Patient Information Leaflet: User Information
Warning! Keep the leaflet. Information on the immediate packaging in a foreign language.
Curacne 5 mg (Isoacne 5 mg)
Soft capsules
Isotretinoin
Curacne 5 mg and Isoacne 5 mg are different trade names for the same medicine.
WARNING
May cause serious harm to an unborn child.
Women must use effective contraception methods.
Do not use during pregnancy or suspected pregnancy.
▼This medicinal product will be subject to additional monitoring. This will allow for quick identification of new safety information. The user of the medicinal product can also help by reporting any adverse reactions that occur after taking the medicine. To find out how to report adverse reactions, see section 4.
You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.
- You should keep this leaflet so that you can read it again if necessary.
- If you have any doubts, you should consult a doctor or pharmacist.
- This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
- If the patient experiences any adverse reactions, including any adverse reactions not listed in the leaflet, they should tell their doctor or pharmacist. See section 4.
Table of Contents of the Leaflet
- 1. What is Curacne 5 mg and what is it used for
- 2. Important information before taking Curacne 5 mg
- 3. How to take Curacne 5 mg
- 4. Possible side effects
- 5. How to store Curacne 5 mg
- 6. Contents of the pack and other information
1. What is Curacne 5 mg and what is it used for
Curacne 5 mg contains the active substance isotretinoin. Isotretinoin belongs to a group of medicines called retinoids.
Curacne 5 mg is indicated for the treatment of severe forms of acne (such as nodular acne, conglobate acne, or acne with a risk of permanent scarring), resistant to properly conducted standard treatment with systemic antibacterial agents and topical agents (cream, gel, ointment, solution).
Treatment with Curacne 5 mg should be carried out under the supervision of a doctor with experience in the treatment of severe forms of acne with retinoids and monitoring of the patient during treatment.
Curacne 5 mg is not indicated for the treatment of acne that occurs before puberty and is not recommended for use in children under 12 years of age.
2. Important information before taking Curacne 5 mg
When not to take Curacne 5 mg:
- If the patient is pregnant or breastfeeding.
- If there is a risk that the patient may become pregnant, it is necessary to follow the precautions listed in the Pregnancy Prevention Program, see "Warnings and precautions" section.
- If the patient is allergic to isotretinoin or any of the other ingredients of this medicine (listed in section 6), particularly peanuts or soy.
- If the patient has liver failure (severe liver disease).
- If the patient has hyperlipidemia (excessive levels of vitamin A in the blood).
- If the patient has elevated lipid levels (cholesterol, triglycerides) in the blood.
- If the patient is being treated with antibiotics from the tetracycline group.
- If the patient is taking vitamin A or other retinoids (acitretin, alitretinoin).
Warnings and precautions
Before starting treatment with Curacne 5 mg, you should discuss the following with your doctor:
- If the patient has ever had mental health problems, including depression, anxiety, aggression, or mood swings, as well as thoughts of self-harm or suicide. This is because Curacne 5 mg may affect the patient's mood.
- If the patient has kidney problems. In this case, the doctor should modify the dose of isotretinoin.
- If the patient is overweight, has diabetes, high cholesterol or triglyceride levels in the blood, and consumes large amounts of alcohol. In all these cases, lipid and triglyceride levels in the blood must be regularly monitored. If this situation applies to the patient, the doctor will order more frequent blood tests. Patients with diabetes during treatment should closely monitor their blood glucose levels. Increased fasting blood sugar levels have been reported, and new cases of diabetes have been diagnosed during isotretinoin treatment.
- If the patient has liver problems. Curacne 5 mg may increase liver enzyme activity (aminotransferases). To check liver function (liver enzyme activity), the doctor will order regular blood tests before and during treatment. Cases of transient and reversible increased aminotransferase activity have been reported. In the event of persistent significant increased liver enzyme activity, the doctor may consider reducing the dose of the medicine or discontinuing treatment.
- If the patient has had intestinal disorders.
You must stop treatment with Curacne 5 mg and contact your doctor immediately:
- If the patient becomes pregnant during treatment or within a month after treatment ends,
- If the following symptoms occur:
- breathing difficulties, itching, and/or hives, as these symptoms may indicate an allergic reaction. Some of these reactions may occur on the skin in the form of bruises or red spots on the arms and legs.
- headache with nausea, vomiting, or impaired vision;
- severe abdominal pain, nausea, or vomiting, or severe diarrhea with blood in the stool;
- difficulty urinating or inability to urinate;
- impaired vision at night and/or vision disturbances;
- mental health problems: in particular, symptoms of depression (feeling unwell, tearfulness, self-harm, feeling isolated from family or friends).
The patient may not notice certain changes in their mood and behavior, so it is very important to tell friends and family members about taking this medicine. These people may notice such changes and help the patient quickly identify problems that need to be discussed with the doctor.
- If the patient experiences yellowing of the eyes or skin and a feeling of dizziness.
Special warning for women taking Curacne 5 mg:
Pregnancy and breastfeeding, Important
Pregnancy Prevention Program
Women who are pregnant must not take Curacne 5 mg
This medicine may cause serious harm to an unborn child (the medicine has a "teratogenic" effect). It may cause serious damage to the brain, face, ear, eye, heart, and certain glands (thymus and parathyroid) of the fetus. It also increases the risk of miscarriage. These effects can occur even if Curacne 5 mg is taken for a short period during pregnancy.
- Do not take Curacne 5 mg if you are pregnant or think you may be pregnant.
- Do not take Curacne 5 mg during breastfeeding. The medicine is likely to pass into breast milk and may harm the baby.
- Do not take Curacne 5 mg if you may become pregnant during treatment.
- The patient must not become pregnant for a month after treatment ends, as the medicine may still be present in the patient's body.
Curacne 5 mg may be prescribed to female patients of childbearing potential only under strict conditions. This is due to the risk of serious birth defects.
The following conditions must be met:
- The doctor must explain the risk of harm to the unborn child (birth defects) to the patient; the patient must understand why they must not become pregnant and how to prevent it.
- The patient must discuss contraception (birth control methods) with the doctor. The doctor will provide the patient with information about contraception methods. The doctor may refer the patient to a specialist for advice on contraception.
- Before starting treatment, the doctor will ask the patient to have a pregnancy test. The test must show that the patient is not pregnant at the start of treatment with Curacne 5 mg.
Female patients must use effective contraception methods before, during, and after treatment with Curacne 5 mg.
- The patient must agree to use at least one highly effective method of contraception (e.g., an intrauterine device or contraceptive implant), or two effective methods that work in different ways (e.g., oral hormonal contraceptives and condoms). The patient should discuss with the doctor which methods are most suitable for them.
- The patient must use a contraceptive method for a month before taking Curacne 5 mg, during treatment, and for a month after stopping the medicine.
- The patient must use contraception, even if they do not menstruate or are not currently sexually active (unless the doctor decides it is not necessary).
Female patients must agree to have pregnancy tests before, during, and after treatment with Curacne 5 mg.
- The patient must agree to have regular check-ups with the doctor, ideally every month.
- The patient must agree to have regular pregnancy tests: before starting treatment, ideally every month during treatment, and after a month after stopping Curacne 5 mg, as the medicine may still be present in the patient's body (unless the doctor decides it is not necessary for the individual patient).
The patient must agree to have additional pregnancy tests as recommended by the doctor.
- The patient must not become pregnant during and for a month after treatment, as the medicine may still be present in the patient's body.
- The doctor will discuss all these issues with the patient, using a checklist, and ask the patient (or their parent or legal guardian) to sign it. This form confirms that the patient has been informed of the risks and agrees to follow the above rules.
If the patient becomes pregnant while taking Curacne 5 mg, they must stop taking the medicine immediatelyand contact their doctor. The doctor may refer the patient to a specialist for advice.
Additionally, if the patient becomes pregnant within a month after treatment ends, they should contact their doctor. The doctor may refer the patient to a specialist for advice.
Advice for men
The amount of oral retinoids in the semen of men taking Curacne 5 mg is too small to harm an unborn child. However, this medicinal product should never be shared with anyone else, especially women.
Additional precautions
Never give this medicinal product to another person. All unused capsules should be returned to the pharmacist after treatment ends.
Do not donate blood while taking this medicine or for a month after stopping Curacne 5 mg. If the patient's blood is given to a pregnant woman, she may give birth to a child with birth defects.
Advice for all patients
- Talk to your doctor if you experience persistent back pain or pain in the buttocks during treatment with Curacne 5 mg. These symptoms may indicate sacroiliitis, a type of back pain caused by inflammation. The doctor may stop treatment with Curacne 5 mg and refer the patient to a specialist for treatment of back pain caused by inflammation. Further evaluation, including imaging tests such as an MRI, may be necessary.
- Isotretinoin may cause dry eyes, corneal clouding, conjunctivitis, intolerance to contact lenses, and vision problems, including impaired night vision. In rare cases, dry eyes have persisted after treatment ended. If the patient experiences any of these symptoms, they should inform their doctor. The doctor may recommend using moisturizing eye ointments or tear substitutes. If the patient experiences intolerance to contact lenses, the doctor may recommend wearing glasses during treatment. If the patient experiences vision problems, the doctor may refer them to a specialist for advice and may recommend stopping isotretinoin.
- Severe skin reactions (such as erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis) have been reported with isotretinoin. The rash may progress to widespread blistering or peeling of the skin. The patient should also be aware of ulcers in the mouth, throat, nose, genitals, and conjunctivitis (redness and swelling of the eyes).
- In the first few weeks of treatment, it is possible to experience an exacerbation of acne with inflammatory lesions on the skin, severe acne (acne fulminans), but this usually resolves during continued treatment, usually within 7-10 days and without the need to adjust the dose.
- After several years of using isotretinoin in very high doses to treat disorders of keratinization (keratin accumulation), abnormalities have been reported, including delayed growth, additional growth, and decreased bone density, as well as calcifications in tendons and ligaments. Both the doses and duration of treatment, as well as the cumulative dose, were generally much higher than those recommended for the treatment of acne.
- Isotretinoin may cause an increase in blood lipid levels, such as triglycerides. The doctor will order blood tests to check these values before, during, and after treatment with isotretinoin. If lipid levels in the blood remain high, the doctor may reduce the dose or discontinue isotretinoin. Elevated lipid levels may also respond to dietary measures. Excessive lipid levels are sometimes associated with pancreatitis, which can be life-threatening.
Children
Do not give Curacne 5 mg to children under 12 years of age, due to the lack of information on safety or efficacy in this age group, and it is not indicated for prepubertal acne.
Curacne 5 mg and other medicines
Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take, including those obtained without a prescription.
While taking Curacne 5 mg, do not take medicines containing
vitamin A, tetracycline antibioticsor use any topical anti-acne products (other retinoids).
During treatment with isotretinoin, do not use topical keratolytic or exfoliative anti-acne products, as local irritation may occur.
Fertility, pregnancy, and lactation
More information on pregnancy and contraception can be found in section 2, "Pregnancy Prevention Program".
Driving and using machines
During treatment, impaired night vision may occur, which in rare cases may persist after treatment ends. These disturbances may occur suddenly, so caution is advised when driving or operating machinery at night.
Rarely, drowsiness and dizziness have been reported.
If these symptoms occur, do not drive, operate machinery, or engage in other activities that may put the patient or others at risk.
Curacne 5 mg contains purified soybean oil
Do not use if you are allergic to peanuts or soy.
Advice on daily life:
- In case of dry skin or lips, use moisturizing creams or lip balms.
- Throughout the treatment period, do not use products that can irritate the skin, such as peeling creams.
- Avoid excessive sun exposure during treatment, as Curacne 5 mg may increase skin sensitivity.
- If sun exposure cannot be avoided, use creams with a sun protection factor (SPF) of at least 15.
- Do not use UV lamps, sunbeds, or quartz lamps.
- During treatment and for 6 months after treatment ends, avoid wax epilation, dermabrasion (a procedure that removes the skin to eliminate scars), and laser treatment, as this may cause scarring, areas of insufficient or excessive skin pigmentation, and skin peeling.
- If you experience dry eye syndrome, stop using contact lenses. Instead, wear glasses until the end of therapy.
- Wear sunglasses to protect your eyes from excessive sun exposure.
- Be careful when operating mechanical devices and driving at night, as vision disturbances may occur suddenly.
- During treatment with Curacne 5 mg, muscle and joint pain may occur. During this period, avoid strenuous physical exercise.
3. How to take Curacne 5 mg
Dosage
Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
Treatment with isotretinoin should be started at a dose of 0.5 mg/kg body weight per day. For most patients, the dose is between 0.5 mg/kg body weight and 1 mg/kg body weight per day.
If you feel that the effect of Curacne 5 mg is too weak or too strong, talk to your doctor.
The capsules should be taken orally with food, once or twice a day, with a glass of liquid. The capsules should be swallowed whole. Do not chew or suck the capsules.
Patients with severe renal impairment
In patients with severe renal impairment, treatment should be started at a lower dose (e.g., 10 mg/day).
Use in children
Isotretinoin is not indicated for the treatment of acne that occurs before puberty and is not recommended for use in children under 12 years of age.
Patients with intolerance
In patients with symptoms of severe intolerance to the medicine after taking the recommended dose, treatment can be continued using the highest dose tolerated by the patient.
Treatment with Curacne 5 mglasts from 16 to 24 weeks. Skin condition may improve even within 8 weeks after treatment ends.
Therefore, at least 8 weeks should pass from the end of treatment before the doctor can consider a second course of treatment. In most patients, only one course of treatment is needed.
Taking a higher dose of Curacne 5 mg than recommended
If a higher dose of Curacne 5 mg than recommended is taken, symptoms of hypervitaminosis A may occur, such as severe headache, nausea, or vomiting, drowsiness, irritability, and itching.
In this situation, you should immediately contact your doctor, pharmacist, or the nearest hospital.
Missing a dose of Curacne 5 mg
Do not take a double dose to make up for a missed dose. Continue taking the medicine as prescribed.
If you have any further doubts about taking the medicine, consult your doctor or pharmacist.
4. Possible side effects
Like all medicines, Curacne 5 mg can cause side effects, although not everybody gets them.
Side effects often resolve during treatment, after a dose change, or after stopping treatment (this should be discussed with the doctor), although some may persist even after treatment ends. If they occur, you should inform your doctor, who will take appropriate action.
Some side effects can be serious
Rare side effects (may affect up to 1 in 1000 people)
- Depression or related disorders. Symptoms include sadness, mood changes, anxiety, discomfort.
- Worsening of existing depression.
- Aggression or violence.
Very rare side effects (may affect up to 1 in 10,000 people)
- Some people have had thoughts or ideas about self-harm or suicide (suicidal thoughts), attempted suicide (suicide attempts), or committed suicide. These people do not have to show symptoms of depression.
- Abnormal behavior.
- Psychotic symptoms: loss of contact with reality, e.g., the patient hears voices or sees things that do not actually exist.
If you experience symptoms of the psychiatric disorders described above, you should
contact your doctor immediately.The doctor may recommend stopping Curacne 5 mg.
Stopping the medicine may not be enough for these effects to resolve; additional help may be necessary, and the doctor can provide it.
- Rare side effects(may affect up to 1 in 1000 people): life-threatening allergic reactions (anaphylactic reactions: difficulty breathing or swallowing due to sudden swelling of the throat, face, lips, and mouth, as well as sudden swelling of the hands, feet, and ankles). If the patient experiences any allergic reaction, they should stop taking Curacne 5 mg and contact their doctor.
- Unknown frequency(frequency cannot be estimated from the available data): severe skin reactions (erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis), which can be life-threatening and require immediate medical attention. Early symptoms include circular patches, often with centrally located blisters, usually on the hands and feet or arms and legs. In more severe cases, blisters may occur on the chest and back. Other symptoms may also occur, such as eye infections (conjunctivitis) or ulcers in the mouth, throat, or nose. Severe skin reactions can progress to widespread peeling of the skin, which can be life-threatening.
If a severe rash or such skin symptoms occur, you should stop taking Curacne 5 mg and contact your doctor immediately.All other side effects are grouped below by frequency of occurrence.
Very common: affects more than 1 in 10 people
- Anemia, thrombocytopenia, thrombocytosis.
- Elevated erythrocyte sedimentation rate (ESR), a marker of acute inflammation.
- Increased triglyceride levels, decreased high-density lipoprotein (HDL) levels.
- Increased liver enzyme activity (aminotransferases). Depending on the situation, the doctor may order blood tests or other necessary tests.
- Red ulcers or deep cracks in the corners of the mouth and lips, conjunctivitis, dry skin, localized peeling of the skin, itching, red skin rashes, skin fragility (injuries due to friction).
- Conjunctivitis with purulent discharge and itching, eye irritation, dry eyes.
- Back pain (especially in adolescents), muscle and joint pain. Therefore, intense physical exercise should be limited during treatment. All these symptoms are reversible after treatment ends.
Common: affects less than 1 in 10 people
- Increased blood sugar and cholesterol levels, hematuria, proteinuria.
- Decreased white blood cell count, which affects the patient's increased susceptibility to infections.
- Headache.
- Dryness of the nasal mucosa, nosebleeds, pharyngitis.
Rare: affects less than 1 in 1000 people
- Allergic skin reactions, hypersensitivity.
- Hair loss (alopecia).
Very rare: affects less than 1 in 10,000 people
- Pancreatitis, gastrointestinal bleeding, colitis. If the patient experiences severe abdominal pain, possibly accompanied by bloody diarrhea, nausea, and vomiting, they should stop taking isotretinoin and contact their doctor immediately.
- Liver disorders (hepatitis), nausea, vomiting, loss of appetite, malaise, fever, itching, jaundice of the skin and eyes.
- Kidney disorders: severe fatigue, difficulty urinating, or inability to urinate, swollen eyelids. If the patient experiences such symptoms during treatment with isotretinoin, they should stop treatment and contact their doctor.
- Elevated blood sugar levels (indicating diabetes) with symptoms such as increased thirst, increased urination, increased appetite with weight loss, feeling tired, dizzy, weak, decreased mood, irritability, and general exhaustion. If these symptoms occur, the patient should contact their doctor.
- Hypertension in the brain in patients who are also taking isotretinoin and certain antibiotics (tetracyclines). This hypertension is accompanied by chronic headaches with nausea, vomiting, or vision disturbances (possibly due to swelling of the optic nerve). In this case, the patient should stop taking Curacne 5 mg and contact their doctor as soon as possible.
- Seizures.
- Narrowing or blockage of blood vessels.
- Worsening of acne symptoms during the first few weeks of treatment, severe forms of acne (acne fulminans). Nevertheless, continued treatment should be accompanied by improvement of acne symptoms and other conditions.
- Colitis.
- Local bacterial infections.
- Facial flushing, skin rash.
- Changes in hair, increased body hair, nail dystrophy, bacterial infections of the nail bed.
- Thickening of post-operative scars.
- Damage to skin vessels and mucous membranes.
- Increased sensitivity to sunlight (photoreactions, see "Advice on daily life", point 2).
- Increased skin pigmentation, increased sweating.
- Enlarged lymph nodes.
- High levels of uric acid in the blood, which can cause gout.
- The medicine may cause impaired night vision and blurred vision, which may occur suddenly. These disturbances may persist even after treatment ends.
- Color blindness, severe eye irritation, corneal clouding, conjunctivitis, blurred vision, cataract, increased sensitivity to light, vision disturbances, intolerance to contact lenses. In this case, the patient should wear sunglasses to protect their eyes from glare. If the patient experiences such symptoms during treatment, they should contact their doctor immediately.
- Hearing impairment.
- Sudden chest tightness with shortness of breath and wheezing (bronchospasm), especially if the patient has asthma, voice changes (hoarseness).
- Dryness in the throat, nausea.
- Malaise.
- Excessive tissue formation during wound healing (increased granulation tissue formation).
- Changes mainly affecting the joints with accompanying pain and swelling, bone abnormalities (delayed growth, additional growth, and decreased bone density), calcifications in soft tissues, tendonitis.
- Activity of certain liver enzymes (creatine kinase), which are released during muscle fiber breakdown, may increase in patients taking isotretinoin who engage in intense physical exercise, muscle breakdown, which can lead to kidney function disorders.
- Drowsiness, dizziness.
Unknown frequency (frequency cannot be estimated from the available data):
- Difficulty achieving or maintaining an erection.
- Decreased libido.
- Breast tenderness or enlargement in men.
- Vaginal dryness.
- Sacroiliitis, a type of back pain caused by inflammation, causing pain in the lower back or buttocks.
- Urethritis.
Reporting side effects
If you experience any side effects, including any side effects not listed in the leaflet, you should tell your doctor, pharmacist, or nurse.
Side effects can be reported directly to the Department of Adverse Reactions to Medicinal Products, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych (Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products)
Al. Jerozolimskie 181 C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
website: https://smz.ezdrowie.gov.pl
By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store Curacne 5 mg
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated.
Do not store above 25°C. Store in the original packaging.
Keep the packaging tightly closed to protect from light.
After treatment ends, return all remaining capsules to the pharmacy.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.
6. Contents of the pack and other information
What Curacne 5 mg contains
The active substance of the medicine is isotretinoin.
1 soft capsule contains 5 mg of isotretinoin.
The medicine also contains purified soybean oil (see section 2), yellow wax, hydrogenated vegetable oil, and the following ingredients in the capsule shell: gelatin, glycerol, purified water, red iron oxide (E 172), yellow iron oxide (E 172), titanium dioxide (E 171) 25% in glycerol.
Ink composition: SDA 35 alcohol, propylene glycol, black iron oxide, polyvinyl acetate phthalate, water, isopropyl alcohol, macrogol, ammonium hydroxide.
What Curacne 5 mg looks like and contents of the pack
30 capsules in blisters, in a cardboard box.
Each 5 mg soft capsule has a two-color, non-transparent red/brown-yellow capsule shell with a light yellow/orange fill and is printed with "5" on one side.
For more detailed information, consult the marketing authorization holder or parallel importer.
Marketing authorization holder in Spain, the country of export:
Pierre Fabre Ibérica, S.A.
C/ Ramón Trias Fargas, 7-11
08005 Barcelona, Spain
Manufacturer:
Catalent France Beinheim SA
74, rue Principale
67930 Beinheim, France
Parallel importer:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Repackaged by:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Spanish authorization number: 653587.5
Parallel import authorization number: 52/24
This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Belgium
ISOCURAL
Czech Republic
CURACNE
France
CURACNE
Italy
ISORIAC
Luxembourg
CURACNE
Poland
CURACNE 5 mg
Spain
ISOACNE
Availability category:
Medicine that requires close monitoring during treatment and is available only on prescription.
For women of childbearing potential:
- Before issuing a prescription, it is necessary to obtain the patient's consent to undergo treatment and provide information on contraception;
- The duration of treatment based on the prescription is limited to 30 days. Extension of treatment requires a new prescription;
- The medicine can only be dispensed if all required information is present on the prescription. Mandatory requirements:
- Start of treatment (first prescription).
- Obtaining patient consent for treatment (signing a form) and providing information on contraception.
- Using at least one effective method of contraception for at least a month before starting treatment.
- Assessing the patient's understanding of the planned treatment.
- Scheduling a pregnancy test date (serum hCG).
- Continuation of treatment (subsequent prescriptions).
- Implementing an effective contraception program.
- Assessing the patient's understanding of the treatment being carried out.
- Specifying the date of the last pregnancy test (serum hCG).
For more detailed information about Curacne, consult a specialist doctor.
Date of leaflet approval: 02.02.2024
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