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NALBUFIN IN'EKCII 10 MG

NALBUFIN IN'EKCII 10 MG

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Doctor

Tomasz Grzelewski

Dermatology21 years of experience

Dr Tomasz Grzelewski is an MD, PhD specialist in allergy, paediatrics, general practice and sports medicine, with a clinical focus on dermatology, endocrinology, allergology and sports-related health. He has more than 20 years of clinical experience and completed his medical training at the Medical University of Łódź, where he defended his PhD thesis with distinction. His doctoral research was recognised by the Polish Society of Allergology for its innovative contribution to the field. Throughout his career, he has gained extensive expertise in diagnosing and managing a wide range of allergic and paediatric conditions, including modern allergen desensitisation techniques.

For five years, Dr Grzelewski served as the Head of two paediatric departments in Poland, managing complex clinical cases and leading multidisciplinary teams. He also worked in medical centres in the United Kingdom, gaining experience across both primary care and specialist environments. With over a decade of telemedicine experience, he has provided online consultations across Europe and is valued for his clear, structured and evidence-based medical guidance.

Dr Grzelewski is actively involved in clinical programmes focused on modern anti-allergic therapies. As a Principal Investigator, he leads research projects on sublingual and oral allergen desensitisation, supporting evidence-based progress in allergy treatment for both children and adults.

In addition to his background in allergology and paediatrics, he completed dermatology studies through the Cambridge Education Group (Royal College of Physicians of Ireland) and a Clinical Endocrinology course at Harvard Medical School. This advanced training enhances his ability to manage skin manifestations of allergies, atopic conditions, urticaria, endocrine-related symptoms and complex immunological reactions.

Patients commonly seek his care for:

  • seasonal and perennial allergies
  • allergic rhinitis and chronic nasal symptoms
  • asthma and breathing difficulties
  • food and medication allergies
  • urticaria, atopic dermatitis and skin reactions
  • recurrent infections in children
  • sports-related health questions
  • general family medicine concerns
Dr Tomasz Grzelewski is known for his clear communication style, structured medical approach and ability to explain treatment options in a concise and accessible way. His multidisciplinary background across allergy, paediatrics, dermatology and endocrinology allows him to provide safe, up-to-date and comprehensive care for patients of all ages.
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About the medicine

How to use NALBUFIN IN'EKCII 10 MG

INSTRUCTIONS for medical use of the medicinal product KYURLED

KYURLED is used in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adult patients.

Composition

Active substance: sofosbuvir; 1 film-coated tablet contains 400 mg of sofosbuvir; excipients: mannitol 60 (E 421), microcrystalline cellulose, sodium croscarmellose, colloidal silicon dioxide, magnesium stearate; tablet coating: Opadry II Blue (85F505068).

Pharmaceutical form

Film-coated tablets.

Main physical and chemical properties

Blue, capsule-shaped, biconvex film-coated tablets with engraving "400" on one side and smooth on the other.

Pharmacotherapeutic group

Antiviral agents for systemic use. Direct-acting antiviral agents. Antiviral agents for the treatment of hepatitis C virus (HCV).

ATC code

J05A P08.

Pharmacological properties

Pharmacodynamics
Mechanism of action

Sofosbuvir is a pan-genotypic inhibitor of the HCV NS5B RNA polymerase, which is essential for the replication of the virus. Sofosbuvir is a nucleotide prodrug that, after intracellular metabolism, forms the pharmacologically active uridine analog triphosphate (GS-461203), which can be incorporated into the HCV RNA by the NS5B polymerase and acts as a chain terminator.

Antiviral activity

In HCV replicon analyses, the effective concentrations (EC50) of sofosbuvir against full-length replicons of genotypes 1a, 1b, 2a, 3a, and 4a were 0.04, 0.11, 0.05, 0.05, and 0.04 μM, respectively, and the EC50 values of sofosbuvir against chimeric replicons of 1b, which encode NS5B from genotypes 2b, 5a, or 6a, were between 0.014 and 0.015 μM.

Resistance

Cell culture. HCV replicons with reduced susceptibility to sofosbuvir were selected in cell culture for multiple genotypes, including 1b, 2a, 2b, 3a, 4a, 5a, and 6a.

Pharmacokinetics

Sofosbuvir is a nucleotide prodrug that undergoes extensive metabolism. The active metabolite is formed in hepatocytes and is not detected in plasma.

Absorption

The pharmacokinetic properties of sofosbuvir and its main circulating metabolite GS-331007 were evaluated in healthy adult subjects and patients with chronic hepatitis C.

Distribution

Sofosbuvir is not a substrate for the uptake transporters OATP1B1 or OATP1B3, or the efflux transporters P-glycoprotein or BCRP.

Metabolism

Sofosbuvir is extensively metabolized in the liver to form the pharmacologically active nucleoside analog triphosphate GS-461203.

Elimination

Following a single oral dose of 400 mg [14C]-sofosbuvir, the mean total recovery of the dose was greater than 92%, consisting of approximately 80%, 14%, and 2.5% recovered in urine, feces, and expired air, respectively.

Clinical characteristics

Indications

KYURLED is used in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adult patients.

Contraindications

Hypersensitivity to the active substances or to any of the excipients of the medicinal product.

Special warnings and precautions for use

Special precautions. KYURLED should not be used as monotherapy and should be used in combination with other medicinal products for the treatment of hepatitis C virus infection.

Severe bradycardia and heart block

When KYURLED is used in combination with other direct-acting antiviral agents (DAAs) (including daclatasvir, simeprevir, and ledipasvir) and concomitantly with amiodarone, cases of severe bradycardia and heart block have been reported.

Patient with HCV genotype 1, 4, 5, or 6 infection who have previously failed treatment

The efficacy of KYURLED in patients with HCV genotype 1, 4, 5, or 6 infection who have previously failed treatment has not been studied.

Patient with HCV genotype 5 or 6 infection who have previously failed treatment

Data on the use of KYURLED in patients with HCV genotype 5 or 6 infection who have previously failed treatment are very limited.

Concomitant use with other direct-acting antiviral agents against HCV

KYURLED can be used in combination with other direct-acting antiviral agents, only if the available data indicate that their efficacy outweighs the risks.

Pregnancy and concomitant use with ribavirin

When KYURLED is used in combination with ribavirin or peginterferon alfa-2/ribavirin, women of childbearing potential or their male partners should use effective contraception during treatment and for a period after treatment.

Use with moderate P-glycoprotein inducers

Medicinal products that are moderate inducers of P-glycoprotein in the intestine (such as oxcarbazepine and modafinil) may decrease the plasma concentration of sofosbuvir, leading to reduced therapeutic effect of KYURLED.

Renal impairment

The safety of KYURLED has not been assessed in patients with severe renal impairment (eGFR <30 mL/min/1.73 m2) or in patients with chronic kidney disease requiring hemodialysis.

HCV/HBV co-infection (hepatitis B virus)

During or after treatment with direct-acting antiviral agents, cases of hepatitis B virus (HBV) reactivation have been reported, some of which were fatal.

Pediatric population

KYURLED is not recommended for use in children (under 18 years of age), as the safety and efficacy have not been established in this population.

Interaction with other medicinal products and other forms of interaction

Sofosbuvir is a nucleotide prodrug that undergoes extensive metabolism. After administration of KYURLED, sofosbuvir is rapidly absorbed and undergoes intensive first-pass metabolism in the liver and stomach.

Interaction table
Medicinal product by therapeutic groupEffect on the medicinal product. Mean ratio (90% confidence interval) for AUC, Cmax, Cmin.a,bRecommendations for use with KYURLED
ANALEPTICSInteraction not studied. Expected: ↓ Sofosbuvir ↔ GS-331007It is expected that concomitant use of KYURLED with modafinil will decrease the concentration of sofosbuvir, leading to reduced therapeutic effect of KYURLED. Such concomitant use is not recommended.
ANTIARRHYTHMIC AGENTSInteraction not studied.Use only when there are no alternative treatments. When used with KYURLED and another DAA (see "Special warnings and precautions for use" and "Adverse reactions"), close monitoring is recommended.
ANTICOAGULANTSInteraction not studied.When using all vitamin K antagonists, it is recommended to closely monitor INR. This is due to changes in liver function during treatment with KYURLED.

Special instructions

Women of childbearing potential/contraception for men and women

When KYURLED is used in combination with ribavirin or peginterferon alfa-2/ribavirin, special attention should be paid to preventing pregnancy in female patients and their male partners.

Use during pregnancy or breastfeeding

There are no or limited data (less than 300 pregnancy outcomes) on the use of sofosbuvir in pregnant women.

Ability to influence the speed of reaction when driving vehicles or operating other mechanisms

KYURLED has a moderate influence on the ability to drive vehicles and work with complex mechanisms.

Method of administration and dosage

Adults

Recommended dose - 400 mg in the form of a tablet, which should be taken orally once a day during meals.

Table of recommendations for concomitant use of medicinal products and duration of comprehensive therapy with KYURLED
Patient population*TherapyDuration of treatment
Patients with genotype 1, 4, 5, or 6 CHCKYURLED + ribavirin + peginterferon alfa-212 weeksa,b
KYURLED + ribavirin24 weeks
Dose adjustment

Dose reduction of KYURLED is not recommended.

Elderly patients

Dose adjustment for elderly patients is not required.

Renal impairment

No dose adjustment of KYURLED is required for patients with mild or moderate renal impairment.

Hepatic impairment

No dose adjustment of KYURLED is required for patients with mild, moderate, or severe hepatic impairment.

Overdose

The maximum reported dose of sofosbuvir is a single dose of 1200 mg, which was administered to 59 healthy subjects.

Adverse reactions

Brief overview of the safety profile. During treatment with sofosbuvir in combination with ribavirin or with peginterferon alfa-2 and ribavirin, the most common adverse reactions were those expected based on the safety profiles of sofosbuvir and peginterferon alfa-2.

Table of adverse reactions
FrequencySOFa+ RBVbSOF + PEGc+ RBV
oftenrhinopharyngitis

Shelf life

3 years.

Storage conditions

Store in the original packaging at a temperature not exceeding 30 °C.

Packaging

White high-density polyethylene bottle with an aluminum foil and a polypropylene child-resistant cap.

Release category

Prescription only.

Manufacturer

Strides Pharma Science Limited.

Manufacturer's location and address

No. 36/7, Suragajakkanahalli, Indlawadi Cross, Anekal Taluk, Bangalore, Karnataka 562106, India.

Applicant

Strides Pharma Science Limited.

Applicant's location

201, Devawrata Sector 17, Vashi, Navi Mumbai – 400 703, India.

Alternatives to NALBUFIN IN'EKCII 10 MG in other countries

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Alternative to NALBUFIN IN'EKCII 10 MG in Polska

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Active substance: nalbuphine
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Discuss dosage, side effects, interactions, contraindications, and prescription renewal for NALBUFIN IN'EKCII 10 MG – subject to medical assessment and local rules.

5.0(2)
Doctor

Tomasz Grzelewski

Dermatology21 years of experience

Dr Tomasz Grzelewski is an MD, PhD specialist in allergy, paediatrics, general practice and sports medicine, with a clinical focus on dermatology, endocrinology, allergology and sports-related health. He has more than 20 years of clinical experience and completed his medical training at the Medical University of Łódź, where he defended his PhD thesis with distinction. His doctoral research was recognised by the Polish Society of Allergology for its innovative contribution to the field. Throughout his career, he has gained extensive expertise in diagnosing and managing a wide range of allergic and paediatric conditions, including modern allergen desensitisation techniques.

For five years, Dr Grzelewski served as the Head of two paediatric departments in Poland, managing complex clinical cases and leading multidisciplinary teams. He also worked in medical centres in the United Kingdom, gaining experience across both primary care and specialist environments. With over a decade of telemedicine experience, he has provided online consultations across Europe and is valued for his clear, structured and evidence-based medical guidance.

Dr Grzelewski is actively involved in clinical programmes focused on modern anti-allergic therapies. As a Principal Investigator, he leads research projects on sublingual and oral allergen desensitisation, supporting evidence-based progress in allergy treatment for both children and adults.

In addition to his background in allergology and paediatrics, he completed dermatology studies through the Cambridge Education Group (Royal College of Physicians of Ireland) and a Clinical Endocrinology course at Harvard Medical School. This advanced training enhances his ability to manage skin manifestations of allergies, atopic conditions, urticaria, endocrine-related symptoms and complex immunological reactions.

Patients commonly seek his care for:

  • seasonal and perennial allergies
  • allergic rhinitis and chronic nasal symptoms
  • asthma and breathing difficulties
  • food and medication allergies
  • urticaria, atopic dermatitis and skin reactions
  • recurrent infections in children
  • sports-related health questions
  • general family medicine concerns
Dr Tomasz Grzelewski is known for his clear communication style, structured medical approach and ability to explain treatment options in a concise and accessible way. His multidisciplinary background across allergy, paediatrics, dermatology and endocrinology allows him to provide safe, up-to-date and comprehensive care for patients of all ages.
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Dr Yakovenko explains complex topics in a clear, accessible way. He works collaboratively with patients to analyse health issues and make evidence-based decisions. His approach is grounded in clinical excellence, scientific accuracy, and respect for each individual.

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