bhpardo/ema_en · Datasets at Hugging Face

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Preparation and administration precautions:
Diabetic Peripheral Neuropathic Pain Table 2 gives the adverse reactions observed from spontaneous reporting and in placebo-controlled clinical trials (comprising a total of 5253 patients, 3289 on duloxetine and 1964 on placebo).
Experience in lamivudine-refractory patients:
To be taken into consideration by patients on a controlled sodium diet.
What Agenerase looks like and the contents of the pack
Occlusion of the dialysis system is possible if heparinisation is not optimum.
Remove the caps from the BeneFIX concentrate and solvent vials, to expose the central portion of the rubber stoppers.
Agenerase must not be used in patients who are taking St John’ s wort (a herbal preparation used to treat depression) or medicines that are broken down in the same way as Agenerase and are harmful at high levels in the blood.
Cancer patients
NAME OF THE MEDICINAL PRODUCT
Placental transfer was minimal.
Impaired renal function including cases of renal failure in patients at risk (see section 4.4)
Lactation
OTHER
Maintenance
No alteration of fertility was detected.
Read the package leaflet before use.
The vaccine should be well shaken before use.
The expiry date refers to the last day of that month.
Atripla.
MedDRA system organ class Skin and Subcutaneous Tissue Disorders
In this way your affected limb will be exposed to BEROMUN for a total of 90 minutes.
Intermittent allergic rhinitis is defined as the presence of symptoms for less than 4 days per week or for less than 4 weeks.
INSTRUCTIONS ON USE
Darbepoetin alfa is produced by gene-technology in Chinese Hamster Ovary Cells (CHO-K1).
1.4 IU/ kg
- swollen and usually itching patches of skin or mucous membranes (urticaria),
Use in renal impairment:
R06A X27
P-values < 0.05 comparing pemetrexed/ cisplatin to gemcitabine/ cisplatin, using Fisher Exact test. Refer to National Cancer Institute CTC (v2.0; NCI 1998) for each Grade of Toxicity. **According to National Cancer Institute CTC (v2.0; NCI 1998), taste disturbance and alopecia should only be reported as Grade 1 or 2.
Dosing should be delayed in the presence of elevated ciclosporin blood levels.
Nephrotoxicity:
Pregnancy
(NaH2PO4.2 H2O) and water for injections.
Pre-filled pen (multidose disposable pen) comprising a pen injector with a cartridge (3 ml).
Attach the needle
In the primary efficacy studies, 75% of intercourse attempts were successful in CIALIS treated patients as compared to 32% with placebo.
Pull the cap off.
BATCH NUMBER
Screening Viral Load > 100,000 copies/ mL
The peak is always well below the peak achieved using the intravenous route (approximately 1/ 20th of the value).
In a prospective, randomised double-blind, placebo-controlled study conducted in 344 anaemic patients with lymphoproliferative malignancies receiving chemotherapy there was a significant reduction in transfusion requirements and an improvement in haemoglobin response (p < 0.001).
A lower bound greater than – 15% demonstrates non-inferiority between Aloxi and comparator. c Chi-square test.
Painful neuropathy (nerve related pain).
solvent:
Production of endogenous erythropoietin is impaired in patients with chronic renal failure and the primary cause of their anaemia is due to erythropoietin deficiency.
Uncommon:
Magyarország Malta.
In the treatment of patients with non-small cell lung cancer, Alimta was as effective as the comparators.
Your doctor may order regular blood tests to see that this is being achieved and to ensure that your medicine is continuing to work properly and your haemoglobin does not exceed a certain level.
INFORMATION IN BRAILLE
HOW TO USE ACTRAPID
BATCH NUMBER
Preclinical data from conventional studies of repeated dose toxicity revealed the expected pharmacological effects including increases in leukocyte count, myeloid hyperplasia in bone marrow, extramedullary haematopoiesis and splenic enlargement.
In the event of overdose, consider standard measures to remove unabsorbed active substance.
Not applicable.
Find a comfortable, well-lit place and put everything you need where you can reach them (the Biograstim pre-filled syringe, alcohol wipes and the puncture-proof container).
24 In a multiple-dose pharmacokinetic study conducted with the tablet formulation in healthy adult subjects, four subjects were found to be poor metabolisers of desloratadine.
DATE OF REVISION OF THE TEXT
Gender:
Ask your pharmacist how to dispose of medicines no longer required.
146 For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Do not use CEPROTIN after the expiry date which is stated on the label after EXP.
6.
– a medicine called colestyramine (used to reduce high cholesterol) or activated charcoal as these medicines can reduce the amount of Arava which is absorbed by the body,
PHARMACEUTICAL PARTICULARS
DO NOT DRAW AIR INTO THE SYRINGE.
Initial dose adjustment to alternate day dosing with 30 MIU (300 μ g)/ day by subcutaneous injection is recommended.
CI = confidence interval * p-value refers to comparison between arms.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
Do not use Actraphane after the expiry date which is stated on the label and the carton.
- if you are taking antacids, because they may increase the effectiveness of Aerinaze.
With prolonged treatment for more than 2 years, regular
These patients should be regularly monitored for clinical, virological and serological parameters associated with hepatitis B, liver and renal function and antiviral response during treatment, and if treatment is discontinued, for at least 6 months thereafter.
Infections and infestations:
Hypersensitivity to the active substance or to any of the excipients or to mouse protein or heparin, except for control of life-threatening thrombotic complications.
If you miss a dose of CELSENTRI, take the missed dose as soon as possible and then take your next scheduled dose at its regular time.
6.1 List of excipients
It is recommended that CellCept should not be administered concomitantly with azathioprine because such concomitant administration has not been studied.
48 9.
Osteoporosis can be treated and it is never too late to begin treatment.
Neuropathic pain or peripheral neuropathy
12.
Hypersensitivity to the active substance or to any of the excipients (see section 4.8).
4.1 Therapeutic indications
Arixtra is available in pack sizes of 2, 7, 10 and 20 pre-filled syringes.
There are no adequate data on the use of insulin glulisine in pregnant women.
How to store Betaferon
Tell your relatives, friends and close colleagues that if you pass out (become unconscious), they must: turn you on your side and seek medical advice straight away.
Each ml of solution contains 10 000 IU of epoetin alfa* corresponding to 84.0 micrograms per ml 1 pre-filled syringe of 0.3 ml contains 3000 international units (IU) corresponding to 25.2 micrograms epoetin alfa
Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use
15.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
DATE OF FIRST AUTHORISATION/ RENEWAL OF THE AUTHORISATION
To ensure that the needle is in the vein, check for blood return by pulling back very slightly on the plunger of the syringe.
5.1 Pharmacodynamic properties
— Accidental contact with the skin or eyes should be treated immediately with copious amounts of water.
Norfloxacin and metronidazole: in healthy volunteers, no significant interaction was observed when CellCept was concomitantly administered with norfloxacin and metronidazole separately.
Do not freeze.
No evidence exists that indicates an interaction between epoetin alfa and G-CSF or GM-CSF with regard to haematological differentiation or proliferation of tumour biopsy specimens in vitro.

Preparation and administration precautions:

Diabetic Peripheral Neuropathic Pain Table 2 gives the adverse reactions observed from spontaneous reporting and in placebo-controlled clinical trials (comprising a total of 5253 patients, 3289 on duloxetine and 1964 on placebo).

Experience in lamivudine-refractory patients:

To be taken into consideration by patients on a controlled sodium diet.

What Agenerase looks like and the contents of the pack

Occlusion of the dialysis system is possible if heparinisation is not optimum.

Remove the caps from the BeneFIX concentrate and solvent vials, to expose the central portion of the rubber stoppers.

Agenerase must not be used in patients who are taking St John’ s wort (a herbal preparation used to treat depression) or medicines that are broken down in the same way as Agenerase and are harmful at high levels in the blood.

Cancer patients

NAME OF THE MEDICINAL PRODUCT

Placental transfer was minimal.

Impaired renal function including cases of renal failure in patients at risk (see section 4.4)

Lactation

OTHER

Maintenance

No alteration of fertility was detected.

Read the package leaflet before use.

The vaccine should be well shaken before use.

The expiry date refers to the last day of that month.

Atripla.

MedDRA system organ class Skin and Subcutaneous Tissue Disorders

In this way your affected limb will be exposed to BEROMUN for a total of 90 minutes.

Intermittent allergic rhinitis is defined as the presence of symptoms for less than 4 days per week or for less than 4 weeks.

INSTRUCTIONS ON USE

Darbepoetin alfa is produced by gene-technology in Chinese Hamster Ovary Cells (CHO-K1).

1.4 IU/ kg

- swollen and usually itching patches of skin or mucous membranes (urticaria),

Use in renal impairment:

R06A X27

*P-values < 0.05 comparing pemetrexed/ cisplatin to gemcitabine/ cisplatin, using Fisher Exact test. **Refer to National Cancer Institute CTC (v2.0; NCI 1998) for each Grade of Toxicity. ***According to National Cancer Institute CTC (v2.0; NCI 1998), taste disturbance and alopecia should only be reported as Grade 1 or 2.

Dosing should be delayed in the presence of elevated ciclosporin blood levels.

Nephrotoxicity:

Pregnancy

(NaH2PO4.2 H2O) and water for injections.

Pre-filled pen (multidose disposable pen) comprising a pen injector with a cartridge (3 ml).

Attach the needle

In the primary efficacy studies, 75% of intercourse attempts were successful in CIALIS treated patients as compared to 32% with placebo.

Pull the cap off.

BATCH NUMBER

Screening Viral Load > 100,000 copies/ mL

The peak is always well below the peak achieved using the intravenous route (approximately 1/ 20th of the value).

In a prospective, randomised double-blind, placebo-controlled study conducted in 344 anaemic patients with lymphoproliferative malignancies receiving chemotherapy there was a significant reduction in transfusion requirements and an improvement in haemoglobin response (p < 0.001).

A lower bound greater than – 15% demonstrates non-inferiority between Aloxi and comparator. c Chi-square test.

Painful neuropathy (nerve related pain).

solvent:

Production of endogenous erythropoietin is impaired in patients with chronic renal failure and the primary cause of their anaemia is due to erythropoietin deficiency.

Uncommon:

Magyarország Malta.

In the treatment of patients with non-small cell lung cancer, Alimta was as effective as the comparators.

Your doctor may order regular blood tests to see that this is being achieved and to ensure that your medicine is continuing to work properly and your haemoglobin does not exceed a certain level.

INFORMATION IN BRAILLE

HOW TO USE ACTRAPID

BATCH NUMBER

Preclinical data from conventional studies of repeated dose toxicity revealed the expected pharmacological effects including increases in leukocyte count, myeloid hyperplasia in bone marrow, extramedullary haematopoiesis and splenic enlargement.

In the event of overdose, consider standard measures to remove unabsorbed active substance.

Not applicable.

Find a comfortable, well-lit place and put everything you need where you can reach them (the Biograstim pre-filled syringe, alcohol wipes and the puncture-proof container).

24 In a multiple-dose pharmacokinetic study conducted with the tablet formulation in healthy adult subjects, four subjects were found to be poor metabolisers of desloratadine.

DATE OF REVISION OF THE TEXT

Gender:

Ask your pharmacist how to dispose of medicines no longer required.

146 For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Do not use CEPROTIN after the expiry date which is stated on the label after EXP.

6.

– a medicine called colestyramine (used to reduce high cholesterol) or activated charcoal as these medicines can reduce the amount of Arava which is absorbed by the body,

PHARMACEUTICAL PARTICULARS

DO NOT DRAW AIR INTO THE SYRINGE.

Initial dose adjustment to alternate day dosing with 30 MIU (300 μ g)/ day by subcutaneous injection is recommended.

CI = confidence interval * p-value refers to comparison between arms.

CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

Do not use Actraphane after the expiry date which is stated on the label and the carton.

- if you are taking antacids, because they may increase the effectiveness of Aerinaze.

With prolonged treatment for more than 2 years, regular

These patients should be regularly monitored for clinical, virological and serological parameters associated with hepatitis B, liver and renal function and antiviral response during treatment, and if treatment is discontinued, for at least 6 months thereafter.

Infections and infestations:

Hypersensitivity to the active substance or to any of the excipients or to mouse protein or heparin, except for control of life-threatening thrombotic complications.

If you miss a dose of CELSENTRI, take the missed dose as soon as possible and then take your next scheduled dose at its regular time.

6.1 List of excipients

It is recommended that CellCept should not be administered concomitantly with azathioprine because such concomitant administration has not been studied.

48 9.

Osteoporosis can be treated and it is never too late to begin treatment.

Neuropathic pain or peripheral neuropathy

12.

Hypersensitivity to the active substance or to any of the excipients (see section 4.8).

4.1 Therapeutic indications

Arixtra is available in pack sizes of 2, 7, 10 and 20 pre-filled syringes.

There are no adequate data on the use of insulin glulisine in pregnant women.

How to store Betaferon

Tell your relatives, friends and close colleagues that if you pass out (become unconscious), they must: turn you on your side and seek medical advice straight away.

Each ml of solution contains 10 000 IU of epoetin alfa* corresponding to 84.0 micrograms per ml 1 pre-filled syringe of 0.3 ml contains 3000 international units (IU) corresponding to 25.2 micrograms epoetin alfa

Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use

15.

Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

DATE OF FIRST AUTHORISATION/ RENEWAL OF THE AUTHORISATION

To ensure that the needle is in the vein, check for blood return by pulling back very slightly on the plunger of the syringe.

5.1 Pharmacodynamic properties

— Accidental contact with the skin or eyes should be treated immediately with copious amounts of water.

Norfloxacin and metronidazole: in healthy volunteers, no significant interaction was observed when CellCept was concomitantly administered with norfloxacin and metronidazole separately.

Do not freeze.

No evidence exists that indicates an interaction between epoetin alfa and G-CSF or GM-CSF with regard to haematological differentiation or proliferation of tumour biopsy specimens in vitro.