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Content of the Ph. Eur. RS catalogue
How to place an RS order
The EDQM announces the availability of:
Catalogue code
Name
Unit Quantity
Y
Betiatide impurity D
10 mg
Y
Betiatide
20 mg
Y
Deferasirox CRS
70 mg
Y
Celiprolol for system suitability CRS
20 mg
Y
Fluoxetine impurity A CRS
15 mg
Y
Ofloxacin impurity D CRS
20 mg
Y
Deferasirox impurity B CRS
10 mg
Y
Rivaroxaban for system suitability CRS
5 mg
Y
Rivaroxaban impurity A CRS
5 mg
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Catalogue code
Name
Batch
Unit
Quantity
Y
Chondroitin sulfate sodium CRS
3
350 mg
Y
Fexofenadine impurity C CRS
2
5 mg
Y
Naproxen impurity L CRS
3
15 mg
T
Trimyristin CRS
3
mg
H
Hydroxyethyl salicylate CRS
3
125 mg
Y
Candesartan cilexetil CRS
2
60 mg
Y
Promethazine for peak identification CRS
3
5 mg
Y
Paclitaxel semi-synthetic for system suitability CRS
3
1.01 mg
A
Acesulfame potassium impurity B CRS
5
15 mg
Y
Pemetrexed impurity mixture CRS
3
0.002 mg
Y
Praziquantel for system suitability CRS
2
10 mg
Y
Lauric acid CRS
2
mg
N
Nimesulide impurity D CRS
6
0.004 mg
D
Dehydrohexetidine CRS
3
50 mg
Y
Flavoxate impurity A CRS
2
15 mg
O
Oxprenolol hydrochloride CRS
2
50 mg
F
Flurbiprofen impurity A CRS
4
25 mg
D
Dexamethasone pivalate CRS
2
50 mg
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Information on price change
Please note that the price of Everolimus CRS, Everolimus for system suitability CRS and Everolimus for impurity C identification CRS batch 2 will be changed to €300.
Information on reference standards removed from the catalogue:
As of 1 April , the following standards have been removed from the catalogue.
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Information on reference standards to be removed from the catalogue in future:
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Information on change of sales units:
None.
If you want to learn more, please visit our website Praziquantel Ep Standard.
Information on changes to EDQM storage/shipping conditions:
In order to ensure better stability, storage and shipping conditions will be changed on 15 May for the following reference standards:
Change in the policy for withdrawing reference standards from sale
At the present time, a reference standard is withdrawn from the catalogue either on the date that a revised monograph which no longer refers to it becomes applicable, or the date on which a monograph is officially withdrawn from the Ph. Eur.
A number of users have informed us that regulatory requirements in their country permit the use of these reference standards (and therefore the corresponding monographs) even after their official withdrawal date. To help these users, the EDQM has decided to modify its withdrawal policy.
Therefore, stocks permitting, sale of these reference standards will continue for 6 months after the official withdrawal date. Similarly, they will remain in the catalogue for a period of 12 months to allow users to print the Batch Validity Statement (BVS) and/or finalise the necessary procedures for controlled substances.
Example:
Fluocortolone pivalate CRS (F) was used in monograph .
The revised monograph entered into force on 1 April .
Current situation:
Reference standard F would have been withdrawn from sale on 1 April .
New policy:
Reference standard F will be available for purchase until 1 October (1 April + 6 months) and will feature in the catalogue until 1 April (1 April + 1 year).
Note: although it will still be listed in the catalogue until 1 April , it will not be possible to order the reference standard after 1 October .
The validity of this standard will thus end on 2 April . As of this date, it will no longer be displayed in the catalogue and therefore can no longer be used.
This policy will be applied from the application of Supplement 10.2 (1 July ).
Information on the current non-availability of a reference standard:
Ph. Eur. Somatropin/Desamidosomatropin resolution mixture CRS (Y) is currently unavailable
In order to overcome the temporary shortage of this CRS, and until the replacement batch is made available, it is advised to prepare the system suitability resolution solution for the test of related proteins described in monographs (Somatropin concentrated solution), (Somatropin) and (Somatropin for injection) by using Ph. Eur. Somatropin CRS Batch 3 (Cat. No. S).
See more information in the Note to users.
Content of the European Pharmacopoeia RS catalogue
The EDQM offers more than 3 000 Ph. Eur. RS including a wide range of highly characterised chemical reference substances (CRS), herbal reference standards (HRS) and biological reference preparations (BRP), as well as reference spectra for the tests and assays to be carried out in accordance with the official methods prescribed in the Ph. Eur. The Ph. Eur. RS catalogue is updated on a daily basis and gives access not only to all the Ph. Eur. RS, but also to:
For your convenience, the Ph. Eur. RS catalogue is published on a daily basis and can be downloaded in pdf format here as well as in XML format here.
How to place an RS order
If you wish to place an order, you can send your request to the EDQM either:
Consumer Medicine Information (CMI) summary
The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.
BILTRICIDE contains the active ingredient praziquantel. BILTRICIDE is used for the treatment of schistosomiasis or bilharziasis, which is a chronic parasitic infestation in humans caused by blood flukes (worms).
For more information, see Section 1. Why am I using BILTRICIDE? in the full CMI.
Do not use if you have ever had an allergic reaction to BILTRICIDE or any of the ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.
For more information, see Section 2. What should I know before I use BILTRICIDE? in the full CMI.
Some medicines may interfere with BILTRICIDE and affect how it works.
A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.
More instructions can be found in Section 4. How do I use BILTRICIDE? in the full CMI.
For more information, see Section 5. What should I know while using BILTRICIDE? in the full CMI.
Common side effects: Vomiting, nausea, diarrhoea, loss of appetite, stomach pains, aching muscles, muscle tenderness or weakness, headache, dizziness, spinning sensation, hives (redness and itchiness of the skin) or rash, drowsiness, sleepiness, general feeling of being unwell, unusual tiredness or weakness, fever.
Serious side effects: rash; swelling of the face, lips, tongue or other parts of the body; shortness of breath, wheezing or trouble breathing; itching; seizures; palpitations and/or chest pain; bloody diarrhoea.
For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.
Active ingredient(s): praziquantel
Consumer Medicine Information (CMI)
This leaflet provides important information about using BILTRICIDE. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using BILTRICIDE.
1. Why am I using BILTRICIDE?
2. What should I know before I use BILTRICIDE?
3. What if I am taking other medicines?
4. How do I use BILTRICIDE?
5. What should I know while using BILTRICIDE?
6. Are there any side effects?
7. Product details
BILTRICIDE contains the active ingredient praziquantel. BILTRICIDE is an anthelmintic which treats parasitic infections.
BILTRICIDE is used for the treatment of schistosomiasis or bilharziasis, which is a chronic parasitic infestation in humans caused by blood flukes (worms). The flukes live in freshwater snails and you may have been infected if you swam or waded in water infested by larvae released from the snails. They are found in Africa (including Madagascar and Mauritius), the Middle East, India, Southeast Asia and South America.
The larvae penetrate the skin, most commonly on the feet, and mature into adult worms in the urinary bladder or the gut.
A rash may occur soon after infestation. Common symptoms of acute infestation are fever, night sweats, lethargy, headache, abdominal pain, loss of appetite, weight loss and a non-productive cough. You may pass blood in the urine.
Infestation with schistosoma parasites may cause no symptoms. However, they may also lead to chronic liver disease or chronic disorders of the urinary tract.
Eggs of the adult worms can occasionally be found in the brain or the spinal cord causing paralysis, or in the eyes, affecting your eyesight.
BILTRICIDE kills blood flukes by causing an immediate contraction and paralysis of the parasite; it also stops the parasite from being able to absorb and use sugars. The parasite then disintegrates with the help of the white blood cells and is passed from the body.
Do not use BILTRICIDE if:
Check with your doctor if you:
Use of BILTRICIDE may be associated with deterioration of your medical condition with symptoms similar to an allergic reaction. This is mainly seen in the acute phase of schistosomiasis (where the worms begin to produce eggs). This can lead to potentially life-threatening events such as lung failure, encephalopathy (disease of the brain), and/or cerebral vasculitis (narrowing or blockage of blood vessels in the brain).
If you take BILTRICIDE for an infestation in your brain or spinal cord, you may get severe headaches and fits. If the doctor wants to treat you for your infestation in the brain, you should be taken to hospital so that a specialist can monitor your treatment.
Your doctor may want to monitor you carefully or hospitalise you while you are taking BILTRICIDE. If you have not told your doctor or pharmacist about any of the above, tell them before you start taking BILTRICIDE.
During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?
Check with your doctor if you are pregnant or intend to become pregnant.
Your doctor can discuss with you the risks and benefits of using BILTRICIDE during pregnancy.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
The active ingredient in BILTRICIDE passes into breast milk and there is a possibility that your baby may be affected. You should not breastfeed your baby on the day you take BILTRICIDE or for 3 days afterwards.
Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.
Do not take BILTRICIDE if you are taking:
Some medicines may interfere with BILTRICIDE and affect how it works.
These medicines may be affected by BILTRICIDE or may affect how well it works. You may need different amounts of your medicines, or you may need to take different medicines.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect BILTRICIDE.
BILTRICIDE should be used regularly at the same time each day. If you miss your dose at the usual time, take the dose as soon as you remember.
If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to and seek your doctor's advice.
Do not take a double dose to make up for the dose you missed.
If you think that you have used too much BILTRICIDE, you may need urgent medical attention.
You should immediately:
You should do this even if there are no signs of discomfort or poisoning.
You may need urgent medical attention.
If you take too many BILTRICIDE tablets, you should take a laxative, which works quickly.
If you are on corticosteroid therapy or if you are about to start taking any new medicine, especially medicines used to treat tuberculosis, leprosy, epilepsy, malaria, stomach acidity, reflux or ulcers, tell your doctor or pharmacist that you are taking BILTRICIDE.
See 3. What if I am taking other medicines? for examples of these medicines.
Remind any doctor, dentist or pharmacist you visit that you are using BILTRICIDE.
Be careful before you drive or use any machines or tools until you know how BILTRICIDE affects you.
You should not drive or operate machinery on the day of treatment and for the next 24 hours because you may feel tired or dizzy after taking BILTRICIDE.
Tell your doctor if you drink alcohol.
Follow the instructions in the carton on how to take care of your medicine properly.
Store it in a cool dry place away from moisture, heat or sunlight; for example, do not store it:
Keep it where young children cannot reach it.
If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.
Do not use this medicine after the expiry date.
Do not take this medicine if the packaging is torn or shows signs of tampering.
If the packaging is damaged, return it to your pharmacist for disposal.
All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.
See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.
Gastrointestinal:
Muscle-related:
Nervous system-related:
Skin-related:
General
Allergic reaction eg.:
Skin-related:
Nervous system-related:
Gastrointestinal:
Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.
Other side effects not listed here may occur in some people.
Side effects seem to happen more often and be more noticeable if you are infected with a large number of the parasites. Some patients may experience mild liver problems.
After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.
Praziquantel.
Biltricide lacquer coated tablets are available as 600 mg of praziquantel.
For the full list of excipients, see Section 6.1 List of Excipients.
Biltricide tablets contain 600 mg praziquantel. The tablets are white to pale yellow lacquer-coated oblong shaped tablets with three scores with Bayer on one side and "LG" on the reverse.
Treatment of schistosoma infections due to various types of blood fluke (e.g. Schistosoma haematobium, S. japonicum, S. mekongi, S. mansoni).
The doctor must prescribe individual doses for individual cases, according to the diagnosis.
20 mg/kg bodyweight three times daily at four hourly intervals for one day, for Schistosoma haematobium, Schistosoma mansoni, Schistosoma japonicum, Schistosoma mekongi.
The tablet has 3 score marks, each fragment contains 150 mg active substance, thus allowing a precise dose to be given, corresponding to the patient's bodyweight. See Table 1.
If 1/4 of a tablet is required, it is convenient to begin by breaking the tablet at one of the outer grooves. The simplest way to break the tablet is to place the thumbnail in the groove.
Biltricide should be swallowed whole with a little liquid, preferably after meals.
Known hypersensitivity to praziquantel or any of the excipients.
Ocular cysticercosis - parasite destruction within the eye may cause irreparable damage.
The concomitant administration of strong inducers of cytochrome P450 such as rifampicin must be avoided as therapeutically effective plasma levels may not be achieved.
Published in vitro data have shown a potential lack of efficacy of praziquantel against migrating schistosomulae. Data from two observational cohort studies in patients indicate that treatment with praziquantel in the acute phase of infection may not prevent progression into chronic phase.
In addition, the use of praziquantel in patients with schistosomiasis may be associated with clinical deterioration (paradoxical reactions, serum sickness Jarisch-Herxheimer-like reactions: sudden inflammatory immune response suspected to be caused by the release of schistosomal antigens). These reactions predominantly occur in patients treated during the acute phase of schistosomiasis. They may lead to potentially life threatening events, e.g. respiratory failure, encephalopathy, and/or cerebral vasculitis.
Patients suffering from cardiac irregularities should be monitored during treatment.
When schistosomiasis or fluke infection is found in patients living in or coming from areas with endemic human cysticercosis, it is advised to hospitalise the patient for the duration of treatment.
As praziquantel can exacerbate central nervous system pathology due to schistosomiasis, paragonimiasis or Taenia solium cysticercosis, as a general rule this drug should not be administered to individuals reporting a history of epilepsy and/or other signs of potential central nervous system involvement such as subcutaneous nodules suggestive of cysticercosis.
Neurocysticercosis is not an approved indication due to insufficient data. In animals, venous thrombosis and the development of granulomas at the site of worm attachment has been observed following treatment with praziquantel. Patients treated with praziquantel (for neurocysticercosis) have had a high incidence of severe headache and seizures. Some patients also developed intracranial hypertension. Because of the potential for undiagnosed neurocysticercosis to be present in patients originating from endemic areas, extra care is necessary in managing such patients. If cerebral cysticercosis is present and treatment is still considered essential, the patient should be hospitalised under specialist care.
The concomitant administration of praziquantel with efavirenz, a strong inducer of cytochrome P 450 should be avoided as therapeutically effective plasma levels of praziquantel may not be achieved (see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions).
Praziquantel is believed to be metabolised via the CYP450 enzyme system. Many categories of drugs are known to inhibit or induce CYP450 enzymes causing an increase or decrease in serum concentrations or bioavailability. Care must therefore be exercised when coadministering such drugs.
Concomitant administration of drugs that increase the activity of drug metabolising liver enzymes (CYP450 inducers), e.g. antiepileptic drugs and dexamethasone may reduce plasma levels of praziquantel. Concomitant administration of strong inducers of CYP450 such as rifampicin must be avoided (see Section 4.3 Contraindications). Chloroquine, when taken simultaneously, can lead to lower concentrations of praziquantel in blood.
Concomitant administration with efavirenz should be avoided as therapeutically effective plasma levels of praziquantel may not be achieved (see Section 4.4 Special Warnings and Precautions for Use) and no dosage recommendation for praziquantel can be given due to missing pharmacokinetic and safety data. Therapeutic alternatives to praziquantel should be considered.
Concomitant administration of drugs that decrease the activity of drug metabolising liver enzymes (CYP450 inhibitors) e.g. cimetidine, ketoconazole, itraconazole, erythromycin and ritonavir may increase plasma levels of praziquantel.
Coadministration of grapefruit juice and praziquantel is not recommended. Coadministration has been reported to increase praziquantel Cmax by 1.6 (90% CI: 1.05, 2.0) and AUC by 1.9 (90% CI: 1.03, 2.47). The effect of this increase in exposure on efficacy and safety of praziquantel has not been studied.
Patients should be warned not to drive or operate machinery on the day of treatment (and during the subsequent 24 hours), as their ability to do so may be temporarily impaired by the use of praziquantel.
Side effects vary according to dose and duration of praziquantel medication; furthermore they are dependent on the parasite species, extent of parasitisation, duration of infection and localisation of the parasites in the body. Side effects occur earlier and are more frequent and pronounced in patients with severe parasitic infestation. Mild increases in liver enzymes have been reported in some patients.
Adverse reactions are based on publications and on spontaneous reports sorted by CIOMS III categories of frequency and MedDRA System Organ Classes (in internationally agreed order). Frequencies of adverse reactions are mainly based on data from medical literature. See Table 2.
It is often not clear whether the complaints reported by patients or the undesirable effects reported by the physician are caused by praziquantel itself (1. direct relation), or may be considered to be an endogenous reaction to the death of the parasites produced by praziquantel (2. indirect relation), or are symptomatic observations of the infestation (3. no relation). It may be difficult to differentiate between the possible variations 1, 2 and 3.
Information on overdosage in humans is not available. Treatment should be supportive and provide symptomatic care.
Activated charcoal may reduce absorption of the drug if given within one to two hours after ingestion. In patients who are not fully conscious or have impaired gag reflex, consideration should be given to administering activated charcoal via a nasogastric tube, once the airway is protected.
For information on the management of overdose, contact the Poison Information Centre on (Australia).
After oral administration praziquantel is rapidly absorbed (80%). It is, however, subject to first pass effect and extensive metabolism. One hour after administration approximately 6% only of the drug in serum is in the unmetabolised form. Both the unchanged drug and the metabolites are excreted primarily by the kidneys.
Maximal serum concentration is achieved 1-3 hours after dosing. The half-life of praziquantel in serum is 0.8-1.5 hours.
Besides the active ingredient, Biltricide tablets also contain the following excipients: hypromellose, macrogol , magnesium stearate, maize starch, microcrystalline cellulose, povidone K25, sodium lauryl sulfate, titanium dioxide (CI).
Incompatibilities were either not assessed or not identified as part of the registration of this medicine.
In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.
Store below 25 degrees Celsius.
Biltricide is sold in bottles of 8 tablets.
In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.
Schedule 4 (Prescription Only Medicine).
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