medication_name stringlengths 6 170 | section_title stringclasses 42
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Kymriah cells dispersion for infusion | Clinical particulars - Fertility, pregnancy and lactation | Interaction with other medicinal products and other forms of interaction
No pharmacokinetic or pharmacodynamic drug interaction studies with tisagenlecleucel have been performed. The co-administration of agents known to inhibit T-cell function has not been formally studied. Administration of low-dose steroids as per th... |
Kymriah cells dispersion for infusion | Clinical particulars - Effects on ability to drive and use machines | Fertility, pregnancy and lactation
Women of childbearing potential/Contraception in males and females
Pregnancy status for females of child-bearing age should be verified prior to starting treatment with Kymriah.
See the prescribing information for lymphodepleting chemotherapy for information on the need for effectiv... |
Kymriah cells dispersion for infusion | Clinical particulars - Undesirable effects | Effects on ability to drive and use machines
Kymriah has major influence on the ability to drive and use machines.
Due to the potential for neurological events, including altered mental status or seizures, patients receiving Kymriah are at risk for altered or decreased consciousness or coordination in the 8 weeks follo... |
Kymriah cells dispersion for infusion | Clinical particulars - Overdose | Undesirable effects
Summary of the safety profile
Safety assessment was based on a total of 424 patients (with paediatric and young adult B-cell ALL, DLBCL and FL) who received Kymriah in three multicentre pivotal clinical studies.
B-cell ALL
The adverse reactions described in this section were characterised in 2... |
Kymriah cells dispersion for infusion | Clinical particulars - Subsection 10 | Overdose
Not applicable.
5. Pharmacological properties
5.1 |
Kymriah cells dispersion for infusion | Pharmacodynamic properties - Pharmacodynamic properties | Pharmacokinetic properties
Following infusion of Kymriah into paediatric and young adult r/r B-cell ALL, r/r DLBCL and r/r FL patients, tisagenlecleucel typically exhibited an initial rapid expansion followed by a slower bi-exponential decline. High inter-subject variability was associated with the in vivo exposure met... |
Kymriah cells dispersion for infusion | Pharmacodynamic properties - Pharmacokinetic properties | Preclinical safety data
Non-clinical safety assessment of Kymriah addressed the safety concerns of potential uncontrolled cell growth of transduced T cells in vitro and in vivo as well as dose-related toxicity, biodistribution and persistence. No such risks were identified based on these studies.
Carcinogenicity and m... |
Kymriah cells dispersion for infusion | Pharmaceutical particulars - List of excipients | List of excipients
Glucose
Sodium chloride
Human albumin solution
Dextran 40 for injection
Dimethylsulfoxide
Sodium gluconate
Sodium acetate
Potassium chloride
Magnesium chloride
Sodium-N-acetyltryptophanate
Sodium caprylate
Aluminium
Water for injections
6.2 |
Kymriah cells dispersion for infusion | Pharmaceutical particulars - Incompatibilities | Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
6.3 |
Kymriah cells dispersion for infusion | Pharmaceutical particulars - Shelf life | Shelf life
9 months.
The product should be administered immediately after thawing. After thawing, the product should be kept at room temperature (20°C-25°C) and infused within 30 minutes to maintain maximum product viability, including any interruption during the infusion.
6.4 |
Kymriah cells dispersion for infusion | Pharmaceutical particulars - Special precautions for storage | Special precautions for storage
Store and transport below -120°C, e.g. in a container for cryogenic storage in the vapour phase of liquid nitrogen.
For storage conditions after thawing of the medicinal product, see section 6.3.
6.5 |
Kymriah cells dispersion for infusion | Pharmaceutical particulars - Nature and contents of container | Nature and contents of container
Ethylene vinyl acetate (EVA) infusion bag with polyvinyl chloride (PVC) tubing and a luer spike interconnector closed by a luer-lock cap containing either 10–30 mL (50 mL bags) or 30–50 mL (250 mL bags) cell dispersion.
Each infusion bag is placed into a secondary packaging layer.
One i... |
Kymriah cells dispersion for infusion | Pharmaceutical particulars - Special precautions for disposal and other handling | Special precautions for disposal and other handling
Inspection and thawing of the infusion bag(s)
Do not thaw the product until it is ready to be used.
The infusion bag should be placed inside a second sterile bag during thawing to protect ports from contamination and avoid spills in the unlikely event of the bag lea... |
Kymriah cells dispersion for infusion | Marketing authorisation holder | Novartis Pharmaceuticals UK Limited
2nd Floor, The WestWorks Building
White City Place
195 Wood Lane
London W12 7FQ
8. Marketing authorisation number(s)
PLGB 00101/1101
9. |
Kymriah cells dispersion for infusion | Date of first authorisation/renewal of the authorisation | 01 January 2021
10. |
Kymriah cells dispersion for infusion | Date of revision of the text | 11 July 2023
LEGAL CATEGORY
POM |
Kyntheum 210 mg Solution for Injection | Name of the medicinal product | Kyntheum 210 mg solution for injection in pre-filled syringe
2. |
Kyntheum 210 mg Solution for Injection | Qualitative and quantitative composition | Each pre-filled syringe contains 210 mg brodalumab in 1.5 ml solution.
1 ml solution contains 140 mg brodalumab.
Brodalumab is a human monoclonal antibody produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology.
For the full list of excipients, see section 6.1.
3. |
Kyntheum 210 mg Solution for Injection | Pharmaceutical form | Solution for injection (injection)
The solution is clear to slightly opalescent, colourless to slightly yellow and free from particles.
4. |
Kyntheum 210 mg Solution for Injection | Clinical particulars - Therapeutic indications | Therapeutic indications
Kyntheum is indicated for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy.
4.2 |
Kyntheum 210 mg Solution for Injection | Clinical particulars - Posology and method of administration | Posology and method of administration
Kyntheum is intended for use under the guidance and supervision of a physician experienced in the diagnosis and treatment of psoriasis.
Posology
The recommended dose is 210 mg administered by subcutaneous injection at weeks 0, 1, and 2 followed by 210 mg every 2 weeks.
Considerat... |
Kyntheum 210 mg Solution for Injection | Clinical particulars - Contraindications | Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Active Crohn's disease.
Clinically important active infections (e.g. active tuberculosis, see section 4.4).
4.4 |
Kyntheum 210 mg Solution for Injection | Clinical particulars - Special warnings and precautions for use | Special warnings and precautions for use
Traceability
In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Inflammatory bowel disease (including Crohn's disease and ulcerative colitis)
Cases of new or exacerbati... |
Kyntheum 210 mg Solution for Injection | Clinical particulars - Interaction with other medicinal products and other forms of interaction | Interaction with other medicinal products and other forms of interaction
Live vaccines should not be given concurrently with brodalumab (see section 4.4).
The formation of CYP450 enzymes can be altered by increased levels of certain cytokines (e.g. IL-1, IL-6, IL-10, TNFα, IFN) during chronic inflammation. Although a r... |
Kyntheum 210 mg Solution for Injection | Clinical particulars - Fertility, pregnancy and lactation | Fertility, pregnancy and lactation
Women of childbearing potential
Women of childbearing potential should use an effective method of contraception during treatment and for at least 12 weeks after treatment.
Pregnancy
There are no or limited amount of data from the use of brodalumab in pregnant women.
Animal studie... |
Kyntheum 210 mg Solution for Injection | Clinical particulars - Effects on ability to drive and use machines | Effects on ability to drive and use machines
Kyntheum has no or negligible influence on the ability to drive and use machines.
4.8 |
Kyntheum 210 mg Solution for Injection | Clinical particulars - Undesirable effects | Undesirable effects
Summary of the safety profile
The most commonly reported adverse reactions are arthralgia (4.6%), headache (4.3%), fatigue (2.6%), diarrhoea (2.2%), and oropharyngeal pain (2.1%).
Tabulated list of adverse reactions
Adverse reactions from clinical trials and post-marketing experience (Table 1) ... |
Kyntheum 210 mg Solution for Injection | Clinical particulars - Overdose | Overdose
Doses up to 700 mg intravenously have been administered in clinical trials with no evidence of dose limiting toxicity. In the event of overdose, it is recommended that the patient be monitored for any signs or symptoms of adverse reactions and appropriate symptomatic treatment be instituted immediately.
5. Pha... |
Kyntheum 210 mg Solution for Injection | Pharmacodynamic properties - Pharmacodynamic properties | Pharmacokinetic properties
Absorption
Based on population pharmacokinetic modelling, the estimated accumulation ratio after 20 weeks of dosing is 2.5-fold. In moderate to severe plaque psoriasis patients following a single subcutaneous administration of brodalumab at 210 mg, the mean maximum serum concentration (Cmax... |
Kyntheum 210 mg Solution for Injection | Pharmacodynamic properties - Pharmacokinetic properties | Preclinical safety data
Non-clinical data reveal no special hazard for humans based on conventional studies of repeated dose toxicity (including safety pharmacology endpoints and assessment of fertility-related endpoints), and toxicity to reproduction and development.
Carcinogenicity studies with brodalumab have not be... |
Kyntheum 210 mg Solution for Injection | Pharmaceutical particulars - List of excipients | List of excipients
Proline
Glutamate
Polysorbate 20
Water for injections
6.2 |
Kyntheum 210 mg Solution for Injection | Pharmaceutical particulars - Incompatibilities | Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
6.3 |
Kyntheum 210 mg Solution for Injection | Pharmaceutical particulars - Shelf life | Shelf life
4 years
6.4 |
Kyntheum 210 mg Solution for Injection | Pharmaceutical particulars - Special precautions for storage | Special precautions for storage
Store in a refrigerator (2°C-8°C).
Do not freeze.
Keep the pre-filled syringe in the outer carton in order to protect from light.
Kyntheum may be stored at room temperature (up to 25°C) once, in the outer carton, for a maximum single period of 14 days. Once Kyntheum has been removed fro... |
Kyntheum 210 mg Solution for Injection | Pharmaceutical particulars - Nature and contents of container | Nature and contents of container
1.5 ml solution in a type I glass pre-filled syringe with stainless steel 27G x ½” needle, covered with an elastomeric needle cap.
Kyntheum is available in unit packs containing 2 pre-filled syringes and in multipacks containing 6 (3 packs of 2) pre-filled syringes.
Not all pack sizes m... |
Kyntheum 210 mg Solution for Injection | Pharmaceutical particulars - Special precautions for disposal and other handling | Special precautions for disposal and other handling
To avoid discomfort at the site of injection, at least 30 minutes should be allowed for the pre-filled syringe to reach room temperature before injecting. The pre-filled syringe should not be warmed in any other way. The pre-filled syringe should not be shaken. The ne... |
Kyntheum 210 mg Solution for Injection | Marketing authorisation holder | LEO Pharma A/S
Industriparken 55
DK-2750 Ballerup
Denmark
8. Marketing authorisation number(s)
PLGB 05293/0171
9. |
Kyntheum 210 mg Solution for Injection | Date of first authorisation/renewal of the authorisation | 19/07/2022
10. |
Kyntheum 210 mg Solution for Injection | Date of revision of the text | 19/07/2022 |
Kyprolis powder for solution for infusion | Name of the medicinal product | Kyprolis 10 mg powder for solution for infusion
Kyprolis 30 mg powder for solution for infusion
Kyprolis 60 mg powder for solution for infusion
2. |
Kyprolis powder for solution for infusion | Qualitative and quantitative composition | Kyprolis 10 mg powder for solution for infusion
Each vial contains 10 mg of carfilzomib.
Excipient with known effect
Each vial contains 37 mg sodium.
Each vial contains 500 mg of cyclodextrin (betadex sulfobutyl ether sodium).
Kyprolis 30 mg powder for solution for infusion
Each vial contains 30 mg of carfilzomib.... |
Kyprolis powder for solution for infusion | Pharmaceutical form | Powder for solution for infusion.
White to off-white lyophilised powder.
4. |
Kyprolis powder for solution for infusion | Clinical particulars - Therapeutic indications | Therapeutic indications
Kyprolis in combination with daratumumab and dexamethasone, with lenalidomide and dexamethasone, or with dexamethasone alone is indicated for the treatment of adult patients with multiple myeloma who have received at least one prior therapy (see section 5.1).
4.2 |
Kyprolis powder for solution for infusion | Clinical particulars - Posology and method of administration | Posology and method of administration
Kyprolis treatment should be supervised by a physician experienced in the use of anti-cancer therapy.
Posology
The dose is calculated using the patient's baseline body surface area (BSA). Patients with a BSA greater than 2.2 m2 should receive a dose based upon a BSA of 2.2 m2. Do... |
Kyprolis powder for solution for infusion | Clinical particulars - Contraindications | Contraindications
• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
• Women who are breast-feeding (see section 4.6).
As Kyprolis is administered in combination with other medicinal products, refer to their summaries of product characteristics for additional contrai... |
Kyprolis powder for solution for infusion | Clinical particulars - Special warnings and precautions for use | Special warnings and precautions for use
As Kyprolis is administered in combination with other medicinal products, the summary of product characteristics of these other medicinal products must be consulted prior to initiation of treatment with Kyprolis. As lenalidomide may be used in combination with Kyprolis, particul... |
Kyprolis powder for solution for infusion | Clinical particulars - Interaction with other medicinal products and other forms of interaction | Interaction with other medicinal products and other forms of interaction
Carfilzomib is primarily metabolised via peptidase and epoxide hydrolase activities, and as a result, the pharmacokinetic profile of carfilzomib is unlikely to be affected by concomitant administration of cytochrome P450 inhibitors and inducers.
... |
Kyprolis powder for solution for infusion | Clinical particulars - Fertility, pregnancy and lactation | Fertility, pregnancy and lactation
Women of childbearing potential/Contraception in males and females
Female patients of child bearing potential treated with Kyprolis (and/or their partners) must use effective contraception measures during and for one month following treatment.
It cannot be excluded that the efficacy... |
Kyprolis powder for solution for infusion | Clinical particulars - Effects on ability to drive and use machines | Effects on ability to drive and use machines
Kyprolis has minor influence on the ability to drive and use machines.
Fatigue, dizziness, fainting, blurred vision, somnolence and/or a drop in blood pressure have been observed in clinical studies. Patients being treated with Kyprolis should be advised not to drive or oper... |
Kyprolis powder for solution for infusion | Clinical particulars - Undesirable effects | Undesirable effects
Summary of safety profile
Serious adverse reactions that may occur during Kyprolis treatment include: cardiac failure, myocardial infarction, cardiac arrest, myocardial ischaemia, interstitial lung disease, pneumonitis, acute respiratory distress syndrome, acute respiratory failure, pulmonary hype... |
Kyprolis powder for solution for infusion | Clinical particulars - Overdose | Overdose
There is currently insufficient information to draw conclusions about the safety of doses higher than those evaluated in clinical studies. Acute onset of chills, hypotension, renal insufficiency, thrombocytopenia and lymphopenia has been reported following a dose of 200 mg of Kyprolis administered in error.
Th... |
Kyprolis powder for solution for infusion | Pharmacodynamic properties - Pharmacodynamic properties | Pharmacokinetic properties
Absorption
The Cmax and AUC following a 2 to 10 minute intravenous infusion of 27 mg/m2 was 4,232 ng/mL and 379 ng•hr/mL, respectively. Following repeated doses of Kyprolis at 15 and 20 mg/m2, systemic exposure (AUC) and half-life were similar on days 1 and 15 or 16 of cycle 1, suggesting t... |
Kyprolis powder for solution for infusion | Pharmacodynamic properties - Pharmacokinetic properties | Preclinical safety data
Carfilzomib was clastogenic in the in vitro chromosomal aberration test in peripheral blood lymphocytes. Carfilzomib was not mutagenic in the in vitro bacterial reverse mutation (Ames) test and was not clastogenic in the in vivo mouse bone marrow micronucleus assay.
Monkeys administered a single... |
Kyprolis powder for solution for infusion | Pharmaceutical particulars - List of excipients | List of excipients
Betadex sulfobutyl ether sodium
Anhydrous citric acid (E330)
Sodium hydroxide (for pH adjustment)
6.2 |
Kyprolis powder for solution for infusion | Pharmaceutical particulars - Incompatibilities | Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Kyprolis powder for solution for infusion must not be mixed with sodium chloride 9 mg/mL (0.9%) solution for injection.
6.3 |
Kyprolis powder for solution for infusion | Pharmaceutical particulars - Shelf life | Shelf life
Powder vial (unopened)
3 years.
Reconstituted solution
Chemical and physical in-use stability of reconstituted solutions in the vial, syringe or intravenous bag has been demonstrated for 24 hours at 2°C - 8°C or for 4 hours at 25°C. The elapsed time from reconstitution to administration should not exceed... |
Kyprolis powder for solution for infusion | Pharmaceutical particulars - Special precautions for storage | Special precautions for storage
Store in a refrigerator (2°C – 8°C).
Do not freeze.
Store in the original carton in order to protect from light.
For storage conditions after reconstitution of the medicinal product, see section 6.3.
6.5 |
Kyprolis powder for solution for infusion | Pharmaceutical particulars - Nature and contents of container | Nature and contents of container
Kyprolis 10 mg powder for solution for infusion
10 mL type I clear glass vial, closed with fluoropolymer laminated elastomeric stopper and aluminium seal with a light blue plastic flip off cap.
Kyprolis 30 mg powder for solution for infusion
30 mL type I clear glass vial, closed wit... |
Kyprolis powder for solution for infusion | Pharmaceutical particulars - Special precautions for disposal and other handling | Special precautions for disposal and other handling
General precautions
Carfilzomib is a cytotoxic agent. Therefore, caution should be used during handling and preparation of Kyprolis. Use of gloves and other protective equipment is recommended.
Reconstitution and preparation for intravenous administration
Kyprolis... |
Kyprolis powder for solution for infusion | Marketing authorisation holder | Amgen Limited
216 Cambridge Science Park
Milton Road
Cambridge
CB4 0WA
United Kingdom
8. Marketing authorisation number(s)
PLGB 13832/0023
PLGB 13832/0024
PLGB 13832/0025
9. |
Kyprolis powder for solution for infusion | Date of first authorisation/renewal of the authorisation | 01/01/2021
10. |
Kyprolis powder for solution for infusion | Date of revision of the text | 21/04/2022 |
Kytril 1 mg film-coated tablets | Name of the medicinal product | Kytril 1 mg film-coated tablets
2. |
Kytril 1 mg film-coated tablets | Qualitative and quantitative composition | 2.1 General description
2.2 |
Kytril 1 mg film-coated tablets | Qualitative and quantitative composition | Each film-coated tablet contains 1 mg granisetron (as the hydrochloride).
Excipients with known effect:
Each tablet contains 69.38 mg of lactose monohydrate.
Sodium starch glycolate
For the full list of excipients, see section 6.1.
3. |
Kytril 1 mg film-coated tablets | Pharmaceutical form | Film-coated tablet.
The tablets are white to almost white triangular biconvex tablets imprinted with K1 on one side.
4. |
Kytril 1 mg film-coated tablets | Clinical particulars - Therapeutic indications | Therapeutic indications
Kytril film-coated tablets are indicated in adults for the prevention and treatment of acute nausea and vomiting associated with chemotherapy and radiotherapy.
Kytril film-coated tablets are indicated in adults for prevention of delayed nausea and vomiting associated with chemotherapy and radiot... |
Kytril 1 mg film-coated tablets | Clinical particulars - Posology and method of administration | Posology and method of administration
Posology
1 mg twice a day or 2 mg once a day for up to one week following radiotherapy or chemotherapy. The first dose of Kytril should be administered within 1 hour before the start of therapy. Dexamethasone has been used concomitantly at doses up to 20 mg once a day orally.
Pa... |
Kytril 1 mg film-coated tablets | Clinical particulars - Contraindications | Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
4.4 |
Kytril 1 mg film-coated tablets | Clinical particulars - Special warnings and precautions for use | Special warnings and precautions for use
As granisetron may reduce lower bowel motility, patients with signs of sub-acute intestinal obstruction should be monitored following its administration.
As for other 5-HT3 antagonists, ECG changes including QT interval prolongation have been reported with granisetron. In patien... |
Kytril 1 mg film-coated tablets | Clinical particulars - Interaction with other medicinal products and other forms of interaction | Interaction with other medicinal products and other forms of interaction
As for other 5-HT3 antagonists, cases of ECG modifications including QT prolongation have been reported with granisetron. In patients concurrently treated with medicinal products known to prolong QT interval and/or which are arrhythmogenic, this m... |
Kytril 1 mg film-coated tablets | Clinical particulars - Fertility, pregnancy and lactation | Fertility, pregnancy and lactation
Pregnancy
There is limited amount of data from the use of granisetron in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3). As a precautionary measure, it is preferable to avoid the use of granis... |
Kytril 1 mg film-coated tablets | Clinical particulars - Effects on ability to drive and use machines | Effects on ability to drive and use machines
Kytril has no or negligible influence on the ability to drive and use machines.
4.8 |
Kytril 1 mg film-coated tablets | Clinical particulars - Undesirable effects | Undesirable effects
Summary of the safety profile
The most frequently reported adverse reactions for Kytril are headache and constipation, which may be transient. ECG changes including QT prolongation have been reported with Kytril (see sections 4.4 and 4.5).
Tabulated list of adverse reactions
The following table of ... |
Kytril 1 mg film-coated tablets | Clinical particulars - Overdose | Overdose
There is no specific antidote for Kytril. In the case of overdose with the tablets, symptomatic treatment should be given. Doses of up to 38.5 mg of Kytril as a single injection have been reported, with symptoms of mild headache but no other reported sequelae.
5. Pharmacological properties
5.1 |
Kytril 1 mg film-coated tablets | Pharmacodynamic properties - Pharmacodynamic properties | Pharmacokinetic properties
Pharmacokinetics of the oral administration is linear up to 2.5-fold of the recommended dose in adults. It is clear from the extensive dose-finding programme that the antiemetic efficacy is not unequivocally correlated with either administered doses or plasma concentrations of granisetron.
A ... |
Kytril 1 mg film-coated tablets | Pharmacodynamic properties - Pharmacokinetic properties | Preclinical safety data
Preclinical data revealed no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, reproductive toxicity and genotoxicity. Carcinogenicity studies revealed no special hazard for humans when used in the recommended human dose. However, when admini... |
Kytril 1 mg film-coated tablets | Pharmaceutical particulars - List of excipients | List of excipients
Lactose monohydrate
Hypromellose
Sodium starch glycolate
Cellulose, microcrystalline
Magnesium stearate
Film-coat:
Hypromellose
Titanium dioxide (E171)
Macrogol 400
Polysorbate 80
6.2 |
Kytril 1 mg film-coated tablets | Pharmaceutical particulars - Incompatibilities | Incompatibilities
Not applicable.
6.3 |
Kytril 1 mg film-coated tablets | Pharmaceutical particulars - Shelf life | Shelf life
5 years
6.4 |
Kytril 1 mg film-coated tablets | Pharmaceutical particulars - Special precautions for storage | Special precautions for storage
This medicinal product does not require any special storage conditions.
6.5 |
Kytril 1 mg film-coated tablets | Pharmaceutical particulars - Nature and contents of container | Nature and contents of container
Opaque PVC blisters sealed with an aluminium foil containing 2 or 10 tablets (1mg) or 1, 5 or 10 tablets (2mg). Not all pack sizes may be marketed.
6.6 |
Kytril 1 mg film-coated tablets | Pharmaceutical particulars - Special precautions for disposal and other handling | Special precautions for disposal and other handling
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
7. |
Kytril 1 mg film-coated tablets | Marketing authorisation holder | Atnahs Pharma UK Limited
Sovereign House
Miles Gray Road
Basildon
Essex
SS14 3FR
United Kingdom
8. Marketing authorisation number(s)
PL 43252/0016
9. |
Kytril 1 mg film-coated tablets | Date of first authorisation/renewal of the authorisation | Date of first authorisation: 15 September 2001
Date of latest renewal: 05 November 2004
10. |
Kytril 1 mg film-coated tablets | Date of revision of the text | 17-July-2017
Detailed information on this medicinal product is available on the Medicines and Healthcare Products Regulatory Agency (MHRA) website : http://www.mhra.gov.uk |
Kytril 2 mg film-coated tablets | Name of the medicinal product | Kytril 2 mg film-coated tablets
2. |
Kytril 2 mg film-coated tablets | Qualitative and quantitative composition | 2.1 General description
2.2 |
Kytril 2 mg film-coated tablets | Qualitative and quantitative composition | Each film-coated tablet contains 2 mg granisetron (as the hydrochloride).
Excipients with known effect:
Each tablet contains 138.76 mg of lactose monohydrate.
Sodium starch glycolate
For the full list of excipients, see section 6.1.
3. |
Kytril 2 mg film-coated tablets | Pharmaceutical form | Film-coated tablet.
The tablets are white to almost white triangular biconvex tablets imprinted with K2 on one side.
4. |
Kytril 2 mg film-coated tablets | Clinical particulars - Therapeutic indications | Therapeutic indications
Kytril film-coated tablets are indicated in adults for the prevention and treatment of acute nausea and vomiting associated with chemotherapy and radiotherapy.
Kytril film-coated tablets are indicated in adults for prevention of delayed nausea and vomiting associated with chemotherapy and radiot... |
Kytril 2 mg film-coated tablets | Clinical particulars - Posology and method of administration | Posology and method of administration
Posology
1 mg twice a day or 2 mg once a day for up to one week following radiotherapy or chemotherapy. The first dose of Kytril should be administered within 1 hour before the start of therapy. Dexamethasone has been used concomitantly at doses up to 20 mg once a day orally.
Pa... |
Kytril 2 mg film-coated tablets | Clinical particulars - Contraindications | Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
4.4 |
Kytril 2 mg film-coated tablets | Clinical particulars - Special warnings and precautions for use | Special warnings and precautions for use
As granisetron may reduce lower bowel motility, patients with signs of sub-acute intestinal obstruction should be monitored following its administration.
As for other 5-HT3 antagonists, ECG changes including QT interval prolongation have been reported with granisetron. In patien... |
Kytril 2 mg film-coated tablets | Clinical particulars - Interaction with other medicinal products and other forms of interaction | Interaction with other medicinal products and other forms of interaction
As for other 5-HT3 antagonists, cases of ECG modifications including QT prolongation have been reported with granisetron. In patients concurrently treated with medicinal products known to prolong QT interval and/or which are arrhythmogenic, this m... |
Kytril 2 mg film-coated tablets | Clinical particulars - Fertility, pregnancy and lactation | Fertility, pregnancy and lactation
Pregnancy
There is limited amount of data from the use of granisetron in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3). As a precautionary measure, it is preferable to avoid the use of granis... |
Kytril 2 mg film-coated tablets | Clinical particulars - Effects on ability to drive and use machines | Effects on ability to drive and use machines
Kytril has no or negligible influence on the ability to drive and use machines.
4.8 |
Kytril 2 mg film-coated tablets | Clinical particulars - Undesirable effects | Undesirable effects
Summary of the safety profile
The most frequently reported adverse reactions for Kytril are headache and constipation, which may be transient. ECG changes including QT prolongation have been reported with Kytril (see sections 4.4 and 4.5).
Tabulated list of adverse reactions
The following table of ... |
Kytril 2 mg film-coated tablets | Clinical particulars - Overdose | Overdose
There is no specific antidote for Kytril. In the case of overdose with the tablets, symptomatic treatment should be given. Doses of up to 38.5 mg of Kytril as a single injection have been reported, with symptoms of mild headache but no other reported sequelae.
5. Pharmacological properties
5.1 |
Kytril 2 mg film-coated tablets | Pharmacodynamic properties - Pharmacodynamic properties | Pharmacokinetic properties
Pharmacokinetics of the oral administration is linear up to 2.5-fold of the recommended dose in adults. It is clear from the extensive dose-finding programme that the antiemetic efficacy is not unequivocally correlated with either administered doses or plasma concentrations of granisetron.
A ... |
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