Kefamycin Vet.

Primær information

  • Handelsnavn:
  • Kefamycin Vet. intramammær salve
  • Lægemiddelform:
  • intramammær salve
  • Brugt til:
  • Dyr
  • Medicin typen:
  • Allopatiske stof

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  • for den brede offentlighed:
  • Oplysningerne indlægssedlen for dette produkt er i øjeblikket ikke tilgængelig, kan du sende en anmodning til vores kundeservice, og vi vil give dig besked, så snart vi er i stand til at opnå det.


    Anmode informationsbrochure for offentligheden.

Lokation

  • Fås i:
  • Kefamycin Vet. intramammær salve
    Danmark
  • Sprog:
  • dansk

Terapeutisk information

  • Terapeutisk gruppe:
  • Kvæg

Andre oplysninger

Status

  • Kilde:
  • Lægemiddelstyrelsen - Danish Medicines Agency
  • Autorisationsnummer:
  • 00110
  • Sidste ændring:
  • 16-07-2018

Produktresumé

17 June 2016

SUMMARY OF PRODUCT CHARACTERISTICS

for

NanoScan, kit for radiopharmaceutical preparation

1.

NAME OF THE MEDICINAL PRODUCT

NanoScan

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION

Active substance

Human Serum Albumin nano sized colloid 500 micrograms.

At least 95 % of human albumin colloidal particles have a diameter ≤ 80 nm.

NanoScan is prepared from human serum albumin derived from human blood donations

tested according to the EEC Regulations and found non-reactive for:

- hepatitis B surface antigen (HBsAg)

- antibodies to human immunodeficiency virus (anti-HIV 1/2)

- antibodies to hepatitis C virus (anti-HCV)

The radionuclide is not part of the kit.

Excipient(s) with known effects:

Sodium: 0.045 mmol

For the full list of excipients, see section 6.1

3.

PHARMACEUTICAL FORM

Kit for radiopharmaceutical preparation.

White powder.

Powder for solution for injection.

To be reconstituted with sodium pertechnetate (

Tc) solution for injection.

4.

CLINICAL PARTICULARS

4.1 Therapeutic indications

This medicinal product is for diagnostic use only.

After radiolabelling with sodium (

Tc) pertechnetate solution, the solution obtained is

indicated in adults, children aged 1 to 18 years and neonates for:

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Intravenous administration:

Bone marrow scanning (The product is not suitable to study the haematopoietic

activity of the bone marrow)

Inflammation scanning in areas other than the abdomen

Subcutaneous administration:

Conventional lymphoscintigraphy to demonstrate integrity of the lymphatic system

and differentiation of venous from lymphatic obstruction

Sentinel node detection in:

Melanoma malignum

Breast cancer

4.2

Posology and method of administration

Posology

Recommended activities in adults are as follows:

Bone marrow scanning: 185-500 MBq as a single intravenous injection.

Inflammation scanning: 370-500 MBq as a single intravenous injection.

Subcutaneous administration:

Conventional lymphoscintigraphy: The recommended activity by single or multiple

subcutaneous injection ranges from 18.5 - 110 MBq per injection site and depends on

the anatomical areas to be investigated and upon the time interval between injection and

imaging. The injected volume should not exceed 0.2 - 0.3 ml. A maximum volume of

0.5 ml per injection is critical.

Sentinel node detection:

Malignant Melanoma: Total activity applied 40 – 100MBq by single or multiple

injection. Other activities can be used in special circumstances and/or conditions.

The volume per injection should be 0.05 – 0.2 ml. At least 4 injections should be

made using an aliquot of the suggested total activity. The injection should be made

intradermally or peritumoral

Breast Cancer: Total activity applied 100 – 200MBq by single or multiple injection.

Other activities can be used in special circumstances and/or conditions. The injected

activity varies depending on the time elapsed between the scintigraphic imaging and

surgery. The volume per injection should be 0.2 – 1.0 ml. The injection should be

made as 1 application when using subdermal and/or subareolar technique and 4

applications should be made when applied peritumoral and/or circum areolar.

Paediatric population

The use in children and adolescents has to be considered carefully, based upon clinical

needs and assessing the risk/benefit ratio in this patient group. The activities to be

administered

children

adolescents

calculated

according

recommendations of the Paediatric Task Group of EANM from the body weight according

to the following table.

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Fraction of adult dose:

3 kg = 0.10

22 kg = 0.50

42 kg = 0.78

4 kg = 0.14

24 kg = 0.53

44 kg = 0.80

6 kg = 0.19

26 kg = 0.56

46 kg = 0.82

8 kg = 0.23

28 kg = 0.58

48 kg = 0.85

10 kg = 0.27

30 kg = 0.62

50 kg = 0.88

12 kg = 0.32

32 kg = 0.65

52-54 kg = 0.90

14 kg = 0.36

34 kg = 0.68

56-58 kg = 0.92

16 kg = 0.40

36 kg = 0.71

60-62 kg = 0.96

18 kg = 0.44

38 kg = 0.73

64-66 kg = 0.98

20 kg = 0.46

40 kg = 0.76

68 kg = 0.99

In very young children (up to 1 year) a minimum dose of 20 MBq (bone marrow scanning)

is necessary in order to obtain images of sufficient quality.

Method of administration:

This medicinal product should be reconstituted before administration to the patient. For

instructions on reconstitution of the medicinal product before administration, see section

This agent is not intended for regular or continuous administration.

Image acquisition

Bone marrow scanning: Images may be acquired 45-60 minutes after administration.

Inflammation scanning: Dynamic imaging is performed immediately. Static imaging

comprises an early phase, 15 minutes post-injection and a washout phase, 30-60 minutes

post-injection.

Conventional lymphoscintigraphy: The injection is given subcutaneously, after

checking by aspiration, that a blood vessel has not been inadvertently punctured. When

imaging the lower limbs, dynamic pictures are taken immediately following injection

and static imaging 30-60 minutes later. In parasternal lymph scanning, repeated

injections and additional images may be required.

Sentinel node detection:

Malignant Melanoma: Lymposcintigraphic images are obtained starting after

injection and regularly thereafter until the SLN is visualized.

Breast Cancer: Scintigraphic scans of breast and axillary region can be acquired 15-

30 min and 3 hours after injection.

4.3

Contraindications

Hypersensitivity to the active substance(s), to any of the excipients listed in section 6.1 or

to any of the components of the labelled radiopharmaceutical. In particular, the use of

Tc-human albumin colloidal particles is contra-indicated in persons with a history of

hypersensitivity to products containing human albumin. During pregnancy,

lymphoscintigraphy involving the pelvis is strictly contraindicated due to the accumulation

in lymph nodes.

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4.4

Special warnings and precautions for use

The preparation without reconstitution with sodium

Tc-pertechnetate must not be

administered to patients.

Potential for hypersensitivity or anaphylactic reactions

If hypersensitivity or anaphylactic reactions occur, the administration of the medicinal

product must be discontinued immediately and intravenous treatment initiated, if

necessary. To enable immediate action in emergencies, the necessary medicinal products

and equipment such as endotracheal tube and ventilator must be immediately available.

Individual benefit/ risk justification

For each patient, the radiation exposure must be justifiable by the likely benefit. The

activity administered should in every case be as low as reasonably achievable to obtain the

required diagnostic information.

It cannot be administered to pregnant or lactating mothers or patients less than 18 years of

age except when the value of the desired clinical information exceeds the risk of the

radiation burden incurred by the patient. With women of child- bearing potential, the

investigation should be performed during the first 10 days after the onset of menses.

Pregnancy, see section 4.6

Lymphoscintigraphy is not advised in patients with total lymphatic obstruction because of

the potential radiation hazard at injection sites. The subcutaneous injection must be made

without pressure into loose connective tissue.

Renal impairment and hepatic impairment

Careful consideration of the benefit risk ratio in these patients is required since an

increased radiation exposure is possible.

Paediatric population

For information on the use in paediatric population, see section 4.2. or 5.1.

Careful consideration of the indication is required since the effective dose per MBq is

higher than in adults (see section 11).

Adolescents, see section 4.2

Patient preparation

The patient should be well hydrated before the start of the examination and urged to void

as often as possible during the first hours after the study in order to reduce radiation.

Specific warnings

It is strongly recommended that the product name and batch number are stated every time

Tc- albumin nanocolloid is given to a patient, in order to maintain a connection between

the patient and the products batch number.

Standard measures for preventing transmission of infections from pharmaceuticals made of

human blood or plasma, include selection of donators, test of individual donators and

plasma pools for finding specific infective agents, and effective manufacturing steps for

inactivation/elimination of virus as a part of manufacturing process as well. In spite of that,

the risk of transmission of infectious agents cannot be eliminated completely, as long as

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pharmaceuticals made of human blood or plasma are used. This also applies to new virus

of unknown nature and other pathogens as well.

There are no reports of virus transmission in connection with albumin, made in accordance

with specifications in Ph. Eur. and in accordance with routine processes.

The human albumin contained in Nanoscan corresponds to the requirements "Note for

Guidance on Plasma Derived Products", CPMP / BWP / 269/95, rev. 2. For the production

of NanoScan only human albumin of plasma of donators was used whose blood on the

occasion of every donation was checked individually with suitable methods for HBsAg and

antibody against HIV-1, HIV-2 and HCV and was found not reactive. Blood or plasma of

donators from a land in which several cases vCJK have appeared is not used for the

production of the human albumin.

This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially

‘sodium-free’.

Precautions with respect to environmental hazard see section 6.6.

4.5

Interaction with other medicinal products and other forms of interaction

Interaction studies have only been performed in adults.

Iodinated contrast media used in lymphoangiography may interfere with lymphatic

scanning using

Tc-NanoScan.

4.6

Pregnancy and lactation

Women of childbearing potential

When an administration of radiopharmaceuticals to a women of childbearing potential is

intended, it is important to determine whether or not she is pregnant. Any woman who has

missed a period should be assumed to be pregnant until proven otherwise. If in doubt about

her potential pregnancy (if the woman has missed a period, if the period is very irregular,

etc.), alternative techniques, not using ionising radiation (if there are any) should be

offered to the patient.

Pregnancy

The subcutaneous administration of

Tc-NanoScan 500micrograms for

lymphoscintigraphy is strictly contraindicated during pregnancy due to the possible

accumulation in pelvic lymph nodes (see section 4.3).

Radionuclide procedures carried out on pregnant women also involve radiation dose to the

foetus. Only essential investigations should therefore be carried out during pregnancy,

when the likely benefit far exceeds the risk incurred by the mother and foetus. An

intravenous dose of 500 MBq of

Tc-NanoScan 500 micrograms, gives rise to an

estimated uterus exposure of 0.9 mGy. An uterus exposure above 0.5 mGy is regarded as a

potential risk to the foetus.

Breast-feeding

Before administering radiopharmaceuticals to a mother who is breast-feeding consideration

should be given to the possibility of delaying the administration of radionuclide until the

mother has ceased breastfeeding, and to what is the most appropriate choice of

radiopharmaceuticals, bearing in mind the secretion of activity in breast milk. If the

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administration is considered necessary, breastfeeding should be interrupted for 13 hours

and the expressed feeds discarded.

4.7

Effects on ability to drive and use machines

NanoScan has no or negligible influence on the ability to drive and use machines.

4.8

Undesirable effects

The following table presents how the frequencies are reflected in this section:

Very common (

1/10)

Common (

1/100 to <1/10)

Uncommon (

1/1,000 to <1/100)

Rare (

1/10,000 to <1/1,000)

Very rare (<1/10,000), not known (cannot be estimated from available data)

Congenital, familial and genetic

disorders

Frequency not known

Hereditary defects.

Neoplasms benign, malignant and

unspecified (including cysts and polyps)

Frequency not known

Cancer induction.

Immune system disorders

Rare

Frequency not known

Protein allergic (hypersensitive)

reaction

Hypersensitivity reactions (including

very rare life-threatening anaphylaxis).

Exposure to ionising radiation is linked with cancer induction and a potential for

development of hereditary defects. As the effective dose is 2.3 mSv when the maximal

recommended activity of 500 MBq is administered these adverse events are expected to

occur with a low possibility.

When a protein-containing radiopharmaceutical such as

Tc-NanoScan is administered to

a patient, hypersensitivity reactions may develop.

Adequate medication and reanimation equipment must therefore always be kept available

during the investigation.

For safety with respect to transmissible agents, see section 4.4.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is

important. It allows continued monitoring of the benefit/risk balance of the medicinal

product. Healthcare professionals are asked to report any suspected adverse reactions via

Lægemiddelstyrelsen

Axel Heides Gade 1

DK-2300 København S

Websted: www.meldenbivirkning.dk

E-mail: dkma@dkma.dk

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4.9

Overdose

The risk of overdose lies in an unintentional high exposure to ionising radiation.

In the event of an overdose of radioactivity being administered when using 99mTc albumin

nanocolloid, no practical measure can be recommended to satisfactorily diminish tissue

exposure as the label is poorly eliminated in urine and faeces.

5.

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties

Pharmacotherapeutic group: Technetium (

Tc), particles and colloids

ATC code: V09DB01

At the chemical concentrations and activities used for diagnostic procedures

NanoScan does not appear to exert any pharmacodynamic effects.

5.2

Pharmacokinetic properties

The NanoScan 500micrograms colloidal product produced from human serum albumin

consists of particles in 95%, below 80 in size.

Distribution

Reticuloendothelial cells in liver, spleen as well as in bone marrow are responsible for

blood clearance after intravenous injection. A small fraction of

Tc radioactivity passes

through kidneys and is eliminated in urine.

The maximum concentration in the liver and spleen is reached after about 30 minutes, but

in the bone marrow after only 6 minutes.

The proteolytic breakdown of the colloid begins immediately after its uptake by the RES,

the products of degradation being excreted through the kidneys into the bladder.

Organ uptake

After subcutaneous injection into connective tissue, 30-40 % of the administered

NanoScan 500micrograms (colloidal particles in 95%, below 80 nm) are filtered into

lymphatic capillaries whose main function is the drainage of proteins from the interstitial

fluid back into the blood pool.

Tc-albumin colloidal particles are then transported along the lymphatic vessels to

regional lymph nodes and main lymphatic vessels, and are finally trapped into the reticular

cells of functionary lymph nodes.

Elimination

A fraction of the injected dose is phagocytized by histiocytes at the injection site. Another

fraction appears in the blood and accumulates mainly in the RES of the liver, spleen and

bone marrow; faint traces are eliminated via the kidneys.

5.3

Preclinical safety data

Non-clinical data reveal no special hazard for humansbased on studies of single-dose

toxicity.

Studies of genotoxicity, carcinogenicity and toxicity to reproduction have not been

performed.

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6.

PHARMACEUTICAL PARTICULARS

6.1

List of excipients

Stannous(II) Chloride dihydrate

Glucose monohydrate

Sodium dihydrogen phosphate dihydrate, di-Sodium hydrogen phosphate dihydrate

Nitrogen

Hydrochloric acid

Sodium hydroxide

6.2

Incompatibilities

None known.

This medicinal product must not be mixed with other medicinal products except those

mentioned in section 6.6 and 12.

6.3

Shelf life

18 months.

Shelf-life after radiolabelling: 8 hours.

Do not store above 25 °C after radiolabelling.

6.4

Special precautions for storage

Do not store above 25 °C.

Store in the original package in order to protect from light.

Storage of radiopharmaceuticals should be in accordance with national regulation on

radioactive materials.

For storage conditions after reconstitution and radiolabelling of the medicinal product, see

section 6.3.

6.5

Nature and contents of container

8 ml colourless, Type I, brosilicate glass multi-dose vials, closed with chlorobutyl rubber

stopper and plastic-aluminium caps (polypropylene-aluminium caps) with turned up edge.

Packsizes

1 pack contains 6 vials.

Sample package: 2 vials.

Bundle pack of 2 packs of 6 vials.

Bundle pack of 4 packs of 6 vials.

Not all pack sizes may be marketed.

6.6

Special precautions for disposal and other handling

General warnings

Radiopharmaceuticals should be received, used and administered only by authorised

persons in designated clinical settings. Their receipt, storage, use, transfer and disposal are

subject to the regulations and/or appropriate licensees of the competent official

organization.

Radiopharmaceuticals should be prepared in a manner which satisfies both radiation safety

and pharmaceutical quality requirements. Appropriate aseptic precautions should be taken.

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Contents of the vial are intended only for use in the preparation of

Tc-NanoScan and are

not to be administered directly to the patient without first undergoing the preparative

procedure.

For instructions on reconstitution of the medicinal product before administration, see

section 12.

If at any time in the preparation of this product the integrity of this vial is compromised it

should not be used.

Technetium (99mTc)-labelled NanoScan must be handled with care and appropriate safety

measures should be used to minimise radiation exposure to clinical staff. Care should also

be taken to minimise radiation exposure to the patient, consistent with proper patient

management.

The content of the kit before extemporary preparation is not radioactive. However, after

reconstitution with sodium pertechnetate (99mTc) Injection, Ph. Eur. is added, adequate

shielding of the final preparation must be maintained.

The administration of radiopharmaceuticals creates risks for other persons from external

radiation or contamination from spill of urine, vomiting etc. Radiation protection

precautions in accordance with national regulations must therefore be taken.

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

requirements.

7.

MARKETING AUTHORISATION HOLDER

Radiopharmacy Laboratory Ltd.

Gyár st. 2

2040 Budaörs

Hungary

8.

MARKETING AUTHORISATION NUMBER(S)

02248

9.

DATE OF FIRST AUTHORISATION

6 September 2011

10.

DATE OF REVISION OF THE TEXT

17 June 2016

11.

DOSIMETRY

Technetium (

Tc) is produced by means of a (

Tc) generator and decays with the

emission of gamma radiation with a mean energy of 140 keV and a half-life of 6.02 hours

to technetium (

Tc) which, in view of its long half-life of 2.13 x 10

years can be regarded

as quasi stable.

The radiation doses absorbed by a patient weighing 70 kg, after intravenous injection of

Tc-human albumin colloidal particles, are reported hereafter.

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Adult and Children Category

Estimated Absorbed Radiation Dose after administration of

Technetium

99m

Tc NanoScan injection

Absorbed doses

Organs

ADULT

MGY/MB

CHILD

Newborn

mGy/MB

q

15yrs

mGy/MBq

10yrs

mGy/MBq

5yrs

mGy/MB

q

1yr

mGy/MB

q

Adrenals

0.00631

0.00771

0.0114

0.0163

0.0282

0.059

Bladder wall

0.00996

0.0132

0.0186

0.0275

0.050

0.111

Bone surfaces

0.00568

0.00686

0.0109

0.0163

0.0361

0.0957

Brain

0.00334

0.00417

0.00677

0.0109

0.0192

0.043

Breast

0.00305

0.00387

0.00563

0.00889

0.0168

0.038

Gall bladder wall

0.00808

0.0101

0.0152

0.0227

0.0314

0.073

Gastrointestinal tract.

Stomach

0.00493

0.0066

0.0106

0.0152

0.0266

0.0568

Intestin

0.00551

0.00688

0.0105

0.0161

0.0277

0.0587

Intestinal wall upper colon

0.00557

0.00722

0.0108

0.0173

0.0282

0.0601

Intestinal wall, lower colon

0.0052

0.00656

0.0103

0.0149

0.0269

0.0534

Myocardium

0.00532

0.00669

0.0099

0.0146

0.0255

0.0545

Kidneys

0.00541

0.00664

0.0101

0.015

0.0255

0.0547

Liver

0.016

0.0203

0.0302

0.0422

0.0756

0.161

Lung

0.00468

0.00599

0.0087

0.0131

0.0232

0.0498

Muscles

0.00396

0.00491

0.00740

0.0112

0.0207

0.0466

Ovaries

0.00575

0.00651

0.0115

0.0181

0.0207

0.0466

Pancreas

0.00637

0.00798

0.0119

0.018

0.0308

0.0636

Red bone marrow

0.00572

0.00663

0.0103

0.0168

0.034

0.0957

Skin

0.00269

0.00323

0.00514

0.00820

0.0152

0.0359

Spleen

0.00411

0.00544

0.00827

0.0121

0.0209

0.0453

Testes

0.00349

0.00558

0.00783

0.011

0.0194

0.0438

Thymus

0.0042

0.00533

0.00779

0.012

0.0215

0.0466

Thyroid

0.00405

0.00514

0.00814

0.013

0.0231

0.0495

Uterus

0.00582

0.00716

0.0109

0.0164

0.0285

0.0589

Effective Dose per unit

activity administered

(mSv/MBq)

0.00624

0.00764

0.0147

0.0205

0.0341

0.0732

Dose calculations were made with the standard MIRD method (MIRD Pamphlet No.1,

Society of Nuclear Medicine, 1976). The Effective Dose Equivalence (EDE) was

determined as specified in ICRP 80 (Ann. ICRP 18 (1-4), 1988). This value varied as

follows: 6.24x10

mSv/MBq for adults and 7.64x10

mSv/MBq, 1.47x10

mSv/MBq,

2.05x10

mSv/MBq, 3.41x10

mSv/MBq and 7.32x10

mSv/MBq respectively, for

children aged 15, 10, 5 and 1 years and for newborns.

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Pregnancy Category

Estimated Absorbed Radiation Dose after administration of

Technetium

99m

Tc-NanoScan injection

Organs

Pregnant

women

mGy/MBq

DURATION OF PREGNANCY

3 months

mGy/MBq

6 months

mGy/MBq

9 months

mGy/MBq

Adrenals

0.00205

0.00205

0.00203

0.00203

Bladder wall

0.000081

0.000081

0.000088

0.000082

Bone surfaces

0.00304

0.00304

0.00304

0.00304

Brain

0.000103

0.000103

0.000103

0.000103

Breast

0.358

0.358

0.358

0.358

Gall bladder wall

0.00147

0.00147

0.00161

0.00161

Gastrointestinal tract.

Stomach

0.00268

0.00268

0.00331

0.00331

Intestin

0.00032

0.00032

0.00057

0.00193

Intestinal wall upper colon

0.00049

0.00049

0.00159

0.00178

Intestinal wall, lower colon

0.000117

0.000117

0.000360

0.000270

Myocardium

0.020

0.020

0.0211

0.0211

Kidneys

0.00082

0.00082

0.00081

0.00081

Liver

0.00293

0.00293

0.00344

0.00344

Lung

0.00811

0.00811

0.00839

0.00839

Muscles

0.00174

0.00174

0.00175

0.00180

Ovaries

0.000117

0.000117

0.000139

0.000142

Pancreas

0.00257

0.00257

0.00253

0.00253

Red bone marrow

0.00189

0.00189

0.00189

0.00189

Skin

0.00278

0.00278

0.00288

0.00293

Spleen

0.00172

0.00172

0.00171

0.00171

Thymus

0.0103

0.0103

0.00916

0.00916

Thyroid

0.00124

0.00124

0.00125

0.00125

Uterus

0.000127

0.000126

0.000641

0.000830

Foetus

0.000158

0.000580

0.000710

Placenta

0.00126

0.00156

Effective Dose per unit activity

administered (mSv/MBq)

0.0574

0.0574

0.0576

0.0576

Dose calculations were made with the standard MIRD method (MIRD Pamphlet No.1,

Society of Nuclear Medicine, 1976).The Effective Dose Equivalence (EDE) was

determined as specified in ICRP 80 (Ann. ICRP 18 (1-4), 1988). This value varied as

follows: 5.74x10

mSv/MBq for women and 5.74x10

mSv/MBq, 5.76x10

mSv/MBq

and 5.76x10

mSv/MBq respectively, for pregnant women in 3, 6 or 9-months.

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Intratumoral application

Estimated Absorbed Radiation Dose after subcutaneous administration of

Technetium

99m

Tc-NanoScan injection

Biokinetic model

The typical procedure is to inject about 20 MBq

Tc-colloid immediately adjacent to the

breast tumour that is later to be removed. The patient is investigated with a gamma camera

4 hours after injection and then operated on for the removal of the tumour very shortly

afterwards. If no uptake of

Tc in the lymph nodes is seen on the scan, the tumour, plus

the site(s) of injection of the radioactivity, is removed surgically. If lymph node uptake of

activity is found, a more radical operation is performed. In either situation the injected

Tc-colloid is removed in its entirety by about 6 hours after injection (this may be

extended to 18 hours in some circumstances). The only significant radiation absorbed dose

is that to surrounding tissues, mainly lung, as a result of irradiation from the local deposit

of radionuclide in the breast during the few hours of exposure. This dose is considered to

be generally very small.

Current ICRP dosimetric models do not permit calculations of dose from breast as a source

organ, and because the doses are likely to be very small the TG does not consider it

necessary to develop a new dosimetric model in which breast is treated as a source organ.

Leakage of radionuclide from the injection site into the systemic circulation is not

considered likely; anyhow, such leakage would be covered by the existing

Tc-colloid

model.

Organs

6 HOURS TO REMOVAL

18 HOURS TO REMOVAL

Adult

15 years

Adult

18 years

Adrenals

0.00079

0.00093

0.0014

0.0016

Bladder wall

0.000021

0.000039

0.000036

0.000068

Bone surfaces

0.0012

0.0015

0.0021

0.0026

Brain

0.000049

0.000058

0.000087

0.00010

Breast

0.0036

0.0039

0.0064

0.0069

Gall bladder wall

0.00053

0.00072

0.00093

0.0013

Gastrointestinal tract.

Stomach

0.00092

0.0013

0.0016

0.0023

0.00011

0.00015

0.0002

0.00027

Colon

0.000083

0.00019

0.00014

0.00033

Intestinal wall upper colon

0.00012

0.00028

0.00020

0.00049

Intestinal wall, lower colon

0.000038

0.00007

0.000066

0.00012

Heart

0.0041

0.0052

0.0071

0.0091

Kidneys

0.00031

0.00042

0.00054

0.00073

Liver

0.0011

0.0014

0.0019

0.0024

Lung

0.0036

0.0039

0.0064

0.0069

Muscles

0.00066

0.00083

0.0012

0.0015

Oesophagus

0.0036

0.0050

0.0062

0.0087

Ovaries

0.000041

0.000048

0.000071

0.000083

Pancreas

0.00097

0.0011

0.0017

0.0020

Red bone marrow

0.00086

0.00092

0.0015

0.0016

Skin

0.0012

0.0014

0.0021

0.0024

Spleen

0.00068

0.00083

0.0012

0.0015

00110_spc.docx

Page 12 of 15

Thymus

0.0036

0.0050

0.0062

0.0087

Thyroid

0.00047

0.00062

0.00082

0.0011

Uterus

0.000041

0.000064

0.000071

0.00011

Remaining organs

0.00066

0.00083

0.0012

0.0015

Effective Dose per unit activity

administered (mSv/MBq)

0.0012

0.0014

0.0020

0.0024

12.

INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS

The preparation contains no bacteriostatic preservative.

Tc-NanoScan is to be used within eight (8) hours from reconstitution. The vial is

reconstituted with an activity ranging from 185MBq to 5.5 GBq of oxidant-free sterile

Sodium (

Tc) pertechnetate. As with any pharmaceutical product, if at any time in the

preparation of this product the integrity of this vial is compromised it should not be used.

In children, it is possible to dilute the product up to 1:50 with sodium chloride for

injection.

This agent is not intended for regular or continuous administration.

Instruction for Preparation of

99m

Tc-NanoScan

Use aseptic procedure throughout and take precautions to minimize radiation exposure by

the use of suitable shielding. Water-proof gloves should be worn during the preparation

procedure.

1.

Remove the protective disc from the vial and swab the closure with an alcohol swab.

2.

Place the vial in a suitable lead vial shield which has a minimum wall thickness of 3

mm (1/8 inch) and which has a fitted lead cap. Obtain 1-5 ml of sterile, non-pyrogenic,

addictive-free Sodium pertechnetate (

Tc) Injection Ph.Eur. (activity: 185 MBq to

5.5 GBq) using shielded syringe.

3.

Add the Sodium Pertechnetate (

Tc) solution to the vial, while avoiding the build-up

of excessive pressure in the vial. Pressure build-up may be avoided by injecting

several millilitres of pertechnetate solution into the vial, then withdrawing several

millilitres nitrogen gas (present to prevent oxidation of the complex) into the syringe.

The procedure is repeated as necessary until the entire amount of pertechnetate is

added to the vial and normal pressure is established within the vial.

4.

Place the lead cap on the vial shield and mix the contents of the shielded vial by

repeated gentle inversion until all the material is suspended. . Than allow standing for

20 minutes at room temperature (15-25° C). Using proper shielding, the vial should be

visually inspected to ensure that the suspension is free of foreign matter before

proceeding, if it is not, the radiopharmaceutical should not be used.

5.

Assay the product in a suitable calibrator, record the radioassay information on the

label which has a radiation warning symbol. Also note the time and date of

preparation. Apply the label to the vial shield.

6.

The radiochemical purity of the finished product should be determined prior the

patient administration. The radiochemical purity should not be less than 95%

00110_spc.docx

Page 13 of 15

7.

Withdrawals for administration must be made aseptically using sterile needle and

syringe. Since the vials contain nitrogen, the vials should not be vented. If repeated

withdrawals are made, the replacement of the contents of the vial with air should be

minimized.

8.

The finished preparation should be discarded after 8 hours. It should also be retained

during its life in a lead vial shield with the lead cap in place. Do not store the labelled

product above +25

9.

After reconstitution the container and any unused contents should be disposed of in

accordance with local requirements for radioactive materials.

Instruction for Quality Control

The quality of labelling (radiochemical purity) can be controlled according to the following

procedure:

Method “A”

Materials

ITLC-SG

9 g/L solution of sodium chloride

Capintec or equivalent instrument for measuring radioactivity in the 0.01 MBq-6 GBq

range. The resolution value is 0.001 MBq

1 ml syringe with a 22-26 gauge needle.

Small developing tank with cover

Procedure

Pour enough Saline into the developing tank (beaker) to have a depth of 3-4 mm of solvent

Apply 1 drop of the kit solution to the ITLC-SG 1.5 cm from the bottom. Dry the spot. Do

not heat!

Develop the plate a distance of 10-15 cm from the spot.

Determine the distribution of radioactivity using suitable detector

Tc-Human Serum Albumin colloid remains at the starting point. Pertechnetate ions

migrates with the solvent front.

Method “B”

Materials

ITLC-SG

Methyl ethyl keton

Capintec or equivalent instrument for measuring radioactivity in the 0.01 MBq-6 GBq

range. The resolution value is 0.001 MBq

1 ml syringe with a 22-26 gauge needle.

Small developing tank with cover

00110_spc.docx

Page 14 of 15

Procedure

Pour enough Methyl ethyl keton into the developing tank (beaker) to have a depth of 3-4

mm of solvent

Apply 1 drop of the kit solution to the ITLC-SG 1.5 cm from the bottom. Dry the spot. Do

not heat!

Develop the plate a distance of 10-15 cm from the spot.

Determine the distribution of radioactivity using suitable detector

Tc-Human Serum Albumin colloid remains at the starting point and pertechnetate ions

migrates with the solvent front.

00110_spc.docx

Page 15 of 15

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