Disodium Pamidronate 15mg/ml Concentrate for Solution for Infusion, 4ml

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

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Patient Information leaflet Patient Information leaflet (PIL)
09-03-2018
Summary of Product characteristics Summary of Product characteristics (SPC)
20-03-2019

Active ingredient:

Pamidronic acid

Available from:

Wockhardt UK Limited

ATC code:

M05BA; M05BA03

INN (International Name):

Pamidronic acid

Dosage:

15 milligram(s)/millilitre

Pharmaceutical form:

Concentrate for solution for infusion

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Bisphosphonates; pamidronic acid

Authorization status:

Not marketed

Authorization date:

2005-08-26

Patient Information leaflet

                                PACKAGE LEAFLET: INFORMATION FOR THE USER
DISODIUM PAMIDRONATE 15MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
- Keep this leaflet. You may need to read it again.
- If you have further questions, please ask your doctor or nurse.
- This medicine has been prescribed for you only. Do not pass it on to
others. It may harm
them, even if their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor or nurse. This
includes any possible side
effects not listed in this leaflet. See section 4.
The name of your medicine is Disodium Pamidronate 15mg/ml Concentrate
for Solution for
Infusion. In the rest of this leaflet it is called Disodium
Pamidronate.
WHAT IS IN THIS LEAFLET:
1. What Disodium Pamidronate is and what it is used for
2. What you need to know before you are given Disodium Pamidronate
3. How Disodium Pamidronate should be given
4. Possible side effects
5. How to store Disodium Pamidronate
6. Contents of the pack and other information
1. WHAT DISODIUM PAMIDRONATE IS AND WHAT IT IS USED FOR
The active ingredient is called Disodium Pamidronate.
Disodium pamidronate belongs to a group of medicines called
bisphosphonates, which
prevent bones from weakening and breaking.
Disodium Pamidronate is used to treat:
• high blood calcium levels (hypercalcaemia) due to tumours
• holes in the bone and bone pain due to the spread of breast cancer
or bone marrow cancer
(myeloma)
• Paget’s disease of the bone (a chronic bone disorder)
2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN DISODIUM PAMIDRONATE
YOU SHOULD NOT BE GIVEN DISODIUM PAMIDRONATE IF YOU:
• are allergic to Disodium Pamidronate, any other bisphosphonate, or
any of the other
ingredients of this medicine (listed in section 6. ‘Contents of the
pack and other information’)
• are pregnant
• are breast feeding
WARNINGS AND PRECAUTIONS
TALK TO YOUR DOCTOR OR NURSE BEFORE BEING GIVEN DISODIUM PAMIDRONATE

                                
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Summary of Product characteristics

                                HealthProductsRegulatoryAuthority
19March2019
CRN008J4D
Page1of10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
DisodiumPamidronate15mg/mlConcentrateforSolutionforInfusion,4ml.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1mlofconcentratecontains15mgdisodiumpamidronate.
Oneampouleof4mlcontains60mgofdisodiumpamidronate.
Excipient with known effect:
Each4mlampoulecontains24mgsodium.
Forthefulllistofexcipients,seesection6.1.
3 PHARMACEUTICAL FORM
Concentrateforsolutionforinfusion.
Colourlesssolution,freefromparticles.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatmentofconditionsassociatedwithincreasedosteoclastactivity:
○ Tumour-inducedhypercalcaemia
○
Osteolyticlesionsandbonepaininpatientswithbonemetastasesassociatedwithbreastcancerormultiplemyeloma
○ Paget'sdiseaseofbone.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Methodofadministration
Disodiumpamidronateconcentratemustneverbegivenasabolusinjection(seeWarnings).Theconcentrateofdisodium
pamidronateconcentrateinampoulesshouldbedilutedinacalcium-freeinfusionsolution(0.9%SodiumChlorideIntravenous
InfusionB.P.isrecommended)andinfusedslowly.
Theinfusionrateshouldneverexceed60mg/hour(1mg/min),andtheconcentrationofdisodiumpamidronateconcentratein
theinfusionsolutionshouldnotexceed90mg/250mL.Adoseof
90mgshouldnormallybeadministeredasa2-hourinfusion
in250mLinfusionsolution.However,inpatientswithmultiplemyelomaandinpatientswithtumour-inducedhypercalcaemia,
itisrecommendednottoexceed90mgin500m
                                
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Disodium Pamidronate 15mg/ml Concentrate for Solution for Infusion, 4ml