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MEDAC DISODIUM PAMIDRONATE 3MG/ML STERILE CONCENTRATE

Active substance(s): PAMIDRONIC ACID / PAMIDRONIC ACID

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ARTWORK INFORMATION
Product name: Medac Disodium Pamidronate 3 mg/ml (15 mg) Article no.: 87010-VAGB

Corrective action:

Change status: EA

Text version: 01.17

KV01_uma_28.11.16

Template no.: VA_37x37x88_DMC_V01

Format: 37 x 37 x 88 mm

Pharma code: 189

Packaging: folding box

Braille: none

Varnish free area:  (37 x 25 mm)

Colours:  HKS 44

 Pantone 264

KV02_uma_06.12.16

Printing area for variable data: 

Printing area for:
Batch: / EXP:
PC:
SN:
NN:
Data Matrix Code

Pamidronate 3 mg/ml

Medac Disodium

15 mg

Medac Disodium
Medac Disodium
Medac Disodium
Medac Disodium
Pamidronate 3 mg/ml Pamidronate 3 mg/ml Pamidronate 3 mg/ml Pamidronate 3 mg/ml
15 mg

sterile
concentrate

15 mg

Read the package leaflet
before use.

4 037353 900028

sterile
concentrate

For intravenous use.
To be used immediately
after dilution.

sterile
concentrate

15 mg

PL 11587/0027

POM

Vial for single use – discard
any unused solution left over
from the first time of use.
Keep out of the sight
and reach of children.

medac
Gesellschaft für klinische
Spezialpräparate mbH
Theaterstr. 6
22880 Wedel
Germany

sterile
concentrate

15 mg

Pamidronate disodium
One vial contains 5 ml
concentrate for infusion,
in which 15 mg of
pamidronate disodium
corresponding to 12.64 mg
of pamidronic acid.
The solution also contains
sodium hydroxide,
hydrogen chloride acid
and water for injections.

1 vial.

87010-VAGB
01.17
EA

ARTWORK INFORMATION
Product name: Medac Disodium Pamidronate 3 mg/ml (15 mg)

Article no.: 87010-VEGB

Corrective action:

Change status: EA

Text version: 01.17

KV01_uma_28.11.16

Template no.: VE_65x23_V01

Format: 65 x 23 mm

Pharma code: 189

Packaging: Label

Braille: none

Varnish free area: none

 Pantone 264

Batch:

Medac Disodium Pamidronate 15 mg
3 mg/ml, sterile concentrate

EXP:

Pamidronate disodium. For intravenous use. Read the package
leaflet before use. One vial contains 5 ml concentrate for solution for
infusion, in which 15 mg of pamidronate disodium corresponding
to 12.64 mg of pamidronic acid. The solution also contains sodium
hydroxide, hydrogen chloride
acid and water for injections.

87010-VEGB 01.17 EA

Colours:  HKS 44

ARTWORK INFORMATION
Product name: Medac Disodium Pamidronate 3 mg/ml (30 mg) Article no.: 87015-VAGB

Corrective action:

Change status: EA

Text version: 01.17

KV01_uma_28.11.16

Template no.: VA_37x37x88_DMC_V01

Format: 37 x 37 x 88 mm

Pharma code: 196

Packaging: folding box

Braille: none

Varnish free area:  (37 x 25 mm)

Colours:  HKS 44

 HKS 3

KV02_uma_06.12.16

Printing area for variable data: 

Printing area for:
Batch: / EXP:
PC:
SN:
NN:
Data Matrix Code

Pamidronate 3 mg/ml

Medac Disodium

30 mg

Medac Disodium
Medac Disodium
Medac Disodium
Medac Disodium
Pamidronate 3 mg/ml Pamidronate 3 mg/ml Pamidronate 3 mg/ml Pamidronate 3 mg/ml
30 mg

sterile
concentrate

30 mg

Read the package leaflet
before use.

4 037353 900035

sterile
concentrate

For intravenous use.
To be used immediately
after dilution.

sterile
concentrate

30 mg

PL 11587/0027

POM

Vial for single use – discard
any unused solution left over
from the first time of use.
Keep out of the sight
and reach of children.

medac
Gesellschaft für klinische
Spezialpräparate mbH
Theaterstr. 6
22880 Wedel
Germany

sterile
concentrate

30 mg

Pamidronate disodium
One vial contains 10 ml
concentrate for infusion,
in which 30 mg of
pamidronate disodium
corresponding to 25.27 mg
of pamidronic acid.
The solution also contains
sodium hydroxide,
hydrogen chloride acid
and water for injections.

1 vial.

87015-VAGB
01.17
EA

ARTWORK INFORMATION
Product name: Medac Disodium Pamidronate 3 mg/ml (30 mg)

Article no.: 87015-VEGB

Corrective action:

Change status: EA

Text version: 01.17

KV01_uma_28.11.16

Template no.: VE_70x25_V01

Format: 70 x 25 mm

Pharma code: 196

Packaging: Label

Braille: none

Varnish free area: none

 HKS 3

Batch:

Medac Disodium Pamidronate 30 mg
3 mg/ml, sterile concentrate

EXP:

Pamidronate disodium. For intravenous use. Read the package
leaflet before use. One vial contains 10 ml concentrate for
solution for infusion, in which 30 mg of pamidronate disodium
corresponding to 25.27 mg of pamidronic acid.
The solution also contains sodium hydroxide, hydrogen chloride
acid and water for injections.

87015-VEGB 01.17 EA

Colours:  HKS 44

ARTWORK INFORMATION
Product name: Medac Disodium Pamidronate 3 mg/ml (60 mg) Article no.: 87020-VAGB

Corrective action:

Change status: EA

Text version: 01.17

KV01_uma_28.11.16

Template no.: VA_37x37x88_DMC_V01

Format: 37 x 37 x 88 mm

Pharma code: 197

Packaging: folding box

Braille: none

Varnish free area:  (37 x 25 mm)

Colours:  HKS 44

 HKS 7

KV02_uma_06.12.16
KV03_uma_16.12.16

Printing area for variable data: 

Printing area for:
Batch: / EXP:
PC:
SN:
NN:
Data Matrix Code

Pamidronate 3 mg/ml

Medac Disodium

60 mg

Medac Disodium
Medac Disodium
Medac Disodium
Medac Disodium
Pamidronate 3 mg/ml Pamidronate 3 mg/ml Pamidronate 3 mg/ml Pamidronate 3 mg/ml
60 mg

sterile
concentrate

60 mg

Read the package leaflet
before use.

4 037353 900042

sterile
concentrate

For intravenous use.
To be used immediately
after dilution.

sterile
concentrate

60 mg

PL 11587/0027

POM

Vial for single use – discard
any unused solution left over
from the first time of use.
Keep out of the sight
and reach of children.

medac
Gesellschaft für klinische
Spezialpräparate mbH
Theaterstr. 6
22880 Wedel
Germany

sterile
concentrate

60 mg

Pamidronate disodium
One vial contains 20 ml
concentrate for infusion,
in which 60 mg of
pamidronate disodium
corresponding to 50.54 mg
of pamidronic acid.
The solution also contains
sodium hydroxide,
hydrogen chloride acid
and water for injections.

1 vial.

87020-VAGB
01.17
EA

ARTWORK INFORMATION
Product name: Medac Disodium Pamidronate 3 mg/ml (60 mg) Article no.: 87020-VEGB

Corrective action:

Change status: EA

Text version: 01.17

KV01_uma_28.11.16

Template no.: VE_90x30_V01

Format: 90 x 30 mm

Pharma code: 197

Packaging: Label

Braille: none

Varnish free area: none

Batch:

Medac Disodium Pamidronate

EXP:

Pamidronate disodium
One vial contains 20 ml concentrate for infusion, in which 60 mg of pamidronate
disodium corresponding to 50.54 mg of pamidronic acid. The solution also
contains sodium hydroxide, hydrogen chloride acid and water for injections.
To be used immediately after dilution. Read the package leaflet before use.
For intravenous use. Keep out of the sight and reach of children. PL 11587/0027
medac GmbH
Theaterstr. 6 · 22880 Wedel · Germany

3 mg/ml, sterile concentrate

60 mg

EA

 HKS 7

87020-VEGB 01.17

Colours:  HKS 44

KV02_uma_14.12.16

ARTWORK INFORMATION
Product name: Medac Disodium Pamidronate 3 mg/ml (90 mg) Article no.: 87025-VAGB

Corrective action:

Change status: EA

Text version: 01.17

KV01_uma_28.11.16

Template no.: VA_37x37x88_DMC_V01

Format: 37 x 37 x 88 mm

Pharma code: 198

Packaging: folding box

Braille: none

Varnish free area:  (37 x 25 mm)

Colours:  HKS 44

 HKS 13

KV02_uma_06.12.16
KV03_uma_16.12.16

Printing area for variable data: 

Printing area for:
Batch: / EXP:
PC:
SN:
NN:
Data Matrix Code

Pamidronate 3 mg/ml

Medac Disodium

90 mg

Medac Disodium
Medac Disodium
Medac Disodium
Medac Disodium
Pamidronate 3 mg/ml Pamidronate 3 mg/ml Pamidronate 3 mg/ml Pamidronate 3 mg/ml
90 mg

sterile
concentrate

90 mg

Read the package leaflet
before use.

4 037353 900059

sterile
concentrate

For intravenous use.
To be used immediately
after dilution.

sterile
concentrate

90 mg

PL 11587/0027

POM

Vial for single use – discard
any unused solution left over
from the first time of use.
Keep out of the sight
and reach of children.

medac
Gesellschaft für klinische
Spezialpräparate mbH
Theaterstr. 6
22880 Wedel
Germany

sterile
concentrate

90 mg

Pamidronate disodium
One vial contains 30 ml
concentrate for infusion,
in which 90 mg of
pamidronate disodium
corresponding to 75.81 mg
of pamidronic acid.
The solution also contains
sodium hydroxide,
hydrogen chloride acid
and water for injections.

1 vial.

87025-VAGB
01.17
EA

ARTWORK INFORMATION
Product name: Medac Disodium Pamidronate 3 mg/ml (90 mg) Article no.: 87025-VEGB

Corrective action:

Change status: EA

Text version: 01.17

KV01_uma_28.11.16

Template no.: VE_90x50_V01

Format: 90 x 50 mm

Pharma code: 198

Packaging: Label

Braille: none

Varnish free area: none

 HKS 13

Batch:

Medac Disodium Pamidronate 90 mg
3 mg/ml, sterile concentrate

Pamidronate disodium
One vial contains 30 ml concentrate for infusion,
in which 90 mg of pamidronate disodium corresponding
to 75.81 mg of pamidronic acid.
The solution also contains sodium hydroxide,
hydrogen chloride acid and water for injections.
To be used immediately after dilution. Read the package leaflet
before use. For intravenous use.
Keep out of the sight and reach of children. PL 11587/0027
EXP:

medac GmbH
Theaterstr. 6 · 22880 Wedel · Germany

87025-VEGB 01.17 EA

Colours:  HKS 44

KV02_uma_14.12.16

Medac Disodium Pamidronate 3 mg/ml · 87010-VP1GB · EA · 01.17 · Pharma-Code: 189
Format: 888 x 150 mm · HKS 44 · Corrective action: KV01_uma_28.11.16

Package leaflet: Information for the patient

Medac Disodium Pamidronate 3 mg/ml,
sterile concentrate
Pamidronate disodium
Read all of this leaflet carefully before you are given this
medicine because it contains important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor
or pharmacist.
• If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in this leaflet.
See section 4.
What is in this leaflet
1. What Medac Disodium Pamidronate 3 mg/ml is
and what it is used for
2. What you need to know before Medac Disodium
Pamidronate 3 mg/ml is administered to you
3. How Medac Disodium Pamidronate 3 mg/ml
is administered to you
4. Possible side effects
5. How to store Medac Disodium Pamidronate 3 mg/ml
6. Contents of the pack and further information

1. What Medac Disodium Pamidronate 3 mg/ml is
and what it is used for
Medac Disodium Pamidronate 3 mg/ml is a medicine which
affects the formation and destruction of bone in the form of
a solution which can be given as a slow injection via a drip.

Medac Disodium Pamidronate 3 mg/ml is used in three ways:
• It reduces high levels of calcium in the blood caused by
cancers.
• It inhibits bone destruction in patients with spread
of breast cancer to the bones.
• It is used in patients with advanced multiple myeloma
(a tumour of bone marrow cells).

2. What you need to know before Medac Disodium
Pamidronate 3 mg/ml is administered to you
Medac Disodium Pamidronate 3 mg/ml will not be used
• if you are allergic to pamidronate disodium, other
bisphosphonate medicines or to any of the other ingredients
of this medicine (listed in section 6).
• if you are breast-feeding.
Warnings and precautions
Talk to your doctor or pharmacist before you are given
Medac Disodium Pamidronate 3 mg/ml
• if you are pregnant.
• if you are on a controlled sodium diet.
• if you have low levels of blood cells (red blood cells,
white blood cells or platelets).
• if you have undergone thyroid surgery.
• if you have heart problems.
• if you have liver problems.
• if you suffer from kidney disease.
• if you are taking other medicines that can affect the kidneys.
• if you are taking other similar medicines that reduce the
calcium level in blood.
• if you have or have had pain, swelling or numbness of the jaw,
a feeling of heaviness in the jaw or loosening of a tooth.
Your doctor may recommend a dental examination before you
start treatment with Medac Disodium Pamidronate 3 mg/ml.

• if you are having dental treatment or are due to undergo dental
surgery, tell your dentist that you are being treated with Medac
Disodium Pamidronate 3 mg/ml and inform your doctor about
your dental treatment.
While being treated with Medac Disodium Pamidronate 3 mg/ml,
you should maintain good oral hygiene (including regular teeth
brushing) and receive routine dental check-ups.
Contact your doctor and dentist immediately if you experience
any problems with your mouth or teeth such as loose teeth, pain
or swelling, non-healing of sores or discharge, as these could be
signs of a condition called osteonecrosis of the jaw.
Patients who are undergoing chemotherapy and/or radiotherapy,
who are taking steroids, who are undergoing dental surgery,
who do not receive routine dental care, who have gum disease,
who are smokers, or who were previously treated with a
bisphosphonate (used to treat or prevent bone disorders) may
have a higher risk of developing osteonecrosis of the jaw.
Your doctor will monitor serum electrolytes, calcium and
phosphate following the initiation of your therapy with Medac
Disodium Pamidronate 3 mg/ml and he will ensure that you are
well hydrated.
Pamidronate should not be prescribed to you if you are pregnant
unless absolutely necessary.
Other medicines and Medac Disodium Pamidronate 3 mg/ml
Tell your doctor or pharmacist if you are taking, have recently
taken or might take any other medicines.
Some medicines can interfere with your treatment. Please inform
your doctor or pharmacist if you are taking any of the following:
• Other medicines for high calcium levels such as calcitonin.

• Other bisphosphonates.
• Other medicines that may affect the kidneys (your doctor or
pharmacist will know which medicines these are).
• Thalidomide (used to treat some cancers).
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant
or are planning to have a baby, ask your doctor or pharmacist for
advice before taking this medicine.
Pregnancy
If you are pregnant or likely to become pregnant, you should
inform your doctor before you take pamidronate disodium.
Breast-feeding
If you are breast-feeding you must not take pamidronate disodium.
Driving and using machines
Do not drive or use machines
• if you feel sleepy or dizzy following Medac Disodium
Pamidronate 3 mg/ml infusion.
• if you experience any effect that may impair your ability
to drive or use machines.

3. How Medac Disodium Pamidronate 3 mg/ml
is administered to you
Method and routes of administration
Medac Disodium Pamidronate 3 mg/ml is a solution which must
be diluted and is then given to you as a slow injection via a drip.
Medac Disodium Pamidronate 3 mg/ml is administered to you
in a prepared solution given very slowly into the vein via the drip
(intravenous infusion). Your doctor will only use freshly prepared and
clear dilutions and will not use the solution if particles are present.

Pamidronate disodium is given only to adults of 18 years and
above under the supervision of a physician with the facilities to
monitor its effects.
Dosage
The dose of medicine given to you will depend upon your medical
condition, the levels of calcium in your blood and how well your
kidneys are working. The usual dose per treatment course is
between 15 mg and 90 mg. Your doctor will decide how many
infusions you need, how often they will be given and how long the
therapy will be continued.
During treatment you will have blood tests and may be asked
to provide urine samples.
If you have received more Medac Disodium
Pamidronate 3 mg/ml than you should
As this medicine will be given to you whilst you are in hospital
it is unlikely that you will be given too little or too much.
If you experience paraesthesia (pins and needles), tetany (muscle
spasm particularly of the jaw or limbs) and hypotension (feeling
light-headed) during treatment with Medac Disodium Pamidronate
3 mg/ml, you should inform the medical staff who will give you
calcium into the vein to reverse the symptoms. It is unlikely that
these symptoms would occur however during the infusion.
If nevertheless you have received doses higher than those
recommended you will be carefully monitored by your doctor.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although
not everybody gets them. Many of the following side effects may
have been related to your underlying disease.
• Very common (may affect more than 1 in 10 people) side
effects are flu-like symptoms and a mild fever (increase
in body temperature of 1 – 2 °C) which occur within the first
48 hours and usually last no longer than 24 hours. Acute
“influenza-like” reactions usually occur only with the first
Medac Disodium Pamidronate 3 mg/ml infusion given to you.
If these effects happen to you they will usually disappear after you
have received Medac Disodium Pamidronate 3 mg/ml for a while,
so you should be able to continue the therapy. Tell your doctor if
any effect becomes troublesome or lasts a long time.
• Not known (cannot be estimated from the available data):
Pain in the mouth, teeth and/or jaw, swelling or non-healing
sores inside the mouth or jaw, discharge, numbness or a
feeling of heaviness in the jaw, or loosening of a tooth. These
could be signs of bone damage in the jaw (osteonecrosis).
Tell your doctor and dentist immediately if you experience
such symptoms while being treated with Medac Disodium
Pamidronate 3 mg/ml or after stopping treatment.
Cases of bone damage (osteonecrosis) - primarily of the jaw
- have been reported predominantly in cancer patients treated
with bisphosphonates including Medac Disodium Pamidronate
3 mg/ml. Many of these patients had signs of local infection
including bone marrow inflammation (osteomyelitis) and the
majority of the reports refer to cancer patients following tooth
extractions or other dental surgeries. Osteonecrosis of the jaw
has multiple well-documented risk factors including a diagnosis of
cancer, concomitant therapies (e.g. chemotherapy, radiotherapy,

The following information is intended for medical or healthcare
professionals only:
Method of administration
Medac Disodium Pamidronate 3 mg/ml is a concentrate for
solution for infusion and must therefore always be diluted in
a calcium-free infusion solution (0.9 % sodium chloride or 5 %
glucose) before use. The resulting solution must be infused slowly.
Tumour-induced hypercalcaemia
Patients must be adequately rehydrated with 0.9 % w/v sodium
chloride solution before or and during administration of
pamidronate disodium.
The total dose of pamidronate disodium to be used for a
treatment course depends on the patient's initial serum calcium
levels. The following guidelines are derived from clinical data on
uncorrected calcium values. However, doses within the ranges
given are also applicable for calcium values corrected for serum
protein or albumin in rehydrated patients.
Table 1
Initial plasma
calcium level

(mmol/l)

The total dose of pamidronate disodium may be administered
either in a single infusion or in multiple infusions over 2 to
4 consecutive days. The maximum dose per treatment course is
90 mg for both initial and repeat courses. Higher doses did not
improve clinical response.
A significant decrease in serum calcium is generally observed
24 to 48 hours after administration of pamidronate disodium,
and normalisation is usually achieved within 3 to 7 days.
If normocalcaemia is not achieved within this time, a further
dose may be given. The duration of the response may vary from
patient to patient, and treatment can be repeated whenever
hypercalcaemia recurs. Clinical experience to date suggests that
pamidronate disodium may become less effective as the number
of treatments increases.
Osteolytic lesions in multiple myeloma
The recommended dose is 90 mg every 4 weeks.
Osteolytic lesions in bone metastases associated with
breast cancer
The recommended dose is 90 mg every 4 weeks. This dose
may also be administered at 3 weekly intervals to coincide with
chemotherapy if desired.
Treatment should be continued until there is evidence of a
substantial decrease in a patient’s general performance status.

Recommended total
dose of
pamidronate
disodium
(mg)

Concentration of
solution for
infusion

Maximum
infusion
rate

mg/ml

mg/h

Indication

15-30
30-60

30/125
30/125
60/250
60/250
90/500
90/500

22.5
22.5

Bone
metastases

Treatment
scheme
90 mg/2h
every 4 weeks

22.5

Multiple
Myeloma

90 mg/4h
every 4 weeks

< 3.0
3.0-3.5

(mg %)
(mg/100ml)
< 12.0
12.0-14.0

3.5-4.0

14.0-16.0

60-90

> 4.0

> 16.0

90

22.5

Solution for
Infusion rate
infusion (mg/ml) (mg/h)
90/250
45

90/500

22.5

Renal impairment
Medac Disodium Pamidronate 3 mg/ml should not be
administered to patients with severe renal impairment (creatinine
clearance < 30 ml/min) unless in case of life-threatening tumourinduced hypercalcaemia where the benefit outweighs the
potential risk.
As with other intravenous bisphosphonates, monitoring of renal
function is recommended, for instance, measurements of serum
creatinine prior to each dose of pamidronate disodium. In patients
receiving pamidronate disodium for bone metastases or multiple
myeloma who show evidence of deterioration in renal function,
treatment with pamidronate disodium should be withheld until
renal function returns to within 10 % of the baseline value.
This recommendation is based on a clinical study, in which
renal deterioration was defined as follows:
• For patients with normal baseline creatinine,
increase of 0.5 mg/dL.
• For patients with abnormal baseline creatinine,
increase of 1.0 mg/dL.
A pharmacokinetic study conducted in patients with cancer
and normal or impaired renal function indicates that the dose
adjustment is not necessary in mild (creatinine clearance 61 to
90 ml/min) to moderate renal impairment (creatinine clearance
30 to 60 ml/min). In such patients, the infusion rate should not
exceed 90 mg/4h (approximately 20 to 22 mg/h).
Hepatic impairment
A pharmacokinetic study indicates that no dose adjustment is
necessary in patients with mild to moderate abnormal hepatic
function. Pamidronate disodium has not been studied in
patients with severe hepatic impairment. Therefore no specific
recommendations can be given for pamidronate disodium in such
patients.

Medac Disodium Pamidronate 3 mg/ml · 87010-VP1GB · EA · 01.17 · Pharma-Code: 189
Format: 888 x 150 mm · HKS 44 · Corrective action: KV01_uma_28.11.16

Paediatric population
The safety and efficacy of pamidronate disodium in children and
adolescents aged < 18 years have not been established.
The infusion rate should never exceed 60 mg/hour (1 mg/min),
and the concentration of pamidronate disodium in the infusion
solution should not exceed 90 mg/250 ml. A dose of 90 mg must
usually be administered as a 2-hour infusion in a 250 ml solution
for infusion. In patients with multiple myeloma and patients with
tumour-induced hypercalcaemia, it is recommended that the
infusion rate does not exceed 90 mg in 500 ml over 4 hours.
In order to minimise local reactions at the infusion site, the
cannula should be inserted carefully into a relatively large vein.
Pamidronate disodium should be given under the supervision
of a physician with the facilities to monitor the clinical and
biochemical effects.
Use only freshly prepared and clear dilutions!
Incompatibilities
Pamidronate will form complexes with divalent cations and
should not be added to calcium-containing intravenous
solutions.
Solutions of pamidronate disodium are not soluble in lipophilic
nutrition solutions, e. g. soya-bean oil.

Special precautions for disposal and other handling

corticosteroids) and co-morbid conditions (e.g. anaemia,
blood-clotting disorders [coagulopathies], infection, pre-existing
oral disease). You should avoid dental surgery while you are
treated with Medac Disodium Pamidronate 3 mg/ml. If you
have developed osteonecrosis of jaw the dental surgery
may exacerbate the condition. It is unknown whether the
discontinuation of bisphosphonate treatment reduces the risk of
osteonecrosis of jaw in patients requiring dental procedure.

Do not use solution if particles are present.
Any portion of the contents remaining after use should be
discarded.
Medac Disodium Pamidronate 3 mg/ml, concentrate for solution
for infusion is for single use only.
The diluted solution for infusion should be visually inspected and
only clear solutions practically free from particles should be used.

If you develop symptoms such as sudden itchy rash, swelling
of the hands, feet, ankles, face, lips, mouth or throat, difficulty
in swallowing or breathing, this can be a severe allergic
reaction. If any of this happens, tell your doctor immediately.

Shelf life and special precautions for storage
Unopened vial: 4 years
Shelf life after dilution in 5 % glucose solution or in 0.9 % sodium
chloride solution:
chemical and physical in-use stability has been demonstrated
for 96 hours at 25 °C.
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
dilution has taken place in controlled and validated aseptic
conditions.

Pamidronate disodium may affect your blood. Your doctor will
monitor for this with blood tests.
Irregular heart rhythm (atrial fibrillation) has been seen in patients
receiving pamidronate. It is currently unclear whether pamidronate
causes this irregular heart rhythm. You should report to your
doctor if you experience irregular heart rhythm during treatment
with pamidronate.
Unusual fracture of the thigh bone particularly in patients on
long-term treatment for osteoporosis may occur rarely. Contact
your doctor if you experience pain, weakness or discomfort in
your thigh, hip or groin as this may be an early indication of
a possible fracture of the thigh bone.

This medicinal product does not require any special storage
conditions.

Very common (may affect more than 1 in 10 people):
• Low level of calcium and phosphate in the blood.
• Fever and influenza-like symptoms sometimes accompanied
by tiredness, shivering, fatigue and flushing.

The medicinal product must not be mixed with other medicinal
products except those mentioned below.
Must be diluted with 5% glucose solution or 0.9% sodium
chloride solution prior to administration.
The concentration of pamidronate disodium in the infusion
solution should not exceed 90 mg/250 ml.

87010-VP1GB
EA

Common (may affect up to 1 in 10 people):
• Low level of red blood cells (anaemia).
• Low level of platelets in the blood (thrombocytopenia).
• Low level of lymphocytes (type of white blood cells)
in the blood.
• Low level of potassium in the blood.
• Low level of magnesium in the blood.
• Symptoms from low blood calcium levels
(pins and needles, muscle cramps or muscle spasm).
• Headache.
• Inability to sleep (insomnia).
• Condition of being sleepy (somnolence).
• Conjunctivitis (“pinkeye”).
• High blood pressure (hypertension).
• Gastrointestinal reactions such as nausea, vomiting,
loss of appetite (anorexia), abdominal pain, diarrhoea,
constipation as well as inflammation of the stomach (gastritis).
• Rash.
• Episodes of bone, joint or muscle pain.
• Pain, rash and swelling at the drip site,
inflammation or thrombosis of the arm vein, general body pain.
• High levels of serum creatinine.
Uncommon (may affect up to 1 in 100 people):
• Hypersensitivity including wheezing (bronchospasm), difficulty
in breathing (dyspnoea), acute swelling of the eyelids, lips and
tongue (angioneurotic oedema).
• Seizures.
• State of restlessness (agitation).
• Dizziness.
• State of being apathetic (lethargy).
• Inflammation of the uvea of the eye (uveitis).
• Low blood pressure (hypotension).
• Indigestion.
• Skin itching.
• Muscle cramps.

• Reduction in the amount of urine produced (kidney failure).
• Abnormal liver and kidney blood tests.
Rare (may affect up to 1 in 1,000 people):
• Unusual fracture of the thigh bone.
• Change in kidney function known as glomerulosclerosis, some
of the symptoms of this condition may be fluid retention,
nausea and fatigue.
• Protein leak into the urine associated with swelling of the legs
and abdomen (nephrotic syndrome).
Very rare (may affect up to 1 in 10,000 people):
• Further episodes of past infection with cold sores or shingles.
• Decreased number of white blood cells in the blood
(leukopenia).
• Anaphylactic shock (life-threatening allergy with immediate
restlessness, lightheadedness or fainting, breathlessness, drop
in blood pressure or itching).
• Elevated level of potassium in the blood.
• High levels of sodium in the blood (hypernatraemia).
• Confusional state (state of disorientation) due to high blood
sodium levels.
• Confusion or visual hallucinations (seeing things that are not
there).
• Irritation/inflammation of the episclera of the eye which causes
pain and redness (episcleritis).
• Inflammation of the sclera of the eye which causes pain and
redness (scleritis).
• Abnormal visual condition in which everything appears to have
a yellow hue (xanthopsia).
• Worsening of heart failure with difficulty in breathing.
• Severe lung disease (acute respiratory distress syndrome).
• Inflammation of the lung (interstitial lung disease).
• Worsening of existing kidney disease.
• Blood in the urine.
• Kidney inflammation.

• Talk to your doctor if you have ear pain, discharge from the ear,
and/or an ear infection. These could be signs of bone damage
in the ear.
Not known (frequency cannot be estimated from
the available data):
• Irregular heart rhythm (atrial fibrillation).
• Inflammation of structures within the orbit (orbital
inflammation).
• Pain in the mouth, teeth and/or jaw, swelling or non-healing
sores inside the mouth or jaw, discharge, numbness or a
feeling of heaviness in the jaw, or loosening of a tooth. These
could be signs of bone damage in the jaw (osteonecrosis).
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or
nurse. This includes any possible side effects not listed in this
leaflet. You can also report side effects directly via the Yellow
Card Scheme at: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information
on the safety of this medicine.

5. How to store Medac Disodium Pamidronate 3 mg/ml
Keep this medicine out of the sight and reach of children.
This medicine is not used after the expiry date which is stated
on the vial label and carton after “EXP”.
This medicine does not require any special storage conditions.
Shelf life after dilution in 5 % glucose solution or in
0.9 % sodium chloride solution:
Chemical and physical in-use stability has been demonstrated
for 96 hours at 25 °C.

Following dilution, 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 dilution has taken place
in controlled and validated aseptic conditions.

Marketing authorisation holder and manufacturer

6. Contents of the pack and other information

This medicinal product is authorised in the Member States
of the EEA under the following names:
Czech Republic Pamidronate medac 3 mg/ml,
koncentrát pro infuzní roztok
Denmark
Pamifos 3 mg/ml,
koncentrat til infusionsvæske, opløsning
Finland
Pamifos 3 mg/ml,
infuusiokonsentraatti, liuosta varten
France
PAMIDRONATE DE SODIUM MYLAN 3 mg/ml,
solution à diluer pour perfusion
Germany
Pamifos 3 mg/ml
Konzentrat zur Herstellung einer Infusionslösung
Hungary
Pamifos 3 mg/ ml,
koncentrátum oldatos infúzióhoz
Netherlands
Pamipro 3 mg/ml,
concentraat voor oplossing voor infusie
Poland
Pamidronat medac 3 mg/ml
koncentrat do sporządzania roztworu do infuzji
Slovak Republic Pamifos 3 mg/ml, infúzny koncentrát
Sweden
Pamifos 3 mg/ml,
koncentrat till infusionsvätska, lösning
United Kingdom Medac Disodium Pamidronate 3 mg/ml,
sterile concentrate

What Medac Disodium Pamidronate 3 mg/ml contains
• The active substance is pamidronate disodium (from the group
of bisphosphonates).
• The other ingredients are: Sodium hydroxide, hydrochloric acid
and water for injections.
What Medac Disodium Pamidronate 3 mg/ml looks like
and contents of the pack
Medac Disodium Pamidronate 3 mg/ml is presented in glass
containers called vials.
Each millilitre (ml) of solution contains 3 milligrams (mg) of
pamidronate disodium as pamidronic acid 2.527 mg.
The 5 ml vial (available in packs of 1, 4 or 10 vials and in
multipacks of 4 packs each containing 1 vial) contains
15 mg of pamidronate disodium.
The 10 ml vial (available in packs of 1, 4 or 10 vials and in
multipacks of 4 packs each containing 1 vial) contains
30 mg of pamidronate disodium.
The 20 ml vial (available in packs of 1, 4 or 10 vials and in
multipacks of 4 packs each containing 1 vial) contains
60 mg of pamidronate disodium.
The 30 ml vial (available in packs of 1, 4 or 10 vials and in
multipacks of 4 packs each containing 1 vial) contains
90 mg of pamidronate disodium.
Not all pack sizes may be marketed.

medac
Gesellschaft für klinische Spezialpräparate mbH
Theaterstr. 6
22880 Wedel
Germany

This leaflet was last revised in 01/2017.
87010-VP1GB
EA

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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