Package Leaflet and Summary of Product Characteristics · Package Leaflet and Summary of Product Characteristics ROTOP - EHIDA, 20,0 mg Kit for radiopharmaceutical preparation Etifenin

Package Leaflet and Summary

of Product Characteristics

ROTOP - EHIDA, 20,0 mg

Kit for radiopharmaceutical preparation

Etifenin

Read all of this leaflet carefully before you start using this medi-cine.

• Keep this leaflet. You may need to read it again.• If you have any further questions, ask your doctor or pharmacist.• This medicine has been prescribed for you. Do not pass it on to oth-

ers. It may harm them, even if their symptoms are the same as yours.• If any of the side effects gets serious, or if you notice any side effects

not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1. What ROTOP - EHIDA is and what it is used for2. Before you use ROTOP - EHIDA3. How to use ROTOP - EHIDA4. Possible side effects5. How to store ROTOP - EHIDA6. Further information

1. WHAT ROTOP - EHIDA IS AND WHAT IT IS USED FOR

Kit for radiopharmaceutical preparation. Powder for preparation of a[99mTc]technetium etifenin injection solution.

After radiolabelling with the sodium [99mTc]pertechnetate injection solu-tion, etifenin forms the diagnostic radiopharmaceutical [99mTc]technetiumetifenin injection solution ([99mTc]EHIDA).

[99mTc]EHIDA is used for hepatobiliary function scintigraphy where thereis the following suspicion:

- Acute cholecystitis- Chronic gall duct changes- Occlusion of ductus choledochus - Congenital aberrances of the gall duct system such as atresia - Provision of evidence of bile leak - For differential diagnosis of intrahepatic growth (suspicion of focal

nodular hyperplasia versus suspicion of liver cell cancer).

The diagnostic significance in liver cancer is rather marginal comparedto other imaging procedures.

2. BEFORE YOU USE ROTOP - EHIDA

Take special care with ROTOP - EHIDA

The patient must be well hydrated before and after administration. Inorder to keep radiation exposure to a minimum, patients must be en-couraged to empty their bladders as often as possible during the firsthours after the examination.

For each patient it should be carefully considered whether the expecteddiagnostic benefits outweigh the risk linked to radiation exposure. Inorder to keep the radiation dose as low as possible, the administeredactivity may not be higher than that required for eliciting the diagnosticinformation.

Radiopharmaceuticals may be received, used and administered only byauthorised persons in areas specially designated for this purpose. Themanipulation and use of these products is subject to the regulations ofthe local supervisory authority and/or requires appropriate permission.

Using other medicines

Opiates and pentobarbital will cause delayed excretion from the intestine,while choleretica such as cholecystokinin will accelerate this process.High doses of nicotinic acid lead to a reduced intake in the hepatocytesas a consequence of a toxic effect.

Bethanechol, a parasympathometic drug belonging to the group ofcholine esters, leads to increased biliary excretion. Morphine and meta-

done lead to an abnormal time required for transport in the duodenum.Paracetamol may cause filling defects in the liver due to hepatotoxicity.Mere parenteral nutrition can lead to missing or delayed entry into thegall bladder or a delayed transport of the tracer in the duodenum. Toavoid detrimental effects on the stability of [99mTc]EHIDA, the latter mustnot be mixed or administered concomitantly with other medicinal prod-ucts or components.

Pregnancy and lactation

Pregnancy: No data on the clinical use of etifenin with pregnant womenis available. If it is necessary to administer a radiopharmaceutical productto a woman of child-bearing age, she must have a pregnancy test first.If a woman has missed a period, it must be assumed that she is preg-nant. In case of doubt, radiation exposure must be reduced to the min-imum amount required to acquire the needed clinical information. In thiscase, alternative investigative methods must be considered that do notuse ionising radiation.

Radiopharmaceutical examinations of pregnant women also expose thefoetus to radiation. The administration of 150 MBq with normal or 420 MBqwith disturbed liver function results in an absorbed dose of 1.6 mGy /4.6 mGy in the uterus. Radiation doses above 0.5 mGy are consideredas a potential hazard for the fetus. For this reason, [99mTc]EHIDA mayonly be used during pregnancy if there is a vital indication and if the ex-pected benefit outweighs the risk to mother and child. [99mTc]EHIDApasses into breast milk.Lactation: Before administering [99mTc]EHIDA to a breast-feeding mother,it must be considered whether the investigation could also be delayeduntil the mother has ceased breast-feeding and as to whether using aradiopharmaceutical is the most appropriate examination method, bear-ing in mind the secretion of activity into breast milk. If administeringROTOP - EHIDA is deemed necessary, breast-feeding must be inter-rupted for at least 12 hours, and the expressed breast milk discarded.

Driving and using machines

Effects on the ability to drive and use machines have not been described.

3. HOW TO USE ROTOP - EHIDA?

Single intravenous injection after reconstitution with sodium [99mTc]per -technetate solution.Adults with a normal liver function will receive an activity of 150 MBq andup to 420 MBq if they have a disturbed liver function with serum bilirubinvalues >25 mol/l. Patients should not eat during at least 2 hours or better4 hours prior to administration. Fasting for 24 or more hours and par-enteral nutrition can cause false positive results. Scintigraphy will startwith the injection. The acquisition of late images may be indicated:

- After 3 to 4 hours in cases of suspected acute cholecystitis wherethe gall bladder is not visible within 40 to 60 min. and for the purposeof finding a bile leak;

- After 18 to 24 hours, in certain cases, in the event of heavy sickness,choledochus occlusion or biliary atresia.

Children

In children, [99mTc]technetium etifenin is used without carrying out formalinvestigations. Clinical experience indicates that the activity should bereduced. The recommendation of the Paediatric Task Group of the Eu-ropean Association of Nuclear Medicine (EANM) of 1990 lists the paedi-atric dose scaled to body weight as a fraction of the adult dose:

Activity for children as a fraction of adult activity(EANM Paediatric Task Group, 1990, and BfS, publication of 10 July2003, Federal Gazette no. 143 of 5 August 2003, pg. 17503 - 17504)

3 kg = 0.1 22 kg = 0.50 42 kg = 0.784 kg = 0.14 24 kg = 0.53 44 kg = 0.806 kg = 0.19 26 kg = 0.56 46 kg = 0.828 kg = 0.23 28 kg = 0.58 48 kg = 0.8510 kg = 0.27 30 kg = 0.62 50 kg = 0.8812 kg = 0.32 32 kg = 0.65 52 - 54 kg = 0.9014 kg = 0.36 34 kg = 0.68 56 - 58 kg = 0.9216 kg = 0.40 36 kg = 0.71 60 - 62 kg = 0.9618 kg = 0.44 38 kg = 0.73 64 - 66 kg = 0.9820 kg = 0.46 40 kg = 0.76 68 kg = 0.99

Activity of less than 10% of the adult dose generally does not allow asatisfactory assessment to be derived from the examination.

If you got more ROTOP - EHIDA than you should

Due to the low amounts of substances used, overdosage in the phar-macological sense is not expected. Exposure to radiation resulting froman overdosage of radioactivity can be reduced by administration of lax-atives.

Precautions for avoiding hazards for the environment

Radiopharmaceuticals must be prepared and used by the user underprecautions for the protection from ionising radiation and taking phar-maceutical quality standards into account. In accordance with the guide-lines for Good Pharmaceutical Manufacturing Practice, work must bedone under aseptic conditions.

Patients treated with radiopharmaceuticals pose a risk for other personsbased on external radiation exposure or contamination due to spillingurine, vomiting, etc. For this reason, the precautionary measures pro-vided by the national radiation protection regulations must be observed.Contamination brought about by radioactivity that has been excreted bythe patient must be avoided.

4. POSSIBLE SIDE EFFECTS

As all medicinal products, ROTOP - EHIDA can cause side effects, al-though not everybody gets them.

For assessing the side effects the frequency is classified as follows:

Very common: observed in more than 1 patient in 10Common: observed in less than 1 patient in 10, but more than 1

patient in 100Uncommon: observed in less than 1 patient in 100, but more than 1

patient in 1,000Rare: observed in less than 1 patient in 1,000, but more than

1 patient in 10,000Very rare: observed in less than 1 patient in 10,000 or not known

No information on adverse reactions after intravenous injection of theready-to-use solution is available. For related substances such as diso -fenin and mebrofenin, hypersensitivity reactions such as flu-like symp-toms, nausea or pruritus have been reported in individual cases. Al-though such reactions are very rare and usually very minor, appropriateinstruments and medications for immediate treatment of allergic reac-tions (adrenaline, corticosteroids and antihistamines) should be withinreach for possible emergency treatment at all times. Since the adminis-tered amounts of active substances are very low, the risks of use aremainly related to radiation exposure.

Ionising radiation can cause cancer and genetic mutations. Since mostradiopharmaceutical examinations are conducted with low effective ra-diation doses of less than 20 mSv, the probability of such effects occur-ring is expected to be low. The effective radiation dose is 7.1 mSv whenthe maximum recommended activity of this medicinal product is applied.

Reporting of side effects

If you notice any side effects please contact your nuclear physician res -ponsible for supervising the administration. This also applies to any sideeffects not listed in this leaflet.You can also report any side effects directly to: Bundesinstitut fürArzneimittel und Medizinprodukte, Abt. Pharmakovigilanz, Kurt-Georg-Kiesinger Allee 3, D-53175 Bonn, website: http://www.bfarm.de.By reporting side effects you can help provide more information on thesafety of this medicine.

5. HOW TO STORE ROTOP - EHIDA

Keep out of the reach and sight of children.Do not use this medicinal product after the expiry date stated on thelabel.

Storage conditions

Store refrigerated (2 to 8 °C) in the original package. Radiopharmaceu-ticals must be stored in accordance with the regulations for radioactiveprotection and in particular be kept from unauthorised access.

Shelf life after radiolabelling

The product labelled with [99mTc]technetium can be injected within 3hours after preparation and during this period can be stored at roomtemperature (15 to 25°C).

6. FURTHER INFORMATION

What ROTOP - EHIDA contains

One vial contains 26.76 mg of powder with the active substance:

Etifenin, 20.0 mg

The other ingredients are:

Stannous chloride dihydrateAscorbic acidSodium hydroxideHydrochloric acid, 36%Nitrogen

What ROTOP - EHIDA looks like and contents of the pack

The package consists of a carton with 5 ROTOP - EHIDA vials.

Marketing Authorisation Holder and Manufacturer

ROTOP Pharmaka GmbH Bautzner Landstr. 400 01328 DresdenGermanyTel.: (0) 351 – 26310-210Fax: (0) 351 – 26310-313Email: [email protected]

This medicinal product is authorised in the Member States of theEEA under the following names:

Germany: ROTOP - EHIDA

This leaflet was last revised in November 2014.

The following information is intended for medical or healthcare profes-sionals only:

PHARMACOLOGICAL PROPERTIES

Pharmacodynamic properties

Pharmacotherapeutic group: Diagnostic radiopharmaceutical for the liverfunction (ATC: V09DA02).

Based on current research, for the low amounts of substances used forimaging techniques no clinically relevant pharmacodynamic effects of[99mTc]EHIDA are expected.

Pharmacokinetic properties

Etifenin crosses the placenta. After intravenous injection, [99mTc]EHIDAis quickly bound to plasma proteins, taken up in the polygonal cells ofthe liver and excreted via the bile. Depending on the type of excretion,radioactivity is either temporarily stored in the gall bladder or directly ex-creted from the hepatobiliary system into the small intestine without prioraccumulation.

Through active transport, [99mTc]EHIDA is taken up in the hepatocytes ina similar way as bilirubin and reaches the peak activity in the liver after12 min.

The liver half-life is 25 to 30 min. in healthy individuals, but can be influ-enced by the plasma albumin concentration, hepatic blood flow and he-patocytes function. If there is no significant bile congestion, only smallquantities are delivered in the urine. In healthy patients, the biliary tree isvisualised within 5 to 20 min. after injection, and the gall bladder within10 to 40 min..

Toxicological properties

No studies on acute toxicity of [99mTc]EHIDA are available. However, onaccount of the low amount administered of etifenin (max. 0.3 mg per kgof body weight) and of tin(II)chloride (max. 0.01 mg per kg of bodyweight), no acute toxic effects must be expected.

No studies are available on the toxicity after repeated use, reproductivetoxicity or mutagenic and carcinogenic effects.

Special precautions for disposal and further directions for handling

The empty package is considered to be regular waste if the permittedlevel for [99mTc]technetium is not exceeded (≤ 0.5 Bq/g or 0.5 Bq/cm2).

This Package Leaflet and Summary of Product Characteristics was translated by the manufacturer based on the original German document (Vs. 07), authorized by the German Federal Institute for Drugs and Medicinal Services in November 2014.

Particulars indicating radioactivity must be removed prior to disposingof the non-radioactive waste and must be destroyed separately. Ra-dioactive waste must be disposed of as provided by law.

MARKETING AUTHORISATION NUMBER

3003665.00.00

DATE OF FIRST AUTHORISATION / RENEWAL OF THE AUTHORI-SATION

17.11.2005

DOSIMETRY

Radiation exposure

According to ICRP Publication 80, the following radiation doses are ab-sorbed by patients with normal liver function:

Table 1

Absorbed dose per unit of activity administered (mGy/MBq) Normal liver function

Organ Adults 15 years 10 years 5 years 1 year

Adrenals 0.0037 0.0048 0.0075 0.011 0.018Bladder wall 0.022 0.028 0.037 0.043 0.076Bone surface 0.0038 0.0047 0.0068 0.01 0.019Brain 0.000034 0.00004 0.000079 0.00014 0.00026Breast 0.00048 0.00065 0.0014 0.0025 0.0048Gall bladder wall 0.11 0.12 0.16 0.28 0.95Stomach wall 0.0056 0.0078 0.013 0.021 0.034Small intestine 0.044 0.055 0.090 0.14 0.25Large intestine 0.074 0.095 0.15 0.25 0.47

Upper large intestine 0.086 0.11 0.18 0.29 0.54Lower large intestine 0.059 0.075 0.12 0.20 0.38Heart 0.0018 0.0024 0.0040 0.0063 0.012Kidneys 0.0061 0.0075 0.011 0.016 0.025Liver 0.014 0.018 0.027 0.040 0.071Lungs 0.0013 0.0019 0.0028 0.0046 0.0086Muscles 0.0029 0.0036 0.0053 0.0078 0.014Oesophagus 0.00041 0.00060 0.00091 0.0017 0.0032Ovaries 0.019 0.024 0.035 0.050 0.083Pancreas 0.0056 0.0076 0.014 0.022 0.034Red bone marrow 0.0039 0.0047 0.0063 0.0077 0.010Skin 0.00089 0.0011 0.0017 0.0027 0.005Spleen 0.0027 0.0036 0.0063 0.010 0.017Testes 0.0015 0.0023 0.0041 0.0062 0.012Thymus 0.00041 0.00060 0.00091 0.0017 0.0032Thyroid 0.00014 0.00023 0.00091 0.00077 0.0019Uterus 0.013 0.017 0.026 0.038 0.061Other tissue 0.0037 0.0046 0.0066 0.0097 0.016

Effective dose per 0.017 0.021 0.029 0.045 0.10unit of activity admin-istered (mSv/MBq)

In an adult (70 kg), after intravenous injection of 420 MBq (maximumdose), the effective dose is 7.1 mSv. The absorbed dose in the targetorgan liver is 5.9 mGy and 46.2 mGy in the gall bladder, while in the crit-ical organs it is 18.5 mGy in the small intestine, 35.1 mGy in the uppercolon and 24.8 mGy in the lower colon.

According to ICRP Publication 53 (page 203), the following radiationdoses are absorbed by patients with parenchymatic liver disease:

Table 2

Absorbed dose per unit of activity administered (mGy/MBq)parenchymal liver disease


Adrenals 0.0021 0.0030 0.0046 0.0067 0.0110Bladder wall 0.069 0.0850 0.1200 0.1900 0.3400Bone surface 0.0017 0.0021 0.0030 0.0046 0.0087Breast 0.00056 0.00057 0.0010 0.0018 0.0035Gall bladder wall 0.0350 0.0400 0.0530 0.0920 0.3000Stomach wall 0.0027 0.0034 0.0058 0.0094 0.0160Small intestine 0.019 0.0240 0.0390 0.0600 0.1100

Upper large intestine wall0.033 0.0400 0.0660 0.1000 0.1900

Lower large intestine wall0.024 0.0300 0.0500 0.0790 0.1500

Kidneys 0.0066 0.0079 0.0110 0.0170 0.0270Liver 0.010 0.0130 0.0200 0.0280 0.0500Lungs 0.00092 0.0013 0.0019 0.0029 0.0054Ovaries 0.0099 0.0120 0.0180 0.0260 0.0420Pancreas 0.0028 0.0038 0.0066 0.0100 0.0170Red bone marrow 0.0038 0.0045 0.0060 0.0074 0.0094Spleen 0.0015 0.0019 0.0032 0.0052 0.0090Testes 0.0025 0.0038 0.0067 0.0110 0.0200Thyroid 0.00023 0.00037 0.00064 0.0011 0.0022Uterus 0.011 0.0140 0.0220 0.0310 0.0510Other tissue 0.0021 0.0025 0.0036 0.0055 0.0095


According to ICRP Publication 53, the following radiation doses are ab-sorbed by a patient with occluded ductus cysticus:

Table 3

Absorbed dose per unit of activity administered (mGy/MBq) Occlusion of ductus cysticus


Adrenals 0.0022 0.0033 0.0052 0.0079 0.013Bladder wall 0.039 0.048 0.070 0.10 0.19Bone surface 0.0023 0.0028 0.0041 0.0061 0.012Breast 0.00051 0.00051 0.00099 0.0019 0.0037Stomach wall 0.0050 0.0062 0.0093 0.015 0.025Small intestine 0.047 0.059 0.096 0.15 0.26Upper large intestine wall

0.084 0.10 0.17 0.27 0.50Lower large intestine wall

0.058 0.072 0.12 0.19 0.37Kidneys 0.0055 0.0065 0.0097 0.014 0.023Liver 0.010 0.013 0.020 0.030 0.054Lungs 0.00084 0.0012 0.0019 0.0031 0.0058Ovaries 0.019 0.023 0.034 0.049 0.079Pankreas 0.0035 0.0047 0.0076 0.012 0.021Red bone marrow 0.0066 0.0075 0.0098 0.012 0.014Spleen 0.0022 0.0027 0.0046 0.0074 0.013Testes 0.0019 0.0030 0.0054 0.0086 0.016Thyroid 0.00015 0.00022 0.00042 0.00077 0.0017Uterus 0.013 0.017 0.027 0.040 0.066Other tissue 0.0027 0.0033 0.0048 0.0073 0.013


According to ICRP Publication 53, the following radiation doses are ab-sorbed by patients with occluded ductus choledochus:

Table 4

Absorbed dose per unit of activity administered (mGy/MBq) Occlusion of ductus choledochus


Adrenals 0.0088 0.013 0.019 0.024 0.036Bladder wall 0.020 0.024 0.036 0.056 0.10Bone surface 0.0024 0.0030 0.0042 0.0065 0.013Breast 0.0023 0.0023 0.0040 0.0064 0.012Stomach wall 0.0037 0.0056 0.010 0.017 0.030Small intestine 0.0036 0.0044 0.0083 0.014 0.024Upper large intestine wall

0.0052 0.0064 0.012 0.021 0.035Lower large intestine wall

0.0015 0.0018 0.0033 0.0057 0.010Kidneys 0.0084 0.0099 0.015 0.021 0.031Liver 0.085 0.11 0.16 0.22 0.39Lungs 0.0049 0.0068 0.0093 0.013 0.022Ovaries 0.0019 0.0026 0.0047 0.0078 0.014Pankreas 0.0083 0.013 0.020 0.030 0.049

Red bone marrow 0.0035 0.0049 0.0066 0.0085 0.012Spleen 0.0019 0.0029 0.0052 0.0085 0.014Testes 0.00076 0.0011 0.0019 0.0033 0.0065Thyroid 0.00034 0.00046 0.00091 0.0018 0.0035Uterus 0.0028 0.0037 0.0066 0.011 0.019Other tissue 0.0023 0.0028 0.0040 0.0060 0.011


According to ICRP Publication 53, the following radiation doses are ab-sorbed by newborns with congenital biliary atresia:

Tabelle 5

Absorbed dose per unit of activity administered (mGy/MBq) Congenital biliary atresia

Organ Newborns

Adrenals 0.033Bladder wall 0.26Bone surface 0.026Stomach wall 0.036Small intestine 0.070Upper large intestine wall 0.12Lower large intestine wall 0.023Kidneys 0.015Liver 0.90Lungs 0.044Ovaries 0.045Pancreas 0.057Red bone marrow 0.047Spleen 0.019Testes 0.035Testes 0.012Uterus 0.037Other tissue 0.021

Effective dose per unit of activity administered (mSv/MBq) 0.85

Radiophysical properties

[99mTc]technetium is produced using a [99Mo/99mTc] sterile generator anddecays releasing gamma radiation with an energy of 140/142 keV witha half-life of 6.02 hours to [99Tc]technetium, which in turn decays to stable[99mRu]ruthenium; However, due to a long half-life of 214,000 years,[99mTc]technetium itself is considered to be stable.

INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTI-

CALS

Instructions for labelling

[99mTc]EHIDA is prepared under sterile conditions with a sodium[99mTc]pertechnetate injection solution (European Pharmacopoeia, 0125or 0283) directly before use. Oxygenation must be avoided.

Place the vial with powder in sufficient lead shielding with ample spaceand disinfect the stopper (allow disinfectant to dry).

Use a syringe with the smallest possible cannula lumen to transfer amaximum of 3 ml of sodium [99mTc]pertechnetate injection solution witha maximum of 8 GBq to the vial. Use the same syringe to withdraw theappropriate gas volume from the vial for pressure compensation.

Lightly shake the vial in order to completely dissolve the powder. Thestopper should be well moistened as well. After 30 minutes reaction time,measure the overall activity. If needed, the finished injection solution canbe diluted with sterile isotonic sodium chloride to a total volume of up to6 ml.

Quality control

The test for radiochemical purity of the [99mTc]technetium etifenin injectionsolution must be performed before administration to the patient and according to the European Pharmacopoeia or to one of the followingmethods:

Method 1:

Test for [99mTc]technetium in colloidal form

Type of test: Thin-layer chromatographyPlates used: Silica gel on a glass fibre plateStarting point: At the lower end of the plateMobile phase: Sodium chloride (9 g/l)Applied volume: Approx. 5 µlDevelopment: Immediately, over a migration distance of 10 to

15 cmDrying: Air-dryingDetection: By means of a suitable detector for (distribution

of) radioactivity

[99mTc]technetium in colloidal form remains at the starting point, and the[99mTc]technetium etifenin complex migrates to nearly the middle of thechromatogram.

Test for [[99mTc]pertechnetate

Type of test: ElectrophoresisPlates used: Chromatography paper strips, W = 20 mm,

L = 400 mm(migration distance: 200 mm + 2 x 100 mm (endsdipped into buffer solution))

Reference solution: Pertechnetate solution which is subjected to elec-trophoresis in the same way on a separate paperstrip

Starting point: In the middle of the strip (see mark)Electrolyte: 0.05 mol/l K/Na phosphate buffer pH 6.8

(KH2PO4 6.8 g/l and Na2HPO4x2H2O 8.8g/l orNa2HPO4x12H2O 17.9 g/l at a 1:1 ratio)

Voltage gradient: 15 V/cmApplication amount: 5 µl of sample solution and pertechnetate solution

at a distance of 2 cmDrying: Air-dryingDetection: By means of a suitable detector for (distribution

of) radioactivity

[99mTc]pertechnetate migrates to the solvent front. The [99mTc]technetiumetifenin complex remains at the point.

Method 2:

Test for [99mTc]technetium in colloidal form

Type of test: Thin-layer chromatographyPlates used: ITLC-SAMobile phase: Water RApplied volume: Approx. 1 to 2 µlDevelopment: Immediately, over a migration distance of 6 to


of) radioactivityRetardation factor: Contamination A= 0.0 to 0.1;

Contamination B and [99mTc]technetium etifenin =0.9 to 1.0.

Test for [99mTc]pertechnetate

Type of test: Paper chromatographyPaper: Paper for chromatography R, saturated with

NaHCO3Pretreatment of the paper: Soak the paper usinga 25 g/l sodium hydrogen carbonate R solution,drying at 80 °C, Store protected from moisture

Mobile phase: Methyl ethyl ketone RApplied volume: Approx. 1 to 2 µlDevelopment: Immediately, over a migration distance of 6 to


of) radioactivityRetardation factor: Contamination A and [99mTc]technetium etifenin =

0.0 to 0.1.Contamination B = 0.9 to 1.0.

Target values: Impurities in colloidal form: ≤ 5.0 %Pertechnetate ions at the solvent front: ≤ 5.0 %Sum of impurities: ≤ 5.0 %

CLASSIFICATION FOR SUPPLY

Pharmacy-only medicine. GFI-EHIDA-DE-eng-01

Documents

Package Leaflet and Summary of Product Characteristics · Package Leaflet and Summary of Product Characteristics ROTOP - EHIDA, 20,0 mg Kit for radiopharmaceutical preparation Etifenin