmacodynamic interactions would be and in men at increased risk of fractures. Treatment of considered low. Pharmacokinetics and pharmacodynamics bone loss associated with hormone ablation in men with of Prolia were not altered by previous alendronate therapy. prostate cancer at increased risk of fractures. Dosage Fertility, pregnancy and lactation: There are no adequate and Administration: 60 mg Prolia administered as a data on the use of Prolia in pregnant women and it is not subcutaneous injection once every 6 months. Patients must recommended for use in these patients. It is unknown be supplemented with calcium and vitamin D. No dosage whether denosumab is excreted in human milk. A risk/ adjustment required in patients with renal impairment. Not benefit decision should be made in patients who are breast recommended in paediatric patients under 18 years of age. feeding. Animal studies have indicated that the absence of Give Prolia patients the package leaflet and patient reminder RANKL during pregnancy may interfere with maturation card. Contraindications: Hypocalcaemia or hypersensitivity of the mammary gland leading to impaired lactation post- to the active substance or to any of the product excipients. partum. No data are available on the effect of Prolia on Special Warnings and Precautions: Hypocalcaemia: Identify human fertility. Undesirable Effects: The following adverse patients at risk for hypocalcaemia. Hypocalcaemia must reactions have been reported: Very common (≥ 1/10) pain in be corrected by adequate intake of calcium and vitamin D extremity, musculoskeletal pain. Common (≥ 1/100 to < 1/10) before initiation of therapy. Clinical monitoring of calcium urinary tract infection, upper respiratory tract infection, levels is recommended before each dose and, in patients sciatica, cataracts, constipation, abdominal discomfort, predisposed to hypocalcaemia, within 2 weeks after the rash, and eczema. Uncommon (≥ 1/1000 to < 1/100): initial dose. Measure calcium levels if suspected symptoms Diverticulitis, cellulitis, and ear infection. Rare (≥ 1/10,000 of hypocalcaemia occur. Renal Impairment: Patients with to < 1/1,000): Osteonecrosis of the jaw, hypocalcaemia severe renal impairment (creatinine clearance < 30ml/ (including severe symptomatic hypocalcaemia) and min) or receiving dialysis are at greater risk of developing atypical femoral fractures. In the postmarketing setting, hypocalcaemia. Regular monitoring of calcium levels in musculoskeletal pain (including severe cases) rare cases these patients is especially important. Skin infections: of severe symptomatic hypocalcaemia, and rare events of Patients receiving Prolia may develop skin infections hypersensitivity (including rash, urticaria, facial swelling, (predominantly cellulitis) requiring hospitalisation and if erythema and anaphylactic reactions) have been reported. symptoms develop then they should contact a health care Please consult the Summary of Product Characteristics for professional immediately. Osteonecrosis of the jaw (ONJ): a full description of undesirable effects. Pharmaceutical ONJ has been reported rarely with Prolia 60 mg every 6 Precautions: Prolia must not be mixed with other medicinal months. Delay treatment in patients with unhealed open products. Store at 2°C to 8°C (in a refrigerator). Prolia may soft tissue lesions in the mouth. A dental examination be exposed to room temperature (up to 25°C) for a maximum with preventative dentistry and an individual benefit:risk single period of up to 30 days in its original container. Once assessment is recommended prior to treatment with Prolia removed from the refrigerator Prolia must be used within in patients with concomitant risk factors. Refer to the SmPC this 30 day period. Do not freeze. Keep in outer carton for risk factors for ONJ. Patients should be encouraged to to protect from light. Legal Category: POM. Presentation, maintain good oral hygiene, receive routine dental check- Basic Costs and Marketing Authorisation Number: Prolia ups and immediately report oral symptoms during treatment 60 mg: Pack of 1 pre-filled syringe with automatic needle with Prolia. While on treatment, invasive dental procedures guard: £183.00; EU/1/10/618/003. Marketing Authorisation should be performed only after careful consideration and Holder: Amgen Europe B.V., Minervum 7061, NL-4817 ZK avoided in close proximity to Prolia administration. The Breda, The Netherlands. Further information is available management plan of patients who develop ONJ should be from Amgen Limited, 240 Cambridge Science Park, set up in close collaboration between the treating physician Milton Road, Cambridge, CB4 0WD. Prolia is a registered and a dentist or oral surgeon with expertise in ONJ. Atypical trademark of Amgen Inc. Date of PI preparation: June 2015 femoral fracture (AFF): AFF has been reported in patients (Ref: UKIE-P-162-0515-106061) receiving Prolia. Discontinuation of Prolia therapy in patients suspected to have AFF should be considered pending Adverse events should be reported. Reporting forms evaluation of the patient based on an individual benefit risk and information can be found at assessment. Concomitant medication: Patients with rare www.mhra.gov.uk/yellowcard Adverse events should hereditary problems of fructose intolerance should not use also be reported to Amgen Limited on Prolia. Dry natural rubber: The needle cover of the pre-filled +44 (0) 1223 436712 syringe contains dry natural rubber (a derivative of latex) Patient support service sponsored by 1. Prolia® (denosumab) Summary of Product Characteristics and patient leaflet Amgen Ltd, 240 Cambridge Science Park, Milton Road, Cambridge, CB4 0WD, UK.
UKIE-P-162-0615-107893 July 2015 29.11.2013 14:52:22

Source: http://www.prolia.co.uk/HCP/pdf/ANG_HCP_guide_APPROVED_July_2015.pdf